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Found 533901 cases in entire database

Case Details (Sorted by Vaccination Date)

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VAERS ID:456024 (history)  Vaccinated:2012-05-22
Age:17.0  Onset:2012-05-22, Days after vaccination: 0
Gender:Male  Submitted:2012-05-22, Days after onset: 0
Location:California  Entered:2012-05-22
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
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB533CA0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0692AA0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B072EA1IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0822AA1IMRA
Administered by: Public     Purchased by: Public
Symptoms: Convulsion, Hyperhidrosis, Hypotonia, Immediate post-injection reaction, Loss of consciousness, Pallor
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow)
Write-up: After administration of vaccine #4, client became limp and lost consciousness. Client immediately began having an upper body seizure, lasting 5-7 seconds, client then became alert for approximately 5 seconds, then had another seizure lasting 5-7 seconds. Client was then alert, but pale and diaphoretic. 911 was called and client was transported to the hospital via ambulance.

VAERS ID:456035 (history)  Vaccinated:2012-05-22
Age:0.7  Onset:2012-05-22, Days after vaccination: 0
Gender:Male  Submitted:2012-05-22, Days after onset: 0
Location:California  Entered:2012-05-23, 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:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC3943BA2IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF629232IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1195AA2PO 
Administered by: Private     Purchased by: Public
Symptoms: Drug administered to patient of inappropriate age
SMQs:
Write-up: Rota given after indicated time frame of 32 weeks. Patient is 34 weeks of age. Patient took rota well with no reaction. Patient observed in office. 15 min. after rota.

VAERS ID:456057 (history)  Vaccinated:2012-05-22
Age:69.0  Onset:2012-05-22, Days after vaccination: 0
Gender:Female  Submitted:2012-05-23, Days after onset: 1
Location:Pennsylvania  Entered:2012-05-23
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
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0811AA1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling, Local reaction, Lymphadenopathy, Pain in extremity, Vaccination complication
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)
Write-up: At 4pm, patient noted raised spot on arm at injection site. At 6pm, site was itchy and reddened, approximately the size of a quarter. Patient took Benadryl. At 2am, patient experienced an ache down arm and in fingers, with swelling under arm. Saw doctor at 9:30am on 5/23/12- diag. local reaction to vaccine, cellulitis. Prescribed Keflex 500 QID.

VAERS ID:456082 (history)  Vaccinated:2012-05-22
Age:54.0  Onset:2012-05-22, Days after vaccination: 0
Gender:Female  Submitted:2012-05-23, Days after onset: 1
Location:Ohio  Entered:2012-05-23
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: Hypertension
Diagnostic Lab Data: Evaluated by covering Employee Health physician. No diagnostic studies ordered.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1740AA2IMRA
Administered by: Public     Purchased by: Other
Symptoms: Chest discomfort, Feeling hot, Flushing, Headache, Neck pain, Palpitations
SMQs:, Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Arthritis (broad)
Write-up: Employee complained of heart palpitation, chest discomfort/tightness, headache, neck pain, felt hot, and face flushed-symptoms started within 30 minutes of administration of 3rd Hepatitis B vaccine.

VAERS ID:456115 (history)  Vaccinated:2012-05-22
Age:33.0  Onset:2012-05-23, Days after vaccination: 1
Gender:Male  Submitted:2012-05-24, Days after onset: 1
Location:North Carolina  Entered:2012-05-24
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: Seasonal allergies
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV3088IMRA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURG11245IMRA
Administered by: Military     Purchased by: Military
Symptoms: Injection site pruritus, Rash erythematous, Vaccination site reaction
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Large red rash to upper arm around vaccine site and itching to site.

VAERS ID:456403 (history)  Vaccinated:2012-05-22
Age:32.0  Onset:2012-05-23, Days after vaccination: 1
Gender:Male  Submitted:2012-05-29, Days after onset: 6
Location:Michigan  Entered:2012-05-29
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 PASTEURU4364AA IMLA
Administered by: Other     Purchased by: Private
Symptoms: Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Patient acquired a fever. Instructions from doctor was to take MOTRIN. Patient also had body aches.

VAERS ID:456516 (history)  Vaccinated:2012-05-22
Age:54.0  Onset:2012-05-23, Days after vaccination: 1
Gender:Female  Submitted:2012-05-30, Days after onset: 7
Location:California  Entered:2012-05-30
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.0742AA0SYRLA
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Pruritus, Rash, Skin warm, Tenderness, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: The day after the injection, I noticed a 3 inch solid red raised welt that was very warm to the touch. After several days, the welt began to break up into individual bumps. This continued and became itchy and a little sensitive. By 7 days, my arm was back to normal.

VAERS ID:456525 (history)  Vaccinated:2012-05-22
Age:69.0  Onset:2012-05-24, Days after vaccination: 2
Gender:Female  Submitted:2012-05-30, Days after onset: 6
Location:Rhode Island  Entered:2012-05-30
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: HTN; Thyroid disease
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0729AA0UNLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site cellulitis, Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Redness, small lump, warm to touch & pain at injection site - treated for cellulitis w/ abx.

VAERS ID:456575 (history)  Vaccinated:2012-05-22
Age:42.0  Onset:2012-05-23, Days after vaccination: 1
Gender:Female  Submitted:2012-05-24, Days after onset: 1
Location:Arizona  Entered:2012-05-31, 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
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1411AA1SCLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Redness, warmth, pain, swelling, and "knot" left upper arm. Pt instructed to apply ice to site, and return to clinic pm.

VAERS ID:456587 (history)  Vaccinated:2012-05-22
Age:  Onset:2012-05-22, Days after vaccination: 0
Gender:Unknown  Submitted:0000-00-00
Location:Tennessee  Entered:2012-05-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Eye infection
Preexisting Conditions: Hypertension; Arthritis (osteo)
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH478AA SYRRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B080DA SYRRA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1716AA SYRRA
Administered by: Other     Purchased by: Unknown
Symptoms: Headache, Pain, Pyrexia, Rash, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Pt received FLUZONE, BOOSTRIX, and ZOSTAVAX injection in right arm May 22, 2012 (Tues). Patient has suffered headaches, fever, swollen bulls eye rash, soreness, etc.

VAERS ID:456588 (history)  Vaccinated:2012-05-22
Age:15.0  Onset:2012-05-23, Days after vaccination: 1
Gender:Male  Submitted:2012-05-24, Days after onset: 1
Location:Pennsylvania  Entered:2012-05-31, 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: Healthy
Preexisting Conditions:
Diagnostic Lab Data: Started KEFLEX QID x 10 d
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4127AA3UNLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURH13402UNLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Warm, red deltoid 2" x 3" no fever.

VAERS ID:456636 (history)  Vaccinated:2012-05-22
Age:39.0  Onset:2012-05-23, Days after vaccination: 1
Gender:Female  Submitted:0000-00-00
Location:Texas  Entered:2012-06-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM10126A0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Oedema peripheral, Swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Talked w/ client on Thursday May 24th around 1:30. She said her (L) arm, crown of her head, and (L) leg swelled the day after receiving MCV4. Note: Pt. also complained of gastric upset following Hep A injection on 5-15-12.

VAERS ID:456655 (history)  Vaccinated:2012-05-22
Age:48.0  Onset:2012-05-31, Days after vaccination: 9
Gender:Female  Submitted:2012-06-01, Days after onset: 1
Location:Pennsylvania  Entered:2012-06-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Allergic to penicillin.
Diagnostic Lab Data: None. Patient did not seek medical evaluation.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC3974AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Back pain, Headache, Rash
SMQs:, Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), Hypersensitivity (narrow)
Write-up: Patient states she has a small raised "bump" on the back of her neck and one behind her right ear. Also complains of headache and low back pain.

VAERS ID:456685 (history)  Vaccinated:2012-05-22
Age:28.0  Onset:2012-05-22, Days after vaccination: 0
Gender:Female  Submitted:2012-06-01, Days after onset: 10
Location:Massachusetts  Entered:2012-06-01
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: History of asthma, migraine headache, rhinitis.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
JEV1: JAPANESE ENCEPHALITIS (IXIARO)INTERCELL AGJEV10M73E IMLA
Administered by: Private     Purchased by: Other
Symptoms: Chest discomfort
SMQs:, Anaphylactic reaction (broad)
Write-up: Received vaccine 330 PM on 5/22 and 6-7 PM while driving home got chest tightness - lasted approximately 1 hour.

VAERS ID:456666 (history)  Vaccinated:2012-05-22
Age:65.0  Onset:2012-05-22, Days after vaccination: 0
Gender:Female  Submitted:2012-06-02, Days after onset: 11
Location:Missouri  Entered:2012-06-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1607AA0SCRA
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site nodule, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Day off or day after patient experienced knot in center of injection site and redness. One week out patient presented to pharmacy with a 4 x 6 red raised itchy rash. Her MD recommended BENADRYL and ice. Patient experienced no SOB or chest pain.

VAERS ID:456701 (history)  Vaccinated:2012-05-22
Age:0.8  Onset:2012-05-22, Days after vaccination: 0
Gender:Female  Submitted:2012-05-24, Days after onset: 2
Location:Michigan  Entered:2012-06-04, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4022AA2IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF753982IMLL
Administered by: Private     Purchased by: Private
Symptoms: Irritability, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad)
Write-up: DTaP & PCV 13 3rd in series given IM. Baby was well. Started to run a fever of 103 degrees at 1600. Fussy, fever all night, continues to be fussy. MOTRIN for comfort.

VAERS ID:456712 (history)  Vaccinated:2012-05-22
Age:66.0  Onset:0000-00-00
Gender:Male  Submitted:2012-06-02
Location:Pennsylvania  Entered:2012-06-04, 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: HBP; Eczema; NKA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0729AA0SCLA
Administered by: Other     Purchased by: Private
Symptoms: Erythema, Feeling hot, Herpes zoster, Induration, Nodule
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Received shot - hard nodule red & hot - lasted about 14 days - has several shingles on body - was treating w/steroid cream thinking it was eczema.

VAERS ID:456724 (history)  Vaccinated:2012-05-22
Age:34.0  Onset:2012-05-23, Days after vaccination: 1
Gender:Male  Submitted:2012-05-29, Days after onset: 6
Location:Delaware  Entered:2012-06-04, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV3085UNRA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURG11245UNRA
Administered by: Military     Purchased by: Military
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Vaccination site swelling, Vaccination site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Reported redness and lumpiness in vaccination site that was spreading swelling, warm to touch, and itching.

VAERS ID:456725 (history)  Vaccinated:2012-05-22
Age:0.2  Onset:2012-05-22, Days after vaccination: 0
Gender:Female  Submitted:2012-05-24, Days after onset: 2
Location:North Carolina  Entered:2012-06-04, Days after submission: 11
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
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B315BA IMRL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.1744AA0IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9172460IMLL
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSA41CB247A0PO 
Administered by: Other     Purchased by: Public
Symptoms: Body temperature increased, Eye disorder, Opisthotonus
SMQs:, Neuroleptic malignant syndrome (broad), Dystonia (narrow), Corneal disorders (broad), Retinal disorders (broad)
Write-up: Seen in ER 05/22/2012 at 22:36 with arched back & eyes appearing large. She had 3 very short spells lasting only seconds. Her temp was 101.6 at the highest. ER provider did not document seizure activity.

VAERS ID:456726 (history)  Vaccinated:2012-05-22
Age:1.0  Onset:2012-05-31, Days after vaccination: 9
Gender:Female  Submitted:2012-06-01, Days after onset: 1
Location:Colorado  Entered:2012-06-04, 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: Otitis media
Preexisting Conditions: GERD; flow murmur (3 mo)
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURUH170AA0UNLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0664AA0UNLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF511823UNRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0971Z0UNRL
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling, Rash generalised
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Patient was administered PCV 13 & varicella on 5/22/2012, 2 days later mother noted a elevated red bump at site of administration of vaccines. On 5/31/2012 diffuse rash entire body. Pt tx 6/1/2012 with BENADRYL & Prednisone. Pt to be seen on 6/5/2012. ER precautions given.

VAERS ID:456737 (history)  Vaccinated:2012-05-22
Age:11.0  Onset:0000-00-00
Gender:Male  Submitted:2012-05-25
Location:Ohio  Entered:2012-06-04, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: NKD/NKDA
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1537AA0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU3461CA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEUR43497CA5IMLA
Administered by: Public     Purchased by: Public
Symptoms: No adverse event, Wrong drug administered
SMQs:
Write-up: The pt. was given Tdap and should have gotten a BOOSTRIX. No adverse reactions.

VAERS ID:456750 (history)  Vaccinated:2012-05-22
Age:0.2  Onset:0000-00-00
Gender:Female  Submitted:2012-06-01
Location:Michigan  Entered:2012-06-04, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Will revaccinate
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURUH523AA UNUN
Administered by: Private     Purchased by: Unknown
Symptoms: Incorrect drug dosage form administered
SMQs:
Write-up: ACTHIB mixed wrong.

VAERS ID:456828 (history)  Vaccinated:2012-05-22
Age:1.1  Onset:2012-05-31, Days after vaccination: 9
Gender:Male  Submitted:2012-06-05, Days after onset: 5
Location:Puerto Rico  Entered:2012-06-05
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: CBC was done
CDC Split Type: MMR
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER 1UNUN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 1UNUN
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 1UNUN
Administered by: Private     Purchased by: Other
Symptoms: Full blood count, Rash generalised, Rash morbilliform
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Measels type rash all over body from head to toe. The child was taken to the hospital and to a private Doctors office. The child was treated with Benadryl and prednisone but the rash has not gone away.

VAERS ID:456833 (history)  Vaccinated:2012-05-22
Age:29.0  Onset:2012-05-22, Days after vaccination: 0
Gender:Female  Submitted:2012-06-05, Days after onset: 14
Location:North Carolina  Entered:2012-06-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site mass
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Lump at injection site.

VAERS ID:456865 (history)  Vaccinated:2012-05-22
Age:10.0  Onset:2012-05-23, Days after vaccination: 1
Gender:Male  Submitted:2012-05-23, Days after onset: 0
Location:New Hampshire  Entered:2012-06-06, 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: No
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1123AA1SCUN
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B074BA0IMUN
Administered by: Public     Purchased by: Public
Symptoms: Body temperature increased, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Child''s aunt reported that he had temp of 101.4 F and vomited x 2. Family provided TYLENOL and clear fluids. Child''s symptoms improved. Symptoms presented on 5/23/12 and resolved by the end of the day.

VAERS ID:456916 (history)  Vaccinated:2012-05-22
Age:5.0  Onset:2012-05-23, Days after vaccination: 1
Gender:Female  Submitted:2012-05-24, Days after onset: 1
Location:Arizona  Entered:2012-06-06, Days after submission: 13
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 BIOLOGICALSAC20B187AA0UNLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1449AA1SCUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1412AA1SCUN
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Mild erythema (L) shoulder secondary to V.

VAERS ID:456917 (history)  Vaccinated:2012-05-22
Age:5.0  Onset:2012-05-23, Days after vaccination: 1
Gender:Female  Submitted:2012-05-24, Days after onset: 1
Location:California  Entered:2012-06-07, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4003AA4UNLL
Administered by: Private     Purchased by: Public
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Seen at Urgent Care on 5/23/12 at 9:06pm for swollen (L) thigh with redness at site of injection & diagnosed with cellulitis no fever. Child seen in office on 5/24/12 with swollen (L) thigh which has decreased as per guardian. Currently taking SEPTRA 200mg/40mg/5mL 7.5 cc PO BID x 10 days as per urgent care.

VAERS ID:456931 (history)  Vaccinated:2012-05-22
Age:0.5  Onset:2012-05-24, Days after vaccination: 2
Gender:Female  Submitted:2012-06-07, Days after onset: 14
Location:Virgin Islands  Entered:2012-06-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Negative
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B329BA1UNRL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.1823AA1UNLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF227212UNLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1464AA2PO 
Administered by: Public     Purchased by: Unknown
Symptoms: Rash maculo-papular, Vaccination site rash
SMQs:, Hypersensitivity (narrow)
Write-up: 2 days after mom notified us by phone - came in that pt had a rash where the sites of the vaccine P. Iz (L) thigh fine maculopapular rash surrounded the area with the shot.

VAERS ID:457382 (history)  Vaccinated:2012-05-22
Age:47.0  Onset:2012-05-23, Days after vaccination: 1
Gender:Female  Submitted:2012-06-13, Days after onset: 21
Location:Pennsylvania  Entered:2012-06-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Blood draw for CBC and chest x-ray.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER    
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Other     Purchased by: Other
Symptoms: Anaemia, Chest X-ray abnormal, Dyspnoea, Full blood count abnormal, Pneumonia, Pyrexia
SMQs:, Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad)
Write-up: Fever of 102. Continued to spike fevers of 102 for a week and had shortness of breath. Personal family doctor ordered blood work which showed anemia and a chest x-ray which showed pneumonia.

VAERS ID:457866 (history)  Vaccinated:2012-05-22
Age:76.0  Onset:2012-05-24, Days after vaccination: 2
Gender:Female  Submitted:2012-06-20, Days after onset: 27
Location:Missouri  Entered:2012-06-21, Days after submission: 1
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: Wellness visit
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4325AB0IMLA
Administered by: Private     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: Received vaccine (L) deltoid 5/22 - onset swelling, redness, warmth 5/24 - failed oral abx - admitted for IV antibiotics 1 wk after vaccine given.

VAERS ID:457915 (history)  Vaccinated:2012-05-22
Age:29.0  Onset:2012-05-24, Days after vaccination: 2
Gender:Male  Submitted:2012-06-22, Days after onset: 29
Location:Virginia  Entered:2012-06-22
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: Shingles March 2012; HHOV
Diagnostic Lab Data: 6/11/12: Troponin I: <0.12; CK 1227 ; CKMB 1.65; CRP <5.0; ESR 21; CBC w/diff & BMP wnl. 6/11/12 EKG: NSR with early repolarization; CXR (PA & LAT). Thin line in the left lung base between 9th and 10th ribs which likely presents artifact, however pneumothorax should be exclude; otherwise normal. Repeat CSR (PA inspiratory/expiratory): Thin vertical line on respiratory views which has pulmonary vascular markings extending peripherally beyond it. The line disappears with expiration. Findings support artifact over pneumothorax. 6/18/12 EKG: NSR with no T wave abnormalities; Echo: EF 55-60%, no wma, normal.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04003A0IDLA
Administered by: Military     Purchased by: Military
Symptoms: Blood creatine phosphokinase MB, C-reactive protein, Chest pain, Chills, Ejection fraction normal, Electrocardiogram abnormal, Electrocardiogram repolarisation abnormality, Fatigue, Hyperhidrosis, Lymphadenopathy, Myalgia, Nausea, Pain in extremity, Pericarditis, Pyrexia, Red blood cell sedimentation rate increased, Troponin I increased
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (narrow), Conduction defects (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Tendinopathies and ligament disorders (broad)
Write-up: The pt received his primary SPV in the left upper arm on 5/22/12. He was in his normal state of good health at the time. About 2 days later he noticed that he was fatigued. On day 3 he noted generalize muscle aches and axillary and cervical lymphadenopathy. On day 7 he felt feverish and chilled-he did not seek medical attention nor did he miss any work days. Additionally, on 5/29/12 (day 7) he noted a 2 minute episode of left sided dull, non-radiating, chest pain (2/10) while at rest. The pt denied N, V, SOB or diaphoresis. He thought that might have "heartburn" as he had eaten fried food for dinner (the pt denies prior hx of "heartburn"). The symptoms resolved without treatment. The pt experienced a second episode of substernal chest pain (4/10) while resting on 6/2/12. The pain lasted about 10 minutes and radiated from the sternum to the anterior chest. It resolved without treatment. He denied any other symptoms (N, V, diaphoresis, SOB). On 6/11/12 around 10 am while at work he noted 10/10 severe substernal chest "pressure" which improved leaning forward and worsened with leaning back. He was diaphoretic and nauseated (he denied V, SOB, or palpitations). The pt stated that the pain radiated to both arms intermittently. The pt reported to the ER. He had a normal PE (no murmur, no chest tenderness). He was given MOTRIN at 1100 with improvement of his chest pain (5/10) after about 90 minutes. The EKG showed NSR with early repolarization. CSR results are below. He was diagnosed with pericarditis and he was started on NAPROSYN 500 mg bid. He was seen in Cardiology Clinic on 6/18/12 where he reported that he continues to experience substernal chest pressure which lasts about 2 minutes and occurs about 2 minutes and occurs about 3 time per day (unrelated to activity). He had an EKG which showed NSR and a normal ECHO. He was diagnosed with atypical chest pain; instructed to continue NAPROSYN bid for 2 more weeks; stress echo will be considered if pain continues or worsens.

VAERS ID:458134 (history)  Vaccinated:2012-05-22
Age:77.0  Onset:2012-06-18, Days after vaccination: 27
Gender:Male  Submitted:2012-06-26, Days after onset: 8
Location:Wisconsin  Entered:2012-06-26
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC. 0UNUN
Administered by: Private     Purchased by: Private
Symptoms: Herpes zoster, Purpura, Rash pustular
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hypersensitivity (narrow)
Write-up: Grouped hemorrhagic pustules in a dermatomal distribution consistent with herpes zoster.

VAERS ID:458334 (history)  Vaccinated:2012-05-22
Age:1.3  Onset:2012-05-22, Days after vaccination: 0
Gender:Female  Submitted:2012-06-20, Days after onset: 29
Location:Texas  Entered:2012-06-28, 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
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALSAHIBC263BA3UNLL
Administered by: Private     Purchased by: Other
Symptoms: Unevaluable event
SMQs:
Write-up: None.

VAERS ID:458336 (history)  Vaccinated:2012-05-22
Age:1.3  Onset:2012-05-22, Days after vaccination: 0
Gender:Male  Submitted:2012-06-20, Days after onset: 29
Location:Texas  Entered:2012-06-28, 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
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALSAHIBC263BA3UNLL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:
Write-up: None.

VAERS ID:458339 (history)  Vaccinated:2012-05-22
Age:3.0  Onset:2012-05-22, Days after vaccination: 0
Gender:Female  Submitted:2012-06-20, Days after onset: 29
Location:Texas  Entered:2012-06-28, 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
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALSAHIBC263BA3UNLL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:
Write-up: None.

VAERS ID:458631 (history)  Vaccinated:2012-05-22
Age:11.0  Onset:2012-05-22, Days after vaccination: 0
Gender:Female  Submitted:2012-07-03, Days after onset: 42
Location:Texas  Entered:2012-07-03
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: TX120034PU
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1495AA IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSX10133 IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3941AA IMLA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Vaccination site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Redness, swelling at site of vaccination.

VAERS ID:458768 (history)  Vaccinated:2012-05-22
Age:0.5  Onset:2012-05-26, Days after vaccination: 4
Gender:Male  Submitted:2012-07-06, Days after onset: 41
Location:New York  Entered:2012-07-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: No
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B326AA0IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH315AA0IMRL
Administered by: Public     Purchased by: Public
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Administered DTaP/IPV/HepB (Pediarix); ActHib on 5/22/2012, developped a temp of 102 on 5/24/2012 and then rose to 104.6 on 5/26/2012 which did not resolve for "several hours" with Tylenol provided every four hours. Mother stated no other signs of acute illness, just a "high temp".

VAERS ID:458989 (history)  Vaccinated:2012-05-22
Age:37.0  Onset:2012-05-29, Days after vaccination: 7
Gender:Male  Submitted:2012-07-11, Days after onset: 43
Location:Virginia  Entered:2012-07-11
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: Egg white; Whole yolk RAST negative 5/25/2012; Gelatin requested and not done
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURG1541 IMLA
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUH139AA SCLA
Administered by: Military     Purchased by: Military
Symptoms: Erythema, Hypersensitivity, Injection site erythema, Injection site rash, Radioallergosorbent test negative, Rash macular, Rash pruritic, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Patient received initial intramuscular typhoid (ViCP SP/G1541) and subcutaneous Yellow Fever (SP/UH139AA) vaccinations to left arm on 5/22/2012 at 0809 hours. Patient advised he left clinic and got haircut, then ate new sub sandwich (*turkey, ham, cheese) with sour cream onion potato chips and a diet coke. Approximately 15 minutes after eating he (about 60 minutes after vaccination) he began to note an itchy (1-2/10) red macular rash to bilateral axilla that spread over the next hour across his upper chest, neck, right eyelid (upper/lower lid) and tops of both hands (to webbing about index fingers) with red blotches (hives) to face (bilateral cheeks and chin). He had a rash to left shoulder around band-aid site. He denied any breathing difficulty, difficulty swallowing, chest pain, or oral swelling. He presented to medical at 0958 hours, now two hours after vaccination, with "facial erythema and urticarial lesions on chin and jaw, erythema to left shoulder". He was diagnosed with urticaria allergic reaction and treated with 0.3 mg epinephrine SQ and 50 mg of IM BENADRYL. Symptoms resolved over next hour and he was released with prescriptions for BENADRYL, EPIPEN and ZANTAC without further recurrence. Patient reported using same barber in past but was unsure about use of new soaps/lotions, detergents or chemicals in barber cleaning supplies. He also denied self use of (or new tubes of) new detergents, deodorants, shampoo, cologne, soaps, razor or shaving gel, or any travel, recent illness or exposure to anyone ill. He did not exercise day of vaccination. On 5/30/2012, he advised he had eaten same sub sandwich, chips and diet coke on 5/22/2012 and had used the same barber again without reactions. No new lotions, soaps, detergents, etc were reported by barber. A RAST test drawn 5/25/2012 for whole egg, yolk and white was negative, however gelatin RAST requested was not performed.

VAERS ID:459638 (history)  Vaccinated:2012-05-22
Age:  Onset:2012-05-22, Days after vaccination: 0
Gender:Unknown  Submitted:2012-07-17, Days after onset: 56
Location:Unknown  Entered:2012-07-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1207USA003594
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Unevaluable event
SMQs:
Write-up: This spontaneous report as received from a medical assistant referred to a patient of unknown age. The patient was vaccinated with dose 2 of GARDASIL late on 22-MAY-2012. The first dose of GARDASIL was given at another provider''s office. No other co-suspects were reported. No concomitant medications were reported. The patient was not experienced any known symptoms. No treatment information was reported. Additional information has been requested.

VAERS ID:466266 (history)  Vaccinated:2012-05-22
Age:59.0  Onset:2012-05-23, Days after vaccination: 1
Gender:Male  Submitted:2012-09-24, Days after onset: 124
Location:Florida  Entered:2012-09-25, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Hay fever; Gout; Psoriasis; Fatty Liver
Diagnostic Lab Data: Heart monitor (abnormal); Blood test; Nerve test (abnormal); Doppler test
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4325AB UNUN
Administered by: Private     Purchased by: Other
Symptoms: Blood test, Cardiac monitoring abnormal, Laboratory test, Nerve stimulation test abnormal, Neuropathy peripheral, Pain in extremity, Palpitations
SMQs:, Peripheral neuropathy (narrow), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad)
Write-up: Burning pain in legs & feet. Heart palpitations heart pulse 180 210 when palpitations happened 3 times diagnosis with peripheral neuropathy LYRICA - prescribed - neurologist - CYMBALTA 30 mg NEURONTIN 300 mg effects still felt.

VAERS ID:472506 (history)  Vaccinated:2012-05-22
Age:4.0  Onset:2012-05-22, Days after vaccination: 0
Gender:Male  Submitted:2012-09-24, Days after onset: 125
Location:Missouri  Entered:2012-10-25, Days after submission: 31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Loratadine
Current Illness: Seasonal Allergy
Preexisting Conditions: No adverse events were reported with previous vaccinations. The reporter stated the "office has seen some reactions to the band aids (that contain latex) when they have been left on. She stated they advised the caregivers/parents to remove a couple hours after the injection.
Diagnostic Lab Data: UNK
CDC Split Type: A0978949A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B196CA4UNRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1123AA UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1407AA UNUN
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 4-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent medical conditions included seasonal allergy. Concurrent vaccination included MMR vaccine (non-gsk); Merck; subcutaneous; left arm given on 22 May 2012; varicella virus vaccine (non-gsk); Merck; subcutaneous; right arm given on 22 May 2012. Concurrent medications included CLARITIN. On 23 May 2012, one day after vaccination with KINRIX, the subject experienced swelling at injection site, hotness at injection site, injection site redness, and redness spreading. The subject was administered KINRIX and by the next morning he had swelling of ten centimeters, redness and heat at the injection site. The redness spared toward the subject''s groin area and he was then seen in the office. The redness extended about three inches by two inches from the site toward the groin area. It was reported that the subject still had on the band aid from the date of vaccination. The subject was prescribed KEFLEX for 10 days. The reporter stated the KINRIX vial was used, by they do use latex band aids. At the time of reporting the swelling at injection site, hotness at injection site, injection site redness, and redness spreading were unresolved. This is the second of two reports regarding KINRIX; please see A0978807A.

VAERS ID:486134 (history)  Vaccinated:2012-05-22
Age:21.0  Onset:2012-05-22, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:Unknown  Entered:2013-03-01
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: BERNA20120437
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF)BERNA BIOTECH, LTD3000009 PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Diarrhoea
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Report received on 24.May.2012 from a nurse and forwarded, ref. no. CVAE-021-2012. This case concerns a 21-year-old female patient who received VIVOTIF (batch number 3000009). The patient''s medical history and concomitant medications were not reported. On 22.May.2012, the patient took the first oral dose of VIVOTIF. On the same day, she experienced diarrhea. The event regressed on the interval day. On 24.May.2012, the patient took the second dose of VIVOIF, with further onset of diarrhea. The patient discontinued VIVOTIF. At the time of the report, the patient''s event was resolving. The event was considered non-serious.

VAERS ID:520375 (history)  Vaccinated:2012-05-22
Age:  Onset:2012-05-22, Days after vaccination: 0
Gender:Unknown  Submitted:2014-01-23, Days after onset: 611
Location:Unknown  Entered:2014-01-23
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: WAES1401USA008601
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1604AA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 17-APR-2012 at 7:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 14 hours. On 22-MAY-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.

VAERS ID:456847 (history)  Vaccinated:2012-05-22
Age:3.0  Onset:2012-05-23, Days after vaccination: 1
Gender:Female  Submitted:2012-06-05, Days after onset: 13
Location:Foreign  Entered:2012-06-05
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: Blood test, May2012, normal; Brain computerized tomography, May2012, normal; Electroencephalogram, see text; Lumbar puncture, May2012, normal
CDC Split Type: B0804400A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSYHAVB475AA1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood test normal, Computerised tomogram head, Computerised tomogram normal, Convulsion, Cyanosis, Electroencephalogram abnormal, Loss of consciousness, Lumbar puncture normal
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a physician via Sales Representative and described the occurrence of cyanosis in a 3-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 22 May 2012, the subject received 2nd dose of HAVRIX (intramuscular, administration site unknown). On 23 May 2012, 1 day after vaccination with HAVRIX, the subject experienced cyanosis, convulsion and unconscious. No fever. The diagnosis was convulsion. The subject was hospitalised and discharged on 25 May 2012. The brain computer tomography, lumbar puncture and blood tests were normal. An electroencephalogram was performed in another hospital, the diagnosis was a possible epilepsy. At the time of reporting, the events were resolved.

VAERS ID:456953 (history)  Vaccinated:2012-05-22
Age:17.0  Onset:2012-05-23, Days after vaccination: 1
Gender:Female  Submitted:2012-06-06, Days after onset: 14
Location:Foreign  Entered:2012-06-07, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Adhesive plaster sensitivity; Cow''s milk intolerance
Preexisting Conditions:
Diagnostic Lab Data: Diagnostic laboratory test, Lab findings only revealed slightly increased inflammatory parameters (not specified); Body temp, 23May12, 39 degree
CDC Split Type: WAES1206USA00310
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NP008602IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Laboratory test abnormal, Myalgia, Pyrexia, Rash, Rash pruritic, Urticaria, Vaccination site reaction
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Case was received from a consumer on 25-MAY-2012. Case was not medically confirmed. A 17-year-old female patient with a medical history of allergy to plaster and cow''s milk intolerance, received dose 3 of GARDASIL (lot-no. NP00860; batch# G01772-2) IM into the left upper arm on 22-MAY-2012. One day later, she developed fever up to 39.0 degree, an itchy rash with wheals on hands and feet, muscle pain which was severe in both calves and a mild vaccination site reaction. She was presented to a paediatric outpatient department where hand, foot and mouth disease and thrombosis were ruled out. Lab findings only revealed slightly increased inflammatory parameters (not specified). Under corrective treatment with FENISTIL and ibuprofen symptoms improved. On 29-MAY-2012 the reporter contacted the company by phone. She reported that on 26-MAY-2012 the rash was additionally seen on both elbows. The patient was treated with 1x 250 mg SOLU-DECORTIN-H IV followed by oral prednisolone. She recovered completely on 28-MAY-2012. Upon medical review the company decided to upgrade the case to serious (other medically important condition/ IV prednisolone treatment). The patient had experienced mild vaccination site reaction after administration of dose 1 and 2 of GARDASIL, given on unspecified dates. CASE IS CLOSED. Other business partner numbers include E2012-03408.

VAERS ID:457154 (history)  Vaccinated:2012-05-22
Age:12.0  Onset:2012-05-22, Days after vaccination: 0
Gender:Female  Submitted:2012-06-08, Days after onset: 17
Location:Foreign  Entered:2012-06-11, Days after submission: 3
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Convulsion; Attention deficit disorder
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1206USA01130
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Apparent life threatening event, Grand mal convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Neonatal disorders (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Case received from the Health Authorities (which received it from a physician) on 02-JUN-2012, under the reference number C201205-1413 via the local site Sanofi Pasteur MSD. Case medically confirmed. A 12 year old female adolescent patient had received the first dose of GARDASIL (batch and lot number not reported) via intramuscular route (administration site not reported) on 22-MAY-2012, and 3 minutes later she experienced an episode of generalized tonic-clonic seizures that lasted one minute and reverted spontaneously. The patient was placed in supine position for approximately 30 minutes. And after, when she was placed in the standing position, she had a new episode of generalized tonic-clonic seizure identical to the first one. The patient was hospitalized for clinical observation. No specific treatment was administered to reverse the adverse event. The patient had a medical history of seizures before the age of 3 years and she suffers from an attention deficit syndrome that had resolved about one year before reporting. She took methylphenidate, with unknown dosage, indicated for the treatment of attention deficit syndrome that had been stopped about one year before reporting. At the time of vaccination, the patient was not taking concomitant medications and it was unknown if she had experienced prior adverse effect to other drugs. The Health Authorities received additional information on 29-MAY-2012: the reporter clarified that the duration of each seizure was 20 seconds. She was placed in side position after the first episode and after the second one; she was admitted to hospital and remained in clinical observation for 24 hours. During hospitalization, there was no change in clinical status of the patient. At the time of reporting, the patient had recovered on 22-MAY-2012. Clonic-tonic seizures was considered to be immediately life-threatening by the reporter. Additional information has been requested.

VAERS ID:460466 (history)  Vaccinated:2012-05-22
Age:2.0  Onset:2012-05-22, Days after vaccination: 0
Gender:Male  Submitted:2012-07-26, Days after onset: 65
Location:Foreign  Entered:2012-07-26
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: WAES1207AUT010157
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Crying
SMQs:, Depression (excl suicide and self injury) (broad)
Write-up: Case received from the Health Authority on 18-Jul-2012 under the reference number AT-BASGAGES-121351. 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: 13.4 kg, height: 91 cm) with no relevant medical history reported, had received a dose (0.5 mL 1 times in 1 total) of MMRVAXPRO (batch number not reported) via intramuscular route and not reported site of administration on 22-May-2012. No concomitant medication was reported. On 22-May-2012, the male patient experienced high-pitched crying. The patient recovered within an unspecified timeframe. The case is closed.

VAERS ID:460458 (history)  Vaccinated:2012-05-22
Age:0.2  Onset:2012-05-22, Days after vaccination: 0
Gender:Unknown  Submitted:2012-07-27, Days after onset: 66
Location:Foreign  Entered:2012-07-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 22May2012, 39deg.C; Body temperature, 23May2012, 38deg.C
CDC Split Type: B0816804A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA20CA781A IMUN
Administered by: Other     Purchased by: Other
Symptoms: Apathy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad)
Write-up: This case was reported by a physician via regulatory authority (# PL-URPL-OCR-20120703008) and described the occurrence of fever in a 2-month-old suspect of unspecified gender who was vaccinated with INFANRIX-Polio-HIB (GlaxoSmithKline). On 22 May 2012, the subject received an unspecified dose of INFANRIX-Polio-HIB (intramuscular, administration site unknown). On 22 May 2012, within hours of vaccination with INFANRIX-Polio-HIB, the subject experienced fever (39 deg.C). On 23 May 2012, 1 day after vaccination with INFANRIX-Polio-HIB, the subject experienced apathy. The body temperature was 38 deg.C. The general condition was good. Normal appetite. The subject was hospitalised for 7 days, from 23 to 29 May 2012 and referred to a infectious diseases department for consultation. The physical examination showed no abnormalities, without local reactions. At the time of reporting, the events were resolved. No further information is expected, the regulatory Authority has provided GSK with all the available information for the time being, if they ever get any further information they will send it to GSK.

VAERS ID:460804 (history)  Vaccinated:2012-05-22
Age:5.0  Onset:2012-05-23, Days after vaccination: 1
Gender:Male  Submitted:2012-07-30, Days after onset: 68
Location:Foreign  Entered:2012-08-01, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 201207058
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURC3712AF IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Injection site erythema, Injection site oedema, Injection site reaction, Injection site warmth, Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Case received from the Health Authorities through the local affiliate on 19 July 2012 under the local number PL-URPL-OCR-20120703002 (local reference number 2012/0225). A 05-year-old male patient, with no reported medical history and concomitant therapy, had received an intramuscular dose of TRIPACEL batch number C3712AF, site of administration not reported, on 22 May 2012. The patient had previously received 4 dose of DTP. On 23 May 2012 the patient presented with injection site reaction in diameter more than 10 cm beyond the nearest joint; large oedema (circumference enlarged twice), redness and warmth of left arm including forearm and shoulder. The patient recovered at the time of reporting. This case was assessed as serious due to "other medical important condition". The Health Authorities coded: "injection site reaction", "swelling arm", "injection site redness" and "injection site warmth". Documents held by sender: none.

VAERS ID:461747 (history)  Vaccinated:2012-05-22
Age:3.0  Onset:2012-05-22, Days after vaccination: 0
Gender:Male  Submitted:2012-08-13, Days after onset: 83
Location:Foreign  Entered:2012-08-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHHY2012BR068520
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FOREIGN)NOVARTIS VACCINES AND DIAGNOSTICSZ0008 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Colitis, Dehydration, Diarrhoea, Fructose intolerance, Haematochezia, Malnutrition, Pyrexia, Weight decreased
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow)
Write-up: Case number PHHY2012BR068520 is an initial spontaneous report received from a consumer (patient''s mother who is also a physiotherapist) on 07 Aug 2012: This report refers to a 3-year-old male infant. His vaccination history included vaccination with seasonal influenza vaccines (manufacturer and batch number: unknown) in 2010 and 2011 (exact dates unspecified) which were reported to be well tolerated. Concomitant medications included ZINAC 250 mg twice daily orally, LOSEC for reflux, at a dose of 200 mg in the morning and 10 mg at night orally and SINGULAIR 4 mg for prevention of future sinus infections once daily orally. He was vaccinated with AGRIPPAL (batch number: Z0008 / 114102 and expiry date: Nov 2012) intramuscularly on 22 May 2012. He did not receive any other vaccine along with AGRIPPAL. On the same day after vaccination, he developed diarrhea at night. He was seen by the physician eight times on unknown dates for investigating the clinical picture of the patient since he was not aware of the cause of diarrhoea. Initially fructose intolerance was suspected. Hence fruits were removed from his diet. However diarrhea still persisted. The reporter also added that after vaccination, if the patient ate any food containing egg, he experienced diarrhea. But diarrhea still persisted, even after discontinuing the use of eggs from his diet. The patient also experienced blood in stools, abdominal pain and high fever. On 26 Jul 2012, the patient was hospitalized and he was diagnosed with colitis due to which he experienced malnutrition and dehydration. As a therapeutic measure, he received saline with dypyrone and BUSCOPAN intravenously and was prescribed FLORATIL for diarrhea. On 30 Jul 2012, he was discharged from the hospital. Three weeks after onset of the reaction, his condition improved. Three weeks later when eggs were introduced in his diet, diarrhoea reoccurred. After the vaccination and the diarrhea episodes, the patient experienced a great weight loss: from 20 Kg to 17.2 Kg. The final outcome of these events was not reported. No further information about causality was provided.

VAERS ID:462683 (history)  Vaccinated:2012-05-22
Age:0.4  Onset:0000-00-00
Gender:Female  Submitted:2012-08-21
Location:Foreign  Entered:2012-08-21
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: No relevant medical history
Diagnostic Lab Data: Body temperature, 02Jun2012, normal; Laboratory test, 02Jun2012, normal; Platelet count, 02Jun2012, normal
CDC Split Type: B0822316A
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA21CB21AB0IMLG
PNC: PNEUMO (PREVNAR)PFIZER/WYETH76090 IMLG
Administered by: Other     Purchased by: Other
Symptoms: Injection site haemorrhage, Laboratory test normal, Petechiae, Platelet count normal, Purpura, Purpura non-thrombocytopenic, Vaccination complication
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)
Write-up: This case was reported by the foreign regulatory authority (reference GR20120420) and described the occurrence of purpura in a 5-month-old female subject who was vaccinated with INFANRIX HEXA (GlaxoSmithKline), INFANRIX QUINTA (GlaxoSmithKline) and PREVENAR (non-gsk). The subject had no relevant medical history and weighed 7.23 kg in June 2012. On 22 May 2012, the subject received a primary course of INFANRIX HEXA (batch A21CB21AB as reported, intramuscular, unknown thigh) and one dose of PREVENAR (batch 76090, intramuscular, unknown other thigh). On 31 May 2012, nine days after vaccination with INFANRIX HEXA and PREVENAR, the subject presented with petechia on ankles then on knees. On 02 June 2012, the subject was referred to emergency unit after consultation of a general practitioner. Clinical examination showed petechial purpura on lower limbs which spread until thighs root. There was no modification of behaviour, fever, crying or sign of bad hemodynamic tolerance. Other part of the clinical examination and biological investigations were normal, including no thrombopenia. There was no recent virosis reported and a nephro pediatrician ruled out a rheumatoid purpura considering the subject''s age. No information was provided about a possible corrective treatment. Clinical course was favourable. A similar episode was reported which occurred one month before, eight to ten days after administration of a primary course of INFANRIX QUINTA (batch A20A742A, unknown thigh, route unknown) administered on 20 April 2012, without seriousness criterion. This episode resolved spontaneously. The subject was hospitalised for the second episode of purpura. At the time of reporting, the purpura was resolved. The agency conclusion stated that the patient experienced a non-thrombocytopenic purpura. Probable post vaccinal reaction, without contraindication for further vaccines. The agency assessed that causal relationship of vaccination with INFANRIX HEXA and PREVENAR as possible, according to the foreign method of assessment. Causality assessment with INFANRIX QUINTA for the first episode of purpura was not provided.

VAERS ID:463212 (history)  Vaccinated:2012-05-22
Age:0.4  Onset:2012-05-31, Days after vaccination: 9
Gender:Female  Submitted:2012-08-23, Days after onset: 84
Location:Foreign  Entered:2012-08-27, Days after submission: 4
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: 20-APR-2012, Past Drug Event, INFANRIX IPV+HIB, Purpura, lot A20CA742A
Diagnostic Lab Data: Clinical examination (unknown date) revealed: Purpura with petechiae on both lower limbs, spreading to the proximal part of the thighs. No behavior change, no cry, no fever, no signs of haemodynamic instability. No laboratory abnormality (no thrombocytopenia). Normal.
CDC Split Type: 2012201613
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA21CB21AB IMLG
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH76090 IMLG
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site haemorrhage, Injection site reaction, Petechiae, Purpura non-thrombocytopenic
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)
Write-up: This is spontaneous initial report received from the regulatory authority, regulatory authority report number GR20120420. A 5-month-old female patient received the suspected vaccines on 22May2012: PREVENAR 13, batch lot 76090, by intramuscular route, 1 dose in the leg; INFANRIX HEXA, batch A21CB21AB, by intramuscular route, 1 dose in the other leg. The patient had no relevant medical history. The patient previously received one injection of INFANRIX QUINTA, batch A20CA742A, on 20Apr2012. No concomitant treatment was reported. The patient developed purpura on 31May2012 which required hospitalization on 02Jun2012. Petechiae occurred on 31May2012 on the ankles and then on the knees. The child was referred to the pediatric emergency following consultation at the treating physician''s practice on 02Jun2012. Clinical examination revealed petechial purpura on both lower limbs, spreading to the proximal part of the thighs. There was no behavior change, no cry, no fever, no signs of haemodynamic instability. The clinical examination was otherwise normal and there was no laboratory abnormality (no thrombocytopenia). A similar episode with spontaneous resolution was reported to have occurred a month before. In both cases, a previous vaccination 8 to 10 days before the onset of the purpura was noted (injection of INFANRIX QUINTA in one leg, batch A20CA742A, on 20Apr2012). Differential diagnosis: there was no history of recent virus infection. Nephro-pediatrician opinion ruled out rheumatoid purpura given the patient''s young age. No therapeutic measure was reported. The purpura resolved spontaneously on an unspecified date. In conclusion: probable vaccination-induced, non-thrombopenic purpura. There was no contraindication to further vaccinations. Based on the Official foreign Method of Causality Assessment, the suspected vaccines were rated by the agency as possible. No FU attempts needed. No further information expected.

VAERS ID:464526 (history)  Vaccinated:2012-05-22
Age:46.0  Onset:2012-05-24, Days after vaccination: 2
Gender:Female  Submitted:2012-09-07, Days after onset: 106
Location:Foreign  Entered:2012-09-10, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2012033295
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chills, Cough, Diarrhoea, Headache, Hyperhidrosis, Influenza like illness, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, Malaise, Oropharyngeal pain, Pyrexia, Sinus congestion
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), 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: This health authority report (initial receipt 29-Aug-2012) concerns a 46-year-old female patient. On 22-May-2012 at 11am, the patient received influenza vaccine (manufacturer and batch no. not specified) 1 dose unspecified. On 24-May-2012, the patient was feeling unwell. By the evening she developed a headache and flu-like symptoms/influenza like illness including aches, sweaty fevers, pyrexia, rigors/chills and general malaise. On 25-May-2012, she developed diarrhoea. On 27-May-2012 she developed additional symptoms of a sore throat/oropharyngeal pain, cough and blocked sinuses/sinus congestion. She took some time off and was treated with PANADEINE and NUROFEN. The patient also developed an injection site reaction. The site was red, sore, itchy, swollen, hot and the size of a 50 cents piece. The outcome for the events was unknown. Reporter''s comment: On 09-Aug-2012, the reporter considered the events as possible in relation to influenza vaccine.

VAERS ID:465188 (history)  Vaccinated:2012-05-22
Age:12.0  Onset:2012-05-22, Days after vaccination: 0
Gender:Female  Submitted:2012-09-15, Days after onset: 116
Location:Foreign  Entered:2012-09-15
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: WAES1209AUS001978
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.G0184451IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Chills, Fatigue, Headache, Muscular weakness, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information was obtained on a request by the Company from the Agency via Public Case Detail form (Local reference # AUS/12/1871, OPR # 301455), concerning a 12 years old female patient, who on 22-MAY-2012 was vaccinated with the second dose of GARDASIL intramuscularly (dose not reported) (Lot # reported as G018445 in verification process). No other co-suspects were reported. No concomitant medications were reported. On 22-MAY-2012, 10 minutes post vaccination patient developed a headache, abdominal pain and then weakness and shaking in her legs 6 hours post vaccination, with generalised fatigue and chills up her spine. The patient presented to Accident & Emergency department (A&E) and admitted for observation. The outcome of all events was reported as not yet recovered. The Agency assessed relationship all of the events to therapy with GARDASIL as possible. The original reporting source was not provided. Upon internal review the events were considered to be other important medical events. Additional information is not expected.

VAERS ID:466762 (history)  Vaccinated:2012-05-22
Age:14.0  Onset:2012-05-24, Days after vaccination: 2
Gender:Male  Submitted:2012-09-27, Days after onset: 126
Location:Foreign  Entered:2012-09-27
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: UNK
CDC Split Type: B0833417A
Vaccination
Manufacturer
Lot
Dose
Route
Site
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER  UNRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC37B077AB IMLA
Administered by: Other     Purchased by: Other
Symptoms: Paralysis, Sensory loss
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: This case was reported by a physician via a regulatory authority (# 176250) and described the occurrence of paralysis in a 14-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline), (non-gsk) MENJUGATE. The subject had no medical history. On 22 May 2012, the received unspecified dose of BOOSTRIX (.5 ml, intramuscular, left deltoid) and unspecified dose of MENJUGATE (unknown, right deltoid, batch number not provided). On 24 May 2012, 2 days after vaccination with BOOSTRIX and MENJUGATE, the subject experienced sudden paralysis with sensitive deficit of right foot. The regulatory authority reported that the events were clinically significant (or requiring intervention). The subject was treated with MEDROL and PEA, NORMAST. At the time of reporting, the events were improved and the physical examination was normal. The regulatory authority reported that the events were possibly related to vaccination with BOOSTRIX and MENJUGATE.

VAERS ID:469569 (history)  Vaccinated:2012-05-22
Age:1.0  Onset:2012-05-22, Days after vaccination: 0
Gender:Male  Submitted:2012-10-10, Days after onset: 141
Location:Foreign  Entered:2012-10-15, Days after submission: 5
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: First, PREVENAR-13; First, INFANRIX HEXA; Second dose, PREVENAR-13; Second dose, INFANRIX HEXA
Diagnostic Lab Data: 22-MAY-2012, Body temperature, 39.5 Centigrade;Tests performed during hospitalization (unknown date): showed elevation of inflammatory markers and negative neurological findings.
CDC Split Type: 2012231049
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA21CB171A2IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF605382IMRL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood culture, Bronchopneumonia, Convulsion, Culture throat, Diarrhoea, Hypertransaminasaemia, Inflammatory marker increased, Loss of consciousness, Neurological examination normal, Pyrexia, Serology test, Status epilepticus
SMQs:, Torsade de pointes/QT prolongation (broad), Liver related investigations, signs and symptoms (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Noninfectious diarrhoea (narrow)
Write-up: This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number 175879. An 1-year-old male patient received 3rd dose of PREVENAR 13, on 22May2012 at 11:01AM lot number F60538, intramuscular in the right thigh and 3rd dose of INFANRIX HEXA, intramuscular, at 11:00AM lot number A21CB171A in the left thigh. The patient medical history and concomitant medications were unknown. The patient received the first dose of PREVENAR 13 and INFANRIX HEXA on 08Sep2011 and second vaccinations on 16Nov2011 without any event occurred. On 22May2012, in the afternoon, the child had a rush of diarrhea and fever in the evening (body temperature 39.5 Centigrade) treated with antipyretic. At 0:30 on the next day (23May2012) the patient presented generalized seizure. The Emergency Medical service was called and given the persistence of the crisis, Micronoan endorectal was administered. At the arrival at the Emergency room the crisis were still present, Midazolam IV was administered with a resolution of the crisis and the patient regained consciousness. Then the patient was hospitalized for investigation and treatment. The tests performed during hospitalization showed elevation of inflammatory markers and negative neurological findings. On 28May2012 the patient was discharged with the diagnosis of "febrile status epilepticus, bronchopneumonia, hypertransaminemia" with the prescription of antibiotic therapy for pulmonary infection, antipyretics for fever and rectal Micronoan in case of seizures. The patient completely recovered on an unspecified date. The reporting physician stated that the etiology of the bronchopneumonic outbreak has not emerged after examination (serology and culture of aspirated pharingonasal and blood). It can therefore to be excluded from streptococcus pn. Follow-up (18Sep2012): New information received from Regulatory Authority includes: hour at vaccines administration (INFANRIX HEXA and PREVENAR 13). Follow-up (25Sep2012): New information received from Regulatory Authority includes: past drug history; clinical and events details. Follow-up (05Oct2012): New information received from the Regulatory Authority includes: the reporting physician''s comment and the outcome of the events.

VAERS ID:471195 (history)  Vaccinated:2012-05-22
Age:14.0  Onset:2012-05-23, Days after vaccination: 1
Gender:Female  Submitted:2012-10-24, Days after onset: 154
Location:Foreign  Entered:2012-10-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Fatigue; Activities of daily living impaired; Nasopharyngitis
Diagnostic Lab Data:
CDC Split Type: WAES1210SWE010812
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Discomfort, Injection site pain, Odynophagia, Oropharyngeal pain, Pain, Pain in extremity
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad)
Write-up: Case received from a Health Care Professional via the Health Authorities on 22-Oct-2012 under the reference number 123160. Case medically confirmed. A 14-year-old female patient had received an injection of GARDASIL (batch number, dose, route and site not reported) on 22-May-2012 and later on 23-May-2012 she developed pain. The following day, the patient presented with, except residual pain in the arm also pain at the injection site in connection with pain when she chewed and swallowed food. When she otherwise swallowed, she had no problems. The symptoms had persisted. It seemed that it came from the throat and spread to the injection site. No visible swelling or redness but some soreness when touching the injection site. It was assessed as a bit vague discomfort by the reporter who decided to wait and see. The patient had experienced many colds during the spring, she was impaired and tired for a long time. The case was reported as serious by HA but no serious criterion was provided. At the time of reporting, the outcome was unknown. According to the reporter, the reaction was unclassifiable in relation to vaccination. No further information expected.

VAERS ID:496914 (history)  Vaccinated:2012-05-22
Age:12.0  Onset:2013-01-18, Days after vaccination: 241
Gender:Female  Submitted:2013-07-16, Days after onset: 178
Location:Foreign  Entered:2013-07-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1307KOR006507
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abasia, Arthralgia, Balance disorder, Crying, Dysstasia, Facial spasm, Laboratory test normal, Muscle spasms
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Arthritis (broad)
Write-up: This spontaneous report as received from a consumer reporting about his daughter, a 12 year old patient. On 22-MAY-2012 the patient was vaccinated with GARDASIL dose 3 (route, dosage and lot number unknown). After the first vaccination the patient experienced knee pain, so the patient cried while sleeping. The reporter thought it was a growing pain so the patient only took a pain reliever at that time. The symptom got worse and on 18-JAN-2013 the patient could not stand up and walk (ataxia) and experienced body spasm and facial spasm. The patient visited emergency room and was told to go to a big hospital. The patient was hospitalized and several tests were performed but there was no abnormal finding. However, the symptoms persisted. The patient could not balance herself on one leg and the knee pain continued. The patient was taking steroid for the treatment. The outcome of knee pain and ataxia was reported as not recovered. The outcome of body and facial spasm was reported as unknown. Additional information is not expected.

VAERS ID:497671 (history)  Vaccinated:2012-05-22
Age:13.0  Onset:2012-11-07, Days after vaccination: 169
Gender:Female  Submitted:2013-07-25, Days after onset: 259
Location:Foreign  Entered:2013-07-25
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:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 22May2012, 36.8Deg. C
CDC Split Type: B0909329A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA162AA2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Abdominal pain upper, Anxiety, Bone pain, Hypoaesthesia, Malaise, Pain, Visceral pain
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Osteonecrosis (broad)
Write-up: This case was reported by physician via a regulatory authority (# V13000446) and described the occurrence of generalized pain in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 22 May 2012, the subject received 3rd dose of CERVARIX (intramuscular, unknown injection site). Before vaccination, subject''s body temperature 36.8 Deg. C. On 7 November 2012, 6 months after vaccination with CERVARIX, the subject experienced abdominal pain on the left side. In November 2012: The subject visited a hospital. In February 2013, the subject regularly visited the reporter''s department with complaints of gastralgia, abdominal pain, and numbness. The pains could be controlled with oral treatment with stomach medicine and an analgesic. In June 2013, the subject started to complain strongly of generalised aching. At the subject''s visit to the hospital in June 2013, the reporting physician was informed that the subject had occasionally complained of the gastralgia and visceral pain to the subject''s mother since approximately 1 year before and that the subject''s mother had not been very concerned about the symptoms at that time. The pains gradually intensified thereafter, and the subject frequently complained of the visceral pain and bone pain in the entire body in June 2013 and felt strong anxiety. The subject was hospitalised for 1 week and was observed. The symptoms other than the gastralgia had subsided during the hospitalisation but were aggravated again after the discharge from the hospital. At the time of reporting, the events were unresolved. The regulatory authority reported that the causal relationship between generalised aching, gastralgia and malaise, and vaccination with CERVARIX was unassessable.

VAERS ID:511358 (history)  Vaccinated:2012-05-22
Age:0.2  Onset:2012-05-22, Days after vaccination: 0
Gender:Male  Submitted:2013-11-04, Days after onset: 531
Location:Foreign  Entered:2013-11-04
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: UNK
CDC Split Type: B0937681A
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  UNUN
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS  PO 
Administered by: Other     Purchased by: Other
Symptoms: Anaphylactic reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a healthcare professional in the frame of an immunization vaccines program and described the occurrence of anaphylaxis in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline), (non-gsk) PREVENAR. On 22 May 2012, the subject received unspecified dose of ROTARIX (oral, unknown batch number), unspecified dose of PREVENAR (unknown route, injection site and batch number). On 22 May 2012, less than one day after vaccination with PREVENAR and ROTARIX, the subject experienced anaphylaxis. The subject was hospitalised and the healthcare professional considered the event was clinically significant (or requiring intervention). The subject was treated with hydrocortisone, oxygen and paracetamol. At the time of reporting the event was unresolved. 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:515283 (history)  Vaccinated:2012-05-22
Age:11.0  Onset:0000-00-00
Gender:Female  Submitted:2013-12-02
Location:Foreign  Entered:2013-12-02
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: GARDASIL; Drug Reaction: Musculoskeletal stiffness; 03/27/2012, GARDASIL; Drug Reaction: Muscle spasms
Diagnostic Lab Data:
CDC Split Type: WAES1312DNK000399
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NN433601IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Back disorder, Fatigue, Hypoaesthesia, Muscle spasms, Musculoskeletal stiffness, Palpitations, Pyrexia, Sensory disturbance, Sudden visual loss, Syncope, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad)
Write-up: Case received from a consumer or other non healthcare professional via the Health Authorities in a foreign country on 25-Nov-2013 under the reference DK-DKMA-ADR 22322182. Case is not medically confirmed. An 11-year-old female patient (weight 64 kg, height 176 cm) with no medical history reported had received the second dose of GARDASIL (batch number G009615) via not reported route and site of administration on 22-May-2012. On an unspecified date, the patient developed visual disturbance, sudden vision loss, sensory disturbance in fingertips and legs, numbness in legs, tiredness (was very tired) and fainted several times without warning. On an unspecified date in Jun-2012, the patient developed very high fever and abdominal cramps. On an unspecified date in 2013, the patient also experienced severe heart palpitation. 11-13 days after vaccination she woke up one night with very high fever and total stiff nec. She visited the emergency doctor who examined her completely. All results were unremarkable. She had severe stomach cramps and increased fever. No cause was found. Subsequently, it gradually got worse and more violent with cramps at night. In the morning she had sensory disturbance in the fingertips, while she had numbness in legs. Suddenly she experienced visual loss, and when it returned she often had visual disturbances (such as water in the side of the vision field). She was very tired, often followed by headaches. She got severe palpitations (without any physical activity). She got stiff neck and back "it locks" - even when she was not physically active. The latest was that she had fainted in the middle of training match in handball and other times without warning, and she had no memories later of what happened. She visited the doctor several times and had blood tests were performed. Results were not provided. The last time the reporter asked the doctor to send the patient to further studies. In Oct-2013, she was examined at the medical center and had further blood tests and EEG as they await a reply. The next meeting was scheduled on 19-Dec-2013 with doctor from medical center to discuss tests and test results. The third dose of GARDASIL was not given due to adverse events (drug WITHDRAWN). The Health Authorities has requested medically confirm and is awaiting for reply. D1 of GARDASIL (batch no. G009615) was given on 27-Mar-2012. After D1, on an unspecified date in Mar-2012, the patient developed stiff neck and back "locks" and cramps. At the time of reporting, the patient had not recovered.

VAERS ID:456053 (history)  Vaccinated:2012-05-23
Age:29.0  Onset:2012-05-23, Days after vaccination: 0
Gender:Male  Submitted:2012-05-23, Days after onset: 0
Location:Texas  Entered:2012-05-23
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: None
Diagnostic Lab Data: Unknown
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB225AA1IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0597AA1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site reaction, Muscle spasms
SMQs:, Dystonia (broad)
Write-up: Muscle spasm in left shoulder. (IM and SQ vaccine administered in the left arm.) No other systemic or local reactions reported or noted.

VAERS ID:456084 (history)  Vaccinated:2012-05-23
Age:12.0  Onset:2012-05-23, Days after vaccination: 0
Gender:Male  Submitted:2012-05-23, Days after onset: 0
Location:California  Entered:2012-05-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS600388 IM 
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSBO66AA IM 
Administered by: Other     Purchased by: Public
Symptoms: Unevaluable event
SMQs:
Write-up: FLUARIX VACCINE GIVEN TO STUDENT WITHOUT PARENT CONSENT. PARENT NOTIFIED VIA TELEPHONE BY SCHOOL NURSE. FATHER REPORTS NO HX OF PROBLEMS WITH VACCINES.

VAERS ID:456085 (history)  Vaccinated:2012-05-23
Age:13.0  Onset:2012-05-23, Days after vaccination: 0
Gender:Female  Submitted:2012-05-23, Days after onset: 0
Location:California  Entered:2012-05-23
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: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS60388 IM 
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSB066AA IM 
Administered by: Other     Purchased by: Unknown
Symptoms: Drug administration error, No adverse event
SMQs:
Write-up: STUDENT WAS GIVEN FLUARIX VACCINE WITHOUT PARENTAL CONSENT. NO ADVERSE SIGNS OR SYMPTOMS NOTED.

VAERS ID:456112 (history)  Vaccinated:2012-05-23
Age:60.0  Onset:2012-05-23, Days after vaccination: 0
Gender:Male  Submitted:2012-05-24, Days after onset: 1
Location:New Hampshire  Entered:2012-05-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0813AA0IMUN
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1056AA0SCUN
Administered by: Other     Purchased by: Public
Symptoms: Chest pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: Chest pain for 20 mins approx 45 mins after vaccine.

VAERS ID:456139 (history)  Vaccinated:2012-05-23
Age:68.0  Onset:2012-05-24, Days after vaccination: 1
Gender:Female  Submitted:2012-05-24, Days after onset: 0
Location:Virginia  Entered:2012-05-24
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: Sulfur allergies
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.000064963410SCLA
Administered by: Other     Purchased by: Private
Symptoms: Arthralgia, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Muscle and Joint pain.

VAERS ID:456168 (history)  Vaccinated:2012-05-23
Age:1.1  Onset:2012-05-24, Days after vaccination: 1
Gender:Female  Submitted:2012-05-24, Days after onset: 0
Location:California  Entered:2012-05-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Nasal Congestion
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER    
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Private     Purchased by: Other
Symptoms: Febrile convulsion
SMQs:, Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Febrile Seizure, lasting 4 minutes.

VAERS ID:456174 (history)  Vaccinated:2012-05-23
Age:54.0  Onset:2012-05-23, Days after vaccination: 0
Gender:Male  Submitted:2012-05-24, Days after onset: 1
Location:Florida  Entered:2012-05-24
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: shrimp, crabs, other shellfish: oxycontin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TETANUS DIPHTHERIA (NO BRAND NAME)UNKNOWN MANUFACTURER    
VARZOS: ZOSTER (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Private
Symptoms: Pain, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: All over body ache like the flu; on the 24th I developed hives, I itch as though I have been rolling in fiberglass insulation.

VAERS ID:456176 (history)  Vaccinated:2012-05-23
Age:10.0  Onset:2012-05-23, Days after vaccination: 0
Gender:Male  Submitted:2012-05-24, Days after onset: 1
Location:California  Entered:2012-05-24
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
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUH296AB0SCLA
Administered by: Public     Purchased by: Private
Symptoms: Cough, Productive cough, Pruritus, Rash erythematous, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)
Write-up: 4:44 Pm 5/23/2012 - C/o coughing, itchy to neck and ear with red rash, throat tightness, cough is productive - 110/80 (L) arm bp, pulse 72. 4:50 PM - BENADRYL - 50 mg/ml (R) D IM give Lot # 07035D exp 7/2012 - 112/80 (L) arm bp, pulse 6B - A/Ox3, lungs clear.

VAERS ID:456208 (history)  Vaccinated:2012-05-23
Age:45.0  Onset:2012-05-23, Days after vaccination: 0
Gender:Female  Submitted:2012-05-24, Days after onset: 1
Location:Wisconsin  Entered:2012-05-25, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0025AE0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Pain at injection site.

VAERS ID:456220 (history)  Vaccinated:2012-05-23
Age:26.0  Onset:2012-05-23, Days after vaccination: 0
Gender:Male  Submitted:2012-05-25, Days after onset: 2
Location:Ohio  Entered:2012-05-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: patient was just getting over head cold- there was no temp associated with this
Preexisting Conditions: allergy to shellfish
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU3957CA0IMRA
Administered by: Unknown     Purchased by: Other
Symptoms: Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Pt developed fever and body aches the evening the injection was administered. Did not have thermometer to check actually temp.

VAERS ID:456225 (history)  Vaccinated:2012-05-23
Age:11.0  Onset:2012-05-24, Days after vaccination: 1
Gender:Female  Submitted:2012-05-25, Days after onset: 1
Location:Texas  Entered:2012-05-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1489AA0IMRA
Administered by: Unknown     Purchased by: Private
Symptoms: Cellulitis, Erythema, Injected limb mobility decreased, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad)
Write-up: Pt in office around 3:30pm. Right arm developed a baseball size area that was red, swollen, and painful. Decreased range of motion in right arm. No fever. Pt given Motrin, Benadryl, and Augmentin for cellulitis.

VAERS ID:456239 (history)  Vaccinated:2012-05-23
Age:0.4  Onset:2012-05-23, Days after vaccination: 0
Gender:Female  Submitted:2012-05-25, Days after onset: 2
Location:Georgia  Entered:2012-05-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NOP
Preexisting Conditions: NO
Diagnostic Lab Data: CBC UA
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B323AA0IMLL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.1525AA0IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETH9172460IMRL
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSA41CB248A0PO 
Administered by: Private     Purchased by: Public
Symptoms: Full blood count, Pyrexia, Urine analysis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: FEVER 101-103.

VAERS ID:456240 (history)  Vaccinated:2012-05-23
Age:11.0  Onset:2012-05-24, Days after vaccination: 1
Gender:Male  Submitted:2012-05-25, Days after onset: 1
Location:Texas  Entered:2012-05-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: None
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1489AA1IMLL
Administered by: Private     Purchased by: Private
Symptoms: Gait disturbance, Oedema peripheral, Pain in extremity, Skin warm
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Came to doctors office at 1540. Left leg swollen, warm to touch, and painful. Child limping. Motrin administered. Dr. rec Benadryl at home.

VAERS ID:456242 (history)  Vaccinated:2012-05-23
Age:1.1  Onset:2012-05-25, Days after vaccination: 2
Gender:Male  Submitted:2012-05-25, Days after onset: 0
Location:Florida  Entered:2012-05-25
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 BIOLOGICALS0271AE1IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0075AE0SCRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9172433IMLL
VARCEL: VARICELLA (VARILRIX)GLAXOSMITHKLINE BIOLOGICALS0138AE0SCLL
Administered by: Unknown     Purchased by: Other
Symptoms: Injection site erythema, Injection site induration, Injection site mass
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: 2.5 inch by 1.25 inch area of redness left thigh with 1 cm hard, red lump where vaccine administered.

VAERS ID:456246 (history)  Vaccinated:2012-05-23
Age:22.0  Onset:2012-05-25, Days after vaccination: 2
Gender:Male  Submitted:2012-05-25, Days after onset: 0
Location:Washington  Entered:2012-05-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none known
Preexisting Conditions: pelvic pain, wt loss, subjective SOB
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4136BA IMLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: A quarter of a dime sized reddened area with moderate amt of Pain at site of injection. Denies any fever, chills, SOB, or hives.

VAERS ID:456248 (history)  Vaccinated:2012-05-23
Age:25.0  Onset:2012-05-24, Days after vaccination: 1
Gender:Male  Submitted:2012-05-26, Days after onset: 2
Location:Washington  Entered:2012-05-26
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 (NO BRAND NAME)UNKNOWN MANUFACTURER   LA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Tendinopathies and ligament disorders (broad)
Write-up: When I woke up the arm that received the shot was sore, and I had a slight fever. I took Dayquil throughout the day. That night, once the Dayquil wore off, I had a fever of 100.5. I took some Nyquil and went to bed. The fever was gone when I woke up the next day, but my arm is still slightly sore 2 days later.

VAERS ID:456252 (history)  Vaccinated:2012-05-23
Age:43.0  Onset:2012-05-24, Days after vaccination: 1
Gender:Male  Submitted:2012-05-26, Days after onset: 2
Location:California  Entered:2012-05-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Small right shin wound
Preexisting Conditions: Mild chronic thrombocytopenia
Diagnostic Lab Data: CBC: Eosinophilia: 772 (normal 15-500) Platelets 115 (patient''s baseline 112) Rest of CBC and BMP normal.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4009BA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Eosinophil count increased, Eosinophilia, Full blood count abnormal, Injection site erythema, Injection site irritation, Injection site swelling, Injection site warmth, Metabolic function test normal, Platelet count decreased
SMQs:, Haematopoietic leukopenia (broad), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: Initially irritation to vaccination site to Left deltoid, then mild swelling on 5/24, worsened by 5/25 pm. Presented 5/26 with moderate swelling, 40% larger diameter left upper arm with redness, warmth and swelling. Patient neurovascularly intact. Treated with iv Solumedrol and clindamycin. Redness and swelling decreased by 60% after iv Solumedrol.

VAERS ID:456258 (history)  Vaccinated:2012-05-23
Age:52.0  Onset:2012-05-25, Days after vaccination: 2
Gender:Female  Submitted:2012-05-27, Days after onset: 2
Location:Minnesota  Entered:2012-05-27
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: Allergic to Amoxicillin, Sulfa drugs, Ceclor, Propoxyphene, Imiprotropim
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURU4304AA IMRA
Administered by: Private     Purchased by: Public
Symptoms: Chills, Diarrhoea, Erythema, Hypoaesthesia, Injection site erythema, Injection site swelling, Injection site warmth, Nausea, Oedema peripheral, Pyrexia, Swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow)
Write-up: Swelling, hot, and progressing redness at site of injection. Swollen limb, numb at tips of fingers of affected arm, fever, chills, increasing redness, nausea, slight diarrhea.

VAERS ID:456277 (history)  Vaccinated:2012-05-23
Age:0.2  Onset:2012-05-25, Days after vaccination: 2
Gender:Female  Submitted:2012-05-28, Days after onset: 3
Location:Ohio  Entered:2012-05-28
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 120 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Former 26 wk premature infant with chronic lung disease.
Diagnostic Lab Data: CBC, blood culture, chest x-ray - all unremarkable
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B285EA0IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH522AB0IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF902920IMLL
Administered by: Private     Purchased by: Private
Symptoms: Blood culture negative, Bradycardia, Chest X-ray normal, Continuous positive airway pressure, Dyskinesia, Full blood count normal, Infantile apnoeic attack, Oxygen saturation decreased
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (narrow), Acute central respiratory depression (narrow), Noninfectious encephalopathy/delirium (broad), Neonatal disorders (narrow), Respiratory failure (narrow)
Write-up: Vaccinations given on 5/23 & 5/24. On 5/25, infant had a severe apneic episode with questionable seizure activity (rhythmic jerking of all extremities), as well as several desaturation episodes, requiring CPAP for 24 hrs. Another apneic/bradycardic event with questionable seizure activity was noted on 5/27.

VAERS ID:456359 (history)  Vaccinated:2012-05-23
Age:24.0  Onset:2012-05-24, Days after vaccination: 1
Gender:Female  Submitted:2012-05-29, Days after onset: 5
Location:Washington  Entered:2012-05-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: EKG, Doctors visit scheduled for this afternoon.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.0104AA0IMRA
Administered by: Military     Purchased by: Military
Symptoms: Back pain, Chest pain, Electrocardiogram, Headache, Lymphadenopathy, Pain
SMQs:, Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: Headache for 6 days now-varying from constant pain to sharp weakening pain. Chest Pain on right side to include pain all the way down to my lower back. Bodyaches. Swelling of glands in armpit area on Right Side.

VAERS ID:456365 (history)  Vaccinated:2012-05-23
Age:1.3  Onset:2012-05-23, Days after vaccination: 0
Gender:Female  Submitted:2012-05-29, Days after onset: 6
Location:Texas  Entered:2012-05-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B149AA3IMLL
Administered by: Unknown     Purchased by: Private
Symptoms: Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Fever and vomiting.

VAERS ID:456470 (history)  Vaccinated:2012-05-23
Age:52.0  Onset:2012-05-24, Days after vaccination: 1
Gender:Female  Submitted:2012-05-29, Days after onset: 5
Location:New York  Entered:2012-05-29
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: Hypothyroidism; Adrenal gland
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4169AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site streaking, Injection site warmth, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Patient received a tdap on 5/23/2012 left deltoid. Patient seen on 5/25/2012 for c/o warmth, redness to left deltoid with fever. 5cm red swelling with streaking toward axilla. Cold compress to arm. F/U if.

VAERS ID:456479 (history)  Vaccinated:2012-05-23
Age:11.0  Onset:2012-05-25, Days after vaccination: 2
Gender:Male  Submitted:2012-05-30, Days after onset: 5
Location:Wisconsin  Entered:2012-05-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None.
Preexisting Conditions: None.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4021AD IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS  IMLA
Administered by: Public     Purchased by: Public
Symptoms: Discomfort, Injection site erythema, Injection site induration, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Right deltoid red, hard and swollen per school Nurse. Area approx. 4"X2". Meningitis Vaccine given in that location. Instructed to ice area and take Tylenol for discomfort.

VAERS ID:456513 (history)  Vaccinated:2012-05-23
Age:17.0  Onset:2012-05-24, Days after vaccination: 1
Gender:Female  Submitted:2012-05-30, Days after onset: 6
Location:Kansas  Entered:2012-05-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM110660IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Headache, Neck pain
SMQs:, Arthritis (broad)
Write-up: Client reports headache and neck ache beginning 5/24/12. Denies any further reactions.

VAERS ID:456521 (history)  Vaccinated:2012-05-23
Age:15.0  Onset:2012-05-24, Days after vaccination: 1
Gender:Female  Submitted:2012-05-30, Days after onset: 6
Location:Kansas  Entered:2012-05-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM110660IMRA
Administered by: Public     Purchased by: Private
Symptoms: Body temperature, Headache, Injection site erythema, Injection site induration, Neck pain, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad)
Write-up: Patient reports hardening and redness at injection site along with mild swelling to (R) forearm. Also report feeling like "I was running a temperature". Pt. denies checking temperature. Also reports headache and neck ache on 5/24/12.

VAERS ID:456523 (history)  Vaccinated:2012-05-23
Age:54.0  Onset:2012-05-28, Days after vaccination: 5
Gender:Male  Submitted:2012-05-30, Days after onset: 2
Location:Unknown  Entered:2012-05-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vit-C; Aspirin 2 tabs
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC3976AA IMRA
Administered by: Military     Purchased by: Military
Symptoms: Erythema, Joint swelling, Pruritus
SMQs:, Anaphylactic reaction (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Redness, swelling and itchy on right arm. Refer to his PCM in clinic because of nationality.

VAERS ID:456528 (history)  Vaccinated:2012-05-23
Age:5.0  Onset:0000-00-00
Gender:Female  Submitted:2012-05-25
Location:North Carolina  Entered:2012-05-31, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: NC12006
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4050AA4UNLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURH13303UNRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1570AA1UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1633AA1UNRA
Administered by: Private     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: Lt arm - red & warm to touch from mid arm down to elbow - 6" long & 4 1/2" around starts below deltoid area down to elbow. No induration (+) soft tissue swelling.

VAERS ID:456572 (history)  Vaccinated:2012-05-23
Age:66.0  Onset:2012-05-26, Days after vaccination: 3
Gender:Female  Submitted:2012-05-31, Days after onset: 5
Location:Pennsylvania  Entered:2012-05-31
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: Erythromycin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1254AA0SCLA
Administered by: Other     Purchased by: Private
Symptoms: Cellulitis, Injection site erythema, Vaccination site inflammation
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Area of vaccination become red and inflamed. Patient reported to pharmacist on Friday 5/25/12 if normal Pharmacist told pt. reaction to vaccine on 5/26/12, Pt. treated by doctor for cellulitis Pharmacist contacted pt. on 5/29 patient doing fine.

VAERS ID:456632 (history)  Vaccinated:2012-05-23
Age:23.0  Onset:2012-06-01, Days after vaccination: 9
Gender:Male  Submitted:2012-06-01, Days after onset: 0
Location:New Mexico  Entered:2012-06-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV3080IMLA
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04003A0IDRA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURG11240IMLA
Administered by: Military     Purchased by: Military
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: 55 mm redness, swelling around vaccination site. Pt states itchiness at site but denies any other symptoms.

VAERS ID:456748 (history)  Vaccinated:2012-05-23
Age:1.6  Onset:0000-00-00
Gender:Female  Submitted:2012-06-01
Location:Michigan  Entered:2012-06-04, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Will revaccinate
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURUH523AA UNUN
Administered by: Private     Purchased by: Unknown
Symptoms: Incorrect drug dosage form administered
SMQs:
Write-up: ACTHIB mixed wrong.

VAERS ID:456768 (history)  Vaccinated:2012-05-23
Age:4.0  Onset:2012-05-24, Days after vaccination: 1
Gender:Male  Submitted:2012-06-04, Days after onset: 11
Location:Arkansas  Entered:2012-06-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC Split Type: AR1210
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B1844IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1006AA1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1225AA1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Pruritus, Rash, Skin tightness
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Telephone call from mother who states Left arm is swollen 4" x 5" area, warm to touch and tightness. States he has 4 raised solid bumps with no fluid approximately 0.5cm in size. No fever, no pain, c/o itching only. Mom will continue to give Tylenol and Benadryl prn and use warm moist compress alternating with ice. To call with any changes or take to PCP if worsens. Mother verbalized understanding.

VAERS ID:456772 (history)  Vaccinated:2012-05-23
Age:30.0  Onset:0000-00-00
Gender:Male  Submitted:2012-06-04
Location:California  Entered:2012-06-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV3080IMRA
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEUR04003A0OTLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURG112410IMRA
Administered by: Military     Purchased by: Unknown
Symptoms: Purulent discharge, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: BUMP WITH PUS ON LT HAND.

VAERS ID:456776 (history)  Vaccinated:2012-05-23
Age:0.3  Onset:2012-05-24, Days after vaccination: 1
Gender:Female  Submitted:2012-06-04, Days after onset: 11
Location:Alabama  Entered:2012-06-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: None
Diagnostic Lab Data: Normal EEG
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4166AA1IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF924721IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1672AA1PO 
Administered by: Private     Purchased by: Private
Symptoms: Electroencephalogram normal, Gaze palsy, Tonic clonic movements
SMQs:, Convulsions (narrow), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (broad)
Write-up: Child was breast feeding. Mom describes her eyes rolling back and 10-15 seconds of tonic-clonic jerking, then resumed breast feeding.

VAERS ID:456792 (history)  Vaccinated:2012-05-23
Age:1.0  Onset:2012-05-31, Days after vaccination: 8
Gender:Male  Submitted:2012-06-04, Days after onset: 4
Location:Pennsylvania  Entered:2012-06-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Prematurity; Methadone exposure in utero; Mom Hep C (+).
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.1586AA0UNLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1001AA0UNLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0945AA0UNRL
Administered by: Private     Purchased by: Other
Symptoms: Injection site discolouration, Injection site mass, Pyrexia, Rash erythematous, Rash generalised
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Presented to office 6/4/12 with full body rash, raised red bumps (12 days post immunizations), fever 102 degrees. Yesterday, "orange sized" lump (L) thigh that is decreased in size today.

VAERS ID:456835 (history)  Vaccinated:2012-05-23
Age:65.0  Onset:0000-00-00
Gender:Male  Submitted:2012-06-04
Location:Alabama  Entered:2012-06-05, 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.0599AE0SCLA
Administered by: Other     Purchased by: Private
Symptoms: Herpes zoster
SMQs:
Write-up: Shortly after vaccine pt way diagnosed w/ shingles.

VAERS ID:456862 (history)  Vaccinated:2012-05-23
Age:73.0  Onset:2012-05-24, Days after vaccination: 1
Gender:Male  Submitted:2012-05-30, Days after onset: 6
Location:New Mexico  Entered:2012-06-06, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Diabetes
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1265AA0UNLA
Administered by: Other     Purchased by: Other
Symptoms: Eye swelling, Rash, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Pt experienced a red rash on the side of his face on top of his head, and swelling in his eye. Pt reported to hospital 5/25/12 due to the involvement of his eye. Pt was discharged on antiviral & pain med.

VAERS ID:456876 (history)  Vaccinated:2012-05-23
Age:62.0  Onset:2012-05-26, Days after vaccination: 3
Gender:Female  Submitted:2012-05-26, Days after onset: 0
Location:Tennessee  Entered:2012-06-06, Days after submission: 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
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1716AA SCLA
Administered by: Other     Purchased by: Private
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site swelling, Pallor
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: 5/26/12 Pt daughter called to report swelling & redness at injection site, swelling greater than 1 inch & redness to elbow from injection site. Daughter reports pt looks pale & pt states she is fatigued. No fever & the other symptoms; 5/28/12 swelling down, no heat, had spot at inj site - otherwise fine.

VAERS ID:456910 (history)  Vaccinated:2012-05-23
Age:49.0  Onset:2012-05-23, Days after vaccination: 0
Gender:Female  Submitted:2012-06-06, Days after onset: 14
Location:D.C.  Entered:2012-06-06
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
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER    
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURER    
YF: YELLOW FEVER (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Other     Purchased by: Other
Symptoms: Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Hives/rashes.

VAERS ID:456963 (history)  Vaccinated:2012-05-23
Age:  Onset:2012-05-25, Days after vaccination: 2
Gender:Female  Submitted:2012-06-06, Days after onset: 12
Location:Unknown  Entered:2012-06-07, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1206USA00205
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Herpes zoster, Injection site nodule
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a registered nurse concerning a female patient who on approximately 23-MAY-2012 "Wednesday or Thursday of last week" was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot # not provided). On approximately 25-MAY-2012 "2 days later", the patient was taken to the Emergency Room (ER) because the patient had a waffle sized knot at the injection site and she also had a shingles breakout on her forehead and was hospitalized. She was treated in the ER medicinally for the shingles however no medications were specified that had been used. At the time of the report, the patient''s outcome was unknown. Additional information has been requested.

VAERS ID:456982 (history)  Vaccinated:2012-05-23
Age:12.0  Onset:2012-05-23, Days after vaccination: 0
Gender:Female  Submitted:2012-05-31, Days after onset: 8
Location:Unknown  Entered:2012-06-07, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient''s medical history and concomitant medications were not reported.
Diagnostic Lab Data: Not reported
CDC Split Type: 201205597
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU3906A IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:
Write-up: Initial report received from Health care professional on 25 May 2012.

VAERS ID:456985 (history)  Vaccinated:2012-05-23
Age:18.0  Onset:2012-05-24, Days after vaccination: 1
Gender:Female  Submitted:2012-06-01, Days after onset: 8
Location:Florida  Entered:2012-06-07, 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: The patient had no illness at the time of vaccination and no past medical history.
Diagnostic Lab Data: Not reported
CDC Split Type: 201205493
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU3906AA1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Balance disorder, Nausea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Initial report was received from a health care professional on 24 May 2012. An 18-year-old female patient had received a dose two intramuscular injection of MENACTRA, Sanofi Pasteur Inc., lot number U3906AA, (site not reported) on 23 May 2012. The next day on 24 May 2012, the patient experienced a fever of 101.9 degrees Fahrenheit (F), nausea, vomiting and disequilibrium. The patient had no illness at the time of vaccination and no past medical history. No further information was available at the time of the report. The patient''s out come was not recovered. Documents held by sender: None.

VAERS ID:457093 (history)  Vaccinated:2012-05-23
Age:0.2  Onset:2012-05-29, Days after vaccination: 6
Gender:Male  Submitted:2012-06-08, Days after onset: 10
Location:Texas  Entered:2012-06-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: no
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B300BA0IMLL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.UH256AA0IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF27900IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1466AA0PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, Erythema multiforme, Rash generalised, Skin lesion
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Hypersensitivity (narrow)
Write-up: Full body rash with target lesions, no mucosal involvement. Diagnosed with erythema multiforme that started 7 days after vaccines. He had temp of 100.2 after getting vaccines, but no other sx and was not given tylenol or any other medication. Rash progressed over 3 days at time of visit on 5/31/12. No difficulty breathing or life threatening illness.

VAERS ID:457096 (history)  Vaccinated:2012-05-23
Age:61.0  Onset:2012-06-03, Days after vaccination: 11
Gender:Female  Submitted:2012-06-09, Days after onset: 6
Location:Florida  Entered:2012-06-09
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: Eye exam
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.    
Administered by: Private     Purchased by: Private
Symptoms: Eye irritation, Herpes zoster, Ophthalmological examination normal, Pain, Rash
SMQs:, Anaphylactic reaction (broad), Corneal disorders (broad), Hypersensitivity (narrow)
Write-up: I received the Zostavax vaccine on 5/23/12. Nearly 2 weeks later on 6/3/12 experienced an irritated feeling in my left eye. Later that day there appeared a raised rash on the outside corner of my eye. Over the next few days there appeared more rash and a sensitive feeling in the area. By 6/6/12 it was so bad I went to my PCP. She diagnosed it as Shingles. It was her opinion that I contracted Shingles from the vaccine. She prescribed Valacyclovir and Methylprednisolone and strongly urged me to see an eye doctor. I saw an eye doctor on 6/7/12. The eye is not included with Shingles at this point, but the doctor wants to see me in 3 weeks because of the danger of the Shingles including the eye later. I have a follow-up visit scheduled for 6/27/12.

VAERS ID:457276 (history)  Vaccinated:2012-05-23
Age:1.2  Onset:2012-06-05, Days after vaccination: 13
Gender:Male  Submitted:2012-06-08, Days after onset: 3
Location:California  Entered:2012-06-12, 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: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1760AA0SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1795AA0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Rash generalized. Tx: BENADRYL.

VAERS ID:457638 (history)  Vaccinated:2012-05-23
Age:22.0  Onset:2012-05-29, Days after vaccination: 6
Gender:Female  Submitted:2012-06-18, Days after onset: 20
Location:Washington  Entered:2012-06-18
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: Penicillin, amoxicillin, bananas
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1769AA0SCRA
Administered by: Public     Purchased by: Private
Symptoms: Arthralgia, Lymphadenopathy, Pain in extremity, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Fever 104 degrees,not resolved with Tylenol x48 hrs. Joint pain, knees, feet, hands. Swollen lymph nodes, Right cervical & bilateral axillary nodes. Fine rash, arms bilaterally & on her neck. She was seen at a local walk-in clinic but cannot recall the exact date. Today, 6-18-12, she is at Co Health Dept., still complaining of joint pain in her fingers, knees, ankles and the arches of her feet.

VAERS ID:457648 (history)  Vaccinated:2012-05-23
Age:53.0  Onset:2012-05-23, Days after vaccination: 0
Gender:Female  Submitted:2012-06-19, Days after onset: 27
Location:Florida  Entered:2012-06-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4325AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Rash macular
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Erythema, swelling, tenderness at injection site. Macular rash from neck to waist that lasted five days. Fatigue for three days.

VAERS ID:459600 (history)  Vaccinated:2012-05-23
Age:17.0  Onset:2012-05-24, Days after vaccination: 1
Gender:Male  Submitted:2012-07-16, Days after onset: 53
Location:California  Entered:2012-07-16
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: WAES1205USA05571
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0101AE1IMLA
Administered by: Other     Purchased by: Other
Symptoms: Abdominal distension, Abdominal pain, Diarrhoea, Rash, Rash generalised
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from a physician concerning a 17 year old male patient who on an unspecified date was vaccinated with an unspecified 0.5mL dose of GARDASIL. It was reported that the patient experienced a diffuse rash in the morning after receiving GARDASIL. The patient sought medical attention by calling the physician. It was reported BENADRYL was given as treatment for the adverse event. On an unspecified date, the patient recovered from diffuse rash. Follow-up information received from the physician revealed that the patient was a 17 year old male with no pre-existing allergies, birth defects or medical conditions and no history of adverse events following prior vaccination and no illness noted at the time of vaccination who on 23-MAY-2012 was vaccinated IM with the second 0.5 mL dose of GARDASIL in his left arm (lot # 672721/0101AE, expiration date 10-OCT-2014). No illness at time of vaccination was noted. On 04-MAY-2012 the patient experienced abdominal pain and bloating, generalized rash and diarrhea. No laboratory tests/diagnostics studies were performed. At the time of reporting, the patient''s outcome was unknown. Additional information has been requested.

VAERS ID:459857 (history)  Vaccinated:2012-05-23
Age:72.0  Onset:2012-05-26, Days after vaccination: 3
Gender:Female  Submitted:2012-06-18, Days after onset: 23
Location:Pennsylvania  Entered:2012-07-20, Days after submission: 32
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4188AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Headache, Injection site discomfort, Injection site erythema, Injection site rash, Pyrexia, Restlessness, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Headache, restless, mild fever, swelling, red spots on arm about an inch below injection site to the shoulder, discomfort.

VAERS ID:462291 (history)  Vaccinated:2012-05-23
Age:63.0  Onset:2012-05-24, Days after vaccination: 1
Gender:Female  Submitted:2012-08-06, Days after onset: 74
Location:Nebraska  Entered:2012-08-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Drug hypersensitivity; Hypertension
Preexisting Conditions: antimicrobial (unspecified), Drug hypersensitivity
Diagnostic Lab Data:
CDC Split Type: WAES1205USA05151
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0693AA0SCLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, 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: Information has been received from a Doctor of Pharmacy concerning a 63 year old female patient with sulfa allergy and high blood pressure who on 23-MAY-2012 was vaccinated SC with a dose of ZOSTAVAX (Merck) (dose not provided) (lot # 670816/0693AA, expiration date). The pharmacist reported that the patient developed a raised area at the injection site spreading 1.5 inches, soreness and itching after vaccination with ZOSTAVAX (Merck). Onset dates not provided. At the time of the report, the patient had not recovered from the events. The patient contacted the pharmacist. Follow up information has been received from the pharmacist concerning the patient with no illness at time of vaccination and no drug reactions or allergies (previously reported as sulfa allergy and high blood pressure), who on 23-MAY-2012 at 14:00, was vaccinated with a first dose of ZOSTAVAX (Merck) (dose not provided) subcutaneously in the upper left arm. The pharmacist reported that on 24-MAY-2012, the patient experienced swelling, itching, redness, pain and rash. There were no Lab diagnosis/studies performed. At the time of the report, the patient''s outcome regarding redness, swelling, itching and rash was unknown. Follow-up information has been received from the pharmacist concerning female patient with none of pre-existing medical conditions. It was reported that on 24-MAY-2012, the patient experienced redness, swelling, looked like a "rash" at the injection site. It was also reported that the patient thought she was getting shingles. At the time of report the patient''s outcome regarding to redness, swelling, looked like a "rash" at the injection site, "thought she was getting shingles" was recovered (date unspecified). The relatedness for the patient''s events was not provided for ZOSTAVAX. Additional information is not expected.

VAERS ID:462888 (history)  Vaccinated:2012-05-23
Age:33.0  Onset:2012-05-23, Days after vaccination: 0
Gender:Male  Submitted:2012-08-07, Days after onset: 76
Location:New York  Entered:2012-08-07
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: WAES1208USA000067
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Rash erythematous
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: This spontaneous report as received from a nurse practitioner refers to a 33 years old male patient with no pertinent medical history and no drug reactions/allergies. The patient was intramuscularly vaccinated with the first dose of GARDASIL (Lot #, dose were unspecified) on 23-MAY-2012. No other co-suspects were reported. No concomitant medications were used. It was reported that the patient was administered the dose in the GARDASIL series on 23-MAY-2012 and "within a couple of hours a red rash appeared on his neck and chest". The patient had sought medical attention via contacting physician via e-mail. No lab diagnostics studies performed. No treatment was given for AE. While the exact date the rash resolved was unknown, the nurse practitioner noted the rash "had resolved by 01-JUN-2012 but may have been earlier". No subsequent doses of GARDASIL had been administered. The outcome was reported as recovered/resolved. Additional has been requested.

VAERS ID:461475 (history)  Vaccinated:2012-05-23
Age:3.0  Onset:2012-05-23, Days after vaccination: 0
Gender:Male  Submitted:2012-08-09, Days after onset: 78
Location:Tennessee  Entered:2012-08-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS 3UNLA
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER 1UNLA
Administered by: Private     Purchased by: Other
Symptoms: Diarrhoea, Injection site erythema, Injection site nodule, Injection site swelling, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), 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: Fever ranging between 100.5-102 for 48 hours treated with ibuprofen. Diarrhea Vomiting Swollen and red area around injection site Knot at injection site that has remained until now (August 2012).

VAERS ID:463888 (history)  Vaccinated:2012-05-23
Age:72.0  Onset:2012-05-30, Days after vaccination: 7
Gender:Male  Submitted:2012-09-03, Days after onset: 96
Location:Illinois  Entered:2012-09-03
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: COPD, ventricular tachycardia, dry macular degeneration
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Private
Symptoms: Arthropathy, Dyskinesia, Limb injury, Suture insertion
SMQs:, Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Arthritis (broad)
Write-up: Knees buckled, less than 5 minutes; on several separate occasions, involuntary jerking of hands & arms, less than 5 minutes; result on 08/21/2012: 3 fingers into table saw, taken to ER, 30 stitches, several visits to hand therapist.

VAERS ID:465036 (history)  Vaccinated:2012-05-23
Age:0.5  Onset:2012-05-23, Days after vaccination: 0
Gender:Female  Submitted:2012-08-22, Days after onset: 91
Location:Maryland  Entered:2012-09-13, Days after submission: 22
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: The subject had RSV in February 2012 resulting in hospitalization for five days. The subject experienced restlessness and increase in body temperature with vaccines for normal schedule. but the reporter could not recall the names.
Diagnostic Lab Data: Body temperature, 102
CDC Split Type: A0980291A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALS  SYRLL
Administered by: Private     Purchased by: Private
Symptoms: Condition aggravated, Injection site erythema, Injection site pain, Pyrexia, Restlessness, Wrong drug administered
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a consumer and described the occurrence of injection site pain in a 6-month old female subject who was vaccinated with HIBERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject''s medical history included jaundice and respiratory syncytial virus. The subject received other vaccines, specific details were unknown. There were no concurrent medications. On the morning of 23 May 2012 the subject received unspecified dose of HIBERIX (unknown, left thigh) and experienced wrong vaccine administered. The subject was given HIBERIX instead of "regular HIB". On an unspecified date, less than one month after vaccination with HIBERIX, the subject experienced injection site pain, injection sire redness, high fever, and restlessness. The subject had a body temperature of 102, which was treated with TYLENOL. At the time of reporting the injection site pain, injection site redness, high fever, and restlessness were resolved.

VAERS ID:475988 (history)  Vaccinated:2012-05-23
Age:0.3  Onset:2012-05-25, Days after vaccination: 2
Gender:Female  Submitted:2012-06-11, Days after onset: 17
Location:Georgia  Entered:2012-11-29, Days after submission: 171
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PRILOSEC
Current Illness: GERD - ongoing; Routine Physical
Preexisting Conditions: GERD
Diagnostic Lab Data: Stool culture; C-Diff; O and P collected - 6-5-12.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC419AA1IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF899121IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0050AE1PO 
Administered by: Private     Purchased by: Private
Symptoms: Clostridium difficile colitis, Crying, Culture stool, Diarrhoea, Faeces discoloured, Haematochezia, Mucous stools, Salmonellosis, Vomiting, Weight decreased
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Pseudomembranous colitis (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (narrow)
Write-up: 2 days after vaccines - child started with black, mucus stools, 2-3 x q day. Then "blood" in stools - stated at day 4. Family went out of town. Loose stools increased to 8-10 x q day. Vomit 1-2 x. Cries during feed. Started losing weight. Pt. started trmt on 6/11/12. Diag: Salmonella sp. not typhi 6-11-12.

VAERS ID:530461 (history)  Vaccinated:2012-05-23
Age:12.0  Onset:2012-05-24, Days after vaccination: 1
Gender:Female  Submitted:2014-05-08, Days after onset: 714
Location:Texas  Entered:2014-05-08
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Lots of blood work which we can obtain the results if needed.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4023AA6IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU3765AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0448AA2SCRA
Administered by: Private     Purchased by: Private
Symptoms: Angioedema, Blister, Blood test, Depression, Diarrhoea, Erythema, Gastrointestinal disorder, Headache, Hypersensitivity, Rash pustular, Respiratory distress, Swelling face, Tremor, Urticaria, Varicella post vaccine, Vomiting
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Oropharyngeal allergic conditions (narrow), Acute central respiratory depression (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (narrow)
Write-up: Woke up with what seemed to be a mild outbreak of Chicken Pox, red, blistery pustules on hands and feet and trunk area. Developed, severe, chronic hives in June 2013 and continues to worsen over time, with no help from any doctors. She has now developed Angioedema, whole face swells, develops severe respiratory distress, gastrointestinal problems, including vomiting and diarrhea, severe headaches, depression, shaking, allergies. She basically is a different child with numerous health problems with no explanation and no cure. My daughter has 2 epi pens kept near her at all times, one with her and one is kept at school. Have spent so much money and numerous specialists to try to find answers to no avail.

VAERS ID:589821 (history)  Vaccinated:2012-05-23
Age:56.0  Onset:2012-05-29, Days after vaccination: 6
Gender:Unknown  Submitted:2012-08-09, Days after onset: 72
Location:New Jersey  Entered:2015-08-10, Days after submission: 1096
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201206273
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4051AA UNLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Mass, Pruritus, Tenderness
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Initial report received from a healthcare professional 18 June 2012. This case is linked to case number 2012-06476 and 2012-06477. A 56-year-old patient (gender not specified), whose medical history and concomitant medications were not reported, received a doses of ADACEL vaccine (batch number: C4051AA, route of vaccination not reported) in the left arm on 23 May 2012. On 29 May 2012, the patient had reaction with redness, Lump, itchy and very tenderness. Corrective medications were not reported. As of 18 June 2012, the outcome of the event was not reported. List of documents held by sender: none.

VAERS ID:457483 (history)  Vaccinated:2012-05-23
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2012-06-14
Location:Foreign  Entered:2012-06-15, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Serum antistreptolysin O antigen test, ??Jan12, negative antistreptolysin serology; Streptococcus group A culture, ??Jan12, negative throat swab (scarlatina ruled out)
CDC Split Type: WAES1206USA01325
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Culture throat negative, Erythema, Fixed eruption, Pain, Pruritus, Rash, Streptococcus test negative
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Serious case received from a physician (paediatrician at the hospital) on 05-JUN-2012 under the reference number TMI-2012-215. Medically confirmed. Seriousness criterion: hospitalization. A 12-year-old female patient (date of birth not reported) had received the first dose of GARDASIL (batch number unknown) on 23-MAY-2012. Vaccination was performed at school. Concomitant medication was: SINUTAB FORTE and DEXA-RHINOSPRAY. Indication was not reported. On 25-MAY-2012, the patient was seen on consultation at the hospital for itching skin on the body (torso and back). Treatment with corticoid was provided (no further details). One week later, she was hospitalized (on 01-JUN-2012) for an intense rash on the skin of body (torso and back) and limbs. Itching was painful. There was no fever. Exams showed negative antistreptolysin serology, negative Streptococcus culture from throat swab (scarlatina ruled out). The dermatologist diagnosed a fixed erythema (fixed exanthema) possibly related to medicines. Treatment: the patient received a medical treatment with corticoids. Outcome: corticoids resulted in improvement. The patient was discharged (with still some symptoms present) on 04-JUN-2012. The reporter (paediatrician) wanted to report the case although it was not clear for him what the cause could be. Other business partner numbers include E2012-03649. Additional information has been requested.

VAERS ID:457585 (history)  Vaccinated:2012-05-23
Age:0.3  Onset:2012-05-24, Days after vaccination: 1
Gender:Male  Submitted:2012-06-14, Days after onset: 21
Location:Foreign  Entered:2012-06-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: 24-MAY-2012, Body temperature, 39 Centigrade; 24-MAY-2012, White blood cell count, 21500 /mm3; 25-MAY-2012, White blood cell count, 14800 /mm3; 27-MAY-2012, White blood cell count, 13900 /mm3
CDC Split Type: 2012127473
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pyrexia, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: This is an initial spontaneous report from a contactable pediatrician. A 3-month-old male patient of an unspecified ethnicity received PREVENAR subcutaneously on 23May2012. No relevant history or concomitant medications were reported. On 24May2012, the patient presented with pyrexia of 39 degrees Centigrade, and his white blood cell count was increased. The patient was hospitalized on an unspecified date. Relevant laboratory data included WBC 21500/mm3 on 24May2012, 14800/mm3 on 25May2012, and 13900/mm3 on 27May2012. The outcomes of the events were recovering as of 25May2012. The reporting pediatrician classified the events as serious because of the patient''s hospitalization and assessed them as probably related to the PREVENAR. Follow-up (12Jun2012): New information reported by the same contactable pediatrician through a Pfizer sales representative included patient age and gender, vaccination date, onset date, relevant laboratory data, outcome information, seriousness criterion, and causality.

VAERS ID:457695 (history)  Vaccinated:2012-05-23
Age:33.0  Onset:2012-05-23, Days after vaccination: 0
Gender:Female  Submitted:2012-06-19, Days after onset: 27
Location:Foreign  Entered:2012-06-19
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: HIV negative, 23May2012, neg; Hepatitis B test negative, 23May2012, neg; Hepatitis C test negative, 23May2012, neg
CDC Split Type: A0979936A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: HIV test negative, Hepatitis B test negative, Hepatitis C test negative, Injury associated with device
SMQs:
Write-up: This case was reported by a pharmacist and described the occurrence of needle stick injury in a subject of unspecified age and gender who was administering TWINRIX (GlaxoSmithKline). On an unspecified date in May 2012 the subject administered an unspecified dose of TWINRIX (unknown) and experienced needle stick injury. At the time of reporting the outcome of the needle stick injury was unspecified. Follow-up information was received on 14 June 2012 via healthcare professional who clarified the suspect vaccine was HAVRIX, not TWINRIX as previously reported. The 34-year-old female subject injured herself while recapping a dirty needle following a HAVRIX injection/administering. Multiple factors were involved in incident occurrence including administering the injection in pick - up area (non-private) of pharmacy and using pre-filled HAVRIX which does not have safety needle. The needle stick occurred on 23 May 2012 and resolved on an unknown date. Laboratory tests performed on 23 May 2012 included Hepatitis B, Hepatitis C and HIV (Human immunodeficiency Virus); results were negative for all tests. The reporting healthcare professional considered the needle stick possibly related to HAVRIX administration. The healthcare professional considered the event life threatening.

VAERS ID:459502 (history)  Vaccinated:2012-05-23
Age:9.0  Onset:2012-05-28, Days after vaccination: 5
Gender:Female  Submitted:2012-07-13, Days after onset: 46
Location:Foreign  Entered:2012-07-17, Days after submission: 4
Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data: 05/29/2012, Autoantibody test, negative, several; 05/29/2012, Biopsy heart, No myocarditis, no cardiomyopathy; 05/29/2012, Biopsy muscle, No anomalies; 05/28/2012, Computerised tomogram, intracranial hemorrhage; 05/28/2012, Echocardiogram, Abnormal; 05/28/2012, Platelet count, Normal; 05/29/2012, Viral test, Negative, No acute infections
CDC Split Type: WAES1207NLD000192
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTIPV: DT + IPV (NO BRAND NAME)UNKNOWN MANUFACTURER143C5UNUN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURERG0076721UNUN
Administered by: Other     Purchased by: Other
Symptoms: Autoantibody negative, Biopsy heart normal, Brain herniation, Cardiac output, Cerebellar haemorrhage, Cerebellar infarction, Computerised tomogram head abnormal, Death, Echocardiogram abnormal, Epistaxis, Headache, Hyporesponsive to stimuli, Microbiology test normal, Platelet count normal, Pyrexia, Resuscitation, Syncope, Viral test negative, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Case received from the Health Authorities on 29-Jun-2012 under the reference number NL-LRB-139774. Medically confirmed. Initial source was a physician (also reported as a specialist doctor, pediatric intensive care). Case reported as serious by the agency (criterion: death). A 9-year-old female patient (weight 30 kg) had received the second dose of MMRVAXPRO (batch number G007672, administration site unknown) and the sixth dose of NVI (batch number 143C, administration site unknown) on 23-May-2012 in the Childhood Immunisation Programme. Concomitant medication was not reported. The day after the vaccinations, the patient developed fever, with 4 nose bleeds and headache at day 2 and 3. It was unknown if she had dizziness or diplopia, there was no rhinorroea. Nose bleeds were never experienced before. In the afternoon of day 4 she had somewhat recovered and went swimming. In the early morning of day 5 she got up from bed with suddenly severe headache and vomiting, and collapsed. She was resuscitated 5 times, transported to the regional hospital, which referred her to a university medical centre for extracorporeal membrane oxygenation (ECMO) therapy, for which anticoagulant therapy is required. At the centre, she had a massive infarction from the arteria basilaris was found by brain CT scanning, with signs of transtentorial herniation. There was decreasing response to stimuli. Further treatment was not done after the which the patient died. Medical history: The patient had no known medical history. She was said to be healthy with good endurance. She had no known past drug therapy. Physical findings and investigations: CT scan cerebrum 28-May-2012: massive hemorrhage and infarction in the right cerebellar region from the arteria basilaris was found by brain scanning, with signs of transtentional herniation and cerebellar edema. Postmortem investigations: the parents did not consent to autopsy, but agreed to less invasive diagnostics. A heart muscle biopsy was done to investigate cardiac anomalies (myocarditis/cardiomyopathy: pathology was normal and no signs of viral infection). Other areas of investigation: microbiology (no indication of acute viral infection), coagulation disorders (normal platelet, no indications of preexisting bleeding disorders), further brain pathology (CT scan brain not suitable to evaluate presence of vascular anomalies eg aneurisms). Treatment and clinical course: After the collapse incident she was resuscitated. Cardiac output was marginal due to diminished contractility and dilatation, however initially responsive to adrenalin. There were no signs for thombotic process elsewhere. Then ECMO treatment was started till it became clear that massive brain damage had occurred. Postmortem myocarditis and cardiomyopathy were excluded, there were no indication for an acute infection, no auto-immune disorder, no thrombocytopenia. Causality assessment and concluding summary: Causality for the eventually fatal intracranial hemorrhage and vaccinations was considered unlikely. This unique but tragic condition had not been reported earlier, and is most likely caused by another yet unknown mechanism. There is no biologic explanation, and the timing of events is inconsistent with known side effects of these vaccines. The following MedDRA LLT was coded by the agency: Intracrainial hemorrhage (5days). Patient outcome: fatal. No further information expected.

VAERS ID:460818 (history)  Vaccinated:2012-05-23
Age:0.3  Onset:2012-05-24, Days after vaccination: 1
Gender:Female  Submitted:2012-07-30, Days after onset: 67
Location:Foreign  Entered:2012-08-01, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical history and concomitant medications were not reported.
Diagnostic Lab Data: Not reported
CDC Split Type: 201207110
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER20910001B SCUN
HIBV: HIB (ACTHIB)SANOFI PASTEURG9965 IMUN
IPV: POLIO VIRUS, INACT. (POLIOVAX)SANOFI PASTEURE5983 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction, 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: Case received from the Health Authorities through the local affiliate in a foreign country on 19 July 2012 under the local number PL-URPL-OCR-2020618007 (local reference number 2012-0227). A 03-month-old patient (unspecified gender), with no reported medical history and concomitant therapy, had received an intramuscular dose of IMOVAX batch number E5983-2, site of administration not reported, an intramuscular dose of ACT-HIB batch number G9965-1, site of administration not reported and a subcutaneous dose of DTP batch number 20910001B, site of administration not reported, on 23 May 2012. On 24 May 2012, the patient presented with injection site reaction 3-5 cm in diameter on the site of DTP administration, tactile pain, redness, oedema and fever up to 39 C. The patient was referred to hospital, wraps at the injection site and antipyretics were recommended. The patient was hospitalized for 2 days (dates not reported) due to persistence of fever. The patient recovered at the time of reporting. The Health Authorities coded: "injection site reaction", "injection site pain", "injection site redness", "injection site oedema" and "fever". Documents held by sender: none.

VAERS ID:461001 (history)  Vaccinated:2012-05-23
Age:1.7  Onset:2012-05-23, Days after vaccination: 0
Gender:Unknown  Submitted:2012-08-01, Days after onset: 70
Location:Foreign  Entered:2012-08-03, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical history not reported.
Diagnostic Lab Data: Not reported
CDC Split Type: 201207083
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER20911001B SCUN
HIBV: HIB (ACTHIB)SANOFI PASTEURG9965 SCUN
IPV: POLIO VIRUS, INACT. (POLIOVAX)SANOFI PASTEURG7158 SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crying, Diarrhoea, Injection site reaction, Pyrexia, Restlessness
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Akathisia (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (narrow)
Write-up: Case received from the Health Authorities through the local affiliate in a foreign country on 19 July 2012 under the local number PL-URPL-OCR-20120626004 (local reference number 2012/0215). A 20-month-old patient (unspecified gender), with no reported medical history and no reported concomitant therapy, had received a subcutaneous dose of ACT-HIB batch number G9965-1, a subcutaneous dose of IMOVAX batch number G7158-1 and a subcutaneous dose of DTP batch number 20911001B, on 23 May 2012. On the same day post vaccination, the patient presented with high fever up to 38.5 C and restlessness. The patient was hospitalized for 6 days (dates not reported). On admission, the patient experienced loose stools. The patient recovered at the time of reporting. The Health Authorities coded: "injection site reaction" and "crying uncontrollable". Documents held by sender: none.

VAERS ID:465594 (history)  Vaccinated:2012-05-23
Age:13.0  Onset:2012-06-15, Days after vaccination: 23
Gender:Female  Submitted:2012-09-19, Days after onset: 96
Location:Foreign  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: UNK
CDC Split Type: B0830675A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA162CA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Arthritis, Gait disturbance, Pyrexia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Arthritis (narrow)
Write-up: This case was reported by a physician and described the occurrence of arthritis in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 23 May 2012, the subject received unspecified dose of CERVARIX (.5 ml, intramuscular, unknown injection site). On 15 June 2012 to around 20 June 2012, 23 days after vaccination with CERVARIX, the subject experienced knee pain. The pain spread to the joint involving lower leg. The subject consulted the reporter. On 28 June 2012, the subject was referred to hospital A. Fever was observed. On 06 July 2012, the subject visited the reporter''s hospital. She had walking difficulty. During July and August 2012, the subject visited the hospital A several times. The physician considered the events were clinically significant (or requiring intervention). On 07 September 2012, the subject was able to walk, and except for fever, all the events were improved. The outcome of fever was unspecified. The physician considered the events were possibly related to vaccination with CERVARIX: when the subject experienced the events, mycoplasmal pneumonia was prevalent in the region and the subject had fever, so she could have been infected by pneumonia, and suspected arthritis due to mycoplasma could not be denied. However, the possibility of arthritis due to CERVARIX could not be denied as well.

VAERS ID:483703 (history)  Vaccinated:2012-05-23
Age:67.0  Onset:0000-00-00
Gender:Male  Submitted:2013-02-06
Location:Foreign  Entered:2013-02-07, 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: 201301594
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4407AA0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Headache
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 foreign Ministry of Health. A male patient (age reported as 67-year-old), whose medical history and concomitant therapies were not reported, had received his 1st dose of FLUZONE, lot number U4407AA (route and anatomical site of administration not reported) on 23 May 2012. On an unspecified date post-vaccination the patient experienced headache. The patient''s outcome was recovered without sequelae. The case was assessed as serious by the Ministry of Health. The patient was hospitalized. Documents held by sender: None.

VAERS ID:483934 (history)  Vaccinated:2012-05-23
Age:56.0  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: No information reported
Diagnostic Lab Data: None reported.
CDC Split Type: 201301469
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4400AA UNUN
TD: TD ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURER1007169 UNUN
YF: YELLOW FEVER (NO BRAND NAME)UNKNOWN MANUFACTURER108VFA062Z UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Feeling hot, Induration, Oedema, Pain
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)
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 foreign Ministry of Health. A 56-year-old female patient, whose medical history and concomitant therapies were not reported, had received her first booster dose of yellow fever vaccination (manufacturer unknown), lot number 108VFA062Z, diphtheria and tetanus toxoid vaccination (manufacturer unknown), lot number 1007169, and FLUZONE vaccination, lot number U4400AA (routes and anatomical sites of administration not reported) on 23 May 2012. On an unspecified date post-vaccination the patient experienced heating, pain, edema, and induration. The patient''s outcome was recovered without sequelae. The case was assessed as serious by the Ministry of Health. The patient was hospitalized. Additional information is not expected. Documents held by sender: None.

VAERS ID:484241 (history)  Vaccinated:2012-05-23
Age:44.0  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? 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: 201301943
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4400AA0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abscess, Induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)
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 "44-year-old"), whose medical history and concomitant therapies were not reported, had received her 1st dose of FLUZONE, lot number U4400AA, (route and anatomical site of administration not reported) on 23 May 2012. On an unspecified date post-vaccination the patient experienced local host abscess and induration. 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:484255 (history)  Vaccinated:2012-05-23
Age:65.0  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? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: not reported
Diagnostic Lab Data: not reported
CDC Split Type: 201301969
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4400AA UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Erythema, Oedema, Pain, Paraesthesia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Arthritis (broad)
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 foreign Ministry of Health. An elderly male patient (age reported as "65 years 10 months old"), whose medical history and concomitant therapies were not reported, had received a dose of FLUZONE during a campaign, lot number U4400AA, (route and anatomical site of administration not reported) on 23 May 2012. On an unspecified date post-vaccination the patient experienced pain, oedema, erythema, paresthesia and arthralgia. The patient''s outcome was recovered with no 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:484530 (history)  Vaccinated:2012-05-23
Age:7.0  Onset:0000-00-00
Gender:Male  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: The patient''s medical history and concomitant medications were not reported.
Diagnostic Lab Data: Not reported
CDC Split Type: 201301818
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4387AA UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Gait disturbance, Headache, Pyrexia, Urticaria, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (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 male patient (age reported as 7 years), whose medical history and concomitant therapies were not reported, had received his campaign dose of FLUZONE vaccine (lot number U4387AA, dose number, route and anatomical site of administration were not reported) on 23 May 2012. On an unspecified date post-vaccination the patient experienced generalized urticaria, fever greater than or equal to 39.5 degree Celsius, difficulty walking, headache and vomiting. The patient''s outcome was recovered ("cure") without sequelae. The action regarding next vaccinations was reported as: contraindication with no scheme change. The case was assessed as serious by the Ministry of Health. The patient was hospitalized. The resolution was reported as: "confirmed". Documents held by sender: None.

VAERS ID:484532 (history)  Vaccinated:2012-05-23
Age:0.9  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: The patient''s medical history and concomitant medications were not reported.
Diagnostic Lab Data: Laboratory data were not reported.
CDC Split Type: 201301815
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4387AA0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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 foreign Ministry of Health. A female patient, whose medical history and concomitant therapies were not reported, had received first dose of FLUZONE, lot number U4387AA, (route and anatomical site of administration not reported) on 23 May 2012. On an unspecified date post-vaccination the patient experienced fever more than or equal to 39.5 degree Celsius. The patient was recovered without sequelae. The action regarding next vaccinations is reported as: scheme maintained. The resolution was reported as ''Indefined''. The case was assessed as serious by the Ministry of Health. The patient was hospitalized. Documents held by sender: None.

VAERS ID:484547 (history)  Vaccinated:2012-05-23
Age:0.9  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: Patient''s medical history and concomitant therapies were not reported.
Diagnostic Lab Data: Not reported
CDC Split Type: 201301976
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4387AA UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pyrexia, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (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 "11-month-14-days-old") whose medical history and concomitant therapies were not reported, had received her dose of FLUZONE, lot number U4387AA (route and anatomical site of administration not reported) on 23 May 2012. On an unspecified date post-vaccination the patient experienced generalized urticaria and fever < 39.5 degrees Celsius. The patient had recovered ("cure") without sequelae. The action regarding next vaccinations is reported as: scheme maintained. The patient''s outcome was recovered without sequelae. The case was assessed as serious by the Ministry of Health. The patient was hospitalized. The resolution was reported as "confirmed". Documents held by sender: None.

VAERS ID:456210 (history)  Vaccinated:2012-05-24
Age:4.0  Onset:2012-05-24, Days after vaccination: 0
Gender:Female  Submitted:2012-05-24, Days after onset: 0
Location:Wisconsin  Entered:2012-05-25, 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: No
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4186AA3IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURH13053SCLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1571AA1SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0046AE1SCRL
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Acute urticarial rash 3x6 inches over anterior thigh. Site of DTaP. BENADRYL given.

VAERS ID:456233 (history)  Vaccinated:2012-05-24
Age:18.0  Onset:2012-05-25, Days after vaccination: 1
Gender:Female  Submitted:2012-05-25, Days after onset: 0
Location:Massachusetts  Entered:2012-05-25
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
HPV4: HPV (GARDASIL)MERCK & CO. INC.0026AE2IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0420AA1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site reaction, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This morning pt noticed red, raised area on back of left arm (injection site of Varicella vaccine) - not painful. Pt was examined at nurse visit and advised to ice area & apply either BENADRYL cream, Hydrocortisone cream, or take BENADRYL PO (per Dr) and call us if it worsens/becomes painful.

VAERS ID:456234 (history)  Vaccinated:2012-05-24
Age:18.0  Onset:2012-05-24, Days after vaccination: 0
Gender:Male  Submitted:2012-05-24, Days after onset: 0
Location:Massachusetts  Entered:2012-05-25, 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
HPV4: HPV (GARDASIL)MERCK & CO. INC.1537AA2SYRLA
Administered by: Private     Purchased by: Unknown
Symptoms: Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: Pt c/o numbness in (L) legafter GARDASIL #3 shot given in (L) arm.

VAERS ID:456253 (history)  Vaccinated:2012-05-24
Age:58.0  Onset:2012-05-26, Days after vaccination: 2
Gender:Female  Submitted:2012-05-26, Days after onset: 0
Location:New York  Entered:2012-05-26
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: Allergies to dust, cats, trees, mold, hay
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Other     Purchased by: Private
Symptoms: Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Hives and itching.

VAERS ID:456352 (history)  Vaccinated:2012-05-24
Age:11.0  Onset:2012-05-25, Days after vaccination: 1
Gender:Male  Submitted:2012-05-29, Days after onset: 4
Location:Florida  Entered:2012-05-29
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: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU3779AA IM 
TDAP: TDAP (ADACEL)SANOFI PASTEURU3486CA IM 
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1148AA SC 
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Quarter size red, warm induration at vaccine site.

VAERS ID:456477 (history)  Vaccinated:2012-05-24
Age:76.0  Onset:2012-05-28, Days after vaccination: 4
Gender:Female  Submitted:2012-05-30, Days after onset: 2
Location:Wisconsin  Entered:2012-05-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No.
Preexisting Conditions: Hypertension, high cholesterol
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC3837BA IMLA
Administered by: Public     Purchased by: Public
Symptoms: Blister, Injection site erythema, Myalgia, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Severe cutaneous adverse reactions (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad)
Write-up: 5/28/12 aching pain to deltoid muscle; 5/29/12 approx 1/4 inch redness at injection point; below point increased aching pain and redness developed approx 1/3"; 5/30/12 AM after rising; a second area of redness developed with possible 3 blisters just below starting point of redness, area approx 1X2". Clear area of skin between both areas of redness. Area is not raised but irregular, not rashy appearing. Client denies itchiness, headache, fever or flu-like symptoms.

VAERS ID:456526 (history)  Vaccinated:2012-05-24
Age:21.0  Onset:2012-05-24, Days after vaccination: 0
Gender:Male  Submitted:2012-05-25, Days after onset: 1
Location:North Carolina  Entered:2012-05-31, 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: ADHD; Acne
Diagnostic Lab Data:
CDC Split Type: NC12007
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0131AE IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURAC52B076AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Disorientation, Dizziness, Excoriation, Eye swelling, Headache, Tremor, Visual impairment, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Pt stated he felt dizzy about 5 min after being given 2 vaccines listed above. Doctor stepped out of room to get patient water. Door to room slammed shut within 5-10 seconds. I ran to room. Patient face down on floor, I rolled him over. He was looking at me but unaware of surroundings & shaking. He recovered in about 10 seconds. He had abrasion to right temple & swelling about right eye. He complained of headache & vision changes. Vision changes resolved about 1 hr. He threw up once 2-3 hr after event. He went home after 1 hour of observation.

VAERS ID:456562 (history)  Vaccinated:2012-05-24
Age:36.0  Onset:2012-05-24, Days after vaccination: 0
Gender:Female  Submitted:2012-05-30, Days after onset: 6
Location:Michigan  Entered:2012-05-31, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma; Drug hypersensitivity; Allergic reaction to antibiotics; Penicillin allergy
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1205USA04754
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Chest discomfort, Hypersensitivity, Paraesthesia oral, Pruritus, Swollen tongue, Tongue disorder, Tongue dry, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a Medical Assistant concerning a 36 year old female patient with "asthma years ago", allergic reaction to BENADRYL, neomycin, KEFLEX, CIPRO, loratadine and penicillin allergy, who on 24-MAY-2012 was vaccinated with a dose of MMR II (lot#, dose and route not reported). Concomitant therapy included tuberculin purified protein derivative, received on 22-MAY-2012 (reported as "received PPD two days ago"). It was reported that on 24-MAY-2012 after vaccination the patient almost immediately had an allergic reaction to the neomycin component of the vaccine. Reporter stated that the patient began to experience itching and then began breaking out in hives. Her tongue swelled and "it was that thick, dry prickly tongue, and she became heavy chested but not short of breath". The medical assistant reported that the patient received epinephrine 0.4ml immediately and "was sent to the emergency room". At the time of reporting the patient status was unknown. Almost immediately allergic reaction to the neomycin component of the vaccine was considered to be immediately life-threatening and other important medical event. Additional information has been requested.

VAERS ID:456644 (history)  Vaccinated:2012-05-24
Age:0.5  Onset:2012-05-28, Days after vaccination: 4
Gender:Male  Submitted:2012-06-01, Days after onset: 4
Location:New York  Entered:2012-06-01
Life Threatening? No
Died? Yes
   Date died: 2012-05-29
   Days after onset: 1
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Otitis media, cough
Preexisting Conditions: none
Diagnostic Lab Data: Xray: No focal pulmonary consolidation. Multiple prominent air filled bowel loops. No free air.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B305CA2IMRL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.UH416AB2IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF654422IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1474AA2PO 
Administered by: Private     Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal mass, Abnormal behaviour, Apnoeic attack, Autopsy, Cardiac arrest, Death, Diarrhoea, Flatulence, Haematochezia, Intussusception, Irritability, Mechanical ventilation, Resuscitation, X-ray abnormal
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (narrow), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow)
Write-up: On 5/28/2012 began having diarrhea. On 5/29/12 am, he was a little fussy in the morning - mom gave gripe water and baby oragel. The babysitter called dad in the afternoon saying that the patient was not himself. When the dad picked him up he said the child was "out of it". Went to grandfathers house and called EMS. On EMS arrival patient had pulse in the 140''s and RR in the 30''s, by the time patient arrived at the ED patient was apneic and asystolic with bag valve mask ventilation being performed. Resusscitation was unsuccessful and the patient passed away. Upon attempt at a rectal temperature, bloody stool was noted in the diaper. There was also a palpable mass in the abdomen. The medical examiner confirmed the presence of intussusception on the autopsy.

VAERS ID:456698 (history)  Vaccinated:2012-05-24
Age:45.0  Onset:2012-05-25, Days after vaccination: 1
Gender:Female  Submitted:2012-05-29, Days after onset: 4
Location:Wisconsin  Entered:2012-06-01, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4008BA IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Axillary pain, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Soreness at site on (R) deltoid & on axilla. Vaccine 5/24/12. Office visit 5/29/12.

VAERS ID:456668 (history)  Vaccinated:2012-05-24
Age:85.0  Onset:2012-05-25, Days after vaccination: 1
Gender:Female  Submitted:2012-06-01, Days after onset: 7
Location:Washington  Entered:2012-06-02, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4329AA0IMRA
Administered by: Other     Purchased by: Unknown
Symptoms: Contusion, Feeling hot, Oedema peripheral, Pain, Skin discolouration, Skin mass
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: Onset: within 24 hours - very large bruise. Bruises, discolored, achy, hot, with a hard lump under the skin. Bruise is slowly resolving w/o treatment. Arm swollen: bruise 3" in diameter day 1 then 5" by day 2.

VAERS ID:456783 (history)  Vaccinated:2012-05-24
Age:44.0  Onset:2012-05-25, Days after vaccination: 1
Gender:Male  Submitted:2012-06-04, Days after onset: 10
Location:Alaska  Entered:2012-06-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Denied
Preexisting Conditions: Seasonal Allergies
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1374911A IMLA
Administered by: Other     Purchased by: Private
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Developed small bumps along the right jaw line to mid chin and then beneath left jaw in upper throat area. Made worse by shaving so he stopped shaving.

VAERS ID:456784 (history)  Vaccinated:2012-05-24
Age:36.0  Onset:2012-05-25, Days after vaccination: 1
Gender:Female  Submitted:2012-06-04, Days after onset: 10
Location:Alaska  Entered:2012-06-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Fatigue, Migraine Headaches
Preexisting Conditions: Migraine Headaches
Diagnostic Lab Data: Done by private health care provider
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS13749111A IMLA
Administered by: Other     Purchased by: Private
Symptoms: Laryngitis, Oropharyngeal pain, Otitis media, Pyrexia, Upper respiratory tract infection
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow)
Write-up: Sore throat, laryngitis, bilateral otitis media, fever, URTI sxs.

VAERS ID:456793 (history)  Vaccinated:2012-05-24
Age:22.0  Onset:2012-05-25, Days after vaccination: 1
Gender:Female  Submitted:2012-06-04, Days after onset: 10
Location:Pennsylvania  Entered:2012-06-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU3906AB1IMUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1881AD1SCUN
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Pain, Pruritus, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Red, bubbly area 2" long. No itching. Warm to touch, pain with pressure 5-25-12. Warm compresses, TYLENOL/ADVIL. ER 5-27-12 MEDROL DOSEPAK. Increased itching 5-28-12 - additional dose ZYRTEC & use BENADRYL cream.

VAERS ID:456851 (history)  Vaccinated:2012-05-24
Age:64.0  Onset:2012-05-24, Days after vaccination: 0
Gender:Male  Submitted:2012-06-05, Days after onset: 12
Location:Unknown  Entered:2012-06-06, Days after submission: 1
Life Threatening? Yes
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: Unknown
CDC Split Type: WAES1205USA05421
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1655AA SCAR
Administered by: Other     Purchased by: Other
Symptoms: Cardiac monitoring, Dyspnoea, Injection site swelling
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)
Write-up: Information has been received from a Registered Pharmacist (R.P.) concerning a 64 year old male patient, with none drug reactions/allergies and none pertinent medical history, who on 24-MAY-2012 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# 672606/1655AA, Expiration date 21-JAN-2013) (dose not reported), SQ. There was no concomitant medication. Pharmacist reported that on 24-MAY-2012, within an hour of being administered ZOSTAVAX (Merck) the arm where the vaccine was administered swelled and that the patient was having difficulty breathing. The patient spent the night at the emergency room but was not admitted to the hospital and had his heart monitored. When the patient left the emergency room he was fine. At the time of reporting the patient status was recovered. The arm where the vaccine was swelled and that the patient was having difficulty breathing were considered to be immediately life-threatening. Additional information has been requested.

VAERS ID:456872 (history)  Vaccinated:2012-05-24
Age:65.0  Onset:2012-05-24, Days after vaccination: 0
Gender:Female  Submitted:2012-05-30, Days after onset: 6
Location:New Hampshire  Entered:2012-06-06, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None.
Preexisting Conditions: HTN; Hypercholesterolemia; Osteopenia.
Diagnostic Lab Data: Ultrasound, venous, negative for DVT
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0616AE0SCLA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site injury, Injection site pain, Injection site swelling, Ultrasound Doppler normal
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 5/24/12 patient received ZOSTAVAX vaccine 5/26/12 - patient presents with minimal pain, superficial swelling, pinpoint cuts at injection site. No other symptoms other than these local reactions.

VAERS ID:456896 (history)  Vaccinated:2012-05-24
Age:1.4  Onset:2012-05-25, Days after vaccination: 1
Gender:Female  Submitted:2012-05-25, Days after onset: 0
Location:New Mexico  Entered:2012-06-06, 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:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B140CA0UNRL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0958AA0UNRL
Administered by: Private     Purchased by: Public
Symptoms: Injection site pain, Injection site reaction, Irritability, Pyrexia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad)
Write-up: Fever 103 degrees - 104 degrees, shaking pain on (R) leg. Very fussy. Started on 5/24/12 around at 7:00 pm.

VAERS ID:456967 (history)  Vaccinated:2012-05-24
Age:17.0  Onset:2012-05-24, Days after vaccination: 0
Gender:Female  Submitted:2012-05-29, Days after onset: 5
Location:Arizona  Entered:2012-06-07, Days after submission: 9
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
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEUR615410IMLA
Administered by: Private     Purchased by: Private
Symptoms: Arthralgia, Headache, Myalgia, Pyrexia, Urticaria
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Pt c/o joint pain & low grade fever, myalgia & HA with subsequent hives (mild).

VAERS ID:457009 (history)  Vaccinated:2012-05-24
Age:53.0  Onset:0000-00-00
Gender:Male  Submitted:2012-06-07
Location:Arkansas  Entered:2012-06-07
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
TDAP: TDAP (ADACEL)SANOFI PASTEURC3941AA IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.07502 IMLA
Administered by: Public     Purchased by: Public
Symptoms: Expired drug administered
SMQs:
Write-up: Expired Medication Administered

VAERS ID:457201 (history)  Vaccinated:2012-05-24
Age:0.3  Onset:2012-05-24, Days after vaccination: 0
Gender:Male  Submitted:2012-05-25, Days after onset: 1
Location:Pennsylvania  Entered:2012-06-11, 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: PA12504
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4026AA0IMRL
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC029CA0IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF137800IMLL
Administered by: Public     Purchased by: Public
Symptoms: Grunting, Pain, Pallor, Skin warm
SMQs:, Hypotonic-hyporesponsive episode (broad)
Write-up: About 5 hours (340) after receiving immunizations mom states child became very pale and was making "grunting noises." Mom states child seemed bothered when she moved his legs. Mom did not check temp but stated child "felt a little warm". Mom states after about 20 min child "seemed more himself". During that time mom put child in a cooler environment. She gave water & TYLENOL at 420pm.

VAERS ID:457206 (history)  Vaccinated:2012-05-24
Age:0.2  Onset:2012-05-24, Days after vaccination: 0
Gender:Male  Submitted:2012-05-25, Days after onset: 1
Location:Michigan  Entered:2012-06-11, Days after submission: 17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B329AB0UNLL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.1785AA0UNLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF533760UNRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1240AA0PO 
Administered by: Public     Purchased by: Public
Symptoms: Crying, Injection site erythema, Injection site haematoma, Mood altered, Somnolence
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Depression (excl suicide and self injury) (broad)
Write-up: Per note at Office visit on 5/24/12 at 4:40 PM- Mom said cried for an hour, could not be consoled. No known fever. Noticed redness of both legs extending thigh to foot, red & bruised appearing (3PM). Slept a lot of the day but did feed a couple of times. Legs much less red at office visit - no swelling of extremities. Bilat exterior legs & abdomen are somewhat pinker than surrounding skin and the intensity of pink tone varied during the exam - Brisk capillary refill. To use APAP UAD PRN for fussiness, cool compresses to legs. If inconsolable or other concerns go to ER. To call tomorrow if further problems. I tried calling mom & also sent postcard to obtain info on recovery. No return call. 6-4-12 at 2:10 pm. Mom returned call and said pinkness dissipated that evening and except for being somewhat moody the rest of the week he was fine.

VAERS ID:457456 (history)  Vaccinated:2012-05-24
Age:46.0  Onset:2012-05-24, Days after vaccination: 0
Gender:Female  Submitted:2012-06-14, Days after onset: 21
Location:Guam  Entered:2012-06-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4305BA IM 
Administered by: Military     Purchased by: Military
Symptoms: Asthenia, Body temperature increased, Dizziness, Headache, Injected limb mobility decreased, Injection site pain, Injection site swelling, Pyrexia, Vaccination complication
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad)
Write-up: Pt afebrile w/slight elev temp. VSS. Pt w/moderate to severe reaction to Tdap vaccination. Requests reaction to be documented. Pt reports receiving imms on 24 May 2012. Awoke following morning w/fever and HA 7/10. Pt took aspirin, reported to work w/mild HA. Home temp was 101.1F, txt at home w/OTC meds (Motrin, Tylenol), which resolved after 3 days. Pt left work early on Fri and began to feel weak and dizzy. Right arm at site of injection was swollen and painful to touch, w/ difficulty lifting arm x 3 days. Pt asymptomatic for moderate to severe Tdap vaccination rxn at this time.

VAERS ID:457642 (history)  Vaccinated:2012-05-24
Age:0.4  Onset:2012-05-25, Days after vaccination: 1
Gender:Female  Submitted:2012-06-19, Days after onset: 25
Location:Florida  Entered:2012-06-19
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
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEUR 1IMLG
Administered by: Private     Purchased by: Other
Symptoms: Eating disorder, Insomnia, Irritability, Pyrexia, Screaming
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad)
Write-up: For the next week my daughter was screaming and fussy beyond control. Maintained a fairly high fever and had trouble sleeping and eating. Symptoms lasted for one week exactly and then all returned to normal.

VAERS ID:458331 (history)  Vaccinated:2012-05-24
Age:1.4  Onset:2012-05-24, Days after vaccination: 0
Gender:Male  Submitted:2012-06-19, Days after onset: 26
Location:Texas  Entered:2012-06-28, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALSAHIBC263BA3UNLL
Administered by: Private     Purchased by: Other
Symptoms: Unevaluable event
SMQs:
Write-up: None.

VAERS ID:458378 (history)  Vaccinated:2012-05-24
Age:63.0  Onset:2012-06-05, Days after vaccination: 12
Gender:Female  Submitted:2012-06-28, Days after onset: 23
Location:Ohio  Entered:2012-06-28
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
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1656AA UNLA
Administered by: Other     Purchased by: Private
Symptoms: Blister, Herpes zoster, Pruritus, Rash
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Mild case of shingles, tiny vesicles on flank area, rash & itching at site of reaction. Showed up the following 2 weeks, received triamcinolone 0.5% cr. on 6/5/12.

VAERS ID:458501 (history)  Vaccinated:2012-05-24
Age:40.0  Onset:2012-05-24, Days after vaccination: 0
Gender:Female  Submitted:2012-06-29, Days after onset: 36
Location:Washington  Entered:2012-06-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRAR
Administered by: Other     Purchased by: Public
Symptoms: Arthralgia, Asthenia, Chills, Ear pain, Fatigue, Headache, Increased upper airway secretion, Musculoskeletal pain, Musculoskeletal stiffness, Nasal congestion, Oropharyngeal pain, Pain, Pain in extremity, Productive cough, Pyrexia, Sinus congestion, Throat irritation
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: 5/24/2012: Sore stiff arm and shoulder on side where shot given, lasting 2 days. Sore throat and ear ache developed in PM, lasting 4 days. 5/25/2012: Exhaustion and weakness, headache, joint aches all over body, chills, slight fever, lasting all day. 5/26/2012: Very slight nasal congestion; heavy, aching lungs and very large amounts of mucous in throat (to the point it felt like it might obstruct breathing several times); lasting 3 days. 5/27/2012: Sinus congestion and productive cough with yellow or dark mucous; lasting about 10 days. 6/8/2012: Nasal congestion reduced but still present; cough becoming drier and less productive, although still somewhat productive; lasting about 2 weeks. 6/22/2012: Nasal congestion mostly gone; cough dry and tickling in throat and lungs with occasional production of large blobs of mucous; lasting one week so far, with no sign of lessened severity at this time.

VAERS ID:458990 (history)  Vaccinated:2012-05-24
Age:63.0  Onset:2012-05-28, Days after vaccination: 4
Gender:Female  Submitted:2012-07-11, Days after onset: 44
Location:California  Entered:2012-07-11
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: CFS; Depression; TMJ; OCD; Raynaud''s; Asthma; Allergic rhinitis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0025AE0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Cellulitis
SMQs:
Write-up: Cellulitis required KEFLEX, IV Vancomycin, BACTRIM DS.

VAERS ID:459405 (history)  Vaccinated:2012-05-24
Age:28.0  Onset:0000-00-00
Gender:Female  Submitted:2012-07-16
Location:Michigan  Entered:2012-07-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4305BA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Maternal exposure during pregnancy, Wrong drug administered
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Pt was pregnant 11.5 weeks and received a Tdap vaccine instead of a f/u injection. The Tdap is recommended for 20 week and over.

VAERS ID:459907 (history)  Vaccinated:2012-05-24
Age:81.0  Onset:2012-05-24, Days after vaccination: 0
Gender:Female  Submitted:2012-07-17, Days after onset: 54
Location:Virginia  Entered:2012-07-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1206USA00511
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1853AA IMUN
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: Information has been received from a Licensed Practical Nurse concerning an 81 year old female patient with no pertinent medical history and no known drug reactions or allergies, who on 24-MAY-2012 was vaccinated with a dose of PNEUMOVAX 23, 0.5ml, intramuscularly, (lot number 672394/1853AA, expiry date: 09-AUG-2013). Concomitant therapy included cephalexin, cyanocobalamin, Hydrocodone/APAP, DIOVAN, metoprolol, LIPITOR, promethazine, NAMENDA, VESICARE, alendronate sodium (manufacturer unspecified), diltiazem HCL, metformin, PLAVIX and amiodarone. It was reported that, on 24-MAY-2012, the patient developed injection site reaction after receiving a dose of PNEUMOVAX 23. The painful red swollen area spread down from the injection site area to the patient''s elbow. The patient sought medical attention (saw the physician). No treatment was given for the symptoms. No laboratory studies were performed. At the time of the report, the patient''s outcome was recovering. This is the first of three cases reported by the nurse. Other two reports are: WAES#1206USA00496 and WAES# 1206USA00486. The reporter requested a lot check of this vaccine due to patients having adverse experiences. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the agency and was released. Additional information has been requested.

VAERS ID:459824 (history)  Vaccinated:2012-05-24
Age:0.6  Onset:2012-05-25, Days after vaccination: 1
Gender:Male  Submitted:2012-07-23, Days after onset: 59
Location:Indiana  Entered:2012-07-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: no
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURH120011IMLL
Administered by: Public     Purchased by: Public
Symptoms: Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Mom states child developed a rash over entire body the day following his vaccination.

VAERS ID:462023 (history)  Vaccinated:2012-05-24
Age:18.0  Onset:2012-05-24, Days after vaccination: 0
Gender:Male  Submitted:2012-08-02, Days after onset: 70
Location:Unknown  Entered:2012-08-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1207USA012240
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1537AA2UNLA
Administered by: Other     Purchased by: Other
Symptoms: Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 18 years old male patient was vaccinated with lot # (671994/1537AA) dose 3 GARDASIL on 24-MAY-2012. On the same day, the patient complained of numbness in left leg after the shot given in left arm. The outcome of the event was unknown. The patient did not seek medical attention. The event was considered to be non serious. Additional information is not expected.

VAERS ID:462383 (history)  Vaccinated:2012-05-24
Age:0.2  Onset:2012-05-27, Days after vaccination: 3
Gender:Female  Submitted:2012-08-13, Days after onset: 78
Location:Georgia  Entered:2012-08-20, Days after submission: 7
Life Threatening? No
Died? Yes
   Date died: 2012-05-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4156AB0UNLL
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1481AA1UNLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9172450UNRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1540AA0PO 
Administered by: Private     Purchased by: Public
Symptoms: Bed sharing, Death, Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)
Write-up: We would like to report that this death occurred within one week of 2 month vaccines. Coroner reported cause of death undetermined - possible SIDS vs. co-sleeping.

VAERS ID:465895 (history)  Vaccinated:2012-05-24
Age:74.0  Onset:2012-05-25, Days after vaccination: 1
Gender:Male  Submitted:2012-08-20, Days after onset: 87
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:
Diagnostic Lab Data:
CDC Split Type: WAES1205USA04661
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1850AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Injected limb mobility decreased, Injection site atrophy, Injection site induration, Injection site pain, Injection site swelling, Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Information has been received from a registered nurse concerning a 74 year old male patient who on 22-MAY-2012 was vaccinated with his first dose of PNEUMOVAX 23 (lot # 672369/1850AA exp date: 28-JUL-2013). On 22-MAY-2012 the patient experienced swelling, pain and hard indentation at the injection site. The patient went to the E/R. The patient was treated with BENADRYL. It was also reported that therapy with PNEUMOVAX 23 was discontinued and not reintroduced. At the time of the report, the patient''s outcome was unknown. Follow up information has been received from a registered nurse refers to a 74 year old male patient (retired) with none illness during vaccination who on 24-MAY-2012 at 11:00 previously reported as 22-MAY-2012) was vaccinated intramuscularly in left deltoid with a first dose of PNEUMOVAX 23 dose not reported) lot# 672369/1850AA. It was reported that on 25-MAY-2012 patient had swollen, red and hot to touch left arm. He had difficulty with moving his arm. Patient required doctor visit. The patient was treated pain management antihistamines for adverse event. The patient was recovered for swollen, red hot to touch left arm and his difficulty with moving with the arm on 01-JUN-2012. Additional information is not expected.

VAERS ID:463793 (history)  Vaccinated:2012-05-24
Age:25.0  Onset:2012-06-02, Days after vaccination: 9
Gender:Female  Submitted:2012-08-31, Days after onset: 90
Location:California  Entered:2012-08-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Allergy test, blood work, 5 different doctors appointments, thyroid ultrasound
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0037AA SCLA
Administered by: Private     Purchased by: Private
Symptoms: Allergy test, Anxiety, Blood test, Dyspnoea, Feeling hot, Food allergy, Food intolerance, Hypersensitivity, Oedema peripheral, Pharyngeal oedema, Rash, Swollen tongue, Tremor, Ultrasound thyroid, Vulvovaginal swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: Throat swelling at least three times a day, rash, restricted breathing, food allergies I have never had before, food intolerance, anxiety attacks, shaking, tremors, hands, tongue, feet and vagina swelling, feeling of warmth all over, toothpaste intolerance, sulfate intolerance.

VAERS ID:464295 (history)  Vaccinated:2012-05-24
Age:25.0  Onset:2012-06-02, Days after vaccination: 9
Gender:Female  Submitted:2012-09-06, Days after onset: 96
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: Drug hypersensitivity, ciprofloxacin
Preexisting Conditions: Ciprofloxacin
Diagnostic Lab Data: 02/--/2012, Allergy test, Allergic to almost everything: some foods given were: eggs, nuts, melon, mustard, tomatoes, peas, beans, everything in the legume family; 02/--/2012, blood test, normal; 02/--/2012, ultrasound scan, normal, slightly enlarged but normal
CDC Split Type: WAES1209USA001095
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0037AA1SCUN
Administered by: Other     Purchased by: Other
Symptoms: Allergy test positive, Blood test normal, Dyspnoea, Emotional distress, Erythema, Food allergy, Fungal infection, Multiple allergies, Oedema peripheral, Panic attack, Pharyngeal oedema, Swelling face, Swollen tongue, Ultrasound scan normal, Vulvovaginal swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow)
Write-up: This spontaneous report as received from a 25 years old female patient with allergy to CIPRO and none pertinent medical history. On 24-MAY-2012, the patient was vaccinated subcutaneously with a second 0.5 ml dose of MMR II, lot number 669517/0037AA exp date 01-FEB-2013. No other co-suspects were reported. Concomitant medications included: hormonal contraceptives (unspecified). The patient reported that she received the second dose and on 02-JUN-2012, she experienced swelling under the chin and under the tongue (medically significant, upon internal review). The consumer was still experiencing swelling under the chin and under the tongue and at the time of the report, back of the tongue 3 times a day. The patient experienced this at anytime, whether she was when she first got up in the morning or exercising or eating. The attacks last from 45 minutes to one hour. She was having constricted breathing (medically significant, upon internal review). At the time of report, the patient had food allergies (medically significant, upon internal review), panic attacks (medically significant, upon internal review), her hands and feet were swollen (medically significant, upon internal review), and she got red (medically significant, upon internal review), her vagina swollen (medically significant, upon internal review) and got a yeast infection (medically significant, upon internal review). She had seen 4 different physicians and an allergist. She stated that at the time of report, she was "allergic to all things" (medically significant, upon internal review) and what she was experiencing was causing distress every day (medically significant, upon internal review) and she was a 2nd year graduate student and this was interfering with her life. The patient carried an epinephrine (medically significant, upon internal review) at the time of report, but had not need to use it yet. Prednisone (manufacturer unknown), CLARITIN, PEPCID and BENADRYL was given as treatment for the events. Food allergy test was performed and showed that the patient was allergic to almost everything, some food given were eggs, nuts, melon, mustard, tomatoes, peas, beans, everything in the legume family. Blood test was also performed and was normal. Ultrasound of throat taken showed slightly enlarged but normal. At the time of report, the patient had not recovered. Additional information has been requested.

VAERS ID:464809 (history)  Vaccinated:2012-05-24
Age:63.0  Onset:2012-05-26, Days after vaccination: 2
Gender:Female  Submitted:2012-06-18, Days after onset: 23
Location:Tennessee  Entered:2012-09-11, Days after submission: 85
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: Ulcerative colitis?
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: Erythema, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Red area, hot 3 inches wide down back side of elbow.

VAERS ID:465482 (history)  Vaccinated:2012-05-24
Age:0.2  Onset:2012-06-14, Days after vaccination: 21
Gender:Female  Submitted:2012-09-18, Days after onset: 96
Location:Unknown  Entered:2012-09-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 7 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Patient had no medical problem immediately after vaccination, however three weeks later patient''s mother noticed scattered petechiae all over patient''s body, patient went to dermatologist and received ointment cream for skin rash, 1 week later patient''s petichiae got worse, patient''s mother took her to a pediatric doctor. Patient was referred to bigger hospital for blood work. When Patient did CBC, platelet count was <20,000. Patient was diagnosed as Idiopathic Thrombocytopenic Purpura.
Preexisting Conditions: None
Diagnostic Lab Data: CBC was checked; Platelet count 7.8 on 14Aug2012, 8.8 on 28Aug2012, 7.9 on 4Sep2012, and 21.1 on 18Sep2012. (unit is x10^4/micro liter).
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B323AA0IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH523AA0IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF899120IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1691AA0PO 
Administered by: Military     Purchased by: Military
Symptoms: Aspiration bone marrow normal, Idiopathic thrombocytopenic purpura, Petechiae, Platelet count decreased, Rash
SMQs:, Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Hypersensitivity (narrow)
Write-up: Patient had petechiae all over the body three weeks after vaccination. Pt was diagnosed as "Idiopathic Thrombocytopenic Purpura" in hospital. Patient''s platelet count was between 20,000 to 30,000 for 1 month, checked bone marrow sample, there was no abnormality for producing platelet. On 18Sept2012 patient''s primary care doctor suggested Pt''s mother to vaccinate patient just one vaccine at a time, to identify if that was from immunization. Hospital will monitor patient''s CBC after vaccine.

VAERS ID:520382 (history)  Vaccinated:2012-05-24
Age:  Onset:2012-05-24, Days after vaccination: 0
Gender:Unknown  Submitted:2014-01-23, Days after onset: 609
Location:Unknown  Entered:2014-01-23
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: WAES1401USA008602
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1604AA SCUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 03-MAR-2013 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 degrees C for an estimated total time out of range of 4 hours. On 17-APR-2012 at 7:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 14 hours. On 24-MAY-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX, lot # 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.

VAERS ID:529813 (history)  Vaccinated:2012-05-24
Age:0.2  Onset:2012-05-24, Days after vaccination: 0
Gender:Male  Submitted:2014-04-30, Days after onset: 706
Location:Ohio  Entered:2014-04-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None at the time of vaccination. Infection of lungs at birth due to meconium, spent 4 days in NICU. Was vaccinated at birth before infection was discovered.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS 0  
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER    
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER    
RVX: ROTAVIRUS (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Private
Symptoms: Crying, Immediate post-injection reaction, Injection site reaction, Injection site swelling, Injection site warmth, Muscle rigidity, Screaming, Somnolence, Speech disorder, Tenderness
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow)
Write-up: Immediately after vaccination, extremely high-pitched screaming and crying for approximately 5 minutes. After going into the car (15 minutes after vaccination) child slept immediately. Upon returning home approximately 30 minutes after vaccination, child continued a screaming cry for approximately 5-6 hours. Approximately 2 hours after vaccination both legs were swollen, hot to the touch and muscles were rigid. When touched, child would flinch away and cry harder. The incidence with the legs and crying continued even with Tylenol and a cold compress being applied for approximately 10 hours until bed time around 9pm. At 2 years of age, child has been qualified for early intervention for speech therapy. Possible apraxia of speech.

VAERS ID:572842 (history)  Vaccinated:2012-05-24
Age:86.0  Onset:2012-06-03, Days after vaccination: 10
Gender:Male  Submitted:2012-06-06, Days after onset: 3
Location:New York  Entered:2015-04-03, Days after submission: 1031
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: Hyperlipidemia 05/04/2012; Hypertension 05/04/2012; Constipation, unspecified 05/04/2013; Bladder cancer 05/04/2012; Ileal conduit, s/p removal of bladder and prostate 2009; Allergic rhinitis 05/04/2012. On ipratropium 0.03% nasal spray; Chronic Kidney Disease, Stage II (Mild) 05/04/2012; On 3/2012 Anemia in Chronic Kidney Disease 05/04/2012; Coronary Artery Disease 05/04/2012; S/p Thallium stress test 2007 mid inf wall ischemia; Asbestosis 05/04/2012 per CT scan 2005; Calcified pleural plaques Dupuytren''s Contracture 05/04/2012; Arthritis , rheumatoid 05/04/2012; Myoclonic jerking 05/04/2012; Mitral valve Insufficiency 05/04/2013; Mod per echo 2005; Skin carcinoma 05/04/2012; Memory loss 05/04/2012; Occlusion and stenosis of Carotid artery
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1716AA1UNRA
Administered by: Other     Purchased by: Other
Symptoms: Herpes ophthalmic, Herpes zoster
SMQs:, Ocular infections (narrow)
Write-up: Shingles on right side of forehead and right eye.

VAERS ID:456669 (history)  Vaccinated:2012-05-24
Age:6.0  Onset:2012-05-24, Days after vaccination: 0
Gender:Female  Submitted:2012-06-01, Days after onset: 8
Location:Foreign  Entered:2012-06-01
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: Seizure; Syncope
Diagnostic Lab Data: UNK
CDC Split Type: B0804296A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Bradycardia, Condition aggravated, Convulsion, Dizziness, Gaze palsy, Hyperhidrosis, Hypotonia, Muscle rigidity, Syncope, Tonic clonic movements, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Parkinson-like events (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a physician and described the occurrence of seizure in a 6-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 24 May 2012, at 11.45 am, the subject received 3rd dose of FLUARIX (route unknown, right thigh). On 24 May 2012, when she was still in the vaccination clinic, less than one day after vaccination with FLUARIX, the subject experienced seizure, syncope, muscular rigidity, dizziness, sweating, hypotonia nos, bradycardia, tremor, tonic-clonic movements and eyes rolling. This case was assessed as medically serious by GSK. The subject remained under observation during 1 hour and after that was discharged. On 24 May 2012, after 1 minute, the events were resolved. The physician considered the events were almost certainly related to vaccination with FLUARIX. Follow-up information received on 24 May 2012: Historic vaccination included combined measles, mumps and rubella vaccine, live, attenuated (new strain); GlaxoSmithKline; unknown; unknown given on an unspecified date. The subject''s medical history included seizure and syncope. See case B0804296B for details regarding previous vaccination with PRIORIX.

VAERS ID:456842 (history)  Vaccinated:2012-05-24
Age:11.0  Onset:2012-05-24, Days after vaccination: 0
Gender:Female  Submitted:2012-06-05, Days after onset: 12
Location:Foreign  Entered:2012-06-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0805637A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA134EH2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Chills, Headache, Pyrexia, Syncope, Viral infection
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a physician via a regulatory authority (# 167729) and described the occurrence of acute febrile viral infection in a 11-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 24 May 2012, the subject received 3rd dose of CERVARIX (intramuscular, unknown injection site). On 24 May 2012, less than one day after vaccination with CERVARIX, the subject experienced lipothymia unspecified, headache and chills which was diagnosed as an acute febrile viral infection. The subject was hospitalised. On 25 May 2012, the physician confirmed the events were improved. The regulatory authority reported that the events were possibly related to vaccination with CERVARIX.

VAERS ID:457041 (history)  Vaccinated:2012-05-24
Age:13.0  Onset:2012-05-24, Days after vaccination: 0
Gender:Female  Submitted:2012-06-08, Days after onset: 15
Location:Foreign  Entered:2012-06-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0806582A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Application site cold feeling, Hypoperfusion, Lividity, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (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), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This case was reported by a physician via a regulatory authority (# CZ-CZSUKL-12000982) and described the occurrence of hypoperfusion in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject had no allergies. On 24 May 2012, the subject received 1st dose of CERVARIX (.5 ml, intramuscular, unknown deltoid). On 24 May 2012, 2 hours after vaccination with CERVARIX, the subject experienced hypoperfusion, cold sensation at application site, slight swelling of fingers and lividity. The subject was hospitalised. At the time of reporting the outcome of the events was unspecified.

VAERS ID:457994 (history)  Vaccinated:2012-05-24
Age:5.0  Onset:2012-05-24, Days after vaccination: 0
Gender:Female  Submitted:2012-06-22, Days after onset: 29
Location:Foreign  Entered:2012-06-25, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1206USA03445
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.RN389551UNUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0143AA0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Burning sensation, Injection site pain, Pain, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This is a spontaneous case report received from a physician via the Health Authority (report id# SI-JAZMP-NCPHV-2012SI0089_194) concerning a 5 year old female child who received her second dose of RECOMBIVAX HB (batch# G018691, lot# RN38955) along with MMR II (batch# G009441, lot# 670562/0143AA) (this was her first vaccination) on 24-MAY-2012. A couple of minutes after vaccines were given the patient collapsed. Further details or outcome of the event was not reported. In the report it was stated that 5 minutes after vaccination (on the location where MMR II was administered) severe burning local pain developed. Action taken or outcome of this event was also unknown. No other concomitant medication or any other important information from the patient''s medical history was provided. No further data on the case was reported. Severe burning injection site pain and patient collapsed a couple of minutes after vaccination were considered to be serious as other medically important conditions by the reporter. No further information is available.

VAERS ID:460139 (history)  Vaccinated:2012-05-24
Age:5.0  Onset:2012-05-26, Days after vaccination: 2
Gender:Unknown  Submitted:2012-07-25, Days after onset: 60
Location:Foreign  Entered:2012-07-25
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: UNK
CDC Split Type: B0816732A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B132BL IMLA
Administered by: Other     Purchased by: Other
Symptoms: Cyanosis, Extensive swelling of vaccinated limb, Injection site erythema, Injection site induration, Injection site pruritus, Injection site reaction, Lymph node pain, Lymphadenopathy, Oedema
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Acute central respiratory depression (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a physician via a regulatory authority (# PL-URPL-OCR-20120628002) and described the occurrence of injection site redness in a 5-year-old subject of unspecified gender who was vaccinated INFANRIX (GlaxoSmithKline). On 24 May 2012, the subject received unspecified dose of INFANRIX (intramuscular, left arm). On 26 May 2012, 2 days after vaccination with INFANRIX, the subject experienced injection site reaction (diameter more than 10 cm with injection site redness and extensive swelling of vaccinated limb. On 28 May 2012, 4 days after vaccination with INFANRIX, the subject experienced injection site pruritus (10x10 cm) without general manifestations. The subject went for observation on 28 May 2012. General condition of the subject was good. Observation and paracetamol (if necessary) were recommended. On 30 May 2012, 6 days after vaccination with INFANRIX, the subject experienced axillary lymphadenopathy. The subject went for observation again. The edema became larger (size 13x11 cm), physically the lymph node in the left lower axillary fossa was perceptible, sensitive and sliding. The child was referred to a hospital. General condition of the subject was good. The regulatory authority reported that the events were clinically significant (or requiring intervention). According to information received from regional administration unit for control of epidemics and hygiene promotion on 5 June 2012, it was established that the subject was not admitted to a hospital. Immunological consultation and compresses with ALTACET were recommended. After consultation former treatment was recommended. A visit to paediatrician for a check-up was scheduled. During the last conversation with the mother it was established that the injection site reaction was still maintaining. It was smaller but still visible, hard, well separated. The skin above the injection site reaction was strongly cyanosis. At the time of reporting injection site itching and axillary lymphadenopathy were resolved. Further information was not expected.

VAERS ID:460459 (history)  Vaccinated:2012-05-24
Age:  Onset:2012-05-28, Days after vaccination: 4
Gender:Unknown  Submitted:2012-07-27, Days after onset: 60
Location:Foreign  Entered:2012-07-27
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: Body temperature, 28May2012, 38.9Deg. C; Body temperature, 28May2012, 38.5Deg. C
CDC Split Type: B0816723A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA20CA781A IMUN
Administered by: Other     Purchased by: Other
Symptoms: Erythema multiforme, Hypersensitivity, Injection site swelling, Injection site warmth, Oedema peripheral, Pyrexia, Vomiting
SMQs:, Cardiac failure (broad), Severe cutaneous adverse reactions (narrow), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a physician via a regulatory authority (# PL-URPL-OCR-20120620002) and described the occurrence of multiforme erythema in a subject of unspecified age and gender who was vaccinated with INFANRIX-POLIO-HIB (GlaxoSmithKline). On 24 May 2012, the subject received unspecified dose of INFANRIX-POLIO-HIB (intramuscular, unknown injection site). On 28 May 2012, 4 days after vaccination with INFANRIX-POLIO-HIB, the subject experienced an allergic reaction with multiforme erythema, fever (38.5-38.9 Deg. C), severe injection site reaction (diameter greater than 10 cm, going to the nearest joint) with injection site warmth and swelling of the whole right arm. Less than 1 month after vaccination with INFANRIX-POLIO-HIB, the subject experienced and vomiting. The regulatory authority reported that the events were clinically significant (or requiring intervention). The subject was treated with ALTACET. Follicular changes were observed probably after the treatment. At the time of reporting arm swelling and injection site warmth were resolved. The outcome of the events was unspecified.

VAERS ID:460819 (history)  Vaccinated:2012-05-24
Age:0.3  Onset:2012-05-24, Days after vaccination: 0
Gender:Female  Submitted:2012-07-30, Days after onset: 67
Location:Foreign  Entered:2012-08-01, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical history and concomitant medications were not reported.
Diagnostic Lab Data: Not reported
CDC Split Type: 201207079
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURG9965 IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF49249 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crying, Injection site reaction
SMQs:, Depression (excl suicide and self injury) (broad)
Write-up: Case received from the Health Authorities through the local affiliate in a foreign country on 19 July 2012 under the local number PL-URPL-OCR-20120628003 (local reference number 2012/0217). A 03-month-old female patient, with no reported medical history and no reported concomitant therapy, had received intramuscular dose of ACT-HIB batch number G9965-1 and an intramuscular dose of PREVENAR 13 batch number F49249, on 24 May 2012. On the same day post vaccination, the patient presented with uncontrollable crying and injection site reaction in diameter 3-5 cm. The patient was hospitalized for 2 days (dates not reported). The patient recovered at the time of reporting. The Health Authorities coded: "crying uncontrollable" and "injection site reaction". Documents held by sender: none.

VAERS ID:460821 (history)  Vaccinated:2012-05-24
Age:0.3  Onset:2012-05-24, Days after vaccination: 0
Gender:Female  Submitted:2012-07-30, Days after onset: 67
Location:Foreign  Entered:2012-08-01, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical history and concomitant medications were not reported.
Diagnostic Lab Data: Not reported
CDC Split Type: 201207081
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURG9965 IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF49249 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crying, Injection site reaction
SMQs:, Depression (excl suicide and self injury) (broad)
Write-up: Case received from the Health Authorities through the local affiliate on 19 July 2012 under the local number PL-URPL-OCR-20120628004 (local reference number 2012/0216). A 03-month-old female patient, with no reported medical history and no reported concomitant therapy, had received an intramuscular dose of ACTHIB batch number G9965-1 and an intramuscular dose of PREVNAR 13 batch number F49249, on 24 May 2012. On the same day post vaccination, the patient presented with injection site reaction in diameter 3-5 cm and uncontrollable crying. The patient was hospitalized for 2 days (dates not reported). The patient recovered at the time of reporting. The Health Authorities coded: "injection site reaction" and "crying uncontrollable". Documents held by sender: none.

VAERS ID:462440 (history)  Vaccinated:2012-05-24
Age:0.4  Onset:2012-05-24, Days after vaccination: 0
Gender:Unknown  Submitted:2012-08-17, Days after onset: 85
Location:Foreign  Entered:2012-08-20, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No medical history reported.
Diagnostic Lab Data: Fever up to 40 degrees C on 24 May 2012.
CDC Split Type: 201207419
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER20910001D SCUN
HIBV: HIB (ACTHIB)SANOFI PASTEURG9952 IMUN
IPV: POLIO VIRUS, INACT. (POLIOVAX)SANOFI PASTEURE5985 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Case received from the health Authorities through the local affiliate in a foreign country on 06 August 2012 under the reference number PL-URPL-OCR-20120710006 (local reference number 2012/0240). A 4-month-old patient (gender not reported) had received an intramuscular injection of ACTHIB (batch number: G9952-1, site of administration not reported) concomitantly with an intramuscular injection of IMOVAX POLIO (batch number: E5985-2, site of administration not reported) and a subcutaneous injection of DTP vaccine (batch number: 20910001D, other manufacturer, site of administration not reported) on 24 May 2012. Six hours after vaccination, on 24 May 2012 the patient experienced fever up to 40 degrees C. The patient was treated by antipyretic drugs. Fever decreased. The next day in the morning, a similar episode occurred without any other symptoms. The patient recovered at an unspecified date. This case was reported as serious, i.e. as other medical important condition. The Health Authorities coded: fever. Documents held by sender: none.

VAERS ID:464833 (history)  Vaccinated:2012-05-24
Age:25.0  Onset:2012-08-28, Days after vaccination: 96
Gender:Female  Submitted:2012-09-12, Days after onset: 15
Location:Foreign  Entered:2012-09-12
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: Iron salt; Folic acid
Current Illness: Unknown
Preexisting Conditions: Delivery of baby
Diagnostic Lab Data: Pregnancy test, positive; Sonogram, 29Aug2012, results: the fet
CDC Split Type: A0992936A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blighted ovum, Maternal exposure during pregnancy, Pregnancy test positive, Ultrasound antenatal screen abnormal, Uterine dilation and curettage, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: This female subject was enrolled in a study. On 24 August 2011 and 24 May 2012, the subject was vaccinated in the left deltoid with the 1st and 2nd dose of ENGERIX B. The subject did not receive the 3rd dose. The subject''s past medical history included one previous pregnancy resulting in a delivery of baby (see case B0403903A for further details); this is her second pregnancy within the study which was not reported. She did not use a birth control method before the pregnancy. Her last menstrual period (LMP) occurred on 20 May 2012. She attended prenatal care. Concomitant medications included Iron and Folic acid during the pregnancy. On 28 August 2012, 96 days after the 2nd dose of ENGERIX B, this 25-year-old subject developed a blighted ovum. The subject was hospitalised. The subject was treated with curettage and vaginal gel. The event resolved on 07 September 2012. The investigator reported the blighted ovum was possibly related to ENGERIX B due to the time elapsed between the last dose of vaccine and the last menstrual period (LMP). Investigator comments: On 10 September 2012 the subject reported spontaneously the following information: She reported that she started with moderate transvaginal bleeding on 28 August 2012 for which she consulted to the emergency room (ER) of the local clinic from where she was transferred to the local hospital. She was admitted the same day and on 29 August 2012 a sonogram was performed and they told her that "the fetus has not developed". She had vaginal gel applied for 3 days. On 04 September 2012 she underwent uterine dilation and curettage. She was discharged the same day in good general condition without treatment and with medical reference to the local clinic. She felt fully recovered on 07 September 2012, approximately. The medical chart will be reviewed when possible. Diagnosis: Blighted ovum.

VAERS ID:481177 (history)  Vaccinated:2012-05-24
Age:13.0  Onset:2012-05-27, Days after vaccination: 3
Gender:Female  Submitted:2013-01-14, Days after onset: 232
Location:Foreign  Entered:2013-01-14
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Asthma
Diagnostic Lab Data: Blood test, Normal; Borrelia test, Negative; Lumbar puncture, Negative, Negative for TBE, Lyme, Herpes and Varicella
CDC Split Type: WAES1210SWE011647
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NN517001SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Blood test normal, Borrelia test negative, Fatigue, Headache, Lumbar puncture normal, Malaise, Musculoskeletal pain, Nausea, Neck pain, Varicella virus test negative, Viral test negative
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Case received from a Health Care professional on 11-Oct-2012. Case medically confirmed. A 14-year-old female patient had received an injection of GARDASIL (batch number unknown, dose 2, route and site not reported) on 24-May-2012 and later on 3-4 days post vaccination she developed nausea, headache, pain in shoulders and neck, malaise and fatigue, around 27-May-2012. Borrelia test carried out on an unspecified date was negative. The patient was previous healthy. She had previously received one dose of GARDASIL on an unspecified date. At the time of reporting, the outcome was not recovered for nausea and malaise and recovered for headache, pain in shoulders and neck and fatigue. No further information expected. Follow-up information was received from the Health care professional on 12-Dec-2012: Batch number reported: G009842. No further information expected. Follow-up information was received from the Health care professional on 02-Jan-2013: The patient had a history of asthma but was otherwise healthy. The nausea persisted and was according to the reporter disabling. She was well investigated, lumbar puncture was performed among other things, but nothing had been found. Other possible causes of nausea had almost been ruled out. The outcome of malaise was not reported. No further information expected. Follow-up information was received from the HCP via a company representative on 08-Jan-2013. The patient has persistent symptoms, particularly with fatigue and nausea. She has rather intense nausea in the mornings that is motion triggered and this is why gastrological involvement probably was not the underlying cause. Symptoms debuted together with rash on the cheeks and this is why the doctor believed in some kind of immunological disorder, possibly an inflammation in the CNS, causing the symptoms. A MRI brain was scheduled. Lumbar puncture test was negative for TBE, Lyme disease, Herpes and Varicella. Blood values were also normal.

VAERS ID:483864 (history)  Vaccinated:2012-05-24
Age:0.9  Onset:0000-00-00
Gender:Male  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: 201301830
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER170010UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (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 foreign Ministry of Health. A male patient (age reported as "12-month-14-day-old"), whose medical history and concomitant therapies were not reported, had received his first dose of Influenza vaccine, mfr unknown, lot number 17001, (route and anatomical site of administration not reported) on 24/May/2012. On an unspecified date post-vaccination the patient experienced exanthema. The patient''s outcome was recovered with no 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:489626 (history)  Vaccinated:2012-05-24
Age:0.3  Onset:2012-05-24, Days after vaccination: 0
Gender:Male  Submitted:2013-04-19, Days after onset: 330
Location:Foreign  Entered:2013-04-19
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: Stool rotavirus antigen positive, 05Apr2013, positive
CDC Split Type: D0079503A
Vaccination
Manufacturer
Lot
Dose
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Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSAROLA490AA0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Diarrhoea, Incorrect route of drug administration, Rotavirus infection, Rotavirus test positive, Vaccination failure, Vomiting
SMQs:, Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: This case was reported by a physician and described the occurrence of ROTATRIX liquid formulation (GlaxoSmithKline). According to the questionnaire, provided by the physician, on 24 May 2012 and 28 June 2012 the subject received 1st and 2nd dose of ROTARIX (intramuscular, unknown application site, inappropriate route of vaccination). On 2 April 2013, 10 and 9 months after vaccination with ROTARIX, respectively, the subject experienced diarrhea with vomiting. The subject was treated with diet. On 9 April 2013, the events were resolved. The reporting physician also provided a targeted follow-up questionnaire for lack of rotaviral vaccination protection: According to the Targeted Follow Up Questionnaire, the genotype of rotavirus was unknown. Symptoms included diarrhea with vomiting. On 5 April 2013, a stool test for rotavirus antigen was positive (rotavirus infection, vaccination failure). This case was assessed as medically serious by GSK. Campylobacter, Adenovirus, Astrovirus, Norovirus and Verotoxin were not detected. It was unspecified whether other pathogens, including Salmonella, Escherichia coli, parasites or any other infective agent were detected. No other laboratory examinations were reported. There was no concurrent medical condition or concurrent medication reported. Concurrent vaccinations included INFANRIX HEXA (GlaxoSmithKline) and PREVENAR 13 (Pfizer) (non-GSK) both given on 2 August 2012. The physician reported about another subject experiencing rotavirus infection after vaccination with ROTARIX. Please see also case D0079511A for additional report regarding the same reporter.

VAERS ID:495385 (history)  Vaccinated:2012-05-24
Age:17.0  Onset:2013-01-09, Days after vaccination: 230
Gender:Female  Submitted:2013-06-27, Days after onset: 168
Location:Foreign  Entered:2013-06-27
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: Electroencephalogram, Apr2013, Normal
CDC Split Type: B0900926A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA162AA2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Dizziness, Electroencephalogram normal, Fall, Narcolepsy, Sleep attacks, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Convulsions (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a physician and described the occurrence of narcolepsy in a 17-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 29 May 2012, the subject received 3rd dose of CERVARIX (intramuscular, unknown injection site, batch number not provided). On 9 January 2013, 7 months after vaccination with CERVARIX, the subject experienced giddiness while riding on a bicycle and fell. Thereafter, the subject experienced narcolepsy, for which she received treatment at the department of psychosomatic medicine at the time of reporting. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting, the outcomes of the events were unspecified. Follow-up information received on 18 June 2013 from the regulatory authority (# V13000281): Concurrent vaccination included 1st and 2nd doses of CERVARIX (GlaxoSmithKline, intramuscular, unknown injection sites given on 15 November 2011 and 13 December 2011. Historic medications included MINOMYCIN. On 24 May 2012 (not on 29 May 2012 as previously reported), the subject received 3rd dose of CERVARIX (intramuscular, unknown injection site, batch number was provided). On 9 January 2013, 8 months after vaccination with CERVARIX, the subject also experienced sleep attacks for a long time (more than 14 hours per day). The subject had been absent from school because she was unable to wake up in the morning. The physician considered the events were clinically significant (or requiring intervention). The subject was on continuous treatment with oral medication at the department of psychosomatic medicine at another hospital, but almost no improvement was observed. In April 2013, Electroencephalography showed no abnormality at the department of psychosomatic medicine at hospital. At the time of reporting, the events were unresolved. The reporter mentioned that it was a rare case because the events developed approximately 8 months after the third vaccination with CERVARIX.

VAERS ID:456241 (history)  Vaccinated:2012-05-25
Age:58.0  Onset:2012-05-25, Days after vaccination: 0
Gender:Male  Submitted:2012-05-25, Days after onset: 0
Location:Massachusetts  Entered:2012-05-25
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Codeine; IVP dye; bees
Diagnostic Lab Data:
CDC Split Type:
Vaccination
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VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1254AA0SCRA
Administered by: Private     Purchased by: Private
Symptoms: Dysgeusia, Headache, Hyperhidrosis, Rash, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: Approx. 30-45mins after leaving office (following appt with Dr.) pt experienced strange taste in mouth followed by onset of profuse sweating rash of upper body including neck, sl wheeze, throbbing (headache that lasted 5-10mins then resolved). Drove back to office, eval by Dr. given 0.2mg epinephrine sq. BP 150/86 AP 100, 10mins later BP160/80 AP 84. States feeling better 10mins after epi, with con''t sense of feeling much better after 20mins. Rash resolving, no further wheezing, OK to leave per Dr. after 40mins of observation. Advised to take Benadryl 50 mg at home call back any concerns. Pt states allergic to shellfish (anaphylaxis) bees (carries epi pen) IPV dye, codeine.

VAERS ID:456245 (history)  Vaccinated:2012-05-25
Age:19.0  Onset:2012-05-25, Days after vaccination: 0
Gender:Male  Submitted:2012-05-25, Days after onset: 0
Location:California  Entered:2012-05-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: resolving cold symptoms
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
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RAB: RABIES (IMOVAX)SANOFI PASTEURG11092IMLA
Administered by: Private     Purchased by: Private
Symptoms: Fatigue, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Feels very tired after each rabies Imovax injection, also c/o nausea symptoms resolve within a few hours.

VAERS ID:456254 (history)  Vaccinated:2012-05-25
Age:59.0  Onset:2012-05-25, Days after vaccination: 0
Gender:Male  Submitted:2012-05-26, Days after onset: 1
Location:Florida  Entered:2012-05-26
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: HYPERTENSION CONTROLLED; ASTHMA CONTROLLED, MULTIPLE ALLERGEN SENSITIVITIES ON ALLERGY THERAPY MAINTAINENCE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
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PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER 1IMRA
Administered by: Unknown     Purchased by: Other
Symptoms: Body temperature increased, Erythema, Fatigue, Hypersomnia, Injection site pain, Injection site swelling, Lethargy, Myalgia, Skin warm
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant 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), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad)
Write-up: SWELLING AND PAIN AT INJECTION SITE DEVELOPED SEVERAL HOURS AFTER INJECTION; GOT WORSE BY EVENING WITH LETHARGY, FATIGUE & MUSCLE ACHES. TEMPERATURE ELEVATED TO 99.8, CALLED ON CALL PHYSICIAN WHO ADVISED USE OF ICE AND IBUPROFEN. THIS WAS DONE. SLEPT NEARLY 12 HOURS, FEVER REDUCED UPON AWAKENING-HOWEVER PAIN SWELLING HAVE EXTENDED THROUGH THE DAY SATURDAY 05 26/2012, TO INCORPORATE ENTIRE BACK PORTION OF UPPER ARM, SKIN IS REDDENED AND REMAINS HOT TO TOUCH DESPITE USE OF ICE. TEMPERATURE ELEVATED ABOVE MY NORMAL 97.4 TO ABOUT 98.3 AT THIS TIME.

VAERS ID:456256 (history)  Vaccinated:2012-05-25
Age:69.0  Onset:2012-05-25, Days after vaccination: 0
Gender:Female  Submitted:2012-05-27, Days after onset: 2
Location:North Carolina  Entered:2012-05-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions:
Diagnostic Lab Data: allergic reaction
CDC Split Type:
Vaccination
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Lot
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PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Other
Symptoms: Erythema, Hypersensitivity, Pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Redness, fever, pain.

VAERS ID:456257 (history)  Vaccinated:2012-05-25
Age:65.0  Onset:2012-05-26, Days after vaccination: 1
Gender:Female  Submitted:2012-05-27, Days after onset: 1
Location:California  Entered:2012-05-27
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: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
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PNC: PNEUMO (PREVNAR)PFIZER/WYETH    
Administered by: Private     Purchased by: Other
Symptoms: Erythema, Headache, Pain in extremity, Pyrexia, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad)
Write-up: Very sore arm. Swelling, redness - increasing in size overnight. Headache. Slightly feverish. Ibuprofen. Ice.

VAERS ID:456285 (history)  Vaccinated:2012-05-25
Age:65.0  Onset:2012-05-26, Days after vaccination: 1
Gender:Female  Submitted:2012-05-27, Days after onset: 1
Location:Colorado  Entered:2012-05-27
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: Chronic neck pain
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
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VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blister, Herpes zoster, Rash erythematous, Skin warm
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Sudden red warm blistering rash looks like shingles.

VAERS ID:456290 (history)  Vaccinated:2012-05-25
Age:5.0  Onset:2012-05-25, Days after vaccination: 0
Gender:Male  Submitted:2012-05-27, Days after onset: 2
Location:New York  Entered:2012-05-27
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: NKDA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B136BB4IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1406AA1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: C/O redness, no itchiness over Rt. arm. No pain. No fever.

VAERS ID:456321 (history)  Vaccinated:2012-05-25
Age:11.0  Onset:2012-05-26, Days after vaccination: 1
Gender:Male  Submitted:2012-05-29, Days after onset: 3
Location:D.C.  Entered:2012-05-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
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MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4021AE0IMLA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Induration, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Red, swollen, hard, warm to touch.

VAERS ID:456353 (history)  Vaccinated:2012-05-25
Age:0.3  Onset:2012-05-25, Days after vaccination: 0
Gender:Male  Submitted:2012-05-29, Days after onset: 4
Location:Pennsylvania  Entered:2012-05-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No reaction at first, reaction happened 4.5 hours later. Unconsolable screaming for almost an hour, bright red, warm/painful injection site on right leg. Temperature of 100.1.
Preexisting Conditions:
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME)SANOFI PASTEUR  IMUN
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
RVX: ROTAVIRUS (NO BRAND NAME)UNKNOWN MANUFACTURER  PO 
Administered by: Public     Purchased by: Other
Symptoms: Emotional distress, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia, Screaming
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad)
Write-up: Unconsolable screaming for almost an hour, fever of 100.1, redness, swelling, and pain on right leg at injection site.

VAERS ID:456361 (history)  Vaccinated:2012-05-25
Age:62.0  Onset:2012-05-26, Days after vaccination: 1
Gender:Female  Submitted:2012-05-29, Days after onset: 3
Location:Texas  Entered:2012-05-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1253AA0SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, 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: Redness, swelling, hard lump at injection site, warmth around injection site, soreness, itching.

VAERS ID:456454 (history)  Vaccinated:2012-05-25
Age:44.0  Onset:2012-05-26, Days after vaccination: 1
Gender:Female  Submitted:2012-05-30, Days after onset: 4
Location:Georgia  Entered:2012-05-30
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
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TDAP: TDAP (ADACEL)SANOFI PASTEURU4325AA0IMRA
Administered by: Private     Purchased by: Other
Symptoms: Diarrhoea, Headache, Joint stiffness, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Fever, stiffness to joints, headache, diarrhea.

VAERS ID:456522 (history)  Vaccinated:2012-05-25
Age:17.0  Onset:2012-05-25, Days after vaccination: 0
Gender:Male  Submitted:2012-05-31, Days after onset: 6
Location:Georgia  Entered:2012-05-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
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TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEUR605070UNRA
Administered by: Private     Purchased by: Private
Symptoms: Abdominal pain, Diarrhoea,