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Found 573164 cases in entire database

Case Details (Sorted by Vaccination Date)

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VAERS ID:304130 (history)  Vaccinated:2008-01-29
Age:1.2  Onset:2008-01-29, Days after vaccination: 0
Gender:Female  Submitted:2008-02-01, Days after onset: 3
Location:California  Entered:2008-02-01
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
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B051AA3IMLL
MM: MEASLES + MUMPS (MM-VAX)MERCK & CO. INC.0413U0SCRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC458923IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1502U0SCRL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site swelling, Injection site warmth, Irritability
SMQs:, 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), Hypoglycaemia (broad)
Write-up: Mild reaction on the LAT, area appears awollen, no pain showed to touch but felt a little warmth to touch, mother denies temperature, pt fussy just the night of the day vaccines were given.

VAERS ID:304138 (history)  Vaccinated:2008-01-29
Age:1.9  Onset:2008-01-31, Days after vaccination: 2
Gender:Male  Submitted:2008-02-01, Days after onset: 1
Location:California  Entered:2008-02-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: RASH ON LEG
Preexisting Conditions: NKDA
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPH: DTAP + HIB (TRIHIBIT)SANOFI PASTEURU1986AB0IMLL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: RED, RAISED SWOLLEN AREA, NON-TENDER ON LEFT UPPER THIGH NO INGUINAL LYMPH NODES FELT. ORDERED PRELONE SYRUP AND TOPICAL HYDROCORTISONE BID.

VAERS ID:304139 (history)  Vaccinated:2008-01-29
Age:11.0  Onset:2008-01-30, Days after vaccination: 1
Gender:Female  Submitted:2008-02-01, Days after onset: 2
Location:Tennessee  Entered:2008-02-01
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2798AA4IMRA
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500498P0IN 
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB214AA1IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1577U1IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Diarrhoea, Erythema, Oedema peripheral, Pyrexia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Varicella vaccine given in right deltoid. On the day after the vaccine was given, the patient developed swelling and erythema circumferentially on her right upper arm. She also had fever and 3 episodes of diarrhea.

VAERS ID:304154 (history)  Vaccinated:2008-01-29
Age:63.0  Onset:2008-01-29, Days after vaccination: 0
Gender:Female  Submitted:2008-02-02, Days after onset: 4
Location:Colorado  Entered:2008-02-01, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Paxil; Premanin
Current Illness: None
Preexisting Conditions: Depression, Post Menopausal
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1826U SCRA
Administered by: Other     Purchased by: Other
Symptoms: Burning sensation, Flushing, Injection site pruritus
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hypersensitivity (broad)
Write-up: Patient given vaccine at clinic and within 12 hours itching at injection site right arm and burning right side of face and neck. Seen by doctor 72 hours later - no vesicles no resp sxs.

VAERS ID:304157 (history)  Vaccinated:2008-01-29
Age:57.0  Onset:2008-01-30, Days after vaccination: 1
Gender:Female  Submitted:2008-02-01, Days after onset: 2
Location:North Carolina  Entered:2008-02-01
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: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2775AA0 LA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Induration
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Induration and erythema.

VAERS ID:304163 (history)  Vaccinated:2008-01-29
Age:2.0  Onset:2008-01-29, Days after vaccination: 0
Gender:Male  Submitted:2008-02-01, Days after onset: 3
Location:Missouri  Entered:2008-02-01
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: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2771AA3IMLL
Administered by: Public     Purchased by: Public
Symptoms: Wrong drug administered
SMQs:, Medication errors (narrow)
Write-up: Tdap was given for 4th dose. DTAP and Tdap on same shelf, close in proximity. Child behind on vaccines. 2 siblings at once, both behind on vaccinations.

VAERS ID:304164 (history)  Vaccinated:2008-01-29
Age:5.0  Onset:0000-00-00
Gender:Female  Submitted:2008-02-01
Location:Missouri  Entered:2008-02-01
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: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEUR210693SCLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0879F1SCRL
TDAP: TDAP (ADACEL)SANOFI PASTEURC2771AA4IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1018U1SCRL
Administered by: Public     Purchased by: Public
Symptoms: Wrong drug administered
SMQs:, Medication errors (narrow)
Write-up: None. Behind on immunizations. Tdap given instead of DTAP by error for 5th dose.

VAERS ID:304171 (history)  Vaccinated:2008-01-29
Age:8.0  Onset:2008-01-30, Days after vaccination: 1
Gender:Female  Submitted:2008-01-31, Days after onset: 1
Location:Massachusetts  Entered:2008-02-01, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Flovent; Nasonex; Lactulose
Current Illness:
Preexisting Conditions: Cystic Fibrosis, Allergic Rhinits
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB217AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1274U1SCLA
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Induration, Local reaction, Pruritus, Tenderness
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Local reaction to posterior left forearm, developed erythema, tenderness, and some itching. 2.5 cm circle indurated at site of injection and total 8 cm of erythema.

VAERS ID:304238 (history)  Vaccinated:2008-01-29
Age:  Onset:2008-01-30, Days after vaccination: 1
Gender:Female  Submitted:0000-00-00
Location:Unknown  Entered:2008-02-04
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: Absence Seizures on Keppra
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Medication error
SMQs:, Extravasation events (injections, infusions and implants) (broad), Medication errors (narrow)
Write-up: Accidental Sub Q injection of MENcn-ACYW vaccine; 4 x 3 cm Red tender indurated Area at site of Sub Q injection left ventral forearm; Advised ice, NSAIDS prn.

VAERS ID:304242 (history)  Vaccinated:2008-01-29
Age:4.0  Onset:0000-00-00
Gender:Female  Submitted:2008-01-31
Location:California  Entered:2008-02-04, 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:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA02983IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0424U1SCRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2864AA4IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1579U1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Inappropriate schedule of drug administration, Medication error, Wrong drug administered
SMQs:, Medication errors (narrow)
Write-up: Dose of TDAP (Adacel) given instead of DTAP (Daptacel).

VAERS ID:304437 (history)  Vaccinated:2008-01-29
Age:24.0  Onset:2008-01-30, Days after vaccination: 1
Gender:Male  Submitted:2008-02-06, Days after onset: 7
Location:Washington  Entered:2008-02-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Military     Purchased by: Military
Symptoms: Unevaluable event
SMQs:
Write-up: Patient came in for a PPD skin test. He came back in two days for the reading and his left arm had a blister about the size of a penny at the site that the test was placed. Dr recommended a repeat on the opposite arm. The PPD skin test was then placed on the right arm. He came back in 48hrs and this time there was no blister. The reading was negative.

VAERS ID:304441 (history)  Vaccinated:2008-01-29
Age:1.1  Onset:2008-01-30, Days after vaccination: 1
Gender:Male  Submitted:2008-01-31, Days after onset: 1
Location:North Carolina  Entered:2008-02-06, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Allergic rhintis; asthma; eczema
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU1985CA IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0862F0IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETH87014583IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1257F0IMLL
Administered by: Private     Purchased by: Public
Symptoms: Injection site induration, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: (R) thigh DTaP, MMR sites induration, warm 2cm x 2cm 24 hr after administration -Benadryl, ice, Tylenol

VAERS ID:304453 (history)  Vaccinated:2008-01-29
Age:29.0  Onset:2008-01-31, Days after vaccination: 2
Gender:Female  Submitted:2008-01-31, Days after onset: 0
Location:Washington  Entered:2008-02-06, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
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.1326F1UNRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Induration, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 2 days after injection, area became red with induration & employee has low grade fever.

VAERS ID:304456 (history)  Vaccinated:2008-01-29
Age:1.0  Onset:2008-02-01, Days after vaccination: 3
Gender:Female  Submitted:2008-02-05, Days after onset: 4
Location:California  Entered:2008-02-06, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURAVPC2570AA3IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURAVP208733SCLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.MSD0867U1SCLA
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: (L) arm w/swelling, redness + slight tenderness.

VAERS ID:304476 (history)  Vaccinated:2008-01-29
Age:9.0  Onset:2008-01-31, Days after vaccination: 2
Gender:Male  Submitted:2008-02-01, Days after onset: 1
Location:Massachusetts  Entered:2008-02-06, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Mild URI
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2513AA6IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1515U1SCLA
Administered by: Public     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: L arm with swelling & redness 12.5 cm x 14.5 cm around site of Varivax injection.

VAERS ID:304485 (history)  Vaccinated:2008-01-29
Age:26.0  Onset:2008-01-29, Days after vaccination: 0
Gender:Male  Submitted:2008-01-30, Days after onset: 1
Location:North Carolina  Entered:2008-02-06, 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: Non productive cough
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1620SCRA
Administered by: Military     Purchased by: Military
Symptoms: Chills, Headache, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Received immunization at 1400, noticed nausea, vomiting, chills, headache at 1830 of 29Jan08.

VAERS ID:304495 (history)  Vaccinated:2008-01-29
Age:20.0  Onset:2008-01-29, Days after vaccination: 0
Gender:Female  Submitted:2008-01-29, Days after onset: 0
Location:Indiana  Entered:2008-02-06, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BC/Vitamins
Current Illness: None
Preexisting Conditions: History of panic attacks. Has been on medsinpact. Last attack several months ago.
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB449AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Feeling abnormal, Hot flush, Hyperhidrosis, Tension, Vision blurred
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)
Write-up: On way back to school, vision became blurry. Started sweating. Felt light and tense. Felt hot. Lasted few minutes. Once she got air ok. Didn''t eat breakfast.

VAERS ID:304523 (history)  Vaccinated:2008-01-29
Age:17.0  Onset:2008-01-29, Days after vaccination: 0
Gender:Female  Submitted:2008-02-07, Days after onset: 9
Location:Ohio  Entered:2008-02-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: FINE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER0?3IMLA
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER0?0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0?0IMLA
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER0?0IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Dizziness, Heart rate decreased, Loss of consciousness, Pallor
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: Pale (White), weakness, LOW heart rate, Dizziness, Passed out, was out for about 90 sec. Put water on face, after came to gave her orange juice. Patient was also given at the same time 3 other shots. Tetanus, Hepatitis A, Meningococcal Vaccine. I had asked before she was given all of the shots if it would be to much for her. They told me that it would be fine.

VAERS ID:304559 (history)  Vaccinated:2008-01-29
Age:1.5  Onset:2008-01-29, Days after vaccination: 0
Gender:Male  Submitted:2008-02-07, Days after onset: 9
Location:Massachusetts  Entered:2008-02-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Thallesemia
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURU2289AA3IMLL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB182AA1IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA01703SCLL
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Feeling hot, Induration, Pruritus, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 1/29 Redness, swelling, itchy; mom administered Benadryl - no effect. 1/30 - returned to office. Area 15% larger, red, indurated, warm area. *Reaction to DTAP*.

VAERS ID:304578 (history)  Vaccinated:2008-01-29
Age:1.1  Onset:2008-02-07, Days after vaccination: 9
Gender:Male  Submitted:2008-02-08, Days after onset: 1
Location:Georgia  Entered:2008-02-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0800U0IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0866U0SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1566U0SCLL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site induration, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Developed a moderate sized area of intense erythema and mild induration near site of MMR injection. Also had a few erythematous macules scattered over body.

VAERS ID:304593 (history)  Vaccinated:2008-01-29
Age:0.6  Onset:0000-00-00
Gender:Female  Submitted:2008-02-04
Location:California  Entered:2008-02-08, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER 2UNUN
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNUN
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER 3UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER 2UNUN
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER 2UNUN
Administered by: Public     Purchased by: Other
Symptoms: Chills, Inappropriate schedule of drug administration, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Fever, chills, vomiting, no coughing.

VAERS ID:304597 (history)  Vaccinated:2008-01-29
Age:15.0  Onset:2008-01-29, Days after vaccination: 0
Gender:Female  Submitted:2008-01-30, Days after onset: 1
Location:New York  Entered:2008-02-08, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0530U0IMLA
Administered by: Military     Purchased by: Military
Symptoms: Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: After receiving Gardasil vaccine pt became dizzy and nauseated. Symptoms subsided after about 10 mins.

VAERS ID:304598 (history)  Vaccinated:2008-01-29
Age:16.0  Onset:2008-01-29, Days after vaccination: 0
Gender:Female  Submitted:2008-01-30, Days after onset: 1
Location:New York  Entered:2008-02-08, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0530U0IMLA
Administered by: Military     Purchased by: Military
Symptoms: Dizziness, Headache, Nausea, Vertigo
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow)
Write-up: After receiving Gardasil vaccine - pt became nauseated, dizzy and c/o head swirling, severe headaches. Symptoms gone after about 15 mins.

VAERS ID:306085 (history)  Vaccinated:2008-01-29
Age:  Onset:2008-01-29, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 16
Location:Unknown  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA05868
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Information has been received form a health department nurse concerning a female who on 29-JAN-2008 was vaccinated with Gardasil. The nurse reported that on 29-JAN-2008, the patient fainted. Additional information has been requested.

VAERS ID:306107 (history)  Vaccinated:2008-01-29
Age:15.0  Onset:2008-01-29, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 16
Location:Texas  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA06112
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a physician concerning a 16 year old female with no known allergies or medical history who on 29-JAN -2008 was vaccinated with her first dose of Gardasil and fainted. Subsequently, the patient recovered from fainting in about five minutes. The patient sought unspecified medical attention. Additional information has been requested.

VAERS ID:307418 (history)  Vaccinated:2008-01-29
Age:0.5  Onset:2008-01-29, Days after vaccination: 0
Gender:Female  Submitted:2008-03-14, Days after onset: 44
Location:North Carolina  Entered:2008-03-17, 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: WAES0802USA00774
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0980F0PO 
Administered by: Private     Purchased by: Private
Symptoms: Inappropriate schedule of drug administration
SMQs:, Medication errors (narrow)
Write-up: Information has been received from a registered nurse concerning a 6 month old patient who on approximately 28-JAN-2008 last week, was vaccinated with the first dose of ROTATEQ. No adverse events were reported. There was no product quality complaint. Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/14/2008. Follow-up information has been received from the reporting registered nurse concerning a 6 month old female who on 29-JAN-2008 was vaccinated PO with her first dose of ROTATEQ vaccine (lot# 655317/0980F). No medical attention was sought. Additional information has been requested.

VAERS ID:307461 (history)  Vaccinated:2008-01-29
Age:14.0  Onset:2008-01-30, Days after vaccination: 1
Gender:Female  Submitted:2008-03-14, Days after onset: 43
Location:Pennsylvania  Entered:2008-03-17, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0802USA00424
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1448U2IMUN
Administered by: Private     Purchased by: Private
Symptoms: Feeling hot, Injection site papule, Injection site swelling, Injection site warmth, Local reaction, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a health professional concerning a 14 year old female who on 29-JAN-2008 was vaccinated with her third dose of GARDASIL (Lot #659653/1448U) in her right deltoid. On 30-JAN-2008 the patient experienced a pimple at the injection site, and the whole deltoid swelled to 1 1/2 sizes larger than normal, and was warm to the touch. The patient did not have a fever. The patient sought unspecified medical treatment with a phone call and nurse states the patient will be seen for follow up. The patient reports the symptoms are not resolved. Follow-up information was received stating that upon evaluation, it was a local reaction.

VAERS ID:307489 (history)  Vaccinated:2008-01-29
Age:24.0  Onset:2008-01-29, Days after vaccination: 0
Gender:Female  Submitted:2008-03-14, Days after onset: 44
Location:Unknown  Entered:2008-03-17, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0802USA00982
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1267U UNUN
Administered by: Other     Purchased by: Other
Symptoms: Menstrual disorder
SMQs:
Write-up: Information has been received from a health professional concerning a 24 year old white female who on 17-JUL-2007 was vaccinated with her first dose of GARDASIL (lot# 658490/0802U). On 29-JAN-2008 the patient was vaccinated with another dose of GARDASIL (lot# 659439/1267U). The patient reported on 29-JAN-2008 that since she began GARDASIL on 17-JUL-2007 she has had three full periods in a two month time frame. Additional information has been requested.

VAERS ID:309990 (history)  Vaccinated:2008-01-29
Age:69.0  Onset:2008-02-01, Days after vaccination: 3
Gender:Male  Submitted:2008-03-26, Days after onset: 53
Location:Texas  Entered:2008-04-16, Days after submission: 21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Lymphoma
Diagnostic Lab Data: None
CDC Split Type: WAES0802USA01787
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Hyperaesthesia, Rash erythematous, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a physician concerning a 69-year-old male with a history of lymphoma that is in remission and no known drug allergies, who on 29-JAN-2008 was vaccinated in the left arm with a dose of Zostavax (Oka/Merck). There was no concomitant medication. It was reported that the patient''s siblings had experienced shingles so the patient''s primary physician recommended the vaccination. "A few days later," on approximately 01-Feb-2008, the patient had a circular, red rash on his right lower abdomen. The affected area grew in size. There were no vesicles, but the area was sensitive and hot "as if there are nerves coming to the surface". The patient sought medical attention in the office. There were no laboratory or diagnostic tests performed. The outcome was reported as not recovered. No product quality complaint was involved. Additional information has been requested.

VAERS ID:312260 (history)  Vaccinated:2008-01-29
Age:70.0  Onset:2008-01-30, Days after vaccination: 1
Gender:Female  Submitted:2008-05-13, Days after onset: 103
Location:Georgia  Entered:2008-05-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions:
Diagnostic Lab Data: Patient has appointment with dermatologist for diagnosis.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0967U0SCLA
Administered by: Unknown     Purchased by: Public
Symptoms: Injection site mass, Rash
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient had a rash after immunization, but lingering wart-like bump at site of injection after 5 months.

VAERS ID:319272 (history)  Vaccinated:2008-01-29
Age:65.0  Onset:2008-02-26, Days after vaccination: 28
Gender:Male  Submitted:2008-06-24, Days after onset: 118
Location:Georgia  Entered:2008-07-11, Days after submission: 17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: lovastatin
Current Illness: Drug hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0803USA01779
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Erythema multiforme, Pruritus
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a physician concerning a 65 year old male consumer with CELEBREX allergy who 6 weeks ago on approximately 29-JAN-2008 was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included lovastatin (manufacturer unknown). The physician reported 3-4 weeks post vaccination approximately 26-FEB-2008 the patient developed erythema multiform after receiving zoster vaccine live (Oka/Merck). The physician stated he is sure it is erythema multiform because of the "characteristic target rash." The patient reported mild itching. Medical attention was sought in the office, there were no lab studies performed. The patient was treated with topical creams with no success. The patient was recently switched from LIPITOR to lovastatin (manufacturer unknown) shortly before the rash appeared. He was switched back to LIPITOR 2 weeks ago but the rash has not resolved. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.

VAERS ID:335606 (history)  Vaccinated:2008-01-29
Age:88.0  Onset:2008-04-28, Days after vaccination: 90
Gender:Female  Submitted:2008-11-17, Days after onset: 203
Location:California  Entered:2008-11-25, 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: Unknown
Preexisting Conditions: The reporter gave details on two separate subjects (A0730576 and A0730976), but indicated that there were more that received this particular TWINRIX, completing the series and not achieving seroprotection. For these additional subjects, refer to case A0731173A.
Diagnostic Lab Data: Hepatitis A antibodies, 28Apr2008, reactive; Hepatitis B surface antibody, 28Apr2008, OIU/ml
CDC Split Type: A0730576A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS 2UNLA
Administered by: Private     Purchased by: Private
Symptoms: Hepatitis A antibody, Hepatitis B antibody negative, Pharmaceutical product complaint
SMQs:
Write-up: This case was reported by a physician via a representative and described the occurrence of an 88 year old female subject not responding to therapy following vaccination with TWINRIX, GlaxoSmithKline. On 29 January 2008, the subject received 3rd dose of TWINRIX (unknown) to complete the vaccination series. The 1st dose was given on 24 July 2007 and the 2nd on 28 August 2007. On 28 April 2008, the subjects titers were tested and it was found that the subject had not responded to therapy. She was hepatitis B antibody negative. The physician felt that there might be something wrong with the TWINRIX vaccination (product complaint). At the time of reporting the events were unresolved. The physician considered the events were probably related to vaccination with TWINRIX. The reporter gave details on two separate subjects (A0730576 and A0730976), but indicated that there were more that received this particular TWINRIX, completing the series and not achieving seroprotection. For these additional subjects, refer to case A0731173A.

VAERS ID:342542 (history)  Vaccinated:2008-01-29
Age:6.0  Onset:2009-02-11, Days after vaccination: 379
Gender:Female  Submitted:2009-03-24, Days after onset: 40
Location:Pennsylvania  Entered:2009-03-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: URI; Headache
Preexisting Conditions: None
Diagnostic Lab Data: EEG; occipital spike and wave, started on DEPAKOTE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1352U1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Convulsion, Electroencephalogram
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: Seizure 13 days post VARIVAX. Seen by neurologist.

VAERS ID:414029 (history)  Vaccinated:2008-01-29
Age:0.2  Onset:2008-01-30, Days after vaccination: 1
Gender:Male  Submitted:2010-11-11, Days after onset: 1016
Location:Washington  Entered:2011-01-04, Days after submission: 54
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Private     Purchased by: Private
Symptoms: Lethargy
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)
Write-up: Lethargy.

VAERS ID:303968 (history)  Vaccinated:2008-01-30
Age:21.0  Onset:2008-01-30, Days after vaccination: 0
Gender:Female  Submitted:2008-01-30, Days after onset: 0
Location:Kentucky  Entered:2008-01-30
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
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0 LA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, Chills, Muscle spasms, Presyncope
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Almost fainted after having Gardasil vaccination. In the 5-6 hours following vaccination had 100 + temperature as well as chilling and muscle cramps.

VAERS ID:304057 (history)  Vaccinated:2008-01-30
Age:1.3  Onset:2008-02-01, Days after vaccination: 2
Gender:Female  Submitted:2008-02-01, Days after onset: 0
Location:Pennsylvania  Entered:2008-02-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: developed a cold..began to sleep more..
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMLL
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER 2IMLL
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 1IMRL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abnormal behaviour, Fatigue, Hypersomnia, Lethargy, Pyrexia, Staring, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Very tired..sleeps more then awake..stares..high fever..very lethargic..not much energy..just generally not acting like her normal self..shaking..and trembling also..

VAERS ID:304162 (history)  Vaccinated:2008-01-30
Age:13.0  Onset:2008-01-31, Days after vaccination: 1
Gender:Female  Submitted:2008-02-01, Days after onset: 1
Location:Massachusetts  Entered:2008-02-01
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:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMLA
Administered by: Private     Purchased by: Public
Symptoms: Body temperature increased, Injection site pain
SMQs:, Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Temperature 101.7, pain at injection site. Advise Tylenol for temperature. Cool compresses to site. Call if symptoms change.

VAERS ID:304173 (history)  Vaccinated:2008-01-30
Age:9.0  Onset:0000-00-00
Gender:Female  Submitted:2008-02-01
Location:New York  Entered:2008-02-01
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 BIOLOGICALSAHAVB207BA IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.150241SCLA
Administered by: Private     Purchased by: Unknown
Symptoms: Blister, Feeling hot
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (broad)
Write-up: 2/1/08 - Left arm 3x3 cm bullae, hot, ruptured - yais morning with surrounding small vesicles. Placed on Keflex 375 mg po 2x daily for 7 days.

VAERS ID:304140 (history)  Vaccinated:2008-01-30
Age:61.0  Onset:2008-01-30, Days after vaccination: 0
Gender:Female  Submitted:2008-02-02, Days after onset: 3
Location:Massachusetts  Entered:2008-02-02
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. 0UNRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Dizziness occurred within an hour of receiving Shingles Vaccine and continued several hours after. Slept sitting up and next day was fine.

VAERS ID:304241 (history)  Vaccinated:2008-01-30
Age:4.0  Onset:2008-01-31, Days after vaccination: 1
Gender:Male  Submitted:2008-02-01, Days after onset: 1
Location:Florida  Entered:2008-02-04, 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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURAC14B051AA4IMLA
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERA02983IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1307U1SCRL
Administered by: Public     Purchased by: Public
Symptoms: Blepharospasm
SMQs:, Dystonia (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow)
Write-up: Soon after receiving vaccine on 1/30/08, child began blinking his eyes uncontrollably - seen by PMD, given Benadryl on 1/31 - much improved 2/01.

VAERS ID:304254 (history)  Vaccinated:2008-01-30
Age:13.0  Onset:2008-01-30, Days after vaccination: 0
Gender:Female  Submitted:2008-02-04, Days after onset: 5
Location:Oklahoma  Entered:2008-02-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: none known
Diagnostic Lab Data: n/a
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0928U1IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Breath holding, Muscle spasms, Pallor, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Dystonia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Hypoglycaemia (broad)
Write-up: Patient was in for her second HPV shot and was given it without any difficulty at approximatly 03:55 pm on 01-30-2008. They had left the health department and got in private vehicle. Mother came running back in and stated that patient had spazed or something. The mother said she had jerked and moved her arms around and was scaring her. I went out to the vehicle and patient was sitting in an upright position and was very pale she was alert and oriented x3. She said she couldn''t hear her mother talking to her and mother said she couldn''t respond. Her mother had asked her if she was joking or what and patient told her no. I brought her back into the health department obtained her vital signs and they were stable (B/P 118|74 heart rate 58, respirations 16). Patient stated that she felt very weak. This was approximately 04:05 pm I layed her down and elevated her feet. She remaind alert and oriented. Her color came back to her face and I released her to her mothers care with instructions to take her to emergency room if any other problems and to let us know at 04:30pm. I called to follow up with her at approximately 05:30pm and patient had had no other problems. Patient was very nervous about the shot but was in the room with her little brother so she tried to be very big about it. She had started laughing and then held her breath for just a second while I was giving the shot. She had watched her little brother take his shots and he was a fighter.

VAERS ID:304272 (history)  Vaccinated:2008-01-30
Age:1.6  Onset:2008-01-31, Days after vaccination: 1
Gender:Male  Submitted:2008-02-04, Days after onset: 4
Location:Pennsylvania  Entered:2008-02-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: History of febrile seizures. PMH: Febrile seizure. Reflux. RSV. Ear tube placement. Allergy to Pulmicort causing headache. Family hx of seizures/epilepsy.
Diagnostic Lab Data: EEG, MRI Urine Tox Screen, CBC. Labs and Diagnostics: EEG normal. CBC and Chemistry WNL. CT brain WNL. EKG WNL. CXR with prominant peri-hilar markings. Urine drug screen (-).
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B054AA3IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chest X-ray, Computerised tomogram normal, Drug screen negative, Electrocardiogram normal, Electroencephalogram normal, Full blood count normal, Hypotonia, Hypotonic-hyporesponsive episode, Laboratory test normal, Scan brain, Unresponsive to stimuli
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: Patient had several episodes of limpness 15-18 hours after receiving a DTaP in the physician''s office. 04/23/2008 MR received for DOS 1/31-2/1/2008 with D/C DX: Hypotonic-hyporesponsive episode of unknown etiology. Pt presented to local ER with episode of limpness with unresponsiveness lasting about 1 min one day s/p vax. Pt had another episode in ER lasting ~30 sec. Neuro consult with normal exam. No further episodes.

VAERS ID:304348 (history)  Vaccinated:2008-01-30
Age:24.0  Onset:2008-01-31, Days after vaccination: 1
Gender:Female  Submitted:2008-02-05, Days after onset: 5
Location:Kansas  Entered:2008-02-05
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: na
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1582SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cellulitis
SMQs:
Write-up: Localized cellulitis.

VAERS ID:304368 (history)  Vaccinated:2008-01-30
Age:0.4  Onset:2008-01-31, Days after vaccination: 1
Gender:Male  Submitted:2008-02-01, Days after onset: 1
Location:New Jersey  Entered:2008-02-05, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 24 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None except Lt undescended testicle. 4/28/08-records received- PMH: febrile seizures viral meningitis by enterovirus at age 7 weeks. Also admitted at age 4 months for febrile seizures.
Diagnostic Lab Data: CT brain, EEG - N. Bld c/s, CSF c/s negative; Urine c/s negative 4/28/08-records received-CT negative. CBC: WBC 14,000. Lumbar puncture protein 63, glucose 89. Potassium 5.5.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B137AA1IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF216AA1IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB54016C1IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1621U1PO 
Administered by: Private     Purchased by: Public
Symptoms: Blood culture negative, Blood potassium increased, CSF culture negative, CSF glucose increased, CSF protein increased, Computerised tomogram normal, Cryptorchism, Culture urine negative, Electroencephalogram normal, Endotracheal intubation, Febrile convulsion, Grand mal convulsion, Intensive care, Pyrexia, Scan brain, White blood cell count increased
SMQs:, Angioedema (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Congenital, familial and genetic disorders (narrow), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Seizure around 4 AM 1-31-08. Fever. Imm. given 1-30-08. 04/28/08-records received for DOS 1/31-2/24/08-DC DX: Febrile seizures. Comples febrile seizures. Left undescended testicle.Presented to ED with fever 100.4 and seizure that was generalized, tonic-clonic and lasted more than 25 minutes. Intubated and admitted to PICU.

VAERS ID:304467 (history)  Vaccinated:2008-01-30
Age:14.0  Onset:2008-01-31, Days after vaccination: 1
Gender:Male  Submitted:2008-02-06, Days after onset: 6
Location:Pennsylvania  Entered:2008-02-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: CXR - neg; CBC - NL; ESR - NL.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2539AA0UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1493U1UNLA
Administered by: Private     Purchased by: Private
Symptoms: Chest X-ray normal, Full blood count normal, Lymphadenopathy, Nasopharyngitis, Pain, Pain in extremity, Pyrexia, Red blood cell sedimentation rate normal
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Received immunizations in left arm 1/30. 1/31 complained of arm soreness and noticed enlarged left supraclavicular node plus achiness. 2/2 fever and cold symptoms develop.

VAERS ID:304489 (history)  Vaccinated:2008-01-30
Age:65.0  Onset:2008-02-01, Days after vaccination: 2
Gender:Male  Submitted:2008-02-04, Days after onset: 3
Location:Delaware  Entered:2008-02-06, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid .05mg; Vitamins; Lipitor 20mg; Omega 3; Fish Oil
Current Illness: None
Preexisting Conditions: Hyperthyroidism
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1541U IMLA
Administered by: Private     Purchased by: Private
Symptoms: Chills, Erythema, Oedema peripheral, Swelling, Tremor
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Day of shot erythema and swelling, shakes and chills. Erythema and swelling in left arm, legs and elbow at night of shot injection.

VAERS ID:304493 (history)  Vaccinated:2008-01-30
Age:34.0  Onset:2008-01-30, Days after vaccination: 0
Gender:Female  Submitted:2008-01-31, Days after onset: 1
Location:Indiana  Entered:2008-02-06, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid 5mcg daily; Astelin Nasal Spray
Current Illness: None
Preexisting Conditions: Hypothyroidism; Seasonal allergies and allergies to citrus, milk, mold, some trees.
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1054U2IMRA
Administered by: Public     Purchased by: Private
Symptoms: Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 1/30/08 patient was given her 3rd Recombivax at 08:40. Patient stated approximately 9pm she had small hives on bilateral arms, maybe some on inside bilateral thighs. Denies fever. Took Benadryl for itching with relief. Took Benadryl this morning also.

VAERS ID:304521 (history)  Vaccinated:2008-01-30
Age:9.0  Onset:2008-02-01, Days after vaccination: 2
Gender:Male  Submitted:2008-02-01, Days after onset: 0
Location:Washington  Entered:2008-02-07, 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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB171AA0UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1746U0SCRA
Administered by: Private     Purchased by: Public
Symptoms: Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 50 mm diameter round swelling on arm.

VAERS ID:304522 (history)  Vaccinated:2008-01-30
Age:51.0  Onset:2008-01-31, Days after vaccination: 1
Gender:Female  Submitted:2008-02-07, Days after onset: 7
Location:Ohio  Entered:2008-02-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Allergies: Levaquin Medical Conditions: Heart Disease, Acid Reflux, Hypothryroidism, Diabetic, Insomnia, Bipolar 2/8/08-records received-PMH: Diabetes mellitus, coronary artery disease, bipolar disorder, hyperlipidemia, gastroesophageal reflux disease, hypothyroidism, asthma.
Diagnostic Lab Data: 2/8/08-records received-CBC unremarkable with slightly elevated WBC 13,000. CT scan no evidence of abscess.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2527AA0IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0554U0SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cellulitis, Chills, Computerised tomogram normal, Full blood count, Injected limb mobility decreased, Injection site erythema, Injection site swelling, Insomnia, Pain in extremity, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: L arm SQ area above elbow from pneumonia shot on Wednesday afternoon- by Thursday morning area became sore - swollen to the size of a quarter -reddened - had violent shivering episodes - Friday at dinnertime noticed it was getting bigger-shivering continued - had trouble moving her arm due to the pain - took Motrin and Darvocet but did not take away pain. Saturday morning awoke and went directly to the ER approx. 11am - the hospital completed blood work - Pt stated she was told she had an infection - a CT scan was completed and IV pain medication was started - CT scan showed no abscess - started on IV antibiotics - was not admitted - Given Vicodin and a PO antibiotic - Was unable to sleep because of pain. Sunday she called her family physician and stated it was worse - PCP told her to go to hospital for admission immediately. Pt was in hospital for 4 days on IV antibiotics and pain medications - diagnosed with cellulitis. Released to home on Wednesday evening with Vicodin and Bactrim BID. Swelling has decreased - pain has decreased "a little" - Will follow up with physician tomorrow. 2/8/08-records received for DOS 2/3-2/06/08-Presented to ED with C/O left arm pain and swelling, pain in left hand. PE: left upper extremity erythema and duration located in triceps region, minimal fluctuance with discomfort on palpation. DX: Left upper extremity cellulitis.

VAERS ID:304595 (history)  Vaccinated:2008-01-30
Age:1.4  Onset:2008-02-01, Days after vaccination: 2
Gender:Male  Submitted:2008-02-01, Days after onset: 0
Location:Arizona  Entered:2008-02-08, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Swelling~DTaP (no brand name)~5~1~In Patient
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B062AA4IMRL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2481EA1IMLL
Administered by: Private     Purchased by: Other
Symptoms: Immunisation reaction
SMQs:
Write-up: Mild Immz. reaction to R upper thigh

VAERS ID:304629 (history)  Vaccinated:2008-01-30
Age:0.5  Onset:2008-01-30, Days after vaccination: 0
Gender:Male  Submitted:2008-02-01, Days after onset: 2
Location:Iowa  Entered:2008-02-08, 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: Omnicef; Tylenol
Current Illness: Left otitis media improving
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2760AA2IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA02732SCRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB54016F2IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1394U2PO 
Administered by: Private     Purchased by: Public
Symptoms: Body temperature increased, Crying, Irritability, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Swollen left leg, extremely irritable, hysterical crying. Temp 103.8 at 1/31/08 visit.

VAERS ID:304718 (history)  Vaccinated:2008-01-30
Age:16.0  Onset:2008-02-08, Days after vaccination: 9
Gender:Male  Submitted:2008-02-11, Days after onset: 3
Location:Ohio  Entered:2008-02-12, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERA03422 IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.086UU SCRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2423AA IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2759AA IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0593U SCLA
Administered by: Other     Purchased by: Public
Symptoms: Erythema, Hypoaesthesia, Pain, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Varicella vaccination given L upper arm sq. on 1/30/08. Father (physician) states pt c/o redness, swelling, warmth, pain & slight numbness on 2/8/08, area 3"x5". Sx slightly worse on 2/9/08. Pt began on Amox. 500 mg one TID x10 days.

VAERS ID:304744 (history)  Vaccinated:2008-01-30
Age:0.2  Onset:2008-02-04, Days after vaccination: 5
Gender:Male  Submitted:2008-02-11, Days after onset: 7
Location:Unknown  Entered:2008-02-12, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Diagnostic laboratory
CDC Split Type: WAES0802USA01314
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  PO 
Administered by: Other     Purchased by: Other
Symptoms: Arrhythmia, Haematochezia, Laboratory test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)
Write-up: Information has been received from a pharmacist concerning an 11 week old male with no known allergies who on 30-JAN-2008 was vaccinated with Rotateq. The pharmacist reported that the patient was admitted to the hospital on 04-FEB-2008 for dysrhythmia. The pharmacist also reported that a physician mentioned to the pharmacist that the patient had bloody stools. Unspecified lab work was done. The patient sought unspecified medical attention. There was no product quality complaint involved. Additional information has been requested.

VAERS ID:304792 (history)  Vaccinated:2008-01-30
Age:5.0  Onset:2008-01-31, Days after vaccination: 1
Gender:Male  Submitted:2008-01-31, Days after onset: 0
Location:Virginia  Entered:2008-02-12, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2655AA4 LL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA01103 RL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0425U1 RL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1594U1 LL
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: 6" area erythema and 1/4" induration, local to injection site, noted by mother. Written 24 hours of administration.

VAERS ID:304797 (history)  Vaccinated:2008-01-30
Age:55.0  Onset:2008-01-30, Days after vaccination: 0
Gender:Male  Submitted:2008-02-01, Days after onset: 2
Location:Alabama  Entered:2008-02-12, 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: None known
Preexisting Conditions: Hypertension; COPD
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0554U0IMLA
Administered by: Military     Purchased by: Military
Symptoms: Erythema, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient received Pneumonia 23 vaccine on 1-30-08. On 2-1-08, phoned clinic complaining of pain, redness and swelling of arm down to elbow area.

VAERS ID:304822 (history)  Vaccinated:2008-01-30
Age:1.3  Onset:2008-01-31, Days after vaccination: 1
Gender:Male  Submitted:2008-02-08, Days after onset: 8
Location:Pennsylvania  Entered:2008-02-13, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: The patient had not been taking any concomitant medications at the time of vaccination.
Current Illness: The patient had no illness at the time of vaccination.
Preexisting Conditions: The patient had no illness, no pre-existing medical conditions and had not been taking any concomitant medications at the time of vaccination.
Diagnostic Lab Data: None reported.
CDC Split Type: 200800333
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURZ081523UNRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB54015 UNLL
Administered by: Private     Purchased by: Other
Symptoms: Convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: Initial report received 31 January 2008 from a health care professional. A 15-month-old male patient, with no pre-existing medical conditions, had received a right thigh injection of ActHIB, lot number UF009AA (sanofi pasteur SA lot number Z0815-2), and a left thigh injection of Prevnar, lot number B54015 (manufacturer Wyeth) and on the following day (in the morning) developed seizures. The patient was taken to the emergency room however, was not admitted. Corrective treatments were unknown at the time of the report and the patient''s recovery status was unknown. No further information was provided.

VAERS ID:304827 (history)  Vaccinated:2008-01-30
Age:1.3  Onset:2008-02-04, Days after vaccination: 5
Gender:Male  Submitted:2008-02-13, Days after onset: 9
Location:Illinois  Entered:2008-02-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No. But URI at time of febrile seizure
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B051AA3IMRL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Febrile convulsion, Upper respiratory tract infection
SMQs:, Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: 5 days post vaccine had a febrile seizure. Did have URI symptoms also.

VAERS ID:304903 (history)  Vaccinated:2008-01-30
Age:0.6  Onset:0000-00-00
Gender:Male  Submitted:2008-02-08
Location:Maine  Entered:2008-02-14, 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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS80956 UNUN
Administered by: Private     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
SMQs:, Medication errors (narrow)
Write-up: 0.25 ml Fluviron given $g 4 yrs Rec no reaction

VAERS ID:305203 (history)  Vaccinated:2008-01-30
Age:18.0  Onset:2008-01-31, Days after vaccination: 1
Gender:Female  Submitted:2008-02-19, Days after onset: 19
Location:Montana  Entered:2008-02-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Fluoxetine 20mg once daily; Benzaclin 1.5% gel
Current Illness: None
Preexisting Conditions: Depression
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1249U0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, Skin lesion
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Erythemic area at injection site 6 cm in diameter, swollen, hot, tender, pruritic and with 3 super imposed pox like lesions still present 20 days after vaccinations. Some resolution since onset. Advised her to try Benadryl.

VAERS ID:306092 (history)  Vaccinated:2008-01-30
Age:20.0  Onset:2008-01-30, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 15
Location:New Jersey  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA05970
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 3UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect dose administered, Malaise, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Medication errors (narrow), Hypoglycaemia (broad)
Write-up: Information has been received from a health professional concerning a 20 year old female who on 17-JAN-2008 was vaccinated with a fourth dose of Gardasil (lot # not reported). The reporter reported that the patient almost fainted and was not feeling well. She was not taken to hospital and she felt better. It was reported that patient got a fourth injection of Gardasil. Additional information has been requested.

VAERS ID:305374 (history)  Vaccinated:2008-01-30
Age:1.1  Onset:2008-02-02, Days after vaccination: 3
Gender:Male  Submitted:2008-02-05, Days after onset: 3
Location:Pennsylvania  Entered:2008-02-21, Days after submission: 16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB214AA0IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0417U0SCLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB08700A2IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1508U0SCRL
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Eye swelling, Joint swelling, Skin warm, Swelling face, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 2/2/8-Child developed swollen ankles. 2/3/8 PM-both knees swollen & L ankle. Knees red & hot. 2/4/8-"spots" all over body. 2/5/8-large red welts over entire body-face swollen, eyes swollen. Instructed to have child evaluated by a physician & call back with diagnosis. Never called back. Left messages 2/7/08, 2/8/08 and 2/19/08. We don''t know if patient was ever seen by a doctor.

VAERS ID:305412 (history)  Vaccinated:2008-01-30
Age:0.6  Onset:2008-02-01, Days after vaccination: 2
Gender:Female  Submitted:2008-02-02, Days after onset: 1
Location:California  Entered:2008-02-21, Days after submission: 19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B128AB1IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC351712IMRL
Administered by: Other     Purchased by: Public
Symptoms: Erythema, Skin nodule, Skin warm
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Immunizations: Pediarix and Prevnar given in (R) thigh on 1/30/08. On 2/2/08 2 firm lumps noted in thigh with erythema - warm to touch. Advised cool compresses and Tylenol.

VAERS ID:306390 (history)  Vaccinated:2008-01-30
Age:3.0  Onset:2008-02-07, Days after vaccination: 8
Gender:Female  Submitted:2008-03-04, Days after onset: 26
Location:Wisconsin  Entered:2008-03-04
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Multivitamin
Current Illness: Unknown
Preexisting Conditions: The subject has no relevant medical history and no history of adverse events following previous vaccinations.
Diagnostic Lab Data: UNK
CDC Split Type: A0713061A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHAVB200BA0UNLL
Administered by: Other     Purchased by: Other
Symptoms: Nonspecific reaction, Serum sickness
SMQs:, Hypersensitivity (narrow)
Write-up: This case was reported by a healthcare professional and described the occurrence of serum sickness in a 3-year-old female subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis. Concurrent medications included multivitamins. On 30 January 2008 at 15:00 the subject received 1st dose of Engerix B at 0.5 ml in the left thigh. On 7 February 2008, 8 days after vaccination with Engerix B, the subject experienced serum sickness (systemic reaction). The healthcare professional considered the events were disabling. At the time of reporting the events were improved.

VAERS ID:306570 (history)  Vaccinated:2008-01-30
Age:60.0  Onset:2008-02-18, Days after vaccination: 19
Gender:Female  Submitted:2008-03-06, Days after onset: 17
Location:Pennsylvania  Entered:2008-03-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none reported
Preexisting Conditions: mold allergy, for which she receives allergy shots; hypertension and back pain
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
RUB: RUBELLA (MERUVAX II)MERCK & CO. INC.0036U SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Joint swelling, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Approximately two and a half weeks after receiving rubella vaccine the patient began having pain in right ankle and both hands. On 2/18/08 her ankle was swollen to double it''s normal size, 2/22/08 still having arthritis symptoms in hands, her left is so swollen, she doesn''t recognize it. She is unable to wear her rings on her fingers. On 2/29/08 she described her arthritic symptoms as resolving, the swelling had decreased and she is able to wear her rings.

VAERS ID:306649 (history)  Vaccinated:2008-01-30
Age:1.0  Onset:2008-01-30, Days after vaccination: 0
Gender:Female  Submitted:2008-02-25, Days after onset: 26
Location:California  Entered:2008-03-07, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol for the fever
Current Illness: None
Preexisting Conditions: Allergies; Eczema
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Private     Purchased by: Other
Symptoms: Abscess, Erythema, Irritability, Limb discomfort, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Patient had a fever following the vaccination. A red, hot bump was at the spot of the immunization (right arm). Redness, soreness and bump lasted for about 2 weeks. Cold ice pack applied to area per doctor''s instructions. Patient was very fussy, still.

VAERS ID:307466 (history)  Vaccinated:2008-01-30
Age:17.0  Onset:2008-01-30, Days after vaccination: 0
Gender:Female  Submitted:2008-03-14, Days after onset: 43
Location:Unknown  Entered:2008-03-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0802USA00447
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1522U2IMUN
Administered by: Other     Purchased by: Other
Symptoms: No reaction on previous exposure to drug, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Initial and follow up information has been received from a physician''s assistant concerning a 17 year old white female student with no previous medical history, who on 25-JUL-2007 was vaccinated with the first dose, on 26-SEP-2007 with the second dose and on 30-JAN-2008 with the third dose of GARDASIL (lot number: 659055/1522U). Concomitant therapy included minocycline HC1 (DENTOMYCIN (minocycline hydrochloride)) and drospirenone (+) ethinyl estradiol (YAZ). On 30-JAN-2008 after the 3rd and final vaccination the patient at the check out window had a syncopal episode. She regained awareness in a matter of < 1 minute. She did have an episode of vomiting after regaining awareness. Subsequently the patient recovered. The patient did not experience any reaction or adverse effect after the 1st and 2nd dose of vaccines. Additional information has been requested. 07/08/08 Initial and follow up information has been received from a physician''s assistant concerning a 17 year old female student with no previous medical history, who on 25-JUL-2007 was vaccinated with the first dose, on 26-SEP-2007 with the second dose and on 10-JAN-2008 with the third dose of GARDASIL (lot number: 659055/1522U). Concomitant therapy included DENTOMYCIN and YAZ. On 30-JAN-2008 after the 3rd and final vaccination the patient at the check out window had a syncopal episode. She regained awareness in a matter of < 1 minute. She did have an episode of vomiting after regaining awareness. Subsequently the patient recovered. The patient did not experience any reaction or adverse effect after the 1st and 2nd dose of vaccines. Additional information has been requested.

VAERS ID:307718 (history)  Vaccinated:2008-01-30
Age:21.0  Onset:2008-01-30, Days after vaccination: 0
Gender:Female  Submitted:2008-03-14, Days after onset: 43
Location:Michigan  Entered:2008-03-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC Split Type: WAES0802USA04380
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1740U0IMLA
Administered by: Other     Purchased by: Private
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a physician concerning a female on an unspecified date who was vaccinated intramuscularly with her first dose of GARDASIL (lot# not reported). Subsequently the patient fainted after receiving the vaccine. The patient felt better after 20 minutes and left the office. Subsequently, the patient recovered from fainting. Additional information has been requested. Follow-up received 07/11/2008. Vaccinated 30-JAN-2008 in the left deltoid, lot #659962/1740U. The patient had not eaten, but improved quickly after drinking juice. Additional information has been requested.

VAERS ID:307761 (history)  Vaccinated:2008-01-30
Age:0.2  Onset:2008-03-04, Days after vaccination: 34
Gender:Female  Submitted:2008-03-21, Days after onset: 16
Location:North Carolina  Entered:2008-03-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: PMH: GERD
Diagnostic Lab Data: LABS: KUB revealed distal SBO. US abdomen (+) IS.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAMAC21B125BB0IMLL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0077U0IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB47442E0IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0980F0PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Appendicectomy, Constipation, Crying, Dehydration, Diarrhoea, Enema administration, Explorative laparotomy, Fatigue, Gastrointestinal oedema, Intussusception, Irritability, Pyrexia, Surgery, Ultrasound abdomen abnormal, Urinary system X-ray, Vomiting
SMQs:, Acute pancreatitis (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: VOMTING, CRYING, DRAWING LEGS UP, DIARRHEA, FEVER, TIRED, DEHYDRATED, THIS OCCURRED FOR THREE DAYS WE TOOK CHILD TO DR TWO DAYS IN A ROW WITH KNOW ANSWER FINALLY WENT TO ER ON THIRD DAY AND THEY DID ULTRASOUND AND FOUND INTUSSUSCEPTION WAS RUSHED TO Hospital AND AIR ENEMA WAS TRIED BUT IT WAS TO LATE SO THEY PERFORMED SURGERY. 4/15/08 Reviewed hospital medical records for 3/8-3/9/2008. FINAL DX: Intussusception, exploratory laparotomy & appendectomy Records reveal patient transferred to higher level of care after having been dx w/IS at outlying ER by US. Had irritability, vomiting, fever, abdominal pain & distention, diarrhea/constipation x 2 days. Underwent air contrast enema w/partial reduction & taken to OR. Findings at time of surgery were resolved IS, edematous bowel. Progressed diet well & d/c to home.

VAERS ID:308327 (history)  Vaccinated:2008-01-30
Age:31.0  Onset:2008-01-30, Days after vaccination: 0
Gender:Female  Submitted:2008-03-26, Days after onset: 55
Location:Unknown  Entered:2008-03-27, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = 1/20/2008)
Preexisting Conditions:
Diagnostic Lab Data: beta-human chorionic 02/27/08
CDC Split Type: WAES0803USA01753
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEUR  UNUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  UNUN
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
TYP: TYPHOID LIVE ORAL TY21A (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: Information has been received from a certified nurse practitioner concerning a 31 year old female with no pertinent medical history reported. The patient had her last menstrual period on 20-JAN-2008. On 30-JAN-2008, the patient was vaccainted with MMR II (lot # 1312U). Concomitant therapy also administered on 30-JAN-2008 included TWINRIX, influenza virus vaccine (unspecified) (manufacturer unspecified). poliovirus vaccine inactivated (Vero) (manufacturer unspecified), diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (manufacturer unspecified), and typhoid vaccine live oral (Ty21a) (manufacturer unspecified). Concomitant therapy administered on 06-FEB-2008 included Japanese encephalitis virus vaccine (manufacturer unspecified), and rabies vaccine (unspecified) (manufacturer unspecified). Subsequently, she became pregnant. Her estimated date of delivery was 26-OCT-2008. On 27-FEB-2008, the patient had a pregnancy test. On 28-FEB-2008, the patient miscarried. Unspecified medical attention was sought. Subsequently, the patient recovered. Upon internal review, the spontaneous miscarriage was determined to be an Other Important Medical Event. Additional information has been requested.

VAERS ID:310232 (history)  Vaccinated:2008-01-30
Age:  Onset:2008-01-30, Days after vaccination: 0
Gender:Female  Submitted:2008-03-26, Days after onset: 55
Location:Illinois  Entered:2008-04-16, Days after submission: 21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: CSF VZV IgG Ab, 01/30?/08
CDC Split Type: WAES0802USA00487
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1080U UNRA
Administered by: Other     Purchased by: Other
Symptoms: Blood immunoglobulin G, CSF test, Discomfort, Herpes zoster, Hypoaesthesia, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a physician concerning a female with no pertinent medical history or drug allergies who on 30-JAN-2008 was vaccinated with a dose of Zostavax (Oka/Merck) (lot# 658602/1080U) in the right deltoid (unspecified route). There was no concomitant medication. On that same day within 4 hours of vaccination, the patient developed initial symptoms of itching of the right breast and numbness followed by a rash over her right shoulder and right breast. On 31-JAN-2008 the patient developed shingles. The patient was seen by the physician for medical attention. Lab diagnostic studies performed included a "VZV IgG" test. The patient was treated with FAMVIR. The patient was noted to be uncomfortable and was not recovered at the time of this report. There was no product quality complaint. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met requirements of CBER and was released by the regulatory agency. Additional information has been requested.

VAERS ID:310681 (history)  Vaccinated:2008-01-30
Age:25.0  Onset:2008-01-30, Days after vaccination: 0
Gender:Female  Submitted:2008-04-14, Days after onset: 74
Location:Missouri  Entered:2008-04-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Pregnancy NOS (LMP = 11/5/2007)
Diagnostic Lab Data: Urine beta-human 02/08 - Positive
CDC Split Type: WAES0803USA02007
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Menstruation irregular, Metrorrhagia, Urine human chorionic gonadotropin positive
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow), Fertility disorders (broad)
Write-up: Information has been received from a physician, through the Pregnancy Registry for GARDASIL, concerning a 25 year old female who on 30-JAN-2008 was vaccinated with her first dose of GARDASIL (Lot # and route not reported). At the time of vaccination, the patient reported that she did not have her period for 3 months. A few days after her vaccination, the patient experienced spotting and went to the emergency room. A pregnancy test was administered and was positive (LMP approximately 05-Nov-2007). The patient was not admitted to the hospital. No further information is available. Additional information has been requested.

VAERS ID:311474 (history)  Vaccinated:2008-01-30
Age:0.2  Onset:2008-01-30, Days after vaccination: 0
Gender:Male  Submitted:2008-04-23, Days after onset: 83
Location:Virginia  Entered:2008-05-02, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2760AA0UNLL
HEP: HEP B (FOREIGN)MERCK & CO. INC.0627U0UNRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF223AB0UNLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA02980UNRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB47300C0UNLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0402U0PO 
Administered by: Private     Purchased by: Private
Symptoms: Unevaluable event
SMQs:
Write-up: None stated.

VAERS ID:312196 (history)  Vaccinated:2008-01-30
Age:63.0  Onset:2008-02-01, Days after vaccination: 2
Gender:Female  Submitted:2008-04-29, Days after onset: 87
Location:California  Entered:2008-05-13, 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: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH0963U IMUN
Administered by: Private     Purchased by: Unknown
Symptoms: Arthralgia, Bone pain, Myalgia, Oedema peripheral, Pyrexia, Rash
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Osteonecrosis (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: wasn''t feeling good on 01-31-08 then on 02-01-08 -arm swelling w/rash that night 102 temp and swelling worse rash larger-joint and muscle pain-Bone pain. Swelling-Rash, temp 102-muscle-bone pain. Still having joint and muscle problem

VAERS ID:312332 (history)  Vaccinated:2008-01-30
Age:48.0  Onset:2008-03-29, Days after vaccination: 59
Gender:Male  Submitted:2008-05-15, Days after onset: 47
Location:Unknown  Entered:2008-05-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: CT brain normal. Lab (CBC, sed rate CRP, Chem, TFT, RPR) normal. Studies performed 1 May 2008
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1735IMLA
Administered by: Military     Purchased by: Military
Symptoms: C-reactive protein normal, Computerised tomogram normal, Full blood count normal, Laboratory test normal, Motor dysfunction, Paraesthesia, Red blood cell sedimentation rate normal, Scan brain, Syphilis test negative, Thyroid function test normal
SMQs:, Peripheral neuropathy (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad)
Write-up: Gradual onset of daily left arm band-like paresthesias; progressive over time from intermittant to constant, and from limited to generalized dermatomal distribution. Daily episodes of tingling paresthesias, same distributuion. Motor involvement of elbow & wrist flexion/extension. No improvement to the present time.

VAERS ID:312750 (history)  Vaccinated:2008-01-30
Age:0.2  Onset:2008-01-30, Days after vaccination: 0
Gender:Unknown  Submitted:2008-05-14, Days after onset: 104
Location:Unknown  Entered:2008-05-16, 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:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0804USA02008
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC. 0PO 
Administered by: Other     Purchased by: Other
Symptoms: No adverse event
SMQs:
Write-up: Information has been received from a registered nurse concerning a 12 week, 4 day old patient who on approximately 30-JAN-2008 was vaccinated PO with the first dose of ROTATEQ. No adverse experience was related to this event. There was no product quality complaint. No further information is available.

VAERS ID:314047 (history)  Vaccinated:2008-01-30
Age:71.0  Onset:2008-01-30, Days after vaccination: 0
Gender:Male  Submitted:2008-05-16, Days after onset: 106
Location:Ohio  Entered:2008-05-23, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0802USA00024
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0065R UNUN
Administered by: Other     Purchased by: Other
Symptoms: Wrong drug administered
SMQs:, Medication errors (narrow)
Write-up: Information has been received from a health professional concerning a 71 year old male who on 30-JAN-2008, was inadvertently vaccinated with varicella virus vaccine live (Oka/Merck) (lot# 646313/0065R) instead of zoster vaccine live (Oka/Merck). The patient sought medical attention at the physician''s office. Current patient status was not reported. The reporter indicated that the event was staff error only. A product quality complaint was not reported. Additional information has been requested.

VAERS ID:313839 (history)  Vaccinated:2008-01-30
Age:69.0  Onset:2008-03-25, Days after vaccination: 55
Gender:Male  Submitted:2008-05-21, Days after onset: 57
Location:Florida  Entered:2008-05-28, 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: Arthritis, Pulmonary modules (benign)
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1079U0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Pain of skin, Rash, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Started as just itching, then painful rash on back extending towards the anterior trunk. Patient was treated with FAMVIR 500mg BID x 7days.

VAERS ID:319443 (history)  Vaccinated:2008-01-30
Age:  Onset:2008-02-02, Days after vaccination: 3
Gender:Female  Submitted:2008-06-24, Days after onset: 142
Location:Florida  Entered:2008-07-11, Days after submission: 17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0805USA00378
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1613U0SCUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site rash
SMQs:, Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a female patient who on 30-JAN-2008 was vaccinated SC with a dose of zoster vaccine live (Oka/Merck) (Lot # 659323/1613U). On 02-FEB-2008 the patient developed an injection site rash. The patient sought unspecified medical attention. At the time of this report, the outcome of the adverse event was unknown. No product quality complaint was involved. Additional information has been requested.

VAERS ID:320528 (history)  Vaccinated:2008-01-30
Age:19.0  Onset:0000-00-00
Gender:Female  Submitted:2008-07-25
Location:Wisconsin  Entered:2008-07-25
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: NKA
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1267U2IMLA
Administered by: Private     Purchased by: Private
Symptoms: Inappropriate schedule of drug administration
SMQs:, Medication errors (narrow)
Write-up: Dose 3 was given too early. It will be repeated per CDC guidelines.

VAERS ID:325275 (history)  Vaccinated:2008-01-30
Age:16.0  Onset:2008-02-01, Days after vaccination: 2
Gender:Female  Submitted:2008-08-14, Days after onset: 194
Location:North Carolina  Entered:2008-08-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown 10/30/08-records received-PMH:ADHD. Benign tumor removed on both ovaries. has been getting Depo for 3 years
Diagnostic Lab Data: Unknown 10/30/2008-records received-7/15/08-Post D&C now C/O pelvic pain and heavy bleeding. Ultrasound normal.
CDC Split Type: WAES0807USA03551
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1062U2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Abdominal pain upper, Dyspareunia, Menometrorrhagia, Menorrhagia, Nausea, Oral contraception, Pelvic pain, Polyp, Proctalgia, Thrombosis, Ultrasound scan normal, Uterine dilation and curettage
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information has been received from a female concerning her 17 year old granddaughter who on unspecified dates was vaccinated with the complete series of GARDASIL. About 7 months ago (in approximately 2008), the patient started to experience blood clots and severe pain on the lower part of her stomach on both sides and still hasn''t recovered. The patient was not hospitalized. It was unspecified if the patient sought medical attention. This is one of three reports from the same source. (WAES: 0807USA03323 and 0807USA03552). Additional information has been requested. 10/30/08-records received-on 1/30/08-received 3rd Gardasil injection. Depoprovera given. 3/5/08-C/O continuous bleeding on Depo, has been getting Depo for 3 years but just started bleeding everyday in the last two month. 3/28/08-C/O nausea, difficulty eating, low abdominal cramping heavy bleeding but no clots. Started birth control early March. 4/25/08-RLQ pain radiating to rectal area bleeding after intercourse. Now on Orhto EVRA patch and continues with Depoprovera. 6/19/08-Menometrorrhagia. Patient requests a D&C. 7/15/08-Post D&C now C/O pelvic pain and heavy bleeding. Polyp removed. 7/18/08-passed large clot and bleeding heavy again. Declines depo provera and mirena.

VAERS ID:323865 (history)  Vaccinated:2008-01-30
Age:11.0  Onset:2008-01-30, Days after vaccination: 0
Gender:Female  Submitted:2008-07-30, Days after onset: 181
Location:New Hampshire  Entered:2008-09-02, Days after submission: 34
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 50 days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: History derived from review of medical record, several of my prior exams and visits, and discussion with PCP; Seasonal allergies.'' PMH: Asthma. Allergic to Augmentin and Benadryl.
Diagnostic Lab Data: Blood lactate 6.6, followed by 5.4 both in free flowing blood, without tourniquet; Pyruvate, requested but not obtained; CPK 103; Blood mitochondrial mutations, normal 14 mutations and 3 deletions, including MERRF mutations; Urine spot HVA: 3.1 ug/mg Cr normal <7.0; Urine spot VMA: 6.0 ug/mg Cr normal <12.0; MIBG and octreatide scans are normal; IgG 1484; IgA 118; IgM 213 high; IgE 638 high; NeoCerebellar degeneration paraneoplastic profile with Recombx, at labs, negative; Recombx Hu negative; Ma1; Ma2; Yo; Ri; CV2; Zio4; All normal; Mycoplasma studies: IgG elevated at 3.48 (normal <0.9); IgM 0.42; normal (<0.9); suggests old prior exposure; ANA positive; $g1:80; ADNA negative; ADNA titre not performed; CANCA neg; PANCA neg; MPO2.8; myeloper
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1266U1IMUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2549AA0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Abasia, Abdominal pain upper, Anger, Angiotensin converting enzyme increased, Antibody test normal, Antineutrophil cytoplasmic antibody negative, Antineutrophil cytoplasmic antibody positive, Antinuclear antibody negative, Antinuclear antibody positive, Asthenia, Ataxia, Atrophy, Blood creatine phosphokinase normal, Blood electrolytes normal, Blood heavy metal normal, Blood immunoglobulin A normal, Blood immunoglobulin E increased, Blood immunoglobulin G normal, Blood immunoglobulin M increased, Blood lactic acid increased, Blood product transfusion, Blood pyruvic acid increased, Blood thyroid stimulating hormone normal, Borrelia burgdorferi serology negative, CSF test normal, Cardiolipin antibody negative, Cerebellar syndrome, Depression, Dizziness, Electroencephalogram normal, Electromyogram normal, Eye movement disorder, Full blood count, Haemoglobin normal, Herpes simplex serology positive, Hyperglycaemia, Hyperreflexia, Hyporeflexia, Laboratory test normal, Malaise, Mood altered, Motor dysfunction, Muscular weakness, Mycoplasma serology positive, Myoclonus, Nausea, Nerve conduction studies normal, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Opsoclonus myoclonus, Oropharyngeal pain, Platelet count normal, Sensory loss, Social avoidant behaviour, Thyroxine free normal, Tremor, Ultrasound abdomen normal, Vertigo, Wheelchair user, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Lactic acidosis (narrow), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (narrow), Hypertension (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (narrow), Vasculitis (broad), Ocular motility disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: In December of 2007 and January of 2008, patient became withdrawn and concerned that she did not lose weight despite diet and exercise, and she started having opsoclonus. She had no illnesses around the time of onset of those symptoms. Brother had been quite ill (thought initially to be meningitis, but turned out to be unknown) and is now better. She had a meningitis vaccine and HPV vaccine at the time that she started to be withdrawn. Over the course of 1-2 weeks she became ataxic, and had very "jumpy arms". This myoclonus spread to her legs such that she could not walk. She denied headaches, nausea, and or vomiting. No muscle aches or leg pain. No tinnitus or hearing loss. At the time of a February 11, 2008 admission she had severe opsoclonus, myoclonus, dysmetria, and perhaps a wide amplitude tremor. An extended evaluation was started looking for a neuroblatoma and a ganglioneuromal, mitochondrial disease, inflammatory diseases, and other diseases. There were a few abnormal lab results, which normalized later. The lactate normalized only after starting mitochondrial vitamins. No evidence of a ganglioneuroma or neuroblastoma was found. Blood mitochondrial mutations were sent and later returned as normal. Because the lactate was high, we added Thiamine 25 mg twice daily and riboflavin 50mg twice daily, CoQ, and Keppra was started later at 1mg/kg/day, and advanced as tolerated, then lowered when she started feeling nauseated. She received steroid x 1 week courses, with marked hyperglycemia, but no improvement. She received IVIG, then sent to hospital. She was discharged from hospital with improved opsoclonus, but still unable to walk or reach easily. She returned to hospital for a second course of IVIG. After that, the mitochondrial meds were stopped, she remained unable to walk, and had variable but usually less opsoclonus. Physical therapists noted some weakness and atrophy, and she had one episode when she would fall to the left side when the tuning fork was put near her left ear. She had had no convulsions and had a normal EEGs, including a normal 24 hour EEG; no emesis; no headache; no deterioration of affect or bizarre behavior. She has had no trouble eating and she can use a fork, but has some difficulty using her knife to cut. She was seen by doctor, who, mother says, gave a cursory exam, stated that patient''s strength was adequate to walk, and that Mother should stand her up, make her walk, and she will be walking in several months. 12/1/08 MR received for 2 admissions: DOS 2/11-29/2008 with D/C DX: Post-infectious myoclonus and opsoclonus with lower extremity weakness. Depression. DOS: 4/17-19/2008 with D/C DX: Upper extremity weakness. Opsoclonus-myoclonus. Two months prior to admission pt noticed new onset of mood changes-depression and anger. One month prior pt noticed abnormal eye movements which resulted in vertigo. Pt presented with worsening eye movements with dizziness and shakiness. Unable to walk unassisted, feeling unwell with sore throat and stomach ache. Some arm tremors. PE (+) for abnormal eye movements, 4/5 strength in lower extremities, ataxia, UE and knee DTRs brisk, difficult to elicit at ankles. Ophth, Rheum and Psych consults. Started on anti-depressant. D/C to inpt rehab. Developed new myoclonus in legs and R arm despite steroids and IVIG. Returned for admission 4/17/08 with new complaint of upper extremity weakness. Now using a w/c and difficult to transition from w/c to bed. New truncal weakness and difficulty with fine motor skills. Unable to stand due to lack of sensation in feet. Again tx with IVIG without resolution of sx.

VAERS ID:335561 (history)  Vaccinated:2008-01-30
Age:7.0  Onset:2008-02-01, Days after vaccination: 2
Gender:Female  Submitted:2008-12-17, Days after onset: 320
Location:Washington  Entered:2008-12-18, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0812USA02556
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1272U1SCUN
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a physician concerning a 7 year old female patient who on 30-JAN-2008 was vaccinated with her second dose of VARIVAX (Merck) (Lot# 658586/1272U) by SQ route. On 01-FEB-2008 the patient developed a small area of red around the site of vaccination. Significantly increased in size through the day to 5x3 1/2 cm area of induration and warmth increased. The patient started on KEFLEX and recovered on 03-FEB-2008. The physician considered the patient''s experiences to be Other Important Medical Events. No further information is available.

VAERS ID:337368 (history)  Vaccinated:2008-01-30
Age:87.0  Onset:2008-09-09, Days after vaccination: 223
Gender:Female  Submitted:2008-12-23, Days after onset: 105
Location:Oregon  Entered:2008-12-29, 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: Unknown
Current Illness: Penicillin Allergy
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0809USA03174
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1079U0SCLA
Administered by: Private     Purchased by: Other
Symptoms: Herpes zoster ophthalmic, Pain
SMQs:, Ocular infections (narrow)
Write-up: Information has been received from a physician concerning an 80 year old female who in January 2008, was vaccinated with ZOSTAVAX (Merck), and a few weeks ago she presented with ophthalmic zoster. At the time of this report, the patient was recovering. The patient sought medical attention in the physician''s office. Follow up information has been received concerning the female patient with Penicillin allergy who on 30-JAN-2008 at 12:00 PM, was vaccinated in the physician''s office with the first dose of ZOSTAVAX (Merck) (Lot # 658210/1079U), subcutaneously, under the left arm. On 09-SEP-2008, the patient developed pain and typical lesions of ZOSTER but not lesions that could be swabbed for viral culture. The patient experience required an ER/doctor visit. Additional information has been requested.

VAERS ID:421838 (history)  Vaccinated:2008-01-30
Age:0.6  Onset:2011-03-14, Days after vaccination: 1139
Gender:Male  Submitted:2011-04-27, Days after onset: 44
Location:New Jersey  Entered:2011-04-28, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma
Preexisting Conditions:
Diagnostic Lab Data: diagnostic laboratory, 03/14/11, rotavirus test positive
CDC Split Type: WAES1104USA02871
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Diarrhoea, Rotavirus infection, Rotavirus test positive, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from a physician concerning a 44 month old male patient with asthma and no known drug allergy who on 23-AUG-2007, 19-NOV-2007 and 30-JAN-2008 were vaccinated with the first, second and third dose of ROTATEQ (lot number 656188/1238F for the first dose). Concomitant medications included: PULMICORT and albuterol (manufacturer unknown). On 14-MAR-2011 patient had symptoms of diarrhea and vomiting so was presented to emergency room and was admitted as an inpatient to the hospital. Laboratory test was positive for Rotavirus. Patient was treated with IV fluids and released on 15-MAR-2011. The patient fully recovered on an unspecified date. No further information is available.

VAERS ID:304647 (history)  Vaccinated:2008-01-30
Age:0.2  Onset:2008-01-30, Days after vaccination: 0
Gender:Male  Submitted:2008-02-08, Days after onset: 9
Location:Foreign  Entered:2008-02-11, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: Relevant medical history was not provided.
Diagnostic Lab Data: None Provided.
CDC Split Type: GBWYEG01002008
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crying, Livedo reticularis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information regarding Prevenar was received from a healthcare professional regarding a 2-month-old male patient who experienced mottling all over body, crying and pyrexia. The patient received a dose on 30-Jan-2008. The patient experienced mottling all over body, crying and pyrexia on 30-Jan-2008. The patient was taken to hospital and discharged two hours later. The patient recovered from the events on 31-Jan-2008. No additional information was available at the time of this report.

VAERS ID:305154 (history)  Vaccinated:2008-01-30
Age:8.0  Onset:2008-01-30, Days after vaccination: 0
Gender:Female  Submitted:2008-02-19, Days after onset: 20
Location:Foreign  Entered:2008-02-19
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: A0710316A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS 2UNRL
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling, Nasopharyngitis, Rash, Urticaria, Viral infection
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a pharmacist and described the occurrence of injection site redness in a 8-year-old female subject who was vaccinated with Twinrix pediatric, GlaxoSmithKline for prophylaxis. On an unspecified date the subject received 3rd dose of Twinrix pediatric in an unknown arm. At an unspecified time after vaccination with Twinrix pediatric, the subject experienced injection site redness and swelling at the injection site. Four days later, she developed a rash on the other arm which got worse and extended to the whole body. It was also reported that the subject had a viral infection at the time the rash started. At the time of reporting the outcome of the events was unspecified. Follow-up information was received on 13 February 2008, via pharmacist, who reported previous and/or concurrent vaccination included Twinrix Junior; GlaxoSmithKline; unknown; unknown given on June 2006 and July 2007. On 30 January 2008, the subject received 3rd dose of Twinrix pediatric (unknown, unknown arm). On 30 January 2008, the subject developed redness and swelling at the injection site. In approximately three days cold symptoms and hives developed. The cold symptoms improved, however the hives became worse. The hives were treated with over the counter antihistamines and diet. The pharmacist reported the previous Twinrix injections did not cause any problems. The pharmacist considered the events serious. At the time of reporting the events were unresolved. The pharmacist considered the events were probably related to vaccination with Twinrix pediatric.

VAERS ID:305535 (history)  Vaccinated:2008-01-30
Age:15.0  Onset:2008-01-30, Days after vaccination: 0
Gender:Male  Submitted:2008-02-22, Days after onset: 23
Location:Foreign  Entered:2008-02-25, 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: Syncope; hypoglycaemia
Diagnostic Lab Data: None
CDC Split Type: WAES0802MEX00011
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Convulsion, Dizziness, Eye movement disorder, Gaze palsy, Immediate post-injection reaction, Loss of consciousness, Tonic clonic movements
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Hypoglycaemia (broad)
Write-up: Information has been received from a physician concerning a 15 year old male with a history of syncope attributable to hypoglycemia (the physician referred two episodes occurred between 6 to 12 years old) who on 30-JAN-2008 was vaccinated with Gardasil. There was no concomitant medication. On 30-JAN-2008 while the patient was receiving the vaccination, the patient experienced loss of consciousness, convulsion that started with dizziness, drop to back and immediately with tonic moves of arms and legs. Followed by 3 to 4 tonic-clonic moves with right gaze deviation. These events had duration of 20 seconds. The patient was totally recovered after few minutes without treatment. The vaccination was off label use. Subsequently, the patient recovered from loss of consciousness and convulsion. The reporter felt that loss of consciousness and convulsion were related to therapy with Gardasil. Additional information has been requested.

VAERS ID:310992 (history)  Vaccinated:2008-01-30
Age:1.0  Onset:2008-01-30, Days after vaccination: 0
Gender:Female  Submitted:2008-04-24, Days after onset: 84
Location:Foreign  Entered:2008-04-28, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: Blood culture 00-UNK-2008 consistent with viral infection
CDC Split Type: DKWYEG01449108
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTPPHIB: DTP + IPV + ACT-HIB (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood culture positive, Musculoskeletal stiffness, Pyrexia, Viral infection
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information regarding Prevenar was received from a healthcare professional via regulatory authority regarding a female patient who experienced fever, neck stiffness and blood test consistent with viral infection. The patient received a dose on 30-Jan-2008. Relevant medical history was not provided. Concomitant medications were not reported. The patient experienced neck stiffness and fever on 30-Jan-2008, 8 hours after vaccination. Blood tests were consistent with viral infection, but the pediatrician is in doubt of whether the events are related to the vaccination or to a viral infection. The patient had been ill almost a week before vaccination, but had been well for a few days. No additional information was available at the time of this report. Blood cultures (results: consistent with viral infection) was done in 2008.

VAERS ID:316965 (history)  Vaccinated:2008-01-30
Age:0.5  Onset:2008-02-27, Days after vaccination: 28
Gender:Male  Submitted:2008-06-23, Days after onset: 116
Location:Foreign  Entered:2008-06-23
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: Gastroesophageal reflux
Diagnostic Lab Data: Ultrasound abdomen, Feb2008, IS
CDC Split Type: B0525609A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Breast feeding, Intestinal mass, Intestinal resection, Intussusception, Irritability, Lethargy, Pallor, Rectal haemorrhage, Ultrasound abdomen abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a healthcare professional and described the occurrence of intussusception in a 7-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). This case is one of 4 cases collected through a study occurring post ROTARIX vaccination since August 2007. The subject was born at term. The subject''s birth weight was 2.6 Kg. The subject''s medical history included gastroesophageal reflux. The subject had no history of intussusception. The subject had no family history of intussusception. The subject had no current medications or traditional medicines. Feeding history: The subject currently fed breast milk. There was no change to the subject''s diet in the last week. The subject had feeding intolerance/food sensitivities (gastroesophageal reflux disease). Previous vaccination included ROTARIX (GlaxoSmithKline; unknown) given on 19 October 2007. On 30 January 2008, the subject received 2nd dose of ROTARIX (unknown). On 27 February 2008, 28 days after vaccination with the 2nd dose of ROTARIX, the subject experienced intussusception. He experienced the following symptoms: abdominal pain, vomiting, lethargy, pallor, irritability, intestinal mass and passage of blood per rectum. No faeces''s sample was collected. The diagnosis of intussusception was made based on abdominal ultrasound exam (site of IS; ascending colon). The subject was treated with air/hydrostatic Enema. Surgical resection was performed. The lead point or other pathology have not been identified. This case was assessed as medically serious by GSK. On 03 March 2008, the subject was discharged. At the time of reporting the outcome of the events was unspecified.

VAERS ID:318748 (history)  Vaccinated:2008-01-30
Age:0.3  Onset:2008-02-19, Days after vaccination: 20
Gender:Female  Submitted:2008-07-11, Days after onset: 142
Location:Foreign  Entered:2008-07-11
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood AFP, 23Feb2008, 230000; Blood AFP, 03Mar2008, 30200; Blood Albumin, 22Feb2008, 2.5; Blood Albumin, 03Mar2008, 2.6; Blood Albumin, 05Mar2008, 3.0; Blood Albumin, 10Mar2008, 2.4; Blood Albumin, 17Mar2008, 2.8; Blood Albumin, 19Mar2008,
CDC Split Type: R0000219A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSAROTA031C1PO 
Administered by: Other     Purchased by: Other
Symptoms: Abdominal distension, Alanine aminotransferase increased, Alpha 1 foetoprotein increased, Anaemia, Ascites, Aspartate aminotransferase increased, Blood albumin decreased, Blood alkaline phosphatase increased, Blood bilirubin increased, Blood chloride increased, Blood cholesterol, Blood creatine normal, Blood lactate dehydrogenase abnormal, Blood potassium increased, Blood sodium normal, Breath sounds abnormal, Carbohydrate antigen 125 increased, Carbohydrate antigen 19-9 increased, Carbohydrate tolerance decreased, Carcinoembryonic antigen increased, Cholestasis, Citrobacter infection, Coagulation test abnormal, Culture urine positive, Cytomegalovirus infection, Cytomegalovirus serology, Dehydration, Gamma-glutamyltransferase increased, Hepatic cirrhosis, Hepatic failure, Hepatic infection fungal, Hepatic neoplasm, Hypoproteinaemia, Inguinal hernia, Jaundice, Klebsiella infection, Liver transplant, Malnutrition, Neonatal cholestasis, Nephrolithiasis, Nuclear magnetic resonance imaging normal, Oedema peripheral, Paracentesis abdomen abnormal, Platelet count decreased, Protein total decreased, Ultrasound abdomen abnormal, Vomiting
SMQs:, Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Congenital, familial, neonatal and genetic disorders of the liver (narrow), Liver infections (narrow), Acute pancreatitis (narrow), Angioedema (broad), Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Tumour markers (narrow), Acute central respiratory depression (narrow), Congenital biliary disorders (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Foetal disorders (broad), Neonatal disorders (narrow), Tumours of unspecified malignancy (narrow), Uterine and fallopian tube malignant tumours (broad), Liver tumours of unspecified malignancy (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Tubulointerstitial diseases (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This female subject was enrolled in the prophylactic double blind study 107625 (Rota-056). On 29 December 2007 and 30 January 2008, she received the 1st and 2nd dose of ROTARIX (HRV) or placebo (po). The subject received ROTARIX (lot AROTA031C). On 19 February 2008, 20 days after the 2nd dose of ROTARIX, this four-month-old subject developed hepatic insufficiency. The subject was hospitalised and the event was disabling, life-threatening and clinically significant (or requiring intervention). The subject was treated with menatetrenone, frusemide, famotidine, cephazolin sodium, amikacin sulfate, ganciclovir, saccharated iron oxide, sultamicillin tosilate, albumin, plasma, white blood cells, triclofos sodium, chloral hydrate, spironoloctone, clostridium butyricum, ferric pyrophosphate, SOLDEM, dextrose, calcium gluconate, electrolytes, sodium chloride, VITAMEDIN, ascorbic acid, PHYSIO 35, VITAJECT, trace elements, heparin sodium, potassium aspartate, HICALIQ, heparin, amino acid, ampicillin sodium + sulbactam sodium, midazolam, ketamine hydrochloride, atropine sulphate, soybean oil, lactic-acid-producing organisms, lactulose, ursodeoxycholic acid, kanamycin sulphate, miconazole, tacrolimus, kaolin, albumin tannate, amlodipine besylate, nifedipine, lansoprazole, dipyridamole, acyclovir, prednisolone, ampicillin trihydrate, cefotaxime sodium and vancomycin hydrochloride. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the hepatic insufficiency may have been caused by ROTARIX and that the event was possibly due to cytomegalovirus infection. Investigator Comments: The subject''s mother reported that the subject experienced a number of emesis and abdominal distention from immediately after the birth. These occurrences were not mentioned in previous consultation or consultation of the study. The subject''s body weight was 3996 g at the Month 1 check up, and 5420 g at the Month 3 check up. The subject was only breast-fed for nutrition before

VAERS ID:319824 (history)  Vaccinated:2008-01-30
Age:19.0  Onset:2008-01-30, Days after vaccination: 0
Gender:Female  Submitted:2008-07-18, Days after onset: 169
Location:Foreign  Entered:2008-07-21, Days after submission: 3
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: Unknown
Current Illness:
Preexisting Conditions: Infection susceptibility increased
Diagnostic Lab Data: spinal tap, Comment: normal; magnetic resonance imaging, Comment: normal; abdominal ultrasound, Comment: normal; electrocardiogram, Comment: normal; serum influenza B virus Ab, Comment: slightly positive antibodies for Influenza B virus
CDC Split Type: WAES0806USA00535
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Back pain, Diplopia, Disturbance in attention, Dysarthria, Electrocardiogram normal, Gait disturbance, Headache, Hyperacusis, Influenza, Influenza serology positive, Lumbar puncture normal, Meningism, Mental impairment, No reaction on previous exposure to drug, Nuclear magnetic resonance imaging normal, Photosensitivity reaction, Ultrasound abdomen normal, Vision blurred
SMQs:, Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Ocular motility disorders (broad), Hypersensitivity (broad), Hypoglycaemia (broad)
Write-up: Initial and follow up information has been received from a physician concerning a 19 year old female with a history of relapsing infections who on 30-JAN-2008 was vaccinated intramuscularly into the upper left arm with her third dose of GARDASIL (Lot # and site not reported). Two days post vaccination the patient complained about headache and asthenia. She was admitted to the hospital for diagnostics (not further specified) and recovered completely within about 1 week. The first and second vaccinations with GARDASIL (Dates, Lot #s, route and sites not reported) were well tolerated. No additional information was provided. In follow up it was reported that on 30-JAN-2008 (also reported as "same day"), she developed meningeal irritation, double and blurred vision, concentration disorder, noise- and photosensitivity, a "dull feeling in head", articulation problems, gait disorder, headache, asthenia and back pain. On 31-Jan-2008 she was admitted to the hospital for diagnostics. Virus diagnostics revealed low-positive antibodies for Influenza B virus. Other virus infections were ruled out. Meningeal irritation due to influenza B virus infection was assumed. A postvaccinal reaction was discussed. A lumbar puncture was performed (normal results) and meningitis could be ruled out. Cranial MRI, abdominal sonography, ECG and neurological examinations showed normal results. Therapy was carried out with unspecified infusions and analgesics. The patient fully recovered and was discharged from the hospital on 06-FEB-2008 (exact duration of symptoms not reported). The file is closed. Other business partner numbers include: E2008-04957. No further information is available.

VAERS ID:322552 (history)  Vaccinated:2008-01-30
Age:14.0  Onset:2008-05-12, Days after vaccination: 103
Gender:Female  Submitted:2008-08-18, Days after onset: 98
Location:Foreign  Entered:2008-08-19, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: spinal tap, normal; diagnostic laboratory test, serology (not specified): normal; magnetic resonance imaging, normal; electromyography, normal; diagnostic laboratory test, Borrelia antibody titer: negative
CDC Split Type: WAES0808USA01991
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.027U2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Borrelia burgdorferi serology negative, Electromyogram normal, Erythema migrans, Fatigue, Headache, Hemiparesis, Lumbar puncture normal, Nuclear magnetic resonance imaging normal, Serology test
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)
Write-up: Information has been received from health authority (HA reference no PEI2008011443) through SPMSD concerning a 14 year old female who on 24-MAY-2007 was vaccinated with the first dose of GARDASIL (Lot No. 1466F; Batch No: NF15720) and on 14-AUG-2007 was vaccinated with the second dose of GARDASIL (Lot no. 1339F; Batch No: NF23310), both doses were well tolerated. On 30-JAN-2008, the patient received the third dose of GARDASIL (Lot No 0227U; Batch No: NG0020) into the left arm. On 12-MAY-2008 the patient developed hemiparesis right, cephalgia and asthenia. On 19-MAY-2008, the patient presented with erythema migrans. The patient was hospitalized on an unknown date. Cervical spinal fluid, serology (not specified), magnetic resonance imaging and electromyography showed normal results. Borrelia antibody titer was negative. Neuroborrelosis and myasthenia were ruled out. It was reported that erythema migrans resolved on 06-JUN-2008, hemiparesis right, cephalgia and fatigue on 17-JUL-2008. Nevertheless outcome was reported to be not recovered at the time of reporting to Health Authority. Other business partner numbers included: E2008-07558. Additional information has been requested.

VAERS ID:322818 (history)  Vaccinated:2008-01-30
Age:21.0  Onset:2008-01-30, Days after vaccination: 0
Gender:Female  Submitted:2008-08-20, Days after onset: 202
Location:Foreign  Entered:2008-08-21, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0808AUS00129
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthma, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: Information was obtained on request by the Company from the agency via a Public Case Detail Form and a Case Line Listing concerning a 21 year old female who on 30-JAN-2008 was vaccinated with the second dose of GARDASIL. On 30-JAN-2008, 30 minutes after vaccination, the patient experienced asthma and dyspnoea and was hospitalised. The patient was treated with VENTOLIN, ATROVENT, PULMICORT (in nebuliser), 0.3 ml s/c of adrenaline and oxygen. At the time of reporting to the agency on 27-FEB-2008, the patient had recovered from asthma and dyspnoea. The agency considered that asthma and dyspnoea were possibly related to therapy with GARDASIL. The original reporting source was not provided. Additional information is not expected.

VAERS ID:335130 (history)  Vaccinated:2008-01-30
Age:  Onset:2008-10-22, Days after vaccination: 266
Gender:Male  Submitted:2008-12-11, Days after onset: 50
Location:Foreign  Entered:2008-12-12, 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: Vaccine exposure during pregnancy
Diagnostic Lab Data: Echocardiography, 22?Oct08, normal sinus rhythm for patient''s age; Echocardiography, 22?Oct08, see narrative; Ultrasound, 22?Oct08, see narrative; Echocardiography, see narrative; Ultrasound, see narrative
CDC Split Type: WAES0812USA01711
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Drug exposure during pregnancy, Echocardiogram abnormal, Foetal disorder, Ultrasound scan abnormal
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Cardiomyopathy (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)
Write-up: Initial information has been received from a health care professional through the patient''s mother. The present case concerns a baby who was born with some abnormalities whose mother was administered one dose of GARDASIL (batch # not reported) during early pregnancy mother linked case WAES# 0805USA00774. The patient''s mother was vaccinated with the second dose of GARDASIL on 30-JAN-2008 and the last menstrual period was 11-JAN-2008. It is reported that the baby, a male, was born after 40 weeks and 4 days of gestation. The baby was born by a cesarean delivery. Weight at birth was 3.4 kg., height at birth was 52 cm, Apgar 1 min = 9; apgar 5 min = 10. On the 22-OCT-2008 the patient had his first pediatrician revision during which a heart murmur was detected. The pediatrician forwarded the patient to the hospital cardiology ward in order to perform further test. According to the hospital report the patient, a 12 hour-old-male, was sent from the clinic where he was born due to a heart murmur that was clinically asymptomatic. Upon examination the child with normal coloring of mucosa and skin, pulse was symmetric. Transcutaneous oxigention 100% with inspired oxygen fraction of room air. Normal respiratory system. From cardiac auscultation they found first and second sounds to be normal with systolic murmur of grade II-III/VI in the meso, pulmonary and aortic focus. Echocardiogram showed a normal sinus rhythm for the patient''s age. An in-depth echocardiogram study was performed. Relevant findings were: situs solitus with concordance A-V and V-A. Normal pulmonary and systemic venous return. Left and right auricles are normal not dilated. Interauricular septum presents a small, 2mm, oval foramen with minimum left to right shunt. Septum interventricular with a 6mm subaortic interventricular communication, there appears to be overriding aorta, being more evident in longitudinal cut, reminding of Fallot''s tetrad. Left ventricle is neither dilated nor hypertrophic presenting a correct function. Right ventricle is neither dilated nor hypertrophyc it appears to be normal. Aortic valve trivalvar with symmetric closing. Coronaries are normal. Aortic arch and descendent aorta are normal. Ductus is nor observed. Pulmonary valve appears to be enlarged, with 8mm truncus an 5 mm branches, no signs of subvalvar or infundibular obstruction, but it does present an accelerating gradient. No pericardial effusion. Doppler ultrasound shows minimum permeable oval foramen with 2 mm left to right shunt, not significant. A 6mm subaortic, interventricular communication has been detected with a left to right shunt with no measurable gradient due to the age of the patient. No measurable thoracic index. No permeable ductus is detected. The patient was diagnosed with a 6 mm subaortic valve communication. (According to the first hospital report it could be fallot''s, it depended on how the presenting anatomy evolved and the right ventricule outflow tract developed). Patient should be checked in one week. According to the patient follow up cardiology report, (date not reported) the patient was 5 weeks-old, and weight 5 kilograms. The patient was asymptomatic. Oxygen saturation 99%. Pulse was symmetric an present, 1R regurgitant murmur in meso with ejection, murmur in pulmonary focus with 2R an week 2P. Echocardiogram results show normal sinus rhythm. Normal PR an right ventricular hypertrophia. Another Echography 2D + Doppler ultrasound was performed. Situs solitus with A-V and V-A concordance. Left ventricle is normal, with a good contractility of the diastolic diameter is 18. Ejection fraction is 75, left ventricle is slightly hypertrophic presenting a muscular bund by the right ventricular outflow tract, presenting good cavity. There is an intraventricular subaortic communication (6mm) with overriding of the aorta. Enlarged pulmonary valve with ring, a 7-8 mm truncus and 8 branches of 5 mm, also a 7 mm infundibulum. Ao

VAERS ID:335701 (history)  Vaccinated:2008-01-30
Age:0.3  Onset:2008-01-30, Days after vaccination: 0
Gender:Female  Submitted:2008-12-18, Days after onset: 323
Location:Foreign  Entered:2008-12-19, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0812AUS00246
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.  UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  UNUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crying, Dyskinesia, Dystonia, Grimacing, Irritability, Myoclonus, Posture abnormal
SMQs:, Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Dystonia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)
Write-up: Information was obtained on request by the Company from the agency via a Public Case Detail Form and a Case Line Listing concerning an 18 week old female who on 30-JAN-2008 was vaccinated with COMVAX. Other suspect therapy included ROTATEQ, INFANRIX-IPV and PREVENAR. On 30-JAN-2008 after vaccination with COMVAX, ROTATEQ, INFANRIX-IPV and PREVENAR, the patient experienced myoclonus and dystonia and was hospitalised. It was described that the child became very irritated and had 10 minute episodes of turning head to side, grimacing and jerking both arms into midline. The child was awake and crying. The second episode occurred in the ambulance 1-2 minutes. Third episode was in the emergency department (not seizure activity) which lasted few seconds. At the time of reporting to the agency on 23-JUL-2008, the patient had recovered from myoclonus and dystonia. The agency considered that myoclonus and dystonia were possibly related to therapy with COMVAX, ROTATEQ, INFANRIX-IPV and PREVENAR. The original reporting source was not provided. Additional information is not expected.

VAERS ID:376752 (history)  Vaccinated:2008-01-30
Age:51.0  Onset:0000-00-00
Gender:Female  Submitted:2010-01-13
Location:Foreign  Entered:2010-01-13
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Biopsy brain, See text
CDC Split Type: B0624343A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB158AB IMLA
Administered by: Other     Purchased by: Other
Symptoms: Biopsy brain abnormal, Granuloma, Immunosuppression, Neurological examination abnormal, Partial seizures, Vasculitis
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vasculitis (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by a regulatory authority (# DMA-DK-20094722) and described the occurrence of isolated cerebral angiitis in a female subject of unspecified age who was vaccinated with HAVRIX adult (GlaxoSmithKline). On 30 January 2008, the subject received unspecified dose of HAVRIX adult (intramuscular, administration site unknown). In March 2008, 2 months after vaccination with HAVRIX adult, the subject experienced primary angiitis of the central nervous system with secondary focal epilepsy. In May 2008, the subject was admitted because of recessive focal epileptic seizures since March 2008. A biopsy of focal lesion in the right parietal region of the brain showed granulomatous and lymphatic inflammation similar to PACS. Examination for vasculitis revealed no clues. Immunosuppression caused discontinuation of the symptoms and the MR-lesion. She still had a few seizures that can be treated with medicine. The PACS may be related to the vaccination which she received before a stay abroad. Examination showed a comprehensive neurological examination including a cerebral biopsy. The subject had no acute health complaints when the vaccine was given. The reporter doesn''t know if the patient was receiving other medication when the adverse event took place. The subject was hospitalized and the regulatory authority reported that the events were disabling. At the time of reporting, the events were improved.

VAERS ID:391798 (history)  Vaccinated:2008-01-30
Age:0.5  Onset:2008-02-18, Days after vaccination: 19
Gender:Female  Submitted:2010-06-30, Days after onset: 862
Location:Foreign  Entered:2010-06-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0662908A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS 1PO 
Administered by: Other     Purchased by: Other
Symptoms: Colectomy, Intestinal anastomosis, Intussusception
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow)
Write-up: This case was reported by a healthcare professional via another manufacturer (Fiocruz) and described the occurrence of intussusception in a 5-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 30 January 2008, the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 18 February 2008, 19 days after vaccination with ROTARIX, the subject experienced right jejuno-ileal intussusception which evolved to a right hemicolectomy and ileocolonic anastomosis. The subject was hospitalised. At the time of reporting the events were resolved. No further information could be obtained; the case has been closed.

VAERS ID:492267 (history)  Vaccinated:2008-01-30
Age:1.0  Onset:2012-03-01, Days after vaccination: 1492
Gender:Male  Submitted:2013-05-21, Days after onset: 445
Location:Foreign  Entered:2013-05-22, 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: The patient has previously received DITEKIPOL/ACT-HIB on 19-Apr-2007 (ACT-HIB dose 1, batch number unknown, route and site not reported and DITEKIPOL, dose 1, batch number unknown, route and site not reported). The patient has previously received PREVENAR on 04-Oct-2007 (Dose 1, batch number not reported, route and site not reported). On 07-Nov-2007 the patient received PREVENAR (Dose 2, batch number not reported, route and site not reported).
Diagnostic Lab Data: Epicutant test with aluminium chloride and aluminium chamber test were performed, both positive (detected allergy).
CDC Split Type: E201303500
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTPIPV: DTP + IPV (NO BRAND NAME)UNKNOWN MANUFACTURER 1UNUN
HIBV: HIB (ACTHIB)SANOFI PASTEUR 1UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Allergy test positive, Allergy to metals, Granuloma
SMQs:, Hypersensitivity (narrow)
Write-up: Case received from a health care professional via Health Authority and other company on 08-May-2013 under the reference numbers DK-DKMA-EFO5675 and DK-DKMA-ADR 22100374. Case medically confirmed. A 12 month-old male patient had received an injection of ACT-HIB (dose 2, batch number unknown, route and site not reported) and DI-TE-KI-POL (dose 2, batch number unknown, route and site not reported) on 30-Jan-2008 and concomitantly on 30-Jan-2008 the patient received PREVENAR, pneumococcal vaccine (Dose 3, batch number not reported, route and site not reported). Later, at the age of 5 years, on an unspecified day in March 2012, it was confirmed that he had developed aliminium granuloma (on his thigh) and detected aluminium allergy. Epicutant test with aluminium chloride and aluminium chamber test were performed, both positive (detected allergy). According to the report from HA it was the doses given on 30-Jan-2008 that were coded as suspected drugs. Reaction upon rechallenge was coded as unknown. Further, on 25-Jun-2008 the patient received DITEKIPOL/ACT-HIBACT-HIB (dose 3, batch number not reported, route and site not reported and DITEKIPOL, dose 3, batch number not reported, route and site not reported). On 07-Mar-2012 the patient received DITEKIPOL BOOSTER (dose 4, batch number not reported, route and site not reported). The patient had previously received DITEKIPOL/ACT-HIBACT-HIB on 19-Apr-2007 (ACT-HIB dose 1, batch number unknown, route and site not reported and DITEKIPOL, dose 1, batch number unknown, route and site not reported). The patient has also previously received PREVENAR, pneumococcal vaccine on 04-Oct-2007 (Dose 1, batch number not reported, route and site not reported). On 07-Nov-2007 the patient received PREVENAR, pneumococcal vaccine (Dose 2, batch number not reported, route and site not reported). Upon medical review the company noted that the ACT-HIB vaccine dose not contain any aluminium. At the time of reporting the outcome was not recovered.

VAERS ID:523393 (history)  Vaccinated:2008-01-30
Age:1.3  Onset:0000-00-00
Gender:Male  Submitted:2014-02-21
Location:Foreign  Entered:2014-02-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1402ITA009170
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0739U UNUN
Administered by: Other     Purchased by: Other
Symptoms: Autism
SMQs:
Write-up: Information has been received from SPMSD (sender''s case report number IT-1577272925-E2014-01338) on 18-FEB-2014. Case received from Health Care Professional (informed through a patient''s request) on 13-FEB-2014 through SPMSD. Case not medically confirmed. A 15 month old male patient was vaccinated on 30-JAN-08 with one dose of MMR (batch n. NG36490, lot number 656619/0739U, expiration date: 19-OCT-2009). Following vaccination he presented with autism. The event was notified by the patient''s parents. The outcome was not reported. The case is closed.

VAERS ID:532418 (history)  Vaccinated:2008-01-30
Age:17.0  Onset:2008-01-31, Days after vaccination: 1
Gender:Female  Submitted:2014-05-23, Days after onset: 2303
Location:Foreign  Entered:2014-05-23
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: Immunisation
Preexisting Conditions: 11/30/2007, GARDASIL, D1
Diagnostic Lab Data: Blood test: No inflammatory syndrome, no viral infection. Borelia test: No Lyme disease. Syphilis test: No syphilis. MRI: Medullar: Normal. Scan: Whole body: Normal.
CDC Split Type: WAES1405FRA011330
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Arthralgia, Asthenia, Blood test normal, Borrelia test negative, Dysuria, Formication, Headache, Hypoaesthesia, Inflammation, Myalgia, Nuclear magnetic resonance imaging normal, Treponema test negative
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Dementia (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Case received from the Health Authorities on 15-May-2014 under the reference number BX20140611 from Sanofi Pasteur (reference # FR-1577272925-E2014-04204) on 20-MAY-2014. Initial reporter was a consumer. A 17-year-old female patient had received a second dose of GARDASIL (batch number unknown) on 30-Jan-2008. She received the first dose on 30-Nov-2007. The day after the second injection, the patient experienced formication in the left arm and numbness in the upper and lower limbs. The third injection was administered on 29-Jul-2008. Evolution in 2013 : the patient was experiencing diffuse pain in muscular and joint limbs associated to fluctuating sensitive and motor disorders. She was also experiencing headaches, important asthenia and dysuria. Blood tests performed showed no inflammatory syndrome nor chronic viral infection. Borrelia test showed no Lyme disease and syphilis test was negative. The medullar MRI and a scan of the whole body were unremarkable. The patient was given sick-leaves as she had difficulties in doing daily activities. She had not recovered at the time of reporting. Upon medical review the company considered relevant to code formication, headache and dysuria that were mentioned in the narrative by the Health Authorities but not coded. To be noted that the Health Authorities coded "fibromyalgia" and "hospitalization" without providing any precision. The Health Authorities did not assess the causal relationship between the reported reactions and vaccination.

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