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Case Details (Sorted by Vaccination Date)

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VAERS ID:173609 (history)  Vaccinated:2001-07-11
Age:4.0  Onset:2001-07-13, Days after vaccination: 2
Gender:Male  Submitted:2001-07-14, Days after onset: 1
Location:Texas  Entered:2001-07-25, 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
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAM982A2 IMLA
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T08412 SCLA
Administered by: Public     Purchased by: 0
Symptoms: Cellulitis, Injection site reaction
SMQs:
Write-up: Pt was seen in MD''s office 3 days post vax with cellulitis at injection site. Pt was treated with oral antibiotics.

VAERS ID:173641 (history)  Vaccinated:2001-07-11
Age:1.5  Onset:2001-07-23, Days after vaccination: 12
Gender:Male  Submitted:2001-07-24, Days after onset: 1
Location:Tennessee  Entered:2001-07-26, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: ;MMR II;1;1.25;In Sibling
Other Medications: Connaught Poliovax, T0841
Current Illness: NONE
Preexisting Conditions: UNK
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)CONNAUGHT LABORATORIESUO378CA IM 
HIBV: HIB (ACTHIB)CONNAUGHT LABORATORIESUA529AA IM 
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0998K SC 
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES475380 IM 
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1494K SC 
Administered by: Public     Purchased by: 0
Symptoms: Rash morbilliform
SMQs:, Hypersensitivity (narrow)
Write-up: Pt experienced 2 days of morbilliform rash.

VAERS ID:173697 (history)  Vaccinated:2001-07-11
Age:31.0  Onset:2001-07-11, Days after vaccination: 0
Gender:Male  Submitted:2001-07-12, Days after onset: 1
Location:Missouri  Entered:2001-07-30, Days after submission: 18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: BP 102/68; pulse 68 and regular
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)CONNAUGHT LABORATORIESUO343AA1IMLA
Administered by: Public     Purchased by: Public
Symptoms: Dizziness, Hypoaesthesia, Hypotension
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad)
Write-up: Pt returned to clinic at 12:00 one day post vax stating he had begun experiencing numbness in face and top of head within 10-20 minutes after receiving vax. He pointed to his cheek and jaw area bilaterally. Pt also c/o dizziness. He was accompanied by wife who stated she had stayed up all night with him because they were both worried. Injection site appeared normal, neuro signs were intact, pt was alert and oriented with no deficits noted.

VAERS ID:173813 (history)  Vaccinated:2001-07-11
Age:0.8  Onset:2001-07-12, Days after vaccination: 1
Gender:Male  Submitted:2001-07-20, Days after onset: 8
Location:Oregon  Entered:2001-08-01, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ;UNK. DTAP;;.00;In Sibling
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: egg allergies
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T07572IMLL
Administered by: Private     Purchased by: Public
Symptoms: Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Rash on arms, bilaterally on 7/12/01; fever 100-102.8 F, 7/15/16/17. Fever down with cool bath and Tylenol. Rash appeared on stomach on 7/19/01 and still present on 7/20/01. Mother reported this to PCP as well as JCHD.

VAERS ID:173829 (history)  Vaccinated:2001-07-11
Age:1.0  Onset:2001-07-23, Days after vaccination: 12
Gender:Female  Submitted:2001-07-25, Days after onset: 2
Location:West Virginia  Entered:2001-08-01, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1159K SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1893K SCRA
Administered by: Private     Purchased by: Public
Symptoms: Infection
SMQs:
Write-up: Varicella/pox rash, 10 days, post vax.

VAERS ID:173882 (history)  Vaccinated:2001-07-11
Age:1.8  Onset:2001-07-12, Days after vaccination: 1
Gender:Male  Submitted:2001-07-13, Days after onset: 1
Location:Hawaii  Entered:2001-08-02, Days after submission: 20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type: HI0108
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)CONNAUGHT LABORATORIESU0311BA IMRL
HIBV: HIB (ACTHIB)CONNAUGHT LABORATORIESUA572AA IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1167K SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0502L SCRA
Administered by: Public     Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt had local swelling and redness with increased warmth about 4cm X 5cm.

VAERS ID:174017 (history)  Vaccinated:2001-07-11
Age:3.0  Onset:0000-00-00
Gender:Male  Submitted:2001-08-06
Location:Massachusetts  Entered:2001-08-08, 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: NONE
Current Illness: NONE
Preexisting Conditions: UNK
Diagnostic Lab Data: UNK
CDC Split Type: HQ4060803AUG2001
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES4771720IM 
Administered by: Private     Purchased by: Other
Symptoms: Angioneurotic oedema, Injection site erythema, Injection site swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: A mother reported that her 3 year old son received his 1st dose of Prevnar on 7/11/01 and developed an injection site reaction characterized by redness and swelling. These symptoms resolved. Her son subsequently, developed "facial swelling or angioedema" which persisted at the date of the report. This event was considered "Medically Important". No further information was available at the date of the report.

VAERS ID:174045 (history)  Vaccinated:2001-07-11
Age:0.2  Onset:2001-07-11, Days after vaccination: 0
Gender:Male  Submitted:2001-07-18, Days after onset: 7
Location:New York  Entered:2001-08-08, Days after submission: 21
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:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAM981A20IMRL
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.1175K0IMLL
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T028320IMLL
Administered by: Other     Purchased by: Public
Symptoms: Crying, Hypersensitivity
SMQs:, Angioedema (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow)
Write-up: Pt experienced allergic reaction to Pertussis. Exhibited by persistent crying that started with immunization administration. Sent to ER.

VAERS ID:174113 (history)  Vaccinated:2001-07-11
Age:1.0  Onset:2001-07-20, Days after vaccination: 9
Gender:Female  Submitted:2001-07-23, Days after onset: 3
Location:Guam  Entered:2001-08-09, Days after submission: 17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Rashes;PREVNAR;1;.75;In Patient
Other Medications:
Current Illness: More than 2 weeks of nasal discharge; Sinusitis
Preexisting Conditions: Also reported before for rashes probably due to shots given on 1/10/01.
Diagnostic Lab Data: 7/23/01-Rubeola IgM 1:20 (high)
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0050L2IMLL
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T09092IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0016L0SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0495L0SCLL
Administered by: Private     Purchased by: Private
Symptoms: Infection, Irritability, Pyrexia, Rash maculo-papular
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypersensitivity (narrow)
Write-up: On 7/20/01, 9 days after MMR, Varicella, IPV and Hep-B vaccines were given, pt had (+) erythematous multiple macular papules with some confluent all over the body with fever for 5 days. Fever went up to 102F and pt was fussy. Measles-like reaction.

VAERS ID:174178 (history)  Vaccinated:2001-07-11
Age:6.0  Onset:2001-07-11, Days after vaccination: 0
Gender:Female  Submitted:2001-07-12, Days after onset: 1
Location:Georgia  Entered:2001-08-10, Days after submission: 29
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: GA01064
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAM992A24IMRA
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T0532 IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1273K1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Ear disorder, Pharyngolaryngeal pain, Pyrexia, Swelling face, Urticaria, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: On 7/11/01 at 21:00, pt had a fever of 101F and vomited. On 7/12/01 AM, pt had a fever of 101F, swelling of face and hives on face. The pt also, complained of a sore throat. Pt was seen by ER physician at 15:00 on 7/12/01 and he said that the pt had fluid in ears and tonsillitis. Antibiotics were given.

VAERS ID:176119 (history)  Vaccinated:2001-07-11
Age:0.9  Onset:2001-07-11, Days after vaccination: 0
Gender:Female  Submitted:2001-10-02, Days after onset: 83
Location:Wyoming  Entered:2001-10-08, 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: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)CONNAUGHT LABORATORIESUO503AA1IMRL
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0005L1IMLL
HIBV: HIB (HIBTITER)LEDERLE PRAXSIS612003A1IMLL
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T07601SCRL
Administered by: Public     Purchased by: Public
Symptoms: Irritability, Pyrexia, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypersensitivity (narrow)
Write-up: After receiving DTaP, IPV, & Hep B on 07/11/01, the patient spiked a fever of 103 and was fussy most of the day and throughout the night. When the patient awoke on 07/12/01, the mother felt she had hives that covered her whole body. The patient was taken to the ER. She was given Benadryl. The ER doctor felt hives were unrelated to the vaccines. Benadryl eleviated hives totally within 8 hours. The client had no further fever or symptoms. The patient''s pediatrician felt public health should be notified of the reaction. The mother did not report reaction to our office until 09/28/01.

VAERS ID:182392 (history)  Vaccinated:2001-07-11
Age:18.0  Onset:2001-07-11, Days after vaccination: 0
Gender:Female  Submitted:2002-03-07, Days after onset: 239
Location:Iowa  Entered:2002-03-13, 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: Tubersol (TB test #C0832AA)
Current Illness: urinary tract infection
Preexisting Conditions: cystitis
Diagnostic Lab Data:
CDC Split Type: WAES01071199
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1654K0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Asthenia, Dizziness, Malaise
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad)
Write-up: Information has been received from a health professional concerning an 18 year old female, with a history of cystitis cystica, no known allergies, and urinary tract infection at the time of vaccination. On 07/11/2001 was vaccinated with the first dose of hep b vaccine recombinant IM in the left deltoid, following a physical examination. Concomitant therapy, that day, included the first TB test (tubersol) administered in the right forearm. There was no other concomitant medication. Two hours later, at 4pm on 07/11/2001, the pt experienced lightheadedness and dizziness, didn''t feel well and thought she may pass out. She complained of feeling "weak and drained." The pt sought unspecified medical attention. It was reported that she did not require any hospitalization or further check-up. It was noted that she "felt better later on that evening." Subsequently, the symptoms resolved and the pt recovered on 07/12/2001. It was noted that neither the pt or a sibling experienced any adverse events following prior vaccinations. No further info is available.

VAERS ID:191484 (history)  Vaccinated:2001-07-11
Age:0.2  Onset:2001-07-11, Days after vaccination: 0
Gender:Female  Submitted:2001-07-18, Days after onset: 7
Location:Virgin Islands  Entered:2002-10-17, Days after submission: 456
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: U200100880
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)AVENTIS PASTEURUO515CA   
HIBV: HIB (ACTHIB)AVENTIS PASTEURUA605AA   
IPV: POLIO VIRUS, INACT. (IPOL)AVENTIS PASTEURT1098   
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES480904   
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypotonia, Pyrexia, Somnolence, Stupor
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: From telephone contact with reporting nurse practiitioner it was stated that a 2 month old female patient received a Tripedia, an IPOl,an ACTHIB and a Prevnar vacciunaton on 07/11/01. Within a few hours, the patient experienced a hyporesponsive episode, was sleepy but able to be aroused. Patient was seem in physician''s office next day, had a fever of 100.4 degrees F. Patient was doing well. Symptoms resolved

VAERS ID:261827 (history)  Vaccinated:2001-07-11
Age:1.1  Onset:2006-08-15, Days after vaccination: 1861
Gender:Female  Submitted:0000-00-00
Location:Kentucky  Entered:2006-08-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)LEDERLE LABORATORIES4749463  
MMR: MEASLES + MUMPS + RUBELLA (VIRIVAC)MERCK & CO. INC.0601L SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1885K SCLA
Administered by: Private     Purchased by: Unknown
Symptoms: Rash, Skin ulcer, Viral infection
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Patient seen for rash (bumpy) on upper back trunk, buttocks. Diagnose: Chicken Pox, 50 plus lesions, no school until lesion crust over.

VAERS ID:173464 (history)  Vaccinated:2001-07-12
Age:2.6  Onset:2001-07-12, Days after vaccination: 0
Gender:Female  Submitted:2001-07-17, Days after onset: 5
Location:Virginia  Entered:2001-07-20, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES4749470IMLL
Administered by: Public     Purchased by: Public
Symptoms: Pruritus, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Fever began 7/12/01 PM, highest temp around 101F, lasted approx 2 days, then developed rash spreading over entire body. Described rash as itching with wh? on 3rd day. Mom states child well until Prevnar given.

VAERS ID:173526 (history)  Vaccinated:2001-07-12
Age:7.0  Onset:2001-07-12, Days after vaccination: 0
Gender:Male  Submitted:2001-07-17, Days after onset: 5
Location:New York  Entered:2001-07-24, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES4809730IMLA
Administered by: Private     Purchased by: 0
Symptoms: Injection site reaction
SMQs:
Write-up: Mom reported very bad reaction. Mom refused appt for pt to be seen. Per phone call on date of report, area had resolved.

VAERS ID:173527 (history)  Vaccinated:2001-07-12
Age:5.0  Onset:2001-07-12, Days after vaccination: 0
Gender:Female  Submitted:2001-07-17, Days after onset: 5
Location:New York  Entered:2001-07-24, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAM970A2  LA
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T01862 SCRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0826K IMRA
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES4809730IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site reaction
SMQs:
Write-up: Mom stated pt had bad reaction but refused appt for pt to be seen. Mom was called on date of report and stated area had resolved.

VAERS ID:173594 (history)  Vaccinated:2001-07-12
Age:1.0  Onset:2001-07-12, Days after vaccination: 0
Gender:Male  Submitted:2001-07-12, Days after onset: 0
Location:California  Entered:2001-07-25, Days after submission: 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: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0448L2IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0591L0SCRA
PNC: PNEUMO (PREVNAR)PFIZER/WYETH4809770IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0924K0SCLA
Administered by: Military     Purchased by: Military
Symptoms: Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: The patient developed a 4cm x 4cm area of swelling below the right mandible within 5 minutes of vaccine administration. The patient was referred to ENT.

VAERS ID:173613 (history)  Vaccinated:2001-07-12
Age:2.0  Onset:2001-07-17, Days after vaccination: 5
Gender:Female  Submitted:2001-07-18, Days after onset: 1
Location:Florida  Entered:2001-07-25, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Obesity
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAM506A23IMLA
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0343L3IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0023L0SCRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt''s left arm had a hard, raised area covering deltoid with surrounding erythema.

VAERS ID:173800 (history)  Vaccinated:2001-07-12
Age:26.0  Onset:2001-07-13, Days after vaccination: 1
Gender:Female  Submitted:2001-07-27, Days after onset: 14
Location:Missouri  Entered:2001-08-02, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Rabies IG given in ER at hospital; just finished Augmentin and Viaxin.
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: Rabies screen?
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (IMOVAX)PASTEUR MERIEUX INST.T012231IM 
Administered by: Public     Purchased by: Other
Symptoms: Dysphagia, Pruritus, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypersensitivity (narrow)
Write-up: Pt had a rash on arms, welts on abdomen and back with itching. Also had trouble swallowing.

VAERS ID:173869 (history)  Vaccinated:2001-07-12
Age:0.4  Onset:2001-07-23, Days after vaccination: 11
Gender:Male  Submitted:2001-07-23, Days after onset: 0
Location:North Carolina  Entered:2001-08-03, 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: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: CBC, Basic Metabolic Panel, UA, urine culture, and blood culture and all were normal.
CDC Split Type: NC01063
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAM99A421IMLL
HIBV: HIB (HIBTITER)LEDERLE LABORATORIES4773931IMLL
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T05621IMRL
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES4818521IMRA
Administered by: Private     Purchased by: Public
Symptoms: Fontanelle bulging, Irritability, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Neonatal disorders (narrow)
Write-up: Pt had fever of 103.7 F, a bulging fontanel, irritable, and inconsolable.

VAERS ID:173888 (history)  Vaccinated:2001-07-12
Age:23.0  Onset:2001-07-13, Days after vaccination: 1
Gender:Male  Submitted:2001-07-23, Days after onset: 10
Location:Virginia  Entered:2001-08-03, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)SMITHKLINE BEECHAM693A60IM 
Administered by: Public     Purchased by: Public
Symptoms: Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Approx. 15:10 on 7/13/01, noted intense itching on back, chest, arms and hives developing soon thereafter. Symptoms treated with Benadryl X 2 on 7/13/01 and X 1 on 7/15/01 and then no further symptoms.

VAERS ID:173961 (history)  Vaccinated:2001-07-12
Age:1.0  Onset:2001-07-13, Days after vaccination: 1
Gender:Female  Submitted:2001-07-20, Days after onset: 7
Location:Wisconsin  Entered:2001-08-07, Days after submission: 18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Iron Supplement
Current Illness: NONE
Preexisting Conditions: Anemia
Diagnostic Lab Data:
CDC Split Type: WI0127
Vaccination
Manufacturer
Lot
Dose
Route
Site
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.0291K2IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0378L0SCLA
PPV: PNEUMO (PNU-IMUNE)LEDERLE LABORATORIES4809022IMLL
Administered by: Public     Purchased by: Public
Symptoms: Rash erythematous
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: On 07/13/2001 in the AM the patient developed small dots on her stomach, which worsened in the PM. On 07/14/2001 the rash spread to her face with swelling. The patient was seen in the ER and was given a shot to stop the swelling. The patient was then treated with Cortisone and Benadryl. The rash was raised like hives. The patient improved after treatment at the ER.

VAERS ID:173997 (history)  Vaccinated:2001-07-12
Age:12.0  Onset:2001-07-28, Days after vaccination: 16
Gender:Male  Submitted:2001-08-12, Days after onset: 15
Location:Indiana  Entered:2001-08-07, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions:
Diagnostic Lab Data: CBC, lymphs, EOS, RBC and Hgb, Amylase, serum
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1822J0IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1389K1SCRA
Administered by: Public     Purchased by: Public
Symptoms: Face oedema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Per mother on 07/28/2001 the patient experienced facial swelling in front of and under his ears to his upper neck and going to his eyes. The patient was seen in the ER. The swelling lasted 1-2 days.

VAERS ID:174135 (history)  Vaccinated:2001-07-12
Age:0.3  Onset:2001-07-18, Days after vaccination: 6
Gender:Male  Submitted:2001-07-23, Days after onset: 5
Location:Tennessee  Entered:2001-08-10, Days after submission: 18
Life Threatening? No
Died? Yes
   Date died: 2001-07-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type: TN01032
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAM989A20IMRL
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.1525K0IMLL
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T08410SCRL
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES4809780IMLL
Administered by: Public     Purchased by: Public
Symptoms: Apnoea, Asphyxia, Aspiration, Atelectasis, Infection, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Acute central respiratory depression (narrow), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: On 7/18/01 at 04:30, infant was found by mother, not breathing. She had checked on twins at 01:30 and both were fine. Father called 911, while mother initiated CPR. Baby was DOA at ER. Autopsy findings report: proximate cause of death to be sever infectious process of perianal nd perineal area; immediate cause of death atelectasis and pulmonary edema; mechanism of death aspiration asphyxia with pulmonary inadequacy.

VAERS ID:174181 (history)  Vaccinated:2001-07-12
Age:1.7  Onset:2001-07-13, Days after vaccination: 1
Gender:Female  Submitted:2001-07-13, Days after onset: 0
Location:Georgia  Entered:2001-08-10, Days after submission: 28
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: CBC-WNL
CDC Split Type: GA01065
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAM991A23IMLA
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0295K3IMRA
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T053222SCLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1384K0SCLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1142K0SCRL
Administered by: Public     Purchased by: Public
Symptoms: Convulsion, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Pt was contacted today by MD from hospital and the pt arrived about 1 hour earlier today after having a seizure. Says temperature is 102F (rectally) and says she has no rash, whelps, difficulty with respirations. No signs of allergic reactions and says believes temperature went up so fast as to cause seizure and that the child''s dad had febrile seizures as a child. Says child seems fine now; and is to be discharged to mother''s care.

VAERS ID:174198 (history)  Vaccinated:2001-07-12
Age:2.5  Onset:2001-07-13, Days after vaccination: 1
Gender:Male  Submitted:2001-08-07, Days after onset: 25
Location:Indiana  Entered:2001-08-10, 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: Benadryl
Current Illness: NONE
Preexisting Conditions: Chronic allergy, allergic to eggs. Diarrhea, vomiting, rash.
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)CONNAUGHT LABORATORIESUA536AB3IMLL
HIBV: HIB (ACTHIB)CONNAUGHT LABORATORIESUA536AB0IMLL
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T04852IMRL
Administered by: Private     Purchased by: Private
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Tenderness
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This child had swelling below injection site to the knee. Tender to touch, slightly red, warm to touch. Patient walking and playing with out complaints.

VAERS ID:174338 (history)  Vaccinated:2001-07-12
Age:28.0  Onset:2001-07-12, Days after vaccination: 0
Gender:Female  Submitted:2001-08-01, Days after onset: 20
Location:California  Entered:2001-08-14, Days after submission: 13
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: States today has allergy to Motrin.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM3376A41IMLA
Administered by: Public     Purchased by: Public
Symptoms: Anorexia, Faeces pale, Fatigue, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Biliary system related investigations, signs and symptoms (broad)
Write-up: Very tired, fever and chills, cream colored stools X 2 days, post vax. Loss of appetite and headaches everyday since injection. Has private insurance. Referred to PMD. Appt scheduled for 8/2/01 at 09:00.

VAERS ID:174441 (history)  Vaccinated:2001-07-12
Age:3.0  Onset:2001-07-12, Days after vaccination: 0
Gender:Female  Submitted:2001-07-26, Days after onset: 14
Location:California  Entered:2001-08-20, Days after submission: 25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type: CA010086
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)SMITHKLINE BEECHAM689A21IM 
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES4792380IM 
Administered by: Private     Purchased by: Public
Symptoms: 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)
Write-up: Pt received Hep-A and Prevnar and within minutes, post vax, pt vomited and fainted.

VAERS ID:174715 (history)  Vaccinated:2001-07-12
Age:0.3  Onset:2001-07-18, Days after vaccination: 6
Gender:Male  Submitted:2001-08-22, Days after onset: 35
Location:Kentucky  Entered:2001-08-28, Days after submission: 6
Life Threatening? No
Died? Yes
   Date died: 2001-07-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAM995A21IMRL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0779K1IMLL
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T07601SCRL
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES4809780IMLL
Administered by: Public     Purchased by: Unknown
Symptoms: Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)
Write-up: SIDS

VAERS ID:174895 (history)  Vaccinated:2001-07-12
Age:9.0  Onset:2001-07-12, Days after vaccination: 0
Gender:Female  Submitted:2001-07-13, Days after onset: 1
Location:Illinois  Entered:2001-08-31, Days after submission: 49
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
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0604K0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Pharyngolaryngeal pain, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Pt developed a rash, located on trunk, thighs and waist. No hives. Complained of a sore throat, no respiratory distress instructed to take over-the-counter Benadryl. Follow-up scheduled for 7/30/01.

VAERS ID:175623 (history)  Vaccinated:2001-07-12
Age:0.2  Onset:2001-07-12, Days after vaccination: 0
Gender:Female  Submitted:2001-09-17, Days after onset: 67
Location:Texas  Entered:2001-09-24, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)CONNAUGHT LABORATORIESU0515AA0IMLL
HIBV: HIB (ACTHIB)CONNAUGHT LABORATORIESUA576AB0IMRL
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T084120 LL
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES4797920IMRL
Administered by: Private     Purchased by: Private
Symptoms: Screaming
SMQs:, Hostility/aggression (broad)
Write-up: Pt developed crying for 6 hours, post vax, at 2 month immunizations of DTAP, IPV, HIB and PCV. DT was given at 4 months.

VAERS ID:175783 (history)  Vaccinated:2001-07-12
Age:4.0  Onset:2001-08-08, Days after vaccination: 27
Gender:Male  Submitted:2001-09-20, Days after onset: 43
Location:Oregon  Entered:2001-09-27, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Mild URI
Preexisting Conditions: NONE
Diagnostic Lab Data: CBC; ESR; Blood cultures-neg; X-ray showing mild joint effusion
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1392K1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Arthralgia, Joint effusion, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad)
Write-up: Pain and swelling of elbow on the same arm as the shot was given. Started 3 weeks, post vax, and lasted about 1 week.

VAERS ID:176672 (history)  Vaccinated:2001-07-12
Age:1.0  Onset:2001-07-12, Days after vaccination: 0
Gender:Male  Submitted:2001-10-17, Days after onset: 97
Location:Virginia  Entered:2001-10-24, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAMA984A23IMRL
HBPV: HIB POLYSACCHARIDE (HIBIMUNE)LEDERLE LABORATORIES4747123IMLL
Administered by: Private     Purchased by: 0
Symptoms: Injection site induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Parents brought child back into office within a half hour of immunization. Child had huge (6 cm in duration) on leg of HIB vaccine. Benadryl 12.5 po, ice pack, and Tylenol. Gave Benadryl through the night.

VAERS ID:177419 (history)  Vaccinated:2001-07-12
Age:9.0  Onset:2001-07-12, Days after vaccination: 0
Gender:Female  Submitted:2001-10-19, Days after onset: 99
Location:Unknown  Entered:2001-11-08, Days after submission: 20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  IMLA
Administered by: Other     Purchased by: Other
Symptoms: Dry throat, Headache, Rash
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)
Write-up: Had Hepatitis B vaccine left deltoid. Shortly after child got home developed rash around waist, chest and thighs areas. Had scratching in throat and headache. No respiratory difficulty.

VAERS ID:182394 (history)  Vaccinated:2001-07-12
Age:  Onset:2001-07-12, Days after vaccination: 0
Gender:Female  Submitted:2002-03-07, Days after onset: 238
Location:Indiana  Entered:2002-03-13, 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: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data:
CDC Split Type: WAES01071329
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0411L   
Administered by: Private     Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a newborn 2 day old white female who on 12 JUL 2001 was vaccinated with a dose of hepatitis B vaccine recombinant (yeast) (Lot # 640031/0411L). Within one hour of being injected the patient developed "bumps" all over her body that looked like mosquito bites on her arms and one hour later the "bumps" disappeared. The physician reported that the patient recovered and that her experience was non-serious. Additional information is not expected.

VAERS ID:182396 (history)  Vaccinated:2001-07-12
Age:54.0  Onset:2001-07-12, Days after vaccination: 0
Gender:Female  Submitted:2002-03-07, Days after onset: 238
Location:Kansas  Entered:2002-03-13, 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: UNK
Current Illness:
Preexisting Conditions: Lightheadedness, pallor, fruit allergy, penicillin allergy
Diagnostic Lab Data:
CDC Split Type: WAES01071685
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0672L1IM 
Administered by: Public     Purchased by: Private
Symptoms: Asthenia, Dizziness, Musculoskeletal stiffness, Pallor
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad)
Write-up: Information has been received from a health professional concerning a 54 year old white female with a banana allergy and a penicillin allergy and a history of pallor and lightheadedness who on 12 JUL 2001 at 4 pm was vaccinated IM in the left deltoind (while sitting down) with a 1.0 mL second dose of hepatitis b vaccine recombinant (yeast) (lot # 639854/0672L). There were no illnesses at the time of vaccination or known adverse events following prior vaccinations. Immediately after being vaccinated (at 16:05) the patient complained of "feeling faint" and became quite pale. She sat quietly for a short time, took a walk, and reclined on the exercise mat for approximately 10 minutes. She drank a glass of grape juice and then stated she "felt better." Normal color had returned to her face and she stood and ambulated without apparent difficulty. She remained at the facility for observation another 10 minutes and then left. The patient stated that the first dose of hepatitis b vaccine recombinant (yeast) (MSD) had not produced any feelings of "faintness." it was reported that the patient recalled being "stiff" and perhaps more tired than usual for two days after the injection. It was reported that the injection site remained unremarkable and no respiratory distress was noted. It was noted that the patient has had the same feelings of feeling faint (lightheadedness) and pallor in the past when she donated blood. Follow up information has been received from the health professional reporting that the events resolved and that no adverse symptoms continue. No further information is available.

VAERS ID:183942 (history)  Vaccinated:2001-07-12
Age:14.0  Onset:2001-11-21, Days after vaccination: 132
Gender:Female  Submitted:2002-03-28, Days after onset: 127
Location:Florida  Entered:2002-04-29, Days after submission: 31
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions:
Diagnostic Lab Data: MRI-no abnormalities; labs-neg; while at the hospital was seen by neurologists and stated there was a questionable area (MRI) possibly viral; Urine cultures-over 100,000 E-coli; Nasopharyngeal and stool cultures-neg for virus
CDC Split Type: FL02006
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1861K1IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0227L0SCLA
Administered by: Public     Purchased by: Public
Symptoms: Abasia, Back pain, Diabetes mellitus, Hemiparesis, Hypoaesthesia, Infection, Laboratory test abnormal, Myelitis transverse, Obesity, Oedema peripheral, Paralysis, Upper respiratory tract infection, Urinary retention, Urinary tract infection
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)
Write-up: On 3/23/02, per telephone call to mother, she states her daughter was paralyzed from the waist down and could not walk in 11/00. Daughter is receiving physical therapy now and has numbness on her right side, leg and back problems, feet swelling and diabetes stage 2. Per Progress Notes: Immunization card states: 1/11/02 vaccine deferred until parent brings OK from physician for shots. Appt on 1/17/02. Parent reports child possible dx with Guillain-Barre'' but not definite. Had weakness from waist down for approx. 2 weeks. Hospitalized. Slight numbness remains in lower right leg. Mother in on 3/26/02 and requests copy of immunization record and it was provided. Record shows child had immunizations on 7/12/01. Hep-b 2nd dose and Varicella 1st dose. Called the hospital and talked with RN and she read the record to me: The pt was admitted to the hospital on 11/22/01 with dx of weakness in legs. On 11/21/01, the pt complained of numb legs, muscle cramps. One month prior to this incident, the pt had a viral upper respiratory infection. She complained of difficulty voiding on the 21st. Denies headache. Also complained of back pain and has a history of trauma to back during a fight with a schoolmate. Do not know when MRI was done but was mentioned in the history. The pt required catheterization while in the hospital for urinary retention. Also received physical therapy and discharged on 11/29/01. "Condition improved". Discharge dx: lower extremity weakness, urinary retention, suspect viral etiology and UTI. The pt weighs 240lbs at 13 years of age. Per call to parent; she states her daughter was dx''d with Guillain-Barre'' but the doctor changed her dx to Transverse Myelitis. The mother states that her daughter is disabled because "she got a double dose of Hep-B". Says "I got no information about that" and she is unaware that her daughter received varicella. She states "they never told me that. They said she didn''t". "They" means the Health Dept. She states she has a medical friend who "told me that may cases of this (paralys

VAERS ID:187545 (history)  Vaccinated:2001-07-12
Age:1.3  Onset:2001-07-12, Days after vaccination: 0
Gender:Male  Submitted:2002-05-30, Days after onset: 322
Location:Pennsylvania  Entered:2002-07-15, Days after submission: 46
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol
Current Illness: Eczema
Preexisting Conditions: allergic rash: anaphylaxis
Diagnostic Lab Data:
CDC Split Type: WAES01071818
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC. 0SC 
Administered by: Private     Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 15 month old male with asthma, eczema, and eggs allergy with anaphylactic reactions and a history of allergic rashes who on 07/12/01 was vaccinated with the first dose of MMRII, SC in the right arm. this does not comply with the recommended dosage. concomitant therapy included albuterol. there was no illness at the time of vaccination. It was reported that within 10 minutes (also reported as 30 minutes) of vaccination the child developed hives "everywhere"but no wheezing. There was no reaction at the site of injection. it was noted that the patient had a history of asthma and many allergic reactions. The patient responded to diphenhydramine HC(Benadryl). It was also reported that on 05/05/01, the patient received the first dose of Varivax SC in the left arm and had no adverse reactions. FOLLOW-UP information, reported that the physician "administered 0.1 cc of the vaccine because the mother thought the child might be allergic to MMRII, although the child received a previous dose of Varivax without complications". No further information is expected.

VAERS ID:197066 (history)  Vaccinated:2001-07-12
Age:  Onset:2003-01-13, Days after vaccination: 550
Gender:Female  Submitted:2003-01-24, Days after onset: 11
Location:Unknown  Entered:2003-02-03, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1181L0 LL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Drug ineffective, Infection, Rash
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Hypersensitivity (narrow)
Write-up: Pt developed a moderate to severe case of varicella disease, including but not limited to skin rash, pustuoles and scarring.

VAERS ID:203909 (history)  Vaccinated:2001-07-12
Age:1.0  Onset:2001-07-13, Days after vaccination: 1
Gender:Male  Submitted:2003-05-14, Days after onset: 670
Location:Pennsylvania  Entered:2003-05-29, Days after submission: 15
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Influenza (unknown mfr);reaction;;0;In Patient
Other Medications:
Current Illness:
Preexisting Conditions: Allergies
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER 3  
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0255L0  
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1467K0  
Administered by: Private     Purchased by: Private
Symptoms: Autism, Coordination abnormal, Mental impairment, Speech disorder
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad)
Write-up: After getting MMR/Chicken Pox, he could no longer talk, comprehend, language further damage. UL DPT on 10/15/2001. Running in circles, loss of eye contact, loss of speech, loss of understanding speech. A follow up report received 6/5/2003 adds: Diagnosed with Autism 12/02. 60 day follow up received on 8/6/03 states he cannot speak as he did before he got his shots and does not understand language as he did before. Also, lost coordination.

VAERS ID:233655 (history)  Vaccinated:2001-07-12
Age:1.0  Onset:2005-01-18, Days after vaccination: 1286
Gender:Female  Submitted:2005-01-18, Days after onset: 0
Location:Massachusetts  Entered:2005-02-10, Days after submission: 23
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: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0405U IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1241U IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Drug ineffective, Infection
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Patient received varicella vaccine 07/12/2001 confirmed Chicken pox-mild case 01/18/2005.

VAERS ID:240666 (history)  Vaccinated:2001-07-12
Age:49.0  Onset:0000-00-00
Gender:Female  Submitted:2005-05-17
Location:Alabama  Entered:2005-06-23, Days after submission: 37
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Hepatitis B exposure; The patient has two brothers that have hepatitis B. The patient''s concurrent conditions and concurrent medications were not reported.
Diagnostic Lab Data: Hepatitis B DNA assay Sep2004 8700 copies/ml; Hepatitis B antibody positive Sep2004 Positive; Hepatitis B core antigen Sep2004 Non-reactive; Hepatitis B e antigen Sep2004 Positive; Hepatitis B screen Dec2000 Negative; Hepatitis B surface an
CDC Split Type: A0527937A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS5160D92 LA
Administered by: Private     Purchased by: Other
Symptoms: Drug ineffective, Hepatitis, Laboratory test abnormal
SMQs:, Hepatitis, non-infectious (narrow), Lack of efficacy/effect (narrow)
Write-up: Hepatitis B, Hepatitis B e antigen positive, Hepatitis B antibody positive, Therapy non-responder; This case was reported by a physician and described a 49-year0old female patient who tested positive for hepatitis B following immunization with hepatitis B vaccine recombinant (Engerix-B). The patient''s medical history was notable for hepatitis B exposure from "two brothers who have hepatitis B." On an unspecified date in December 2000, the patient "tested negative for hepatitis B." The patient received a series of three doses of Engerix-B on 09 January 2001, 08 February 2001 and 12 July 2001. The lot number for all three doses of Engerix-B is ENG5160D9. The reporter stated that, "A titer was not done when the series was completed." On an unspecified date in September 2004, the patient was donating blood and "tested positive for hepatitis B." She was seen at a physician''s office. Laboratory analyses revealed that the antibody to hepatitis B core antigen was "non-reactive," hepatitis B surface antigen was "non-reactive," IgM antibody to hepatitis B surface antigen was "non-reactive," hepatitis Be antigen was positive, antibody to hepatitis Be antigen was positive and polymerase chain reaction by focus technology revealed 8700 copies/ml of hepatitis B virus.

VAERS ID:392787 (history)  Vaccinated:2001-07-12
Age:21.0  Onset:2010-07-12, Days after vaccination: 3287
Gender:Female  Submitted:2010-07-13, Days after onset: 1
Location:Tennessee  Entered:2010-07-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: No
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0508Y0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B043BA0IMRA
Administered by: Public     Purchased by: Other
Symptoms: Erythema, Injected limb mobility decreased, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Patient complained of right arm being red, swollen, unable to move arm, and painful.

VAERS ID:423504 (history)  Vaccinated:2001-07-12
Age:1.0  Onset:2011-03-12, Days after vaccination: 3530
Gender:Female  Submitted:2011-05-12, Days after onset: 60
Location:Florida  Entered:2011-05-18, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1103USA02132
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Varicella
SMQs:
Write-up: Information has been received from a physician concerning a 10 year old female patient who on 12-JUL-2001, was vaccinated with the first dose of VARIVAX (Merck) (dose and lot number not reported). It was noted that the patient never received a second dose of VARIVAX (Merck). The patient was diagnosed this past Saturday, on 12-MAR-2011 with chickenpox. It was reported that the patient received treatment but the reporter was not exactly "sure of the details". At the time of the report the outcome of the patient was not provided. The patient sought unspecified medical attention. Additional information has been requested.

VAERS ID:173745 (history)  Vaccinated:2001-07-12
Age:1.7  Onset:2001-07-12, Days after vaccination: 0
Gender:Male  Submitted:2001-07-25, Days after onset: 13
Location:Foreign  Entered:2001-08-01, Days after submission: 7
Life Threatening? Yes
Died? Yes
   Date died: 2001-07-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ascorbic acid, vitamins (unspecified)
Current Illness:
Preexisting Conditions: Concurrent conditions: vitamin supplementation
Diagnostic Lab Data: UNK
CDC Split Type: WAES01079949
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC. 2IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Epistaxis, Gastrointestinal haemorrhage, Mouth haemorrhage, Pyrexia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal haemorrhage (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Ischaemic colitis (broad)
Write-up: Information has been received from a physician concerning a pt who was vaccinated on 7/12/01 with hepatitis B vaccine II (MSD). Concomitant therapy included ascorbic acid and multivitamins. On the afternoon of 7/12/01 the pt experienced low grade fever and was given paracetamol. The pt then slept, woke up once then slept again. Approx that same night, the pt was found dead with profuse oral bleeding. The pt was rushed to the hospital. The mother said there was absence of convulsion. Upon arrival in the hospital the child was declared dead. An autopsy was ordered. Oral bleeding was considered life threatening. Additional information has been requested. This is a follow-up report. The reporting physician suspected GI hemorrhage since nose bleeding was also noted. The reporting physician felt that oral bleeding, nose bleeding, low-grade fever and death are definitely not related to the therapy with Hep-B vaccine. The reporting physician also considered nose bleeding as life threatening. This is a corrected report. "The cause of death was unknown" was added to the narrative. *Attempts were made to obtain autopsy findings but the reporting MD refused to provide the results. No further info is expected.*

VAERS ID:173949 (history)  Vaccinated:2001-07-12
Age:1.3  Onset:2001-07-14, Days after vaccination: 2
Gender:Female  Submitted:2001-08-02, Days after onset: 19
Location:Foreign  Entered:2001-08-07, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Fever;Vaccine not specified;;.00;In Patient
Other Medications: UNK
Current Illness:
Preexisting Conditions: Fever after receiving previous unspecified vaccines
Diagnostic Lab Data: Temperature-39C and again, same day, 40C-7/21/01
CDC Split Type: WAES01072706
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0797K0SCGM
Administered by: 0     Purchased by: 0
Symptoms: Convulsion, Loss of consciousness, Lymphadenopathy, Pyrexia, Rash, Skin discolouration, Swelling face
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a health professional concerning her 15 month old daughter with a history of fever after previous unspecified vaccinations who on 7/12/01 was vaccinated, in the right buttock, with a 1st dose of MMRII. On 7/14/01, 2 days, post vax, the pt experienced a cutaneous rash described as little red spots. The rash was treated with "mequitazine". On 7/21/01, 9 days, post vax, the pt experienced a fever of 39C and then 40C which did not diminish after paracetamol and ibuprofen, alternatively. It was noted that the child later had a convulsion that lasted 5 minutes and she was seen at the ER. She also had inguinal lymphadenopathies on the right side and left cheek edema which persisted for 4 days. As of 7/25/01, the cutaneous rash and lymphadenopathy were not resolved. The pt''s experience was considered an "Other Important Medical Event". Additional information is expected. F/U states the fever persisted for 48 hours. The convulsion was associated with loss of consciousness. She also had inguinal lymphadenopathies on the right side which started on 7/21/01 and lasted until 9/10/01. She also had left cheek edema "bluish cheek" which appeared on 7/21/01 and persisted for 4 days. As of 7/25/01, the cutaneous rash and lymphadenopathy were not resolved. F/U information from a health professional indicated that the pt was considered completely recovered as of 9/25/01. It was noted that the reporter felt this was a non-serious case. The case is closed. The pt''s experience was considered an "Other Important Medical Event".

VAERS ID:175286 (history)  Vaccinated:2001-07-12
Age:8.0  Onset:2001-08-03, Days after vaccination: 22
Gender:Male  Submitted:2001-08-24, Days after onset: 21
Location:Foreign  Entered:2001-09-14, Days after submission: 21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: Spinal Tap 08/03/01 - 98 cells / microL. CSF glucose 08/03/01 - 78 mg / dl - corresponding serum level 120 mg / dL. Cerebrospinal fluid protein test 08/03/01 - 35 mg / dL. F/U CSF-showed "elevated cell count and protein, but no germs"; F/U
CDC Split Type: WAES01081848
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1550J IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Laboratory test abnormal, Malaise, Meningitis aseptic
SMQs:, Noninfectious meningitis (narrow)
Write-up: Information has been received from a health professional concerning a 8 year old male who on 06/12/2001 was vaccinated IM with a dose of MMRII (lot # 633825/1550J; batch HL61377). On 08/03/01, this patient became ill and was hospitalized. A lumbar puncture was performed and a diagnosis of aseptic meningitis was made. The boy was treated with certriaxone and his condition rapidly improved. It was reported that the boy will be discharged when "fully recovered in the following days". It was not known if the boy had received a previous dose of MMR vaccine. It was noted that the situation was not considered to be life threatening. The reporters assessment was unassessible. FOLLOW-UP information received on 11/27/2001 from a business partner indicated that on 11/12/2001 that the lab test was available. FOLLOW-UP rerceived on 11/22/2001 indicated that according to the laboratory physician some of the lab results were reported in error. the physician confirmed that no CSF antibodies had been examined and that a technical data error had occurred. Additional information expected Other business partner numbers include I-MMR 01-013, GE 10815 and PEI 4616-2001

VAERS ID:176717 (history)  Vaccinated:2001-07-12
Age:40.0  Onset:2001-07-13, Days after vaccination: 1
Gender:Female  Submitted:2001-12-06, Days after onset: 146
Location:Foreign  Entered:2001-10-25, Days after submission: 42
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:
Preexisting Conditions: History of Allergic asthma
Diagnostic Lab Data: CXR-nml; EEG-discrete subcortical disorder; CSF-nml; Hemoglobin-10.8g/dl; CRP-6.6 mg/l; ESR-21mm; All other routine parameters (not specified)-WNL; UA-nml
CDC Split Type: U2001010690
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.R09451   
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0205K IM 
TBE: TICK-BORNE ENCEPH (NO BRAND NAME)UNKNOWN MANUFACTURER198041   
TD: TD ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURER013041 IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cough, Dyspnoea, Electroencephalogram abnormal, Haemoglobin decreased, Headache, Hypokinesia, Hyporeflexia, Laboratory test abnormal, Meningism, Muscular weakness, Neurological symptom, Paraesthesia, Pyrexia, Red blood cell sedimentation rate increased, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Peripheral neuropathy (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: It was reported that a 40 year old female pt was vaccinated on 7/12/01 with IPV, Pneumovax 23, combined tetanus and diphtheria (Td-pur, Chiron Behring) and tick-borne vaccine (Encepur, Chiron Behring). The next morning, she had difficulties in moving her head, trunk and arms and complained of a headache and dyspnea. On arrival of the ER assistant, all symptoms had disappeared, only headache was present. So that she was not taken to the hospital. In the evening, however, she developed a fever up to 39.7C, headache, chills, coughing and she vomited once. On admission to the hospital on 7/13/01, she presented meningism; further neurological exams showed discrete weakness in the left arm and both legs, paresthesia of both hands palmar and reduced Achilles and patellar tendon reflexes. A control on 7/17/01, showed normal results. The pt recovered after symptomatic therapy and was discharged on 7/18/01. An allergic pathogenesis was discussed. Further information is not expected. File closed. F/U states: neurological sign/symptom was added as a serious adverse event, hemoglobin level was added and the narative was updated. This is a consolidation of 2 reports concerning the same pt. WAES01102322 was submitted to the FDA on 10/22/01.

VAERS ID:173469 (history)  Vaccinated:2001-07-13
Age:0.6  Onset:2001-07-13, Days after vaccination: 0
Gender:Female  Submitted:2001-07-16, Days after onset: 3
Location:Kentucky  Entered:2001-07-20, 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: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type: KY2001050
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAM950A22IMRL
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T07602SCRA
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES4753800IMLL
Administered by: Public     Purchased by: Public
Symptoms: Irritability, Pyrexia, Rash erythematous, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypersensitivity (narrow)
Write-up: Pt developed fever 2 hrs post vax. Mom noticed a rash on face and chest that she thought was from bottle spilling. The next morning rash was very red with hives all over pt''s body. Pt had fever and was irritable all day. She was treated with Benadryl and Tylenol. On 7/15/01, hives were gone and rash was less red, and pt had no fever. On 7/16/01, pt back to normal with only slight rash still noted.

VAERS ID:173500 (history)  Vaccinated:2001-07-13
Age:1.3  Onset:2001-07-14, Days after vaccination: 1
Gender:Female  Submitted:2001-07-16, Days after onset: 2
Location:Georgia  Entered:2001-07-23, 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:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)CONNAUGHT LABORATORIESUO514DA3IMRL
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.0788K2IMLL
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T10982IMLL
Administered by: Military     Purchased by: Military
Symptoms: Cellulitis, Erythema, Feeling hot, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: One day post vax, pt''s leg was red. Two days post vax, pt''s leg started swelling and became warm to touch. Three days post vax, pt diagnosed with cellulitis and given Keflex.

VAERS ID:173518 (history)  Vaccinated:2001-07-13
Age:0.3  Onset:2001-07-13, Days after vaccination: 0
Gender:Male  Submitted:2001-07-16, Days after onset: 3
Location:Louisiana  Entered:2001-07-24, Days after submission: 8
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: Reflux
Diagnostic Lab Data: NONE
CDC Split Type: LA010703
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAM982A22IMRL
HIBV: HIB (HIBTITER)PFIZER/WYETH5934532IMLL
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T06972SCRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETH4797912IMLL
Administered by: Public     Purchased by: Public
Symptoms: Agitation, Crying, Screaming, Vaccine positive rechallenge
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad)
Write-up: Pt started with high pitched cry and was inconsolable 30 min post vax. It lasted for about 3 hrs. He was taken to MD''s office and was given Benadryl and Infant Tylenol. Pt experienced high pitch cry (3 hrs) after first DTAP.

VAERS ID:173576 (history)  Vaccinated:2001-07-13
Age:0.2  Onset:2001-07-13, Days after vaccination: 0
Gender:Female  Submitted:2001-07-19, Days after onset: 6
Location:Tennessee  Entered:2001-07-25, Days after submission: 6
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: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: Spinal Tap (-); CBC-nml; UA-nml; EKG-nml; ECHO-nml; EEG-nml; Viral cultures are pending
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)CONNAUGHT LABORATORIESU0532AA0IMRL
HIBV: HIB (ACTHIB)CONNAUGHT LABORATORIESU9604AA0IMLL
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T08160SCLL
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES4809040IMRL
Administered by: Private     Purchased by: Private
Symptoms: Coma, Hypotonia, Respiratory depression
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Pt found hypotonic/unresponsive with poor respiratory effort approximately 5 hrs post vax. Pt admitted to the hospital for r/o sepsis. Discharged from hospital after cultures negative for 48 hrs.

VAERS ID:173602 (history)  Vaccinated:2001-07-13
Age:24.0  Onset:2001-07-14, Days after vaccination: 1
Gender:Female  Submitted:2001-07-16, Days after onset: 2
Location:Massachusetts  Entered:2001-07-25, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
YF: YELLOW FEVER (YF-VAX)CONNAUGHT LABORATORIESUA361AB0SCLA
Administered by: Military     Purchased by: Military
Symptoms: Chills, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: On 07/14/2001 at 5AM the patient developed hives and itching on her left and right forearms. On 07/14/2001 at 4PM the patient''s hands were swollen, the hives and itching had spread to her hands and feet and she experienced chills. The patient was treated with Deaconess, Nashoba and Benadryl.

VAERS ID:173611 (history)  Vaccinated:2001-07-13
Age:37.0  Onset:2001-07-13, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:Missouri  Entered:2001-07-25
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: Bee sting allergy, diverticulosis, osteoporosis
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)SMITHKLINE BEECHAM658A41IMLA
Administered by: Other     Purchased by: Private
Symptoms: Abdominal pain upper, Headache, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Approximately 1 hour post vax, pt developed headache, nausea and stomach pain. Symptoms persisted for 7 days. Pt was seen by MD and given an injection of Demerol for headache pain.

VAERS ID:173619 (history)  Vaccinated:2001-07-13
Age:1.3  Onset:2001-07-14, Days after vaccination: 1
Gender:Male  Submitted:2001-07-16, Days after onset: 2
Location:Arkansas  Entered:2001-07-25, 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 (INFANRIX)SMITHKLINE BEECHAM988A23IMLL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.1413K3IMRL
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T07822SCLL
Administered by: Private     Purchased by: Public
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt had local erythema and swelling at 24 hours, post vax, with 7cm X 7cm area on anterior thigh (L). Was given Cephalexin po X 10 days for cellulitis vs local reaction.

VAERS ID:173658 (history)  Vaccinated:2001-07-13
Age:1.0  Onset:2001-07-21, Days after vaccination: 8
Gender:Female  Submitted:2001-07-24, Days after onset: 3
Location:Indiana  Entered:2001-07-27, 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: Augmentin
Current Illness: NONE
Preexisting Conditions: Neonatal - CMV - related Hepatitis, resolved and allergic colitis.
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1901K0SCLL
Administered by: Private     Purchased by: Private
Symptoms: Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: The patient experienced fever and varicella rash.

VAERS ID:173663 (history)  Vaccinated:2001-07-13
Age:39.0  Onset:2001-07-14, Days after vaccination: 1
Gender:Female  Submitted:2001-07-16, Days after onset: 2
Location:Ohio  Entered:2001-07-30, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type: OH0044
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1893K0SCRA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: The patient states the injection site became reddened and with a hard lump under the surface. The erythema area was reported as softball size.

VAERS ID:173789 (history)  Vaccinated:2001-07-13
Age:1.6  Onset:2001-07-20, Days after vaccination: 7
Gender:Female  Submitted:2001-07-24, Days after onset: 4
Location:Washington  Entered:2001-08-01, 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: Pulmicort
Current Illness: NONE
Preexisting Conditions: Reactive airway disease
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAM994A23IMRL
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES4792390IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0231L0SCLL
Administered by: Private     Purchased by: 0
Symptoms: Erythema induratum, Injection site oedema, Rash papular, Skin ulcer
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vasculitis (narrow)
Write-up: The patient developed erythema with induratum at the left thigh in an area 4 1/2cm x 2cm. The patient had multiple erythematous papules and vesicles. The left thigh had an edematous base with papular lesions scattered over the trunk and arms.

VAERS ID:173807 (history)  Vaccinated:2001-07-13
Age:4.0  Onset:2001-07-15, Days after vaccination: 2
Gender:Male  Submitted:2001-07-16, Days after onset: 1
Location:Florida  Entered:2001-08-01, Days after submission: 16
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAM983A24IMLA
Administered by: Private     Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Left arm red and warm to touch, swollen. Ice and Benadryl given at ER visit on 7/14/01. Cape Hospital called in Keflex.

VAERS ID:173825 (history)  Vaccinated:2001-07-13
Age:5.0  Onset:0000-00-00
Gender:Female  Submitted:2001-07-19
Location:Pennsylvania  Entered:2001-08-01, Days after submission: 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: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAM995A2 IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0020L SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1884K SCLA
Administered by: Private     Purchased by: 0
Symptoms: Injection site induration, Injection site reaction, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: 4" circular, warm area on RUA; 2" inner area, more firm. (DTAP given in that area).

VAERS ID:173912 (history)  Vaccinated:2001-07-13
Age:10.0  Onset:2001-07-13, Days after vaccination: 0
Gender:Female  Submitted:2001-07-30, Days after onset: 17
Location:New York  Entered:2001-08-06, 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: Claritin
Current Illness: NONE
Preexisting Conditions: PCN allergy
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (IMOVAX)PASTEUR MERIEUX INST.R131424IMLA
Administered by: Public     Purchased by: Public
Symptoms: Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Pt developed generalized rash with itching and was treated with Benadryl.

VAERS ID:173974 (history)  Vaccinated:2001-07-13
Age:  Onset:2001-07-13, Days after vaccination: 0
Gender:Unknown  Submitted:0000-00-00
Location:Montana  Entered:2001-08-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Wellbutrin, Axid, Levoxyl, Neurontin, Serozone, Estradiol
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type: MT0108
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)SMITHKLINE BEECHAM704A40IMRA
TD: TD ADSORBED (NO BRAND NAME)CONNAUGHT LABORATORIESU0385AA IMRA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)CONNAUGHT LABORATORIESR1407 IMLA
YF: YELLOW FEVER (YF-VAX)CONNAUGHT LABORATORIESUA450AA0SCLA
Administered by: Public     Purchased by: Private
Symptoms: Asthenia, Back pain, Chills, Headache
SMQs:, Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad)
Write-up: Post vax the patient developed severe back pain, weakness and was tired. These symptoms progressed as the day went on accompanied by chills and a headache. The patient was advised to seek medical attention.

VAERS ID:174202 (history)  Vaccinated:2001-07-13
Age:5.0  Onset:2001-07-20, Days after vaccination: 7
Gender:Female  Submitted:0000-00-00
Location:California  Entered:2001-08-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: Fragile X
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAM998A24IMLL
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T07573SCLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0155L1SCLL
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt developed red, swelling in leg, 1 week, post vax, lasting about a week.

VAERS ID:174610 (history)  Vaccinated:2001-07-13
Age:0.0  Onset:2001-07-13, Days after vaccination: 0
Gender:Male  Submitted:2001-08-09, Days after onset: 27
Location:New York  Entered:2001-08-23, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cyanosis neonatal, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad)
Write-up: Newborn boy received Hep-B vaccine (5mg IM). Less that 10 minutes, post vax, RN noticed baby was cyanotic. Pt was stimulated and given O2 by face mask. The baby responded and was transferred to NICU. Baby was discharged on 7/15/01.

VAERS ID:174900 (history)  Vaccinated:2001-07-13
Age:18.0  Onset:2001-07-13, Days after vaccination: 0
Gender:Female  Submitted:2001-07-16, Days after onset: 3
Location:Virginia  Entered:2001-08-31, Days after submission: 46
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
MEN: MENINGOCOCCAL (MENOMUNE)CONNAUGHT LABORATORIESUA410AA0SCLA
Administered by: Public     Purchased by: Public
Symptoms: Ear pain, Neck pain, Pyrexia, Swelling, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Arthritis (broad)
Write-up: Pt developed swelling of right jaw, pain in right ear and neck, wheezing and fever. She denies any rash.

VAERS ID:175074 (history)  Vaccinated:2001-07-13
Age:38.0  Onset:2001-07-13, Days after vaccination: 0
Gender:Female  Submitted:2001-08-11, Days after onset: 29
Location:Maryland  Entered:2001-09-06, Days after submission: 26
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Humulin N
Current Illness: Dog bite to hand on 7/8/01
Preexisting Conditions: IDDM; Sponge kidney on right
Diagnostic Lab Data: Cranial MRI-reportedly neg
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)CONNAUGHT LABORATORIES0381AA IMLA
Administered by: Private     Purchased by: Public
Symptoms: Analgesic effect, Balance disorder, Facial palsy, Headache, Muscular weakness, Myalgia, Vision blurred
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Vestibular disorders (broad)
Write-up: Pt reported that soon after receiving the TD vaccine, she developed dysequilibrium, visual blurring, facial discomfort, severe pain of the right upper extremity and right trapezius area and right upper extremity analgesia. She was later noted with a facial droop and right medial pectus weakness.

VAERS ID:175077 (history)  Vaccinated:2001-07-13
Age:18.0  Onset:2001-07-18, Days after vaccination: 5
Gender:Female  Submitted:2001-08-07, Days after onset: 20
Location:Colorado  Entered:2001-09-06, Days after submission: 30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations: unspecified;Td, Adsorbed, Adult (Mfr not specified);1;15.00;In Patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: CSF Fluid-neucleated 17; Diff: Poly-71, lymphs-24, glucose-48, protein-54
CDC Split Type: CO01012
Vaccination
Manufacturer
Lot
Dose
Route
Site
MEN: MENINGOCOCCAL (MENOMUNE-A/C)CONNAUGHT LTD.UB036AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: CSF test abnormal, Dizziness, Headache, Hyperventilation, Pyrexia
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad)
Write-up: The pt experienced a fever on 7/13/01 which continued until 7/16/01. On 7/18/01 developed a severe debilitating headache. Pain was on "top" of head. Pain was so bad it caused the pt to hyperventilate and become very dizzy.

VAERS ID:175226 (history)  Vaccinated:2001-07-13
Age:1.0  Onset:2001-07-14, Days after vaccination: 1
Gender:Female  Submitted:2001-07-25, Days after onset: 11
Location:North Carolina  Entered:2001-09-11, Days after submission: 48
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: NONE
Preexisting Conditions:
Diagnostic Lab Data: Blood work; Urinalysis and X-rays
CDC Split Type: NC01079
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (HIBTITER)LEDERLE PRAXSIS4773813IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1510K0SCLA
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES4792341IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0468L0SCRA
Administered by: Public     Purchased by: Public
Symptoms: Pyrexia, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Mother states that child had a fever of 105F, starting the night of the shots. The next day, a red, raised rash occurred. The child was taken to ER and a Urinalysis was done. On Sunday, 7/15/01, she was taken back to ER and blood work and X-rays done. Now the child is here on 7/18/01 and was seen at encouragement of nurse to be seen by PMD due to continued rash and fever. Taken in by mother on 7/25/01. No fever since 7/19/01 and no rash since 7/21/01. The pt has frequent fevers per mother.

VAERS ID:175321 (history)  Vaccinated:2001-07-13
Age:1.2  Onset:2001-07-17, Days after vaccination: 4
Gender:Female  Submitted:0000-00-00
Location:Wisconsin  Entered:2001-09-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WI0128
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAM99A42 IMRL
HIBV: HIB (ACTHIB)CONNAUGHT LABORATORIESUA349AA/UA574AA IMLL
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES479791 IMRL
Administered by: Public     Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Localized erythema and swelling at injection site on right leg. Seen at ER on 7/15/01.

VAERS ID:175963 (history)  Vaccinated:2001-07-13
Age:52.0  Onset:2001-07-13, Days after vaccination: 0
Gender:Female  Submitted:2001-07-13, Days after onset: 0
Location:Washington  Entered:2001-10-02, Days after submission: 81
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: "Heart condition" taking a lot of medications
Current Illness: NONE
Preexisting Conditions: Heart condition
Diagnostic Lab Data:
CDC Split Type: WA011772
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)SMITHKLINE BEECHAM684D60IMLA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Headache, Pain
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Pt received vaccine on 7/13/01 about 09:00 without incident. At 14:00 on 7/13/01, the pt had a sudden onset of headache, cheeks became red, hot and had a burning sensation. No complaint of difficulty swallowing, no rash or hives, no complaint of increased SOB or wheezing and no chest pain.

VAERS ID:178099 (history)  Vaccinated:2001-07-13
Age:1.0  Onset:2001-07-13, Days after vaccination: 0
Gender:Female  Submitted:2001-10-10, Days after onset: 89
Location:North Carolina  Entered:2001-11-21, Days after submission: 42
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: UNK
Preexisting Conditions: UNK
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPH: DTAP + HIB (NO BRAND NAME)UNKNOWN MANUFACTURER 3IM 
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER 2  
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER 2  
Administered by: Private     Purchased by: Other
Symptoms: Injection site swelling, Injection site warmth, Irritability, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Vaccine given 7/13/01 on 7/15 pt adm to ED for swelling from knee up since receiving vaccination. Has been fussy. (LLE) hot to touch. treatment: ibuprofen, cool compress.

VAERS ID:180416 (history)  Vaccinated:2001-07-13
Age:26.0  Onset:2001-07-13, Days after vaccination: 0
Gender:Female  Submitted:2001-07-23, Days after onset: 10
Location:South Dakota  Entered:2002-01-24, Days after submission: 185
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Ortho Tri-Cyclen (ethinyl estradiol)
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Blood sugar at 08:00-55mg/dl and 51mg/dl at 10:00
CDC Split Type: 20010176441
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM3384B61IMRA
Administered by: Other     Purchased by: Other
Symptoms: Blood glucose decreased, Chills, Dizziness, Injection site pain, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: On an unspecified date, the pt received her 1st dose of Engerix-B without adverse event. On 7/13/01, at 08:00, the pt received her 2nd right deltoid dose of Engerix-B. Two hours later, the pt reported severe dizziness, injection site pain, nausea and chills. She was brought to the clinic where her blood sugar was found to be 55mg/dl at 08:00 and 51mg/dl at 10:00. She was treated with Benadryl and 5% dextrose and 1/2 normal saline. The pt did eat prior to receiving her 2nd dose of Engerix-B. The pt was now sleeping. As of 7/13/01, the adverse events were resolving.

VAERS ID:180421 (history)  Vaccinated:2001-07-13
Age:40.0  Onset:2001-07-13, Days after vaccination: 0
Gender:Female  Submitted:2001-11-21, Days after onset: 131
Location:North Carolina  Entered:2002-01-24, Days after submission: 64
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: Medical history, concurrent conditions, and concurrent medications were not specified. The pt had no illness at the time of immunization.
Diagnostic Lab Data:
CDC Split Type: 20010180111
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM52345A42IMLA
Administered by: Private     Purchased by: Other
Symptoms: Back pain, Headache, Hypoaesthesia, Injection site pain, Injection site swelling, Injection site warmth, Neck pain, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad)
Write-up: Report 2001018011-1 describes pain at the injection site in a pt who rec''d hepatitis B vaccine (Engerix-B). Medical history, concurrent conditions, and concurrent medications were not specified. The pt had no illness at time of immunization. On 11/1/99, 02/02/01 (R deltoid), and 7/13/01 (IM, L deltoid) , the pt rec''d her first, second, and third 20mcq dose of Engerix-B, respectively. Within hrs after receiving her third injection of Engerix-B, the pt experienced pain at the injection site, and numbness and tingling of her left ring and fifth fingers. These events persisted on 7/16/01, and she reported them to her manager. At that time, she also complained of swelling and warmth at the injection site, headaches, and pain in her neck and back. The pt was sent to the ER for evaluation on 7/20/01. The ER physician prescribed a rapidly-tapering course of methylprednisolone (Medro DosePak). On 8/2/01, the injection site warmth had resolved. The pt continued to complain of cramping in the fingers and neck pain. She was referred to an orthopedic surgeon. The most recent information was rec''d on11/8/01. The pt was under care of 2 physicians. She was initially treated with dexropropoxphene acetaminophen (Darvocet N) and an unspecified muscle relaxant. The pain persisted, and she was treated with gabapentin (Neurontin) the dosage was initially 100mg daily and was increased to the current dosage of 400 mg 3 times daily. The pt does not feel she is improving and states she has pain all the time at the injection site. The pain radiated underneath the mid arm and on down to the little and ring finger. The outcome of the other events were not specified. The pt was cleared for light duty, but could not lift anything heavier than 5 pounds. As a result, she worked part-time and her job duties were changed. Because it resulted in job restrictions, the pain at the injection site is considered to be incapacitating. Therefore, this report has been reclassified as serious.

VAERS ID:183911 (history)  Vaccinated:2001-07-13
Age:30.0  Onset:2002-04-04, Days after vaccination: 265
Gender:Female  Submitted:2002-04-22, Days after onset: 17
Location:Missouri  Entered:2002-04-26, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Blood and CSF-positive for Neisseria Meninitidis Serogroup C
CDC Split Type: U200200295
Vaccination
Manufacturer
Lot
Dose
Route
Site
MEN: MENINGOCOCCAL (MENOMUNE)AVENTIS PASTEUR    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Laboratory test abnormal, Meningitis
SMQs:, Noninfectious meningitis (narrow)
Write-up: It was reported that a 30 year old female pt received a Menomune vaccination on 07/13/2001. On 04/04/2002 the pt developed an onset of Meningitis symptoms. From telephone correspondence received at manufacturer on 4/29/02, the lot numbers are either UB0091AA [a yellow fever diluent as per regulatory affairs] or UB0095AA. They received Menomune, MMR, Tet booster, IPV, YF and Hepatitis. All three cases are considered recovered.

VAERS ID:188335 (history)  Vaccinated:2001-07-13
Age:36.0  Onset:2001-07-13, Days after vaccination: 0
Gender:Female  Submitted:2002-07-30, Days after onset: 382
Location:Unknown  Entered:2002-08-02, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: Temperature Measurement - 07/13/01- 103.5 F
CDC Split Type: WAES01071696
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.    
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad)
Write-up: Information has been received from a physician concerning a 36 year old female who on07/13/01 was vaccinated with pneumococcal vaccine 23 polyvalent. On 07/13/01, in the evening, the patient experienced body aches, fatigue and a fever of 103.5. Unspecified medical attention was sought. Additional information has been requested.

VAERS ID:188485 (history)  Vaccinated:2001-07-13
Age:2.1  Onset:2001-07-14, Days after vaccination: 1
Gender:Male  Submitted:2002-08-01, Days after onset: 383
Location:California  Entered:2002-08-06, 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: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.1764K IMLL
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES480895 IMRL
Administered by: Private     Purchased by: Private
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: 106F fever post Prevnar; 104F in clinic; 106F at home.

VAERS ID:190365 (history)  Vaccinated:2001-07-13
Age:1.1  Onset:2001-07-14, Days after vaccination: 1
Gender:Female  Submitted:2001-10-31, Days after onset: 109
Location:Washington  Entered:2002-09-19, Days after submission: 322
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: Downs syndrome
Diagnostic Lab Data: None
CDC Split Type: WA011786
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (IPOL)AVENTIS PASTEURT08162SCLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1181K0IMLL
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES4797910IMRL
Administered by: Private     Purchased by: Public
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Seen at ER on 7/15/01 with complaints of rash on abdomen, chest, carms. Received IPV, MMR, Prevnar on 7/13/01. No other significant symptoms. Received Benadryl and Prelone in ER with marked relief of symptoms. Did not report to PCP until 15 months well baby exam. Follow up: notes exist in chart; reporter no longer with practice. Prescription not known. Site reaction not known.

VAERS ID:192830 (history)  Vaccinated:2001-07-13
Age:  Onset:2001-07-14, Days after vaccination: 1
Gender:Female  Submitted:2001-11-17, Days after onset: 126
Location:New Jersey  Entered:2002-11-07, Days after submission: 355
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: U200100891
Vaccination
Manufacturer
Lot
Dose
Route
Site
YF: YELLOW FEVER (YF-VAX)AVENTIS PASTEURUA228AA  RA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: From telephone contact with reporting physician it was stated that an adult female patient received a YF-Vax vaccination on 7/13/01. Reportedly on 7/14/01 the patient developed a local reaction of redness, swelling and hardness. Patient was treated with Benadryl and the symptoms resolved. From additional correspondence received on 9/27/01, it was reported that the Benadryl treatment made the symptoms resolve temporarily. Four days later due to persistent swelling the patient was treated with Dicloxacillin with complete resolution of symptoms. This case is closed.

VAERS ID:233717 (history)  Vaccinated:2001-07-13
Age:53.0  Onset:2001-07-31, Days after vaccination: 18
Gender:Female  Submitted:2002-03-15, Days after onset: 227
Location:Michigan  Entered:2005-02-11, Days after submission: 1064
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid, Paxil, Allegra, Testerace
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type: BIT010034
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV048B10SCLA
Administered by: Other     Purchased by: Private
Symptoms: Fatigue, Headache, Injection site erythema, Injection site swelling, Neck pain, Pruritus
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (broad)
Write-up: A 53 year old female with no previous medical conditions, received the 11th dose of Anthrax vaccine on 07/13/2001. No other vaccines were given on this date. Concomitant medications at the time of the event included Synthroid, Paxil, Allegra and Testeraca. The patient did not have any illness at the time of the vaccination and had no history of reactions to previous vaccinations. Two hours post vaccination, the patient experienced headache and fatigue that persisted for 4 days and left sided neck pain that lasted 24 hours. The patient also experienced redness, itching, and swelling at the injection site that measured at a maximum 2x1-5/8 in diameter. The headaches were treated with Tylenol and Ibuprofen, but they did not change in intensity. The neck pain resolved on 07/14/2001 and the headache and fatigue resolved 07/16/2001. The redness, itching, and swelling at the injection site resolved on 07/17/2001.

VAERS ID:292971 (history)  Vaccinated:2001-07-13
Age:54.0  Onset:2007-07-25, Days after vaccination: 2203
Gender:Female  Submitted:2007-10-14, Days after onset: 81
Location:New Hampshire  Entered:2007-10-14
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: prinivil, lopressor, norvasc, ambien (had missed for 2 days), flexeril, effexor, lipitor, denavir, prevacid, glucosamine, coral calcium
Current Illness: None
Preexisting Conditions: HTN, L frontal spontaneous intracerebral hemorrhage 6/05, hyperlipidemia, herpes labalis. Hx L frontal lobe spontaneous intracerebral hemorrhage 6/2005. Hx HTN. Hx hyperlipidemia. Hx of tobacco abuse.
Diagnostic Lab Data: negative CT head for acute changes, normal electrolytes, normal cardiac exam, no episodes while hospitalized, MRI 7/26/07- L frontal previous hemorrhage w/ residual blood products, minimal encephalomalacia, old R cerebellar infarct w/ encep
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2769AA0IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood electrolytes normal, Cardiac enzymes normal, Cardiac function test normal, Cerebellar infarction, Computerised tomogram normal, Confusional state, Convulsion, Depressed level of consciousness, Electroencephalogram abnormal, Encephalomalacia, Full blood count, International normalised ratio, Loss of consciousness, Mental status changes, Nuclear magnetic resonance imaging abnormal, Postictal state, Prothrombin time normal, Ultrasound Doppler
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), Ischaemic cerebrovascular conditions (narrow), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: On 7/25 pt had an episode of loss of conciousness, reported seizure activity (by 8 yo witness). Pt did have a very prolonged recovery phase- consistent with a post ictal period. Pt evaluated in the ER 7/25, admitted to the hospital for observation. 10/18/2007 MR received for DOS 7/25-26/2007 for D/C DX of Confusion. Hx L frontal lobe spontaneous intracerebral hemorrhage 6/2005. Hx HTN. Hx hyperlipidemia. Hx of tobacco abuse. Pt was found by husband lying on the floor. Eyes were open however pt was not responding in verbally meaningful way. Pt was confused but was reovering upon arrival to ER. Pt has no recollection of event. Admitted for eval of mental status change.

VAERS ID:175197 (history)  Vaccinated:2001-07-13
Age:43.0  Onset:2001-07-17, Days after vaccination: 4
Gender:Female  Submitted:2001-09-04, Days after onset: 49
Location:Foreign  Entered:2001-09-10, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Hysterectomy in 1995
Diagnostic Lab Data: MRI-no abnormalities; LP and various blood tests revealed no infection
CDC Split Type: 20010181491
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM  IMRA
Administered by: 0     Purchased by: 0
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Myelitis, Nervous system disorder
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow)
Write-up: On 7/13/01, the pt received a dose of Engerix-B on her right upper arm. Five days later, on 7/17/01, the pt developed numbness down her left side which included the left side of her face, left arm and leg and across the back. Guillain-Barre was suspected but the pt had not suffered any infection or virus. The pt was dx''d as having inflammation of the brain and myelitis. The pt was hospitalized and referred to a neurologist. The initial reporter stated that the pt was still able to walk. The most recent information received on 8/24/01, reports that the numbness in the face and arm resolved by 7/24/01, 8 days after onset. Numbness across the back resolved by 8/8/01, 23 days after onset and there is still some numbness ongoing in the leg. The reporter noted that the pt had been advised not to have Engerix-B again without consultation with a neurologist.

VAERS ID:175293 (history)  Vaccinated:2001-07-13
Age:  Onset:2001-08-06, Days after vaccination: 24
Gender:Male  Submitted:2001-09-10, Days after onset: 35
Location:Foreign  Entered:2001-09-14, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: History of previous miscarriage.
Diagnostic Lab Data:
CDC Split Type: 20010186401
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER    
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (narrow)
Write-up: This patient had a previous miscarriage. On 07/13/01, the vaccinee received a dose of Hepatyrix vaccine. The vaccinee later found out that she was pregnant at the time of vaccination. Estimated date of delivery 04/02. The most recent info received on 08/29/01 reports that the vaccinee underwent a scan on 08/06/01, which confirmed she had a miscarriage. The vaccinee''s doctor considered the event to be a spontaneous abortion and it is unlikely the vaccine is implicated.

VAERS ID:177191 (history)  Vaccinated:2001-07-13
Age:2.0  Onset:2001-07-21, Days after vaccination: 8
Gender:Male  Submitted:2001-10-29, Days after onset: 100
Location:Foreign  Entered:2001-11-06, Days after submission: 8
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: 7/21/01 were 6,000/MM3 (thrombopenia) and thereafter were 355,000/MM3
CDC Split Type: 20010251381
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAM(A) IM 
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER(C) IM 
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER(B) IM 
Administered by: Other     Purchased by: Other
Symptoms: Haematoma, Thrombocytopenia, Thrombocytopenic purpura
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad)
Write-up: On 7/21/01, 8 days post vax, the pt developed diffuse hematoma (except shock areas) with purpura predominant on lower limbs. No bleeding was observed. Dx of idiopathic thrombopenic purpura was made. The pt was treated with an unspecified corticoid drug at a dose of 2mg/kg/day for 5 days. This case was considered to be life threatening. The most recent information received on 10/24/01, reports the outcome of the pt as recovered without sequelae. Causality assessment was reported as dubious for Infanrix-Polio-Hib.

VAERS ID:173542 (history)  Vaccinated:2001-07-14
Age:4.0  Onset:2001-07-14, Days after vaccination: 0
Gender:Male  Submitted:2001-07-17, Days after onset: 3
Location:Arizona  Entered:2001-07-24, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)CONNAUGHT LABORATORIESU0532AA3IMLA
HEP: HEP B (FOREIGN)MERCK & CO. INC.0475L1IMRA
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T08164 LA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0149L1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Oedema, Pain, Pyrexia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: On 07/14/2001 the patient developed erythema. The patient awoke on 07/15/2001 with edema and severe pain in the right upper arm and shoulder. The patient was seen in the ER and treated with Ceclor. The patient had a low grade fever 07/15/2001 through 07/17/2001.

VAERS ID:173547 (history)  Vaccinated:2001-07-15
Age:86.0  Onset:2001-07-15, Days after vaccination: 0
Gender:Female  Submitted:2001-07-17, Days after onset: 2
Location:California  Entered:2001-07-24, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zestril, Coumadin, Niaspan, Verelan, Leseol
Current Illness: NONE
Preexisting Conditions: Hypertension, High Cholesterol, Hypertriglycierides, Atrial Fibrillation
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1067K0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Post-vax the patient experienced localized erythema and tenderson.

VAERS ID:175168 (history)  Vaccinated:2001-07-15
Age:23.0  Onset:2001-07-28, Days after vaccination: 13
Gender:Male  Submitted:0000-00-00
Location:Mississippi  Entered:2001-09-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: CBC-WNL; RPR-Pending
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1381K1SCRA
Administered by: Other     Purchased by: Public
Symptoms: Lymphadenopathy, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: 10 days, post vax, pt had a rash and right anterior cervical adenopathy.

VAERS ID:177931 (history)  Vaccinated:2001-07-15
Age:2.0  Onset:0000-00-00
Gender:Female  Submitted:2001-11-02
Location:North Carolina  Entered:2001-11-19, 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: NONE
Current Illness: NONE
Preexisting Conditions: Allergic to Amoxicillin.
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Private     Purchased by: Public
Symptoms: Erythema
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Right thigh red, warm to touch. Three inches diameter area. Atarax Rx

VAERS ID:239425 (history)  Vaccinated:2001-07-15
Age:42.0  Onset:2001-07-15, Days after vaccination: 0
Gender:Male  Submitted:2005-05-27, Days after onset: 1412
Location:New Mexico  Entered:2005-06-03, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: serum measles IgG 01/21/02 3.42 serum mumps IgG antibody 01/21/04 1.69 serum rubella IgG 04/07/04 negative serum rubella IgG 01/21/04 not immune serum rubella IgG 07/12/04 rubella status immune
CDC Split Type: WAES0405USA00147
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.    
Administered by: Private     Purchased by: Private
Symptoms: Unevaluable event
SMQs:
Write-up: Information has been received from a physician concerning a 41 year old male who on 15-Juo-2001 was vaccinated with a dose of measles virus vaccine live (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot number unknown). Laboratory evaluations on 21-Jan-2004 reveled that rubella IgG was negative, mumps IgG was 1.69 (positive) and rubeola IgG was 3.42 (positive). On 26-Mar-2004, the patient was vaccinated with a dose of measles virus vaccine live (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) )Lot number 642230/0181M). On 07-Arp-2004, laboratory evalutations revealed rubella IgG was negative. On 16-Apr-2004, the patient was vaccinated subcutaneously in the left arm with another dose of measles virus vaccine live (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot number 642641/0346M). Vaccination history included hepatitis A virus vaccine on 22-Jun-1997 and 19-Oct-2001, hepatitis B virus vaccine on 07-Aug-1998, and 23-Jul-2001, typhoid USP on 03-Oct-2003, Anthrax vaccine on 01-Jan-1991, 09-Nov-2002, and 03-Oct-2003, tuberculin purified protein derivative (PPD) on 02-Oct-2003, influenza virus vaccine 02-Oct-2003, and meningococcal virus vaccine on 29-Mar-2002. Additional information received from the physician indicated that on 12-Jul-2004, laboratory evaluations revealed rubella IgG status was immune No additional information is expected.

VAERS ID:173496 (history)  Vaccinated:2001-07-16
Age:0.3  Onset:2001-07-17, Days after vaccination: 1
Gender:Male  Submitted:2001-07-17, Days after onset: 0
Location:New York  Entered:2001-07-23, 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
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T06970IM 
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES4809010IM 
Administered by: Private     Purchased by: Private
Symptoms: Injection site pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: The patient developed a rectal fever of 100.8F with mild soreness at the injection site. The patient was treated with Tylenol or Motrin.

VAERS ID:173946 (history)  Vaccinated:2001-07-16
Age:65.0  Onset:2001-07-17, Days after vaccination: 1
Gender:Male  Submitted:2002-02-21, Days after onset: 219
Location:Unknown  Entered:2001-08-07, Days after submission: 198
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Atrial fibrillation; Alzheimer''s Disease; Cardiac disorder
Diagnostic Lab Data:
CDC Split Type: WAES01071828
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1187K IMRA
Administered by: Other     Purchased by: Other
Symptoms: Bradycardia, Cellulitis, Coma, Fall, Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from an RN concerning a 90 year-old male assisted living pt with Alzheimer''d disease, cardiac problems and no known allergies and a history of atrial fibrillation and dementia who on 7/16/01 was vaccinated IM on the right deltoid with a 0.5 ml dose of pneumococcal vaccine 23 polyvalent. On 7/17/01, the pt was found unresponsive and bradycardic on the bathroom floor at the assisted living facility. The pt was transferred to the ER. In the ER, it was noted that the pt''s right arm was red, swollen and warm to touch. The pt was treated for cellulitis with IV amoxicillin trihydrate (+) clavulanate potassium (Augmentin). He was admitted to the hospital for his cardiac condition and was discharged from the hospital on 7/23/01 to a nursing home facility. The nurse reported that the pt''s unresponsiveness was not related to the pneumococcal vaccine 23 polyvalent, it was related to his cardiac problems. The pt was discharged on PO amoxicillin trihydrate (+) clavulanate potassium (Augmentin) and it was noted that his arm swelling had greatly improved. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. It was reported that another pt (WAES 01072423) had a similar experience following exposure to pneumococcal vaccine 23 polyvalent (lot 637369/1187K). FOLLOW-UP information indicated that the pt was hospitalized for five days and subsequently, recovered. Upon internal medical review, the pt''s cellulitis was considered to be another important medical event. Additional information has been requested.

VAERS ID:173948 (history)  Vaccinated:2001-07-16
Age:65.0  Onset:2001-07-18, Days after vaccination: 2
Gender:Female  Submitted:2001-08-02, Days after onset: 15
Location:Unknown  Entered:2001-08-07, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data:
CDC Split Type: WAES01072423
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1187K IM 
Administered by: Other     Purchased by: Other
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a health professional concerning a female assisted living pt over the age of 65 who on 7/16/01 was vaccinated, IM, with a 0.5 ml dose of pneumococcal vaccine 23 polyvalent (lot 637369/1187K). On 7/18/01, the pt was taken to the ER for cellulitis with symptoms of swelling, redness and a warm to touch arm from the site of the injection down to her fingers. She was treated with IV ceftriaxone sodium (Rocephin) and was released back to the assisted living facility, hospital admission was not needed. It was reported that the pt has subsequently recovered. The reporter expressed a concern with the lot. It was reported that another pt (WAES 0107128) had a similar experience following exposure to pneumococcal vaccine 23 polyvalent (lot 637369/1187K). Upon internal medical review, the pt''s cellulitis was considered to be an "Other Important Medical Event". Additional information has been requested.

VAERS ID:173966 (history)  Vaccinated:2001-07-16
Age:1.1  Onset:2001-07-25, Days after vaccination: 9
Gender:Female  Submitted:2001-08-02, Days after onset: 8
Location:Alabama  Entered:2001-08-07, 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: PPD
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T05621 LL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0162K1SCRL
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES4749561IMLL
Administered by: Public     Purchased by: Public
Symptoms: Rash morbilliform
SMQs:, Hypersensitivity (narrow)
Write-up: The patient developed a morbilliform rash.

VAERS ID:174365 (history)  Vaccinated:2001-07-16
Age:1.3  Onset:2001-07-16, Days after vaccination: 0
Gender:Female  Submitted:2001-07-19, Days after onset: 3
Location:Arizona  Entered:2001-08-15, Days after submission: 27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)CONNAUGHT LABORATORIESU0514AA3IM 
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES4792340IM 
Administered by: Public     Purchased by: Public
Symptoms: Cellulitis, Injection site induration, Injection site reaction, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Pt developed bilateral thigh cellulitis, right more than left. Temperature of 100.6F. The right thigh was 7cm X 3cm and left thigh was 2 1/2cm X 1 1/2cm area under cellulitis with firmness, not fluctuant. No TTP.

VAERS ID:174386 (history)  Vaccinated:2001-07-16
Age:1.3  Onset:0000-00-00
Gender:Male  Submitted:2001-08-15
Location:California  Entered:2001-08-16, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: Recurring ear infections; spontaneously draining ear; otitis media NOS; cellulitis; cough; Grommet insertion; rhinitis
Diagnostic Lab Data: Blood culture X 2-(+) Streptococcus pneumonia; bone scan-neg; CSF-neg; CXR-neg; X-ray distal femur-(+); Ultrasounds of his hip and knee-neg; CBC-WBC-32,000 (H) with neutrophil-36% and a "lymphocytic predominance" of 56%; hemoglobin-32.8 (H)
CDC Split Type: HQ4354908AUG2001
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPH: DTAP + HIB (TRIHIBIT)AVENTIS PASTEURU03532C3IMRL
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM5204A23IMLA
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES4809013IMRL
Administered by: Other     Purchased by: Other
Symptoms: Bacterial infection, Blood disorder, Difficulty in walking, Feeling hot, Hypokinesia, Immune system disorder, Irritability, Laboratory test abnormal, Osteomyelitis, Pain, Platelet count increased, Pyrexia, White blood cell count increased
SMQs:, Haematopoietic cytopenias affecting more than one type of blood cell (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Osteonecrosis (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Following vax, the pt developed pneumococcal bacteremia osteomyelitis. This event is considered "medically important". Additional info recvd 8/12/01 indicated blood culture, bone scan and x-ray of the distal femur were performed. The pt was being treated with an unspecified IV antibiotic. The reporter suspected an "underlying immunocompromise." F/U information states that the pt had a medical history of recurrent ear infections and a spontaneously draining ear. The pt developed pneumococcal osteomyelitis following receipt of the 4th dose of Prevnar. Blood culture was positive; the bone scan was negative "on day 4". The X-ray of the pt''s distal femur "on day 12" was positive. The pt was being treated with an unspecified IV antibiotic. F/U info received on 9/27/01, indicated that the pt received his 4th doses of Prevnar and TriHibit, as well as his 3rd dose of Engerix-B on 7/26/01. The pt had a medical history of multiple infections including recurrent otitis media (PE tubes inserted), cellulitis of his fingers and a neck infection. Two weeks prior to admission, he developed a cough and runny nose. On 7/22/01, the pt''s mother noticed that her son was tip-toeing on his right foot. He then refused to walk and mostly crawled. He was irritable and had developed an intermittent low-grade fever which ranged to 100.1F. The pt was seen by the pediatrician; X-rays of his extremities were performed and were normal. On 7/25/01, he was seen again by his pediatrician and was noted to bear more weight on his right leg. His activity level had increased. On 7/27/01, the pt''s activity level had decreased and he was admitted to the hospital on 7/28/01. He was seen by an infectious disease physician on 7/29/01. Physical exam revealed "positive" PE tubes. His extremities were difficult to examine because the pt cried when moved. He refused to walk. When he attempted to ambulate, his right leg was externally rotated. Ultrasounds of his hip and knee were performed and were negative. While hospitalized, the pt experienced 1 episode of fe

VAERS ID:174389 (history)  Vaccinated:2001-07-16
Age:1.0  Onset:2001-07-24, Days after vaccination: 8
Gender:Female  Submitted:2001-07-26, Days after onset: 2
Location:North Carolina  Entered:2001-08-16, Days after submission: 21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Fluoride drops
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: UA and CBC-both WNL
CDC Split Type: NC01071
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (HIBTITER)LEDERLE PRAXSIS4773933IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1510K0SCLL
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES4792343IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0225L0SCRL
Administered by: Private     Purchased by: Public
Symptoms: Pyrexia, Rash papular
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: On 7/24/01, pt developed a fever of 104.1F. Had a fever between 102.9F and 104F for 2 days. Also had scattered papular rash on trunk on 7/26/01.

VAERS ID:174642 (history)  Vaccinated:2001-07-16
Age:1.0  Onset:2001-07-26, Days after vaccination: 10
Gender:Male  Submitted:2001-07-30, Days after onset: 4
Location:Texas  Entered:2001-08-24, Days after submission: 25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PPD/Aventis/C0579AA/LFA/0 previously
Current Illness: NONE
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: TX01105
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (HIBTITER)LEDERLE PRAXSIS622363A3IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1273K0SCLA
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES4797952IMRL
Administered by: Private     Purchased by: Public
Symptoms: Rash maculo-papular, Rash vesicular
SMQs:, Hypersensitivity (narrow)
Write-up: Pt developed some vesicles and maculopapular rash of torso.

VAERS ID:176547 (history)  Vaccinated:2001-07-16
Age:42.0  Onset:2001-07-19, Days after vaccination: 3
Gender:Female  Submitted:2001-10-02, Days after onset: 75
Location:Michigan  Entered:2001-10-22, Days after submission: 20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type: MI2001079
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)CONNAUGHT LABORATORIESU0375AA IMLA
Administered by: Public     Purchased by: Public
Symptoms: Joint range of motion decreased, Pain
SMQs:, Arthritis (broad)
Write-up: Post vax on 07/19/2001 the patient experienced pain in her left arm. By 07/20/2001 the patient was unable to lift her arm above should level. There is no local redness or swelling. The patient has been seen by a chiropractor 6-7 times since August. The patient is being treated with exercises and heat. The patient feels the arm is worsening.

VAERS ID:197225 (history)  Vaccinated:2001-07-16
Age:67.0  Onset:2001-07-19, Days after vaccination: 3
Gender:Female  Submitted:2001-07-24, Days after onset: 5
Location:New Jersey  Entered:2003-02-04, Days after submission: 560
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: Past medical history of spinal condition.
Diagnostic Lab Data:
CDC Split Type: U200100894
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)AVENTIS PASTEURU0301AA   
Administered by: Unknown     Purchased by: Unknown
Symptoms: Myopathy
SMQs:, Rhabdomyolysis/myopathy (narrow)
Write-up: From phone contact with reporting MD, it was stated that a 67 y.o. female PT received a TD adult vaccination on 7/16/01. Reportedly on 7/19/01, the PT complained of non-specific symptoms in her left leg. All she relayed to the physician was it didn''t feel right and wasn''t working the way she wanted. PT was doing housework at the time. No neurological or vascular deficits on exam. Asymptomatic 7/20/01. PT has past medical history of spinal condition. Physician feels it is related to that condition. Prescribed Ibuprofen 400mg 4 times a day.

VAERS ID:256647 (history)  Vaccinated:2001-07-16
Age:1.1  Onset:2001-09-19, Days after vaccination: 65
Gender:Male  Submitted:2006-05-12, Days after onset: 1696
Location:Hawaii  Entered:2006-05-17, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0509USA02789
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.    
Administered by: Other     Purchased by: Other
Symptoms: Drug ineffective, Viral infection
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Information has been received from a registered nurse (RN) concerning a 15-month-old male who on 16-JUL-2001 was vaccinated with a dose of varicella virus vaccine live. On 19-SEP-2001 the patient experienced breakthrough varicella. The patient had less than 50 lesions and no treatment was necessary, though unspecified medical attention had been sought. The patient''s present status was unknown at the time of reporting. No product quality complaint was involved. Additional information has been requested.

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