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Found 500157 cases in entire database

Case Details (Sorted by Vaccination Date)

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VAERS ID:169755 (history)  Vaccinated:2001-05-05
Age:3.5  Onset:2001-05-05, Days after vaccination: 0
Gender:Male  Submitted:2001-05-07, Days after onset: 2
Location:Michigan  Entered:2001-05-11, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES4777240IM 
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain, Skin discolouration
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: The pt experienced a localized reaction that 12 cm area of redness, swelling, induration, tenderness and dark skin color.

VAERS ID:169840 (history)  Vaccinated:2001-05-05
Age:20.0  Onset:2001-05-05, Days after vaccination: 0
Gender:Male  Submitted:2001-05-08, Days after onset: 3
Location:Texas  Entered:2001-05-15, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: Has had allergic reaction while camping-source unknown.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.1361K0IMRA
YF: YELLOW FEVER (YF-VAX)CONNAUGHT LABORATORIESUA433AA0SCRA
Administered by: Private     Purchased by: Private
Symptoms: Bradycardia, Dyspnoea, Hyperhidrosis, Hypotension, Malaise, Pallor, Rash
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: At 11:00, pt complained of "not feeling right", was pale, diaphoretic, (red) rash beginning to appear on chest and neck. Also, pt complained of shortness of breath. At 11:01, laid pt in prone position and administered Benadryl 50mg, IM and Epi 1:10000, 0.3ml, SQ. Given O2 via NC. Vital signs: HR 70, BP 108/58; RR 20. Pt transported to ER via EMS.

VAERS ID:169851 (history)  Vaccinated:2001-05-05
Age:5.0  Onset:2001-05-06, Days after vaccination: 1
Gender:Female  Submitted:2001-05-08, Days after onset: 2
Location:Missouri  Entered:2001-05-15, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAMA989A24IMLA
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T04843SCLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0162L1SCRA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: 2cm area of erythema at injection site for 72 hours.

VAERS ID:169944 (history)  Vaccinated:2001-05-05
Age:  Onset:2001-05-05, Days after vaccination: 0
Gender:Male  Submitted:2001-05-29, Days after onset: 24
Location:Texas  Entered:2001-05-18, Days after submission: 11
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:
Preexisting Conditions: Splenectomy. trauma.
Diagnostic Lab Data: Arterial Blood O2 05/04/01 - decreased.
CDC Split Type: WAES01050742
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC. 3IM 
Administered by: Other     Purchased by: Other
Symptoms: Hypoxia, Injury, Rash
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a pharmacist concerning a male who was hospitalized and had a splenectomy due to trauma in early April 2001. On April 07, 2001, he received the 1st dose of Pneumococcal vaccine 23 polyvalent, 2nd dose on an unspecified date before 05/04/01, the patient''s oxygen saturation levels began to decrease and he was placed on a ventilator. Additional info has been requested. After the fourth dose, the pt developed a rash on his upper body and at the same time his oxygen saturation levels began to decrease. he was transferred to the intensive care unit and was placed on a ventilator. The pharmacist felt that it was unknown if the rash was associated with the excessive number of doses of pneumococcal vaccine as an overdose an allergic reaction or if it was coincidental that it occurred after the fourth dose. On 05/17/2001, th ept remained hospitalized and it was unknown if the pt was still on the ventilator. Additional info has been requested.

VAERS ID:172884 (history)  Vaccinated:2001-05-05
Age:33.0  Onset:2001-05-06, Days after vaccination: 1
Gender:Female  Submitted:2001-06-09, Days after onset: 34
Location:Wyoming  Entered:2001-07-03, Days after submission: 24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: acid reflux
Diagnostic Lab Data: lab tests - nml
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
YF: YELLOW FEVER (YF-VAX)CONNAUGHT LABORATORIESU0330AA1SCLA
Administered by: Military     Purchased by: Military
Symptoms: Diarrhoea, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: The pt experienced extreme diarrhea for 3 weeks plus. Given a prescription to control fever of 102.

VAERS ID:174340 (history)  Vaccinated:2001-05-05
Age:41.0  Onset:2001-05-05, Days after vaccination: 0
Gender:Male  Submitted:2001-07-08, Days after onset: 64
Location:Illinois  Entered:2001-08-14, Days after submission: 37
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
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1123K1IMLA
Administered by: 0     Purchased by: 0
Symptoms: Dizziness, Hyperhidrosis, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Vestibular disorders (broad)
Write-up: Pt began to feel light-headed approx. 1 hour, post vax, with tachycardia and diaphoresis. EMS was called and tool pt to ER. Treated with Vicodin and Tagamet. No Benadryl given.

VAERS ID:180346 (history)  Vaccinated:2001-05-05
Age:32.0  Onset:2001-05-06, Days after vaccination: 1
Gender:Female  Submitted:2001-06-02, Days after onset: 27
Location:New York  Entered:2002-01-23, Days after submission: 235
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: swelling @ site
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TTOX: TETANUS TOXOID (NO BRAND NAME)CONNAUGHT LABORATORIESU0365AA1IMRA
Administered by: Military     Purchased by: Military
Symptoms: Injection site mass, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Arm swelled up, knot on right arm hot moist heat, antiflammatories

VAERS ID:169781 (history)  Vaccinated:2001-05-07
Age:47.0  Onset:2001-05-07, Days after vaccination: 0
Gender:Female  Submitted:2001-05-10, Days after onset: 3
Location:Pennsylvania  Entered:2001-05-11, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: HCTZ, Pulmicort, chromium picolinate
Current Illness: NONE
Preexisting Conditions: congenital heart defects, tetralogy of fallot
Diagnostic Lab Data: tests - pending
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1820K1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Chills, Condition aggravated, Injection site erythema, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: The pt experienced erythema, arm tingling, numbness, right leg numbness and chills. The pt also experienced uncontrolled arrhythmia.

VAERS ID:169817 (history)  Vaccinated:2001-05-07
Age:6.0  Onset:2001-05-08, Days after vaccination: 1
Gender:Female  Submitted:2001-05-09, Days after onset: 1
Location:California  Entered:2001-05-15, 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: NONE
Current Illness: NONE
Preexisting Conditions: Allergies to PCN, Sulfa, Novocain
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES4783150IMLA
Administered by: Private     Purchased by: Public
Symptoms: Injection site rash, Injection site swelling, Rash
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Swelling and rash at injection site. Treated with cool compress, Benadryl and protection from direct sun exposure.

VAERS ID:169825 (history)  Vaccinated:2001-05-07
Age:44.0  Onset:2001-05-07, Days after vaccination: 0
Gender:Female  Submitted:2001-05-08, Days after onset: 1
Location:New York  Entered:2001-05-15, 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: Erythromycin and sulfa allergies.
Diagnostic Lab Data: ER work-up-neg
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
LYME: LYME (LYMERIX)SMITHKLINE BEECHAMLY128A22IMLA
Administered by: Private     Purchased by: Private
Symptoms: Headache, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad)
Write-up: Headache, muscle aches, feverish and chills. Given epinephrine and Benadryl. ER work-up was negative.

VAERS ID:169838 (history)  Vaccinated:2001-05-07
Age:4.0  Onset:2001-05-07, Days after vaccination: 0
Gender:Female  Submitted:2001-05-07, Days after onset: 0
Location:Georgia  Entered:2001-05-15, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAM981A23IMLL
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T053223 LA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1382K1SCRA
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)MERCK & CO. INC.0300K0 RL
Administered by: Public     Purchased by: Public
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: ? hives on left lower arm. Treated with po Benadryl at 22:10. Temperature 99F, pulse 98 and respirations 20. No redness and not raised around injection site. No difficulty with respirations.

VAERS ID:169867 (history)  Vaccinated:2001-05-07
Age:51.0  Onset:2001-05-07, Days after vaccination: 0
Gender:Female  Submitted:2001-05-07, Days after onset: 0
Location:North Carolina  Entered:2001-05-15, 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: NONE
Current Illness: NONE
Preexisting Conditions: Allergic Formaldehyde.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS3375A40IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS671A40IMLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)CONNAUGHT LABORATORIESR112720IMRA
Administered by: Public     Purchased by: Unknown
Symptoms: Dizziness, Headache, Pruritus, Pyrexia, Vision blurred
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypersensitivity (broad)
Write-up: Vasomotor response, then complains of dizziness, blurred vision, pounding headache in the back of the head then moved to the front of his head, forehead area. Here 1 1/2 hours when leaving complained of itching all over. Had a fever over the weekend and a headache. Much better.

VAERS ID:169893 (history)  Vaccinated:2001-05-07
Age:1.0  Onset:2001-05-08, Days after vaccination: 1
Gender:Female  Submitted:2001-05-09, Days after onset: 1
Location:Michigan  Entered:2001-05-16, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: CBC, U/A, and CXR-all normal
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.1409K2IMLA
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES4774492IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1610K0SCLA
Administered by: Private     Purchased by: Private
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: Within 24 hours, post vax, developed fevers of 102F-105F. 30 hours, post vax, had a brief febrile seizure.

VAERS ID:169909 (history)  Vaccinated:2001-05-07
Age:5.0  Onset:2001-05-08, Days after vaccination: 1
Gender:Female  Submitted:2001-05-09, Days after onset: 1
Location:New York  Entered:2001-05-16, 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: allergy
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAM998A24IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: The pt experienced an erythematous slightly indurated area measuring 9" x 6 1/2".

VAERS ID:169912 (history)  Vaccinated:2001-05-07
Age:19.0  Onset:2001-05-07, Days after vaccination: 0
Gender:Female  Submitted:2001-05-08, Days after onset: 1
Location:Kentucky  Entered:2001-05-16, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0002L1 LA
Administered by: Public     Purchased by: 0
Symptoms: Contusion, Diarrhoea, Dizziness, Rash, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)
Write-up: After Hepatitis B # 1, this patient had vomiting and diarrhea 1 week after the injection, and it lasted 1 - 2 days. Hepatitis B # 1 done on 04/05/01. Hepatitis B # 2, had on 05/05/01, the patient had vomiting, dizziness, was light headed, rash on the left arm, and a bruise on the right leg and left arm. Her sickness started 11 - 12 hours after the injection.

VAERS ID:169917 (history)  Vaccinated:2001-05-07
Age:1.7  Onset:2001-05-09, Days after vaccination: 2
Gender:Female  Submitted:2001-05-10, Days after onset: 1
Location:New Mexico  Entered:2001-05-16, 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 (INFANRIX)SMITHKLINE BEECHAM995A23IMLA
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T048432SCRA
Administered by: Private     Purchased by: Public
Symptoms: Injection site hypersensitivity, Injection site oedema, Pruritus
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: This infant had a local reaction at the left deltoid site of DTaP # 4. She had swelling, redness, and itching that started on 05/09/01 at 1:00 PM. She was seen by a doctor on 05/09/01 at 5:00 PM. Not cellulitis. Home treatment with Benadryl PO and Ice to the site.

VAERS ID:169922 (history)  Vaccinated:2001-05-07
Age:5.5  Onset:2001-05-08, Days after vaccination: 1
Gender:Male  Submitted:2001-05-19, Days after onset: 11
Location:Pennsylvania  Entered:2001-05-16, 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: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)CONNAUGHT LABORATORIES60341BA4IMRA
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T011723IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1308K1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: This child had a temperature of 102, and a headache less than 24 hours.

VAERS ID:169928 (history)  Vaccinated:2001-05-07
Age:4.0  Onset:2001-05-08, Days after vaccination: 1
Gender:Female  Submitted:2001-05-10, Days after onset: 2
Location:New Mexico  Entered:2001-05-16, 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 (INFANRIX)SMITHKLINE BEECHAM995A24 RA
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T048434SCRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1388K1SCLA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Pruritus
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: The pt experienced a local reaction, complained of pain, swelling, redness and itching. Treated with Benadryl.

VAERS ID:169959 (history)  Vaccinated:2001-05-07
Age:1.3  Onset:2001-05-08, Days after vaccination: 1
Gender:Male  Submitted:2001-05-09, Days after onset: 1
Location:Minnesota  Entered:2001-05-17, 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: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAM992A2 IMLL
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.1041K IMRL
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T0559 SCRL
Administered by: Private     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: Would be considered "side effect" and not significant adverse event. Child received DTAP vaccine in left upper thigh. Within 18 hours, developed 6cm X 8cm area of redness/swelling. Was seen 36 hours, post vax, and noted to have local reaction, no cellulitis or "urticarial" type reaction. No other sequela noted.

VAERS ID:169983 (history)  Vaccinated:2001-05-07
Age:1.8  Onset:2001-05-09, Days after vaccination: 2
Gender:Male  Submitted:2001-05-10, Days after onset: 1
Location:Georgia  Entered:2001-05-17, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAM994A23IMLL
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.1523K2IMLL
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T05612SCRA
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES4720471IMRL
Administered by: Private     Purchased by: Private
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt experienced swelling, redness, warmth and hardening of the thigh; cellulitis. Put on omnicef. Pt treated with antibiotic therapy.

VAERS ID:170008 (history)  Vaccinated:2001-05-07
Age:5.0  Onset:2001-05-11, Days after vaccination: 4
Gender:Female  Submitted:2001-05-14, Days after onset: 3
Location:Ohio  Entered:2001-05-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAM984A24IMLA
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T06243SCLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0020L1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Hypokinesia, Injection site erythema, Injection site oedema, Injection site pain
SMQs:, Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: This child had swelling and tenderness in her left arm it hurts to lift her arm, very painful redness. The patient instructed to take Tylenol and use warm compresses 15-20 minutes every 2 - 3 hours. Call if not better.

VAERS ID:170041 (history)  Vaccinated:2001-05-07
Age:4.0  Onset:2001-05-09, Days after vaccination: 2
Gender:Male  Submitted:0000-00-00
Location:Illinois  Entered:2001-05-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)CONNAUGHT LABORATORIESU0357AA4IMLL
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T05620SCRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0051L1SCRL
Administered by: Private     Purchased by: 0
Symptoms: Injection site erythema, Injection site oedema
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: The pt experienced right thigh swelling of entire anterior thigh. with redness.

VAERS ID:170046 (history)  Vaccinated:2001-05-07
Age:4.0  Onset:2001-05-07, Days after vaccination: 0
Gender:Male  Submitted:0000-00-00
Location:California  Entered:2001-05-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Claritin, Benadryl, Motrin, Patanol
Current Illness: NONE
Preexisting Conditions:
Diagnostic Lab Data: No relevant lab data at this time.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0352J0IMLL
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)CONNAUGHT LABORATORIESR117050IMRL
Administered by: Private     Purchased by: Private
Symptoms: Face oedema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: About 1 hour, post vax, Typhoid and Hep-A, pt had edema of face with dramatic improvement after starting Benadryl po every 6 hours per MD. Asymptomatic by 5/10/01 at 09:00. Patanol opth. drops ordered, 1 drop in each eye, every 12 hours X 1-2 weeks; Epi Pen Jr Rx given to use, prn.

VAERS ID:170057 (history)  Vaccinated:2001-05-07
Age:11.0  Onset:2001-05-07, Days after vaccination: 0
Gender:Female  Submitted:2001-05-08, Days after onset: 1
Location:California  Entered:2001-05-21, Days after submission: 13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
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.1861K0IMLA
HEPA: HEP A (VAQTA)MERCK & CO. INC.1407K0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: The pt felt dizzy, faint, was pale. After 15 minutes the pt felt better. Also drank water.

VAERS ID:170155 (history)  Vaccinated:2001-05-07
Age:3.0  Onset:2001-05-12, Days after vaccination: 5
Gender:Male  Submitted:2001-05-16, Days after onset: 4
Location:California  Entered:2001-05-23, 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: NONE
Current Illness: Neck lump
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.1358K0IMLA
HIBV: HIB (ACTHIB)CONNAUGHT LABORATORIESUA564AA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1895K0SCRA
Administered by: Public     Purchased by: Public
Symptoms: Infection
SMQs:
Write-up: Pt was vaccinated with varicella on 5/7/01. On 5/12/01, per mom, pt has skin lesion on face and left hand and finger. Questionable skin lesion. Looks like chickenpox reaction. Lesions appear healing. No other symptoms. Denied fever. No meds given.

VAERS ID:170166 (history)  Vaccinated:2001-05-07
Age:1.3  Onset:2001-05-08, Days after vaccination: 1
Gender:Male  Submitted:2001-05-11, Days after onset: 3
Location:California  Entered:2001-05-23, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAM998A02IMLL
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.1526K2IMRL
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T02832 RL
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site mass
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Prevnar administered on 5/7/01 in left thigh. Injection site with small knot and slight redness of skin over site.

VAERS ID:170273 (history)  Vaccinated:2001-05-07
Age:21.0  Onset:2001-05-10, Days after vaccination: 3
Gender:Female  Submitted:2001-05-14, Days after onset: 4
Location:Texas  Entered:2001-05-24, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cold/URI
Preexisting Conditions: Allergic rhinitis; asthma; mental retardation
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNU-IMUNE)LEDERLE LABORATORIES4691320IMRA
Administered by: Private     Purchased by: 0
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Red, swollen, warm and tender mass, 8cm raised by 1cm on lateral right arm by 3rd day, post vax.

VAERS ID:170279 (history)  Vaccinated:2001-05-07
Age:1.3  Onset:2001-05-08, Days after vaccination: 1
Gender:Male  Submitted:2001-05-16, Days after onset: 8
Location:Rhode Island  Entered:2001-05-24, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)AVENTIS PASTEURU0357AA3IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1280K0SCRA
Administered by: Private     Purchased by: Public
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Fever 11 days, post vax.

VAERS ID:170282 (history)  Vaccinated:2001-05-07
Age:5.0  Onset:2001-05-08, Days after vaccination: 1
Gender:Female  Submitted:2001-05-09, Days after onset: 1
Location:Colorado  Entered:2001-05-24, Days after submission: 15
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: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAM995A24IMLL
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T06243SCRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0025L1SCLL
Administered by: Private     Purchased by: Private
Symptoms: Feeling hot, Injection site erythema, Pruritus, Rash macular
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Erythematous, macular rash, itchy and warm. Tx: Augmentin and Benadryl.

VAERS ID:170301 (history)  Vaccinated:2001-05-07
Age:39.0  Onset:2001-05-07, Days after vaccination: 0
Gender:Female  Submitted:2001-05-11, Days after onset: 4
Location:Minnesota  Entered:2001-05-25, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Ventolin, Aeroloid, Serevent, Colace, Allegra, Beconase, Minocin
Current Illness: Mild URI symptoms, cough, congestion, stomachache
Preexisting Conditions: Asthma
Diagnostic Lab Data: WBC; Sed rate; C-reactive protein; CXR
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNU-IMUNE)LEDERLE LABORATORIES4743660IMLA
Administered by: Private     Purchased by: Private
Symptoms: Chills, Cough, Headache, Injection site pain, Pain, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Pt received Pneumococcal 23 in AM of 5/7/01 and that evening, she developed shaking-chills, body aches, headache and discomfort at injection site. On 5/8/01, she was seen and evaluated by NP who ordered CXR for her cough and this was negative. She was started on Biaxin XL 500mg, 2 tabs together for 7 days. She was cautioned to return to office if symptoms exacerbate and redness increases over 1 cm, over the next 48 hours. She returned to office on 5/9/01 and was seen by physician who ordered labs, started her on Dicloxacillin and ordered injection of Rocephin. She was to monitor symptoms and report to ER if the symptoms got worse or higher temperatures. We telephoned her each day, to monitor her progress. Addendum: On 5/14/01, she returns to office with her daughter and her arm looks much better, only small area of hardness at injection site.

VAERS ID:170368 (history)  Vaccinated:2001-05-07
Age:0.2  Onset:2001-05-07, Days after vaccination: 0
Gender:Female  Submitted:2001-05-17, Days after onset: 10
Location:California  Entered:2001-05-30, Days after submission: 13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAM991A20IMLL
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.1761K0IMRL
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T05330SCRL
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES4749530IMLL
Administered by: Private     Purchased by: Public
Symptoms: Screaming
SMQs:, Hostility/aggression (broad)
Write-up: Inconsolable crying for 3 1/2 hours, non-stop.

VAERS ID:170373 (history)  Vaccinated:2001-05-07
Age:2.0  Onset:2001-05-12, Days after vaccination: 5
Gender:Male  Submitted:2001-05-17, Days after onset: 5
Location:Virginia  Entered:2001-05-30, Days after submission: 13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAM 2IM 
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER 2  
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 0SC 
Administered by: Public     Purchased by: Public
Symptoms: Abscess, Cough, Lacrimation increased, Pyrexia, Rash, Rhinorrhoea
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Lacrimal disorders (narrow), Hypersensitivity (narrow)
Write-up: On 5/12/01, low-grade fever, runny eyes, coughing and runny nose. On 5/14/01, placed on antibiotic for "pus pocket" throat. On 5/16/01, rash and antibiotic stopped. On 5/18/01, clear.

VAERS ID:170447 (history)  Vaccinated:2001-05-07
Age:1.0  Onset:2001-05-23, Days after vaccination: 16
Gender:Female  Submitted:2001-05-24, Days after onset: 1
Location:Massachusetts  Entered:2001-05-31, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0584K0SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1609K0SCLA
Administered by: Private     Purchased by: Public
Symptoms: Infection
SMQs:
Write-up: 20 or so pox on trunk and thighs. A couple on arms. First ones to appear have broken open and scabbed over. No s/s itching. No treatment at this time.

VAERS ID:170633 (history)  Vaccinated:2001-05-07
Age:2.0  Onset:2001-05-21, Days after vaccination: 14
Gender:Female  Submitted:2001-05-30, Days after onset: 9
Location:Washington  Entered:2001-06-06, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAM99A23IM 
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1340K0SC 
Administered by: Private     Purchased by: Public
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Rash under left arm, 2 weeks, post vax.

VAERS ID:170654 (history)  Vaccinated:2001-05-07
Age:1.7  Onset:2001-05-10, Days after vaccination: 3
Gender:Male  Submitted:2001-06-10, Days after onset: 31
Location:California  Entered:2001-06-06, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: Normal
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 0SC 
Administered by: Private     Purchased by: Other
Symptoms: Cough, Eye disorder, Infection, Pyrexia, Rash
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Corneal disorders (broad), Retinal disorders (broad), Hypersensitivity (narrow)
Write-up: 5/10/01; increased fever of 105F, not reduced by Tylenol until the next day. (Cough, eye infection the following week). Went to ER at 20:00. 5/11/01; rash on upper left thigh in the afternoon and rash on right leg and left foot in the evening.

VAERS ID:171111 (history)  Vaccinated:2001-05-07
Age:  Onset:2001-05-09, Days after vaccination: 2
Gender:Unknown  Submitted:0000-00-00
Location:Unknown  Entered:2001-06-12
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
TD: TD ADSORBED (NO BRAND NAME)LEDERLE LABORATORIES  IM 
Administered by: 0     Purchased by: 0
Symptoms: Injection site hypersensitivity, Injection site swelling, Injection site vesicles, Injection site warmth, Pruritus
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Based upon report received from medical professionals, a pt was inadvertently given TD but was supposed to be given a PPD instead. The pt experienced symptoms at the injection site which included, swelling the size of a grapefruit, a dime sized blister, itching and warmth to the touch.

VAERS ID:171162 (history)  Vaccinated:2001-05-07
Age:0.6  Onset:2001-05-07, Days after vaccination: 0
Gender:Male  Submitted:2001-05-14, Days after onset: 7
Location:Mississippi  Entered:2001-06-13, Days after submission: 30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: limp, difficult to arouse, hypotonic;TRIPEDIA;0;.20;In Patient
Other Medications:
Current Illness: resolving otitis media
Preexisting Conditions: paroxysmal episodes
Diagnostic Lab Data:
CDC Split Type: MS01019
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)CONNAUGHT LABORATORIESUO357CA2IMRL
Administered by: Private     Purchased by: Public
Symptoms: Depressed level of consciousness, Eye disorder
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Corneal disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Patient noted to be asleep and then began groaning and eyes were half open. He could not be aroused with stimulation. The episode lasted 45 seconds to 1 minute. Then the patient''s eyes opened wide and he came around. Patient was seen by neurology.

VAERS ID:171544 (history)  Vaccinated:2001-05-07
Age:4.0  Onset:2001-05-07, Days after vaccination: 0
Gender:Female  Submitted:2001-10-25, Days after onset: 171
Location:California  Entered:2001-06-15, Days after submission: 132
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: ;Varicella (Varivax);;0;In Patient
Other Medications: Tuberculin purified protein/LL
Current Illness: NONE
Preexisting Conditions: Allergy to sulfa
Diagnostic Lab Data:
CDC Split Type: WAES01051900
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)AVENTIS PASTEURVQ2998A4IMLL
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.R14373SCLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0149L1SCRL
Administered by: Private     Purchased by: Other
Symptoms: Cellulitis, Drug ineffective, Herpes zoster, Infection, Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Lack of efficacy/effect (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 4 year old female, who on 5/7/01, was vaccinated with MMRII, in the leg. Concomitant therapy, also given on 5/7/01, included DPT and poliovirus vaccine. It was also reported that the pt had received her varicella virus vaccine live, on approx. 6/27/97, in the pt''s left leg in which she received the MMRII, DPT, tuberculin purified protein derivative and poliovirus vaccinations became hot and swollen. On the next day, the pt''s symptoms worsened and she was dx''d with cellulitis. The child was treated with cephalexin (Keflex) and subsequently, recovered from the cellulitis. On approx. 5/18/01, the pt developed a "very severe case of chicken pox with approx. 50 lesions, on the left leg around the injection site". Upon internal review the cellulitis is considered an "Other Medical Event". Additional information has been requested. F/U It was further reported that on 5/10/01 she was seen again and that the area was more extensive. As of 5/17/01, the cellulitis was resolving. Subsequently on 5/24/01 the pt recovered. It was also reported that the pt had rec''d one dose of varicella virus vaccine live (site unknown) at one yr of age on approximately 6/27/97 and on approximately 5/17/01 developed chicken pox (WAES01091138). Upon internal review the cellulitis was considered to be an other important medical event. No further info is expected. F/U states: Information has been received from a physician and an RN concerning her 4 year old white female, family member, with an allergy to sulfa, no illness at the time of vaccination and reported to be in "otherwise good health" who on 5/7/01 (also reported as 5/9/01) was vaccinated with the 2nd dose of MMRII, SC, in the right thigh (lot 637433/0149L). Concomitant therapy, that day, included the 5th dose of alum, potassium (+) diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (Tripedia), IM, in the left thigh (lot V02998A), 1 dose of tuberculin purified protein derivative (Tubersol) (site not reported) and the 4th dose

VAERS ID:171787 (history)  Vaccinated:2001-05-07
Age:32.0  Onset:0000-00-00
Gender:Female  Submitted:2001-05-14
Location:South Carolina  Entered:2001-06-18, Days after submission: 35
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
YF: YELLOW FEVER (YF-VAX)CONNAUGHT LABORATORIESUA440AA0SC 
Administered by: Military     Purchased by: Military
Symptoms: Pain, Skin nodule
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Patient developed a hard, sore knot on the left arm.

VAERS ID:172159 (history)  Vaccinated:2001-05-07
Age:32.0  Onset:2001-05-07, Days after vaccination: 0
Gender:Male  Submitted:2001-06-07, Days after onset: 31
Location:Nevada  Entered:2001-06-20, 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: ASA-daily; sinus OTC meds; GNC dietary supplement
Current Illness: "Normal allergy symptoms"
Preexisting Conditions: Seasonal allergies
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.1361K0IMLA
Administered by: Public     Purchased by: Private
Symptoms: Ear discomfort, Nasal congestion, Pyrexia, Sinus headache
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Developed fever the night the shot was received. Pt reports temperature of 102F-103F. Took ASA to reduce fever (2 tablets) X 1. When pt awoke the next AM, he had head congestion, stuffy nose, sinus pressure and right ear "completely plugged". Pt complained of continued head congestion to this day.

VAERS ID:172372 (history)  Vaccinated:2001-05-07
Age:3.0  Onset:2001-05-08, Days after vaccination: 1
Gender:Female  Submitted:2001-06-18, Days after onset: 41
Location:North Carolina  Entered:2001-06-25, 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: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: Mom reports provider ordered blood tests for mono and strep throat
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1894K0SCRA
Administered by: Public     Purchased by: Public
Symptoms: Anorexia, Fatigue, Headache, Lymphadenopathy, Sleep disorder
SMQs:
Write-up: On 6/13/01, mom reported child, in her opinion, had a reaction to varicella. Headache, swollen glands and went to doctor. Also had fatigue, disturbed sleep and loss of appetite. Treatment occurred on Thursday.

VAERS ID:172412 (history)  Vaccinated:2001-05-07
Age:1.6  Onset:2001-05-08, Days after vaccination: 1
Gender:Male  Submitted:2001-05-09, Days after onset: 1
Location:California  Entered:2001-06-26, 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:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type: CA010070
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAMA986A23IMRL
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES4783300IMLL
Administered by: Public     Purchased by: Public
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Red, swollen and painful left upper thigh with fever. Local reaction of cellulitis. Treated with antibiotic therapy, Keflex suspension 1 tsp 3 X per day X 10 days.

VAERS ID:172451 (history)  Vaccinated:2001-05-07
Age:18.0  Onset:2001-05-14, Days after vaccination: 7
Gender:Female  Submitted:2001-05-16, Days after onset: 2
Location:Pennsylvania  Entered:2001-06-26, Days after submission: 41
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Zoloft
Current Illness: NONE
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PA0142
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1265K0IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1381K1SCRA
TD: TD ADSORBED (NO BRAND NAME)CONNAUGHT LABORATORIESU0375AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Pruritus, Rash maculo-papular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Pt had MMR vaccine for school on 5/7/01. On 5/16/01, presented to office with macular papular and itchy rash of chest and abdomen.

VAERS ID:173248 (history)  Vaccinated:2001-05-07
Age:16.0  Onset:2001-05-09, Days after vaccination: 2
Gender:Male  Submitted:2001-06-22, Days after onset: 44
Location:California  Entered:2001-07-12, Days after submission: 20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: CA010072
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1323K0IMLA
HEPA: HEP A (HAVRIX)SMITHKLINE BEECHAM0062L0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0934K0SCRA
Administered by: Other     Purchased by: Public
Symptoms: Erythema
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: 3cm Indurational redness rt arm

VAERS ID:173372 (history)  Vaccinated:2001-05-07
Age:4.0  Onset:2001-05-07, Days after vaccination: 0
Gender:Male  Submitted:2001-05-09, Days after onset: 2
Location:California  Entered:2001-07-16, Days after submission: 68
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAM991A24IMLL
HEPA: HEP A (VAQTA)MERCK & CO. INC.0062L0IMRL
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T056323SCRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0152L1SCLA
Administered by: Private     Purchased by: Public
Symptoms: Abasia, Feeling abnormal, Feeling hot, Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: On 5/7/01, at 20:00, complained of pain of left thigh, swelling and redness, felt warm and did not feel well. On 5/8/01, pt did not want to walk on leg due to pain with increased swelling and redness. On 5/9/01, was able to walk.

VAERS ID:175186 (history)  Vaccinated:2001-05-07
Age:72.0  Onset:2001-05-08, Days after vaccination: 1
Gender:Female  Submitted:2001-08-27, Days after onset: 111
Location:North Carolina  Entered:2001-09-07, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Occasional Tylenol.
Current Illness: Dog bite to the lower calf.
Preexisting Conditions: Allergies to Sulfa and Amoxicillin.
Diagnostic Lab Data: NONE
CDC Split Type: NC01078
Vaccination
Manufacturer
Lot
Dose
Route
Site
TTOX: TETANUS TOXOID (NO BRAND NAME)CONNAUGHT LABORATORIESUO193AA2IMLA
Administered by: Public     Purchased by: Public
Symptoms: Back pain, Pain
SMQs:, Retroperitoneal fibrosis (broad)
Write-up: About 3 or 4 hours after shot the site had a little redness and itching about it. No real pain / soreness. The next day the patient noted she was sore all over, legs, back, (generalized). She states this problem has not been resolved at all and keeps her from alot of activities; until this date 08/27/01, still having problems. No fever during this episode or any problems.

VAERS ID:175614 (history)  Vaccinated:2001-05-07
Age:0.1  Onset:2001-05-07, Days after vaccination: 0
Gender:Male  Submitted:2001-05-14, Days after onset: 7
Location:Virginia  Entered:2001-09-21, Days after submission: 130
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: U2001007120
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)CONNAUGHT LABORATORIESU0378AA IMLL
Administered by: 0     Purchased by: 0
Symptoms: Crying, Injection site erythema, Injection site swelling, Oral intake reduced, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad)
Write-up: It was reported that a 1 month old infant pt received a Tripedia vaccination on 5/7/01. Reportedly, that same day, the pt presented with a high-pitched scream, his left upper thigh was red and swollen greater than 10mm. Refused feeding, his temperature with Tylenol was 99.3F. His right thigh was 6.5" and his left thigh was 7".

VAERS ID:176216 (history)  Vaccinated:2001-05-07
Age:4.0  Onset:2001-05-07, Days after vaccination: 0
Gender:Female  Submitted:2001-10-02, Days after onset: 148
Location:Unknown  Entered:2001-10-11, 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: PPD/Tubersol 5 TU/6374330/0149
Current Illness: NONE
Preexisting Conditions: Sulfa Allergy
Diagnostic Lab Data:
CDC Split Type: U2001010300
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)CONNAUGHT LABORATORIESV02998A4IMLL
IPV: POLIO VIRUS, INACT. (IPOL)AVENTIS PASTEURR14373SCLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0149L1SCRL
Administered by: 0     Purchased by: 0
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: A 4 year old white female, with no illness at the time of the vaccination, on 05/07/01 (also reported as 05/09/01) was vaccinated with a 2nd dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live, SC in the right thigh. Concomitant therapy that day included the 5th dose of alum, potassium (+) diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (Tripedia), administration IM in the left thigh, one dose of tuberculin purified protein derivative, and the fourth dose of poliovirus vaccine (IPOL), SC, in the left thigh. It was noted that the child was being vaccinated for kindergarten. Subsequently, on approximately 05/07/01 (also reported 05/10/01), the patient''s left leg in which she received alum, potassium (+) diphtheria toxoid () pertussis vaccine (+) tetanus toxoid and poliovirus vaccinations became hot and swollen. On the next day the patient''s symptoms worsened. That morning, on 05/08/01, she had redness and swelling of the left thigh, was seen in urgent care, and was diagnosed with cellulitis. The child was treated with cephalexin (Keflex). It was further reported that on 05/10/01, the cellulitis was resolving. Subsequently, on 05/24/01, the patient recovered. It was also reported that the patient had received one dose of varicella virus vaccine live at one year of age, on approximately 06/27/97 and on approximately 05/17/97 developed chicken pox. Upon internal interview the cellulitis was considered to be an other important medical event. From faxed information "F/U: corrected report: tuberculin purified protein derivative (Tubersol 5 TU) has been injected the same day, 5/7/01.

VAERS ID:176485 (history)  Vaccinated:2001-05-07
Age:0.2  Onset:2001-05-07, Days after vaccination: 0
Gender:Male  Submitted:2001-07-17, Days after onset: 71
Location:Kansas  Entered:2001-10-19, Days after submission: 94
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: KS200127
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAM965AZ0IMRL
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.1190K1IMRL
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T06240SCLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETH4749550IMLL
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: Post vax that evening the patient had a temperature of 105F with no other symptoms. The patient was seen in the ER where he had a convulsion. The patient was treated with medicine to lower the fever and sent home. Dr will be giving the next set in her office.

VAERS ID:178824 (history)  Vaccinated:2001-05-07
Age:0.2  Onset:2001-05-09, Days after vaccination: 2
Gender:Male  Submitted:2001-05-23, Days after onset: 14
Location:California  Entered:2001-12-11, Days after submission: 202
Life Threatening? No
Died? Yes
   Date died: 2001-05-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions:
Diagnostic Lab Data: Autopsy pending
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAM986A20IMRL
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM5768A21IMRL
HIBV: HIB (ACTHIB)CONNAUGHT LABORATORIESUA560AA0IMLL
IPV: POLIO VIRUS, INACT. (POLIOVAX)AVENTIS PASTEURT04720SCLL
Administered by: Private     Purchased by: Other
Symptoms: Feeling cold, Injury, Musculoskeletal stiffness
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Arthritis (broad)
Write-up: Possible SIDS. Mother found infant at 06:57 on 5/9/01, lying prone in his crib (stiff and cold). Paramedics responded to 911 call and pronounced the death. No trauma or injury found. Information obtained from Sheriff-Coroner''s initial death report. Unable to contact mother. On 8/9/01, dx received from Deputy Coroner of blunt force traumatic injuries of torso.

VAERS ID:182377 (history)  Vaccinated:2001-05-07
Age:25.0  Onset:2001-05-09, Days after vaccination: 2
Gender:Female  Submitted:2002-03-07, Days after onset: 302
Location:Unknown  Entered:2002-03-13, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data:
CDC Split Type: WAES01052445
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0721K   
Administered by: Other     Purchased by: Other
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Information has been received from a physician concerning a 25 year old female who on 05/07/2001 was vaccinated one dose of hep b vaccine recombinant. On 05/09/2001 the pt experienced feelings of fever and chills at 1700 hours daily since then. Unspecified medical attention was sought. Additional info has been requested.

VAERS ID:184638 (history)  Vaccinated:2001-05-07
Age:25.0  Onset:2001-05-09, Days after vaccination: 2
Gender:Female  Submitted:0000-00-00
Location:Indiana  Entered:2002-05-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid, Zoloft
Current Illness: NONE
Preexisting Conditions: UNK
Diagnostic Lab Data: UNK
CDC Split Type: HQ0850214MAY2001
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)LEDERLE LABORATORIES465319 IM 
Administered by: Other     Purchased by: Other
Symptoms: Injection site hypersensitivity, Injection site inflammation, Injection site oedema, Injection site vesicles, Pruritus
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: A physician''s office manager reported that a 25 year old female inadvertently received an intradermal injection of Tetanus and Diphtheria Toxoids Adsorbed, Purogenated on 05/07/2001. On 05/09/2001, the pt developed an injection site reaction characterized by a swollen area "the size of a grapegruit," a "dime sized blister," inflammation, and itching. The physician prescribed application of Lidex cream.

VAERS ID:185857 (history)  Vaccinated:2001-05-07
Age:1.3  Onset:2001-05-09, Days after vaccination: 2
Gender:Female  Submitted:2002-05-16, Days after onset: 372
Location:Michigan  Entered:2002-05-31, Days after submission: 15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Nystatin, Hydrocortisone, Bacitracin
Current Illness: Diaper rash
Preexisting Conditions: Non-specified allergies
Diagnostic Lab Data: UNK
CDC Split Type: A0347304A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAM    
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This report described injection site induration in a 15 month old female. On 05/07/01, the vaccinee received her fourth right thigh dose of DTaP. She subsequently experienced injection site induration, edema and redness (3" X 3" area). The parents contacted the physician within two days of vaccination. On 05/09/01, diphenhydramine hydrochloride was prescribed. As of 05/11/01, the adverse events were resolving.

VAERS ID:187527 (history)  Vaccinated:2001-05-07
Age:1.1  Onset:2001-05-18, Days after vaccination: 11
Gender:Female  Submitted:2002-05-30, Days after onset: 377
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: UNK
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type: WAES01052024
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1386K0  
Administered by: Private     Purchased by: Other
Symptoms: Rash erythematous, Rash maculo-papular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a licensed practical nurse concerning a 13 month old female who 05/04/01 was vaccinated with a first dose of MMRII in the left leg. There was no illness at the time of vaccination. The licensed practical nurse reported that on 05/18/01, the patient presented to the office with an erythematous maculo-papular rash on her face, back and legs, which "blanches with pressure, 1-4 mm diameter". The patient was treated with diphenhydramine hydrochloride, (Benadryl). The patient recovered from her experience. No further information is available.

VAERS ID:188173 (history)  Vaccinated:2001-05-07
Age:55.0  Onset:2001-05-07, Days after vaccination: 0
Gender:Female  Submitted:2002-07-26, Days after onset: 445
Location:California  Entered:2002-07-30, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: Has had adverse rx to anesthesia
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1861K1IMRA
Administered by: Private     Purchased by: Private
Symptoms: Hypokinesia, Injection site mass, Injection site pain, Pain
SMQs:, Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Recombivax-HB series started 04/06/01. Second injection given 05/07/01. Pt c/o pan at injection site 06/21/01. Returned to clinic 07/16/02 with c/o pain. lump rt deltoid and pain lifting arm. Referred to general surgeon.

VAERS ID:195510 (history)  Vaccinated:2001-05-07
Age:2.5  Onset:2002-11-25, Days after vaccination: 567
Gender:Female  Submitted:2002-12-16, Days after onset: 21
Location:Florida  Entered:2002-12-26, 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: Developmental Delay
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0085L0IMLL
Administered by: Private     Purchased by: Private
Symptoms: Infection, Skin ulcer
SMQs:
Write-up: Broke out with greater than 50 lesions. Secondary skin infection from scratching.

VAERS ID:199477 (history)  Vaccinated:2001-05-07
Age:47.0  Onset:2001-05-14, Days after vaccination: 7
Gender:Male  Submitted:2003-03-13, Days after onset: 668
Location:Virginia  Entered:2003-03-14, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lipitor
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: A large amount of data is available and tests have been done
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
LYME: LYME (LYMERIX)GLAXOSMITHKLINE BIOLOGICALS 1  
Administered by: Private     Purchased by: Private
Symptoms: Arthralgia, Fatigue, Joint stiffness, Joint swelling, Pain, Rheumatoid arthritis, Synovitis
SMQs:, Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (narrow)
Write-up: A few weeks after my second Lymerix vaccine I started to get severe pain in both my left and right forearms. The pains then started to travel to different parts of my body, hands, legs, arms (everywhere). Swelling of the hands and finger in this time period I went from no rheumatood factor to a high factor. I am ready to refill my prescription of Lipitor and have a question for you. I am not sure if there is a correlation but for the last two to three months I have had pain in my forearms and or elbow joints. At first I thought this was caused by some physical work that I have done. For the last month I have eliminated that possibility but still have the symptoms. Is there an alternative to Lipitor that I can try to see if I could reduce the stiffness and pain? Requested to evaluated by MD. Delightful fellow who works in IT but is also on search and rescue. During the course of this he was immunized at least three injections of hepatitis vaccine in two of the Lyme vaccine. He developed generalized aches and pains, perhaps some swelling in the small joints of the feet and hands. He is not sure. In the course of the workup he was also placed on Lipitor was discontinued. He was continued with morning stiffness, generalized, moderate in severity but less than one-half hour. Swelling of the joints has dissipated. There are some aches and pains. He has some fatigue but no fever or other constitutional symptoms. He denies skin rashes, sun sensitivity or any known tick bites. He has tried some Celebrex with minimal improvement. No neck or low back pain, painful red eye, bloody diarrhea, pleuritic chest pain or fever. Pain on the bottom of the feet when he walks. Has seen a foot specialist and was told it was "tendons." Follow up labs including quantitative titer of rheumatoid factor and western blot on the lyme antibody, ANA, CPK. Continue Celebrex, 200mg daily. HLA-B27 antigen. Rheumatoid arthritis, serologically positive. Pt has some mild synovitis in a small joints of the hands. Begin Methotrexate 10mgs q week. Begin

VAERS ID:216958 (history)  Vaccinated:2001-05-07
Age:45.0  Onset:0000-00-00
Gender:Male  Submitted:2004-02-05
Location:Unknown  Entered:2004-02-26, Days after submission: 21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Atorvastatin calcium
Current Illness: UNK
Preexisting Conditions: ATYPICAL CHEST PAIN, EXERTIONAL DYSPNEA, HYPERCHOLESTEROLEMIA. History of trauma to different joints with rotator cuff problems. Previous surgical history ruptured disc (L5) in 1983, right knee arthroscopy (December 1999), bilateral rotator cuff arthroscopies in 1998. Since the shoulder surguries, patient had experienced residula intermittent bilateral paresthesias in fourth and fi
Diagnostic Lab Data: Rheumatoid factor, May 2002, 1410U/L, high normal. March 11, 2002: Rheumatoid arthritis (RA) Latex Test was positive. May 2002: Lyme antibody titer, HLA B27 antigen, and ANA were negative; CMP, CBC, C-reactive protein and TSH were normal.
CDC Split Type: A0430146A
Vaccination
Manufacturer
Lot
Dose
Route
Site
LYME: LYME (LYMERIX)GLAXOSMITHKLINE BIOLOGICALS 1  
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Back pain, Laboratory test abnormal, Pain in extremity, Rheumatoid arthritis, Sensory disturbance, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (narrow), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (narrow)
Write-up: Rheumatoid Arthritis, Arthralgia, Back Pain. This report described the occurrence of a burning sensation in a male patient who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. Medical records were subsequently provided. The patients medical history included trauma to different joints and rotator cuff problems, atypical chest pain on exertion (first reported on 08 march 2001 and noted to be "Resolved" on 03 may 2001), dyspnea on exertion (first reported on 08 March 2001). Concurrent medications included atorvastatin (Lipitor). The patient received injections of LYMErix on 04 April 2001, 07 May 2001, and 04 April 2002. On 04 April 2001, the patient also received his first dose of hepatitis B vaccine (manufacturer unknown). His second dose was received on 04 May 2001 and his third dose on 04 October 2001. On 03 September 2003, the patient''s attorney alleged that the patient "suffered burning of the forearms, swelling of his wrist, hand, fingers and ankles, pain in his shoulders, legs, back and feet beginning one to two weeks after his second (LYMErix) vaccination according to the client." Treatment and outcomes of the alleged events were not reported. The following information was received via medical records. The patient was evaluated by a rheumatologist on 26 march 2002, for intermittent joint pain and swelling primarily of the wrists and hands. The pain was described as a burning sensation that lasts approximately one week. The patient had diffuse swelling of both hands (including digits) and had decreased range of motion in wrist with flexion and extension. There was no warmth or erythema noted. The clinical impression was that the patient either had arthralgia possibly due to an inflammatory process, or that he had an auto-immune disorder, or possibl a "Lyme vaccine induced syndrome". He was placed on Celebrex. The joint swelling subsided but he continued to have aches and pains and morning stiffness. The patient was subsequently diagnosed with rheumatoid arthritis on the basis of red,

VAERS ID:247105 (history)  Vaccinated:2001-05-07
Age:5.0  Onset:2005-11-02, Days after vaccination: 1640
Gender:Male  Submitted:2005-11-04, Days after onset: 2
Location:Pennsylvania  Entered:2005-11-08, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Augmentin for otitis
Current Illness: on treatment for otitis media for 48 hrs.
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1466K0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Drug ineffective, Infection
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Chickenpox vaccine breakthrough. Diagnosed with varicella by DR. in our office on 11/3/05. Developed rash 11/2/05. Had approximately 5 lesions in genital area some papules, some vesicles, some crusted. no fever. Had varicella vaccine 5/7/01.

VAERS ID:256206 (history)  Vaccinated:2001-05-07
Age:2.0  Onset:2005-05-30, Days after vaccination: 1484
Gender:Male  Submitted:2006-05-12, Days after onset: 347
Location:Virginia  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: NONE
Diagnostic Lab Data: UNK
CDC Split Type: WAES0506USA02052
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 0  
Administered by: Private     Purchased by: Private
Symptoms: Drug ineffective, Infection
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Info has been received from a woman at a physician''s office concerning a 6 year old male student with no pre-existing allergies or medical conditions who on 5/7/01 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 5/30/05, the pt developed $g52 lesions; he was seen in the physician''s office on 6/2/05 and was dx''d with questionable varicella. An immunization record was received and it was noted that the pt had received the following immunizations in the previous 6 years; poliovirus vaccine given 5/7/99, 7/19/99 and 3/3/00 and polio vaccine IPOL, given in the R arm on 6/4/04; DTP given on 5/7/99, 7/19/99, 10/28/99, 10/19/00 and Tripedia on 6/4/04, given in the left arm; MMRII given 6/13/00 and 6/4/04 given in the left arm; Hib vaccine given on 5/7/99, 7/19/99, 10/19/00; Prevnar given on 6/13/00, 10/19/00. The outcome of the adverse experience was not reported. Additional info has been requested.

VAERS ID:350180 (history)  Vaccinated:2001-05-07
Age:  Onset:2001-05-07, Days after vaccination: 0
Gender:Male  Submitted:2009-05-29, Days after onset: 2944
Location:Unknown  Entered:2009-06-17, Days after submission: 19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0901USA04120
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0019L0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information has been received from a consumer concerning her son with reaction to all vaccines and medications he has received that contain gelatin who on 07-MAY-2001 was vaccinated with the first dose of MMR II (lot # 636662/0019L). On 19-MAY-2005 the patient was vaccinated with the second dose of MMR II (lot # 648478/0634P). The patient experienced vomiting after vaccination. Subsequently, the patient recovered from the events. The patient also experienced an adverse event on VARIVAX (Merck) (WAES#0902USA00178). Additional information has been requested.

VAERS ID:388930 (history)  Vaccinated:2001-05-07
Age:5.0  Onset:2009-11-14, Days after vaccination: 3113
Gender:Female  Submitted:2010-05-14, Days after onset: 180
Location:Unknown  Entered:2010-05-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Serum measles IgM, 11/16/09, negative; Serum measles IgG, 11/16/09, 6.15; Serum amylase test, 11/16/09, 178
CDC Split Type: WAES1001USA02079
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood amylase normal, Blood immunoglobulin G, Blood immunoglobulin M normal, Body temperature normal, Mumps, Parotitis
SMQs:, Oropharyngeal infections (narrow)
Write-up: Information has been received from a physician concerning a 13 year old female who on 05-MAY-1997 and 07-MAY-2001 was vaccinated with the first and second dose of MMR II HSA (lot# not reported). On 14-NOV-2009 (also reported on 30-DEC-2009) the patient experienced mumps. On 16-NOV-2010 the patient had his first blood work and showed: serum measles immunoglobulin M antibody test: negative, serum measles immunoglobulin G antibody test: 6.15 and serum amylase test: 178. On 16-NOV-2010 the patient was diagnosed L parotitis. The patient was afebrile. At the time of the report, the patient''s outcome was unknown.

VAERS ID:172382 (history)  Vaccinated:2001-05-07
Age:0.3  Onset:2001-05-10, Days after vaccination: 3
Gender:Female  Submitted:2001-06-18, Days after onset: 39
Location:Foreign  Entered:2001-06-26, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data: EEG-nml
CDC Split Type: U2001008030
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTPIPV: DTP + IPV (NO BRAND NAME)BERNA BIOTECH, LTD0044 SC 
HIBV: HIB (ACTHIB)CONNAUGHT LABORATORIEST0630 SC 
Administered by: 0     Purchased by: 0
Symptoms: Eye movement disorder, Hypotonia, Pallor, Petit mal epilepsy, Stupor
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: It was reported that a 3 month old baby girl was concomitantly vaccinated on 5/7/01 with a dose of haemophilus influenza type b vaccine and a dose of DPT inactivated Poliomyelitis vaccine (DI-TE-KI-POL, manufacturer SSI). Three days later, the pt was hospitalized due to absences. She recovered without sequelae. Further information will be requested. F/U on 9/28/01: It was reported that the baby girl was previously healthy. She experienced at 17:00 hours, when she normally is awake; an episode of 2-3 minute duration with eyes rolled up, hypotonia, hyporesponsiveness and paleness of face. No symptoms remained upon hospitalization. EEG was normal and no further episodes occurred. Lot numbers were provided. No further information is available. The case is closed.

VAERS ID:174485 (history)  Vaccinated:2001-05-07
Age:81.0  Onset:2001-05-16, Days after vaccination: 9
Gender:Female  Submitted:2001-08-15, Days after onset: 91
Location:Foreign  Entered:2001-08-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Calcium-Sandoz Forte; Pepdul; Vasotec; (therapy unspecified); diclofenac; hydrochlorothiazide (+) triamterene (+) verapamil; famotidine; enalapril maleate
Current Illness:
Preexisting Conditions: Hypertension; bacteriuria; congestive heart failure; coronary artery disease; diabetes mellitus; osteoporosis; polyarthropathy; urinary incontinence; varicosity
Diagnostic Lab Data: UNK
CDC Split Type: WAES01080768
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0380K0IM 
Administered by: 0     Purchased by: 0
Symptoms: Pyrexia, Urinary tract infection
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Information has been received from a health authority concerning an 81 year old female pt who on 5/7/01, was vaccinated, IM, with the 1st dose of pneumococcal vaccine 23 polyvalent (lot HL79280). On 5/16/01, 9 days, post vax, the pt developed a fever with a maximum of 39.5C. She was subsequently, admitted to the hospital where a dx of urinary tract infection was made. The pt recovered after 2 days. The vaccinating physician assessed a "possible" relation with pneumococcal vaccine 23 polyvalent, given the fact that the pt had chronic bacteriuria. No further information is available. F/U states that information has been received concerning an 81 year old female pt who on 5/7/01 was vaccinated IM with the 1st dose of pneumococcal vaccine 23 polyvalent (lot number HL79280; 635674/0380K). Concomitant therapy included enalapril maleate, famotidine, hydrochlorothiaside + triamterene + verapamil, "ASS 100" calcium carbonate + calcium glubionate (Calcium-Sandoz Forte), and diclofanac. On 5/16/01, 9 days post vax, the pt developed a fever with a maximum temperature of 39.5C. She was subsequently admitted to the hospital where a dx of urinary tract infection was made. The pt recovered after 2 days. The vaccinating physician assessed a "possible" relation with pneumococcal vaccine 23 polyvalent, given the fact that the pt had chronic bacteruria. No further info is available. The US lot number has been added to the report.

VAERS ID:169835 (history)  Vaccinated:2001-05-08
Age:5.2  Onset:2001-05-08, Days after vaccination: 0
Gender:Male  Submitted:2001-05-10, Days after onset: 2
Location:Texas  Entered:2001-05-15, 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:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)CONNAUGHT LABORATORIESU0311CA4IMLA
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T08163SCLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0162L1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: The pt experienced left deltoid with pink, well circumscribed, warm, swollen and slightly tender area 4-6cm.

VAERS ID:169890 (history)  Vaccinated:2001-05-08
Age:1.3  Onset:2001-05-09, Days after vaccination: 1
Gender:Male  Submitted:2001-05-10, Days after onset: 1
Location:Florida  Entered:2001-05-16, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.1797K2IMLL
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES4774501IMLL
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt experienced some redness, swelling and warmth accompanied by tenderness to the left anterior thigh with mild cellulitis.

VAERS ID:169903 (history)  Vaccinated:2001-05-08
Age:1.0  Onset:2001-05-08, Days after vaccination: 0
Gender:Male  Submitted:2001-05-10, Days after onset: 2
Location:Virginia  Entered:2001-05-16, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.1409K IMLL
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T03952  LL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1517K SCLA
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: Mother says that child ran fever of 102F and had a seizure at about 14:30. Mom had given Tylenol. Was taken to ER and was told that seizure was due to immunizations.

VAERS ID:169905 (history)  Vaccinated:2001-05-08
Age:3.0  Onset:2001-05-08, Days after vaccination: 0
Gender:Male  Submitted:2001-05-09, Days after onset: 1
Location:Texas  Entered:2001-05-16, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Wheals;UNK. MEASLES, MUMPS & RUBELLA VIRUS LIVE;1;1.00;In Patient
Other Medications: Sudafed
Current Illness: Runny nose
Preexisting Conditions: Hypospadias
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.1344K0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Red wheals on arms and chest, within 24 hours, post vax.

VAERS ID:169980 (history)  Vaccinated:2001-05-08
Age:1.3  Onset:2001-05-11, Days after vaccination: 3
Gender:Female  Submitted:2001-05-11, Days after onset: 0
Location:Arizona  Entered:2001-05-17, 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: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DT: DT ADSORBED (NO BRAND NAME)CONNAUGHT LABORATORIESU0357BB3IMLL
HIBV: HIB (ACTHIB)CONNAUGHT LABORATORIESUA563AB3IMLL
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES4747201IMLL
Administered by: Private     Purchased by: Private
Symptoms: Injection site oedema, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 2-3 days post vax the pt experienced swelling of the left thigh accompanied by a fever of 103+.

VAERS ID:169982 (history)  Vaccinated:2001-05-08
Age:0.3  Onset:2001-05-10, Days after vaccination: 2
Gender:Male  Submitted:2001-05-10, Days after onset: 0
Location:Georgia  Entered:2001-05-17, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAM991A21IMLL
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.1525K1IMLL
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES4720471IMRL
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt experienced swelling, redness, fever and hardening of left thigh. Pt was treated with antibiotic therapy.

VAERS ID:170035 (history)  Vaccinated:2001-05-08
Age:0.4  Onset:2001-05-09, Days after vaccination: 1
Gender:Female  Submitted:2001-05-09, Days after onset: 0
Location:Florida  Entered:2001-05-21, Days after submission: 12
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, afebrile
Preexisting Conditions: NONE
Diagnostic Lab Data: CSF-wnl; U/A-wnl; CXR-wnl; WBC-25,000
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAMA917A22IMLL
HIBV: HIB (HIBTITER)LEDERLE PRAXSIS4747122IMRL
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.P08241 LL
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES4774501IMRL
Administered by: Private     Purchased by: Public
Symptoms: Dyskinesia, Pyrexia, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (narrow), Anticholinergic syndrome (broad), Dyskinesia (narrow), Noninfectious encephalopathy/delirium (broad)
Write-up: Vaccines given 5/8/01 afternoon. Pt slept all afternoon and night. On 5/9/01 AM, pt had several jerking movements of head, hands and feet for a few seconds duration with 10-15 minute intervals. Pt febrile.

VAERS ID:170053 (history)  Vaccinated:2001-05-08
Age:5.0  Onset:2001-05-10, Days after vaccination: 2
Gender:Female  Submitted:2001-05-11, Days after onset: 1
Location:Washington  Entered:2001-05-21, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)CONNAUGHT LABORATORIESU0060AB4IMLL
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.920300 RL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.001411SCRL
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 10cm X 12cm swelling, erythema and heat at left anterior thigh adjacent to DTAP injection. Also had a fever. Should do fine.

VAERS ID:170086 (history)  Vaccinated:2001-05-08
Age:2.4  Onset:2001-05-10, Days after vaccination: 2
Gender:Male  Submitted:2001-05-11, Days after onset: 1
Location:California  Entered:2001-05-22, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)SMITHKLINE BEECHAM679A0IMLL
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES4749520IMRL
Administered by: Private     Purchased by: Private
Symptoms: Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Child had local reaction 5cm X 7cm raised area and hot to touch. Pt was treated with 5 days of Augmentin 400mg BID and Orapred 5mg BID.

VAERS ID:170111 (history)  Vaccinated:2001-05-08
Age:64.0  Onset:2001-05-09, Days after vaccination: 1
Gender:Female  Submitted:0000-00-00
Location:Texas  Entered:2001-05-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HRIG/618W01A/IM/RFA
Current Illness: Exposure to cat bite
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (RABAVERT)CHIRON CORPORATION2770112IMLA
Administered by: Private     Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Pt given Rabavert on 5/8/01 and returned on 5/9/01 with generalized rash.

VAERS ID:170280 (history)  Vaccinated:2001-05-08
Age:82.0  Onset:2001-05-15, Days after vaccination: 7
Gender:Female  Submitted:2001-05-21, Days after onset: 6
Location:Pennsylvania  Entered:2001-05-24, 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: Toprol XL, Zyrtec; Centrum Silver; Pravachol; Fosamax
Current Illness: NONE
Preexisting Conditions: Allergy to adhesive tape, prednisone
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)CONNAUGHT LABORATORIESU0298AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Hypertension, Hypotension, Injection site erythema, Injection site induration, Injection site warmth, Pruritus
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypertension (narrow), Hypersensitivity (broad)
Write-up: One week, post vax, site erythemic induration and area measured in size to about 8cm in diameter, was very itchy and warm to touch. Rx''d Biaxin 500 mg BID x 7 days, Benadryl cream, Zyrtec 10mg and ice pack. Vital signs on 5/15/01, BP 172/100; HR-64; Afebrile; RR-16.

VAERS ID:170387 (history)  Vaccinated:2001-05-08
Age:4.3  Onset:2001-05-09, Days after vaccination: 1
Gender:Male  Submitted:2001-05-10, Days after onset: 1
Location:Oklahoma  Entered:2001-05-30, 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:
CDC Split Type: OK0123
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)CONNAUGHT LABORATORIESU0328AB4IMLA
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T03953SCLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: The pt''s left arm was swollen from the shoulder to the elbow. Severe erythema and fever was noted in the swollen area. The pt was referred to physician for follow-up and palliative care.

VAERS ID:170399 (history)  Vaccinated:2001-05-08
Age:0.5  Onset:2001-05-09, Days after vaccination: 1
Gender:Female  Submitted:2001-05-18, Days after onset: 9
Location:Virginia  Entered:2001-05-31, Days after submission: 13
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Methadone, Valium, Zantac, Phenobarbital, Lasix, Poly-Vi-Sol
Current Illness:
Preexisting Conditions: Pierre-Robin; Neuronal Migration Defect; Pulmonary Insufficiency
Diagnostic Lab Data: Sepsis workup-neg (CBC; Chemistries; blood cx; CSF count/cx; urine cx
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAM957A21IMLL
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.1825K1IMRL
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T05321 LL
PNC: PNEUMO (PREVNAR)PFIZER/WYETH4733610IMRL
Administered by: Military     Purchased by: Military
Symptoms: Hypotension, Nervous system disorder, Pyrexia, Shock, Tachycardia
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Pt was stable in PICU and preparing for discharge. Received immunizations and within 24 hours, became hypotensive, tachycardic, febrile-shock state. All septic workup was negative. Required ionotropic support X 48 hours. Returned to baseline. From the acute event, child will not recover from the congenital problems. She is presently still on vent at hospital for rehab.

VAERS ID:170446 (history)  Vaccinated:2001-05-08
Age:5.0  Onset:2001-05-22, Days after vaccination: 14
Gender:Female  Submitted:2001-05-22, Days after onset: 0
Location:Massachusetts  Entered:2001-05-31, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)CONNAUGHT LABORATORIESU0356BA4IMLA
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T03943SCLA
Administered by: Private     Purchased by: Public
Symptoms: Pruritus, Rash vesicular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: "Chickenpox" looking rash on back, mainly under right scapula. 7 or 8 pox on left side of back. No cold symptoms, fever or pain. Very itchy. Treat with Aveeno bath and Benadryl.

VAERS ID:170490 (history)  Vaccinated:2001-05-08
Age:40.0  Onset:2001-05-08, Days after vaccination: 0
Gender:Female  Submitted:2001-05-09, Days after onset: 1
Location:California  Entered:2001-06-01, 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: UNK
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: UNK
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.069221  
TD: TD ADSORBED (NO BRAND NAME)CONNAUGHT LABORATORIES0377AA1IM 
Administered by: Public     Purchased by: Private
Symptoms: Arthralgia, Back pain, Bruxism, Chills, Muscle spasms, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Arthritis (broad)
Write-up: At approx 6:30 pm - decreased back pain when to muscle spasms in hands/ feet, joint pain, chills with teeth chattering. Temp increased 102s. On 05/09/01 - Temp decreased 101 degrees with tylenol and discomfort.

VAERS ID:170495 (history)  Vaccinated:2001-05-08
Age:3.3  Onset:2001-05-08, Days after vaccination: 0
Gender:Unknown  Submitted:0000-00-00
Location:Florida  Entered:2001-06-01
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
DTP: DTP (NO BRAND NAME)CONNAUGHT LABORATORIES998A21IM 
Administered by: Public     Purchased by: Private
Symptoms: Arthritis, Erythema, Pain
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Hypersensitivity (broad), Arthritis (narrow)
Write-up: Arthritic type reaction with confluent red on anterior 3rd left finger, down into distal above the knee. Child still with active play; no systemic signs and symptoms. Given steroid and Zrytec-resolved on 24-36 hrs. Seen recheck 05 05/11/001.

VAERS ID:170634 (history)  Vaccinated:2001-05-08
Age:1.0  Onset:2001-05-13, Days after vaccination: 5
Gender:Male  Submitted:2001-05-30, Days after onset: 17
Location:California  Entered:2001-06-06, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: URI, OM
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0156L0SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1338K0SCLL
Administered by: Private     Purchased by: Private
Symptoms: Erythema multiforme
SMQs:, Severe cutaneous adverse reactions (narrow), Hypersensitivity (narrow)
Write-up: Erythema Multiforme; onset 13 days, post varicella vax. Initial lesion over vaccine site.

VAERS ID:171025 (history)  Vaccinated:2001-05-08
Age:0.2  Onset:2001-05-08, Days after vaccination: 0
Gender:Female  Submitted:2001-05-10, Days after onset: 2
Location:Ohio  Entered:2001-06-11, Days after submission: 32
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: eczema
Preexisting Conditions: born to 18 year old IDDM mom
Diagnostic Lab Data: CBC, LP, UA, UC, blood culture
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAM983A20IMLL
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.1823K0IMRL
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.T053L0 LL
Administered by: Public     Purchased by: Other
Symptoms: Pyrexia, Sepsis, Tremor
SMQs:, Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: The pt received vaccines on 5/8/01 and on 5/8/01 PM the pt developed fever, shaking episode and brought to the ER. The pt was admitted to rule out sepsis. Diagnosis was fever only.

VAERS ID:172421 (history)  Vaccinated:2001-05-08
Age:1.4  Onset:2001-05-09, Days after vaccination: 1
Gender:Female  Submitted:2001-05-23, Days after onset: 14
Location:California  Entered:2001-06-26, Days after submission: 34
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions:
Diagnostic Lab Data: NONE
CDC Split Type: CA010067
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)CONNAUGHT LABORATORIESU0173CA3IMLL
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES4774531IMRL
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Vomiting
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Left thigh swelling, induration, red; also vomited multiple times.

VAERS ID:173191 (history)  Vaccinated:2001-05-08
Age:10.0  Onset:2001-05-08, Days after vaccination: 0
Gender:Male  Submitted:2001-06-05, Days after onset: 28
Location:Idaho  Entered:2001-07-11, Days after submission: 36
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Cyclosporin
Current Illness: Nephrotic syndrome
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: ID01030
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNU-IMUNE)LEDERLE LABORATORIES4691330IMLA
Administered by: Private     Purchased by: Public
Symptoms: Pain, Pyrexia, Rash macular
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: The patient experienced pain in the arm, a fever, red blotches on dorsal aspect of the arm. The patient was treated with Tylenol with codeine, Demerol, and Benadryl.

VAERS ID:173386 (history)  Vaccinated:2001-05-08
Age:1.0  Onset:2001-05-10, Days after vaccination: 2
Gender:Male  Submitted:2001-07-10, Days after onset: 61
Location:Utah  Entered:2001-07-18, 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: Tylenol
Current Illness: Cold symptoms, teething
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.0298K1IMRL
IPV: POLIO VIRUS, INACT. (POLIOVAX)AVENTIS PASTEURT05062SCLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0401K0SCRL
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES4753850 LL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1391K0SCLL
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: Pt developed fever of 100-102 2 days post vax. Three days post vax, fever was 103, and parents took pt to ER where he was treated with Ibuprofen and Benadryl. Pt taken to MD the next day and fever improved that day. One mo later, pt developed a rash over torso, legs and neck, described as red and raised. The duration was 3-4 days and he had a fever of 101.

VAERS ID:174754 (history)  Vaccinated:2001-05-08
Age:33.0  Onset:0000-00-00
Gender:Female  Submitted:2001-05-14
Location:Florida  Entered:2001-08-28, Days after submission: 106
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 LABORATORIESU0371AB IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Pt developed mild erythema on left shoulder with warmth. Treated with Clindamycin 150mg #28 1 QID.

VAERS ID:175885 (history)  Vaccinated:2001-05-08
Age:1.0  Onset:0000-00-00
Gender:Male  Submitted:2001-08-27
Location:California  Entered:2001-10-01, Days after submission: 35
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Diagnostic Lab Data: X-ray NOS-neg; Blood tests (unspecified)-neg
CDC Split Type: HQ3906131JUL2001
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES 0IMRL
Administered by: Private     Purchased by: Other
Symptoms: Abasia
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad)
Write-up: A mother and a pharmacist reported that a 12 month old male received his 1st dose of Prevnar vaccine and subsequently was unable to bear weight on his right leg. Prior to immunization, the child was able to stand on his own, take 3 to 4 steps, lean on furniture and walk. He was seen by his doctor who described the symptoms as "no weight bearing". At the date of this report the event has continued for 2 to 2.5 months. No additional information was available as of the date of this report. Additional information received on 8/2/01, contained the name and address of Orthopedic MD. Additional information received on 8/6/01, contained name and address of pharmacist. A 15-day follow up report received 10/09/2001 adds: Laboratory data includes x-rays and blood tests (unspecified) with negative results. Orthopedic physician indicated that child was disabled for 4 months. This case was upgraded to serious based on new info stating that child was disabled for 4 months.

VAERS ID:177993 (history)  Vaccinated:2001-05-08
Age:1.1  Onset:2001-05-08, Days after vaccination: 0
Gender:Female  Submitted:2001-11-14, Days after onset: 190
Location:South Carolina  Entered:2001-11-20, 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:
CDC Split Type: SC0157
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1513K0SC 
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES4774SS1IM 
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1142K0SC 
Administered by: Private     Purchased by: Private
Symptoms: Injection site reaction, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: The patient''s mother states the patient had a fever of 103F and a rash on the day of vaccinations. The patient was seen in the ER and was diagnosed with a reaction to the vaccination. The mother states you could feel the rash.

VAERS ID:178221 (history)  Vaccinated:2001-05-08
Age:1.0  Onset:2001-05-14, Days after vaccination: 6
Gender:Male  Submitted:2001-11-20, Days after onset: 190
Location:Arizona  Entered:2001-11-27, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: Platelet count-6,000 initially and on 10/01 it was 38,000
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0025L0SC 
Administered by: Private     Purchased by: Private
Symptoms: Idiopathic thrombocytopenic purpura, Platelet count decreased, Rhinitis
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Hypersensitivity (narrow)
Write-up: Chicken pox and MMR vaccine received and had decreased platelet count, 6 weeks later (ITP). Was hospitalized and received Winrho, prednisone.

VAERS ID:180530 (history)  Vaccinated:2001-05-08
Age:28.0  Onset:2001-11-02, Days after vaccination: 178
Gender:Female  Submitted:2001-11-15, Days after onset: 13
Location:Texas  Entered:2002-01-25, Days after submission: 71
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Diagnostic Lab Data: Titer-negative
CDC Split Type: 20010268181
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 2IM 
Administered by: Other     Purchased by: Other
Symptoms: Drug ineffective
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Report 20010268181 describes a 28 year old female who did not respond to the hep B vaccine (Engerix-B) immunization series. Medical history, concurrent conditions, and concurrent medications were not specified. On 11/14/2000, 12/19/2000, and 05/08/2001, the vaccinee received her first, second and third IM injections of Engerix-B, respectively. A titer (NOS) drawn for this vaccinee on 11/02/2001, approx. six months after the third injection of Engerix-B, was "negative."

VAERS ID:257411 (history)  Vaccinated:2001-05-08
Age:1.0  Onset:2006-02-06, Days after vaccination: 1735
Gender:Female  Submitted:2006-05-12, Days after onset: 94
Location:Massachusetts  Entered:2006-05-17, 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: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: body temp 2/5/06, afebrile
CDC Split Type: WAES0602USA05863
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.636575/1467K1SC 
Administered by: Private     Purchased by: Public
Symptoms: Viral infection
SMQs:
Write-up: Information has been received from an employee at a physician''s office concerning a 5-year-old white female who on 09-MAY-2001 was vaccinated SC with a second dose of varicella virus vaccine live. On 06-FEB-2006, the patient developed a papulovesicular rash on the upper torso, "20 to 30", and had no fever. The patient recovered on 13-FEB-2006. No further information is expected.

VAERS ID:170357 (history)  Vaccinated:2001-05-08
Age:1.2  Onset:2001-05-10, Days after vaccination: 2
Gender:Male  Submitted:2001-05-25, Days after onset: 15
Location:Foreign  Entered:2001-05-30, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: 05/13/01 Blood Potassium - 4.0 meq/1. Blood Sodium - 141 meq/1. Erythrocyte sedimentation rate - 4 mm/hr. Haemoglobin 9.9%. Red blood Cell Count - 4,150,000 cells per cubic millimeter. White Blood Cell Count - 8,000 cells per cubic millimet
CDC Split Type: HQ1232323MAY2001
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 1  
Administered by: 0     Purchased by: 0
Symptoms: Diarrhoea, Gastroenteritis, Laboratory test abnormal, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from an investigator regarding a 14 month old male who received his 2nd dose of study vaccine on 5/8/01 as part of the study. On 5/10/01, the child developed diarrhea and vomiting. When his symptoms did not improve by 5/13/01, he was hospitalized. A serum potassium level was 4.0 meg/1 and a sodium level was 141 meg/1. Hemoglobin was 9.9. WBC and RBC counts were normal. The child was dx''d with gastroenteritis. He recovered by 5/14/01. The investigator believes that gastroenteritis (unexpected per the investigator brochure) was not related to study vaccine administration (nasal solution). The medical monitor believes that ''although a causal relationship is unlikely, there does exist a temporal relationship that may be excluded with stool microscopy/culture results.'' Therefore, the medical monitor believes that the event is "possibly" related to study vaccine.

VAERS ID:170511 (history)  Vaccinated:2001-05-08
Age:0.7  Onset:2001-05-10, Days after vaccination: 2
Gender:Unknown  Submitted:2001-05-31, Days after onset: 21
Location:Foreign  Entered:2001-06-04, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: 05/10/01 Blood Potassium - 4 mEq/L. Blood Sodium - 140 mEq/L. Erythrocyte sedimentation rate - 120 m. Haemoglobin - 8.3 g%. White Blood Cell Count - 22,100 mm3.
CDC Split Type: HQ1284924MAY2001
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 1  
Administered by: 0     Purchased by: 0
Symptoms: Anaemia, Leukocytosis, Pneumonia, Pyrexia, Red blood cell sedimentation rate increased, Vomiting
SMQs:, Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad)
Write-up: Information has been received from an investigator regarding an 8 month old who received the 2nd dose of study vaccine or placebo as part of the study, "A Prospective, Randomized, Double-blind, Placebo-Controlled Trial to Compare the Safety, Tolerability, Immunogenicity and Efficacy of One Dose and Two Doses of a Cold-Adapted (CAIV-T) Compared with Placebo in Healthy Children" on 5/8/01. On 5/10/01, the pt developed a fever of 38C and respiratory distress. A CBC, erythrocyte sedimentation rate and electrolytes were performed. On 5/14/01, the pt began vomiting; the symptoms worsened. The pt was admitted to the hospital where a dx of pneumonia was made. The investigator considered pneumonia (unexpected per the Investigator''s Brochure) not related to vaccine administration. The medical monitor indicated that an association with the study vaccine could not be excluded because of the temporal nature of this event, therefore, this event is considered possibly related to vaccine administration.

VAERS ID:203578 (history)  Vaccinated:2001-05-08
Age:29.0  Onset:0000-00-00
Gender:Male  Submitted:2003-05-20
Location:Foreign  Entered:2003-05-23, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: Abdominal ultrasound: normal with some little mobile calculus in the vesicle, no sign of cholecystitis intra-hepatic biliary ductus non dilated (5/27/01); chest x-ray normal 5/27/01; neurological examination normal, not showing a deficit bu
CDC Split Type: WAES0305USA01644
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.    
YF: YELLOW FEVER (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anxiety, Asthenia, Chills, Dyspepsia, Headache, Hepatitis C virus, Hyperhidrosis, Meningitis, Pyrexia, Somnolence
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific dysfunction (narrow)
Write-up: Information has been received from a health professional concerning a 29 year old male who on 5/8/01 was vaccinated with a dose of hep B virus vaccine rHBsAg. Suspect vaccination therapy received on 5/9/01 included a dose of yellow fever virus vaccine live. According to a neurologist report, the pt was hospitalized as of 5/27/01 until 6/9/01 because he was presenting with headaches, chills, sweating and fever. Between 5/27/01 and 6/9/01 the pt had a neurologic exam that was normal and not showing a deficit but "meningism"; a lumbar puncture with leucocytose with lymphocytar majority (97%); blood cultures which showed a positive hep C, a mycoplasma pneumoniae measured with a dilution of 320 (normal value under 40), and a normal liver metabolism with an isolated increase of the direct bilirubin and the total bilirubin; and an abdominal echography which was normal with some little mobile calculus in the vesicle. It was reported that an IV treatment with antibiotics was begun in this case of highly symptomatic lymphocytar meningitis awaiting the result of the explorations. When the pt received cetriaxone IV all symptoms of the headache, fever and dyspepsia decreased, then disappeared. The pt received ciprofloxacine (500mg 2DD) when he left the hospital. On 7/10/01 the pt was seen again by the neurologist. No more episodes of headache or fever were mentioned by the pt but he was now suffering "of important asthenia." According to the neurologist, the asthenia could easily be explained by the hepatitis, by the previous history of meningitis, but especially by the high doses of antibiotics received during a few days. On 7/10/01 a neurological exam was reported as normal. The neurologist mentions "the voluntary slimming cure of the pt since a few months and his anxious personality that the pt recognizes spontaneously. He even presented a good mechanism of psychological defense." It was noticed that the pt presented with a nocturnal snoring which could also be contributed to his asthenia. On somnolence since May 2001, the

VAERS ID:244331 (history)  Vaccinated:2001-05-08
Age:74.0  Onset:0000-00-00
Gender:Male  Submitted:2005-09-15
Location:Foreign  Entered:2005-09-20, Days after submission: 5
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: Bowel cancer; Intestinal resection
Diagnostic Lab Data: Strep pneumonia serotype 4 was isolated.
CDC Split Type: WAES0509AUS00065
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bacterial infection, Drug ineffective
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Information was obtained on request by the company from the agency concerning a 74 yr old male with a history of bowel cancer requiring resection in 1985 who on 08May01 was vaccinated with pneumococcal 23v polysaccharide vaccine, 1 dose, 1 time as a prophylactic vaccination. Subsequently the pt experienced pneumococcal infection (described as invasive pneumococcal disease) and vaccination failure and was hospitalized. Strep pneumonia serotype 4 was isolated. The pt was treated in hospital with intravenous antibiotics. At the time of reporting to the agency on 16Jun05 the pt''s pneumococcal infection and vaccination failure persisted. The agency felt that pneumococcal infection and vaccination failure were possibly related to therapy with pneumococcal 23v polysaccharide vaccine. The original reporting source was not provided. Additional information is not expected.

VAERS ID:412758 (history)  Vaccinated:2001-05-08
Age:  Onset:2001-05-20, Days after vaccination: 12
Gender:Male  Submitted:2010-12-14, Days after onset: 3495
Location:Foreign  Entered:2010-12-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: ONYCHOMYCOSIS (TOE NAILS OF FOOT)
Preexisting Conditions: DIARRHEA; SINUSITIS
Diagnostic Lab Data: Examination cerebrospinal NMR 20.03.2002: inflammation in thoracic spine (myelitis), cerebral signal intense inflammatory foci paraventricular with diametre of few mm. Lumbar puncture: normal cell count with oligoclonal bands typical for multiple sclerosis, no viruses or bacteria were found. Cerebrospinal NMR October 2003: new inflammatory foci.
CDC Split Type: D0064391A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSVHA628C6 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Acute disseminated encephalomyelitis, Bacterial test negative, CSF cell count normal, CSF oligoclonal band present, CSF virus no organisms observed, Coordination abnormal, Diarrhoea, Fatigue, Hypoaesthesia, Lumbar puncture normal, Malaise, Multiple sclerosis, Myelitis, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal cord abnormal, Paraplegia, Vaccination complication, Vertigo, Viral test negative
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (narrow), Noninfectious diarrhoea (narrow)
Write-up: This case was reported by a consumer and described the occurrence of multiple sclerosis in an adult male subject who was vaccinated with HAVRIX 1440 (GlaxoSmithKline). This case was legally significant. On an unspecified date the subject received a dose of HAVRIX (unknown route and application site). At an unspecified time after vaccination with HAVRIX, the subject experienced vaccine reaction. At the time of reporting the outcome of the event was unspecified. Follow-up information was received on 6 December 2010 from the consumer including medical evidence. The consumer stated that multiple sclerosis was caused by HAVRIX 1440 vaccination given on 8 May 2001 (unknown route and application site). Previous vaccination included TD-PUR given on 28 September 1998, 3 November 1998 and 11 June 1999, VAQTA given on 16 August 2000, IPV-VIRELON given on 28 September 1998 and 11 June 1999. The subject also received STAMARIL on 16 August 2000. The subject was healthy until May 2001. Concurrent medical conditions included onychomycosis of left great toe nail since August 2000. Therefore the subject was treated with ITRACONAZOL. In October 2000 acute sinusitis was diagnosed as well as diarrhea over a period of approximately 2 weeks after a foreign flight. No pathogens were found. In April 2001 the subject was suffering from diarrhea again. According to medical records no acute adverse reactions of vaccination were documented. The subject presented to a doctor on 25 May 2001 with diarrhea (without fever) existing since 20 May 2001 and extreme tiredness with general malaise. Tiredness and malaise resolved at an unspecified date. During a job suitability examination on 13 August 2001 nothing was found. On 6 February 2002 the subject gave a report about vertigo attacks to the general practitioner. On 19 February 2002 no further vertigo attacks occurred and the subject felt better. In the middle of March 2002 the subject developed numbness in feet spreading up to height of belly button during the following days. Additionally the subject experienced coordination disorder at fast walking. The subject was hospitalised on 20 March 2002 over a period of 3 days. At hospitalisation the subject showed sensible T9 paraplegia syndrome and coordination disturbance of legs. According to cerebrospinal NMR there was myelitis at thoracic region. The NMR findings were interpreted as suspected encephalomyelitis disseminate. Lumbar puncture established normal cell count with multiple sclerosis typical oligoclonal bands showing acute immunological cerebral reaction. Viral or bacterial pathogens were not found. The hospital physician diagnosed probable encephalomyelitis disseminate. In October 2003 new inflammatory foci in brain and spine were found in NMR. Diagnose of multiple sclerosis was confirmed. The subject was treated with massive dose cortisone in 2003 and 2004. Symptoms improved partially. According to medical evidence ITRACONAZOL was suspected to be the reason for diarrhea as this medication was known to cause gastrointestinal complaints. The medical expert stated the subject was probably damaged by vaccination with HAVRI X1440 (WHO criteria). This expert considered post vaccination tiredness and malaise as first symptoms of neurological disease. Another medical expert did not see a relation between tiredness episode in May 2001 and multiple sclerosis/acute encephalomyelitis disseminate diagnose because of a time interval of 8 months. He considered vertigo attack in February 2002 as first manifestation of multiple sclerosis/acute encephalomyelitis disseminate. No further information will be available.

VAERS ID:414811 (history)  Vaccinated:2001-05-08
Age:0.2  Onset:2001-08-04, Days after vaccination: 88
Gender:Unknown  Submitted:2011-01-17, Days after onset: 3453
Location:Foreign  Entered:2011-01-18, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No reported medical history and concomitant therapy
Diagnostic Lab Data: Platelet count was at 8X10^3/mm3 and haemoglobin was 9g/dL
CDC Split Type: 201100122
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNUN
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER 1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Haemoglobin decreased, Immunoglobulin therapy, Platelet count decreased, Thrombocytopenic purpura
SMQs:, Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad)
Write-up: Literature case received on 03 January 2011 in foreign country. 6 linked cases were created: - 1 case for DTaP vaccine: 2011-00122 - 2 cases for DTaP-IPV-Hib vaccine: 2011-00123 and 2011-00124 - 2 cases for MMR II: 2011-00125 and 2011-00126 - 1 case for varicella vaccine: 2011-00127 This literature article concerns a retrospective study about 20 thrombocytopenic purpura (children (platelet count < 150X10^3/mm3) under the age of 3 years who were hospitalized between 1989 and 2010, to search for a relationship between vaccination and TP or the cause of TP. These six cases were considered to be post-vaccination TP. A 02-month-old patient, with no reported medical history and concomitant therapy, had received a first dose of DTaP vaccine (manufacturer unknown, batch number, site and route of administration not reported) and a second dose of hepatitis B vaccine (other manufacturer, batch number, site and route of administration not reported) on 08 May 2001. On 04 August 2001, the patient presented with thrombocytopenic purpura. Platelet count was at 8X10^3/mm3 and haemoglobin was 9g/dL. The patient was treated with intravenous immunoglobin (IVIG) 2g/kg over period of 2-4 days. The patient recovered within 1.5 days without recurrence, even after receiving the same vaccination later on. Documents held by sender: literature article.

VAERS ID:415021 (history)  Vaccinated:2001-05-08
Age:0.2  Onset:2001-08-04, Days after vaccination: 88
Gender:Unknown  Submitted:2011-01-19, Days after onset: 3455
Location:Foreign  Entered:2011-01-20, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: hemoglobin, 9.0 g/dL; platelet count, 8000 /mm^3, thrombocytopenia
CDC Split Type: WAES1101USA01466
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC. 1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Haemoglobin decreased, Immunoglobulin therapy, Platelet count decreased, Thrombocytopenic purpura
SMQs:, Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad)
Write-up: It was reported in a published article, titled as stated above, concerning an approximately 11 week old (2 month and 26 days) patient (case 6, tale 1) who 08-MAY-2001 was vaccinated IM with the second dose of RECOMBIVAX HB (manufacturer, dose and Lot# were not identified). On 04-AUG-2001 the patient experienced and diagnosed thrombocytopenia purpura. The hemoglobin was 9.0 and the platelet count was 8000 after the vaccination. The patient was treated with intravenous immunoglobulin during the hospitalization. Subsequently, the patient recovered from thrombocytopenia purpura within 1.5 days without recurrence after receiving the same vaccination later on. The author implied the use of the second dose of RECOMBIVAX HB was related to thrombocytopenia purpura. This is one of the 7 reports from the same source. No further information is available.

VAERS ID:415624 (history)  Vaccinated:2001-05-08
Age:0.3  Onset:2001-08-04, Days after vaccination: 88
Gender:Unknown  Submitted:2011-01-27, Days after onset: 3463
Location:Foreign  Entered:2011-01-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0695996A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Haemoglobin decreased, Immunoglobulin therapy, Platelet count decreased, Thrombocytopenic purpura
SMQs:, Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad)
Write-up: This case was reported in a literature article and described the occurrence of thrombocytopenic purpura in an approximately 3-month-old (2 months and 26 days) subject of unspecified gender who was vaccinated with HEPATITIS B (manufacturer unspecified), and DTPA. On 8 May 2001 the subject received 2nd dose of HEPATITIS B (unknown, lot number not provided), 1st dose of DTPA (unknown, lot number not provided). On 4 August 2001, 88 days after vaccination with DTPA and HEPATITIS B, the subject experienced thrombocytopenic purpura. The subject was hospitalised. Relevant test results included platelet count: 8x10^3/mm3 and hemoglobin: 9 unt. The subject was treated with normal immunoglobulin. At the time of reporting the event was resolved. The author considered the event was related to vaccination with HEPATITIS B and DTPA. The event did not reoccur. Summary of the literature article: The etiology of thrombocytopenia during infancy and early childhood may be different from that of older children, because young children frequently receive vaccines. The following study was performed to understand whether there was a causal relationship between vaccinations and thrombocytopenia. Methods: The authors retrospectively studied, through chart review, the relationship between vaccination and thrombocytopenic purpura in 20 children with thrombocytopenia (platelet count <150 ? 103/mm3) under the age of 3 years who were hospitalized between 1989 and 2010. Cases with a history of infectious symptoms/signs between vaccination and the occurrence of thrombocytopenia were excluded. Thrombocytopenia cases not diagnosed as idiopathic thrombocytopenia purpura but as post-vaccination thrombocytopenic purpura should have a similar vaccination-to-thrombocytopenia interval as reported in Western journals, but which should not be more than 9 weeks after vaccination. Results: Of the 20 cases of thrombocytopenic purpura, 12 followed vaccination and 8 were considered idiopathic. Of the 12 post-vaccination cases, 5 occurred after the second dose of hepatitis B virus vaccine at 1 month of age, 4 occurred after the first dose of diphtheria-tetanus-acellular pertussis-containing vaccine at 2-3 months of age, 2 occurred after the first dose of measles-mumps-rubella vaccine at 16 months of age, and 1 occurred after the first dose of varicella vaccine at 14 months of age. One of these 12 cases, who also had a marked decrease in hemoglobin level without bleeding, was suspected to have Evans syndrome. Conclusion: Vaccination may be a risk factor for infant thrombocytopenic purpura.

VAERS ID:476719 (history)  Vaccinated:2001-05-08
Age:35.0  Onset:2002-03-16, Days after vaccination: 312
Gender:Male  Submitted:2012-12-06, Days after onset: 3918
Location:Foreign  Entered:2012-12-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data: 05/25/2001, Bacterial test negative, Normal; 05/25/2001, Blood test, Normal; CSF cell count, 6 cells; CSF immunoglobulin increased, Increased; CSF oligoclonal band, Positive; Chest X-ray, Normal; Electrocardiogram, Normal; Nuclear magnetic resonance imaging, myelitis thoracic spine; Somatosensory evoked potentials, Normal; Visual evoked potentilas, Normal
CDC Split Type: WAES1212DEU001857
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Bacterial test negative, Blood test normal, CSF cell count increased, CSF immunoglobulin increased, CSF oligoclonal band present, Chest X-ray normal, Diarrhoea, Electrocardiogram normal, Fatigue, Gait disturbance, Laboratory test normal, Malaise, Multiple sclerosis, Myelitis, Nuclear magnetic resonance imaging spinal abnormal, Paraesthesia, Paraplegia, Sensory disturbance, Somatosensory evoked potentials, Stool analysis normal, Vertigo, Visual evoked potentials normal
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (narrow), Noninfectious diarrhoea (narrow)
Write-up: Case was received from the Health Authorities on 13-Aug-2012 (reference number PEI2010038396). Case is medically confirmed. A 34-year-old male patient received a first dose of MUTAGRIP (lot-no. P5856-1) IM into the right buttock on 03-Nov-1998. 2.5 years later, on 20-May-2011, he presented with diarrhoea (4 times a day). He had no fever but complained of feeling extremely unwell and exhausted (coded as fatigue by Health Authority). A blood sample was without pathologic findings and stool was negative for pathogens (25-May-2001). No medical records were provided after May 2001 until 2010, but there was inpatient treatment. On 23-Mar-2010, the patient had an outpatient check-up in a multiple sclerosis clinic. At this time, he was free of complaints (Expanded Disability Status Scale - EDSS 1.0). Regarding his personal history, the patient reported that he had suffered in 2001 from an accentuated fatigue-syndrome, vertigo and gait disturbance. Following the patient''s information, in 2002, suspicion of multiple sclerosis was made (myelitis of thoracic spine, intrathecal IgG-synthesis) and he had developed moderate to mild sensory disturbance in arms and legs twice a year until 2004 and further episodes in October 2006 and May 2008. As to the patient, MRI controls did not show progression over the years. During the consultation on 23-Mar-2010, it was questioned whether the events could retrospectively be considered as acute demyelinating encephalomyelitis (ADEM). This was denied because of the course of the disease and was considered as benign relapsing-remitting multiple sclerosis. An immuno-modulatory therapy was not considered necessary at this time. Reportedly, the following exams were performed during the years but the results were not provided: MRI, CSF, visual evoked potential, auditory evoked potential, magnetical evoked potential and slow synaptic potential. To be noted that the reporting form was filled in by the patient himself (consumer), but medical records were provided as attachments. Additional information was gathered from Health Authority on 16-Aug-2012: Onset date of multiple sclerosis was considered as 20-May-2001 (= onset of AE fatigue). Follow-up information received from HA on 21-Aug-2012: A hospital report dated 10-Apr-2002 was provided. The patient had inpatient neurological check-up from 20-Mar-2002 until 22-Mar-2002. Upon admission, he reported of ascending paraesthesia of the lower limbs from thoracic nerve Th9/10 downwards since about one week. He showed sensible paraplegia, gait and standing were stable. Besides this, no further focal neurological deficiency. The following exams were performed during hospital stay: CSF showed 6 cells, slight IgG synthesis, positive oligoclonal bands. Visual evoked potentials, magnetically evoked potentials and somatosensory evoked potentials showed no pathological findings. Chest X-ray and ECG were normal. A cranial and spinal MRI which was performed prior to the hospital stay in another clinic, showed myelitis of the thoracic spine and single paraventricular foci. The hospital''s diagnosis was "probable multiple sclerosis" (= encehpal(omyel)itis disseminata, ICD10 G35). Therapy with IV corticosteroids was planned, but refused by the patient at this point in time. Symptoms improved spontaneously and the patient left the hospital against medical advice on 22-Mar-2002. Paraesthesia was coded as ''sensory disturbance'' by HA. Follow-up information received from HA on 27-Nov-2012. Vaccination documents were provided. The following additional vaccinations before onset of symptoms were reported: 28-Sep-1998: First dose of TD-PUR (Novartis Vaccines, lot-no. 003081) and a dose of IPV VIRELON (Novartis Vaccines, lot-no. 024031). 03-Nov-1998: MUTAGRIP (lot-no. P5856-1) and a second dose of TD-PUR (Novartis Vaccines, lot-no. 003081). 11-Jun-1999: Third dose of TD-PUR (Novartis Vaccines, lot-no. not reported) and a dose of IPV VIRELON (Novartis Vaccines, lot-no. not reported). 16-Aug-

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