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Case Details (Sorted by Vaccination Date)

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VAERS ID: 117431 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Utah  
Vaccinated:1998-11-23
Onset:1998-11-23
   Days after vaccination:0
Submitted: 1998-11-27
   Days after onset:4
Entered: 1998-12-16
   Days after submission:19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 860A2 / 2 - / -
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0216H / 2 - / -
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. NO147 / 2 - / -

Administered by: Public       Purchased by: Public
Symptoms: Screaming
SMQs:, Hostility/aggression (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NONE~ ()~~~In patient
Other Medications: Tylenol
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: UT980622

Write-up: Pt recv vax on 11/23/98; post vax pt exp inconsolable crying $g 4 hr


VAERS ID: 117590 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: New York  
Vaccinated:1998-11-23
Onset:1998-11-25
   Days after vaccination:2
Submitted: 1998-11-30
   Days after onset:5
Entered: 1998-12-18
   Days after submission:18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV: ROTAVIRUS (ROTASHIELD) / PFIZER/WYETH - / 1 MO / PO

Administered by: Private       Purchased by: Other
Symptoms: Gastrointestinal disorder
SMQs:

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations: UNK~ ()~~~In patient
Other Medications: UNK
Current Illness: none
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: 898335068A

Write-up: Pt recv vax on unknown day; post vax pt exp intussusception


VAERS ID: 117815 (history)  
Form: Version 1.0  
Age: 67.0  
Gender: Female  
Location: Iowa  
Vaccinated:1998-11-23
Onset:1998-11-30
   Days after vaccination:7
Submitted: 1998-12-23
   Days after onset:23
Entered: 1998-12-30
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES 0985920 / 5 RA / -

Administered by: Private       Purchased by: Private
Symptoms: Blood creatine phosphokinase increased, Guillain-Barre syndrome
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Guillain-Barre syndrome (narrow), Demyelination (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Premarin;Medrol;Calcium;
Current Illness: NONE
Preexisting Conditions: chronic bronchiectasis, leg deep veins thrombosis (post operative);
Allergies:
Diagnostic Lab Data: CPK 200;ESR 21;EMG study dx of GBS;
CDC Split Type:

Write-up: development of GBS requiring hospitalization & plasmapheresis;


VAERS ID: 118277 (history)  
Form: Version 1.0  
Age: 51.0  
Gender: Female  
Location: Texas  
Vaccinated:1998-11-23
Onset:1998-11-23
   Days after vaccination:0
Submitted: 1998-11-24
   Days after onset:1
Entered: 1999-01-22
   Days after submission:59
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUOGEN) / PARKDALE PHARMACEUTICALS 00408P / 1 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Injection site hypersensitivity, Injection site mass, Injection site oedema, Vasodilatation
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: UNK~ ()~~~In patient
Other Medications: Premarin, Diazide, Doltarin, Lotensin, Plaquevin, Colchicine
Current Illness: NONE
Preexisting Conditions: Rheumatoid arthritis, High blood pressure
Allergies:
Diagnostic Lab Data: Aplisol test supposed to be given
CDC Split Type: FLU90231198

Write-up: Pt recv vax on 11/23/98; on same day pt exp raised, red, edematous, warm area of LA; vax supposed to be given IM


VAERS ID: 118279 (history)  
Form: Version 1.0  
Age: 41.0  
Gender: Female  
Location: Texas  
Vaccinated:1998-11-23
Onset:1998-11-23
   Days after vaccination:0
Submitted: 1998-11-24
   Days after onset:1
Entered: 1999-01-22
   Days after submission:59
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUOGEN) / PARKDALE PHARMACEUTICALS OO4O8P / 1 - / SC

Administered by: Private       Purchased by: Private
Symptoms: Dyspnoea, Injection site hypersensitivity, Injection site mass, Injection site oedema, Rash
SMQs:, Anaphylactic reaction (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NONE~ ()~~~In patient
Other Medications: Norvasc, Zytrec, Aspirin
Current Illness: UNK
Preexisting Conditions: High blood pressure, Allergic to eggs & milk
Allergies:
Diagnostic Lab Data: Supposed to give Aplisol injection
CDC Split Type: FLU90241198

Write-up: Pt recv vax on 11/23/98; on same day pt exp red, edematous, raised area, rash over body, shortness of breath x 24 hr; vax given SC


VAERS ID: 118695 (history)  
Form: Version 1.0  
Age: 22.0  
Gender: Female  
Location: Michigan  
Vaccinated:1998-11-23
Onset:1998-11-23
   Days after vaccination:0
Submitted: 1999-01-06
   Days after onset:44
Entered: 1999-02-09
   Days after submission:34
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1091H / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Ageusia, Paraesthesia, Tongue disorder, Vasodilatation
SMQs:, Peripheral neuropathy (broad), Taste and smell disorders (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NONE~ ()~~~In patient
Other Medications: Norplant-birth control
Current Illness: NONE
Preexisting Conditions: allergy: PCN;acyclovir
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: flushed red face, feels hot;loss of taste & tongue felt numb gave DPH & took to urgent care @ 4PM;tongue sx became worse while there 0.3cc of epi given w/relief;


VAERS ID: 157526 (history)  
Form: Version 1.0  
Age: 3.0  
Gender: Female  
Location: Illinois  
Vaccinated:1998-11-23
Onset:1999-08-11
   Days after vaccination:261
Submitted: 2000-05-16
   Days after onset:279
Entered: 2000-07-19
   Days after submission:64
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1258H / 1 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Dermatitis bullous, Drug ineffective, Infection
SMQs:, Severe cutaneous adverse reactions (narrow), Lack of efficacy/effect (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~Varicella (Varivax)~~1.40~In Sibling
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES99082074

Write-up: On 11/24/98, this pt recieved vax. Subsequent to receiving one dose of varicella virus vax, in 08/99, the pt experienced clinical varicella with more than 50 papulovesicular lesions with oozing. The eruptions lasted 2 weeks, cleared then reappeared. The pt was afebrile. The pt sought unspecified medical treatment. Additionally the pharmacist reported that his other child experienced a similar reaction. Follow up information received from the physician indicated that on 08/11/1999 the pt experienced atypical varicella. The pt''s sibling experienced the same reaction on 07/28/1999. On an unspecified date the pt recovered. No further information is available.


VAERS ID: 157700 (history)  
Form: Version 1.0  
Age: 28.0  
Gender: Male  
Location: Connecticut  
Vaccinated:1998-11-23
Onset:1999-04-01
   Days after vaccination:129
Submitted: 2000-07-19
   Days after onset:474
Entered: 2000-07-21
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (NO BRAND NAME) / MICHIGAN DEPT PUB HLTH FAV030 / 4 - / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arthralgia, Hypersensitivity, Muscular weakness, Oedema peripheral, Red blood cell count decreased, Urticaria, Weight increased
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haematopoietic erythropenia (narrow), Peripheral neuropathy (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Family history of DM
Allergies:
Diagnostic Lab Data: On exam-muscle weakness. TSH/RF/ESR/ANA, Chem 16-wnl, normal labs. On 2/17/99, Hep-C antibody was nonreactive. On 2/17/99, RBC-low, MCV-high, MCH-high
CDC Split Type:

Write-up: 28 year old male with complaint of intermittent rash and increasing bilateral knee and hand swelling and pain that began, post vax, 3rd dose and progressively worsened after the 4th dose on 11/23/98. Hard to climb stairs. Abnormal weight gain despite strenuous exercise program at physical training. Anthrax provider thought it might be related to vaccine received 8 or 9 months ago. Skin had mild bilateral erythematous region. Temporal region with blanches. Minimal erythema left and right of anterior neck at collar line. Questionable exercise induced urticaria vs less likely reaction to Anthrax vaccine.


VAERS ID: 172238 (history)  
Form: Version 1.0  
Age: 1.0  
Gender: Male  
Location: Unknown  
Vaccinated:1998-11-23
Onset:2001-03-05
   Days after vaccination:833
Submitted: 2001-05-15
   Days after onset:70
Entered: 2001-06-01
   Days after submission:17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Skin ulcer, Viral infection
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES01030822

Write-up: On 03/05/2001 the patient experienced a chicken pox outbreak, greater than 20 pox, mostly on the trunk and groin areas. The patient experienced nausea and vomiting. The patient had no fever. The reporter was not sure if the patient was exposed to a wild type virus. No additional information is expected.


VAERS ID: 226053 (history)  
Form: Version 1.0  
Age: 6.0  
Gender: Male  
Location: Texas  
Vaccinated:1998-11-23
Onset:2004-08-23
   Days after vaccination:2100
Submitted: 2004-08-23
   Days after onset:0
Entered: 2004-08-31
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Drug ineffective, Viral infection
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Pt received vaccine on 11/23/98 and on this date 8/23/04 with a mild case of chicken pox.


VAERS ID: 237869 (history)  
Form: Version 1.0  
Age: 1.7  
Gender: Male  
Location: Oklahoma  
Vaccinated:1998-11-23
Onset:2004-04-18
   Days after vaccination:1973
Submitted: 2005-05-16
   Days after onset:393
Entered: 2005-05-23
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1324E / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Skin ulcer, Viral infection
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0404USA01770

Write-up: Information has been received from a physician concerning a 7 year old male pt who on 23Nov98 was vaccinated with a dose of varicella virus vaccine live (624656/1324E). On 18Apr04 the pt experienced a chickenpox rash with 13+ lesions. No other symptoms were reported. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 248461 (history)  
Form: Version 1.0  
Age: 1.0  
Gender: Male  
Location: Kentucky  
Vaccinated:1998-11-23
Onset:2005-11-13
   Days after vaccination:2547
Submitted: 2005-11-25
   Days after onset:12
Entered: 2005-11-30
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 2725A2 / 3 LL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0197 / 4 LL / -
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1261H / 1 LA / -

Administered by: Private       Purchased by: Private
Symptoms: Drug ineffective, Skin lesion, Varicella, Viral infection
SMQs:, Lack of efficacy/effect (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Number of lesions were moderate (50-500). Per 60 day follow up report-Since he had varicella menigo encephalitis his long term outlook is uncertain at this time. The Varicella was a wild virus (not vaccine strain) so adverse event was failure to protect.


VAERS ID: 257404 (history)  
Form: Version 1.0  
Age:   
Gender: Male  
Location: Massachusetts  
Vaccinated:1998-11-23
Onset:2006-02-18
   Days after vaccination:2644
Submitted: 2006-05-12
   Days after onset:82
Entered: 2006-05-17
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Private       Purchased by: Public
Symptoms: Rash vesicular
SMQs:, Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0602USA05666

Write-up: Varicella Information has been received from a woman in a physician''s office concerning a male who on 23-NOV-1998 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). The woman reported that on 18-FEB-2006 the patient developed chickenpox symptoms after being exposed to chickenpox two weeks prior. The patient was noted to be afebrile. Medical attention was not sought. At the time of this report, the outcome was unknown. Additional information has been requested.


VAERS ID: 383888 (history)  
Form: Version 1.0  
Age: 25.0  
Gender: Male  
Location: Unknown  
Vaccinated:1998-11-23
Onset:1998-12-09
   Days after vaccination:16
Submitted: 2010-03-31
   Days after onset:4129
Entered: 2010-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (NO BRAND NAME) / MICHIGAN DEPT PUB HLTH FAV030 / UNK UN / UN

Administered by: Military       Purchased by: Military
Symptoms: Dyspnoea, Headache, Nausea, Paraesthesia, Skin tightness, Sleep apnoea syndrome
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Reported shortness of breath one day post vaccination with AVA # 2. Noted that his arm felt tight with tingling for one week and that his nodes felt tender. Noticed occasional headaches AVA # 4, increase in headaches after # 5. He would get 2-3 headaches per week, associated with nausea, and would last approx. 24 hrs. Headaches eventually cleared but returned after deployment. Also reported that approx 1 wk after #5, he wife said he stopped breathing while he was sleeping and she had to pound on him to wake him up. Symptom: Headache(784.0).


VAERS ID: 122169 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:1998-11-23
Onset:0000-00-00
Submitted: 1999-05-13
Entered: 1999-05-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM - / 2 - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: 23Oct98 pt recv Hep dose #1 & 2 days later devel nausea & fever~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 19990103581

Write-up: pt recv vax on 23NOV98 & devel incapacitating fatigue & hands acroparesthesia;


VAERS ID: 150037 (history)  
Form: Version 1.0  
Age: 71.0  
Gender: Male  
Location: Foreign  
Vaccinated:1998-11-23
Onset:1998-11-23
   Days after vaccination:0
Submitted: 2000-02-21
   Days after onset:455
Entered: 2000-03-14
   Days after submission:22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 2 - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Infection, Injection site hypersensitivity, Pruritus, Pulmonary fibrosis, Sepsis
SMQs:, Anaphylactic reaction (broad), Agranulocytosis (broad), Interstitial lung disease (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: bacterial sepsis, pulmonary fibrosis
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES98121651

Write-up: On the same day the pt received his vax, he presented with a 2 to 3 cm bullous injury at the injection site. He also developed injection site redness, generalized itching, and secondary infection of the bullae. The pt was treated with glucocortisoids, methylprednisolone, and loratidine. As of 12/29/98, the pt''s condition persisted. In January or February 1999, he was hosptalized for an underlying condition of lung fibrosis and septicemia with acinetobacter. He later died, but the reporter felt that his death was related to his underlying medical conditions and not to the vax.


VAERS ID: 160178 (history)  
Form: Version 1.0  
Age: 40.0  
Gender: Male  
Location: Foreign  
Vaccinated:1998-11-23
Onset:1998-11-24
   Days after vaccination:1
Submitted: 2000-09-27
   Days after onset:672
Entered: 2000-09-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Convulsion, Diabetes mellitus
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Insulin-dependent diabetes mellitus
Preexisting Conditions: Insulin-dependent diabetes mellitus
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES00091929

Write-up: Information has been received from a physician concerning a 40 year old male who, 24 hours post vax, developed a convulsion and was hospitalized. On an unspecified date, the pt recovered. The pt''s experiences were considered by the reporter to be an "Other Medical Event". The reporting doctor considered the events to be unrelated to vaccination but associated with a primary condition of blood sugar levels. No further information is available.


VAERS ID: 306586 (history)  
Form: Version 1.0  
Age: 2.0  
Gender: Male  
Location: Foreign  
Vaccinated:1998-11-23
Onset:1998-12-17
   Days after vaccination:24
Submitted: 2008-03-06
   Days after onset:3367
Entered: 2008-03-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 200023VH / UNK UN / UN
HEP: HEP B (GENHEVAC B) / SANOFI PASTEUR P03911 / UNK UN / UN
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS 200023VH / UNK UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER 200023VH / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Attention deficit/hyperactivity disorder, Developmental delay, Grand mal convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: D0056333A

Write-up: This case was reported by a regulatory authority (# DE-PEI-PEI2008000932) and described the occurrence of grand mal epilepsy in a 2-year-old male subject who was vaccinated with Infanrix-IPV/Hib (GlaxoSmithKline) for prophylaxis. Co-suspect vaccines included Polio vaccine (unknown manufacturer) and Gen H-B-Vax K (Sanofi Pasteur). On 23 November 1998 the subject received unspecified dose of Infanrix-IPV/Hib (unknown route and application site), unspecified dose of Polio vaccine (unknown route), unspecified dose of Gen H-B-Vax K (unknown route and application site). On 17 December 1998, 24 days after vaccination with Gen H-B-Vax K, Infanrix-IPV/Hib and Polio vaccine, the subject experienced grand mal epilepsy. In February 2002 the subject developed developmental delay and attention deficit hyperactivity disorder or hyperactive disorder. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified. No further information will be available.


VAERS ID: 348511 (history)  
Form: Version 1.0  
Age: 59.0  
Gender: Female  
Location: Foreign  
Vaccinated:1998-11-23
Onset:1998-12-01
   Days after vaccination:8
Submitted: 2009-06-04
   Days after onset:3837
Entered: 2009-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 5 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Arthritis, Inflammation, Metatarsalgia, Polyarthritis, Synoviorthesis, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unspecified date: Knee puncture fluid analysis evidenced 25 000 white blood cells.
CDC Split Type: B0575683A

Write-up: This case was reported by a foreign regulatory authority (number PS20090430, PS090430) and described the occurrence of inflammatory polyarthritis in a 59-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline), and GENHEVAC B (non-gsk). Medical conditions were unspecified. The subject belonged to the association. On 06 November 1992, the subject received first dose of ENGERIX B (injection site and batch unknown). On 11 December 1992 and 11 January 1993, the subject received second and third dose of GENHEVAC B (batch vo233-1). On 10 January 1994, the subject received fourth dose of ENGERIX B (batch unknown). On 23 November 1998, the subject received fifth dose of ENGERIX B (intramuscular, injection site and batch unknown). In December 1998, about one week after last vaccination with ENGERIX B, and more than 4 years after last vaccination with GENHEVAC B, the subject experienced and episode of inflamed toe with "sausage-like toe" (fifth right toe), event considered as first symptom of inflammatory polyarthritis. Then, on unspecified date, the subject started to experience right and left first metatarsus pain, then second and third left metatarsus pain. She also experienced left ankle and knee arthritis. Knee puncture fluid revealed a white blood cell count at 25 000. Then the subject developed fifth and first right metatarsus pain. In August 1999, the subject presented with right sternoclavicular joint pain. In February 2000, the subject was hospitalised for synoviorthesis with HEXATRIONE because of right hip arthritis, as part of inflammatory rheumatism. On discharge, the subject was treated with CYCLADOL, DI-ANTALVIC, and PLAQUENIL. The agency noted that the event were disabling. At the time of reporting the outcome of inflammatory polyarthritis was unknown. The agency considered inflammatory polyarthritis as unlikely related to vaccination with ENGERIX B and GENHEVAC B, according to the foreign method of imputability.


VAERS ID: 116932 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Female  
Location: North Carolina  
Vaccinated:1998-11-24
Onset:1998-11-24
   Days after vaccination:0
Submitted: 1998-11-25
   Days after onset:1
Entered: 1998-11-30
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER 0942540 / 2 - / IM L
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER 360753A / 2 RL / IM
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 451517 / 2 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Convulsion, Hyponatraemia, Hypothermia, Hypoxia
SMQs:, Asthma/bronchospasm (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Hyponatraemia/SIADH (narrow), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: pt recv vax 11AM & 5PM had sz & presented to ER in status epilepticus, hypothermic, hyponatremic;stabilized, intubated transferred to another hosp;


VAERS ID: 117033 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: New York  
Vaccinated:1998-11-24
Onset:1998-11-24
   Days after vaccination:0
Submitted: 1998-11-25
   Days after onset:1
Entered: 1998-12-03
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES 0925880 / 1 LL / IM
HIBV: HIB (PROHIBIT) / CONNAUGHT LABORATORIES 0939480 / 1 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. N00322 / 1 RL / SC

Administered by: Private       Purchased by: Other
Symptoms: Agitation, Apnoea, Crying, Salivary hypersecretion
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: x-rays negative
CDC Split Type:

Write-up: pt recv vax & mom states child fussy & screamed;T99.6;mom was on phone w/friend when states child foamed @ mouth & stopped breathing;friend called the amb;


VAERS ID: 117094 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Virginia  
Vaccinated:1998-11-24
Onset:1998-11-24
   Days after vaccination:0
Submitted: 1998-11-26
   Days after onset:2
Entered: 1998-12-04
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (ACEL-IMUNE) / PFIZER/WYETH 454759 / 1 LL / -
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1013H / 1 RL / -
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. N10351 / 1 RL / -

Administered by: Military       Purchased by: Unknown
Symptoms: Apnoea, Bradycardia, Cyanosis, Hypotonia, Hypoxia, Pallor, Somnolence
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: Zantac, Reglan, Caffeine, Aldactazio, NACL
Current Illness: apnea-prematurity, prematurity 26wk
Preexisting Conditions: NKA;prematurity 26wk;
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: pt became pale, cyanotic, lethargic, limp, apneic & bradycardic heart rate 60''s, given blow by 100% flow then positive pressure ventilation;MD notified pt responded to ventilation then placed on nasal cannula;


VAERS ID: 117247 (history)  
Form: Version 1.0  
Age: 68.0  
Gender: Male  
Location: South Carolina  
Vaccinated:1998-11-24
Onset:1998-11-24
   Days after vaccination:0
Submitted: 1998-12-01
   Days after onset:7
Entered: 1998-12-09
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES 0981810 / UNK RA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0664E / 2 RA / SC
TD: TD ADSORBED (NO BRAND NAME) / CONNAUGHT LABORATORIES 0908180 / UNK LA / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NA~ ()~~~In patient
Other Medications:
Current Illness: NA
Preexisting Conditions: HTN, hx polyps & stomach problems;arterial sclerosis;
Allergies:
Diagnostic Lab Data:
CDC Split Type: SC98083

Write-up: pt reports onset of swelling in posterior rt arm on 24NOV98 in the vicinity of pneumococcal vax;swelling cont to an approx 10" x 3" area above the elbow & was accompanied by soreness & sl redness;


VAERS ID: 117270 (history)  
Form: Version 1.0  
Age: 1.3  
Gender: Unknown  
Location: Oklahoma  
Vaccinated:1998-11-24
Onset:1998-11-24
   Days after vaccination:0
Submitted: 1998-11-24
   Days after onset:0
Entered: 1998-12-10
   Days after submission:16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0842H / 1 RA / SC

Administered by: Private       Purchased by: Other
Symptoms: Injection site hypersensitivity, Vasodilatation
SMQs:, Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NONE~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: OK9847

Write-up: pt had a localized red rash around inj site of varicella then dissipated w/in 2min;


VAERS ID: 117310 (history)  
Form: Version 1.0  
Age: 36.0  
Gender: Male  
Location: New York  
Vaccinated:1998-11-24
Onset:1998-11-25
   Days after vaccination:1
Submitted: 1998-12-07
   Days after onset:12
Entered: 1998-12-11
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 109110 / 5 LA / -

Administered by: Private       Purchased by: Private
Symptoms: Haemorrhage, Hypertonia, Injection site pain, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NONE~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: allergic to PCN
Allergies:
Diagnostic Lab Data: lt shoulder soft tissue x-ray lt deltoid pain s/p vaccine r/o hematoma, indurated;
CDC Split Type:

Write-up: pt recv vax arm/shoulders sharp tightening pain has been non-stop;suspected rxn lt shoulder myalgia r/o muscular hematoma;


VAERS ID: 117378 (history)  
Form: Version 1.0  
Age: 36.0  
Gender: Male  
Location: Idaho  
Vaccinated:1998-11-24
Onset:1998-11-24
   Days after vaccination:0
Submitted: 1998-12-07
   Days after onset:13
Entered: 1998-12-15
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Public       Purchased by: Private
Symptoms: Cough, Dyspnoea, Hyperhidrosis, Myalgia, Pyrexia, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: NONE
Current Illness: sniffles
Preexisting Conditions: jellyfish allergy
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: chills, severe shaking, high temp 104, lasting approx 1 1/2hr, body aches, sweating profusely by 3AM recovered;problem breathing, some coughing;


VAERS ID: 117405 (history)  
Form: Version 1.0  
Age: 0.5  
Gender: Male  
Location: Colorado  
Vaccinated:1998-11-24
Onset:0000-00-00
Submitted: 1998-12-04
Entered: 1998-12-15
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (TETRAMUNE) / PFIZER/WYETH 453471 / 3 - / -
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 2713A2 / 3 - / -
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 455727 / 3 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Skin nodule
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Pt recv vax on 11/24/98; 1.5 wk post vax pt exp knot on leg


VAERS ID: 117485 (history)  
Form: Version 1.0  
Age: 58.0  
Gender: Female  
Location: West Virginia  
Vaccinated:1998-11-24
Onset:1998-12-04
   Days after vaccination:10
Submitted: 1998-12-07
   Days after onset:3
Entered: 1998-12-17
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / CONNAUGHT LABORATORIES 0977220 / UNK LA / -

Administered by: Private       Purchased by: Private
Symptoms: Asthenia, Dizziness, Pharyngitis, Pyrexia, Rhinitis
SMQs:, Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NONE~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: Allergic to pollen, molds, rabbit hair; Scarlet fever at 8 yr age
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Pt recv vax on 11/24/98; on 12/4/98 pt exp sore throat, runny nose, fever &chills, dizzy, weak, nasal congestion; tx=allergy tablets


VAERS ID: 117880 (history)  
Form: Version 1.0  
Age: 18.0  
Gender: Female  
Location: South Dakota  
Vaccinated:1998-11-24
Onset:0000-00-00
Submitted: 1998-12-24
Entered: 1999-01-04
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 2706A2 / 1 RA / IM

Administered by: Private       Purchased by: Public
Symptoms: Alopecia
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Pt recv #1 dose of HepB 9/10/98; exp hair loss~ ()~~~In patient
Other Medications: Multivitamin
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Free T4, TSH-WNL
CDC Split Type:

Write-up: Pt recv vax on 11/24/98; pt exp ongoing hair loss


VAERS ID: 117970 (history)  
Form: Version 1.0  
Age: 45.0  
Gender: Female  
Location: Alabama  
Vaccinated:1998-11-24
Onset:1998-11-25
   Days after vaccination:1
Submitted: 1998-11-25
   Days after onset:0
Entered: 1999-01-07
   Days after submission:43
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES 0978490 / UNK LA / -

Administered by: Public       Purchased by: Public
Symptoms: Asthenia, Asthma, Tachycardia
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NA
CDC Split Type: AL9817

Write-up: pt recv vax @ approx 2PM 24NOV98 & 6PM had some wheezing, rapid heart beat & felt weak;


VAERS ID: 118157 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Female  
Location: Illinois  
Vaccinated:1998-11-24
Onset:1998-11-24
   Days after vaccination:0
Submitted: 1999-01-07
   Days after onset:44
Entered: 1999-01-19
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 2617A2 / 2 LA / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1235E / 2 RA / SC
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 0794K / 4 MO / PO

Administered by: Public       Purchased by: Public
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NONE~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: IL99001

Write-up: mom called to say that child had devel hives p/vax which went away p/taking DPH;mom denied any other sx or problems;


VAERS ID: 118412 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Indiana  
Vaccinated:1998-11-24
Onset:1998-11-24
   Days after vaccination:0
Submitted: 1999-01-25
   Days after onset:62
Entered: 1999-01-28
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER A862A2 / 1 LL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 361503A / 1 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. NO498 / 1 RL / -
RV: ROTAVIRUS (ROTASHIELD) / PFIZER/WYETH 4988080 / 1 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Screaming
SMQs:, Hostility/aggression (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: UNK~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Pt recv vax on 11/24/98; on same day pt exp non-stop crying for 4 day


VAERS ID: 119035 (history)  
Form: Version 1.0  
Age: 19.0  
Gender: Female  
Location: Maine  
Vaccinated:1998-11-24
Onset:1998-11-24
   Days after vaccination:0
Submitted: 1998-11-25
   Days after onset:1
Entered: 1999-02-16
   Days after submission:83
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 2712A2 / 3 - / -

Administered by: Private       Purchased by: Public
Symptoms: Insomnia, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NONE~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: Innocent heart murmur age 18
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: ME98033

Write-up: Pt recv vax on 11/24/98; on same day pt exp vomiting


VAERS ID: 119036 (history)  
Form: Version 1.0  
Age: 0.1  
Gender: Female  
Location: Maine  
Vaccinated:1998-11-24
Onset:1998-11-24
   Days after vaccination:0
Submitted: 1998-11-25
   Days after onset:1
Entered: 1999-02-16
   Days after submission:83
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 2712A2 / 2 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Agitation, Hyperhidrosis, Insomnia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NONE~ ()~~~In patient
Other Medications: NONE
Current Illness: Rash on face/chin-eczema
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: ME98032

Write-up: Pt recv vax on 11/24/98; 1 hr post vax pt exp fussiness, spitting up, increased sleeping, night sweating; tx=Pedialyte


VAERS ID: 119397 (history)  
Form: Version 1.0  
Age: 25.0  
Gender: Male  
Location: Washington  
Vaccinated:1998-11-24
Onset:1998-11-24
   Days after vaccination:0
Submitted: 1998-12-09
   Days after onset:15
Entered: 1999-02-25
   Days after submission:78
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUOGEN) / PARKDALE PHARMACEUTICALS 06408P / 1 LA / -

Administered by: Other       Purchased by: Private
Symptoms: Face oedema, Rhinitis, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: unk~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: PCN & erythro
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WA991527

Write-up: 4wk p/vax sneezing, hives, lt eye swelled shut got DPH over the noc & sx resolved;brought to medical unit of residential treatment;


VAERS ID: 120066 (history)  
Form: Version 1.0  
Age:   
Gender: Male  
Location: Pennsylvania  
Vaccinated:1998-11-24
Onset:1998-11-25
   Days after vaccination:1
Submitted: 1999-03-01
   Days after onset:96
Entered: 1999-03-03
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Face oedema, Injection site hypersensitivity
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: no relevant data;~ ()~~~In patient
Other Medications: unk
Current Illness:
Preexisting Conditions: unk
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES98120135

Write-up: pt recv vax 24NOV98 & 25NOV98 pt exp a hypersensitivity rxn, a rash @ the inj site that became disseminated & eye swelling;


VAERS ID: 119777 (history)  
Form: Version 1.0  
Age: 1.3  
Gender: Female  
Location: New Mexico  
Vaccinated:1998-11-24
Onset:1998-11-25
   Days after vaccination:1
Submitted: 1998-12-01
   Days after onset:6
Entered: 1999-03-08
   Days after submission:97
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 862A2 / 4 RL / IM
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / MEDEVA PHARMA, LTD. E20098GA / UNK LL / -
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0672H / 1 LL / SC

Administered by: Public       Purchased by: Public
Symptoms: Agitation, Asthma, Convulsion, Febrile convulsion, Pyrexia
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations: unk~ ()~~~In patient
Other Medications: albuterol;Nitrofurantoin
Current Illness: mild viral synd (URI)
Preexisting Conditions: poor growth, vesicoureterel reflux, VSD, gastroesophageal reflux, developmental delay
Allergies:
Diagnostic Lab Data: all blood cult & urine cult x 2 negative no growth;
CDC Split Type: NM98027

Write-up: child fussy on 24NOV98 p/vax given & then had fever 25NOV98 brief sz;pt got blood cult & urine cult;pt was wheezing so given med;sent home but came back w/another sz & adm 25NOV98 until 26NOV98;came back later w/fever-looked good sent home


VAERS ID: 120107 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Minnesota  
Vaccinated:1998-11-24
Onset:1999-02-04
   Days after vaccination:72
Submitted: 1999-03-05
   Days after onset:29
Entered: 1999-03-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Private       Purchased by: Other
Symptoms: Abortion
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: No relevant data;~ ()~~~In patient
Other Medications: unk
Current Illness:
Preexisting Conditions: unk
Allergies:
Diagnostic Lab Data: 15DEC98 beta-human chorionic gon-positive;
CDC Split Type: WAES98121673

Write-up: pt recv vax 24NOV98 & a pregnant test was positive on 15DEC98;LMP 27NOV98;EDD is 3SEP99;f/u was recv from RN. pt had an elective abortion on 4FEB99 @ 9 1/2wk from LMP;


VAERS ID: 120920 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Male  
Location: Wisconsin  
Vaccinated:1998-11-24
Onset:1998-11-24
   Days after vaccination:0
Submitted: 1998-11-25
   Days after onset:1
Entered: 1999-04-05
   Days after submission:130
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 2706A2 / 2 LA / -

Administered by: Unknown       Purchased by: Public
Symptoms: Dyspnoea, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: inhalants for asthma PRN
Current Illness: NONE
Preexisting Conditions: asthma, hyperactivity, no allergies
Allergies:
Diagnostic Lab Data:
CDC Split Type: WI98063

Write-up: devel generalized itching p/vax 24NOV98;devel generalized hives, some SOB which subsided w/DPH;seen by MD;


VAERS ID: 124373 (history)  
Form: Version 1.0  
Age: 1.0  
Gender: Female  
Location: Massachusetts  
Vaccinated:1998-11-24
Onset:1998-11-25
   Days after vaccination:1
Submitted: 1999-05-14
   Days after onset:169
Entered: 1999-05-21
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1262H / 1 - / SC

Administered by: Private       Purchased by: Public
Symptoms: Dermatitis bullous, Pyrexia
SMQs:, Severe cutaneous adverse reactions (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: sibling, rash, varicella virus~ ()~~~In Sibling
Other Medications: unk
Current Illness:
Preexisting Conditions: unk
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES98121643

Write-up: approx 36hrs following vax pt devel 1 lesion, @ time of rpt pt had 15 scattered vesicles on face & trunk. & fever.


VAERS ID: 124378 (history)  
Form: Version 1.0  
Age: 7.0  
Gender: Female  
Location: Massachusetts  
Vaccinated:1998-11-24
Onset:1998-12-18
   Days after vaccination:24
Submitted: 1999-05-14
   Days after onset:146
Entered: 1999-05-21
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1058H / 1 LA / SC

Administered by: Private       Purchased by: Public
Symptoms: Dermatitis bullous
SMQs:, Severe cutaneous adverse reactions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: no relevant data~ ()~~~In patient
Other Medications: unk
Current Illness:
Preexisting Conditions: unk
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES98121728

Write-up: approx 1mo p/vax pt devel 6 pustules on scalp & forehead


VAERS ID: 122615 (history)  
Form: Version 1.0  
Age: 1.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:1998-11-24
Onset:1998-12-05
   Days after vaccination:11
Submitted: 1999-05-21
   Days after onset:166
Entered: 1999-05-24
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 1 - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Otitis media, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: No Relevant Data~ ()~~~In patient
Other Medications: unk
Current Illness:
Preexisting Conditions: unk
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES98121000

Write-up: p/vax pt devel a flat & patchy rash on face & trunk that looked like rubeola, as well as otitis;pt sought unspecified medical attention & tx w/amoxicillin;


VAERS ID: 125943 (history)  
Form: Version 1.0  
Age: 70.0  
Gender: Unknown  
Location: Nebraska  
Vaccinated:1998-11-24
Onset:1998-11-24
   Days after vaccination:0
Submitted: 1999-07-12
   Days after onset:229
Entered: 1999-07-14
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1247H / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Headache, Injection site oedema, Malaise, Oedema peripheral, Pyrexia, Vomiting
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: No Relevant Data~ ()~~~In patient
Other Medications: unk
Current Illness:
Preexisting Conditions: unk
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES98120025

Write-up: p/vax pt devel a fever 102-103, inj site swelling, swelling of arm, malaise, nausea, vomiting & severe h/a;pt recovered;


VAERS ID: 126250 (history)  
Form: Version 1.0  
Age: 0.5  
Gender: Unknown  
Location: Oklahoma  
Vaccinated:1998-11-24
Onset:1998-11-29
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 1999-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES 0944770 / 3 - / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1363H / 3 - / IM
RV: ROTAVIRUS (ROTASHIELD) / PFIZER/WYETH 48006 / 1 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Dehydration, Intestinal obstruction, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations: ~ ()~~~In patient
Other Medications: Amoxicillin
Current Illness: rt OM
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: p/vax pt devel vomiting w/ no diarrhea & was then hosp later in the day cont vomiting & was found to be obstructed;was transferred to another hosp & had surgery for intussusception;


VAERS ID: 127355 (history)  
Form: Version 1.0  
Age: 0.6  
Gender: Female  
Location: Ohio  
Vaccinated:1998-11-24
Onset:1998-11-24
   Days after vaccination:0
Submitted: 1999-07-30
   Days after onset:247
Entered: 1999-08-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (ACEL-IMUNE) / PFIZER/WYETH - / 3 - / -
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. - / 3 - / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / 3 - / -

Administered by: Public       Purchased by: Public
Symptoms: Agitation, Diarrhoea, Haemolysis, Hypertension, Hyponatraemia, Infection, Laboratory test abnormal, Pyrexia, Rash, Respiratory disorder, Vomiting
SMQs:, Haemolytic disorders (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Hostility/aggression (broad), Hypertension (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: No Relevant Data~ ()~~~In patient
Other Medications:
Current Illness: common cold
Preexisting Conditions: asthma
Allergies:
Diagnostic Lab Data: 11/24/98 CXR-nl;BP;chem 7: NA=129;K=5.0;Cl=100;BUN=6;creatinine=0.4;lymphocytes=17;monocytes=6;eosinophils=2;strep throat negative;pulse oximetry nl;11/24/98 HGB 30.7;neutrophil count 65;T103.5;HCT 37;full blood chem;platelet count 373
CDC Split Type: WAES99042019

Write-up: while vaccinating pt the plunger rod became loose & vaccine squirted out;pt recv less than recommended dose of vax;pt will be re-vaccinated;pt exp fussiness, vomiting & diarrhea;T103.5;BP 126/77;HGB 30.7;neutrophil 65;diaper rash, URI;


VAERS ID: 151181 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: Iowa  
Vaccinated:1998-11-24
Onset:1998-11-24
   Days after vaccination:0
Submitted: 2000-03-07
   Days after onset:469
Entered: 2000-05-02
   Days after submission:55
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (ACEL-IMUNE) / PFIZER/WYETH - / 1 - / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1190H / UNK - / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH - / 1 - / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. - / 1 - / -

Administered by: Private       Purchased by: Private
Symptoms: Irritability
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES00010051

Write-up: Information has been received from a physician concerning a 10 week old male who, post vax, became very fussy and inconsolable. On 11/25/98, the pt was seen by a physician who noted the pt to be less irritable. On an unspecified date, the pt recovered. Additional information has been requested. Follow up provided no additional data.


VAERS ID: 152419 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Male  
Location: Unknown  
Vaccinated:1998-11-24
Onset:1998-12-03
   Days after vaccination:9
Submitted: 2000-05-26
   Days after onset:539
Entered: 2000-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. - / 2 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Eczema, Platelet count decreased, Thrombocytopenic purpura
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Eczema, petechial rash, URI
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: platelet count-decreased
CDC Split Type: WAES98120486

Write-up: Information has been received from a physician concerning a 5 month old male who entered a study. On 11/24/1998, the pt was seen for his 5 month visit and was noted to have a petechial rash on his forearms and lower legs that was thought to be due to a virus. On 11/24/1998, the pt was vaccinated with a second dose of Haemophilus B conjugate vaccine (+) Hep-B vaccine recombinant 0.5 ml IM. On 12/3/1998 the pt returned to the physician to rule out an ear infection. Petechiae were noted on the lower extremities, buttocks, trunk, and extremities. The pt was dx''d with an URI and a CBC with a platelet count was ordered. On 12/4/1998, platelet count results were 25,000 k/ml and the pt was admitted to a hospital with a dx of thrombocytopenia. While hospitalized, the pt was administered with a first dose of IVIG. On 12/5/1998 a platelet count was 34,000 and second dose of IVIG was given. On 12/6/1998 the pt had a platelet count 97,000 and he was discharged. On 12/11/1998 a follow-up visit with a doctor revealed a platelet count of 293,000 and a CBC was normal. No petechial rash was noted and the doctor felt the ITP had resolved. The pt was dx''d with facial eczema and treated with Eucerin creme. After consideration, the study doctor elected to drop the pt from the study, however, the doctor did not consider the pt''s experience related to study vaccine. No further information is available.


VAERS ID: 121527 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Male  
Location: Pennsylvania  
Vaccinated:1998-11-24
Onset:1998-11-24
   Days after vaccination:0
Submitted: 1998-12-03
   Days after onset:9
Entered: 2000-06-22
   Days after submission:566
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (ACEL-IMUNE) / PFIZER/WYETH 456817 / UNK - / -
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1665E / UNK - / -
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. N1035 / UNK - / -
RV: ROTAVIRUS (ROTASHIELD) / PFIZER/WYETH 4988043 / 1 MO / PO

Administered by: Private       Purchased by: Other
Symptoms: Abdominal pain, Diarrhoea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: unk~ ()~~~In patient
Other Medications: unk
Current Illness: NONE
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: stool specimens-negative for C difficile toxins & for ova & parasites;positive for rotavirus antigens;
CDC Split Type: 898341077A

Write-up: pt recv vax 24NOV98 & that evening pt devel a low grade fever & severe diarrhea w/cramping;stool specimens were negative for C difficile toxin & ova & parasites & positive for rotavirus antigens;


VAERS ID: 155394 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: Texas  
Vaccinated:1998-11-24
Onset:1998-11-30
   Days after vaccination:6
Submitted: 1999-12-22
   Days after onset:387
Entered: 2000-06-23
   Days after submission:183
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (ACEL-IMUNE) / PFIZER/WYETH - / UNK - / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH - / UNK - / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / PASTEUR MERIEUX INST. - / UNK - / -
RV: ROTAVIRUS (ROTASHIELD) / PFIZER/WYETH 4978318 / 1 MO / PO

Administered by: Private       Purchased by: Other
Symptoms: Diarrhoea, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Stool specimens-neg; stool culture-neg
CDC Split Type: U1999010910

Write-up: "A PA reported that a 2 month old male, post vax on 11/30/98, vomited twice. He was seen by the reporter who, prescribed Pedialyte. The infant was seen again on 12/3/98, because he had developed watery diarrhea (3-4 watery brown stools per day), which began on 11/30/98, after leaving the office. The infant''s formula was changed from Similac to Isomil. On 12/4/98, the mother reported that the infant had 1 firm stool. On 12/7/98, the mother reported that the infant recovered."


VAERS ID: 129391 (history)  
Form: Version 1.0  
Age: 1.0  
Gender: Male  
Location: New Hampshire  
Vaccinated:1998-11-24
Onset:1999-10-04
   Days after vaccination:314
Submitted: 1999-10-06
   Days after onset:2
Entered: 2000-07-10
   Days after submission:278
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0957H / UNK RL / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1262H / UNK LL / SC

Administered by: Private       Purchased by: Public
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: pt had rash on lt groin x 2 days spread to lt buttock;


VAERS ID: 171904 (history)  
Form: Version 1.0  
Age: 1.0  
Gender: Male  
Location: Florida  
Vaccinated:1998-11-24
Onset:2000-11-09
   Days after vaccination:716
Submitted: 2001-05-15
   Days after onset:186
Entered: 2001-06-01
   Days after submission:17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 6281481324H / 2 - / SC

Administered by: Private       Purchased by: Private
Symptoms: Blister, Rash pruritic
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Speech disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES00111833

Write-up: On 11/09/2000 the patient experienced greater than 30 lesions on his body. The lesions were described as pruritic fluid-filled vesicles. Additional information has been requested.


VAERS ID: 237962 (history)  
Form: Version 1.0  
Age: 2.0  
Gender: Female  
Location: Unknown  
Vaccinated:1998-11-24
Onset:2004-02-01
   Days after vaccination:1895
Submitted: 2005-05-16
   Days after onset:469
Entered: 2005-05-24
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Drug ineffective, Infection
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0405USA00742

Write-up: Information has been received from a health professional concerning a 7 year old female who on 11/24/1998 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently in February 2004, the patient experienced breakthrough chickenpox. It was reported that there was a total of 45 cases of breakthrough in the patient''s school, including the patient, and 17 were vaccine recipients. Unspecified medical attention was sought. There was no product quality complaint involved. The reporter indicated that 16 other patients had similar experiences following exposure to varicella virus vaccine live (Oka/Merck). Additional information has been requested.


VAERS ID: 255652 (history)  
Form: Version 1.0  
Age: 24.0  
Gender: Male  
Location: Idaho  
Vaccinated:1998-11-24
Onset:1998-11-25
   Days after vaccination:1
Submitted: 2006-05-17
   Days after onset:2729
Entered: 2006-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV017 / 1 LA / IM

Administered by: Military       Purchased by: Military
Symptoms: Cyst, Ear discomfort, Ear disorder, Nasopharyngitis, Otitis media, Sinusitis, Tinnitus
SMQs:, Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Severe ear infection in both ears; see # 7 above.
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Endoscopic exam of sinuses demonstrated fairly significant inflammatory changes in adenoid tissue consistent with sinusitis which most likely is cause for ETD. Normal audiometry exam. Paranasal Sinus CT 7/14/1999 revealed inflammatory changes in left maxillary sinus. Sinus CT 01/16/2001 revealed maxillary retention cyst and no other changes of active sinonasal inflammatory disease, multiple anatomic changes predisposing of the ostiomeatal pathway with very mild septal deviation bilateral concha bullosa right Haller air cell and small bony ridge and very long uncinate process with narrowing of the hiatus semilunaris.
CDC Split Type:

Write-up: In 1998 after receiving the first Anthrax shot, I immediately developed a severe ear infection in both ears. I was unable to fly for over 1 month due to Eustachian Tube Dysfunction. I was put on several decongestants and antibiotics after seeing 2 ENT specialists. Over the next 2 years, I still had problems completely clearing my ears at all times. I eventually had sinus surgery in Jan 2001 in an attempt to relieve the symptoms. This gave me little to no relief and I still have chronic problems with both ears. The main symptoms that still exist after 8 years are constant crackling and popping in both ears, completely clogged Eustachian tubes on occasion, especially when flying inverted, and occasional ringing of the ears. I have since seen 3 more ENT specialists and an Allergist who have been unable to help. I was forced to take 3 more Anthrax boosters through Nov of 1999, despite my symptoms; I was also never told or advised that I could fill out a VAERS form until now for the reactions that I had after the shot. I was told that there was no possible way that the Anthrax shots were linked with my Eustachian Tube Dysfunction. 54 page medical history received from patient-these records encompass dates of service 11/30/1998-4/21/2006 from both military and civilian medical providers of care. Office notes for visit of 11/30/1998, 6 days after anthrax vaccine (11/24/1998) patient arrived with c/o 3-4 day of left ear pressure and crackling, ear ache and inability to Valsalva. Current medication include Afrin. Physical exam revealed normal right tympanic membrane with normal Valsalva and left slightly bulging with slow Valsalva. DX eustachian tube dysfunction (ETD). RX included Entex LA and follow-up in 3 days at which time records document on 12/2/1998 normal right TM and Valsalva with left bulging and no valsalvae. RX with Sudafed, DC Entex. Continued with same complaints and changes to RX to include Prednisone through 12/7/1998 at which time a referral to civilian physician was made due to patient''s role as pilot of an F15 that requires toleration of barometric pressure between 8000'' and 11,000'' and he experiences difficulty with Valsalva maneuvers on left.. Note of 12/11/1998 documents that patient drove in the mountains shortly after Anthrax vaccine and has continued with ETD. Physical exam revealed nasopharyngitis with blocked eustachian tube. RX with Augmentin. Follow-up visit on 12/14/1998 revealed clear ears without difficulty, notices a nonpainful squeak in left ear with clearing. DX Sinusitis, ETD resolved. Symptoms returned 1/28/1999, Subsequently RX''s with Zithromax and Floxin ear drops. 01/18/2001 bilateral anterior intranasal endoscopic ethmoidectomy and bilateral endoscopic maxillary antrostomy performed. No medical visits for c/o ETD between 02/08/2001 and 06/24/2004.


VAERS ID: 256217 (history)  
Form: Version 1.0  
Age: 1.37  
Gender: Female  
Location: Ohio  
Vaccinated:1998-11-24
Onset:2005-06-13
   Days after vaccination:2393
Submitted: 2006-05-12
   Days after onset:333
Entered: 2006-05-17
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES 0939790 / 4 - / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH M240RL / 4 - / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1054H / UNK - / -

Administered by: Public       Purchased by: Other
Symptoms: Rash vesicular, Viral infection
SMQs:, Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: chickenpox~Varicella (Varivax)~~6.00~In Sibling
Other Medications: Adderall tablets, Clonidine; Zoloft
Current Illness:
Preexisting Conditions: Attention deficit/hyperactivity disorder
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0506USA02387

Write-up: Information has been received from a RN concerning a 7 year old Caucasian female with attention deficit disorder and no drug allergies who on 24Nov98 was vaccinated with a dose of varicella virus vaccine live (lot 626966/1054H). Concomitant vaccination given on the same day included the fourth dose of diphtheria toxoid (+) pertussis acellular Biken vaccine (+) tetanus toxoid (Tripedia) (lot0939790) given IM in the left vastus lateralis (LVL) and the fourth dose of Hib conj vaccine (CRM197) (Hibtiter) (lot M240RL) given IM in the LVL. There was no illness at the time of vaccination. Concomitant therapy included sertraline HC1 (Zoloft), clonidine and amphetamine aspartate/amephetamine SO4/dex (Adderall tablets). On 13Jun05 (previously reported as 11Jun05) the pt developed breakthrough chickenpox characterized by a lot of pox on her chest, back and perineal area. Unspecified medical attention was sought. No lab or diagnostic tests were performed. The pt was reported to be in active recovery as of 17Jun05. The reporter also noted that the pt had received the following vaccinations on 14Jul98: the first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot625314/1681E) given SC in the LVL and the third dose of poliovirus vaccine inactivated (IPOL) (lot U0903) given IM in the RL. No product quality complaint was involved. The nurse also reported that the pt''s brother developed breakthrough chickenpox (associated WAES0506USA02915). Additional information is not expected.


VAERS ID: 256904 (history)  
Form: Version 1.0  
Age: 1.23  
Gender: Female  
Location: Ohio  
Vaccinated:1998-11-24
Onset:2005-10-31
   Days after vaccination:2533
Submitted: 2006-05-12
   Days after onset:192
Entered: 2006-05-17
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0644H / UNK - / -

Administered by: Private       Purchased by: Private
Symptoms: Diarrhoea, Drug ineffective, Infection, Vomiting
SMQs:, Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: Diaper rash
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0511USA09075

Write-up: Info has been received from a health professional concerning an 8 year old white female student who on 11/24/98 at 11:17 AM was vaccinated in the left arm with varicella virus vaccine live (lot 625475/0644H). It was noted that she had a diaper rash at the time of vaccination. On 10/31/05, the pt developed vomiting and diarrhea. The symptoms continued and the pt presented to the physician''s office on 11/8/05. Additional info has been requested.


VAERS ID: 282050 (history)  
Form: Version 1.0  
Age: 1.2  
Gender: Male  
Location: Ohio  
Vaccinated:1998-11-24
Onset:2007-02-21
   Days after vaccination:3011
Submitted: 2007-05-16
   Days after onset:83
Entered: 2007-05-24
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0790H / 1 UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0846H / 1 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Body temperature increased, Incorrect route of drug administration, Pruritus, Scab, Skin lesion, Varicella
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Hypersensitivity (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: STRATTERA, FOCALIN
Current Illness: Attention/deficit/hyperactivity disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: body temp 101 degree
CDC Split Type: WAES0702USA04074

Write-up: Information has been received from a registered nurse (RN) concerning a 9 year old male with a concurrent condition of attention Deficit Hyperactivity Disorder (ADHD), with no reported drug reaction or allergies, who on 24-November-1998 was vaccinated with a first 0.5 ml dose intramuscularly with Varivax (Lot Number 626959/0846H). Concomitant therapy that day included a first MMR II, which was also administered on 24-November-1998, and dexmethylphenidate hydrochloride (FOCALIN) and atomoxetine hydrochloride (STRATTERA). On 21-February-2007, the patient developed chickenpox, including red lesions on the chest and back, along with a temperature of 101 F. The patient''s was not recovered at the time of this report. Unspecified medical attention was sought. Follow up information indicated that on 21-FEB-2007 the patient developed red lesions on his chest and back for one week. There were scabbing over and his skin was sensitive and itching. He was treated with acyclovir 400mg TID. The outcome was recovered. The reporter considered the event to be an other important medical event. There was no product quality complaint. No additional information is expected.


VAERS ID: 388507 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Female  
Location: Unknown  
Vaccinated:1998-11-24
Onset:2009-11-15
   Days after vaccination:4009
Submitted: 2010-05-14
   Days after onset:179
Entered: 2010-05-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Mumps, Oropharyngeal pain, Parotitis
SMQs:, Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: serum immunoglobulin M, 11/18/09, < 1:10; serum immunoglobulin G, 11/18/09, 2.27; serum amylase test, 11/18/09, 352
CDC Split Type: WAES1001USA02286

Write-up: Information has been received from a physician concerning a 15 year old female who on 20-AUG-1995 was vaccinated with a first dose of MMR II (route, site, dose and lot number not reported). On 24-NOV-1998, the patient was vaccinated with a second dose of MMR II (route, site, dose and lot number not reported). On 22-NOV-2009, the patient experienced mumps (thought the date diagnosed was reported as 01-DEC-2009). The patient was afebrile and did not have parotitis. The outcome for mumps was not reported. Follow-up information was received from a physician who reported that the patient experienced mumps on 15-NOV-2009 (previously reported as 22-NOV-2009) and was diagnosed on 18-NOV-2009 (previously reported as 01-DEC-2009). It was reported that the patient had left parotitis and as other symptoms sore throat. On 18-NOV-2009, the following labs were taken: serum immunoglobulin M test which showed < 1:10, serum immunoglobulin G test which showed 2.27 and serum amylase test which 352. This is one of several reports from the same source. No further information is available.


VAERS ID: 118187 (history)  
Form: Version 1.0  
Age: 0.9  
Gender: Male  
Location: Foreign  
Vaccinated:1998-11-24
Onset:1998-11-30
   Days after vaccination:6
Submitted: 1999-01-08
   Days after onset:39
Entered: 1999-01-20
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK - / SC
MEA: MEASLES (ATTENUVAX) / MERCK & CO. INC. - / 1 - / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Guillain-Barre syndrome, Hypertension, Hyporeflexia, Mental retardation severity unspecified, Neuropathy, Somnolence
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Demyelination (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations: ~ ()~~~In patient
Other Medications: Doliprane;TInset;Recombivax HB 21SEP98;
Current Illness:
Preexisting Conditions: atopic dermatitis;
Allergies:
Diagnostic Lab Data: electromyography neurogenous aspect but nl conduction speed;
CDC Split Type: WAES99010099

Write-up: pt exp drowsiness;2DEC98 hosp troubles of consciousness, severe hypersomnia, psychomotor regression, hebetude;loss of tendon reflexes of lower limbs;motor deficiency & hypertension;loss of tendon reflexes;motor weakness;GBS;


VAERS ID: 133638 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:1998-11-24
Onset:1999-07-09
   Days after vaccination:227
Submitted: 2000-01-26
   Days after onset:201
Entered: 2000-02-02
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK - / SC A

Administered by: Other       Purchased by: Other
Symptoms: Abnormal labour
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES99032666

Write-up: Pt was 5 1/2 wks preg when she rcvd vax. Pt had uncomplicated pregnancy and delivery of healthy full-term baby. Baby was delivered by C-section because of a long labor. The long labor was considered an "other medical event".


VAERS ID: 117093 (history)  
Form: Version 1.0  
Age: 72.0  
Gender: Female  
Location: Ohio  
Vaccinated:1998-11-25
Onset:1998-11-25
   Days after vaccination:0
Submitted: 1998-11-30
   Days after onset:5
Entered: 1998-12-04
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNU-IMUNE) / PFIZER/WYETH 456692 / 1 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Oedema peripheral, Vasodilatation
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: pt exp illness in 1946 w/flu vax;sibling was ill w/flu vax~ ()~~~In patient
Other Medications: antivert;Glaucoma med
Current Illness: NONE
Preexisting Conditions: NKA
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: arm swelled from shoulder to wrist-red, hot;ice & ibuprofen given took approx 5 days for swelling to decrease;


VAERS ID: 117097 (history)  
Form: Version 1.0  
Age: 67.0  
Gender: Male  
Location: Colorado  
Vaccinated:1998-11-25
Onset:1998-11-25
   Days after vaccination:0
Submitted: 1998-11-30
   Days after onset:5
Entered: 1998-12-04
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0490E / 1 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Myalgia, Oedema peripheral, Pruritus, Pyrexia, Rash
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: unk~ ()~~~In patient
Other Medications: albuterol, Azmacort
Current Illness: NONE
Preexisting Conditions: allergic rhinitis, asthma
Allergies:
Diagnostic Lab Data: NOEN
CDC Split Type:

Write-up: fever?/chills first day, very sore to movement of lt arm x 2 days;lt forearm swollen, mildly erythematous & itchy;inj site non tender & w/o swelling or redness;as needed treatment w/claritin & Ibuprofen;


VAERS ID: 117205 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: Delaware  
Vaccinated:1998-11-25
Onset:1998-11-27
   Days after vaccination:2
Submitted: 1998-12-03
   Days after onset:6
Entered: 1998-12-08
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (ACEL-IMUNE) / PFIZER/WYETH 456817 / 1 RL / IM
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 2633A2 / 2 LL / -
HIBV: HIB (HIBTITER) / PFIZER/WYETH 361453A / 1 LL / -
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 0972L / 1 MO / PO
RV: ROTAVIRUS (ROTASHIELD) / PFIZER/WYETH 48017 / 1 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Abnormal faeces, Diarrhoea, Dyspnoea, Hypokinesia, Malaise, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NONE~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: Mild neonatal jaundice-no tx
Allergies:
Diagnostic Lab Data: CBC, BC, UA & Chest X-ray: normal
CDC Split Type:

Write-up: Pt recv vax on 11/25/98; on 11/27/98 pt exp decreased appetite, non-active, bad smelling bowel movement, loose bowels, made grunting noises, fever; pt imp 11/28/98


VAERS ID: 117227 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Alaska  
Vaccinated:1998-11-25
Onset:1998-11-25
   Days after vaccination:0
Submitted: 1998-11-25
   Days after onset:0
Entered: 1998-12-08
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1180H / 2 LA / SC

Administered by: Public       Purchased by: Public
Symptoms: Convulsion, Hypertonia, Hyperventilation, Hypotension, Pallor, Syncope, Tremor, Urinary incontinence
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: PPD by Connaught lot@ 249511 given 25NOV98
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: AK98037

Write-up: pt recv vax & had clenched fists, both arms contracted, curled body forward, rhythmic arm & head tremors;color pale, bladder control lost;BP 90/60, appear faint;hyperventilate;vasovagal vs sz activity;


VAERS ID: 119176 (history)  
Form: Version 1.0  
Age: 0.1  
Gender: Female  
Location: Arizona  
Vaccinated:1998-11-25
Onset:1998-11-26
   Days after vaccination:1
Submitted: 1999-02-08
   Days after onset:74
Entered: 1999-02-19
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES 093710 / 1 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1014H / 2 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. N0596 / 1 RL / SC

Administered by: Private       Purchased by: Unknown
Symptoms: Oedema peripheral, Rash
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness: resolving URi
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: rash on digits, hands, feet w/minimal edema on trunk lasting 5-6 days;appeared w/in 24hr of vax;2nd & 3rd doses of DTAP, HIB were given;IPV #2 given no rxn was noted;


VAERS ID: 120085 (history)  
Form: Version 1.0  
Age: 3.0  
Gender: Female  
Location: California  
Vaccinated:1998-11-25
Onset:0000-00-00
Submitted: 1999-03-01
Entered: 1999-03-03
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0112H / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: No relevant data;~ ()~~~In patient
Other Medications: unk
Current Illness:
Preexisting Conditions: unk
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES98121765

Write-up: pt recv vax 25NOV98 & NOV98 pt exp a high fever up to 105 which lasted 24-48hr;


VAERS ID: 121526 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Female  
Location: New Jersey  
Vaccinated:1998-11-25
Onset:1998-12-01
   Days after vaccination:6
Submitted: 1998-12-02
   Days after onset:1
Entered: 1999-04-23
   Days after submission:141
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV: ROTAVIRUS (ROTASHIELD) / PFIZER/WYETH - / 1 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Agitation, Diarrhoea, Gastrointestinal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: vitamins
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 898341039A

Write-up: pt recv vax 25NOV98 & 1DEC98 pt devel diarrhea w/bloody mucous & irritability;


VAERS ID: 121529 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: California  
Vaccinated:1998-11-25
Onset:1998-12-06
   Days after vaccination:11
Submitted: 1998-12-09
   Days after onset:3
Entered: 1999-04-23
   Days after submission:134
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES 0942540 / 2 - / IM
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES 0994270 / 2 - / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. N0699 / 2 - / IM
RV: ROTAVIRUS (ROTASHIELD) / PFIZER/WYETH 4988050 / 1 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Diarrhoea, Gastrointestinal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NONE~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: stool cult negative;guaiac positive;
CDC Split Type: 898345020A

Write-up: pt recv vax 25NOV98 & 6DEC98 devel diarrhea;the diarrhea contained mucus & blood;stool cult were negative;guaiac was positive;MD changed the formula fed tot he infant & sx resolved;


VAERS ID: 121969 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Male  
Location: Michigan  
Vaccinated:1998-11-25
Onset:1998-11-25
   Days after vaccination:0
Submitted: 1999-04-21
   Days after onset:146
Entered: 1999-05-07
   Days after submission:16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0987H / 1 - / IM
TD: TD ADSORBED (NO BRAND NAME) / CONNAUGHT LABORATORIES 0977220 / UNK - / IM

Administered by: Public       Purchased by: Public
Symptoms: Rash maculo-papular
SMQs:, Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: MI99051

Write-up: pt recv vax & devel sand paper raised rash covering face & some on trunk;appeared w/in a few hr p/vax;lasted about 1wk;mom reported this on 24MAR99 when pt in for 2nd dose;


VAERS ID: 121970 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Female  
Location: Michigan  
Vaccinated:1998-11-25
Onset:1998-11-25
   Days after vaccination:0
Submitted: 1999-04-21
   Days after onset:146
Entered: 1999-05-07
   Days after submission:16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0987H / 1 LA / IM
TD: TD ADSORBED (NO BRAND NAME) / CONNAUGHT LABORATORIES 0977220 / UNK RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Hypersensitivity, Rash maculo-papular
SMQs:, Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: NONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: MI99049

Write-up: pt recv vax 25NOV98 & mom reported on 24MAR99 that w/in a hr noticed a rash which was described as raised sand paper like red bumps on the face & trunk;disappeared in about 3 days;mom felt poss allerg rxn;


VAERS ID: 121971 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Female  
Location: Michigan  
Vaccinated:1998-11-25
Onset:1998-11-25
   Days after vaccination:0
Submitted: 1999-04-21
   Days after onset:146
Entered: 1999-05-07
   Days after submission:16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0987H / 2 LA / -

Administered by: Public       Purchased by: Public
Symptoms: Rash maculo-papular
SMQs:, Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: pt exp crying 1 1/2hr @ 5mo w/DTP dose 2;~ ()~~~In patient
Other Medications: unk
Current Illness: unk
Preexisting Conditions: allergic to cinnamon
Allergies:
Diagnostic Lab Data: unk
CDC Split Type: MI99050

Write-up: pt recv vax 25NOV98 & raised red rash mostly on trunk, splotchy, a few on face & a few on trunk;rash disappeared in about 3 days;mom fearful will have worse rxn next time;


VAERS ID: 122109 (history)  
Form: Version 1.0  
Age: 27.0  
Gender: Female  
Location: North Carolina  
Vaccinated:1998-11-25
Onset:1998-12-02
   Days after vaccination:7
Submitted: 1998-12-17
   Days after onset:15
Entered: 1999-05-13
   Days after submission:146
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEA: MEASLES (ATTENUVAX) / MERCK & CO. INC. 0783E / 1 LA / -

Administered by: Public       Purchased by: Private
Symptoms: Arthralgia, Arthritis, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: N/A~ ()~~~In patient
Other Medications: Pt recv PPD, Connaught, #248421, LA on 11/11/98; Synthroid daily, Tylenol
Current Illness: Backache
Preexisting Conditions: Hx of Grave''s disease 3 yr prior, Hypothyroid
Allergies:
Diagnostic Lab Data: 12/4/98 X-rays showed arthritis in back/ hips; 12/8/98 Lab work TSH, Lupus, rheumatoid arthritis -normal
CDC Split Type:

Write-up: Pt recv vax on 11/25/98; on 12/2/98 pt exp fever (100), joint pain


VAERS ID: 124372 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Female  
Location: Ohio  
Vaccinated:1998-11-25
Onset:1998-12-17
   Days after vaccination:22
Submitted: 1999-05-14
   Days after onset:147
Entered: 1999-05-21
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1257H / 1 LL / SC

Administered by: Private       Purchased by: Private
Symptoms: Dermatitis bullous, Infection, Pruritus
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: no relevant data~ ()~~~In patient
Other Medications: unk
Current Illness:
Preexisting Conditions: varicella exposure
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES98121637

Write-up: approx 22days p/vax pt exp chickenpox all over body w/rash consisting of approx 70 lesions, pt also exp itching.


VAERS ID: 124419 (history)  
Form: Version 1.0  
Age: 6.0  
Gender: Male  
Location: New Jersey  
Vaccinated:1998-11-25
Onset:1998-12-11
   Days after vaccination:16
Submitted: 1999-05-14
   Days after onset:153
Entered: 1999-05-21
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 2 RA / -

Administered by: Public       Purchased by: Public
Symptoms: Infection, Injection site hypersensitivity, Otitis media
SMQs:, Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: No Relevant Data~ ()~~~In patient
Other Medications: Mantoux Test 11/25/98
Current Illness:
Preexisting Conditions: unk
Allergies:
Diagnostic Lab Data: Mantoux test;
CDC Split Type: WAES99010393

Write-up: p/vax pt devel skin lesions @ site of inj & lt shoulder;pt went to ER & was dx w/chickenpox & an ear infect;pt was prescribed amoxicillin for the ear infect;


VAERS ID: 125942 (history)  
Form: Version 1.0  
Age: 70.0  
Gender: Female  
Location: Nebraska  
Vaccinated:1998-11-25
Onset:1998-11-25
   Days after vaccination:0
Submitted: 1999-07-12
   Days after onset:228
Entered: 1999-07-14
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1247H / UNK - / IM

Administered by: Private       Purchased by: Private
Symptoms: Arthralgia, Headache, Injection site hypersensitivity, Injection site oedema, Injection site pain, Malaise, Myalgia, Nausea, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: No Relevant Data~ ()~~~In patient
Other Medications: unk
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES98120024

Write-up: p/vax pt exp general malaise, a fever, & body aches;over next 24 to 48hr pt cont to feel ill w/T101, nausea, severe h/a, arthralgia;rt arm was swollen, erythematous & tender to touch from shoulder to elbow;


VAERS ID: 125958 (history)  
Form: Version 1.0  
Age: 74.0  
Gender: Male  
Location: Nebraska  
Vaccinated:1998-11-25
Onset:1998-11-25
   Days after vaccination:0
Submitted: 1999-07-12
   Days after onset:228
Entered: 1999-07-14
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Hypertonia, Injection site hypersensitivity, Injection site oedema, Malaise
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: No Relevant Data~ ()~~~In patient
Other Medications: unk
Current Illness:
Preexisting Conditions: unk
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES98121878

Write-up: p/vax pt devel inj site swelling & inj site erythema the size of a large first, general malaise, & stiffness of rt arm for tow to three days;pt recovered;


VAERS ID: 125964 (history)  
Form: Version 1.0  
Age: 72.0  
Gender: Unknown  
Location: New York  
Vaccinated:1998-11-25
Onset:1998-11-26
   Days after vaccination:1
Submitted: 1999-07-12
   Days after onset:227
Entered: 1999-07-14
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Cellulitis
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: No Relevant Data~ ()~~~In patient
Other Medications: unk
Current Illness:
Preexisting Conditions: unk
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES99010396

Write-up: p/vax pt devel cellulitis;the reporting MD felt that cellulitis was r/t vax;


VAERS ID: 127352 (history)  
Form: Version 1.0  
Age: 1.3  
Gender: Female  
Location: Washington  
Vaccinated:1998-11-25
Onset:1998-12-04
   Days after vaccination:9
Submitted: 1999-07-30
   Days after onset:237
Entered: 1999-08-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 4 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. - / 3 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 1 RL / SC
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Febrile convulsion
SMQs:, Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations: No Relevant Data~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions: unk
Allergies:
Diagnostic Lab Data: head CAT scan-nl;
CDC Split Type: WAES99041621

Write-up: p/vax pt exp febrile sz & was hosp x 2 days;head CT scan was nl;pt recovered;


VAERS ID: 128670 (history)  
Form: Version 1.0  
Age: 28.0  
Gender: Female  
Location: Ohio  
Vaccinated:1998-11-25
Onset:1999-02-01
   Days after vaccination:68
Submitted: 1999-09-22
   Days after onset:232
Entered: 1999-09-28
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RUB: RUBELLA (MERUVAX II) / MERCK & CO. INC. 1144E / 2 - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abortion
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: No Relevant Data~ ()~~~In patient
Other Medications: Tri-Levlen
Current Illness:
Preexisting Conditions: pregnancy ( LMP=11/17/98) erythromycin allergy;
Allergies:
Diagnostic Lab Data: ultrasound-preg confirmed;serum beta-human-preg confirmed;
CDC Split Type: WAES98121695

Write-up: pt preg, LMP 11/17/98; preg confirmed by ultrasound & BHCG; pt had miscarriage @ 9wk gestational age;pt had D&C;


VAERS ID: 154639 (history)  
Form: Version 1.0  
Age: 19.0  
Gender: Female  
Location: New York  
Vaccinated:1998-11-25
Onset:1998-11-25
   Days after vaccination:0
Submitted: 1998-12-01
   Days after onset:6
Entered: 2000-06-19
   Days after submission:565
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (IMOVAX) / PASTEUR MERIEUX INST. M10533 / UNK RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bradycardia, Convulsion, Dizziness, Facial palsy, Hypotension
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hearing impairment (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: U199800849

Write-up: Pt experienced dizziness, seizure activity with facial drooping heart rate dropped to 40, blood pressure 90/50 and tonic-clonic movements of upper extremities. Treated with oxygen and observation.


VAERS ID: 194500 (history)  
Form: Version 1.0  
Age: 1.0  
Gender: Female  
Location: Massachusetts  
Vaccinated:1998-11-25
Onset:2002-11-21
   Days after vaccination:1457
Submitted: 2002-11-22
   Days after onset:1
Entered: 2002-12-03
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1057H / 1 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Pruritus, Rash erythematous, Skin ulcer
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Multiple raised, red lesions; some with vesicles, very itchy. Some appear like flea bites.


VAERS ID: 228641 (history)  
Form: Version 1.0  
Age: 1.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:1998-11-25
Onset:2004-10-24
   Days after vaccination:2160
Submitted: 2004-10-27
   Days after onset:3
Entered: 2004-11-02
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1325H / 1 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Drug ineffective, Rash papular, Viral infection
SMQs:, Lack of efficacy/effect (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt was seen in our office by Dr on 10/26/04 with varicella. Rash started 10/24/04. Pt had scattered papules, approx 25 lesions, on torso and behind ears, face and legs. Pt was afebrile. Had varicella vaccine on 11/25/98.


VAERS ID: 349412 (history)  
Form: Version 1.0  
Age: 28.0  
Gender: Male  
Location: Unknown  
Vaccinated:1998-11-25
Onset:0000-00-00
Submitted: 2006-10-27
Entered: 2009-06-17
   Days after submission:964
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV048B / UNK UN / SC

Administered by: Private       Purchased by: Private
Symptoms: Arthralgia, Cognitive disorder, Computerised tomogram normal, Disturbance in attention, Fatigue, Headache, Insomnia, Libido decreased, Memory impairment, Neuropathy peripheral, Night sweats, Nodule, Nuclear magnetic resonance imaging abnormal, Pyrexia, Radiculopathy, Ultrasound scan normal
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None 8/24/09 Medical records received w/PMH: lactose intolerance. Allergy: codeine (rash).
Allergies:
Diagnostic Lab Data: 8/24/09 Medical records received w/LABS: CT sinus c/w chronic sinus disease. CT chest c/w pulmonary nodules. CT abdomen WNL. Polysomnogram WNL. EMG/NCS WNL. MRI brain WNL. MRI c-spine w/degenerative changes C6-7.
CDC Split Type:

Write-up: Description: Had febrile illness within 24 hours for both vaccines. 1st episode required hospitalization. Developed chronic headaches after 2000 dose and also chronic fatigue, arthralgias. This developed into full CFS that has persisted to the present. See full summary. Symptom: Joint Pain, multiple joints. Symptom: Headache, general. Symptom: Insomnia. Symptom: Fatigue. Symptom: Cognitive deficiency. Symptom: Neuropathy. 08/24/09 Received medical & vaccine records. FINAL DX: chronic fatigue syndrome Records reveal patient experienced the following after the initial anthrax vaccine & aggravation of symptoms after subsequent vaccinations: alterations in memory, difficulty concentrating, muscle cramps, joint pain, chronic fatigue, paresthesias of left arm/leg, sleep disturbance, decreased sexual drive, erectile dysfunction, intermittent blurred vision, migraine HA, intermittent tinnitus, alternating constipation & diarrhea, pulmonary nodules, chronic rhinitis, C6 radiculopathy, chills, night sweats, extreme fatigue, . Multiple consults done. Follow-up: Was still symptomatic as of December 08 but have lost contact now.


VAERS ID: 119120 (history)  
Form: Version 1.0  
Age: 47.0  
Gender: Male  
Location: Foreign  
Vaccinated:1998-11-25
Onset:1998-12-04
   Days after vaccination:9
Submitted: 1999-02-15
   Days after onset:73
Entered: 1999-02-18
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM - / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: CSF test abnormal, Delirium, Encephalitis, Headache, Influenza, Nuchal rigidity, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 21 days
   Extended hospital stay? Yes
Previous Vaccinations: Pt recv HepB, age 47, #1, exp rash on torso & back~ ()~~~In patient
Other Medications: Comeprazole
Current Illness: Moderate rash
Preexisting Conditions: Allergy to Penicillin-hosp as a teenager
Allergies:
Diagnostic Lab Data: CT head-Diffuse brain swelling; 2/3/99 HepB antibody test for titres-results not available
CDC Split Type: 19980294451

Write-up: Pt recv vax on 11/25/98; on 12/4/98 pt exp worsened rash; 12/23/98 pt hosp x 3 wk w/ encephalitis, headaches, flu-like sx, stiff neck


VAERS ID: 127054 (history)  
Form: Version 1.0  
Age: 31.0  
Gender: Female  
Location: Foreign  
Vaccinated:1998-11-25
Onset:1999-07-06
   Days after vaccination:223
Submitted: 1999-08-03
   Days after onset:28
Entered: 1999-08-05
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DPP: DIPHTHERIA TOXOID + PERTUSSIS + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK - / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Amenorrhoea, Foetal disorder, Infection transmission via personal contact
SMQs:, Foetal disorders (narrow), Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unk
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: ultrasound nl at 12wk amenorrhea;
CDC Split Type: WAES99031335

Write-up: p/vax pt was found to be pregnant;EDC - 5/28/99; course of preg completely nl;echography at 12 weeks of amenorrhea was nl;pt gave birth to a female w/Down''s synd;Apgar score was 10/10-no fetal distress, cranial perimeter was 32cm


VAERS ID: 321252 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Male  
Location: Foreign  
Vaccinated:1998-11-25
Onset:2007-11-01
   Days after vaccination:3263
Submitted: 2008-08-04
   Days after onset:277
Entered: 2008-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 3 UN / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 3 UN / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / 3 UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abnormal behaviour, Acquired epileptic aphasia, Agitation, Cognitive disorder, Complex partial seizures, Electroencephalogram abnormal, Learning disorder, Memory impairment, Myoclonus, Partial seizures, Speech disorder
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0530540A

Write-up: This case was reported by a regulatory authority ((vaccines, biologicals) # PEI-2008010523) and described the occurrence of Landau-Kleffner syndrome in a male subject. This event was reported by the father of the subject. On November 2007, 9 years after the 3rd dose of INFANRIX QUINTA, 9 years after the 3rd dose of ENGERIX B, 8 years after the 4th dose of INFANRIX HEXA, this 9 years old subject developed Landau Kleffner syndrome. The subject was hospitalised. The subject was treated with methylphenidate hydrochloride and levetiracetam. Outcome was unspecified at time of reporting. Medical report (10 December 2007): Diagnosis of epilepsy: Crytogenic focal epilepsy. ICD: G40.1, G40.2. Types of seizures: Simple and complex partial seizures (above all, based on the symptoms, myoclonias both in the left side of the face and in the left extremities - rarely secondary generalization). Suspected Landau-Kleffner syndrome. Further diagnoses: Academic skills disorder. Behavioral problems. ICD: F81.9. Comment and course: The subject was presented for optimization of the medication with further increasing clinical symptoms representing cognitive loss (downgrading to school for disabled persons) and behavioral problems under OXC therapy. On admission to the hospital, we documented a massive deterioration of EEG findings under TIMOX therapy, and therefore this curative attempt was rapidly discontinued. Under described above and, e.g., forgetfulness and paraphrasia persisted. With very agitated behavior of the patient, we initiated an attempt with RITALIN with cautious increase to 2 X 10 mg RITALIN. We recommended to continue this therapy for at least 12 months to allow for the clear assessment of any success of this medication. Overall, we recommend an inpatient presentation in 2-3 months.


VAERS ID: 118403 (history)  
Form: Version 1.0  
Age: 53.0  
Gender: Female  
Location: Alabama  
Vaccinated:1998-11-26
Onset:1998-11-27
   Days after vaccination:1
Submitted: 1999-01-25
   Days after onset:59
Entered: 1999-01-28
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 2632A2 / 3 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Arthralgia, Dysphagia, Headache, Hypertension, Infection, Insomnia, Malaise, Myalgia, Pain, Phlebitis, Pleural disorder, Pneumonia, Pruritus, Pyrexia, Serum sickness, Urticaria
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 21 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Pred, cortisone oxicodone, Iversorbide, oraprorph;ambian;
Current Illness: NONE
Preexisting Conditions: PCN, ASA, sulfa, codeine, DDACP, HTN, MVP, hyperthyroid;anemia,von Willebrand''s disease
Allergies:
Diagnostic Lab Data: biopsies of rash areas-lupus negative;Blood, x-rays, liver enzymes;
CDC Split Type:

Write-up: itching in ears, felt like something was wrong;devel high temp, chills, rash & whelps, itching, stinging, burning all over body; devel pneumonia, could not sleep;dx serum sickness;unable to walk;pain joint & hands;infect, h/a;pleurisy; per follow-up received 9/11/00, pt still continues to have severe arthritis in both hands, extreme joint damage with constant pain and swelling; especially in thumbs and wrists.


VAERS ID: 160127 (history)  
Form: Version 1.0  
Age: 3.9  
Gender: Male  
Location: Massachusetts  
Vaccinated:1998-11-26
Onset:1998-11-26
   Days after vaccination:0
Submitted: 2000-09-18
   Days after onset:661
Entered: 2000-09-26
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES 0929690 / 5 - / IM
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 0794L / 4 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Abnormal behaviour, Autism, Dementia
SMQs:, Dementia (narrow), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: PDD
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Then 3 year old with PDD, mom feels that she noted a regression in behavior for 6 weeks after immunization.


VAERS ID: 117413 (history)  
Form: Version 1.0  
Age: 1.5  
Gender: Female  
Location: Foreign  
Vaccinated:1998-11-26
Onset:1998-11-30
   Days after vaccination:4
Submitted: 1998-12-11
   Days after onset:11
Entered: 1998-12-16
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 1 - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Hypotonia, Stupor
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: unk
CDC Split Type: WAES98120583

Write-up: pt recv vax 26NOV98 & 30NOV98 pt exp a hypotonic hyporesponsive episode;it was reported that pt had an episode of limpness, remoteness & lack of response w/no fever of convuls;pt hosp;pt recovered w/o sequelae;


VAERS ID: 117646 (history)  
Form: Version 1.0  
Age: 59.0  
Gender: Male  
Location: Foreign  
Vaccinated:1998-11-26
Onset:1998-11-27
   Days after vaccination:1
Submitted: 1998-12-22
   Days after onset:25
Entered: 1998-12-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Speech disorder, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations: UNK~ ()~~~In patient
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: Chronic renal failure, Hepatitis C infection
Allergies:
Diagnostic Lab Data: Blood film-malaria
CDC Split Type: 19980293721

Write-up: Pt recv vax on 11/26/98; on same day pt exp tremors of body & difficulty speaking; 11/27 pt hosp; tx=Chlorpheniramine maleate & Hydrocortisone, Carbamazepine, hemodialysis


VAERS ID: 120238 (history)  
Form: Version 1.0  
Age: 55.0  
Gender: Female  
Location: Foreign  
Vaccinated:1998-11-26
Onset:1998-11-28
   Days after vaccination:2
Submitted: 1999-03-12
   Days after onset:104
Entered: 1999-03-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / MEDEVA PHARMA, LTD. E81025DAI / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Eczema, Hepatic function abnormal, Rash, Skin disorder
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: liver function;
CDC Split Type: MPU199900097

Write-up: pt recv vax 26NOV98 & 2 days later presented w/irritation & rash around face;24FEB99 vax adm to hosp, remaining for 8 days;liver function test gave adverse results;dx toxic exanthema & eczema secondary to flu inj;


VAERS ID: 125434 (history)  
Form: Version 1.0  
Age: 55.0  
Gender: Female  
Location: Foreign  
Vaccinated:1998-11-26
Onset:1998-11-30
   Days after vaccination:4
Submitted: 1999-07-06
   Days after onset:217
Entered: 1999-07-08
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / MEDEVA PHARMA, LTD. - / UNK - / -

Administered by: Public       Purchased by: Public
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: REG199900228

Write-up: few days p/ inj, pt devel toxic erythema & erythroderma & required hosp;still recovering p/ 6 mo


VAERS ID: 117420 (history)  
Form: Version 1.0  
Age: 54.0  
Gender: Female  
Location: Georgia  
Vaccinated:1998-11-27
Onset:1998-11-27
   Days after vaccination:0
Submitted: 1998-12-03
   Days after onset:6
Entered: 1998-12-16
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / CONNAUGHT LABORATORIES 968370 / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site hypersensitivity, Vasodilatation
SMQs:, Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: UNK~ ()~~~In patient
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type:

Write-up: Pt recv vax on 11/27/98; within 24 hr pt exp hot rx at vax site


VAERS ID: 117867 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: Minnesota  
Vaccinated:1998-11-27
Onset:1998-12-08
   Days after vaccination:11
Submitted: 1998-12-30
   Days after onset:22
Entered: 1999-01-04
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES 939790 / 1 RL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 361503A / 1 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. N0498 / 1 LL / IM

Administered by: Private       Purchased by: Other
Symptoms: Cyanosis, Sudden infant death syndrome
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1998-12-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: autopsy pending
CDC Split Type:

Write-up: death-found in crib cyanotic;


VAERS ID: 123348 (history)  
Form: Version 1.0  
Age: 52.0  
Gender: Female  
Location: Michigan  
Vaccinated:1998-11-27
Onset:1998-11-27
   Days after vaccination:0
Submitted: 1999-02-26
   Days after onset:91
Entered: 1999-06-07
   Days after submission:100
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES 0984540 / UNK LA / -

Administered by: Private       Purchased by: Private
Symptoms: Chest pain, Diarrhoea, Dizziness, Hypersensitivity, Hypoaesthesia oral, Injection site erythema, Injection site hypersensitivity, Injection site oedema, Injection site pruritus, Injection site swelling, Muscle spasms, Nasal congestion, Nausea, Paraesthesia oral, Pruritus, Rhinitis
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ojen, Flovent, Serevent, inhalers, Flonase, Rhinocort nasal inhalers
Current Illness:
Preexisting Conditions: asthma & allergy to feathers
Allergies:
Diagnostic Lab Data:
CDC Split Type: U199900123

Write-up: after vax pt devel local react, numb lips, lightheadedness/returned at intervals approx. 8 hours apart x3 days. also exp pain, within 15 min. above clavicles lasting 2 hours and would also return at intervals. inject site redness/itching/swelling would also come and go. Prior to the shot I ate eggs without allergy. In the past 3 wks I''ve had eggs 3 times and experienced nasal congestion, diarrhea, cramps and nausea. I respond to MSG and sulfates this way. 6/1/99 states was recently skin tested for allergy to eggs. Showed sensitivity, not true allergy. Follow up information received at Aventis Pasteur Inc on April 8, 2002 reported that the patient recovered from this experience. No further information is expected. This case is closed.


VAERS ID: 150091 (history)  
Form: Version 1.0  
Age: 24.0  
Gender: Female  
Location: Texas  
Vaccinated:1998-11-27
Onset:1998-12-01
   Days after vaccination:4
Submitted: 2000-03-03
   Days after onset:458
Entered: 2000-03-15
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (NO BRAND NAME) / MICHIGAN DEPT PUB HLTH - / 4 - / SC

Administered by: Military       Purchased by: Military
Symptoms: Injection site mass, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Immediately after receiving shots, the pts left leg would swell an inch bigger than the right leg. This would last for days. All three times the pt went to the MD, they advised him to come back if it happened again. Pt also developed knots in arm that lasted for weeks


VAERS ID: 155216 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Michigan  
Vaccinated:1998-11-27
Onset:1998-11-27
   Days after vaccination:0
Submitted: 1999-02-26
   Days after onset:91
Entered: 2000-06-22
   Days after submission:481
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES 0984540 / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Dizziness, Hypoaesthesia oral, Injection site reaction
SMQs:, Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Asthma and allergy to feathers
Allergies:
Diagnostic Lab Data:
CDC Split Type: U1999001230

Write-up: It was reported that a female pt received Fluzone SV ''98-''99 USP on 11/27/98 and reportedly, the pt has asthma and an allergy to feathers, and was told by allergists to receive IZ. The pt experienced a local reaction, numb limps, and lightheadedness that evening of the vaccination.


VAERS ID: 221543 (history)  
Form: Version 1.0  
Age: 9.0  
Gender: Female  
Location: Indiana  
Vaccinated:1998-11-27
Onset:0000-00-00
Submitted: 2004-05-14
Entered: 2004-05-24
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Infection
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0401USA00023

Write-up: Information has been received from a medical assistant concerning a 9 year old female who on 27Nov98 was vaccinated with a dose of varicella virus vaccine live. Subsequently the pt experienced breakthrough chickenpox. The pt was see at the doctors office by the physician and no fever was noted. There was no product quality complaint involved. The reporter indicated that two other pt''s had similar experiences following exposure to varicella virus vaccine live. Additional information has been requested.


VAERS ID: 117860 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:1998-11-27
Onset:1998-11-28
   Days after vaccination:1
Submitted: 1998-12-21
   Days after onset:23
Entered: 1999-01-04
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / CONNAUGHT LABORATORIES - / UNK - / -
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES - / UNK - / -
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1998-11-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: U199800908

Write-up: pt died suddenly the day p/vax;the death was probably linked to bedding conditions;pt had been well tolerated apart from a sl fever 38C observed the morning after, for which recv APAP;


VAERS ID: 119119 (history)  
Form: Version 1.0  
Age: 34.0  
Gender: Male  
Location: Foreign  
Vaccinated:1998-11-27
Onset:1998-11-29
   Days after vaccination:2
Submitted: 1999-02-16
   Days after onset:79
Entered: 1999-02-18
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / SMITHKLINE BEECHAM - / 1 - / IM A

Administered by: Other       Purchased by: Other
Symptoms: Face oedema, Hypersensitivity, Jaundice, Nausea, Pain
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations: UNK~ ()~~~In patient
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: Pt son had Hep A infection at the time of vax
Allergies:
Diagnostic Lab Data: Serology-acute hepatitis A
CDC Split Type: 19980288441

Write-up: Pt recv vax on 11/27/98; on 11/29/98 pt exp swollen & red cheeks, forehead to ears, icterus, nausea & limb pain; dx=acute hepatitis A & allergic rx; tx=antihistamines, corticosteroids


VAERS ID: 182995 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Male  
Location: Foreign  
Vaccinated:1998-11-27
Onset:1998-12-01
   Days after vaccination:4
Submitted: 2002-05-03
   Days after onset:1248
Entered: 2002-04-01
   Days after submission:31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM - / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Circulatory collapse, Hypotonia, Stupor, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: D0038211A

Write-up: In 1999, the vaccinee received his 2nd Engerix-B and 24 hours, post vax, the vaccinee developed circulatory collapse and vomiting. The pt was hospitalized. A hypotonic-hyporesponsive episode was suspected. The most recent information received on 3/21/02, reports the outcome of the event as resolved. The reporter did not specify the causality. Additional information has been requested. The most recent info received on 4/23/02 reports the outcome of the event as resolved. In the opinion of the reporting physician, the events were possibly related to vaccination with Engerix B.


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