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Case Details (Sorted by Vaccination Date)

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VAERS ID:94757 (history)  Vaccinated:1997-01-13
Age:76.0  Onset:1997-01-20, Days after vaccination: 7
Gender:Female  Submitted:1997-01-28, Days after onset: 8
Location:Pennsylvania  Entered:1997-02-03, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vasotec, diabeta, HCTZ, Humulin insulin
Current Illness: no acute
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)CONNAUGHT LABORATORIES5271095 IMLA
Administered by: Private     Purchased by: Public
Symptoms: Injection site hypersensitivity, Injection site oedema, Pruritus
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: local hypersensitivity rxn: raised, pruritic erythematous patch approx 3in diameter @ site of inj;

VAERS ID:97585 (history)  Vaccinated:1997-01-13
Age:33.0  Onset:1997-01-23, Days after vaccination: 10
Gender:Male  Submitted:0000-00-00
Location:New Hampshire  Entered:1997-04-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: No relevant data;
CDC Split Type: WAES97020305
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0563D0  
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Dermatitis bullous, Lung disorder
SMQs:, Severe cutaneous adverse reactions (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow)
Write-up: pt recv vax 13JAN97 & on 23JAN97 pt exp fatigue & resp sx; 24JAN97 pt devel a diffuse exanthem clinically consistent w/varicella;pt had no known outside exposure of varicella;

VAERS ID:100066 (history)  Vaccinated:1997-01-13
Age:1.4  Onset:1997-01-20, Days after vaccination: 7
Gender:Female  Submitted:0000-00-00
Location:California  Entered:1997-06-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions:
Diagnostic Lab Data: blood tests & CT scan nl; EEG & LP nl;
CDC Split Type: WAES97011750
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0889D0SCLL
Administered by: Private     Purchased by: Other
Symptoms: Convulsion, Pyrexia, Somnolence
SMQs:, 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), Generalised convulsive seizures following immunisation (narrow)
Write-up: pt recv vax 13JAN97 & 20JAN97 pt exp a gen sz, temp 100.4-102 & took a longer nap;pt was taken to ER & tx w/Ativan & Rocephin;blood tests & CT scan nl;pt seem OK during MD visit 22JAN97;EEG & LP nl;

VAERS ID:100396 (history)  Vaccinated:1997-01-13
Age:8.4  Onset:0000-00-00
Gender:Male  Submitted:1997-07-15
Location:Georgia  Entered:1997-07-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: NA
Other Medications:
Current Illness: NONE
Preexisting Conditions: NA
Diagnostic Lab Data: no lab work done @ hosp
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DT: DT ADSORBED (NO BRAND NAME)CONNAUGHT LABORATORIES6H812694 RA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.088D2 LA
Administered by: Private     Purchased by: Private
Symptoms: Drug ineffective, Infection
SMQs:, Lack of efficacy/effect (narrow)
Write-up: tx @ hosp on 6JUL97;sx acute mumps 072.9;quick strep-negative;txPenVeek;

VAERS ID:101652 (history)  Vaccinated:1997-01-13
Age:5.0  Onset:1997-01-13, Days after vaccination: 0
Gender:Male  Submitted:0000-00-00
Location:Indiana  Entered:1997-08-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type: IN97017
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (ACEL-IMUNE)LEDERLE LABORATORIES4319554 LA
OPV: POLIO VIRUS, ORAL (ORIMUNE)LEDERLE LABORATORIES0745F3PO 
Administered by: Public     Purchased by: Public
Symptoms: Oedema, Oedema peripheral, Pyrexia, Vasodilatation
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)
Write-up: temp 100.5;arm swelling from shoulder to elbow of lt arm across chest;swelling lasting 48hr;arm also, red;

VAERS ID:105991 (history)  Vaccinated:1997-01-13
Age:37.0  Onset:1997-01-20, Days after vaccination: 7
Gender:Male  Submitted:1997-10-20, Days after onset: 272
Location:New York  Entered:1997-10-30, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type: 970028991
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM 0IMA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: pt recv vax 13JAN97 & 1wk later pt exp urticarial all over trunk & body which waxed & waned over the next 2 days;ER or MD visit was required;pt was treated w/epi & antihistamines (DPH, claritin) & hydroxyzine & event resolved;

VAERS ID:202554 (history)  Vaccinated:1997-01-13
Age:7.0  Onset:2003-04-29, Days after vaccination: 2297
Gender:Female  Submitted:2003-04-29, Days after onset: 0
Location:Pennsylvania  Entered:2003-05-05, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Diagnostic Lab Data: UNK
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.    
Administered by: Private     Purchased by: Other
Symptoms: Drug ineffective, Infection
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Varicella disease diagnosed: 04/29/2003, mild

VAERS ID:222601 (history)  Vaccinated:1997-01-13
Age:9.0  Onset:2004-06-09, Days after vaccination: 2704
Gender:Female  Submitted:2004-06-10, Days after onset: 1
Location:Indiana  Entered:2004-06-11, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions: UNK
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Private     Purchased by: Private
Symptoms: Infection
SMQs:
Write-up: Pt was seen in office on 06/10/2004 and diagnosed with C-pox. Pt was vaccinated on 1/13/1997.

VAERS ID:263903 (history)  Vaccinated:1997-01-13
Age:0.6  Onset:0000-00-00
Gender:Male  Submitted:2006-10-03
Location:Unknown  Entered:2006-10-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: A0621545A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (ACEL-IMUNE)LEDERLE LABORATORIES 2 UN
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 2 RL
Administered by: Other     Purchased by: Other
Symptoms: Aggression, Autism, Cognitive disorder, Drug toxicity, Hypokinesia, Injury, Mental retardation severity unspecified, Nerve injury, Otitis media, Psychomotor hyperactivity, Sensory disturbance, Speech disorder, Upper respiratory tract infection
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Parkinson-like events (broad), Drug abuse and dependence (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Hostility/aggression (narrow), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a lawyer and described the occurrence of nerve damage in a male subject of unspecified age who was vaccianted with hepatitis B vaccine (Engerix B, hepatitis B vaccine, DTaP, Oral polio, MMR and Varicella. A physician or other health care professional has not verified this report. On 1/13/97 and 8/29/96 the subject received 3rd and 3nd dose of Engerix B (unk), on 6/21/96 the subject received 1st dose of Hep B (unk). On 8/15/00 the subject received 5th dose of Dtap (unk). On 8/15/00 and 1/13/96 the subject received 4th dose and 3rd dose of OPV. On 8/15/00 the subject received 2nd dose of MMR vaccine (unk), 1st dose of Varicella vaccine (unk). At an unspecified time after vaccination with DPTa, Engerix B, Hep B, MMR, OPV, and Varicella, the subject experienced nerve damage, toxic effect of mercury and its compounds, communication disorder, pervasive developmental disorder, attention deficit, impulsivity, motor deficiency, aspergers syndrome, violent outburst, aggression, sensitivity and delayed speech. According to the legal complaint at an unspecified time after vaccination with hepatitis B vaccine, the subject experienced neurological damage, which was attributed to cumulative mercury toxicity. The following information was received via medical records. Mother was a 30 year old gravida 2 par 1 to 2. Delivery at 38 weeks and 6 days of gestation. Pregnancy consisted of uncomplicated labor and delivery with a term spontaneous vaginal delivery. Apgar was unk. No significant complications during the pregnancy. No alcohol or tobacco used. Infant weighed 8 lbs and 6.2 oz. 3/600 an audiology evaluation was normal. On 11/17/00 subject was 4 years old and was evaluated for significant social delay, atypical language development. Past medical history was unremarkable except for rare otitis medical and upper respiratory infection. Symptoms include difficulty with transitions, some perseveration, mouthing of objects and some anxiety. The physical examination revealed that his language appeared younger

VAERS ID:94617 (history)  Vaccinated:1997-01-13
Age:22.0  Onset:1997-01-16, Days after vaccination: 3
Gender:Male  Submitted:1997-01-30, Days after onset: 14
Location:Foreign  Entered:1997-02-03, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: unk
Current Illness:
Preexisting Conditions: no relevant history
Diagnostic Lab Data: No relevant data;
CDC Split Type: WAES97011732
Vaccination
Manufacturer
Lot
Dose
Route
Site
DT: DT ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURER    
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.    
OPV: POLIO VIRUS, ORAL (NO BRAND NAME)LEDERLE LABORATORIES    
Administered by: Unknown     Purchased by: Unknown
Symptoms: CSF test abnormal, Facial palsy, Hepatitis, Infection, Influenza, Meningitis, Vomiting
SMQs:, Hepatitis, non-infectious (narrow), Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: pt recv vax 13JAN97 & 16JAN97 pt exp nausea & vomiting;meningitis was suspected & the pt was hosp;no further details were provided;

VAERS ID:98221 (history)  Vaccinated:1997-01-13
Age:42.0  Onset:1997-01-19, Days after vaccination: 6
Gender:Male  Submitted:1997-05-14, Days after onset: 114
Location:Foreign  Entered:1997-05-23, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Carbimazol,
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 970116441
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM1953A4   
HEPA: HEP A (HAVRIX)SMITHKLINE BEECHAMVHA502136A   
OPV: POLIO VIRUS, ORAL (NO BRAND NAME)UNKNOWN MANUFACTURER    
TD: TD ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Haemorrhage, Mouth ulceration, Petechiae, Rash maculo-papular, Thrombocytopenic purpura
SMQs:, Severe cutaneous adverse reactions (broad), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)
Write-up: pt recv vax 13JAN97 & 19JAN97 6 days post vax pt devel petechiae on the lower part of legs & papules in mouth;pt was hosp;@ the hosp pt also had petechiae round the joint & some small point bleedings in the mouth;dx ITP;tx pred;

VAERS ID:110601 (history)  Vaccinated:1997-01-13
Age:54.0  Onset:1998-02-25, Days after vaccination: 408
Gender:Male  Submitted:0000-00-00
Location:Foreign  Entered:1998-05-05
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unk
Current Illness:
Preexisting Conditions: blood transfusion;nasal sinus surgery;
Diagnostic Lab Data: 25FEB98 lab test ELISA; positive for HIV;
CDC Split Type: WAES98041184
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC. 2  
Administered by: Unknown     Purchased by: Unknown
Symptoms: HIV test positive
SMQs:
Write-up: pt recv vax 13JAN97 & 25FEB98 an ELISA test was positive for HIV; A western blot was also positive for HIV;pt exp was reported as permanently disabling;

VAERS ID:217551 (history)  Vaccinated:1997-01-13
Age:29.0  Onset:2003-03-06, Days after vaccination: 2243
Gender:Female  Submitted:2004-03-09, Days after onset: 369
Location:Foreign  Entered:2004-03-10, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Diagnostic Lab Data: On 03/17/03: Left deltoid muscular biopsy: normal muscular fibers. No necrotic nor regenerative basophil fibers. Good differentiation of fibers. No ragged red fiber. No glycogenic overload. In fascia, macrophagic granuloma, FAS positiv
CDC Split Type: B0314941A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Other     Purchased by: Other
Symptoms: Cognitive disorder, Fasciitis, Fatigue, Laboratory test abnormal, Pain, Rash, Sleep disorder, Vertigo
SMQs:, Anaphylactic reaction (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (narrow), Hypersensitivity (narrow)
Write-up: This case was reported and described the occurrence of macrophagic myofacitis in a 35 year old female subject who was vaccinated with hepatitis B vaccine for prophylaxis. The subject belonged to the EMMM association. On 07/27/1995, the subject was vaccinated with DTPolio (diphtheria, tetanus, poliomyelitis vaccine) and on 08/04/1995, with Monovax (tuberculosis vaccine). On 09/06/1995, 10/26/1995, 11/28/1995, the subject received three injections of Genhevac B (hepatitis B vaccine). In December 1995, the subject experienced vertigo, sleeping disorder, diffuse pain, eruption, fatigue and cognitive problems. On 01/18/1997, he received a dose of unspecified hepatitis B vaccine. On an unknown date, the subject was hospitalized. On 03/06/03, left deltoid muscular biopsy showed lesions of macrophagic myofascitis. At the time of reporting, the subject had not recovered. This case had been considered as serious by AFSSaPS because the subject was hospitalized and the events were disabling. According to the APSSaPS, the events were unlikely related to Genhevac B and DTPolio. (OMIC). Information from Annual Follow-up report states this report was received from a regulatory authority. No further information is available.

VAERS ID:250545 (history)  Vaccinated:1997-01-13
Age:44.0  Onset:1997-06-15, Days after vaccination: 153
Gender:Female  Submitted:2006-01-19, Days after onset: 3140
Location:Foreign  Entered:2006-01-19
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Toxoplasmosis
Diagnostic Lab Data: Computerized tomography abnormal, Echography abnormal, electrocardiogram abnormal, electroencephalogram normal, electromyogram normal, At an unspecified dates, neurological and rheumatological examination were normal. Computerized tomograph
CDC Split Type: B0406602A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSENG1921AG IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER    
TD: TD ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Other     Purchased by: Other
Symptoms: Extrasystoles, Fatigue, Fibromyalgia, Pericardial effusion, Toxoplasmosis
SMQs:, Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tachyarrhythmia terms, nonspecific (narrow)
Write-up: This case was reported and described the occurrence of fibromyalgia in a 44 year old female subject who was vaccinated with hepatitis B vaccine (Engerix B adult) and tetanus and diphtheria toxoids absorbed and inactivated poliomyelitis virus vaccine (DT polio) for prophylaxis. Past medical history included possible toxoplasmosis. The past vaccination of the subject included hepatitis B vaccine (Engerix B 20 mcg, intramuscular) given on 12/17/1991 batch number ENGBC782C6, 01/21/1992 batch number ENGBE774B6B, 02/19/1992 batch number ENGBE779C6 and 12/07/1992 batch number ENG967C6 and tetanus and diphtheria toxoids absorbs and inactivated poliomyelitis virus vaccine (DT polio batch number not available) given in 02/1980, 03/11/1985 and 02/19/1990. On 03/11/1995, the subject received a 8th dose of DT polio batch number not available. On 01/13/1997, the subject received a 5th dose of Engerix B adult (20 mcg intramuscular, batch number ENG1921AG). On June 15 1997, five months after vaccination with Engerix B adult, the subject developed fibromyalgia and chronic fatigue syndrome. At an unspecified dates, neurological and rheumatological examination were normal. Computerized tomography showed several sequelae of toxoplasmosis. Electroencephalogram was normal. MRI showed syringomyely and vertebral MRI was normal. Electromyogram showed no peripheric neurogenic anomaly. Echography and electrocardiogram showed pericardial effusion and extrasystoles. At the time of reporting, the outcome of the events were unknown. The events were disabling and dubiously related to vaccination with DT polio an Engerix B. No more information will be available. This case has been closed.

VAERS ID:492384 (history)  Vaccinated:1997-01-13
Age:40.0  Onset:2012-04-10, Days after vaccination: 5566
Gender:Female  Submitted:2013-05-22, Days after onset: 407
Location:Foreign  Entered:2013-05-22
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Myalgia; Ovulation disorder
Preexisting Conditions: Cervical fracture; Road traffic accident
Diagnostic Lab Data: Antinuclear antibody, 09Aug2012, Positive (1/80); Biopsy muscle, 10Apr2012, Abnormal; Cardiolipin antibody, 09Aug2012, 35UMPL; Electromyogram, 09Aug2012, Abnormal; 09 August 2012: - Electromyogram: Myogenous tracings in four limbs, in right lower limb and upper limb and nerve conduction abnormality which could be suggestive of dysfunction in the trunk of peroneal nerve. 10April2012 - Left deltoid muscular biopsy: Tissues frozen, embedded in paraffin with histochemistry staining (hematein eosine, Masson Trichrome, oxidative reaction to NADHTR, mitochondria cox reaction PAS and black Sudan). Inflammation suggestive of macrophagic myofasciitis lesion was identified while no significant histological anomaly was found. Abnormality related to mac
CDC Split Type: B0891458A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Antinuclear antibody positive, Biopsy muscle abnormal, Bone pain, Cardiolipin antibody positive, Electromyogram abnormal, Headache, Inflammation, Laboratory test abnormal, Myalgia, Myofascitis, Nerve conduction studies abnormal, Neurological examination normal, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Systemic lupus erythematosus (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Osteonecrosis (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by the foreign Regulatory authority (reference PC20130222) and described the occurrence of macrophagic myofasciitis in a 55-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject''s medical history included surgery of cervical fracture following road traffic accident at the age of 25. Prior to vaccination with ENGERIX B, around the age of 29, the subject developed the first symptoms with chronic myalgia while she was treated by hormonal therapy for ovulation disorder (unspecified medications). Co-suspect vaccination included REVAXIS (non-gsk). On 11 March 1988, the subject received 1st dose of ENGERIX B, (batch, route and injection site unknown). On 22 April 1988, more than one month after receiving 1st dose, the subject received 2nd dose of ENGERIX B (batch, route and injection site unknown) (dose administration interval too long). On 27 May 1988 the subject received 3rd dose of ENGERIX B (batch, route and injection site unknown). On 19 December 1988, the subject received 4th dose of ENGERIX B (batch, route and injection site unknown) (dose administration interval too short). On 25 April 1995 and 13 January 1997, the subject received two extra doses of ENGERIX B (batch, route and injection site unknown). On 14 April 2005, the subject received one dose of REVAXIS (batch, route and injection site unknown). Throughout the years, pain remains with mainly lower limb chronic myalgia, permanent in calves. In upper limbs pain were predominant on the right side with hemi-belt irradiating pain. Lumbar and cervical rachialgia as well as headaches were reported. There was no arthromyalgia associated. On unspecified date, neurological examination did not show anomaly in long-standing nerve. There were 7 trigger points. Muscle strength was within the range limit. On 10 April 2012, the result of left deltoid muscular biopsy evoked a macrophagic myofasciitis lesion and characterized the persistence of aluminium following vaccinal injections. On 09 August 2012, the subject was seen in consultation. Lab test showed moderate dysimmunitary anomalies: antinuclear antibody was positive at 1/80 as well as cardiolipin antibody of IgM type at 35 UMPL. Electromyogram showed myogenous tracings in four limbs, and showed anomaly of nerve conduction which could be suggestive of dysfunction in the trunk of peroneal nerve. On 26 September 2012, unspecified exam evidenced hypometabolism in amygdala, hippocampus, precuneus and upper cerebellar areas. The regulatory authority reported that the events were disabling. At the time of reporting, macrophagic myofasciitis was unresolved. According to the regulatory authority, based on the foreign method of assessment, macrophagic myofasciitis was dubiously related to ENGERIX B and/or REVAXIS.

VAERS ID:93985 (history)  Vaccinated:1997-01-14
Age:19.8  Onset:1997-01-14, Days after vaccination: 0
Gender:Female  Submitted:1997-01-15, Days after onset: 1
Location:Ohio  Entered:1997-01-22, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NA
Diagnostic Lab Data: NA
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)SMITHKLINE BEECHAMVHA460A60IMRA
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)PFIZER/WYETH49680900SCLA
Administered by: Military     Purchased by: Military
Symptoms: Injection site hypersensitivity, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: urticaria of face, neck, extremities 4hr p/vax;localized wheal @ typhoid inj site;

VAERS ID:94001 (history)  Vaccinated:1997-01-14
Age:6.4  Onset:1997-01-16, Days after vaccination: 2
Gender:Unknown  Submitted:0000-00-00
Location:California  Entered:1997-01-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: allergic dermatitic
Diagnostic Lab Data: allergic dermatitis
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Private     Purchased by: Public
Symptoms: Oedema peripheral, Vasodilatation
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: rt side hip red & swollen-rxn from DTP;

VAERS ID:94024 (history)  Vaccinated:1997-01-14
Age:4.1  Onset:1997-01-20, Days after vaccination: 6
Gender:Female  Submitted:1997-01-21, Days after onset: 1
Location:Pennsylvania  Entered:1997-01-24, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NA
Other Medications:
Current Illness: NA
Preexisting Conditions: failed hearing screen;borken teeth
Diagnostic Lab Data: NA
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)CONNAUGHT LABORATORIES6C81349 IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1471B1IMRA
OPV: POLIO VIRUS, ORAL (ORIMUNE)LEDERLE LABORATORIES437361 PO 
Administered by: Private     Purchased by: Public
Symptoms: Injection site mass
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: 5cm to 3cm area of induration @ inj site starting 6 days p/vax;

VAERS ID:94428 (history)  Vaccinated:1997-01-14
Age:1.3  Onset:1997-01-15, Days after vaccination: 1
Gender:Male  Submitted:1997-01-17, Days after onset: 2
Location:New York  Entered:1997-01-27, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: URI
Preexisting Conditions: NA
Diagnostic Lab Data: NA
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.79279050IM 
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0778D0IM 
Administered by: Private     Purchased by: Unknown
Symptoms: Pyrexia, Somnolence
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad)
Write-up: pt recv vax & devel lethargy x 24hr, then fever & irritability on day #1 & 2;

VAERS ID:94431 (history)  Vaccinated:1997-01-14
Age:27.5  Onset:1997-01-15, Days after vaccination: 1
Gender:Male  Submitted:1997-01-16, Days after onset: 1
Location:California  Entered:1997-01-27, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TTOX: TETANUS TOXOID (NO BRAND NAME)UNKNOWN MANUFACTURER4382753IMA
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)PFIZER/WYETH49682453IMA
Administered by: Military     Purchased by: Military
Symptoms: Injection site oedema, Injection site pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: tenderness w/edema to inj site;elevated temp 102.5;

VAERS ID:94471 (history)  Vaccinated:1997-01-14
Age:74.4  Onset:1997-01-14, Days after vaccination: 0
Gender:Female  Submitted:1997-01-24, Days after onset: 10
Location:Virginia  Entered:1997-01-29, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Synthroid
Current Illness: significant confusion;pain lt side head, weakness
Preexisting Conditions: diverticulitis, memory loss, HTN, colon pylops
Diagnostic Lab Data: multiple dx studies, blood eval-EKG, neuro, internal;
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DT: DT ADSORBED (NO BRAND NAME)CONNAUGHT LABORATORIES5E71025  A
Administered by: Private     Purchased by: Private
Symptoms: Asthenia
SMQs:, Guillain-Barre syndrome (broad)
Write-up: pt exp weakness late @ noc until following date, referred to hosp d/t significant weakness;

VAERS ID:94490 (history)  Vaccinated:1997-01-14
Age:29.0  Onset:1997-01-18, Days after vaccination: 4
Gender:Male  Submitted:1997-01-24, Days after onset: 6
Location:California  Entered:1997-01-29, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NA
Current Illness: NONE
Preexisting Conditions: unk
Diagnostic Lab Data:
CDC Split Type: CA970040
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 0  
Administered by: Public     Purchased by: Public
Symptoms: Lymphadenopathy, Pruritus, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: rash, itch, swelling of tonsils (under the jaw) t104, fever for two days shivering, & chills;pt took medicine for allergy & Ibuprofen for fever;

VAERS ID:94555 (history)  Vaccinated:1997-01-14
Age:1.2  Onset:1997-01-14, Days after vaccination: 0
Gender:Female  Submitted:1997-01-15, Days after onset: 1
Location:Texas  Entered:1997-01-30, Days after submission: 15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NONE
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions:
Diagnostic Lab Data: NONE
CDC Split Type: TX97007
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTPHIB: DTP + HIB (TETRAMUNE)LEDERLE LABORATORIES4391941 LL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0399D0SCLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site hypersensitivity, Vasodilatation
SMQs:, Hypersensitivity (narrow)
Write-up: pt recv vax & stayed for 15min observation p/15min found 4cm round, red area w/o raised area;

VAERS ID:94806 (history)  Vaccinated:1997-01-14
Age:1.7  Onset:1997-01-14, Days after vaccination: 0
Gender:Male  Submitted:1997-01-14, Days after onset: 0
Location:California  Entered:1997-02-04, Days after submission: 21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1357D0SCLA
Administered by: Other     Purchased by: Public
Symptoms: Injection site hypersensitivity
SMQs:, Hypersensitivity (narrow)
Write-up: sudden onset erythema flair wheal rash @ inj site;

VAERS ID:94841 (history)  Vaccinated:1997-01-14
Age:2.2  Onset:1997-01-15, Days after vaccination: 1
Gender:Male  Submitted:1997-01-16, Days after onset: 1
Location:Pennsylvania  Entered:1997-02-06, Days after submission: 21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: NONE
Other Medications: Amoxicillin
Current Illness: bronchitis
Preexisting Conditions: NONE x/eczema
Diagnostic Lab Data: CXR, blood CXR negative;
CDC Split Type: PA9703
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)CONNAUGHT LABORATORIES6M711843 A
Administered by: Public     Purchased by: Public
Symptoms: Hypertonia, Infection, Pyrexia, Stupor
SMQs:, Neuroleptic malignant syndrome (narrow), Anticholinergic syndrome (broad), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad)
Write-up: pt unresponsive w/abn posturing x 3min;in ER t40.8C but otherwise stable;discharged to home p/eval;dx acute viral synd vs vaccine adverse event;

VAERS ID:94845 (history)  Vaccinated:1997-01-14
Age:1.1  Onset:1997-01-23, Days after vaccination: 9
Gender:Male  Submitted:1997-01-29, Days after onset: 6
Location:Ohio  Entered:1997-02-06, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: NONE
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: blood test, throat cult & EEG to follow this week;
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (HIBTITER)LEDERLE PRAXSISM005PF3IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0101D0SCLA
Administered by: Public     Purchased by: Other
Symptoms: Convulsion, Diarrhoea, Ear disorder, Infection, Lymphadenopathy, Pharyngitis, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Oropharyngeal infections (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)
Write-up: pt devel a sl fever & was given APAP 2hr later;temp was 105.1 & given sponge bath & more APAP;t105.8 then had a sz;before ambulance could arrive;also devel a rash, diarrhea, swollen glands & throat/ear infect;

VAERS ID:94857 (history)  Vaccinated:1997-01-14
Age:0.3  Onset:1997-01-14, Days after vaccination: 0
Gender:Female  Submitted:1997-01-20, Days after onset: 6
Location:South Carolina  Entered:1997-02-06, Days after submission: 17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: NONE
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type: SC97004
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTPHIB: DTP + HIB (TETRAMUNE)LEDERLE LABORATORIES4335671IMRL
IPV: POLIO VIRUS, INACT. (POLIOVAX)CONNAUGHT LTD.L07020SCLL
Administered by: Public     Purchased by: Public
Symptoms: Pyrexia, Screaming
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hostility/aggression (broad)
Write-up: pt recv vax & began crying in clinic & cont to cry $g3hr & was seen @ clinic;exam WNL x/for crying & referred to MD;t103.0 R;

VAERS ID:94946 (history)  Vaccinated:1997-01-14
Age:61.8  Onset:1997-01-24, Days after vaccination: 10
Gender:Female  Submitted:1997-01-28, Days after onset: 4
Location:Tennessee  Entered:1997-02-11, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type: TN97010
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)CONNAUGHT LABORATORIES6F81202 IMLA
Administered by: Public     Purchased by: Public
Symptoms: Hypokinesia, Injection site mass, Injection site pain, Skin striae, Vasodilatation
SMQs:, Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: pt recv vax 14JAN97 & started getting sore & stiff @ site on 24JAN97;site became hard & more sore on 25JAN97;difficult to lft arm on 26JAN97;red streak noticed 4" below inj site-redness about 1 1/2 in wide from side to side across bic

VAERS ID:94999 (history)  Vaccinated:1997-01-14
Age:33.1  Onset:1997-01-23, Days after vaccination: 9
Gender:Female  Submitted:1997-01-28, Days after onset: 5
Location:Illinois  Entered:1997-02-12, Days after submission: 15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
RUB: RUBELLA (MERUVAX II)MERCK & CO. INC.119403520IMLA
Administered by: Private     Purchased by: Private
Symptoms: Lymphadenopathy, Rash maculo-papular
SMQs:, Hypersensitivity (narrow)
Write-up: 23JAN97 one lump @ back of neck;28JAN97 papular rash hands, arms, trunk;

VAERS ID:95318 (history)  Vaccinated:1997-01-14
Age:26.7  Onset:1997-01-16, Days after vaccination: 2
Gender:Female  Submitted:1997-01-27, Days after onset: 11
Location:Georgia  Entered:1997-02-27, Days after submission: 31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Minocin
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type: GA97014
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1433B1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Arthralgia, Hypokinesia, Laryngospasm, Lymphadenopathy, Osteoarthritis, Pain, Rash, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (narrow)
Write-up: 16JAN97 w/severe itching of head;by 12noon was covered w/red welts;by PM 16JAN the bottom of feet hurt & was covered w/rash;17JAN97 could not walk w/o pain;went to MD;throat & glands around throat swollen;pain in joints;swollen ankle

VAERS ID:95564 (history)  Vaccinated:1997-01-14
Age:1.4  Onset:1997-01-21, Days after vaccination: 7
Gender:Male  Submitted:1997-01-27, Days after onset: 6
Location:Michigan  Entered:1997-03-10, Days after submission: 42
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: blood cult, CBC
CDC Split Type: MI97012
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTPHIB: DTP + HIB (TETRAMUNE)LEDERLE LABORATORIES4386213IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0892D0SCRA
Administered by: Public     Purchased by: Unknown
Symptoms: Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: 21JAN97 fever 103 on 23JAN devel full body rash;saw MD on 23JAN & 24JAN & t104.5;MD sent to ER was given ATB & APAP;fever down 27JAN rash remains sl;

VAERS ID:95857 (history)  Vaccinated:1997-01-14
Age:1.2  Onset:1997-01-16, Days after vaccination: 2
Gender:Male  Submitted:1997-01-21, Days after onset: 5
Location:Illinois  Entered:1997-03-17, Days after submission: 55
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations: NA
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: UA sl cloudy;Protein 1+;UA microscopic bacteria-u 2+; crystals-u 1+;Neutrophil Seg 67;
CDC Split Type: IL97020
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (HIBTITER)LEDERLE PRAXSISM230NB3IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1426B0IMRL
Administered by: Public     Purchased by: Public
Symptoms: Convulsion, Laboratory test abnormal, Leukocytosis, Pyrexia, Urine analysis abnormal
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: pt recv vax & 16JAN97 devel t103 gave APAP, temp cont 17JAN97 made appointment w/MD;210PM had sz lasting 2min had approx 6 more sz lasting 45sec in MD office;temp inc 104-105;on d/c 18JAN97 t102;

VAERS ID:96573 (history)  Vaccinated:1997-01-14
Age:15.7  Onset:1997-01-16, Days after vaccination: 2
Gender:Female  Submitted:1997-02-17, Days after onset: 32
Location:Wisconsin  Entered:1997-03-31, Days after submission: 42
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: pain in rt foot & ankle @ time of 3rd dose hep B
Preexisting Conditions: NONE
Diagnostic Lab Data: 21JAn rheumatoid arthritis & lupus screens-positive;
CDC Split Type: WI97003
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0459D2IMLA
Administered by: Public     Purchased by: Public
Symptoms: Arthralgia, Chills, Deep vein thrombosis, Myalgia, Osteoarthritis, Pyrexia, Rheumatoid arthritis, Systemic lupus erythematosus
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Eosinophilic pneumonia (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad)
Write-up: 1st wk in JAN97 pt started having pain in rt ankle that moved to pain in knee;approx 2 days p/3rd dose ankle began to swell;has had extreme tiredness & gen body aches & pains that are transient;had chills & fever;DVT in rt calf 7FEB97;

VAERS ID:96721 (history)  Vaccinated:1997-01-14
Age:62.9  Onset:1997-01-22, Days after vaccination: 8
Gender:Female  Submitted:1997-01-24, Days after onset: 2
Location:New Hampshire  Entered:1997-04-04, Days after submission: 70
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Lotensin;Apalat;Atenolol;baby ASA;
Current Illness:
Preexisting Conditions: HTN, NIDDM
Diagnostic Lab Data:
CDC Split Type: NH97003
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Public     Purchased by: Unknown
Symptoms: Injection site hypersensitivity, Pain, Pallor, Serum sickness, Vasodilatation
SMQs:, Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: local swelling p/vax 14JAN97 on 22JAN97 arthurs type rxn;redness, pallor, pain;lacy, maculopapular rash @ local inj site;

VAERS ID:96799 (history)  Vaccinated:1997-01-14
Age:40.9  Onset:1997-01-20, Days after vaccination: 6
Gender:Female  Submitted:1997-01-21, Days after onset: 1
Location:Maryland  Entered:1997-04-09, Days after submission: 77
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NKDA
Diagnostic Lab Data:
CDC Split Type: MD97001
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)CONNAUGHT LABORATORIES6F812041IMRA
Administered by: Public     Purchased by: Unknown
Symptoms: Injection site hypersensitivity, Injection site oedema, Pruritus
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: pt c/o swelling, erythema & itching since evening of 20JAN97 in rt deltoid area;area is approx 95mm x 70mm;afeb;encouraged warm compresses;denies pain or soreness;referred to FMP;MD prescribed DPH;pt seen by dentist on 20JAN97 given lidocai

VAERS ID:98252 (history)  Vaccinated:1997-01-14
Age:1.1  Onset:1997-01-14, Days after vaccination: 0
Gender:Male  Submitted:1997-05-06, Days after onset: 111
Location:Tennessee  Entered:1997-05-27, Days after submission: 21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations: NONE
Other Medications: unk date & naem of allergy shot;APAP
Current Illness: mother denies;
Preexisting Conditions: takes allergy shot occ
Diagnostic Lab Data: requested records from hosp
CDC Split Type: TN97027
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTPHIB: DTP + HIB (TETRAMUNE)LEDERLE LABORATORIES4348082IMLL
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM2130A22IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0107D0SCRL
OPV: POLIO VIRUS, ORAL (ORIMUNE)LEDERLE LABORATORIES0744M2PO 
Administered by: Public     Purchased by: Public
Symptoms: Headache, Injection site pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: spiked fever w/in 4 hr of 14JAN97 vax, appeared to have h/a a lot of pain in leg where shot was given went to PMD;2 days post, went in hosp x 3 days;dx vaccine adverse rxn;

VAERS ID:98476 (history)  Vaccinated:1997-01-14
Age:17.0  Onset:1997-01-16, Days after vaccination: 2
Gender:Female  Submitted:1997-05-27, Days after onset: 130
Location:Massachusetts  Entered:1997-06-02, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: DPH
Current Illness: rash, face;itching
Preexisting Conditions: lymphadenopathy, gen;bruise, inc;purpura,thrombocytopenic;hepatosplenomegaly;hyperplasia, lymph nodes;bacteremia, streptococcal;glomerulonephritis;allergy augmentin, nodule tongue;
Diagnostic Lab Data: lab eval @ time of vax WBC 3,000;hematocrit 33, platelet count 104, 37% neutrophils, 7% bands, 34% lymphocytes, 9% monocytes, 13% eosinophils (elevated);21JAN97 WBC 4.0, hematocrit 10.3, platelet count 100 w/56% polys, 26% lymph, %5 mono
CDC Split Type: WAES97011496
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC. 0IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaemia, Cardiovascular disorder, Erythema multiforme, Hepatomegaly, Jaundice, Splenomegaly, Thrombocytopenia
SMQs:, Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Severe cutaneous adverse reactions (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: pt devel sore throat w/diff swallowing;17JAN97 t104, seen by MD;jaundice noted;bilat subconjunctival hemorrhages & faint scleral icterus;dx lymphadeno, splenomegaly w/acute hepatomegaly,heart murmur, rash, fever;devel erythema mult;wheal;

VAERS ID:98613 (history)  Vaccinated:1997-01-14
Age:1.3  Onset:1997-01-16, Days after vaccination: 2
Gender:Female  Submitted:1997-05-28, Days after onset: 131
Location:Vermont  Entered:1997-06-03, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: VT97004
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTPHIB: DTP + HIB (NO BRAND NAME)UNKNOWN MANUFACTURER4410993 RA
Administered by: Private     Purchased by: Public
Symptoms: Febrile convulsion, Injection site hypersensitivity, Injection site oedema, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (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), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow)
Write-up: Febrile seizure, t103.8, red swollen arm;

VAERS ID:101546 (history)  Vaccinated:1997-01-14
Age:20.2  Onset:0000-00-00
Gender:Female  Submitted:1997-03-05
Location:Maine  Entered:1997-07-22, Days after submission: 138
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Birth control pills
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type: 897077014L
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)LEDERLE LABORATORIES4367606IMLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site mass
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: pt recv vax & devel a nodule w/a blackhead pimple @ the inj site;pt had been squeezing it & draining a lot of stuff;nodule was still palpable 5 wk p/vax;

VAERS ID:102587 (history)  Vaccinated:1997-01-14
Age:0.4  Onset:1997-01-14, Days after vaccination: 0
Gender:Male  Submitted:1997-01-23, Days after onset: 9
Location:Georgia  Entered:1997-09-22, Days after submission: 241
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: sz disorder
Diagnostic Lab Data: EEG-CXR-CAT Scan & Bloodwork;
CDC Split Type: GA97113
Vaccination
Manufacturer
Lot
Dose
Route
Site
DT: DT ADSORBED (NO BRAND NAME)CONNAUGHT LABORATORIES5E71013 IMRL
DTP: DTP (NO BRAND NAME)CONNAUGHT LABORATORIES6H71044 IMRL
HIBV: HIB (ACTHIB)CONNAUGHT LABORATORIES6A71053 IMRL
Administered by: Public     Purchased by: Public
Symptoms: Condition aggravated, Convulsion, Gaze palsy, Hypertonia, Hypotonia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Parkinson-like events (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: mom called 21JAN97 & reported pt had sz 1115PM on 14JAN97 & was taken to Er;mom described sz as very rigid, eyes rolled, head back;hosp x 2 days Wednesday & Thursday;test done EEG -CXR-CAT Scan-blood work WNL;

VAERS ID:105520 (history)  Vaccinated:1997-01-14
Age:34.0  Onset:1997-01-15, Days after vaccination: 1
Gender:Male  Submitted:1997-05-22, Days after onset: 126
Location:Unknown  Entered:1997-10-30, Days after submission: 161
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 970011961
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM1996A20IMA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chills, Headache, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: pt recv vax on 14JAN97;15JAN97 pt exp a h/a, chills & tingling of the skin on hand;the event required visit to ER or MD visit

VAERS ID:108261 (history)  Vaccinated:1997-01-14
Age:  Onset:0000-00-00
Gender:Male  Submitted:0000-00-00
Location:Massachusetts  Entered:1998-03-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: No relevant data;
Other Medications: unk
Current Illness:
Preexisting Conditions: unk
Diagnostic Lab Data:
CDC Split Type: WAES97011310
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC. 0  
Administered by: Other     Purchased by: Other
Symptoms: Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: pt recv vax 14JAN97 & exp systemic rash & fever up to 39.5 degrees;

VAERS ID:108700 (history)  Vaccinated:1997-01-14
Age:28.8  Onset:1997-01-15, Days after vaccination: 1
Gender:Female  Submitted:1997-01-16, Days after onset: 1
Location:Washington  Entered:1998-03-16, Days after submission: 424
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)PFIZER/WYETH4968021 IMLA
Administered by: Military     Purchased by: Public
Symptoms: Injection site hypersensitivity, Injection site oedema, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: red, swollen, tender arm-local rxn, resolved by itself;

VAERS ID:111355 (history)  Vaccinated:1997-01-14
Age:21.9  Onset:1997-02-25, Days after vaccination: 42
Gender:Male  Submitted:1998-05-29, Days after onset: 457
Location:Montana  Entered:1998-06-02, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 14 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: unk
Diagnostic Lab Data: 2/27/97-nerve conduction test-predominantly demyelinating polyneuropathy
CDC Split Type: WAES97040781
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0398D1SC 
Administered by: Public     Purchased by: Public
Symptoms: Guillain-Barre syndrome, Laboratory test abnormal, Neuropathy
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow)
Write-up: pt recv second dose of hep B vax; devel GBS; seen in ER and was hosp for 14 days;

VAERS ID:123786 (history)  Vaccinated:1997-01-14
Age:24.9  Onset:1998-08-03, Days after vaccination: 566
Gender:Male  Submitted:1999-05-14, Days after onset: 284
Location:Indiana  Entered:1999-05-21, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: no relevant data
Other Medications: unk
Current Illness:
Preexisting Conditions: penicillin allergy
Diagnostic Lab Data: lab test: 8/3/98, varicella zoster AB IGG non immune
CDC Split Type: WAES98080586
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1076D1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Drug ineffective
SMQs:, Lack of efficacy/effect (narrow)
Write-up: p/ pt recv vax approx 1yr later lab evaluation revealed varicella zoster AB IGG non-immune

VAERS ID:124593 (history)  Vaccinated:1997-01-14
Age:4.8  Onset:1999-02-25, Days after vaccination: 772
Gender:Male  Submitted:1999-05-14, Days after onset: 77
Location:New York  Entered:1999-05-21, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: no relevant data
Other Medications: unk
Current Illness:
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type: WAES99030126
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0567D0SCRA
Administered by: Public     Purchased by: Public
Symptoms: Dermatitis bullous, Drug ineffective, Infection
SMQs:, Severe cutaneous adverse reactions (narrow), Lack of efficacy/effect (narrow), Hypersensitivity (narrow)
Write-up: approx 2yrs1mo p/vax pt exp mild breakthrough varicella w/10 lesions. no further info avail

VAERS ID:153109 (history)  Vaccinated:1997-01-14
Age:4.5  Onset:2000-04-10, Days after vaccination: 1182
Gender:Male  Submitted:2000-04-13, Days after onset: 3
Location:Massachusetts  Entered:2000-06-08, Days after submission: 56
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  SC 
Administered by: Private     Purchased by: Other
Symptoms: Infection
SMQs:
Write-up: The pt broke out with chicken pox. (Approximately 20 pox marks.)

VAERS ID:186261 (history)  Vaccinated:1997-01-14
Age:6.0  Onset:2002-01-12, Days after vaccination: 1824
Gender:Male  Submitted:2002-05-15, Days after onset: 122
Location:Unknown  Entered:2002-06-10, Days after submission: 26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Cefzil
Current Illness: Ecxema, OM NOS
Preexisting Conditions: Milk allergy
Diagnostic Lab Data:
CDC Split Type: WAES0201USA01910
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0734D0SC 
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0838D0  
Administered by: Private     Purchased by: Other
Symptoms: Rash vesicular
SMQs:, Hypersensitivity (narrow)
Write-up: Information has been received from a registered nurse concerning a 6 year old male who on 01/14/97 was vaccinated in the left thigh with the first dose of Varivax. Concomitant vaccination on 01/14/97 included the first dose of MMRII SC in the right thigh. The child''s mother reported that on 01/12/02 the child woke up with chickenpox in his scalp, which subsequently spread to the child''s abdomen. The child''s mother stated that there chickenpox looked exactly like the chickenpox the child''s sister had developed 2 years prior. The child subsequently recovered from the event. No further information is available.

VAERS ID:194200 (history)  Vaccinated:1997-01-14
Age:2.0  Onset:2002-11-17, Days after vaccination: 2133
Gender:Male  Submitted:2002-11-18, Days after onset: 1
Location:Florida  Entered:2002-11-27, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0888D0SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1107D SCLA
Administered by: Private     Purchased by: Private
Symptoms: Pyrexia, Skin ulcer
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Temp 40-50 lesions.

VAERS ID:238533 (history)  Vaccinated:1997-01-14
Age:1.3  Onset:2002-12-26, Days after vaccination: 2172
Gender:Unknown  Submitted:2005-05-16, Days after onset: 871
Location:Ohio  Entered:2005-05-31, Days after submission: 15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES0409UZA01861
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.    
Administered by: Other     Purchased by: Other
Symptoms: Drug ineffective, Viral infection
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Information has been received from a physician concerning a 7 year old pt who on 01/14/1997 was vaccinated with varicella virus vaccine live. ON 12/26/2002, The pt experienced a breakthrough varicella. There were less than 50 lesions. . Unspecified medical attention was sought no tx or hospitalization . the pt recovered. no product quality complaint is involved. This is one pt out of 40 reported. 39 other cases (WAES 0407USA01446, 0407USA01855, 0409USA01860, 0409USA01862 through 0409USA01893) experienced breakthrough varicella after vaccination with varicella virus vaccine live. Additonal information is not expected.

VAERS ID:251610 (history)  Vaccinated:1997-01-14
Age:1.3  Onset:2005-07-02, Days after vaccination: 3091
Gender:Female  Submitted:2006-02-07, Days after onset: 220
Location:Pennsylvania  Entered:2006-02-17, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Zoster treated with acyclovir
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.    
Administered by: Other     Purchased by: Other
Symptoms: Herpes zoster, Pruritus, Rash macular, Rash papular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Seen in Hospital ER for an itchy maculopapular dermatomal rash T8.

VAERS ID:256097 (history)  Vaccinated:1997-01-14
Age:1.0  Onset:2005-05-21, Days after vaccination: 3049
Gender:Male  Submitted:2006-05-12, Days after onset: 356
Location:Ohio  Entered:2006-05-17, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data: Body temp 5/21/05-no fever
CDC Split Type: WAES0505USA03102
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0734D0SC 
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1106D0SC 
Administered by: Private     Purchased by: Other
Symptoms: Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Info has been received from a health professional concerning a 9 year old white male, with no medical history and no allergies, who on 1/14/97 was vaccinated with a SC 1st dose of varicella virus vaccine live. Concomitant vaccine included a SC 1st dose of MMRII. There was no illness at the time of vaccination. It was reported that the pt''s mother called and stated that the child started on 5/21/05, at 10:15, with 2 lesions that the mother thought were insect bites. Today the pt had about 20 lesions that itched on his back, torso, neck and head with no fever. It was noted that the mom stated she would use "calahyst", calamine, camphor (+) pramoxine hydrochloride (Aveeno) anti-itch, and avena (Aveeno Bath). It was reported that the pt recovered on 5/23/05. There were no lab or diagnostic tests performed. Additional info is not expected.

VAERS ID:100472 (history)  Vaccinated:1997-01-14
Age:6.0  Onset:1997-06-18, Days after vaccination: 155
Gender:Male  Submitted:1997-07-16, Days after onset: 28
Location:Foreign  Entered:1997-07-28, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 970164061
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAM 2IM 
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER    
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaemia, Aplastic anaemia
SMQs:, Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Haematopoietic erythropenia (narrow), Myelodysplastic syndrome (broad)
Write-up: 1wk p/vax hemoglobin dec & anemia occured for which pt was hosp;during the hosp stay which lasted 10 days pt values for hemoglobin & red blood cells nl w/o tx;a reason for these events was not found;

VAERS ID:102483 (history)  Vaccinated:1997-01-14
Age:14.1  Onset:1997-01-18, Days after vaccination: 4
Gender:Male  Submitted:1997-09-04, Days after onset: 228
Location:Foreign  Entered:1997-09-15, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 970204131
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)SMITHKLINE BEECHAM190A9A0  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Agitation, Convulsion, Similar reaction on previous exposure to drug
SMQs:, Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: pt had a fit 2-3 days p/1st dose of havrix;

VAERS ID:107130 (history)  Vaccinated:1997-01-14
Age:  Onset:1997-01-14, Days after vaccination: 0
Gender:Female  Submitted:1998-01-19, Days after onset: 370
Location:Foreign  Entered:1998-02-02, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 980008061
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM 2  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactoid reaction, Coma, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: pt recv vax 14JAN97 & pt collapsed @ the time report had been unconscious for about an hr;pt was not responding to painful stimuli & was to be transferred to a hosp accident & ER dept;no signs to suggest anaphylactic rxn;

VAERS ID:107418 (history)  Vaccinated:1997-01-14
Age:0.3  Onset:1997-01-15, Days after vaccination: 1
Gender:Male  Submitted:1998-01-15, Days after onset: 365
Location:Foreign  Entered:1998-02-11, Days after submission: 27
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tribax by Evans given 14JAN97
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: EEG very abnormal but no hypsarrhythmic;CT of brain: mild cerebral atrophy w/dilation of cortical sulci;metabolic studies nl;chromosome analysis nl;
CDC Split Type: 898027010L
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (HIBTITER)LEDERLE PRAXSIS 1SC 
Administered by: Other     Purchased by: Other
Symptoms: Cerebrovascular disorder, Convulsion, Electroencephalogram abnormal, Injection site reaction, Mental retardation severity unspecified, Muscle spasms, Muscle twitching, Opisthotonus
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dyskinesia (broad), Dystonia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: pt recv vax & devel inj site rxn & arching of the back;fluttering of the eyelids;there episodes dx as infantile spasms;some evidence of developmental delay noted;@ 9mo devel myoclonic epilepsy;

VAERS ID:107667 (history)  Vaccinated:1997-01-14
Age:0.2  Onset:1997-01-14, Days after vaccination: 0
Gender:Male  Submitted:1997-12-14, Days after onset: 334
Location:Foreign  Entered:1998-02-13, Days after submission: 61
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: CO7155
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)CONNAUGHT LABORATORIESM04200  
HIBV: HIB (ACTHIB)CONNAUGHT LABORATORIESM03040  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chills, Cyanosis, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: pt recv vax 14JAN97 & 4hr post vax pt presented w/fever, cyanosis & became frigid;pt hosp & stayed under observation for 24hr;all exams including EEG & CT scan were nl & reported to have recovered w/o sequelae;

VAERS ID:252735 (history)  Vaccinated:1997-01-14
Age:10.0  Onset:0000-00-00
Gender:Male  Submitted:2006-03-10
Location:Foreign  Entered:2006-03-14, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES0603USA00914
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1390B  UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Epilepsy
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received regarding a case in litigation concerning a 10 year old male who on 1/14/1997, at 16 months of age, was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 618169/1390B, batch HB60620). Subsequently, the patient experienced epilepsy on an unspecified date. No outcome was reported at the time of this report. Upon internal review, epilepsy was considered to be an other important medical event (OMIC). Additional information has been requested.

VAERS ID:427534 (history)  Vaccinated:1997-01-14
Age:13.0  Onset:1997-09-22, Days after vaccination: 251
Gender:Female  Submitted:2011-07-15, Days after onset: 5044
Location:Foreign  Entered:2011-07-15
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Psychomotor retardation
Preexisting Conditions: Episodes of convulsion
Diagnostic Lab Data: Electromyogram, 22Oct1997, See Lab text; Electromyogram, 20Nov1997, See Lab text; Lumbar puncture, 22Oct1997, Normal; Nuclear magnetic resonance ima, 22Oct1997, Normal; 22 October 1997: Electromyogram: conduction block in median and normal conduction velocity; 20 November 1997: Electromyogram: normal conduction velocity with neurogenic tracing
CDC Split Type: B0731043A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dysstasia, Electromyogram abnormal, Faecal incontinence, Gait disturbance, Lumbar puncture normal, Mobility decreased, Muscle disorder, Muscular weakness, Myelitis, Nuclear magnetic resonance imaging normal, Paralysis flaccid, Urinary incontinence
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Noninfectious diarrhoea (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by the regulatory authority (number PS20110689) and described the occurrence of myelitis in a 14-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent conditions included psychomotor retardation evolving since childhood with notions of sporadic convulsions. Concomitant medications were unspecified. On 10 April 1996, 22 May 1996 and 14 January 1997, subject received a full course of hepatitis B vaccination with three primary doses of ENGERIX B (intramuscular, batch numbers in injection site unknown). On 22 September 1997, eight months after the last dose with ENGERIX B, the subject presented with difficult to get up (coded unable to get up), a decrease in muscle strength in lower limb and sphincter disorder. On 25 September 1997, the subject presented with flaccid paraplegia and could not remain sitting. On 22 October 1997, the subject was hospitalised for further myelitis investigations. Lumbar puncture and medullar MRI were normal. At first Guillain-Barre syndrome was evoked. Electromyogram revealed conduction block in median and normal conduction velocity. Later on the subject totally recovered from the events in upper limbs but not completely in lower limbs. One month later, the subject was able to walk helpless. On 20 November 1997, electromyogram revealed normal conduction velocity with neurogenic tracing. Sphincter disorder was persistent. In March 2008, vesical sphincter disorder and anorectal sphincter disorder were persistent. She presented with fecal and urinary leakage (date of onset unspecified) requiring diapers, night and day. The subject was diagnosed with myelitis. The regulatory authority reported that the events were disabling. At the time of reporting, myelitis was unresolved. The Agency assessed the role of ENGERIX B in the occurrence of myelitis as dubiously, according to the method of imputability.

VAERS ID:93936 (history)  Vaccinated:1997-01-15
Age:0.4  Onset:1997-01-15, Days after vaccination: 0
Gender:Female  Submitted:1997-01-15, Days after onset: 0
Location:Ohio  Entered:1997-01-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 897021008L
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTPHIB: DTP + HIB (TETRAMUNE)LEDERLE LABORATORIES4386231IMRL
OPV: POLIO VIRUS, ORAL (ORIMUNE)LEDERLE LABORATORIES0756D1PO 
Administered by: Private     Purchased by: Private
Symptoms: Convulsion, Gaze palsy, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow)
Write-up: pt recv vax & exp sz;pt was hosp;responsible MD submitted this report directly to VAERS;pt exp sz characterized by shaking & eye rolling which persisted for 15-20seconds;pt was not hosp;pt has recovered;

VAERS ID:93972 (history)  Vaccinated:1997-01-15
Age:9.1  Onset:1997-01-15, Days after vaccination: 0
Gender:Male  Submitted:1997-01-15, Days after onset: 0
Location:Texas  Entered:1997-01-22, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NA
Other Medications: NA
Current Illness: NA
Preexisting Conditions: NA
Diagnostic Lab Data: NONE
CDC Split Type: TX97091
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0877D0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Asthenia, Hypertension, Syncope, Visual disturbance
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Hypertension (narrow), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: pt recv vax & 5-6min p/vax pt couldn''t see well & felt weak then fainted for 3 seconds;BP 90/60, p96, repeat BP 92/62, p 80;pt doing fine p/15min;

VAERS ID:93973 (history)  Vaccinated:1997-01-15
Age:0.4  Onset:1997-01-15, Days after vaccination: 0
Gender:Female  Submitted:1997-01-16, Days after onset: 1
Location:Massachusetts  Entered:1997-01-22, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: pediazole
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)CONNAUGHT LABORATORIES6K711271IMRL
HIBV: HIB (HIBTITER)LEDERLE PRAXSISM330PD1IMLL
OPV: POLIO VIRUS, ORAL (ORIMUNE)LEDERLE LABORATORIES755141PO 
Administered by: Private     Purchased by: Public
Symptoms: Agitation, Anorexia, Crying, Insomnia, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad)
Write-up: high pitched screaming for 40" on evening of 15JAN97 & x 2 on 16JAN97;refusing food, t101 R;up during the noc, crying on 16-17JAN;

VAERS ID:93980 (history)  Vaccinated:1997-01-15
Age:21.3  Onset:1997-01-15, Days after vaccination: 0
Gender:Female  Submitted:1997-01-16, Days after onset: 1
Location:California  Entered:1997-01-22, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Norethin
Current Illness: NONE
Preexisting Conditions: cold urticaria
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURER6K813662IM 
Administered by: Private     Purchased by: Other
Symptoms: Injection site oedema, Injection site pain, Oedema peripheral, Pain
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: severe pain & swelling in arm from shoulder to elbow;took APAP did not reduce any pain or swelling;pain started in shot area immed then radiated to rest of upper arm w/in 1 1/2hr;swelling w/in 3inch radius of shot area;

VAERS ID:93996 (history)  Vaccinated:1997-01-15
Age:4.2  Onset:1997-01-16, Days after vaccination: 1
Gender:Male  Submitted:1997-01-17, Days after onset: 1
Location:Virginia  Entered:1997-01-22, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE-PE
Preexisting Conditions: NONE
Diagnostic Lab Data: NA
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)CONNAUGHT LABORATORIES6D813964IMA
OPV: POLIO VIRUS, ORAL (ORIMUNE)LEDERLE LABORATORIES754E53PO 
Administered by: Private     Purchased by: Private
Symptoms: Injection site mass, Injection site oedema
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 8x9 1/2cm area of induration & swelling;

VAERS ID:94432 (history)  Vaccinated:1997-01-15
Age:21.1  Onset:1997-01-15, Days after vaccination: 0
Gender:Male  Submitted:1997-01-16, Days after onset: 1
Location:California  Entered:1997-01-27, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: viral synd
Preexisting Conditions: NONE
Diagnostic Lab Data: WBC 11,000
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)PFIZER/WYETH49682451IMLA
Administered by: Military     Purchased by: Military
Symptoms: Chills, Hyperventilation, Injection site hypersensitivity, Injection site oedema, Injection site pain, Pyrexia, Tetany, Vasodilatation
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: tenderness w/edema & warmth @ inj site;hyperventilation w/tetany & fever/chills;

VAERS ID:94541 (history)  Vaccinated:1997-01-15
Age:1.4  Onset:1997-01-18, Days after vaccination: 3
Gender:Female  Submitted:1997-01-23, Days after onset: 5
Location:Illinois  Entered:1997-01-30, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: IL97047
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1176B0SCLL
Administered by: Public     Purchased by: Public
Symptoms: Infection, Leukocytosis, Pharyngitis, Pyrexia
SMQs:, Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow)
Write-up: 22JAN97 mom called indicated pt started w/99.8 18JAN97 in AM;PM noted high fever but didn''t take it 19JAN97 fever 104 & was giving Ibuprofen;15JAN97 PM fever 105.2 R;taken to ER;fever 105.7;CBC done by WBC inc;saw spots;poss viral

VAERS ID:94549 (history)  Vaccinated:1997-01-15
Age:21.7  Onset:1997-01-15, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:Hawaii  Entered:1997-01-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NONE
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)PFIZER/WYETH49680390SCLA
Administered by: Military     Purchased by: Military
Symptoms: Asthenia, Hyperhidrosis, Hypotension, Pallor, Pyrexia, Shock, Tremor
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: 15JAN97 10:50 c/o weakness & not feeling well;skin diaphoretic w/shallow color, pt trembling;BP 82/40, AP 65, R16;tx shock;pt placed w/legs inc, warmed w/a blanket;BP, pulse monitored;BP 104/66, AHR 88;12:15 T101.4, BP 102/58;

VAERS ID:94550 (history)  Vaccinated:1997-01-15
Age:11.3  Onset:1997-01-15, Days after vaccination: 0
Gender:Female  Submitted:1997-01-15, Days after onset: 0
Location:California  Entered:1997-01-30, Days after submission: 15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type: CA970001
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM2151A20IMLA
Administered by: Other     Purchased by: Public
Symptoms: Bradycardia, Hypotension, Malaise, Pallor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: pt recv vax 950AM;around 10:02 AM pt observed to be very pale;pt stated not well;color was poor & rapidly changing placed on mat;BP very low & not recorded around 64/40;unable to get radial or brachial pulse;911 called;epi given;

VAERS ID:94758 (history)  Vaccinated:1997-01-15
Age:1.9  Onset:1997-01-15, Days after vaccination: 0
Gender:Male  Submitted:1997-01-16, Days after onset: 1
Location:Maine  Entered:1997-02-03, Days after submission: 18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NONE
Other Medications: NONE
Current Illness: runny nose
Preexisting Conditions: asthma as infant
Diagnostic Lab Data: NONE
CDC Split Type: ME97004
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTPHIB: DTP + HIB (TETRAMUNE)LEDERLE LABORATORIES4348002 LL
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1163A  RL
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER    
OPV: POLIO VIRUS, ORAL (ORIMUNE)LEDERLE LABORATORIES0741D2PO 
Administered by: Public     Purchased by: Public
Symptoms: Somnolence, Stupor, 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)
Write-up: pt recv vax 1030AM & @ 2PM began to vomit, was lethargic & glassy eyes;vomited 6-8 times since;more alert 17JAN 11AM-taking fluids;

VAERS ID:94839 (history)  Vaccinated:1997-01-15
Age:1.1  Onset:1997-01-23, Days after vaccination: 8
Gender:Male  Submitted:1997-01-28, Days after onset: 5
Location:Texas  Entered:1997-02-06, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: NONE
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type: TX97089
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTPHIB: DTP + HIB (TETRAMUNE)LEDERLE LABORATORIES4391943 LL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0886D0 LA
Administered by: Public     Purchased by: Public
Symptoms: Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: 1wk p/vax pt devel a fever 103 which did not respond to APAP or Ibuprofen;rash devel all over the body;pt taken to clinic;pt seen by MD dx roseola;

VAERS ID:94992 (history)  Vaccinated:1997-01-15
Age:52.4  Onset:1997-01-22, Days after vaccination: 7
Gender:Female  Submitted:1997-02-06, Days after onset: 15
Location:New York  Entered:1997-02-12, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
RUB: RUBELLA (MERUVAX II)MERCK & CO. INC.0680D0SC 
Administered by: Other     Purchased by: Unknown
Symptoms: Malaise, Pyrexia, Rash maculo-papular
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: 22JAN started to have gen body, malaise;25JAN body malaise became worse w/fever;27JAN body malaise more severe, fever & devel red spots arms, thighs, back, chest & abd area;

VAERS ID:95050 (history)  Vaccinated:1997-01-15
Age:40.9  Onset:1997-01-18, Days after vaccination: 3
Gender:Female  Submitted:1997-01-22, Days after onset: 4
Location:Pennsylvania  Entered:1997-02-14, Days after submission: 23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: NA
Other Medications:
Current Illness: NONE
Preexisting Conditions:
Diagnostic Lab Data: NA
CDC Split Type: PA9705
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)CONNAUGHT LABORATORIES6D81109  RA
Administered by: Public     Purchased by: Unknown
Symptoms: Cellulitis, Injection site hypersensitivity
SMQs:, Hypersensitivity (narrow)
Write-up: cellulitis-local rxn;

VAERS ID:95273 (history)  Vaccinated:1997-01-15
Age:6.0  Onset:1997-01-26, Days after vaccination: 11
Gender:Male  Submitted:1997-02-19, Days after onset: 24
Location:Pennsylvania  Entered:1997-02-24, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: rapid strep, throat cult
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)CONNAUGHT LABORATORIES6H710442 LA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0322D2 RA
OPV: POLIO VIRUS, ORAL (ORIMUNE)PFIZER/WYETH4398671PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Infection, Pharyngitis, Rash
SMQs:, Anaphylactic reaction (broad), Agranulocytosis (broad), Oropharyngeal infections (narrow), Hypersensitivity (narrow)
Write-up: gen rash, throat cult, rapid strep, rash occurred 5 days;no fever;

VAERS ID:95295 (history)  Vaccinated:1997-01-15
Age:1.2  Onset:1997-01-22, Days after vaccination: 7
Gender:Male  Submitted:1997-01-27, Days after onset: 5
Location:Georgia  Entered:1997-02-24, Days after submission: 28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: GA97008
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (ACEL-IMUNE)LEDERLE LABORATORIES4309573IMLL
HIBV: HIB (HIBTITER)LEDERLE PRAXSISM230HB3IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1169B0SCRA
Administered by: Public     Purchased by: Public
Symptoms: Ear disorder, Febrile convulsion, Infection, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: 22JAN97 fever of 100 to 101-rash;23JAN97 fever of 103.1 was seen in ER-had sz while @ ER-fever was recorded in ER as 104.8;MD states febrile seizure;24JAN97 was seen by MD minor rt ear infect;28JAN97 t102

VAERS ID:95226 (history)  Vaccinated:1997-01-15
Age:0.1  Onset:1997-01-26, Days after vaccination: 11
Gender:Female  Submitted:1997-02-05, Days after onset: 10
Location:Minnesota  Entered:1997-02-27, Days after submission: 22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: also NM gastroesophagel study-nl;CT scan of brain question of agenesis of the corpus callosum;
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM2139A21IMRL
Administered by: Private     Purchased by: Public
Symptoms: Apnoea, Delirium, Gaze palsy, Hypertonia, Pallor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow)
Write-up: pt recv vax 15JAN97 & 27JAN97 pt body went rigid & turned white, eyes rolled back & stopped breathing for 30-45sec;pt adm to hosp for observation & EEG, pneumogram-both were nl;also ECG nl, CXR nl;

VAERS ID:96255 (history)  Vaccinated:1997-01-15
Age:10.5  Onset:1997-01-19, Days after vaccination: 4
Gender:Female  Submitted:1997-02-05, Days after onset: 17
Location:Washington  Entered:1997-03-14, Days after submission: 37
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NA
Other Medications: NA
Current Illness: NA
Preexisting Conditions: NA
Diagnostic Lab Data: NA
CDC Split Type: WA971332
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0881D1SCLA
TD: TD ADSORBED (NO BRAND NAME)CONNAUGHT LABORATORIES6D811090 RA
Administered by: Public     Purchased by: Public
Symptoms: Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: 19JAN97 pt spiked temp to 103 temp ranged between 100-103 for next 3 days;unable to retain oral or liquid APAP;was able to retain food & other liquids;also slept well;temp nl by 27JAN97;

VAERS ID:96559 (history)  Vaccinated:1997-01-15
Age:46.0  Onset:1997-01-22, Days after vaccination: 7
Gender:Female  Submitted:1997-02-05, Days after onset: 14
Location:Unknown  Entered:1997-03-24, Days after submission: 47
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Guaifenesin;oral contraceptive;
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: 22JAN97 SGOT 280;SGPT 612;LDH 267;24JAN97 SGOT 266;SGPT 586;LDH 249;
CDC Split Type: 970024031
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 0  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Asthenia, Blood lactate dehydrogenase increased, Gamma-glutamyltransferase increased, Hepatic function abnormal
SMQs:, Liver related investigations, signs and symptoms (narrow), Guillain-Barre syndrome (broad)
Write-up: pt recv vax 15JAn97 & felt tired;22JAN97 pt liver function tests results were SGOT 280, SGPT 612;LDH 267;GGTP 24;& on 24JAN97 they were SGOT 266;SGPT 586;LDH 249;pt is undergoing a work-up;

VAERS ID:96519 (history)  Vaccinated:1997-01-15
Age:35.8  Onset:1997-01-27, Days after vaccination: 12
Gender:Female  Submitted:1997-03-21, Days after onset: 53
Location:Vermont  Entered:1997-03-28, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: PCN0env. allergy-hayfever
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1130B0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Dermatitis bullous, Mouth ulceration, Pruritus
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)
Write-up: 28JAN97 pt devel pustules on forehead, chin, lower throat & rt arm;29JAN97 devel cold sore on rt lower lip;30JAN97 3x3 patch pustules x 5 or rt lower abd;27JAN97 gen pruritus lasting x 1wk;

VAERS ID:97528 (history)  Vaccinated:1997-01-15
Age:36.2  Onset:1997-01-17, Days after vaccination: 2
Gender:Female  Submitted:0000-00-00
Location:Unknown  Entered:1997-04-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: No relevant data;
CDC Split Type: WAES97011447
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 0  
Administered by: Other     Purchased by: Other
Symptoms: Headache, Lymphadenopathy
SMQs:
Write-up: pt recv vax 15JAN97 & 17JAN97 pt exp a h/a & devel swollen glands in neck;it was reported that the pt was not administered the 2nd dose;

VAERS ID:97549 (history)  Vaccinated:1997-01-15
Age:32.8  Onset:1997-01-20, Days after vaccination: 5
Gender:Female  Submitted:0000-00-00
Location:Georgia  Entered:1997-04-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Acyclovir;Vantin;
Current Illness:
Preexisting Conditions: exposure, varicella;
Diagnostic Lab Data: 1997 x-ray negative;polymerase chian reaction wild type;
CDC Split Type: WAES97011952
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1080D0 LA
Administered by: Other     Purchased by: Other
Symptoms: Dermatitis bullous, Drug ineffective, Dyspnoea, Headache, Infection, Nausea, Pyrexia, Somnolence
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: pt recv vax 15JAN97 & 20JAN97 pt devel more than 300 vesicular lesions;24JAN97 pt was very sick w/a fever of 104 & full blown chickenpox;pt also exp some problem breathing;x-ray negative & pt otherwise healthy;lethargic & exp nausea;

VAERS ID:97131 (history)  Vaccinated:1997-01-15
Age:27.5  Onset:1997-02-05, Days after vaccination: 21
Gender:Female  Submitted:1997-02-05, Days after onset: 0
Location:New York  Entered:1997-04-21, Days after submission: 74
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: allergic to PCN;otherwise no notable history
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: NA
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0890D   
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypertonia, Malaise, Osteoarthritis, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypersensitivity (narrow), Arthritis (narrow)
Write-up: pt recv vax 15JAN97 & on 29JAN97 pt to ER w/gen skin rash upper torso, malaise, stiffness to hands/wrist;p/eval by MD pt recv DPH & Ibuprofen & instruction to f/u w/pvt MD;

VAERS ID:100087 (history)  Vaccinated:1997-01-15
Age:57.7  Onset:1997-02-03, Days after vaccination: 19
Gender:Female  Submitted:0000-00-00
Location:Unknown  Entered:1997-06-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: No relevant data;
CDC Split Type: WAES97021130
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  SC 
Administered by: Other     Purchased by: Other
Symptoms: Osteoarthritis, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Arthritis (narrow)
Write-up: pt recv vax 15JAN97 & 3FEB97 pt exp numbness from elbow down & joint swelling;

VAERS ID:100583 (history)  Vaccinated:1997-01-15
Age:1.3  Onset:1997-03-28, Days after vaccination: 72
Gender:Female  Submitted:0000-00-00
Location:Texas  Entered:1997-07-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: exposure, varicella;
Diagnostic Lab Data: No relevant data;
CDC Split Type: WAES97040045
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1341D0SC 
Administered by: Other     Purchased by: Public
Symptoms: Dermatitis bullous, Herpes zoster, Infection
SMQs:, Severe cutaneous adverse reactions (narrow), Hypersensitivity (narrow)
Write-up: pt recv vax 15JAN97 & 28MAR97 pt devel herpes zoster consisting of a vesico bullous rash down one side of rt leg;

VAERS ID:100787 (history)  Vaccinated:1997-01-15
Age:4.1  Onset:1997-07-16, Days after vaccination: 182
Gender:Female  Submitted:1997-07-21, Days after onset: 5
Location:Washington  Entered:1997-07-29, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NONE
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: nONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM2282A20 RA
Administered by: Private     Purchased by: Private
Symptoms: Injection site hypersensitivity, Injection site oedema, Vasodilatation
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: presented @ 3dasy w/ 2day hx inc red & swelling 6x7cm of inj site;hard, warm, red;

VAERS ID:102148 (history)  Vaccinated:1997-01-15
Age:0.5  Onset:1997-01-15, Days after vaccination: 0
Gender:Male  Submitted:1997-08-14, Days after onset: 210
Location:New Mexico  Entered:1997-09-04, Days after submission: 21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: APAP drops
Current Illness: tx 9JAN w/cephalxin, dordex DM, APAP
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type: NM97019
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)CONNAUGHT LABORATORIES6J710592IMLL
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM2144A22IMRL
HIBV: HIB (ACTHIB)CONNAUGHT LABORATORIES6C710702IMLL
OPV: POLIO VIRUS, ORAL (ORIMUNE)LEDERLE LABORATORIES4349862PO 
Administered by: Public     Purchased by: Public
Symptoms: Apnoea, Bronchitis, Cyanosis, Hypotonia, Pneumonia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (narrow)
Write-up: the noc of vax mom reports pt quit breathing turned blue & became flaccid;taken to hosp ER;on EMS arrival pt w/o problems 02 sat 75%, t103.2; to ER;no report available from ER;ER dx bronchitis poss pneumonia;

VAERS ID:105980 (history)  Vaccinated:1997-01-15
Age:  Onset:1997-01-16, Days after vaccination: 1
Gender:Female  Submitted:1997-02-03, Days after onset: 18
Location:California  Entered:1997-10-30, Days after submission: 269
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 970014491
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM2196A20IMA
Administered by: Other     Purchased by: Other
Symptoms: Mouth ulceration
SMQs:, Severe cutaneous adverse reactions (broad), Systemic lupus erythematosus (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (broad)
Write-up: pt recv vax 15JAN97 & w/in 24hr of vax pt noticed a single cold sore in mouth which progressed to several;no other provided;

VAERS ID:107579 (history)  Vaccinated:1997-01-15
Age:  Onset:1997-01-15, Days after vaccination: 0
Gender:Female  Submitted:1997-11-29, Days after onset: 318
Location:Unknown  Entered:1998-01-15, Days after submission: 47
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: CO7099
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)CONNAUGHT LABORATORIES6F71226   
Administered by: Unknown     Purchased by: Unknown
Symptoms: Ecchymosis, Injection site hypersensitivity, Injection site pain, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad)
Write-up: pt recv vax 15JAN97 & it was reported that w/in 6 to 9 hr p/vax pt exp local erythema (approx 6 inches in size) & muscle pain @ the site;it was a week a/it subsided, bruising was reportedly present p/vax given;

VAERS ID:107580 (history)  Vaccinated:1997-01-15
Age:  Onset:1997-01-15, Days after vaccination: 0
Gender:Female  Submitted:1997-11-28, Days after onset: 317
Location:Massachusetts  Entered:1998-01-15, Days after submission: 48
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: CO7100
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)CONNAUGHT LABORATORIES6F71226   
Administered by: Unknown     Purchased by: Unknown
Symptoms: Influenza, Injection site hypersensitivity, Injection site mass, Vasodilatation
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: pt recv vax 15JAN97 & w/in 6 to 9 hr it was reported that pt exp flu sx & the inj site was red, warm & indurated;

VAERS ID:117324 (history)  Vaccinated:1997-01-15
Age:1.5  Onset:1998-07-21, Days after vaccination: 552
Gender:Female  Submitted:1998-12-10, Days after onset: 142
Location:Virginia  Entered:1998-12-14, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PPD by Connaught lot# 243113;
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)CONNAUGHT LABORATORIES07954503  
HIBV: HIB (PROHIBIT)CONNAUGHT LABORATORIES07954503  
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1106D   
Administered by: Private     Purchased by: Private
Symptoms: Drug ineffective, Infection
SMQs:, Lack of efficacy/effect (narrow)
Write-up: break through varicella virus-full course;rx zovirax;DPH;

VAERS ID:123081 (history)  Vaccinated:1997-01-15
Age:4.3  Onset:1998-05-05, Days after vaccination: 475
Gender:Female  Submitted:1999-05-14, Days after onset: 374
Location:Rhode Island  Entered:1999-05-21, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: No Relevant Data;
Other Medications: unk
Current Illness:
Preexisting Conditions: unk
Diagnostic Lab Data:
CDC Split Type: WAES98050538
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 0SC 
Administered by: Public     Purchased by: Public
Symptoms: Dermatitis bullous, Pyrexia, Rash
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: pt recv vax & devel approx 50 skin lesions all over body;the reporting MD felt pt exp was not r/t varicella vax;pt devel mild rash w/low grade temp;

VAERS ID:123648 (history)  Vaccinated:1997-01-15
Age:1.1  Onset:1998-07-12, Days after vaccination: 543
Gender:Female  Submitted:1999-05-14, Days after onset: 306
Location:Pennsylvania  Entered:1999-05-21, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: No Relevant Data
Other Medications:
Current Illness:
Preexisting Conditions: unk
Diagnostic Lab Data:
CDC Split Type: WAES98070954
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1077D0SC 
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1077D0SC 
Administered by: Private     Purchased by: Other
Symptoms: Dermatitis bullous, Drug ineffective, Infection
SMQs:, Severe cutaneous adverse reactions (narrow), Lack of efficacy/effect (narrow), Hypersensitivity (narrow)
Write-up: p/vax pt devel breakthrough chickenpox;it was noted that pt md was notified of varicella rash via phone call;rash was verified by MD:

VAERS ID:156906 (history)  Vaccinated:1997-01-15
Age:1.2  Onset:1999-04-26, Days after vaccination: 831
Gender:Female  Submitted:2000-05-16, Days after onset: 386
Location:Georgia  Entered:2000-07-17, Days after submission: 62
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data:
CDC Split Type: WAES99041927
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 0SC 
Administered by: Other     Purchased by: Other
Symptoms: Drug ineffective, Infection
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Subsequent to receiving one dose of varicella virus vaccine live on 1/15/97, the pt experienced chickenpox with 23 spots on 4/26/99. By two days later she had developed 98 spots. At the time of this report the pt had not recovered. Additional information has been requested.

VAERS ID:157099 (history)  Vaccinated:1997-01-15
Age:6.0  Onset:1999-06-08, Days after vaccination: 874
Gender:Male  Submitted:2000-05-16, Days after onset: 343
Location:Massachusetts  Entered:2000-07-18, Days after submission: 63
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data:
CDC Split Type: WAES99060595
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  SCRA
Administered by: Private     Purchased by: Other
Symptoms: Drug ineffective, Infection, Rash
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Hypersensitivity (narrow)
Write-up: On June 8, 1999 the pt broke out in chickenpox with more than 50 fluid-filled lesions. She was vaccinated with varicella virus vaccine live on 1/15/97. The pt was seen by a physician who confirmed a dx of varicella.

VAERS ID:158195 (history)  Vaccinated:1997-01-15
Age:3.0  Onset:0000-00-00
Gender:Male  Submitted:2000-07-26
Location:Georgia  Entered:2000-08-01, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: CSF-positive for Haemophilus type b
CDC Split Type: WAES00072313
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC. 0IM 
Administered by: Other     Purchased by: Other
Symptoms: Bacterial infection, Infection, Meningitis
SMQs:, Noninfectious meningitis (narrow)
Write-up: Subsequent to first dose of Haemophilus b conjugate vax, this pt developed meningitis and a cerebrospinal fluid analysis was positive for Haemophilus type b due to vaccine failure. These events were considered other medical events. Subsequently, the pt "survived." Sixteen additional pts had similar experiences following exposure to Haemophilus b conjugate vax. Received on 11/19/2000: "Information has been received concerning a 39-month-old caucasian male patient who on 01/15/1992 was vaccinated with a first dose of Haemophilus b conjugate vaccine. Subsequently, the patient developed meningitis and a cerebrospinal fluid analysis was positive for Haemophilus type b due to vaccine failure. These events were considered other medical events. Subsequently, the patient "survived". Sixteen additional patient''s (WAES #''s 00072311, 00072312, and 00072314 through 00072327 had similar experiences following exposure to Haemophilus b conjugate vaccine. Additional information has been received from a published abstract titled "Haemophilus influenzae invasive disease among children aged <5 years--epidemiology in the United States, 1994-1995" from the 34th National Immunization Conference on Vaccine Preventable Diseases (WAES # 00102472); abstract is attached.

VAERS ID:183315 (history)  Vaccinated:1997-01-15
Age:1.3  Onset:1998-10-03, Days after vaccination: 626
Gender:Male  Submitted:2002-04-05, Days after onset: 1280
Location:Georgia  Entered:2002-04-10, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: Leaky gut syndrome
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  IM 
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  SC 
Administered by: Public     Purchased by: Other
Symptoms: Autism, Gastrointestinal disorder, Hyperacusis, Speech disorder
SMQs:, Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hearing impairment (narrow)
Write-up: Severe language delay and hearing sensitivity after vaccines with MMR and Hep-B. Child is now Autistic. Received, ABA, Speech and Occupational therapy. Leaky Gut Syndrome. On annual report received 04/25/2003 mother states, "he is autistic - he has high levels of mercury and lead in his gut. His vaccines contained thermirasol."

VAERS ID:235331 (history)  Vaccinated:1997-01-15
Age:1.8  Onset:2005-03-15, Days after vaccination: 2981
Gender:Male  Submitted:2005-03-17, Days after onset: 2
Location:Michigan  Entered:2005-03-22, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None done
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.    
Administered by: Private     Purchased by: Private
Symptoms: Drug ineffective, Infection
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Patient was with cousin overnight, who had chicken pox, at the end of Feb 2005. About 3 weeks later patient complained of being itchy at school. Patient had a total of 15 pox. Physician consulted, no diagnostic tests performed.

VAERS ID:238727 (history)  Vaccinated:1997-01-15
Age:2.0  Onset:2004-10-27, Days after vaccination: 2842
Gender:Female  Submitted:2005-05-16, Days after onset: 201
Location:Missouri  Entered:2005-06-01, Days after submission: 16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: UNK
CDC Split Type: WAES0411USA00062
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.    
Administered by: Other     Purchased by: Other
Symptoms: Pyrexia, Rash vesicular, Viral infection
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 9 year old female who on 1/15/97 was vaccinated with a dose of varicella virus vaccine live. On 10/27/04 the patient developed chicken pox rash of about 20 vesicular lesions with some crusting. The rash was spread over her face, upper torso, and groin. It was reported that the patient also had a low grade fever. Unspecified medical attention was sought. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested.

VAERS ID:97985 (history)  Vaccinated:1997-01-15
Age:12.0  Onset:1997-03-14, Days after vaccination: 58
Gender:Female  Submitted:1997-05-08, Days after onset: 54
Location:Foreign  Entered:1997-05-14, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~~ ~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: 16MAR97 SGOT 420;total neutrophils 75;WBC count 11000;21MAR97 SGOT 440;MAR97 fever 39C;rheumatistic tests negative;thraot smear negative;
CDC Split Type: 970092761
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Laboratory test abnormal, Pruritus, Pyrexia, Rash, Red blood cell sedimentation rate increased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: pt recv vax 15JAN97 & 14MAR97 till 27MAR97 pt exp migrating arthralgia which affected another joint every day: feet, hands, shoulders, knees, spinal column;also devel fever in the evening up to 39C, erythema & pruritus;

VAERS ID:114352 (history)  Vaccinated:1997-01-15
Age:0.5  Onset:1997-01-22, Days after vaccination: 7
Gender:Male  Submitted:1998-09-14, Days after onset: 599
Location:Foreign  Entered:1998-09-24, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: U199800538
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)SMITHKLINE BEECHAM    
HIBV: HIB (ACTHIB)CONNAUGHT LABORATORIES    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Grand mal convulsion, Laboratory test abnormal, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow)
Write-up: pt recv vax & the next day appeared high fever (no value mentioned) & 2-3 days later appeared unspecified rash;tertain fever dx confirmed by lab tests;sx disappeared but 22JAN97 appeared sz of grand mal lasting 30-40seconds;adm to hosp

VAERS ID:325259 (history)  Vaccinated:1997-01-15
Age:24.0  Onset:0000-00-00
Gender:Male  Submitted:2008-09-16
Location:Foreign  Entered:2008-09-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic sinusitis; Cyst on knee
Preexisting Conditions: Knee meniscus surgery; Pneumopathy
Diagnostic Lab Data: Blood count, 1999, normal; Chest X-ray, 1999, normal; Histology, 2000, see text; Scan abnormal, 2000, see text; Visual acuity tests, 2008, see text. In 1999, gastric fiberscopy: normal; 02 April 1999, node puncture was negative. 15 November
CDC Split Type: B0536151A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Biopsy lymph gland, Blood count normal, Burning sensation, Chest X-ray normal, Dyspnoea, Echography abnormal, Endoscopy gastrointestinal normal, Formication, Histology abnormal, Hodgkin's disease, Lymphadenopathy, Muscular weakness, Musculoskeletal stiffness, Pain, Pain in extremity, Retinal disorder, Scan abnormal, Visual acuity reduced, Visual acuity tests abnormal, Wound secretion
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (narrow), Malignant tumours (narrow), Malignant lymphomas (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by a physician via GSK legal department and described the occurrence of Hodgkin''s disease in a 25-year-old male subject who was vaccinated Hepatitis B vaccine. The subject''s medical history included knee meniscus surgery. Concurrent medical conditions included chronic sinusitis and cyst on knee. Previous vaccination included tetanus vaccine on 14 September 1993 and hepatitis B vaccine recombinant given on 04 December 1996 (batch number not available, unknown manufacturer). On 15 January 1997 the subject received 2nd dose of Hepatitis B vaccine (batch number not available, unknown manufacturer). Four to five months after the second injection, the subject experienced formication, burning feeling on swallowing and stiff neck which bothered him during bodybuilding exercises. In 1997-1998, during bodybuilding exercises, the subject noticed neck swelling on the left side. Progressively the subject experienced breathing difficulty. In December 1998, left sub-clavicular node (adenopathy) was evidenced. In 1998-1998, the subject underwent several check-up. At an unspecified date an oozing would appeared on the node site. On 02 April 1999, node puncture was negative. On 17 May 1999, treatment with MEDROL was prescribed. On 15 November 1999, cervical echography evidence adenopathy suggestive of Hodgkin''s disease. On 01 February 2000, cyto-puncture and biopsy on adenopathy were performed. Node histology evidenced inflammatory granulomatous modification suggestive of benign lymphoreticulosis of Hodgkin''s disease. No precise diagnosis. From 19 to 27 April 2000 the subject was hospitalised and underwent adenopathy surgery (biopsy) on 20 April 2000. The subject presented with left cervical mass well perceptible with complete division and lymph like oozing more or less infected. This mass was painful on alcohol intake. Thoracic scan evidenced cervico-medistinal mass not well delimited with para-aortic node. Histological exam evidenced sclerosing nodular Hodgkin''s disease (type 2) with mixed cellularity (sub

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