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Case Details (Sorted by Vaccination Date)

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VAERS ID: 75897 (history)  
Form: Version 1.0  
Age: 55.0  
Gender: Male  
Location: Foreign  
Vaccinated:1995-06-01
Onset:0000-00-00
Submitted: 1995-06-10
Entered: 1995-07-17
   Days after submission:37
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Hepatic function abnormal, Leukopenia, Pyrexia, Thrombocytopenia
SMQs:, Liver related investigations, signs and symptoms (narrow), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions: graft vs host diaseas (post-heart transplantation) heart transplantation (cause not specified) in SEP94
Allergies:
Diagnostic Lab Data: JUN95 Lymphocytes; Platelets 82000; abd ultrasonography nl; liver fxu test abnormal
CDC Split Type: 950057461

Write-up: pt recv vax & was w/o efficacy (neg HBs antibodies); JUN95 8days p/vax pt was hospitalized for fever; the lab results showed abn liver function test, thrombopenia, lymphopenia;


VAERS ID: 203433 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Male  
Location: Foreign  
Vaccinated:1995-06-01
Onset:1995-07-30
   Days after vaccination:59
Submitted: 2003-07-01
   Days after onset:2893
Entered: 2003-05-21
   Days after submission:41
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthritis, Fasciitis, Laboratory test abnormal
SMQs:, Systemic lupus erythematosus (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Alcohol abuse, tobacco abuse
Preexisting Conditions: Amygdalectomy
Allergies:
Diagnostic Lab Data: HLA B27 typing research: negative; Hemoglobin: 14.4 g/dl; Hemoglobin: 16g/dl; Platelet count: 300G/l; Platelet count: 300G/l; Polymerase chain reaction: <5mg/l; Polymerase chain reaction: 8mg/l; WBC: 7.9G/l; WBC: 9G/l; 09/02/96 & 08/07/97: Radiology evidenced dorsolumbar scloiosis. 04/99: Radiology: modreate dorsolumbar scoliosis and possible sacroillitis. Ionogram renal and hepatic check up: Normal; Sedimentation rate: 1 at the first hour. Protein electrophoresis: no monoclonal gammapathy. HLA B27 typing research: negative. 05/99: Radiology: bilateral sacroilliitis (stade II) and ankylosing spondylarthritis were diagnosed. 02/00: No inflammatory syndrome. Electrophoresis of protein: hypogammaglobulinemia. Ionogram: limit of the normal. Oesogastroduodenoscopy: moderate oesophagitis and erythematous bulitis. 11/24/03: Left deltoid biopsy: peri-muscular fascis inflammatory infiltrate of PAS positive macrophages and lymphocytes. No lipid nor glucidic overload. Conclusion: lesions of macrophagic myofascitis.
CDC Split Type: B0298973A

Write-up: A regulatory Authority reported the occurrence of an ankylosing spondylarthritis in a 16 year old male subject treated with for Engerix B for prophylaxis against hepatitis B. On 30 March 1995 and 01 June 1995, the subject received intramuscular injections of Engerix B at 20 mcg. On 30 July 1995, one month after the second injection, the subject developed an ankylosing spondylarthritis. On 13 Dec 1995, the subject received a third injection of Engerix B. At an unspecified date, the HLA B27 typing research was negative. No additional information is available. The most recent information received on 05May2003 reports the outcome of the event as unknown. the regulatory authority considered as dubiously related to Engerix B. From 30 July 1995, one month after the second injection, the subject reported the first adverse events (no more prescision). Within an unspecified delay, she complained of joint and muscular pain, generalised muscle weakness, asthenia, cognitive and memory disorders, tinnitus, visual disorders, headache, digestive disorders and loss of weight (7 kg). In 1999, a diagnosis of ankylosing spondylarthritis HLA B27 research was negative. In May 1999, radiology evoked sacroilitis. On 24 November 2003, a muscular biopsy showed lesions of macrophagic myofasciitis in peri-musular fascia. At an unspecified date, the subject was hospitalised. At the time of reporting, the outcome of the events was unknown. The regulatory authority considered the events as unlikely related to Engerix B. manufacturer case number B028973A was a duplicate of B0325236A. B0325236A has been voided and all future correspondence will be submitted to B028973A. Follow up information on 05/28/04 states: "No new information."


VAERS ID: 217874 (history)  
Form: Version 1.0  
Age: 39.0  
Gender: Male  
Location: Foreign  
Vaccinated:1995-06-01
Onset:1995-06-08
   Days after vaccination:7
Submitted: 2004-03-16
   Days after onset:3204
Entered: 2004-03-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 1715B6 / UNK - / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER K5983 / UNK - / -
TTOX: TETANUS TOXOID (NO BRAND NAME) / UNKNOWN MANUFACTURER K5983 / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Balance disorder, Difficulty in walking, Dysuria, Fatigue, Hypercholesterolaemia, Hyperkinesia, Hypertriglyceridaemia, Hypokinesia, Laboratory test abnormal, Multiple sclerosis, Muscular weakness, Neuropathy, Optic neuritis, Paraesthesia, Paralysis, Peripheral vascular disorder, Scotoma, Thermal burn, Urinary tract infection, Vision blurred, Visual disturbance
SMQs:, Rhabdomyolysis/myopathy (broad), Dyslipidaemia (narrow), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Akathisia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Glaucoma (broad), Optic nerve disorders (narrow), Demyelination (narrow), Lens disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Lipodystrophy (broad), Ocular infections (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Tobacco abuse
Preexisting Conditions: Tibia fracture. Father dead from leukemia.
Allergies:
Diagnostic Lab Data: On 9/6/95: BP was at 13/8. On October 1995: Brain MRI: several hypersignals (left side). Lumbar puncture: intrathecal igG synthesis. Lyme''s disease serology: negative. Medullar MRI: hypersignals C5, C7, D1. visual evoked potentials: abnormal at the right side. On 6/25/96: blood cholesterol: increased level. Blood triglyceride: increased level. Mixt dyslipidemia. On 8/3/99: EDSS at 4.5. On 12/20/02: EDSS at 5
CDC Split Type: B0221015A

Write-up: This case was reported by a foreign regulatory authority and described the occurrence of multiple sclerosis in a 39 year old male subject vaccinated with Engerix B for hepatitis B prophylaxis. This follow up was reported by the manufacturer legal department. Concurrent medical condition included tobacco abuse (one paquet and half per day) since the age of 15-16 to the beginning of 1995. On 6/1/95, the subject received his first Engerix B injection at a dose of 20mcg and a T Polio booster injection for tetanus and poliomyelitis prophylaxis. One week later, he reported burning and tingling at lower limbs, didn''t consult his physician. On 7/20/95, he received his second Engerix B injection. On 9/3/95, he presented with both lower limb dysesthesia associated with walking and balance disorders. On 9/5/95, dyesthesia progressed to the hands. Clinical exam revealed hypermetria without evident cerebellar syndrome. Osteotendinous reflexes were normal and Romberg, Hoffman, and Babinski''s signs negative. There was no muscular nor occulomotricity troubles. A diagnosis of multiple sclerosis or GBS was evoked. The subject was hospitalized from 9/6 to 9/18/95. He presented with severe fatigue, anesthesia (from the feet to the armpit) and severe inability to grasp objects. Unspecified urinary sphincter disorders also occurred. From 10/12 to 10/13/95, he was again hospitalized. A mild Lhermitte''s sign, abnormal visual evoked potentials and absence of abdominal skin reflexes were noticed. Brain and medullar MRI revealed several hypersignals. Lumbar puncture revealed Intrathecal IgG synthesis. The diagnosis of multiple sclerosis was again evoked. The subject was treated with Solumedrol and the symptomatology regressed excepted fatigue. On 4/19/96, the subject experienced a flare up with left lower limb motor deficit for which he was hospitalized from 4/19 to 4/23/96. Events mildly improved after 3 bolus of Solumedrol. On 5/23/96, he developed a new flare up necessitating a hospitalization and a treatment with corticoids. Diagnosis of multiple sclerosis was made. From 6/12 to 6/17/96, he was hospitalized for a new bolus of Solumedrol. Neurological exam showed a tetrapyramidal syndrome, left lower limb paresthesia, hypoesthesia and motor deficit, and abolition of cutanec-abdominal reflexes. Mixt dyslipidemia, hypercholesterolaemia and hypertriglyceridemia were also discovered. Solumedrol improved walking difficulty. On 10/12/96, a treatment with interferon beta 1-a was initiated. The subject was on sick leave until 4/12/97. At the end of October 1996, the subject developed scotoma and blurred vision (right side). The diagnosis of optic neuropathy was made and the subject was again hospitalized from 11/1 to 11/6/96 for new bolus of Solumedrol. On 1/30/97, clinical exam showed mild walking instability, nystagmus and lower limb Babinski''s sign and sharp reflexes. There wass no upper limb motor deficit. He also complained of fatigability. In April 1997, the subject experienced a new flare up with left lower limbs deficit. In June 1997, he presented with a new flare up and was hospitalized from 6/3 to 6/6/97. A treatment with corticoid was initiated during five days and symptoms improved ten days later. On 8/7/97, he presented with walking instability, positive Romberg''s signs and bilateral Babinski''s sign. At end of October 1997, he presented with a new flare up and was hospitalized from 11/5 to 11/9/97. On 12/22/97, he again developed a new flare up and was hospitalized from 1/2 to 1/8/98. Despite a treatment with perfusion of corticoids, symptoms slightly improved with persistence of claudication and fatigability at walk. On 3/10/98, clinical exam showed mild ataxic walk, a slight hypermetria, and sharp and polykinetic lower limb osteotendinous reflexes with bilateral Babinski''s signs. From 4/9 to 4/17/98, he was hospitalized for a new massive flare up with an almost complete lower limb motor deficit and micturition disorders. Treatment with corticoids was initiated during five days associated with mitoxanthrome, one bolus per month for 12 months. Recovery was very slow and more difficult than previously. He was on sick leave. On 5/9/98, Avonex was discontinued because of inefficacy. From 5/12 to 5/20/98, he was hospitalized for an aggravation of lower limbs motor deficit. At the admission, severe spastic paraparesis, tetrapyramidal syndrome, and lower limb hypoesthesia were noticed. On 5/19/98, a treatment with Solumedrol associated with Novantrone was given. On 6/2/98, motor deficit was improving. The subject presented with urinary sphincter incontinence with feeling of pressing micturition and dysuria treated with function re-education. Clinical exam revealed pyramidal syndrome with hyperreflexia and Babinski''s sign. There was no upper limbs sensitivomotor deficit. On 9/22/98, clinical exam showed ataxic walk, lower limb bilateral Babinski''s sign with a slight dysmetria, slight adiadochokinesia at left upper limb and mild nystagmus. After 6 months of Novantrone treatment, an important improvement of functional disability and sphincterian disorders had occurred. Dysuria and poliakiuria still remained. In May 1999, Novantrone was discontinued. On 8/3/99, EDSS was at 4.5. The subject complained of ataxic feeling with pain at D7 level. In September 1999, interferon betala was initiated. On 12/20/02, EDSS was at 5 and doses of Rebif were increased. On 12/17/03, the subject complained of lower limbs muscular weakness and thus had to use a wheelchair to move. The symptomatology has been considered as disabling. Causality assessment was coded as dubious for Engerix B.


VAERS ID: 220960 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Foreign  
Vaccinated:1995-06-01
Onset:1995-07-01
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2004-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arthralgia, Erythema, Fasciitis, Fatigue, Hot flush, Memory impairment, Myalgia, Myoclonus, Myofascitis, Palpitations, Tinnitus, Vertigo, Visual disturbance
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Vestibular disorders (narrow), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Smoking; Medical history of ankylosing spondylitis and tobacco abuse.
Allergies:
Diagnostic Lab Data:
CDC Split Type: E200401493

Write-up: It was reported that a 17 years old male with a medical history of ankylosing spondylosis and tobacco abuse was vaccinated with hepatitis B vaccine on 6/1/95, with IPV vaccine on 7/13/94, with DT IPV vaccine on 7/6/94 and with DT wP IPV on 6/28/80. Since 7/95, the patient presented myalgia, arthralgia, chronic fatigue, memory impairment, vision abnormal, erythema, bilateral tinnitus, palpitations, vertigo, hot flush and myoclonus. The muscular biopsy done on 11/24/03 showed a lesion of macrophagic myofascitis on perimuscular fascia. Symptoms ongoing at the time of reporting. To be noticed that the case is registered also for a ankylosing spondylitis HLA B27 negative. Case is closed. Follow up on 06/16/04: "Records from health authorities were received. The diagnosis of ankylosing spondylosis was performed, according to the pt on 05/20/99. The man had been hospitalized in Apr 1999 for check up of chronic dorsolombalgia evolving for 4 years. These pain had been explained in 1997 by a moderate dorsolumbar scoliosis. He had been treated with paracetamol/codeine, piroxicam. Radiography and bone scintigraphy had showed signs in favour of a bilateral sacro-iliitis, but should be confirmed by MRI. He was again hospitalized in Jan 00. He received piroxicam, naproxene, but were few efficacious and lead to tinnitus or cutaneous allergy. No inflammatory syndrome was present. At time of medical record from feb 00, he had not yet recovered. Case closed."


VAERS ID: 229113 (history)  
Form: Version 1.0  
Age: 44.0  
Gender: Female  
Location: Foreign  
Vaccinated:1995-06-01
Onset:0000-00-00
Submitted: 2004-11-10
Entered: 2004-11-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK GM / UN

Administered by: Other       Purchased by: Other
Symptoms: Cyst, Laboratory test abnormal, Systemic lupus erythematosus
SMQs:, Systemic lupus erythematosus (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Carpal Canal Syndrome; Coxarthrosis; Dyspnea
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Anti-Ro antibody positive; Antinuclear antibody 1600; Anti DNA native antibody negative.
CDC Split Type: B0350890A

Write-up: This case was reported by a foreign regulatory authority and described the occurrence of systemic lupus erythematous in a 44 year old female subject who received Engerix B for hepatitis B prophylaxis. Concurrent medical condition included right carpal canal syndrome, dyspnea, and coxarthrosis. In June 1995, the subject received a first booster of Engerix B. In 2000, more than 4 years after this injection, a diagnosis of systemic lupus erythematosus was made and confirmed by a rheumatologist. At unspecified date, he presented with polyalgia and right wrist synovial cyst. Antinuclear and anti-SSA antibodies were positive and anti DNA native antibodies were negative. The subject was treated with hydroxychloroquine sulphate and corticosteroid. At the time of reporting, the outcome of the events was unknown. This case was assessed as medically serious (OMIC). No further information available (Foreign agency case).


VAERS ID: 232649 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Male  
Location: Foreign  
Vaccinated:1995-06-01
Onset:0000-00-00
Submitted: 2005-01-21
Entered: 2005-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Erythema, Joint swelling, Rheumatoid arthritis
SMQs:, Anaphylactic reaction (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0364654A

Write-up: This case was reported and described the occurrence of Still''s disease in a male subject (the subject is approximately 12 year old) who received Engerix B for hepatitis B prophylaxis. The subject''s medical history was unknown. Concomitant medical condition was unknown. In December 1994, January 1995, and June 1995, the subject received an injection of Engerix B. Within an unspecified delay, the subject developed an fingers, foot and knee swelling, wrists deformity, arthralgia, and erythematous plaques on the whole body. A diagnosis of Still''s disease was made. At the time of reporting, the events were unresolved. According to the reporter, the events were disabling. Causality assessment with Engerix B vaccine was specified.


VAERS ID: 74605 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Female  
Location: West Virginia  
Vaccinated:1995-06-02
Onset:1995-06-02
   Days after vaccination:0
Submitted: 1995-06-05
   Days after onset:3
Entered: 1995-06-07
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (TETRAMUNE) / PFIZER/WYETH - / 2 RL / -
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 380947 / 2 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Agitation, Injection site hypersensitivity, Injection site mass, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: pt recv vax; in eve, fussy w/ fever; red, knot on pt''s rt leg;


VAERS ID: 74637 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Pennsylvania  
Vaccinated:1995-06-02
Onset:1995-06-02
   Days after vaccination:0
Submitted: 1995-06-03
   Days after onset:1
Entered: 1995-06-08
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / CONNAUGHT LABORATORIES 4J51164 / 1 - / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1358A / 1 - / IM
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES 4J51164 / UNK - / IM
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 394923 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: none~ ()~~~In patient
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: none
CDC Split Type: PA95154

Write-up: pt recv vax; was crying for more than 3 hr;


VAERS ID: 74664 (history)  
Form: Version 1.0  
Age: 1.2  
Gender: Female  
Location: North Carolina  
Vaccinated:1995-06-02
Onset:1995-06-02
   Days after vaccination:0
Submitted: 1995-06-05
   Days after onset:3
Entered: 1995-06-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (TETRAMUNE) / PFIZER/WYETH 390956 / 4 LL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0406B / 1 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Convulsion, Leukocytosis, Pyrexia, Stupor
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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: WBC 31,000; LP nl; CT scan nl;
CDC Split Type:

Write-up: 2 1-2mins sz, generalized tonic postictal state-30min; low grade fever, lasting 12 hr;


VAERS ID: 74674 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Male  
Location: Florida  
Vaccinated:1995-06-02
Onset:1995-06-02
   Days after vaccination:0
Submitted: 1995-06-02
   Days after onset:0
Entered: 1995-06-09
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / LEDERLE LABORATORIES 380916 / 6 - / IM

Administered by: Military       Purchased by: Military
Symptoms: Hyperhidrosis, Hypotension, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: p/receiving TD pt fell to floor w/short period of unconsciousness; VS were stable upon sitting, BP 80/40, pt became diaphoretic & lost consciousness; IV started Epi given; pt put in trendelenberg VSS; transported to ER;vasovagal rxn dx ER


VAERS ID: 74677 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: New York  
Vaccinated:1995-06-02
Onset:1995-06-03
   Days after vaccination:1
Submitted: 1995-06-03
   Days after onset:0
Entered: 1995-06-09
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (TETRAMUNE) / PFIZER/WYETH 426149 / 2 LL / IM
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 1539A2 / 2 RL / IM
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 0720M / 2 MO / PO

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

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

Write-up: prolonged (506 hr) crying w/o apparent cause starting 24 hr p/vax;


VAERS ID: 74794 (history)  
Form: Version 1.0  
Age: 72.0  
Gender: Unknown  
Location: Pennsylvania  
Vaccinated:1995-06-02
Onset:1995-06-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 1995-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / CONNAUGHT LABORATORIES 3L51092 / UNK RA / -

Administered by: Private       Purchased by: Unknown
Symptoms: Oedema peripheral, Pain, Skin nodule
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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

Write-up: pt recv vax 2JUN95 c/o swelling & pain rt arm 3JUN95; presented to ER 8JUN95 rt arm swollen hand & painful;


VAERS ID: 74797 (history)  
Form: Version 1.0  
Age: 33.0  
Gender: Female  
Location: Arizona  
Vaccinated:1995-06-02
Onset:1995-06-02
   Days after vaccination:0
Submitted: 1995-06-02
   Days after onset:0
Entered: 1995-06-12
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 1543A4 / 1 LA / IM

Administered by: Other       Purchased by: Unknown
Symptoms: Dizziness, Nausea, Paraesthesia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NA~ ()~~~In patient
Other Medications:
Current Illness: NONE
Preexisting Conditions: no allergy to yeast, no cardiopulmonary problems, medical hx unk
Allergies:
Diagnostic Lab Data: NA
CDC Split Type:

Write-up: pt recv vax several hr p/vax & exp nausea, dizziness, tingling in lt arm; pt was doing a student rotation;


VAERS ID: 74847 (history)  
Form: Version 1.0  
Age: 52.0  
Gender: Female  
Location: Illinois  
Vaccinated:1995-06-02
Onset:1995-06-05
   Days after vaccination:3
Submitted: 1995-06-07
   Days after onset:2
Entered: 1995-06-13
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DT: DT ADSORBED (NO BRAND NAME) / CONNAUGHT LABORATORIES 5B71048 / UNK RA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: Premarin, Provera, Metrogel; Fiorinal-PRN
Current Illness: NONE
Preexisting Conditions: acne rosacea; vascular headaches
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: local erythema c/u SC urticaria on entire upper arm; rx w/DPH


VAERS ID: 74861 (history)  
Form: Version 1.0  
Age: 1.6  
Gender: Male  
Location: Massachusetts  
Vaccinated:1995-06-02
Onset:1995-06-02
   Days after vaccination:0
Submitted: 1995-06-07
   Days after onset:5
Entered: 1995-06-13
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / MASS. PUB HLTH BIOL LAB DTP291 / 4 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: t104.4 & vomiting "6-8" hr p/shot; resolved 24 hr tx APAP & Advil


VAERS ID: 74886 (history)  
Form: Version 1.0  
Age: 5.0  
Gender: Female  
Location: California  
Vaccinated:1995-06-02
Onset:1995-06-03
   Days after vaccination:1
Submitted: 1995-06-05
   Days after onset:2
Entered: 1995-06-13
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / CONNAUGHT LABORATORIES 4C61144 / 5 LA / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1376A / 2 RA / -
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 0720K / 4 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Injection site hypersensitivity, Injection site mass, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: PPD by connaught, lot #239511
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: WBC done; WNL=7.4;
CDC Split Type:

Write-up: pt recv vax;pain & erythema at site; no fever;T 98; WBC=7.4; pt pleasant; 2" erythema & tenderness at site w/ ? nodule;


VAERS ID: 74927 (history)  
Form: Version 1.0  
Age: 55.0  
Gender: Female  
Location: Arizona  
Vaccinated:1995-06-02
Onset:1995-06-05
   Days after vaccination:3
Submitted: 1995-06-05
   Days after onset:0
Entered: 1995-06-14
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DT: DT ADSORBED (NO BRAND NAME) / PFIZER/WYETH 4948165 / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Abscess
SMQs:

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

Write-up: rt arm abscess; tx Keflex/warm compresses;


VAERS ID: 74930 (history)  
Form: Version 1.0  
Age: 3.0  
Gender: Male  
Location: Florida  
Vaccinated:1995-06-02
Onset:1995-06-04
   Days after vaccination:2
Submitted: 1995-06-05
   Days after onset:1
Entered: 1995-06-15
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES 4H51035 / UNK LA / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0450A / 3 RA / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH M305LF / 4 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0822A / 1 RL / SC

Administered by: Public       Purchased by: Public
Symptoms: Apnoea, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Blood lactate dehydrogenase increased, Cardiac arrest, Convulsion, Cyanosis, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Acute central respiratory depression (narrow), Biliary system related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: PPD by Connaught lot# 238011
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: SGOT 37; LActid acid 314; UA & chem 12; SP gr 1.005; Chem alk phos 244;
CDC Split Type: FL95040

Write-up: pt had sz starting @ approx 1030PM on 4JUN95; mom states did not think pt had temp; became cyanotic; father gave CPR; t101;


VAERS ID: 75183 (history)  
Form: Version 1.0  
Age: 64.0  
Gender: Male  
Location: Texas  
Vaccinated:1995-06-02
Onset:1995-06-02
   Days after vaccination:0
Submitted: 1995-06-02
   Days after onset:0
Entered: 1995-06-19
   Days after submission:17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 1199A6 / 5 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Injection site pain, Myasthenic syndrome, Nausea, Neck pain, Oedema peripheral, Osteoarthritis, Pain
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Malignancy related conditions (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NONE~ ()~~~In patient
Other Medications: diabetes med
Current Illness: NONE
Preexisting Conditions: diabetes
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: TX95103

Write-up: On Monday 5JUN95 approx 1030AM & 2JUN95 10PM lt arm began to hurt; later that noc lt arm was swollen & painful;pt also reported discomfort in back of neck & rt arm; also c/o weakness in both arms & nausea


VAERS ID: 75220 (history)  
Form: Version 1.0  
Age: 57.0  
Gender: Female  
Location: Illinois  
Vaccinated:1995-06-02
Onset:1995-06-05
   Days after vaccination:3
Submitted: 1995-06-12
   Days after onset:7
Entered: 1995-06-19
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / CONNAUGHT LABORATORIES 4G61080 / UNK LA / IM

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

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

Write-up: pt recv vax; small red area, swelling; 5jun95 intense itching; dph given; 12jun95 resolved;


VAERS ID: 75245 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: New York  
Vaccinated:1995-06-02
Onset:1995-06-05
   Days after vaccination:3
Submitted: 1995-06-07
   Days after onset:2
Entered: 1995-06-19
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1290A / 3 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Ecchymosis, Injection site mass, Injection site pain, Pruritus, Purpura, Vasodilatation
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: 5 d. p/ IM hep b 10 mcg injection LT deltoid developed warmth, pruritus, pain, black & blue discoloration; in ofc 1/2 x 1/2 purpura @ inj site, 6x5 cm induration @ deltoid below injection site;


VAERS ID: 75254 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Male  
Location: California  
Vaccinated:1995-06-02
Onset:1995-06-02
   Days after vaccination:0
Submitted: 1995-06-12
   Days after onset:10
Entered: 1995-06-19
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / CONNAUGHT LABORATORIES 5E61043 / 4 RA / -
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES 5E61043 / 3 RA / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1383A / 2 LA / -
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 394929 / 5 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Bradycardia, Hypotension
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad)

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

Write-up: bradycardia, hypotension near syncopal episode shortly p/vax given; 0.3cc epinephrine 1,000 given; much improvement; d/c in satisfactory condition;


VAERS ID: 75472 (history)  
Form: Version 1.0  
Age: 65.0  
Gender: Female  
Location: Florida  
Vaccinated:1995-06-02
Onset:1995-06-03
   Days after vaccination:1
Submitted: 1995-06-05
   Days after onset:2
Entered: 1995-06-27
   Days after submission:22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TTOX: TETANUS TOXOID (NO BRAND NAME) / CONNAUGHT LABORATORIES 360912 / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Headache, Injection site oedema, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (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), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NONE~ ()~~~In patient
Other Medications: Mevocor; Inderal; Tranfene
Current Illness: laceration forearm
Preexisting Conditions: Lopid (rash, Calan (constipations)
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: fever 100.2, h/a, muscle aches, sore all over; swelling @ inj site w/o rxn of redness;


VAERS ID: 75487 (history)  
Form: Version 1.0  
Age: 0.6  
Gender: Female  
Location: Ohio  
Vaccinated:1995-06-02
Onset:1995-06-02
   Days after vaccination:0
Submitted: 1995-06-07
   Days after onset:5
Entered: 1995-06-28
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / CONNAUGHT LABORATORIES 4H51073 / 3 - / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0699A / 3 - / IM
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES 4H51073 / UNK - / IM
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 0718H / 3 MO / PO

Administered by: Public       Purchased by: Public
Symptoms: Agitation, Crying, Injection site hypersensitivity, Injection site mass, Pyrexia, Screaming, Vasodilatation
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: none~ ()~~~In patient
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: none
CDC Split Type: OH95076

Write-up: pt recv vax;1 hr later,became quite irritable & 3-4 hr p/ vax T of 104;screamed all day & noc; leg at inject site became red, hard & hot; MD called;tx apap w/ codeine & ped motrin;


VAERS ID: 75533 (history)  
Form: Version 1.0  
Age: 34.0  
Gender: Female  
Location: Colorado  
Vaccinated:1995-06-02
Onset:1995-06-11
   Days after vaccination:9
Submitted: 1995-06-19
   Days after onset:8
Entered: 1995-06-30
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1315A / 2 LA / SC

Administered by: Other       Purchased by: Unknown
Symptoms: Asthenia, Lymphadenopathy, Malaise, Rash, White blood cell disorder
SMQs:, Anaphylactic reaction (broad), Haematopoietic leukopenia (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: mono test neg; atypical lymph=20;
CDC Split Type:

Write-up: pt recv vax; 9 days later , lymphadenopathy, malaise, fatigue, rash occurred 11 days p/ vax;


VAERS ID: 75835 (history)  
Form: Version 1.0  
Age: 60.0  
Gender: Male  
Location: California  
Vaccinated:1995-06-02
Onset:0000-00-00
Submitted: 1995-06-09
Entered: 1995-07-10
   Days after submission:31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / CONNAUGHT LABORATORIES 4H61156 / UNK LA / -

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

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

Write-up: lt upper outer arm @ inj site w/marked firmness & swelling; neg redness very tender instructed cold packs to lt arm;


VAERS ID: 75924 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Michigan  
Vaccinated:1995-06-02
Onset:1995-06-03
   Days after vaccination:1
Submitted: 1995-06-12
   Days after onset:9
Entered: 1995-07-17
   Days after submission:35
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / MICHIGAN DEPT PUB HLTH TR1224A / 2 LL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH M265LJ / 2 RL / IM
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 0715E / 2 MO / PO

Administered by: Public       Purchased by: Public
Symptoms: Abscess, Ecchymosis, Infection, Skin nodule, Skin striae
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: none~ ()~~~In patient
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: none
CDC Split Type: MI95064

Write-up: mom noticed red and bruised knot the size of a 50 cents piece on pt''s leg;7jun95 noticed red streak going up pt''s leg fr inj site;mom called MD;augmentin prescribed;dx:sterile abscess;12jun95,infect had subsided but knot still remained;


VAERS ID: 75996 (history)  
Form: Version 1.0  
Age: 0.5  
Gender: Female  
Location: New York  
Vaccinated:1995-06-02
Onset:1995-06-04
   Days after vaccination:2
Submitted: 1995-07-14
   Days after onset:40
Entered: 1995-07-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 - / -

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

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

Write-up: pt reportedly recv vax & 2JUN95; 4JUN95 pt found in bed limp, grey nonresponsive taken to ER; improved ABGs nl sent home;


VAERS ID: 76016 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Female  
Location: New Jersey  
Vaccinated:1995-06-02
Onset:1995-06-05
   Days after vaccination:3
Submitted: 1995-07-17
   Days after onset:42
Entered: 1995-07-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (TETRAMUNE) / PFIZER/WYETH 380969 / 3 LL / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations: NONE~ ()~~~In patient
Other Medications: none
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: WBC 30.5; polys 54 lymp 40, mono 4
CDC Split Type:

Write-up: urticaria, inc WBC count, swollen hands & feet, fever;


VAERS ID: 76034 (history)  
Form: Version 1.0  
Age: 1.4  
Gender: Female  
Location: Georgia  
Vaccinated:1995-06-02
Onset:1995-06-02
   Days after vaccination:0
Submitted: 1995-06-19
   Days after onset:17
Entered: 1995-07-21
   Days after submission:32
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (TETRAMUNE) / PFIZER/WYETH 386987 / 2 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0551A / 1 LA / SC
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 0718F / 2 MO / PO

Administered by: Public       Purchased by: Public
Symptoms: Hypersensitivity, Injection site hypersensitivity, Oedema
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NONE~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: GA95090

Write-up: 2JUN95 pt vax that day when mom got home w/pt noted sl swelling lt arm w/white blister appearance;mom phoned MD & felt would be OK;13JUN95 pt had small raised reddened areas on lt arm around site of inj;15JUN95 pt saw MD allerg reaction


VAERS ID: 77090 (history)  
Form: Version 1.0  
Age: 3.0  
Gender: Female  
Location: Massachusetts  
Vaccinated:1995-06-02
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 1995-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: No relevant data;
CDC Split Type: WAES95060326

Write-up: pt recv vax 2JUN95 & devel chickenpox described as small fluid filled pimples there was one on forehead, 2 on buttocks, one on chest & 2 on legs & 1 on arm;


VAERS ID: 77095 (history)  
Form: Version 1.0  
Age: 1.7  
Gender: Male  
Location: North Carolina  
Vaccinated:1995-06-02
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 1995-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0433B / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Erythema multiforme, Hypokinesia, Osteoarthritis, Pruritus, Rash
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: NONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: No relevant data;
CDC Split Type: WAES95060377

Write-up: pt recv vax 2JUN95 & 24-36 hrs p/vax devel rash which covered entire body;8JUN95 pt was seen by MD & was noted to have bulls eye lesions over body which were pruritic;dx erythema multiforme;also had puffiness of ankles & knees w/pain


VAERS ID: 77099 (history)  
Form: Version 1.0  
Age: 3.0  
Gender: Female  
Location: Virginia  
Vaccinated:1995-06-02
Onset:1995-06-06
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 1995-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0397B / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: No relevant data;
CDC Split Type: WAES95060390

Write-up: pt recv vax 2JUN95 & 6JUN95 pt exp gen chickenpox rash & temp between 100 & 101; No further details were provided;


VAERS ID: 77132 (history)  
Form: Version 1.0  
Age: 25.0  
Gender: Female  
Location: California  
Vaccinated:1995-06-02
Onset:1995-06-13
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 1995-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0387B / 1 - / SC

Administered by: Private       Purchased by: Private
Symptoms: Dermatitis bullous, Injection site hypersensitivity, Injection site oedema, Lymphadenopathy, Pruritus
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: No relevant data;
CDC Split Type: WAES95060661

Write-up: pt recv vax 2JUN95 & 13JUN95 pt exp swelling & redness on arm @ inj site & swollen lymph node on the arm; very itchy;


VAERS ID: 76112 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: California  
Vaccinated:1995-06-02
Onset:1995-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 1995-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (TETRAMUNE) / PFIZER/WYETH 426151 / UNK - / L

Administered by: Private       Purchased by: Private
Symptoms: Crying, Screaming
SMQs:, Hostility/aggression (broad), Depression (excl suicide and self injury) (broad)

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

Write-up: pt recv vax; 4-5 hr later, had 5-6 hr cont high pitched screaming;


VAERS ID: 76176 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Indiana  
Vaccinated:1995-06-02
Onset:1995-06-02
   Days after vaccination:0
Submitted: 1995-07-21
   Days after onset:49
Entered: 1995-07-26
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / CONNAUGHT LABORATORIES 4A61098 / 1 - / IM
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 1616A2 / 2 - / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0027B / 1 - / IM
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 392938 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness: NONE
Preexisting Conditions: 2month old cries for 3-4 hrs every noc
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: cried for 8 hr beginning 4 hr p/vax; t98.6;


VAERS ID: 76210 (history)  
Form: Version 1.0  
Age: 1.3  
Gender: Male  
Location: Unknown  
Vaccinated:1995-06-02
Onset:1995-06-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 1995-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Private       Purchased by: Unknown
Symptoms: Agitation, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: pt recv vax; fever of 105.8 on 4jun95 & was irritable;


VAERS ID: 76245 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Male  
Location: North Carolina  
Vaccinated:1995-06-02
Onset:1995-06-02
   Days after vaccination:0
Submitted: 1995-07-18
   Days after onset:46
Entered: 1995-07-31
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (TETRAMUNE) / PFIZER/WYETH 386988 / 2 LL / -
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 0712H / 2 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Agitation, Injection site oedema
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness: none
Preexisting Conditions: neg
Allergies:
Diagnostic Lab Data: none
CDC Split Type: NC95073

Write-up: pt recv vax; inconsolable crying; swelling at inject site; inc amount of analgesia required;


VAERS ID: 76361 (history)  
Form: Version 1.0  
Age: 3.0  
Gender: Female  
Location: Ohio  
Vaccinated:1995-06-02
Onset:0000-00-00
Submitted: 1995-07-31
Entered: 1995-08-03
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Interstitial lung disease, Rash
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: No relevant data;
CDC Split Type: WAES95071043

Write-up: pt recv vax & 1 to 2wk following vax pt devel lesions on the knees, thighs, & soles of feet; 18JUL95 pt was in the peds ICU w/interstitial pneumonia;


VAERS ID: 76465 (history)  
Form: Version 1.0  
Age: 52.0  
Gender: Female  
Location: Washington  
Vaccinated:1995-06-02
Onset:1995-06-08
   Days after vaccination:6
Submitted: 1995-06-09
   Days after onset:1
Entered: 1995-08-07
   Days after submission:59
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / CONNAUGHT LABORATORIES 4F61059 / UNK - / IM A
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF) / BERNA BIOTECH, LTD. 1367326 / 1 MO / PO

Administered by: Public       Purchased by: Public
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Pruritus
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NONE~ ()~~~In patient
Other Medications: Synthroid, Estratest, Medaprogesterone
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WA951136

Write-up: pt recv vax 2JUN95 arm very sore painful for 2 days then cleared up; 8JUN95 arm became swollen, red & very itchy, tender over most of upper arm but not into joint area; still visible on afternoon 9JUN95


VAERS ID: 76474 (history)  
Form: Version 1.0  
Age: 45.0  
Gender: Female  
Location: Colorado  
Vaccinated:1995-06-02
Onset:1995-06-02
   Days after vaccination:0
Submitted: 1995-08-02
   Days after onset:61
Entered: 1995-08-07
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / LEDERLE LABORATORIES 368918 / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site oedema, Injection site pain, Pain, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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

Write-up: lt arm pain since DT administered on 2JUN95; dec sensation over 2nd & 3rd digits of lt hand; no fever, local swelling; tx NSAIDS, heat, referral to PT


VAERS ID: 76579 (history)  
Form: Version 1.0  
Age: 3.0  
Gender: Female  
Location: West Virginia  
Vaccinated:1995-06-02
Onset:1995-06-16
   Days after vaccination:14
Submitted: 1995-08-02
   Days after onset:47
Entered: 1995-08-08
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0412B / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Dehydration, Emphysema, Gastrointestinal haemorrhage, Hypotension, Immune system disorder, Pneumonia, Pneumothorax, Skin necrosis
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: none
Preexisting Conditions: iron deficiency anemia
Allergies:
Diagnostic Lab Data: 1JUL-LDH1500;19JUL-HGB10.4,SGOT-400,SGPT-140,WBC-4900;JUL95-CXRinterstit pneum;SKIN BX-Necrotic Skin;EBV-IGM+;bronchoalveolar lavage-pneumocystis carinii.
CDC Split Type: WAES95070987

Write-up: recv vax,exp dec appetite;16JUN devel rash on extremities,fever,anemia;12JUL9cough/pneumonia;hosp w/resp distress-intubated,dx w/GianottiCrostiSynd,immune system defect,pneumocystis carinii pneumonia,early EBV infect,expired 24AUG95,COD-Acu


VAERS ID: 79335 (history)  
Form: Version 1.0  
Age: 1.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:1995-06-02
Onset:1995-07-11
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 1995-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0407B / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: No relevant data;
CDC Split Type: WAES95070862

Write-up: pt recvd vax 2JUN95 & 11JUL95 pt presented w/five generalized lesions which the nurse felt were related to vax;No further details were provided;


VAERS ID: 79423 (history)  
Form: Version 1.0  
Age: 2.0  
Gender: Female  
Location: New York  
Vaccinated:1995-06-02
Onset:1995-07-10
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 1995-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Private       Purchased by: Other
Symptoms: Agitation, Dermatitis bullous, Pyrexia
SMQs:, Severe cutaneous adverse reactions (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: no relevant data
CDC Split Type: WAES95070641

Write-up: pt recvd vax; 10jul95 exp skin rash & lesions described as gen vesicular papular eruption; also exp fever of 101 & irritability;by 20jul95 recovered;


VAERS ID: 79445 (history)  
Form: Version 1.0  
Age: 1.0  
Gender: Male  
Location: Florida  
Vaccinated:1995-06-02
Onset:1995-06-18
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 1995-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 720E5 / 3 MO / PO
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0406B / 1 - / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: NONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: No relevant data;
CDC Split Type: WAES95060950

Write-up: pt recvd vax 2JUN95 & 18JUN95 pt devel 15 umbilicated lesions on forehead, chest & buttocks;lesions that were not umbilicated were present on back;pt had no other systemic sxs;


VAERS ID: 79468 (history)  
Form: Version 1.0  
Age: 5.0  
Gender: Female  
Location: Nebraska  
Vaccinated:1995-06-02
Onset:1995-06-23
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 1995-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0405B / 1 - / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: No relevant data;
CDC Split Type: WAES95061123

Write-up: pt recvd vax 02JUN95 & 22JUN95 pt tonsils were removed; 23JUN95 pt devel rash w/3 pustules on back & 1 on thigh;presented to MD;pt recovered;


VAERS ID: 82465 (history)  
Form: Version 1.0  
Age: 22.0  
Gender: Female  
Location: Unknown  
Vaccinated:1995-06-02
Onset:1995-06-02
   Days after vaccination:0
Submitted: 1995-06-13
   Days after onset:11
Entered: 1995-11-14
   Days after submission:154
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM - / 2 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Dizziness, Headache, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: pt exp achy joint back, hip, lightheaded, h/a, nausea w/Hep B dose 1~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions: NKA
Allergies:
Diagnostic Lab Data:
CDC Split Type: 950050961

Write-up: pt recvd vax 2JUN95 & 15-20mins p/vax exp achy joints,back,hips,nausea,lightheadedness,& h/a;sx cont;


VAERS ID: 82467 (history)  
Form: Version 1.0  
Age: 33.0  
Gender: Female  
Location: Unknown  
Vaccinated:1995-06-02
Onset:1995-06-02
   Days after vaccination:0
Submitted: 1995-07-31
   Days after onset:59
Entered: 1995-11-14
   Days after submission:106
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 1543A4 / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Nausea, Paraesthesia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 950051041

Write-up: pt recvd vax & hrs post vax exp tingling in lt arm which comes & goes,nausea,dizziness;pt sent to ER for eval;sx are cont;MD states pt is lost to f/u no further info available


VAERS ID: 85840 (history)  
Form: Version 1.0  
Age: 1.7  
Gender: Female  
Location: Missouri  
Vaccinated:1995-06-02
Onset:1996-02-02
   Days after vaccination:245
Submitted: 0000-00-00
Entered: 1996-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0403B / 1 - / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness: Otitis media
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: no relevant data
CDC Split Type: WAES96020883

Write-up: pt recv vax; devel breakthrough chicken pox p/ being exposed to wild type on 21jan96;devel only a few pox;


VAERS ID: 87788 (history)  
Form: Version 1.0  
Age: 31.0  
Gender: Female  
Location: North Carolina  
Vaccinated:1995-06-02
Onset:1995-06-02
   Days after vaccination:0
Submitted: 1995-06-08
   Days after onset:6
Entered: 1996-06-18
   Days after submission:376
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / LEDERLE LABORATORIES - / UNK - / IM

Administered by: Private       Purchased by: Private
Symptoms: Abscess, Injection site hypersensitivity, Injection site pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NONE~ ()~~~In patient
Other Medications: NONE
Current Illness: healthy
Preexisting Conditions: healthy
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: 895160007L

Write-up: pt recv vax 2JUN95 & 1-2 days post vax pt presented w/sterile abscess-5cm in diameter @ the inj site;area was also red & tender;pt also had a low grade fever;cool compresses prescribed;as of 8JUN95 inj site abscess persists;


VAERS ID: 88523 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Missouri  
Vaccinated:1995-06-02
Onset:1996-04-10
   Days after vaccination:313
Submitted: 0000-00-00
Entered: 1996-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 10APR96 IGG negative; IGM negative
CDC Split Type: WAES96050340

Write-up: pt recv 2 doses of vax 5MAY95 & 2JUL95 & 10APR96 lab eval was negative for IgM & IgG;no further details were provided


VAERS ID: 90879 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Female  
Location: Maryland  
Vaccinated:1995-06-02
Onset:1996-05-22
   Days after vaccination:355
Submitted: 0000-00-00
Entered: 1996-10-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0404B / 1 - / SC

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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: varicella zoster immune globulin on 22JAN92;
Current Illness: NONE
Preexisting Conditions: exposure, varicella;CVA;surgery, cardiac; tetralogy of fallot;sz;colostomy;neurological abn;
Allergies:
Diagnostic Lab Data: No relevant data;
CDC Split Type: WAES96062095

Write-up: pt recv vax 2JUN95 & 22MAY96 pt devel chicken pox w/141 pox;tx w/med;pt recovered;MD felt this was a vaccine failure;


VAERS ID: 93606 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Male  
Location: Texas  
Vaccinated:1995-06-02
Onset:1996-12-17
   Days after vaccination:564
Submitted: 1996-12-31
   Days after onset:14
Entered: 1997-01-07
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0413B / 1 LL / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: pt sibling exp varicella @ 8yr w/varivax dose 1;~ ()~~~In Sibling
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: pt sibling dx w/chicken pox 30NOV96 (had recv vax 28JU95);mom called office 17DEC96 & reported pt breaking out that AM-zovirax called in;


VAERS ID: 101016 (history)  
Form: Version 1.0  
Age: 1.0  
Gender: Male  
Location: North Carolina  
Vaccinated:1995-06-02
Onset:1997-05-18
   Days after vaccination:716
Submitted: 0000-00-00
Entered: 1997-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0412B / 1 - / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness: otitis med,bilat, fever;
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: No relevant data;
CDC Split Type: WAES97052600

Write-up: pt recv vax 2JUN95 & 18MAY97 pt devel varicella all over body x/head;tx w/amoxil & APAP;


VAERS ID: 101113 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Male  
Location: New York  
Vaccinated:1995-06-02
Onset:1997-05-20
   Days after vaccination:718
Submitted: 0000-00-00
Entered: 1997-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0404B / 1 - / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: pt sibling devel chickenpox @ 9y w/varivax dose 1;~ ()~~~In Sibling
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: No relevant data;
CDC Split Type: WAES97061238

Write-up: pt recv vax 2JUN95 & 30MAY97 pt devel breakthrough chickenpox;


VAERS ID: 101114 (history)  
Form: Version 1.0  
Age: 7.0  
Gender: Female  
Location: New York  
Vaccinated:1995-06-02
Onset:1997-06-02
   Days after vaccination:731
Submitted: 0000-00-00
Entered: 1997-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0404B / 1 - / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: pt sibling devel chickenpox @ 6yr old w/varivax dose 1;~ ()~~~In Sibling
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: No relevant data;
CDC Split Type: WAES97061239

Write-up: pt recv vax 2JUN95 & 15JUN97 pt devel breakthrough chickenpox;


VAERS ID: 156466 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Male  
Location: New Hampshire  
Vaccinated:1995-06-02
Onset:1999-11-14
   Days after vaccination:1626
Submitted: 2000-05-16
   Days after onset:183
Entered: 2000-07-13
   Days after submission:58
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0394B / 1 - / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES99111656

Write-up: On 11/14/99, subsequent to receiving one dose of varicella virus vaccine live, the pt developed 25 varicella lesions. The pt sought unspecified medical attention. Subsequently, the pt recovered from varecella lesions. No further information is available.


VAERS ID: 195793 (history)  
Form: Version 1.0  
Age: 8.0  
Gender: Male  
Location: California  
Vaccinated:1995-06-02
Onset:2002-12-21
   Days after vaccination:2759
Submitted: 2003-01-02
   Days after onset:12
Entered: 2003-01-06
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0410B / 1 - / SC

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

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

Write-up: Pt diagnosed with varicella on 12/23/2002. Sym: fever, rash on back, groin, chest, temp. 102.6 x 2 days


VAERS ID: 220522 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Male  
Location: Connecticut  
Vaccinated:1995-06-02
Onset:2003-03-22
   Days after vaccination:2850
Submitted: 2004-05-14
   Days after onset:418
Entered: 2004-05-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ritalin
Current Illness:
Preexisting Conditions: Attention deficit/ hyper-activity disorder: Drug hypersensitivity.
Allergies:
Diagnostic Lab Data: body tem 03/22/03: no fever. VZV strain 04/03/03: WT VZV
CDC Split Type: WAES0303USA02955

Write-up: Information has been received from a physician''s assistant concerning a 13 year old male student with attention deficit/ hypersensitivity disorder and a "sulfa" allergy who on 02JUN1995 was vaccinated with a 0.5ml dose of varicella virus vaccine live. Concomitant therapy included methlyphenidate HCl (RITALIN) 10mg q AM and q noon. There was no history of chickenpox and no recent exposure to chickenpox or herpes zoster. On 22MAR2003, the patient developed herpes zoster, which was noted to be on his right thigh. The patient was seen in the physician''s office The rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. It was noted that the child had no fever, quantified his pain at a 5-6 (0 being the least; 10 being the most), and complained of itching. The patient was placed on famciclovir (FAMVIR) for seven days. After one month, the patient recovered from the herpes zoster. Results of PCR analysis revealed that the zoster lesion contained the WT varicella zoster virus. Additional information is not expected.


VAERS ID: 238491 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Maryland  
Vaccinated:1995-06-02
Onset:2001-12-23
   Days after vaccination:2396
Submitted: 2005-05-16
   Days after onset:1239
Entered: 2005-05-31
   Days after submission:15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0407B / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0409USA01066

Write-up: Information has been received from a RN concerning a pt who on 02Jun95 was vaccinated with a dose of varicella virus vaccine live (lot 608579/0407B). Subsequently, on 23Dec01, the pt developed chickenpox. The pt was seen in the office. The reporter also indicated that 30 other pts were vaccinated with varicella virus vaccine live and developed chickenpox (WAES0409USA00600, WAES0409USA01045, WAES0409USA01046, WAES0409USA01047, WAES0409USA01048, WAES0409USA01049, WAES0409USA01050, WAES0409USA01051, WAES0409USA01052, WAES0409USA01053, WAES0409USA01054, WAES0409USA01055, WAES0409USA01056, WAES0409USA01057, WAES0409USA01058, WAES0409USA01059, WAES0409USA01060, WAES0409USA01061, WAES0409USA01062, WAES0409USA01063, WAES0409USA01064, WAES0409USA01065, WAES0409USA01067, WAES0409USA01068, WAES0409USA01069, WAES0409USA01070, WAES0409USA01071, WAES0409USA01072, WAES0409USA01073, WAES0409USA01074). No further information is expected.


VAERS ID: 77581 (history)  
Form: Version 1.0  
Age: 39.0  
Gender: Male  
Location: Foreign  
Vaccinated:1995-06-02
Onset:0000-00-00
Submitted: 1995-09-15
Entered: 1995-09-22
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Leukopenia, Retinal disorder
SMQs:, Haematopoietic leukopenia (narrow), Systemic lupus erythematosus (broad), Retinal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 950086001

Write-up: AE: unspecified retinal disorder & lymphocytopenia (values not reported); cortancyl indication not separated; case reported, w/o further information, by the french agency


VAERS ID: 93804 (history)  
Form: Version 1.0  
Age: 27.0  
Gender: Male  
Location: Foreign  
Vaccinated:1995-06-02
Onset:1995-06-20
   Days after vaccination:18
Submitted: 1997-01-08
   Days after onset:568
Entered: 1997-01-15
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM - / 2 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood creatine phosphokinase increased, Myositis, Neuropathy
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 1995 creatine phosphokinase inc enzymes;
CDC Split Type: 960200481

Write-up: pt recv vax 2JUN95 & 18 days later pt devel peripheral neuroapthy & polymyositis;pt hosp;lab tests showed inc CPK enzymes;4AUG95 pt recovered;


VAERS ID: 134405 (history)  
Form: Version 1.0  
Age:   
Gender: Male  
Location: Foreign  
Vaccinated:1995-06-02
Onset:0000-00-00
Submitted: 2000-02-23
Entered: 2000-02-29
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. HW28840 / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Mental retardation severity unspecified
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: UNK
Current Illness:
Preexisting Conditions: Diarrhea
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES00021389

Write-up: Subsequent to MMR, pt exp developmental delays. No further info available.


VAERS ID: 204669 (history)  
Form: Version 1.0  
Age: 1.0  
Gender: Male  
Location: Foreign  
Vaccinated:1995-06-02
Onset:0000-00-00
Submitted: 2003-06-04
Entered: 2003-06-10
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0234A / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cognitive disorder, Neurodevelopmental disorder, Speech disorder
SMQs:, Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0305USA02782

Write-up: Information has been received from a foreign legal firm regarding a case in litigation concerning a male who at 12 months of age on 6/2/95 was vaccinated with a dose of MMR II (610745/0234A; HW28840). It was alleged that subsequent to the vaccination, the pt experienced developmental delay, delayed speech and language and communication skills. Upon internal review the pt''s developmental delay, delayed speech and language and communication skills were considered important medical events (OMIC). No further info is available. A 15-day follow up report received 8/25/2003 adds no new info.


VAERS ID: 204815 (history)  
Form: Version 1.0  
Age: 1.08  
Gender: Female  
Location: Foreign  
Vaccinated:1995-06-02
Onset:1995-06-16
   Days after vaccination:14
Submitted: 2003-06-09
   Days after onset:2915
Entered: 2003-06-12
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0284A / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abnormal behaviour, Antisocial behaviour, Autism, Cognitive disorder, Gastrointestinal disorder, Infection, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: Rubella
Allergies:
Diagnostic Lab Data: Hearing test normal 1/15/97
CDC Split Type: WAES99031446

Write-up: Information has been received concerning a 13 month old female with a history of suspected rubella infection in late 1994 who on 6/2/95 was vaccinated with MMR II (611482/2084A; HW35700). It was alleged that subsequent to the vaccination, the pt experienced autism and bowel problems. Follow up info has been received from a foreign legal firm regarding a case in litigation that indicated that the pt''s mother did not recall that the pt had an immediate reaction to the vaccination of MMR II but this did not rule out the possibility that such a reaction took place unobserved. On approximately 6/16/95, the pt contracted chicken pox but there were no complications noted. It was noted that by the beginning of August 1995 that the pt was no longer interested in playing with other children and would run away from them. In September or October of 1995, the pt developed a high temperature and was very ill. The pt''s physician indicated that the pt had a viral illness and was to be treated with Calpol. The pt''s mother noticed that the pt was no longer speaking the words she learned before the vaccination. At the same time, the pt began to point at objects that she wanted or guided her mother''s hand directly to the object, which she had not done before the vaccination. Shortly before Christmas of 1995, the pt began to line things up and began playing with her food rather than eating it. It was noted at the same time that if the pt''s mother''s moved the objects she had lined up, the pt would notice this and immediately move the objects to their original position. The pt demonstrated no interest in the Christmas decorations or her presents which fascinated her the year before. At the same time, the pt began to distance herself from other people and preferred to go to her room. While the pt was in her room, she became very destructive, breaking and throwing things around. The pt''s diet became restrictive where she no longer ate the same food as the rest of the family. On 1/16/96, at the pt''s 18-24 month check up, she was referred for a hearing test because of parental concerns. During the pt''s second year, the pt''s bowel movements became looser and it was extremely difficult to potty train her. The pt''s mother indicated that the pt''s "bowel motions" were of clay-like consistency, which they had not been before the vaccination. At the same time, the pt started to try and climb out of a window in her bedroom. The pt''s mother moved the radiator in the pt''s room so she could not climb out of the window. On 8/30/96, the pt was evaluated by a speech language therapist who indicated that the pt did not understand a single word. The pt was referred for a further assessment but was unable to tolerate the group sessions. The pt was found to use jargon and did not respond readily to her name. Her eye contact was poor. On 1/15/97, a hearing test confirmed that the pt''s hearing was within normal limits. In February 1997, a physician indicated that the pt was demonstrating a number of aspects of her behavior seen in autistic children. In May of 1997, a physician confirmed that the pt''s diagnosis of autistic spectrum disorder. At the same time the pt began to turn the furniture upside down at home. The pt''s mother had to fit locks to all of the doors to prevent the pt from escaping. The pt continued to be very active and impulsive. A consulting physician recommended to the pt''s mother to place the pt on a gluten free diet. The pt''s mother believed that the gluten free diet made a significant difference in the pt''s behavior, concentration, eye contact and improved her diarrhea. On 8/26/98, a physician who specialized in genetics confirmed that the pt was not dysmorphic and considered it unlikely that the pt had any chromosomal abnormality. On 8/10/99, a physician evaluated the pt in relation to her previous problems. The physician considered it unlikely that the pt had coeliac disease. It was noted that the pt''s behavior had now improved and she no longer tried to run away as often as she once did. The pt''s obsessive behavior was less and she was more tolerant of other people. The pt''s "bowel motions" were not as loose as they were, although they remained of a clay-like consistency. The pt''s concentration was poor and her speech was very repetitive and immature. The pt had little sense of danger and had to be watched at all times, especially when out of the home. Follow up info was received on 6/2/03 which pertained to the event that occurred in September and October of 1995 following the first vaccination received on 6/2/95. This info contained the following adverse experience: viral illness. Upon internal review, the pt''s autism and intestinal function disorder were considered important medical events (OMIC). No further info is available. Follow up information was received on June 2, 2003 which pertained to the event that occurred in September abd October of 1995 following the first vaccination received on June 2, 1995. This information contained the following adverse experience: viral illness (September, October 1995). In follow up information received on September 16, 2003, it was reported that the patient was referred by her health visitor to the audiology department at age 21 months when she had a speech and language delay. From there, at the age of 2 years, to the child development team when it became apparent that she was not coping in the group situation and appeared to have very little in the wasy of symbolic play in addition to very little expressed or understood language. The family was initially reluctant to accept speech and language therapy and also to accept the need for brain evoked response audiometry as the patient had been unable to perform performance hearing tests. The patient''s mother had become concerned that the patient may have autism. The patient''s parents are seperated but are working together to try and help the patient occurred when the famly was splitting up or through the pregnancy. The parenancy was reportd as being uneventful, with the patient''s mother in good health. The patient was the first pregnancy to her unrelated parents. The patient''s mother did not take alcohol or cigarettes. She delivered the patient at at term and she weighed 3.37 kilograms. The apgar was reported as 6 and 9 and there were no neonatal problems. There is no family history of autism or a language disorder. The patient''s maternal grandfather was said to be a late walker and a maternal cousin was said to be adifficult baby and young child. One of the mother''s sister''s did not start talking until she was 3 years old but is now normal at 5 tears. there was no significant family history on teh father''s side. The patient''s full immunizations had been completed. A hearing test was awaited. There is no history of signoficant medical problems. As a baby the patient was described as being easy. She had a variable sleep patern, smiled, and laughed at 6 months of age, walked at 11 months of age and by 21 months was not following instructions and had no speech. She had little conversational speech but could recite the alphabet, count and repeat some nursery rhymes. On specific questioning it was clear that she had very little developed symbolic play, she showed little evidence of joint interest activities involving her parents but would respond to her own name. The patient was not toilet trained, she would feed herself but was very fussy about some types of food. In motor activities, she was mobile and active. The patient was described as a sturdy, well grown girl with no dysmorphic features. She was clearly self-absorbed but explored widely within he room. Her interaction with adults was fleeting and she showed very little sustained interest in adults. She shoewed much reduced eye contact and dod not use uttered language for any communicative purpose. She showed some postured gross movements and some almost repetitive dance movements. In summary, the community pediatrician reported that the patient was a 2 year nine month old girl who had significantly delayed communication and language skills associated with abnormal socialization and a reduction in symbolic play and joint interest behaviors. It was reported that she was clearly within the Autistic Spectrum Disorder. The patient''s non verbal skills were not significantly delayed.


VAERS ID: 204817 (history)  
Form: Version 1.0  
Age: 1.2  
Gender: Male  
Location: Foreign  
Vaccinated:1995-06-02
Onset:0000-00-00
Submitted: 2003-06-09
Entered: 2003-06-12
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1583W / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Gastrointestinal disorder
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0306USA00292

Write-up: Information has been received from a foreign legal firm regarding a case in litigation concerning a male child who on 6/2/95, at the age of 14 months, was vaccinated with a dose of MMR II (610070/1583W; 856280U). Subsequently, it is alleged that the pt developed chronic bowel problems. Upon internal review, chronic bowel problems were considered to be other important medical events (OMIC). No further info is available. A 15-day follow up report received 9/30/2003 adds: Subsequently, it is alleged that the pt developed Asperger''s syndrome/developmental coordination disorder, mild receptive language delay and chronic bowel problems. The pt''s brother suffered from episodes of constipation that lasted up to 2 weeks. He took lactulose but that did not seem to work. It was revealed that his brother had 2-3 blockages in his bowels. It was reported that his stools were watery in texture and that he was unable to control his bowel movements and sometimes had accidents on his way to the toilet. On the day of the vaccination, the pt developed a temperature and was floppy, pale and constantly crying. The pt did not sleep well that night. Within 2 weeks of the MMR II, the pt no longer responded to his pet name. Within a month of receiving the vaccination, there was a change in his bowels and he was no longer passing solid stools but more diarrhea. It was reported that it seemed like the pt was in pain when moving his bowels. The pt''s mother became concerned about the diarrhea and therefore took the pt to the doctor. The pt was also suffering from a high temperature and vomiting, however the general practitioner labeled this as toddler diarrhea. Within a month of the vaccination the pt had lost the words that he had already learned. It was noted that he was no longer learning new words and was not processing in his speech and language. Also within a month of the MMR II vaccination, the pt''s eye contact became fleeting. The pt developed an increased thirst and started to drink copious amounts of water and developed a series of urine infections. At the same time, the pt became more inconsiderate to other peoples emotions. He longer understood what was said to him. Within a month of receiving the MMR II vaccination, the pt started to suffer from convulsions. He was therefore admitted to the hospital in August 1995 for local seizures which started in his left leg. The pt was seen by the pediatric registrar at the hospital for his convulsions and was prescribed vigabatrin (Sabril) 250 mg. This resulted in a complete cessation of attacks. Within 2 months of the MMR II vaccination, the pt''s appetite changed in that he started to eat more. However, despite his excessive eating, the pt was not putting on any weight. Within 2 months of the MMR vaccination, the pt became obsessed with spinning things. The pt had an MRI on 08/02/1995 which was normal. An EEG was done on 08/04/1995 and it showed no focal or paroxysmal activity. The pt was noted to be in excess of fast activity for a child of his age. In Sept 1995, a consultant pediatrician raised the possibility of epilepsy. The pt was therefore weaned off the vigabatrin to see whether the epilepsy returned. Following his convulsions, the pt would no longer concentrate on what was being said to him. It was noted that he would also ignore everyone and carried a blank expression on his face. By the age of 2 years, the pt started to sweat excessively at night. It was reported that he no longer wanted to sleep with a duvet. By April 1997, the pt became obsessed by noises. The pt started to suffer from constipation in August 1998. The physician noted that on one occasion the pt seemed constipated and on other occasions he was having loose motions and diarrhea. In Oct 1998, following the operation on his testicles, the pt started to complain of central abdominal pain which occurred around twice a week. There were no aggravating factors towards the pain which became worse after eating. The pain would last a few hours and was colicky in nature. The pt continues to be in pain during defacation. Also in Oct 1998, the pt became very hyperactive and would run around the house repeatedly. In Sept 1999, the health visitor referred the pt to a speech and language therapist. She noted that the pt presented with general language delay and consequently required speech and language therapy to develop his understanding and his use of grammar. The physician saw the pt on 03/03/2000 because he had attentional difficulties in school. The physician noted that he had great difficulty following instructions and sustaining attention to tasks. The pt did not listen and would shift from one uncompleted activity to another. The physician felt that the pt would be able to improve his ability to concentrate more by starting him on methylphenidate hydrochloride (Ritalin) 5 mg 3 times daily. By July 2000, the pt''s parents had taken him off the methylphenidate hydrochloride (Ritalin). Since then, it became noticeable at school that the pt''s attention deteriorated markedly. The pt was put back on Ritalin 5 mg twice daily. The physician saw the pt again in Dec 2000 and he noted concerns of the school staff who indicated that the pt was suffering from social and communication difficulties. The pt played alone and systemically walked backwards and forwards in the playground. It was noted that the pt''s social and communication difficulties were more apparent when he was not on Ritalin. In March 2001, the pt''s mother became concerned about his obsessions. Initially the pt had an obsession with washing machines and then later developed an obsession with fans and light switches. The physician indicated that the pt had significant social and communication difficulties and these could well be consistent with Asperger''s Syndrome. The pt was referred to the consultant community pediatrician on 04/06/2001. The pt attended the clinic on 05/08/2001 and the physician confirmed complex difficulties including a degree of developmental coordination disorder and mild receptive language delay. However, he recommended continued follow up of the pt in order to obtain a more specific diagnosis. It was reported that the pt was born at term, had a normal delivery and weighed 7 pounds 6 ounces at birth. His developmental milestones were normal. The pt had colic as a baby but did not cry a lot. He was a very active toddler who was bored easily and wanted to explore. He did, however, sleep well. Presently, the pt gets bored very easily and cannot sit still and watch a video and often wants to be the center of attention. The pt''s mother felt that the pt fell into the category of "Attention Deficit Disorder". It was decided that the pt would be able to improve his ability to concentrate more and was therefore started on a trial of Ritalin 5 mg 3 times a day. A physical exam revealed no abnormality. Blood pressure was 100/60. The pt''s mother discontinued the Ritalin because she thought it was producing side effects such as feelings of nausea and abdominal pain and she felt that the medication was changing the pt''s personality. Reports from the pt''s school however indicated that the Ritalin helped the pt''s concentration and attention span. At the office visit on 05/08/2001 the pt''s mother felt that there had been an improvement over the recent months and that she is happier about the pt. At this time a diagnosis of Autistic Spectrum Disorder (Asperger''s Syndrome) was discussed. The pt''s mother did not personally feel that was an appropriate diagnosis at that time. It was noted by the physician that the pt clearly had learning difficulties and received extra help with reading and numeracy. The pt had complex difficulties including a degree of a developmental coordination disorder. The pt''s mother did not want a specific label regarding the pt''s social and communication weaknesses at that time. She did mention some concern about the pt''s hearing. A hearing retest was planned. It was noted that the pt did have a mild repetitive language delay. The pt was seen by a speech and language therapist since Sept 1999. In 1999 he presented for an initial assessment and had a general language delay and consequently received some speech and language therapy to help develop his understanding and use of grammar. The pt failed to attend an appointment on 05/31/2000 and after no reply to a further request; he was discharged from speech and language therapy on 06/23/2000. The pt was re-referred in Nov 2000 by his school regarding concerns with his comprehension of language. The pt failed to attend the first 2 appointments on 01/04/2001 and 02/20/2001. However he attended 2 assessment sessions on 04/19/2001 and 04/26/2001. It was noted that the pt was able to follow adult direction. However he was easily distracted by his environment and needed reminders to return his attention. His classroom teacher reported that the pt finds it difficult to attend any group situation in school. It was noted that he had not been observed in a group situation. The pt''s understanding of language was assessed using "The Test for Reception of Grammar (TROG)" on 04/19/2001. He passed 11 blocks, which at a chronological age of 7.00 years gives an age equivalent score of 5 years 6 months. The pt''s expressive language was assessed using the "Renfrew Action Picture Test (RAPT)" on 04/19/2001. This looked at both the information provided (content of expressive language) and the use of grammatical structures in his sentences. Verbal prompting was required throughout the assessment. However his final score was follows: Information content: the pt scored 31.5 giving an age equivalent of 5 years 6 months. Grammar used: he scored 16 giving an age equivalent of 3 years 6 to 11 months. The score reflected informally his expressive language. The pt uses no complex grammar; in particular he demonstrates errors in verb tense and omits personal pronouns. In addition, the pt was often disfluent. He would repeat the initial sound in a word. This was most noticeable in the testing situation. The pt''s ability to assess appropriate vocabulary was assess using the "Renfrew Word Finding Vocabulary Scale (RWFVS)" on 04/19/2001. His final score gave an age equivalent of 5 years 11 months. To 6 years 1 month. There were no particular concerns regarding his expressive vocabulary. The pt''s connected speech was generally clear; therefore he had not been formally assessed. Occasionally he used an immature articulation of "s", but this was not consistent. The pt''s reasoning skills were assessed using the Verbal Reasoning Skills Assessment which looks specifically at more abstract areas of language such as logic, cause-effect relationships and inference. His final scorer gave an age equivalent of 5 years, he was beginning to use some of the skills expected at a 6 year level. In order to determine the level of functioning in the area of language, the "Pragmatics of Everyday Communication Skills In school-aged Children" was completed with the pt''s m;other. This aspect of his language was also discussed with his class teacher. The results were as follows: At home: it was reported that the pt was able to verbally complete communicative functions such as requesting help or info. However in school it was reported that he never requested assistance. At home: it was reported that the pt would have a conversation and at times timed he plays a minimal part in the conversation, at other times an equal part. At school his teacher has to ask very direct questions and the pt often responded with just one or two word responses. At home: it was reported that the pt had limited interaction with his peers and tends to be left on the sidelines. In school it was also reported that he did not mix with his peers. There are other examples of difficulties with social interaction reported in school. The pt presented with a moderate delay in both his receptive and expressive language, his social use of language also appeared to be in line with these skills. He also presented with some difficulties in using grammatical structures. Short term aims were to develop understanding and use of personal pronouns and to develop reasoning skills. Other recommendations included a program to meet the stated short term targets, to be devised by a qualified speech and language therapist together with a teacher who had experience with children with moderate special needs. The program would involve a combination of direct and indirect approaches. Direct interventions would be delivered in a small group and/or individual sessions within a class and/or quiet room and would occur once weekly in blocks of 5 or 6 weeks with breaks of no more than 12 weeks between each block to allow for consolidation and generalization. The direct interventions would be carried out by a qualififed speech and language therapist who would delegate to others those tasks which she knows to be within their competence. The overall management of the speech and language therapy program remained with the speech and language therapist. The indirect interventions would be carried out in class/at home by school staff/parents who will be guided by a therapist. The programs frequency and method of intervention would be reviewed termly 6 monthly and altered as indicated. The therapist would provide updated reports for annual review, would contribute to the pt; individual plan and be available by appointment to the parents for advice and liaison. Previous vaccinations included: A first dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown) on 05/20/1994 (batch #EB4478E), a second dose on 07/15/1994 (batch #E34478E) and a third dose on 10/21/1994 (batch #EE4008E). A first dose of poliovirus vaccine inactivated (unspecified) (manufacturer unknown) was given on 05/20/1994 (batch #APTF/73/13), a second dose was given on 07/15/1994 (batch #S575AZ) a third dose on 10/21/1994 (batch #S760A1) and a booster dose on 09/01/1998 (batch #61259L). A booster dose of diphtheria toxoid (manufacturer unknown) was given on 09/01/1998 (batch #N0204). A first dose of the Hib conj vaccine (unspecified carrier) (manufacturer unknown) vaccine was given on 05/20/1994 (batch #J0031, J0168), a second dose on 07/15/1994 (batch #J0031, J0168) and a third dose on 10/21/1994 (batch #J1027, K0297). Info was received on 08/08/2003 which pertained to the events that occurred 3 years following the discontinuation of MMR II on 06/02/1995. This info contained the following adverse experiences: hyperphagia (1995), sweating increased (1996) and abdominal pain (1998). Upon internal review, Asperger''s Syndrome/developmental coordination disorder, mild receptive language delay and chronic bowel problems were considered to be other important medical events. No further info is available. A copy of the pt''s medical record is available upon request.


VAERS ID: 74639 (history)  
Form: Version 1.0  
Age: 43.0  
Gender: Female  
Location: Ohio  
Vaccinated:1995-06-03
Onset:1995-06-04
   Days after vaccination:1
Submitted: 1995-06-05
   Days after onset:1
Entered: 1995-06-08
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / PFIZER/WYETH 4958004 / UNK LA / IM

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

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

Write-up: pt recv vax; lt arm became swollen w/ redness; approx quarter size surrounding inject site;


VAERS ID: 74859 (history)  
Form: Version 1.0  
Age: 10.0  
Gender: Male  
Location: Utah  
Vaccinated:1995-06-03
Onset:1995-06-04
   Days after vaccination:1
Submitted: 1995-06-05
   Days after onset:1
Entered: 1995-06-13
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TTOX: TETANUS TOXOID (NO BRAND NAME) / PFIZER/WYETH - / 6 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Headache, Nausea, Oedema peripheral, Pain, Pyrexia, Vasodilatation
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: pt reacted to Pertussis @ 18mos w/sz~ ()~~~In patient
Other Medications: Cephalexin/Ritalin
Current Illness: laceration to lt lower leg;
Preexisting Conditions: NKA pt is on Ritalin 40SR daily hyperactivity
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: axillary t102; h/a, nausea, red & swollen arm; pain in arm & shoulder;


VAERS ID: 77027 (history)  
Form: Version 1.0  
Age: 1.1  
Gender: Male  
Location: New York  
Vaccinated:1995-06-03
Onset:1995-06-11
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 1995-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Agitation, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: No relevant data;
CDC Split Type: WAES95060653

Write-up: pt recv vax 11JUN95 & exp a fever of 104; pt was taken to ER & hospitalized for treatment; No further details were provided;


VAERS ID: 76202 (history)  
Form: Version 1.0  
Age: 28.0  
Gender: Male  
Location: Florida  
Vaccinated:1995-06-03
Onset:1995-06-03
   Days after vaccination:0
Submitted: 1995-07-15
   Days after onset:42
Entered: 1995-07-28
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TTOX: TETANUS TOXOID (NO BRAND NAME) / CONNAUGHT LABORATORIES 4K61084 / 2 - / IM A
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME) / PFIZER/WYETH 4948192 / 3 - / IM A

Administered by: Military       Purchased by: Military
Symptoms: Dizziness, Dyspnoea, Headache, Hypertension
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad)

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

Write-up: pt c/o SOB, high blood pressure, dizziness & ha/; EMS started IV ;


VAERS ID: 79221 (history)  
Form: Version 1.0  
Age: 2.0  
Gender: Female  
Location: California  
Vaccinated:1995-06-03
Onset:1995-08-01
   Days after vaccination:59
Submitted: 0000-00-00
Entered: 1995-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0400B / 1 - / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: atb
Current Illness:
Preexisting Conditions: high fever, bite dog; rash arm;
Allergies:
Diagnostic Lab Data: no relevant data
CDC Split Type: WAES95080735

Write-up: pt recvd vax;devel gen rash;seen by diff ped who felt rash related to heat;10aug95 seen by dermatologist who felt marks looked liked chicken pox;spots were clearing at time of rpt;


VAERS ID: 79429 (history)  
Form: Version 1.0  
Age: 1.5  
Gender: Male  
Location: Pennsylvania  
Vaccinated:1995-06-03
Onset:1995-06-12
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 1995-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: pt''s sib exp croup @17m w/varivax dose 1; pt exp atypical measles @ 15mo w/MMR~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: No relevant data;
CDC Split Type: WAES95060816

Write-up: pt recvd vax 3JUN95 & 12JUN95 devel croup;pt was treated w/Pred sodium phosphate for 3 days;20JUN95 devel shingles w/30-35 vesicles;sxs resolved w/in 3 days;pt''s brother was also vaxed w/varicella vax & devel croup;


VAERS ID: 79430 (history)  
Form: Version 1.0  
Age: 1.5  
Gender: Male  
Location: Pennsylvania  
Vaccinated:1995-06-03
Onset:1995-06-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 1995-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 1 - / -

Administered by: Private       Purchased by: Other
Symptoms: Laryngitis
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: pt''s sibling exp croup & shingles @ 17mon w/Varivax dose 1~ ()~~~In Sibling
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: No relevant data;
CDC Split Type: WAES95060817

Write-up: pt recvd vax 3JUN95 & 5JUN05 pt devel croup & was treated for 3 days;pt''s brother was also vaxed & devel croup & a rash


VAERS ID: 79440 (history)  
Form: Version 1.0  
Age: 3.0  
Gender: Male  
Location: New Jersey  
Vaccinated:1995-06-03
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 1995-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 1 - / SC

Administered by: Private       Purchased by: Other
Symptoms: Rash, Skin discolouration
SMQs:, Anaphylactic reaction (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: No relevant data;
CDC Split Type: WAES95060903

Write-up: pt recvd vax 3JUN95 & 16JUN95 pt devel rash on elbow of the opposite arm which inj had been given;rash was 3 inch circumference discoloration;depigmented area of pt rt arm


VAERS ID: 82225 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Ohio  
Vaccinated:1995-06-03
Onset:1995-06-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 1995-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RUB: RUBELLA (MERUVAX II) / MERCK & CO. INC. - / UNK - / -

Administered by: Private       Purchased by: Other
Symptoms: Convulsion, 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), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: EEG-abn
CDC Split Type: WAES95060334

Write-up: Pt recvd vax 3JUN95 & 6JUN95 pt exp tremor;follow up from the pts MD indicated that pt exp sz activity;EEG suggested that pt had a long standing undetected abn;


VAERS ID: 85936 (history)  
Form: Version 1.0  
Age: 5.0  
Gender: Female  
Location: Texas  
Vaccinated:1995-06-03
Onset:1996-02-01
   Days after vaccination:243
Submitted: 0000-00-00
Entered: 1996-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0401B / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness: none
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: No relevant data;
CDC Split Type: WAES96020142

Write-up: pt recv vax 3JUN95 & devel a light case of chickenpox w/approx 15 to 20 lesions;


VAERS ID: 100646 (history)  
Form: Version 1.0  
Age: 2.0  
Gender: Female  
Location: New Jersey  
Vaccinated:1995-06-03
Onset:1997-04-09
   Days after vaccination:676
Submitted: 0000-00-00
Entered: 1997-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 1 - / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: No relevant data;
CDC Split Type: WAES97041013

Write-up: pt recv vax 3JUN95 & 9APR97 pt exp chickenpox w/30 lesions;


VAERS ID: 76362 (history)  
Form: Version 1.0  
Age: 43.0  
Gender: Male  
Location: Foreign  
Vaccinated:1995-06-03
Onset:1995-06-17
   Days after vaccination:14
Submitted: 1995-07-31
   Days after onset:44
Entered: 1995-08-03
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Gamma-glutamyltransferase increased, Headache, Influenza, Laboratory test abnormal, Pyrexia
SMQs:, Liver related investigations, signs and symptoms (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: Mopral (omeprazole)
Current Illness:
Preexisting Conditions: Meningitis in 1985; oesophagitis grade 1 treated by mopral
Allergies:
Diagnostic Lab Data: 17JUN95 GGT 189; 24JUN95 GGT 125; 17JUN95 glutamic pyruvic serum 87;24JUN95 glutamic pyruvic serum 56; SOGT 13; 17JUN95 SOGT 72; HBS antibody neg; HBS antigen pos; 24JUN95 HBS antibody neg; HBS antigen neg;
CDC Split Type: 950062781

Write-up: Pt recv vax 03JUN95 & 14JUN95 pt exp influenza like sx including cephalea & fever; fever 38.5C & cephalea; lab data showed HBs Antigen pos in the absence of contagium notion & neg anti-HBs antibodies, inc value of gamma GT 189, SGPT & SGOT


VAERS ID: 328804 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Male  
Location: Foreign  
Vaccinated:1995-06-03
Onset:0000-00-00
Submitted: 2008-10-16
Entered: 2008-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 4 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Bladder disorder, Brain stem syndrome, Eyelid ptosis, Facial palsy, Gait disturbance, Hemiparesis, Micturition urgency, Motor dysfunction, Multiple sclerosis, Muscle spasms, Nuclear magnetic resonance imaging abnormal, Paraparesis
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Optic nerve disorders (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hearing impairment (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hep B vaccine (Non-GSK); Hep B vaccine (Non-GSK)
Current Illness: Unknown
Preexisting Conditions: The subject belongs to the REVAHB association (number 2293)
Allergies:
Diagnostic Lab Data: Nuclear magnetic resonance ima, Oct2004, see text. October 2004: MRI evidenced lesions (NOS)
CDC Split Type: B0540522A

Write-up: This case was reported by a foreign regulatory authority and described the occurrence of multiple sclerosis in a 26-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Co-suspect vaccine included GENHEVAC B. On 05 February, 08 March and 13 April 1994, the subject was vaccinated with GENHEVAC B (intramuscular, unknown batch number). On 03 June 1995 the subject received 4th dose of ENGERIX B ADULT (intramuscular, unknown batch number). In 2004, i.e. approximately nine years after vaccination with ENGERIX B adult, the subject progressively presented with right upper limb motor impairment and then urinary disorder urgent urination like. In October 2004, remitting multiple sclerosis was diagnosed with visualisation of lesions on the MRI. In November 2004, the subject experienced a flare-up with paraparesis and attack of two upper limbs, which appeared within two weeks. In February 2005, the subject experienced right hemiparesia. A treatment with AVONEX was introduced. In April 2005, the subject experienced a flare-up involving brain stem. It was reported that the outcome of each flare-up was favourable after corticoids treatment but walking perimeter progressively decreased to reach 500 metres in April 2005. In May 2005, the subject experienced a new flare-up with right facial paralysis and ptosis of right eye. He was treated with bolus of SOLUMEDROL at 1 gram daily for five days. Treatment with AVONEX was stopped and replaced by REBIF 44. A treatment with MANTADIX for permanent and disabling asthenia and TEGRETOL in order to limit facial hemispasm and synkinesis was also introduced. On 03 April 2008, it was reported that treatment with REBIF 44 was on going and bladder-sphincter disorder were treated with CERIS. The subject did not experience flare-up since 2005. Performances were stable with walking perimeter between 800 and 1 000 metres. At the time of reporting, the multiple sclerosis was unresolved. The agency reported that the multiple sclerosis was disabling and considered it as dubiously related to vaccination with ENGERIX B ADULT and/or to GENHEVAC B according to the foreign method of imputability.


VAERS ID: 349364 (history)  
Form: Version 1.0  
Age: 18.0  
Gender: Female  
Location: Foreign  
Vaccinated:1995-06-03
Onset:2007-07-01
   Days after vaccination:4411
Submitted: 2009-06-17
   Days after onset:717
Entered: 2009-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 4 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Demyelination, Dysarthria, Multiple sclerosis, Nuclear magnetic resonance imaging abnormal, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Optic nerve disorders (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Nuclear magnetic resonance ima, see lab text; On unspecified date, MRI showed demyelinating areas.
CDC Split Type: B0578219A

Write-up: This case was reported by the regulatory authority (number SE20090155) and described the occurrence of multiple sclerosis in a 31-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject belongs to association under reference 2418. Medical conditions were unspecified. On 25 April 1994, 10 June 1994 and 22 July 1994, the subject received a first, a second and a third dose of ENGERIX B (injection sites and batches unknown). On 03 June 1995, the subject received a fourth dose of ENGERIX B (injection site and batch unknown). In July 2007, 12 years after vaccination with ENGERIX B, the subject suddenly experienced dysarthria, asthenia and right hand paresthesia. She was hospitalised for complete check up: a MRI revealed demyelinating areas. Multiple sclerosis was diagnosed. In September 2008, a second multiple sclerosis flare up occurred. The subject was treated with corticosteroid (Corticoids). In April 2009, the subject experienced a third flare up and was treated with corticosteroids. The authority noticed that the events led to hospitalisation. At the time of reporting, multiple sclerosis was unresolved. The authority considered multiple sclerosis as unlikely relate to vaccination with ENGERIX B, according to the method of imputability.


VAERS ID: 75650 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Female  
Location: New Jersey  
Vaccinated:1995-06-04
Onset:1995-06-04
   Days after vaccination:0
Submitted: 1995-06-26
   Days after onset:22
Entered: 1995-07-07
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / CONNAUGHT LABORATORIES 4C61144 / 5 - / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0989A / UNK - / SC
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 0720D / 4 MO / PO

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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: NJ9529

Write-up: temp elevated as high as 103 x 24 hr did not respond to APAP; vomited 1x morning of 22JUN95; temp nl late afternoon of 22JUN95; seen by MD 23JUN95 early AM; pt OK


VAERS ID: 89446 (history)  
Form: Version 1.0  
Age: 54.0  
Gender: Female  
Location: Oregon  
Vaccinated:1995-06-04
Onset:1995-06-05
   Days after vaccination:1
Submitted: 1996-06-19
   Days after onset:380
Entered: 1996-08-23
   Days after submission:65
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / CONNAUGHT LABORATORIES 4F61059 / UNK LA / -

Administered by: Private       Purchased by: Other
Symptoms: Injection site hypersensitivity, Injection site oedema, Pruritus, Vasodilatation
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: Pred, Doxicillin
Current Illness:
Preexisting Conditions: HTN, fatigue, CAD
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO5972

Write-up: site raised, red, swollen, warm over deltoid area, itchy;


VAERS ID: 97676 (history)  
Form: Version 1.0  
Age: 6.0  
Gender: Female  
Location: California  
Vaccinated:1995-06-04
Onset:1995-07-01
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 1997-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0404B / 1 - / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: Intal;
Current Illness: NONE
Preexisting Conditions: Asthma;
Allergies:
Diagnostic Lab Data: No relevant data;
CDC Split Type: WAES97010166

Write-up: pt recv vax 4JUN95 & approx 5wk later, pt exp an unspecified mild rxn to the vax;21DEC96 pt devel full blown chickenpox w/a fever;sx lasted 5-7 days;


VAERS ID: 131021 (history)  
Form: Version 1.0  
Age: 2.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:1995-06-04
Onset:1999-11-20
   Days after vaccination:1630
Submitted: 1999-11-22
   Days after onset:2
Entered: 1999-11-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0407B / 1 - / SC

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

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

Write-up: pt broke out w/ chicken pox rash on 11/20/99 @ 40 on face;rt leg 3 on buttocks;mom states fluid filled, itchy called on 11/22/99;


VAERS ID: 74680 (history)  
Form: Version 1.0  
Age: 9.0  
Gender: Male  
Location: Georgia  
Vaccinated:1995-06-05
Onset:1995-06-05
   Days after vaccination:0
Submitted: 1995-06-05
   Days after onset:0
Entered: 1995-06-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 1649A2 / 1 LA / -

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

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

Write-up: approx 30-45 sec p/inj completed, pt slumped forward in mom''s arms, eyes open but limp & unresponsive; lifted to table & had 30sec episode of rigid posturing, head arched back, fists clenched, arms flexed to chest; pt spontaneously relaxed


VAERS ID: 75388 (history)  
Form: Version 1.0  
Age: 0.1  
Gender: Female  
Location: Florida  
Vaccinated:1995-06-05
Onset:1995-06-05
   Days after vaccination:0
Submitted: 1995-06-06
   Days after onset:1
Entered: 1995-06-26
   Days after submission:20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / CONNAUGHT LABORATORIES 4B61012 / 1 LL / IM
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 1650B2 / 1 RL / IM
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES 4E61006 / 1 LL / IM
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 0714D / 1 MO / PO

Administered by: Public       Purchased by: Public
Symptoms: Agitation, Anorexia, Injection site oedema, Injection site pain, Insomnia, Pyrexia, Screaming
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NONE~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NA
CDC Split Type: FL95043

Write-up: pt recv vax 5JUN95 went home w/mom & slept 15 mins pt started to cry 5PM-would not eat or sleep; pt cried till 830PM; took pt to ER & mom cont APAP & apply ice packs to leg; pain lt thigh; fever; crying; lt leg swollen;


VAERS ID: 75401 (history)  
Form: Version 1.0  
Age: 29.0  
Gender: Female  
Location: South Carolina  
Vaccinated:1995-06-05
Onset:1995-06-11
   Days after vaccination:6
Submitted: 1995-06-12
   Days after onset:1
Entered: 1995-06-26
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / CONNAUGHT LABORATORIES 4H61118 / UNK LA / -

Administered by: Public       Purchased by: Public
Symptoms: Hypersensitivity, Oedema peripheral, Skin nodule, Vasodilatation
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SC95048

Write-up: pt presented in clinic on 12JUN95 w/ 5x7cm area, overlying the deltoid of redness & induration; seen by MD allerg react; 14JUN95 swelling


VAERS ID: 75410 (history)  
Form: Version 1.0  
Age: 1.0  
Gender: Female  
Location: Wyoming  
Vaccinated:1995-06-05
Onset:1995-06-08
   Days after vaccination:3
Submitted: 1995-06-21
   Days after onset:13
Entered: 1995-06-26
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0701A / 3 LA / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0342A / 1 RA / SC

Administered by: Public       Purchased by: Public
Symptoms: Nausea, Pyrexia, Rash, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NONE~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Blood work drawn @ ER
CDC Split Type: WY9514

Write-up: 14JUN t102 APAP given would not bring down; AM 15JUN took to ER 0200 t103.4 & rash; ER MD drew blood & put on Advil 6-8hr;8JUN nausea & vomiting x 24 hr;


VAERS ID: 75872 (history)  
Form: Version 1.0  
Age: 33.0  
Gender: Male  
Location: Texas  
Vaccinated:1995-06-05
Onset:1995-06-15
   Days after vaccination:10
Submitted: 1995-07-10
   Days after onset:25
Entered: 1995-07-14
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 1544A4 / 1 - / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0387B / 1 - / SC

Administered by: Other       Purchased by: Other
Symptoms: Confusional state, Encephalitis, Headache, Pyrexia, Rash maculo-papular, Stupor, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: PPD GIVEN ON 5JUN95, CONN #239211
Current Illness:
Preexisting Conditions: NKA, HISTORY OF SPINAL TAP
Allergies:
Diagnostic Lab Data: No relevant data;
CDC Split Type: WAES95060759

Write-up: pt recv vax 5JUN95 & 15JUN95 pt devel a fever of 104, syncope, maculopapular rash of 4 lesions & a h/a; pt was hospitalized for tx; pt''s severe h/a persisted;


VAERS ID: 75874 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Ohio  
Vaccinated:1995-06-05
Onset:1995-06-30
   Days after vaccination:25
Submitted: 1995-07-07
   Days after onset:7
Entered: 1995-07-14
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 1657A2 / 1 RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0400B / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Dehydration, Dermatitis bullous, Headache, Vomiting
SMQs:, Severe cutaneous adverse reactions (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations: pt''s sibling exp rxn w/varicella in JUN95 dose 1~ ()~~~In Sibling
Other Medications: Clariten
Current Illness: NONE
Preexisting Conditions: allergic rhinitis
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: pt recv vax 5JUN95 & on 1JUL95 seen in ofc for severe h/a, vomiting & vesicular lesions (approx 10-15mins) on trunk & extremities; adm to hosp for dehydration;


VAERS ID: 75913 (history)  
Form: Version 1.0  
Age: 2.0  
Gender: Female  
Location: North Carolina  
Vaccinated:1995-06-05
Onset:1995-06-05
   Days after vaccination:0
Submitted: 1995-07-05
   Days after onset:30
Entered: 1995-07-17
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (TETRAMUNE) / PFIZER/WYETH 386987 / UNK LL / -

Administered by: Public       Purchased by: Public
Symptoms: Gaze palsy, Muscle twitching, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dyskinesia (broad), Dystonia (broad), Ocular motility disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: none~ ()~~~In patient
Other Medications: none
Current Illness: none known
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: none
CDC Split Type: NC95057

Write-up: pt recv vax; approx 2 hr p/ vax was playing & laughing on the floor; fell over & started jerking all over, eyes rolled back;lasted 10 mins per mom; to ped; T 104.4 R;had been given apap at 3pm prior to shot;


VAERS ID: 76295 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: New York  
Vaccinated:1995-06-05
Onset:1995-06-05
   Days after vaccination:0
Submitted: 1995-07-25
   Days after onset:50
Entered: 1995-07-31
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (TETRAMUNE) / PFIZER/WYETH 384975 / 1 LL / IM
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 1737A2 / 2 RL / IM
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 715126 / 1 MO / PO

Administered by: Public       Purchased by: Public
Symptoms: Agitation, Crying, Screaming
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: 10MAY95 colic/OM 28JUN95; oral thrush 20JUL95
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: NYS95041

Write-up: a period of atypical, inconsolable crying following 2mo immun; 3-4 hr induration; symptomatic care no other treatment than acetaminophen given resolved w/o apparent sequellae next AM;


VAERS ID: 76320 (history)  
Form: Version 1.0  
Age: 1.1  
Gender: Female  
Location: Texas  
Vaccinated:1995-06-05
Onset:1995-06-05
   Days after vaccination:0
Submitted: 1995-06-05
   Days after onset:0
Entered: 1995-08-01
   Days after submission:57
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (TETRAMUNE) / PFIZER/WYETH 426118 / 4 - / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0989A / 1 - / SC

Administered by: Public       Purchased by: Public
Symptoms: Hypertonia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NONE~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: TX95110

Write-up: pt recv vax 245PM it was reported that pt had a quiver p/receiving vax; mom stated pt had 4 separate episodes of shivering about 10 mins following vax;


VAERS ID: 77516 (history)  
Form: Version 1.0  
Age: 65.0  
Gender: Female  
Location: Hawaii  
Vaccinated:1995-06-05
Onset:1995-07-18
   Days after vaccination:43
Submitted: 1995-09-15
   Days after onset:59
Entered: 1995-09-19
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / SMITHKLINE BEECHAM VHA440A6 / 1 - / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. K0227 / UNK - / SC
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0536A / UNK - / SC
TD: TD ADSORBED (NO BRAND NAME) / CONNAUGHT LABORATORIES 51371053 / UNK - / IM
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Military       Purchased by: Military
Symptoms: CSF test abnormal, Guillain-Barre syndrome, Hypokinesia, Hypotonia, Laryngospasm, Movement disorder
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Demyelination (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 55 days
   Extended hospital stay? Yes
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness: NONE
Preexisting Conditions: bipolar disorder
Allergies:
Diagnostic Lab Data: CSF protein 90%, no cells
CDC Split Type:

Write-up: 20JUL devel acute severe GBS; presently on ventilator day 55, no motor activity; in hosp 21JUL to present;


VAERS ID: 79399 (history)  
Form: Version 1.0  
Age: 22.0  
Gender: Female  
Location: Missouri  
Vaccinated:1995-06-05
Onset:1995-06-23
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 1995-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0412B / 1 - / SC

Administered by: Private       Purchased by: Private
Symptoms: Dermatitis bullous, Drug ineffective, Headache, Infection, Myalgia, Pyrexia, Rash maculo-papular
SMQs:, Rhabdomyolysis/myopathy (broad), Severe cutaneous adverse reactions (narrow), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: Pred, Carafate, Pentasa, Triphasil
Current Illness:
Preexisting Conditions: Crohn''s disease; allergy, sulfa; allergy, mercaptopurine
Allergies:
Diagnostic Lab Data: JUN95 culture neg; 29JUN95 culture + for varicella virus;
CDC Split Type: WAES95070139

Write-up: pt recvd vax 5JUN95 & 23JUN95 pt devel low grade fever, h/a, myalgias;25JUN95 pt broke out in maculopapular rash;on exam pt had approx 20 varicelliform lesions on chest & abd;shell viral culture of lesions was positive for varicella virus;


VAERS ID: 79438 (history)  
Form: Version 1.0  
Age: 2.0  
Gender: Female  
Location: California  
Vaccinated:1995-06-05
Onset:1995-06-14
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 1995-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK - / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: No relevant data;
CDC Split Type: WAES95060833

Write-up: pt recvd vax 5JUN95 & 14JUN95 pt devel open lesions & on 19JUN95 pt devel fever; no further details were provided;


VAERS ID: 82472 (history)  
Form: Version 1.0  
Age: 38.0  
Gender: Female  
Location: Unknown  
Vaccinated:1995-06-05
Onset:1995-06-05
   Days after vaccination:0
Submitted: 1995-06-15
   Days after onset:10
Entered: 1995-11-14
   Days after submission:152
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM - / 1 - / IM A

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Nausea, Pain, Vertigo, Vomiting
SMQs:, Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: Theodur;Ventolin
Current Illness:
Preexisting Conditions: asthma;NKA
Allergies:
Diagnostic Lab Data:
CDC Split Type: 950052991

Write-up: pt recvd vax & 1 hrs post vax exp vertigo,nausea,vomiting,weakness & burning of the face;sensation of burning of the face lasted 45mins;other sx cont;pt was examined by MD who recommended forced fluids in the evening;


VAERS ID: 81902 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Wisconsin  
Vaccinated:1995-06-05
Onset:1995-06-05
   Days after vaccination:0
Submitted: 1995-06-06
   Days after onset:1
Entered: 1996-02-05
   Days after submission:244
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / CONNAUGHT LABORATORIES 4H51098 / 2 - / IM
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES 4H51098 / 2 - / IM
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 719K3 / 2 MO / PO

Administered by: Public       Purchased by: Public
Symptoms: Agitation, Crying, 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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: pt exp rxn @ 2mo w/DTP/HIB dose 1~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WI95043

Write-up: mom states pt had high pitched screaming & whining began 130PM 6MAY95;t99.2 gave cool both & APAP


VAERS ID: 85269 (history)  
Form: Version 1.0  
Age: 38.0  
Gender: Male  
Location: Washington  
Vaccinated:1995-06-05
Onset:1995-06-06
   Days after vaccination:1
Submitted: 1995-06-29
   Days after onset:23
Entered: 1996-04-01
   Days after submission:277
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / PFIZER/WYETH 4958008 / UNK LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 895261006L

Write-up: pt recv vax; w/in 24 hrs, devel gen pruritus & mild erythema w/out hives;


VAERS ID: 112101 (history)  
Form: Version 1.0  
Age: 60.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:1995-06-05
Onset:1995-06-12
   Days after vaccination:7
Submitted: 1997-09-09
   Days after onset:820
Entered: 1998-06-23
   Days after submission:287
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / LEDERLE LABORATORIES 380916 / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Hypertonia, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: unk
Current Illness: injury to lt rotator cuff
Preexisting Conditions: this pt may have had a light case of polio @ age 10
Allergies:
Diagnostic Lab Data:
CDC Split Type: 897255014L

Write-up: pt recv vax & 1wk post vax pt exp severe pain in lt shoulder, felt generally wiped out & devel a fever;pt exp cramps in lt deltoid & tricep muscles;


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