MedAlerts Home
  Read the MedAlerts Blog Subscribe to the MedAlerts Blog 

Found 466004 cases in entire database

Case Details (Sorted by Age)

This is page 2684 out of 4661

Result pages: prev   2585 2586 2587 2588 2589 2590 2591 2592 2593 2594 2595 2596 2597 2598 2599 2600 2601 2602 2603 2604 2605 2606 2607 2608 2609 2610 2611 2612 2613 2614 2615 2616 2617 2618 2619 2620 2621 2622 2623 2624 2625 2626 2627 2628 2629 2630 2631 2632 2633 2634 2635 2636 2637 2638 2639 2640 2641 2642 2643 2644 2645 2646 2647 2648 2649 2650 2651 2652 2653 2654 2655 2656 2657 2658 2659 2660 2661 2662 2663 2664 2665 2666 2667 2668 2669 2670 2671 2672 2673 2674 2675 2676 2677 2678 2679 2680 2681 2682 2683 2684 2685 2686 2687 2688 2689 2690 2691 2692 2693 2694 2695 2696 2697 2698 2699 2700 2701 2702 2703 2704 2705 2706 2707 2708 2709 2710 2711 2712 2713 2714 2715 2716 2717 2718 2719 2720 2721 2722 2723 2724 2725 2726 2727 2728 2729 2730 2731 2732 2733 2734 2735 2736 2737 2738 2739 2740 2741 2742 2743 2744 2745 2746 2747 2748 2749 2750 2751 2752 2753 2754 2755 2756 2757 2758 2759 2760 2761 2762 2763 2764 2765 2766 2767 2768 2769 2770 2771 2772 2773 2774 2775 2776 2777 2778 2779 2780 2781 2782 2783   next


VAERS ID:107129 (history)  Vaccinated:1997-11-01
Age:17.3  Onset:1997-12-01, Days after vaccination: 30
Gender:Female  Submitted:1998-01-20, Days after onset: 50
Location:Foreign  Entered:1998-02-02, Days after submission: 13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: sister suffering from optic nerve agenesia (birth)
Diagnostic Lab Data: DEC97 Electromyogram nl;
CDC 'Split Type': 980009051
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM  IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Muscle atrophy, Neuralgia, Pain
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: pt recv vax NOV97 & 1mo later in DEC97 pt devel rt shoulder pain & amytrophia;electromyogram was nl;pt hosp during 2 days;dx parsonage-Turner synd;

VAERS ID:108908 (history)  Vaccinated:1997-05-05
Age:17.1  Onset:1997-07-28, Days after vaccination: 84
Gender:Female  Submitted:1998-03-24, Days after onset: 239
Location:Foreign  Entered:1998-03-27, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: pt exp abd pain approx 2-3wk p/Hep B vax;
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': 19980075661
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM 2IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Similar reaction on previous exposure to drug
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: pt recv vax & approx 3wk later devel abd pain & dx of pancreatitis was made;relevant physical findings, lab data & test results have been requested;pt was not hosp;

VAERS ID:112219 (history)  Vaccinated:1998-05-01
Age:17.0  Onset:1998-05-01, Days after vaccination: 0
Gender:Male  Submitted:1998-06-24, Days after onset: 54
Location:Foreign  Entered:1998-06-29, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unk
Current Illness: unk
Preexisting Conditions: depression
Diagnostic Lab Data: unk
CDC 'Split Type': WAES98060829
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Hepatitis, Hepatocellular damage, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Hepatitis, non-infectious (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad)
Write-up: pt recv vax & 10 days post vax pt exp arthralgia, myalgia & fever & was hosp;lab tests revealed hepatic cytolysis (X7N) & negative serology for hepatitis A:

VAERS ID:112888 (history)  Vaccinated:1993-12-10
Age:17.0  Onset:1994-02-10, Days after vaccination: 62
Gender:Female  Submitted:1998-07-28, Days after onset: 1628
Location:Foreign  Entered:1998-07-29, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: intolerance to sun exposure since the childhood face erythema for a long time (no more precision leukopenia (WBC 3900);
Diagnostic Lab Data: OCT97 urine-protein-random .12;FEB89 WBC count 3900;1994 WBCC 3200;MAY95 WBC count 3100;anti-SSA antibodies positive;antinuclear antibodies positive;
CDC 'Split Type': 19980189931
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM 3SC 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Antinuclear antibody, Condition aggravated, Laboratory test abnormal, Lymphadenopathy, Pharyngitis, Systemic lupus erythematosus, Systemic lupus erythematosus rash
SMQs:, Agranulocytosis (broad), Systemic lupus erythematosus (narrow), Oropharyngeal infections (narrow)
Write-up: pt exp cervical adenopathys w/tonsillitis & inc antistraptolysine 0 level;leukopenia worsening noticed;MAR97 consulted MD for face erythema;OCT97 pt devel lupus-like eruption;ANA speckled were positive;dx lupus erythematous;

VAERS ID:113540 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:1998-08-20
Location:Foreign  Entered:1998-08-21, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Corticoids;
Current Illness:
Preexisting Conditions: Behcet''s synd, buccal aphtosis, cutaneous hyperegia, recidivans inflammatory cutaneous nodule;
Diagnostic Lab Data:
CDC 'Split Type': 19980206821
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM 0  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Skin nodule
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: pt recv vax & 6 days p/vax pt devel an inflammatory & necrotic nodular eruption;tx w/med;

VAERS ID:113541 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:1998-08-20
Location:Foreign  Entered:1998-08-21, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: pt devel inflammatory & necrotic nodular eruption w/dose 1 hep b vax;
Other Medications: Corticoids
Current Illness:
Preexisting Conditions: Behcet''s synd;Buccal aphtosis, cutaneous hyperergia, recidivans inflammatory cutaneous nodule;
Diagnostic Lab Data:
CDC 'Split Type': 19980206821A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM 2  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Adverse drug reaction, Retinal vascular disorder, Uveitis
SMQs:, Retinal disorders (narrow), Ocular infections (broad)
Write-up: pt recv vax & 6wk p/vax devel a posterior uveitis w/an ischemic retinitis;given med;2yr later;

VAERS ID:114024 (history)  Vaccinated:1995-06-09
Age:17.0  Onset:1995-07-23, Days after vaccination: 44
Gender:Male  Submitted:1998-09-08, Days after onset: 1143
Location:Foreign  Entered:1998-09-10, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: no hx of familial auto-immune disease;
Diagnostic Lab Data:
CDC 'Split Type': 19980220701
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM 2IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Diabetes mellitus
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow)
Write-up: pt recv vax 9JUN95 & 23JUL95 6week later pt exp diabetic ketoacidosis;dx diabetes mellitus made;

VAERS ID:115889 (history)  Vaccinated:1997-12-24
Age:17.3  Onset:1998-03-01, Days after vaccination: 67
Gender:Male  Submitted:0000-00-00
Location:Foreign  Entered:1998-11-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: 29AUG98 ANA 1/40 negative;Cryofibrinogen positive;1998 cryoglobulin IGG, IGA & IGM positive;AUG98 EOSINOPHILS 6.4; rheumatoid factors 11;skin biopsyperivascular round cell infiltration w/eos & lymphoid cells noted;
CDC 'Split Type': 19980260381
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM 1IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dermatitis bullous, Laboratory test abnormal, Oedema, Rash maculo-papular, Skin disorder, Skin hypertrophy, Vasculitis
SMQs:, Cardiac failure (broad), Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Vasculitis (narrow), Hypersensitivity (narrow)
Write-up: 2wk p/vax devel skin eruption on lt deltoid area;MAR98 visited an hosp;exam dull reddish plaque w/mild oozing & crusting @ lt deltoid area;papuloplaques;skin biopsy revealed parakeratosis & acanthosis w/elongation;dx drug induced vasculitis

VAERS ID:116248 (history)  Vaccinated:1998-04-27
Age:17.0  Onset:0000-00-00
Gender:Male  Submitted:1998-11-09
Location:Foreign  Entered:1998-11-12, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': 19980266091
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM2495A6 IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Encephalitis
SMQs:, Noninfectious encephalitis (narrow)
Write-up: pt recv vax 27SEP98 & devel encephalitis;pt adm to hosp;

VAERS ID:118199 (history)  Vaccinated:1997-04-24
Age:17.0  Onset:1997-12-15, Days after vaccination: 235
Gender:Female  Submitted:1999-01-13, Days after onset: 394
Location:Foreign  Entered:1999-01-20, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: LP lymphocytes & hypergammaglobulins levels increased;MRI nl;
CDC 'Split Type': 19990001731
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: CSF test abnormal, Globulins increased, Leukocytosis, Neuropathy
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad)
Write-up: pt recv vax 24APR97 & in the middle of NOV97 pt exp first flare-up of demyelinating disease;MRI was nl & LP showed lymphocytes & gammaglobulin levels increased;

VAERS ID:120388 (history)  Vaccinated:1998-11-16
Age:17.0  Onset:1998-11-20, Days after vaccination: 4
Gender:Female  Submitted:1999-03-10, Days after onset: 110
Location:Foreign  Entered:1999-03-17, Days after submission: 7
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: tick borne encephalitis vaccine 26JUN98
Current Illness:
Preexisting Conditions: bizarre behavior;
Diagnostic Lab Data: EEG abn;MRI abn;15DEC95 CSF pleocytosis of 80 cells;4JAN99 CSF cultpleocytosis of 36 cels;21JAN99 total serum protein-protein raised from 22 to 70;CSF cult pleocytosis of 2-3cells;blood cult oligoclonal bands
CDC 'Split Type': WAES99030420
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Unknown
Symptoms: CSF test abnormal, Convulsion, Dysarthria, Electroencephalogram abnormal, Encephalitis, Encephalopathy, Headache, Hypertonia, Hypoxia, Laboratory test abnormal, Leukopenia, Malaise, Neuropathy, Nystagmus, Personality disorder, Somnolence, Trismus
SMQs:, Asthma/bronchospasm (broad), Haematopoietic leukopenia (narrow), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Dystonia (narrow), Parkinson-like events (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hostility/aggression (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad)
Write-up: 20NOV98 pt exp h/a & malaise;29NOV98 exp tonic clonic sz & was hosp;dx lymphocytic encephalitis made w/differential dx of viral encephalitis & postvaccinal encephalitis resp evoked;pt vigilance, sociability & cooperation unstable, drowsy;

VAERS ID:121005 (history)  Vaccinated:1999-03-29
Age:17.6  Onset:1999-03-29, Days after vaccination: 0
Gender:Female  Submitted:1999-03-31, Days after onset: 2
Location:Foreign  Entered:1999-04-07, Days after submission: 6
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': U199900203
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)SMITHKLINE BEECHAM 1  
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)CONNAUGHT LABORATORIESP02881  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pallor, Shock
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: pt recv vax 29MAR99 & w/in 10min pt collapsed;pt was pale remained conscious & maintained a pulse throughout;BP was not recorded;tx w/SC adrenaline, IV hydrocortisone & chlorpheniramine pt recovered w/in 15min;

VAERS ID:121201 (history)  Vaccinated:1998-05-01
Age:17.4  Onset:1998-05-01, Days after vaccination: 0
Gender:Male  Submitted:1999-04-09, Days after onset: 343
Location:Foreign  Entered:1999-04-14, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: pt had prev recv DTP & MMRw/no problems;pt has no hx of epilepsy;
Diagnostic Lab Data:
CDC 'Split Type': 19990078141
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Encephalitis, Guillain-Barre syndrome, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (narrow), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (narrow), Cardiomyopathy (broad), Demyelination (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: pt recv vax MAY98 & 24hr p/vax pt exp a sz during which lost consciousness;pt hosp & dx as having encephalitis;

VAERS ID:121206 (history)  Vaccinated:0000-00-00
Age:17.5  Onset:0000-00-00
Gender:Female  Submitted:1999-04-13
Location:Foreign  Entered:1999-04-14, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: pt exp acute hearing loss x 10 days w/dose 2 hep b;
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': 19990080371
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM 2IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bone disorder, Deafness, Deafness transitory, Ear disorder, Similar reaction on previous exposure to drug
SMQs:, Hearing impairment (narrow)
Write-up: pt recv 2nd vax & approx 5 days later had acute hearing loss for 10 days. Pt was hospitalized, discharge not available. Third vax given pt had impaired hearing, no med tx given

VAERS ID:122245 (history)  Vaccinated:1999-03-12
Age:17.0  Onset:1999-03-16, Days after vaccination: 4
Gender:Female  Submitted:1999-05-18, Days after onset: 62
Location:Foreign  Entered:1999-05-19, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TEVAX 2 mo prior to Hep vax
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: 3/99 WBC w/diff nl; CRP 0.2
CDC 'Split Type': 19990109321
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM 1IMA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Headache, Hyperacusis, Meningism, Photophobia
SMQs:, Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Hearing impairment (narrow)
Write-up: pt recv vax 12MAR99 & 16MAR99 pt devel meningeal rxn w/severe cephalagia & photophobia increasing w/noise;15APR99 @ time of report, an improvement had occurred;

VAERS ID:123269 (history)  Vaccinated:1996-05-03
Age:17.0  Onset:1997-08-15, Days after vaccination: 469
Gender:Female  Submitted:1999-06-01, Days after onset: 655
Location:Foreign  Entered:1999-06-03, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: pt-10/27/95 Hep dose #1-pain w/menses; pt-11/25/95 Hep dose #2-legs pain & numb
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: 3/98 histological exam lupus erythematosus disseminated;
CDC 'Split Type': 19990119271
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Adverse drug reaction, Systemic lupus erythematosus
SMQs:, Systemic lupus erythematosus (narrow)
Write-up: pt recv vax 5/3/96 & 15mo later 8/15/97 & pt exp a lupus erythematosus disseminated;dx was histologically confirmed in 3/98;

VAERS ID:123270 (history)  Vaccinated:1995-06-23
Age:17.0  Onset:1996-12-10, Days after vaccination: 536
Gender:Male  Submitted:1999-06-01, Days after onset: 902
Location:Foreign  Entered:1999-06-03, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Motorbike fall in1994 w/lt lower limb traumatism & prolonged limping;
Diagnostic Lab Data: 7/97 anti-phospholipides antibodies & antinuclear factor negative;2/97 Brain MRI hypersignal T2 in the white matter of the rt hemisphere;Brain MRI regression of the lesions;Converting enzyme nl
CDC 'Split Type': 19990117621
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypertonia, Laboratory test abnormal, Myasthenic syndrome
SMQs:, Neuroleptic malignant syndrome (broad), Malignancy related conditions (narrow), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad)
Write-up: pt recv vax 6/23/95 & 18mo post vax pt devel lt hand muscle weakness & lt lower limb hypertonia;EMG revealed sensory & motor disorder;pt hosp 2/97 or 3/97;Brain MRI showed hypersignal in T2;

VAERS ID:124767 (history)  Vaccinated:1998-11-16
Age:17.0  Onset:1998-11-29, Days after vaccination: 13
Gender:Female  Submitted:1999-06-11, Days after onset: 193
Location:Foreign  Entered:1999-06-15, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unk
Current Illness: unk
Preexisting Conditions: unk
Diagnostic Lab Data: 11/98 EEG abn; CSF fluid abn-total serum protein increased to 70mg/dL
CDC 'Split Type': WAES99060704
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Unknown
Symptoms: CSF test abnormal, Convulsion, Electroencephalogram abnormal, Encephalitis, Encephalopathy, Headache, Malaise, Nystagmus, Pleocytosis
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad)
Write-up: pt exp signs of toxic encephalopathy that was considered disabling & abn CSF;11/98 pt exp abn EEG & nystagmus;11/2/98 pt exp h/a & malaise;11/29/98 pt exp convuls & encephalitis;12/98 pt exp pleocytosis;MD felt sx not r/t vax;

VAERS ID:124807 (history)  Vaccinated:1996-04-04
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:1999-06-09
Location:Foreign  Entered:1999-06-16, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: pt recv 2 doses hep b vax 9/13/95, 10/28/95 by SKB; 4/4/96 Rudivax
Current Illness:
Preexisting Conditions: unk
Diagnostic Lab Data: HLAB27 positive; 1/96-8/97 numerous lab tests, see f/u report
CDC 'Split Type': 19990129681
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM    
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER 2  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthritis, Asthenia, Pain, Thyroiditis
SMQs:, Systemic lupus erythematosus (broad), Guillain-Barre syndrome (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Arthritis (narrow)
Write-up: pt recv 1st 2 doses HEP by SKB w/ rxns (see box 21);pt recv 3rd dose vax (fr mfr) 4/96-had asthenia, severe pain; 6/97 dx:arthritis, thyroiditis;pt had to stop studies because symptoms incapacitating; pt as yet not recovered

VAERS ID:129171 (history)  Vaccinated:1996-01-25
Age:17.0  Onset:1997-04-01, Days after vaccination: 432
Gender:Female  Submitted:1999-10-08, Days after onset: 919
Location:Foreign  Entered:1999-10-12, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: pt exp lymphocytic meningitis w/dose 1 hep b vax;
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': 1999026222
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM 2IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Adverse drug reaction, Multiple sclerosis, Neuritis
SMQs:, Peripheral neuropathy (narrow), Optic nerve disorders (broad), Demyelination (narrow)
Write-up: p/vax pt devel a retrobulbar neuritis followed by several flare-ups (no more precision) dx disabling remittent mult sclerosis made;pt not yet recovered;

VAERS ID:129570 (history)  Vaccinated:1998-10-23
Age:17.0  Onset:1999-02-13, Days after vaccination: 113
Gender:Female  Submitted:1999-10-19, Days after onset: 247
Location:Foreign  Entered:1999-10-20, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: pregnant LMP 14/Oct/98
Diagnostic Lab Data:
CDC 'Split Type': U199900740
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)CONNAUGHT LABORATORIES    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion, Foetal disorder
SMQs:, Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: pt recv vax who was probably preg since 10/20/98;pt preg was stopped in reason of no closing of dome of the skull & anencephaly;

VAERS ID:129816 (history)  Vaccinated:1996-03-14
Age:17.0  Onset:1996-10-01, Days after vaccination: 201
Gender:Female  Submitted:1999-10-22, Days after onset: 1116
Location:Foreign  Entered:1999-10-26, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Lumbar Puncture-demyelinating Disease;MRI-demyelinating Disease;
CDC 'Split Type': 1999027395
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM 2IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypokinesia, Neuropathy, Paraesthesia
SMQs:, Peripheral neuropathy (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: p/vax pt devel limbs paresthesia w/face paresthesia w/a regressive motor activity deficiency; then rt lower limb paresthesia;several flare-up occurred in 10/96, 4/97 & 6/98;pt hosp;MRI & LP were in favor of demyelinating disease;tx med;

VAERS ID:134245 (history)  Vaccinated:2000-02-01
Age:17.0  Onset:2000-02-08, Days after vaccination: 7
Gender:Female  Submitted:2000-02-18, Days after onset: 10
Location:Foreign  Entered:2000-02-29, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': U2000000880
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTIPV: DT + IPV (FOREIGN)PASTEUR MERIEUX INST.    
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)CONNAUGHT LABORATORIES  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Epistaxis, Haematuria, Thrombocytopenic purpura
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)
Write-up: On 2/1/00, pt recv''d typhoid,TD, & poliomyelitis vax. On 2/8/00, she exp purpura thrombopenic idiopathic characterized by mucous memb purpura,epistaxis,& hematuria.Pt was hospitalized & tx w/ veinoglobulins & corticotherapy.

VAERS ID:150783 (history)  Vaccinated:1997-01-01
Age:17.0  Onset:1997-03-18, Days after vaccination: 76
Gender:Female  Submitted:2000-04-04, Days after onset: 1112
Location:Foreign  Entered:2000-04-06, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC 'Split Type': 20000086601
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM632 IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crohn's disease, Erythema nodosum
SMQs:, Gastrointestinal premalignant disorders (narrow), Ischaemic colitis (broad), Hypersensitivity (narrow)
Write-up: Report from a physician referring to a female pt aged 17. In September 1996, November 1996 and January 1997, the pt was vaccinated with Engerix-B. On 3/18/1997, she experienced erythema nodosa and was hospitalized. She had an etiologic check up that led to the dx of Crohn''s disease. The pt was treated with unspecified corticoid drug and with mesalamine for Crohn''s disease. The most recent information received on 3/28/2000 reports the outcome of the pt as not yet recovered. The reporter''s causality assessment was not specified.

VAERS ID:156063 (history)  Vaccinated:2000-04-27
Age:17.0  Onset:2000-06-27, Days after vaccination: 61
Gender:Male  Submitted:2000-07-05, Days after onset: 8
Location:Foreign  Entered:2000-07-06, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: UNK
CDC 'Split Type': 2000198761
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)SMITHKLINE BEECHAM  IM 
Administered by: Other     Purchased by: Other
Symptoms: Aplastic anaemia
SMQs:, Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Haematopoietic erythropenia (narrow), Myelodysplastic syndrome (broad)
Write-up: Approximately eight weeks post vax, the vaccinee was dx with aplastic anemia. The vaccinee was hospitalized. A bone marrow transplantation was planned. The event was considered as life-threatening. Follow-up dated 7/13/00 from the reporting physician indicated that the vaccinee''s outcome is unknown so far because he is still in in-patient treatment.

VAERS ID:156525 (history)  Vaccinated:1998-09-08
Age:17.0  Onset:1998-11-19, Days after vaccination: 72
Gender:Female  Submitted:2000-07-07, Days after onset: 595
Location:Foreign  Entered:2000-07-13, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: EEG - discrete theta-dysrhythmia without focus or potentials typical for epilepsia, MRI - Some cerebral lesions bilateral and trabecular but no cortical lesions, Neurological exam - nml, Cerebrospinal fluid cx - abn.
CDC 'Split Type': WAES00064414
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.5570112IM 
Administered by: 0     Purchased by: 0
Symptoms: CSF test abnormal, Electroencephalogram abnormal, Encephalitis, Grand mal convulsion, Laboratory test abnormal, Loss of consciousness, Movement disorder, Multiple sclerosis, Muscle twitching, Nuclear magnetic resonance imaging brain abnormal, Paresis
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), 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 (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Optic nerve disorders (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a healthcare professional concerning a 17 year old female. On 11/19/98, the pt developed the first disturbance of consciousness accompanied with repeated twitching of arms and legs lasting for 1-5 minutes. The frequency of twitching increased and led finally to a loss of consciousness. No biting of the tongue, wetting, etc. had been observed. The symptoms were seen as further ictal disturbance of movement. On 11/19/98, the pt experienced a grand mal convulsion and a paresis was noted. A multiple sclerosis was dx''d later. A juvenile myoclonic epilepsia was assumed and had been treated with valproic acid. The pt was hospitalized for clarification of the cerebral lesions. On 7/15/99, the pt was examined by a neurologist. The pt reported that during the last hospitalization, the CSF revealed pathological results but at the time of reporting, the results were not available. The CSF had been performed for clarification of the MRI results. One week before the exam, on 7/15/99, the pt had developed, for 3 days, a feeling of numbness of the left thigh and left arm from which she recovered. The EEG detected general changes without signs for convulsion. No further information is available. 15-day follow-up states a diagnosis of encephalomyelitis was confirmed and then the diagnosis of idiopathic epilepsy was made. Symptoms started in the summer of 1999. The pt experiences were considered to be an "other medical event". F/U this is an amended report, the onset date of the ictal syncope was changed to 12/18/98. The date of the EEG was changed to 7/15/99.This is a corrected report as amended.

VAERS ID:161426 (history)  Vaccinated:2000-09-01
Age:17.0  Onset:2000-10-01, Days after vaccination: 30
Gender:Male  Submitted:2000-11-02, Days after onset: 32
Location:Foreign  Entered:2000-11-07, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: alcohol abuse
Diagnostic Lab Data: Labs showed increased transaminases; an increased GGT, SGOT and SGPT.
CDC 'Split Type': WAES00102156
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Alanine aminotransferase increased, Alcohol poisoning, Aspartate aminotransferase increased, Gamma-glutamyltransferase increased
SMQs:, Liver related investigations, signs and symptoms (narrow)
Write-up: It was reported that he was hospitalized due to his alcohol abuse. Subsequently in approximately 10/00, the pt lab findings showed increased transaminases, increased GGT, SGOT, SGPT. No further information is available. A follow up report received 2/5/2003 adds: Information has been received from a health professional concerning a 17 year old male pt with a history of chronic alcohol abuse for the last 3 years who on 09/07/2000 was vaccinated with a dose of Hepatitis B vaccine recombinant (yeast) (lot #R0125-1). It was reported that he was hospitalized due to his alcohol abuse. Subsequently, in approximately September 2000, the pt''s laboratory findings showed increased transaminases and increased CGT, SGOT and SGPT. Follow-up information from a health care professional received on 10/31/2000 indicated that the pt had his last alcohol intake on 09/28/2000. His laboratory findings were reported: on 09/09/2000 ALATA 3.12 mmol/LASAT 1.89 mmol/L. gamma-OT 6.06 mmol/L; 09/17/2000 ALAT 6.13 mmol/L, ASAT 2.42 mmol/L, gamma-OT 7.09 mmol/L; on 09/19/2000 ALAT 5.62 mmol/L, ASAT 1.82 mmol/L, gamma-OT 6.21 mmol/L and on 09/20/2000 ALAT 3.86 mmol/L, ASAT 1.43 mmol/L, gamma-OT 5.99 mmol/L. The normal reference values were reported as ASAT: 0.25 to 0.52 mmol/L, ALAT: 0.28 to 0.52 and Gamma-OT: 0.12 to 0.30 mmol/L. The Hepatitis A, B and C antibody tests were negative. It was reported that the pt was discharged from the hospital and remains in outdoor control. No further information is available. Follow-up information received on 01/20/2003 indicated that no further information is available.

VAERS ID:164368 (history)  Vaccinated:1993-12-06
Age:17.0  Onset:0000-00-00
Gender:Male  Submitted:0000-00-00
Location:Foreign  Entered:2001-01-03
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Platelet count-low; WBC-low with hyperbasophilic cells, bleeding time upper than 30 minutes (nml <5 minutes); bone marrow cell count-mild megaloblastosis; Coomb''s test-positive with IgG; LP; Immune-anti-platelet antibody and anti-nuclear an
CDC 'Split Type': 20000363841
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM 2IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaemia megaloblastic, Antinuclear antibody positive, Asthenia, Coombs direct test positive, Gingival bleeding, Haematoma, Influenza, Leukopenia, Lymphadenopathy, Marrow hyperplasia, Myalgia, Paranoia, Psychotic disorder, Purpura, Pyrexia, Rash, Rectal haemorrhage, Seborrhoeic dermatitis, Skin ulcer, Splenomegaly, Thrombocytopenia
SMQs:, Rhabdomyolysis/myopathy (broad), Haemolytic disorders (narrow), Anaphylactic reaction (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal haemorrhage (narrow), Gingival disorders (narrow), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), Ischaemic colitis (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Myelodysplastic syndrome (broad)
Write-up: On 10/15/93, 11/19/93 and 12/06/93, the pt was vaccinated with Engerix-B. In December, 1993, after 3rd vaccination, pt experienced severe asthenia with fever and flu-like syndrome. He was treated with cefixime. On 12/27/93, he developed hematoma on both hands and forehead, purpura on feet and knees and also had severe gingival bleedings. Severe thrombocytopenia was also observed associated with leukocytopenia. The pt was hospitalized 2 days later. At admission, the pt had a mild spenomegalia and adenopathy. A dx of auto-immune cytopenia was made. The pt was treated with unspecified corticoid and leukopenia and thrombocytopenia rapidly regressed. Anemia resolved and pt discharged with prednisolone. In 12/95, acute paranoid reaction occurred. Pt was treat with Solian. On 3/11/96, he was hospitalized because of paranoid reaction. Symptoms worsened. Neuro-lupus was suspected. Prednisone was prescribed and platelet count increased and pt discharged on 3/19/96. In May 1996, neutropenia persisted and was treated with corticoid and progressively regressed. In 11/96, corticoid stopped and Haldol and lithium was started. In 11/97, pt underwent surgery for recurrent mandible luxation and in 1999, the pt developed rectal hemorrhage and forehead, eyelid and nose cutaneous eruption and was treated with calciprotriol. On 1/25/00, pt was hospitalized a new time for muscular pain of his knees. Biological exam show leukopenia. The dx of chronic psychosis with Evan''s syndrome and seborrheic dermatitis. Pt discharged on 1/26/00, also put on Ketodern for seborrheic dermatitis. Then 6 days later, the pt came back to hospital because he experienced hair skin lesion. The most recent information received on 12/21/00, reports the outcome of the pt as unknown. The reporter''s causality assessment is: not specified.

VAERS ID:164554 (history)  Vaccinated:1994-12-01
Age:17.0  Onset:1994-12-15, Days after vaccination: 14
Gender:Female  Submitted:2001-01-04, Days after onset: 2212
Location:Foreign  Entered:2001-01-10, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: UNK
CDC 'Split Type': WAES00121783
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC. 1IM 
Administered by: Other     Purchased by: Other
Symptoms: Meningitis, Pyrexia, Viral infection
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious meningitis (narrow)
Write-up: 15 days post 2nd vax, the pt was hospitalized and diagnosed with viral meningitis. It was also reported that the pt had a fever. No further information is available.

VAERS ID:165715 (history)  Vaccinated:1999-10-08
Age:17.0  Onset:1999-10-15, Days after vaccination: 7
Gender:Male  Submitted:2001-02-01, Days after onset: 475
Location:Foreign  Entered:2001-02-09, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: A blood exam showed increased SGOT, SGPT as well as an extremely elevated HBs-antibody titer.
CDC 'Split Type': 20010024521
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM2656A4 IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Diarrhoea, Gastrointestinal disorder, Jaundice, Vomiting
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Acute pancreatitis (broad), Pseudomembranous colitis (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: This patient was reported to have hepatitis, diarrhea, gastrointestinal disorder nos, and vomiting. Report number 2001002452-1 describes the occurrence of hepatitis in a 17 year old male receiving Engerix-B for prophylaxis. This report was received from the regulatory authority (PEI, number 134-2001). The vaccinee''s medical history included two Engerix-B vaccinations on 09/22/98 and on 11/12/98. The toleration was not reported. On 10/08/99 the vaccinee received the third Engerix-B (Hepatitis B vaccine). Approximately one week post vaccination the vaccinee experienced gastrointestinal disorder, diarrhea, vomiting, and icterus. Three weeks later, in the beginning on November, he went to see a physician. A blood examination showed increased SGOT, SGPT (values unknown) as well as an extremely elevated HBs-antibody titre (value Unknown). The vaccinee was hospitalized for four days and diagnosed with hepatitis. The most information received on 01/30/01 did not report the out come of the vaccinee. The reporter did not specify the causality. No other additional information requested.

VAERS ID:169946 (history)  Vaccinated:2001-04-09
Age:17.0  Onset:2001-04-14, Days after vaccination: 5
Gender:Female  Submitted:2001-05-23, Days after onset: 39
Location:Foreign  Entered:2001-05-18, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Mononucleosis undiagnosed at time of vaccination.
Diagnostic Lab Data:
CDC 'Split Type': U2001007090
Vaccination
Manufacturer
Lot
Dose
Route
Site
MEN: MENINGOCOCCAL (MENOMUNE)CONNAUGHT LABORATORIES444AA SC 
Administered by: Other     Purchased by: Other
Symptoms: Abasia, Cerebellar syndrome, Dysarthria, Viral infection, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: "A 17 year old female student received Menomune, lot #UA444AA, on 4/9/01. About 5 days later (4/14/2001) she became very ill. Admitted to hospital 4/20/01. Dx''d with Epstein-Barr with cerebellar syndrome. She couldn''t write, read, walk and had slurred speech and vomiting. No other available information. Requested investigation and laboratory information." Follow up received on 05/16/2001 states that the pt is still recuperating. She still has problems to walk, write or read.

VAERS ID:175721 (history)  Vaccinated:2001-07-17
Age:17.0  Onset:2001-07-17, Days after vaccination: 0
Gender:Unknown  Submitted:2001-09-24, Days after onset: 69
Location:Foreign  Entered:2001-09-26, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: beclomethasone; Salbutamol were both stopped about 1 week prior to exacerbation of asthma and eczema.
Current Illness:
Preexisting Conditions: Asthma; Eczema
Diagnostic Lab Data:
CDC 'Split Type': 20010221991
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)SMITHKLINE BEECHAM  IM 
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)CONNAUGHT LABORATORIES  IM 
Administered by: 0     Purchased by: 0
Symptoms: Asthma, Condition aggravated, Eczema, Fatigue, Headache, Injection site inflammation, Injection site swelling, Muscle spasms, Musculoskeletal stiffness, Pyrexia
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: This report describes the occurrence of aggravated asthma in a 17 year old vaccinee (sex unknown) receiving Hep-A vaccine (Havrix) for prophylaxis. Concomitant vaccine included typhoid (Typhim VI) which is also a suspect vaccine. On 7/17/01, the pt received a dose of Havrix along with a dose of typhoid vaccine. On the same day, the pt experienced tiredness and cramps in both legs, swelling and stiffness of the arm into which the typhoid injection was given, headache, injection site inflammation and pyrexia. On 7/31/01, 2 weeks, post vax, the pt developed aggravated asthma and exacerbation of eczema. The reporter considered the reaction to be disabling. The most recent information received on 7/18/01, reports the outcome of the events as unknown. No other details were given. No further information is expected.

VAERS ID:175785 (history)  Vaccinated:2000-12-11
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2001-09-26
Location:Foreign  Entered:2001-09-28, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Pregnancy (LMP= UNK).
Diagnostic Lab Data: UNK
CDC 'Split Type': WAES01092083
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  SC 
Administered by: 0     Purchased by: 0
Symptoms: Abortion
SMQs:, Termination of pregnancy and risk of abortion (narrow)
Write-up: Information has been received from a health care professional concerning a 17 year old female who was noted that the pt was immunized with MMRII at the beginning of her pregnancy. According to follow-up information, the pt experienced a voluntary termination of her pregnancy due to person reasons. The case is closed. No more information is available.

VAERS ID:176053 (history)  Vaccinated:1995-12-06
Age:17.0  Onset:0000-00-00
Gender:Male  Submitted:2001-10-02
Location:Foreign  Entered:2001-10-05, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data:
CDC 'Split Type': 20010230281
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Diabetes mellitus
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow)
Write-up: On 12/6/95 and 1/24/96, the pt received an injection of Engerix-B at a dose of 20 mcg. In 3/96, the pt developed insulin-dependent diabetes. On 7/1/96, the pt received another injection of Engerix-B, still at a dose of 20 mcg. This was considered as disabling. The most recent information received on 9/27/01, reports the outcome of the pt as not yet recovered. Causality assessment was reported as dubious for Engerix-B.

VAERS ID:176126 (history)  Vaccinated:2001-07-17
Age:17.0  Onset:2001-07-17, Days after vaccination: 0
Gender:Unknown  Submitted:2001-10-04, Days after onset: 79
Location:Foreign  Entered:2001-10-09, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Beclomethasone; Salbutamol
Current Illness:
Preexisting Conditions: Previous history of asthma treated with Salbutamol (2 puff prn) from 1999 to 07/25/2001 and eczema treated with topical Beclamethasone starting on 05/22/2001
Diagnostic Lab Data:
CDC 'Split Type': U2001010360
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)SMITHKLINE BEECHAM  IM 
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)CONNAUGHT LABORATORIES  IM 
Administered by: 0     Purchased by: 0
Symptoms: Asthma, Condition aggravated, Eczema, Fatigue, Headache, Injection site inflammation, Injection site swelling, Muscle spasms, Oedema peripheral, Pyrexia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: It was reported that a 17 year old pt was concomitantly administered, on 7/17/01, a Typhoid vaccine and a Hep-A vaccine. On 7/17/01, he experienced pyrexia and muscle cramps (leg), headache, injection site inflammation, fatigue and upper limb edema and subsequently on 7/31/01, exacerbating of asthma and eczema. The swelling and stiffness were in the arm where the Typhoid vaccine was given. The reporter considers the reaction to be serious because it was disabling. To be noticed, that from 1999 to 7/25/01, the pt received Salbutamol for asthma (2 puffs prn, respiratory inhalation). Also topical Beclomethasone for Eczema, commencing 5/22/01. No further information is expected. The case is closed. From follow-up information faxed from France: "corrected report on 10/05/2001; The eczema which started on 05/25/2001 was aggravated on 06/31/2001."

VAERS ID:178215 (history)  Vaccinated:2001-10-25
Age:17.0  Onset:2001-10-25, Days after vaccination: 0
Gender:Female  Submitted:2001-12-07, Days after onset: 43
Location:Foreign  Entered:2001-11-27, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: UNK
CDC 'Split Type': WAES01111167
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.  IM 
Administered by: Unknown     Purchased by: Other
Symptoms: Fatigue, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a health professional concerning a pt who was vaccinated with a dose of hepatitis b vaccine . Thirty minutes post vaccination the pt experienced an anaphylactic reaction. The reporter indicated that it was a serious adverse event. Upon medical review, anaphylactic reaction was considered to be an other important medical event. Additional information is expected. Conflicting follow-up info was received which stated the pt was vaccinated on 10/25/01. Thirty minutes post vaccination the pt experienced fatigue and an erythematous rash. The duration was reported to be 12-24 hours and it was reported that the pt recovered. Allergy testing was planned for the pt. The pt''s fatigue and rash were considered non-serious by the reporter. No further info is available.

VAERS ID:180308 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:2000-07-24
Gender:Male  Submitted:2002-01-24, Days after onset: 549
Location:Foreign  Entered:2002-01-23, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: Biopsy report
CDC 'Split Type': 20020005301
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Fasciitis, Injection site reaction, Muscle disorder
SMQs:, Rhabdomyolysis/myopathy (broad)
Write-up: At a time as yet unknown, the pt was vaccinated with an unspecified Hep-B vaccine at a dose of 10mcg. Within an unspecified delay, on 7/24/00, the pt developed an injection site reaction. The dx of macrophage myofasciitis was made by a neurologist. This case was reported according to a certificate made by the neurologist on the pt''s father''s request, a photocopy of the pt''s health record clarifying: "muscle biopsy leading to a dx of macrophage myofasciitis after a vaccination for hepatitis B prophylaxis". However, no symptom, no date of vaccination, no date of the adverse event appearance, no vaccine name and no route of administration were reported. Further information (hospitalization report and biopsy report) are expected. The pt was hospitalized for the event. The most recent information received on 1/17/02, reports the outcome of the event as not yet resolved. Causality assessment was coded as dubious for Hep-B vaccine. Follow up on 1/21/02, it was reported that the pt was vaccinated with Genhevac B and not with Engerix B. Therefore this case was logically deleted from the data base.

VAERS ID:181705 (history)  Vaccinated:1999-11-03
Age:17.0  Onset:1999-11-03, Days after vaccination: 0
Gender:Female  Submitted:2002-09-20, Days after onset: 1051
Location:Foreign  Entered:2002-02-26, Days after submission: 205
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0260423A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM 0IM 
Administered by: Other     Purchased by: Other
Symptoms: Encephalitis, Nausea, Neck pain, Photophobia
SMQs:, Acute pancreatitis (broad), Noninfectious encephalitis (narrow), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Arthritis (broad)
Write-up: This report describes the occurrence of an encephalitis in a 20-29 year old pt (student) of unknown age and gender. On 11/3/99, a 1st dose of Engerix-B, 20mcg, was given. The same day, post vax, this pt developed neck pain, nausea and photophobia. Subsequently, the pt was hospitalized and a dx of encephalitis was made. As of 2/15/02, at the time of this report, the outcome was unknown. The reporting physician considered the events to be unrelated to Engerix-B. Additional information has been requested. The vaccination course has ben discontinued. No additional information is expected and this case has been closed.

VAERS ID:181772 (history)  Vaccinated:2002-01-21
Age:17.0  Onset:2002-01-21, Days after vaccination: 0
Gender:Male  Submitted:2002-02-21, Days after onset: 31
Location:Foreign  Entered:2002-02-27, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: UNK
CDC 'Split Type': WAES0202USA01207
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.R10573 IM 
TD: TD ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURER  IM 
Administered by: 0     Purchased by: 0
Symptoms: Convulsion, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been rec''d concerning a pt who on 1/21/02 was vaccinated IM in the upper arm with a 3rd dose of hepatitis B (lot# R0157-3). Concomitant vaccination included a 2nd dose of DT (batch #014021) given IM in the other upper arm. Within 5 minutes of vaccination, the pt experienced loss of consciousness, collapse and muscle twitching. The pt recovered after 1-2 minutes. Suspicion of a cerebral convulsion was reported. The pt''s events were considered other important medical events by the reporter. It was reported that the pt''s previous vaccinations were well tolerated. He was vaccinated with a 1st and 2nd dose of hepatitis B vaccine on 9/18/00 and 11/18/00, respectively and a 1st dose of DT on 2/21/97. No further information is available. Other business partners numbers included MA20020061 and PEI01992002.

VAERS ID:182803 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2002-03-20
Location:Foreign  Entered:2002-03-26, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Pregnancy (LMP-unknown)
Diagnostic Lab Data: UNK
CDC 'Split Type': WAES0203USA01219
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  SC 
Administered by: 0     Purchased by: 0
Symptoms: Abortion
SMQs:, Termination of pregnancy and risk of abortion (narrow)
Write-up: Information has been received from a health professional concerning a 17 year old female who in 2002 was vaccinated with MMRII when she was 10 days pregnant. No reaction reported. Follow-up information from a health care professional indicated that it was described by the pt and her family to voluntarily abort the pregnancy. The abortion was performed at 10 weeks of pregnancy. No further information is available.

VAERS ID:183989 (history)  Vaccinated:1997-04-20
Age:17.0  Onset:1997-05-03, Days after vaccination: 13
Gender:Female  Submitted:2002-05-24, Days after onset: 1847
Location:Foreign  Entered:2002-04-30, Days after submission: 24
Life Threatening? Yes
Died? Yes
   Date died: 1997-05-09
   Days after onset: 6
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IMOgam USP (human immunoglobulin) on 4/22/97 per F/U 5/31/02
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Rabies virus was identified in corneal impression by a positive fluorescent antibody test. Per F/U 5/21/02-skin biopsy from the back of the neck
CDC 'Split Type': U200200317
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (IMOVAX)PASTEUR MERIEUX INST.  IMLA
TTOX: TETANUS TOXOID (NO BRAND NAME)UNKNOWN MANUFACTURER  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Agitation, Brain stem syndrome, Condition aggravated, Confusional state, Delirium, Headache, Hyperaesthesia, Nervous system disorder, Paralysis, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: On 4/20/97, while sleeping in the dessert, a 17 year old woman was bitten on the upper lip by a fox. Her husband immediately, drove her to the district hospital, where 2 deep lacerations on her upper lip were cleaned and dressed, but not stitched. Two 1-ml doses of inactivated rabies HDCV (Imovax) were administered by IM injection into each deltoid, according to the Ministry of Health protocol. Anti-tetanus toxoid was given. At the time, HRIG was unavailable in the hospital, but the woman was ordered to go immediately to the regional hospital, a distance of several hours'' drive on a surfaced road, where HRIG was available. Unfortunately, she delayed attending the regional hospital until 4/22/97, when, according to official guidelines for pts presenting more than 48 hours after injury, she was given 800 international units of (29 IU/kg body weight) of HRIG (Imogam) IM into the gluteal region only (with no infiltration of the wound). Since Oman followed the 2-1-1 regimen (two 1.0ml doses of HDCV on day 0, and 1 dose on days 7 and 21, respectively) for vaccine administration, on 4/26/97, she was given the 3rd 1-ml dose of HDCV into the deltoid muscle. On 5/3/97, the pt developed fever, headache and vomiting and on 5/7/97, she presented to the district hospital with fever, delirium, hyperesthesia and serophobia. She was referred at once, to another hospital as a case of suspected rabies. She brought her 7 month old infant boy with her; she had continued to breast feed the child despite being bitten by the fox. On admission, the pt was febrile, agitated, confused and had hydrophobia. There were 2 healed lacerations on her upper lip. She had signs of brain stem dysfunction, including a right 6th cranial nerve palsy, but no signs of meningitis. The clinical dx of rabies was confirmed and she was transferred to the ICU, where she was sedated, from the back of the neck and corneal impressions and washings were obtained. A positive fluorescent antibody test for rabies virus was obtained only from the corneal washings. Seru

VAERS ID:185526 (history)  Vaccinated:2000-09-11
Age:17.0  Onset:2000-09-21, Days after vaccination: 10
Gender:Female  Submitted:2002-05-17, Days after onset: 603
Location:Foreign  Entered:2002-05-29, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: Hepatic function tests-increased
CDC 'Split Type': WAES0205USA00804
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Diarrhoea, Fatigue, Liver function test abnormal, Pyrexia
SMQs:, Liver related investigations, signs and symptoms (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from a health professional concerning a 17 year old female who on 09/11/2000 was vaccinated with a second dose in the buttock of hep B vaccine. On 09/21/2000, 10 days after vaccination, the pt experienced a high fever, diarrhea, and an increase of hepatic enzymes. These symptoms lasted for 8 weeks. Since then the pt is suffering from chronic fatigue syndrome-like symptoms. Several examinations have been carried out to rule out an autoimmune disease, but no diagnosis was established. It was noted that on 08/04/2000 the pt received the first dose of hep B vaccine concomitantly with tetanus vaccine. Both of these vaccines were well tolerated. It was also noted that the pt''s mother experienced a fever, diarrhea and an increase of hepatic enzymes after vaccination on the same day. High fever, diarrhea, increase of hepatic enzymes and chronic fatigue syndrome-like symptoms were considered to be disabling. Additional info is expected. A 15-day follow up report received 6/19/2002 adds: Laboratory findings: In October 2000: complete blood count, blood glucose value, creatinine, gamma-glutamyl transferase, thyroid stimulating hormone (TSH) were normal. On 09/24/2001: Chloinesterase, liver enzymes, alkaline phosphatase, bilirubin, TSH, total serum triiodothyronine (T3), total serum thyroxine (T4), AKMI and TRAK were normal. On 09/27/2001: Immunoglobulins quantitative, serum protein electrophoresis, kappa light chain, lambda light chain, kappa-lambda-quotient, total protein, albumin electrophoresis were normal. Borella antibodies IgG I=64, and IgM were negative. On 01/28/2002, Prokollagen 3 peptide was 19. On 01/30/2002 pancreas-elastase (stool) was $g500. On 03/15/2002 no mutations of cationic trypsinogen or pancreatic trypsin-inhibitor. Diagnostic procedures: In Sept 2001 thyroid sonography was normal. In Nov 2001 magnetic resonance imaging (MRI) of the brain was normal. Dec 2001 and January 2002 abdominal sonography was normal. In Feb 2002 computed axial tomography (CT) of the pancreas was

VAERS ID:189673 (history)  Vaccinated:1995-09-15
Age:17.0  Onset:1996-04-09, Days after vaccination: 207
Gender:Female  Submitted:2002-10-30, Days after onset: 2395
Location:Foreign  Entered:2002-09-04, Days after submission: 56
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: A diagnosis of macrophagic myofascitis was made on a muscle biopsy performed on 11/6/01 but results were not available. CRP, firbronogen, ESR normal. Muscle enzymology, ionic, renal, hepato-biliary, lipidic, serum iron check-up normal.
CDC 'Split Type': U200200676
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)AVENTIS PASTEURY0113   
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Asthenia, Fibromyalgia, Fibrosis tendinous, Headache, Sleep disorder
SMQs:, Guillain-Barre syndrome (broad), Arthritis (broad)
Write-up: From faxed correspondence received at manufacturer on 8/22/2002, it was reported: It was reported by a female patient that when she was 17 years old she received on 4/9/96 a booster injection of ENGERIX B. She was previously vaccinated with typhoid vaccine on 9/15/95. According to her, she developed on 4/9/96 a generalized rash and then (time of onset not reported) persisting asthenia, arthralgia, myalgia, and headache. A diagnosis of macrophagic myofascitis was made on a muscle biopsy performed on 11/6/01 but results are not available. Case to be medically completed. The follow up on 9/19/02 through health authorities: this case wzas medically confirmed: The pt received another dose of Engerix B on 4/18/01. Since 1996, she presented with asthenia which aggravated progressively, without sleeping disorders and not responsive to various treatments (vitamin C, magnesium UTP). Since 1999, she also experienced flare-ups of arms and legs myalgia, described as tension, or insistent, during two to five days. Etiological check-up was performed in Sep 01. Clinical examination was normal, no muscle or joint pain (examination as the pt was not experiencing a flare-up), no sensitive-motor deficiency, no reflex disorder, no argument in favor of fibromyalgia. Muscle biopsy was performed at the site of vaccination on 9/13/01 and was compatible with MMF but could not exclude a macrophagic disease such as sarcoidosis or whipple disease, Ziehl and Gram coloration showed neither bacteria nor mycobacteria. Gallium scintigraphy performed in Sep 01 was normal. To be noted that generalized rash was not mentione din the medical records transmitted. Case closed. *F/UP #2 on 10/21/02: It was reported that the cephagia reported by the PT was in fact cervical rachis pain. All the events were medically confirmed except for the "generalized rash"; therefore it was deleted from the coding in box #7.*

VAERS ID:191310 (history)  Vaccinated:2002-01-11
Age:17.0  Onset:2002-01-13, Days after vaccination: 2
Gender:Male  Submitted:2002-10-11, Days after onset: 270
Location:Foreign  Entered:2002-10-14, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0281486A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS206A90IM 
Administered by: Other     Purchased by: Other
Symptoms: Apraxia
SMQs:, Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: This report describes the occurrence of apraxia in a 17 year old male subject receiving hepatitis A/ Hepatitis B vaccine (Twinrix pediatric) for prophylaxis. On 01/01/02, a 1st dose of Twinrix pediatric (IM) was given. On 01/13/2002, 2 days after vaccination, the subject developed apraxia. As of 09/30/02, at the time of this report, the outcome was unknown. The reporting physician considered the event to be definitely related to Twinrix Ped. Additional information has been requested but will unlikely be available.

VAERS ID:191311 (history)  Vaccinated:2001-11-01
Age:17.0  Onset:2002-01-12, Days after vaccination: 72
Gender:Male  Submitted:2002-10-11, Days after onset: 271
Location:Foreign  Entered:2002-10-14, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0281494A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS203B6 IM 
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Muscle twitching
SMQs:, Dyskinesia (broad), Dystonia (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: This report describes an occurrence of subsultus in 17 year old male subject receiving hepatitis A and hepatitis B vaccine (Twinrix Adult) for prophylaxis. On 11/01/01, a dose of Twinrix Adult (IM) was given. On 01/12/02, 72 days after vaccination, the subject developed pain at the site of injection, subsulous and erythema induration. Subsequently, he was hospitalized. As of 09/30/2002, at the time of this report, the outcome was unknown. The reporting physician considered the events to be possibly related to Twinrix Adult. Additional information has been requested but will unlikely be available.

VAERS ID:191414 (history)  Vaccinated:2002-09-10
Age:17.0  Onset:2002-09-11, Days after vaccination: 1
Gender:Male  Submitted:2002-10-14, Days after onset: 33
Location:Foreign  Entered:2002-10-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': D0039515A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS203C6 IMLA
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURERU0379BA  RA
Administered by: Other     Purchased by: Other
Symptoms: Injection site reaction, Pain, Paresis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: A physician reported the occurrence of suspected paresis in a 17 year old male who was vaccinated with hepatitis A and B vaccine (Twinrix adult) for prophylaxis. This report was received from the regulatory authority. No current medical conditions and no concurrent medications were reported. There were former vaccinations with hepatitis A and B vaccine and pertussis vaccine. On 9/10/02 the subject received hepatitis A and B vaccine, in the left deltoid. Concomitantly, a pertussis vaccine was administered in the right deltoid. One day post vaccination on 9/11/02 the subject developed a suspected paresis of the right upper arm, pain in the right arm and injection site reaction (arm unknown). The subject was hospitalized on an unknown date in 2002. A the time of reporting, suspected paresis was unresolved; the outcome of the other events was not reported.

VAERS ID:193080 (history)  Vaccinated:2002-08-08
Age:17.0  Onset:2002-08-08, Days after vaccination: 0
Gender:Female  Submitted:2002-11-04, Days after onset: 88
Location:Foreign  Entered:2002-11-13, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: Test not specified-normal, rheumatoid factors negative, sedimentation time normal, MRI right knee synovitis
CDC 'Split Type': WAES0210USA01750
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.B6790110IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthritis, Synovitis
SMQs:, Systemic lupus erythematosus (broad), Arthritis (narrow)
Write-up: Information has been received from a health care professional concerning a 17 year old female with no prior medical history who on 8/5/02 was vaccinated with IM in the right deltoid with a first dose of hep B vaccine recombinant (batch B679011-invalid number). On 8/8/02 the pt developed arthritis in her right knee. "Laboratory findings were normal" and results are pending for a MRI, performed by an orthopedist. As of 10/14/02, the pt had not recovered. Follow-up info received from the health authorities on 10/23/02 stated that the pt''s MRI showed synovitis of the right knee. Laboratory findings included rheumatoid factors negative and sedimentation time normal. Synovitis of the right knee was considered to be disabling. Further info is expected. Follow up info received from the health care professional on 11/4/02 stated that in one of the pt''s history reports it is mentioned that the pt had a contusion of the knee on the medial side about a year ago. lab finding sincluded Borrelia IgM and IgG antibodies negative, anti-HBs 6.4 IE/L, anti-HBc negative, HBs-antigen engative, glucose normal, blood count normal, cholesterol normal, uric acid normal, GGt normal, GOT normal, creatinine normal, potassium normal and sodium normal. On 9/10/02, the pt had an orthopedic consultation with a tentative diagnosis of a lesion of the right medical meniscus. An x-ray of the right knee was normal. On 9/20/02, a MRI of the right knee showed synovitis, no rupture, no laceration of the medial meniscus, chondromalacia and no joint effusion. Synovitis of the right knee was considered to be disabling. Further info is not expected. File closed.

VAERS ID:196814 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:2001-10-23
Gender:Female  Submitted:2003-01-24, Days after onset: 458
Location:Foreign  Entered:2003-01-27, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Malarone
Current Illness: UNK
Preexisting Conditions: NONE
Diagnostic Lab Data: Lab analysis confirmed species plasmodium ovale. Glucose 6-phosphate dehydrogenase was normal.
CDC 'Split Type': B0271199B
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS    
RAB: RABIES (NO BRAND NAME)UNKNOWN MANUFACTURER    
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Other     Purchased by: Other
Symptoms: Anorexia, Eye disorder, Infection parasitic, Laboratory test abnormal, Nausea, Nuchal rigidity, Pyrexia, Vomiting, Weight decreased
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Corneal disorders (broad), Retinal disorders (broad)
Write-up: A physician reported that a 17 year old female received Malarone tablets, unspecified daily dose, for malaria prophylaxis, before travelling to, and during, a three-week trip to another country. She continued malarone therapy for one week after returning home. She also received the following vaccines prior to travelling: Twinrix, Typhim and Imovax. Approximately three months after returning home, she was hospitalized. She had developed a high temp (39 deg C), anorexia, nausea and vomiting and had lost 5kg in weight. Moderate neck rigidity and fluttering of the eyelids were noted and the pt was unconscious at admission. Lab analyses revealed the malaria species plasmodium ovale and moderate thrombopenia. There was no deficiency in glucose-6-phosphate dehydrogenase. She was treated with IV antibiotics, Vibratab and quinino sulphate and was discharged five days later, subsequent treatment was with Primaquine. The final outcome was resolved. The physician reported that the pt had experienced a lack of efficacy and consequently the events were related to Malarone.

VAERS ID:197692 (history)  Vaccinated:1995-01-06
Age:17.0  Onset:1995-02-15, Days after vaccination: 40
Gender:Female  Submitted:2003-02-07, Days after onset: 2914
Location:Foreign  Entered:2003-02-12, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Aortic valve disease, chronic sinusitis, obesity
Diagnostic Lab Data: The following exams were normal: electromyogram, visual evoked potential, neurological scanography, cerebral and rachitis MRI.
CDC 'Split Type': B0291504A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Depression, Difficulty in walking, Paraesthesia, Visual acuity reduced
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (narrow)
Write-up: A foreign regulatory authority reported the occurrence of paresthesia in a 17 year old female who was vaccinated with Engerix B for hepatitis B prophylaxis. Concurrent medical conditions included obesity, aortic valve disease. On 11/3/94, 12/6/94, 1/6/95, and 2/10/96, the subject received four injections of Engerix. In February 1995, the patient developed paresthesia, walking difficulties, asthenia, depression and visual disorders. The events were considered disabling for the patient. At the time of the report, the patient had not yet recovered. According to the authority, the events were considered as unlikely related to Engerix B. A 15-day follow up report received 03/13/2003 adds: In February 1995, three months after the first injection, the pt developed paresthesia with recurrent episodes of sensorimotor disorders in the lower limbs with sensations of weakness and instability, during a few minutes to some hours, walking difficulties, asthenia, depression, micturation disorders, memory disorders and visual disorders. The socio-professional repercussions were important. the following exams were normal: electromyogram, visual evoked potential, neurological scanography, cerebral and rachitis MRI. The events were considered disabling for the pt. At the time of the report, on 02/25/2003, the pt has not yet recovered. According to the health agency, the events were considered as unlikely related to Engerix B.

VAERS ID:197796 (history)  Vaccinated:2002-11-12
Age:17.0  Onset:2002-11-12, Days after vaccination: 0
Gender:Female  Submitted:2003-02-12, Days after onset: 92
Location:Foreign  Entered:2003-02-14, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0292042A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  IM 
Administered by: Other     Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This report was received from the medicines board and describes the occurrence of a cold arm in a 17 year old female subject receiving hep B vaccine (Engerix B) for prophylaxis. On 11/12/02, a dose of Engerix B was given. The same day, after vaccination, this subject developed injection site pain as well as temperature changed sens (cold arm). As of 2/10/03, at the time of this report, the events were ongoing. The reporter considered the events to be serious (OMIC). He did not assess a causal relationship. Additional info has been requested. This case has been voided. Number B0292042A is a duplicate of B0290671A. All future correspondence will be submitted to B0290671A.

VAERS ID:198217 (history)  Vaccinated:2002-11-12
Age:17.0  Onset:2002-11-12, Days after vaccination: 0
Gender:Female  Submitted:2003-02-24, Days after onset: 104
Location:Foreign  Entered:2003-02-25, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Allergy to penicillin, cigarette smoker, unknown back problem.
Diagnostic Lab Data: X-rays NOS chest normal, x-ray of cervical spine normal, x-ray of shoulder and upper arm normal 1/2003. On 1/4/03 examination of injection site: no tenderness, redness or swelling noted.
CDC 'Split Type': B0290671A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS5329B6 IMLA
Administered by: Other     Purchased by: Other
Symptoms: Hypoaesthesia, Injection site pain, Muscle twitching, Oedema
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)
Write-up: This report was received initially from a nurse and the follow-up was received from the Medicines Board. This report describes the occurrence of a shooting pain in the left arm in a 17 year old female subject receiving hep B vaccine for prophylaxis. Medical history included penicillin allergy and back problem NOS. On 11/12/02, a 1st dose of Engerix B (5329B6) IM was given in left deltoid. On the same day, after vaccination, this subject developed twitching sensation in left deltoid, sore fingers, cold fingers, swollen, sore and painful arm (left deltoid), injection site pain and a temperature changed sens (cold arm). On 1/4/03, she suffered from numbness and shooting pain in the left arm. On the same day, the injection site was inspectated but there was no tenderness, redness or swelling noted. On 1/9/03, she had the left hand swollen, as well as swollen and cold to touch fingers. She visited the neurologist on 1/12/03, 1/16/03 and 1/20/03. On 1/23/03, she was seen by the occupational health physician and had bone scan of left humorus, chastand cervical spine. All these x-rays were normal. On 12/18/02, a 2nd dose of Engerix B was given in right deltoid. After this second vaccination, no adverse event occurred. They decided not to give her a third dose as she still had problems with her arm. AS of 2/10/03, at the time of this report, an appointment with vascular surgeon had been arranged. The reporter considered this case as serious (OMIC) because it jeopardized the pt or required intervention. He did not assess a causal relationship. This case B0290671A is the case of record. Manufacturer case number B0292042A is a duplicate record of B0290671A. The case B0292042A will be voided and all future correspondence will be submitted to case B0290671A. No further info is needed, this case has therefore been closed. The follow up received on 5/14/03 states the pt was referred from the causalty consultant to the consultant general vascular surgeon who diagnosed a thoracic outlet syndrome. The management plan is to review

VAERS ID:198806 (history)  Vaccinated:1995-11-17
Age:17.0  Onset:2001-03-12, Days after vaccination: 1942
Gender:Female  Submitted:2003-03-04, Days after onset: 722
Location:Foreign  Entered:2003-03-05, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Lumbar scoliosis
Preexisting Conditions:
Diagnostic Lab Data: Deltoid muscular biopsy: accumulation of PAS positive macrophages and lymphocytes in interstitial tissue and muscle tissue. No ragged red fibers. No overload. Conclusion: important macrophagic myofascitis.
CDC 'Split Type': B0285436A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS    
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Asthenia, Depression, Feeling hot, Fibrosis tendinous, Myalgia, Pain, Sleep disorder, Weight increased
SMQs:, Rhabdomyolysis/myopathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (narrow), Arthritis (broad)
Write-up: This case was reported by the regulatory authority and described the occurrence of macrophagic myofascitis in a 17 year old female who received Engerix B and Havrix for prophylaxis. This subject belongs to an association. Family history of depressive syndrome in the subject''s father. The subject and history of dorsolmbar scoliosis. Vaccinial history included four injections of diphtheria, tetanus, pertussis and poliomyelitis vaccine from 2/24/81 to 5/13/82 and rubella vaccine in 1991. Diphtheria, tetanus and poliomyelitis vaccine administered in 1997 was co-suspected by the authority. On 10/19/94, 11/15/94, 12/15/94 the subject received three injections of Engerix B. On 11/17/95. she received an injection of Havrix and a booster injection of Engerix B. On 11/19/97, she received an injection of diphtheria, tetanus and poliomyelitis vaccine. In 1998, the subject experienced psychic and physical asthenia since the morning, sleeping disorders with nocturnal and diurnal hypersomnia and frequent nocturnal awakening. She also presented lumbar pain, cervicalgia, diffused myalgia (especially in fore-arms) and arthralgia. In October 1998, the subject was treated for depression (no other info). In January 2001, she had gained weight (15 kg in two years) and reproted permanent hot feeling. On 3/13/01, a diagnosis of macrophagic myofascitis was made after deltoid muscular biopsy. At an unspecified date, Zoloft was prescribed. In September 2001, a treatment with C vitamin, selenium and unspecified analgesic was prescribed. Zoloft was discontinued due to lack of efficacy. A treatment with Athymil was prescribed and then stopped due to inefficiency. In March-April 2002, the pt experinenced two flare-up of fore-arms myalgia and lumbar pain. According to a physician, her pains were correlated and majored by her thymic troubles. Treatment with Rivotril at increased dose was initiated. The case was considered as serious (OMIC) by regulatory authority as the subject was hospitalized. At the time of reporting, the pt had not yet recov

VAERS ID:198913 (history)  Vaccinated:2001-12-17
Age:17.0  Onset:2001-12-17, Days after vaccination: 0
Gender:Female  Submitted:2003-03-03, Days after onset: 441
Location:Foreign  Entered:2003-03-06, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: UNK
CDC 'Split Type': WAES0302USA02514
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Fatigue, Pain, Polyarteritis nodosa, Vasculitis
SMQs:, Interstitial lung disease (broad), Eosinophilic pneumonia (broad), Vasculitis (narrow)
Write-up: Information has been received from a health authority concerning a 17 year old female patient who on 11/22/01 and 12/17/01 was vaccinated with a first and second dose of hepatitis B vaccine recombinant (yeast) (manufacturer unknown), respectively. After the second dose the patient suffered lightly from fatigue and pain in the legs. On 2/11/02, the situation had improved but the patient had not fully recovered. It was noted that the treatment was high dose prednisolon. On 5/19/02 the patient developed vasculitis and polyarteritis nodosa after receiving the third dose of hepatitis B vaccine recombinant IM that same day. The reporter noted that the polyarteritis nodosa involved hospitalization. Additional information is not expected. A 15-day follow up report received 7/15/2003 adds: On 02/11/2002, the situation had improved but the pt had not fully recovered. The reporter noted that the polyarteritis nodosa involved hospitalization. Follow-up info on 06/26/2003 revealed the following laboratory data: "results received on 06/23/2003": sedimentation rte: 129mm/hour; Hb 4.7 mmol/L; MCV 80fl; "leuko 17, 1 x 10*9/L diff: 90% neutro, 5% lympho, 4% mono, 1% eo, 0% baso thrombo 595 x 10*9"; "Na 136; K 4.3; Urea 7.7; Creat 101; CRP 260; AF 231; ASAT 88; ALAT 164; GGT 286; CK 15; LD 247; glucose 5.6; Fe 4; Fe binding capacity 41; Fe saturation 9.0%; vit B12 180; Folic acid 7.0; ferritine 877; cryoglobulin nl; haptoglobine 4.51; ACE 9.1; troponine I (new investigation) nl; comp C 3 1380; cmop. C4 296; APTT again, slightly increased; 49 sec; ANA neg; ANCA neg, f VIII act. 300%; f IX act 150%". Bacteriology: "urine culture (new investigation), blood culture (new investigation), skin culture: no indication of infection, parvo IgG pos."; "Rx stomach/duodenum: nl"; PET scan: "vasculitis feet"; Bone biopsy: "active myelopoiese, remaind erythropoieses (probably reactif)"; "ECG nl"; "Anapath biopsy back of the foot: vasculitis image of the middle great arteria, no granulome, image that can be considered as periarteritis nodosa".

VAERS ID:205839 (history)  Vaccinated:2003-06-06
Age:17.0  Onset:2003-06-19, Days after vaccination: 13
Gender:Female  Submitted:2003-07-03, Days after onset: 14
Location:Foreign  Entered:2003-07-07, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: Body temperature increased 39.8 deg C
CDC 'Split Type': D0041271A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS    
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Other     Purchased by: Other
Symptoms: Leukocytosis, Myalgia, Pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad)
Write-up: A physician reported the occurrence of muscle pain in a 17 year old female who was vaccinated with MMR vaccine and hepatitis B vaccine for prophylaxis. No current medical conditions and no concurrent medications were reported. On 6/6/03, the subject received MMR vaccine and hepatitis B vaccine. On an unknown date, short post vaccination, the subject developed muscle pain and limb pain. On 6/19/03, the subject developed fever up to 39 degrees C. Leukocytosis with shift to the left and increased C-reactive protein were detected. The subject was hospitalized. No infection was found. The outcome was not reported. The follow up received on 7/15/03 states exhaustion, muscle pain and headache resolved after 17 days, on 6/27/03. Fever resolved after six days, on 6/25/03. The outcome of hte other events were not reported. The reporter considered that exhaustion, muscle pain, headache and fever were possibly related to the vaccinations. The reporter considered that fever was serious and that exhaustion, muscle pain and headache were nonserious.

VAERS ID:205938 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2003-07-03
Location:Foreign  Entered:2003-07-09, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data: UNK
CDC 'Split Type': WAES0306USA03096
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Paresis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: Information has been received from a health professional concerning a 17 year old female patient, with no previous medical history reported, who in 2001 was vaccinated with a dose of hepatitis B virus vaccine in the arm. After the vaccination, on an unspecified date, she developed facial paresis. The patient was hospitalized. It was reported that the patient recovered one week later. No further information is available. A 15-day follow up report received 7/15/2003 adds: This is an amended report. The reporter now reads physician instead of health professional. This report is corrected as amended. The follow up received on 7/8/03 states the pt was vaccinated in 2000. It was reported that the pt recovered one week later. It was also noted that the pt was hospitalized from 5/16/00 to 5/23/00. No further info is available.

VAERS ID:208896 (history)  Vaccinated:2003-03-01
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2003-09-03
Location:Foreign  Entered:2003-09-08, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Doxycycline; Metronidazole; Trimethoprim; Folic Acid
Current Illness: Gardnerellal vaginitis; UTI
Preexisting Conditions: Chlamydia
Diagnostic Lab Data: UNK
CDC 'Split Type': B0295432A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS035B6   
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURER035B6   
Administered by: Other     Purchased by: Other
Symptoms: Abortion, Drug administration error, Unintended pregnancy
SMQs:, Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: This case was received from a physician and described the termination of pregnancy in a 17 year old female who was vaccinated with hepatitis A and typhoid vaccine for prophylaxis. The subject''s partner had a family history of spina bifida. The subject had contact of chlamydia in November 2002. Concurrent medical conditions included urinary tract infection and gardnerellal vaginitis. Concomitant medications included doxycycline, metronidazole, trimethroprim and folic acid. On an unknown date during 3/03 the subject received a 1ml dose of hepatits A and typhoid vaccine IM whilst four weeks pregnant. The last menstrual period was 2/8/03. The subject was exposed during the first trimester of pregnancy. The patient''s pregnancy was terminated for social reasons.

VAERS ID:209252 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2003-09-12
Location:Foreign  Entered:2003-09-16, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: Cerebrospinal fluid lymphocyte 90%
CDC 'Split Type': B0308201A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS  IM 
Administered by: Other     Purchased by: Other
Symptoms: CSF test abnormal, Headache, Influenza like illness, Laboratory test abnormal, Meningitis, Nuchal rigidity, Photophobia
SMQs:, Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad)
Write-up: This case was reported by a physician and described the occurrence of meningitis syndrome in an approximately 17 year old female subject who had received hepatitis A, hepatitis B injection for prophylaxis. Three days after receiving a dose of Twinrix, this subject developed influenza like syndrome. Approximately 10 days after vaccination, she developed meningeal symptoms with headache, photophobia and neck rigidity. Subsequently, she was hospitalized. A lumbar puncture was performed which as slightly trouble and retrieved 90% of lymphocytes. Her condition improved rapidly. The reporting physician considered the event was possibly related to vaccination with Twinrix. Additional information has been requested.

VAERS ID:210227 (history)  Vaccinated:1996-12-01
Age:17.0  Onset:0000-00-00
Gender:Male  Submitted:2003-10-06
Location:Foreign  Entered:2003-10-10, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: Muscular biopsy: macrophagic myofascitis 1/21/02; circulating immune complexes 3.3 ug/mL; arteriography: medullar normal; visual evoked potential: upper limbs normal; somatosensory evoked potential: upper limbs normal; serology syphilis unr
CDC 'Split Type': WAES0309USA02854
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Condition aggravated, Coordination abnormal, Difficulty in walking, Fasciitis, Laboratory test abnormal, Myalgia, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad)
Write-up: Information has been received from a health authority concerning a 17 year old male who between June 1995 and December 1996, was vaccinated with three doses of hepatitis B virus vaccine. It was reported that in about early 1997 the patient developed walking disorders, which progressively became aggravated, and intermittent feet paresthesia. In December 1998, the patient was seen by a neurologist. The examination revealed ataxic-spasmotic walking, pyramidal syndrome of both lower limbs and bilateral Babinski sign without motor deficiency. Investigations performed December 1998 and April 1999 included a cerebral MRI, cervical MRI, EMG, serum protein electrophoresis, long chain fatty acids in plasma, coagulation, BCC/haemogram, ESR, CSF, plasma and globular folates, plasma vitamin B12, electrolytes and an enzyme work up (results not provided). An angio-converting enzyme test, serology syphilis and Lyme test were unremarkable. Circulating immune complex was 3.3 ug/mL, complement was 22 U/mL, antinuclear antibodies were positive at 1/50, antiDNA and IgG were negative, and antiphospholipid and anticadiolipid antibodies were negative. Visual, auditive and somesthesic evoked potentials of the upper limbs were normal. Somesthesic evoked potentials of the lower limbs revealed conduction troubles between the dorsal spinal cord and cortex. Motor evoked potentials revealed lower limb nerve conduction of the upper limbs. A medullar arteriography was normal. The patient was treated with baclofen for a while without improvement. A diagnosis of myelopathy with dorsal clinical expression of unknown origin. No genetic disease was identified. In September 2000 an neurological examination had not changed from previous, but there was functional improvement. On 1/21/02, a muscle biopsy revealed macrophagic myofascitis. On 2/12/02, the patient was again seen by a neurologist who observed the patient''s muscle pain and walking disorders (persisting pyramidal syndrome of lower limbs). Examination revealed that the patient had an iron defic

VAERS ID:210229 (history)  Vaccinated:2003-09-10
Age:17.0  Onset:2003-09-10, Days after vaccination: 0
Gender:Female  Submitted:2003-10-06, Days after onset: 26
Location:Foreign  Entered:2003-10-10, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data: UNK
CDC 'Split Type': WAES0309USA03153
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0784M  LA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Convulsion, Dizziness, Staring
SMQs:, Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a health professional concerning a 17 year old female with "no previous history reported" who on 9/10/03 was vaccinated in the left arm with a booster dose of hep B virus vaccine (644077/0784M; HS40250). On 9/10/03, "immediately post vaccination," the pt was fainting and had "kind of convulsions (extension of limbs) with the eyes gazing to the left." The symptoms lasted for 2-3 minutes and were then resolving. It was noted that the pt was hospitalized, "for a short while," for monitoring. There was no information about clinical findings such as "blood pressure, heart rate or ECG" or that any therapy was given. Further info is not expected. The file is closed.

VAERS ID:210341 (history)  Vaccinated:2003-10-01
Age:17.0  Onset:2003-10-01, Days after vaccination: 0
Gender:Female  Submitted:2003-10-10, Days after onset: 9
Location:Foreign  Entered:2003-10-14, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data: ECG, abdominal sonografy, thyroid sonografy, chest x-ray, TTE, long term blood pressure measuring, long term ECG, pulonary functions test and lab finding were normal.
CDC 'Split Type': E200302669
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (IMOVAX)AVENTIS PASTEUR    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Cardiovascular disorder, Depression, Hypoaesthesia, Nausea, Pain, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow)
Write-up: It was reported that a 17 year old female pt was vaccinated on 10/1/03 with a dose of inactivated rabies vaccine into the arm. The same day she experienced pain and numbness in the vaccinated arm. On 10/4/03 she experienced fever, nausea, vomiting and circulatory disorder. On 10/7 she was hospitalized because the symptoms persisted. Further info expected. File to be completed. Follow up on 26-Jan-04: We received the hospital report. The patient was hospitalized from 7Oct03 to 14Oct03. It was reported that the patient had an attaack of weakness at work and was hospitalized. The patient herself assumed a relationship to the vaccination. Physical examination including neurological examination was normal as well as all technical examinations (see lab comments) which were carried out. The physicians didn''t see a relationship to the vaccine. The patient herself started two days before the hospitalization again a treatement with Zyprexa without consulting a physician. The physicians in hospital stated that the patient is a very anxious person and that the reaction was due to her fear of the vaccination. They established the diagnosis "orthostatic dysregulation" and "known mild depression". The patient was in good physical condition when she left the hospital. File closed.

VAERS ID:210762 (history)  Vaccinated:2003-07-09
Age:17.0  Onset:2003-07-10, Days after vaccination: 1
Gender:Male  Submitted:2003-10-20, Days after onset: 102
Location:Foreign  Entered:2003-10-22, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions: Allergy
Diagnostic Lab Data: Alanine aminotransferase 108U/l, 286U/l, 125U/l, Normal, 14U/l; Alkaline phosphatase 145U/l, 182U/l, 88U/l; Aspartate aminotransferase 82U/l, 173U/l, 43U/l, Normal, 16U/l; Bilirubin total 144mcmol/l, 36.7 mcmol/l, 18mcmol/l; Bilirubin urine
CDC 'Split Type': B0311415A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS  IM 
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER  IM 
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Chills, Chromaturia, Dysphagia, Faeces pale, Laboratory test abnormal, Nausea, Pyrexia, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Biliary system related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad)
Write-up: This case received from foreign authorities described the occurrence of a liver injury mixed in a 17 year old male subject receiving hepatitis A and hepatitis B vaccine from prophylaxis. Concurrent drugs included Revaxis. Relevant Medical History included allergy (NOS). On 7/09/03, a dose of Twinrix was given. On 7/10/03, 6 hours after vaccination, the subject developed fever, chills, nausea and vomiting. On 7/11/03, the emergency physician measured 39 C fever and a normal CRP, however symptoms of infection were missing. On 7/12/03, he still had fever (39C), nausea, joint pain, slight swallowing difficulties and arthralgia. From 7/11/03 to 8/8/03 lab tests were performed. Together with those lab tests, bilirubin and nitrite were found in the urine, and all those results referred to an acute liver injury. On 7/15/03, the bright faeces and dark urine occurred. A hepatitis serology was negative for hepatitis A Antibodies, IgM hepatitis A, hepatitis B and hepatitis C antibody. On 7/22/03, the subject was free of symptoms with good appetite and normalized color of faeces and urine. At the beginning of 9/03, the subject was in a good general state, normal body weight regained. The reporting physician considered the events to be possibly related to Twinrix. The regulatory authority reported that the events were disabling. Further information has been requested.

VAERS ID:212540 (history)  Vaccinated:2003-09-22
Age:17.0  Onset:2003-09-24, Days after vaccination: 2
Gender:Female  Submitted:2003-11-18, Days after onset: 55
Location:Foreign  Entered:2003-11-19, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ibuprofen
Current Illness:
Preexisting Conditions: Lymphadenopathy; Psoriasis
Diagnostic Lab Data: UNK
CDC 'Split Type': B0314616A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS5477A5 IM 
Administered by: Other     Purchased by: Other
Symptoms: Psoriasis
SMQs:
Write-up: This case was reported by a regulatory authority and described the occurrence of exacerbation of psoriasis in a 17 year old female subject who had received hep B vaccine (Engerix B) for routine immunization. Concurrent medical conditions included lymphadenopathy and psoriasis. Concurrent medications included Ibuprofen. On 9/22/03 the subject received the 1st dose of hep B vaccine IM at 1ml. Approximately two days after receiving hep B vaccine, on 9/24/03, the subject experienced exacerbation of psoriasis. The pt had no known allergies. The event was unresolved. The reaction was assessed as serious (OMIC) by a manufacturer physician. Information from Annual Follow-up report states reported by MHRA. MHRA have been asked for the information above. Additional correspondence received from MHRA on March 8, 2005: No further information is available.

VAERS ID:213645 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:2003-11-24
Gender:Female  Submitted:2003-12-03, Days after onset: 9
Location:Foreign  Entered:2003-12-09, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: UNK
CDC 'Split Type': WAES0312USA00142
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Facial palsy, Influenza like illness
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad)
Write-up: Information has been received from an ENT specialist concerning a 17 year old female who on unspecified date was vaccinated with a first dose of hep B virus vaccine. Subsequently, the pt suffered from an influenza-like syndrome for several weeks according to her mother. On 11/12/03 the pt was vaccinated with a second dos eof hep B virus vaccine. On 11/24/03 the pt presented with left facial peripheral paralysis. She reportedly had a left lumping eyelid and facial asymmetry. At the time of the report the pt was considered as not recovered. The reporter indicated that she will not see the pt again so the outcome "will not be documented." The reporter considered left facial peripheral paralysis to be an other important medical event (OMIC). No further info is available. The case is closed.

VAERS ID:217402 (history)  Vaccinated:1995-12-13
Age:17.0  Onset:0000-00-00
Gender:Male  Submitted:2004-03-08
Location:Foreign  Entered:2004-03-09, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: On 11/24/03: left deltoid biopsy: peri-muscular fascia inflammatory infiltrate of PAS positive macrophages and lymphocytes; no lipid nor glucidic overload. Conlclusion: lesion of macrophagic myofascitis.
CDC 'Split Type': B0325236A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  IMLA
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Arthritis, Arthropathy, Asthenia, Cognitive disorder, Dyspepsia, Fibrosis tendinous, Headache, Memory impairment, Muscular weakness, Myalgia, Tinnitus, Visual disturbance, Weight decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Systemic lupus erythematosus (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific dysfunction (narrow), Optic nerve disorders (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Arthritis (narrow)
Write-up: This report received from the regulatory authority described the occurrence of ankylosing spondylarthritis in a 16 year old male subject vaccinated with hep B vaccine for prophylaxis. Concurrent medical condition was unknown. On 4/5/79, 5/3/79, 6/28/79 and 6/28/80, the subject received four injections of Tetracoq. On 7/26/84, 7/19/89 and 7/6/94, the subject received three boosters of DT Polio. On 7/13/94, the subject received an injection of anti-rabiees vaccine. On 3/30/95, 6/1/95 and 12/13/95 the subject received three injections of Engerix B 20. In 1995, the subject reported the first symptoms (no more precision). Within an unspecified delay he complained of joint and muscular pain, generalized muscles weakness, asthenia, cognitive and memory disorders, tinnitus, visual disorders, headache and digestive disorders. The subject experienced loss of weight (with 7Kg). In 1999, the subject was diagnosed with ankylosing spondylarthritis. On 11/24/03, a muscular biopsy showed lesions of macrophagoc myofascitis in peri-muscular fascia. At the time of report, the outcome of the events was unknown. The reporter''s causality was not assessed. This case was considered as medically serious (OMIC) by manufacturer. Case number B0325216A is a duplicate of B029B973A. Future correspondence will be submitted to B0298973A.

VAERS ID:220960 (history)  Vaccinated:1995-06-01
Age:17.0  Onset:1995-07-01, Days after vaccination: 30
Gender:Male  Submitted:0000-00-00
Location:Foreign  Entered:2004-05-20
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Smoking; Medical history of ankylosing spondylitis and tobacco abuse.
Diagnostic Lab Data:
CDC 'Split Type': E200401493
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS    
IPV: POLIO VIRUS, INACT. (IPOL)AVENTIS PASTEUR    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Erythema, Fasciitis, Fatigue, Hot flush, Memory impairment, Myalgia, Myoclonus, Palpitations, Tinnitus, Vertigo, Visual disturbance
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (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)
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:222641 (history)  Vaccinated:2004-05-22
Age:17.0  Onset:2004-05-22, Days after vaccination: 0
Gender:Female  Submitted:2004-06-14, Days after onset: 23
Location:Foreign  Entered:2004-06-15, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure: 50/20 MM/Hg
CDC 'Split Type': B0334662A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  IM 
Administered by: Other     Purchased by: Other
Symptoms: Blood pressure decreased, Depressed level of consciousness, Shock
SMQs:, Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of shock in a 17 year old female subject who received Hepatitis B vaccine injection for prophylaxis. On 5/22/04, she received the third dose of Hepatitis B vaccine (IM). The same day, following vaccination, she experienced shock and her blood pressure was of 50/20 MM/Hg. Her conscience was not clear. After half an hour, she was recovering from the shock. This case was assessed as medically serious (OMIC). The reporting physician considered the event was possibly related to vaccination with Hepatitis B vaccine. Further information has been requested.

VAERS ID:225615 (history)  Vaccinated:1993-07-24
Age:17.0  Onset:1997-07-20, Days after vaccination: 1457
Gender:Female  Submitted:2004-08-13, Days after onset: 2581
Location:Foreign  Entered:2004-08-19, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: EDSS=2.0; Head computed axial tomography normal; Spinal tap: 7 elements and proteins normal; lymphocytosis; MRI: Multiple hyposignals T1-weighted, bilateral periventricular hypersignals T2-weighted.
CDC 'Split Type': WAES0408USA00629
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (GENHEVAC B)SANOFI PASTEUR  IM 
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cerebellar syndrome, Dysuria, Hemiparesis, Hepatocellular damage, Jaundice, Laboratory test abnormal, Lymphocytosis, Micturition disorder, Multiple sclerosis, Optic neuritis, Paralysis, Pyrexia
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Optic nerve disorders (narrow), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Ocular infections (broad)
Write-up: Information has been received from a health authority and attorney concerning a 17 year old female pt who on 24Jul1993 was vaccinated with a dose of measles virus vaccine live (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Other suspect therapy included hepatitis B virus vaccine rHBpreS2/sAg (mammalian) (Genhevac B), first and second dose administered on 15Nov96 and 12Dec96; and a 1.0 IM third dose administered on 29May1997. It was noted that in December 1996, the pt experienced an episode of sensitive troubles of the right arm, but the information was not confirmed. On 20Jul1997, also reported as two months after the third hepatitis B virus vaccine rHBpreS2/sAg (mammalian) (Genhevac B) injection she was hospitalized for an acute left hemiparesis and presented with an MS-like syndrome. It was noted that two flare ups were incompletely treated with high dose Intravenous corticosteroids, and then in April 1998, she was started on therapy with interferon. Further investigations led to the diagnosis of multiple sclerosis. It was noted that an encephalic MRI was compatible with the diagnosis. Medical records from a lawyer confirmed that on 20Jul97 the pt presented with a peripheral left facial palsy which resolved within the day but was followed next day by a left hemiparesis which led to her hospitalization. On admission to the hospital she was slightly febrile (38.5C) and investigations were performed. A cerebral CT scan was normal, lumbar puncture showed seven elements and normal proteins and lymphocytosis, and cerebral MRI which showed multiple hyposignals T1-weighted and bilateral periventricular hypersignals T2-weighted. The diagnosis of MS was confirmed. The medical records also reported she had several relapses, one in 1998, one in 1999, two in 2000, and one in January 2001. On 28May2001 she was examined by a neurologist (EDSS=2.0) and suffered from sequelae of optic neuritis, signs of cerebellar syndrome and pyramidal irritation without deficiency and micturition imperiosity. It was noted the pt had the following other flare ups after 20Jul97; 01Feb98 her right upper limb, 05Nov99 the left hand and foot, 26Feb00 retrobulbar optic neuritis, 20Jun00 V3G territory, January2001 left hemicorpus, June02 four limbs, 28Mar03 again four limbs, 04Mar04 limbs and lumbar area. In March98 and April2003 following treatments with corticoids she presented with episodes of icterus with hepatocellular disorder. On March2004 she presented with pyramidal tetrasyndrome without deficit and a moderate sphincter-vesical impairment as dysuria. This was originally reported by a health professional. The case is closed. Additional information has been requested.

VAERS ID:225749 (history)  Vaccinated:2004-05-04
Age:17.0  Onset:2004-05-04, Days after vaccination: 0
Gender:Female  Submitted:2004-08-20, Days after onset: 108
Location:Foreign  Entered:2004-08-24, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: Body temp: 39 degrees C
CDC 'Split Type': WAES0408AUS00039
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)AVENTIS PASTEUR98001 SC 
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0175N   
Administered by: Unknown     Purchased by: Unknown
Symptoms: Back pain, Medication error, Neck pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Arthritis (broad)
Write-up: Information has been received from another company (a licensee who distributes vaccines) who received report from an agency concerning a 17 year old female who on 5/4/04 was vaccinated with pneumococcal 23v polysaccharide vaccine, lot number 645851/0175N. Other suspect therapy included influenza virus split virion 3v vaccine inactivated (FLUVAX) (batch number 98001), which was administered SC, at the same time. On 5/5/04, the patient was hospitalized with a painful neck and spine and a temperature of 39 degrees C. Subsequently, the patient''s symptoms resolved. The agency considered that the patient''s symptoms were possibly related to therapy with pneumococcal 23v polysaccharide vaccine and/or influenza virus split virion 3v vaccine. The original reporting source was not provided. Additional information is not expected.

VAERS ID:229745 (history)  Vaccinated:2004-11-08
Age:17.0  Onset:2004-11-08, Days after vaccination: 0
Gender:Male  Submitted:2004-11-22, Days after onset: 14
Location:Foreign  Entered:2004-11-29, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data: UNK
CDC 'Split Type': WAES0411USA02438
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.X03861   
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1199N   
Administered by: Unknown     Purchased by: Unknown
Symptoms: Convulsion, Muscle rigidity, Muscle twitching, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a health professional concerning a 17 year old male with no relevant history reported, who on 11/8/04 was vaccinated with a dose of hepatitis A vaccine (batch # not reported) and a second dose of MMR (batch # HV06120; lot equivalent 647678/1199N). Five minutes post vaccination, the patient experienced what was thought to be a fit (although not fully clear if it was a fit or a faint), with loss of consciousness, rigidity, jerking and twitching of limbs. The symptoms lasted for five minutes, after which he was recovered. Fit was considered to be an other important medical event (OMIC). Additional information has been requested. It was noted that this report was linked with WAES0411USA02437 (E200403904) which described similar events after vaccination with MMR. Other business partner numbers include: E200403905.

VAERS ID:230941 (history)  Vaccinated:2004-11-08
Age:17.0  Onset:2004-11-08, Days after vaccination: 0
Gender:Male  Submitted:2004-12-13, Days after onset: 35
Location:Foreign  Entered:2004-12-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0358521A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER    
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.HV06120   
Administered by: Other     Purchased by: Other
Symptoms: Loss of consciousness, Muscle twitching, Musculoskeletal stiffness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad)
Write-up: This case was reported by a foreign regulatory authority and described the occurrence of loss of consciousness in a 17 year old male subject who received Hepatitis A vaccine. Concurrent medication included MMR II vaccine. On 11/8/04, the subject received Hepatitis A vaccine. Five minutes later, the subject experienced what was thought to be a fit (although not fully clear if it was a fit or faint), which loss of consciousness, rigidity, jerking and twitching of limbs. The symptoms lasted for five minutes after which the subject recovered. The case was assessed as medically serious (OMIC).

VAERS ID:231218 (history)  Vaccinated:2004-11-03
Age:17.0  Onset:2004-11-04, Days after vaccination: 1
Gender:Male  Submitted:2004-12-16, Days after onset: 42
Location:Foreign  Entered:2004-12-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions: Fine dust desensitization ended on 4/3/04.
Diagnostic Lab Data: Alanine aminotransferase 0.9mnol/l; Alanine aminotransferase rise to 2.23 unit; C-reactive protein 63mg/l; C-reactive protein falling; Leukocyte count NOS 3900mm3; Nodules normal; Heart normal; Lungs normal; Liver normal; Spleen normal; No
CDC 'Split Type': B0358361A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSHAB27306 IMLA
Administered by: Other     Purchased by: Other
Symptoms: Fatigue, Laboratory test abnormal, Pyrexia, Viral infection
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: This case was reported by a physician and described the occurrence of virosis in a 17 year old male subject who had received hepatitis A and hepatitis B vaccine injection for prophylaxis. On 11/3/04, the subject received the 3rd dose of Twinrix (IM). On 11/4/04, the subject developed body temperature increase (39C), fatigue, torpid and suffused throat. On 11/5/04, examination was performed and showed to be normal. (See lab text for details.) Lab test was also performed and showed increased CRP which fell the next day. The outcome of the events is unknown. The reporting physician considered the events to be clinically significant (or requiring intervention) (OMIC). Additional information has been requested. Follow up 8/19/05: Completely recovered.

VAERS ID:231272 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2004-12-15
Location:Foreign  Entered:2004-12-20, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: Serum hepatitis B surface Ab: not sufficient.
CDC 'Split Type': WAES0412USA01006
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Drug ineffective, Dystonia, Laboratory test abnormal
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Dystonia (narrow)
Write-up: Information has been received from a health professional concerning a 17 year old female who in 1998, 1999, and 2001 was vaccinated with 5 doses with the same thimerosal containing recombinant Hepatitis B vaccine and did not produce sufficient antibody levels. On 11/23/01 she was vaccinated with the sixth booster dose of thimerosal containing recombinant hepatitis B vaccine. A few weeks after the sixth dose, the patient experienced dystonia of unknown etiology and was hospitalized. No diagnosis could be established during the several hospital stays and she is now in a wheel chair and considered to be disabled. At the time of this report, no further information was available. The dystonia of unknown etiology was considered to be disabling. Other business partner numbers include E200404557. Additional information has been requested.

VAERS ID:233255 (history)  Vaccinated:2004-12-10
Age:17.0  Onset:2005-01-15, Days after vaccination: 36
Gender:Male  Submitted:2005-02-01, Days after onset: 17
Location:Foreign  Entered:2005-02-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: Bilirubin total 4.2g/l, 3.9g/l, 2.9g/l.
CDC 'Split Type': D0045723A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Other     Purchased by: Other
Symptoms: Blood bilirubin increased, Diarrhoea, Nausea
SMQs:, Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (narrow), Pseudomembranous colitis (broad), Biliary system related investigations, signs and symptoms (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: A physician reported the occurrence of increased bilirubin in a 17 year old male subject who was vaccinated with hepatitis B vaccine (Engerix-B) for prophylaxis. On 10 November 2004 the subject received the first and on 10 December 2004 the second dose of hepatitis B vaccine, route unknown. Four to six weeks post vaccination, in January 2005 the subject developed diarrhea and nausea and went to his family doctor. Bilirubin was increased (4.2 g/l). The subject was hospitalized. In hospital bilirubin was at 3.9 g/l. Glutamate-oxalacetate transaminase (GOT), glutamate-pyruvate transaminase (GPT) and alkaline phosphatase were in normal ranges. On discharge from hospital, on 26 January 2005, bilirubin was at 2.9 g/l and the other symptoms had improved.

VAERS ID:235380 (history)  Vaccinated:2005-03-01
Age:17.0  Onset:2005-03-01, Days after vaccination: 0
Gender:Female  Submitted:2005-03-21, Days after onset: 20
Location:Foreign  Entered:2005-03-24, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data: UNK
CDC 'Split Type': WAES0503USA03017
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chest discomfort, Paraesthesia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: Information has been received from a health authority concerning a 17 year old female pt with no reported medical history who on 01-MAR-2005 was vaccinated with MMR vaccine. Following vaccination on 01-MAR-2005 the pt experienced chest tightness and tingling in the fingers and toes. Subsequently, the pt recovered from chest tightness and tingling on the same day. Additional information is not expected. Case is closed. The regulatory authority considered the pt''s symptoms to be an important medical event (OMIC). Other business partner numbers include E200501067.

VAERS ID:235646 (history)  Vaccinated:2005-02-11
Age:17.0  Onset:2005-02-20, Days after vaccination: 9
Gender:Male  Submitted:2005-03-31, Days after onset: 39
Location:Foreign  Entered:2005-04-01, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC 'Split Type': E200501143
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)AVENTIS PASTEURAC39A001CA IM 
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERAC39A001CA IM 
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)AVENTIS PASTEURY014010IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Meningitis, Myelitis
SMQs:, Noninfectious meningitis (narrow)
Write-up: It was reported that a 17 year old male was vaccinated with a dose of typhoid vi polysaccharide vaccine (Typhim Vi, lot no. Y0140-1) and concomitantly a dose of Td-acP-IPV (Boostrix Polio, lot no. AC39A001CA) on 11-Feb-2005 both administered into the deltoid muscle. On 20-Feb-2005 he experienced meningomyelitis. he was admitted to hospital and MRT and LP were performed to confirm the diagnosis. At the time of reporting the pt was not recovered. We''ll ask for further information.

VAERS ID:236239 (history)  Vaccinated:2005-03-07
Age:17.0  Onset:2005-03-10, Days after vaccination: 3
Gender:Female  Submitted:2005-04-12, Days after onset: 32
Location:Foreign  Entered:2005-04-18, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data: UNK
CDC 'Split Type': WAES0504USA00276
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0580P IM 
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0526N IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Eosinophilia, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Hypersensitivity (broad)
Write-up: Information has been received from a health authority concerning a 17 year old female, with no previous medical history reported who on 3/7/05 was vaccinated IM with a dose of hepatitis B virus vaccine (lot # 649878/0580P; batch # NA16420). Suspect vaccinations included a dose of MMR (lot # 646426/0526N; batch # X95937) administered IM on an unspecified date. On 3/10/05 the patient experienced eosinophilia and pleuropericarditis and was hospitalized. On 3/16/05, the patient has not yet recovered. Follow up information received from the health authority on 4/7/05 indicates that the symptomatological evolution of the patient is favorable except for hypereosinophilia which is persistent. The patient is reported as not yet recovered. Other business partner numbers include: E200501284. Additional information has been requested.

VAERS ID:236835 (history)  Vaccinated:2005-02-16
Age:17.0  Onset:2005-03-10, Days after vaccination: 22
Gender:Female  Submitted:2005-04-27, Days after onset: 47
Location:Foreign  Entered:2005-05-02, Days after submission: 5
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Skin papilloma
Preexisting Conditions: Skin papilloma
Diagnostic Lab Data: UNK
CDC 'Split Type': WAES0504USA03985
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Thrombocytopenic purpura
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)
Write-up: Information has been received from a health authority concerning a 17 year old female with skin papilloma and no significant medical history, who on 2/16/05 was vaccinated with an IM dose of MMR. Concomitant therapy included ethynil estradiol (+) levonorgestrel, oral administration, once daily, for contraception and glutaraldehyde, topical administration, from December 2004 for skin papilloma. On 3/10/05, the patient experienced thrombotic thrombocytopenic purpura and was hospitalized. Outcome was not reported. The reporter considered the thrombotic thrombocytopenic purpura to be serious since it was life threatening, required hospitalization, and was an other important medical event (OMIC). The reporting authority also considered the event to be serious. Other business partner numbers include: E200501509 and S002460. The case is closed. No further information is expected.

VAERS ID:237478 (history)  Vaccinated:2004-11-17
Age:17.0  Onset:2004-12-08, Days after vaccination: 21
Gender:Male  Submitted:2005-05-17, Days after onset: 159
Location:Foreign  Entered:2005-05-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': D004654BA
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS  SC 
Administered by: Other     Purchased by: Other
Symptoms: Deafness, Tinnitus
SMQs:, Hearing impairment (narrow)
Write-up: This case was reported by an unknown physician via a regulatory authority and described the occurrence of sudden deafness in a 16 yr old male subject who was vaccinated with hepatitis A-B vaccine (Twinrix ) for prophylaxis. This report was received from a regulatory authority. The subject''s medical history, concurrent medical conditions and concomitant medications have not been reported. Co-suspect vaccination included tick-borne encephalitis vaccine (encepurErwachsene) 0.5m; SQ given on 11/30/2004 at an unknown application site. The previous vaccinations with both Hepatitis A-B vaccine and tick-borne encephalitis vaccine were well tolerated. On 11/17/2004 the subject received third dose of Hepatitis A-B vaccine, 1ml SQ, at an unknown application site. On 12/08/2004, approximately three weeks post vaccination with hepatitis A-B vaccine approximately eight days post vaccination with tick-borne encephalitis vaccine, the subject experienced sudden deafness and tinnitus. Surgery, performed on the next day, on 12/09/2004, by an otorhinolarynogolist was without success. The subject was hospitalized for the event on an unknown date. Laboratory values were unchanged. Approximately four months later, at the time of reporting on 04/07/2005, the events were still unresolved. The reporting physician considered that the events were possibly related to vaccination with Hepatitis A-B vaccine and/or tick- born encephalitis vaccine.

VAERS ID:241508 (history)  Vaccinated:2005-06-20
Age:17.0  Onset:2005-06-21, Days after vaccination: 1
Gender:Female  Submitted:2005-07-19, Days after onset: 28
Location:Foreign  Entered:2005-07-20, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC 'Split Type': E200502675
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (FOREIGN)MERCK & CO. INC.    
HEPA: HEP A (VAQTA)MERCK & CO. INC.    
RAB: RABIES (NO BRAND NAME)UNKNOWN MANUFACTURER    
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Haematemesis, Headache, Nausea, Petechiae, Pyrexia, Tachycardia
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: This case was initially reported by a foreign health authority on 7/8/05. This case concerns a 17 year old female patient. No details of the patient''s medical history were reported. The patient received a hepatitis B vaccine, batch number and manufacturer unknown and a hepatitis A and typhoid vaccine, Hepatyrix, batch number not reported on 6/10/05. The patient received a rabies vaccine, manufacturer and batch number not reported on 6/20/05 for foreign travel. On 6/21/05, one day after the rabies vaccine and 11 days after the hepatitis B vaccine and hepatitis A and typhoid vaccine, the patient vomited blood once. The patient also experienced a fever, nausea, headache, tachycardia, and a petechial rash. The patient was referred to accident and emergency to exclude meningitis. The patient was discharged from accident and emergency the same day and meningitis was excluded. At the time of reporting the patient is recovering. The reporter considered the reaction to be medically significant (OMIC). The agency considered this to be a serious reaction. No further information is expected, case is closed.

VAERS ID:244682 (history)  Vaccinated:1996-06-15
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2005-09-28
Location:Foreign  Entered:2005-09-28
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Multiple sclerosis, optic neuritis retrobulbar.
Preexisting Conditions:
Diagnostic Lab Data: March 2003, Expanded disability status scale (EDSS) was at 4.5.
CDC 'Split Type': B0395162A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSUNK  UN
Administered by: Other     Purchased by: Other
Symptoms: Cerebellar syndrome, Condition aggravated, Multiple sclerosis, Nervous system disorder, Optic neuritis, Optic neuritis retrobulbar, Vaccine positive rechallenge
SMQs:, Noninfectious encephalitis (broad), Optic nerve disorders (narrow), Demyelination (narrow), Ocular infections (broad)
Write-up: This case was reported directly and described the occurrence of multiple sclerosis relapse in a 19 year old female subject who was vaccinated with hepatitis B vaccine (Engerix B) for prophylaxis. Co suspect vaccination included two doses of hepatitis B vaccine (Genhevac B), given on Nov 08 1995 and Dec 06 1995. Two months after that vaccination, in Feb 1996, the subject was diagnosed with multiple sclerosis with optic retrobulbar neuritis on right side. A treatment with interferon beta la(Avon) , and then interferon beta la (Rebif) was given. On June 15 1996, the subject received the 3rd dose of hepatitis B vaccine (Engerix B) (batch number not available). During the year 1999, between 2 to 3 years after vaccination with Engerix B, the subject experienced three relapses of multiple sclerosis. At that time, the subject was under treatment with interferon. At an unspecified date, the subject presented with progressive aggravation of symptomatology, with severe kinetic cerebellar syndrome. In march 2003, the subject was hospitalized for corticoid flash therapy course. The performed examination showed major kinetic cerebellar syndrome of four limbs and minor static syndrome, associated with tetra pyramidal syndrome (bilateral pyramidal syndrome). The expanded Disability status scale (EDSS) was 4.5. At the time of reporting, the outcome of the events was unspecified. According to the reporter, the events were considered as disabling. The reporter considered the multiple sclerosis as unlikely related to Genhevac B. Causality relationship of multiple sclerosis relapses and Engerix B was not assessed. Case closed, no more information will be available.

VAERS ID:244725 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2005-09-29
Location:Foreign  Entered:2005-09-29
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: Magnetic resonance tomogram (MRT) and computed tomogram: results: no tumor, brain swelling. Cerebrospinal fluid test: no signs for infection. Urine: traces of opiates.
CDC 'Split Type': D0047602A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB047BA  UN
TBE: TICK-BORNE ENCEPH (NO BRAND NAME)UNKNOWN MANUFACTURERUNK  UN
Administered by: Other     Purchased by: Other
Symptoms: Brain oedema, Coma, Disorientation, Drug toxicity, Eye disorder, Laboratory test abnormal, Liver disorder, Malaise, Mydriasis
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Drug abuse and dependence (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Corneal disorders (broad), Retinal disorders (broad)
Write-up: This case was reported by a physician and described the occurrence of coma in a 17 year old female subject who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix adult) tick borne encephalitis vaccine for prophylaxis. Concurrent medical conditions included changed life situation. In September 2005, about six days before the initial report, the subject received 1st dose of Twin adult (unknown) together with an unspecified dose of FSME immun (unknown). In Sept 2005, at an unspecified time after vaccination with FSME immun and Twinrix adult, the subject experienced malaise and disorientation. An unspecified time later the subject developed coma and was hospitalized by emergency to a neurological intensive case unit. The physician considered the events were life threatening. The subjects pupils were fixed dilated and not reacting to light. Magnetic resonance tomogram (MRT) and computed tomogram showed brain swelling, but no tumour. Test of cerebrospinal fluid showed no signs for infection. In urine traces of opiate were found. The subject had severe liver changes. Hepatogens coma due to opiate intoxication was suspected. At the time of reporting the outcome of the events was unspecified.

VAERS ID:246915 (history)  Vaccinated:2005-09-27
Age:17.0  Onset:0000-00-00
Gender:Male  Submitted:2005-11-07
Location:Foreign  Entered:2005-11-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': D0047819A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Other     Purchased by: Other
Symptoms: Haemorrhagic diathesis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Chronic kidney disease (broad)
Write-up: This case was reported by a consumer and described the occurrence of increased bleeding tendency in a 16 year old male subject who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine for prophylaxis. A physician or other health care professional has not verified this report. On 9/27/05, the subject received first dose of Twinrix adult (unknown). In 2005, at an unspecified time after vaccination with Twinrix adult, the subject experienced increased bleeding tendency after an injury. This case was assessed as medically serious (OMIC). At the time of reporting the outcome of the events was unspecified.

VAERS ID:248211 (history)  Vaccinated:2005-10-19
Age:17.0  Onset:2005-10-19, Days after vaccination: 0
Gender:Female  Submitted:2005-11-21, Days after onset: 33
Location:Foreign  Entered:2005-11-28, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure measurement 19Oct05 150/80;total heartbeat count at 12:10 19Oct05 60;total heartbeat count at 12:35 19Oct05 68
CDC 'Split Type': WAES0511USA02832
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0197R IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Heart rate irregular, Hypertension, Malaise, Visual disturbance
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Cardiac arrhythmia terms, nonspecific (narrow)
Write-up: Information has been received from a health authority concerning a 17 year old female with no medical problems who on 19-Oct-2005 at 11:55-12:00 pm was vaccinated IM with a 0.5ml dose measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (batch #NB4560). At 12:10 on 19-Oct-2005, the patient felt unwell and had a problem with her vision and couldn''t see but this soon cleared. Her arms and legs felt dead. At 12:10 she was lying down, was very pale and felt sick. Her pulse was 60. At 12:35 her pulse was 68 and her blood pressure was 150/80. The patient''s mother arrived to take her home. The ends of the patient''s fingers and her feet felly "funny". The patient was able to walk to the car. The mother was advised to take the patient to GP if she did not feel well after one hour. At the time of reporting the patient was still recovering. It was noted that the MHRA considered this case to be serious. The patient''s adverse experiences were considered to be other important medical events (OMIC). Other business partner numbers include: E2005-04650 and ADROIT ref. 498265. Additional information has been requested

VAERS ID:248946 (history)  Vaccinated:2005-10-26
Age:17.0  Onset:2005-10-26, Days after vaccination: 0
Gender:Female  Submitted:2005-12-07, Days after onset: 42
Location:Foreign  Entered:2005-12-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': B0401843A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS   UN
Administered by: Other     Purchased by: Other
Symptoms: Hypotonia, Loss of consciousness, Pallor, Stupor, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a physician and described the occurrence of loss of consciousness in a 17 year old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, absorbed (Boostrix) for prophylaxis. Concurrent medical condition and medication were unknown. There was no medical history of spasm or any other similar event. On Oct 26 2005, the subject received a booster dose of Boostrix (batch not available). One minute after vaccination with Boostrix, the subject experienced hypotonic hyporesponsive episode and pallor. She has dramatically developed loss of consciousness with tremors during five seconds. During this episode, no cardiac disorder and hypotension was observed. Blood pressure was at 130/80. The subject has completely recovered between 30 and 45 minutes later. This case was assessed as medically serious by manufacturer (OMIC). The physicians causality assessment was unknown. The hypothesis of epileptic fit or vagal malaise were ruled out.

VAERS ID:249156 (history)  Vaccinated:2005-10-01
Age:17.0  Onset:2005-10-01, Days after vaccination: 0
Gender:Female  Submitted:2005-12-12, Days after onset: 72
Location:Foreign  Entered:2005-12-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': B0402492A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS  IMRA
Administered by: Other     Purchased by: Other
Symptoms: Loss of consciousness, Syncope vasovagal, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a physician and described the occurrence of a vasovagal reaction in a 17 year old female subject who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix) for prophylaxis. The subject is reportedly healthy. On Oct 1 2005 the subject received 1st dose of Twinrix (intramuscular, unknown). the subject was somewhat anxious. On Oct 1 2005, 3 minutes after vaccination with Twinrix, the subject experienced a vasovagal syncope with a short moment of unconsciousness. She was positioned in a Trendelenburg position and woke up after a short moment. Later on at home she vomited once. This case was assessed as medically serious by manufacturer (OMIC). On Oct 1 2005 she had fully recovered. The physician considered the events were almost certainly related to vaccination with Twinrix.

VAERS ID:251167 (history)  Vaccinated:2006-01-04
Age:17.0  Onset:2006-01-07, Days after vaccination: 3
Gender:Female  Submitted:2006-01-30, Days after onset: 23
Location:Foreign  Entered:2006-02-02, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES0601USA03118
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Angioneurotic oedema, Malaise, Pruritus, Urticaria, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (broad), Oropharyngeal allergic conditions (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a health authority concerning a 17 year old female, with no reported medical history, who on 04-Jan-2006 was vaccinated with an intramuscular dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. Concomitant therapy included ethinyl estradiol/norgestimate (CILEST) oral administration, beginning in November 2005. On 07-Jan-2006, three days post vaccination, the patient developed urticaria, angioedema, wheeze, itchiness and general malaise. The patient was admitted to accident and emergency and was not initially treated for an allergy. She was then readmitted and given adrenalin and steroids as corrective treatment. The patient recovered at home on 09-Jan-2006. The reaction was considered serious as it was considered to be medically significant by the reporter (OMIC). No further information is expected. The case is closed. Other business partner numbers include: E2006-00391 and ADROIT number W815011.

VAERS ID:253181 (history)  Vaccinated:2005-06-06
Age:17.0  Onset:2006-02-03, Days after vaccination: 242
Gender:Female  Submitted:2006-03-22, Days after onset: 47
Location:Foreign  Entered:2006-03-23, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Medroxyprogesterone ACE, Diclectin
Current Illness: Nausea during pregnancy, smoker
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure 2/3/2006 130/86 mmHg, Pregnancy test urine 12/07/2005 positive, Pulse rate 2/3/2006 107 pulse min, Ultrasound antenatal screen 2/3/2006 Abnormal.
CDC 'Split Type': B0403561A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSDVHA817A9 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Abortion missed, Laboratory test abnormal, Muscle spasms, Nausea, Unintended pregnancy, Uterine enlargement, Vaginal haemorrhage
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: This female subject was enrolled in the prophylactic double blind study 580299/008. On 12/09/2004, 1/13/2005 and 06/06/2005, the subject received the 1st, 2nd and 3rd dose of human papilloma virus type 16 and 18 vaccine HPV, IM deltoid or hepatitis A vaccine Havrix 720 EU, IM deltoid. This subject received Havrix (lot number DVHA817A9). The subjects past medical history included no previous pregnancy. The mother and the father had no abnormal medical and family history. The subject smoked 10/15 cigarettes per day during her pregnancy. She was treated with Diclectin from 2005 until 2/3/2006 for nausea during pregnancy. On 12/9/2005, 3 months after the 3rd dose of blind vaccine, this 17 year old subject was reported to be pregnant. Depro Provera injections were used as contraception method (last injection was given in 8/2005). Her last menstrual period occurred on 10/21/2005. The subject was exposed to the vaccine before conception. On 12/07/2005, urine pregnancy test was positive. The estimated delivery date was 7/28/2006. On 2/3/2006, eight months after the 3rd dose of Blinded vaccine, this 17 year old subject went to the local ER with lower abdominal pain, cramping and vaginal bleeding after 18 weeks of pregnancy. An ultrasound antenatal screen was preformed and revealed a fetal pole consistent with 8 weeks and 4 days in size. laboratory test and exams were performed, abdominal exam normal, pelvic exam showed vulva and vagina normal. Cervix was opening and containing old blood from cervical OS and uterus was slightly enlarged. A diagnosis of missed abortion was made. The subject was seen by local obstetrician gynecologist and options were discussed. Finally, suction, dilation and curettage were chosen. On 2/3/2006, this intervention was performed by the local obstetrician gynecologist. Products of conceptions were removed from uterine cavity (8-1) weeks gestation and uterus was manually massaged. Then , Oxytocin infusion was given intravenously, Uterus contracted well post procedure. The event resolved on 2/3/20

VAERS ID:253758 (history)  Vaccinated:2004-03-26
Age:17.0  Onset:2004-04-09, Days after vaccination: 14
Gender:Male  Submitted:2006-04-04, Days after onset: 725
Location:Foreign  Entered:2006-04-06, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Relevant test/laboratory data: Stool testing, CMV testing performed. CSF culture neg, CSF cell count was 5 (RBCs 1, WBCs 3 mkl).
CDC 'Split Type': 200600728
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)AVENTIS PASTEURC1834A  UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Back pain, Bone pain, CSF test abnormal, Fatigue, Gait disturbance, Guillain-Barre syndrome, Headache, Nausea, Paraesthesia, Photophobia, Rash, Red blood cell abnormality, White blood cell disorder
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haematopoietic leukopenia (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Demyelination (narrow), Corneal disorders (broad), Retinal disorders (broad), Osteonecrosis (broad), Hypersensitivity (narrow)
Write-up: Initial report on 29Mar06. A 17 yr old male pt was diagnosed with Guillain Barre Syndrome 14 days after receiving the injection of Adacel, lot number C 1834AA on 26Mar04. The pt developed back pain 11 days post immunization, nausea 13 days post immunization, fatigue, photophobia, abnormal gait, headache, rash, paraesthesia and bone pain 14 days post immunization. Onset date of symptoms not reported. The pt was hospitalized from three days and had stool testing, CMV testing performed. CSF culture negative, CSF cell count was 5 ( RBCs 1, WBCs 3 mkl). Recovery status not reported. Relevant test/laboratory data: Stool testing, CMV testing performed. CSF culture neg, CSF cell count was 5 (RBCs 1, WBCs 3 mkl).

VAERS ID:259252 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2006-07-06
Location:Foreign  Entered:2006-07-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': B0429471A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS    
RAB: RABIES (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Other     Purchased by: Other
Symptoms: Paraesthesia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a nurse and described the occurrence of paresthesia in a 17 yr old female subject who was vaccinated with hep A inactivated and hep B recombinant vaccine (Twinrix) for prophylaxis. Concurrent medication included Rabies vaccine. On an unspecified date the subject received unspecified dose of Twinrix and collapsed. Five days after the third vaccination the pt developed paraesthesia. This case was assessed as medically serious by manf (OMIC). At the time of reporting the outcome of the events were unspecified.

VAERS ID:259395 (history)  Vaccinated:2006-06-27
Age:17.0  Onset:2006-06-28, Days after vaccination: 1
Gender:Female  Submitted:2006-07-11, Days after onset: 13
Location:Foreign  Entered:2006-07-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': B0429802A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB211AF   
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSATYAB009AB   
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURERATYAB009AB   
Administered by: Other     Purchased by: Other
Symptoms: Facial palsy, Hypotonia, Movement disorder, Sensation of heaviness
SMQs:, Peripheral neuropathy (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a nurse and described the occurrence of paralysis on the left side of the face in a 17 year old female subject who was vaccinated with hepatitis B vaccine, hepatitis A and polysaccharide typhoid vaccine for prophylaxis. On 6/27/06, the subject received 1st dose of Engerix B and Hepatyrix in different arms. On 6/28/06, in the morning, the patient''s arms felt heavy and limp, and her arms were difficult to lift. The patient also woke the next day (first thing in the morning) with mild paralysis on the left side of her face, which resolved later on in the day. The patient reported that her left side of her face was not as quick as her right side. The patient did not have any vision problems or headache. This case was assessed as medically serious (OMIC). At the time of reporting, the events were resolved. A nurse reported that a patient received Hepatyrix and their first dose of Engerix B on the 6/27/06. The patient is on the accelerated schedule (0, 7, 21 day, 12 month booster) for Engerix B as the patient is going overseas at the end of August. The patient received the vaccines in different arms. The following morning (6/28/06), the patient''s arms felt heavy and limp, and her arms were difficult to lift. The patient also woke the next day (first thing in the morning) with mild paralysis on the left side of her face, which resolved later on in the day. The patient told the nurse that her left side of her face was not as quick as her right side. The nurse reported that the patient did not have any vision problems or headaches.

VAERS ID:261440 (history)  Vaccinated:2006-07-19
Age:17.0  Onset:2006-07-19, Days after vaccination: 0
Gender:Female  Submitted:2006-08-11, Days after onset: 23
Location:Foreign  Entered:2006-08-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': B0433366A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBUB112CL IMUN
Administered by: Other     Purchased by: Other
Symptoms: Apnoea, Loss of consciousness, Muscle contractions involuntary, Mydriasis, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of apnea in a 17 year old female subject who was vaccinated with hepatitis B vaccine (Engerix B) for prophylaxis. On 19 July 2006 the subject received unspecified dose of Engerix B (intramuscular). On 19 July 2006, less than one day after vaccination with Engerix B, the subject experienced vasovagal syncope with loss of consciousness (which lasted 40 seconds) and apnea (which lasted 20 seconds), she also presented mydriasis and muscle contraction. This case was assessed as medically serious (OMIC) by the manufacturer. At the time of reporting the outcome of the events was unspecified. The regulatory authority reported that the events were possibly related to vaccination with Engerix B.

VAERS ID:262419 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2006-08-29
Location:Foreign  Entered:2006-08-31, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': E200604299
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS    
RAB: RABIES (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Circulatory collapse, Paraesthesia
SMQs:, Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow)
Write-up: This case was initially reported on 21-Aug-2006. This case concerns a 17 year old female patient. The patient''s medical history was not provided. The patient received Rabies vaccine, manufacturer not reported, batch number not reported, on an unknown date. The patient received Twinrix, Hepatitis A and B vaccine on an unspecified date and collapsed. Five days after the third vaccination the patient developed paraesthesia. It was unknown if the patient recovered from the events. Both the reporter and the agency considered this case to be serious. (OMIC)

VAERS ID:267386 (history)  Vaccinated:2006-09-26
Age:17.0  Onset:2006-09-26, Days after vaccination: 0
Gender:Female  Submitted:2006-11-20, Days after onset: 55
Location:Foreign  Entered:2006-11-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': B0446316A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB0521BI  RL
Administered by: Other     Purchased by: Other
Symptoms: Asthma, Chest pain, Dizziness, Hypotension, Infection, Malaise, Unintended pregnancy, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Normal pregnancy conditions and outcomes (narrow), Hypersensitivity (broad)
Write-up: This case was reported by a physician and described the occurrence of recurrent infection in a 17 year old female subject who was vaccinated with Twinrix for prophylaxis. On 9/26/06 the subject received 1st dose of Twinrix (unk). On 9/26/06, less than one day after vaccination with Twinrix, the subject became sick, she experienced dizziness, recurrent infection, hypotension and episodic vomiting. On 10/24/06 the subject returned for the second dose but the physician did not continue the vaccination course. At the clinic the subjects blood pressure was 110/70. On 11/9/06 the subject was hospitalized for hypotension. The physician suspected a pregnancy. On 11/10/06 the subject complained of chest pain. The subject was still on a nebulizer newly diagnosed asthmatic. At the time of reporting the events were unresolved.

VAERS ID:267941 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2006-11-27
Location:Foreign  Entered:2006-11-29, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': E200606093
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER   UN
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)AVENTIS PASTEUR   UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Coma, Confusional state, Delirium, Fatigue, Hallucination, Hypotonia, Pyrexia, Rhinorrhoea, Somnolence
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case is linked with the case number E200606223 regarding other adverse reactions following influenza and typhoid vaccinations. Initial report on 11/16/06 it was reported that a female pt born on 8/12/82 received a dose of typhoid vaccine (Typhim VI, batch number not reported). in 1999 or 2000. Under 48 hours post vaccination, possibly during the following night, she developed severe fever, hallucinations, delirium and episodes of coma like state. The symptoms considered as severe quickly resolved in a few hours, ie less than 24 hours. The pt was neither seen by a doctor nor hospitalised. No final diagnosis was made. No other causes but vaccination were found. Additional information on 11/22/06 the reporter described the coma like state, the pt was found to be somnolent and confused, she did not control her thought and was not aware of reality whereas she was usually mentally well balanced. The confusional state lasted 48 hours. Fever and fatigue persisted during 2 to 4 days more. The pt received doses of Typhoid vaccine (Typhim VI and influenza vaccine (Vaxigrip) on 11/17/06. Two hours later she had fever of 38C and felt off colour all day long. On 11/21/06 she also experienced running nose, fatigue and loss of tonus (Case E200606223). According to the reporter the symptoms were due to influenza instead of typhoid vaccination. (OMIC).

VAERS ID:271897 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2007-02-06
Location:Foreign  Entered:2007-02-07, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: platelet count Comment: decreased
CDC 'Split Type': WAES0701USA04997
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Contusion, Platelet count decreased
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Accidents and injuries (narrow)
Write-up: Information has been received from a health authority concerning a 17 year old female who was vaccinated IM with a 0.5 ml dose of MMR II vaccine (manufacturer unknown). Subsequently, post vaccination the patient experienced a profound decreased in platelet count (value not provided) and extensive bruising. It was known if the patient has recovered. The patient''s experiences were considered to be an other important medical events by the reporter and health authority. No more is available, this case is closed. Other business partner numbers included E2006-00655 and 20083528.

VAERS ID:272718 (history)  Vaccinated:2006-10-29
Age:17.0  Onset:2006-10-29, Days after vaccination: 0
Gender:Female  Submitted:2007-02-19, Days after onset: 113
Location:Foreign  Entered:2007-02-20, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: Phobic anxiety
Preexisting Conditions:
Diagnostic Lab Data: blood pressure 29Oct06 110/67 mmHg Comment: sitting BP, physical examination 29Oct06 Comment: Pulse rate 55, Glasgow come scale 29Oct06 Comment: 15/15
CDC 'Split Type': WAES0612AUS00040
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0444F IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood pressure decreased, Bronchospasm, Dizziness, Dyspnoea, Glasgow coma scale, Heart rate decreased, Oxygen supplementation, Pallor, Palpitations, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 17 year old female who on 29-OCT-2006 was vaccinated with Gardasil (lot No 654672/0444F, batch no NE01680, Expiry date 23-FEB-2009) on her left deltoid muscle. The patient is needle phobic and had nothing to eat on 29-OCT-2006 until the patient received vaccination on 12:02pm. On 29-OCT-2006 the patient experienced syncope and bronchospasm. Four minutes after injection, the patient had syncope. The symptoms included light headedness, pallor, feeling like fainting and palpitation. The patient had no chest pain but had bronchospasm with dyspnoea. The patient''s sitting blood pressure was 110/67 mmHg and pulse rate was 55. Glasgow Coma Score was 15/15. The patient had oxygen mask. The patient was not hospitalized. The physician considered her diagnosis as phobia, syncope vs drug reaction. Subsequently the patient recovered from syncope and bronchospasm. The physician considered syncope and bronchospasm were related to therapy with Gardasil and asked the patient to reconsider about continuing the next dose of Gardasil. Syncope and bronchospasm were considered to be life threatening by the reporting physician. Additional information is not expected.

VAERS ID:274234 (history)  Vaccinated:2007-02-15
Age:17.0  Onset:2007-02-15, Days after vaccination: 0
Gender:Female  Submitted:2007-03-16, Days after onset: 28
Location:Foreign  Entered:2007-03-19, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: UNK
CDC 'Split Type': WAES0703CAN00131
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0444F   
Administered by: Unknown     Purchased by: Unknown
Symptoms: Confusional state, Fall, Head injury, Subarachnoid haemorrhage, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic cerebrovascular conditions (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a physician concerning a 17 year old female who on 15-FEB-2007 was vaccinated with Gardasil (lot # 654672/0444F). There was no concomitant therapy. On 15-FEB-2007, 2-3 minutes after Gardasil injection the patient experienced syncopal episode, fell and hit her head. The patient had a head injury and central lateral subarachnoid bleeding and was hospitalized. The patient''s syncopal episode and head injury and central lateral subarachnoid bleeding persisted. It was reported that the patient had a gradual clearing of confusion. Additional information has been requested.

VAERS ID:274362 (history)  Vaccinated:2007-03-01
Age:17.0  Onset:2007-03-01, Days after vaccination: 0
Gender:Female  Submitted:2007-03-19, Days after onset: 17
Location:Foreign  Entered:2007-03-20, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Amenorrhea; Affect lability
Diagnostic Lab Data: UNK
CDC 'Split Type': WAES0703USA02432
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0572F0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Loss of consciousness, Meningism, Muscle spasms, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Information has been received from a gynecologist concerning a 17 year old female with a history of emotional lability and probably "stress-related" amenorrhoea who on 01-MAR-2007 was vaccinated with the first dose of Gardasil, IM into the left arm. Concomitant medication was not reported. On 01-MAR-2007, about 2 minutes post vaccination, the patient experienced a convulsion syncope with meningism, muscular spasm and unconsciousness. Subsequently after about 3 minutes, the patient recovered from convulsion syncope. The patient was admitted to the hospital. Other business partner numbers included E2007-01514. Additional information is not expected.

VAERS ID:275510 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2007-04-02
Location:Foreign  Entered:2007-04-03, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0703USA04719
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Cold sweat, Dyspnoea, Injection site pain, Malaise, Sensation of foreign body
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad)
Write-up: Information has been received from a company representative via a physician''s office concerning a 17 year old female who on an unspecified date was vaccinated with the first dose of Gardasil. Concomitant medication was not reported. Subsequently on an unspecified date, immediately following vaccination, the patient complained about injection site pain. The patient left the practice together with her mother. About 15 minutes post vaccination, the patient and her mother returned. At that time, the patient complained about feeling unwell and an intense global feeling in her pharynx. The patient felt like not being able to breath. The patient was treated with corticosteroids. After about 1 hour, the patient recovered from the global feeling in her pharynx but was asthenic and showed cold sweat. The patient was admitted to the hospital. The patient recovered after two days and was discharged from the hospital. Other business partner numbers included E2007-01818. Additional information is not expected.

VAERS ID:275681 (history)  Vaccinated:2007-03-08
Age:17.0  Onset:2007-03-08, Days after vaccination: 0
Gender:Female  Submitted:2007-04-05, Days after onset: 27
Location:Foreign  Entered:2007-04-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Cileste (Ethinyloestradiol + Norgestimate)
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC 'Split Type': B0464851A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB2541A IM 
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Headache, Loss of consciousness, Pallor, Photophobia, Syncope vasovagal, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a regulatory authority and described the occurrence of vasovagal attack in a 17-year-old female subject who was vaccinated with Engerix B for prophylaxis. Previous vaccination included hepatitis B vaccine, intramuscular given on 6 February 2007; polysaccharide typhoid vaccine; intramuscular given on 6 February 2007. Concurrent medications included Cileste. On 8 March 2007 the subject received 2nd dose of Engerix B (intramuscular). On 8 March 2007, just seconds after vaccination with Engerix B, the subject experienced "what appeared to be fit, vasovagal attack. The whole body tremor lasted approximately 10 to 15 seconds with loss of consciousness. Very pale headache and aversion to light." This case was assessed as medically serious by manufacturer. On 8 March 2007, the events were resolved.

Result pages: prev   2585 2586 2587 2588 2589 2590 2591 2592 2593 2594 2595 2596 2597 2598 2599 2600 2601 2602 2603 2604 2605 2606 2607 2608 2609 2610 2611 2612 2613 2614 2615 2616 2617 2618 2619 2620 2621 2622 2623 2624 2625 2626 2627 2628 2629 2630 2631 2632 2633 2634 2635 2636 2637 2638 2639 2640 2641 2642 2643 2644 2645 2646 2647 2648 2649 2650 2651 2652 2653 2654 2655 2656 2657 2658 2659 2660 2661 2662 2663 2664 2665 2666 2667 2668 2669 2670 2671 2672 2673 2674 2675 2676 2677 2678 2679 2680 2681 2682 2683 2684 2685 2686 2687 2688 2689 2690 2691 2692 2693 2694 2695 2696 2697 2698 2699 2700 2701 2702 2703 2704 2705 2706 2707 2708 2709 2710 2711 2712 2713 2714 2715 2716 2717 2718 2719 2720 2721 2722 2723 2724 2725 2726 2727 2728 2729 2730 2731 2732 2733 2734 2735 2736 2737 2738 2739 2740 2741 2742 2743 2744 2745 2746 2747 2748 2749 2750 2751 2752 2753 2754 2755 2756 2757 2758 2759 2760 2761 2762 2763 2764 2765 2766 2767 2768 2769 2770 2771 2772 2773 2774 2775 2776 2777 2778 2779 2780 2781 2782 2783   next

New Search

Link To This Search Result:
http://www.medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=2684&PERPAGE=100&ESORT=AGE


Copyright © 2014 National Vaccine Information Center. All rights reserved.
407-H Church Street, Vienna, Virginia 22180