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From the 1/14/2022 release of VAERS data:

Found 508 cases where Vaccine is 6VAX-F or ADEN or ADEN_4_7 or ANTH or BCG or CEE or CHOL or DF or DPIPV or DPP or DT or DTAP or DTAPH or DTAPHEPBIP or DTAPIPV or DTAPIPVHIB or DTIPV or DTOX or DTP or DTPHEP or DTPHIB or DTPIHI or DTPIPV or DTPPHIB or DTPPVHBHPB or EBZR or FLU(H1N1) or FLU3 or FLU4 or FLUA3 or FLUA4 or FLUC3 or FLUC4 or FLUN(H1N1) or FLUN3 or FLUN4 or FLUR3 or FLUR4 or FLUX or FLUX(H1N1) or H5N1 or HBHEPB or HBPV or HEP or HEPA or HEPAB or HEPATYP or HIBV or HPV2 or HPV4 or HPV9 or HPVX or IPV or JEV or JEV1 or JEVX or LYME or MEA or MEN or MENB or MENHIB or MER or MM or MMR or MMRV or MNC or MNQ or MNQHIB or MU or MUR or OPV or PER or PLAGUE or PNC or PNC10 or PNC13 or PPV or RAB or RUB or RV or RV1 or RV5 or RVX or SMALL or SSEV or TBE or TD or TDAP or TDAPIPV or TTOX or TYP or UNK or VARCEL or VARZOS or YF and Symptom is Aortic thrombosis or Arterial thrombosis or Arterial thrombosis limb or Arteriovenous fistula thrombosis or Arteriovenous graft thrombosis or Atrial thrombosis or Axillary vein thrombosis or Basilar artery thrombosis or Brachiocephalic vein thrombosis or Brain stem thrombosis or Cardiac ventricular thrombosis or Carotid artery thrombosis or Catheter site thrombosis or Cavernous sinus thrombosis or Cerebellar artery thrombosis or Cerebral artery thrombosis or Cerebral thrombosis or Cerebral venous sinus thrombosis or Cerebral venous thrombosis or Coronary artery thrombosis or Coronary bypass thrombosis or Deep vein thrombosis or Foetal placental thrombosis or Graft thrombosis or Hepatic artery thrombosis or Hepatic vascular thrombosis or Hepatic vein thrombosis or Iliac artery thrombosis or Infective thrombosis or Injection site thrombosis or Intracranial venous sinus thrombosis or Intrapericardial thrombosis or Jugular vein thrombosis or Mesenteric artery thrombosis or Mesenteric vein thrombosis or Ophthalmic artery thrombosis or Ophthalmic vein thrombosis or Ovarian vein thrombosis or Paraneoplastic thrombosis or Pelvic venous thrombosis or Penile vein thrombosis or Peripheral artery thrombosis or Portal vein thrombosis or Portosplenomesenteric venous thrombosis or Postoperative thrombosis or Postpartum thrombosis or Postpartum venous thrombosis or Precerebral artery thrombosis or Prosthetic cardiac valve thrombosis or Pulmonary artery thrombosis or Pulmonary thrombosis or Pulmonary venous thrombosis or Renal artery thrombosis or Renal vascular thrombosis or Renal vein thrombosis or Retinal artery thrombosis or Retinal vascular thrombosis or Retinal vein thrombosis or Shunt thrombosis or Spinal artery thrombosis or Splenic artery thrombosis or Splenic thrombosis or Splenic vein thrombosis or Subclavian artery thrombosis or Subclavian vein thrombosis or Superficial vein thrombosis or Superior sagittal sinus thrombosis or Thrombosis or Thrombosis corpora cavernosa or Thrombosis in device or Thrombosis mesenteric vessel or Thrombosis prophylaxis or Thrombosis with thrombocytopenia syndrome or Transverse sinus thrombosis or Truncus coeliacus thrombosis or Tumour thrombosis or Umbilical cord thrombosis or Vaccination site thrombosis or Vascular access site thrombosis or Vascular graft thrombosis or Vascular stent thrombosis or Vena cava thrombosis or Venous thrombosis or Venous thrombosis in pregnancy or Venous thrombosis limb or Vertebral artery thrombosis or Visceral venous thrombosis and Vaccination Date from '1990-01-01' to '2020-11-30'

Government Disclaimer on use of this data

Table

   
Event OutcomeCountPercent
Death183.54%
Permanent Disability6813.39%
Office Visit326.3%
Emergency Room18436.22%
Emergency Doctor/Room285.51%
Hospitalized26351.77%
Hospitalized, Prolonged234.53%
Recovered13927.36%
Life Threatening11522.64%
Not Serious7113.98%
TOTAL† 941† 185.24%
† Because some cases have multiple vaccinations and symptoms, a single case can account for multiple entries in this table. This is the reason why the Total Count is greater than 508 (the number of cases found), and the Total Percentage is greater than 100.



Case Details

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VAERS ID: 26971 (history)  
Form: Version 1.0  
Age: 66.0  
Sex: Female  
Location: California  
Vaccinated:1990-10-30
Onset:1990-10-30
   Days after vaccination:0
Submitted: 1990-11-21
   Days after onset:22
Entered: 1990-12-12
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES 0F11203 / UNK LA / IM
TD: TD ADSORBED (NO BRAND NAME) / SCLAVO 110A1 / UNK RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Pain, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: Apresoline
Current Illness:
Preexisting Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: CA9015

Write-up: Pt vaccinated with Influenza/TD developed intense pain & inability to move. MD prescribed antibiotics Cephalexin. Few days later still no improvement. MD removed blood clot & pt instantly regained ROM.


VAERS ID: 27649 (history)  
Form: Version 1.0  
Age: 42.0  
Sex: Male  
Location: California  
Vaccinated:1990-12-24
Onset:1990-12-25
   Days after vaccination:1
Submitted: 1991-01-25
   Days after onset:31
Entered: 1991-01-30
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / PFIZER/WYETH 4908027 / UNK RA / IM

Administered by: Military       Purchased by: Military
Symptoms: Cerebrovascular accident, Injection site reaction, Rash, Thrombosis, Vasodilatation
SMQs:, Anaphylactic reaction (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: 24 hrs post inject - slight warming & redness at inject site progressed to shoulder & neck over a 48 hr period of time. Denies problems 2nd & 3rd day. On 5th day thrombosis of rt carotid Artery resulting in stroke.


VAERS ID: 30452 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:1990-04-09
Onset:1990-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 1991-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Angina pectoris, Asthenia, Coronary artery thrombosis, Dizziness, Hypotension, Malaise, Myocardial infarction
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), Other ischaemic heart disease (narrow), Vestibular disorders (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: EBW918020

Write-up: 9APR90 vaccinee rec''d Engerix B & began to feel dizzy, weak, unwell & had an acute myocardial infarction; The vaccine caused severe hypotension, coronary artery spasm & superimposed coronary thrombosis;


VAERS ID: 42125 (history)  
Form: Version 1.0  
Age: 45.0  
Sex: Female  
Location: New Jersey  
Vaccinated:1992-04-01
Onset:1992-04-04
   Days after vaccination:3
Submitted: 1992-05-18
   Days after onset:43
Entered: 1992-05-21
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 2014T / 1 RA / IM

Administered by: Other       Purchased by: Public
Symptoms: Confusional state, Cyanosis, Dyspnoea, Laryngeal oedema, Paraesthesia, Peripheral vascular disorder, Thrombosis, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: ?dx 15APR92 subclavian steal synd
Allergies:
Diagnostic Lab Data: 15APR92 digital angiogram subtraction;
CDC Split Type:

Write-up: Devel hives arms/chest 4APR92; inc urticaria 7APR92; DPH & Aristocort given; 8 & 9APR inc urticaria;10APR PM laryngeal edema/SOB; taken to ER given meds; 11APR92 n,v,d, pain/numbness lt wrist, hand/finger; adm to hosp;


VAERS ID: 48145 (history)  
Form: Version 1.0  
Age: 37.0  
Sex: Female  
Location: Missouri  
Vaccinated:1992-10-29
Onset:1992-11-16
   Days after vaccination:18
Submitted: 1992-12-14
   Days after onset:28
Entered: 1992-12-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / PFIZER/WYETH 4928114 / UNK LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Arterial thrombosis, Neoplasm
SMQs:, Embolic and thrombotic events, arterial (narrow), Non-haematological tumours of unspecified malignancy (narrow)

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

Write-up: pt reported to clinc; hospitalization for a papillary fibroelastoma tumor on mitral valve which caused an occlusion of the main artery to the optic nerve of the lt eye; presented to ER 16NOV92;


VAERS ID: 48503 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Male  
Location: Alabama  
Vaccinated:1992-11-30
Onset:1992-12-17
   Days after vaccination:17
Submitted: 1992-12-22
   Days after onset:5
Entered: 1992-12-31
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MER: MEASLES + RUBELLA (MR-VAX II) / MERCK & CO. INC. 0442V / 2 LA / SC

Administered by: Public       Purchased by: Public
Symptoms: Cyanosis, Oedema, Pain, Paraesthesia, Thrombosis
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Peripheral neuropathy (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: doppler studies, venogram;
CDC Split Type: AL92038

Write-up: MD had no problems until 1 wk p/vax when arm became swollen, cool to touch & blue from shoulder to hand; was seen in ER 8DEC & 9DEC due to inc swelling & pain; venogram revealed clot in ax vein; hospitalized 14DEC to 19DEC92;


VAERS ID: 50507 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Illinois  
Vaccinated:1993-01-22
Onset:1993-01-27
   Days after vaccination:5
Submitted: 1993-03-03
   Days after onset:35
Entered: 1993-03-05
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Cerebral haemorrhage, Cerebral venous thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: Vitamin K
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: No relevant data;
CDC Split Type: WAES93020472

Write-up: pt recvd vax & 1 or 2 days old was administered 1st Hep B vax on approx 22JAN93 & 27JAN93 age of 7 days devel cerebral venous thrombosis w/intraventricular hemmorhage; exp prolonged hospitalization;


VAERS ID: 54006 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Illinois  
Vaccinated:1992-09-21
Onset:1992-10-30
   Days after vaccination:39
Submitted: 1993-06-08
   Days after onset:220
Entered: 1993-06-16
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / CONNAUGHT LABORATORIES 2A41126 / 1 RL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH M175HN / 1 LL / IM
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 0665C / 1 MO / PO

Administered by: Public       Purchased by: Public
Symptoms: Apnoea, Cardiac arrest, Convulsion, Thrombosis
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: IL93039

Write-up: pt recvd vax 21SEP92 & had sz 30OCT92 & taken to hosp; spent 5 wks in treatment dx sleep apnea; 24NOV92 stopped breathing & husband did CPR; hospitalized; had brain surgery 4DEC92 to remove blood clots; MD do not know cause of this;


VAERS ID: 55205 (history)  
Form: Version 1.0  
Age: 40.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:1991-08-08
Onset:1991-09-03
   Days after vaccination:26
Submitted: 1993-08-11
   Days after onset:708
Entered: 1993-08-13
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / 2 - / -

Administered by: Private       Purchased by: Other
Symptoms: Anxiety, Confusional state, Deep vein thrombosis, Depression, Infection, Myelitis, Neuropathy, Paraesthesia
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (narrow), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations: pt exp numbness & tingling in toes p/Hep B #1 dose;~ ()~~~In patient
Other Medications: Septra;
Current Illness:
Preexisting Conditions: Knee surgery, bladder surgery, TIA, low back pain, bladder cancer, bradycardia, blood transfusions, needle stick, tonsillectomy, adenoidectomy;
Allergies:
Diagnostic Lab Data: MRI 08OCT91 lesion from T-1 thru T-7 poster;
CDC Split Type: WAES93071292

Write-up: Pt recvd vax 8AUG91 & on 9SEP91 pt exp episode of presyncope & garbled speech, & was hospitalized; condition was dx as post-vaccination transverse myelitis;


VAERS ID: 56721 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Female  
Location: California  
Vaccinated:1993-10-09
Onset:1993-10-10
   Days after vaccination:1
Submitted: 1993-10-12
   Days after onset:2
Entered: 1993-10-25
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / PFIZER/WYETH 4938180 / UNK - / IM A

Administered by: Public       Purchased by: Other
Symptoms: Deep vein thrombosis, Nausea, Pulmonary embolism, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1993-10-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: Dicloxacillin; APAP w/codeine, Prilosec, Mevacor, Tenormin, Zestril, Colchicine, Tagamet, Indocin, HCTZ, Reglan;
Current Illness:
Preexisting Conditions: Hypertension, diverticulitits, hiatal hernia, severe coronary artherosclerosis, nephrosclerosis, pituitary adenoma, obesity;
Allergies:
Diagnostic Lab Data:
CDC Split Type: 893285016J

Write-up: pt recvd flu vax 9OCT93 approx 24 hrs later pt devel fever & nausea; died in the ambulance on the way to the hosp;


VAERS ID: 63043 (history)  
Form: Version 1.0  
Age: 64.0  
Sex: Male  
Location: Mississippi  
Vaccinated:1993-10-14
Onset:1993-10-21
   Days after vaccination:7
Submitted: 1994-05-17
   Days after onset:208
Entered: 1994-05-23
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES 3F41016 / 1 - / A

Administered by: Unknown       Purchased by: Public
Symptoms: Infection, Pyrexia, Thrombosis, Vasculitis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Vasculitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? Yes
Previous Vaccinations: ~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: pt recvd flu vax & 6 days later was real ill from then until 5MAR t100-103.5 24 hrs day; went into hosp 15NOV93; ATB for 40 days; temp cont; hosp 16FEB-26; vasculitis from virus; 4MAY blood clot; no sx of cold or illness until took flu shot


VAERS ID: 67868 (history)  
Form: Version 1.0  
Age: 35.0  
Sex: Female  
Location: California  
Vaccinated:1994-10-22
Onset:1994-10-23
   Days after vaccination:1
Submitted: 1994-10-24
   Days after onset:1
Entered: 1994-10-31
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUSHIELD) / PFIZER/WYETH 4948068 / UNK LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Dyspnoea, Ecchymosis, Hyperhidrosis, Injection site hypersensitivity, Nausea, Skin discolouration, Thrombosis
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

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

Write-up: pt reports 2 hrs p/vax started perspiring 3-4 hrs p/inject had SOB & felt nauseated; next day pt noticed a reddened site 2 inches wide (that reportedly looked like a bruise); 23OCT93 pt was advised to go to ER; MD stated was blood clot;


VAERS ID: 71426 (history)  
Form: Version 1.0  
Age: 60.0  
Sex: Male  
Location: Utah  
Vaccinated:1994-10-28
Onset:1994-11-03
   Days after vaccination:6
Submitted: 1995-01-27
   Days after onset:85
Entered: 1995-02-13
   Days after submission:17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES 4F51072 / UNK - / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1474W / 1 - / IM

Administered by: Public       Purchased by: Public
Symptoms: Condition aggravated, Deep vein thrombosis, Hyperkalaemia, Lung neoplasm malignant, Pleural effusion, Pneumonia, Renal failure, Sepsis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1994-12-05
   Days after onset: 32
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations: NONE~ ()~~~In patient
Other Medications: Tenex, Procardia, Furosemide, Aludent-Furoxaline
Current Illness: kidney failure, hip replace SEP94
Preexisting Conditions: Kidney failure, hip replacement SEP94, HTN, bilateral pulmonary emboli, mononeuritis multiplex w/muscle atrophy, mesangioglomerulonephritis 2ndary to IgM nephropathy, chronic leukocytosis & elevated creatinine; degenerative joint disease;
Allergies:
Diagnostic Lab Data:
CDC Split Type: UT952703

Write-up: wife says flu like sx & SOB hospitalized for pneumonia 22NOV94 x 8 days; readmitted 04DEC94-expired 05DEC94; says had been on meds for kidney failure, HTN-autopsy revealed lung cancer;


VAERS ID: 71510 (history)  
Form: Version 1.0  
Age: 60.0  
Sex: Male  
Location: Michigan  
Vaccinated:1994-10-05
Onset:1994-10-11
   Days after vaccination:6
Submitted: 1995-01-11
   Days after onset:92
Entered: 1995-02-16
   Days after submission:36
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES 4F51165 / UNK LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Jaundice, Pain, Peripheral vascular disorder, Thrombosis
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Acute pancreatitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: vitamins
Current Illness: back pain, surgery 1985
Preexisting Conditions: went thru series of allergy shot for mold & oth things;
Allergies:
Diagnostic Lab Data: visiting nurse does blood testing every wk;
CDC Split Type: MI95007

Write-up: pt recvd vax;approx 1 wk later,devel pain leg;adm to hosp for blood clot; at home in 7days w/ coumadin;


VAERS ID: 77774 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Male  
Location: Texas  
Vaccinated:1994-10-01
Onset:1994-11-10
   Days after vaccination:40
Submitted: 1995-09-20
   Days after onset:313
Entered: 1995-09-29
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUOGEN) / PARKE-DAVIS 00184P / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Guillain-Barre syndrome, Paralysis, Pulmonary embolism, Thrombosis
SMQs:, Peripheral neuropathy (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 189 days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: Nifedipine XL, Timolol, EC-ASA
Current Illness:
Preexisting Conditions: Glaucoma, HTN
Allergies:
Diagnostic Lab Data: 14NOV94 Glucose; Protein 60; CSF no WBC; 17NOV94 Glucose, Protein 128, CSF 8WBCS; CT Scan & CSF r/o other etiologies
CDC Split Type: 0010150950200

Write-up: pt recvd vax OCT94 & exp ascending paralysis & was hospitalized w/GBS from 1NOV94 until 19MAY95;event considered disabling;during hospitalization exp blood clot & a pulmonary embolus (MAR95);


VAERS ID: 93776 (history)  
Form: Version 1.0  
Age: 42.0  
Sex: Female  
Location: Utah  
Vaccinated:1996-10-23
Onset:1996-11-01
   Days after vaccination:9
Submitted: 1996-12-10
   Days after onset:39
Entered: 1997-01-13
   Days after submission:34
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0785B / 1 LA / SC
TTOX: TETANUS TOXOID (NO BRAND NAME) / CONNAUGHT LABORATORIES 6C81110 / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Coronary artery disease, Lung disorder, Thrombosis, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Other ischaemic heart disease (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: blood titer, CT scan, CXR, chset CT scan
CDC Split Type: UT961826

Write-up: severe hives resulting in Pred med x 1mo;superficial saphenous vein clot, poss pulmonary arterial venous malformation;


VAERS ID: 96573 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:1997-01-14
Onset:1997-01-16
   Days after vaccination:2
Submitted: 1997-02-17
   Days after onset:32
Entered: 1997-03-31
   Days after submission:42
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0459D / 3 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Arthralgia, Chills, Deep vein thrombosis, Myalgia, Osteoarthritis, Pyrexia, Rheumatoid arthritis, Systemic lupus erythematosus
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Eosinophilic pneumonia (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: NONE
Current Illness: pain in rt foot & ankle @ time of 3rd dose hep B
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: 21JAn rheumatoid arthritis & lupus screens-positive;
CDC Split Type: WI97003

Write-up: 1st wk in JAN97 pt started having pain in rt ankle that moved to pain in knee;approx 2 days p/3rd dose ankle began to swell;has had extreme tiredness & gen body aches & pains that are transient;had chills & fever;DVT in rt calf 7FEB97;


VAERS ID: 102290 (history)  
Form: Version 1.0  
Age: 50.0  
Sex: Female  
Location: Ohio  
Vaccinated:1997-01-06
Onset:1997-02-06
   Days after vaccination:31
Submitted: 1997-09-02
   Days after onset:207
Entered: 1997-09-10
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR I) / MERCK & CO. INC. 1427B / UNK - / -

Administered by: Private       Purchased by: Private
Symptoms: Arthralgia, Deep vein thrombosis, Osteoarthritis
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Arthritis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: Premarin, Provera, Aldoastone;Advil, APAP
Current Illness: unk
Preexisting Conditions: allergic macrodantin, Furodantin
Allergies:
Diagnostic Lab Data: CBC, creatinine, liver enzymes & rheumatoid factor were negative;
CDC Split Type:

Write-up: 4wk p/vax devel pain & swelling lt knee;DXT in lt calf MAY97;rx w/NSAIDS & pred;dx oligoarthritis w/knee effusion;still has pain & swelling in joints;MD now recommended course of methotresate;


VAERS ID: 102885 (history)  
Form: Version 1.0  
Age: 1.4  
Sex: Male  
Location: Louisiana  
Vaccinated:1997-08-29
Onset:1997-09-06
   Days after vaccination:8
Submitted: 1997-09-11
   Days after onset:5
Entered: 1997-10-02
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (TETRAMUNE) / PFIZER/WYETH 438087 / 4 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0598E / 1 LA / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1353D / 1 RA / SC

Administered by: Public       Purchased by: Public
Symptoms: Brain oedema, Coagulopathy, Confusional state, Convulsion, Febrile convulsion, Thrombophlebitis, Thrombosis, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations: NA~ ()~~~In patient
Other Medications: NONE;Poly Vi Flor vitamins;
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: MRI & MRA showed venous sinus thrombosis;CT scan showed prelimentary reading of arterio-venous malformation;
CDC Split Type: LA970905

Write-up: pt devel sz;pt in hosp;MD felt was febrile sz;mom reports pt transferred to another hosp d/t CT scan was abn showed arterio-venous malformation;MD felt blood clot hemorrhaged which caused swelling brain;v, disoriented


VAERS ID: 106370 (history)  
Form: Version 1.0  
Age: 58.0  
Sex: Female  
Location: Illinois  
Vaccinated:1997-11-10
Onset:1997-11-11
   Days after vaccination:1
Submitted: 1997-12-16
   Days after onset:35
Entered: 1998-01-13
   Days after submission:28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / MEDEVA PHARMA, LTD. E33276A / 1 RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Hypertonia, Hypokinesia, Myasthenic syndrome, Thrombosis
SMQs:, Neuroleptic malignant syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related conditions (narrow), Parkinson-like events (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NONE~ ()~~~In patient
Other Medications:
Current Illness: NONE
Preexisting Conditions: NIDDM;HTN;obesity
Allergies:
Diagnostic Lab Data: ultrasound of neck & arm NOV97
CDC Split Type: IL97113

Write-up: pt stated had no sx for 24hr p/shot;6PM following day began to have spasms in shoulder & neck & could not lift head;went to MD day 2 p/shot 7 was given muscle relaxants which did not help;blood clot;


VAERS ID: 107088 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:1997-10-23
Onset:1997-10-23
   Days after vaccination:0
Submitted: 1997-12-17
   Days after onset:55
Entered: 1998-01-30
   Days after submission:44
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES 7F81793 / 1 RA / IM

Administered by: Other       Purchased by: Public
Symptoms: Blindness, Optic neuritis, Thrombosis, Visual disturbance
SMQs:, Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Glaucoma (broad), Optic nerve disorders (narrow), Demyelination (narrow), Lens disorders (broad), Retinal disorders (broad), Ocular infections (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: MRI various medical consults
CDC Split Type: PA9804

Write-up: lost vision in rt eye;to ER dept @ mercy hosp 5PM 24OCT97;adm to hosp 25OCT97;IV steroids, dx optic neuritis;d/c on pred;vision poor;blood clot devel;tx w/eye drops;seen by MD;


VAERS ID: 114425 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: North Carolina  
Vaccinated:1998-03-17
Onset:1998-03-24
   Days after vaccination:7
Submitted: 1998-09-23
   Days after onset:182
Entered: 1998-09-28
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 2392AR / 1 - / IM A

Administered by: Other       Purchased by: Other
Symptoms: Congenital anomaly, Deep vein thrombosis, Hypertonia, Hypokinesia, Infection, Oedema peripheral, Pyrexia, Vomiting
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Congenital, familial and genetic disorders (narrow), Embolic and thrombotic events, venous (narrow), Parkinson-like events (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 19980236221

Write-up: pt recv vax & approx 12 days later 29MAR98 pt devel a deep vein thrombosis;hosp for 11 days @ the end of MAR98 & tx w/coumadin;


VAERS ID: 114759 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:1998-08-05
Onset:0000-00-00
Submitted: 1998-09-22
Entered: 1998-10-06
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TTOX: TETANUS TOXOID (NO BRAND NAME) / LEDERLE LABORATORIES - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Deep vein thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: unk
Current Illness: unk
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 898267035A

Write-up: pt recv vax & may have devel a deep vein thrombosis in the upper arm;diagnostic eval was not complete as of 22SEP98;


VAERS ID: 125184 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: North Carolina  
Vaccinated:1999-06-03
Onset:1999-06-05
   Days after vaccination:2
Submitted: 1999-06-24
   Days after onset:19
Entered: 1999-06-28
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 2544A2 / 1 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Cerebral thrombosis, Convulsion, Dehydration, Electroencephalogram abnormal, Rhinitis
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (narrow), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations: N/A~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 6/8/99 crainal ultrasound -blood flow seen in superior sagital sinus & transverse venous sinuses confirms flow in dural sinuses, 6/6/99 CT scan-nl, EEG-rt hemispheric focal sz, electrolytes-nl & cxs-neg, 6/7/99 MRI brain sinus draining,
CDC Split Type: 19990143081

Write-up: p/vax pt exp sz, apnea, & was found to have a cerebral thrombosis;pt hosp;lab test results & treatment were not specified;the reporting nurse indicated that the responsible MD did not feel the events were vaccine related;


VAERS ID: 125380 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Virginia  
Vaccinated:1999-06-10
Onset:1999-06-12
   Days after vaccination:2
Submitted: 1999-06-28
   Days after onset:16
Entered: 1999-07-07
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (FOREIGN) / MERCK & CO. INC. 0108J / 1 RL / IM

Administered by: Private       Purchased by: Private
Symptoms: Cerebral ischaemia, Cerebral thrombosis, Laboratory test abnormal, Meningitis, Thrombosis
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Noninfectious meningitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: MRI sinus thrombosis
CDC Split Type:

Write-up: Aseptic Meningitis & Thrombosis of the Superior Sagittal Sinus in Brain 2 days p/vax; Annual follow-up dated 9/22/00 provided no additional data.


VAERS ID: 128065 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:1999-06-10
Onset:1999-07-22
   Days after vaccination:42
Submitted: 1999-08-06
   Days after onset:15
Entered: 1999-09-07
   Days after submission:32
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1399H / 1 RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Ascites, Coordination abnormal, Coronary artery thrombosis, Ear pain, Encephalitis, Generalised oedema, Headache, Hypertonia, Hypokinesia, Infection, Meningitis, Myalgia, Myocarditis, Neck pain, Neuropathy, Otitis externa, Otitis media, Sepsis, Splenomegaly, Thinking abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Parkinson-like events (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1999-08-01
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MMR & Td in ''98 w/o problem; none
Current Illness: none
Preexisting Conditions: Lorabid & PCN allergies; severe ear infections, usually otitis externa, H/A for many years, controlled w/ ibuprofen; no sz hx
Allergies:
Diagnostic Lab Data: CSF-no growth p/72hr;blood culture-no growth p/48hr; CT-nl; MRI-lt mastoiditis; CSF gram stain smear-mod. segmented WBC-no organisms
CDC Split Type: PA9956

Write-up: pt seen by FMD c/o lt ear pain; dx: otitis externa;7/26 c/o lt ear pain;h/a;off balance;dx OM;tx:Bactrim DS; 7/28-severe h/a,neck pain;difficulty walking;change in mental status,+ Kernig''s sign;hosp;IV Claforan, Vanco, Acyclovir; expired 8/


VAERS ID: 128329 (history)  
Form: Version 1.0  
Age: 52.0  
Sex: Female  
Location: New Jersey  
Vaccinated:1998-10-14
Onset:1998-10-14
   Days after vaccination:0
Submitted: 1999-09-15
   Days after onset:336
Entered: 1999-09-17
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES - / 6 - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Back pain, Eye pain, Faecal incontinence, Hypokinesia, Myelitis, Neuralgia, Neuropathy, Oedema peripheral, Pain, Paraesthesia, Paralysis, Thrombosis, Tremor, Urinary incontinence, Urinary retention
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: irritable bowel syndrome
Allergies:
Diagnostic Lab Data: Doppler ultrasound-DVT (deep vein thrombosis);10/20/99 lumbar puncture,brain scan,two MRI''s
CDC Split Type: U199900673

Write-up: pt exp burning sensation eyes;pt exp lower back pain;rt leg shaky & both legs hurting;took motrin;saw MD-poss pinched nerve;med given;could not stand or void;Dx transverse myelitis;disch w/cane & catheter;legs swollen; blood clot;Dx DVT


VAERS ID: 133386 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Male  
Location: South Carolina  
Vaccinated:2000-01-03
Onset:2000-01-04
   Days after vaccination:1
Submitted: 2000-01-06
   Days after onset:2
Entered: 2000-01-20
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (NO BRAND NAME) / MICHIGAN DEPT PUB HLTH FAV031 / 5 LA / -

Administered by: Military       Purchased by: Military
Symptoms: Dermatitis exfoliative, Oedema peripheral, Thrombosis, Vasodilatation
SMQs:, Cardiac failure (broad), Severe cutaneous adverse reactions (narrow), Angioedema (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Red, swollen entire lt tricep extending up to shoulder and down arm below elbow. Some chaffing around site of injection. Tx w/ aspirin and ice. The next day it got worse w/ some blood clots around the injection site;seen in hosp for tx.


VAERS ID: 133432 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:1999-10-29
Onset:1999-11-26
   Days after vaccination:28
Submitted: 2000-01-17
   Days after onset:52
Entered: 2000-01-24
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNU-IMUNE) / PFIZER/WYETH - / UNK - / IM

Administered by: Private       Purchased by: Other
Symptoms: Haemoptysis, Pneumonia, Thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Zithromax "Pfizer" UNK
Current Illness: UNK
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: HQ0453713JAN2000

Write-up: Klebsiella Pneumonia: 11/26/99 pt coughed up copious amts of dark red blood twice. 11/27 pt hospitalized. Diag w/ bleeding Klebsiella pneumonia. Xray showed blood clot on lung. Treated w/ Ceftin (Roche). Had rxn. Treated w/ Benadryl.


VAERS ID: 150257 (history)  
Form: Version 1.0  
Age: 10.0  
Sex: Female  
Location: California  
Vaccinated:1999-01-27
Onset:1999-01-27
   Days after vaccination:0
Submitted: 2000-03-08
   Days after onset:406
Entered: 2000-03-21
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Influenza like illness, Pyrexia, Rash, Thrombocytopenic purpura, Thrombosis, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 22 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever to 104. Flu-like symptoms within 8 hours. Vomiting, dizziness and light headedness. Red small spots on the extremities (legs and hands). Plasma transfusion for 10 days. Major surgery for clot on right leg. 1/28 She was confined for disease call ITTP - Idiopathic Thrombocytophenic Thrombatic Purpura. 60 day follow-up dated 7/10/00 stated a change of age and states the pt has fully recovered. 06/16/2000 call to MD to review her app 2 prior request for this child''s record to confirm DGX. Said she will sent the records and ger shot on recent appointments with the pt. 06/20/2000 record received via fax. DGX of TTP confirmed. Case complete.


VAERS ID: 154907 (history)  
Form: Version 1.0  
Age: 51.0  
Sex: Female  
Location: California  
Vaccinated:1998-10-22
Onset:1998-10-23
   Days after vaccination:1
Submitted: 1998-12-22
   Days after onset:60
Entered: 2000-06-21
   Days after submission:546
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR 0977170 / UNK LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Venous thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: PCN, sulfa allergies.
Allergies:
Diagnostic Lab Data:
CDC Split Type: U199800726

Write-up: It was reported that a 50 year old female received Fluzone SV 98-99 USP vaccine on 10/22/1998. Reportedly on 10/24/1998 the pt developed distal vein thrombosis out left arm. Reportedly the pt recovered from this experience. From additional information received on 11/16/1998 it was reported that the date of the adverse reaction was 10/23/98 at 11:00 PM not 10/24/98 at 6:00am as previously reported.


VAERS ID: 164275 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: South Carolina  
Vaccinated:2000-11-07
Onset:2000-11-13
   Days after vaccination:6
Submitted: 2000-12-18
   Days after onset:35
Entered: 2000-12-29
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 917A2 / UNK LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR P1067AA / UNK - / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR T0025 / UNK - / SC

Administered by: Public       Purchased by: Unknown
Symptoms: Cerebral haemorrhage, Child maltreatment syndrome, Convulsion, Fungal infection, Gastrooesophageal reflux disease, Hearing impaired, Infection, Oral intake reduced, Platelet count increased, Subdural haematoma, Thrombosis, Visual disturbance
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Gastrointestinal nonspecific dysfunction (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 45 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Per F/U 8/9/01: PR-163; BP-93/63; CT scan of brain revealed trace rim of right-sided temporal extra-axial hemorrhage and subdural hematoma on 11/12/00. Platelet count-417
CDC Split Type:

Write-up: No data provided. 60 day follow-up states the pt has seizures. Discharge summary states diagnosis is shaken baby syndrome,inferior vena cava thrombus. Per F/U 8/9/01: Hypertonicity; right visual defect/deficit and Shaken Baby Syndrome resulting in seizure disorder and visual problems. Pt had PEG placed 12/00 secondary to feeding intolerance. Pt now in foster care since January. Foster mother reports steady weight gain and has not used the G-tube for about 9 weeks. After consultation, foster mother requested G-tube removal. Discharge DX: Shaken Baby Syndrome; Inferior vena cava thrombus; vision impairment; hearing impairment; reflux; S/P fungemia (Candida) and also VRE bacteremia; respiratory distress


VAERS ID: 164422 (history)  
Form: Version 1.0  
Age: 66.0  
Sex: Female  
Location: Oregon  
Vaccinated:2000-10-04
Onset:2000-10-13
   Days after vaccination:9
Submitted: 2000-10-31
   Days after onset:18
Entered: 2001-01-03
   Days after submission:64
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0045J / 1 LA / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Arterial thrombosis limb, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Embolic and thrombotic events, arterial (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: NONE
Preexisting Conditions: Vertigo; history of rheumatoid arthritis, Raynaud''s Syndrome
Allergies:
Diagnostic Lab Data: Ultrasound yielded non-occlusive clot
CDC Split Type: OR200042

Write-up: Edema in left arm, 2 weeks later. Edema in right arm, 3 weeks later. Ultrasound demonstrates non-occlusive clot left axilla, subclavian brachial vein.


VAERS ID: 167575 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: New Hampshire  
Vaccinated:2001-02-01
Onset:2001-02-01
   Days after vaccination:0
Submitted: 2001-03-16
   Days after onset:43
Entered: 2001-03-21
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1237K / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood disorder, Thrombosis
SMQs:, Haematopoietic cytopenias affecting more than one type of blood cell (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES01030309

Write-up: Information has been received from a hospital worker concerning a patient who in February 2001, was vaccinated with Pneumococcal vaccine 23 polyvalent. Subsequently the patient experienced blood clots. Unspecified medical attention was sought. No other Info was available. Upon internal review, blood clots were considered to be an Other Important Medical Event. Follow up on 06/29/2001: "Patient date of birth and age at time of vaccination is not provided."


VAERS ID: 168836 (history)  
Form: Version 1.0  
Age: 1.25  
Sex: Male  
Location: Nebraska  
Vaccinated:2001-03-28
Onset:2001-03-28
   Days after vaccination:0
Submitted: 2001-04-11
   Days after onset:13
Entered: 2001-04-18
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 96042 / 5 RL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1328J / 1 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 474728 / 2 LL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1601K / 1 RL / SC

Administered by: Private       Purchased by: Private
Symptoms: Cough, Deep vein thrombosis, Hypoxia, Neutropenia, Pyrexia, Stridor
SMQs:, Anaphylactic reaction (broad), Agranulocytosis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 12 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Blood cultures, brochioalveolar lavage with negative cultures, influenza and para influenza (-). RSV (-). Neutropenia.
CDC Split Type:

Write-up: This infant had a fever of 104 F the day of his vaccine. He then had a fever of 104 F, cough, stridorous retractions, hypoxic, requiring intubation for subglottic stenosis. 2 days after the vaccinations he was given IV antibiotics. Until cultures returned with negative results. He was found to be neutropenic. The patient developed DVT requiring anticoagulation.


VAERS ID: 169154 (history)  
Form: Version 1.0  
Age: 57.0  
Sex: Female  
Location: Maryland  
Vaccinated:1999-06-22
Onset:1999-09-01
   Days after vaccination:71
Submitted: 2001-04-24
   Days after onset:601
Entered: 2001-04-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM - / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Arthralgia, Arthritis, Bone development abnormal, Bone disorder, Deep vein thrombosis, Erythema, Inflammation, Joint range of motion decreased, Joint stiffness, Joint swelling, Muscle atrophy, Red blood cell sedimentation rate increased, Rheumatoid arthritis, Rheumatoid factor, Synostosis, Thrombosis
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Congenital, familial and genetic disorders (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prempro
Current Illness:
Preexisting Conditions: Colitis; Peptic Ulcer disease 30 to 40 years ago and had an appendectomy; Tick exposure and regulary pulled them off her skin; her mother had deformed hands bilaterally which came on as she got older.
Allergies:
Diagnostic Lab Data: ESR - 0 Result text: "inflammation". CRP - 0 Result text: "inflammation". RF - 0 Result text: positive. Joint Fluid - Result text: X3 "Showed Nothing". X-Ray (NOS) - Result text: "Inflammation". MRI - Result text: "Inflammation"; X-rays-showed bone loss; MRI-showed inflammation; 12/7/99 lab-shows ESR-37mm/hr; CBC-nml; serum protein electrophoresis-nml
CDC Split Type: 20010100921

Write-up: Report 2001010092-1 described rheumatoid arthritis and deep vein thrombosis in the leg in a 57 year old female who received Lyme disease vaccine recombinant OspA (Lymerix) for the prevention of Lyme disease. This report was received from the vaccinee''s spouse and has been verified by the PCP and medical records from a rheumatologist. The vaccinee had no known allergies. Her medical history included colitis and stomach problems (NOS) every four to five months. She received estrogens conjugated / medroxyprogesterone acetate (Prempro). ON May 25, 1999 and on June 22, 1999, the vaccinee received her 1st and 2nd doses of Lymerix, respectively. Approximately six to eight weeks after receiving the 2nd dose of Lymerix (in August or Sept 1999), the vaccinee experienced a swollen left wrist. MRI, x-ray (NOS), and labs including erythrocyte sedimentation rate and C-reactive protein were performed. The vaccinee was told that her diagnosis was "inflammation". Her left wrist remained swollen for several months. In the spring 2000, the vaccinee''s left knee swelled. The joint swelling then shifted to the right knee and then back to the left knee. Joint fluid was obtained three times. It "showed nothing" The vaccinee was seen by several physician''s and, subsequently, more lab tests were performed. Rheumatoid factor was found to be positive. At no time did any of the vaccinee''s physician''s suggest a link between her symptoms and Lymerix. In August 2000, the vaccinee developed a blood clot in the leg which was treated with warfarin sodium (Coumadin). As of 04/20/01, the joint swelling and inflammation were resolved. The outcome of the blood clot was not specified. The adverse events of "joint swelling'' and "joint inflammation" do not meet ICH serious criteria, but are being submitted as an expedited report by special FDA request per the June 28, 2000 letter. Per F/U, rheumatologist medical record of 3/21/00 states that in 9/99, while working on some stained glass, the pt noticed a "pop" and swelling in the left wrist. She has had significant pain since that time but that it has gradually progressed and she was left more with stiffness. On 5/10/01, the pt''s PCP reported that the pt''s rheumatoid arthritis began on 9/1/99, when she developed swelling and redness to the left wrist. In 11/99, the pt noticed muscle loss in the forearms. X-rays showed bone loss and MRI showed inflammation. The left hand only, pronated and supinated approx. 80 degrees. She had 20 degrees of left wrist extension and 30 degrees of flexion. The wrist was warm, swollen and tender on palpation. There was swelling over the dorsum of the left, less prominant over the volar aspect. There was significant and advanced atrophy of the left forearm musculature. Assessment: monoarthritis affecting the left wrist. The pt developed bilateral knee pain and swelling with resolution of the right knee inflammation when a physician aspirated and injected the knee with steroid (NOS). She had the left knee aspirated but not injected and it did not improve until it was aspirated again and injected with steroid (NOS). She had fallen off her bike and injuured the left wrist. The pt''s ESR was running in the 30''s to 50''s. Assessment: We are probably looking at the early onset of rhematoid arthritis. Celebres 200mg 1 twice daily orally was prescribed. At some later date, the physician prescribed hydroxychloroquine (Plaquenil). The pt telephones the physician on an unspecified date and stated that she had been having a rash where she sweated and her ankle and wrist were swollen. The physician held Plaquenil. On 8/24/00, the pt developed a deep vein thrombosis in the leg which was treated with warfarin sodium (Coumadin). This resolved in 6 months. The pt reported severe abdominal bloating and had to stop the Plaquenil. Her exam showed active synovitis in the left wrist and right knee with swelling and pain. On 2/01, Plaquenil 200mg 1 po twice daily was re-prescribed. On 4/6/01, the pt developed borderline hypertension. The PCP stated the rheumatoid arthritis was possibly related to Lymerix and also that the adverse events could be associated with PremPro therapy.


VAERS ID: 170015 (history)  
Form: Version 1.0  
Age: 57.0  
Sex: Female  
Location: Florida  
Vaccinated:2000-11-29
Onset:2000-11-30
   Days after vaccination:1
Submitted: 2001-08-16
   Days after onset:258
Entered: 2001-05-21
   Days after submission:87
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUSHIELD) / PFIZER/WYETH - / UNK - / IM

Administered by: Private       Purchased by: Other
Symptoms: Blood pressure increased, Dehydration, Hypoaesthesia, Livedo reticularis, Mononeuritis, Pain in extremity, Peroneal nerve palsy, Red blood cell sedimentation rate increased, Renal failure, Thrombosis, Type IV hypersensitivity reaction, Vasculitis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Hypertension (narrow), Vasculitis (narrow), Chronic kidney disease (narrow), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow), Immune-mediated/autoimmune disorders (narrow), Sexual dysfunction (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Dyazide, Tenormin
Current Illness: NONE
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Erythrocyte sedimentation rate-increased; C-reactive protein-increased; positive p-antineutrophil cytoplasmic antibody
CDC Split Type: HQ0890815MAY2001

Write-up: A 57 year old female reported that she received Flu-Shield (''00-''01 formula) on 11/29/00. On 11/30/00, she experienced pain and numbness in her right leg and foot. She was seen by her physician "who was more concerned about her elevated blood pressure." On 12/20/00, the pain reportedly intensified and had spread to her left leg. She was admitted to the hospital where a dx of vasculitis was made. She was treated with cyclophosphamide and was released. On 1/25/01, she developed kidney failure, dehydration and clots and was re-admitted to the hospital. She was told that a virus attacked her T-cells. She underwent a cardiac catheterization to look for clots. She was discharged; however, as of 5/14/01, she was still experiencing pain and numbness in both of her legs. Following changes were made: no other vaccines were given within 4 weeks, this event was considered life-threatening. Follow-up info received from the physician on 08/15/2001, indicated that the pt was diagnosed with mononeuritis multiplex, livedo reticularis, and foot drop. Test results revealed an elevated erythrocyte sedimentation rate, elevated C-reactive protein, and a positive p-antineutrophil cytoplasmic antibody.


VAERS ID: 170073 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: New Mexico  
Vaccinated:2000-11-28
Onset:2000-12-01
   Days after vaccination:3
Submitted: 2001-05-15
   Days after onset:164
Entered: 2001-05-22
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1806J / 1 RA / IM

Administered by: Other       Purchased by: Public
Symptoms: Anaemia, Conjunctivitis, Deep vein thrombosis, Fatigue, Glomerulonephritis, Immune system disorder, Malaise, Myalgia, Renal failure, Wegener's granulomatosis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Severe cutaneous adverse reactions (broad), Haematopoietic erythropenia (broad), Interstitial lung disease (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Eosinophilic pneumonia (broad), Vasculitis (narrow), Conjunctival disorders (narrow), Ocular infections (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

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

Write-up: This patient became ill in Dec 2000 with myalgia & fatigue after the 1st dose Hep B 11/28/00. Dose # 2 Hep B was given 01/30/01, and continued with constitutional s/sx. Had conjunctivitis 3/01 & continued follow up with local physician. On 05/08/01 was diagnosed with renal failure and subsequently with Wegener''s Granulomytosis is currently on hemodialysis and steroids. Also diagnosed with glomerulonephritis, end stage renal dx, deep vein thrombosis, anemia Per annual follow up: auto immune disease, renal failure, dialysis every 2.5 hours. Only able to go to shcool part time.


VAERS ID: 178670 (history)  
Form: Version 1.0  
Age: 44.0  
Sex: Female  
Location: Arkansas  
Vaccinated:2001-11-13
Onset:2001-11-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2001-12-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0606L / UNK LA / SC

Administered by: Other       Purchased by: Private
Symptoms: Anorexia, Colitis, Thrombosis
SMQs:, Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific inflammation (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (broad), Immune-mediated/autoimmune disorders (broad)

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

Write-up: Four days after receiving MMR pt complained of "colitis", unable to eat, no vomiting, no diarrhea but states passed bloody mucus per rectum. Seen in ER


VAERS ID: 179777 (history)  
Form: Version 1.0  
Age: 58.0  
Sex: Female  
Location: Unknown  
Vaccinated:2001-10-18
Onset:2001-10-20
   Days after vaccination:2
Submitted: 2001-12-27
   Days after onset:68
Entered: 2002-01-09
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES E06731KA / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Aneurysm, Carotid artery thrombosis, Hemiparesis
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Premarin; Flonase; Claritin
Current Illness:
Preexisting Conditions: Hysterectomy 1998; osteoarthritis of right knee; menopause; glaucoma within the last year
Allergies:
Diagnostic Lab Data:
CDC Split Type: PJP2002000010

Write-up: The pt received a flu vaccine on 11/5/99 without incidence. On 10/18/01 or 10/19/01, the pt received a Fluvirin vaccine on her deltoid muscle. Within 48 hours, 10/20/01, the pt was dx''d with a cerebral thrombosis and was admitted to a hospital. The pt experienced cerebral thrombosis, MCA with right hemiparesis and aneurysm on the left carotid artery. The pt was discharged on 10/29/01 and at the time of the report was undergoing rehabilitation therapy. The reporter has stated that the pt''s family doctor believed that there was a possible relationship with Fluvirin. The pt did not have a risk factor for stroke per her family physician. The left carotid aneurysm found on exam was a risk factor already present, although unknown. Also, the concomitant use of Premarin would have increased the pt''s risk of cardiovascular events. It is more likely that the combination of the aneurysm and the use of Premarin resulted in this event rather than the vaccination with Fluvirin. Further information regarding the other risk factors will be requested from the reporter.


VAERS ID: 181698 (history)  
Form: Version 1.0  
Age: 51.0  
Sex: Female  
Location: Rhode Island  
Vaccinated:1999-04-20
Onset:1999-05-14
   Days after vaccination:24
Submitted: 2002-10-02
   Days after onset:1237
Entered: 2002-02-26
   Days after submission:217
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / SMITHKLINE BEECHAM 120B9 / 2 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Amnesia, Arthralgia, Arthropathy, Back pain, Crohn's disease, Disturbance in attention, Gastrointestinal disorder, Infection parasitic, Injection site pain, Neck pain, Pain, Pyrexia, Serum sickness, Thrombosis, Vision blurred
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal premalignant disorders (narrow), Thrombophlebitis (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Ischaemic colitis (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Ferrous sulfate; progesterone; thyroxine sodium; vitamin E; ascorbic acid
Current Illness: UNK
Preexisting Conditions: Her family history includes four brothers w/o any thrombosis. The mother has no thromobotic history. The father has no thrombotic history but died of coronary disease at 42. Autns, uncles and grandparents include multiple individuals with heart disease in there (sic) 80s and 90s. The children are health. She does have one daughter who was some hypochdriasis. There is no history of multiple miscarriage or very earl deaths." *Follow-up on 10/10/02: Chronic sinusitis, deviated nasal septum, streee.
Allergies:
Diagnostic Lab Data: Albumin serum 2.5g/dL 7/21/99; antimitochondrial antibody <1:20 6/19/00; antinuclear antibody 1:80 7/3/00, homogeneous 7/3/00, 1:320 7/6/00; antiamoothmuscle antibody <1:20 6/4/00; antithrombin IIII 106%; erythrocyte sed rate 120mm/hr 7/1/99, 35mm/hr 6/19/00, 65mm/hr 7/6/00, 48mm/hr 7/5/01, 52mm/hr 8/23/01; G. glutamyl transferase serum 59U/L 7/1/00; HLA-B27 positive 7/6/00; hep B surface antibody positive 6/4/00, hep B surface antigen negative 6/4/00; hep C antibody negative 6/4/00; RA titer <20mm/hr 6/19/00; SGOT 47U/L 6/19/00, 82U/L 7/1/00, 63U/L 7/6/00; SGPT 97U/L 6/19/00, 134U/L 7/1/00, 83U/L 7/6/00; white blood cell count 13,800/cu mm 7/1/99. Electrocardiogram 7/22/99: normal sinus rhythm with an RSR prime conduction delay and electrocardiogram with right sided leads revealed no elevation in lead V4R. Echocardiogram 7/22/99: normal left ventricular function, moderate right ventricular dysfunction, moderate to severe tricuspid regurgitation and no evidence of aortic insufficiency, mitral regurgitation or pericardial effusion. VQ scan 7/22/99: patchy perfusion with only some segmental defects. Transesophageal echocardiogram 7/22/99: adherent thrombus in the right ventricle. There is also a significant RV dilation and RA dilation with RV hypokinesis. Esophagogastroduodenoscopy 9/30/99: erosive duodentitis at the junction between the first and second portion of the duodenum. Diffuse chronic gastritis. Normal esophagus. Total colonoscopy to the terminal ileum 9/30/99: moderately severe colitis. Severe terminal ileisis. Biopsies of antrum, gastric body, duodenum, terminal ileum, right colon, transverse colon, left colon, rectum 9/30/99: changes from the terminal ileum to left colon are consistent with chronic active IBD with involvement of the gastric antrum and possibly first portion of the duodenum. Rectim is relatively spared. No dysplasia is seen. Small bowel x-ray series with contrast 10/20/99: impression-moderate to severe abnormality of the distal 30 to 35cm of the ileum consistent with Crohn''s disease. No ulceration, stricture or fistula formation identified. Total colonoscopy to the terminal ileum 3/31/00: rectum, colon and terminal ileum were all completely healed. There were only a few areas of very subtle scarring in the signoid colon with slight distortion of the vascular pattern, but no active Crohn''s disease. No stricture. Lyme IgG western blot 7/8/00: 20, 23, 31, 24kD bands present. Lyme IgM western blot, 7/5/00: 31kD band present. Esophagogastroduodenoscopy 11/15/01: esophagus was normal. Stomach-antrum with minimal erythema, no erosioins or ulcerations. Multiple biopsies were obtained to rule out H. pylori. The gastric body, cardia and fundus were all normal. The duodenum was normal to the second protion. The previously seen inflammatory bowel disease was no longer present. Total colonoscopy to the terminal ileum 11/15/01: terminal ileum-involved with circumferential fibrin based ulcerations. There was no stricture. The proximal right colon was ulcerated with normal intervening mucose. There was slight mottling and very subtle ulcerations around the transverse colon and a few in the left colon. Rectum normal. Impression: recurrent Crohn''s disease. Biopsies of antrum, terminal ileum, random colon 11/15/01: colonic biopsies and biopsy of ileum show active chronic inflammatory bowel disease and focal ulceration in the ileum consistent with Crohn''s ileocolitis. No dysplasia is noted. *Follow-up report on 10/10/02: Folate, 3/14/02, result 14.5 ng/mL, range 2.0-16/0; Lyme IgA, EIA, 6/27/00, result <1; Lyme IgG, EIA, 6/27/00, result <1;Lyme IgM, EIA, 6/27/00, result <1; WNF antibody, 8/3/00, result Neg; Sjogren''s SS-A antibody, 8/3/00, result Neg; Sjogren''s SS-B antibody, 8/3/00, result Neg; Smith antibody, 8/3/00, result Neg; Thyroid paroxidase antibody, 2/28/02, result $g 70IU/mL, range 0-2; Vitamin B12, 3/14/02, result $g2000 pg/mL, range 150-950. Transenoptageal echocardiogram, 7/22/99: "CONCLUSION: 1) Normal left ventricular size and systolic function. 2) Right atrial and right ventricular enlargement w/right ventricle hypokinesia and mobile chrombus noted in the right ventricle. 3) Severe tricuspid regurgitation w/pulmonary hypertension." Bilateral lower extremity venous ultrasound, 7/23/99: "CONCLUSION: No evidence of venous thrombosis involving either lower extremity." CT chest, 7/23/99: "Impression: 1) moderate bilateral ploural effusions with bibasillar consolidation and smaller patchy areas of consolidation in each upper lobe. The focus in the periphery of the left upper lobe does have a somewhat rounded configuration and an evolving pulmonary infarct cannot be excluded. 2) Evidence of thrombus in the superior vena cava." MRI Chest, 7/24/99: "Impression: No evidence of thrombus or tumor w/in the superior vena cava. The right atrium and right ventricle are less well visualized, however, no filling defects are deomnstrated at these levels". MRI cardiac, 7/26/99: "Impression: There is a linear structure noted w/in the right ventricle which may correlate w/the findings seen on echocardiography. No rounded or mass-like intraventricular lesioin is seen. 2) Area of questionable thickening along the tricuspid valve. This may very well be secondary to turbulent flow, however recommend correlation w/the findings on the recently performed transesophageal echocardiogram". Transosophageal echocardiogram, 7/26/99: "Conclusion: 1) Normal left ventricular systolic function. 2) Significant right ventricular thickening of the valvular apparatus extending to the ventricular wall. The differential diagnosis includes a normal variant w/significant thickening; however, a thrombi and tumor are also in the diffrential. 3) Mild trisuspid regurgitation w/out pulmonary hypertension." CT Chest and pulmonary arteries, 7/26/99: "Impression: No evidence of thrombus w/in the great vessels. Interval increase in bilateral pulmonary infiltrates w/in the upper lobe. These could be infectious due to septic or pulmonary emboli. Bilateral effusions, larger on the left than on the right". Lyme immunoblot, 6/27/00: 18, 29, 30, 31 kD bands present. X-rays hands, 7/7/00: "Impression: Intact bilateral hand series w/out visualized abnormality by plain film assessment." Lyme IgG Wester blot, 8/3/00: "Uninterpretable. Lyme vax interference. Unable to rule out Lyme disease on vax pt''s." Lyme IgG ELISA, 10/16/01: 160 (normal <80); Lyme IgG Western blot, 10/16/01, Negative, 31 kd band present; Lyme IgM Western blot, 10/16/01, Negative, zero band present; MarDX Western Blot IgG, 10/16/01: Negative, one unspecified band present; Immenetics Western blot IgG, 10/16/01, Negative, 23, 28, 41 kd band and five unspecified bands present;
CDC Split Type: A0359781A

Write-up: The pt reportedly received Lymerix; the number of injections administered was not reported. In a Statement of Injuries, her attorney alleged that the pt "suffers from arthropathy and aches in her ankles, shoulders, neck, lower back, hips, thighs and hand joints, thrombosis, persistent headaches and low-grade fevers, blurred vision and memory loss/difficulty concentrating. (She) also suffers from a Crohn''s disease-like auto-immune syndrome manifesting itself in an inflammatory bowel disease involving the stomach, duodenum, terminal ileum and entire colon". Time to onset following immunization, treatment and outcomes of the alleged events were not reported. Mecial records from a henatogolist, dated 6/22/01, indicated that the vaccinne "has a history of multisystem complaints, both neurologic and systemic. She tells me that this is thought to be in the aftermath of a Lyme vacine. The patient''s history is as follow: In april 1999 she had an elevated sed rate, six weeks later she devleoped a clot in the right rear vetricle of her heart. She had TPA (tissue plasminogen activator) therapy. She is under the impression that the clot dissolved. She was on Heparin and coumadin for a year and half. She took herself off the coumadin. It is my impression that some physicians thought she should go off coumadin and someth thought she should remain on. The patient is seeing (an infectious disease specialist). I subsequently discussed the case with (the infectious disease specialist) and she said that she had some thromboses occurring in the aftermath of Lyme vaccine. The patient has been pregnant four times, leading to three live births and one child who died with a congential anomaly. She has never had a miscarriage or a previous clot. She is being worked up for Lyme vaccine problems, Lyme and multiple sclerosis. Her family history includes four brothers w/o any thrombosis. The mother has no thromobotic history. The father has no thrombotic history but died of coronary disease at 42. Autns, uncles and grandparents include multiple individuals with heart disease in there (sic) 80s and 90s. The children are health. She does have one daughter who was some hypochdriasis. There is no history of multiple miscarriage or very earl deaths." The vaccinee returned to the hematologist on 7/10/01. She reported "that she recently had a flare of her Lyme syndrome. She took Remicade and feels better. She is also on some ? fish tablets for three weeks. She became better shortly after she started the remicade. In reviewing her history, she appears to have a clot in her heart. There is some disagreement still regarding this point but she does not appear to have any persistent thrombus. There was a possible second clot in the SVC (superior vena cava) and pulmonary artery but this was never confirmed. This also appears to be absent at this time. These both occurred in the setting of a multisystem disease this is probably related to the Lyme vaccine I told her I believe she has a very highly provoked clot. The vaccinee returned to the hematologist on 9/14/01. She reported that she "has had a yeast infection in her throat. She was referred here with a positive antiphospholipid antibody and lupus anticoagulant. She was also known to have an elevated Factor VIII level. Of note her repeat studies in June and July showed normal lupus anticoagulant and ? anticordiolipin antibody. She tells me ''negative genetic analysis for lupus'', told her that I suspect that her thrombosis occurred in the setting of inflammation. It is alos possible that the Factor VIII is a marker of increased susceptibility to thrombosis. It is unclear whether the Factor VIII will will remain elevated. As a result of her inflammatory state or wheter it will now return to normal. She is open to a strategy of intermittent coumadin use or lovenox use. the most recent information received on 5/14/02, indicated that the thrombosis resolved in 1999. Outcomes of the other reported events were not provided. Inflammatory bowel disease and thrombosis are considered "Medically Serious". The follow up states the report describes Crohn''s disease. The medical history included chhamydia infection, microscopic hematuria, hypercholesterolemia, cervical carcinoma in situ (1978), eczema, psoriasis, fatigue, urinary frequency and incontinence, and a 30 pack-year history of tobacco use. She reportedly stopped smoking in August 1999. Testing for HLA-B27 positive; testing was also reportedly positive for HLA-DR4. Family history was significant for inflammatory bowel disease (grandmother), premature coronary artery disease (father died of myocardial infarction at age 41, family members on father''s side had premature coronary artery disease), "thromboembolic problem" of the lower extremity (grandmother), asthma (brother and grandson), and goiter (aunt). Surgical history included bilateral tubal ligation (1979), cone biopsy of the cervix, and grafting for periodontal disease. Medications at the time of immunization were not specified. Following the reported onset of Crohn''s disease, the vaccinee experienced two episodes of "flu" and hypothyroidism. The vaccinee reportedly received three injections of LYMErix. She reported different dates of immunization to different physicians. She told one infectious disease specialist that she received two injections of LYMErix in March 1999, and one in May 2000; exact dates were not provided. She told another infectious disease specialist that she received LYMErix in 3/23/99, 4/20/99 and 5/30/99. She told a rheumatologist that she received LYMErix in March 99, April 99, and March 2000; exact dates were not provided. Records from the vaccine provider, that would clarify the dates of immunization, have not been forwarded by the vaccinee''s attorney. The vaccinee presented to a gastroentarologist on 5/14/99 "with multiple GI complaints. She carried a diary and described what has transpired with her heealth status and personal problems over the past year. In 9/98 her grandson, who had moved out of her home because of poly substance abuse, was in a car accident that resulted in partial amputation of his right arm, injury to his right eye and closed head injury. THis event caused a great deal of stress in her family. She also discovered that her husband was having an affair and she finally quit her job, where she had a boss who was constantly borating her. With all this stress, she developed "irritable bowel" with twenty loose stools per day, crrampy abdominal pain and excessive gas with loud bowel sounds. She had a long list of symptoms, including loss of focus, forgetfulness, change in spousal relationship, sleeping all day, waking up in the middle of the night with excessive gas and since 9/98, she has gained fifteen pounds. In February she was started on Zithromax for nasal congestion and a sore throat. She required multiple prescriptions for antibiotics to clear this infection. When questioned about her diet, pt did admit to ingesting a great deal of dairy products. She uses chocolate, milk, cream, yougurt and cottage cheese daily, a lot of butter and ice cream once a month. When questioned about what types of food precipitate problems, each and every one contained lactose. In fact she recently prresented to an ER with a severe attack of gas and cramps following the ingestion of creamy clam chowder, prime rib, garlic mashed potatoes with some type of cream sauce and bread and butter. Medications at the time of evaluation included vitamin B, "high dose" vitamin C, iron sulfate, Lomotil prescribed at the ER, and Compazine prescribed at the ER. Physical examination revealed "hyperactive bowel sounds." The abdomen was "soft, nontender." The gastroenterologist''s impression was "new onset of crampy abdominal pain, excessive gas, and frequent diarrhea. Pt states that she has replaced meat with dairy products. The onset of her symptoms correspondes to when she made this dietary change. Recommendations: I therefore suspect tha tmost, if not all, of her symptoms are secondary to lactose intolerance. Pt was given the usual recommendations for this problem." The vaccinee presented to the local ER on 7/21/99 "with six days of chest discomfort radiating across her substernal area, through to her shoulder blades, as well as up into the left neck and ear area. This waxed and waned, did not seem to get any worse with exertion, but had been associated with diaphoresis, dyspnea and exertion, and even shortness of breath at rest. She denied any recent palpitations. She denied any recent peripheral edema. She did note a respiratory infection approximately a week prior to this and had been on Zithromax for potential bronchitis after being sent to the hospital. She denied recent fevers, chills, change in bowel or bladder. She had some nausea but no vomiting. Past medical history: hypercholesterolemai. Status post bilateral tubal ligation. The The pt was admitted to the ICR, heparinized, given aspirin. Cardiac consultation was obtained. In the early morning hours the pt''s blood pressure dropped. She had been on some IV nitroglycerin which was discontinued. She was given fluid bolutes, but with failure to respond. Cardiology came in and did a bedside echocardiogram who demonstrated significant RV dysfunction with a question fo thrombus in the right ventricle. She was given TPA. There was a substantial improvement in the pt''s cardiac function over the next 12 to 24 hrs. The pt underwent transesophageal echocardiogram which continued to suggest the presence of an abnormality in the right ventricle. CT scan of the chest raised some question of extension of abnormality into the superior vena cava and into the pulmonary artery, but follow up studies could not substantiate this finding. She was maintained on heparin and eventually changed over to Coumadin. There was also a suggestion on CT of the possibility of pneumonia and she was started on antibiotics. This ultimately turned out to be some atypical pulmonary edema, probably relating to the fluid resuscitation, and this resolved rather promptly with diuresis. The pt eventually underwent MRI scanning of the heart to try to identify what had been suggested by transesophageal echocardiogram. A cardiac MRI demonstrated a tubular structure in the right ventricle of questionable etiology. Interestingly, a lung scan that was performed shortly after the diagnosis of thrombus was of low probability. Follow up TSE demonstrated resolution of the thrombus. Chest films normalized. The pt''s prothrombin time became therapeutic and it was felt that she could be safely discharged to home on 7/30/99." She was actually discharge don 7/31/99. Discharge diagnosis were "right ventricular thrombus. Pulmonary embolus. Respiratroy insufficiency. Right ventricular abnormality of questionale etiology. Hypoalbuminemia." Discharge medications included Coumadin 5mg daily, Zithromaz 500mg for one day then 250mg dialy for four days, Augmentin 875mg twice daily for five days, Feosol 325mg twice daily for 30 days, and progesterone cream 0.25mg twice daily. The vaccinee returned to the gastroenterologist on 9/17/99 "with a chief complaint of who has turned against me." She states that hse has lost 20 pounds since the sping. She has noticed undigested french fries and oranges along with red peppers and celary in her stool, and believes she is not absorbing nutrients. Impression: weight loss with visualized food particles in stool. This suggests pancreatic maldigestion or small bowel malabsorption. Recommendations: trial of Pancrease with meals and snacks to determine if maldigestion is playing a role. D-xylose test to tell if the small bowel is absorbing properly." The vaccinee was hospitalized by the gastroenterologist on 9/30/99 to undergo endoscopy wiht small bowel biopsy and duodenal aspirate, as well as, total colonoscopy to the terminal ileum. The vaccinee "was initially seen by me several months ago and at that time, it appeared her diarrhea was secondary to lactose intolerance. It resolved on a lactose-free diet. However, subsequnetly, she was admitted to a hosptial 7/21/99 with complaints of chest pain. Mycardial infarction was ruled out and cardiac echo revealed a right ventricular thrombus. She also presented with an albumin of 2.5. Her diarrhea seems to have changed to what she describes as undigested food coming out intact. She does have some vague diffuse abdominal discomfort. At this point, the diarrhea is debilitating and she is contemplating quitting her job. I already placed her on high dose Pnacreane and it absolutely had no effect on her diarrhea. The two most likely causes would be malabsorption syndrome from small bowel disease or inflammatory bowel disease because of her high sed rate." colonoscopy revealed "moderately severe colitis. Severe terminal ileitis." Esophagogastroduodenoscopy revealed "erosive duodenitis at the junction between the first and second portion of hte duodenum. Diffuse chronic gastritis, normal esophagus." Biopsies taken fromt he gastric antrum, terminal ileum, right colon, transverse colon, and left colon were "consistent with chronic active IBD Crohn''s disease with involvement of hte gastric antrum and possibly first portion of the duodemun. Rectum is relatively spared." The gastroenterologist prescribed metronidazole 500mg three times daily, Asacci two tablets three times daily and ranitidine 150mg twice daily. On 10/20/99, a small bowel x-ray series with contrast revealed "moderate to severe abnormality of the distal 30 to 35cm of the ileum consistent iwth Crohn''s disease." The vaccinee returned to the gastroenterologist on 11/12/99. She "stated that she started the Omega-3, six per day, and since then all of her GI symptoms have completely resolved. She is now able to eat without any difficulty and is gaining weight. She does not want to consider taking any other medications because of the response she has had with the fish oil. Impression: Very extensive Crohn''s disease involving all areas of the GI tract except the esophagus. Recommendations: Increrase the Omega-3 to nine per day." The vaccinee was seen by the gastroenerologist on January 2000. "She is very pleased with the progress she has made since I strated her on systemic steroids and states that hse is currently enjoying the best quality of life compared to the past few years. On her own, she decided to take on herbal remedy to stimulate her immmune system. I looked this up in the PDR for herbal medicine and found that it has been reported to stimulate tissue necrosis factor, interleukin-1 and T cell mediated immunity. I explained to her that I palced her on steroids and Remicade to supress the immune system and that she should discontinue this herb. Upon physical examination, she had a markedly protuberant abdomen with hyperactive bowel sounds. Abdomen however was only mildy tender in the right lower quadrant. Impression: Severe Crohn''s disease involving stomach, ileum, and entire colon. The mildest area of inflammation was the colon and the pt is now having formed stool. I suspect that if she cntinues to heal at her current rate, the partial small bowel obstruction would resolve. She was again advised to avoid any high residue foods. Recommendations: Decrease Prednisone from 60mg to 30mg per day for one week, and then decrease to 30mg per day. Continue Asscol at six per day. Continue Metronidazele 500mg po tid. Continue Fibersco. Continue Coumadin. I gave her an txtensive literature search on the association between clotting disorders and inflammatory bowel disease. I told her that hse would be highest risk for clotting during the times of severre exacerbation. Because pt is having symptoms of feeling wired and is experiencing trouble sleeping, I prescribed Elonopin 0.5 to 1mg po bid. She was given Ativan when she was discharged form the hospital and is only taking it once per day and the effects are only lasting one to two hours." The vaccinee was hospitalized on 3/19/00 due to a small bowel obstruction. The gastroenterologist wrote: "initially the pt refused conventional therapy because of potential side effects and placed herself on Omega 3 fish oil, nine per day. She surpricingly did well for about three weeks, and then on Thanksgiving day, 1999, she called me with complaints of severe night sweats, abdominal pain and diarrhea. She was hospitlaized on the following day and treated iwth Remicade 5mg/kg IV. Within two weeks, she had a very positive response to therapy with almost total resolution of her diarrhea, abdodminal discomfort, night sweats and an increase in her overall sense of well being. She was on Metronidazole for a short time but this was discontinued because she could not tolerate the taste. I therrefore continued the Omega 3 fish oil and gave her Asacol at the usual dosage for Crohn''s colitis. She did fairly well until one month ago despite being on steroids at a farily high dose for over a month now, there has been absolutely no change in her abddominal girth, although her disease is heading toward remission except for a small area in the ileum which is causing obstruction. Since pt has 35cm of small bowel disease, I would like to avoid surgery if at all possible. I therefore recommended hospitalization, N.G.(nasogastric)suction, maximum dose IV steroids, IV Metronidazole and hyperalimentation." The gastroenterologist''s imprression was "small bowel obstruction secondary to Crohn''s disease involving hte terminal ileum." Colonoscopy perfomed on 3/31/00 revealed that the "rectum, colon and terminal ileum were all completely healed. There were only a few areas of very subtle scarring in the sigmoid colon with slight distortion of the vascular pattern, but no active Crohn''s disease. No stricture." The vacinee was seen by the gastroenterologist on 6/16/00. She reported that "she has had symptoms of arthritis involving her ankles and hands as well as edema around her ankles. Recent labs drawn by another physician showed that she has elevated transaminase. Hep B studies were consistent with prior negative, and the ferritin was normal. Bilirubin and alkaline phosphatase were not done. Pt did receive antoher dose of Remicade for treatment of the arthritis, thinking that the arthritis was an extra intestinal manifestation of the Crohn''s disease. She did notice some mild improvement post-infusion, which was two weeks ago. Impression: arthritic complaints with elevated transaminases. I suspect that this pt may have further extra intestinal manifestations of her Crohn''s disease such as sclerosing cholangitis or autoimmune hepatitis." On 7/11/00, the gastroenterolgoist wrote that Remicade "did not seem to have such benefit" with regard to the arthritic symptoms. The vaccinee "has since performed a search on the internet and found that she received a particular Lyme vaccine, which has caused reactions in multiple pts. Impression: Inflammatory bowel disease. Pt''s symptoms had their onset very shortly after she received this Lyme vaccine. I have never seen Crohn''s disease severe and extensive as hers resolve so quickly and it is also unusual for a pt who has inflammatory bowel disease in remission to experience a flare-up of arthritis. I suspect that her suspicion may be true in that she is having a serum sickness-like illness secondary to this immunization." The vaccinee was seen by a rheumatologist on 7/6/00 "in consultation for a multi-systemic autoimmune disease." At this evaluation, the vaccinee reported that she "was in excellent health until after beginning to receive her LYMErix vaccinations which were given in March 1999, April 1999 and March 2000." She reported that "in mid-April 2000 she began noticing pain and swelling in her fingers, palms of her hands, legs, soles of feet traveling to her knee. She had been given least Remicade infusion on 6/3/00 which did not help her musculoskeletal symptoms. Her GI symptoms have remained quiscent had this Remicade infusion was only given for the musculoskeletal symptpoms. She had also noticed increased stiffness. Her recent beginning of Celebrex has helped her a great deal with these symptoms. She also ntoes that she has had LFT abnormalities which a physician confirmed on transaminase elevations to approximately 100 with a negative workup thus far." On physical examination, there was "no active synovitis, no sausage digits, no psoriasis, but enthesitis in her finger tendons as well as Achilles tendons bilaterally and for a nail pit line in the same plac ein her nails of all her fingers." The rheumatologist''s impression was "her problems fall into five categories: Crohn''s disease which in presently inactive and will be treated by GI. Her enthesitis which can certainly be seen with seronegative spondyloarthropathy but she presently does not have frank arthritis. her episode of thrombosis for which she is on Coumadin. The etiology is unclear a tthis time. Her series of LYMErix vaccines. It is unclear whether this is causal either solely or as an environmental trigger. Certainly, there is a very good time relationship; however, the pt also has a family history of ulcerative colitis/inflammatory bowel disease. Perhaps molecular mimicry may be playing a role here. I have discussed with the pt that I will not be able to establish a causal or noncausal relationship but wil try to help her with the condition she has. Her LFT abnormalities." Lab analyses revealed antinuclear antibody titer of 1:320, anticardiolipin IgM titer of 1:32, aspartate aminotransferase 63, alanine aminotransferase 83, hematocrit 33%, and erythrocyte sedimentation rate 65mm/hr. HLA typing revealed HLA-B27. On 8/3/00, the rheumatologist noted that the vaccinee "believes that her Lyme vaccine is the causal element in her problems. She reports feeling better both physically and mentally. She saw an infectious disease specialist in early July who, as per the vaccinee, tested her for Lyme and told her that his results showed that she had Lyme previous to the vaccine and this is why she had these problems." The vaccinee was seen by an infectious disease specialist on 7/8/00, who noted that "from 1991 to 1995 she did research in the field on deer populations in India. She received her first Lyme injection on March 23, 1999, within a week she had problems with feeling like her legs were buckling, there was no real pain and she had some fatigue. After a second injection on 4/20/99, she developed some headaches, some confusion, some blurry eyes, fatigue became worse. She quit work, she developed SOB. She was evaluated and hospitalized for three weeks in July for an apparrent clot in her heart. She had a sedimentation rate of 120. In March of this year she developed some severe diarrhea, had evaluation and was told that she had Crohn''s disease of her bowel and her stomach. She received a third injection of Lyme vaccine on May 30th with worsening of her symptoms thereafter. She has fatigue, aches in her ankles, her shoulders, her neck, her lower back, her hips, her thighs, thumbs, MP joints of her ifngers, burning in the soles of her feet and on the palms of her hand, headaches, low grade fevers over the past year, a lot of sweating, blurriness of her eyes, some jaw and tooth pains, some twitches over the past year along with a balance problem, labored breathing, heart fluttering and pounding, urinary frequency, mentall concentration fogginess, memory issues." On physical examination, "her extremities are without edema. She has good ROM. She has slight swelling of both knees a Lyme vaccine induced reactivation of latent Lyme disease. We will start her on a therapeutic trial of Clarithromycin 500mg bid and hydroxychloroquine 200mg bid. We will do this over a three month period of time and evaluate her progress at that time." The vaccinee''s gastroenterologist prescribed physical therapy. In a letter to the gastroenterologist, dated 7/20/00, the physical therapist wrote, "Your pt came in for evaluation on 7/19/00. She has a new diagnosis with symptoms in her hands and feet. She requested tratment for these symtpoms and wanted to defer treatment of piriformis syndrome at this time. Your prescription was for treatment of piroformis syndrome. Pt decided to not proceed with evaluation until she spoke with her other physician." The vaccinee returned to the infectious disease specialist on 11/18/00. He noted that a western blot showed an IgM reaction to the 31kD protein and an IgG reaction to the 20, 23, 31, and 34 kD proteins. The reaction to the 23 and 34 kD proteins documenting prior exposure to the Lyme bacteria and the IgM reaction against the 31 kD protein consistent with ongoing active disease. She had an MRI of her brain in October that shown numerous scattered foci of what matter signals, hyperintensity involving the posterior frontal and parietal lobes, the right occipital region, medial inferior left temporal and the left brachium pontus. This is consistent with what can be seen in Lyme disease. We started her on a combination of Plaquenil and Biaxin and on this treatment she feels that she improved to about 50% of more. She is teaching again, tires easily. She is maintaining an active exercise program. She has balance problems and weakness problems, some word searching and memory issues. Visual and auditory symptomatology are 40% worse. She was a couple of rheumatologist who felt that these symptoms were nonspecific and not to be taken seriously. She does recall that in the summer of 1998 she had episodes of fatigue and urinary frequency and incontinence that were unexplained and did abate after she had the vaccine. My impression is that she is improving. We changed her over to Tetracycline 500mg tid. The vaccinee was seen by the gastroenterologist on 1/19/01. Medications included Coumadin 4.5mg daily, tetracycline 500mg three times daily, Celebrex 200mg daily, omega 3 fish oil, and Klonopin 1mg daily at bedtime. "She states that she has been haivng very severe muscle spasm involving her neck, biceps, and proximal thighs, she has been in contact with the FDA several times and they have stated that there have been approximately 1700 pts with similar problems who received the Lyme vaccine. Pt does describe having a pain down the back of her legs which tends to be worse when she is on her feet and the end of the day or in bed. She is loosing strength in both hands. Upon physical examination, pt seems to have improved compared to previous office visits. She does have severe posterior neck muscle spasm bilateraly involving the trapetius and paraspinal muscles. There is some atrophy of the thenar eminence of both hands. Grip strength is decreased bilaterally. There is tenderness to palpation over the right biceps tendon. Upon examination, I was able to reproduce the aciatica by stretching the piriformis muscle, indicating that she does have piriformis syndrome. Impression: I suspect that pt''s inflammatory bowel disease as well as her arthritic muscle problem is probably secondary to receiving Lyme vaccine. She might have had active Lyme disease at the time of the vaccination or that the Lyme disease vaccine cross-reacted to Chlamydia. She states that she has a history of having Chlamydia infection. The FDA told her that some pts with a history of Chlamydia had an adverse reaction to the vaccine. Recommendations: continue Omega 3 to prevent recurrence of inflammatory bowel disease. Referral to physical therapy for evaluation and treatment of muscle complaints. Pt will also be evaluated and treated for the piriformis syndrome." The vaccinee presented for physical therapy evaluation on 1/31/01. At that time, the vaccinee reported that she was working full time. She reported that in "May 2000 72 hrs paralyzed, falling three to four times per week-five to six times per day, fell while cycling. September-began stationary cycle, treadmill, changed jobs-multiple aches, pains, fatigue, decreased energy, memory deficits and problems with proprioception and kinesthesia." Her symptoms were relieved by rest and she went to bed nightly by 15:30. She was to undergo physical therapy twice per week for six to eight weeks. On 2/20/01, the pt stated to the physical therapist, "Those exercises are too much two times per day-I''m doing them for 1.5 hours. Pt inappropriately asking for disability rating in waiting room. Sitting and refusing PT exercises. Home exercise program only consists of stretches-never added strength to HEP. Therefore, pt performing exercises without direction." The vaccinee reported "Left UE paresthesia-relieved with proper posture." On 3/1/01, the vaccinee was discharged from physical therapy to home exercise and pool programs. The vaccinee returned to the infectious disease specialist on 2/3/01. "She has been taking Tetracycline for the last three months with no overall change as far as she can tell. She started some physical therapy, which is helping with some of her symptoms. She has gained some weight on the Tetracycline, has had a second episode of flu this month. She continues to have some pins and needles and pains in her arms, her hips are achy, continus pain in her arms, her neck and her back. With the Tetracycline she got some worsening, then some better and then some worsening. She appears to be going in streaks of one to two weeks each. Mental concentration is poor. She has had some crying, some limping. Her energy remains low. She feels that she is exhausted. Her hair has stopped falling out. My impression is that she continues to have chronic Lyme disease symptomatology. We may be turning the corner with the medication but after this next month of Tetracycline, we will change her back to the Plaquenil and Biaxin for another three to four months. I have also given her some Amantadine to try to boost the activity of the Tetracycline and to prevent or treat any influenza exposure that she has." The vaccinee was seen by a second infectious disease specialist who "is a specialist in chronic fatigue and immune disorders." In an office note dated 4/20/01, the specialist wrote, "I have been asked to evaluate the pt for Lyme disease. The pt believes that her problems began in March 1998. At that time, she was given the first shot of the Lyme vaccine. Within a few days, she was hospitalized with severe dehydration, sweats, gaastrointestinal pain, weakness and other complaints. The cause of this illness was at that time unknown. She developed some bladder control problems and was unable to exercise. In March 1999, she was given the second shot of the Lyme vaccine. Very shortly after the second shot, she was found to have a clot in her right ventricle. She was in the ICU for three weeks. After discharge from the hospital, having developed severe gastrointestinal symptoms, she was referred to a gastroenterologist. It was thought that she had Crohn''s disease. It was not thought to be typical Crohn''s however, she was treated with remicade, Asacol and prednisone. She was proposed as a candidate for GI surgery but it was noted that all of the ulceration and other GI problems had cleared. Howwever, she was left feeling very weak over the winter of 1999-2000, she had multiple hospitalizations because of the GI symptoms. She had the third shot of the Lyme vaccine in 5/00. In June, she noted that she was so weak that she was literally unable to walk. She developed a severe arthritic condition and had some elevated liver enzymes. It was also thought that she might have developed MS but this was ruled out. The pt said that she developed extremely poor special abilities such that she would reach for something and miss it or try to take a step and miss the step. She was searching for words and searching for ideas. She also noted some atrophy of the muscles in her hand. She would typically fall over when she would try to get up from a chair. She found it hard to walk and hard to do stairs. An MRI of the head showed le


VAERS ID: 182807 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2001-12-17
Onset:2002-01-01
   Days after vaccination:15
Submitted: 2002-03-15
   Days after onset:73
Entered: 2002-03-26
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUSHIELD) / PFIZER/WYETH 4018043 / UNK LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Back pain, Deep vein thrombosis, Difficulty in walking, Guillain-Barre syndrome, Paralysis, Pulmonary embolism
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, venous (narrow), Parkinson-like events (broad), Thrombophlebitis (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 65 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: UNK
Current Illness: NONE
Preexisting Conditions: Penicillin allergy, coronary artery disease, spinal stenosis
Allergies:
Diagnostic Lab Data: Diagnostic testing; plasmapheresis; IG; Cellsept
CDC Split Type:

Write-up: The pt had lower back pain, difficulty walking and weight bearing. He did not have further complaints per daughter. Dx''d by Neurologist with Guillain-Barre Syndrome. The discharge summary states deep vein thrombosis, pulmonary embolism, and quadraparesis. A 60-day follow up report received 6/26/2003 adds: His muscles are approximately 80% of what they were before his 7 month hospitalization.


VAERS ID: 186195 (history)  
Form: Version 1.0  
Age: 27.0  
Sex: Male  
Location: California  
Vaccinated:2000-02-12
Onset:2000-02-17
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2002-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV024 / 1 RA / -
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Military       Purchased by: Military
Symptoms: Deep vein thrombosis, Fatigue, Oedema peripheral, Pharyngolaryngeal pain, Sinusitis, Sleep apnoea syndrome, Somnolence, Subcutaneous nodule
SMQs:, Cardiac failure (broad), Angioedema (broad), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypoglycaemia (broad)

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

Write-up: History of present illness. Deep vein thrombophlebitis-pt states in he is still experiencing feeling of "fullness" and epriodic soreness and swelling in his left leg, especially when lying down. He occasionally takes Tylenol for pain but "tries to stay away from anything that will interfere with the Coumadin." Currently his INRs are between 2.6-2.8 on 12.5 mg f Coumadin/day. He takes no other medications. Pulmonary 6mm right upper lobe nodule and an 8mm pleural parenchymal scar. CT scan 04/12/01, 04/19/99-chest X-ray, PA and lateral-normal chest; chest PA 02/17/1998, WNL, no active disease. He is in the process of seeking follow-up care with a Pulmonologist for possible PEP scan. He has an appointment scheduled 04/24/2002. Chronic fatigue onset temporally associated with anthrax vaccination: he sleeps poorly, "I toss and turn all night-watching the clock" averaging 1-3 hrs of sleep after going to bed between 10-11pm. Feels tired all the time. Sleep studies conducted on 3/17 & 3/18/02 were positive for sleep apnea with severe daytime drowsiness. A CPAP mask was recommended with a 2nd study to assess results during napping in 4-6 weeks. Sinusitis: he has daily problems with congestion, PND and sore throat "almost every day I have a sore throat" says he has been told that he may need t have his tonsils and adenoids removed. CT scan of sinuses without IV contrast on 04/11/01 was negative.


VAERS ID: 193298 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Female  
Location: Oregon  
Vaccinated:2002-10-16
Onset:2002-10-21
   Days after vaccination:5
Submitted: 2002-11-06
   Days after onset:16
Entered: 2002-11-15
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0968AA / 3 LA / -
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 1 RA / -

Administered by: Private       Purchased by: Other
Symptoms: Asthenia, Asthma, Deep vein thrombosis, Dehydration, Diarrhoea, Ecchymosis, Fall, Influenza, Laboratory test abnormal, Nausea, Pneumonia, Rash, Respiratory distress, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Asthma/bronchospasm (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: hypertension, hyperlipidemia, hypothyroid, COPD, Alcoholism, Allergy, Malnutrition, Edema, tobacco abuse,
Allergies:
Diagnostic Lab Data: abnorm chest film, Labs abnormal
CDC Split Type:

Write-up: Pt had flu shot on 10/16/02 then had nausea/vomiting, diarrhea, feeling weak. Apparently collapsed in apt-found down post three days. Was treated in ICU for pneumonia. Also weak in LE (but reflexes present). Still recovering. Nurse follow up on 07/21/04 states: "Aspiration, DVT rt upper ext, Mental status change, Bronchospasm, Rash, flu reaction, dehydration, ecchymosis,


VAERS ID: 194982 (history)  
Form: Version 1.0  
Age: 50.0  
Sex: Male  
Location: New York  
Vaccinated:2002-11-07
Onset:2002-12-07
   Days after vaccination:30
Submitted: 2002-12-10
   Days after onset:3
Entered: 2002-12-16
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES E32072GA / 4 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Anaemia, Deep vein thrombosis, Hyperglycaemia, Myelitis transverse, Paralysis, Thrombocytopenia, Urinary retention, Urinary tract infection
SMQs:, Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: Mental Retardation
Allergies:
Diagnostic Lab Data: CT scan/MRI spine/LP Medical records state decreased plateletts, anemia, hyperglycemia. msv
CDC Split Type:

Write-up: Dx transverse meylitis 12/7/02. Sudden onset. Etiology not known. Received two flu vaccines 10/08/2002, 11/07/2002. 60 day follow up states pt has not recovered. Transverse myelitis- no change in symptoms. The annual follow up received on 1/13/04 states persistent paralysis. Discharge summary states deep vein thrombosis. msv Medical records state anemia, urinary retention, urinary infection. msv


VAERS ID: 195749 (history)  
Form: Version 1.0  
Age: 0.67  
Sex: Male  
Location: Iowa  
Vaccinated:2002-11-07
Onset:2002-11-11
   Days after vaccination:4
Submitted: 2002-12-02
   Days after onset:21
Entered: 2003-01-03
   Days after submission:32
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0946AA / 1 RL / -

Administered by: Public       Purchased by: Public
Symptoms: Paralysis, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: MRI x2; Echocardiogram EKG''s x2; Numerous blood tests.
CDC Split Type: IL02067

Write-up: Paralysis affecting left arm, leg and facial features. Hospitalized after Dr''s office visit on 11/11/02. Parents told two blood clots in brain. Treatment-physical therapy one baby aspirin daily. Diagnosed with opening between atria of heart. Being treated for mitochondrial defect and blood clotting disorders. In process of recovery. On 60-day followup report received 04/25/2003, reporter states, "Patient was tested at facility after Vx and they found a hole in his heart and said it was not Vx-related. Pt is going back to facility in 5 months to see if hole in heart has closed." Annual follow up on 04/21/04: "Pt has recovered from adverse event."


VAERS ID: 200721 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Male  
Location: Virginia  
Vaccinated:2002-12-11
Onset:2002-12-22
   Days after vaccination:11
Submitted: 2003-03-24
   Days after onset:92
Entered: 2003-04-02
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0938AA / UNK RA / IM

Administered by: Other       Purchased by: Private
Symptoms: Asthenia, Chills, Coma, Convulsion, Deep vein thrombosis, Dizziness, Encephalitis, Laboratory test abnormal, Loss of consciousness, Myalgia, Psychotic disorder, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (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), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Mental changes
Allergies:
Diagnostic Lab Data: Patient states diagnosis of Right sided encephalitis; subsequent LLE DVT. Labs abnormal.
CDC Split Type:

Write-up: Pt states dx of rt. sided encephalitis; subsequent LLE DVT. 12/11/03 received flu immunization at workplace setting. Note: MD remembers this as being given on 12/18/02. Our consent form and clinic tracking records all clearly state 12/11/02. MD states he felt he "had a kind of a cold" several days prior to the clinic, as well as on the day of the clinic. Denies any fever or congestion, but did have a sore throat and blocked nose. States he has a history of frequent colds. After screening, the nurse told him it was appropriate to have the immunization. 12/19/03 developed a fever. Did not take temperature, but felt hot. Self-treated with Tylenol. Note: MD feels this was actually one day after he received the immunization. 12/22/03 developed "shivering hands," fell down/collapsed. Also complained of feeling dizzy and having a fever. Drove to urgent care center for treatment, transferred to hospital. Was in a coma for the next seven days; eventually diagnosed with encephalitis on the right side of the brain. Hospitalized for total of 9 days. One week post-discharge, readmitted to hospital for left lower leg DVT. Hospitalized for total of 10 days. Post-hospitalization required a month of home physical therapy to regain strength in left leg. Was on coumadin therapy, but switched to heparin injections on 3/20/03. Leg remains swollen and is unable to walk long distances. Has returned to work but has decreased stamina. The discharge summary received on 1/2/04 states chills, weakness, seizure, psychosis.


VAERS ID: 201572 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: New York  
Vaccinated:2002-12-01
Onset:2002-12-01
   Days after vaccination:0
Submitted: 2003-04-04
   Days after onset:124
Entered: 2003-04-16
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C0813AA / 2 LL / IM
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES UA758AF / 2 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. W013 / 2 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 490532 / 2 RL / IM

Administered by: Private       Purchased by: Private
Symptoms: Aneurysm, Arterial thrombosis, Diarrhoea, Kawasaki's disease, Laboratory test abnormal, Oedema peripheral, Pyrexia, Splenomegaly, Vomiting
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vasculitis (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Echo positive for aneurysms of coronary artery; Others in hospital charts.
CDC Split Type:

Write-up: Baby started vomiting and diarrhea and fever 1st week. effected by swelling of hands, feet, reports splenomegaly, fever resolved. Admitted to med center. Dx Kawasaki, + coronary aneurysm, fever not responding to IgG x 4 courses, steroids and eventually ? in 1 month. Discharged with aneurysm readmitted for thrombus treated at hospital. A follow up report received 6/30/2003 adds: Coronary aneurysm still persists at 8mm diameter. Follow up in 2004: No information reported. Huge coronary aneurysms still persists. Under cardiologists care. On Aspirin & Coumadin, check INR of monthly.


VAERS ID: 202501 (history)  
Form: Version 1.0  
Age: 42.0  
Sex: Female  
Location: Texas  
Vaccinated:2003-03-12
Onset:2003-04-16
   Days after vaccination:35
Submitted: 2003-05-01
   Days after onset:15
Entered: 2003-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020077 / 2 LA / ID

Administered by: Other       Purchased by: Public
Symptoms: Chest pain, Embolism, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: PRE-EXISTING HEART DISEASE, HX HTN
Allergies:
Diagnostic Lab Data: EKG, lab work, stress test
CDC Split Type:

Write-up: Pt began to experience chest pain at work on 04-16-2003 and drove to the ER where she consulted her cardiac specialist. She was hospitalized, an EKG and stress test were performed. No heart inflammation or damage noted, diagnosis was blood clot that traveled to her heart. She was put on blood thinners and kept for observation for two day. She was homebound for 8 days after release. No further complications noted. Dr. stated that he did not believe smallpox vaccination was the cause nor had any adverse effect to cause this incident.


VAERS ID: 203186 (history)  
Form: Version 1.0  
Age: 39.0  
Sex: Male  
Location: New York  
Vaccinated:2003-03-05
Onset:2003-04-06
   Days after vaccination:32
Submitted: 2003-05-15
   Days after onset:38
Entered: 2003-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS - / 1 - / -
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020071 / UNK - / -

Administered by: Military       Purchased by: Military
Symptoms: Cardiovascular disorder, Deep vein thrombosis, Muscle spasms, Pulmonary embolism, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Dystonia (broad), Thrombophlebitis (broad), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2003-04-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Aspirin?
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Heterozygous for Factor V Leiden mutation R506Q, indicating 3-6-fold increase in risk for vein thrombosis.
CDC Split Type:

Write-up: Deep-vein thrombosis of L lower extremity, leading to multiple pulmonary thromboemboli with near complete occlusion of L pulmonary artery. Dilated, tortuous deep veins of both lower extremities. Hypertensive atherosclerotic cardiovascular disease. Preliminary Autopsy Report: Cause of death: Pulmonary Thromboembolism due to DVT. Manner: Natural. Autopsy performed 10 Apr 03. Reports will be faxed. News article, dated 7 Apr 03, asserts "Three days ago, patient had complained of cramps behind his knee. Like most of us journalists "embedded" in the military, he had endured days and nights of working, eating, and sleeping in our vehicles as convoys snaked their way around. He consulted military doctors and described his symptoms over the phone to overseas physicians. They suspected DVT, or deep veinous thrombosis, and advised him to seek proper medical attention. He ignored their advice, swallowed some aspirins, and kept on working."


VAERS ID: 206162 (history)  
Form: Version 1.0  
Age: 29.0  
Sex: Female  
Location: Missouri  
Vaccinated:2003-06-17
Onset:2003-06-17
   Days after vaccination:0
Submitted: 2003-07-02
   Days after onset:15
Entered: 2003-07-14
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 765B6 / 1 LA / -

Administered by: Other       Purchased by: Private
Symptoms: Contusion, Fatigue, Hepatic enzyme abnormal, Nausea, Thrombosis
SMQs:, Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Complained of feeling nauseated and tired evening of vaccination. Bruising behind knee-went to MD with diagnosis: down pepliteal pulse/blood clot. Prescribed 6 Asprin x 2 days and sent home with bedrest. Liver enzymes up. All resolved by Monday (2 days later).


VAERS ID: 211160 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Male  
Location: Washington  
Vaccinated:2002-10-22
Onset:2003-09-29
   Days after vaccination:342
Submitted: 0000-00-00
Entered: 2003-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac failure, Coma, Condition aggravated, Deep vein thrombosis, Fluid overload, Mental impairment, Pulse absent
SMQs:, Cardiac failure (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-10-01
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: RSV/Placebo, Allopurinol, Atenolol, Furosemide, Simvastatin, ASA, insulin, Mirtazapine, Doss, Loperamide, Simethicone
Current Illness:
Preexisting Conditions: DM, CHF, CAD, PVD, gout, UTI (recurrent). Above the knee amputation
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302676

Write-up: This subject is a 69 year old male who died while enrolled in RSV11 S & I study with RSV vaccine. The subject received RSV vaccine or Placebo and influenza vaccine on 10/22/02. The subject died 342 days post immunization on 10/01/2003. Subject was admitted on 9/29/03. He was transferred from ICU post AKA for decrease MS and possible CHF exacerbation. He was volume overloaded on admission and IV diuresis was started. Pt showed bilateral DVT''s and was placed on Heparin and then Lovenox the same day. He remained stable until October 1, 2003 in the evening when he was found unresponsive and pulseless. Subject expired more than 30 minutes of unsuccessful resuscitation. Diagnosis: DVT with presumed PE, cardiopulmonary failure secondary to DVT, CHF exacerbation, DM, GRI, and altered MS. The death was reported by the investigator as not related to the study vaccine. Follow up on 11/26/03: "Initial SAE report received on 10/22/03. This subject is a 69 year old male who died while enrolled in RSV11 S & I study with RSV vaccine. The subject received RSV vaccine or Placebo and Influenza vaccine on 10/22/02. The subject died 342 days post immunization on 10/01/2003. Subject was admitted on 09/29/03. He was transferred from ICU post AKA for decreased MS and possible CHF exacerbation. He was volume overloaded on admission and IV diuresis was started. Patient showed bilateral DVT''s and was placed on Heparin and then Lovenox the same day. He remained stable until 10/01/03 in the evening when he was found unresponsive and pulseless. Subject expired after more than 30 minutes of unsuccessful resuscitation. Diagnosis: 1) DVT with presumed PE. 2) Cardiopulmonary failure secondary to #1. 3) CHF exacerbation. 4) DM. 5) GRI. 6) Altered MS. The death was reported by the Investigator was not related to the study vaccine. Additional information received 11/18/03. Death certificate: Cause of death: Pulmonary Embolism due to deep vein thrombosis due to congestive heart failure. The pulmonary embolism secondary to deep vein thrombosis secondary to congestive heart failure was reported by the investigator as not related to the study vaccine."


VAERS ID: 211715 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Male  
Location: California  
Vaccinated:2003-08-22
Onset:2003-08-24
   Days after vaccination:2
Submitted: 2003-11-04
   Days after onset:72
Entered: 2003-11-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / SANOFI PASTEUR U0837AA / UNK - / -

Administered by: Public       Purchased by: Other
Symptoms: Cerebral haematoma, Coordination abnormal, Dizziness, Headache, Laboratory test abnormal, Pyrexia, Rash, Sinusitis, Thrombosis, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 24 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Multiple including CT scans showing above findings. Sinus fluid CS.
CDC Split Type:

Write-up: Patient was admitted to hospital 8/28/03 - 9/20/03 for sinusitis, sagittal sinus thrombosis and right frontal cerebral hematoma with infarct with symptoms of fever, headache and emesis starting 5 days prior to admission. Temporally related to Td immunization. Required oriniectomy and partial right frontal lobectomy.


VAERS ID: 212051 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Pennsylvania  
Vaccinated:2003-09-03
Onset:2003-09-04
   Days after vaccination:1
Submitted: 2003-10-31
   Days after onset:57
Entered: 2003-11-11
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1197M / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Pain, Swelling, Thrombosis
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Lupus; Beta thalassemia; Sickle cell trait
Allergies:
Diagnostic Lab Data: Ultrasound left upper extremity - left bascilic vein clot.
CDC Split Type:

Write-up: Patient received Pneumovax injection on 9/3/03. Returned to PCP office 9/4/03. Complaints of left upper arm pain and swelling. LUE ultrasound showed left bascilic vein clot. Patient admitted to hospital; started on Heparin and Coumadin. Discharged from hospital 9/5/03 on Coumadin.


VAERS ID: 212174 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:1991-05-15
Onset:1991-05-15
   Days after vaccination:0
Submitted: 2003-11-11
   Days after onset:4563
Entered: 2003-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS ? / UNK UN / -

Administered by: Military       Purchased by: Military
Symptoms: Anaphylactic shock, Arthralgia, Arthropathy, Coagulopathy, Deep vein thrombosis, Ecchymosis, Injury, Oedema, Skin ulcer
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 45 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness: None
Preexisting Conditions: hay fever when younger
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: immediate lesion at injection site on arm, followed by lesion on left foot following day which lasted hours and prevented me to put on boot and train that day in boot camp. Heard the DI''s state that they "were glad not to be getting these shots" lesions continued througout bootcamp progressively getting more frequent predominately on legs. After completion of boot camp my DI pulled me aside to address his concerns for the reaction I had due to innoculations. I continued on in the military and so did the lesions and I have had numerous visits to base clinics for the lesions. After leaving the military, I continued the lesions which were leaving no area of my body untouched and went to numerous hospitals both emergency and non with no understanding of what the lesions were. I also had a major change in that I developed anaphalytic shock to expectorants in cold medicine (I attribute this to the major disturbances in my body due to reaction to vaccine(s)) I did in approx 93 go to the hospital to make a claim for the lesions and the hospital did say they were service-connected but not compensatable. I continued to work for the next few years until 95 when I developed dvt in my left leg in my return vein to my heart and also is the time my lesions completly disappeared ( the lesions were so detrimental physically and mentally and I thought this sickness was killing me and probably was but I was actually relieved when I got to the hospital even with the blood clot?? So basically now I have an incompetent venous system and a blocked stent and recurring ulcers on left foot which I currently do have an open ulcer that won''t heal and am currently applying for SSD benefits and reopened my VA claim with these current health problems. I feel and have felt the need to report this years ago but have been reluctant to do so because of lack of supporting evidence but now with all the stories of sickness and death or the GWS of which I am on the gulf war registry? I see too many parallels to myself through others who have determined or have been determined to have suffered reactions to the vaccines. Thank You. The discharge summary received on 3/30/04 states diagnosis of deep vein thrombosis confirmed. Add hypercoagulation syndrome, edema of left extremity, accidental electric shock, pain L ankle, stiffness L ankle and ecchymosis L leg.


VAERS ID: 212314 (history)  
Form: Version 1.0  
Age: 31.0  
Sex: Female  
Location: Texas  
Vaccinated:2003-04-16
Onset:2003-04-21
   Days after vaccination:5
Submitted: 2003-11-13
   Days after onset:206
Entered: 2003-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS UNKNOWN / 2 RA / SC

Administered by: Military       Purchased by: Military
Symptoms: Cellulitis, Deep vein thrombosis, Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: redness, swelling of vaccination site right arm
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Ultrasound, venogram, PT, PTT
CDC Split Type:

Write-up: Patient developed a large local reaction of the right arm following anthrax vaccinations in April 2003. Redness, pain and swelling persisted x 6-7 weeks. On 7 June, she was re-evaluated for ongoing symptoms and was diagnosed with a DVT in the right subclavian vein. The medical record received on 2/24/04 confirms diagnosis of deep vein thrombosis. Also states cellulitis of right antecubital fossa. 60-day follow up on 02/10/04: "Pt has recovered from adverse events."


VAERS ID: 213043 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Female  
Location: Ohio  
Vaccinated:2000-10-08
Onset:2003-10-12
   Days after vaccination:1099
Submitted: 2003-11-25
   Days after onset:44
Entered: 2003-11-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Contusion, Infection, Pyrexia, Thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Accidents and injuries (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Patient had been in good health previously, except for some ear infections, and tympanostomy tubes 8/2003. Seemed to be fine the day of the vacination 10/08/03. Four days later she had a fever of 103 and small old bruises on her shins tripled and quadrupled in size. The next day she was seen in pediatric office by the doctor who saw blood clots in her ears by tympanostomy tubes but no ear infection. A platelet count was done and the results were normal however she developed another bruise under her eye where she was rubbing it because she was crying during the blood draw


VAERS ID: 213876 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Male  
Location: California  
Vaccinated:2002-10-22
Onset:2003-09-23
   Days after vaccination:336
Submitted: 0000-00-00
Entered: 2003-12-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Atrial fibrillation, Bacterial infection, Deep vein thrombosis, Infection, Leukopenia, Muscular weakness, Neutropenia, Pneumonia, Pulmonary haemorrhage, Renal failure, Respiratory failure, Thrombocytopenia, Vasculitis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Agranulocytosis (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Vasculitis (narrow), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-10-08
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 15 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: RSV/Placebo; tRinalin; Seravent; Aeobid; Glucophage; Glucotrol; Lipitor; Digoxin; Zestril; Aldacton; Lasix;
Current Illness:
Preexisting Conditions: Emphysema, asthma, CHF, HTN, COPD, chronic bronchitis; Endstate renal failure, Vaculitis;
Allergies:
Diagnostic Lab Data: Aspergillus infection; thrombocytopenia and leukopenia
CDC Split Type: 200303297

Write-up: The subject is a 78 year old male who was admitted to the hospital due to respiratory failure, lower extremity weakness and died while enrolled in RSV11 study. The study received RSV vaccine or Placebo and influenza vaccine on 10/22/02. The subject developed lower extremity weakness with SOB 336 days post immunization and was admitted to the hospital on 9/23/03. He was found to have a large syrinx (syringomyelia) in the thoracic spinal cord probably secondary to chronic ischemia which had progressed to the point where there was compromise of his lower extremity innervation causing his weakness. Pneumonia was found on his chest x-ray which accounted for his respiratory failure; he was treated with antibiotics. He developed thrombocytopenia and leukopenia secondary to his immunosuppressive therapy and was treated with granulocyte colony-stimulation factor. His counts improved. He was maintained on hemodialysis. He developed further respiratory failure secondary to mucous plugging and required intubation for deep suctioning. He developed a subsequent left upper lobe infiltrate which was felt to be secondary to Aspergillus. Deep venous thrombosis was discovered and he was treated with Heparin. There was a long discussion undertaken with wife and the family requested comfort care only and to extubate the pt. Subject was extubated, given IV morphine for comfort and expired 15 days after admission on 10/8/03, 351 days post immunization. Discharge summary: 9/23/03-10/8/03. Admission diagnosis: respiratory failure, lower extremity weakness. Discharge diagnosis: Respiratory failure secondary to pneumonia exacerbating chronic obstructive pulmonary disease. Large thoracic spine syrinx probably ischemic in origin. neutropenia secondary to Cytoxan. ANCA positive vasculitis with secondary glomerulonephritis and end-stage renal disease, hemodialysis-dependent. Alveolar, ar hemorrhage syndrome secondary to ANCA positive vasculitis. Paroxysmal atrial fibrillation. Mucous plugging of the bronchial tubes with further respiratory failure. Deep venous thrombosis. Aspergillus pneumonia. The respiratory failure, large thoracic spine syrinx, neutropenia, ANCA positive vasculitis, alveolar hemorrhage, paroxysmal A. fib, mucous plugging on bronchial tubes, deep vein thrombosis, and Aspergillus pneumonia were reported by the investigator as not related to the study vaccine. The death certificate received on 1/2/04 states renal failure and vasculitis.


VAERS ID: 213944 (history)  
Form: Version 1.0  
Age: 72.0  
Sex: Male  
Location: Colorado  
Vaccinated:2003-10-17
Onset:2003-11-24
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2003-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1137HA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Cough, Deep vein thrombosis, Dyspnoea, Hypoxia, Lobar pneumonia, Pyrexia
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 17 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Serovent; Albuterol; Flovent; Atrovent; Aleve; Pseudoephedrine; Predforte; Depotesterone; RSV/Placebo
Current Illness:
Preexisting Conditions: COPD; Arthritis; Glaucoma
Allergies:
Diagnostic Lab Data: 9/12/03 Sputum culture obtained-results pending 11/26/03 Sputum culture grew Beta Hemolytic Strep Group A
CDC Split Type: 200303236

Write-up: This subject is a 72 year old male who was admitted to the hospital due to Pneumococcal Pneumonia while enrolled in RSV11 study. The vaccination received prior to the event was Influenza vaccine lot # U1137HA on 10/17/03. The subject also received RSV vaccine or Placebo and Influenza vaccine on 11/1/02. The subject developed shortness of breath, fever and cough 38 days post immunization and was admitted to the hospital on the same day, 11/24/03. Diagnosis of Pneumococcal Pneumonia. Chest x-ray showed left lower lobe pneumonia. Subject was started on Rocephin, Zithromax with good response. Subject is also on bi-pap. The subject''s outcome is ongoing. The Pneumonia was reported by the investigator as possibly related to the study vaccine. Additional info received 12/11/03. Subject was intubated and on the ventilator 11/26/03 thru 3/12/03. He was diagnosed with a pulmonary embolism at that time. He was started on a heparin drip that continues at this time and also started on Coumadin. A sputum culture was obtained 9/12/03 with pending results. Subject will be transferred to rehab before he is discharged home. Diagnosis: Pneumococcal pneumonia, pulmonary embolism. The Pneumococcal pneumonia and pulmonary embolism was assessed by the investigator as possibly related to the study vaccine. Additional info received 12/12/03. Complimentary Information Form: confirmed that the SAE is possibly related to RSV vaccine. Confirmed that the SAE is not related to the Influenza vaccine. Last administration date before the SAE for RSV vaccine is 17/10/2003. Follow up SAE form provided. Additional information received Jan 7, 2004. Medical records: The pt was admitted to the medicine service for severe chronic obstructive pulmonary disease exacerbation. He was mechanically intubated for oxygenation and ventilation purposes. He did well on the ventilator, however, due to his severe chronic obstructive pulmonary disease, weaning him from the ventilator was quite difficult. he was extubated to face mask oxygen where he did well. The pt was placed on bilevel at night which significantly help his oxygenation-ventilation status and likely help by contributing to relief of his severe pulmonary hypertension. He was maintained on Flovent, Combivent, and Serevent, and continued to use these as nebulizers. His oxygenation levels were stable and he was eventually weaned down to approximately 2 L of oxygen by nasa cannula. The pt did have group A streptococcus bacteremia for which was treated with Zosyn. His cultures did eventually clear and he remained afebrile and stable off of the antibiotic. The pt did have a deep venous thrombosis diagnosed by an ultrasound in 11/26 in the left common femoral vein. The pt therefore required long ter anticoagulation and started on Heparin and then eventually Warfarin. There were also some questions whether he did have apulmonary embolism, however, the CT dated 11/26 did not show any evidence for pulmonary embolism. The pt was severely deconditioned after being taken off the ventilator and required significant pulmonary and physical rehabilitation. Procedures: 1. Intubation 2. CT scan of chest, abdomen, and pelvis. 3. Ultrasound, left lower extremity. 4. Transthoracic echocardiogram with an ejection fraction approximately 40% with increased right ventricular volume and moderate pulmonary hypertension with PA systolic of 40 to 50 mmHg. Discharge medications: Combivent, Lovenox, Warfarin, Flovent, Aspirin, Pepcid, Serevent. Subject recovered and was discharged from the hospital into a rehabilitation center 17 days later on Dec 11,2003. Additional information received on Mar 2, 2004 Subject was admitted to the ICU with severe SOB, fever. Chest X-ray showed a right lower lobe infiltrate, most likely representing inflammatory process/pneumonia. He was on the ventilator from 26/11/03 to 02/12/03. Sputum culture grew Beta Hemolytic Strep Group A. Blood Cultures grew Alpha Strep, not pneumococcus and staph. Hominis both contaminates according to PI. Arterial Duplex performed on 11/26/2003 showed left lower extremity deep venous thrombosis of the common femoral vein. Chest CT Scan on 11/26/2001 confirmed areas of atelectasis in the right middle lobe, and nasal segments of the left lower lobes bilaterally. There is also focus on density in the anterior segment of the right upper lobe. There is no pleural or pericardial effusion or pulmonary embolis. Treatment included Azithromycin, Ceftriaxone, Penicillin G, Eosyn, Heparin IV and Solumedrol. Subject recovered and will continue in the study. The Group A Beta Strep pneumonia and deep vein thrombosis was reported by the Investigator as possibly related to the study vaccine. Additional documents available with source file. Medical records: Admission date 11/24/03-Discharge date 12/11/2003, Chest CT W NON IONIC (11/26/2003) Arterial duplex Le Bilat 11/26/03, Progress report, Laboratory results: 11/24/2003-12/09/2003, Chest single view VW port (11/25/2003) Chest PA/Lateral (12/9/2003)


VAERS ID: 214442 (history)  
Form: Version 1.0  
Age: 37.0  
Sex: Female  
Location: Colorado  
Vaccinated:1991-07-01
Onset:1991-09-01
   Days after vaccination:62
Submitted: 2003-12-17
   Days after onset:4490
Entered: 2003-12-29
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (FOREIGN) / MERCK & CO. INC. - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arthralgia, Deep vein thrombosis, Injury, Joint swelling, Rheumatoid arthritis
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (narrow), Tendinopathies and ligament disorders (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Repeated blood tests, X-rays, and bone scans
CDC Split Type:

Write-up: Within weeks of getting the hepatitis b vaccination series, my joints began swelling and hurting. I have subsequently been diagnosed with rheumatoid arthritis. It began suddenly and severely and has been disabling since 1995. Accidental needle stick with contaminated needle. The medical record received on 1/13/04 states deep vein thrombosis. Chronic arthritis pain. Per annual follow up report continued debilitating arthritis pain.


VAERS ID: 214845 (history)  
Form: Version 1.0  
Age: 45.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2000-06-06
Onset:2003-07-30
   Days after vaccination:1149
Submitted: 2004-01-12
   Days after onset:166
Entered: 2004-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV031MIP / 6 RA / IM

Administered by: Military       Purchased by: Military
Symptoms: Amnesia, Arthritis, Blood creatine phosphokinase increased, Coagulation time prolonged, Cough, Dyspepsia, Dyspnoea, Fatigue, Fibromyalgia, Immune system disorder, Liver function test abnormal, Lung disorder, Pneumonia, Polymyositis, Pulmonary embolism, Rhinitis allergic, Skin disorder, Systemic lupus erythematosus, Thrombocytopenia, Thrombosis, Vasculitis, Vertigo, Wheezing
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Myocardial infarction (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific dysfunction (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (narrow), Vasculitis (narrow), Hypersensitivity (narrow), Arthritis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 16 days
   Extended hospital stay? No
Previous Vaccinations: BURNING IN MUSCLES~Anthrax (Biothrax)~3~43.00~In Patient
Other Medications: SUDAFED
Current Illness:
Preexisting Conditions: SINUSITIS
Allergies:
Diagnostic Lab Data: POLYMIASITIS, PNEUMONIASITIS,VASCULITIS, LUPUS ANTICOAGULATION. Elevated liver enzymes, elevated CPK, and positive antiphospholipid antibody serology.
CDC Split Type:

Write-up: BURNING IN JOINTS,PNEUMONIASITIS,BLOODCLOTTING,VASCULITIS,VERTIGO, LOSS OF SHORT TERM MEMORY, FIBROMYALGIA, CRONIC FATIGUE. FROM 24 OCT 98 TO 23 NOV 98 I RECEIVED 3 ANTHRAX SHOTS. IS THIS NOT TOO MUCH TOO SOON? The hospital d/c summaries confirms polymyositis and thrombosis. SOB, bilateral pneumonia, acute pulmonary embolism, thrombocytopenia, tinea corpus, dyspepsia, cough, wheezing and severe allergic rhinitis were added as symptoms.


VAERS ID: 215785 (history)  
Form: Version 1.0  
Age: 38.0  
Sex: Male  
Location: Washington  
Vaccinated:2003-03-14
Onset:2003-03-15
   Days after vaccination:1
Submitted: 2004-01-30
   Days after onset:321
Entered: 2004-01-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV070 / 1 RA / SC
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020071 / 1 LA / ID

Administered by: Military       Purchased by: Military
Symptoms: Deep vein thrombosis, Pain, Swelling, Vaccine positive rechallenge
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: AD A VIENAGRAM AND A DOPPLER ULTRASOUND. CONFIRMED A DVT IN LEFT LEG AND WAS STARTED ON DURGS 19JUNE 2003.
CDC Split Type:

Write-up: HAD WHOLE BODY SWELLING ABOUT 1-2 DAYS BEFORE IT WAS NOTICED. LEFT LEG SWELLED UP BY INCHES AND STAYED THAT WAY FOR SEVERAL MOS. STARTED ASA AS PROCAUTION FOR DVT. AFTER EACH SHOT I HAD SWELLING THAT WENT DOWN AFTER A DAY OR SO BUT MY LEFT LEG HAD SOME PAIN DURING THIS TIME BUT WENT AWAY WITH TIME. 60 day follow up 4/5/04: DVI has resolved itself with medication. I now have vascular deficiency in my left leg for life.


VAERS ID: 216223 (history)  
Form: Version 1.0  
Age: 43.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2003-12-01
Onset:2003-12-02
   Days after vaccination:1
Submitted: 2004-02-06
   Days after onset:66
Entered: 2004-02-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS - / 3 UN / SC
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / IM

Administered by: Military       Purchased by: Military
Symptoms: Chest pain, Coronary artery thrombosis, Dizziness, Dyspnoea, Laboratory test abnormal, Myocardial infarction, Pharyngitis, Rhinitis, Rhinorrhoea
SMQs:, Anaphylactic reaction (broad), Agranulocytosis (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Oropharyngeal infections (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Medications: oPrior to his MI, he took an occasional aspirin for headaches or muscle aches and an occasional MVI. oCurrently taking: -Zocor 40 mg at night -ASA 325 mg every day -Toprol 25 mg every day -Altace 2.5 mg every day -Plavix 75 mg
Current Illness: Patient reports mild URI symptoms.
Preexisting Conditions: Past Medical History: oMI 12/2/03 with stent placement oHyperlipidemia- Reports that he was told he had high cholesterol in the past but was not started on medications. He tried to control it through dietary changes. He is now taking Zocor 40 mg every night. oMVA-1992-suffered from left anterior chest wall injuries with significant bruising. oDenies any history of CHF, heart murmur, CVA, carotid artery disease, arrythmias, thyroid dysfunction, asthma, cancer, diabetes, eczema, or migraines. Surgical History: oProcedure to repair fractured finger Allergies/ Adverse Drug Reaction History: oNo known food or drug allergies oNo past reactions to vaccinations.
Allergies:
Diagnostic Lab Data: Diagnostic Tests: oEKG-per H& P-12/2/03 at 0400-Borderline ST elevation in the inferior leads 12/3/03 at 0600-probable inferior infarct oEchocardiogram-12/4/03 oLeft Ventricle normal in size. Normal left ventricular wall thickness. Left ventricular systolic function is low normal. Estimated ejection fraction is 50-55%. Basal and mid inferior wall is hypokinetic. oCardiac Catheterization with Stent RCA 12/4/03 oRCA (Mid), 99% Lesion. Successful stent placed with 0% post-stenosis. oLAD Patent oCX Patent oChest X-Ray 12/2/03 oLeft hemidiaphragmatic elevation, which is of uncertain etiology or chronicity. If this is a new finding clinically, this should be further evaluated with a CT of the chest and/or fluoroscopic "Sniff Test" to evaluate for diaphragmatic paralysis. oChest CT with contrast 12/02/03 oThe mediastinum is free of lymphadenopathy. No evidence of hilar soft tissue mass. The great vessels, and heart are normal in contour. No evidence of pleural effusion. The left hemidiaphragm does demonstrate marked elevation as compared to the right. The etiology of this is not clear based on this examination. oEvaluation of the lungs demonstrates bilateral basilar, patchy, parenchymal opacification, which has "ground glass" appearance. This is limited to the patient''s lung bases bilaterally and does not appear associated with bronchiectasis. This would suggest entity such as subacute hypersensitivity pneumonitis, UIP, DIP, or less likely but still in the differential, bronchiolitis obliterans. The vessels in the area of relative hyperdensity appear similar to size to that of the more lucent areas, suggesting this does not represent mosaic perfusion, though both ground glass opacity and mosaic perfusion are usually high resolution CT diagnoses. There is a single noncalcified 5 mm nodule evident within the right lower lobe peripherally. Both this and the abnormal parenchymal opacities within both lung bases will require further pulmonary work-up, to include sequential CTs of the chest, to evaluate this nodule for growth over a total period of 2 years. The usual prescribed sequence of CT is at 3, 6, 12, and 24 months. oChest X-Ray 12/3/03: oLeft lower lobe subsegmental atelectasis Laboratory Data: oCardiac Enzymes Date & Time Normal Values: CK 22-269 CK-MB 2.3-9.5 Relative Index 0-2.5 Troponin I 0-1.5 12/3/03 @0714 770 H 43.5 H 5.6 H 37.31 H 12/3/03 @ 0330 746 H 45.1 H 6.0 H 34.78 H 12/2/03 @ 2245 605 H 40.1 H 6.6 H 25.25 H 12/2/03 @ 1710 439 H 7.2 H NPP 8.79 H 12/2/03 @ 1105 242 15.3 H 6.3 H 1.37 12/2/03 @ 0458 102 <0.07 12/2/03: oC Reactive Protein 0.5 oESR 4 oMyoglobin 306.68 H oCBC o12/2/03 @0458 WNL except WBC 11.4 H, Neut # 8.8 H o12/2/03 @1105 WNL except WBC 13.7 H, Neut % 89.2 H, Lymph % 7.1 L, Neut # 12.2 H, SEGS% 88 H, Lymph % 5 L oChemistry WNL except CA 8.9 L oCholesterol Total 235, Triglyceride 139, HDL 34, LDL 173, VLDL 28, Chol/HDL 6.9 oTSH Sensitive 2.14 12/3/03: oCBC WBC 12.2 H, RBC 4.08 L, HGB 11.4 L, HCT 34.2 L oChemistry WNL except CA 8.2 L
CDC Split Type:

Write-up: Cc: I had a heart attack 1 day after receiving my 3rd Anthrax Vaccination. This service member is a 43 yo male with a history of hyperlipidemia and family history of premature coronary artery disease who had an Inferior MI (99% occlusion of RCA) with subsequent stent placement. He is concerned that recent immunizations may have contributed to his MI. IMMUNIZATION DATE SYMPTOMS Smallpox-primary 3 jabs Hep A #1 Hep B #1 MMR IPV TD Typhoid Anthrax Influenza PPD 14 Oct 03 Received vaccinations on this date. Reports that he received smallpox and anthrax brochures and briefings. Did not experience any known adverse reactions to vaccinations. Reports that his smallpox site was small but healed normally. He thinks he may have had smallpox in the past but he had no record and no Jennerian scar was visible. Denies any chest pain after the vaccines. He experienced baseline dyspnea on exertion, which he had been having for months. He does recall having cold-like symptoms (runny nose) for weeks. He does not recall a fever. He states that he had a small, rapidly healing smallpox vaccination site. No rashes. Anthrax #2 27 Oct 03 No systemic symptoms after Anthrax #2. He does recall a small lump at the site of the vaccine that has now resolved. Anthrax #3 Hep B #2 01 Dec 03 No problems on the date of the vaccines. He reports that he received the vaccines that morning, and afterwards he went to the range. He reports that they were short staffed that day and he did have to load heavy documents and water onto a truck. However, he did not experience any chest pain while working. He experienced baseline dyspnea on exertion. He did not PT that day. 02 Dec 03 He awoke at 0130 with pressure on the left side of his chest. He initially thought it was heartburn but the pressure then got worse. He took 3 aspirin and tried to sleep. The pressure increased, and then his left arm and hand started throbbing. He took an additional 2 aspirin with no relief. Pain slightly relieved by sitting upright and was worse with lying down. Someone in his barracks alerted the medic who took him to Emergency Department where he was admitted. His initial EKG showed borderline ST elevation in the inferior leads, and a second EKG showed probable inferior infarct. Serial cardiac enzymes were elevated. 12/03/03 Transferred for cardiac catheterization with subsequent stent placement. Discharge summary indicates that during his hospital course, he was managed medically with ASA, Lovenox, beta-blockers, IV nitroglycerin, IV Integrelin, ACE inhibitor, and Zocor. The patient underwent cardiac catheterization which showed subtotal occlusion of the mid right coronary artery with thrombus. He was treated with percutaneous transluminal coronary angioplasty and stent of this vessel. He had residual thrombus in the right ventricular branch which was treated with ReoPro, aspirin, and Plavix. He was discharged home on 12/06/03. 02/03/04 Presented to Health Care Center. Reports that overall he is doing well. He is currently in Med Hold. He is scheduled for a stress test on 02/04/04 and also has a follow-up appointment with his internal medicine physician that afternoon. He states that he occasionally experiences chest pain that he describes as a sharp shooting pain on the left side of his chest that lasts only a few seconds. No radiation to arm or neck. The momentary pain occurs at rest or with exertion. He also reports that he occasionally notices that he gets lightheaded if he bends over. The lightheadedness only lasts a few seconds, and he has not had any syncopal episodes. He reports that his blood pressure has been normal each time he has had it checked. He reports that his weight is stable, and he denies cough, pedal edema, or fatigue. At this time, he is considered non-deployable. 60 day follow up 04/12/2004 he reports that he is doing well overall, but he continues to have occasional chest pain at rest or with exertion. He had a normal exercise stress test (2/5/04). He is also being evaluated for abnomral chest CT results from 12/03.


VAERS ID: 216508 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Male  
Location: Washington  
Vaccinated:2003-10-23
Onset:0000-00-00
Submitted: 2004-01-06
Entered: 2004-02-18
   Days after submission:43
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Muscle spasms, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zirtec;
Current Illness: NONE
Preexisting Conditions: Dust allergy; Sulfa; Ibuprofen;
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WA041991

Write-up: Tightness in right calf, got worse, to ER for ultrasound. Diagnosis was blood clot. Now on blood thinners. Cause unknown. Began a few weeks after vaccination. Due to the circumstances of vaccination that generated this VAERS report, the vaccine manufacturer, the lot number, the injection site and the providers name and phone number were not available to us.


VAERS ID: 218269 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Male  
Location: Florida  
Vaccinated:2003-11-15
Onset:2003-12-01
   Days after vaccination:16
Submitted: 2004-03-29
   Days after onset:119
Entered: 2004-03-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1090AA / UNK UN / -

Administered by: Private       Purchased by: Private
Symptoms: Deep vein thrombosis, Difficulty in walking, Laboratory test abnormal, Muscular weakness, Neuropathy, Paralysis
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Parkinson-like events (broad), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: Hyperlipidemia, DM, Hypertension, Glaucoma, CA of prostate, Diabetis Mellitis,
Allergies:
Diagnostic Lab Data: mri, spinal tap, muscle biopsy, emg, lab tests abnormal
CDC Split Type:

Write-up: Felt weakness in legs initially; progessed to the point over 6 weeks of paralysis in legs and arms. Finally diagnosed with CIDP, a form of Guillan Barre Syndrome. Still recovering as of now. In outpatient physical therapy. Still walking with a walker or in a wheelchair Nurse follow up on 06/28/04 states: "ADD: DVT, EMG abnormal." Nurse follow up on 08/04/04 states: "Chronic inflammatory demyelinating polyneuritis


VAERS ID: 218425 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Texas  
Vaccinated:2003-10-23
Onset:0000-00-00
Submitted: 2004-03-18
Entered: 2004-04-01
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1139AA / 7+ - / SC

Administered by: Private       Purchased by: Other
Symptoms: Arthritis, Dehydration, Gastrointestinal haemorrhage, Glomerulonephritis, Laboratory test abnormal, Loss of consciousness, Pleural effusion, Pruritus, Pulmonary haemorrhage, Syncope, Thrombophlebitis, Thrombosis, Vasculitis
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Gastrointestinal haemorrhage (narrow), Thrombophlebitis (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Vasculitis (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Arthritis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Zithromax, Ribitussin, Benzalin
Current Illness: Bronchitis
Preexisting Conditions: Reactive airway disease
Allergies:
Diagnostic Lab Data: C3, C4-wnl. ANA negative, C-ANCA positive
CDC Split Type:

Write-up: Developed palpable purpuric rash, arthritis, gastrointestinal bleeding, needed blood transfusion. Also developed blood clot in left arm needing anticoagulation. Work-up showed crescentic glomerulonephritis and C-ANCA positive vascultiis. Later had pulmonary hemorrhage. Information from Annual Follow-up report states this patient is still on anti-congulation therapy. Nurse follow up on 08/31/04 states: "loss of consciousness; Dehydration; venious thrombosis; pleural effusion." Nurse follow up on 09/15/04 states: "loss of consciousness, dehydration, venious thrombosis, pleural effusion."


VAERS ID: 220293 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Male  
Location: Oregon  
Vaccinated:2004-05-03
Onset:2004-05-04
   Days after vaccination:1
Submitted: 2004-05-13
   Days after onset:9
Entered: 2004-05-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 5588A4 / 1 LA / -

Administered by: Private       Purchased by: Other
Symptoms: Arterial thrombosis limb, Thrombosis
SMQs:, Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Ultrasound Doppler: thrombosis. Tests 6MAY04: Left arm venous dublex compresion ultrasound results: Small, noncompressible tubular structures anterior to the brachial artery, presumable representing small thrombosed brachial veins; subcutaneous edema near elbow.
CDC Split Type: A0510165A

Write-up: This case was reported by a nurse and described the occurrence of left brachial vein thrombosis in a 22 year old male patient who received hepatitis B vaccine recombinant. On 5/3/04, the patient received the first dose of Engerix B vaccine (lot ENG5588A4) in the left arm. On 5/6/04, the patient was seen in an emergency room and underwent a doppler ultrasound of the left arm. The ultrasound revealed left brachial vein thrombosis. The patient reported to the nurse that the adverse event began the day after receiving the injection. The event improved. Comment: Vein thrombosis was assessed as medically serious (OMIC). Follow UP: The immunization series with Engerix B was discontinued. The events resolved on 21MAY2004. The nurse considered the events to possibly be related to vaccination with Engerix B.


VAERS ID: 222203 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: New York  
Vaccinated:2003-10-22
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2004-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arteriosclerosis, Asthenia, Back pain, Bone neoplasm, Cardiac arrest, Cholecystitis, Colitis, Coronary artery disease, Cough, Dyspnoea, Dysuria, Faecal incontinence, Gait disturbance, Gastrointestinal disorder, Hepatic neoplasm, Laboratory test abnormal, Lung neoplasm malignant, Lymphoedema, Myocardial infarction, Thrombosis, Vascular anomaly, Wheezing
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Congenital, familial and genetic disorders (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Thrombophlebitis (broad), Acute central respiratory depression (broad), Infectious biliary disorders (narrow), Gallbladder related disorders (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific inflammation (narrow), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Other ischaemic heart disease (narrow), Liver tumours of unspecified malignancy (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (broad), Respiratory failure (broad), Hypoglycaemia (broad), Non-haematological malignant tumours (narrow), Non-haematological tumours of unspecified malignancy (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-05-13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The subject received dose 1 of RSV vaccine or Placebo and Influenza vaccine on 10/11/02. Additional information received 05/25/04. Hypertension, chronic ischemic heart disease, CHF, MI 1994, CABG 1004, Arthritis, Hypercholesterolemia, Angina
Allergies:
Diagnostic Lab Data: Chest CT on 04/09/04-Left upper lobe lung mass most likely primary lung neoplasm with metastasis to caudate lobe of liver, left adrenal mass, multiple kidney lesions and multiple metastases to vertebrae. Right L3 core biopsy on 04/16/04-Netastatic adenocarcinoma.
CDC Split Type: 200401445

Write-up: This subject is a 86 year old male who was admitted to the hospital due to increasing back pain over the past several weeks and increasing SOB over the last week while enrolled in a Comparative Randomized Study of Safety and Immunogenicity of a Non-Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine versus an RSV Vaccine Adjuvanted with Aluminum Phosphate when Administered Concomitantly with a Licensed Influenza Vaccine in High Risk Adults $g or = 65 years of age. The subject received 2 doses of RSV vaccine or Placebo and Influenza vaccine. The last dose prior to the event was given on 10/22/03. The subject developed increased back pain and shortness of breath, and was admitted to hospital 169 days post immunization on 4/8/04. Treatment and discharged date were not reported. The subject''s outcome was unknown at the time of this report. The increasing back pain over the past several weeks and increasing SOB over the last week were reported by the investigator as unrelated to the study vaccine. Additional information received on 5/25/04. Subject was admitted to the hospital for increasing back pain, difficulty urinating and difficulty ambulating for several weeks. Shortness of breath and wheezing for 1 week. Subject was diagnosed with primary lung cancer with metastasis to the bone 170 days post immunization. Investigations included a chest CT on 4/9/04 which revealed a left upper lobe lung mass most likely primary lung neoplasm with metastasis. Abdomen CT on 4/9/04 revealed metastasis to caudate lobe of liver, left adrenal mass, multiple kidney lesions and multiple metastases to vertebrae. A right L3 core biopsy on 4/16/04 showed metastatic adenocarcinoma. Subject underwent several days of radiation and was maintained on normal routine medications. Subject has not recovered and was discharged to hospice 11 days later on 4/19/04. Subject discontinued the study on 4/23/04. Additional documents available with source files: Pathology and Laboratory report - Right L3 Transverse Process Core Biopsy; CT Abdomen with and without contrast; CT Chest with and without contrast; Concomitant medications. Additional information received 5/26/04. Notified by spouse that while at home on hospice, subject died on 5/13/04, 204 days post immunization. The subject''s death was reported by the investigator as unrelated to the study vaccine. Additional documents available with source files: Pathology and Laboratory report - Right L3 Transverse Process Core Biopsy; CT Abdomen with and without contrast; CT Chest with and without contrast; Concomitant medications. Nurse follow up on 06/14/04 states: "bowel incontinence; thrombosis; diverticulitis; GERD; Lymphedema; Arthrosclerosis; Cholecystitis; Aortic aneurism; Weakness; Cough." 6/25/04 Death certificate received which revealed COD to be cardiac arrest, Myocardial infarction, coronary artery disease & metastatic lung cancer.


VAERS ID: 223381 (history)  
Form: Version 1.0  
Age: 40.0  
Sex: Male  
Location: Iowa  
Vaccinated:2003-03-12
Onset:2003-03-26
   Days after vaccination:14
Submitted: 2004-06-24
   Days after onset:455
Entered: 2004-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (NO BRAND NAME) / MICHIGAN DEPT PUB HLTH FAV072 / 3 LA / IM

Administered by: Military       Purchased by: Military
Symptoms: Deep vein thrombosis, Laboratory test abnormal, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tricor,Zocor,Synthroid
Current Illness: None
Preexisting Conditions: Weak Thyroid - Being Treated, Elevated Colesterol - Being Treated; prothrombin 20210 mutation; Factor V Leiden Mutation;
Allergies:
Diagnostic Lab Data: Doppler Ultrasound - Multiple DVT''s In Left Leg, lab tests Abnorm
CDC Split Type:

Write-up: Developed Blood Clots In Left Leg Soon After I Received The Anthrax,Small Pox,And Other Required Vaccinations Approx. Late FEB - Early MAR 03. Doppler Ultrasound Identified Multiple DVT''s. Put On Lovanox And Coudimin And Continued Treatment Until MAR 04. Doctor Discontinued Coudimin And Clots Returned In JUN 04. I Am Back On Coudimin And Being Treated Again. Prior To Receiving The Vaccinations I Was IN Good Health,No Injury Or Reason For A Clot To Develope And Exercised Regularly. I Have Never Had Any Health Issue''s And No Family History Of This.


VAERS ID: 223962 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Female  
Location: Georgia  
Vaccinated:2003-09-05
Onset:2003-10-03
   Days after vaccination:28
Submitted: 2004-07-01
   Days after onset:272
Entered: 2004-07-15
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 5367A2 / 3 LA / -

Administered by: Private       Purchased by: Other
Symptoms: Abdominal distension, Cardiomyopathy, Dehydration, Face oedema, Hepatomegaly, Lethargy, Oral intake reduced, Proteinuria, Rash, Renal disorder, Thrombosis, Urinary incontinence, Vomiting
SMQs:, Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Systemic lupus erythematosus (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Proteinuria (narrow), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 17 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: Had heat rash on neck and arms.
Preexisting Conditions: Eczema
Allergies:
Diagnostic Lab Data: Please add Proteinuria
CDC Split Type:

Write-up: Symptoms lasted one month until being hospitalized. From the day of the hepatitis B vaccination, my daughter started vomiting, not eating, became lethargic, swelling on abdomen, limbs, and face. Cold peripherals, wetting herself. She had a clot in the heart, enlarged liver, kidney leaking proteins, rash on arms and legs. Diagnosis: diluted cardiomyopathy. Medications: Warfarin, Dioxin, Captopril, Pruesimide. Per telephone follow up with mother: please add dehydration. Information from Annual Follow-up report states she has diluted cardio myopathy and is on medication prognosis unknown.


VAERS ID: 227394 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2003-10-24
Onset:2004-09-23
   Days after vaccination:335
Submitted: 0000-00-00
Entered: 2004-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1137HA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Deep vein thrombosis, Gastrointestinal necrosis, Gastrointestinal neoplasm, Intestinal obstruction, Pulmonary embolism, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Gastrointestinal obstruction (narrow), Thrombophlebitis (broad), Ischaemic colitis (narrow), Non-haematological tumours of unspecified malignancy (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-09-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Vitamin C, E, B complex; Testosterone injections; Slo K; Maxide; Lasix; Acupril; Zyloprim; ASA;
Current Illness:
Preexisting Conditions: Received a dose of RSV vaccine or Placebo and Influenza vaccine. Administration date not reported. Blood pressure high; Hypertension; Congestive Heart Failure; Osteoarthritis; wac degenerative; Left orchiectomy in 2002;
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200403234

Write-up: This subject is a 67 year old male who was admitted to the hospital and died while enrolled in a study. The subject received two doses of RSV vaccine or Placebo and Influenza vaccine. The last dose prior to the event was given on 10/23/03. The subject was hospitalized for a stomach mass, date of hospitalization not reported. While in the hospital subject developed a blood clot and died 334 days post immunization on 9/21/04. The subject''s death due to a blood clot was reported by the investigator as unknown in relationship to the study vaccine. Follow up on 10/08/04 states: "There was no autopsy done for this decedent." Nurse follow up on 10/14/04 states: "pulmonary embolism; deep vein thrombosis." Nurse follow up on 10/19/04 states: "small bowel mass." Nurse follow up on 11/11/04 states: "fat necrosis of the mesentery with partial small bowel obstruction."


VAERS ID: 229517 (history)  
Form: Version 1.0  
Age: 33.0  
Sex: Female  
Location: Florida  
Vaccinated:2003-02-19
Onset:2003-05-15
   Days after vaccination:85
Submitted: 2004-11-22
   Days after onset:557
Entered: 2004-11-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV069 / 3 UN / SC
MEN: MENINGOCOCCAL (MENOMUNE) / SANOFI PASTEUR UB22944 / UNK UN / IM
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020071 / UNK LA / ID

Administered by: Military       Purchased by: Military
Symptoms: Arthralgia, Constipation, Diarrhoea haemorrhagic, Endometriosis, Fibromyalgia, Injection site mass, Injection site swelling, Joint stiffness, Menorrhagia, Nausea, Ovarian cyst, Pain, Peritonitis, Pyrexia, Thrombosis, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal perforation (narrow), Gastrointestinal haemorrhage (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DENIES
Current Illness: DENIES
Preexisting Conditions: ENDOMETRIOSIS
Allergies:
Diagnostic Lab Data: ENDOMETRIOSIS WITH POST OP CLOT AND BOWEL INVOLVEMENT.
CDC Split Type:

Write-up: Pt is a 34-year-old female who developed multiple medical problems during the past year and feels that it is a result of the anthrax (AVA) immunizations that she had received. She reported the following problems: AVA # 1 on 7 Nov 99: she developed a knot and some swelling to the vaccination site that persisted for a couple of weeks. She also reported body aches and a fever that was bad for the first 3-4 days that then became "tolerable" for 3 wks. She said she took 2-3 days off work and denied any medical attention. She also stated that symptoms would clear before subsequent vaccinations. AVA #2 on 9 Jan 00: She reported same symptoms as above. AVA #3 on 19 Feb 03: As above. AVA #4 on 30 Jul 03: As Above. She stated that she had no problems with her endometriosis until she was in the desert. While in the desert she developed new symptoms that were different from her previous episodes. She now described severe bleeding during the first 24 hrs of her menses associated with clots, foul odor and severe pain in her back, pelvic area and body aches. She stated that she would bleed for 3 days, then it would stop for 24 hrs and then return with excessive bleeding that would last for 24 hrs. She said that this cycle would repeat itself every 2 wks. She said that she went to the medic twice and each time she was told it was stress and did not have a pelvic exam performed. She stated that the bleeding continued from May 2003 until her surgery in May 2004. She reported that since her surgery, her endometriosis has not been bothering her. During her surgery in May 04 an ovarian cyst was discovered. On 23 Jun 04 a second surgery was required to evacuate a large blood clot between her uterus and rectum. She stated that the clot was the size of a melon and that the clot was there since her surgery in May. Also during this second surgery it was discovered that part of her rectum and bowel was attached to her uterus, peritonitis was developing and there was some remaining endometriosis outside of her uterus. She stated that there was another cyst on her ovary that was the size of a grapefruit that was drained and biopsied with a negative biopsy. She was treated with antibiotics for her peritonitis and developed the third ovarian cyst. Patient now reports bowel problems since her first surgery in May that persists today. She stated that she is requiring medication for her bowel movements and has episodes of bloody diarrhea with intermittent constipation. She said that the blood is throughout her stool and noticed this since 04 Aug 04. On 09 Jul 04 she began to notice joint pain throughout her entire body involving all of her joints. Pain is increased in the morning, associated with stiffness and will ease during the day. She reports that it is difficult to get up and sit down and also reports periods of stiffness with inactivity. She is taking Vioxx and the Duragesic patch and reports no relief. She stated that she had some relief with the steroid pack and that one-week after the pack was finished her pain would return. She was evaluated by Rheumatology in Aug of this year when she was hospitalized for her pain, nausea and vomiting. She stated that her muscles are fine with occasional aches. She stated she was diagnosed with fibromylagia and that some of her blood test was showing RA. She reports that she has had fevers since May 04. Stated that her temperature at times reaches 101 and that they still persist today. She stated that she feel hot all over to touch but that she experiences chills and her joints would ache. She reported that she is usually very healthy and that since June she has had 3 upper respiratory tract infections. She states she is a non smoker.


VAERS ID: 232265 (history)  
Form: Version 1.0  
Age: 59.0  
Sex: Female  
Location: Unknown  
Vaccinated:2001-10-18
Onset:2001-10-20
   Days after vaccination:2
Submitted: 2002-10-10
   Days after onset:355
Entered: 2005-01-14
   Days after submission:827
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES E06731KA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cerebral thrombosis, Hemiparesis, Intracranial aneurysm
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Premarin; Flonase; Claritin;
Current Illness:
Preexisting Conditions: Menopausal and Post-menopausal disorders; Glaucoma; Osteoarthritis; Surgery; Allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: PJP200200001

Write-up: A report was received from a health care professional on 12/27/01 concerning a 58 year old female patient who experienced cerebral thrombosis, which led to hospitalization, within 48 hours of receiving Fluvirin on 10/18/01 or 10/19/01. The patient had a hysterectomy in 1998, has been diagnosed for years with osteoarthritis of the right knee, has had menopause diagnosed for years, and was diagnosed within the last year with glaucoma. The patient takes Conjugated Estrogens for menopause, and Fluticasone Propionate and Loratadine for allergy. The patient received a flu vaccine of unknown source on 11/5/99 without incidence. On 10/18/01 or 10/19/01, the patient received a Fluvirin vaccine on her deltoid muscle. Within 48 hours (10/20/01), the patient was diagnosed with a cerebral thrombosis and was admitted to a hospital. The patient experienced cerebral thrombosis, MCA with right hemiparesis, and aneurysm on the left carotid artery. The patient was discharged on 10/29/01 and at the time of the report was undergoing rehabilitation therapy. The reporter has stated that the patient''s family doctor believed that there was a probable relationship with Fluvirin. The patient did not have a risk factor for stroke per her family physician.


VAERS ID: 232910 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: Texas  
Vaccinated:1994-02-08
Onset:1994-02-09
   Days after vaccination:1
Submitted: 2005-01-09
   Days after onset:3987
Entered: 2005-01-26
   Days after submission:17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RUB: RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: Public
Symptoms: Haemorrhage, Sepsis, Shock, Thrombosis, Unintended pregnancy, Vaginal haemorrhage
SMQs:, Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (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), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Normal pregnancy conditions and outcomes (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnant 6 wks, vaginal infection
Preexisting Conditions: Chronic post-traumatic stress disorder with delayed onset; Vaginal infection
Allergies:
Diagnostic Lab Data: CBC; UA; UC; STS; T&S; Stat quant BHCG; Gyne U/S; Rubella; Lipase serum MSAFP.
CDC Split Type:

Write-up: 2/8/94 date is not clear. 2/10/94 Shock (septic) threatened abortion. Immunization verified on immunization record book and lab 2/10/94. Progress notes states treatment for septic infection. Pregnant verified 6 weeks. Bleeding and blood clots. Sent to ER for hemorrhaging after Rubella immunization. Return to hospital 2/15/94 0100 Benadryl 50mg IM.


VAERS ID: 234875 (history)  
Form: Version 1.0  
Age: 28.0  
Sex: Female  
Location: Michigan  
Vaccinated:2002-09-18
Onset:2002-10-27
   Days after vaccination:39
Submitted: 2003-05-22
   Days after onset:207
Entered: 2005-03-11
   Days after submission:659
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV063 / 3 LA / SC

Administered by: Other       Purchased by: Private
Symptoms: Angioneurotic oedema, Deep vein thrombosis, Hyperthyroidism, Oedema peripheral, Pruritus, Rash macular, Rheumatoid arthritis, Skin burning sensation, Systemic lupus erythematosus
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Systemic lupus erythematosus (narrow), Embolic and thrombotic events, venous (narrow), Oropharyngeal allergic conditions (narrow), Thrombophlebitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hyperthyroidism (narrow), Hypersensitivity (narrow), Arthritis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Azelastine HCl
Current Illness: NONE
Preexisting Conditions: Possible rheumatoid arthritis.
Allergies:
Diagnostic Lab Data: Blood samples were taken at time of visit on 11/10/02, results unknown.
CDC Split Type: PCRN02AV0012

Write-up: On October 27, 2002, patient experienced burning and itching sensation in toes and ball of right foot. October 28,2002 red dots appeared on bottom of right foot and toes began to swell. Patient saw physician and was diagnosed with angioedema. Treated with epinephirine and cortisone shots with relief of symptoms. On November 8, 2002, patient noted index finger on left had was red and itchy. On November 9, 2002, red dots, burning, itching and swelling of left hand were noted. Treated with oral prednisone. On November 10, 2002, red dots noted to increase and appear on palm of left hand. Treated with cortisone shots. Symptoms resolved. Follow up information received on 2/11/03 On Feb 11 2003 patient reports new findings of Deep vein thrombosis, rheumatoid arthritis, systemic lupus erythematos and probable hyperthyroidism.


VAERS ID: 236232 (history)  
Form: Version 1.0  
Age: 55.0  
Sex: Male  
Location: Unknown  
Vaccinated:1999-05-28
Onset:0000-00-00
Submitted: 2005-01-25
Entered: 2005-04-18
   Days after submission:82
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Amnesia, Antinuclear antibody negative, Arthralgia, Autoimmune neuropathy, Balance disorder, Biopsy skin abnormal, Blindness, Blood immunoglobulin G normal, Blood immunoglobulin M, C-reactive protein normal, Carpal tunnel syndrome, Chest X-ray, Chronic fatigue syndrome, Coccydynia, Computerised tomogram normal, Deep vein thrombosis, Disturbance in attention, Dizziness, Drug tolerance, Electromyogram abnormal, Fatigue, HLA marker study positive, Headache, Herpes zoster, Hypertension, Hyporeflexia, Immunology test, Impaired driving ability, Injection site erythema, Injection site pain, Insomnia, Intervertebral disc degeneration, Joint swelling, Leukoaraiosis, Lyme disease, Memory impairment, Mental disorder, Muscular weakness, Musculoskeletal stiffness, Myalgia, Nasal septal operation, Neck pain, Nerve injury, Neuropathy peripheral, Non-cardiac chest pain, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging spinal cord abnormal, Oedema peripheral, Osteoarthritis, Pain, Paraesthesia, Polyarthritis, Polyneuropathy, Post procedural infection, Prostatomegaly, Radiculopathy, Red blood cell sedimentation rate normal, Rotator cuff syndrome, Spinal X-ray abnormal, Spinal osteoarthritis
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Lack of efficacy/effect (narrow), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Dystonia (broad), Parkinson-like events (broad), Drug abuse and dependence (broad), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Hypertension (narrow), Optic nerve disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Skin tumours of unspecified malignancy (broad), Hypersensitivity (broad), Arthritis (narrow), Tendinopathies and ligament disorders (narrow), Hypoglycaemia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: ALCOHOL USE, AMPUTATION FINGERS HAND (TRAUMATIC), CHEST PAIN, CHRONIC SINUSITIS, ESOPHAGEAL STRICTURE, EX-SMOKER, GASTROESOPHAGEAL REFLUX DISEASE, HIATAL HERNIA, HYPERCHOLESTEROLEMIA, HYPERTENSION ARTERIAL, SLEEP APNEA, TENSION HEADACHE; A physical examination report conducted in September 1999 noted a history of arthritis and headaches (dates of diagnoses not provided). Family history of fatal brain tumor in the patient''s father.
Allergies:
Diagnostic Lab Data: Antinuclear antibody, 03July2000, Negative; C-reactive protein, 03July2000, 6.2mg/L, 0, 4.9; C-reactive protein, 12Jan2001, 0.9mg/dL, 0.08, 0.80; Erythrocyte sedimentation rate, 16Oct2000, 12mm/hr, 0, 15; Erythrocyte sedimentation rate 15Oct2002, 5mm/hr, 0, 15; HLA marker study, 11Sep2000, positive; Rheumatoid factor, 03 Jul2000, <10.0IU/mL, 0, 9.9; 11 July 1999: Computed tomography scan of pelvis showed no evidence of bony fractures, coccyx intact, no evidence of para-coccygeal mass or inflammatory changes noted.; 09 August 1999: Magnetic resonance imaging of lumbar spine showed normal bone signal, degenerative disc changes noted with dessication of the discs; mild disc protrusion of L5-S1.; 15 September 1999: Pathological evaluation of coccyx tissue revealed external surface covered by variable thick fibrous cartilaginous tissue which showed focal degenerative change, fragmentation of surface cartilage noted. Actual inflammation or neoplastic process was not seen.; 17 December 1999: Status post coccygectomy, radiology showed no evidence of pelvic abscess, edema noted; no evidence of osteomyelitis of the sacrum.; 03 July 2000: Lyme IgG Western Blot positive, Lyme IgM Western Blot negative, B, Microti IgN and IgG negative. 16 October 2000: HLA DR4 positive, Lyme IgG Western Blot positive for the following bands: 31, 91, and equivocally positive at 41 and 45; Lyme IgM wan clinically positive at 37 and 66 which was nondiagnostic.; 05 November 2001: Lyme IgG and IgM Western Blot negative, Marlox and Immunities Western Blot IgG negative, Overall interpretation: No evidence of seroreactivity beyond that expected from the Lyme vaccine.; 21 January 2003: Radiologic examination of the cervical spine showed multilevel degenerative disc disease and spondylosis most severe at C5-6; bilateral significant foraminal stenosis and mild bony stenosis present at C5-6.; 03 February 2003: Magnetic resonance imaging of lumbar spine without contrast showed small right lateral disc hernia at L5-S1; mild degenerative disc bulging at L3-L4 and L4-L5 superimposed on facet arthropathy, sacral region "unremarkable". MRI of pelvis showed normal artioulation of hips bilaterally, and sacroiliac joints and sacrum "unremarkable. There was considerer to be "overall improvement" compared to previous MRI on 16 April 2001.; 03 June 2004: Thoracic spine x-rays showed advanced degenerative disc and degenerative joint disease throughout thoracic spine; normal bone mineralization.; 18 April 2005: X-rays of pelvis/hips showed mild osteoarthritis of the hips without acute abnormality noted.; 29 September 2005: Sacral MRI showed unremarkable sacrum with stable post-operative changes in the coccygeal area, L5-S1 degenerative disc and facet disease. MRI of the lumbar spine showed a new small right disc herniation causing new right lateral recess narrowing without central stenosis or foraminal narrowing at L5 to S1, stable T11 to T12 degenerative joint and facet disease, trace amount of broad-based bulge at L3 to L4 and L4 to L5 (unchanged), and mild multi-level facet arthropathy and ligamentum flavum hypertrophy (unchanged).; 17 April 2006: Needle EMG examination showed the presence of distal polyneuropathy with multifocal abnormalities and superimposed carpal tunnel syndrome. 18 April 2006: Skin biopsy (right arm) showed epidermal nerve fiber density of 12.4/mm; right thigh normal epidermal nerve fiber density, right leg "significantly low" epidermal nerve fiber density.; 10 May 2006: MRI of the brain indicated a normal brain pre and post contrast, mild subcortical deep white mass leukoaraiosis on the basis of chronic small vessel ischemic change, mild thickening of the ethmoid air cells, separated right sphenoid sinus, no evidence of any enhancing lesion of the brain post contrast, and mild inflammatory retention cyst involving the floor of the left maxillary measuring 1 centimeter.
CDC Split Type: A0527200A

Write-up: This case was reported by a lawyer and described the occurrence of loss of concentration in a 61 year old male patient who received LYME disease vaccine recombinant OspA (LYMErix) injection for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date, the patient received LYMErix. At an unknown time after receiving LYMErix, the patient experienced " severe joint pain, fatigue, loss of concentration, and insomnia". Time to onset, treatment, and outcome were not reported. This report describes a 61-year-old male subject who received LYMERIX injection. A physician or other health care professional has not verified this report. On an unspecified date, the subject received LYMERIX. At an unknown time after receiving LYMERIX, the subject experienced "severe joint pain, fatigue, loss of concentration, and insomnia". Time to onset, treatment, and outcome were not reported. A statement of injuries was received on 05 May 2006 via medical records. The subject received LYMERIX on 28 April 1999 and 28 May 2009. Following the initial vaccine, the subject developed hip soreness. By June 1999, "shortly" after receiving LYMERIX, the subject developed sacrococcygeal pain, burning pain in the shoulders and arms, and some sharp pains in the fingers and toes, followed by neuropathic pain. It was noted that he intentionally attributed symptoms to injury after sitting on hard/cold ground and leaning against a tree for a prolonged time. He was diagnosed with chronic coccydynia in cold September 1999, initially treated with injections of XYLOCAINE and DEPOMEDROL. Other diagnosis at that time included osteoarthritis and insomnia. In October 1999 or November 1999, he underwent resection of the coccyx which was unsuccessful at alleviating his pain, and was complicated by a postoperative infection that "may actually have increased (his pain)". On examination on 18 February 2000, the subject continued to experience sacrococcygeal pain following a regimen of physical therapy. The evaluating physical noted that the pain was likely multifactorial in etiology, probably caused by a combination of "the precipitation condition, the surgery, and the post-surgery complications". On 03 November 2000, assessment included coccydynia, arthralgias and myalgias, HLA DR4 positive, positive IgG bands on Western Blot, fatigue, and sleep disturbance. Treatment involved AMYTRIPTYLINE which was noted to be working better that pain medicines. He was diagnosed with fibromyalgia, and the evaluating physician stated "my hypothesis is that he had a reaction to the infection he had with coccydynia. I doubt that it relates to Lyme vaccine and his genetic predisposition, although I cannot be confident about that." In July 2000, the subject was reportedly diagnosed with Lyme disease characterized by chronic fatigue syndrome, and chronic pain and swelling in his fingers and knees. No reportedly also experienced mental health/memory problems. In May 2001, the subject presented with neuropathic pain in the sacrococcygeal region, with radiculopathy and neuropathic pain of the S2 nerve root, which was treated with epidural nerve bloc with subsequent relief. Other treatment included NEURONTIN and RELAFEN. The subject was hospitalized from 16 July 2002 to 18 July 2002 for evaluation of noncardiac chest pain and to rule out possible myocardial infarction. While hospitalized, the subject complained of chronic shooting neuritic type pain and body stiffness. At the time of discharge, diagnosis included "inflammatory arthritis secondary to LYMERIX vaccine" and chronic pain. In January 2003 and February 2003, complaints included neck and upper back pain, and diagnostic evaluations revealed degenerative disc disease, spondylosis, and osteoarthritic changes. On 02 May 2003, the subject was diagnosed by magnetic resonance imaging with a small right lateral disc hernia at L5-S1 and mild degenerative disc bulging superimposed on facet arthropathy. On 27 May 2003, the subject was seen in follow up by a pain management specialist. The pain was characterized as "extremely debilitating", and treatment included NEURONTIN, VICODIN, and CELABREX. In June 2003, chronic sacrococcygeal pain was treated with a trial of dorsal column stimulation. By 25 June 2003, he experienced approximately 20 percent pain relief, and on 02 July 2003 the dorsal column stimulator was removed. On 07 January 2004, the subject was referred to a neurologist for re-evaluation of sacral pain, in addition to complaints of hand pain and "burning numbness" in his shoulders. The subject reported past treatment that included OXYCONTIN, HYDROCODONE, PROPOXYPHENE, CYCLOBENZAPRINE, IBUPROFEN, PREDNISONE, and LORAZEPAM. Sensory testing showed generally normal pinprick sensation in the extremities. Impression was coccydynia, without identification of any changes that might be suggestive of a neurologic process. According to a progress note dated 22 June 2004, the subject had been diagnosed with chronic pain syndrome and advanced arthritis of the thoracolumbar spine, and chronic inflammatory arthritis secondary to Lyme vaccine. Additional problems included pelvic pain, low back pain, and peripheral neuropathy. The subject received physical therapy in June and July 2004, and underwent a nerve block in October 2004, According to a letter written by his primary care physician on 16 March 2005, the subject was "unable to drive, let alone sit or stand for long periods of time" due to severe back pain and chronic medical illness. Treatment with LIDODERM PATCH was prescribed. On 23 September 2005, diagnostic testing demonstrated L5-S1 degenerative disc and facer disease. In March 2000, the subject was diagnosed with a herpes zoster rash on his chest. On 28 May 2002, the subject underwent a septoplasty for treatment of sinusitis. Other events included chest pain for which the subject was hospitalized in February 2001 and July 2002, intermittent dizziness, hearing loss, and vision loss. There were considered to be incidental findings upon review of medical records. Follow up information was received on 30 January 2007 via medical records. Medical history included traumatic amputation of left hand digits 2 through 5 in 1977. On 10 May 2006, the subject underwent magnetic resonance imaging of the brain due to continued memory loss, stinging sensation in his fingers and nerve damage. The results of the MRI indicated a normal brain pre and post contrast, mild subcortical deep white matter leukoaraiosis on the basis of chronic small vessel ischemic change, mild mucosal thickening of the ethmoid air cells, separated right sphenoid sinus, no evidence of any enhancing lesions of the brain post contrast, and mild inflammatory retention cyst involving the floor of the left maxillary measuring 1 centimeter. Follow up information was received on 07 February 2007 via medical records. According to an information sheet completed by the subject, he was diagnosed with Lyme disease in July 2000 with symptoms including chronic fatigue, mental health/memory problems, joint swelling and pain in the fingers, knees, toes, and hips, and inability to sit due to sacral area pain. Additionally, the subject noted that he had experienced pain and redness at the injection sites, lasting approximately two weeks after vaccination with LYMERIX. The subject was evaluated 13 February 2003 for a four to six-week history of "rather insidious" onset of neck pain, scapula pain, and headaches with some paresthesias in the right upper extremities. Electromyographic findings included cervical paraspinal irritability with normal findings throughout the right upper extremity and shoulder girdle musculature, considered to be suggestive of right cervical radiculitis. Electrical findings were suggestive of mild median neuropathy at the wrist, without electrical evidence of significant ulnar neuropathy. The subject underwent an initial physical therapy evaluation, but did not return for scheduled therapy visits. On 07 June 2004, he was again evaluated for physical therapy due to complaints of back pain, decreased active lumbar range of motion, decreased flexibility, increased pain, tenderness to palpation, and decreased strength. Physical therapy was planned for twice weekly for five weeks duration. In August 2006, the subject received intravenous Immunoglobulin. Follow up information was received on 31 March 2007 via medical records On 17 April 2006, electrodiagnostic studies showed polyneuropathy with multifocal abnormalities and superimposed carpal tunnel syndrome. On 18 April 2006, a skin biopsy showed low epidermal nerve fiber density in the right leg, with normal right thigh and borderline normal forearm epidermal nerve fiber density results, assessed to be consistent with small fiber neuropathy. Neurological examination showed pain in the seated and supine positions, with stocking and glove sensory lose to vibration, cold temperature, and light touch, imbalance of stance and gait, mild weakness in the proximal and distal leg muscles, inability to hop, mildly hypoactive tendon leg reflexes, and intact cognition and cranial nerves. According to the evaluating neurologist, findings were consistent with "post-LYMERIX peripheral small and large fiber neuropathy and dysautonomia". In July 2006, his primary care physician characterized his condition as "chronic pain syndrome status post LYMERIX vaccination", and noted that the subject continued treatment with "chronic narcotics, anticonvulsants, anti-inflammatories with minimal relief to the point that he is unable to work, disabled". Follow up information was received on 25 April 27 via orthopaedists records. On 15 September 1999, pathological diagnoses based on evaluation of coccyx tissue included focal degenerative change and fragmentation of surface cartilage. In October 1999, he experienced pain and some serious drainage around the surgical site. Following coccygectomy, the subject did not return to work until approximately November 1999. 3/25/2010 Follow up information was received on 17 may 2007 via medical records. On 26 April 2007, the subject''s neurologist provided an expert opinon summary to the subject''s lawyers following reveiw of medical records, stating "It is my expert opinon to a degree of medical certanity that this patient suffered from painful large and small fiber peripheral neuropathy and coccydynai caused by LYMERIX vaccination. These injuries are permanent and disabling. "Accordign to a letter written by the neurologist dated 12 June 2006, the subject developed hip and nuropathic complaints "several weeks" following vaccination with LYMERIX on 26 April 1999, with an exeacerbation following the second LYMERIX vaccine on 28 May 1999. The neurologist stated that finding were "consistent with post-LYMERIX dysimmune peripheral small and large fiber neuropathy and dysautonomia". Follow up information was received on 16 november 2007 via medical records, which confirmed tha tthe subject''s coccygectomy was performed on 15 September 1999. Between February 2000 and Pril 2000 the subject was examinde for myalgias and back pain, and on 04 February 2000 Lyme testing (ELISA) was positive. Follow up information was received on 07 January 2007 via medical records. THe subject was diagnosed with bilateral deep vein thrombosis characterized by leg pain, and was hospitalized from 10 July 2007 to 20 July 2007. Intake records indicated that the subject underwent a coccygectomy in 1999 due to "back and sacral pain secondary to LYMERIX vaccination and immune stimulation". At the time of discharge, it was also noted that the subject had "chronic pain with inflammatory polyneuropathy secondary to LYMRIX vaccination and exposure and immune mediation", as well as degenerative joint disease. He had previously been treated with immunoglobulin for chronic pain and inflammatory autoimmune polyneuropathy secondary to LYMERIX vacciantion, and was reported to have undergone back stimulation, epidurals, and pulse frequency ablation for back pain, Notes indicated that the subject also experienced leg/ankle swelling. Concurrent diagnoses included chronic pain syndrome, chronic neuropathy, and limb and back pain. According to an anticoagulation clinic visit noted dated 24 September 2007, the subject was being followed by pain clinic, and his dose of gabapentin had been recently increased. Other medications included Oxycodone and Neurontin. In late march 2007 or early April 2007, the subject experienced a "sharp intense pain in his shoulders'' after "shoveling sidewalks out of his yard", and reported that magnetic resonance imaging of the shoulder was negativie fora tear but showed tendonitis of the rotator cuff. He was subsequently enrolled in physical therapy from 11 April 2007 and 30 April 2007, and was also treated with oxycodone, Celebrex, and pain patches. The subject was diagnosed with bilateral deep vein thrombosis chareacterized by leg pain, and was hospitalized from 10 July 2007 to 20 July 2007. Dep vein thrombosis was treated with Coumadin and Lovenox. These events were assiesed to be incidental findigns upon review of medical records. Follow up information was received on 04 June 2009 via medical records. on 20 March 2007, impression of the subject''s condition by a pain clinic physician included "neuropathic type pain related to LYMERIX vaccine", and he was instructed to increase gabopentin. By 09 April 2007, the subject ahd completed intravenous immunoglobulin injections for post-LYMERIX vaccination with snsory neuropathy "thought to be secondary to that process". There was no change in symptoms with IVIC. Impressions included small fiber snsory plyneuropathy "possibly a post LYMERIX vaccination reaction", and chronic low back and coccya pain. On 12 September 2007, the subject was seen for evaluation at a pain clinic with an impression of worsening low back pain following discontinuation of Lidoderm, recent deep vein thrombosis, status post LYMERIX vaccine with associated pain, hypertension, enlarged prostate and opioid tolerance. Medications at the time included OxyContin, and Lidoderm was restarted. On 23 February 2008, the subject re ported discomfort in his legs since being off Coumadin, stating that it felt like deep vein thrombosis did.


VAERS ID: 237787 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Male  
Location: Maryland  
Vaccinated:2005-03-31
Onset:2005-04-02
   Days after vaccination:2
Submitted: 2005-04-13
   Days after onset:10
Entered: 2005-05-23
   Days after submission:40
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 616A2 / 2 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0070N / 2 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W1582 / 2 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 494033 / 2 LL / IM

Administered by: Other       Purchased by: Other
Symptoms: Anaemia, Aspiration, Brain oedema, Cardio-respiratory arrest, Convulsion, Electrolyte imbalance, Haemolytic anaemia, Haemolytic uraemic syndrome, Nephritis, Pulmonary congestion, Pyrexia, Renal failure, Thrombosis, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (broad), Haemolytic disorders (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Renovascular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-04-04
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Mefloquine 30mg q wk; Acetaminophen 80mg q 4h prn.
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Anemia, Electrolyte Imbalance
CDC Split Type:

Write-up: Vomiting, low grade fever, anemia, electrolyte imbalance, seizure like activity, and cardiopulmonary arrest. Received autopsy report which revealed COD as hemolytic uremic syndrome w/glomrulo microthrombi & bilateral acute interstitial nephritis. Other findings at autopsy: cerebral edema, hemolytic anemia, acute renal failure, pulmonary congestion c/w aspiration pneumonia.


VAERS ID: 238845 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Male  
Location: Florida  
Vaccinated:2002-11-07
Onset:2003-02-17
   Days after vaccination:102
Submitted: 2005-05-31
   Days after onset:833
Entered: 2005-06-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER N1002AA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain upper, Arterial thrombosis, Blood calcium decreased, Blood creatinine increased, Blood glucose increased, Bronchitis, Chest pain, Condition aggravated, Dyspnoea, Infection, Laboratory test abnormal, Oesophagitis, Platelet disorder, Skin ulcer, White blood cell disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haematopoietic leukopenia (broad), Haematopoietic thrombocytopenia (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Tumour lysis syndrome (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Combivent; Flovent; Levoxyl
Current Illness:
Preexisting Conditions: Bronchitis/Emphysema; Hypothyroidism; Chronic intermittent upper epigastric/musculoskeletal chest pain.
Allergies:
Diagnostic Lab Data: Cardiac catheterization on 2/21/03 revealed normal coronary artery, normal left ventricular ejection fraction, 60% right common iliac lesion. Portable chest x-ray on 2/18/03 which revealed a right apical opacity, age not identified, need comparison with older radiograph or CT scan of the thorax. Sodium 137, potassium 5.2, chloride 96, CO2 33, glucose 186, BUN 36, serum creatinine 1.6, calcium 8.6, AST 38, ALT 52, White count 10, hemoglobin 13.2, hemocrit 39.5, platelets 196.
CDC Split Type: C200300056

Write-up: Additional information received on 3/18/05. A 67 year old male received RSV vaccine or placebo and Influenza vaccine on 11/7/02 and 102 days later was admitted to the hospital for chest pain. A chest x-ray revealed bronchitis and infection of the lungs per patient. ECG and catheterization was done to rule out cardiac condition. The patient was treated with Prednisone 40mg QD from 2/17/03 to 3/3/03 and Tequin 400mg from 2/17/03 to 2/29/03. The patient recovered and was discharged on 2/22/03. The investigator assessed the events as possibly related to the study products. Follow up information received 2/28/03: Patient is a pleasant 67 year old, white male with a history of chronic intermittent upper epigastric/musculoskeletal chest pain, history of emphysema/COPD, hypothyroidism, with a recent negative Cardiolite stress test and negative GI work up, who presents with upper epigastric substernal chest pressure with shortness of breath on exertion. Patient has received negative GI work up recently with negative ultrasound of the bladder and questionable ROD for esophagitis. On admission, the patient was placed on rule out myocardial infarction. Cardiology evaluation with a recommendation of cardiac catheterization on 2/21/03 with normal coronary arteries with 60% right common iliac lesions. The cardiac cause of pain was then ruled out. During this admission, the patient was placed on Prevacid 30mg twice a day with improvement of his upper epigastric/lower sternal chest pain. Patient is waiting for an outpatient follow up with Gastroenterology for further evaluation of his atypical chest pain which could be gastrointestinal or musculoskeletal in origin. Discharge diet is cardiac diet. Activities as tolerated. Condition is stable. Follow up in 7 to 10 days. Also follow up in gastroenterology in 7 to 10 days. Additional information received on 3/18/05. Investigator reported that discharge diagnoses were considered pre-existing conditions. Also confirmed the causality as possible. Unblinding information received on 5/16/05. The subject received Non-Adjuvanted RSV vaccine.


VAERS ID: 241933 (history)  
Form: Version 1.0  
Age: 5.0  
Sex: Female  
Location: Illinois  
Vaccinated:2005-07-26
Onset:2005-07-27
   Days after vaccination:1
Submitted: 2005-07-30
   Days after onset:3
Entered: 2005-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DPP: DIPHTHERIA TOXOID + PERTUSSIS + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK LA / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Discomfort, Injection site pain, Injection site swelling, Pruritus, Rash, Thrombosis
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: pulmonic stenosis, Chiari 1 malformation, lymphanic malformation on l arm, thyroglossal cyst trunk removal, on low potassium diet high carbs for potassium peaks throughout the day.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: My daughter had her MMR shot placed in l upper arm and her diphtheria tetanus pertussis and polio put on her r upper arm. Reactions as follows- on her r arm after 24 hrs abnormal swelling and tenderness to the size of a peach. My daughter has a lymphanic malformation from birth and it was not reacting until the day after the MMR where her lymphanic malformation seemed to have a thrombosis reaction and appeared to clot. Doctor prescribed an aspirin a day and warm packs for the left arm until the thrombosis or clot goes away and cold packs to reduce the discomfort of the r arm swelling. She also started to react with an all over rash or uncontrollable itchiness which starts in the pm and was prescribed benadryl until discomfort goes away.


VAERS ID: 246007 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Male  
Location: California  
Vaccinated:2002-12-18
Onset:0000-00-00
Submitted: 2005-10-24
Entered: 2005-10-25
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV063 / 3 - / -

Administered by: Military       Purchased by: Military
Symptoms: Acute coronary syndrome, Angioplasty, Arterial thrombosis, Arthralgia, Cardiac disorder, Cardiac failure, Catheterisation cardiac abnormal, Chest discomfort, Chest pain, Coronary arterial stent insertion, Coronary artery disease, Cough, Dizziness, Dyspnoea, Electrocardiogram ST segment elevation, Electrocardiogram normal, Fatigue, Headache, Hyperhidrosis, Labyrinthitis, Myalgia, Nausea, Pain, Palpitations, Pericarditis, Sinusitis, Skin ulcer, Sleep disorder, Vertigo
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Other ischaemic heart disease (narrow), Vestibular disorders (narrow), Chronic kidney disease (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Nitroglycerin as needed sublingual, Ambien 10mg 1 tab oral, Vicodin 500mg-5mg) 2 Tablets every 6-8 hrs as needed oral, Atenolol 100mg 1 time a day oral, Norvasc 2.5mg oral, Lasix 40mg 1 tablet 4 times a day oral, Zestril 20mg 1 tablets 2 t
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Developed atherothrombosis that quickly spread to multiple coronary arteries requiring stents. On 23Dec02 he experienced headache, nausea and dizziness. Patient contacted the Vaccine Healthcare Center for evaluation of his coronary artery disease and the possibility that its onset is associated with the receipt of the anthrax vaccine received in 2002-03. He is a DOD civilian who received the anthrax vaccine as Emergency Essential Personnel. He received no other vaccines simultaneously. The following is an accunt of the sequellae: 18 Dec 02: Anthrax vaccine #1: Experienced no immediate local or systemic reaction, however on 23 Dec 02 he experienced headache, nausea and dizziness. He sought medical care and was given no specific diagnosis or treatment. To the best of his memory all symptoms from above resolved by the time of anthrax #2. 14 Jan 03 Anthrax vaccine #2: On 25 Jan 03 he awakened and was not able to stand due to dizziness, nausea and sweating. He was taken to an urgent care center and was diagnosed with vertigo and labyrinthitis and given Valium and "anti-motion sickness pills.'' EKG was unchange. These symptoms have diminished but are still present in mild forms at times. 29 Jan 03 Anthrax vaccine #3: He still had vertigo when he received the immunization and it continues intermittently to this day. No other post vaccine symptoms. On July 6th 2003 he became short of breath when running up a flight of stairs and developed pain across the shoulders. These symptoms subsided with rest. However, the next evening while exercising, he felt his heart "just stop and cramp up like a charley horse." He began coughing and felt palpitations. With an active attempt to relax the symptoms subsided. Over the next 3 days he became increasingly fatigued and on 9 July 03 felt chest pressure and sought medical treatment. Cardiac labs were negative, there were no changes in his EKG however BP was 160/100. The diagnosis of acute coronary syndrome was made and he was admitted to telemetry. Cardiac cath revealed "high grade proximal RCA and mid-LAD lesions. Both were successfully stented and he felt "great for about a month." (1st angioplasty - 1st and 2nd stent- 10 Jul 03). In mid Aug 2003 he began getting short of breath on exertion and feeling fatigued. On 14 Aug 03 he began having chest tigntness. He also was not sleeping well. Angiogram revealed a right posterior descending artery occlusion. It was successfully stented. (2nd angioplasty 3rd stent-15 Aug 03). In Feb 04 he again experienced chest pain in the center/left side of the heart and was evaluated in an emergency room. His CK-MB, troponin, and CPK were within normal limits but his EKG showed "widespread ST elevation consider pericarditis." He also presented with symptoms of sinusitis. He was given an antibiotic and told to take anti-inflammatory drugs. All symptoms resolved within a few days. If he laid on his side or sat up and forward the pain resolved. Intermittently he has this same pain everyday at different levels. He occasionally takes ibuprofen 2-4 tabs for relief of the pain. Two weeks later in March 2004 he again felt pressure and pain across the shoulders. On cardiac cath a high grade stenosis in the body of the left circumflex was found. Another stent was placed. (3rd angioplasty 4th stent-15 Mar 04). In May 2004 he again experienced pressure and pain across the shoulders and right arm. "The doctor decided to stent every suspected diseased artery on my heart that had the slightest indication." Stents were placed in the distal left anterior descending and left circumflex obtuss marginal arteries. (4th angioplasty 5th, 6th and 7th stent - 18 May 04). Patient reports joint pain started with right elbow and generalized muscle soreness around mid 2004. Patient states his docotrs believe this is due to the antilipid drugs. Currently he has this pain in the AM and is intermittently related to position or activity and pressure in right elbow and left knee. He was asymptomatic and active until January 2005 when once again he experienced shortness of breath and shooting pain across the right side of the chest and into the right arm that was relieved by nitroglycerin. He was then diagnosed with 2 more blocked arteries and he had stents in the 1st obtuse marginal and posteriolateral (5th angioplasty 8th and 9th stent - 25 Jan 05). In July 05 he required 3 more stents in the mid to distal left anterior descending artery and the descending 1st diagonal artery and the left anterior descending artery that were 80-90% blocked. (6th angioplasty and 12th stent). A 4th stent will be performed shortley to the (7th angioplasty and 13th stent). He states during this time his BP has been labile and fluctuates from 220/120 and down to 120/75. He also gets palpitations lightheadedness (He states this not the same as the vertigo described above and symptoms are not related to hypoglycemia). Patient is concerned that his progressive cardiac condition may be secondary to the anthrax vaccine since symptoms began after receipt of the vaccine and a cardiac catherization in Jan 95 determined that he did no need stenting. (Patient states he had a catheterization done because he required a pre-surgery physical that showed a possible "clogged artery and damaged heart." However, it was determined that the test was not conclusive, so a catherterization was performed). Cardiac catheterization results Jan 1995: 1. "Hypertrophic, obliterative left ventricle" 2. "30% Mid LAD is the only coronary disease." Currently patient states his providers are baffled regarding the rapid progression of his coronary artery disease. He requests cardiology review for possible association of the anthrax vaccine series and his disease progression, indentification of the possible mechanisms involved and recommendations for treatment to abort this mechanism. Information from 60 day follow-up report states: DOD cardiologists did not feel pt''s RAD and multiple stents were the result of AVA. Pt still pursing issue by sending EKG''s before the vaccine (normal) and EKG''s after the vaccine (abnormal). Medical direction will take case again to cardiac working group. Pt''s CAD continues to progress. 1/1/10 follow up - the WRAMC cardiologist CAD was vaccine related. pt did not want to accept this. have not had further contact


VAERS ID: 246079 (history)  
Form: Version 1.0  
Age: 1.01  
Sex: Male  
Location: Connecticut  
Vaccinated:2005-01-10
Onset:2005-01-12
   Days after vaccination:2
Submitted: 2005-10-18
   Days after onset:278
Entered: 2005-10-26
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVA130AB / 2 - / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0437P / UNK - / IM

Administered by: Private       Purchased by: Private
Symptoms: Anaphylactic reaction, Cardiac arrest, Disseminated intravascular coagulation, Febrile convulsion, Nervous system disorder, Respiratory distress, Sepsis, Thermal burn, Thrombosis, Toxic epidermal necrolysis
SMQs:, Torsade de pointes/QT prolongation (broad), Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-03-02
   Days after onset: 49
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: H/O bronchitis and eczema, sister with JRA and food allergies
Allergies:
Diagnostic Lab Data: Skin BX consistent with TENS.
CDC Split Type:

Write-up: Febrile seizure 2 days after administration. Developed worsening febrile seizures. Was put on phenobarbital and eventually died from complications of TENS. Received D/C summary which revealed final dx: TENS, septicemia, cardiopulmonary arrest, DIC, ARDS, right femoral artery thrombosis. Developed TENS after receiveing Pb & augmentin for febrile sz & had anaphylaxis to IVIG given for atypical Kawasaki dx w/50% total body desquamation.


VAERS ID: 248173 (history)  
Form: Version 1.0  
Age: 36.0  
Sex: Male  
Location: Virginia  
Vaccinated:2005-11-08
Onset:2005-11-20
   Days after vaccination:12
Submitted: 2005-11-24
   Days after onset:4
Entered: 2005-11-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020072 / 1 LA / ID

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood creatine phosphokinase increased, Chest pain, Electrocardiogram abnormal, High density lipoprotein decreased, Injection site erythema, Injection site pain, Injection site reaction, Laboratory test abnormal, Lymphadenopathy, Malaise, Muscle spasms, Pyrexia, Respiratory disorder, Thrombosis
SMQs:, Rhabdomyolysis/myopathy (broad), Dyslipidaemia (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Thrombophlebitis (broad), Acute central respiratory depression (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Lipodystrophy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: Mild upper respiratory infection without fever.
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: As above in clinical course. Note that there is no evidence by ECG or symptoms or echocardiogram of any pericarditis. Initial ECG on 20NOV05 with 3mm ST elevations in V4-V6 (and less so in V3, II, F, I and L) with resolution to normal ECG on 23NOV05.
CDC Split Type:

Write-up: On 20Nov2005 the patient had severe chest pain and evaluation showed 3mm ST elevation on ECG; pain relieved with one Aspirin and one sublingual nitro. Total 90 mins pain before sought care and got nitro. Sent to hospital where was pain free but got lytic therapy for continued ST elevation. Cardiac enzymes positive with total CK 1394, total MB 96. Cardiac risk factors of smoking and low HDL (HDL 24 on 23NOV05). Smoker of 1 ppd for over 20 years. Pain free now since 20November after first nitroglycerine administration. Cardiac cath on 23NOV (sent to hospital on 22NOV05) showed normal coronary arteries with no thrombus, no muscle bridging, and no spasm. Wall motion by LV-gram and by echocardiogram on 23NOV was normal, with EF 60%. Normal echocardiogram other than mild left atrial enlargement. My assessment as his cardiologist: Acute ST elevation MI due to vasospasm and possibly some degree of acute plaque rupture or thrombus, but relieved with nitroglycerine. 90 minutes of pain with enzyme proven cardiac injury. Likely related to a combination of factors: (1) Patient was febrile, had severe local reaction to vaccinia site with erythema and pain and local lymphadenopathy and was feeling generally ill from 18-20NOV 2005, (2) Patient had upper respiratory illness starting 5NOV2005 that he felt became worse and more symptomatic over same time period of 18-20NOV05, (3) Smoker chronically and at the time of event, and (4) Possible abnormal lipids lending to endothelial dysfunction. It seems likely that the brisk local and systemic reaction to the vaccine played a role in the event.


VAERS ID: 248442 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: Delaware  
Vaccinated:2003-02-27
Onset:2003-03-01
   Days after vaccination:2
Submitted: 2005-11-29
   Days after onset:1004
Entered: 2005-11-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV069 / 1 LA / SC

Administered by: Military       Purchased by: Military
Symptoms: Abasia, Anaemia, Arthralgia, Asthenia, Blood sodium increased, Chills, Decreased appetite, Dehydration, Diarrhoea, Dizziness, Haematocrit decreased, Headache, Hyperhidrosis, Hypokinesia, Hypotension, Influenza like illness, Injection site oedema, Laboratory test abnormal, Lymphopenia, Monocytosis, Nausea, Pain, Pyelonephritis, Pyrexia, Rash, Red blood cell count decreased, Serum sickness, Tenderness, Thrombosis, Upper respiratory tract infection, Visual disturbance, Vomiting, White blood cell count increased
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Parkinson-like events (broad), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Dehydration (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: PCN cephalosporin and sulfa drug allergies (rash)
Allergies:
Diagnostic Lab Data: Labs 03/06/2003 urine pregnancy negative, blood culture no growth after 5 days urine clean catch culture moderate WBC''s, few squamous epithelial cells, moderate gram negative rods, vaginal micro flora seen 7000 CFU/ML E Coli, 3000 CFU/ml mixed gram positive organisms (resistant to ampicillin gentamicin Tobramycin, Trimeth -sulfa, 03/07/03 Sodium 135 (136-146), Potassium 3.5, Chloride 107, Total CO2 24 BUN 4 (8-22), creatinine 0.8, Anion gap 6, CBC, WBC 11.4 (3.5 - 11.0), RBC 3.78 (3.8 - 5.2), HCT 32.1 (35-48), PLT 248, Elec ANC 6.6 (1.8 - 6.3), Autom grans 58.0, Autom lymph 21.5 (25-40), Autom monos 18.9 (4 - 10), Autom Eos 1.1, Autom EOS 1.1, Autom Basos 0.5, Neutrophils 55 Bands 10 (0-1) Lymphocyte 20 (25-40), Lymph atypical 4 (0), Monocyte 11 (4-10), Hypochromasia slight, Protime 12.0, INR 1.1, PTT 28
CDC Split Type:

Write-up: 1 week after service member received anthrax vaccine (1) she developed fever up to 104, headaches, myalgias, back pain, anorexia and dizziness. History was obtained from hospital records dated 03/04 through 03/08/2003 and a telephone interview with service member on 09/27/2005. Service member has poor recall of specific details surrounding reaction as she was acutely ill and it was over 2 years ago. 27 year old female who received her first anthrax vaccine on 02/27/2003 (Thursday). Service member received the anthrax vaccine in her left arm. She does not recall if she received the vaccine in the triceps or deltoid region, but recalls some swelling and tenderness surrounding the site, she does not recall other details pertaining to a local reaction. Approximately 1-2 days after vaccine receipt, service member developed fever, chills alternating with sweats, nausea and generalized body aches. It felt like she was coming down with the flu. After the symptoms persisted for 48 hours, she called the Immunization clinic and was told to call back in a few days if the problems persisted. When she called back in a few days as instructed, she was told over the phone that her symptoms were probably not from the vaccination. During the next two days, she continued to run a temperature up to 104 degrees and experienced nausea and had difficulty taking in fluids and food. Her symptoms continued to worsen to the point where she was dizzy, very weak, and she could not keep anything down. She reports virtually no fluid intake (when subtracting input from output) for 3-4 days and continued to run high fevers. Around post vaccination day 4 or 5, She still had generalized aches, but also developed severe joint pains which affected all her joints. She described this pain as every single joint in my body hurt like never before. She was unable to walk and was only able to do minimal activities of daily living not much of anything functional, except breath and it even hurt to do that. She rates the joint pain intensity as a level 8 using a pain scale of 0 no pain to 10 worst pain ever experienced). She does not recall any joint redness, warmth, or significant edema. She also began experiencing some flank pain left $g right side, this pain intensified with coughing and deep breaths. On 9/4/2005 she made an appointment with her primary care provided, who after consulting web sites and infectious disease physician, stated that she was very confident this was in fact a reaction from the anthrax vaccination, She was seen again on 3/6/03 at the clinic where it was noted that she was hypotensive and severely dehydrated. She was then referred to the ER. While in the ER, she received 6 liters of IV fluids and was then admitted. Her diagnoses at time of hospital discharge were, Pyelonephritis (both her primary care provider and service member feel that her dehydration contributed to the development of of pyelonephritis, serum sickness due to anthrax vaccine, and Anemia. It was later determined that this episode was line of duty and her related medical expenses were covered through the military. After she was discharged, she recalls being on bed rest for a week before returning to her usual routine. She has had no recurrence of pyelonephritis, but does typically have 1-2 UTI''s per year. She was instructed by an infectious disease physician not to receive additional anthrax vaccines. her anemia was treated with iron supplements and has continued to be monitored, according to service member, it was improved without additional evaluation or treatment. Patient denies similar reactions following vaccinations or medication prior to March 2003 or since then. She does not specifically recall any rashes or cutaneous manifestations, but her hospital records note a faint rash on her abdomen. her records also mention headache, visual changes with her dizziness, passing a clot vaginally the morning after admission (1 1/2 weeks following her LMP), and one diarrhea stool on the morning of admission, but none prior. She does not specifically recall details recall details related to theses symptoms as she was acutely ill. She had no recent travel prior to her admission. She was out of the country 5 month prior). She denied any infections prior to vaccine receipt. She has no history of STD''s. She says that her GU related symptoms did not occur until after she was dehydrated, she does not recall experiencing any dysuria, hematuria, or urgency. She had not initiated any new medications prior to symptom on set. Refer to Family history below.


VAERS ID: 252727 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Michigan  
Vaccinated:2006-02-13
Onset:2006-02-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2006-03-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1858EA / UNK LA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0740R / 1 RA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Cellulitis, Injection site pain, Lymphadenopathy, Synovitis, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Rheumatoid Arthritis, Autism Discharge summary states allergy, otitis media. msv
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Rx axillary lymph node swelling and rt arm discomfort. Cellulitis requiring hospitalization and IV-ABX sent home with picc line and IV-ABX developed clots hospitalized again. Dc''d with PO ABX and Coumadin. DVT''s L arm Discharge summary states synovitis. msv


VAERS ID: 257932 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Female  
Location: Florida  
Vaccinated:2006-04-28
Onset:2006-04-30
   Days after vaccination:2
Submitted: 2006-05-31
   Days after onset:31
Entered: 2006-06-06
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Deep vein thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0605USA04661

Write-up: Information has been received from a physician concerning a 74 year old female with reportedly no adverse drug reaction or allergy, who on 4/28/2006 the patient experienced deep vein thrombosis DVT and was admitted to the hospital. It was reported that the patient had blood work performed. The patient was given intravenous IV heparin. It was reported, that the patient was on enoxaparin sodium Lovenox therapy until the patients warfarin sodium Coumadin became therapeutic. Additional information has been requested. Follow-up: This WAES number was voided, as it was determined to be a duplicate of WAES number 0606USA01896.


VAERS ID: 258918 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Male  
Location: Maine  
Vaccinated:2006-04-20
Onset:0000-00-00
Submitted: 2006-06-26
Entered: 2006-06-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0505R / UNK RA / UN

Administered by: Private       Purchased by: Public
Symptoms: Abdominal pain, Abscess, Bacterial infection, Coagulation time prolonged, Constipation, Cough, Dyspnoea, Hepatocellular damage, Laboratory test abnormal, Pericardial effusion, Pleural effusion, Pneumonia, Sepsis, Thrombosis, Vomiting
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: Blood culture positive Alpha hemolytic streptococci 5/6/06. CXR revealed pneumonia. BC positive for alpha strep. CXR repeated nodular pneumonia identified. CT of chest and abdomen showed lung nodules, right pleural effusion and a large liver abscess. Liver abscess drained and positive for alpha strep and negative for malignancy. Repeat CT scan on 5/11/06 showed clot in right hepatic vein extending through junction of hepatic vein and IVC with some extension into IVC. Lab and Diagnostic Data: WBC 9.9; Hgb 9.0, HCT 26.3, Plat 248, 10 bands, 17 lymphs, 3 monos, 68 polys. INR 1.4, PTT 29, fibrinogen 494, PT 12.3. Factor V Leiden positive for heterozygous for factor V Leiden mutation. PT gene negative. CMP; sodium 131, potassium 4.4, chloride 101 bicarb 24, BUN 7, creatinine 0.5, protein 5.8, albumin 2.2, alk phos 99, AST 61, ALT 51, iron saturation 19, ferritin 450, iron blood level 32 and TIBC 169. Blood cultures positive for alpha strep intermedius. CXR 5/12/06 moderate right pleural effusion. CXR 5/16/06 continued moderate right pleural effusion. Initial and repeat Cardiac echo showed small pericardial effusion but no evidence of valvular disease.
CDC Split Type:

Write-up: Alpha strep intermittent pneumonia, empyema, liver abscess, hepatic vein clot. 07/17/06-records received from Maine Med Ctr the receiving hospital for transfer of patient. DOS 5/11-5/19/06 DC Principal DX: Alpha strep intermedius pneumonia and bacteremia. DC Secondary DX: Empyema Liver abscess Hepatic vein clot Constipation Fact V Leiden heterogeneous deficiency Reason for Admission: Beginning symptoms present on 4/20/06 at time of hepatitis B vaccine. Three days later he developed fever, cough and vomiting and three days later PCP DX viral syndrome. Symptoms persisted included 7-10 pound weight loss and CXR revealed pneumonia. BC positive for alpha strep. Presented at ED for c/o persistent cough, abdominal pain and diarrhea. Admitted to ICU. Transferred to Maine Med Ctr. C/O SOB attributed to drainage of empyema. Hospital Course and Treatment: Ceftriaxone, gentamicin, heparin, enoxaparin . DC included IV home therapy, enoxaparin sc. krk


VAERS ID: 259192 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-03-01
Onset:2006-05-22
   Days after vaccination:82
Submitted: 2006-07-05
   Days after onset:44
Entered: 2006-07-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Abortion spontaneous, Laboratory test abnormal, Pelvic pain, Thrombosis, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Termination of pregnancy and risk of abortion (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood human chorionic gonadotr 06/09/2006 96 UI/L low 15 (normal 3-4W) High 150 (normal 3-4W); Pregnancy test positive 05/29/2006; Urine pregnancy test doubtful 06/06/2006,
CDC Split Type: B0428352A

Write-up: This 20-year-old female subject was enrolled in a blinded study (580299 099) for the prophylaxis of cervical intraepithelial neoplasia (CINII) associated with human papillomavirus (HPV); 16 and/or HPV-18 in health young females. The subject received intramuscular investigational product single dose on 09/21/2005, 11/01/2005 and 03/01/2006 after negative urine pregnancy test. Site of injection was the left deltoid. On 09/21/2005, 11/01/2005 and 03/01/2006, the subject received the first, second and third intramuscular injection of blinded study vaccine in the left deltoid. The subject had been randomized to receive the active control in this trial, an investigational formulation of Havrix vaccine containing 720 ELISA units of hepatitis A antigen and 500 ug AL (OH) 3. Lot number was not provided. On 05/22/2006, 82 days after the third dose of Blinded vaccine, this 20-year-old subject developed abundant vaginal bleeding with clots associated with pelvic pain. (last menstrual period: 03/15/2006, the subject was exposed to the vaccine before conception). On 05/28/2006, the vaginal bleeding stopped. On 05/09/2006, the subject performed a blood pregnancy test which was positive. the microbiologist indicated that the result was only slightly positive and recommended her to visit a doctor because it could be a miscarriage. The subject didn''t consult a doctor because the vaginal bleeding stopped on 05/28/2006 and she felt well. On 06/05/2006, she was evaluated by the study doctor. He documented a closed, formed cervix, without vaginal bleeding, an uterus with normal height and doubtful urine pregnancy test (non serous adverse event). On 06/09/2006, when she was 12+1 weeks pregnant according to the date of last menstrual period, a quantified HCG test was performed. On 06/20/2006, the result of this test was received: 96 UI/L (normal values after 3-4 weeks pregnancy: 15-150 UI/L). The subject was finally diagnosed as having had a complete spontaneous miscarriage since she presented with vaginal bleeding and a positive blood pregnancy test with decreased HCG. The event resolved on 05/28/2006. The subject will continue in the study. The investigator reported the complete spontaneous abortion as possibly related to investigational product due to the temporal association between the last vaccine dose administration and the date of the last menstrual period. This event has been considered to be medically important. (OMIC)


VAERS ID: 261076 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Kansas  
Vaccinated:2006-05-08
Onset:2006-05-27
   Days after vaccination:19
Submitted: 2006-08-01
   Days after onset:66
Entered: 2006-08-04
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U1769A / 1 RA / -
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS ACSB004AB / 6 LA / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abortion spontaneous, Endometritis decidual, Inflammation, Necrosis, Thrombosis, Unintended pregnancy, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient has no past medical history, illness or allergies. From follow up information received on 7/24/06, it was reported that it is unknown whether the patient had ever experienced any adverse event following prior vaccination. The date of the patients last menstrual period was in Feb 2006 and her estimated date of delivery was in Nov 2006. She had no history of previous pregnancies.
Allergies:
Diagnostic Lab Data: The patient had a positive pregnancy test on an unspecified date. A copy of the surgical pathology report dated 5/27/06 was provided. Products of conception was submitted for examination and were determined to consist of gestational endometrium and decidua with necrosis and inflammation. Also included were portions of blood clot. Chorionic villi were not identified. No changes were present to suggest malignancy.
CDC Split Type: 200601075

Write-up: Initial report received from a healthcare provider on 5/9/06. A 16 year old female patient had received a right deltoid injection of Menactra, lot number U1769AA, and a left deltoid injection of Boostrix, lot number ACSB004AB, on 5/8/06. The patient had no period for two months and was referred to an OB.GYN for pregnancy follow up. An estimated date of delivery was not provided. Per the reporter, there was no adverse event. Follow information received on 6/26/06. Per the reporter, the patient was not evaluated in their medical office. Follow up information received on 7/24/06. The date of the patients last menstrual period was in Feb 2006 and her estimated date of delivery was in Nov 2006, She had no history of previous pregnancies. On 5/27/06, 19 days post vaccination, the patient was seen by a physician for bleeding during pregnancy. She was determined to be having a spontaneous abortion (less than 20 weeks gestation). A copy of the surgical pathology reported dated 5/27/06 was provided. Products of conception was submitted for examination and included were portions of blood clot. Chorionic villi were not identified. No changes were present to suggest malignancy. The patient has no known maternal drug exposure. She had no exposure to alcohol, tobacco or recreational drugs during her pregnancy. It was not reported whether the patient recovered from the event. Based upon the new information provided in this follow up report, this case is being upgraded to serious (OMIC).


VAERS ID: 261671 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: Delaware  
Vaccinated:2004-10-04
Onset:2005-02-01
   Days after vaccination:120
Submitted: 2006-08-15
   Days after onset:559
Entered: 2006-08-17
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV088 / 5 UN / SC
MEN: MENINGOCOCCAL (MENOMUNE) / CONNAUGHT LABORATORIES UB505AA / 2 UN / SC

Administered by: Military       Purchased by: Military
Symptoms: Antineutrophil cytoplasmic antibody, Antinuclear antibody, Blood thyroid stimulating hormone, C-reactive protein, DNA antibody, Deep vein thrombosis, Electrocardiogram normal, Fracture, Full blood count, Hypercoagulation, Laboratory test abnormal, Laboratory test normal, Metabolic acidosis, Pain in extremity, Pulmonary hypertension, Respiratory distress, Sepsis, Septic shock, Streptococcus test positive, Ultrasound Doppler abnormal
SMQs:, Anaphylactic reaction (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Toxic-septic shock conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (narrow), Accidents and injuries (narrow), Cardiomyopathy (broad), Osteoporosis/osteopenia (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 15 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: Refer to Clinical Summary Raynaud syndrome history of migraine Lipomas
Allergies:
Diagnostic Lab Data: ECG NSR, normal ECG, 2/23/05 Lung perfusion scan impression normal lung perfusion study with no evidence of pulmonary embolism, 2/26/2005 ultra sound venous Doppler right leg impression no thrombus in right common superficial femoral and popliteal, thrombus in the proximal portion of right tibial and peroneal veins just below the bifurcation. Lab 1/20/04Lymes, ANA RF SCL 70 ESR CRP hep profile, SSA, SSB, SM, RNP, C3, C4, JO 1 antibody ANCA, TSH, CBC, Chem panel all normal or negative. 3/14/05 Factor 5 Leiden mutation B mutation this test is a direct mutation analysis of leukocyte genomic DNA by the invader assay system. Factor leiden mutation is heterozygous. This individual dose have factor Leiden mutation on one allele Heterozygous carrier. The factor 5 Leiden mutation is a risk factor for venous thrombo embolism. Recurrent miscarriage complication of pregnancy and possible arterial thrombosis. The individual may have other genetic and other environmental risk factors for thrombosis. Consider additional testing for hemostatic disorders associated with increased thrombosis risk if indicated. Consider genetic consultant and counseling of potentially effected family members regarding lab testing.
CDC Split Type:

Write-up: She received her fifth anthrax vaccine, along with meningococcal vaccine on 10/04/04. She does not recall any significant local reaction or prolonged or debilitating systemic symptoms following vaccine receipt. She began experiencing left foot pain in early Feb 2005, She was first seen in military hospital. Medical notation of splint applied on right lower extremity between 2/2/05 and 2/14/05 fro suspected right foot stress fracture. Note from 2/16/05 with CC right calf pain since 2/12 was followed by an ultrasound to rule out DVT. Service member was admitted on 2/17/05 for right lower extremity DVT and was started on Lovenox and Coumadin. On 2/2205, she was med evac''d to hospital with diagnosis of right popliteal vein deep venous thrombosis confirmed by Doppler study on 2/17. At that time, she was taking Coumadin as directed. On 2/23/05, she was cleared for duty through Internal Medicine on Lovenox and Coumadin. She then transferred on 3/4/05. On 3/14/05 she was tested through the clinic and findings were positive for factor V leiden mutation (heterozygous disorder, but service member did not received results until Oct 2005. She also reports being told she has anti thrombin 3 deficiency, but there are no lab reports in the medical records available. Service member was a light smoker at the time she developed DVT. She had stopped her BCPs in Feb 2004. GYN noted from 8/04 notes birth control abstinence. With her initial presentation of right calf pain, she did not experienced any chest pain, fever, shortness of breath, or hemoptysis. She had no previous history of deep vein thrombosis or pulmonary embolus and denies any family history of thrombosis. Note in chart mentions possible family history of hypercoagulable disorder. Symptom Pain start 2/2004 comment right foot pain. Follow-up: Patient became pregnant before being separated from the military. She was placed on subcutaneous heparin throughout her pregnancy. She delivered a 6 pounds 8 ounce baby boy on 2/20/07 at 37 weeks 2 days. Initial APGAR was 8 at one minute and 9 at 5 minutes. On February 21st the infant began experiencing respiratory difficulties and was transferred to medical center where he expired later that day. Final diagnoses: sepsis, distributive septic shock, pulmonary hypertension, respiratory distress, and metabolic acidosis. Culture from patient on admission was positive for Group B strep.


VAERS ID: 265328 (history)  
Form: Version 1.0  
Age: 44.0  
Sex: Male  
Location: South Carolina  
Vaccinated:2003-09-02
Onset:2004-09-01
   Days after vaccination:365
Submitted: 2006-10-24
   Days after onset:783
Entered: 2006-10-25
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV077 / 3 UN / -

Administered by: Military       Purchased by: Military
Symptoms: Chest discomfort, Chest pain, Cough, Deep vein thrombosis, Dyspnoea, Injection site erythema, Injection site pain, Laboratory test abnormal, Lung disorder, Oedema peripheral, Pulmonary embolism, Respiratory tract infection, Syncope, Thrombosis
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Diagnostic Tests: 08 Sep 04: CT Chest-prominent clot burden in the pulmonary arteries bilaterally. The pulmonary parenchymal changes are minimal in magnitude at this time however. 08 Sep 04: bilateral lower extremity Doppler Venous Ultrasound-DVT demonstrated in the distal superficial femoral vein and popliteal vein of the left leg. 08 Sep 04: Chest PA and Lat-negative, 09 Sep 04: Echocardiogram: evidence of pressure overload right heart consistent with pulmonary embolism, 24 Sep 04: CT scan revealed left DVT at popliteal bifurcation and superficial deep femoral vein. Labs: 08 Sep 04: ABG''s-PCO2 53; PO2 56, HCO3-22.4, Lupus Panel-Thromboplast TM 37 (n: 23-36); APTT Mix- Baseline APTT 39 (n 23-36); Immediate mix 34; 1 hour Uncub mix 34, Russell''s Viper-65 (n <=44s), PTT-LA-51 (n<=40s), STACLOT-LA) is confirmed, a lupus anticoagulant is present, Antithrombin 3-93 (n 80-120%), RA screen-Negative, ANA-< 1:40-negative, 24 Sep 04: Chem-glucose 112, alk phos 150, Serum for Dipository prior to Sep 03: Cardiollpin IGG-7 (<23), Cardiollpin IGM-5 (<10), Cardiollpin IGA-1.2 (<22), Lupus Hexagonal-Negative
CDC Split Type:

Write-up: Pt reports being recently discharged from the hospital with a diagnosis of blood clots in both lungs and his left leg. Stated he had problems with his left leg being swollen for the past couple of months and was admitted after he experienced problems breathing and fainted while climbing the stairs. For about a week prior to his admission he noted some problems with his breathing but not as bad as it was when he was admitted. He stated he was seen for his breathing problems and was given antibiotics for a respiratory infection. He had a dry cough and some chest discomfort but was told that this was due to his blood clots. Is currently at home and is on Coumadin. He stated he had no problems with AVA 1 and 2 in Sep 03 and 3 in Dec 03. Other than slight arm soreness and redness, he denied fever, headaches, muscle and joint pain or swelling. Follow up 10/06 pt states he has been off his coumadin since April. Has had no further episodes of clotting since Sep 04, however the clot remains in his leg. he continues to wear his support stockings. Symptom Dyspnea (shortness of breath) start 9/2/04 end 9/15/04, chest pain start 9/2/04 end 9/4/04, swelling start 7/2004. Comment left leg swelling.


VAERS ID: 267181 (history)  
Form: Version 1.0  
Age: 66.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-10-28
Onset:2006-10-29
   Days after vaccination:1
Submitted: 2006-11-19
   Days after onset:21
Entered: 2006-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA234AA / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Epistaxis, Petechiae, Platelet count decreased, Thrombosis
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Aspirin: 81 mg Premarin Centrum Silver
Current Illness: none
Preexisting Conditions: Retinal Detachment (Right eye)
Allergies:
Diagnostic Lab Data: Platelet count: 1,100 (improved to 70,000 with treatment) LABS: Admit labs: Hgb 13.6, plts 1000, fibrogen 356, DDimer 0.57, PT 12.9, INR 0.97, PTT 27 & smear showed marked thrombocytopenia. D/C labs: plts 70,000. US of abd 11/2 revealed spleen size WNL.
CDC Split Type:

Write-up: ITP: petechial rash all over body, including over site of vaccine administration; blood clot in mouth, epistaxis, platelet count of 1100, events started 18 hours after administration of influenza vaccine (fluarix); symptoms improved with administration of steroids and IVIG in hospital, patient was discharged 6 days after admission with increased platelet count to 70,000 after treatment and had no further bleeding/petechiae after administration to hospital and treatment. 1/9/07 Received medical records from hospital which reveal patient admitted 10/31/06-11/6/06 with bleeding. Had red bumps on legs, arms, trunk & back for 2 days prior to admit after received flu shot on day bumps began. Also had a bloody nose & saw PCP who obtained labs which revealed plts of 1100 & patient sent for admit. Exam in ER revealed positive blood clot in left buccal mucosa, positive petechiae in upper palate, under tongue, bilateral extremities & back. Slight tender cervical LAD. Received steroids & IVIG in ER after heme consult. Slowly improved & d/c to home on tapering steroids & heme clinic follow up. FINAL DX: Idiopathic thrombocytopenia.


VAERS ID: 274003 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Male  
Location: Georgia  
Vaccinated:2006-01-18
Onset:2006-01-20
   Days after vaccination:2
Submitted: 2007-03-08
   Days after onset:412
Entered: 2007-03-15
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1063R / 7+ LA / IM

Administered by: Public       Purchased by: Other
Symptoms: Pain in extremity, Venous thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow), Tendinopathies and ligament disorders (broad)

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

Write-up: 1/20/06 "superficial calf pain, then severe calf pain 1/25/06. MD told patient of her "superficial vein thrombosis" secondary to Hepatitis B vaccine. After 3 weeks, bed rest, recovered, but vein remain sclerosed. Info per MD.


VAERS ID: 274556 (history)  
Form: Version 1.0  
Age: 0.35  
Sex: Male  
Location: Missouri  
Vaccinated:2006-11-06
Onset:2006-12-09
   Days after vaccination:33
Submitted: 2007-03-22
   Days after onset:102
Entered: 2007-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS ? / 2 UN / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 2 UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. ? / 2 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Barium double contrast, Bowel movement irregularity, Cold sweat, Crying, Decreased appetite, Foaming at mouth, Haematochezia, Hypotonia, Insomnia, Intussusception, Irritability, Pain, Screaming, Shock, Stomach discomfort, Thrombosis, Ultrasound abdomen, Vomiting, Wheezing, X-ray
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (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), Convulsions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Zantac
Current Illness:
Preexisting Conditions: Reflux PMH: GERD, bilat ing hernia repair, chickenpox, Birth HX: full term, unremarkable
Allergies:
Diagnostic Lab Data: LABS: air contrast enema revealed & successfully treated IS. No x-ray reports included w/records.
CDC Split Type:

Write-up: Our son has been having severe bowel cramping ever since the first dose of the rotavirus vaccine RotaTeq. He has suffered from abdominal cramping, severe crying spells, problems passing bowel movements, decreased appetite, fussiness, and loss of sleep. After having the second dose of the vaccine, his symptoms worsened until he finally developed intussuception. The day he developed this adverse reaction he began the morning with his usual fussiness. He hadn''t slept well the night before and was having trouble being held and bending in the middle. As I tried to give him his morning feeding, he persistantly refused to nurse and became more and more fussy. He arched his back and his stomach became hard. He began screaming out in pain and essentially foaming at the mouth. Following a severe screaming and crying spell, he went into shock. His skin became cool and clammy and he went limp in my arms. We called the pediatrician and they told us to take a rectal temperature. While taking a rectal tempature he passed a large bowel movement containing jelly-like blood clots. We rushed him to the emeregency room where he began to wheeze and vomit up bile. They took an X-ray of his abdomin, and followed up the X-ray with an ultrasound. The ultrasound confirmed the bowel telescoping. They did an air contrast enema to reduce the obstruction and then kept him in the hospital for the next two days for monitoring. When we met with our pediatrician following the intussuception, he didn''t mention that it could be related to the rotavirus vaccine. He went ahead and administered the third dose of the vaccine about a month after our son''s hospitalization. Since the third dose of the vaccine, we have been back to the emergency room with the same symptoms, but the bowel twisting has resolved itself without further medical enemas. 3/23/07 Received ER medical records which reveal patient experienced nasal congestion, pulling at left ear & irritability for approx 3 days prior to being seen in ER on 3/18/07. Exam revealed reddened left TM. PMH: s/p IS 3 wks ago. FINAL DX: left otitis media. 4/13/07 Received medical records from treating hospital which reveals patient experienced jaw clenching, diaphoresis, screaming, pallor, gen fussiness & bloody stools. In ER had bilious vomiting. Held overnight s/p IS reduction by enema. Progressed well & d/c to home. FINAL DX: Intussusception, reduced by air contrast enema.


VAERS ID: 279409 (history)  
Form: Version 1.0  
Age: 40.0  
Sex: Male  
Location: Ohio  
Vaccinated:2004-02-24
Onset:2007-01-08
   Days after vaccination:1049
Submitted: 2007-05-23
   Days after onset:134
Entered: 2007-05-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 5 UN / SC

Administered by: Military       Purchased by: Military
Symptoms: Cough, Deep vein thrombosis, Dyspnoea, Influenza like illness, Malaise, Pain in extremity, Pulmonary embolism, Pyrexia, Swelling
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations: denied~ ()~~0.00~Patient|denied~ ()~~0.00~Sibling
Other Medications: denied
Current Illness: denied
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: unavailable Records received 7/13/07-US revealed blood clot. DVT. Pulmonary function test revealed inflammation.
CDC Split Type:

Write-up: This 43 year old reported receipt of 6 Anthrax vaccinations between 1999 and 2004. He remembers typically experienced adverse events to include malaise, flu-like syndrome and fevers for one week. Onset cough, sob, calf pain, swelling Jan-March 2007 with dx Pulm embolism and DVT: common and superficial veins of leg. 7/13/07-records received-12/06 began to experience right calf pains, 1/07-experienced shortness of breath with wheezing. DX bronchitis. 3/07 right calf pain and calf swollen from knee to foot, US revealed blood clot. DVT. Treated with anticoagulant therapy. Surgery and TPA to remove clot. Right basal segmental pulmonary emboli.


VAERS ID: 281539 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-05-30
Onset:2007-05-30
   Days after vaccination:0
Submitted: 2007-06-12
   Days after onset:13
Entered: 2007-06-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0387U / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Oedema peripheral, Pain in extremity, Thrombosis
SMQs:, Cardiac failure (broad), Angioedema (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: ultrasound 06/04/07 - thrombosis in the left arm records received 6/21/07-Color duplex ultrasound of upper extremity venous system demonstrated acute deep vein thrombosis in left arm.
CDC Split Type: WAES0706USA00602

Write-up: Information has been received from a nurse concerning a 17 year old female who on 30-MAY-2007 was vaccinated with Gardasil (Lot #657621/0387U). There was no concomitant medication. On 30-MAY-2007 the patient developed impressive swelling and pain in her left shoulder down to her wrist. This occurred after the patient went swimming. It was reported that "the swelling gets less when the arm is not used but comes back when the patient uses the arm". A physician in the office told the patient to elevate and ice the arm in the area for a couple of days, but this did not help. On 04-JUN-2007 a Doppler ultrasound was performed which revealed thrombosis in the arm. It was reported that the swelling and pain were disabling to the patient. The patient''s swelling and pain persisted. No further information is available at this time. Additional information has been requested. 6/21/07-records received for DOS 6/11 and 6/17/07- Letter from PCP indicated that DVT is not thought to be due to vaccine it has probably been present for a few weeks. unfortunately it began to grow around the time of HPV thus the apparent association. Received HPV 5 days ago from this visit of 6/4/07-developed impressive swelling and pain that day while swimming. Arm literally twice normal size with pitting edema into arm pit. Swelling lessesn when not using arm but returns when she tries to swim or exerices. PE:left arm with non pitting swelling over entire arm, skin over arm is warm and well perfused fingers are cool on both hands but well perfused. ROM fine. Treatment, thrombolysis and mechanical thrombectomy, subclavian vein was virtually completely freed of thrombus. An underlying compression of the vein at the thoracic inlet was documented


VAERS ID: 283520 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Michigan  
Vaccinated:2007-03-06
Onset:2007-03-06
   Days after vaccination:0
Submitted: 2007-06-29
   Days after onset:114
Entered: 2007-07-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0187U / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abortion, Deep vein thrombosis, Drug exposure during pregnancy, Dyspnoea, Laboratory test, Thrombosis
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Pregnancy NOS (LMP = 1/28/2007)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: diagnostic laboratory - results not provided 7/11/07-records received Labs: Sticky platelet syndrome epinephrine response mildly increased ADP response normal amplitutde. PTT 25.3, PT 12.6. INR 1.1. D-Dimer 8706 high. Antithrombin III low 76. Doppler venous unilateral: acute deep venous thrombosis of left common femoral, superficial femoral and popliteal veins.X-rays no fracture.
CDC Split Type: WAES0706USA04112

Write-up: Information has been received from the Merck Pregnancy Registry from a physician concerning a 17 year old female with no pertinent medical history who on 06-MAR-2007 was vaccinated intramuscularly with the first dose of Gardasil (Lot # 656049/0187U). The patient was prescribed ethinyl estradiol (+) norgestimate (ORTHO TRI-CYCLEN) on the day she received the vaccination, but the reporter did not have any information regarding whether the patient was taking them or not. It was later learned that the patient was pregnancy when she received the vaccination. On 07-APR-2007, the patient experienced shortness of breath. On 14-APR-2007, she was hospitalized due to shortness of breath. It was later determined that the patient was experiencing a blood clot in her left leg, deep vein thrombosis (DVT). On 16-APR-2007, the hospital determined that the patient was 11 weeks and 1 day pregnant. The estimated date of delivery was 04-NOV-2007. Subsequently, the patient had an abortion performed for personal reasons not related to the vaccine. On 14-JUN-2007, the patient had not recovered from the blood clot and the reporter indicated that an unspecified blood thinner was recommended as treatment. At the time of the report, the blood clot persisted. The physician considered shortness of breath, abortion and blood clot in left leg to be other important medical events. The physician considered shortness of breath and blood clot in left leg to be immediately life threatening events. Additional information has been requested. 7/11/07-ER records received for DOS 4/14/07-DX: Recently diagnosed deep venous thrombosis. Possible pulmonary embolism. DX of blood clot 2 weeks prior. 4/14/07-attempted to terminate pregnancy, 12 weeks pregnant. Procedure not performed. C/O dyspnes on exertion. RX with Lovenox. No chest pain. Left let swelling and tenderness especially in popliteal fossa this has been ongoing for 2-3 weeks. 8/24/07-records received for DOS 04/07-04/10/07- DC DX: Deep venous thrombosis, left lower extremity. Intrauterine pregnancy. Status post trauma. Hypercoagulable state. Found to have a DVT of the lower extremity. Seen on 4/07/07-HX of few days before admission falling off the tub in the bathroom and hurting her legs. PE: tenderness and swelling in left lower extremity at level of calf and distal area of left thigh. Peripheral pulses present.


VAERS ID: 283826 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Missouri  
Vaccinated:2007-05-03
Onset:2007-05-21
   Days after vaccination:18
Submitted: 2007-07-03
   Days after onset:43
Entered: 2007-07-05
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0387U / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Metrorrhagia, Pregnancy test positive, Thrombosis, Ultrasound scan normal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AUGMENTIN mg, trichloroacetic acid
Current Illness: Pregnancy NOS (LMP = 4/15/2007) Folliculitis; Genital wart
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Ultrasound 05/21/07 - 5 week gestational sac Reason for test was clotting/spotting, total serum human 05/25/07 - 2231, total serum human 05/30/07 - 118
CDC Split Type: WAES0705USA04344

Write-up: Information has been received from a registered nurse through the Merck pregnancy registry concerning a 17 year old female patient with folliculitis, genital condyloma and no medical history or allergies, who on 07-MAR-2007 was vaccinated IM with a first 0.5ml dose of Gardasil (Lot# 655618/0186U). On 03-MAY-2007 the patient received a second dose of Gardasil (Lot# 657621/0387U). Concomitant therapy included, AUGMENTIN and trichloroacetic acid. The patient stated her last menstrual period was 15-APR-2007. The nurse reported that the patient kept changing the date at each visit. The patient was sent to an OB/GYN and it was determined that she was 4 weeks pregnant as of 21-MAY-2007. Diagnostic laboratory studies performed were an ultrasound on 21-MAY-2007 due to clotting/spotting which resulted as 5 week gestational sac. On 25-MAY-2007 and 30-MAY-2007, HCG quantitative test were performed which resulted as 2231 and 118, respectively. The nurse mentioned that the patient has not experienced any difficulties with the pregnancy as this time. On 27-MAY-2007, it was reported that the patient had a spontaneous abortion. She was 6 weeks from LMP. Unspecified medical attention was sought. At the time of this report, the patient''s outcome was unknown. No product quality complaint was involved. Upon internal review, spontaneous abortion was considered to be an other important medical event. Additional information is not expected.


VAERS ID: 289488 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Michigan  
Vaccinated:2007-04-10
Onset:2007-04-18
   Days after vaccination:8
Submitted: 2007-08-14
   Days after onset:118
Entered: 2007-08-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0091U / 3 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Antiphospholipid antibodies negative, Antithrombin III, Blood homocysteine normal, Blood test normal, Cardiolipin antibody negative, Coagulation factor V level normal, Coagulation factor decreased, Deep vein thrombosis, Immunology test normal, Protein C, Protein total normal, Prothrombin level normal, Skin discolouration, Subclavian vein thrombosis, Ultrasound Doppler, Venogram
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Haemorrhage laboratory terms (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Hypotonic-hyporesponsive episode (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None Heme/onc consult 8/14/07 reports pt has never been on oral contraceptives or hormone tx.
Allergies:
Diagnostic Lab Data: Ultrasound; venography, CT venogram; Factor II activity test within normal limits; Plasma protein C test within normal limits; Blood factor V Leiden within normal limits: Serum Angiostrongylus within normal limits; Serum homocysteine within normal limits; Antithrombin III test within normal limits; Lupus anticoagulant within normal limits. 6/24/08 Received only US of LUE report which revealed probable thrombosis within left internal jugular vein & proximal subclavian vein. Labs and Diagnostics: Venous Doppler US of ULE 4/18/2007 (+) for thrombosis in left internal jugular vein and proximal subclavian vein. Repeat 7/02/2008 WNL except inability to visualize cephalic vein. CT scan of LUE and thorax (+) for minimal non-occlusive thrombus in the mid left subclavian vein region, less extensive than in April. Repeat CT 11/15/07 with no residual thrombus seen. MTHFR C677T heterozygous (+). PT and INR repeatedly high 4/19/07-2/11/08. Ultrasound, 04/18/07, positive DVT Left I.J. and proximal subclavian veinvenography
CDC Split Type: WAES0707USA03234

Write-up: Information has been received from a physician concerning a 16 year old female patient with no medical history or allergies who on 05-OCT-2006, was vaccinated IM into her left arm with a first 0.5ml dose of Gardasil (Lot# 653937/0637F). On 21-DEC-2006, the patient was vaccinated IM into her right arm with a second 0.5 ml dose of Gardasil (Lot# 654885/1424F) and on 10-APR-2007 she was vaccinated IM into her left arm with a third 0.5ml dose of the vaccine (Lot # 655322/0091U). There was no concomitant medication. On 18-APR-2007, the patient developed a deep vein thrombosis in her left arm after her third dose of the vaccine. It was reported that the patient was initially treated with LOVENOX and is currently being treated with COUMADIN. Laboratory diagnostic studies performed included Prothrombin, protein C, factor V Leiden, anticardiolipin antibodies, Homocysteine, Antithrombin III and Lupus Anticoagulant. All were reported to be within normal limits. A doppler ultrasound and a CT venogram were also performed. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested. 7/7/08 ER visit dated 7/02/07 and labs from 4/18/07-2/11/08. Pt seen in ER for c/o L arm tingling, color changes and swelling following a DX of DVT of L subclavian from 4/18/2007. PE (+) for hyperemia of the L arm, venous engorgement of the L arm, L jugular, and the L lingual area, resolving colatereralization of the L chest wall venous systems. DX: Hyperemia of Left Arm, Deep Vein Thrombosis by hx, Hypocoagulation 2'' to Warfarin. 7/15/2008 MR received for OVs 4/23/2007-10/26/2007 . Seen in f/u for ER visit with DX: Thrombus Left carotid jugular. Pt started on COUMADIN. ER f/u again 7/13/07 with Assessment: DVT with L arm paresthesias. Doing well by 5/10/07 on COUMADIN. This is in follow-up to report (s) previously submitted on 8/14/2007. On 18-APR-2007, a doppler ultrasound was performed reporting a positive DVT in the left I.J. and proximal subclavian vein. A CT venogram was also performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. Deep vein thrombosis was considered to be life threatening. Additional information has been requested.


VAERS ID: 299056 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2007-09-12
Onset:2007-09-30
   Days after vaccination:18
Submitted: 2007-12-07
   Days after onset:68
Entered: 2007-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 RA / ID

Administered by: Unknown       Purchased by: Unknown
Symptoms: Adnexa uteri pain, Anaemia, Arthralgia, Diarrhoea, Dizziness, Headache, Menorrhagia, Menstruation irregular, Nausea, Pyrexia, Thrombosis, Vomiting, Weight increased
SMQs:, Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Fertility disorders (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: none~ ()~~0.00~In Patient|none~ ()~~0.00~In Sibling|none~ ()~~0.00~In Sibling
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Will give upon request-too lengthy
CDC Split Type:

Write-up: I received my first Gardasil vaccine Sept. 12, 2007 and reluctantly received my second one on Nov. 12, 2007. I also had blood work done while I was at the Dr''s. office Sept. 12, 2007 which came back completely normal. On Sept. 30, 2007 I began to have horrible pain in my lower abdomen (mainly my ovaries). I then began having irregular periods-to every extreme of irregular. The timing is off-way off, the flow is extremely heavy-I have clots in my blood now, the length of my periods has almost doubled, the pain is so severe-I can not even get out of bed half of the time, I began having nausea and vomiting, headaches, fever, diarrhea, dizziness, aneamia, weight gain, and major pain in the joint of the middle toe on my left foot. These symptoms have not subsided since Sept. 30th. I made a visit to my gynecologist and reported the symptoms and told him that I think it is linked with the vaccine and he said that it was just a coincidence and acted like it was no big deal. I have had 8 periods from Sept. 30th-Dec. 7th-to me that is a big deal. I had to go to the emergency room Nov. 18th, 2007 because the symptoms and bleeding were so severe-the e.r. doctor did blood work and said my blood count was pretty low and that I was aneamic and told me to begin iron supplements. He also gave me prescriptions for ibuprofen, provera, and phenergan and told me to see my gyno asap. I did not take the provera. I got in with my gynecologist two days later and he still acted like it was not a big deal. He did an ultrasound and put me on birth control. Since then I have still not gotten any relief and I made a call to his office two days ago to let them know and his nurse told me that if it is not better by Mon. (Dec. 10th) to call back. It is now Friday (Dec. 7th,2007)and my period is just as heavy and painful today as it was last Monday (Dec. 3rd). I have NEVER had ANY health concerns and I have never been sexually active, I am a virgin-so I thought the vaccine would be beneficial for me. I think I made a major mistake by getting this vaccine. I now have major concerns about my current health. I am worried and scared that I may never be able to have children and that this is going to do permanent damage. I have NEVER had any irregular periods in all of my years of having them. I really hate that this is happening to me and that no one can give me any answers-but most of all I would hate for this to happen to others. I have a strong feeling that Gardasil is the cause of all of my problems because I have discovered some people that have the same symptoms that have received this vaccine. This needs to be researched. Please help me.


VAERS ID: 299369 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: Illinois  
Vaccinated:2007-10-20
Onset:2007-11-25
   Days after vaccination:36
Submitted: 2007-12-12
   Days after onset:17
Entered: 2007-12-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1263U / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Back pain, Blood test, Thrombosis, Ultrasound Doppler, Ultrasound scan
SMQs:, Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Ibuprofen for back pain, vicadin if necessary (but not used), birth control pills
Current Illness: none - some back pain and leg numbness which may have been associated with a disk issue
Preexisting Conditions: none 4/14/08-records received-PMH: back pain, bulging disc. Oral contraceptive pills (Sprintec) since age of 16.
Allergies:
Diagnostic Lab Data: To be obtained from doctor office. CT Scan, doplar of legs, ultrasound heard, multiple blood tests, etc. 4/14/08-records received-CT PE protocol found to have bilateral PEs with some pulmonary infarction. Echocardiogram normal. Venous duplex no acute deep vein thrombosis.
CDC Split Type:

Write-up: Multiple blood clots in lungs 4/14/08-records received-Presented to ED on 11/30/07-with C/O SOB/DOE, pleuritic left chest and shoulder pain times 5 days. Pain began after a 5 hour car ride. 8/25/08-records received for DOS 11/29-12/1/07- DC DX: Pulmonary emboli, low back pain. Per 60 day follow up: Patient is still on blood thinner as of 2/26/08. Has not been re-screened for clotts yet. There is no warning to patients about potential for blood clots or adverse effect. These situation have been reported on internet why not tell the public. 1/20/2010 She just finished blood thinner meds not too long ago. Unknown if issue wil return.


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