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From the 11/19/2021 release of VAERS data:

Found 8,894 cases where Symptom is Aortic thrombosis or Arterial thrombosis or Arterial thrombosis limb or Atrial thrombosis or Axillary vein thrombosis or Basilar artery thrombosis or Brachiocephalic vein thrombosis or Carotid artery thrombosis or Cavernous sinus thrombosis or Cerebral artery thrombosis or Cerebral thrombosis or Cerebral venous sinus thrombosis or Cerebral venous thrombosis or Coronary artery thrombosis or Deep vein thrombosis or Hepatic vein thrombosis or Iliac artery thrombosis or Injection site thrombosis or Intracranial venous sinus thrombosis or Jugular vein thrombosis or Mesenteric vein thrombosis or Ophthalmic artery thrombosis or Ophthalmic vein thrombosis or Pelvic venous thrombosis or Peripheral artery thrombosis or Portal vein thrombosis or Postpartum venous thrombosis or Pulmonary artery thrombosis or Pulmonary thrombosis or Retinal artery thrombosis or Retinal vascular thrombosis or Retinal vein thrombosis or Spinal artery thrombosis or Splenic vein thrombosis or Subclavian vein thrombosis or Superior sagittal sinus thrombosis

Government Disclaimer on use of this data

Table

   
AgeCountPercent
< 3 Years140.16%
3-6 Years20.02%
6-9 Years20.02%
12-17 Years630.71%
17-44 Years1,15913.03%
44-65 Years2,00322.52%
65-75 Years1,02511.52%
75+ Years89410.05%
Unknown3,73241.96%
TOTAL8,894100%



Case Details

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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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 227807 (history)  
Form: Version 1.0  
Age: 60.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2004-10-12
Entered: 2004-10-15
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / GLAXOSMITHKLINE BIOLOGICALS - / 4 - / -

Administered by: Private       Purchased by: Unknown
Symptoms: Arthritis, Arthropathy, Bone disorder, Condition aggravated, Deep vein thrombosis, Fall, Injury
SMQs:, Systemic lupus erythematosus (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Arthritis (narrow), 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: 3/3/05 - Review of d/c summary indicateds PMH of back surgery in 1992 and shoulder surgery in 1985.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: After shot my arthritis got worse, resulting in having both knees replaced. Discharge Summary received on 3/07/2005 states DVT R Leg s/p total knee replacement. Medical Records received on 03/21/2005 states total R knee replacement due to severe DJD ? degenerative joint disease. - 3/2/05 Medical records for 6/03 reviewed. Final diagnosis was ''DVT R LEG''. Chief complaint was ''fall, lac to head, no LOC". 3/3/05 Review of d/c summary confirms diagnosis of DJD and procedure of left total knee replacement.


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: 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: 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: 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: 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: 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: 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: 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: 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: 301598 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2007-05-09
Onset:2007-06-23
   Days after vaccination:45
Submitted: 2008-01-03
   Days after onset:194
Entered: 2008-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0387U / 2 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Coagulation test normal, Contraception, Deep vein thrombosis, Thoracic outlet syndrome, Ultrasound scan abnormal, Venogram abnormal
SMQs:, Embolic and thrombotic events, venous (narrow), Malignancy related therapeutic and diagnostic procedures (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? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Sprintec, Prozac, Restasis eye drops
Current Illness: None
Preexisting Conditions: Keratitis, Dysthymia, Anxiety Disorder 1/24/08-records received- PMH: depression, suicidial ideation OCP, keratitis.
Allergies:
Diagnostic Lab Data: Duplex Ultrasound positive for DVT. Hypercoagulable evaluation negative. Venography demonstrated thoracic outlet syndrome. Chest x-ray normal. US DVT. PT 10.3, INR 1, PTT 22.9.
CDC Split Type:

Write-up: Patient received first Gardasil vaccine on 3/7/07 and second Gardasil vaccine on 5/9/07. Patient developed a DVT in the right upper extremity subclavian and axillary veins on 6/23/07. At the time, she was also on oral contraceptives. She was subsequently found to have thoracic outlet syndrome in the same extremity. 1/24/08-records received for DC DX: Deep vein thrombosis, right arm. Depression. One day prior to admission noted dull pain in right shoulder, swelling developed of right shoulder and arm, then discoloration of distal arm. Treated with anticoagulant therapy.


VAERS ID: 305313 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: California  
Vaccinated:2007-05-18
Onset:2007-05-18
   Days after vaccination:0
Submitted: 2008-02-14
   Days after onset:272
Entered: 2008-02-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Deep vein thrombosis, Drug exposure during pregnancy, Incorrect route of drug administration, Injection site pain, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Drug abuse and dependence (broad), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Medication errors (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:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA00548

Write-up: Information has been received from a health professional concerning a female who was vaccinated with the first dose of Gardasil. Subsequently the patient experienced pain when receiving the vaccine and subsequent doses were given in the buttocks. Medical attention was sought. The patient''s outcome is unknown. No product quality complaint was involved. Additional information has been requested. 03/25/2010 The patient''s date of last menstrual period was 25-APR-2007. Subsequently, the patient developed blood clots and was hospitalized. Medical attention was sought. The representative reported that the nubmer of doses administered were unknown, the number of days the patient was hospitalized was unknown and the details for the patient''s pregnancy was unknown. Follow-up information was received from the nurse practioner. The patient was administerd GARDASIL on 18-MAY-2007. The patient was scheduled to be induced on 09-FEB-2008 since she was past her due date which was 30-JAN-2008. The details regarding the intervention for the blood clot in the hospital was unknwon. Follow up information was received from the physician''s office via phone. THe patient''s name was updated. On 8-FEB-2008, the patient went into the hospital with contractions. The patient failed to progression and then the patient was induced. The patient delivered "as far as they know a healthy boy". The baby weighed 7 pounds 10 ounces. Follow-up information was received via pregnancy forms. On27-JUN-2007 and 31-AUG-2007 ultrasounds were performed for dating of the pregnancy. During the pregnancy the patient had deep vein thrombosis in the left leg and a urinary tract infection. On 10-JUN-2007 the patient was given nitrofurantoin (MACROBID) 100mg BID for 7 days for UTI, enoxaparin sodim (LOVENOX)1.5 mg on 30-NOV-2007 and heparin was given subcutaneously on 15-JAN-2008. The patient gave birth on 08-FEB-2008 41 weeks from LMP. Additional information is not expected.


VAERS ID: 307028 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Washington  
Vaccinated:2008-02-27
Onset:2008-02-28
   Days after vaccination:1
Submitted: 2008-03-12
   Days after onset:12
Entered: 2008-03-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0052X / 2 LA / UN

Administered by: Private       Purchased by: Private
Symptoms: Chest X-ray, Deep vein thrombosis, Electrocardiogram, Pain in extremity, Ultrasound Doppler, Ventilation/perfusion scan
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), 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? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NuvaRing; Fluoxetine 3/27/08-records received:current medications include Fluoxetine and NuvaRing.
Current Illness: none
Preexisting Conditions: Allergic rhintis; Depression/Anxiety disorder NuvaRing.
Allergies:
Diagnostic Lab Data: Doppler lower extremity/VQ lung scan/CXR/ EKG 3/27/08-records received-Doppler showed acute deep venous thrombosis in right posterior tibial vein in the righ midcalf.
CDC Split Type:

Write-up: Right lower leg D.V.T. Shot given 2/27/08 approx 10:30 am. On 2/28/08 pt noticed ache in (R) lower leg. Worsened daily and to ER 3/21/08- Doppler confirmed RLE DVT Deep right posterior tibial vein. 3/27/08-records received for DOS 3/2-3/3/08- DC DX: Acute right lower extremity deep venous thrombosis. Admitted with C/O right lower extremity pain and swelling that started 4 days ago with swelling in right calf and some local pain which has increased. C/O shortness of breath. Follow-up: Pt also found to have Factor V Leiden Heterozygous (1 copy of gene).


VAERS ID: 308146 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2000-10-27
Submitted: 2008-03-25
   Days after onset:2706
Entered: 2008-03-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Aspiration joint, Back injury, Back pain, Bradycardia, Contusion, Deep vein thrombosis, Depression, Erythema, Joint arthroplasty, Joint crepitation, Joint manipulation, Joint stiffness, Joint swelling, Knee arthroplasty, Mobility decreased, Nuclear magnetic resonance imaging abnormal, Occupational therapy, Osteoarthritis, Physiotherapy, Sciatica, Skin warm, X-ray abnormal
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, venous (narrow), Parkinson-like events (broad), Thrombophlebitis (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (narrow), Osteonecrosis (broad), Hypersensitivity (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: BACK PAIN, BENIGN PROSTATE HYPERTROPHY, CHEST PAIN, ELEVATED CHOLESTEROL, HYPERTENSION, LAMINECTOMY, OBSTRUCTIVE UROPATHY, PLANTAR FASCIITIS, SHOULDER DISLOCATOIN, SHOULDER RECONSTRUCTION, TENDON RUPTURE. The subject experienced a medial gastrocnemius muscle tear on 12 August 1992. He was noted to have "chronic side effects" attributed to his ACE inhibitor therapy.
Allergies:
Diagnostic Lab Data: 27 October 2000: X-ray of left knee showed mild degenerative changes primarily involving the medial joint compartment with no fracture; degenerative osteophytes at the medial margins of the femoral condyles and the tibial spines; tricompartmental arthritis. Magnetic resonance imaging (MRI) of left knee showed partial tear involving the quadriceps tendon of uncertain chronicity, mild tibial plateau contusion, joint effusion, no evidence of meniscal or cruciate ligament tear. 16 November 2001: X-rays (PA, standing, lateral, and bilateral patella view) showed bone-on-bone arthrosis on the left and near-so on the right; more osteophyte formation on the articular margins medially and patellofemoral joint, also some Teton sign on left; tibiofemoral alignment on right "essentially neutral", on left 7 degrees of varus. 12 May 2003: X-rays (PA, standing, lateral, and bilateral patella view) showed continued severe bone-on-bone arthrosis on the left knee and now the right knee as well; no evidence of any acute calcifications; consideration that his tibial eminence may have a fracture in this area on the notch view. 17 June 2003: X-rays showed total knee arthroplasty with intact components. Surgical pathology of bone and soft tissue from right knee (following total knee replacement) revealed degenerative joint disease consistent with osteoarthritis. 02 July 2003: X-rays of right knee showed satisfactory alignment of prosthetics. 26 August 2003: -rays (PA, standing, lateral, and sunrise view) showed an uncemented LCS with metal backed resurfaced patella uncemented; tibial cut distal to the fibular head with possible distalized femoral component; appropriate size, good axial alignment; central tracking of the patella in the trochlea groove. 27 October 2003: MRI of right knee without contrast showed unsatisfactory findings due to extensive void artifact associated with the knee prosthesis; knee joint could not be evaluated. 04 April 2004: X-rays of left knee (PA, standing, lateral, and bilateral patella view) showed tricompartmental osteoarthritis; LCS rotating platform appeared to be in good position with no evidence of osteolysis or positional changes.
CDC Split Type: A0717373A

Write-up: This case was received via medical records forwarded by a lawyer and described the occurrence of adverse event(s) in an adult male subject who was vaccinated with LYMErix (GlaxoSmithKline) for prophylaxis. On an unspecified date the subject received unspecified dose of LYMErix (unknown). Medical history included gastrocnemius tendon tear, shoulder dislocation/reconstruction, and back pain with laminectomy. On 31 October 2000, the subject presented to an orthopedist with a complaint of left knee pain after feeling a "pop in his knee and intense pain in the left knee" on 27 October 2000. Assessment included left knee bone bruise of the tibia on the medial tibial plateau, and underlying mild degenerative joint disease. On 26 November 2000, he was advised that he could return to work without restriction. On 28 December 2000, the patient presented with lower back pain radiating to the left leg, and assessment was of lumbar strain versus sciatica. Medication at that time included Vioxx. Upon follow up on 26 November 2001, he experienced continued pain in his left knee and right knee pain. Assessment included left greater than right degenerative joint disease described as "severe bilaterally", and he was instructed to continue Vioxx. Treatment also included a left knee interarticular injection of DepoMedrol and lidocaine. On 25 February 2002, Hyalgan was prescribed for visco-supplementatoin, with some subsequent improvement of knee pain. On 09 December 2002 he was fitted for a knee brace, and he also began receiving Synvisc injections. Upon follow-up on 12 May 2003 he complained of increasing right knee pain, reporting that he had recently "heard a crack and felt some swelling and sharp pain in the knee". He was diagnosed with right knee severe degenerative joint disease and possible tibial eminence fracture of "little added significance". The subject was hospitalized on 17 June 2003, and on the same date underwent a total right knee replacement. He did well postoperatively and the surgery was characterized as "successful". Medications included Celebrex. Surgical pathology findings included degenerative joint disease consistent with osteoarthritis. He was discharged on 19 June 2003. During an initial physical therapy consultation on 02 July 2003, the patient reported that he had "arthritis in both of his knees for a number of years". On 26 August 2003, he presented for evaluation of knee stiffness, with failure of progression in obtaining range of motion in the preceding several weeks. Mild erythema and warmth of the knee were noted, and aspiration of the knee was recommended to rule out infection. He continued to experience some discomfort and stiffness of the knee, and on 06 September 2003 his orthopedist advised that manipulation of the knee would be appropriate. On 30 September 2003, he was hospitalized and underwent aspiration and manipulation of the knee under anesthesia. Secondary diagnoses included osteoarthritis. He was discharged to home on 01 October 2003 in medically stable condition. The patient underwent a left total knee replacement on 06 April 2004. Postoperatively he experienced bradycardia, and was placed on Lovenox and heparin for deep vein thrombosis prophylaxis. Pain management included Percocet. He was transferred for orthopedic rehabilitation on 08 April 2004, and underwent physical and occupational therapy before his discharge on 10 April 2004. At that time pain was improved and he was continued on Percocet, as well as outpatient physical therapy. Upon follow up on 20 April 2004 was "doing very well in regards to his functional knee replacement". On 06 April 2005, he was reportedly doing "exceptionally well" with functional recuperation. On 15 November 2005, he was seen for follow up of left total knee replacement with complaints including crepitation, which was assessed to be self-limiting. At the time of reporting the outcome of the events was unspecified. Post-knee arthroplasty complications included deep vein thrombosis which required anticoagulation with Coumadin. He was also diagnosed with depression secondary to "major surgery" and was treated with Effexor. Additionally, he experienced postoperative bradycardia in April 2004 which resolved prior to his discharge from inpatient rehabilitation services. These were assessed to be incidental findings based upon medical record review.


VAERS ID: 312496 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Male  
Location: Ohio  
Vaccinated:2004-03-13
Onset:2006-02-07
   Days after vaccination:696
Submitted: 2008-05-18
   Days after onset:830
Entered: 2008-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV077 / 4 RA / UN

Administered by: Military       Purchased by: Military
Symptoms: Deep vein thrombosis, Dyspnoea, Factor V Leiden mutation, Pulmonary embolism
SMQs:, Anaphylactic reaction (broad), Congenital, familial and genetic disorders (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Lab Results on Blood resulted in Factor V Leiden Defiency.
CDC Split Type:

Write-up: Shortness of breath.DVT, Right leg. DVT Showered into lungs, Multiple Bilateral Pulmonary Emboli.


VAERS ID: 316336 (history)  
Form: Version 1.0  
Age: 28.0  
Sex: Male  
Location: Ohio  
Vaccinated:2008-02-12
Onset:2008-04-18
   Days after vaccination:66
Submitted: 2008-06-16
   Days after onset:59
Entered: 2008-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV114 / 7+ RA / UN

Administered by: Military       Purchased by: Other
Symptoms: Aortic embolus, Deep vein thrombosis, Dyspnoea, Pulmonary artery dilatation, Pulmonary embolism, Pulmonary hypertension
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (narrow), Cardiomyopathy (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, 7 days
   Extended hospital stay? Yes
Previous Vaccinations: Pulmonary Embolism~Anthrax (Biothrax)~6~26.50~Patient
Other Medications: None
Current Illness: None
Preexisting Conditions: Factor V Leiden Deficiency
Allergies:
Diagnostic Lab Data: Pulmonary Hypertension, Pulmonary Artery Dialated to 33mm
CDC Split Type:

Write-up: Bilateral Pulmonary Embolism (Saddle Embolus), Shortness of Breath, Deep Vein Thrombosis - Left Leg.


VAERS ID: 318322 (history)  
Form: Version 1.0  
Age: 72.0  
Sex: Female  
Location: Washington  
Vaccinated:2008-06-10
Onset:2008-06-14
   Days after vaccination:4
Submitted: 2008-06-20
   Days after onset:6
Entered: 2008-07-07
   Days after submission:17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. 0204X / 1 RA / SC

Administered by: Other       Purchased by: Other
Symptoms: Deep vein thrombosis, Pain, Pyrexia, Ultrasound scan abnormal
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Thrombophlebitis (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: Hetz 25mg; Nadolol 40mg
Current Illness: None
Preexisting Conditions: Linden V Factor. PMH: Factor V Leiden heterozygote. HTN. elevated cholesterol, arhtritis, DVT, patent foramen ovale
Allergies:
Diagnostic Lab Data: DVT of left calf, ultrasound of leg and rest of body for clots. Labs and Diagnostics: Ultrasound (+) for DVT. Chest CT (-) for PE. Arterial US (-) for aneurysm.
CDC Split Type:

Write-up: Saturday 14th was walking, develop pain in left calf up thigh, low grade fever, painful to walk. Used ice, baby aspirin and Aleve. Went to doctor''s on Monday. Doctor sent patient to get ultrasound. After ultrasound went to ER. DVT diagnosed using Lovenix and Coumadin for treatment. 08/14/2008 MR received from PCP. Pt presented to office 6/16/2008 with c/o popliteal tenderness. Sent for US which revealed DVT above the left popliteal vein. Refered for anti-coagulation therapy. 9/25/08 ER record received for DOS 6/16/08 with DX: Lower extremity pain. DVT. Presented with pain and swelling of RLE. D/C home on Coumadin and then Lovenox. Seen 6/25 with c/o knee/leg pain on the R 2'' to L leg issues. Rx-percocet.


VAERS ID: 321276 (history)  
Form: Version 1.0  
Age: 41.0  
Sex: Unknown  
Location: Colorado  
Vaccinated:2003-03-06
Onset:2003-08-23
   Days after vaccination:170
Submitted: 2008-08-04
   Days after onset:1808
Entered: 2008-08-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Activated partial thromboplastin time normal, Activated protein C resistance test, Antithrombin III, Blood fibrinogen normal, Blood homocysteine increased, Cardiolipin antibody negative, Deep vein thrombosis, Diagnostic procedure, International normalised ratio decreased, Laboratory test normal, Myalgia, Pain in extremity, Palpitations, Protein C, Protein S normal, Prothrombin time prolonged, Thrombophlebitis superficial, Ultrasound scan abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Liver-related coagulation and bleeding disturbances (narrow), Haemorrhage laboratory terms (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Thrombophlebitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: blood pressure meds
Current Illness:
Preexisting Conditions: 05/01/2008 Complication, peripheral vascular (Resolved), 09/15/2007 Phlebitis, superficial vessel, lower limb (Resolved), 03/18/2004 Embolism/thrombosis, deep vessels lower extrm NOS (Resolved)
Allergies:
Diagnostic Lab Data: 4/28/08, ACA screen, neg, FV Leiden Mut., neg, MTHFR C677T mutation, neg, PTMUT-P, neg, AT III, 90 (80-120), APC/CACL, 99.4, CACL, 40.3, Act Prot C Ration, 2.5 (normal), DRVVT, neg, Protein C, func, 125 (65-167), Protein S, func, 76 (70-143), Homocysteine, 17H (3.7-13.9), Protime, 14.0 sec, INR, 1.0, PTT, 27.5 (26.0-35.5), Fibrinogen, 257 (200-450), PT ON 81MG ASA QD; 8/23/03, Venous Duplex lower left extremity, Impression, Acute deep venous occlusive disease of the left distal superficial femoral, popliteal, and proximal calf veins; 3/18/04, Venous Duplex Sonography of the left leg, Impression, No evidence of dvt in left lower extremity; 8/28/07, US lower extremity (venous), Impression, No deep venous thrombosis on the left lower extremity, Incidental very short segment superficial venous thrombosis; 4/29/08, Upper ext. venous duplex, Impression, superficial venous thrombosis of the right arm without involvement of the deep system.
CDC Split Type:

Write-up: Pt complained of a 3 weeks hx of left calf pain after running. Pt had also had a cross country flight. Dx with left LE DVT. Pt on coumadin and lovenox til 4/20/04. 6/07 pt experienced left calf pain and pain dorsum of left foot for about 5 weeks prior to a flight and a one week cruise. Upon return the pt went to the hospital and it was determined that he had a left foot superficial venous thrombosis. 3/17/08 pt was treated in ER for palpitations. Pt had an IV. Upper Ext Venous Duplex which showed superficial venous thrombosis. Pt wonders if this is caused by AVA? Symptoms: Muscle Pain, Muscle Pain, Muscle Pain.


VAERS ID: 323972 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: Unknown  
Vaccinated:2008-03-19
Onset:2008-04-28
   Days after vaccination:40
Submitted: 2008-09-02
   Days after onset:127
Entered: 2008-09-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1060U / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Axillary vein thrombosis, Oedema peripheral, Pain in extremity, Subclavian vein thrombosis, Ultrasound scan abnormal, Vaccine positive rechallenge, Vena cava thrombosis
SMQs:, Cardiac failure (broad), Angioedema (broad), Embolic and thrombotic events, venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Thrombophlebitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (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, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown. PMH: Spondylolisthesis at L5, tonsillectomy 1997, cholecystectomy 3/08. Oral contraceptives.
Allergies:
Diagnostic Lab Data: ultrasound - acute thrombus present within the left subclavian, axillary, basilic, brachial, proximal cephalic veins. Labs and Diagnostics: X-ray shoulder (-). CT shoulder (-). Doppler/duplex exam of LUE (+) for thrombus within L subclavian, axillary, basilic, brachial and proximal cephalic veins. Holter monitering 5/20/08-sinus rhythm with sinus tach up to 160 bpm. CT angiogram (+) for PE. Previously noted PEs have resolved. Anti-cardiolipin IgG (+) 146. dRVVT-APL (+). Beta-2 glycoprotein IgG 167. Labs and Diagnostics: PT 29.5. APTT 52. INR 2.7. DRVVT (+). CT angio of chest 7/22/08 - no evidence of pulmonary thromboembolic
CDC Split Type: WAES0808USA04005

Write-up: Information has been received from an office manager, concerning a 25 year old female patient who on an unspecified date was vaccinated with the second dose of GARDASIL. The patient experienced pain and swelling in her left arm after the vaccine was given. The patient was given GARDASIL in another clinic but she presented to the physician''s office with this reaction. The reporter stated the patient had pain and swelling after the first dose but was not this severe. The pain and swelling lasted one week after this second dose was given. The patient was sent to the hospital and admitted. The patient recovered on an unknown date. The patient sought medical attention at physician''s office. There was no product quality complaint. Follow up information has been received from medical records and the office manager, concerning a 25 year old female patient who on an unknown date was vaccinated with 0.5 mL of the second dose of GARDASIL IM. On 01-MAY-2008, the patient was seen in office for swelling and pain in arm which began on 28-APR-2008. The patient was sent over for ultrasound and it was determined she had a hypoechoic thrombus that completely occluded and moderately expanded the left subclavian vein, axillary vein, mid and proximal basilic vein, mid and proximal brachial vein and proximal - most cephalic vein. No blood flow identified within these particular structures. The thrombus did not extend distal to the antecubital fossa. The patient was hospitalized for an unspecified number of days. Approximately, on 05-MAY-2008 (also reported as one week) the patient was recovered. The reporter considered the event to be life-threatening and an other important medical event. No further information is expected. All available medical records will be provided upon request. 9/15/2008 MR received from PCP including some hospital records. Pt presented to PCP on 4/28/08 with c/o shoulder pain x 5 days, tingling fingertips. Pain from shoulder to elbow with movement. DX: LUE radiculopathy. Sent for X-ray and CT-both (-). Acute thrombus dx by doppler/duplex exam. 10/20/2008 MR received for DOS 5/1-6/2008 and ER visit 7/22/08. D/C DX: RUE DVT. Pulmonary embolism. Positive for lupus anticoagulant. Pt presented with 1 week hx of progressive L shoulder pain and swelling of the L arm associated with L-sided chest pain and slight shortness of air. Tx with TPA followed by heparin and coumadin. Labs c/w antiphospholipid syndrome. D/C on Lovenox. Pt returned to ER 7/22/08 with c/o chest pain and funny sensation of the L arm. W/u (-).


VAERS ID: 328176 (history)  
Form: Version 1.0  
Age: 50.0  
Sex: Unknown  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2008-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB123 / 2 LA / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Angiogram, Chest pain, Deep vein thrombosis, Dizziness, Pulmonary embolism
SMQs:, Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Diagnostic CTA chest 10/1/08
CDC Split Type:

Write-up: Multiple pulmonary embolic DVT diagnosed 10/1/08. Onset lightheadedness, (R) sided chest pain started on 09/1/08


VAERS ID: 329214 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Iowa  
Vaccinated:2008-08-26
Onset:2008-10-19
   Days after vaccination:54
Submitted: 2008-10-20
   Days after onset:1
Entered: 2008-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0053X / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Computerised tomogram abnormal, Deep vein thrombosis, Oedema peripheral, Pain in extremity, Pulmonary embolism, Ultrasound scan abnormal
SMQs:, Cardiac failure (broad), Angioedema (broad), Embolic and thrombotic events, venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Thrombophlebitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (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: Birth Control Pills
Current Illness:
Preexisting Conditions: 12/4/08-records received-Family history notable for upper extremity deep venous thrombosis.
Allergies:
Diagnostic Lab Data: CT chest on 10/19/08 showed several small pulmonary emboli. Ultrasound of left upper extremity, 10/19/08, showed extensive DVT. 12/4/08-records received-Ultrasound showed extensive deep venous thrombosis. WBC 13.4 84% neutrophils 11% lymphocytes. Liver function test normal. INR 1 and PTT 26. Left upper extremity deep venous thrombosis with a few very small pulmonary emboli identified in right lung as well on chest computerized tomography.
CDC Split Type:

Write-up: Patient received Gardasil around 8/1/08 in left arm. While attending a forum for high school students, she presented to ER on 10/19/08 with left arm swelling and pain. Ultrasound demonstrated LUE DVT, and CT of chest showed small pulmonary emoboli. Only other risk factor for DVT is birth control pills. 12/04/08-records received for DOS 10/19-10/23/08-DC DX:Left upper extremity deep venous thrombosis with a few very small pulmonary emboli identified in right lung as well on chest computerized tomography. Transient orthostatic hypotension. Thoracic outlet syndrome on left likely contributing to deep venous thrombosis. Oral birth control pills started within last 4-6 months-now discontinued. Presented to ED with acute swelling of left upper extremity. 2/26/09-office visit note for DOS 8/26/08 received follow-up visit for dysmenorrhea now improved.


VAERS ID: 329588 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-10-21
Entered: 2008-10-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / 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? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0810USA03315

Write-up: Information has been received from a physician concerning an 18 or 19 year old patient with no family history of deep vein thrombosis (DVT) and previously healthy who was vaccinated with a first dose of GARDASIL. 5 days after the vaccination, the patient came in the hospital with a right upper extremity DVT that required "Lyticx". At the time of this report, the outcome was unknown. Additional information has been requested.


VAERS ID: 331253 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Arizona  
Vaccinated:2008-10-10
Onset:2008-10-16
   Days after vaccination:6
Submitted: 2008-11-04
   Days after onset:19
Entered: 2008-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1968 U / 3 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Computerised tomogram abnormal, Dehydration, Jaundice, Mesenteric vein thrombosis, Pyrexia, Vomiting
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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, 12 days
   Extended hospital stay? No
Previous Vaccinations: none~Vaccine not specified (no brand name)~~0.00~In Patient|N?A~ ()~~0.00~In Sibling
Other Medications: none
Current Illness: none
Preexisting Conditions: none. PMH: none.
Allergies:
Diagnostic Lab Data: Ct scan positive for a superior mesenteric vein thrombosis. Labs and Diagnostics: CBC with WBC 14,200, Hgb 9.7, MCV 76. Ferritin high. AST 81. ALT 57. Creatinine 1.34. Alk Phos 306. Bilirubin total 6.6. Bili direct 4.4. GGT 161. Albumin 2.7. Amylase low at 19. PT 16. APPT 34. Protein C low at 33. Protein S low at 30. Cardiolipin IgA <12, IgG <15, IgM 516. MTHFR heterozygote. Na+ 132. K+ 2.8. UA (+) for ketones & bilirubin. CT abd/pelvis (+) for thrombosis, bowel wall thickening, gb contracted, liver lesion and small R pleural effusion. Pelvic US simple ovarian cyst. Abd US (+) for contracted GB and Liver size top normal. MRI abd (+) for thrombosis, abnormal GB and liver parenchymal abnormality.
CDC Split Type:

Write-up: Fever, adominal pain and emesis .started 6 days after last dose of Gardasil.progressed to jaundice and dehydration. MANUFACTURER MERCK. 11/12/2008 MR received for DOS 10/23-11/4/2008 with D/C DX: Superior mesenteric venous thrombosis. Direct hyperbilirubinemia. Hyponatremia, Hypokalemia, Acute Renal Insufficiency, Thrombocytosis, Anemia (iron deficiency). Pt presented with a 1 week hx of fevers, emesis, decreased po intake, appetite and urine output, abdominal pain and one episode of diarrhea. Pt noted to be dehydrated and icteric on admission. On PE abdomen noted to be distended with some tenderness in the RuQ and epigastric regions. Started on Lovenox, coumadin, and abx. No resolution of thrombus but no further extension. LFTs improved. Creatinine improved with hydration. D/C for continued outpt f/u.


VAERS ID: 336931 (history)  
Form: Version 1.0  
Age: 49.0  
Sex: Female  
Location: Utah  
Vaccinated:2008-10-10
Onset:2008-10-10
   Days after vaccination:0
Submitted: 2009-01-09
   Days after onset:91
Entered: 2009-01-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 89975 / UNK RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Chest X-ray, Deep vein thrombosis, Dyspnoea, Flushing, Hyperhidrosis, Immediate post-injection reaction, Injection site pruritus, Injection site warmth, Oedema peripheral, Pain in extremity, Pruritus, Throat tightness, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, venous (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None. PMH: C4-C5 fusion. hiatal hernia repair. NKDA.
Allergies:
Diagnostic Lab Data: Arterial Blood Gas / Chest XRay (findings unknown). Labs and Diagnostics: CXR WNL. CK 46 WNL. CKMB 1.9. Lactate (H) 2.5.
CDC Split Type:

Write-up: 1) 5 min after injection, heat flush & abd cramping. 2) 10 min after, itching & heat @ injection site. 3) 15 min after, itching & hives over entire arm/shoulder area. 50mg Benadryl given. 4) 25-30 min after, heat flush, diaphoretic taken next door to urgent care. 5) 45 min after, diaphoretic, shortness of breath, spasms in throat. Epi dose of 0.3mg given. Ambulance called to urgent care. 6) ER - O2 100% NRB face mask, patient doesn''t remember other treatments except stated she was given ativan. She was in the hospital for 3 days. After discharge, saw primary care physician for severe arm pain & swelling. Ultrasound showed DVT in arm from infiltrated IV. Currently on Coumadin for 6 months. Primary physician will have to strip vein. Released for return to work on 10/31/08. 2/10/2009 MR received for DOS 10/10-12/2008 with D/C DX: Anaphylactic Reaction to Flu vaccine. Mild metabolic acidosis. Tachycardia. Pt presented to ER following receipt of Flu shot and immediate flushing, hives, diaphoresis, abdominal pain and H/A. Received Benadryl, Solumedrol and epi prior to arrival with poor response. Becam tachycardic, hypertensive and anxious en route to hospital. Upon arrival pt still c/o of throat closing and difficulty breathing. BP 212/69. PE WNL. Admitted for further med mgmt.


VAERS ID: 337473 (history)  
Form: Version 1.0  
Age: 6.0  
Sex: Male  
Location: Oregon  
Vaccinated:2008-11-05
Onset:2008-11-17
   Days after vaccination:12
Submitted: 2009-01-15
   Days after onset:59
Entered: 2009-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 500589P / 1 NS / IN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Basilar artery thrombosis, Ischaemic stroke, Thrombectomy
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)

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, 20 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: PMH: URI s/s x 1 mo. Recurrent OM & ear tube insertion.
Allergies:
Diagnostic Lab Data: LABS: WBC 20.9, ANC 17.8(H), lymphs 10.3%(l). Creatinine 0.3(L), ALK 150(L), AST 58(H). CT brain abnormal. Protein C 0.72(L), protein S antigen, free 54(L). CT angiogram abnormal & c/w acute left PCA distribution ischemic infarct. Echocardiogram WNL.
CDC Split Type:

Write-up: Acute icshemic stroke (basilar artery thrombus). Underwent mechanical thrombectomy 11/25/08. 2/2/09 Received ER medical records of 11/19/2008. FINAL DX: acute non-specific HA Records reveal patient experienced worsening HA x 5 days w/cloudy vision left eye, fatigue, irritability & nausea. Had been seen by PCP 2 days prior & dx w/left otitis media. Tx w/oral antibiotics. Exam in ER was WNL & tx w/IVF & IV meds. Improved & d/c to home. 2/3/09 Received PCP office records of 11/17/08-1/18/2009. FINAL DX: left OM w/viral URI Records reveal patient experienced left eye vision deficit, decreased hearing left ear, left side headache, decreased appetite & energy. Tx w/oral antibiotics & would refer to Ophtho if s/s persisted. RTC 11/21 s/p ER visit w/URI & OM resolving. RTC 11/22 w/persistent but intermittent HA & had missed school. OM had resolved but tx w/oral antibiotics. Referred for MRI. RTC 1/12/09 s/p recent hospitalization for acute ischemic stroke with basilar artery thrombus occlusion s/p mechanical thrombectomy on 11/25/08 & having vomiting. Sent for urgent MRI. RTC 1/15/09 for conference. 2/09/09 Received hospital medical records of 11/24-12/3/2008. FINAL DX: acute ischemic stroke, basilar artery thrombus occlusion w/resultant bilateral posterior circulation strokes; s/p mechanical thrombectomy 11/25/08. D/C Summary mixed in with records which reveal patient had been transferred to PICU from outlying ER. Patient experienced retroorbital eye pain & HA x 10 days prior to admit. One week prior to admit had trouble catching ball from left side. Five days prior to admit had severe HA behind left eye. One day prior to admit had dizziness, vomiting, peripheral vision loss but no pain. On day of admit, had generalized pain, abnormal behavior, talking nonsense, incomplete sentences. Deficits at d/c included: right arm dysmetria w/minimal weakness, LLE dysmetria, quandrantanopia, dysarthria & left side sensory deficit, required assist to walk due to incoordination. D/C to inpatient rehab on continued ASA. was to f/u w/peds neuro & ophtho when d/c from rehab & to have repeat labs. Neuro. Ophtho clinic notes of 2/3/2009. Doing well & had returned to school. Reading speed was significantly slower but otherwise approx same level as prior to stroke. Had developed behavior issues w/hyperactivity & outbursts. Visual fields deficits. 2/17/09 Received ER records of 11/23 & 11/24/2008. FINAL DX: right occipital lobe AV malformation; acute ischemic stroke left occipital lobe; altered mental status secondary to above; leukocytosis secondary to above. Pt transferred by ambulance due to inclement weather to higher level of care. Incomplete homonymous hemianopsia, behaviour problems.


VAERS ID: 337664 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-01-16
Entered: 2009-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / GLAXOSMITHKLINE BIOLOGICALS - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Arthralgia, Autoimmune disorder, Cognitive disorder, Deep vein thrombosis, Fatigue, Headache, Hypoaesthesia, Influenza like illness, Loss of consciousness, Muscle spasms, Musculoskeletal pain, Musculoskeletal stiffness, Nervous system disorder, Paraesthesia, Poor quality sleep, Rash, Retinal vein occlusion, Vision blurred, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Embolic and thrombotic events, venous (narrow), Dystonia (broad), Parkinson-like events (broad), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (narrow), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The subject''s medical history, concurrent conditions and concurrent medications were not reported.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A0605304A

Write-up: This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). On an unspecified date after vaccination with LYMERIX, the subject experienced joint pain, stiffness, headaches, flu-like symptoms, fatigue, tingling in extremities, vision problems, possible memory loss, decreased activities of daily life, and rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all reported to be caused by vaccination with LYMERIX. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 12 January 2009 via medical records. The subject received his first, second, and third doses of LYMERIX all in 2001. A few months after the second or third dose of LYMERIX. He developed skin rashes, shoulder pain, and tingling and numbness in the fingers and hands that subsequently progressed. In 2002 or 2003 he developed headaches. In 2003 or 2004 he developed leg cramps and deep vein thrombosis. In 2003, 2004, or 2005 he experienced fatigue and poor sleep. In 2005 or 2006 he experienced "black-outs". On an unknown date (possibly prior to LYMERIX vaccination), he developed an "intravenal occlusion of retina in both eyes". Treatment included anti-fungal/anti-bacterial creams and COUMADIN. With the exception of the skin rashes, headaches, and black-outs, the events were unresolved at the time of this report. The subject reported that "one eye has cleared up" and that the right eye was back to 20/20 vision, while the left eye remained blurry. The events of deep vein thrombosis and black-outs were assessed to be medically significant by GSK.


VAERS ID: 338846 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Male  
Location: Florida  
Vaccinated:2008-11-13
Onset:2008-11-15
   Days after vaccination:2
Submitted: 2009-02-02
   Days after onset:79
Entered: 2009-02-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Private       Purchased by: Public
Symptoms: Deep vein thrombosis, Injection site reaction, Phlebitis, 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? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0812USA02105

Write-up: Information has been received from a physician concerning a patient who was vaccinated with a "booster" dose of PNEUMOVAX 23 (Lot # not provided). After patient received PNEUMOVAX 23, the patient experienced blood clots at the injection site and phlebitis of the extremities. This is one of two reports from the same source. Additional information has been received from Health Care worker concerning a 82 year old male patient who was vaccinated with PNEUMOVAX 23 (Lot # not provided). Concomitant therapy included FLUOGEN on 15-NOV-2008. On 15-NOV-2008 he developed deep vein thrombosis in right arm. Patient was hospitalized for 5 days. Additional information is not expected.


VAERS ID: 339768 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2009-01-16
Onset:2009-01-25
   Days after vaccination:9
Submitted: 2009-02-09
   Days after onset:15
Entered: 2009-02-18
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0947X / 3 LA / UN

Administered by: Private       Purchased by: Private
Symptoms: Deep vein thrombosis, Viral infection
SMQs:, 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? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Yaz (1st pack)
Current Illness: 2/26/09-Last week C/O sore throat, cervical lymphadenopathy, excessive fatigue with increased sleeping, hepatic tenderness and elevated LFTs.
Preexisting Conditions: 2/26/09-records received- Recently started oral contraception use Yaz 3 weeks prior to onset of symptoms.
Allergies:
Diagnostic Lab Data: Ultrasound; numerous blood tests. Doppler ultrasound demonstrated 2/26/09-records received-Left lower extremity deep vein thrombosis in left mid superficial femoral vein to popliteal vein. Anemia with hematocrit of 33.3. Elevated LFTs.
CDC Split Type:

Write-up: 1/6/09 - Vaccine administered. 1/19/09 - Developed severe viral symptoms. 1/25/09 - Dx with DVT and hospitalized; put on Heparin. 1/27/09 - D/C on Lovanox inj and Coumadin. 2/26/09-records received-for DOS 1/26-1/27/09-DC DX: Left lower extremity deep vein thrombosis in left mid superficial femoral vein to popliteal vein. Possible infectious mononucleosis versus cytomegalovirus (acute). Elevated liver function tests. Presented with 3 day history of left lower extremity pain


VAERS ID: 350818 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Female  
Location: Michigan  
Vaccinated:2008-10-13
Onset:2008-11-25
   Days after vaccination:43
Submitted: 2009-06-23
   Days after onset:209
Entered: 2009-07-06
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 881123P / UNK LA / UN

Administered by: Other       Purchased by: Private
Symptoms: Abasia, Asthenia, Blood pressure decreased, Death, Deep vein thrombosis, Dyspnoea, Endotracheal intubation, Gait disturbance, Gastrointestinal tube insertion, Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture, Muscular weakness, Somnolence, Transfusion
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Angioedema (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, venous (narrow), Dystonia (broad), Parkinson-like events (broad), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Demyelination (narrow), Respiratory failure (broad), Hypoglycaemia (broad), Dehydration (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, 200 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Hypertension; T2 DM; atrial fibrillation; CHF 8/27/09 Medical records received w/PMH: hypothyroidism; dyslipidemia; obstructive sleep apnea; s/p gastric bypass Roux-en-Y; overweight
Allergies:
Diagnostic Lab Data: EMG; lumbar puncture; neurology consultation 8/27/09 Medical records received w/LABS: Initial CSF: protein (N). Initial EMG/NCS c/w diffuse axonal demyelinating neuropathy of sensory & motor. Initial labs: sodium (L), potassium (L). Blood c/s (+), sputum c/s (+)CT neg. Brain MRI/MRA c/w old stroke
CDC Split Type:

Write-up: Less than one week later sleepiness, weakness. By 2 wk after the vaccination she developed bilat leg weakness and could no longer walk. She was admitted to hospital 12-6-2008. Was diagnosed with GUILLAIN BARRE syndrome. Follow up received 7/21/2010: She only partially recovered from the Guillain Barre and died at the hospital last year. I do not have access to her chart now and cannot remember the exact date. 8/27/09 Received hospital medical records of 12/6/08-6/23/2009 FINAL DX: acute inflammatory demyelinating polyneuropathy/Guillain-Barre syndrom w/quadriparesis w/respiratory failure, s/p tracheostomy, s/p ventilator, s/p IVIG; s/p G-tube placement; recurrent UTI due to VRE/Klebsiella; atrial fib s/p pacemaker; acure renal failure, resolved. Records reveal patient experienced acute onset generalized weakness, leg cramps, dyspnea, sleepy, difficulty walking, fall. Neuro consult done. Intensive care. BP dropped, developed dysphagia, atrial fib, areflexic, fever, sepsis, multiple UTIs, decreased mental status, intubated & mech ventilation, bradycardia, DVT right arm, Tx w/IVIG x 5 doses x 2 courses, blood transfusions, IV antibiotics, pacemaker insertion, Progress very slow & ultimately d/c to inpatient rehab facility. Principal ICD9 codes: 3570, 34400, 51881, 5990


VAERS ID: 352518 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: New Mexico  
Vaccinated:2009-01-07
Onset:2009-04-08
   Days after vaccination:91
Submitted: 2009-07-24
   Days after onset:107
Entered: 2009-07-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1311X / 1 UN / IM

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NECON 1/35
Current Illness:
Preexisting Conditions: Unknown. 8/10/09 ER Records received DOS 4/9/09. Alcohol use, Smoker, UTI, Acne, HPV. 8/17/09 Consultant records received DOS 4/13/09 to 6/04/09. Urinary tract infections. Smokes.
Allergies:
Diagnostic Lab Data: Unknown. 8/10/09 ER Records received DOS 4/9/09. LABS and DIAGNOSTICS: Venous Doppler Study - Abnormal. 8/17/09 Consultant records received DOS 4/13/09 to 6/04/09. LABS and DIAGNOSTICS: Positive Doppler report with extension of DVT. INR 2.18 (H)
CDC Split Type: WAES0907USA02326

Write-up: Information has been received from a physician concerning a 26 year old female with no known allergies or reported medical history who on 07-JAN-2009 was vaccinated with the first and only dose of GARDASIL (lot# 661531/1311X) 0.5 ml, I.M. route. Concomitant therapy included NECON 1/35. On 08-APR-2009, the patient experienced deep vein thrombosis. The patient was treated with anticoagulation therapy including LOVENOX and COUMADIN. Subsequently, the patient was recovered. The physician stated that "clots can be dangerous" and deep vein thrombosis was considered to be immediately life-threatening. Additional information has been requested. 8/10/09 ER Records received DOS 4/9/09. Assessment: Soleal vein thrombosis left mid calf. Patient presents with pain of left calf exacerbated by walking/movement. Stopped taking birth control pills today. 8/17/09 Consultant records received DOS 4/13/09 to 6/04/09. Assessment: Acute DVT left perineal and soleus veins. Patient reported to physican''s office with left leg pain and was sent to ER for initiation of therapy for DVT. Placed on anticoagulation. Sent to consultant''s office for follow-up. Presents with left calf tenderness. Urinary tract infection. left ear pain, congested, pressure and slight dizziness. Increased anxiety. Fatigue. Tympanic membranes show serous fluid accumulation.


VAERS ID: 354508 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Male  
Location: Ohio  
Vaccinated:2003-01-13
Onset:2007-09-01
   Days after vaccination:1692
Submitted: 2009-08-18
   Days after onset:717
Entered: 2009-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS - / UNK LA / -

Administered by: Military       Purchased by: Military
Symptoms: Chest pain, Deep vein thrombosis, Fatigue, Gene mutation identification test negative, Pleural effusion, Pulmonary embolism, Pulmonary function test abnormal, Skin discolouration
SMQs:, Systemic lupus erythematosus (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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, 30 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: FACTOR V - NORMAL GENETIC MUTATION- NORMAL NO FAMILY HISTORY ALSO
CDC Split Type:

Write-up: 01/2003 SKIN DISCOLORATION 09/2007 - 3 PULMONARY EMBOLISM RIGHT LUNG THEN 9/2007 PLEURAL EFFUSION 7/2008 DVT IN RIGHT BICEP 2/2009 1 PULMONARY EMBOLISM. mY TREATMENT HAS BEEN COUMADIN AS OF RIGTH NOW I TAKE 10MG FRI-SUN 7.5MG MON-THU I HAVE HAS FACTOR V AND GENETIC MUTATION BLOOD WORK ALL CAME BACK NORMAL. I EXPERIENCE PAIN IN MY LUNGS FATIGUE HAD PULMONARY FUNCTIONS TEST FEV1 AT 70% OF PREDICTED LEVELS.


VAERS ID: 357350 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Michigan  
Vaccinated:2007-08-21
Onset:2009-04-12
   Days after vaccination:600
Submitted: 2009-09-15
   Days after onset:156
Entered: 2009-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1208F / 4 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Laboratory test normal, Pulmonary thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow)

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, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: Was in Hospital for 5 days, they ran all the relevant test for blood clots. Then went to clinic, and they ran numerous tests related to blood clots and she does not have any risk factors associated with blood clotting.
CDC Split Type:

Write-up: Blood Clot in lung on 4-12-2009 and will have to be on blood thinners rest of her life. She is currently on 15mg of warifin daily to keep her blood thinned between 2-3 INR.


VAERS ID: 358983 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2009-06-02
Onset:2009-06-12
   Days after vaccination:10
Submitted: 2009-09-30
   Days after onset:110
Entered: 2009-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1968UOB / 2 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Computerised tomogram, Deep vein thrombosis, Echocardiogram, Intensive care, Pain in extremity, Pulmonary embolism, Thrombolysis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Tendinopathies and ligament disorders (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, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: On Subcutaneous heparin secondary to post-partum.
Current Illness: Post-partum 6 weeks, factor v leiden on heparin for 6 weeks, prior to pregnancy no medications for anti-coagulation.
Preexisting Conditions: Previously diagnosed factor v leiden, post-partum 7 weeks on onset of adverse event. PMH: Factor V Leiden Heterozygous Disease, Hx of DVT''s 18 mos prior Allergies: NKDA
Allergies:
Diagnostic Lab Data: Labs: CBC, CMP WNL, Troponin high at 0.44, PT and PTT elevated, O2 sats low (70''s) Dx studies/X-rays: Doppler US rt leg + for DVT, CT Angiogram + for bilateral PE''s, EKG norm
CDC Split Type:

Write-up: Recieved Gardasil HPV Vaccine on 06/02/09, had symptoms of leg pain on 06/07/09 and was hospitalized 06/12/09 with extensive DVT and bilteral PE extensive clot. IVC in the setting of post-partum and heterozygous Factor V leiden. Required thrombolysis with TPA, IVC filter placement and echocardiogram and CT scans. Required Intensive Care Unit stay and anti-coagulation with coumadin for 6 months. 10/16/2009 received hospital records for dates 6/12-6/15/2009. Patient presents 10 days post vaccine with sx of dyspnea , cough, chest tightness and rt leg pain. Tx: IV Heparin, Lovenox SQ, IVC filter placement.


VAERS ID: 364185 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Male  
Location: Michigan  
Vaccinated:2009-10-23
Onset:2009-10-23
   Days after vaccination:0
Submitted: 2009-11-01
   Days after onset:9
Entered: 2009-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 98433P1 / UNK RA / IJ

Administered by: Unknown       Purchased by: Unknown
Symptoms: Angiogram, Blood test, Computerised tomogram, Deep vein thrombosis, Dyspnoea, Electrocardiogram, Pericarditis, X-ray
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune 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? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: glipizide Er 2.5mg actos 30 mg lisinopril 5 mg lipitor 10 mg zyrtec fish oil tablets CO-Q 10 600 mg senior multi-vitamin alpha lipoic acid 200 mg & acetyl L--Carnitine 400 mg aspirin (regular size; one daily) FLU VACCINE WENT DIRECTLY INT
Current Illness: no
Preexisting Conditions: diabetic 11/10/09 Hospital records received for dates 10/24/09. PMH: diabetes type 2, hyperlipidemia, CAD, appendectomy.
Allergies:
Diagnostic Lab Data: EKG; blood test; angiogram; X-ray; CT scan 11/10/09 Hospital records received for dates 10/24/09. Diagnostics/Labs: cardiac echo(-), troponin(-), HCT 34(L), lymphs% 16(L), mono% 14(H).
CDC Split Type:

Write-up: Difficulty breathing; more comfortable sitting up than lying down; ended up hospitalized with pericarditis on 10/24/09 11:30 AM blood clot developed in right leg calf 11/9/09 Vaccine record received. 11/10/09 Hospital records received for dates 10/24/09. DX: chest pain Assessment: mild distress, thoracic back pain. Presented with c/o chest pain, back pain, vomiting, diaphoretic.


VAERS ID: 365363 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Washington  
Vaccinated:2009-03-31
Onset:2009-04-24
   Days after vaccination:24
Submitted: 2009-11-05
   Days after onset:195
Entered: 2009-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0615X / 2 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cerebral venous thrombosis
SMQs:, Ischaemic 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? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Oral contraceptives
Current Illness:
Preexisting Conditions: Patient on oral contraceptives at time of reaction. 11/24/09 ER records received for date 4/24/09 to 4/25/09. PMH: asthma, mononucleosis(+), BCP.
Allergies:
Diagnostic Lab Data: 11/24/09 ER records received for date 4/24/09 to 4/25/09. Diag/Labs: MRI abnormal, blood test WNL.
CDC Split Type:

Write-up: Patient developed a cerebral venous thrombosis post vaccination. Patient hospitalized and placed on coumadin for 6 months. 11/24/09 ER records received for date 4/24/09 to 4/25/09. DX: venus sinus thrombosis, mononucleosis. Pt Presented w/ left sided transverse sinus thrombosis via CT scan results. SX: HA x2wks, N&V, flu like symptoms, cervical lymphadenopathy on left side. Assessment: (+)HA, otherwise WNL. Pt started on anticoag. tx and dc following day stable.


VAERS ID: 370771 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2007-12-19
Onset:2008-07-12
   Days after vaccination:206
Submitted: 2009-08-25
   Days after onset:409
Entered: 2009-12-01
   Days after submission:98
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1266U / 3 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / UNK LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Chest X-ray normal, Computerised tomogram normal, Deep vein thrombosis, Feeling cold, Feeling hot, Hyperaesthesia, Lymphadenitis, Oedema peripheral, Paget-Schroetter syndrome, Pain in extremity, Paraesthesia, Thoracic outlet syndrome
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALLEGRA 60 mg daily
Current Illness: Well child visit
Preexisting Conditions: Seasonal allergic Rhinitis PMH: Seasonal allergies Rhinitis Allergies: NKDA
Allergies:
Diagnostic Lab Data: 07/17/08 Cat Scan chest negative Labs: CBC, CMP, Uric acid, LDH, Anticardiolipin AB all WNL, PT elevated Dx studies: CT chest normal, Doppler study RUE abnormal + for DVT
CDC Split Type:

Write-up: 07/12/2008 presented to doctor office with hx 5 days of "Right arm aching/swelling". Diagnosis? Rt. axillary adenitis placed on KEFLEX 500 mg tid. No known Hx trauma. Has sensation to touch/heat/cold etc.; yet "tingly". Dx DVT and Paget Schroetter syndrome Aug 08. I called Mom this evening to discuss further her question regarding patient''s Gardasil vaccine series and her n/o blood clot. Patient has had something called Paget Schroetter syndrome which is a subset of thoracic outlet syndrome. This is usually due to inadequate space for the subclavian vein to run through at the shoulder due to anatomic variations in the 1st rib and clavicle (thus causing blood clot) or can also be from anterior scalene hypertrophy from repetive UE use. Patient used to participate in karate so this possibly may have put her at risk for this. I also reviewed office visit notes. I also reviewed the time course of patients Gardasil vaccines. Her initial visit here for RUE swelling was 6-7 mos following her 3rd Gardasil vaccine. I researched Gardasil and blood clots over the weekend and most of the alleged cases of causality are in clots that occurred within days to weeks following Gardasil vaccine. I reviewed this w/Mom and advised that, given the cause of patient''s clot being an anatomic etiology, and the fact that her Gardasil series was several months prior to her blood clot, I don''t think the two are related. However I again emphasized that we may never know the true answer and I am only relating my observations based on my research into Paget Schroetter Syndrome and Gardasil/blood clots. Mom said she was relieved to hear this, I think she was experiencing alot of guilt for having patient complete the Gardasil series, in light of the complications patient has had from surgery for the aforementioned syndrome ( had a pneumothorax as a complication from surgery to remove part of a rib to make room for her R subclavian vessel). I also disc''d the VAERS reporting service and advised that we would submit patient info to them which may help eventually establish causality or otherwise down the road when they look at Gardasil. 12/1/2009 PCP and Specialist records from 7/2008 to 9/2009. Patient with c/o''s sudden onset RUE swelling and pain. Tx''d initially with po ABX, Doppler + for DVT and placed on anticoagulant therapy. Patient had extensive surgery 6/2009, scalenectomy, brachial plexus neuroplasty, first rib resection and anteriolysis of subclavian artery. Patient had complication post op: pnemothorax. Dx''d with Paget Schroetter syndrome


VAERS ID: 374388 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Mississippi  
Vaccinated:2009-11-27
Onset:2009-11-30
   Days after vaccination:3
Submitted: 2009-12-21
   Days after onset:21
Entered: 2009-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE)) / MEDIMMUNE VACCINES, INC. 500782P / UNK NS / IN

Administered by: Other       Purchased by: Public
Symptoms: Blindness unilateral, Blood culture positive, Cavernous sinus thrombosis, Eye swelling, Headache, Malaise, Nuclear magnetic resonance imaging brain abnormal, Periorbital cellulitis, Skin lesion, Staphylococcal bacteraemia, Visual impairment
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Ocular infections (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (broad), Opportunistic infections (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, 17 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: MRSA in blood cultures MRI Brain 12/6/09 Bilateral cavernous sinus thrombosis, bilateral superior ophthalmic vein thrombosis. The MRV is otherwise within normal limits with widely patent dural venous sinuses and deep cerebral venous structures.
CDC Split Type:

Write-up: Patient had immunization for H1N1 via nasal device at school and noted a nasal skin lesion 2 days after immunization. She began having a headache as well as general malaise and eventually saw a providor at another facility. She was told she had MRSA and was treated with Tamiflu as well. At day 8 after her immunization she noted vision changes, swelling of her left eye and severe headaches and presented to the ER. She eventually was noted to have cavernous sinus thrombosis, peri-orbital cellulitis and MRSA bacteremia which required an extended hospital stay. The patient also is now premenently blind in her left eye and is being discharged from the hospital today with close follow-up. I am the attending physician on record for the patient.


VAERS ID: 383374 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2009-11-13
Onset:2010-02-14
   Days after vaccination:93
Submitted: 2010-03-16
   Days after onset:29
Entered: 2010-03-23
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 9784592 / UNK RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Deep vein thrombosis, Endotracheal intubation, Guillain-Barre syndrome, Intensive care, Lumbar puncture, Muscular weakness, Respiratory arrest
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Hypersensitivity (broad), Respiratory failure (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, 21 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Perennial allergic rhinitis.
Allergies:
Diagnostic Lab Data: Spinal tap results from ER (pending).
CDC Split Type:

Write-up: 16 wks after flu shot pt began with generalize lower extremity weakness with progression to respiratory arrest and intubation x 14 days. Dx with G.B.S. by ICU. Still in Rehab. Now with D.V.T.


VAERS ID: 390503 (history)  
Form: Version 1.0  
Age: 52.0  
Sex: Female  
Location: New Mexico  
Vaccinated:2010-04-23
Onset:2010-04-30
   Days after vaccination:7
Submitted: 2010-06-11
   Days after onset:42
Entered: 2010-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B042BA / UNK UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Deep vein thrombosis, Lumbar puncture abnormal, Muscular weakness, Rhabdomyolysis
SMQs:, Rhabdomyolysis/myopathy (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 25 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ZOCOR possibly started simvastatin to ZOCOR; Propranolol; Hydrochlorothiazide; ZANAX; Trazodone
Current Illness: None
Preexisting Conditions: Hypertension; palpitations; anxiety; dyslipidemia
Allergies:
Diagnostic Lab Data: Lumbar puncture consistent with GUILLAIN-BARRE.
CDC Split Type:

Write-up: Acute onset lower extremity weakness 30Apr10, with diagnosis of, rhabdomyolysis, right leg deep vein thrombosis, and possible GUILLAIN BARRE SYNDROME. Required renal dialysis and is currently in a rehabilitation hospital.


VAERS ID: 390652 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-06-15
Entered: 2010-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Deep vein thrombosis, Rheumatoid arthritis
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Arthritis (narrow), 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? No
Previous Vaccinations:
Other Medications: no other medications
Current Illness: unknown
Preexisting Conditions: Hypothyroidism; Splenectomy; Reflux oesophagitis; Oesophagogastric fundoplasty
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2010GB36970

Write-up: Initial report received from a physician on 09 Jun 2010: This patient with medical history of hypothyroidism, total splenectomy in 2004, fundoplication for reflux oesophagitis in 2004 was vaccinated for with INFLUENZA virus vaccine seasonal (manufacturer unknown) (dose and batch number unknown) intramuscularly in 2006. Following the vaccination, after 01 week the patient experienced rheumatoid arthritis in 2006 and the patient also developed deep vein thrombosis during a 10 month stay at hospital in 2006. The outcome of the events was not reported.


VAERS ID: 399527 (history)  
Form: Version 1.0  
Age: 30.0  
Sex: Male  
Location: Florida  
Vaccinated:1999-03-03
Onset:2010-07-13
   Days after vaccination:4150
Submitted: 2010-09-20
   Days after onset:69
Entered: 2010-09-22
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV036 / UNK UN / UN

Administered by: Military       Purchased by: Military
Symptoms: Activities of daily living impaired, Angiogram pulmonary abnormal, Antibody test normal, Antinuclear antibody negative, Antithrombin III, Arthralgia, Arthropod bite, Asthma, Asthma exercise induced, Atelectasis, Back pain, Blood culture negative, Blood magnesium normal, Blood phosphorus normal, Blood testosterone normal, Blood thyroid stimulating hormone, Blood thyroid stimulating hormone normal, Borrelia test negative, C-reactive protein increased, Cardiolipin antibody, Cardiolipin antibody positive, Cellulitis, Chest X-ray abnormal, Chest discomfort, Chest pain, Deep vein thrombosis, Dermatitis contact, Dizziness postural, Dyspnoea, Dyspnoea exertional, Dysstasia, Echocardiogram normal, Electrocardiogram normal, Erythema, Fatigue, Full blood count normal, Groin pain, Haematocrit decreased, Haemoglobin decreased, Heat rash, Induration, Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling, Insomnia, International normalised ratio normal, Joint swelling, Laboratory test normal, Liver function test normal, Lower extremity mass, Metabolic function test, Muscle strain, Musculoskeletal pain, Myalgia, Osteoarthritis, Pain, Pain in extremity, Phlebitis, Platelet count decreased, Pleurisy, Pneumonia, Pneumonitis, Protein total normal, Prothrombin time prolonged, Pulmonary embolism, Pulmonary function test normal, Pyrexia, Rash erythematous, Rash pruritic, Rash pustular, Red blood cell count decreased, Red blood cell sedimentation rate normal, Red cell distribution width normal, Respiratory disorder, Rheumatoid factor negative, Skin warm, Tenderness, Thrombophlebitis, Ultrasound Doppler abnormal, Vena cava filter insertion, Wheezing, White blood cell count normal, X-ray limb normal
SMQs:, Rhabdomyolysis/myopathy (broad), Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (narrow), Haematopoietic erythropenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (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 (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (narrow), Osteonecrosis (broad), Hypersensitivity (narrow), Arthritis (narrow), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (narrow), Immune-mediated/autoimmune 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? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: See HPI
Allergies:
Diagnostic Lab Data: WBC 7.8?6.2; RBC 4.80?4.5, HGB 14.6?13.8; HCT 42.3?39.7; RDW & platelet normal; High sensitivity CRP 9.795; Antithrombin III 124; PT 14.6; INR 1.1; Blood culture no growth x 5 days; Normal comprehensive metabolic profile; Magnesium; Phosphorus; & total protein; Cardiolipin AB IGG 0.8; IGM 1.3; and IGA 1.4. A Doppler ultrasound of the RLE showed a DVT to right popliteal and superficial thrombophlebitis in the superficial right calf area other wise normal exam. CXR was normal. Right Tib/Fib x-ray normal. CT pulmonary angiogram chest showed bilateral lower lobe pulmonary emboli left greater than right, and minimal right lower love atelectasis. 2D echo normal with EF 60%. No evidence pulmonary hypertension or right ventricular dilation. EKG NSR.
CDC Split Type:

Write-up: Received ANTHRAX vac 3/3/1999 (FAV036), 3/17/99 (FAV033), 3/31/1999 (FAV033), 9/13/199 (lot number unknown), 1/25/03, 2/3/04, 6/236/05, and 6/13/07. He remembers each injection site burning, being red and swollen, and having dull achy diffuse arthralgia (elbows, knees, hips) lasting approximately one week. Symptoms did not worsen with sequential vaccinations and did resolve with intermittent use of MOTRIN. (However, 2 days prior to AVA #2, he had been on 30 days of INDOCIN for right hip bursitis). He reported receipt of several other vaccinations before and after each Anthrax vaccine with no unexpected adverse events (1/25/2003 AVA #5, 2/13/2003 SPV) in February 2003 (< 30 days post vac) his wife reported onset of pruritic red pustular rash from anterior neck to navel in husband. His wife described this rash as a "heat rash with white heads". He denied any new clothing, food groups, detergents, deodorants, travel, pets, etc. There was no associated fever, malaise or chest pain. He treated with BENADRYL cream with resolution. (6/13/07 AVA #8) 23 Jun 2007 (day 10) focal pruritic skin rash c/o papules w/o pustules or other s/s over a 4" x 2" area over sternum x 1 day after working out. He was diagnosed with contact dermatitis and treated oral BENADRYL and hydrocortisone cream. 29 Sep 2008 he complained of 2 day history of lower right back pain, difficulty standing erect and sleeping after playing 18 holes of golf being diagnosed with back strain. That evening, he went to a local Emergency Room with additional complaints of "flu like"symptoms, chest pain, shortness of breath, and fever. He was admitted (9/30/2008-10/6/2008) for community acquired pneumonia and pleurisy per CXR. Following his release, he continued to experience generalized fatigue, positional dizziness, and dyspnea on exertion (room air O2 sats 97-99%). By March 2009 he reported he felt able to return to his prior work status and was able to exercise reporting PRT run times as "good". However, he continued to report persistence of fatigue, myalgia, arthralgia, chest discomfort, and wheezing with cold air (similar to Oct 2008 pneumonia). Follow up labs (March 2009) showed normal CBC with low platelets at 153 (169-413), elevated CRP 0.73 (0-0.33) and ESR 11 (0-9), normal chem, TSH, hepatic panel, testosterone, and negative nuclear Ab, RF, and Lyme Ab. His PFT''s were normal with FVX 92% and FEV1 99%. Evaluation by Internal Medicine 4/7/09 documented his respiratory symptoms may be due to "post-pneumonia airway reactivity or irritant pneumonitis" and his knee/shoulder pains were likely due to "osteoarthritis". From 2/17/2010 to 3/23/2010 he presented to sick call complaining of recurrent shortness of breath. Providers diagnosed cold induced asthma exercised induced asthma. Given ALBUTEROL and SINGULAIR. He advised feeling only episodic relief. He was evaluated by medical several times between 7/13/2010 to 7/31/2010 initially complaining of a painful knot to right medial lower leg x 2-3 weeks and recurrent shortness of breath while running or at rest. Initial providers documented a tender palpable warm pink/purple knot suggestive of an insect bite and treated for cellulitis then phlebitis. Despite various antibiotic and steroid therapies, his symptoms worsened to include complaints of a deep constant 8/10 ache from his right groin to ankle, a palpable firm node to mid-medal calf, increased erythema and swelling to his ankle, and a tender palpable cord over the femoral vein. Bilateral lower chest pain and worsening shortness of breath began 7/30/2010 during a run being taken to near-by ER. He was admitted with right lower leg deep vein thrombosis and bilateral pulmonary embolism (see 7/2010 lab-diagnostic studies). AN IVC filter was inserted on 7/31/2010. As of August 2010, this SM is slowly recovering and is on COUMADIN. He continues to complain of shortness of breath with exertion. Symptoms: Swelling/mass/lump, localized superficial (782.2), Symptoms inv skin/integumentary tissue NEC (782.9), Shortness of breath (786.05), Rash, oth nonspecific skin eruption(782.1), Symptoms, inv skin/integumentary tissue NEC(782.9).


VAERS ID: 412691 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Male  
Location: New York  
Vaccinated:2010-11-01
Onset:2010-11-09
   Days after vaccination:8
Submitted: 2010-12-10
   Days after onset:31
Entered: 2010-12-14
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3639CA / 3 RA / IM

Administered by: Private       Purchased by: Other
Symptoms: Computerised tomogram thorax abnormal, Cough, Deep vein thrombosis, Headache, Malaise, Pulmonary embolism, Pyrexia, Ultrasound Doppler abnormal
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Cardiomyopathy (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? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: C/O pain in (R) side only when wrestling.
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Leg doppler u/s; Chest CT
CDC Split Type:

Write-up: Became ill 11/9/10 fever, h/a, cough on 11/16/10 large left positive deep vein thrombosis and bilateral pulmonary emboli dx.


VAERS ID: 418593 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2011-02-16
Onset:2011-02-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2011-03-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Private
Symptoms: Anticoagulant therapy, Cardiomyopathy, Condition aggravated, Deep vein thrombosis, Dyspnoea, Hypercapnia, Laboratory test, Lethargy, Obstructive airways disorder, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Many
Current Illness:
Preexisting Conditions: Age; obstructive lung disease; cardiomyopathy
Allergies:
Diagnostic Lab Data: Labs & X-ray
CDC Split Type:

Write-up: Was seen in ER 2/18/11. Lethargy increased SOB increased wheezes obstructive lung disease. Had been hospitalized 12/10 hypercapnia with PCO2, CHF, cardiomyopathy, DVT, anticoagulant therapy.


VAERS ID: 424919 (history)  
Form: Version 1.0  
Age: 32.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-06-06
Entered: 2011-06-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Antinuclear antibody negative, Antiphospholipid antibodies negative, Anxiety, C-reactive protein normal, Cardiolipin antibody negative, Cellulitis, Coagulation test normal, Deep vein thrombosis, Dyspnoea, Fibrin D dimer increased, Homans' sign positive, International normalised ratio, Laboratory test abnormal, Muscle injury, Oedema peripheral, Pain, Pain in extremity, Palpitations, Protein C, Protein S normal, Prothrombin time, Pulmonary embolism, Restlessness, Sepsis, Tachycardia, Tachypnoea, Tenderness, Ultrasound Doppler abnormal, Venous occlusion
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Akathisia (broad), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Sepsis (narrow), 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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: antiseptics; warfarin
Current Illness: Animal bite; Unprovoked bite by a stray dog causing a penetrating, lacerated wound on his right calf and thigh, and bleeding from the site of wound.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Fibrin D dimer, 5131 ng/ml, High
CDC Split Type: PHHY2011IN44349

Write-up: Case number PHHY2011IN44349 is an initial literature report received on 24 May 2011. The authors discussed a rare case of calf muscle injury due to dog bite leading to deep vein thrombosis. This report refers to a 32 year old man presented with a history of unprovoked bite by a stray dog causing a penetrating, lacerated wound on his right calf and thigh, and bleeding from the site of wound. He was treated with local antiseptic and was vaccinated with rabies virus vaccine (manufacturer and batch number: unknown). Two days later, the patient experienced a swelling of the right calf which was ignored. Over the next 10 days, the swelling worsened and progressed from the calf to the thigh and was associated with pain in the right leg while walking. He also had acute onset of breathlessness, uneasiness, restlessness, palpitations and intolerable pain in the right leg for which he was hospitalized. On examination, the patient was restless and writhing in pain. His vital parameters were normal except for tachycardia and tachypnoea. No other abnormality was found on chest and cardiovascular examination. Local examination revealed swelling and tenderness over the right calf and thigh. Pratt sign and the Homan''s test were positive. A differential diagnosis of deep vein thrombosis (DVT) with pulmonary embolism and cellulitis with septicemia were made. The patient was investigated and a Doppler of the right leg showed total occlusion of the right common femoral vein below the saphno-femoral junction by a thrombus with partial occlusion above the junction. His D-dimer level was 5131 ng/ml which was significantly raised. no evidence of pulmonary embolism was found on further investigations. The patient was treated with low molecular weight heparin and then shifted over to oral warfarin after overlapping the treatment for 4 days. The pain, swelling and dyspnoea improved during hospital stay and he was discharged with a target international normalized ratio (INR) between 2 and 3. On follow up, his symptoms, prothrombin time (PT) and INR were monitored. No contributory thrombophilic factors (cardiolipin antibody, C-reactive protein, lupus anticoagulant, factor V Leiden, anti-thrombin, antinuclear antibody (ANA), protein C and protein S) were found during the 6 months post-injury examinations. The author commented that the patient''s only identifiable major thrombotic risk factor was the traumatic injury due to the dog bite.


VAERS ID: 437377 (history)  
Form: Version 1.0  
Age: 58.0  
Sex: Female  
Location: California  
Vaccinated:2011-09-21
Onset:2011-09-23
   Days after vaccination:2
Submitted: 2011-10-09
   Days after onset:16
Entered: 2011-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH478AC / 2 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Arthralgia, Asthenia, Deep vein thrombosis, Fibrin D dimer, Full blood count, Hyperaesthesia, Immunoglobulins, Joint swelling, Laboratory test, Muscular weakness, Ultrasound scan, Urine analysis
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), 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: Triam/HCTZ 37.5-25 cap QD Nortriptylin 25 mg PRN sleep Fluoxetine HCL 20 mg QD Famotidine 20 mg QD Aspirin 81 mg QD
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: D-Dimer, immunoglobulins, chem panel, CBC, UA, DVT ultrasound.
CDC Split Type:

Write-up: On 9/23, backs of thighs hurt & felt weak. Pain moved to ankles-felt like they were sprained. Pain about the same for several days, but involved calves also. On 9/30, ankles started to swell. Called doctor & made appt. After weekend of resting, still had pain & swelling. On Tuesday, thighs were hypersensitive & weak. Wednesday, legs were weak & painful & ankles stayed swollen. Dr put me on prednisone and symptoms got better.


VAERS ID: 437501 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Male  
Location: California  
Vaccinated:2011-09-30
Onset:2011-10-01
   Days after vaccination:1
Submitted: 2011-10-03
   Days after onset:2
Entered: 2011-10-10
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LA / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Deep vein thrombosis, Local reaction, Oedema peripheral, Ultrasound Doppler abnormal
SMQs:, Cardiac failure (broad), Angioedema (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)

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

Write-up: Received vaccine (L) deltoid. (L) arm swollen the next day - presumed local reaction. Day 2, a (L) axillary deep vein thrombosis was identified on ultrasound. Started on LOVENOX & COUMADIN in the ER.


VAERS ID: 452019 (history)  
Form: Version 1.0  
Age: 49.0  
Sex: Female  
Location: California  
Vaccinated:2012-03-12
Onset:2012-03-12
   Days after vaccination:0
Submitted: 2012-03-16
   Days after onset:4
Entered: 2012-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1072AA / UNK UN / IM

Administered by: Private       Purchased by: Public
Symptoms: Deep vein thrombosis, Erythema, Injection site swelling, Pharyngeal oedema, Rash, Swelling, White blood cell count normal
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Embolic and thrombotic events, venous (narrow), Oropharyngeal allergic conditions (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? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None that 24 hour period.
Current Illness: No
Preexisting Conditions: Allergies to most Antibiotics, mango, peanuts, squash
Allergies:
Diagnostic Lab Data: Tested for WBC and DVT''s in the ER on 3/15/2012 - negative.
CDC Split Type:

Write-up: Started with a mild facial rash & a little throat swelling. Over next two days my arm swelled at injection sight, then increased to swelling of the neck, back and most of the upper arm with redness, heat and extreme pain.


VAERS ID: 460403 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2012-06-25
Onset:2012-07-08
   Days after vaccination:13
Submitted: 2012-07-27
   Days after onset:19
Entered: 2012-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B078BA / 1 LA / IM

Administered by: Unknown       Purchased by: Other
Symptoms: Condition aggravated, Deep vein thrombosis, Guillain-Barre syndrome, Immunoglobulin therapy, Maternal exposure during pregnancy, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), 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, 16 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: albuterol Zyrtec
Current Illness: None
Preexisting Conditions: Asthma, history of DVT during previous pregnancy.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Progressive upper and lower extremity weakness felt to be Guillain Barre Syndrome. Please note patient is pregnant. Given IVIG, found to have DVTs left lower extremities, now receiving Gamunex (different type of IVIG) with full dose Lovenox. Slight improvement in upper extremity strength but patient extremely weak in lower extremities 3/5 strength at hips.


VAERS ID: 465894 (history)  
Form: Version 1.0  
Age: 41.0  
Sex: Male  
Location: Ohio  
Vaccinated:2003-12-06
Onset:2004-03-03
   Days after vaccination:88
Submitted: 2012-09-21
   Days after onset:3123
Entered: 2012-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV079 / UNK UN / UN
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1167M / UNK UN / UN

Administered by: Military       Purchased by: Military
Symptoms: Computerised tomogram abnormal, Deep vein thrombosis, Dyspnoea, Fatigue, Laboratory test normal, Oedema peripheral, Pulmonary embolism
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (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)

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: None
Current Illness: None
Preexisting Conditions: Not noted
Allergies:
Diagnostic Lab Data: Factor V mutation-neg; CT/PE 10 Mar- rt main pulmonary embolus with extension into the right middle lobe pulmonary artery and the rt lower lobe pulmonary arteries, as well as the superior and posterior basal segments lower lobe pulmonary arteries; Rt lower ext DVT
CDC Split Type:

Write-up: SOB and leg swelling Dx with DVT and PE, also c/o fatigue for past yr. In May 2011 developed another DVT.


VAERS ID: 469461 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Illinois  
Vaccinated:2012-05-02
Onset:2012-05-02
   Days after vaccination:0
Submitted: 2012-10-12
   Days after onset:163
Entered: 2012-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1860AA / 2 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Abdominal pain upper, Computerised tomogram abdomen abnormal, Diarrhoea, Dizziness, Eating disorder, Gait disturbance, Gastroenteritis, Hepatic vein thrombosis, Laboratory test, Liver function test abnormal, Pyrexia, Ultrasound biliary tract, Ultrasound scan abnormal, Vomiting, White blood cell count increased
SMQs:, Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab work; Gallbladder U/S; CT Scan Abd pelvis
CDC Split Type:

Write-up: One hour after inj. fever 99.8 degrees F, dizzy, lightheaded, diff. in walking & eating, labs drawn WNL, then 5/29 vomiting, diarrhea with mid epigastric pain. Labs on 5/29 increased LFT''s & WBC increased. 5/30 pt admitted for gastroenteritis sx''s D/C after 1 day, then 6/14 pt c/o worsening RUQ pain, Abn gallbladder U/S, ordered stat CT Abd & Pelvis, (+) hepatic vein thrombosis. Pt admitted & given LOVENOX & COUMADIN.


VAERS ID: 481446 (history)  
Form: Version 1.0  
Age: 27.0  
Sex: Male  
Location: Virginia  
Vaccinated:2004-09-23
Onset:2005-06-01
   Days after vaccination:251
Submitted: 2013-01-15
   Days after onset:2785
Entered: 2013-01-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Military       Purchased by: Military
Symptoms: Antiphospholipid syndrome, Arthralgia, Beta-2 glycoprotein antibody positive, Blood immunoglobulin G increased, Cardiolipin antibody positive, Deep vein thrombosis, Fatigue, Limb injury, Pain in extremity, Protein S increased, Varicophlebitis
SMQs:, Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Accidents and injuries (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (broad), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (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? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Cardiolipin ab IgG: 100 (H); Beta2 GPI ab IgG: 84.6 (H); Protein S Ag P: 139 (H)
CDC Split Type:

Write-up: Pt developed varicose vein in left leg. Developed some minor systemic symptoms such as fatigue and arthralgias with exercise. In 2007 varicosity became extremely painful and swollen, 3 DVTs found and diagnosed with antiphospholipid antibody syndrome. Comprehensive evaluation for vaccine causality conducted by the clinic with rheumatology input. RESULTS: After extensive investigation by the clinic and Rheumatology consultants, it is our expert opinion that patient''s antiphospholipid antibody syndrome should be considered a LINE OF DUTY YES based on recommendation 1 above and the following variables: a. He was symptom and disease-free at entry level of job with indeterminate/negative autoantibodies. b. He developed the 1st symptoms of thrombosis while at work in 2004-5 one month after experiencing hand trauma. c. He received multiple vaccinations during service and antibody levels continued to rise sequentially. These vaccinations include the vaccine (tetanus) which has a biologically plausible mechanism described for triggering autoimmunity via a molecular mimicry mechanism.


VAERS ID: 491245 (history)  
Form: Version 1.0  
Age: 59.0  
Sex: Female  
Location: Texas  
Vaccinated:2013-03-09
Onset:2013-03-09
   Days after vaccination:0
Submitted: 2013-05-05
   Days after onset:56
Entered: 2013-05-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. 0467AE / UNK AR / SC

Administered by: Other       Purchased by: Private
Symptoms: Deep vein thrombosis, Optic neuritis, Retinal haemorrhage, Retinitis, Varicella virus test positive
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Optic nerve disorders (narrow), Demyelination (narrow), Retinal disorders (narrow), Ocular infections (narrow), Opportunistic infections (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, 10 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Valacyclovir; Amantadine; Hydrocodone
Current Illness:
Preexisting Conditions: Mod/sev formaldahyde; Recurrent shingles; Neuralgia cranial nerves V and X (left)
Allergies:
Diagnostic Lab Data: Varicella zoster (positive)
CDC Split Type:

Write-up: Optic neuritis and retinitis (right eye) resulting in retinal bleeding due to DVT. Five day course IV steroids starting day 13. Bromfenac ophthalmic BID starting (day 40). Intramuscular steroid injection (day 51).


VAERS ID: 491651 (history)  
Form: Version 1.0  
Age: 44.0  
Sex: Female  
Location: New York  
Vaccinated:2013-04-30
Onset:2013-05-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2013-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C4365AA / UNK RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Deep vein thrombosis, Injection site erythema, Injection site swelling, Pain in extremity, Swelling, Ultrasound Doppler abnormal
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had no illness at the time of vaccination and allergies to penicillin, clindamycin, tetracycline and NAPROSYN.
Allergies:
Diagnostic Lab Data: The patient had a doppler sonogram which documented a small DVT of right brachial complex.
CDC Split Type: 201305706

Write-up: Initial report was received from a healthcare professional on 03 May 2013. A 44-year-old female patient had received an intramuscular injection in the right deltoid of ADACEL, lot number C4365AA, on 30 April 2013. The next day, on 01 May 2013, the patient experienced soreness of the arm, swelling of the injection area and under the arm. Two days later, on 03 May 2013, the patient reported very painful arm with redness around the injection site and axilla swelling. The patient was directed to go to the hospital emergency room for evaluation and treatment. A doppler sonogram documented a small deep vein thrombosis (DVT) of right brachial complex. The patient was hospitalized and is being treated with anticoagulant. The patient had no illness at the time of vaccination and allergies to penicillin, clindamycin, tetracycline and NAPROSYN. Outcome was not recovered. Documents held by sender: None.


VAERS ID: 493203 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Female  
Location: New York  
Vaccinated:2013-04-23
Onset:2013-05-04
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2013-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4567AA / UNK LA / IM
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. H019038 / 1 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Anti-cyclic citrullinated peptide antibody negative, Atrial fibrillation, Borrelia test negative, CSF culture negative, CSF oligoclonal band, CSF protein increased, CSF test abnormal, CSF virus no organisms observed, CSF white blood cell count, Coma, Deep vein thrombosis, Electrocardiogram abnormal, Encephalitis, Endotracheal intubation, Grand mal convulsion, HIV test negative, Hepatitis C test negative, Herpes simplex serology negative, Intensive care, Nuclear magnetic resonance imaging brain normal, Polymerase chain reaction, Pulmonary embolism, Rheumatoid factor, Unresponsive to stimuli
SMQs:, Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Convulsions (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (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, 14 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ALEVE; Calcium/Vitamin D; Multiple vitamin; TOPROL XL; Lisinopril
Current Illness: Uncontrolled hypertension
Preexisting Conditions: Hypertension; Osteoporosis
Allergies:
Diagnostic Lab Data: MRI - did not have stroke per neurology 5/8/13; Lumbar puncture 5/6/13 = Few WBC, elevated protein 145, hi RF (48), culture (-), (-) CCP, anti CCP, viral CSF studies, oligoclonal bands; 5/6/13 (-) HIV, (-) Lyme, (-) HSV PCR, (-) Hepatitis C
CDC Split Type:

Write-up: Found unresponsive 5/4/13 - EMS witnessed generalized tonic-clonic seizure x1 minute. ECG showed Afib in field, intubated brought to (7AM) medical center where she was r/o for stroke. S/P imaging, thought to have seizure in setting of possible TIA in setting of Afib. Day 3 she became extremely encephalitic (non verbal, not following commands). Coma continued in ICU until 5/8/13 where she improved then developed bilateral pulmonary embolism (PE) and LE DVT calf. D/C home 5/15/13.


VAERS ID: 498498 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Michigan  
Vaccinated:2012-06-11
Onset:2012-10-02
   Days after vaccination:113
Submitted: 2013-08-05
   Days after onset:307
Entered: 2013-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0100AE / 1 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0022AE / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Alopecia, Arthralgia, Chest pain, Decreased appetite, Deep vein thrombosis, Fatigue, Menstrual disorder, Migraine, Myalgia, Pain in jaw, Palpitations, Pyrexia, Vision blurred, Weight decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Hyperglycaemia/new onset diabetes mellitus (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 (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Osteonecrosis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Progressively worse symptoms since shot administered. Severe migraines and blurred vision in Left eye beginning in October. On February 10th, patient had deep vein thrombosis of the left arm. Has progressively gotten worse over time with joint pain, muscle pain, fatigue, high fevers daily, lower jaw pain, chest pain, racing heart, hair loss, abnormal menstrual cycle, weight loss, appetite loss and continues will all mentioned symptoms today.


VAERS ID: 515992 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2013-09-30
Onset:2013-11-18
   Days after vaccination:49
Submitted: 2013-11-30
   Days after onset:12
Entered: 2013-12-09
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4768AA / 5 UN / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. H017759 / UNK UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Blood culture, Blood test, Bone densitometry, Cardiomyopathy, Catheterisation cardiac, Computerised tomogram head, Computerised tomogram thorax, Deep vein thrombosis, Electrocardiogram, Mental status changes, Muscular weakness, Nuclear magnetic resonance imaging, Pneumonia, Respiratory failure, Sputum culture
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (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), Dementia (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (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, 15 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: NKDA; CKD; HTN; Seizures
Allergies:
Diagnostic Lab Data: Heart Cath; CT head and chest; DEXA; MRI; Blood cultures; EKG; Sputum Culture; Blood tests
CDC Split Type:

Write-up: Lower extremity weakness, respiratory failure, cardiomyopathy, possible Guillain Barre, pneumonia, EF = 30-35%. DVT''s in legs, altered mental status.


VAERS ID: 519198 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Florida  
Vaccinated:2008-06-23
Onset:2012-12-26
   Days after vaccination:1647
Submitted: 0000-00-00
Entered: 2014-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAJB233AA / 2 RA / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1967U / 3 LA / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Deep vein thrombosis, Ultrasound Doppler abnormal
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Cardiomyopathy (broad)

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

Write-up: DVT in Rt upper arm -$g COUMADIN x 3 months. DVT resolved (by Doppler).


VAERS ID: 531384 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-05-13
Entered: 2014-05-20
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / ID

Administered by: Other       Purchased by: Other
Symptoms: Albumin CSF, Areflexia, Blood creatinine increased, Blood pressure abnormal, CSF cell count abnormal, CSF immunoglobulin increased, CSF protein increased, CSF white blood cell count increased, Computerised tomogram abdomen normal, Computerised tomogram head normal, Computerised tomogram normal, Computerised tomogram thorax normal, Constipation, Coordination abnormal, Creatinine renal clearance decreased, Cytomegalovirus test negative, Deep vein thrombosis, Electromyogram abnormal, Epstein-Barr virus test negative, Full blood count normal, Gait disturbance, Guillain-Barre syndrome, Hypertension, Hypoaesthesia, Immunoglobulin therapy, Metabolic function test normal, Muscular weakness, Neuralgia, Neurological examination normal, Nuclear magnetic resonance imaging spinal normal, Paraesthesia, Peripheral sensory neuropathy, Varicella virus test negative
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), 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), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Demyelination (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow), Sexual dysfunction (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, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Dronabinol
Current Illness: Chronic obstructive pulmonary disease; Weight decreased, loss of weight few months before hospitalization
Preexisting Conditions: Tobacco user; Hernia repair; Foot operation; Cataract operation
Allergies:
Diagnostic Lab Data: Albumin CSF, 24.8 g/l, Low; Blood creatinine, 1.2 mg/dl, Normal; Blood creatinine, 1.5 mg/dl, High; Blood pressure, 169/92 mmHg, Significant, 155-169/74-92 mmHg; CSF cell count, Abnormal, Significant; CSF immunoglobulin, 19.4 mg/dl, High; CSF protein, 66 mg/dl, High; CSF test, Abnormal, Significant, Abnormal CSF cell count indicated albuminocytologic dissociation; CSF white blood cell count, 17 cells/mm, High; Creatinine renal clearance, 46.7 ml/min, Significant; Cytomegalovirus test, Negative, Normal; Epstein-Barr virus test, Negative, Normal; Heart rate, 92/min, Significant; Heart rate, 64/min, Significant; Metabolic function test, Normal; Respiratory rate, 18/min, Significant; Respiratory rate, 16/min, Significant; Varicella virus test, Negative, Normal
CDC Split Type: PHHY2014US056236

Write-up: Case number PHHY2014US056236, is a combined initial and follow up literature report received on 07 May 2014 and 09 May 2014 respectively. In this article the author reported a case of Guillain-Barre syndrome (GBS) in an older man following influenza vaccination. This report refers to an 81 year old male patient. His medical history included chronic obstructive pulmonary disorder (he had not taken any medicine for COPD), loss of weight few months before hospitalization. He was a cigarette smoker and claimed to smoke about 10 cigars per day. There was no recent history of fever, diarrhea or upper respiratory symptoms as well as no history of head trauma. He had hernia, foot and cataract surgeries in the past. He did not have any recent hospitalizations and his previous admissions were considered noncontributory. He had no vaccination history or drug allergies. His concomitant medication included dronabinol at a dose of 2.5 mg as needed for appetite stimulation approximately 06 weeks before hospitalization. On an unknown date, he was vaccinated with a trivalent seasonal influenza vaccine (manufacturer and batch number not reported. Hence, conservatively taken as seasonal influenza INN) via intradermal route. Two weeks after vaccination, he began to experience numbness and tingling in both feet. He was hospitalized when the numbness and tingling began ascending toward the waistline. It was reported that he discontinued the use of dronabinol three weeks before admission because he thought the medication might have been responsible for his symptoms. The patient then complained of intense neuropathic pain in his lower extremities. On presentation, his gait and coordination were not entirely intact. At the time of hospitalization his blood pressure was 155-169/74-92 mmHg, respiratory rate was 16 to 18 breaths/min, heart rate was 64 to 92 beats/min and body temperature of 36.3 to 36.5 degree Celsius. Heart and lung examinations were normal. During the neurologic examination, he was noted to be calm alert and oriented. He displayed no weakness in all four extremities but he lacked deep tendon reflexes in his ankles. Whereas, magnetic resonance imaging of the lumbar and thoracic spine and computed tomography of thorax, brain, head, abdomen and pelvis were all negative for pathogenic signs of neuropathy as well as for alternative diagnoses. His metabolic panel and complete blood count were all within normal limits with the exception of an elevated serum creatinine of 1.5 mg/dL. His creatinine level decreased to 1.2 mg/dL on hospital day 03, with a calculated Cockcroft-Gault creatinine clearance estimate of 46.7 mL/min. A lumbar puncture revealed clear and colorless cerebrospinal fluid (CSF) with a slightly elevated GSL protein of 66 mg/dL. Lumbar puncture also revealed an elevated CSF white blood cell count of 17 cells/mm and elevated CSF immunoglobulin G (IgG) with a value of 19.4 mg/dL. Other values of the lumbar puncture included red blood count: 0, monocytes: 24, albumin: 24.8 g/L, and CSF index: 2.61. All CSF and blood cultures were negative and common viral studies (cytomegalovirus, Epstein-Barr, varicella) that have been associated with GBS were also negative. Based on the Brighton Collaboration''s case definitions of GBS, clinical, laboratory, and electrophysiological criteria must be assessed to determine with certainty that a patient has GBS. The patient exhibited clinical findings of symmetrical bilateral ascending paralysis and loss of deep tendon reflexes with an onset of symptoms within 02 weeks of vaccine administration. On electrophysiological studies, the patient''s EMG was positive for sensorimotor axonal polyneuropathy. While a low CSF total white cell count was not observed. Elevated CSF protein, elevated CSF IgG and elevated CSF index were noted despite the absence of albuminocytologic dissociation. He met Brighton level 03 diagnostic certainties as a result of meeting only clinical criteria for GBS along with electrophysiological findings. On day 05 of hospitalization, he was treated with intravenous immunoglobulin (IVIG) 0.4 g/kg/d and continued for 5 days. The patient also received amlodipine at a dose of 2.5 mg daily for hypertension, docusate at a dose of 100 mg daily for constipation, enoxaparin at a dose of 30 mg daily for deep-vein thrombosis prophylaxis and gabapentin at a dose of 100 mg at bedtime for neuropathic pain. He was given morphine at a dose of 04 mg and hydrocodone/acetaminophen at a dose of 7.5/325 mg as needed for pain management. After receiving the IVIG and other supportive therapies including intravenous fluids, he had progressively improved sensation in his extremities as well as improved gait. He was discharged after a 10 day hospital admission, approximately 07 weeks after the administration of the seasonal influenza vaccine. He was discharged with a prescription for gabapentin 100 mg at bedtime to help with any persistent neuropathic pain. In conclusion the author stated that although GBS was rare, it should be considered in older patients who experienced adverse reactions after administration of the influenza vaccine. Despite the seriousness of GBS, the benefits of an annual influenza vaccination outweigh the risk of developing GBS. As the number of patients receiving the annual influenza vaccine increased, further research was needed to understand which patient populations were at the highest risk for development of this possible life-threatening disease.


VAERS ID: 536399 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2014-07-07
Onset:2014-07-09
   Days after vaccination:2
Submitted: 2014-07-11
   Days after onset:2
Entered: 2014-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H020901 / 2 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Blindness unilateral, Echocardiogram abnormal, Ophthalmological examination abnormal, Pupil dilation procedure, Pupillary reflex impaired, Retinal artery thrombosis
SMQs:, Embolic and thrombotic events, arterial (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Corneal disorders (broad), Retinal 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, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Fluoxetine and Risperidone
Current Illness: Major Depression
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Patient was diagnosed with occlusion/thrombosis of retinal artery. He has been evaluated for stroke/hypercoaguability. Results are pending. Cardiac echo revealed minimal right to left shunting making thromboembolic event possible etiology.
CDC Split Type:

Write-up: Patient presented to the Emergency Room with acute onset of unilateral vision loss. Exam notable for absent pupillary reflex. Was transferred to an eye specialist. Dilated eye exam was suspicious for thrombosis of retinal artery.


VAERS ID: 538058 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Unknown  
Vaccinated:2014-07-02
Onset:2014-07-16
   Days after vaccination:14
Submitted: 2014-07-29
   Days after onset:13
Entered: 2014-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J009788 / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Myectomy, Subclavian vein thrombosis, Surgery
SMQs:, Embolic and thrombotic events, venous (narrow), Malignancy related therapeutic and diagnostic procedures (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, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1407USA012660

Write-up: This spontaneous report as received from a physician via field representative (learning of the AE within 24 hours) refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of GARDASIL (strength, dosage and route unknown) in the left arm. Concomitant therapies included oral typhus vaccine given at the same time with GARDASIL. The patient was diagnosed with subclavian deep vein thrombosis, approximately 2-3 weeks after receiving GARDASIL. The patient was treated with Tissue plasminogen activator (t-PA) and had surgery involving the removal of her first rib and 2 unspecified muscles. The patient was in hospital on the reporting time. The outcome of the event was not reported. Upon internal review, subclavian deep vein thrombosis which needs surgery, removal of first rib and 2 unspecified muscles was determined to be medically significant. Additional information has been requested.


VAERS ID: 544209 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Male  
Location: New York  
Vaccinated:2014-09-02
Onset:2014-09-04
   Days after vaccination:2
Submitted: 2014-09-17
   Days after onset:13
Entered: 2014-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U5003AA / 1 LA / UN
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. K000327 / 1 LA / UN

Administered by: Other       Purchased by: Private
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? Yes
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:
CDC Split Type:

Write-up: 2 days after receiving FLUZONE High Dose and ZOSTAVAX immunizations patient had DVT in (L) upper leg.


VAERS ID: 552456 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Georgia  
Vaccinated:2014-04-03
Onset:2014-07-21
   Days after vaccination:109
Submitted: 2014-11-06
   Days after onset:108
Entered: 2014-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS JR737 / 1 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J009243 / 1 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4593AB / 1 RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 3D425 / 1 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J007954 / 2 LA / UN

Administered by: Public       Purchased by: Private
Symptoms: Coagulation test abnormal, Compartment syndrome, Deep vein thrombosis, Drug hypersensitivity, Fasciotomy, Leg amputation, Local swelling, Surgery
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (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, 28 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Tri- sprentec; citalopram
Current Illness: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data: Blood work- Factor V Leiden positive, heparin allergy
CDC Split Type:

Write-up: Entire right leg swelled. Iced and elevated. Next day she was diagnosed with a DVT from abdomen to ankle. 6 surgeries within 7 days, including fasciotomies for compartment syndrome of the calf and eventually AK amputation of right leg.


VAERS ID: 601637 (history)  
Form: Version 1.0  
Age: 38.0  
Sex: Female  
Location: California  
Vaccinated:2015-09-23
Onset:2015-10-03
   Days after vaccination:10
Submitted: 2015-10-08
   Days after onset:5
Entered: 2015-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UI440AD / 1 LA / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site vesicles, Localised infection, Nausea, Pain in extremity, Pulmonary thrombosis, Vomiting
SMQs:, Acute pancreatitis (broad), Embolic and thrombotic events, venous (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Blood clot
Allergies:
Diagnostic Lab Data: XARELTO 20 mg since June. (2) blood clots to lungs.
CDC Split Type:

Write-up: Arm pain, infected bump (L) arm. (L) deltoid with 2 cm induration/erythema with small crusted pinpoint vesicles. (+) firm with pain at shoulder. NV intact likely rxn. Pain: 7/10. Pain to move, tingly (L) arm. MOTRIN.


VAERS ID: 615755 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Male  
Location: Texas  
Vaccinated:2015-11-11
Onset:2015-11-11
   Days after vaccination:0
Submitted: 2015-12-10
   Days after onset:29
Entered: 2015-12-21
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1514701 / 1 RA / SYR

Administered by: Other       Purchased by: Other
Symptoms: Angiogram, Arthralgia, Coagulation test, Deep vein thrombosis, Echocardiogram, Pain, Pain in extremity, Peripheral swelling, Ultrasound Doppler abnormal
SMQs:, Cardiac failure (broad), Angioedema (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Arthritis (broad), Tendinopathies and ligament disorders (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, 4 days
   Extended hospital stay? No
Previous Vaccinations: fever~DTP (no brand name)~0~1.00~Patient|fever, chills~Influenza (Seasonal) (no brand name)~0~21.00~Sibling
Other Medications: None
Current Illness: None
Preexisting Conditions: Hyperkeratosis of soles - PPK.
Allergies:
Diagnostic Lab Data: Positive Duplex Doppler (ultrasound) of left leg. DVT calf to groin. Blood work for coagulation studies, CT angiogram, echo cardiogram.
CDC Split Type:

Write-up: Pain in back of left knee 8 hours after Flu vaccine injection. Pain and noticeable swelling in left calf by morning. Severe pain upon walking and standing. Saw Dr on 11/17/2015; he sent me to radiology at Medical Center where a blood clot (DVT) was detected in left leg from calf to groin. Admitted into Emergency Room immediately. Treated with LOVENOX and oral warfarin. 4 days in hospital. XARELTO prescribed.


VAERS ID: 617023 (history)  
Form: Version 1.0  
Age: 35.0  
Sex: Female  
Location: Iowa  
Vaccinated:1999-02-10
Onset:1999-08-16
   Days after vaccination:187
Submitted: 2016-01-02
   Days after onset:5983
Entered: 2016-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 RA / SYR

Administered by: Public       Purchased by: Other
Symptoms: Computerised tomogram abnormal, Nuclear magnetic resonance imaging, Portal vein thrombosis, Ultrasound scan abnormal
SMQs:, Embolic and thrombotic events, venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow)

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, 3 days
   Extended hospital stay? No
Previous Vaccinations: BODILY ITCHING SEVERE PLUS RASH AT INJECTION SITE~Hep B (no brand name)~2~25.92~Patient
Other Medications: MULTIVITAMIN; ONE PER DAY. IBUPROFEN; PRN
Current Illness: NONE/ DATE AND TIME OF VACCINATIONS IS APPROXIMATE
Preexisting Conditions: ENDOMETRIOSIS, PMS
Allergies:
Diagnostic Lab Data: ULTRASOUNDS ON 08/17/1999 AND EXTENSIVE ULTRASOUNDS, CT SCANS, MRI''S EXAMINATIONS, AND HEALTH CARE PROVIDER CARE SINCE THAT TIME NOW AS CONTINUOUS. 6 MONTHS OF ANTICOAGULANT THERAPY AFTER DISCHARGE FROM HOSPITAL IN 1999. LAST VACCINATION OF SERIES OF 3 WAS APPX 3 WEEKS BEFORE PORTAL VEIN THROMBOSIS WAS DIAGNOSED BY ULTRASOUND AND CT SCANS. THE RELEVANT CONNECTION BETWEEN THE SERIES OF 3 HEPATITIS B VACCINATIONS AND THE PORTAL VEIN THROMBOSIS IS NOT KNOWN BY PATIENT AS FAR AS FACTUAL AND POSSIBLE IN HAPPENING.
CDC Split Type:

Write-up: SYMPTOMS AND SECONDARY ILLNESSES LEADING UP TO PORTAL VEIN THROMBOSIS WHICH WAS DECIDED FINAL DIAGNOSIS AFTER SERIES OF THREE VACCINATIONS FOR HEPATITIS B. I DO NOT HAVE ACTUAL KNOWLEDGE IF VACCINATIONS AND FINAL DIAGNOSIS CAN HAVE A POSSIBILITY OF BEING CONNECTED TO EACH OTHER AS CAUSE AND EFFECT.


VAERS ID: 622085 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Male  
Location: Unknown  
Vaccinated:2014-10-01
Onset:2014-10-20
   Days after vaccination:19
Submitted: 2016-02-08
   Days after onset:476
Entered: 2016-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Acute kidney injury, Alanine aminotransferase increased, Alpha 1 globulin normal, Alpha 2 globulin, Angiotensin converting enzyme increased, Anticoagulation drug level, Antiphospholipid antibodies, Antithrombin III, Ascites, Aspartate aminotransferase normal, Atelectasis, Atrial flutter, Bacterial test positive, Beta globulin, Beta-2 glycoprotein antibody, Bilevel positive airway pressure, Biopsy bladder, Biopsy kidney normal, Bladder disorder, Blood bicarbonate increased, Blood bilirubin decreased, Blood creatine increased, Blood creatine phosphokinase normal, Blood culture negative, Blood gases, Blood glucose increased, Blood immunoglobulin A normal, Blood immunoglobulin G normal, Blood immunoglobulin M normal, Blood pH normal, Blood phosphorus increased, Blood potassium increased, Blood sodium decreased, Blood test, Blood thyroid stimulating hormone decreased, Blood urea increased, Blood urine, Blood urine present, Cardiolipin antibody negative, Cardioversion, Central venous catheterisation, Chest X-ray abnormal, Chest pain, Chromaturia, Computerised tomogram abdomen abnormal, Computerised tomogram pelvis, Computerised tomogram thorax abnormal, Condition aggravated, Culture urine negative, Cystoscopy abnormal, Deep vein thrombosis, Fibrin D dimer increased, Glucose urine absent, Glycosylated haemoglobin increased, Haematocrit increased, Hepatic cirrhosis, Hydronephrosis, Hypertension, Immunoglobulins, Intensive care, International normalised ratio normal, Joint dislocation, Lethargy, Liver function test normal, Lung consolidation, Nephrolithiasis, Nitrite urine absent, PCO2 increased, PO2 decreased, Platelet count decreased, Pleural effusion, Prostatic specific antigen normal, Protein C decreased, Protein S normal, Protein total normal, Protein urine present, Prothrombin time normal, Pyelogram retrograde abnormal, Red blood cell sedimentation rate normal, Red blood cells urine positive, Renal cyst, Respiratory failure, Scan with contrast abnormal, Specific gravity urine normal, Tachycardia, Troponin T normal, Type 2 diabetes mellitus, Ultrasound abdomen abnormal, Ultrasound bladder normal, Ultrasound kidney abnormal, Ultrasound scan abnormal, Urinary casts, Urinary sediment present, Urine abnormality, Urine analysis abnormal, Urine ketone body absent, Urine leukocyte esterase, Urobilinogen urine increased, Ventilation/perfusion scan normal, White blood cell count increased, White blood cells urine positive, pH urine normal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (narrow), 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), Malignancy related therapeutic and diagnostic procedures (narrow), Thrombophlebitis (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (narrow), Proteinuria (narrow), Tubulointerstitial diseases (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Multivitamin + minerals; Ibuprofen; DULERA
Current Illness: 1990, Chronic obstructive pulmonary disease; 2009, Osteoarthritis; 2011, Bronchial hyperreactivity; 2011, Oedema peripheral; 2012, Hypertension
Preexisting Conditions: 1992, Nephrolithiasis
Allergies:
Diagnostic Lab Data: Chest X-Ray (PA and Lateral): Lateral views were performed in a chair. Study is at least mildly limited technically due to patient body habitus. Heart size if borderline, although this may be accentuated by AP technique and relatively low lung volumes. There are ill-defined right basilar airspace opacities. Left lung is grossly clear of confluent airspace opacity. No pneumothorax or pleural effusion identified. IMPRESSION: Right basilar airspace disease, compatible with atelectasis versus pneumonia. Clinical correlation and radiographic follow up until resolution are advised. Chest X-Ray (AP); new right IJ pelvis catheter and Central line. Tips both cavoatrial junction. No change cardiomegaly with pulmonary edema/heart failure. Urinalysis: cloudy, yellow urine, pH 7.0, specific gravity 1.025; negative for glucose, ketones, nitrite, and leukocyte esterase. Positive for protein 30 mg per dL, trace amount of blood, and urobilinogen 1 mg/dL. Microscopic urinalysis notable for white blood cells 50 to 100 per hpf, red blood cells 5 to 10 per hpf, hyaline casts 20 to 50 hpf, squamous epithelial cells 3 to 5 per hpf, and a few bacteria; mucous and amorphs were present. Renal and Bladder Ultrasound; Technologist notes body habitus of 330 pounds with distended abdomen. Right kidney measures 11.6 cm in length. Left kidney measures 12.6 cm in length. A lobular hypoechoic cortical defect or anteromedial right kidney measures 2.3 by 2.3 by 2.1 cm. Its echogenicity is similar to cortex. There is no hydronephrosis. Left renal echogenicity is normal. No hydronephrosis, solid or cystic mass or shadowing stones. Limited views of bladder are unremarkable. Incidentally noted is a small amount of right upper quadrant ascites; 10/21/2014, Alanine aminotransferase, 42 IU/L; 10/22/2014, Alanine aminotransferase, 35 IU/L; 10/23/2014, Alanine aminotransferase, 27 IU/L; 10/22/2014, Alpha 1 globulin, 0.3 g/dL; 10/22/2014, Alpha 2 globulin, 0.7 g/dL; 12/11/2014, Antiphospholipid antibodies, 1.62, 50.9 sec and 82.5 sec; 12/11/2014, Antithrombin III, 93%; 10/21/2014, Aspartate aminotransferase, 32 IU/L; 10/22/2014, Aspartate aminotransferase, 25 IU/L; 10/23/2014, Aspartate aminotransferase, 14 IU/L; 10/22/2014, Beta globulin, 1.2 g/dL; 12/11/2014, Beta-2 glycoprotein antibody, 3 and 0; 10/21/2014, Blood bilirubin, 0.3 mg/dL; 10/22/2014, Blood bilirubin, 0.2 mg/dL; 10/23/2014, Blood bilirubin, 0.4 mg/dL; 10/20/2014, Blood creatine, 1.13 mg/dL; 10/21/2014, Blood creatine, 1.66 mg/dL; 10/22/2014, Blood creatine, 2.52 mg/dL; 10/23/2014, Blood creatine, 1.66 mg/dL; 10/24/2014, Blood creatine, 1.4 mg/dL; 10/24/2014, Blood creatine phosphokinase, 91 IU/L; 10/23/2014, Blood culture, Negative; 10/23/2014, Blood gases, Not available; 10/23/2014, Blood gases, see text; 10/20/2014, Blood glucose, 148 mg/dL; 10/21/2014, Blood glucose, 212 mg/dL; 10/22/2014, Blood glucose, 188 mg/dL; 10/23/2014, Blood glucose, 164 mg/dL; 11/04/2014, Blood glucose, 124, 100 and 170 mg/dL; 10/22/2014, Blood immunoglobulin A, 245 mg/dL; 10/22/2014, Blood immunoglobulin G, 1361 mg/dL; 10/22/2014, Blood immunoglobulin M, 114 mg/dL; 10/22/2014, Blood phosphorus, 7.6 mg/dL; 10/20/2014, Blood potassium, 4.8 mmol/L; 10/21/2014, Blood potassium, 5.9 mmol/L; 10/22/2014, Blood potassium, 6.2 and 6.0 mmol/L; 10/23/2014, Blood potassium, 5.3 mmol/L; 11/04/2014, Blood potassium, 4.6 mmol/L; 10/20/2014, Blood pressure measurement, 136/106 and 164/87 mmHg; 10/20/2014, Blood sodium, 133 mmol; 10/21/2014, Blood sodium, 131 mmol; 10/22/2014, Blood sodium, 132 mmol; 10/23/2014, Blood sodium, 130 mmol; 11/04/2014, Blood sodium, 135 mmol; 10/22/2014, Blood test, 0.40 IU/ml; 10/20/2014, Blood thyroid stimulating hormone, 1.35; 10/20/2014, Blood urea, 28 mg/dL; 10/21/2014, Blood urea, 36 mg/dL; 10/22/2014, Blood urea, 52 mg/dL; 10/23/2014, Blood urea, 48 mg/dL; 11/04/2014, Blood urea, 29 mg/dL; 10/20/2014, Body temperature, 97.8 and 97.9 degree F; 12/11/2014, Cardiolipin antibody, IgG and IgM- Negative; 10/22/2014, Fibrin D dimer, 559 ng/mL; 10/22/2014, Glycosylated haemoglobin, 9.3%; 10/20/2014, Haematocrit, 49.0% and 15.6 g/dl; 10/21/2014, Haematocrit, 50.9% and 16.0 g/dl; 10/23/2014, Haematocrit, 45.2% and 15.1 g/dl; 10/20/2014, Heart rate, 148 and 165 bpm; 10/22/2014, Immuglobulins, 1.4 g/dL; 10/21/2014, International normalized ratio, 1.13; 10/20/2014, Oxygen saturation, 83, 92 and 93%; 10/20/2014, Platelet count, 131; 10/21/2014, Platelet count, 139; 10/23/2014, Platelet count, 115; 10/22/2014, Prostatic specific antigen, 0.15 ng/mL; 12/11/2014, Protein C, 41%; 12/11/2014, Protein S, 68%; 10/22/2014, Protein total, 7.0 g/dL; 10/21/2014, Prothrombin time, 12.5 sec; 10/21/2014, Red blood cell sedimentation rate, 1 mm/hr; 10/20/2014, Troponin T, 0.02, 0.01 and 0.01 ng/mL; 10/22/2014, Troponin T, 0.01 ng/mL; 10/22/2014, Urine analysis, Abnormal; 10/20/2014, White blood cell count, 8.8; 10/21/2014, White blood cell count, 11.8; 10/23/2014, White blood cell count, 8.8
CDC Split Type: US2016GSK011102

Write-up: This case was reported by a pharmacist via other manufacturer and described the occurrence of atrial flutter in a 53-year-old male patient who received ENGERIX B adult. On 1st October 2014, the patient received the 2nd dose of ENGERIX B adult. In October 2014, less than a month after receiving ENGERIX B adult, the patient experienced deep vein thrombosis (serious criteria GSK medically significant), acute renal failure (serious criteria GSK medically significant) and hepatic cirrhosis (serious criteria GSK medically significant). On 20th October 2014, the patient experienced atrial flutter (serious criteria hospitalization and other: As per reporter), respiratory failure (serious criteria GSK medically significant), hypertension aggravated, tachycardia and chest pain. On an unknown date, the patient experienced type II diabetes mellitus (serious criteria GSK medically significant), ascites (serious criteria GSK medically significant), bladder disorder, pulmonary effusion and lethargy. The patient was treated with COUMADIN, carvedilol, VICTOZA, NOVOLOG, Sliding Scale Insulin, LANTUS, amiodarone and lisinopril. On an unknown date, the outcome of the atrial flutter, deep vein thrombosis, acute renal failure, respiratory failure, hypertension aggravated and bladder disorder were recovered/resolved and the outcome of the hepatic cirrhosis, type II diabetes mellitus, ascites, pulmonary effusion, lethargy, tachycardia and chest pain were unknown. The reporter considered the atrial flutter, acute renal failure, hepatic cirrhosis, type II diabetes mellitus, respiratory failure, hypertension aggravated and bladder disorder to be unrelated to ENGERIX B adult. The reporter considered the deep vein thrombosis to be possibly related to ENGERIX B adult. It was unknown if the reporter considered the ascites, pulmonary effusion, lethargy, tachycardia and chest pain to be related to ENGERIX B adult. Additional details were received as follows: The blinded study vaccine was confirmed to be ENGERIX B adult. The patient was 53 years old man, who was enrolled in the other manufacturer''s sponsored study. Relevant medical history included chronic obstructive pulmonary disease (COPD) (1990), kidney stones (1992), osteoarthritis in bilateral hands (2009), bilateral pedal edema (2011), reactive airway disease (2011), and hypertension (2012). It was noted that the subject was homeless and lived out of his car. Relevant concomitant medications included multivitamin, ibuprofen and DULERA. On 3rd September 2014, the patient received 1st dose of blinded study vaccine (ENGERIX B adult). On 1st October 2014, the patient received 2nd dose of blinded study vaccine (ENGERIX B adult). On 20th October 2014, 19 days after the most recent dose of blinded study vaccine (ENGERIX B adult), the patient went to his primary care physician (PCP) for the evaluation of chest pain and he was advised to go to the hospital. The site confirmed that the outcome of the event cirrhosis will remain unchanged and that the subject reported that his deep vein thrombosis was asymptomatic. The deep vein thrombosis (DVT) was discovered during testing while the subject was hospitalized, that the DVT was treated with heparin while hospitalized and that the patient was discharged on COUMADIN. The site confirmed that the history of "stones" referred to kidney stones. Corrected adverse events form for the event of deep vein thrombosis, confirming the onset date as 23-Oct-2014 and the investigator''s assessment of relationship to study vaccine as possibly related. The site stated that they would provide an update after the subject had completed the week 56 site visit to clarify the outcome status of the events of cirrhosis, focal thickening on the posterior wall of the urinary bladder, and type II diabetes. The updated outcome and end date for the event of focal thickening on the posterior wall of the urinary bladder (resolved on 4th December 2014), and updated outcomes for the events of cirrhosis and type II diabetes (not resolved, chronic but stable). The patient was hospitalized for atrial flutter and was subsequently diagnosed with the important medical events of acute renal failure, cirrhosis, focal thickening on the posterior wall of the urinary bladder, type II diabetes, worsening hypertension, deep vein thrombosis, and respiratory failure. Vital signs upon arrival were as follows at 11:29 am: blood pressure 136 per 106 mmHg, heart rate 165 beats per minute, temperature 97.8 degrees Fahrenheit, oxygen saturation 83 percent on room air, and oxygen saturation 93 percent on 2 liters via nasal cannula. At 3:42 pm on the day of arrival vital signs were as follows: blood pressure 164 per 87 mmHg, heart rate 148 beats per minute, body temperature 97.9 degrees Fahrenheit, and oxygen saturation 92 percent on 2 liters via nasal cannula. Laboratory test results on arrival included the following: total white blood cell count 8.8 per liter, haemoglobin 15.6 g per dL, haematocrit 49.0 percent, platelet count 131 per liter, glucose 148 mg per dl, sodium 133 mmol/L, potassium 4.8 mmol/L, blood urea nitrogen (BUN) 28 mg per dL, creatinine 1.13 m per dL, and thyroid stimulating hormone (TSH) 1.35 mcIU per mL, serial Troponin T values (0.02 ng per mL, 0.01 ng per mL, 0.01 ng per mL were within normal range, chest x-ray showed right basilar airspace disease, compatible with atelectasis versus pneumonia. The patient was admitted to the hospital with respiratory failure and was found to be in atrial flutter. He was transferred to the intensive care unit where he needed bilevel positive airway pressure (BiPAP) to improve his respiratory status. He was still in atrial flutter with a fast rate and subsequently underwent electrical cardioversion with good response. He returned to sinus rhythm, but was tachycardiac with a heart rate of 104 beats per minute at rest. Supplemental oxygen was not required. The subject was also found to have worsening hypertension. On 21st October 2014, laboratory results were notable for potassium 5.9 mmol/L, blood urea nitrogen (BUN) 36 mg per dL, creatinine 1.4 mg per dL, and glucose 212 mg per dL, sedimentation rate was 1 mm per hour, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and bilirubin were all within normal range. On 22 October 2014, the subject''s laboratory results included creatinine 2.52 mg per dL, blood urea nitrogen (BUN) 52 mg per dL, potassium 6.0 mmol/L, and phosphorus 7.6 mg per dL. The acute renal failure was thought to be exacerbated by Angiotensin converting enzyme inhibitors, BACTRIM and nonsteroidal anti-inflammatory drugs (NSAIDS) (the investigator assessed that it was unknown if the ACE inhibitors, BACTRIM, and NSAIDs were co-suspect medications). Additional laboratory results on that day included blood glucose 188 mg per dL and haemoglobin A1C 9.3 percent. D dimer was 559 ng per mL and heparin level was 0.40 IU per mL. IgA, IgG, IgM, total protein albumin, alpha 1 globulin, alpha 2 globulin, beta globulin, and gamma globulin were all within the reference range. Urinalysis revealed cloudy, yellow urine with pH 7.0, specified gravity 1.025, urine was negative for glucose, ketones, nitrite, and leukocyte esterase and was positive for protein 30 mg per dL, a trace amount of blood, and urobilinogen 1mg per dL. Microscopic urinalysis was notable for white blood cells 50 to 100 per hpf, red blood cells 5 to 10 per hpf, hyaline casts 20 to 50 per hpf, squamous epithelial cells 3 to 5 per hpf, and a few bacteria; mucous and amorphs were present. A renal and bladder ultrasound showed no urinary tract obstruction. A nonspecific 2.3 cm irregular lobular hypoechoic cortical defect on right kidney was indeterminate for solid or cystic mass. There was mild ascites. A chest x-ray confirmed placement of the central lines and no change cardiomegaly with pulmonary edema or heart failure. On 23rd October 2014, 23 days after the most recent dose of blinded study vaccine (ENGERIX B adult), the subject underwent a bilateral lower extremity venous ultrasound, which revealed an acute, partially occluding deep venous thrombosis of the left popliteal vein, no evidence of deep venous thrombosis of the right lower extremity, and no evidence of superficial venous thrombosis of the bilateral great saphenous veins. A lower extremity arterial duplex ultrasound showed normal artery size bilaterally throughout the lower extremities, no hemodynamically significant evidence of arterial disease in either lower extremity, and normal blood flow velocities throughout both lower extremities. The subject was asymptomatic. Heparin therapy was initiated for the deep vein thrombosis (DVT). Laboratory results included blood urea nitrogen (BUN) 48 mg per dL, creatinine 1.66 mg per dL, sodium 130 mmol/L, potassium 5.3 mmol/L and glucose 164 mg per dL. Blood cultures drawn on 22nd October 2014 were reported as negative and urine was negative for Streptococcus pneumoniae antigen. Arterial blood gases were notable for pH 7.36, PC02 61, P02 57, bicarbonate 33.5 and oxygen saturation 89.4. On 24th October 2014, a nuclear medicine ventilation perfusion scan showed no significant segmental or sub segmental defects. There was a very low probability of pulmonary thromboembolism. A Computer tomography (CT) scan of the chest and abdomen without contrast showed small moderate right pleural effusion. There was collapse of the right lower lobe and small left pleural effusion. There was consolidation and volume loss in the posterior left lower lobe. The upper lung zones were clear and minimal centrilobular emphysema was seen at the lung apices. Abnormal findings included a small amount of ascites, a well circumscribed, 2.1 by 1.4 cm hyperdense cyst at the lateral aspect of the upper right kidney. There was a 2 mm stone in the lower pole of the right kidney. No stones or masses were seen in the left kidney. There were no adrenal masses. The impression included bilateral pleural effusions with consolidation of the lower lobes of the lungs, greater on right than left consistent with atelectasis. Underlying pneumonia was not excluded. There was no evidence of pulmonary edema at this time. There was a hyperdense cyst of the lateral right kidney. The appearance of the liver was suggestive of cirrhosis, liver function test results remained within normal ranges. On 25th October 2014, 25 days after the most recent dose of study vaccine (ENGERIX B adult), Computer tomography (CT) scan of the abdomen and pelvis with and without contrast showed cirrhosis with free peritoneal fluid. Bilateral pleural effusions were noted causing bibasilar volume loss. A hyperdense lesions on the posterior lateral right kidney did not enhance and most likely represented a cyst that contained protein or blood products. There were at least two other small low-density lesions in the inferior right kidney that were too small to characterize and warranted follow up CT Scan in 6 months. A bilateral pars defect at L5 caused mild subluxation. Two rounded areas of focal thickening on the posterior wall of the urinary bladder were subtle. They could represent ureteroceles but were not typical. Bladder wall neoplasm was noted as a possibility. There was also a focal area of bladder wall thickening involving the right side of the upper right. On 27th October 2014, a chest x-ray showed persistent small bilateral pleural effusions with bibasilar atelectasis, minimal diffused interstitial congestion. A new right PICC line was visible. No pneumothorax was noted. On 30th October 2014, the subject underwent a cystoscopy with bilateral retrograde pyelograms. Findings included a partially duplicated collecting system on the right with slow drainage, mild to moderate hydronephrosis on the right, and erythematous patches in the bladder concerning for carcinoma in situ versus cystitis and irritation. Biopsies of the bladder were taken, followed by fulguration of the biopsy sites. On 3rd November 2014, the event of atrial flutter was considered resolved. The patient''s blood sugars were controlled by VICTOZA, NOVOLOG sliding scale insulin (SSI), and LANTUS and the patient was provided with nutrition counseling as he usually ate a lot of candy and regular drinks. The glucose levels improved from 199 to 152 mg per dL and it was assessed that the glucose level could be controlled with carbohydrate limitations and oral medication. On 4th November 2014, laboratory test results included sodium 135 mmol per L, blood urea nitrogen (BUN) 29 mg per dL, potassium 4.6 mmol per L, glucose 100 mg per dL and repeat glucose 170 mg per dL and 124 mg per dL. The respiratory status had slowly improved, he was ambulating well. Overall left ventricular ejection fraction was approximately 40 to 50 percent. The patient was discharged with instructions to follow-up in 6 days. (Atrial flutter). Amiodarone and COUMADIN were initiated for treatment of atrial flutter. LANTUS therapy was also started for newly diagnosed type II diabetes, carvedilol and lisinopril were prescribed for hypertension and torsemide was prescribed for edema. Discharge medications included COUMADIN (confirmed as prescribed for the deep vein thrombosis (DVT), LANTUS, amiodarone, COREG, lisinopril, DEMADEX, potassium chloride, and DULERA. Discharge diagnoses included capo exacerbation, atrial flutter, respiratory failure, deep vein thrombosis and type II diabetes mellitus. The events of acute renal failure, worsening hypertension, deep vein thrombosis and respiratory failure were considered resolved on the day of discharge. The investigator noted that the bilateral effusions of lower lobes of lungs, mild ascites, capo, and lethargy were considered non-serious adverse events. On an unspecified date, the patient reported that a biopsy of the right kidney cyst was performed which was reported as benign. The patient reported this information to the study staff on 13th November 2014, and reported that he is scheduled for follow-up appointments with a cardiologist on 18th November 2014 and with an urologist on 4th December 2014. On 4th December 2014, the event of focal thickening on the posterior wall of