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VAERS ID: 152601 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:1999-08-16
Onset:1999-08-17
   Days after vaccination:1
Submitted: 2000-06-01
   Days after onset:289
Entered: 2000-06-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH - / 1 - / IM
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH - / 1 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Lung disorder, Pneumonitis, Pulmonary haemorrhage, Viral infection
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (narrow), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1999-08-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Autopsy
CDC Split Type: HQ6614630MAY2000

Write-up: A 2 month old female received vaccines on 8/16/99 and subsequently developed viral pneumonia. She died on 8/17/1999. Autopsy revealed viral pneumonitis. The infant''s lungs had multiple foci of acute chronic inflammation affecting the alveoli and septa. Changes were present in all sections examined. No viral inclusions were seen. Foci of fresh hemorrhage were present but no definite features of aspiration. The reporter noted that "the appearances are those of viral pneumonitis and appear to be of several days duration".


VAERS ID: 154205 (history)  
Form: Version 1.0  
Age: 1.5  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2000-06-08
Entered: 2000-06-14
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Autopsy
CDC Split Type: WAES00060390

Write-up: Information has been received concerning a pt who at approximately 13 months old was vaccinated with MMR. Subsequently at 18 months old the pt died with a diagnosis of erythrophagocytic lymphohistiocytosis. Autopsy revealed a "giant cell pneumonitis". It was also noted that "measles RNA (presumably) was detected in lung tissue". Additional information has been requested.


VAERS ID: 154213 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:1999-11-08
Onset:1999-12-01
   Days after vaccination:23
Submitted: 2000-06-09
   Days after onset:190
Entered: 2000-06-14
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / MEDEVA PHARMA, LTD. 736042 / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Cerebrovascular accident, Dysphagia, Pneumonia, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations: flu-like reaction?~Influenza (Seasonal) (no brand name)~?~0.00~In Patient
Other Medications: None reported
Current Illness:
Preexisting Conditions: myocardial infarction, occlusion of artery in leg, possible history of bronchiectasis; chronic lymphocytic leukemia (not actively treated)
Allergies:
Diagnostic Lab Data:
CDC Split Type: MPU2000003300

Write-up: Approximately one month post vax, this pt experienced a cerebrovascular accident. As a result, she developed swallowing difficulties requiring insertion of a PEG tube. She then developed pneumonia and died. The report states Fluvirin was given because she had an immunoglobulin deficiency. Her WBC was raised. The report states that she had received the vax in October 1996 which was followed by a flu-like reaction and then another Fluvirin with a pneumococcal vax in April (no problems reported).


VAERS ID: 154241 (history)  
Form: Version 1.0  
Age: 6.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2000-06-14
Entered: 2000-06-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 2 - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Meningitis
SMQs:, Noninfectious meningitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Splenectomy
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES00061129

Write-up: Information has been received from a literature article concerning a 6 year old male pt with a history of splenectomy who was "vaccinated against pneumococci" on two different occasions. The literature article indicated that the pt received the first dose of "pneumococci" vaccine prior to the splenectomy and the second dose 2 years later. In addition, the pt received penicillin for 2 years after the splenectomy. Two and a half years post-splenectomy, the pt developed pneumococcal meningitis and died. The cause of death was pneumococcal meningitis. Six additional pt''s had similar experiences following exposure to "pneumococci" vaccine. (WAES00060912, WAES00061128, WAES00061130, WAES00061131, WAES00061132, WAES00061133)


VAERS ID: 154242 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2000-06-14
Entered: 2000-06-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Sepsis
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Splenectomy
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES00061128

Write-up: Information has been received from a literature article concerning a pt with a history of splenectomy and no antibiotic prophylaxis who was "vaccinated against pneumococci". The literature article indicated that the pt developed sepsis and subsequently died. the cause of death was sepsis. Six additional pt''s had similar experiences. (WAES00060912, WAES00061129, WAES0061130, WAES00061131, WAES00061132.)


VAERS ID: 154243 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2000-06-14
Entered: 2000-06-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 2 - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chills, Headache, Infection, Influenza, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Hereditary spherocytosis, splenectomy
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES00060912

Write-up: Information received from a literature regarding a 24 year old female who received vax against pneumococci. "While her first affected child was under regular follow-up, the pt received the vax and was advised to take oral PCN daily in case of febrile illness. Three years later, 9 weeks after having delivered a second child, the pt had a mild flu but considered oral PCN inappropriate while breast-feeding. A few days later she complained about having headaches and chills and was prescribed aspirin by a physician. A few hours later she became unconscious and died the same day, 16 year post splenectomy, in spite of resuscitation maneuvers. The cause of death was post splenectomy infection.


VAERS ID: 154244 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2000-06-14
Entered: 2000-06-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Infection
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: splenectomy
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: Waes00081130

Write-up: Information has been received from a literature article concerning 4 pts with a history of splenectomy who were vaccinated against pneumococci. The literature article indicated that the pts subsequently developed severe postsplenectomy infectious and died. The cause of death was postsplenectomy infection.


VAERS ID: 154245 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2000-06-14
Entered: 2000-06-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
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: Penicillin
Current Illness:
Preexisting Conditions: Splenectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES00061133

Write-up: Information has been received from a literature article concerning two pts with a history of splenectomy who were vaccinated against pneumococci. The literature article indicated that subsequently the pts developed severe pneumococcal infections. The pt''s lab results showed an insufficient response to pneumococcal vaccination. Six additional pts had similar experiences following exposure to pneumococci vaccine.


VAERS ID: 154246 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2000-06-14
Entered: 2000-06-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Infection
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Splenectomy
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES00061131

Write-up: Information has been received concerning 13 pts with a history of splenectomy, who, post vax, subsequently, developed severe postsplenectomy infections (considered an other medical event). Six additional pts had similar experiences following exposure to


VAERS ID: 154521 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2000-06-12
Entered: 2000-06-16
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES - / UNK - / IM
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Meningitis, Shock
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Noninfectious meningitis (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: U2000004360

Write-up: Post vax, the child died of the effects of severe Hib infection with initial shock and meningitis. Of the cases encountered in 1998 and 1999 all but one were culture confirmed. All but one were considered healthy children prior to the reported infection.


VAERS ID: 155238 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2000-06-21
Entered: 2000-06-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH - / UNK - / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: NONE
Preexisting Conditions: Fetal growth retardation, Premature baby
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: HQ7515619JUN2000

Write-up: A 2 month old pt received Menigitec (meningococcal group C conjugate vaccine, Hib, DTP and Poliomyelitis virus vaccines and 1 day post vax, the infant died. Postmortem result was determined to be sudden infant death syndrome. The pt was born premature at 31 weeks gestation and has a history of intrauterine growth retardation. The reporter noted that the infant was well the day prior to immunization. Sudden infant death syndrome is not expected per the investigator brochure.


VAERS ID: 156146 (history)  
Form: Version 1.0  
Age: 1.6  
Sex: Male  
Location: Foreign  
Vaccinated:2000-04-17
Onset:2000-05-11
   Days after vaccination:24
Submitted: 2000-07-06
   Days after onset:56
Entered: 2000-07-10
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES PO917 / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Brain oedema, Viral infection, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol, Quadracel
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Autopsy revealed - slight swelling of the brain maybe due to virus, heart, lungs and stomach are okay
CDC Split Type: U2000005220

Write-up: Mother reported that son received vax on 04/17/2000. He had no side effects post vax. On 05/11, he vomited once, wasn''t sick, no temperature. Grandmother put him to sleep on 05/12 and he never woke up. 911 called. Police and coroner came to the house. From the autopsy report: slight swelling of brain, may be due to virus; heart, lung and stomach okay. Mother is to meet with coroner on 05/22. Further information requested.


VAERS ID: 152554 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Foreign  
Vaccinated:2000-05-10
Onset:2000-05-14
   Days after vaccination:4
Submitted: 2000-06-09
   Days after onset:26
Entered: 2000-07-12
   Days after submission:33
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER 14H0166 / 3 - / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH - / 3 - / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER 752680 / 3 - / -
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER 44632 / 3 - / -

Administered by: Other       Purchased by: Other
Symptoms: Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-05-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: HQ7064908JUN2000

Write-up: On 5/14/00, the infant died. Probable cause of death was reported as sudden infant death syndrome. No postmortem examination was performed.


VAERS ID: 157629 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2000-06-13
Onset:2000-06-15
   Days after vaccination:2
Submitted: 2000-07-19
   Days after onset:34
Entered: 2000-07-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-06-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Dalivit, lactulose, Sytron, saline nasal drops
Current Illness:
Preexisting Conditions: nasal congestion
Allergies:
Diagnostic Lab Data:
CDC Split Type: 20000213441

Write-up: Approximately two days post vax, the vaccinee died. The cause of death was given as sudden infant death syndrome. No other details were given.


VAERS ID: 157860 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:1999-05-12
Onset:1999-05-27
   Days after vaccination:15
Submitted: 2000-07-19
   Days after onset:419
Entered: 2000-07-24
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anaemia, Emphysema, Hypochromic anaemia, Leukocytosis, Obstructive airways disorder, Pneumonia
SMQs:, Angioedema (broad), Asthma/bronchospasm (broad), Haematopoietic erythropenia (broad), Neuroleptic malignant syndrome (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 1999-07-13
   Days after onset: 47
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: radiotherapy
Current Illness: COPD, pneumonia
Preexisting Conditions: COPD, lung malignant neoplasm, pneumonia,
Allergies:
Diagnostic Lab Data: hematocrit -34%, hemoglobin - 11.7, platelet count - 101, WBC - 8.39, RBC - 3.73, plasma triglyceride - 40 mg, serum HDL - 30, serum LDL - 58 mg, platelet count (7/13/99) - 3, RBC (7/13/99) - 3.04,
CDC Split Type: WAES00079650

Write-up: Information has been received concerning a 74 year old male with a hx of lung cancer, COPD and pneumonia which required hospitalization who on 5/12/99 was vaccinated with pneumococcal vaccine. Concomitant therapy included radiotherapy. On 5/27/99, the pt experienced worsening of pneumonia and COPD and was hospitalized. The pt also experienced emphysema. The adverse events were considered Life-threatening. The pt died on 7/13/99. The cause of death was pneumonia and COPD and Emphysema. The reporting physician felt that lung cancer and pneumonia and COPD were note related to therapy with pneumococcal vaccine.


VAERS ID: 157861 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:1999-04-21
Onset:2000-01-26
   Days after vaccination:280
Submitted: 2000-07-19
   Days after onset:174
Entered: 2000-07-24
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anaemia, Hypochromic anaemia, Hypoglycaemia, Obstructive airways disorder, Pneumonia, Thrombocytopenia
SMQs:, Angioedema (broad), Asthma/bronchospasm (broad), Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Systemic lupus erythematosus (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (narrow), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
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: UNK
Current Illness:
Preexisting Conditions: COPD, pneumonia
Allergies:
Diagnostic Lab Data: blood glucose - 21, arterian blood - 69.1, hematocrit - 32.8, hemoglobin - 10.7, platelet count - 120, WBC count - 4.98, RBC - 3.48
CDC Split Type: WAES00079651

Write-up: Information has been received concerning a 75 year old male with COPD and pneumonia who on 4/21/99 was vaccinated with pneumococcal vaccine. On 1/26/00, the pt experienced COPD. The pt also experienced pneumonia. The pt was hospitalized. The events were considered life-threatening. Subsequently the pt died. The cause of death was pneumonia and worsening COPD. The reporting physician felt that COPD and pneumonia were not related to therapy with pneumococcal vaccine.


VAERS ID: 158386 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Foreign  
Vaccinated:2000-05-09
Onset:2000-05-11
   Days after vaccination:2
Submitted: 2000-08-02
   Days after onset:83
Entered: 2000-08-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM - / 2 - / IM
HEP: HEP B (FOREIGN) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-05-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
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:
CDC Split Type: U2000005920

Write-up: Next day post vax, the pt was sleepy. Two days post vax, he died.


VAERS ID: 158471 (history)  
Form: Version 1.0  
Age: 6.0  
Sex: Male  
Location: Foreign  
Vaccinated:1996-10-29
Onset:1997-05-01
   Days after vaccination:184
Submitted: 2000-08-04
   Days after onset:1191
Entered: 2000-08-07
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM - / 4 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardio-respiratory arrest, Hypoxia, Muscle atrophy, Nervous system disorder, Osteoporosis, Osteoporotic fracture, Pericarditis, Rash, Rheumatoid arthritis
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Osteoporosis/osteopenia (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Arthritis (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2000-02-13
   Days after onset: 1018
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: MRI, 10/98-Medullary compression (D2 and D8) MRI, 12/98-3 compressions in D12, D8, D3-D4
CDC Split Type: 20000231491

Write-up: Post 4th vax, in 05/97, this 6-year-old child developed Still''s disease with general status deterioration, skin eruption and arthritis of left knee, then of the ankles for which he was hospitalized. Aspirin and corticotherapy were started in 06/97. Pericarditis occurred in 08/97. Methotrexate was initiated in 10/97. The pt developed amyotrophia. 09/98 the pt began to wear a plaster cast, then corset on back due to back pain. 10/98 Cervical traction and corset were necessary. The pt then experienced osteoporosis and vertebral compression. The disease progressed. In 02/99, the methotrexate was stopped. Surgical operation was performed and oxygen desaturation followed. On 02/13 a cardiorespiratory arrest from unk origin occurred leading to the pt''s death on the that same day. Causality assessment was coded as dubious for the Hepatitis B vax.


VAERS ID: 158472 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Male  
Location: Foreign  
Vaccinated:2000-07-04
Onset:2000-07-05
   Days after vaccination:1
Submitted: 2000-08-01
   Days after onset:27
Entered: 2000-08-07
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DT: DT ADSORBED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER R10783 / 2 - / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 121011A / 2 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Malaise, Sepsis
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Obesity, metabolic disorder
Allergies:
Diagnostic Lab Data: Autopsy revealed cause of death as pneumococcal sepsis.
CDC Split Type: WAES00072420

Write-up: This 11-year-old male received vaxs and one day post vax, became "severely ill (not specified) and was admitted to the hospital. Reanimation was unsuccessful and the pt died. An autopsy was performed that revealed a pneumococcal sepsis," which was the cause of death. Severe malaise was also considered life threatening event.


VAERS ID: 159019 (history)  
Form: Version 1.0  
Age: 0.15  
Sex: Female  
Location: Foreign  
Vaccinated:2000-08-14
Onset:2000-08-14
   Days after vaccination:0
Submitted: 2000-08-21
   Days after onset:7
Entered: 2000-08-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (TETRAMUNE) / PFIZER/WYETH - / 1 - / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 MO / PO
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Lethargy, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2000-08-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: NONE
Preexisting Conditions: premature baby
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: HQ9926216AUG2000

Write-up: This pt received first dose of study vax and concomitant vaxs. Approximately 9 hours post vax, she became lethargic and sleepy. Approximately 2 hours later, she was brought to the hospital and was pronounced dead on arrival. Due to the temporal relationship to the vax, the medical monitor and investigator agree that this adverse event is possibly due to vax administration.


VAERS ID: 159020 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2000-06-16
Onset:2000-07-22
   Days after vaccination:36
Submitted: 2000-08-21
   Days after onset:30
Entered: 2000-08-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (ACEL-IMUNE) / PFIZER/WYETH - / 1 LL / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 RL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH - / 1 LL / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 MO / PO
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Sudden infant death syndrome, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-07-22
   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: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Autopsy pending.
CDC Split Type: HQ9762311AUG2000

Write-up: Vaxs were received on 06/16/2000. On 07/22, the infant was fed solids and put down to sleep in the afternoon. Around 15:30, she was found to be lifeless with vomit around her face and on the sheets. She was taken to the hospital and pronounced dead on arrival at approximately 18:17. A dx of sudden infant death syndrome was made. Autopsy results are pending. Because of lack of temporal relationship, the medical monitor does not feel that there is a causal relationship between the vax and the adverse event.


VAERS ID: 159421 (history)  
Form: Version 1.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2000-08-01
Onset:2000-08-11
   Days after vaccination:10
Submitted: 2000-08-30
   Days after onset:19
Entered: 2000-09-07
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0522J / 1 - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthma, Condition aggravated
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-08-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Combivent, Seretide, hydrocortisone, imipramine
Current Illness:
Preexisting Conditions: skin disorder, asthma, COPD, smoking
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES00081933

Write-up: On 8/11/00, the pt died of an apparent severe asthma attack at home. This was certified by the general practitioner. It was noted that the pt had been admitted to the hospital in 9/99 and 5/00 for an acute asthma attack, Additional information has been requested.


VAERS ID: 159506 (history)  
Form: Version 1.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2000-01-12
Onset:2000-01-17
   Days after vaccination:5
Submitted: 2000-09-07
   Days after onset:233
Entered: 2000-09-11
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 2527C6 / 5 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arthralgia, Chest pain, Fatigue, Malaise, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-08-18
   Days after onset: 213
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Mepronyzine, Seropram, Tranxene
Current Illness:
Preexisting Conditions: severe depression, stroke, rheumatic fever
Allergies:
Diagnostic Lab Data:
CDC Split Type: 20000037791

Write-up: Five days post vax, the pt developed fatigue, nausea, malaise, arthralgia, myalgia, and localized thoracic pain. Chest pain did not provoke discomfort during the day (only during the night) and was not aggravated by movement. On 8/18/00, about seven months after those events, the pt died from an unspecified cause.


VAERS ID: 159668 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2000-08-01
Onset:2000-08-02
   Days after vaccination:1
Submitted: 2000-09-13
   Days after onset:42
Entered: 2000-09-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER R00013 / 1 - / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 402132 / 1 - / IM
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER 42497 / 1 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Convulsion, Encephalopathy
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
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: Acyclovir, Amoxicillin, Cefotaxime, chloral hydrate, Lamotrigine, Vigabatrin
Current Illness:
Preexisting Conditions: epilepsy, encephalopathy
Allergies:
Diagnostic Lab Data: CT scan of the head showed "white matter abnormalities". EEG''s
CDC Split Type: HQ0654205SEP2000

Write-up: On 8/2/00, pt developed an increased frequency and severity of seizures with a prolonged apneic phase. The pt was treated with loading and maintenance doses of phenytoin and phenobarbitone, however, he died that day. The possible cause of death was listed as convulsions aggravated. Condition aggravated, epilepsy aggravated and apneic attack are unexpected per the Investigator''s Brochure.


VAERS ID: 159871 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2000-03-27
Onset:2000-04-27
   Days after vaccination:31
Submitted: 2000-09-13
   Days after onset:139
Entered: 2000-09-19
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-04-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES00082984

Write-up: On 4/27/00, the pt collapsed and died from an unknown cause. No post-mortem was performed. The pt took no other drug within the past three months. The reaction text stated "Probably first fit but no clear evidence. Question was raised as the whether MMR is relevant to seizure. No further information is available.


VAERS ID: 159960 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2000-09-05
Onset:2000-09-06
   Days after vaccination:1
Submitted: 2000-09-19
   Days after onset:13
Entered: 2000-09-21
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (YF-VAX) / CONNAUGHT LABORATORIES - / UNK - / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Grand mal convulsion, Subarachnoid haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Haemorrhagic central nervous system vascular conditions (narrow), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-09-14
   Days after onset: 8
Permanent Disability? No
Recovered? No
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:
CDC Split Type: U2000006920

Write-up: "An adult female received a Yellow Fever vaccine on 9/5/00 as a pre-travel vaccination. Within the 1st day, she experienced a grand mal seizure and subarachnoid hemorrhage. Pronounced death 9/14/00. Follow-up received 9/27/00 states specimens have been sent to national lab. Liver transplant recipient has liver abnormality-not known whether related to Yellow Fever Liver transplant or other cause. Biopsy samples also sent. From F/U received on 7/3/02, it was reported: 6/28/02 as date F/U received. A 50 year old Canadian female collapsed from a sub-arachnoid neurological event, she died 10 days later. At the request of her family, her organs were harvested for transplantation. Her 2 kidneys, liver and both lungs were subsequently transplanted in Canada. Her heart was transplanted into an internation recipient. The risk of transplantation into a pt population comprised by inter-current disease, surgery and immunosuppressive post-transplantation therapy. Conclusions: It is known the Yellow Feveer virema can persist up to 11 days after vaccination. While transmission of Yellow Fever virus was not demonstrated in any of the organ transplant recipients, there was a potential risk that these organ recipients received viremic organs. Awareness of the potential risks of live viral vaccines, including Yellow Fever, to organ recipients needs to be balanced against the real risks of the inter-current disease requiring transplantation.


VAERS ID: 160003 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Foreign  
Vaccinated:2000-05-09
Onset:2000-05-10
   Days after vaccination:1
Submitted: 2000-09-20
   Days after onset:133
Entered: 2000-09-25
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK - / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Restlessness, Somnolence, Sudden infant death syndrome
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Neonatal disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-05-12
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Had a history frequent vomiting, dyspnea and rhinorhea. Developed a rotavirus infection after viral infection in January 2000, 10 days after this infection developed RSV infection and pneumonia. Concurrent condition umbilical hernia.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES00091225

Write-up: Next day post vax, the pt was sleepy and two days post vax, the pt died. Post-mortum exam: Sudden Infant Death Syndrome. 2 days post-vax the pt was abnormally restless.


VAERS ID: 160006 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2000-07-01
Onset:2000-08-11
   Days after vaccination:41
Submitted: 2000-09-22
   Days after onset:42
Entered: 2000-09-25
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM - / 2 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Demyelination, Encephalitis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Optic nerve disorders (broad), Demyelination (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-08-28
   Days after onset: 17
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: intra pelvic bleeding
Allergies:
Diagnostic Lab Data:
CDC Split Type: 20000275091

Write-up: On 8/11/00, the pt developed acute disseminated encephalomyelitis with extensive demyelination extending down into the brain stem with involvement of the entire subcortical, thalamic, and cerebral peduncles as well as mid brain areas. She was hospitalized and rapidly put on ventilator. On 8/28/00, she died due to multiorgan failure caused by the acute disseminated encephalomyelitis.


VAERS ID: 160183 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2000-09-17
Entered: 2000-09-28
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
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:
CDC Split Type: 20000292711

Write-up: This report describes the occurence of death in a 9 month old baby 18 hours after receiving Engerix-B. The reporting physician did not assess a causal relationship. As of 9/21/00, at the time of the report, no further information was available. Further information has been requested. It was reported that the nurses assisting the vaccinating physician attested that the child had no temperature (through touching the baby) prior to vaccination. However, the child''s mother stated that the baby''s palms were quiet hot before the vaccination.


VAERS ID: 160271 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Foreign  
Vaccinated:2000-09-23
Onset:2000-09-23
   Days after vaccination:0
Submitted: 2000-10-02
   Days after onset:9
Entered: 2000-10-04
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM ENG3168A3 / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Coma, Dehydration, Diarrhoea, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-09-23
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Routine lab tests done 9/23/00: hemoglobin 13.14, white blood cell count 14900, platelets 196000, and hematocrit (illegible on form).
CDC Split Type: 20000288341

Write-up: Same day post vax, the pt developed diarrhea. The boy was brought back to the clinic due to several episodes of diarrhea. He was hospitalized with acute diarrhea and moderate dehydration. He was treated with Claforan, Kalmethasone, Sasestam, and Ringer lactate infusion. The boy fell down into a severe dehydration, stupor, and comatose status. He was also breathless. At 22:00, he was declared dead. The reporting physician considered the events to be possibly related to the vaccine. Further information has been requested.


VAERS ID: 160335 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2000-06-26
Onset:2000-06-28
   Days after vaccination:2
Submitted: 2000-09-28
   Days after onset:92
Entered: 2000-10-05
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIHI: DT+IPV+HIB+HEPB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / 1 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pyrexia, Viral infection
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
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: UNK
Allergies:
Diagnostic Lab Data: Labs on hospitalization: leukocytes 19300, 64% lymphocytes, hemoglobin 12g/100ml, platelets 431000, CRP <9, midstream urine specimen normal. After death labs: viral serologies were negative for parainfluenza, enteroviru, adenovirus, and RSV. Lab values for 7/1//00 included leukocytes 40700/mm3, hemoglobin 1.7g/100ml, platelets 877000mm3, and echography normal.
CDC Split Type: WAES00091814

Write-up: On 6/28/00, it was reported that the pt presented with viral infection. The pt developed a moderate fever 48 to 72 hours after vax and he was seen by the pediatrician who prescribed antipyretics. He was discharged to home but the fever, 100.4 F, persisted. Three to four days after discharge, sometime in the beginning of July 2000, the pt''s grandmother found him dead in his bed. Pediatrician concluded to a sudden death without specific origin.


VAERS ID: 160336 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2000-09-19
Onset:2000-09-21
   Days after vaccination:2
Submitted: 2000-09-29
   Days after onset:8
Entered: 2000-10-05
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. HJ42460 / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-09-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: alcohol abuse, Korsakoff''s syndrome
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES00091994

Write-up: On 9/19/2000, the pt was vaccinated with the first dose of pneumococcal vaccine. On 9/21/00, the pt was found dead in his bed. Additional information has been requested. Autopsy revealed myocardial infarction as cause of death.


VAERS ID: 160393 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2000-09-13
Onset:2000-09-14
   Days after vaccination:1
Submitted: 2000-10-02
   Days after onset:18
Entered: 2000-10-10
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0525J / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-09-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Bricanyl, Lanoxin, Meptid, Nu-seals
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES00091995

Write-up: On 9/14/2000, the pt experienced cardiac arrest and died. The cause of death was cardiac arrest. It was reported that the case is closed. No further information is expected.


VAERS ID: 160501 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2000-09-08
Onset:2000-09-09
   Days after vaccination:1
Submitted: 2001-04-27
   Days after onset:230
Entered: 2000-10-12
   Days after submission:197
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 14940D9B / UNK UN / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. - / UNK UN / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Agitation, Anorexia, Bacterial infection, Blood culture positive, C-reactive protein increased, Chest X-ray normal, Crying, Death, Meningitis, Meningitis pneumococcal, Pyrexia, Sepsis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-09-14
   Days after onset: 5
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: Prior to 28aug00, the child developed an upper respiratory tract infection. He experienced a persistent cough and a chest x-ray was therefore performed on 28aug00, but nothing abnormal was detected.
Allergies:
Diagnostic Lab Data: x-ray chest, 28-AUG-2000, nothing abnormal detected; c-reactive protein, 10-SEP-200 0, 226 mg/l; blood culture, 10-SEP-2000, positive for streptococcus pneumoniae
CDC Split Type: 20000292971

Write-up: 1 day post vax, the pt developed a fever and unusual crying. Additionally he stopped eating, refusing to take his bottle. He was treated with Panadol. On 9/10/00 he was hospitalized. A diagnosis of meningitis was made. On 9/14/00, he died. the reporting physician did not asses a causal relationship. Prior to 8/28/00 child developed upper respiratory tract infection and persistent cough; chest xray revealed nothing abnormal. Despite several attempts no more details could be obtained. This case is therefore been closed. This report describes the occurrence of meningitis and subsequent death in a 2 month old boy receiving INFANRIX. On 08-sep-00, a 1st dose of INFANRIX (lot 14940098 IM) and POLIO SABIN were given. On 09-sep-00, 1 day after vaccination, this 2 month old boy developed fever and unusual crying. Additionally, he stopped eating, refusing to take his bottle. He was treated with PANADOL. On 10-sep-00, he was hospitalised with a classical picture of meningitis. No CSF culture was performed. C-Reactive protein was measured at 226 mg/l and blood culture was positive for streptococcus pneumoniae. A diagnosis of meningitis was made. On 14-sep-00, he died. The reporting physician considered the events, with regard to the vaccine, to be coincidental, not causal. Despite several attempts no more details could be obtained. This case has therefore been closed.


VAERS ID: 160608 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2000-10-13
Entered: 2000-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / 1 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES00103430

Write-up: One day post vax, the 2 day old infant died. The cause of death was not reported. Additional information is not expected.


VAERS ID: 160609 (history)  
Form: Version 1.0  
Age: 1.25  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2000-10-13
Entered: 2000-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. - / UNK - / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES00103431

Write-up: Within one week post vax, the pt died. The cause of death was unknown. Additional information is not expected.


VAERS ID: 160695 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Male  
Location: Foreign  
Vaccinated:2000-09-28
Onset:2000-09-28
   Days after vaccination:0
Submitted: 2000-10-16
   Days after onset:18
Entered: 2000-10-18
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM - / 1 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-09-29
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: regurgitation
Allergies:
Diagnostic Lab Data:
CDC Split Type: 20000297461

Write-up: On 9/28/00, at about 09:30, a dose of Engerix-B was given. The same day, post vax, the child was reported to be a bit drowsy but had a normal appetite. He was breast fed at 22:00. On 9/29/00, at 03:00, when his mother woke up for the next feed, she found him dead. In the information received on 10/10/00, it was mentioned that an autopsy is being performed and that results are awaited. The reporting physician did not assess a causal relationship. Further information has been requested.


VAERS ID: 160711 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2000-10-07
Onset:2000-10-08
   Days after vaccination:1
Submitted: 2000-10-17
   Days after onset:9
Entered: 2000-10-19
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER 000030 / UNK LL / IM
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES R07941 / UNK RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anaemia, Cerebral haemorrhage, Convulsion, Dyspnoea, Fontanelle bulging, Hypothermia, Hypoxia, Mental retardation severity unspecified, Mydriasis, Pyrexia, Shock
SMQs:, Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2000-10-15
   Days after onset: 7
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:
Allergies:
Diagnostic Lab Data: MRI-subdural bleed; post-mortem LP was bloody, bleeding time and clotting time-wnl
CDC Split Type: U2000007380

Write-up: One day post vax, the pt experienced fever which totally resolved after antipyretic treatment. On day 4, the baby refused breast fed and presented with sudden deterioration of mental status. On day 5, he presented with convulsions and at mid day he was admitted to hospital. On admission, he experienced severe convulsions which needed diazepam administration, irregular breathing, bulging fontanel, mydriatic pupil, and anemia. The prescribed treatment was blood transfusion, ventilatory support, oxygen, and antibiotics. After blood transfusion, the anemia was corrected but relapsed the next day. MRI was performed showing a subdural bleed. As the baby''s condition was very bad, it was not possible to perform neurosurgery. According to the investigator, the underlying disease was subdural bleeding. The baby experienced shock, hypothermia, and he died about 6 hours later.


VAERS ID: 160820 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:1997-03-01
Onset:1999-05-01
   Days after vaccination:791
Submitted: 2000-10-23
   Days after onset:541
Entered: 2000-10-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood fibrinogen increased, Blood sodium decreased, Blood urea increased, Cardiac arrest, Cardiac failure, Coagulopathy, Dyspnoea, Hyperhidrosis, Hypotension, Hypothermia, Leukocytosis, Metabolic acidosis, Myocarditis, Pallor, Pleuritic pain, Pneumonia, Prothrombin time prolonged, Pulmonary congestion, Pulmonary haemorrhage, Renal failure, Rhabdomyolysis, Sepsis, Shock, Sinus tachycardia
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (narrow), Acute renal failure (narrow), Cardiac failure (narrow), Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (narrow), Lactic acidosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Accidents and injuries (broad), Hyponatraemia/SIADH (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Hypersensitivity (narrow), Tumour lysis syndrome (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
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: UNK
Current Illness:
Preexisting Conditions: hx of excessive alcohol consumption
Allergies:
Diagnostic Lab Data: EEG-sinus tachycardia; chest X-ray-extensive bilateral patchy shadowing of the lungs; he had marked neutrophilia; renal impairment; a severe anion gap metabolic acidosis and consumption coagulopathy; mild rhabdomyolysis; severe cardiac damage; creatine kinase was 4470 g/l; CK-MB was 742 U/L and troponin I was 1220 U/L; hemoglobin 154 g/L; white cell count-34.9x10 (9)/L; neutrophils 27.8x10 (9)/L; sodium 132 mmol/L; potassium 3.0 mmol/L; glucose 7.7 mmol/L; urea 8.2 mmol/L; creatinine 0.21 mmol/L; pH 7.25; PC02 29 mmHg; P02-75 mmHg; bicarbonate 12 mmol/L; anion gap 23 mmol/L; actual base excess -13.3 mmol/L prothrombin time 17; activated partial thromboplastin time 42 and fibrinogen $g9.0
CDC Split Type: WAES00103434

Write-up: It has been reported that a 21 year old Aboriginal man was vaccinated with pneumococcal polysaccharide vaccine in 3/97 and in 5/99 the pt presented to a medical center with a 3 day history of pleuritic pain and shortness of breath. Although not a recognized alcoholic, he had a history of intermittent heavy drinking and apparently had been on a recent binge. On exam he was acutely ill with hypothermia and hypotension; blood cultures were taken, antibiotics were administered and urgent transfer to hospital was arranged. On admission, he was pale, sweaty, severely short of breath but not cyanosed. His temperature we 34C; BP was unrecordable and there were bilateral chest crepitations. A presumptive dx of septic shock was made and resuscitation commenced. About an hour after admission, the pt had a cardiac arrest and died, despite intensive cardiopulmonary resuscitation. A postmortem exam showed that an excessive area of red consolidation occupied most of the inferior lobe of the left lung, and that the remaining lobe and right lung were markedly congested and edematous. Microscopy showed extensive recent alveolar hemorrhages and acute pneumonia in the left inferior lobe, and foci of recent alveolar hemorrhages elsewhere in the lungs. Apart from a few petechia on the epicardial surface of the left atrium, the heart appeared normal. However, microscopy revealed a diffuse transmural infiltrate of inflammatory cells and scattered necrotic myocytes, indicating acute myocarditis. Streptococcus pneumonia was isolated from the blood cultures; the isolate was subsequently identified as serotype 5. Although the rhabdomyolysis may have been related to acute alcohol poisoning, the reporters considered it more likely to be consistent with his fulminant septicemia. His myocarditis appeared to be a contiguous inflammatory response to the adjacent severe hemorrhagic pneumonia.


VAERS ID: 160821 (history)  
Form: Version 1.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:1998-06-01
Onset:1999-12-01
   Days after vaccination:548
Submitted: 2000-10-23
   Days after onset:326
Entered: 2000-10-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anaemia, Anuria, Ascites, Bacterial infection, Cardiac arrest, Cardiac failure congestive, Coagulopathy, Confusional state, Dyspnoea, Hyperglycaemia, Hyperkalaemia, Hyponatraemia, Hypotension, Hypothermia, Hypoxia, Metabolic acidosis, Peritonitis, Renal failure acute, Respiratory distress, Tachypnoea
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Haematopoietic erythropenia (broad), Lactic acidosis (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Gastrointestinal perforation (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Hyponatraemia/SIADH (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Hx of alcohol abuse; diabetes mellitus; chronic diabetic renal failure
Allergies:
Diagnostic Lab Data: hemoglobin-51; white cell count-35.2; neutrophils-35.2; sodium-128; potassium-8.1; glucose-14.6; creatinine-1.74; bicarbonate-6.0; anion gap-20; actual base excess-30; prothrombin time-32; activated partial thromboplastin time-72; fibrinogen-less than 5.0
CDC Split Type: WAES00103436

Write-up: In December 1999, the pt presented to a medical centre with a two-week history of increasing shortness of breath. On examination he was in extremis, with hypothermia and hypotension, blood cultures were taken, parenteral antibiotics were administered and urgent transfer to hospital was arranged. On admission he was extremely ill, with severe respiratory distress. There were widespread chest crepitations. He was urgently intubated and ventilated, and resuscitation commenced. He was anemic and had marked neutrophilia, he was hyponatremic, hyperkalemic, and hyperglycemic. He had severe acute on chronic renal failure, congestive cardiac failure, severe anion gap metabolic acidosis and consumption coagulopathy. Shortly after admission, the pt had a hyperkalemic cardiac arrest. He was resuscitated and given treatment for hyperkalemic crisis. He was noted to be anuric and was placed on continuous veno-veno hemofiltration. Within 15 hours of admission his metabolic condition was much improved, and he was extubated. However, after about 17 hours, his condition suddenly deteriorated, with marked confusion, tachypnea, and profound hypotension. He had to be reintubated and resuscitated again, he responded slowly and remained anuric. On the 2nd day his abdomen was noted to be distended and tender, and ascites was detected. The distension increased, and he developed guarding, the next day the abdomen was tense and bowel sounds were absent. A provisional dx of spontaneous pneumococcal peritonitis was made and purulent peritoneal fluid was aspirated. Despite intensive therapy his condition steadily deteriorated and he eventually died 13 days after admission. A post-mortem examination showed small kidneys with advanced diabetic nephropathy, cardiomegaly with left ventricular hypertrophy, heavy and edematous lungs with both diffuse alveolar damage and diffuse pneumonic changes, and an enlarged liver but no evidence of either fatty change or cirrhosis. In the discussion section of the literature report, it was stated that the pt had a long history of alcohol abuse and pre-existing conditions of diabetes and chronic renal failure and these conditions would have predisposed the pt to invasive pneumococcal disease. The septicemic process would, in turn, have exacerbated the pre-existing conditions. However, it was considered that the invasive pneumococcal disease was the precipitating event in the pt''s terminal illness. No further information is expected.


VAERS ID: 160822 (history)  
Form: Version 1.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2000-10-23
Entered: 2000-10-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cough, Dyspnoea, Hepatomegaly, Hyperbilirubinaemia, Hyperglobulinaemia, Hypoalbuminaemia, Jaundice, Liver disorder, Metabolic acidosis, Pneumonia, Pyrexia, Respiratory alkalosis, Restlessness, Sepsis
SMQs:, Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Acute pancreatitis (narrow), Asthma/bronchospasm (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
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: UNK
Current Illness:
Preexisting Conditions: alcoholism, hepatic disorder
Allergies:
Diagnostic Lab Data: hemoglobin-109; white cell count-5.2; neutrophils-4.24; sodium-134; potassium-2.6; glucose-5.7; creatinine-0.10; bicarbonate-8.2; anion gap-9; actual base excess-13.3
CDC Split Type: WAES00103437

Write-up: In approximately 1999, ten months post vax, the pt presented to hospital with a few days history of cough and shortness of breath. She was a known alcoholic with chronic liver disease and had had numerous hospital admissions. On examination she was restless, febrile, and there were radiological signs of left-sided basal pneumonia. She was jaundiced, her liver was 3 cm enlarged but there were no obvious clinical signs of acute hepatic failure. She had primary respiratory alkalosis, probably related to chronic liver disease and sepsis, and a hyperchloremic metabolic acidosis. She had hypoalbuminemia, hypergammaglobulinemia, and conjugated hyperbilirubinemia consistent with severe chronic liver disease. She was considered to have septicemia supervening on chronic liver disease. Blood cultures were taken and IV antibiotics given. Although initially her condition appeared to improve, it subsequently deteriorated. The pt had increasing respiratory difficulties and died on the third day after admission. A postmortem was not performed. In the discussion section of the literature report, it was stated that the pt had a long history of alcohol abuse and a pre-existing condition of chronic liver disease and these conditions would have predisposed the pt to invasive pneumococcal disease. The septicemic process would in turn have exacerbated the pre-existing condition. However, it was considered that the invasive pneumococcal disease was the precipitating event in the pt''s terminal illness. No further information is expected.


VAERS ID: 161332 (history)  
Form: Version 1.0  
Age: 0.9  
Sex: Unknown  
Location: Foreign  
Vaccinated:2000-10-28
Onset:2000-10-28
   Days after vaccination:0
Submitted: 2000-11-01
   Days after onset:4
Entered: 2000-11-06
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 2901A1 / UNK - / IM
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES - / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-10-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
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:
CDC Split Type: 20000316351

Write-up: 2.5 hours post vax, the child was brought to the hospital. On arrival he was already dead. Delayed hypersensitivity reaction was evoked as possible cause of the death. The reporting physician considered the event to be possibly related to Engerix-B and/or to the concomitant Hibact.


VAERS ID: 161586 (history)  
Form: Version 1.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:1999-03-31
Onset:1999-04-29
   Days after vaccination:29
Submitted: 2000-11-03
   Days after onset:554
Entered: 2000-11-08
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Infection, Injury
SMQs:, Accidents and injuries (narrow), Hostility/aggression (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
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:
CDC Split Type: U2000007920

Write-up: The pt was bitten by a rabid dog on 3/29/99 and treated with 5 doses of antirabies vaccine. The wound, which consisted of two deep punctures on the forearm, was promptly washed with water and disinfected. Despite this treatment, characteristics clinical manifestation of rabies appeared one month after exposure and the pt died 48 hours later. This case raises the question of the causes for failure of the preventive recommendations proposed by the WHO for category of animal bites. In our case, two possible causes of failure and subsequent lethal outcome are that serotherapy was not associated and the incubation period was short. Other possible causes of rabies after post-exposure therapy are discussed with reference to the literature.


VAERS ID: 162098 (history)  
Form: Version 1.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2000-10-17
Onset:2000-10-17
   Days after vaccination:0
Submitted: 2000-11-06
   Days after onset:20
Entered: 2000-11-17
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / MEDEVA PHARMA, LTD. - / 3 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Circulatory collapse
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-10-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Paracetamol, Bisacodyl, Cagipen, Micralax, Mystecline
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: MPU2000005610

Write-up: Approximately 1 - 1.5 hours post vax, a 93 year old pt subsequently experienced sudden collapse and then sudden death which was unexplained. The pt was very frail but in satisfactory condition when the Fluvirin was given.


VAERS ID: 162178 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Male  
Location: Foreign  
Vaccinated:2000-10-01
Onset:2000-10-20
   Days after vaccination:19
Submitted: 2000-11-16
   Days after onset:27
Entered: 2000-11-20
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABAVERT) / NOVARTIS VACCINES AND DIAGNOSTICS - / 3 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Demyelination, Encephalitis, Pyrexia, Restlessness
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Optic nerve disorders (broad), Demyelination (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2000-10-24
   Days after onset: 4
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: Cefotoxime, antimalarials, human red blood cells
Current Illness: UNK
Preexisting Conditions: injury to face and neck, dog bite from stray dog
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20000648

Write-up: A male child of 3 years old, from a rural area, was bitten by a stray dog around 10/1/00, on the face. Pt developed fever and restlessness on 10/20/00 and was hospitalized on 10/21/00. The pt had received 3 doses of 1 ml Rabipur and probably his wound was also sutured prior to hospitalization. Pt was administered Cefotaxime, antimalarial treatment and blood transfusion. Pt was put on manual ventilator. He expired 3 days later. The doctor felt the cause of death to be demyelinating encephalitis. Preliminary assessment: Seriousness criteria: death, hospitalization and life-threatening. Causality: pending.


VAERS ID: 162632 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2000-10-05
Onset:2000-11-03
   Days after vaccination:29
Submitted: 2000-11-22
   Days after onset:19
Entered: 2000-11-28
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 RA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Gangrene, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-11-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ferrousSo4, glyburide, tolbutamide
Current Illness:
Preexisting Conditions: diabetes mellitus, metabolic disorder
Allergies:
Diagnostic Lab Data: blood culture
CDC Split Type: WAES00111386

Write-up: Approximately 4 weeks post vax, the pt experienced gas gangrene of the left arm and was hospitalized. She had been unwell for two days before admission, initially with a sore left arm and then systematically unwell. On 11/3/00 within several hours of admission to the hospital, the pt died. Clostridium septicus was cultured from blood cultures on 11/7/00. A post-mortem apparently showed no other pathology, although histology results were awaited. The sites of vaccination were not recorded and therefore are unavailable. The cause of death was gangrene. F/U no further info is expected. The case is considered closed.


VAERS ID: 162761 (history)  
Form: Version 1.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2000-10-06
Onset:2000-10-12
   Days after vaccination:6
Submitted: 2000-11-21
   Days after onset:40
Entered: 2000-11-29
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute leukaemia, Back pain, Chest X-ray abnormal, Chest pain, Cough, Leukocytosis, Pyrexia, Thrombocytopenia
SMQs:, Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-11-07
   Days after onset: 26
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: CXR-showed an infiltrate; blood tests-showed leucocytosis (23000/microL) and thrombocytopenia; bone marrow biopsy-pending.
CDC Split Type: WAES00111387

Write-up: Information has been received from a healthcare professional concerning a 61 year old male pt who on 10/6/00 was vaccinated with pneumococcal vaccine 23 polyvalent and influenza virus vaccine. On 10/12/00, the pt developed a cough, chest pain and back pain and was treated with antibiotics. He presented again with fever on 10/31/00. He was admitted to the hospital where a dx of acute leukemia was made. The pt died one week later. To be noticed that on 9/22/00, all laboratory findings, including total blood count had been within the normal range. Further information is expected. The cause of death was acute leukemia. F/U states; no further information is available. The case is closed.


VAERS ID: 162989 (history)  
Form: Version 1.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2000-10-01
Onset:2000-10-10
   Days after vaccination:9
Submitted: 2000-11-27
   Days after onset:48
Entered: 2000-12-05
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / SC

Administered by: Other       Purchased by: Other
Symptoms: Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-10-16
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prednisolone, Morphine, Amitriptylline, Temazepam
Current Illness:
Preexisting Conditions: Date unknown: fibrosing alveolitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: MPU2000006100

Write-up: An anonymised single pt print received concerning a 71 year old man who developed Guillain-Barre Syndrome, 9 days, post vax. He died 6 days, later. A post mortem was not carried out but the probable cause of death was reported as GBS. No further information was provided.


VAERS ID: 163136 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2000-10-03
Submitted: 2000-11-29
   Days after onset:57
Entered: 2000-12-06
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / MEDEVA PHARMA, LTD. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-10-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Atenolol, aspirin, tamsulosin, Phenergan
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MPU2000006240

Write-up: The pt died suddenly a few days after receiving one dose of Fluvirin. There was no allergic reaction at the time of vaccination. The pt was also receiving atenolol and aspirin for angina pectoris, tansulosin and Phenergan. A postmortem exam was not performed. Cause of death is reported as unknown. However the reporter thinks the sudden death may have been caused by long standing IHD, and the role of Fluvirin vaccine was coincidental.


VAERS ID: 163253 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2000-11-15
Onset:2000-11-17
   Days after vaccination:2
Submitted: 2000-12-04
   Days after onset:17
Entered: 2000-12-07
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM - / UNK - / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-11-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
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:
CDC Split Type: 20000346621

Write-up: Two days post vax on 11/17/00, the pt was found dead by her mother. The reporter considered that the event was probably unrelated to treatment with Infanrix, IPV, HIB. He mentions that in this age sudden infant death may happen spontaneously. Additional information has been requested.


VAERS ID: 163254 (history)  
Form: Version 1.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2000-10-11
Onset:2000-11-05
   Days after vaccination:25
Submitted: 2000-11-29
   Days after onset:24
Entered: 2000-12-07
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / MEDEVA PHARMA, LTD. 757702 / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-11-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pulmicort, Salbutamol
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: MPU2000006190

Write-up: A 50 year old man experienced a sudden unexplained death, 25 days post vax. The pt was also on Pulmicort and salbutenol for asthma. A postmortem exam was not performed. Cause of death unknown. The reporter states they were merely reporting an occurrence and there was no additional relevant information to note.


VAERS ID: 163595 (history)  
Form: Version 1.0  
Age: 0.75  
Sex: Male  
Location: Foreign  
Vaccinated:2000-10-28
Onset:2000-10-28
   Days after vaccination:0
Submitted: 2000-12-08
   Days after onset:41
Entered: 2000-12-12
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM - / 2 LL / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER R0332 / 1 GM / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cold sweat, Cyanosis, Mydriasis, Sudden infant death syndrome, Tongue disorder
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-10-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
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:
CDC Split Type: U2000009600

Write-up: "It was reported that a 9 month old boy received 1st dose of Haemophilus influenza type b vaccine (Hibest-Aventis Pasteur) and a booster dose of Hep-B (Engerix-B) on 10/28/00 at 11:35. The baby was well and went to sleep. He was found dead at 15:00 at home. His skin was cold and clammy, pupils were semi-dilated, he was cyanosed and his tongue has fallen back. Resuscitation was unsuccessful." This case is considered as a SIDS


VAERS ID: 163777 (history)  
Form: Version 1.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2000-10-27
Onset:2000-11-02
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2000-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / MEDEVA PHARMA, LTD. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-11-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ventolin, Becotide, KEtotifen, Co-Amilofruse, Flecainide
Current Illness:
Preexisting Conditions: asthma, allergic rhinitis, atrial fibrillation, left ventricular failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: MPU2000006440

Write-up: A 63 year old male pt with a hx of asthma, allergic rhinitis, atrial fibrillation and left ventricular failure, developed a pulmonary embolism 6 days after receiving Fluvirin vaccine. The pt was also receiving Ventolin, Recotide, ketotifen, Co-amilofruse, and flecenide. The pt died the day of the event. The reported considered this event to be unrelated to the Fluvirin vaccination.


VAERS ID: 164035 (history)  
Form: Version 1.0  
Age: 10.0  
Sex: Female  
Location: Foreign  
Vaccinated:2000-08-31
Onset:2000-09-04
   Days after vaccination:4
Submitted: 2000-12-15
   Days after onset:102
Entered: 2000-12-21
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER 548 / 4 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Dyspnoea, Headache, Paralysis, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
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: UNK
Preexisting Conditions: Licked by a stray dog on the leg.
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20000473

Write-up: We received the following information concerning a 10 year old female pt was licked by a stray dog on leg (class I type). Wound toilet was performed with plain water immediately. Pt was administered 4 doses of 1 ml Rabipur IM on 8/17/00, 8/20/00, 8/24/00 and 8/31/00. On 9/2/00, 2 days after the 4th dose of Rabipur, pt developed a headache and fever. On 9/3/00, pt had pain in abdomen and vomiting. On 9/4/00, pt developed ascending paralysis of left leg, right leg and difficulty in respiration. Pt was initially admitted to hospital. We are awaiting further data. Preliminary assessment: Seriousness criteria: hospitalization and life-threatening; causality: pending; Company assessment: Contrary to the case report, "licking" constitutes class II type contact. A "wound" toilet presumes a wound-which would constitute class III type contact. In cases of uncertainty, even class II type contacts require administration of rabies-specific immunoglobulin. No causality assessment possible without further information on dx and course of disease. Addendum 12/5/00: We received the information that the child died in the hospital. No other details are available.


VAERS ID: 164269 (history)  
Form: Version 1.0  
Age: 1.6  
Sex: Male  
Location: Foreign  
Vaccinated:2000-07-21
Onset:2000-07-27
   Days after vaccination:6
Submitted: 2000-12-27
   Days after onset:153
Entered: 2000-12-29
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (ACEL-IMUNE) / PFIZER/WYETH - / UNK - / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Sudden infant death syndrome, Upper respiratory tract infection
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Autopsy
CDC Split Type: 4988218

Write-up: A 19 month old male received Hib-Titer and TripAcel on 7/21/00 and subsequently, developed URI. The pt died on 7/27/00. The autopsy report showed no "obvious cause of death-SIDS?". The reporter indicated a "possible" relationship between this event and immunization.


VAERS ID: 164281 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2000-11-15
Onset:2000-11-17
   Days after vaccination:2
Submitted: 2000-12-22
   Days after onset:35
Entered: 2000-12-29
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DT: DT ADSORBED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / IM
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM - / 1 - / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / 1 - / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-11-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Autopsy-Sudden infant death syndrome
CDC Split Type: WAES00121155

Write-up: Information has been received from a health authority concerning a 11 week old male who on 11/15/00 *was vax''d w/the first dose of Hep B vax recombinant (yeast). Concomitant therapy that same day included the 1st dose of Infanrix-IPV-HIB.* On 11/17/00, the pt was found dead in prone position. The autopsy report stated that the boy died of sudden infant death syndrome (SIDS). *F/up info indicated that no written autopsy report is available. The file is closed.* No further information is available.


VAERS ID: 164643 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2000-05-18
Onset:2000-05-19
   Days after vaccination:1
Submitted: 2001-01-09
   Days after onset:235
Entered: 2001-01-11
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH - / 2 - / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Injection site necrosis, Myositis, Sudden infant death syndrome
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-05-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Autopsy (culture tissue specimen)-Klebsiella identified in infant''s lungs.
CDC Split Type: HQ5620108JAN2001

Write-up: A physician reported that a 2 month old female received Meningitec, haemophilus influenza type B, DTP and Poliomyelitis virus vaccines on 5/18/00 and the next day, the pt died. An autopsy was performed on 5/23/00. The pathologist reported that the baby was known to be co-sleeping with her parents, was appropriately grown and without metabolic inherited disease. Klebsiella was identified in the infant''s lungs; however, no evidence of bronchopneumonia was noted. There was focal necrosis at the injection site and evidence of myositis. No evidence of myelitis was found. The pathologist stated that "there was no way to implicate Meningitec and the death was probably someway due to the co-sleeping arrangement". Cause of death was unascertained. Sudden infant death syndrome, injection site necrosis and myositis are unexpected per the Investigator''s Brochure.


VAERS ID: 164759 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2001-01-12
Entered: 2001-01-17
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNU-IMUNE) / PFIZER/WYETH - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pneumonia
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: HQ5682208JAN2001

Write-up: A physician reported that several pts in an "elderly institution" received Pnu-Imune 23 and subsequently, developed pneumonia. Later, these pts died. This is 1 of 3 from this facility of adverse events following receipt of this vaccine.


VAERS ID: 164760 (history)  
Form: Version 1.0  
Age: 1.9  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2001-01-12
Entered: 2001-01-17
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Meningitis
SMQs:, Noninfectious meningitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The pt was born after 32 weeks'' gestation.
Allergies:
Diagnostic Lab Data:
CDC Split Type: U2001000500

Write-up: "It was reported that a baby girl was vaccinated at the age of 18 months with a dose of Haemophilus influenza type b vaccine. At the age of 23 months, she presented with meningitis. She died. To be noticed that she had been born after 32 weeks'' gestation."


VAERS ID: 164761 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2001-01-12
Entered: 2001-01-17
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The baby was born at 34 weeks'' gestation and had received 2 previous doses of haemophilus type b vaccines.
Allergies:
Diagnostic Lab Data: Serum specimen-found to have a low IgG concentration
CDC Split Type: U2001000510

Write-up: "It was reported that a 4 month old baby girl was vaccinated on an unknown date with a 3rd dose of Haemophilus influenza type b vaccine and 19 days, post vax, she developed a Haemophilus influenza type pneumonia (at 4.8 month of age). The pt died. She was found to have a low total IgG concentration in a serum specimen drawn during the acute phase of her illness. To be noticed that the pt was born at 34 weeks'' gestation and received previously 2 doses of Haemophilus influenza type b vaccine. Further information has been requested."


VAERS ID: 164821 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2000-05-18
Onset:2000-05-19
   Days after vaccination:1
Submitted: 2001-01-11
   Days after onset:237
Entered: 2001-01-18
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM
MNC: MENINGOCOCCAL (MENINGITEC) / PFIZER/WYETH - / UNK - / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injection site reaction, Muscle necrosis, Sudden infant death syndrome
SMQs:, Rhabdomyolysis/myopathy (narrow), Neuroleptic malignant syndrome (broad), Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-05-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
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:
CDC Split Type: 20010004501

Write-up: This report describes the occurrence of cot death in a female infant pt receiving diphtheria, tetanus, pertussis and haemophilus influenza type B vaccine (DTP-HIB). She also had meningococcal GP C conjugate (Meningitec). On 5/18/00, the vaccinee received vaccinations and on 5/19/00, the vaccinee died in her cot. Histology of the site of the Meningitec injection revealed muscle necrosis. The most recent information was received on 1/9/01. No other details were given. No further information is expected.


VAERS ID: 165100 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2001-01-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Sepsis
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: splenectomy
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES00061130

Write-up: Information has been received from a literature article concerning 4 patients with a history of spenectomy who were "vaccinated against pneumococci". The literature article indicated that the pt''s subsequently developed severe post/splenectomy infections and died. The cause of death was post/spenectomy infection. Six additional pts (WAES00060912, 00061128 to 00061129 and 00061131 to 00061133) had similar experiences following exposure to "pneumococci" vaccine.


VAERS ID: 165526 (history)  
Form: Version 1.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:1996-01-18
Onset:0000-00-00
Submitted: 2002-07-03
Entered: 2001-02-02
   Days after submission:515
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM - / 4 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Bone disorder, Cerebrovascular accident, Cerebrovascular disorder, Dysphagia, Muscle atrophy, Muscle contractions involuntary, Muscle disorder, Myalgia, Respiratory disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1998-06-19
Permanent Disability? No
Recovered? No
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: CT scan showed small strokes and brain MRI was normal; brain MRI showed many T2 hypersignlas (04/98); CT scan-cerebrovascular attacks.
CDC Split Type: 20010020911

Write-up: At an unspecified date in 1995 or 1996, the pt developed severe asthenia, myalgia and fasiculations. It is currently unknown if this symptom started prior or after the first, second, third or booster injection of Engerix. Then swallowing difficulties occurred and a gastric catheter was set up. The pt also developed phonation and respiratory disorders. Three diagnosis were suspected, amyotrophic lateral sclerosis, Kennedy disease or bulbo-spinal atrophy. On 6 19/98 approximately 1 1/2 year after the Engerix-B vax, the pt died. The most recent information received on 1/26/01 reports the outcome of the pt as died due to unknown cause. Follow up states that the final diagnosis was probable Kennedy syndrome with suspected cerebral vasculitis. According to the hospital report, the first events occurred in 1997. CT scan showed small cerebrovascular attacks. In April 1998, brain MRI showed many T2 hypersignals. Encephalopathy of a vascular etiology was suspected. According to the reporter, the pt was suffering from bulbo-spinal atrophy. Hypothesis of amyotrophic lateral sclerosis and Kennedy''s syndrome were suggested. The most recent info received on 06/18/02. Reporter''s causality assessment: probably unrelated to drug intake.


VAERS ID: 165666 (history)  
Form: Version 1.0  
Age: 1.6  
Sex: Unknown  
Location: Foreign  
Vaccinated:1996-07-19
Onset:1998-10-11
   Days after vaccination:814
Submitted: 2001-02-06
   Days after onset:849
Entered: 2001-02-08
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES L1036 / 3 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Drug ineffective, Infection, Meningitis
SMQs:, Lack of efficacy/effect (narrow), Noninfectious meningitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: First dose (P1) of Act-Hib (lot #L0803) on 05/21/96. Second dose (p2) of Act-Hib (lot #L0803) on 06/20/96. The patient was described as a normal child.
Allergies:
Diagnostic Lab Data:
CDC Split Type: U2001003720

Write-up: "It was reported that a 19 month old baby was vaccinated on 7/19/96 with a 3rd dose of Haemophilus influenza type b vaccine. On 10/11/98, the baby developed an Haemophilus type b Meningitis and subsequently died. To be noticed that the pt was described as a normal child. The pt previously received the 1st dose on 5/21/96 lot #L0803 and the 2nd dose on 6/20/96 lot #L0803. Further data is not expected. Case is closed."


VAERS ID: 165667 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Unknown  
Location: Foreign  
Vaccinated:1999-01-29
Onset:1999-03-26
   Days after vaccination:56
Submitted: 2001-02-06
   Days after onset:683
Entered: 2001-02-08
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER E83059A / 2 - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The pt had a chromosomal anomaly. First vaccination (P1) with Act-Hib DTP (lot #P5106) on 11/20/1998. P1 lot # and name to be verified.
Allergies:
Diagnostic Lab Data:
CDC Split Type: U2001003730

Write-up: On 3/26/99, the baby developed a Haemophilus type b bacteremia and subsequently died. To be noticed that the pt had a chromosomal anomaly.


VAERS ID: 165792 (history)  
Form: Version 1.0  
Age: 1.08  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2001-02-06
Entered: 2001-02-13
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Aspiration, Dizziness, Gastritis, Hypotonia, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: sibling hx of flaccid attacks unrelated to vaccinations.
Allergies:
Diagnostic Lab Data: autopsy - aspiration of vomit caused by acute gastritis
CDC Split Type: WAES01012076

Write-up: 8 days post vax the parents noted flaccidity and faintness a few hours preceding the death, but the symptoms subsided immediately and the pt seemed entirely healthy when put to bed. Forensic autopsy disclosed the cause of death as aspiration of vomit caused by acute gastritis. No further information is available. No date of death available.


VAERS ID: 165862 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2000-10-12
Onset:2000-11-27
   Days after vaccination:46
Submitted: 2001-02-12
   Days after onset:77
Entered: 2001-02-14
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNU-IMUNE) / PFIZER/WYETH - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Bronchitis, Coronary artery disease, Pneumonia
SMQs:, Eosinophilic pneumonia (broad), Other ischaemic heart disease (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-11-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: aspirin, Doxazosin, Glicazide, Nifedipine, Omeprazole, Trandolapril
Current Illness: UNK
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Autopsy Results - Bronchopneumonia, coronary artery disease
CDC Split Type: 7038609

Write-up: It was reported that a 76 year old male received an injection of Pneumococcal vaccine on 10/12/00. On 11/27/00, the patient died suddenly. A post mortem examination revealed the cause of death as bronchopneumonia and coronary artery disease. The reporter did note that the death of the patient was possibly coincidental. This report was received from the Medicine Control Agency (Ref No. 420716).


VAERS ID: 166141 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2000-10-23
Onset:2000-11-27
   Days after vaccination:35
Submitted: 2001-02-15
   Days after onset:80
Entered: 2001-02-26
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bronchitis, Cardiac disorder, Cardiac failure, Pneumonia
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-11-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Omeprazole, Aspirin, Simvastatin, Gliclazide, Nifedipine, Trandolapril, and Doxazosin.
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES01020713

Write-up: Information has been received from a health professional concerning a 76 year old male who on 10/12/00 was vaccinated IM with a dose of Pneumococcal vaccine 23 Polyvalent. Concomitant therapy included on 10/23/00, a dose of Influenza virus vaccine. It was reported that the patient suddenly died on 11/27/00. A post mortem was performed and revealed the cause of death a bronchopneumonia, ischemic heart disease, and heart failure. The reporter states that the death was possibly coincidental. Further info is not expected. The case is closed.


VAERS ID: 167085 (history)  
Form: Version 1.0  
Age: 1.5  
Sex: Male  
Location: Foreign  
Vaccinated:2001-02-21
Onset:2001-02-23
   Days after vaccination:2
Submitted: 2001-03-08
   Days after onset:13
Entered: 2001-03-15
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0615J / UNK - / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Agitation, Bacterial infection, Blood pressure decreased, Brain oedema, Disseminated intravascular coagulation, Hepatomegaly, Hypotension, Hypoxia, Leukocytosis, Liver function test abnormal, Pyrexia, Sepsis
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-02-25
   Days after onset: 2
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: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: BP-50/30; temp-35C; pertinent blood results from this hospital were: WBC-33,000,000/liter (leukocytosis); lymphocytes-56%; neutrophils 34%; monocytes 9%; basophils 1%; "deranged" liver function tests; Nml ammonia and blood cultures showed coagulase neg staphylococci indentified as being skin contaminants; post mortem was being conducted on 2/25/01.
CDC Split Type: WAES01030189

Write-up: Information was received from a health professional concerning an 18 month old male who on 02/21/01, in the afternoon, was vaccinated with the MMRII. On 02/23/01, at 3 AM he was found in his bed "having a fit" with a temp of 40 degrees C. He was admitted to the hospital where he deteriorated rapidly. At 7:20 AM he was transferred to the pediatric ICU at another hospital. During his transfer, the child deteriorated and was described as "flat" and essentially brain dead on arrival. The anaesthetist suspected the patient may have "coned" (coning: axial displacement of the cerebellar tonsils through the foramen magnum) at that point. He was resuscitated by treatment with inotropes, antibiotics and ventilation. He had overwhelming sepsis with DIC. He was ventilated from 02/24/01 in the AM. On 02/25/01 the ventilator was switched off and the patient died. The cause of death was bacterial sepsis and disseminated intravascular coagulopathy. A post mortem was being conducted on 02/26/01. This information was received by Aventis Pasteur MSD manufacturer # UK011318. On F/U, the post mortem conducted on 2/26/01 revealed large swollen liver, clear meninges and a swollen brain. The cause of death was established as sepsis and a microscopic exam of the lung showed a 2 day old bronchopneumonic condition. No organism has yet been identified. It was reported that the family history is significant for a similar episode in sibling (did not report if related to a certain vaccination). The mother had 5 pregnancies, of which only 2 children remain. One was a stillbirth at term. One was a 4.5 year old child who died during a "fit" of a very rare degenerative brain condition (Otoharan syndrome). This is an amended report. The batch number HK45610 has been added to the narrative.


VAERS ID: 167093 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Unknown  
Location: Foreign  
Vaccinated:2001-02-28
Onset:2001-03-01
   Days after vaccination:1
Submitted: 2001-03-09
   Days after onset:8
Entered: 2001-03-15
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 14959A9C (A) / 2 - / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. - / UNK - / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
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:
CDC Split Type: 20010057711

Write-up: On 2/28/2001, a 2nd dose of Infanrix (lot # 14949A9C) was given. On 3/1/01, 1 day, post vax, this child suddenly died. The reporting physician did not assess a causal relationship. Additional information has been requested. Despite several attempts, no additional information could be obtained. This case has therefore been closed.


VAERS ID: 167882 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2001-01-08
Onset:2001-01-09
   Days after vaccination:1
Submitted: 2001-06-12
   Days after onset:153
Entered: 2001-03-28
   Days after submission:75
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / SANOFI PASTEUR R5301 / UNK - / -
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Agitation, Apnoea, Oral intake reduced, Sudden infant death syndrome
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Neonatal disorders (narrow), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-01-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: U200100477

Write-up: "It was reported that a 1 year old boy was concomitantly vaccinated with Diphtheria-Tetanus-Pertussis vaccine, Hib vaccine conjugate with Diphtheria protein and Inactivated Poliomyelitis vaccine. The child was apparently healthy. He was well during the night, only cried, no fever or other complaints. Following day he did not want food but was well, fell asleep afterwards and was found lifeless around 10:30 AM. To be noticed that it was not the first administration of vaccines. This case was notified due to near temporal relationship between death and vaccination. Notifier does not have any additional suspicion (relative to) this case." "Follow up on 03/12/01: The patient is a 4 month old infant (DOB 08/12/01). There is a discrepancy about the vaccination date (02/08/01) and the death date (01/09/01). More info will be available." Corrected report on 06/05/2001 states the initial received date of version 0 was not correct: 02/14/2001 corresponds to the date received by HA in Portugal. The right date corresponding to the date received by affiliate in Portugal was 03/05/2001. Therefore, the version 0 of this report is not to be considered LATE for reporting to Health authorities. Follow up on 01/21/2002: no more info was obtained. The case is closed.


VAERS ID: 168015 (history)  
Form: Version 1.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2001-03-23
Entered: 2001-04-02
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anaemia, Autoimmune disorder, Bacterial infection, Blood disorder, CSF test abnormal, Chills, Gastrointestinal disorder, Headache, Hypoxia, Laboratory test abnormal, Meningitis, Pyrexia, Respiratory distress, Sepsis, Spleen disorder
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Haematopoietic cytopenias affecting more than one type of blood cell (broad), Haematopoietic erythropenia (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
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: penicillin (unspecified)
Current Illness:
Preexisting Conditions: Erythrocyte disorder; immunodeficiency; spenectomy
Allergies:
Diagnostic Lab Data: Bronchial irrigation - no pathological agent. Diagnostic Lab Test - poor antibody response, to pneumococcal vaccination Diagnostic Lab Test - polysaccharide antibody level (serotype 3) - before admission. Diagnostic Lab Test - polysaccharide antibody level (serotype 19F) before admission. Diagnostic Lab Test - polysaccharide antibody level (serotype 19F) after admission. Pulmonary Puncture - no pathological agent. Spinal Tap - Nml - 0.28 g/l. Spinal Tap - Cloudy. Spinal Tap - 14,300 - nucleated elements. Spinal Tap - type 18F pneumococcus. Spinal Tap - type 3 pneumococcus. Spinal Tap - 11.5 g/l - total protein. Spinal Tap - 3 nucleated elements. Spinal Tap - clear. Diagnostic Lab Test - Salmonella typhimurium +. Diagnostic Lab Test- polysaccharide antibody level (serotype 3) - after admission. Blood Culture - type 3 pneumococcus. Blood Culture - no pathological agent.
CDC Split Type: WAES01032399

Write-up: Information from an abstract of a literature article indicated that two patients (one fatal) who received a dose of pneumococcal vaccine 23 polyvalent developed post splenectomy pneumococcal sepsis. Both patients exhibited a poor response to the pneumococcal vaccine 23 polyvalent (MSD). The cause of death was pneumococcal infection of post splenectomy pneumococcal sepsis. Follow up from an English translation of a literature article failure of pneumococcal vaccination and prophylactic antibiotic treatment in two splenectomized subjects. New French hematology review indicated that a 28 year old male who had been monitored since 1972 due to autoimmune hemolytic anemia with partial erythroblastopenia and an immune deficiency who received a dose of pneumococcal vaccine 23 polyvalent. The persistence of the hemolytic component of the anemia, despite the administration of the corticotheraphy associated for some time with cyclophosphamide, which led to a splenectomy, and was performed six weeks after the APV. The patient also received 1,200,000 units of benzathine-benzyl-penicillin IM every 15 days after the splenectomy. No immunosuppressive treatment was administered. The sudden occurrence of febrile syndrome accompanied by shivering, 22 months after the splenectomy and 8 days after an IM injection of benzathine-benzyl-penicillin, led to re-hospitalization of the patient 5 hours after the onset of the symptoms. There were no signs of shock and no meningeal irritation upon admission, but the patient complained of headaches. Pulmonary auscultation revealed the presence of a left basal seat associated with hypoxemia. the patient was re-admitted to the ICU several times due to infectious syndromes, which included two instances of septicemia of gastrointestinal origin (Salmonella typhimurium), and two instances of acute respiratory distress. Each of the latter episodes required continuous positive pressure ventilation, although no pathological agent could be detected through blood cultures, a transtracheal puncture, or alveolar lavage. Progress was favorable with the administration of latamoxef and erythromycin. It was noted that the 28 year old male patient died 24 hours after re-admission in June 1986, of pneumococcal septicemic meningitis (serotype 18F, not contained in the vaccine. It was also reported that this infectious syndrome was probably encouraged by the suspension of prophylactic antibiotic treatment, due to poor compliance by the patient. Another patient from this article was identified with similar experiences. No further info is available.


VAERS ID: 168623 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:1997-10-20
Onset:0000-00-00
Submitted: 2001-04-10
Entered: 2001-04-12
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Epilepsy, Speech disorder
SMQs:, Systemic lupus erythematosus (broad), Dementia (broad), Convulsions (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Generalised convulsive seizures following immunisation (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-01-24
Permanent Disability? No
Recovered? No
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:
CDC Split Type: 20010086621

Write-up: On 10/29/97, the vaccinee received a dose of DTP-HIB. Nine days later, the vaccinee developed severe epilepsy and delayed speech. On 1/24/01, approx. 3 1/4 years later, the vaccinee died. No autopsy was performed. Probable cause of the unexplained death was reported to be epilepsy. The reporter considered the reaction to be serious as it was disabling and the vaccinee died. The most recent information was received on 4/5/01. No other details were given. No further information is expected.


VAERS ID: 168970 (history)  
Form: Version 1.0  
Age: 10.0  
Sex: Male  
Location: Foreign  
Vaccinated:2000-11-04
Onset:2000-11-10
   Days after vaccination:6
Submitted: 2001-04-19
   Days after onset:159
Entered: 2001-04-24
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABAVERT) / NOVARTIS VACCINES AND DIAGNOSTICS - / 4 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Cardiac failure, Coma, Dysphagia, Guillain-Barre syndrome, Hypotension, Lymphocytosis, Muscular weakness, Paralysis flaccid, Pyrexia, Respiratory arrest, Respiratory failure, Tracheo-oesophageal fistula, Urinary retention, Viral infection
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2000-12-19
   Days after onset: 39
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: Open wound (dog bite) of knee, leg (except thigh), and ankle, complicated (class III bite)
Preexisting Conditions: Bit by a stray dog left calf (class III bite).
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20000787

Write-up: A male child of 10 years was bitten by a stray dog in the left calf on 10/20/00. The child had received 4 doses of 1ml Rabipur IM on 10/20/00, 10/23/00, 10/27/00 and 11/04/00. Five days after the 4th dose of Rabipur, the pt developed paraparesis and was admitted in hospital on 11/9/00. Pt was conscious, had fever (104F), retention of urine and acute flaccid paraplegia. On 11/10/00, the pt had varying degree of consciousness and weakness spread to upper limbs. On 11/13/00, the pt had total respiratory arrest and slipped into coma. On 11/25/00, pt was having normal deglutition. On 11/27/00, pt developed tracheo-oesophageal fistula and his respiration was weak. Pt continued in deep coma. On 12/3/00, he developed hypotension. On 12/6/00, the deglutition reflex disappeared. On 12/19/00, he had cardiac, respiratory failure and expired. We are awaiting further data. Preliminary assessment; Seriousness criteria; death, life-threatening and hospitalization. Causality: pending. Addendum on 2/2/01: information was requested but not available at the time. Addendum on 4/11/01; no further information about the dx (rabies versus Guillain-Barre Syndrome) and the result of the corneal smear are available. No change in assessment.


VAERS ID: 169140 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2002-05-06
Entered: 2001-04-27
   Days after submission:374
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (TICE) / ORGANON-TEKNIKA - / 1 - / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Chromosome abnormality, Cough, Hepatomegaly, Irritability, Lymphadenopathy, Oral intake reduced, Pancytopenia, Pyrexia, Respiratory failure, Splenomegaly
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Myelodysplastic syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 32 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: At autopy-M. Bovis var BCG, was recovered from lung tissue and numerous acid-fast bacilli were observed in bone marrow and 1 adrenal gland, confirming the dx of disseminated BCG infection. Immunologic investigations revealed normal number of T & B lymphocytes and related functions. A defect was detected in the IFNGRI gene.
CDC Split Type: U200100661

Write-up: "Male infant was born in 8/96, following a normal pregnancy. He was well initially. BCG vaccine was administered in the left arm at 3 weeks of age. At 9 weeks of age, he was seen in hospital with a brief history of cough and fever. He was found to have markedly enlarged liver, spleen and was admitted for investigation. CMV was cultured from his urine; treatment was undertaken with ganciclovir and IV immunoglobulin on suspicion that the virus was responsible for his hepatosplenomegaly. While in hospital, that infant developed enlarged left axillary nodes. At the same time, his liver enlargement increased and pancytopenia became severe, necessitating repeated platelet infusions. Excision biopsy of an axillary lymph node showed abundant acid-fast bacilli, later identified as M. bovis, var BCG. He was treated with isoniazid, rifampin, pyrazinamide and clarithromycin on suspicion that he had disseminated BCG infection. However, he failed to improve and died of respiratory failure after 32 days in hospital; 17 days of anti-TB therapy took place during this time. Details of the infant''s disorder and studies of his parents will be published separately. The parents were healthy and unrelated. F/U received 4/16/01; F/U-has been published as Disseminated bacille Calmette-Guerin infection in an infant with a novel deletion in the interferon-gamma receptor gene. From fazed correspondence on 4/29/02-6 weeks after receiving BCG vax, an aboriginal infant presented with suspected sepsis, lymphadenopathy and hepatosplenomegaly. Other mutations in this gene have led to disseminated atypical mycobacterial infections in children as well. The authors believed that the infant''s impaired response to anti-tuberculosis therapy and eventual fatal infection was consistent with the interferon-gamma receptor gene mutation. Standard 0.05ml BCG vaccine was administered in the left deltoid at 2 weeks of age. He presented at 8 weeks of age with a 3 day history of cough, irritability, decreased feeding and a 1 day history of fever. The liver edge was approx. 9cm below the right costal margin, with significant spenomegaly. The latest date of F/U info was 4/26/02 not 4/29/02 as reported. From faxed correspondence recieved on 04/29/02, states that six weeks after receiving BCG vaccination, an aboriginal infant presented with suspected sepsis, lymphadenopathy and hepatosplenomegaly. Lymphnode biopsy revealed macrophages filled with acid-fast bacilli. Mycobacterium bovis was cultured from tissue specimens and there was evidence of concomitant cytomegalovirus disease. The infant died of disseminated BCG infection. A novel deletion at nucleotide 165 in the interferon-gama receptor was identified. Other mutations in this gene have led to disseminated atypical mycobacterial infections in children as well. The authors believed that the infant''s impaired response to antituberculosis therapy and eventual fatal injection was consistent with the interferon-gamma receptor gene mutation. Standard 0.05ml BCG vaccine was administered in the left deltoid at 2 weeks of age. He presented at 8 weeks of age with a 3 day history of cough, irritability, decreased feeding and a day history of fever. The liver edge was approximately 9cm below the right costal margin, with significant splenomegaly.


VAERS ID: 169945 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2001-02-15
Onset:2001-02-17
   Days after vaccination:2
Submitted: 2001-05-09
   Days after onset:80
Entered: 2001-05-18
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / BERNA BIOTECH, LTD. - / UNK - / IM
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES 0937 / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Sepsis
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-02-17
   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:
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: U2001007010

Write-up: A foreign report from Aventis Pasteur SA (F2001-014200 regarding events in Denmark. Case reported by Health Authorities {case reference number: 20010531} through AP MSD Denmark (local number DK105073). "It was reported that a 3 month old girl was administered concomitantly a Haemophilus influenzae type B and a Diphtheria-Tetanus-Acellular Pertussis-inactivated Poliomyelitis (Mfr.SS) vaccines. Two days later, the infant was hospitalized due to meningococcal meningitis. Patient outcome is not reported. Further info is awaited." Followup received states pt died on 2/17/01 from meningococcal sepsis. It was decided in agreement with the county doctor to report the event though the causal relationship was found to be unlikely. This case is closed


VAERS ID: 170245 (history)  
Form: Version 1.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2001-05-18
Entered: 2001-05-24
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNU-IMUNE) / PFIZER/WYETH - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal distension, Abdominal pain, Alcohol poisoning, Anaemia, Anuria, Cardiac failure congestive, Cardiomegaly, Confusional state, Dyspnoea, Hepatomegaly, Hyperglycaemia, Hyperkalaemia, Hyponatraemia, Hypotension, Hypothermia, Hypoxia, Laboratory test abnormal, Lung disorder, Peritonitis, Renal failure chronic, Tachypnoea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Haematopoietic erythropenia (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Gastrointestinal perforation (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Alcoholism, Chronic Renal failure.
Allergies:
Diagnostic Lab Data: Temperature was 34.3 degrees, his blood pressure was 110/50mmHg and his respiratory rate was 40/min. Blood cultures were taken. White cell count 3500 x 10 (9) / L, 91% polymorphs; no growth upon culture. Streptococcus pneumoniae serotype 6B was isolated from the blood cultures.
CDC Split Type: HQ0934116MAY2001

Write-up: Information has been received from a published literature article (Three Fatal Pneumococcal Polysaccharide Vaccine Failures. Medical Journal of Australia 2000; 173:305-307). It was reported that a 51 year old Aborigine male received Pneumococcal vaccine polyvalent. The patient has a past history of alcoholism and chronic renal failure was diagnosed 6 months previously. In December, 1999, 18 months post immunization, he presented to a medical center with a two week history of increasing shortness of breath. On examination he was "in extremis", with hypothermia and hypotension; blood cultures were taken, parenteral antibiotics were administered and urgent transfer to hospital was arranged. On admission he was extremely ill, with severe respiratory distress. His temperature was 34.3 degrees, his blood pressure was 110/50mmHg and his respiratory rate was 40/min. There were widespread chest crepitations. He was urgently intubated and ventilated, and resuscitation commenced. He was anemic and had marked neutrophilia; he was hyponatraemic, hyperkalaemic, and hyperglycemic. He had severe acute-on-chronic renal failure, congestive cardiac failure, severe anion gap metabolic acidosis and consumption coagulopathy. Shortly after admission the patient had a hyperkalaemic cardiac arrest. He was resuscitated and given treatment for hyperkalaemic crisis. he was noted to be anuric (producing less than 10ml urine in the first 3 hours) and was placed on continuous veno-veno haemofiotration. Within 15 hours of admission his metabolic condition was much improved, and he was extubated. However, after about 17 hours, his condition suddenly deteriorated, with marked confusion, tachypnoea, and profound hypotension. He had to be reintubated and resuscitated again; he responded slowly and remained anuric. On the second day his abdomen was noted to be distended and tender, and ascites was detected. The distention increased and he developed guarding; the next day the abdomen was tense and bowel sounds were absent. A provisional diagnosis of spontaneous pneumococcal peritonitis was made and purulent peritoneal fluid (white cell count 3500 x 10 (9) / L, 91% polymorphs; no growth upon culture) was aspirated. Despite intense therapy his condition steadily deteriorated and he eventually died 13 days after admission. A post mortem exam showed small kidneys with advanced diabetic nephropathy, cardiomegaly with left ventricular hypertrophy, heavy and oedematous lungs with both diffuse alveolar damage and diffuse pneumonic changes, and an enlarged liver but no evidence of either fatty change or cirrhosis. Streptococcus pneumoniae serotype 6B was isolated from the blood cultures.


VAERS ID: 170247 (history)  
Form: Version 1.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2001-05-18
Entered: 2001-05-24
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNU-IMUNE) / PFIZER/WYETH - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Blood gases abnormal, Cough, Dyspnoea, Haemoglobin decreased, Hepatocellular damage, Hepatomegaly, Hyperbilirubinaemia, Hyperchloraemia, Hyperglobulinaemia, Hyperventilation, Hypoalbuminaemia, Hypokalaemia, Hyponatraemia, Immunoglobulins increased, Jaundice, Metabolic acidosis, Pneumonia, Pyrexia, Respiratory alkalosis, Restlessness, Sepsis
SMQs:, Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Acute pancreatitis (narrow), Asthma/bronchospasm (broad), Haematopoietic erythropenia (broad), Lactic acidosis (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Hyponatraemia/SIADH (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Tubulointerstitial diseases (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Hypokalaemia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
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: UNK
Current Illness: Alcoholism; Hepatic disease NOS
Preexisting Conditions: History of alcoholism and chronic liver disease.
Allergies:
Diagnostic Lab Data: Blood cultures-streptococcus pneumoniae serotype 18C was isolated; hypoalbuminemia at 15 g/L; Blood bicarbonate low at 8.2 mmol/L; hyperbilirubinemia at 99 umol/L; carbon dioxide low; Blood chloride high at 120 mmol/L; Blood potassium low at 2.6 mmol/L; Blood sodium low at 134 mmol/L; Haemoglobin low at 109 g/L; Immunoglobulins high at 83 g/L; PO2 high at 131.7 mmHg; CXR-left-sided basal pneumonia; PH NOS high at 7.48 (Ref range 7.35-7.45)
CDC Split Type: HQ0934216MAY2001

Write-up: It was reported that a 42 year old female received pneumococcal vaccine polyvalent. The pt has a past history of alcoholism and chronic liver disease. Ten months, post vax, she presented to a hospital with a "few days" history of cough and shortness of breath. On exam, she was restless, febrile at 39.7C and had a respiratory rate of 36/min; there were clinical and radiological signs of left-sided basal pneumonia. She was jaundiced, her liver was 3cm enlarged but there were no obvious clinical signs of acute hepatic failure. She had primary respiratory alkalosis, "probably related to chronic liver disease and sepsis" and a hyperchloremic metabolic acidosis. She had hypoalbuminemia, hypergammaglobulinemia and conjugated hyperbilirubinemia consistent with severe chronic liver disease. She was considered to have septicemia supervening on chronic liver disease. Blood cultures were taken and IV antibiotics were given. Although, initially, her condition reportedly appeared to improve, it subsequently, deteriorated. The pt had increasing respiratory difficulties and died on the 3rd day after admission. A postmortem was not performed. Streptococcus pneumoniae serotype 18C was isolated from the blood cultures.


VAERS ID: 171018 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Female  
Location: Foreign  
Vaccinated:2001-05-23
Onset:2001-05-24
   Days after vaccination:1
Submitted: 2001-06-06
   Days after onset:13
Entered: 2001-06-11
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 3377A2 / 2 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Weight decreased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-05-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Weight was normalized as of 5/23/01; Oral cavity normal; lungs normal; abdomen normal; heart normal.
CDC Split Type: 20010135741

Write-up: This report describes the occurrence of death in a 1 month old girl receiving Engerix-B. On 04/23/01, a 1st dose of Engerix-B was given. On 05/11/01, the girl was seen at the clinic for a control-check of the child''s general condition. On that date, she was in a general good condition, breastfed, with typical regular stools. On physical examination, oral cavity, lungs, heart and abdomen were without any change. She was weighing 2930 gm. Since in the physician''s opinion, the constitution of the girl was rather weak and her weight lower than normal range, he decided separate in time the scheduled vaccinations (2nd dose of Engerix-B and DTP). On 05/23/01, at the age of 1 month, a 2nd dose of Engerix-B was given, physical exam retrieved no change in oral cavity, lungs, heart and abdomen. Reflexes were correct and weight was 3380 gm. After vaccination, no distressing symptoms were noted and the child was sent home. On 05/24/01, at 04:00, she was breastfed and slept with her mother. On 05/24/01 in the morning, 1 day after vaccination, this girl was found dead in her bed. On the same day, the treating pediatrician was notified by the police about the girl''s death. As of 06/01/01, at the time of this report, no information regarding an autopsy or the cause of death was available. The reporting physician considered the event to be unrelated to Engerix-B. However, it was reported that the parents were investigating a lot. Additional information has been requested.


VAERS ID: 172584 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2000-07-06
Onset:2000-07-09
   Days after vaccination:3
Submitted: 2001-06-27
   Days after onset:353
Entered: 2001-06-29
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH - / 2 - / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -
MNC: MENINGOCOCCAL (MENINGITEC) / PFIZER/WYETH - / UNK - / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: HQ2560527JUN2001

Write-up: It was reported that a female infant received the vaccines on 7/6/00. On 7/9/00, the infant died. The probable cause of death was reported as sudden infant death syndrome.


VAERS ID: 172585 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2001-05-31
Onset:2001-06-02
   Days after vaccination:2
Submitted: 2001-06-20
   Days after onset:18
Entered: 2001-06-29
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK - / IM
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-06-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Cisapride therapy
Current Illness:
Preexisting Conditions: Gastroesopheal reflux
Allergies:
Diagnostic Lab Data:
CDC Split Type: U200100809

Write-up: Two days post vaccines on 6/2/01 the pt died. The death was defined as sudden infant death syndrome. It was reported that the baby did not have a fever. To be noticed that until 5/29/01, the baby was treated with cisapride. More information has been requested. It was reported that a 2 month old baby boy was concomitantly vaccinated with Diphtheria-Tetanus-Polio-acellular Pertussis vaccine and haemophilus influenzae type B vaccine on 05/31/2001. Two days later, on 06/02/2001, he died. The death was defined as sudden infant death syndrome. The baby was weighing 5.2 kg and it is reported that he presented no fever after the vaccine administration. To be noticed that until 05/29/2001, this baby was treated with cisapride. More info has been requested. Follow up on 01/21/2002 as additional info was impossible to obtain, the case is considered as closed. From faxed correspondence received on 03/13/2002 it was repored the mother was aged 25, had already 2 male children. Her pregnancy was normal and delivery occurred at term. The baby was born at term with a weight of 2.84 kg. Apgar at birth wasa 9/10 and 10 mins later was 10/10. The baby suffered of no malformation but he had gastroesophgeal reflux. The baby was living in a rural environment, parents were probably non-smokers and the baby was sleeping on his back. No more information is awaited. case is closed.


VAERS ID: 172889 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2000-07-06
Onset:2000-07-09
   Days after vaccination:3
Submitted: 2001-06-27
   Days after onset:353
Entered: 2001-07-05
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-07-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: U2001008290

Write-up: "It was reported that a less than 1 year old baby girl was concomitantly administered a Diphtheria-Tetanus-Pertussis, an Haemophilus influenza type B, a Meningococcal and a Poliomyelitis vaccine. The baby died 3 days later and the probable cause of death is Sudden Infant Death Syndrome. There is no Post Mortem performed. Further information is not expected, the case is closed."


VAERS ID: 173273 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2001-04-23
Onset:2001-04-23
   Days after vaccination:0
Submitted: 2001-07-11
   Days after onset:79
Entered: 2001-07-17
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / 3 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac arrest, Diabetes mellitus, Dyspnoea, Hyperkalaemia, Renal disorder, Respiratory arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2001-04-24
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Aquaphor, Delix, diltiazem HCL, Sortis, Torem, aspirin, venlafaxine HCL, Calciumacetat-Nefro, Omebeta,
Current Illness: Anemia; CHF; DM; diabetic nephropathy; diabetic vascular disease; hemodialysis; proliferative diabetic retinopathy; polyneuropathy; osteoporosis; hyperglycemia; hypertension; hyperuricemia; involutional depression; obesity
Preexisting Conditions: Carpal tunnel decompression; CVA; ophthalmic laser therapy; retinal detachment; myocardial infarction x 2; femoral neck fracture; humeral fracture
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES01070100

Write-up: Three hours post vax, pt developed dyspnea and respiratory arrest. Pt was hospitalized and was successfully resuscitated. It was reported that the pt died in the evening on 4/24/01. The cause of death was initially reported as respiratory arrest. According to medical report, the diagnosis of exitus letalis after CPR with asystole within metabolic dysfunction due to diabetic nephropathy with hyperkalemia was made. Respiratory arrest, asystole, hyperkalemia, and dyspnea were considered to be immediately life-threatening by the reporter. No further info is available.


VAERS ID: 173274 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2001-01-01
Onset:2001-01-02
   Days after vaccination:1
Submitted: 2001-07-13
   Days after onset:191
Entered: 2001-07-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (TRITANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Crying, Dysphagia, Hypotonia, Injection site pain, Pallor, Pyrexia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Acetaminophen - Application of towels on wet towels on head.
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Autopsy-pending Autopsy with cultures of the brain, heart, kidney and spleen
CDC Split Type: 20010160291

Write-up: This report describes the occurrence of death in a 2 month old child of unknown gender receiving Tritanrix-HB. Twenty-four hours, post vax, a dose of Tritanrix-HB and Hiberix (see case 20010160292), this child died (NOS). An autopsy report is awaited. The reporting physician did not assess a causal relationship. Additional information has been requested. On 07/03/2001, a 1st dose of Tritanrix-HB and a 1st dose of oral polio vaccine were given. The same day, at 11:00, 2 hours after vaccination, this girl developped fever, irritability and tenderness at the injection site (left gluteus), paleness of the face generalized flaccidity, crying and difficulty to swallow. She was treated with Acetaminophen and the application of wet towels on her head. The fever decreased a little and she drank less than 90 ml. During the afternoon, and the night, the symptoms remained with persistent fever and crying. During that time, the girl drank 1-2 bottles of milk. No further medication was given during the rest of the afternoon and the night. On 07/04/2001, between 20:00:00 and 21:00:00, the grandmother noticed that the child was pale, flaccid and non responsive to stimuli. Subsequently, she took her to the Healthcare centre. She was then transferred to a hospital wher she died at 23:45. The findings of the autopsy were not reliable since these cultures were done post moxtem too long after the demise. A post-moxtem blood cluture retrieved enterobacter closcae. Specialized virological studies indicated that all the cultures were negative on the day of the vaccination, the patient presented a mild rhinitis and sporadic coughing. After an evaluation by the healthcare cnetre''s physician, no contraindication for the administration of the vaccines was found.


VAERS ID: 173744 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2001-06-11
Onset:2001-07-13
   Days after vaccination:32
Submitted: 2001-07-26
   Days after onset:13
Entered: 2001-08-01
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / 1 - / -
JEV: JAPANESE ENCEPHALITIS (J-VAX) / CONNAUGHT LABORATORIES EJN195B / 3 - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac arrest, Cyanosis
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-07-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
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:
CDC Split Type: U2001008960

Write-up: It is reported that this patient was vaccinated on 05/08/01, 05/21/01 and 06/11/01 against Japanese encephalitis (Biken). On 06/11/01 a booster dose of HBVax was also administered to this patient. Proguanil had been prescribed as prophylactic measure for the first 12 weeks of his trip to Asia. The family doctor confirmed there was no anamnesis of allergic (type 1). According to the information given by the pt he was under no drug therapy and had no disease. Yet selbutamol was prescribed in 1999 against effort linked wheezing. The pt dies suddenly on 07/13/01 of cardiac arrest and acute cyanosis. It is said that he was complaining of diarrhea since a few days. An autopsy has been released in Agra (India) but the results are not yet known. Closure of file.


VAERS ID: 173745 (history)  
Form: Version 1.0  
Age: 1.7  
Sex: Male  
Location: Foreign  
Vaccinated:2001-07-12
Onset:2001-07-12
   Days after vaccination:0
Submitted: 2001-07-25
   Days after onset:13
Entered: 2001-08-01
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / 3 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Epistaxis, Gastrointestinal haemorrhage, Mouth haemorrhage, Pyrexia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal haemorrhage (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Ischaemic colitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2001-07-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ascorbic acid, vitamins (unspecified)
Current Illness:
Preexisting Conditions: Concurrent conditions: vitamin supplementation
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES01079949

Write-up: Information has been received from a physician concerning a pt who was vaccinated on 7/12/01 with hepatitis B vaccine II (MSD). Concomitant therapy included ascorbic acid and multivitamins. On the afternoon of 7/12/01 the pt experienced low grade fever and was given paracetamol. The pt then slept, woke up once then slept again. Approx that same night, the pt was found dead with profuse oral bleeding. The pt was rushed to the hospital. The mother said there was absence of convulsion. Upon arrival in the hospital the child was declared dead. An autopsy was ordered. Oral bleeding was considered life threatening. Additional information has been requested. This is a follow-up report. The reporting physician suspected GI hemorrhage since nose bleeding was also noted. The reporting physician felt that oral bleeding, nose bleeding, low-grade fever and death are definitely not related to the therapy with Hep-B vaccine. The reporting physician also considered nose bleeding as life threatening. This is a corrected report. "The cause of death was unknown" was added to the narrative. *Attempts were made to obtain autopsy findings but the reporting MD refused to provide the results. No further info is expected.*


VAERS ID: 173936 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2001-03-09
Onset:2001-06-01
   Days after vaccination:84
Submitted: 2001-08-03
   Days after onset:63
Entered: 2001-08-07
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 3155A6 / 1 - / SC

Administered by: Other       Purchased by: Other
Symptoms: Hepatic encephalopathy, Hepatic failure, Hepatitis, Jaundice, Laboratory test abnormal, Nausea, Petechiae, Vomiting
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Hepatitis, non-infectious (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Noninfectious encephalopathy/delirium (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-07-24
   Days after onset: 53
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: Arteritis, diabetes mellitus, essential hypertension, hemodialysis, renal failure, anemia, cholecystectomy
Allergies:
Diagnostic Lab Data: Hepatitis B core antibody, surface antigen-positive; polymerage chain reaction-positive
CDC Split Type: 20010183951

Write-up: In 3/01, the pt was vaccinated with a 1st Engerix-B. In 6/01, the pt developed fulminant B Hepatitis, leading to or prolonging hospitalization and requiring a transfer in the resuscitation unit. In 7/01, the pt died. Death was due to the event. The most recent information was received on 7/31/01. The reporter''s causality assessment was not specified. In July 2001, the pt experienced vomiting, nausea, major cytolysis, petechiae, confusion and cutaneous icterus. The pt''s conditions aggravated. Diagnosis of fulminant B hepatitis was made. Biological examination showed coagulation disorder wit prothrombin time increased. At a date as yet unknown, the pt was transferred in the resuscitation unit. On 07/23/2001 the pt experienced shock. Diagnosis of major hepatic failure and encephalopathy were made. On 07/24/2001, the pt died due to fulminant B hepatitis. It was noticed that two dialysis pt were carrying hep b virus.


VAERS ID: 174275 (history)  
Form: Version 1.0  
Age: 5.0  
Sex: Female  
Location: Foreign  
Vaccinated:1999-10-08
Onset:1999-10-11
   Days after vaccination:3
Submitted: 2001-08-03
   Days after onset:662
Entered: 2001-08-14
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / SC
YF: YELLOW FEVER (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Alanine aminotransferase increased, Anaemia, Anorexia, Aspartate aminotransferase increased, Cardio-respiratory arrest, Dehydration, Diarrhoea, Hyperaemia, Hyperbilirubinaemia, Hyperchromic anaemia, Hypochromic anaemia, Hypotension, Infection, Interstitial lung disease, Laboratory test abnormal, Prostration, Pruritus genital, Pyrexia, Respiratory distress, Tachypnoea, Vomiting, Vulval disorder
SMQs:, Torsade de pointes/QT prolongation (broad), Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (narrow), Asthma/bronchospasm (broad), Haematopoietic erythropenia (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1999-10-16
   Days after onset: 5
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: Aseptic meningitis; bronchitis; diarrhea; low birth weight
Allergies:
Diagnostic Lab Data: Biopsy-diffuse interstitial infiltrate; neurological exam of CSF-nml: WBC-12,000/L; hematocrit-34%; serum aspartate aminotransferase-114 IU/L; total serum bilirubin-18.8 umol/L; serum immunoglobulin M test-neg. WBC count 12000. Post-mortem bx-histopathological exam revealed changes consistent with those seen in wild-type yellow fever; serum protein electrophoresis was positive for yellow fever virus
CDC Split Type: WAES01077925

Write-up: Information has been received from a physician concerning a 5 year old white female who on 10/8/99 was vaccinated with MMRII and was given a simultaneous but separate vaccine of yellow fever virus vaccine live. Three days, post vax, the pt developed a fever (39.6C) and diarrhea, and the next day, anorexia, vomiting and vulva pruritus and was seen in the ER. On exam, the pt was tachypenic, had a hyperemic pharynx, was anemic (hematocrit 34%) and had raised serum aminotransferase concentrations (aspartate aminotransferase 114 IU/L, alanine aminotransferase 160 IU/L), bilirubin concentration was slightly raised (18.9 umol/L). On the 4th day, the pt had prostration, respiratory distress, increased vomiting and diarrhea, dehydration and scleral icterus. Abdominal exam revealed enlarged, tender liver. Possible meningismus was noted. Differential dx of pneumonia and meningitis was added. CSF exam was normal. CXR revealed diffuse interstitial infiltrate in the left lung. The hematocrit fell to 30%, total leucocyte count was 12,000/L. The next day, the pt was admitted to ICU and was hypotensive, not perfusing, cyanotic, in acute respiratory distress. The pt had a cardiorespiratory arrest, was resuscitated but died within the next hour. On 10/16/99, the pt died. The cause of death was yellow fever. A meeting of yellow fever experts was convened in May 2000 and the panel unanimously concluded that the vaccine virus was the probable cause of fatal infections, which closely resembled wild-type yellow fever. Additional information is not expected.


VAERS ID: 174276 (history)  
Form: Version 1.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2001-06-11
Onset:2001-07-11
   Days after vaccination:30
Submitted: 2001-08-03
   Days after onset:23
Entered: 2001-08-14
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK - / IM
JEVX: JAPANESE ENCEPHALITIS (NO BRAND NAME) / UNKNOWN MANUFACTURER EJN195B / 3 - / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac arrest, Cyanosis
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-07-13
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Wheezing in 1999, for which salmeterol was prescribed.
Allergies:
Diagnostic Lab Data: Autopsy-pending; Autopsy: massive aspiration of vomit that induced suffocation;
CDC Split Type: WAES01072809

Write-up: Information has been received from a health professional concerning a 27 year old male who on 6/11/01 was vaccinated with a booster dose of Hep-B vaccine recombinant (yeast) and Japanese encephalitis vaccine that was administered on 5/8/01, 5/21/01 and 6/11/01 (lot EJN195B). The pt was prescribed "Proguanil" as a prophylactic measure for the first 12 weeks of his trip to Asia. The pt''s family doctor confirmed that there was no anamnesis of allergic (type I). Prior therapy included salmeterol in 1999 for the pt''s wheezing. On 7/13/2001, the pt died suddenly of a cardiac arrest and acute cyanosis. It was reported that the pt complained of diarrhea a few days prior. An autopsy was performed, but results were not yet known. Additional information is not expected.F/U additional info is not expected. File closed. Other business partner numbers include NJE-HBV2001-55. Follow up on 12/05/2003: "On 11/20/2003, the autopsy report was received and it was reported that the most important result was a massive aspiration of vomit that induced suffocation of the patient. According to the physician who performed the autopsy, an infection of the digestion tractus could be a possible cause. That would explain the complains of diarrhea and the mesenteric lymphadenopathy observed. It is precised that no more results had been obtained by histologic investigation. Regarding the final neuropathologic report, it is said that neither anomaly or cerebral inflammation has been observed. According to the initial reporter, there is no relation with the vaccination. No more information is expected. The case is closed. Other business partner numbers include NJE-HBV2001-55 & E2003-03472."


VAERS ID: 174296 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2001-06-16
Onset:2001-08-03
   Days after vaccination:48
Submitted: 2001-08-10
   Days after onset:7
Entered: 2001-08-14
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM - / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: CSF test abnormal, Encephalitis, Paresis, Quadriplegia, Visual disturbance
SMQs:, Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Encorton, Leukeran
Current Illness:
Preexisting Conditions: Chronic lymphatic Leukemia
Allergies:
Diagnostic Lab Data: Cerebrospinal fluid-8/3/01-transparent and colorless; CSF-Cytosis-5 cells over 3 areas seen in the microscope norm-3/3; CSF-Glucose-73 md/DL; CSF-proteins-17 mg/DL; CSF-test for blood Bentidine; MRI-signs of Encephalitis; 7/26/01 MRI-probable ischemic demyelination; 7/29/01 CT scan-no addtl changes in comparison with MRI; 8/3/01 MRI-inflammatory changes in CNS and progression of edematic changes in parietal region on the right side, possibly due to viral infection; 8/6/01 stool occult blood test-99/132mm. F/U 8/3/01 MRI (encephalomalacia - softening of the tissue)
CDC Split Type: 20010191921

Write-up: On 6/16/01, a 2nd dose of Engerix-B was given. Post vax, pt developed a fever which lasted about 3 days. She also complained of "bad self-consciousness,"(F/U bad general feeling) diminution of strength and headaches. After 3 days, tremor of upper limbs occurred, especially of the right upper limb. Slowly, other signs of damage to the CNS began to appear: disturbances of deep sensitivity, disturbances of balance control, difficulty walking, decreased strength of muscles of lower limbs. On 7/20/01 she was hospitalized in a neurology ward because of tremor, balance problems, difficulty walking, decreased strength and problems with reading. During this hospitalization, moderate pyramidal paresis of the left side, dysgraphy, bilateral Babinksi reflex and all 4 limb ataxia were observed. Ischemic damage of the CNS was suspected. Moderate left hemiparesis and signs of disseminated damage of the nervous system were diagnosed. She was treated with Mannitol, Nootropil, Aspirin-Polopiryn. On 8/3/01, pt''s state worsened and she was admitted to ICU with dysfunction of eye muscles and quadriparesis. A diagnosis of encephalitis was made. On 8/5/01, she was started on Zovirax, Sandoglobin P and Tarfiakson. As of 8/10/01 the events were ongoing. The reporting MD considered the events to be life-threatening and disabling/incapacitating and the encephalitis to be possibly related to the vaccine. F/U rec''d 8/27/01 mentioned that the pt, on her own request, was transferred to the internal disease dept of another hosp. Her status had not changed. In a follow-up received on 11/12/2001, it was mentioned that the subject had died (no date provided). The cause of the death was leucoencephalitis. this diagnosis was based on the laboratory findings and not on the autopsy. This diagnosis was also given by the consulted physician. The reporting physician considered the leucoencephalitis to be possibly related to Engerix-B.


VAERS ID: 175175 (history)  
Form: Version 1.0  
Age: 0.8  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2001-09-04
Entered: 2001-09-07
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNU-IMUNE) / PFIZER/WYETH - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: HQ5498104SEP2001

Write-up: A 10 month old patient received a 23-valent pneumococcal polysaccharide vaccine by mistake instead of pneumococcal conjugate vaccine. Medical history and concomitant therapy were not provided. The pt died 2 days following vaccination. Sudden Infant Death Syndrome was noted. The reporting agency did not suspect the pneumococcal vaccination to have contributed to the pt''s death. No further information was available at the date of this report.


VAERS ID: 175391 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2001-04-17
Onset:2001-04-18
   Days after vaccination:1
Submitted: 2001-09-11
   Days after onset:146
Entered: 2001-09-17
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (ACEL-IMUNE) / PFIZER/WYETH - / UNK - / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH - / UNK - / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: HQ5710509SEP2001

Write-up: One day post vax, the child was found dead. An autopsy was performed; however, the results were not reported. The reporter described the event as Sudden Infant Death Syndrome.


VAERS ID: 175392 (history)  
Form: Version 1.0  
Age: 0.8  
Sex: Male  
Location: Foreign  
Vaccinated:2001-08-28
Onset:2001-08-31
   Days after vaccination:3
Submitted: 2001-09-10
   Days after onset:10
Entered: 2001-09-17
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK - / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0701K / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pneumonia, Sudden infant death syndrome
SMQs:, Eosinophilic pneumonia (broad), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2001-08-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Anemia; prophylaxis; scabies
Allergies:
Diagnostic Lab Data: UNK F/U autopsy - suggestive of pneumonia
CDC Split Type: WAES01093407

Write-up: One day post vax, the pt died. The cause of death is unknown. No cause was apparent. Unknown cause of death was considered to be immediately life-threatening. Additional information has been requested. F/U states: Information has been received from a health professional concerning a 10 month old pt who was vaccinated with pneumococcal polysaccharide vaccine 23 polyvalent. The polysaccharide vaccine had been given in error, in mistake for conjugate pneumococcal vaccine (nod). Subsequently, the pt died on 8/30/01, the day after administration of pneumococcal vaccine 23 polyvalent (also reported in follow-up correspondence on 9/5/01 as the pt being vaccinated 2 days prior to death). The cause of death was SIDS. No other cause of death was apparent. The reporter did not suspect that pneumococcal vaccination had contributed to the pt''s death. SIDS was considered to be immediately life threating. Additional information has been requested. F/U on 9/17/01 info was rec''d conflicting follow up info from the orginal reporter, a hlth professional from the CDC. It was reported that the infant had been vaccinated with polysaccharide vaccine 23 polyvalent on approx 8/28/01 because of high risk for pneumococcal disease. On 8/31/01 at 6:00am the infant was found expired in bed, face down, cold and blue with blankets over him. The post-mortem was suggestive of pneumonia. No further details are available, eg. coroner''s report.


VAERS ID: 175558 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2001-09-10
Onset:2001-09-11
   Days after vaccination:1
Submitted: 2001-09-18
   Days after onset:7
Entered: 2001-09-21
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIHI: DT+IPV+HIB+HEPB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-09-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
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:
CDC Split Type: 20010219831

Write-up: This report describes the occurrence of death of unknown cause in a 3 month old boy receiving Engerix-B on 9/10/01. On 9/11/01, 1 day, post vax, this boy died. Previous to his death, he did not show any signs/symptoms referring to an adverse event. The reporting physician did not assess a causal relationship. An autopsy has been required. Additional information has been requested. F/U rec''d 9/25/01, it was mentioned that the autospy report would be available after 90 days. Additional info has been requested.


VAERS ID: 175992 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2001-10-01
Entered: 2001-10-03
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Convulsion, Nervous system disorder, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Premature baby; epilepsy.
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: HQ6418326SEP2001

Write-up: A physician reported that an unidentified patient received a 2nd dose of Prevnar vaccine. The patient has a past history of preterm birth, "polypathia", and frequent epileptic seizures caused by brain damage. Four days post immunization, the child developed fever and "severe" seizures. The child died. Follow up info received 09/25/01. In opinion the treating physician a causal connection between the adverse event and Prevnar is "relative improbable".


VAERS ID: 176106 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:1999-01-01
Onset:1999-01-01
   Days after vaccination:0
Submitted: 2001-10-02
   Days after onset:1004
Entered: 2001-10-08
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / IM
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Cardiovascular disorder, Fatigue, Immune system disorder, Injection site erythema, Injection site oedema, Injection site pain, Nausea, Pyrexia, Renal failure acute, Respiratory tract infection, Sepsis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES01100101

Write-up: Information has been received from a published article July 19, 2001, concerning a female patient who was vaccinated with one dose of pneumococcal vaccine 23 polyvalent through a prospective observation study that was conducted from June to November 1999. Subsequently the patient developed a staphylococcal septicemia from which she died. It was noted that "the attending physician did not designate this case as one related to the vaccination". It was also noted that the patient could have developed fever, nausea, chills, fatigue and or local reactions of swelling, erythema and/or pain. Documentation lists the median duration of the local reactions as three days with the range being 1 to 8 days. Concomitant therapy included one dose of another immunization possibly influenza virus vaccine (manufacturer unk). It was noted within two weeks before or after the pneumococcal vaccine 23 polyvalent, 1026 patients (24 %) received another immunization, in 93.7 % the immunization was against influenza and in 6.5 % there were no indications given. In the 24 % of the patients who received a 2nd immunization at that time as the pneumococcal vaccine 23 polyvalent, 1.0 % developed local reactions. The pneumococcal vaccine 23 polyvalent was administered as the initial vaccination in 4253 patients and a a booster in 18. In 3392 patients, the vaccine was administered IM and in 733 cases it was given SC. It was noted that this information was obtained from a prospective observational study done in 1999 involving 4347 vaccinations. It was noted that 83.5 % of the patients were older than 60 years old. Risk factors for some patients included chronic respiratory tract disease, cardiovascular disease, metabolic disease, tumor disease, immunodeficiency / low resistance, HIV/AIDS and or obesity. It was also noted that in 95.9 % of the 4271 evaluable patients, local and in 97.3 % systemic tolerability was assessed to be very good / good. Only the 1.4 % or 60 patients experienced local and/or systemic adverse events. Sixteen of the sixty patients received a 2nd vaccination within 14 days. A total of sixty patients developed events that were reported as adverse drug reaction : 11 patients developed an event not documented on a form; 31 patients developed local reactions reported as erythema, swelling and/or pain; 4 patients developed systemic reactions reported as fever, nausea, chills, and or fatigue. Included in these sixty patients was a patient who developed acute renal failure and this patient who developed staphylococcal septicemia. No further info available. This is an amended report. From F/U, the journal title, MMW Fortschritte Der Medizin, was added. WAES01100097, 01100098, 01100099 and 0110100 did not meet the criteria for submission. It was reported on 7/19/01 that a female pt who was vaccinated with 1 dose of penumococcal vaccine 23 polyvalent 0.5ml and subsequently, developed a staphylococcal septicemia from which she died. It was noted that "the attending physician did no designate this case as one related to the vaccination". Concomitant therapy included 1 dose of another IZ possibly influenza virus vaccine.


VAERS ID: 176214 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2001-09-22
Onset:2001-09-25
   Days after vaccination:3
Submitted: 2001-10-02
   Days after onset:7
Entered: 2001-10-11
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES 11742 / 1 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-09-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
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:
CDC Split Type: U2001010330

Write-up: It was reported that a 4 month old boy received the haemophilus vax on 9/22/01 and he died on 9/25/01 at 4:00am. No other vax was given. Further information is awaited. F/U states: This 4 month old boy received his 1st injection of Hib on 9/22/01. From follow-up information received on 11/16/01, it was reported that the autopsy and investigations done by the police concluded to a sudden infant death syndrome, not related with the vaccine.


VAERS ID: 176570 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Male  
Location: Foreign  
Vaccinated:2001-09-25
Onset:2001-09-26
   Days after vaccination:1
Submitted: 2001-10-16
   Days after onset:20
Entered: 2001-10-23
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER T07819 / UNK LL / IM
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES R0459 / UNK RL / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER T07819 / UNK LL / IM

Administered by: Other       Purchased by: Other
Symptoms: Multiple congenital abnormalities, Oral intake reduced, Restlessness, Sudden infant death syndrome
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Congenital, familial and genetic disorders (narrow), Akathisia (broad), Noninfectious encephalopathy/delirium (broad), Neonatal disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-09-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Born week 36/37 after 7 pregnancies (3 children). Was treated in perinatal center for "conjugational jaundice", encephalopathia I-II after hypoxia, "intranatal" asphyxia.
Allergies:
Diagnostic Lab Data:
CDC Split Type: U2001010580

Write-up: It was reported that a 7 month old baby boy was vaccinated with Tetracoq (P2) and Act-Hib (P2) on 9/25/01. At 24:00, the mother discovered the baby to be restless; temperature was not measured, paracetamol suppository (Efferalgan) was administered (80mg). On 9/26/01, at 05:00, the baby was again restless, refused to take the breast feeding. He received the same treatment. At 10:00, the mother detected the death of the baby. The dx of autopsy was "sudden infant death syndrome". The autopsy showed that suprarenal glands were practically not developed (histology missing) the hypophysis was visually "strange". Fingers of one hand were missing. At the date of the report, results of histology are expected. F/U on 10/24/01: Pathology dx of the case was reported: "Main dx was: multiple congenital anomalies-hypoplasia of suprarenal glands, hyperplasia of thymus. Aplesia of the left hand. Side dx was: reaction after injection of diphtheria toxoid".


VAERS ID: 177571 (history)  
Form: Version 1.0  
Age: 1.08  
Sex: Female  
Location: Foreign  
Vaccinated:1992-05-20
Onset:1999-01-15
   Days after vaccination:2431
Submitted: 2001-11-06
   Days after onset:1026
Entered: 2001-11-12
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEA: MEASLES (ATTENUVAX) / MERCK & CO. INC. - / UNK - / SC

Administered by: Other       Purchased by: Other
Symptoms: Apraxia, CSF test abnormal, Disturbance in attention, Dysarthria, Dyskinesia, Electroencephalogram abnormal, Encephalitis, Hyperglobulinaemia, Hyperreflexia, Immunoglobulins increased, Personality change, Repetitive speech, Strabismus, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dyskinesia (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
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: UNK
Current Illness:
Preexisting Conditions: Failure to thrive; respiratory tract infection NOS
Allergies:
Diagnostic Lab Data: 10/99; Blood test-elevated (34,000 IU/ml or hyperglobulinorrachia) IgG antibodies to measles in serum: more than 325 IU/ml is positive; Clinical exam revealed increased osteo-tendinous reflexes in the right leg, dysarthria, perseveration, vismoconiructive apraxia and writing difficulties; Romberg''s test-pos: EEG-slow waves and diffuse delta-activity with periodic slow wave complexes time-locked to synchronous generalized myoclonic jerks on video: CSF-oligoclonal banks of immunoglobulins and elevated IgG antibodies to measles virus (14,000 mIU/ml, Bochringer Elisa processor) and in serum.
CDC Split Type: WAES01104436

Write-up: An 8 1/2 year old girl was admitted to out hospital with mild tremor of the right hand and mouth for 3 months and occasional drop attacks. At school, the teacher noticed an altered writing pattern, diminished concentration, declining results and changes in behaviour. We managed to observe the mild tremor described by the mother and we clearly saw myoclonic jerks of the mouth and neck together with eye deviation to the right. The girl was born in the Philippines. Her Belgian parents adopted her in 10/92 at an age of 1 year and 2 months. There is little known about her 1st period of life except that she was hospitalized shortly before the adoption for a severe lung infection and failure to thrive. She received the essential vaccinations including MMR on 5/20/92. Although vaccination against measles virus was administered at 9 months of age, which is common in endemic areas, the dx of SSPE (Subacute sclerosing panencephalitis) based on the clinical presentation and disease progression. The initial treatment with valproate acid showed no beneficial effect on the myoclonic jerks. Therapy therefore was changed to carbamazepine with temporary improvement. One month after the dx, Isoprinosine (2000 mg/day) was added. After a disease progression of 7 months, the girl died in a vegetative state. F/U 8/2/02 states: The reporters noted that SSPE in vaccinated individuals had been reported before and that these cases were probably attributed to vaccine failure, not to the attenuated vaccine virus. No further information is available.


VAERS ID: 177572 (history)  
Form: Version 1.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2000-02-11
Onset:0000-00-00
Submitted: 2001-11-08
Entered: 2001-11-12
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / IM
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Cough, Dyspnoea, Hypoxia, Interstitial lung disease, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Interstitial lung disease (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), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: prednisolone
Current Illness:
Preexisting Conditions: Pulmonary fibrosis
Allergies:
Diagnostic Lab Data: Oxygen saturation was 60% on exercise
CDC Split Type: HQ8100406NOV2001

Write-up: It was reported that a 60 year old male received Flu-Shield (2000-2001) vaccine on 2/11/00. Additional suspect medication included Pneumovax II vaccine (Morson and Sons) (pneumococcal vaccine) and prednisolone. Following immunization, the pt developed an "activation of lung fibrosis" with increasing shortness of breath on exertion and a progressive cough. He was treated with an increased dose of prednisolone (increased from 10mg daily to 30mg daily). The pt developed progressive cryptogenic pulmonary fibrosis and died of respiratory failure with hypoxia after 8 months. Upon safety review info received 11/28/2001, the reporting product was changed to Begrivac. Pt received Begrivac vaccine on 02/11/2000.


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