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VAERS ID: 177680 (history)  
Form: Version 1.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2001-10-10
Onset:2001-10-11
   Days after vaccination:1
Submitted: 2001-11-08
   Days after onset:28
Entered: 2001-11-14
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Back pain, Injection site pain, Myalgia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-10-11
   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: Deltacortril; Xanax; Lanoxin; Agelan (indapamide)
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PJP200100344

Write-up: A report was received on 10/31/01 concerning a 72 year old male pt who experienced back pain, injection site pain, myalgia and syncope, which were considered serious as the pt later died, 1 day after receiving the Fluvirin vaccine on 10/10/01. Relevant concomitant medications taken included prednisolone,alprazolam, digexin and indapamide homahydrate. On 10/11/01,the patient experienced back pain,injection site pain, myalgia, syncope, 1 day after receiving the fluvirin vaccine on 10/10/01. The patient subsequently died, date and cause of death have not been provided. The reporter has assessed the relationship of study medication to the event as possible. Further information received on 02/02/02 indicated the following: The patient had sognificant concomitant illnesses including possible vasculitis, anxiety, paroxysmal atrial fibrillation and high blood pressure. The patient initially experienced local pain in the deltoid area and than flu-like myalgia, followed by left lumbar pain, prostration, hospitalization and death.The cause of death is possible viral septicaemia but this has not been confirmed.The patient had been given intravenous antibiotics for his symptoms. No death certificate available.


VAERS ID: 177953 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2000-11-02
Onset:2001-07-01
   Days after vaccination:241
Submitted: 2001-11-14
   Days after onset:136
Entered: 2001-11-20
   Days after submission:6
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: Other       Purchased by: Other
Symptoms: Alveolitis fibrosing, Condition aggravated, Cough, Dyspnoea, Hypoxia, 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), 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: Cough, dyspnea, pulmonary fibrosis
Preexisting Conditions: Pulmonary fibrosis
Allergies:
Diagnostic Lab Data: Pulse Oximetry-60%
CDC Split Type: WAES01110870

Write-up: Information has been received from the Health Authority concerning an 80 year old male who on 11/2/00 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent and also an influenza virus vaccine. It was reported that, post vax, the pt presented with activation of lung fibrosis with increasing shortness of breath on exertion and progressive cough. Eight months later, in approx. 7/01, the pt died from progressive cryptogenic fibrosing alveolitis. It was reported that the pt required increased steroids (prednisolone increased from his usual 10mg daily to 30mg). Oxygen saturation was 60% on exercise. The pt died of respiratory failure with hypoxia. Cryptogenic pulmonary fibrosis had been stable for 3 years. No post mortem was performed. It was reported that the case was closed. No further info is available.


VAERS ID: 178150 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2001-10-15
Onset:2001-10-15
   Days after vaccination:0
Submitted: 2001-11-19
   Days after onset:35
Entered: 2001-11-26
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES 759803 / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Cardiac arrest, Coma, Convulsion, Electroencephalogram abnormal, Malaise
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-11-02
   Days after onset: 18
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: Mixtard; Levothyroxine Sodium; Lasilix Special (furosemide); Cibacene (benazepril hydrochloride); Zopiclone; Epoietine (erythropoietin); Speciafoloine (folic acid); Emla; Polaramine; Imodium; Eucalcic (calcium carbonate); Xayexalate (sodium
Current Illness:
Preexisting Conditions: Obesity; Renal failure; Essential Hypertension; Diabetes Mellitus; Congestive heart failure; Unspecified Hypothyroidism
Allergies:
Diagnostic Lab Data: EEG on 10/17/01 revealed post anoxic damage of the encephalon trunk which had expanded to the cortex on 10/19/01; CT scan on 10/24/01 revealed old lacuna and post anoxic oedema; Cardiac echography, cervical doppler and inferior limb doppler were nml.
CDC Split Type: PJP2001003930

Write-up: On 10/15/01, the pt received Fluvirin while glucose level was 0.90 g/l. A few hours later, she experienced malaise which was reported as moderate and persistent (no further details). On 10/16/01, the pt experienced sudden malaise followed by convulsions and a cardiac arrest. The pt was revived shortly after cardiac massage and dialysis was commenced in case of hyperkalemia (no prior checking of potassium and glucose levels was performed). The pt''s outcome was dx''d as coma with status convulsions. The pt died on 11/2/01 and the cause of death was reported as status convulsions. The reporter stated that potassium levels prior to dialysis were frequently high due to pt non-compliance. There was also an important sodium retention. There was insufficient information to determine the reporter''s assessment.


VAERS ID: 178594 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2001-11-12
Onset:2001-11-14
   Days after vaccination:2
Submitted: 2001-12-13
   Days after onset:29
Entered: 2001-12-05
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Laboratory test abnormal, Obstructive airways disorder, Pneumonia, Pyrexia, White blood cell count decreased
SMQs:, Angioedema (broad), Asthma/bronchospasm (broad), Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-11-16
   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: clarithromycin
Current Illness:
Preexisting Conditions: Chronic obstructive pulmonary disease and pneumoconiosis
Allergies:
Diagnostic Lab Data: Labs revealed WBC-3980/mcL and C-reactive protein-0mg/dL; chest x-ray-pneumonia
CDC Split Type: WAES01112581

Write-up: Information has been received from a physician concerning a male with chronic obstructive pulmonary disease and pneumoconiosis who on 12-NOV-2001 was vaccinated with pneumococcal vaccine 23 polyvalent. Concomitant therapy included clarithromycin. On 12-NOV-2001, laboratory findings revealed that WBC was 3980/mcL and a body temperature of 38.9 degrees C. The pt was hospitalized. On 16-NOV-2001, the pt died. The cause of death was pneumonia and chronic obstructive lung disease. The reporting physician felt that pneumonia was possibly related to vaccination with pneumococcal vaccine 23 polyvalent. No further information is available.


VAERS ID: 178961 (history)  
Form: Version 1.0  
Age: 1.3  
Sex: Male  
Location: Foreign  
Vaccinated:2001-10-15
Onset:2001-10-20
   Days after vaccination:5
Submitted: 2002-01-30
   Days after onset:102
Entered: 2001-12-13
   Days after submission:48
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 1 LA / SC

Administered by: Other       Purchased by: Other
Symptoms: Abnormal behaviour, Cyanosis, Eye disorder, Hypoxia, Laboratory test abnormal, Neurological symptom, Pyrexia, Respiratory distress, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-10-27
   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: UNK
Current Illness:
Preexisting Conditions: Varicella
Allergies:
Diagnostic Lab Data: Radiology-revealed b/l fleecy pneumopathy; ophthalmologica exam-did not follow light (papilla with pale coloration); arterial blood gas measurement-hypoxamia reacting to oxygen w/0 hypercapnia; total heartbeat count-tachycardia; CSF glucose-glycorrachia; cerebrospinal fluid total protein test-proteinorrhachia; cerebrospinal fluid culture-sterile
CDC Split Type: WAES01113361

Write-up: Information has been received from a health professional concerning a 16 month old male who in 11/01 was vaccinated in the left arm with a 1st dose of MMRII. Five days, post vax, the child experienced a fever and breathing disorder. Then, within the following night, his respiratory disorder was aggravated and in the morning he presented with cyanosis, respiratory distress and neurological trouble (shifty eyes). He was hospitalized, received oxygen and was ventilated. A few days later, he died. The dx was acute respiratory distress syndrome probably of viral origin. The exact cause of death was not specified. It was noted that he had received previous immunizations without any problem. No autopsy was performed. No further information is available. Follow-up info from the hospital medical record indicated that the boy was the third child of a three children family in good general state of health and was born at 36.5 weeks of amenorrhea. He experienced varicella in July 2001. He received his MMR on 10/15/2001. The infant did not present with any pathology and had an excellent psychomotor development. The first symptoms appeared on 10/20/2001 with febrile syndrome and respiratory troubles associated with a laryngitis treated with homeopathy. On 10/21/2001, two episodes of post food vomiting occurred and the child was cyanotic and dyspneic when he woke up. The prarents described their child as absent and with an altered behavior. There was no notion of head injury or drug poisoning. He received prednisone and epinephrine and was transferred to an intensive care unit. Upon admission, hemodynamic was correct, saturometry (83%) at ambient temperature. He received oxygen by nasal route and saturation reached 92-93%, fever was at 40 deg. C, tachycardia at 180/min. There was also dyspnea., absence of ocular following intermittent strabismus, obnibulation and peripheral hypertonia. The ENT examination was normal. Thorax radiography revealed a bilateral fleecy pneumopathy. Arterial garometry showed hypoxemia reacting to oxygen without any hypercapnia. The first diagnosis was the following: infectious pneumopathy associated with an infectious or hypoxic encephalopathy. During hospitalization, pulmonary lesions aggravated with stubborn hypoxemia and signs of typical and severe acute respiratory distress syndrome which necessitated intubation, ventilation controlled with enalgesic sedation and curarisation. Pneumothorax right then left were drained by pleurocath. A diffuse, generalized ventilated received antibiotics and received dobutamine after placement of a central venous route and azots monoxide. The child was transferred to another intensive care unit on the fifth day of care for severe SDRA (azote monoxide dependent) and a therapy with oscillator and respiratory assistance were introduced. On 10/27/2001 the child died. In conclusion, the child experienced an acute respiratory distress syndrome, probably secondary to an infectious pulmonary pathology, from probable viral origin. It was not possible to distinguish a hypoxic encephalopathy secondary to the SDRA and a viral infectious encephalitis. Serum and CSF were still available. No further info is available.


VAERS ID: 179129 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2001-10-19
Onset:2001-10-24
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2001-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 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? 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: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES01120584

Write-up: Information has been rec''d from a physician concerning a 79 year old male who on 10/15/01 was vaccinated IM with a dose of pneumococcal vaccine 23 polyvalent (batch #061011). On 10/24/01, the pt developed pneumonia and was hospitalized. In 2001 (exact date unknown), the pt died. The cause of death was pneumonia. Pneumonia was considered to be immediately life threatening. No further information is available. Other business partner''s numbers include MA200010835.


VAERS ID: 179338 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Unknown  
Location: Foreign  
Vaccinated:2000-09-26
Onset:2000-12-19
   Days after vaccination:84
Submitted: 2001-12-26
   Days after onset:372
Entered: 2001-12-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1039K / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Bacterial infection, Cough, Infection
SMQs:, Anaphylactic reaction (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-12-21
   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: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Autopsy-haemophilus influenza bacteremia in pus from lungs.
CDC Split Type: WAES01128754

Write-up: Information has been received from a physician concerning a 5 month old pt who on 26-SEP-2000 was vaccinated with Comvax. The pt received the second vaccination on 01-NOV-2001. On 19-DEC-2000 the pt developed a cough. On the morning of 21-DEC-2000 the pt was found dead in their cot. Initial diagnosis was meningococcal disease, which on post mortem was found to be haemophilus influenza bacteremia in pus from the lungs. Additional information has been requested. The onset date was changed from 12/21/2000 to 12/19/2000, the age was changed from 5 months to 20 weeks and the lot number was added to the suspect therapy section. Additional info has been requested.


VAERS ID: 179776 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2001-10-15
Onset:2001-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2002-01-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 75980J / UNK - / SC

Administered by: Other       Purchased by: Other
Symptoms: Blood potassium increased, Brain oedema, Cardiac arrest, Coma, Electroencephalogram abnormal, Hypoglycaemia, Malaise, Sodium retention, Status epilepticus
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Hypoglycaemia (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-11-02
   Days after onset: 18
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: Mixtard; levothyroxin sodium; Lasilix Special; Cibacene; zopiclone; erythopoeitin; furosemide; Speciafoldine; Emla; Dolamamine; Imodium; Eucalcic; Kayexalate Nifluril; Piascledine; Atarax; Voltaren
Current Illness:
Preexisting Conditions: Diabetes Mellitus; obesity; dialysis for renal failure due to diabetes; hypertension; congestive heart failure; hypothyroidism
Allergies:
Diagnostic Lab Data: EEG-post anoxic damage of the encephalon trunk which had expanded to the cortex on 10/19/01; CT scan-old lacuna and post anoxic oedema; cardiac echography, cervical doppler and inferior limp doppler-nml
CDC Split Type: PJP200100393

Write-up: A report was received on 11/13/01 regarding a 68 year old female pt who experienced malaise, coma, convulsions and a cardiac arrest on 10/16/01 and who later died from status convulsions on 11/2/01 after receiving Fluvirin vaccine on 10/15/01. The pt had previously received influenza vaccine with no side effects. She had no history of convulsions. On 10/15/01, the pt received Fluvirin while glucose level was 0.90g/l. A few hours later, she experienced sudden malaise followed by convulsions and a cardiac arrest. The pt was revived shortly after cardiac massage and dialysis was commenced in case of hyperkalemia (no prior checking of potassium and glucose levels was performed). The pt''s outcome was dx''d as coma with status convulsions. The pt died on 11/2/01 and the cause of death was reported as status convulsions. The reporter stated that potassium levels prior to dialysis were frequently high due to pt non-compliance. There was also an important sodium retention. There was insufficient information to determine the reporter''s causality assessment. Further information was received on 12/28/01; According to the reporter, the risk factors and the onset period of the convulsions (which was a slightly too long) after the vaccination, makes it difficult for a causal relationship between the flu vaccination and the convulsions followed by a cardiac arrest to be established. On the other hand, aporex (Di-Antalvic) may have been at the origin of the convulsions through hypoglycemia.


VAERS ID: 180072 (history)  
Form: Version 1.0  
Age: 0.16  
Sex: Male  
Location: Foreign  
Vaccinated:2001-11-29
Onset:2001-12-03
   Days after vaccination:4
Submitted: 2002-01-15
   Days after onset:43
Entered: 2002-01-17
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / IM
PNC: PNEUMO (PREVNAR) / 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: 2001-12-03
   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: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: HQ9897514JAN2002

Write-up: Information has been received concerning a 2 month old male who received Prevnar and Infanrix Hexa (GSK) vaccines on 11/29/01. The infant died 4 days later, on 12/3/01. A dx of sudden infant death syndrome was made. No further information was available at the date of this report. This report was received from Wyeth, Germany (Ref No.24- 2002). This report of a serious, labeled event is being submitted in a 15 day time frame as requested by the FDA.


VAERS ID: 180555 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Female  
Location: Foreign  
Vaccinated:1992-09-24
Onset:0000-00-00
Submitted: 2001-12-04
Entered: 2002-01-28
   Days after submission:55
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Encephalopathy
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? 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: 20010011681

Write-up: On an unspecified date in 1992, the child received a dose of Engerix-B: some time later, she started to suffer from unspecified symptoms and during 1994, she died with a dx of encephalopathy of unknown origin, which was confirmed by autopsy and a copy of the autopsy report is not available. The father reports that the event had been reported to local Regulatory Authority at the time of onset and that causality assessment was not specified.


VAERS ID: 180557 (history)  
Form: Version 1.0  
Age: 1.25  
Sex: Male  
Location: Foreign  
Vaccinated:2001-03-06
Onset:0000-00-00
Submitted: 2001-12-04
Entered: 2002-01-28
   Days after submission:55
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 308B0 / 1 - / IM
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Hyperthermia, Otitis media
SMQs:, Accidents and injuries (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-03-09
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: On an unknown date, an autopsy was performed of which the report is not yet available.
CDC Split Type: 20010120602

Write-up: On 3/6/01, the vaccinee received the 1st Engerix-B pediatric together with the 1st Priorix (measles, mumps, rubella vaccine). On a date unknown, the vaccinee developed otitis media with hyperthermia. Three days, post vax, on 3/9/01, the child was found dead in bed. The reporting physician suspected a post vax reaction. In the information received on 5/17/01, the reporter considered that the event was possibly related to treatment with Priorix. The causality of Engerix-B pediatric was not specified. A 15-day follow up report received 4/19/2002 adds: One day before vaccination, on 03/05/2001 an ear, nose and throat specialist found fluid in the middle ears. An autopsy was performed and showed that the cause of death was probable prurulent otitis media on both ears with hyperthermia. The pt was obviously vaccinated in a current infection. In the info received on 05/17/2001 the reporter considered that the event was possibly related to treatment with Priorix. The causality of Engerix-B pediatric was not specified. Follow-up info, taken from a publication of PEI (Auswartung der Meldungen von Verdachtsfoellen and Imptkomplikationen nach dem Infektionsachutzgesetz. April 2002) contained the info about fluid __ and the autopsy results. The PEI assessed the event as "unlikely" related.


VAERS ID: 180777 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:1999-09-21
Onset:1999-09-22
   Days after vaccination:1
Submitted: 2001-01-16
   Days after onset:482
Entered: 2002-02-01
   Days after submission:381
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIHI: DT+IPV+HIB+HEPB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 GM / IM
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM - / 1 GM / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Gastrooesophageal reflux disease, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific dysfunction (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1999-09-22
   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: Autopsy-pending
CDC Split Type: 19990251541

Write-up: On 21-SEP-1999, at 10:00 AM, the pt received in one buttock her first Engerix-B injection for hepatitis B prophylaxis and in her other buttock poliomyelitis prophylaxis. At this occasion, a mild esophageal reflux was noticed by the physician. On 22-SEP-1999, in the morning, fever and droopy appearance (asthenia). An autopsy is scheduled. The reporter''s causality assessment is not specified.


VAERS ID: 180943 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Female  
Location: Foreign  
Vaccinated:2001-07-26
Onset:2001-07-26
   Days after vaccination:0
Submitted: 2002-01-30
   Days after onset:188
Entered: 2002-02-06
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (TRITANRIX) / GLAXOSMITHKLINE BIOLOGICALS 15856A3 / 3 - / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER 5809 / 3 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anaphylactic shock, Apnoea, Crying, Cyanosis, Hepatitis, Hypotonia, Nervous system disorder, Pulmonary congestion, Pulmonary haemorrhage, Pulmonary oedema, Renal disorder
SMQs:, Cardiac failure (narrow), Hepatitis, non-infectious (narrow), Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Autopsy-anaphylactic shock; pulmonary edema; congested brain; kidney-congested at the cortico-medullary junction; larynx/trachea-congested; Lungs-(pleural) congested with petechial hemorrhages, alveolar hemorrhage and edema
CDC Split Type: 20010197011

Write-up: Less than 1 hours, post vax, the girl died. Post mortem result showed that the baby died of anaphylactic shock, an acute allergy to drugs. The father challenged the authenticity of the post mortem results, arguing that his daughter died as a result of negligence by nurses at the hospital. He claimed a wrong drug was administered to his daughter. Police seized some vaccine from the clinic as part of their investigations. It is also mentioned in the article, that a single DPT vaccine container serves 10 babies, suggesting that 9 other children of the same age should have been vaccinated that day. A medical doctor, who requested anonymity for professional reasons, made the following comments: "the girl could have reacted to the drug if it was her 1st vaccination. Other children who shared the same DTP container could be at risk. The vaccine could be "hypersensitive" to some people although such cases were rare. I have only read about this in books, but have never come across such a case in my 18 years as a medical doctor. A vaccine allergy usually manifested itself through swollen body tissues and rash. The victim would die as a result of blocked airways in blood vessels." The mother of the girl said that she was devastated by the death of her daughter and made the following comment: "Before this, the nurse was just reckless when she administered the drug on my daughter. I did not like the way she handled the injection." A city medical practitioner who also requested anonymity said, "there was a need for authorities to trace the other 9 children who were vaccinated. There are 2 instances here. Either the baby died as a result of a reaction caused by an allergy or there was something wrong with the drug itself". This was a 5 month old baby who received her 3rd dose of DTP, HB + OPV on 7/26/01 (batch 15856A3 and 5809. The child had been a healthy child and had not had any major problems with previous immunization except crying episodes which usually resolved within a few hours. The child was vaccinated on 7/26/01 at about 09:00, having been seen 1st by a qualified nurse at the clinic and found to be healthy. The vaccines were administered by final year nursing student on attachment at the clinic. The child cried after the vaccination and was consoled and breastfed by the mother in the clinic. When the baby had calmed down, the mother put the baby on her back and walked home. On arrival home, about 45 minutes later, she took the baby off her back and found the baby to be blue, limp and no longer breathing. The baby was already dead and had no chance of getting medical attention. The baby had not vomited and the mother had not noticed any cough or difficulty in breathing on the way. The police were informed, who took the baby to the hospital and also informed the clinic staff and took from them the remaining vaccine in use for further tests. The vaccine was not put in a cooler box. The baby had a post-mortem exam and it showed a well nourished child with no evidence of chronic illness and no rash or edema. The brain and lungs were congested on gross inspection and the histological exam showed cerebral congestion, mild chronic persistent hepatitis, congestion of corhea-medullary junction in the kidney and the lungs had alveolar hemorrhage and edema. All the other organs were normal. These findings are in keeping with acute shock lung syndrome most likely due to reaction to the vaccine or some of it''s components. Unfortunately, due to the transport condition of the vaccine by the police, further investigation of the vaccine itself is not possible. The conclusion was the child who had enjoyed good health to date, most likely died from an unavoidable idiosyncratic reaction to one of the components of DTP-HIB + OPV vaccines.


VAERS ID: 181097 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2002-01-09
Onset:2002-01-28
   Days after vaccination:19
Submitted: 2002-05-23
   Days after onset:114
Entered: 2002-02-08
   Days after submission:103
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Infection, Meningitis, Purpura fulminans
SMQs:, Haemorrhage terms (excl laboratory terms) (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: CSF-"infection with meningococcus B"; blooc culture positive-infection with meningoccus B
CDC Split Type: 0493105

Write-up: A physician reported that a 3 month old male received a 1st dose of Prevnar and Pentavac (Pasteur Merieux; diphtheria, tetanus, pertussis, poliomyelitis and haemophilus influenza vaccine). Fifteen days, post vax, the infant developed meningitis complicated by purpura fulminans. The pt was hospitalized and he died within a few hours after hospitalization. Based on the bacteriological result, the reporter ruled out a relation with Prevnar. No additional information was available as of the date of this report.


VAERS ID: 181399 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2001-10-31
Onset:2001-11-01
   Days after vaccination:1
Submitted: 2002-02-11
   Days after onset:102
Entered: 2002-02-14
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood alkaline phosphatase increased, Haematocrit decreased, Oral intake reduced, Pneumonia aspiration, Pyrexia, Red blood cell count decreased, White blood cell count decreased
SMQs:, Liver related investigations, signs and symptoms (broad), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Biliary system related investigations, signs and symptoms (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-12-27
   Days after onset: 56
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: Marzulene-S; Mg oxide; rebamipide
Current Illness:
Preexisting Conditions: Bone malignant neoplasm: femoral fracture; spinal compression fracture; cerebral infarction; senile dementia; constipation
Allergies:
Diagnostic Lab Data: Numerous blood tests; WBC-4000/mcl; Hematocrit-36.8% (low); Serum alkaline phosphatase test-176 IU/L (high); RBC-399 10000/mcL (low); CXR
CDC Split Type: WAES0112USA01212

Write-up: Information has been received from a physician concerning an 86 year old male inpatient who on 10/31/01 was vaccinated with pneumococcal vaccine 23 polyvalent. On 11/01/01, the pt developed a fever of 38.5C. The pt was treated with unspecified antipyretics and antibiotics and recovered. On 11/16/01, the pt developed a fever of 38.3C. Again, the pt was treated with unspecified antipyretics and antibiotics but did not recover. The pt had a fever from 38.0C to 39.0C "everyday". On 11/17/01 and on 11/21/01, CXR revealed no pneumonia. On 11/19/01, the pt experienced an "impaired" appetite. The pt was placed on a fluid infusion but the impaired appetite persisted and on 11/24/01, the pt was hospitalized. On 11/25/01, the pt recovered from the fever but the impaired appetite persisted. Fluid infusion was given. On 12/23/01, the pt developed a fever of 39.0C and unspecified lab findings revealed aspiration pneumonitis. Fluid infusion, antibiotics and oxygen therapy was given but the pt''s symptoms persisted. Subsequently, on 12/27/01, the pt died of aspiration pneumonitis. The physician felt that the causality between the impaired appetite and therapy with the pneumococcal vaccine 23 polyvalent was unclear. He felt that the fever was non-serious and was possibly related to the pneumococcal vaccine 23 polyvalent. Additional information has been requested.


VAERS ID: 181497 (history)  
Form: Version 1.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:1998-07-01
Onset:1999-12-01
   Days after vaccination:518
Submitted: 2002-03-11
   Days after onset:831
Entered: 2002-02-20
   Days after submission:19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Coagulopathy, Condition aggravated, Cyanosis, Hypoxia, Laboratory test abnormal, Leukocytosis, Pneumonia, Pyrexia, Renal failure, Sepsis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Haemorrhage laboratory terms (broad), 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), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (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? No
Previous Vaccinations:
Other Medications: Crimivan, lamivudine
Current Illness: HIV
Preexisting Conditions: splenectomy, HIV infection, Hodgkin''s lymphoma
Allergies:
Diagnostic Lab Data: Physical examination-very poor general state; blood culture-growth of strepococcus pneumoniae serogroup 18C
CDC Split Type: WAES0202USA00138

Write-up: It was reported that a 37 year old pt with human immunodeficiency virus infection and a history of splenectomy was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently, the pt experienced pneumococcal sepsis and was hospitalized. No further information is available. It was reported in a letter to the editor that a female splenectomized pt with HIV infection developed a fulminant sepsis due to Streptococcus pneumoniae, in spite of having bee vaccinated. This report concerns a s37 year old female pt with HIV infection since 1986, Hodgkin''s disease and a history of parenteral drug addiction who was vaccinated in July 1998 with a dose of Prevnar. Concomitant medication included indinavir sulfate, estavudine and lamivudine which were all started in 1996. It was reported that the pt was vaccinated after her splenectomy in July 1998. chemotherapy with instituted with prednisone, mitoxactrone and vinblastine; in the fourth treatment cycle the pt exhibited neutropenia with fever together with severe hepatic toxicity, which reuired suspension of the medicaiton. In February 1999, the disease was found to have progressed with retroperitoneal and para-aortic adenopathies and chemotherapy was initiated with ABVD, which was well tolerated and resulted in complete response. In December 1999, the pt presented for a consultation because of a syndrome of fever and chills that had been progressing for 12 hrs. She reported experiencing pain in the right hypochondrium, vomiting and soft stools with no pathological products. The last CD4 count was 469 and the HIV viral load <200 couples. Physical examination: very poor general state, conscious. The pt''s blood pressure 80/50 mmHg, temp 39 deg C, heart rate 140 bpm, RR 32, and oliguria-anuria. distal cyanosis and peripheral hypoperfusion were noted. Cardiopulmonary suscuitation was normal and her abdomen was soft and depressible with diffuse pain. o peritonism, no nuchal rigidity and no meningeal signs were noted. In the view of the septic shock condition, the pt was admitted to the intensive care unit, where blood and urine culturew were done and the pt was treated empirically with cefotaxime, artreonsm, and fluconerole. Intensive hemodynamic support and correction of the scidosis was specified, but the response was poor. 24hrs after her admission, the pt developed hypoxemia, refractory to oxygen therapy, and bilateral alveolar infiltration compatible with an acute respiratory distress syndrome that required intubation and mechanical ventilation. The pt''s clinical condition deteriorated and she developed extensive leukocytosis with neutrophilia, prerenal and renal failure, and diffuse intravascular coagulation. The pt died 36 hrs after her admission. Subsequently, the blood cultures showed growth of Streptococcus pneumoniae, serogroup 18C. No autopsy was performed. In this case, the authors reported that the vaccination failure was due to the immunodepression caused by the HIV and the fact that the vaccine was administered after the splenectomy, both of which were considered to be responsible for the worse response. The pt''s worsening Hodgkin''s disease was considered to be incidental findings. No further info is available.


VAERS ID: 181614 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2002-02-20
Entered: 2002-02-22
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 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:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: HQ0722915FEB2002

Write-up: A physician reported that an unidentified child received PREVNAR and 14 days, post vax, the pt developed SIDS. No additional information was available as of the date of this report. Additional information received on 2/20/02 from reporting physician. Physician stated "he did not see a relationship to vaccination due to time interval". Further details will be provided by the physician at a later date.


VAERS ID: 181766 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2002-01-02
Onset:2002-01-11
   Days after vaccination:9
Submitted: 2002-02-21
   Days after onset:41
Entered: 2002-02-27
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER 0051 / UNK - / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK - / SC
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / SC

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: 2002-01-11
   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: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: U200200132

Write-up: It was reported that a 4 month old baby boy was concomitantly vaccinated with a primary dose of Haemophilus Influenza type b vaccine and diphtheria-tetanus-acellular Pertussis-inactivated Poliomyelitis vaccine (SSI mfr) on 1/2/02. In the morning of 1/11/02, the baby was found dead. An autopsy was not performed. The county doctor stated that the cause probably was SIDS. No further information is available. The case is closed.


VAERS ID: 181776 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Foreign  
Vaccinated:1995-01-19
Onset:1995-01-21
   Days after vaccination:2
Submitted: 2002-02-22
   Days after onset:2589
Entered: 2002-02-27
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chromosome abnormality
SMQs:, Congenital, familial and genetic disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1995-01-21
   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: Bactrim; Ergenyl; valproic acid
Current Illness:
Preexisting Conditions: Chromosomal abnormality; Seizure disorder
Allergies:
Diagnostic Lab Data: Autopsy-death related to Wolf-Hirschhorn Syndrome (chromosome disorder)
CDC Split Type: WAES0202USA01840

Write-up: Information has been received from a health authority concerning a 2 year old male with Wolf-Hirschhorn Syndrome, a disease with a defection in chromosome no. 4 and epilepsy who on 1/19/95 was vaccinated SC with MMRII. Two days later on 1/21/95, the boy was found dead in his bed. It was reported that 35% of children with Wolf-Hirschhorn Syndrome will die before the age of 2 years. There was no indication per autopsy, of any other explanation for his death. The reporter felt that it was unlikely that the sudden death related to Wolf-Hirschhorn Syndrome was related to therapy with MMRII. No further information is available.


VAERS ID: 181875 (history)  
Form: Version 1.0  
Age: 1.5  
Sex: Female  
Location: Foreign  
Vaccinated:2002-01-22
Onset:2002-01-28
   Days after vaccination:6
Submitted: 2002-12-12
   Days after onset:318
Entered: 2002-03-04
   Days after submission:283
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1321K / UNK - / SC

Administered by: Other       Purchased by: Other
Symptoms: Nasopharyngitis, Pharyngitis, Pyrexia, Rhinitis, Sudden infant death syndrome
SMQs:, Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-01-29
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~Measles + Mumps + Rubella (MMR II)~~1.50~In Sibling
Other Medications: UNK
Current Illness:
Preexisting Conditions: Twin birth; premature birth; protrusion tongue; respiratory tract infection NOS; starbismus
Allergies:
Diagnostic Lab Data: Diagnostic lab test-Rhinovirus in nasopharynx, Haemophilus influenzae in nasopharynx; serum C-reactive protein-18; cerebrospinal fluid culture-normal; Body weight measurement, 7/25/00, 2350 grams, temp measurement, 1/28/02, 39 C; Blood culture, 1/29/02, normal.
CDC Split Type: WAES0202USA01616

Write-up: Information has been received from a consumer concerning his *18* month old twin daughter who on 1/22/02 was vaccinated with 1 dose of MMRII. After vaccination, the pt developed a common cold with fever. *It was reported that in the afternoon of 1/28/02, the PT had a fever of 39 C and was treated w/paracetamol, whereafter the fever decreased. Seven days, post vax, on 1/29/01, the pt died. The cause of death was unknown. Additional information has been requested. Follow-up info noted that Rhinovirus and Haemophilus influenzae were found in the pt''s nasopharynx, CRP 18, spinal fluid and blood culture normal. Both her adrenal glands were smaller than normal than expected for her age. The cause of death was assessed as SIDS. No further info is available. Follow up info received from a health authority indicated that the pt was not a monozygotic twin, that she had been born four weeks before term and weighed 2150 grams at birth. The pt was reportedly "somewhat behind her sister in motoric development during her first year." It was noted that eye contact could not be easily established by the doctor and strabismus was observed at 8 months of age. She also had a tendency to stick out her tongue. She was sick more often than her sister during her first year, with fever and respiratory tract infections. Following an examination on 12/12/00 it was extablished that her development was within normal limits. From one year of age the pt had no problems and was not seen by a doctor until the vaccination at 18 months of age. The pt had a good appetite and "normal growth," and when she was examined in connection with the vaccination visit she was found to be trustful with "normal development." It was noted that the pt''s twin sister was vaccinated on the same day, with the same batch, and had developed a "high fever" the day after the pt died. The pt''s mother was noted to be a non-smoker and does not drink alcohol. An autopsy report has been requested. *F/UP report on 12/19/02: F-UP info indicated that an autopsy has been done and the results showed no abnormalities. It was noted that the parents were against providing details of the autopsy.* No further info is available.


VAERS ID: 181997 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:1999-11-29
Onset:1999-11-29
   Days after vaccination:0
Submitted: 2000-12-11
   Days after onset:378
Entered: 2002-03-05
   Days after submission:449
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER 39975 / UNK - / IM
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM - / 1 - / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Coma, Encephalitis, Flatulence, Hypovolaemia, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: HC03-1.9mmhg; PH-6.82IU; PCO2-11.4mmhg; creatinine-.9mg/DL; oxygen saturation-92.1%; PO2-1294mmhg; Urea-44IU
CDC Split Type: 19990320821

Write-up: On 11/29/99, a 1st dose of Engerix-B and Polio Sabin (lot 164) were given. The same day, post vax, this 2 month old child developed flatulence, vomiting and high temperature. On 11/30/99, at 15:00, 28 hours post vax, this boy was hospitalized due to suspected encephalitis and coma. A final dx of hypovolemia in blood circulation and brain due to coma and unconsciousness was made. 30 children vaccinated with the same batch numbers at the same session and 89 children vaccinated in a nearby area with the same batch numbers were examined by an expert committee. All were found in good health. No illnesses were reported. Review of the data on these and previously reported fatal cases, of the rate of death and the rate of contagious diseases in the area and of the quality of the used vaccines, permitted the expert committee to conclude that there is no relation between the fatal cases and the vaccination. This was considered to be an "Other Important Medical Event". This child also received a dose of DTP vaccine (lot 39975 Serum Institute of India).


VAERS ID: 182011 (history)  
Form: Version 1.0  
Age: 1.5  
Sex: Female  
Location: Foreign  
Vaccinated:1993-08-18
Onset:1993-12-01
   Days after vaccination:105
Submitted: 2002-03-06
   Days after onset:3017
Entered: 2002-03-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / SC

Administered by: Other       Purchased by: Other
Symptoms: Bone marrow depression, Cerebral haemorrhage, Loss of consciousness, Platelet count decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Myelodysplastic syndrome (broad), 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: UNK
Allergies:
Diagnostic Lab Data: Diagnostic radiology-showed large intra-cerebral hemorrhage; Platelet count-low on 12/93-and extremely low on 1/94-(1); Bone marrow punction-showed a toxic influence on the bone marrow, especially on the myeloposesis and the thrombopoesis.
CDC Split Type: WAES0202USA02477

Write-up: Information has been received from a journalist concerning an 18 month old female who on 8/18/93 was vaccinated with MMRII. According to her parents, low platelet counts were measured in the beginning of 12/93. Her condition deteriorated and she was referred to the hospital in 1/94 for further investigation. This investigation gave the result that her low platelet values were probably due to an idiopathic reaction and she was discharged from the hospital. However, some time thereafter, she was re-admitted due to unconsciousness. Investigation at that time, showed a large intra-cerebral hemorrhage and she was referred to Neurosurgery for further treatment in the beginning of 2/94. It was reported that there were no signs that this reaction was ITP. However, the girl died shortly thereafter due to the large intra-cerebral hemorrhage. The case was evaluated by a physician with the dept of Pediatrics. His conclusion was that "among all the cases reported with this thrombocytopenia, this case was the only one with aplastic changes". The report was assessed as possibly related to vaccination with MMRII. No further information is available.


VAERS ID: 182012 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Female  
Location: Foreign  
Vaccinated:1983-08-31
Onset:1983-09-04
   Days after vaccination:4
Submitted: 2002-03-06
   Days after onset:6758
Entered: 2002-03-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1983-09-04
   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: WAES0202USA02476

Write-up: Information has been received from a journalist concerning a 1 year old female who on 8/31/83 was vaccinated with MMRII. On 9/4/83, the pt died. The dx was reported as sepsis. The pt''s death was not reported to be related to the vaccination with MMRII. No further information is available.


VAERS ID: 182013 (history)  
Form: Version 1.0  
Age: 1.5  
Sex: Male  
Location: Foreign  
Vaccinated:1989-10-01
Onset:1989-10-08
   Days after vaccination:7
Submitted: 2002-03-14
   Days after onset:4540
Entered: 2002-03-06
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / SC

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Injury, Laboratory test abnormal, Sepsis
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1989-10-13
   Days after onset: 5
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: Head computed axial tomography-general edema; blood culture-growth of staph aureaus in one of 4 samples; serum c-reactive protein-increase max 115 mg/L
CDC Split Type: WAES0202USA02475

Write-up: Information has been received regarding a report from a journalist concerning an 18 month old male who on 10/01/1989 was vaccinated with a dose of MMRII. Subsequently, the pt developed sepsis and on 10/13/89, the pt died. The reporter felt that sepsis was not related to therapy with MMRII. No further information is available. Follow-up info from the physician indicated that on 10/08/1989 the pt experienced a mild head trauma and he did not faint or seem affected. That night he experienced convulsions and was hospitalized at 3am on 10/11/1989 iwth a temp of 40 deg. C., had periphery blood circulation, superficial breathing, his heart rate was approx. 180/min and his BP could not be measured. Hypotoneness of his extremities was noted. HIs pupils showed no abnormalities and his "glucosis was 0.6." Intensive care treatment was reported, "liquor" showed no abnormalities. Growth of Staphylococcul aureus was noted in one of 4 samples. On 10/12/1989 the pt''s right pupil did not react to light and his left pupil was miotic. Emergency Ct scan of the brain showed general edema. he was transferred to another hospital facility for treatment. On the morning of 10/13/1989 the pt was brain dead and respirator treatment was stopped. The cause of death was unclear. metabolic diseases were excluded. "Antibody determination of liuor and serum for herpes, morbilli, petotitis, rubella negative." Virus isolation was negative. CRP increased to max 115mg/L and 1 positive blood test was noted. Otherwise, no basis of bacterial infection. ASA and paracetamol in serum were negative. The reported physicians "assess that it is possible that the child has some kind of sepsis that has lead to severe edema of the brain." No results were reported from the autopsy. The possibility of encephalitis caused by the vaccines will be examined. Further info received reported that the investigation pointed at sepsis.The forensic scientist assessed "that there is not causal relationshi to the vaccine." No further info is available.


VAERS ID: 182014 (history)  
Form: Version 1.0  
Age: 1.5  
Sex: Male  
Location: Foreign  
Vaccinated:1988-04-25
Onset:1988-04-29
   Days after vaccination:4
Submitted: 2002-03-12
   Days after onset:5065
Entered: 2002-03-06
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / SC

Administered by: Other       Purchased by: Other
Symptoms: Cough, Laboratory test abnormal, Lethargy, Pneumonia, Pyrexia, Rhinitis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1988-05-04
   Days after onset: 5
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: Microbiology test-growth of betaemolyzing streptocuccus group A in the lungs and resp. system
CDC Split Type: WAES0202USA02474

Write-up: Information has been received regarding a report from a journalist concerning an 18 month old male who on 4/25/88 was vaccinated with a dose of MMRII. Subsequently, the pt developed pneumonia and on 5/4/88, the pt died. The reporter felt that pneumonia was not related to therapy with MMRII. No further information is available. Follow-up info from a hospital physician indicated that on 04/29/1988 the pt developed fever which increased over the next couple of days to $g40 deg. c. On 05/03/1988 the pt experienced rhinitis and a slight cough and was lethargic. He was seen by a physician who reported that the pt ha dleft sided otitis. He was treated with cn, Nezeril drops and Alvedon. The possibility for a vaccine reaction was discussed, but the duration of fever was considered to have been more than expected. The following morning on 05/04/1988. The pt was found dead in his bed by his parents with much foaming, bloody liquid from his mouth. The autopsy showed inflammation of the lungs and respiratory system. A picture of interstitial pneumonia and peri-broncial inflammation which are seen in connection with inflammation caused by virus. Growth of betahemolyzing streptococcus group A could be measured in the lungs and respiratory system but was difficult to assess whether it contributed to his death. No trace of alcohol or pharmaceuticals was noted. The reporter felt that pneumonia was not related to therapy with MMR. No further info is available.


VAERS ID: 182015 (history)  
Form: Version 1.0  
Age: 1.5  
Sex: Female  
Location: Foreign  
Vaccinated:1985-11-13
Onset:1985-11-17
   Days after vaccination:4
Submitted: 2002-03-14
   Days after onset:5961
Entered: 2002-03-06
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / SC

Administered by: Other       Purchased by: Other
Symptoms: Laboratory test abnormal, Petechiae, Pyrexia, Rash, Sepsis, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1985-11-18
   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: UNK
Current Illness:
Preexisting Conditions: Otitis media, upper respiratory infection, urinary tract infection
Allergies:
Diagnostic Lab Data: CSP differential white cell count:white 14, poly 8, mono 6; cerebrospinal fluid culture:very little growth of menigococcals all sensible to every antibiotic; throat culture:nasopharyax much pneumococcals and klebaiella
CDC Split Type: WAES0202USA02473

Write-up: Information has been received regarding a report from a journalist concerning an 18 month old female (also reported as male) who on 11/13/85 was vaccinated with a dose of MMRII. Subsequently, the pt developed sepsis and on 11/18/85, the pt died. The reporter felt that the pt''s sepsis was not related to therapy with MMRII. No further information is available. Follow-up info from a hospital physician indicated that the pt developed fever and vomiting in the afternoon on 11/17/1985. On 11/18/1985, at about three o''xlock, a blue-reddish rash in groins was spreading to generalized. The pt was hosptialized at 4:45 with widespread petechiae and no stiffness of her nek. her LP included: 173 red; 14 white; poly 8, mono6, protein 0.10 and glucose 12. Her cultures included: nasopharynx with much pneumonia and klebsiella: urine -0 and blood-0. Liquor: showed very little growth of meningococcals all sensible to every antibiotic used. The pt received intensive treatment with hydrocortisone sodium succinate and Zinacef, but the pt died at 8:50 on 11/18/1985. Section showed petechiae, swelling of the brain and bilaterally necrosis of adrenal glands. Microscopy showed masive adrenal gland bleeding and surface of cerebrum shows edemic and dry bloody meninges but not meningitis. It was reported that the pt died due to other causes than pharmaceutical and the relationship was incidental. No further info is available.


VAERS ID: 183917 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Male  
Location: Foreign  
Vaccinated:2002-03-30
Onset:2002-03-30
   Days after vaccination:0
Submitted: 2002-04-24
   Days after onset:24
Entered: 2002-04-26
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (TRITANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Crying, Epistaxis, Haematemesis, Meconium increased, Peritonitis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal perforation (narrow), Gastrointestinal haemorrhage (narrow), Depression (excl suicide and self injury) (broad), Foetal disorders (narrow), Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-03-30
   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: Zinc salt
Current Illness: UNK
Preexisting Conditions: At birth, the child has a meconium peritonitis (no medication taken). On a date as yet unknown, untrasound was performed. In the first month, the baby gained weight. The child took Eevit (mino vitamin supplement drops)
Allergies:
Diagnostic Lab Data: On a date as yet unknown, TORCH screen (testing for presence of Toxoplasma, rubella, cytomegalovirus and herpes simplex) was performed but the results were not provided.
CDC Split Type: B0265151A

Write-up: On 3/30/02, at 10:00, a dose of Tritanrix-HB (IM) was given. On the same day, in the next 2 hours after vaccination, the boy developed excessive crying. At 11:50, he developed nose bleeding and bloody vomiting. He was rushed to the hospital where the pediatrician declared him dead. No autopsy was performed but a liver autopsy was done and the results are still awaited. The reporting physician considered meconium peritonitis and concomitant medication to be associated with the experience. *Follow-up report on 7/9/02: No further details will follow and this case has therefore been closed.


VAERS ID: 183989 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:1997-04-20
Onset:1997-05-03
   Days after vaccination:13
Submitted: 2002-05-24
   Days after onset:1847
Entered: 2002-04-30
   Days after submission:24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (IMOVAX) / PASTEUR MERIEUX INST. - / UNK LA / IM
TTOX: TETANUS TOXOID (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Agitation, Brain stem syndrome, Condition aggravated, Confusional state, Delirium, Headache, Hyperaesthesia, Nervous system disorder, Paralysis, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 1997-05-09
   Days after onset: 6
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: IMOgam USP (human immunoglobulin) on 4/22/97 per F/U 5/31/02
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Rabies virus was identified in corneal impression by a positive fluorescent antibody test. Per F/U 5/21/02-skin biopsy from the back of the neck
CDC Split Type: U200200317

Write-up: On 4/20/97, while sleeping in the dessert, a 17 year old woman was bitten on the upper lip by a fox. Her husband immediately, drove her to the district hospital, where 2 deep lacerations on her upper lip were cleaned and dressed, but not stitched. Two 1-ml doses of inactivated rabies HDCV (Imovax) were administered by IM injection into each deltoid, according to the Ministry of Health protocol. Anti-tetanus toxoid was given. At the time, HRIG was unavailable in the hospital, but the woman was ordered to go immediately to the regional hospital, a distance of several hours'' drive on a surfaced road, where HRIG was available. Unfortunately, she delayed attending the regional hospital until 4/22/97, when, according to official guidelines for pts presenting more than 48 hours after injury, she was given 800 international units of (29 IU/kg body weight) of HRIG (Imogam) IM into the gluteal region only (with no infiltration of the wound). Since Oman followed the 2-1-1 regimen (two 1.0ml doses of HDCV on day 0, and 1 dose on days 7 and 21, respectively) for vaccine administration, on 4/26/97, she was given the 3rd 1-ml dose of HDCV into the deltoid muscle. On 5/3/97, the pt developed fever, headache and vomiting and on 5/7/97, she presented to the district hospital with fever, delirium, hyperesthesia and serophobia. She was referred at once, to another hospital as a case of suspected rabies. She brought her 7 month old infant boy with her; she had continued to breast feed the child despite being bitten by the fox. On admission, the pt was febrile, agitated, confused and had hydrophobia. There were 2 healed lacerations on her upper lip. She had signs of brain stem dysfunction, including a right 6th cranial nerve palsy, but no signs of meningitis. The clinical dx of rabies was confirmed and she was transferred to the ICU, where she was sedated, from the back of the neck and corneal impressions and washings were obtained. A positive fluorescent antibody test for rabies virus was obtained only from the corneal washings. Serum was obtained for rabies antibody measurement, but unfortunately the specimen was not processed and was discarded. The infant received HRIG in admission and a full course of HDCV was administered. He remained well. Per F/U 5/21/02-She was transferred to ICU, where she was sedated, paralyzed and given assisted ventilation. The pt died on 5/9/97. F/U correction on 5/24/02, it was decided by corporate decision to remove the code of "viral infection" in the introduction of the infection occurred prior to the administration of products. From follow up information received at Aventis Pasteur received date 13 Mar 2003 it was reported: 13/02/02: Corrective report to update the manufacturer of the Pasteurized Rabies immuglobulin. Case is closed.


VAERS ID: 184002 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2002-05-23
Entered: 2002-04-30
   Days after submission:23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (IMOVAX) / PASTEUR MERIEUX INST. - / 2 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Superinfection
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Imogam (human antirabies immunoglobulin)
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Rabies virus was identified in corneal impression by a (+) fluorescent antibody test.
CDC Split Type: U200200316

Write-up: A 5 month old female child was severely bitten by a fox on the face and scalp, exposing the pericranium. No suturing was performed. She received 2 1-ml doses of inactivated rabies HDCV (Imovax Rabies) injected into the deltoid, 60 IU of HRIG infiltrated into the wounds and 60 IU injected into the gluteal region. She received the 2nd 1-ml dose of HDCV on day 7, but developed rabies on day 14 and died, 2 days later. Rabies virus was identified in corneal impression by a positive fluorescent antibody test. The child was breast-fed by her mother who had been biten by a wolf and waited 48 hours to go to the hospital and get shots. Follow-up correction on 5/24/02, it was decided by corporate decision to remove the code of "viral infection" as the introduction of the infection occurred prior to the vaccine and HRIG. Follow up from 5/10/02: as requested by the FDA this report is being submitted as a follow up with a copy of the literature article.


VAERS ID: 184146 (history)  
Form: Version 1.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2002-05-13
Entered: 2002-05-02
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (IMOVAX) / SANOFI PASTEUR - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Coma, Condition aggravated, Nerve injury, Viral infection
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), 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: Imogam USP (Human Rabies Immunoglobulin (300 IU/2ml) X 2
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Rabies virus was detected in corneal impressions, using the fluorescent antibody test. Serum obtained 2 days before decease, revealed rabies antibodies at a titer of 1:810 in the neutralizing cell-culture test.
CDC Split Type: U200200323

Write-up: The pt , a 45 year old woman, was severely bitten on the face (with severance of the left facial nerve), scalp, neck and arm by a wolf (Cania lupus Arabs). Within 5 hours, she received 2 1ml doses of inactivated rabies HDCV, IM, into each deltoid, 600IU (20IU/kg) of HRIG into the wounds and 600IU into the gluteal muscles. On day 7, she received 1ml HDCV by IM injection into the deltoid. Rabies developed on day 13 and she died in a coma on day 18. Rabies virus was detected in corneal impressions, using the fluorescent antibody test. Serum obtained, 2 days before decease, revealed rabies antibodies at a titer of 1:810 in the neutralizing cell-culture test. Three other pts bitten on the same day by the same wolf, including 2 who had multiple severe bites on the face and head, were similarly immunized and remained well. Follow-up correction on 5/24/02, it was decided by corporate decision to remove the code of "infection" as the introduction of the infection occurred prior to the administration of products. Follow up from 5/10/02: as requested by the FDA this report is being submitted as a follow up with a copy of the literature article.


VAERS ID: 184487 (history)  
Form: Version 1.0  
Age: 2.3  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2002-05-08
Entered: 2002-05-14
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Infection, Meningitis
SMQs:, Noninfectious meningitis (narrow), 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: No lab data was given.
CDC Split Type: U200200365

Write-up: It is said that this pt (called pt O in the article) died as a result of Hib Meningitis complications when she was 2 years and 4 months and this despite an administration of probably 4 Hib vaccines. The pt could have received the Hib vaccine mixed with a local produced DTP-IPV vaccine. It is also specified that the child''s height and weight were within the normal range (+/-2SD) for age according to the Dutch standard curves. No lab data was given. More information will be asked. File to be completed. These events were considered to be "Other Important Medical Events".


VAERS ID: 184745 (history)  
Form: Version 1.0  
Age: 0.7  
Sex: Female  
Location: Foreign  
Vaccinated:2000-09-19
Onset:2000-09-29
   Days after vaccination:10
Submitted: 2002-05-20
   Days after onset:598
Entered: 2002-05-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / SANOFI PASTEUR PIT00602 / 1 - / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR P1T00602 / 1 - / IM
MNC: MENINGOCOCCAL (MENINGITEC) / PFIZER/WYETH 156331A2 / UNK - / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Encephalopathy, Hyperglycaemia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? 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: Lab test abnormal NOS-biochemical test showed hyperglicinemia
CDC Split Type: HQ2317915MAY2002

Write-up: A regulatory authority reported that an 8 month old female received Hib-Titer mixed with Anatoxal Diteper (diphtheria and tetanus toxoids and pertussis), Polio Sabin Oral (poliovirus vaccine live oral) and Meningitec vaccine on 9/19/00. On 9/29/00 until 3/13/01, the child experienced encephalopathy that resulted in death. Necrosia and biochemical tests showed hyperglicinemia, so the authorities assessment was that there have been amino acid metabolism disorders. The death has not been related to any of the vaccines that the child received. Follow-up info received on 05/17/02. The reporting product is Meningitec. Correspondence and info concerning aMeningitec lot number was also received.


VAERS ID: 184904 (history)  
Form: Version 1.0  
Age: 2.08  
Sex: Male  
Location: Foreign  
Vaccinated:2001-05-16
Onset:2001-06-03
   Days after vaccination:18
Submitted: 2002-05-14
   Days after onset:345
Entered: 2002-05-21
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 1 - / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Aspiration, Blood calcium decreased, Blood chloride decreased, Blood creatine phosphokinase increased, Conjunctivitis, Cyanosis, Pyrexia, Sudden infant death syndrome, Upper respiratory tract infection
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Conjunctival disorders (narrow), Ocular infections (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-06-04
   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: NONE
Current Illness:
Preexisting Conditions: Febrile convulsion
Allergies:
Diagnostic Lab Data: CRP-less than 7; leucocytes-6.2; hemoglobin-13.5; thrombocytes-153; neutrophils-1.99; lymphocytes-3.42; monocytes-0.72; cephatest-70H; creatinine-95H; urea-4.6; sodium-139; chloride-84; calcium-1.83; glucose-14.1; plasma aspartate aminotransferase test 1612; plasma alanine aminotransferase test-1132; serum alkaline phosphatase test-375; serum lactate dehydrogenase test-6567; serum creatine kinase test-5424; total protein-62; albumin-39; urine clear; Autopsy-no certain cause of death
CDC Split Type: WAES0205USA00328

Write-up: Information has been received from a health authority concerning a 25 month old male with a history of 2 episodes of uncomplicated fever convulsions who on 5/16/01 was vaccinated with the 1st dose of MMRII (lot unknown). There was no concomitant medication. On 6/4/01, 19 days post vax, the pt was found lifeless in his bed at 11:55 AM on his back with blue lips and vomit in his pharynx. It was reported that he had conjunctivitis the day before, upper respiratory infection for 1 day and a fever of 38.6C, in the morning but seemed unaffected. He went to sleep about 09:30 AM and at 11:30 AM was observed to be sleeping on his stomach. No petechia or other rash was noted. The autopsy showed no certain cause of death and the cause of death was classified as borderline SIDS. It was reported that no findings point to causal relationship to the vaccine. No further information is available.


VAERS ID: 185990 (history)  
Form: Version 1.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:1995-09-08
Onset:1996-11-15
   Days after vaccination:434
Submitted: 2002-06-03
   Days after onset:2025
Entered: 2002-06-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 3 - / -

Administered by: Other       Purchased by: Other
Symptoms: Dyskinesia, Muscle atrophy, Paralysis
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0269446A

Write-up: Report number B0269446A describes the occurrence of amyotrophic lateral sclerosis in a 51 year old male patient vaccinated with an unspecified hepatitis B vaccine for hepatitis B prophylaxis. Medical and drug histories were unknown in this patient. On 15 Nov 1989, the patient was vaccinated with Hevac B at an unspecified dose. On 17 SEPT 1994 and on 08 SEP 1995, he was vaccinated with an unspecified hepatitis B vaccine at an unspecified dose. At an unspecified date, after the third vaccination, the patient experienced estonia. In November 1996, he experienced amyotrophy, paralysis, dyskinesia, right upper limb dysesthesia and then low limb motorial troubles. In the end of 1997, the diagnosis of amyotrophic lateral sclerosis was made by the neurologist. Treatments with riluzole (Rilutek) and venlafaxine (Effexor) were initiated. In 1999, the symptoms were aggravated. In 2000, the patient died of his symptoms. The most information received on 13 MAY 2002. The reporters causality assessment was not informed.


VAERS ID: 187101 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Female  
Location: Foreign  
Vaccinated:2002-05-22
Onset:2002-06-03
   Days after vaccination:12
Submitted: 2002-06-28
   Days after onset:25
Entered: 2002-07-02
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABAVERT) / NOVARTIS VACCINES AND DIAGNOSTICS - / 4 - / SC

Administered by: Other       Purchased by: Other
Symptoms: Aphasia, Demyelination, Hemiplegia, Hypotonia, Pyrexia, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (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), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Optic nerve disorders (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2002-06-03
   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: NONE
Current Illness: UNK
Preexisting Conditions: Feeding difficulties and mismanagement
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20020332

Write-up: A 3 year old malnourished female child suffered from third degree dog bite and was administered immediately Rapipur after proper cleaning of wounds. She was vaccinated with Rabipur SC on 05/08/2002, 05/11/2002, 05/15/2002 and on 05/22/2002. The local physician recommended urgent administration of immunoglobulins; which was not done. The child developed fever after the second dose; however, Rabipur administration was continued till complete of 4th dose. The child was referred to pediatrician 10 days after the 4th dose (according to differing info on 05/28/02), as symptoms of demyelination with involvement of brain-stem developed (loss of speech, neck flop, left hemiplegia, respiratory failure). The pt died on 06/03/2002 (due to respiratory failure) during investigations. The last doctor attending did not observe rabies symptoms and hence does not exclude a causal relationship to vaccination. We are awaiting further data. The lack of immunoglobulins is a serious deviation from treatment guidelines. As no lab tests were performed (to test for rabies infection) and as the foudroyant course is extremely untypical for post-vaccination neurological disorders, atypical rabies are the more likely cause.


VAERS ID: 187286 (history)  
Form: Version 1.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2002-06-18
Onset:2002-06-19
   Days after vaccination:1
Submitted: 2002-09-04
   Days after onset:77
Entered: 2002-07-09
   Days after submission:57
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABAVERT) / NOVARTIS VACCINES AND DIAGNOSTICS - / 4 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Cardio-respiratory arrest, Chills, Confusional state, Medication error, Oral intake reduced, Paralysis, Vaccination complication
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), 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), Dementia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Respiratory failure (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2002-06-19
   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: NONE
Current Illness: UNK
Preexisting Conditions: Rheumatic Heart Disease, Paralytic symptoms, malnutrition, paralytic symptoms (5-6 years before developing hydrophobia)
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20020353

Write-up: We received the following report from Bangladesh. A 30 year old malnourished female patient was bitten (grade 3) from a stray dog in the right elbow area on 1 JUN 202. The same day she received the first dose of Rabipur, but no RIG. She was given the fourth dose of Rabipur on 18 JUN 2002 (date of second and third injection not available). On 15 JUN 2002 she developed shivering, confusion, and difficulties in eating and drinking. Sudden weakness and paralysis in right upper and lower limbs appeared on 17 JUN 2002. On 19 JUN 2002 she also showed weakness and paralysis of left lower limb. The woman died due to cardiorespiratory failure on 19 JUN 2002. Anamnestic known: rheumatic heart disease, she developed mild paralytic symptoms for a few days 5 to 6 years ago. The dog died on 1 JUN 2002. We are awaiting further information. 1 JUL 2002, we received the additional information, that the patient was hospitalized on 19 JUN 2002 at 11:05 a.m. and that no autopsy was done. No change in assessment. The reporting physician do not see a causal relationship between Rabipur administration and the death of the pt. Assessment: unchanged.


VAERS ID: 187688 (history)  
Form: Version 1.0  
Age: 1.25  
Sex: Unknown  
Location: Foreign  
Vaccinated:2001-11-22
Onset:2001-11-27
   Days after vaccination:5
Submitted: 2002-10-10
   Days after onset:316
Entered: 2002-07-17
   Days after submission:85
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 2 - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cystitis, Pyelonephritis
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-11-27
   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: UNK
Current Illness:
Preexisting Conditions: NKA
Allergies:
Diagnostic Lab Data: Autopsy - subacute cystitis with a focus of acute pyelonephritis in the left kidney; Diagnostic lab test - haemoculture sterile; Spinal Tap - sterile (All done on 11/27/01.
CDC Split Type: WAES0206USA02446

Write-up: Information has been received from a health authority concerning a 15 month old patient who on 11/22/2001 was vaccinated with the first dose of MMRII vaccine. On 11/27/01, the patient died. An autopsy revealed a subacute cystitis with a focus of acute pyelonephritis in the left kidney. The physician who reported the case to the health authority concluded that this disorder was not the cause of death. Lab results included: sterile Haemoculture and spinal fluid. No further information is available. dollow up information indicated that the patient was being treated with Priorix not MMRII (MSD) as previously reported. Therefore WAES#0206USA02446 is being deleted from our files for MMRII


VAERS ID: 187764 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2002-07-18
Entered: 2002-07-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Hypertension, Polyarthritis, Rheumatoid arthritis, Rheumatoid factor
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Hypertension (narrow), Arthritis (narrow), 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? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0273617A

Write-up: Report number B0273617A describes the occurrence of a rheumatoid polyarthritis in a 18 year old female pt vaccinated with an unspecified hep B vaccine. Medical and drug histories are unknown in this pt. At an unspecified date, the pt received an injection of an unspecified hep b vaccine. Three months after the injection, the pt experirenced rheumatoid polyarthritis. Approximately three years after the vaccination, the pt died of pulmonary arterial hypertension. The most info received on 07/09/2002. The hospital physician''s causality assessment for the vaccine was not related.


VAERS ID: 187791 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2002-03-15
Onset:2002-03-15
   Days after vaccination:0
Submitted: 2002-12-20
   Days after onset:280
Entered: 2002-07-22
   Days after submission:151
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM - / UNK - / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-03-15
   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: Bronchokod, Carbocistaine
Current Illness: UNK
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0269758A

Write-up: Report number B0269758A describes the occurrence of sudden death in a 3 month old boy receiving Infanrix for prophylaxis. Bronchokod was also reported as a co-suspected drug. *The subject had a twin brother and was born after 34 gastational weeks. He had no relevant concurrent disorder (no gastroesphogeal reflux). On 03/15/2002 at 4pm, the subject received his 1st injection of Infanrix Quinta.* Bronchokod syrup for infants and children was administered orally. *During this day the subject had no fever.* On the same day at 9pm, five hours after vaccination, the boy died. *There was no autopsy performed.* The doctors will try to obtain the batch number. The most recent info received on 05/31/02 reports the outcome of the event as fatal. Causality assessment was coded as dubious for Infanrix and Bronchokod.


VAERS ID: 188087 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2002-07-25
Entered: 2002-07-29
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 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: 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: DE9121923JUL2002

Write-up: Information has been received from a registry concerning a 7 month old female pt with unspecified risk factors, who received Prevnar injection for immunization on an unknown date. It is unknown if the pt was taking concomitant therapy. The pt died as a result of Sudden Infant Death Syndrome. The investigator''s assessment of relatedness between SIDS and Prevnar was probably not related.


VAERS ID: 188088 (history)  
Form: Version 1.0  
Age: 9.0  
Sex: Female  
Location: Foreign  
Vaccinated:1982-01-01
Onset:1982-04-01
   Days after vaccination:90
Submitted: 2002-07-23
   Days after onset:7417
Entered: 2002-07-29
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEA: MEASLES (ATTENUVAX) / MERCK & CO. INC. - / UNK - / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Brain oedema, Cardio-respiratory arrest, Cerebellar syndrome, Choking, Coma, Difficulty in walking, Disturbance in attention, Drooling, Dyskinesia, Electroencephalogram abnormal, Encephalitis, Hypotonia, Infection, Irritability, Lethargy, Mood swings, Pneumonia, Posturing, Visual disturbance
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), 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), Dementia (broad), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), 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: ABO incompatibility; chickenpox; croup; jaundice NOS; measles; pneumonia NOS
Allergies:
Diagnostic Lab Data: 4/19/90; EEG-bilateral slow delta waves over the posterior temporal regions; Physical exam-blunt affect, slow responses, well oriented, head and neck including cranial nerves were nml; normal muscle mass, tone and reflexes bilaterally, difficulty walking in a straight line, mild dysdiadochokinesis and impaired finger-nose touching; Renal function study-nml; urinalysis-neg for lead and mercury; CSF-nml; serum electrolytes-nml; thyroid function-nml; CBC-nml; 4/23/90 measles antibody titers on-1:128,000 serum; Elisa-1:6400 CSF; both plantars upgoing; myoclonic jerks; reflexes including jaw jerk were brisk, deficits in gait and other motor skills worsened; complement fixation test-1:4 CSF; complement fixation test-1:1024 serum; EEG-periodic discharge activity synchronous with myoclonic jerks; serum and CSF displayed prominent antibody reactivity; measles IgM was present in CSF; 5/19/90 decorticate posturing; Autopsy 5/90 ?-brain was diffusely edematous, flattened gyri, narrowed sulci, slit-like ventricles; brain weight 14 days formalin fixation 1410 grams; multiple foci of cortical necrosis; numerous intranuclear and cytoplasmic eosinophilic viral inclusion bodies were observed; lungs showed severe bronchopneumonia; spinal chord not examined; electron microscopy confirmed presence of numerous tubular nucleocapsids
CDC Split Type: WAES0207CAN00051

Write-up: Information has been received from authors of a literature article concerning a 9 year old female with a history of jaundice due to ABO incompatibility in the neonatal period, chickenpox at 2 years of age, croup at the age of 2 and a half, and pneumonia NOS at 7 and a half years of age who in 1/82, was vaccinated with MMR. In 4/82, the pt experienced an attack of presumed measles. The authors reported that the pt had progressed in her development well and was doing well in school, the pt was 1 of 3 siblings, in which 1 of her siblings had mild visual perception difficulties. One of the pt''s maternal aunts on her father''s side was thought to suffer from a demyelinating neurotic disease. A maternal cousin had multiple sclerosis and it was also reported that there was no history of consanguinity. On approx. 4/10/90, the pt experienced deterioration in hand writing and difficulty in walking and in concentrating. The authors also reported that the pt was moody and irritable with marked deterioration of vision and increasing lethargy. On 4/17/90, the pt started drooling and had 2 episodes of choking. Ten days earlier, she had been able to do gymnastics. On 4/19/90, the pt experienced delayed acute measles inclusion body encephalitis and was hospitalized. The authors reported that upon physical exam, the pt had a blunt affect, slow responses and well oriented. The head and neck including cranial nerves were normal. The pt''s muscle mass and tone were normal and had normal bilateral reflexes, both plantar reflexes were down going. The pt''s sensory system was reported as normal. The pt had difficulty in walking in a straight line, mild dysdiadochokinesis, and had impaired finger-nose touching. On 4/23/90, the pt was referred to a Hospital for further investigation, at which point, all the pt''s reflexes were brisk including her jaw jerk, both plantars were up going and the pt''s deficits in gait and other motor skills steadily worsened. The pt started having myoclonic jerks and a repeat EEG showed periodic discharge activity synchronous with myoclonic jerks. The pt underwent further test. The authors reported that the pt was thought to have subacute sclerosing panencephalitis. On 5/19/90, the pt''s lever of consciousness deteriorated and started having decorticate posturing. Her condition deteriorated rapidly, she became comatose and developed multiple episodes of aspiration pneumonia. Subsequently, she had a cardiorespiratory arrest. She died 6 weeks after the onset of symptoms. A diagnostic pathological exam that was performed 2 hours after death, showed that the brain was diffusely edematous, flattened gyri, narrowed sulci, slit-like ventricles and weighed 1410 grams after 14 days formalin fixation. The authors also reported that there were multiple foci of cortical necrosis, numerous intranuclear (Cowdry type A) and cytoplasmic eosiniphillic viral inclusion bodies that were observed in neurons and glial cells were present in the brain as well as in the leptomenginges. No neurofibrillary tangles of Alzheimer type or demyelination were observed and gliosis was not prominent. A marked contrast of the measles viral antigen distribution between the gray matter and white matter of the cerebral hemispheres was revealed in the immunohistologic exam. The white matter of the cerebral hemispheres was heavily loaded with the viral antigen, which was easily noticeable with unaided eye. However, the upper portion of the cortex was virtually free of the viral antigen. In between them, some neurons in the deeper portion of the cortex displayed a linear distribution of the viral antigen in the cytoplasmic extensions as well as in the cell bodies. The viral antigen was seen in the dendrites with acute angle branches and also in the straight axons with rare right angle branches. There was also M protein present in the cytoplasm of the cells. In situ hybridiration with digoxigenin labeled probes for NP gene revealed the presence of numerous tubular nucleocapsids (of 20nm in diameter) in the cytoplasm as well as in he nucleus of neurons and the glial cells. There was also the presence of clusters of tubular nucleocapsids in the dendrites and axons. A severe bronchopneumonia was revealed in the lungs. No viral inclusions or antigen could be demonstrated in any other organ than the brain. The authors concluded by saying that the cause of death was "delayed type of acute measles inclusion body encephalitis and severe bronchopneumonia". The authors reported that the pt followed, for only 6 weeks after onset, a rapidly progressive downhill course. The latent period was aprox. 7 years following vaccination and measles infection. This case is reported as being consistent with delayed acute type of measles inclusion body encephalitis without immunosuppression. The observed features in this case probably reflect the short duration of illness. The heavy involvement of the white matter by the viral antigen is consistent with the clinical history of predominant motor dysfunction and relative preservation of intelligence in the beginning as well as the absence of seizure activity. No further information is available.


VAERS ID: 188281 (history)  
Form: Version 1.0  
Age: 0.7  
Sex: Female  
Location: Foreign  
Vaccinated:2002-05-24
Onset:2002-06-05
   Days after vaccination:12
Submitted: 2002-08-30
   Days after onset:86
Entered: 2002-08-01
   Days after submission:29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arrhythmia, Cardiac arrest, Cardiomyopathy, Hypertrophy
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 (narrow), Cardiac arrhythmia terms, nonspecific (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-06-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Cardiac arrest~Hep B (no brand name)~0~0.00~In Patient
Other Medications: UNK
Current Illness:
Preexisting Conditions: Concurrent conditions: Congenital heart disease; Congenital abnormality; cardiomyopathy NOS; microcephaly; foetal growth retardation Past conditions: Cardiac arrest; sepsis NOS; Wolff-Parkinson-White syndrome
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: HQ3520730JUL2002

Write-up: A consumer reported that a 9 month old female received an injection of Prevnar on 05/30/02. The reporter indicated that the infant has a history of cardiac arrest following immunization with hep B vaccine a one month of age and congenital malformation of her lip and her heart. On 06/05/02, she experienced a cardiac arrest and died. No further info was available at the date of this report. Additional info received on 07/30/02, from a pediatrician provided revised date of vaccination, medical history, pt demographics and additional adverse event info. Info has been received from a pediatrician regarding a 9 month old female. On 05/24/02 at 8 months of age, she received an injection of Prevnar. The reporter indicated that the infant has a history of cardiac arrest following immunization with hepatitis B vaccine at one month of age, congenital malformation of her lip and her heart, "agesic ofcorpus callous," congenital hyeprtrophic cardiomyopathy, microcephaly, fetal retardation development and sepsis. On 06/05/02, she experienced maligant ventricular arrhythmia secondary to congenita hypertrophic cardiomyopahty, cardiac arrest and death.


VAERS ID: 189080 (history)  
Form: Version 1.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2001-12-14
Onset:2001-12-25
   Days after vaccination:11
Submitted: 2002-08-28
   Days after onset:245
Entered: 2002-08-20
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 2 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cough, Dyspnoea, Immunoglobulins decreased, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-12-25
   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: UNK
Current Illness:
Preexisting Conditions: HIV infection NOS,tuberculosis NOS, penumonia NOS, herpes zoster, abscess bacterial NOS, cough
Allergies:
Diagnostic Lab Data: CD4 lymphocytes 98 cells/mm^3; haemoglobin 9.7 g/dL (12/14/01)
CDC Split Type: 3655207

Write-up: Information has been received from an investigator regarding a 37 year old female with a history of HIV infection who received a dose of Prevnar in December, 2001,as part of the study entitled, " Investigation of the humoral immune response to pneumococcal polysaccharides and the role of a conjugate pneumococcal vaccine in secondary prevention of invasive pneumococcal disease in HIV-infected Africans." One week post-vaccination, the patient died. An autopsy was performed. Reportedly, the patient experienced an acute onset of fever associated with cough and difficulty breathing prior to her death. Her CD4 count at the time of death was 98 cells/cubic mm. According to the current US package insert, fever and difficulty breathing are expected events; cough CD$ count of 98 cells/cubic mm, and death are unexpected events. The investigator''s and the medical assessments are unknown. Follow-up info received from the investigator on 8/22/02 provided pt details, vaccine administration details, medical history, symptom onset, date of death, laboratory data, and investigator/medical monitor assessments. Info has been received from an investigator regarding a 37 year old, HIV-positive female who received her second dose of Prevnar on 12/14/01 as part of the study entitled, "Investigation of the humoral immune response to pneumococcal polysaccharides and the role of a conjugate pneumococcal vaccine in secondary prevention of invasive pneumococcal disease in HIV-infected." The pt''s medical history is notable for chronic cough of uncertain etiology. On the date of the vaccination, hte pt''s CD4 count was 98 cells/uL, and her hemoglobin was 9.7 g/dL. Possible early Kaposi''s sarcoma of the palate was noted at that time. On 12/25/01, nine days post-vaccination, the pt died. An autopsy was performed; prior to her death, the pt reportedly experienced an acute onset of fever asociated with 48 hours of cough and dyspnea. The investigator reported that the pt''s death was likely HIV disease-related. Both the investigator and the medical monitor agreed that the death (unexpected per the current package insert) was "probably not related" to Prevnar administration; however, the medical monitor reported that vaccine failure could not be ruled out. Final report.


VAERS ID: 189675 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2002-08-24
Onset:2002-08-26
   Days after vaccination:2
Submitted: 2002-09-12
   Days after onset:17
Entered: 2002-09-04
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR U12811 / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Agitation, Sudden infant death syndrome
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Neonatal disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-08-26
   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: Capillary bronchitis (from 4/29/02 to 5/2/02), DTaP (IM - right thigh) (P2)
Allergies:
Diagnostic Lab Data:
CDC Split Type: U200200690

Write-up: A 4 month old infant was given Act-Hib (batch U1281-1) alone on 8/24/02 at 10:00 am and died around 10:00 am on 8/26/02 after passing 48 hours. Father of the infant is a medical doctor of obstetrics and gynecology. The pediatrician and the father approached the case as Sudden Infant Death Syndrome. **Follow-up report on 9/18/02: From follow-up (#1) received on 9/10/02 from a mnft''r (rec''d date 9/6/02), it was ported that "The 4-month old infant presented w/crying and irritation on 8/26/02, 48 hrs after vaccination w/Act-Hib, only a maternal grandmother saw these symptoms. When pediatrician investigated at 10:20 a.m. in hospital the baby was already dead on arrival. Guardians insisted therapy despite of MD''s explanation of death. So MD did CPR and oxygen w/incubation and then transferred to ER via an ambulence car. (At least 25 mins passed from stopping breath to first CPR). At ER, x-ray was taken and hemothorax at one side was revealed. Medical MD of chest surgery dept. at ER pulled out 450ml at one side. The first MD investigator of pediatrician, considered that hemothorax could result from severe and continuous CPR. Because she confirmed normal airway and good ariation with ausculation while she conducted incubation before transferring to ER."


VAERS ID: 189975 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2002-08-20
Onset:2002-08-27
   Days after vaccination:7
Submitted: 2002-11-08
   Days after onset:73
Entered: 2002-09-11
   Days after submission:58
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR UB142AA / UNK - / SC

Administered by: Other       Purchased by: Other
Symptoms: Arthritis, Back pain, Coma, Dysphonia, Gait disturbance, Hypertension, Laboratory test abnormal, Myalgia, Purpura, Rhabdomyolysis, Urine analysis abnormal
SMQs:, Rhabdomyolysis/myopathy (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Eosinophilic pneumonia (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-09-03
   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? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Complication: Gallstone (for 10 yrs); Past ADR: Rash due to parasolone drugs.
Allergies:
Diagnostic Lab Data: WBC Count, 8/29/02 - 6.6, 8/30/02 - 10.9; WBC Count, 8/29/02 - 475 10000/micro, 8/30/02 - 567 10000/micro; Hemoglobin, 8/29/02 - 15.7, 8/30/02 - 18.7; Hematicrit, 8/29/02 - 46.7, 8/30/02 - 55.7; Platelet count, 8/29/02 - 14.7 10000/micro, 8/30/02 - 15.1 10000/micro; GOT, 8/29/02 - 38, 8/30/02 - 659; GPT, 8/29/02 - 50, 8/30/02 - 272; LDH, 8/30/02 - 2300; ALP, 8/29/02 - 101, 8/30/02 - 133; Gamma-GTP, 8/30/02 - 106; Cholinenterase, 8/30/02 - 5.37; CPK, 8/29/02 - 300, 8/30/02 - 52300; CK-MB, 8/30/02 - 1445; Creatinine, 8/29/02 - 0.55, 8/30/02 - 0.43; Uric acid, 8/29/02 - 5.8; Bun, 8/29/02 - 21, 8/30/02 - 29; Glucose, 8/30/02 - 202; Sodium, 8/29/02 - 141, 8/30/02 - 146; Potassium, 8/29/02 - 4.2, 8/30/02 - 4.7; Chloride, 8/29/02 - 104, 8/30/02 - 107; Amylase, 8/20/02 - 31, 8/30/02 - 26; CPR, 8/29/02 - 0.9, 8/30/02 - 4.1; pH, 8/29/02 - 7.393; pC02, 8/29/02 - 32.3; PO2, 8/29/02 - 94; HCO3, 8/30/02 - 19.3; BE: 8/30/02 - (Illegible), Sa02, 8/30/02 - 95.8; Total bilirubin, 8/29/02 - 0.5, 8/30/02 - 0.8; Direct bilirubin, 8/30/02 - 0.3.
CDC Split Type: U200200706

Write-up: From correspondence received at manufacturer on 9/04/02 from a foreign manufacturer, it was reported that a 69 year old male received Yellow Fever Vaccine. No date of administration provided. Lot number is UB142AA. It was reported, patient died due to Rhabdomyolysis after vaccination. More information is pending. *Follow-up report on 9/18/02: From follow-up #1 correspondence received at manufacturer on 9/12/02 from a medical institution received date 9/6/02 it was reported "8/20/02: The PT was given a yellow fever vax before his trip to South America at a clinic. He routinely sprayed an agricultural chemical (fenitrothion) w/out using any protector. 8/27: He developed back pain w/out any apparent cause. 8/28: The PT visited th eorthopedic department. For detailed exam, he was transferred to another hospital, where findings at the visit were clear consciousness, body temp 35.4 C, blood pressure 150/90 mmHg, and pain involving the back/low back area to all the muscles of both lower extremities. Lumbar x-ray revealed spinal osteoarthritis. Hoarseness was also noted. No neurological Sx''s were present. Because of the severe pain, the PT was unable to walk on his own and was hospitalized for detailed exam and bed rest. Because of the severe pain, he was given IM pentazocine 15 mg x 2. Japan Coma Scale was 1. 8/10: In the morning, purpura was noted on the lumbar region and face. Findings were BT 36, 4C, BP 200/100 mmHg, pulse rate 78, Sp02 98%, and JCS 2-3. Because of HTN, sublingual nifedipine 5 mg was given, but the BP remained unchanged at 187/20 mmHg and thur intravenous drip infusion of nicardipine HCl at 6 mg/hr was started. Head CT showed no abnormalities, while abdominal CT revealed enlargement of stomach bubbles. Brown urine was noted. Around noon, progression of disturbed consciousness (JCS 10) was noted. Since his hypercreatine phosphokinasemia and disturbed consciousness required ICU management, the PT was transferred to the Emergency center of a local hospital at 14:30. 09/03: at 8:30, the PT died. Further info. from the reporting MD has been requested." Follow up correspondence received on 11/6/02 stated, "we are not able to obtain any detailed info from the hospital where te pt had been transferred. Although we asked the doctor of this hospital to write an adverse event case report, he refused this request. This is now described in the adverse reaction report, which has been submitted."


VAERS ID: 190737 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Foreign  
Vaccinated:2002-09-04
Onset:2002-09-07
   Days after vaccination:3
Submitted: 2002-10-28
   Days after onset:51
Entered: 2002-09-30
   Days after submission:28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Pyrexia, Sepsis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-09-11
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Congenital Immunodeficiency
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Immunoglobulin A, Serum, Sep 02, result - not detected; Immunoglobulin M, Serum, Sep 02, result - not detected; Immunoglobulin G, Serum, Sep 02, result - not detected; Blood culture, Sep 02 - pseudomonae seroginosa.
CDC Split Type: B0280515A

Write-up: This report received from a physician described the occurrence of a sepsis and subsequent death of a 6 month old boy receiving diphtheria tetanus acellular pertussis, inactivated polio and haemolphilus influenza B vaccine and hepatitis B vaccine for prophylaxis. The boy''s relevant medical history included a congenital immunodeficiency. On 9/4/02 a dose of Infanrix Polio Hib and a dose of Engerix B (two distinct injection sites) were given. On 9/7/02, three days after vaccination, this boy developed fever. On 9/9/02, he was hospitalized. On 9/11/02, he died with a diagnosis of sepsis and pseudomonas aeruginosa infection. The reporter did not assess a causal relationship. Additional information has been requested. *F/UP report on 11/5/02: The reporting MD considered the events to be possibly related to Infanrix-Polio=Hib and Engerix B. He states that the eveents could also be associated w/the congenital immunodeficiency the child? was suffering of. No autopsy was performed. Add''l info has been requested.*


VAERS ID: 190992 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2002-07-03
Onset:2002-07-22
   Days after vaccination:19
Submitted: 2002-09-30
   Days after onset:70
Entered: 2002-10-04
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pyrexia, White blood cell count increased
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: 2002-07-22
   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: Valsartan
Current Illness: Diabetes mellitus NOS; Hypertension NOS
Preexisting Conditions: Pneumonia NOS;
Allergies:
Diagnostic Lab Data: Chest x-ray: ST-segment and T-wave changes; WBC count 38600/mcl; blood glucose 162mg/dL; body temp 36.5C 7/3/02, 39.6C 7/6/02
CDC Split Type: WAES0209USA01803

Write-up: Information has been received from a health professional concerning an 80 year old male patient with DM, hypertension and a history of pneumonia (3/8/02) who on 7/3/02 was vaccinated with a 0.5 dose of pneumococcal vaccine 23 polyvalent (manufacturer unknown). Concomitant therapy included valsartan 80 mg daily dose for hypertension. On 7/6/02, the patient developed pyrexia of 39.6C, and an increased white blood cell count. An X-ray of the chest was normal. An ECG showed a ST-segment and T-wave changes. On 7/8/02, the patient was admitted to another hospital. On 7/22/02, the patient died, cause unknown. The reporting physician felt that the adverse events were possibly related to the pneumococcal vaccine 23 polyvalent (manufacturer unknown). Other business partners numbers include NU-0125. Additional information has been requested.


VAERS ID: 191069 (history)  
Form: Version 1.0  
Age: 7.0  
Sex: Female  
Location: Foreign  
Vaccinated:2002-03-08
Onset:2002-03-20
   Days after vaccination:12
Submitted: 2002-11-06
   Days after onset:231
Entered: 2002-10-08
   Days after submission:29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABAVERT) / NOVARTIS VACCINES AND DIAGNOSTICS 667 / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Agitation, Depressed level of consciousness, Ear pain, Encephalitis, Hallucination, Headache, Muscle spasms, Musculoskeletal stiffness, Nystagmus, Paralysis, Pyrexia, Restlessness, Somnolence, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Akathisia (broad), Dystonia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (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: 2002-03-23
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: UNK
Preexisting Conditions: Dog bite
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: MA20020550

Write-up: An about 10 year old child received, the first day of being bitten in the head, Rabipur. The child was not co-administerred immunoglobulin. The child died due to rabies infection. We are awaiting further information. Preliminary assessment: seriousness criterion: death. Causality: not related. We received a follow up info: A female child, born on 4/7/(2002?) 1992(?) with no underlying disease before, was vaccinated with PCEC vaccine (lot no 667), 8 sited on 3/8/02 for the first time (intradermally or subcutaneously, differing reports). On 3/20/02 she suffered from high grade fever, drowsiness and neck stiffness. Finding check: nystagmus, motor grade 4/5. DD: encephalitis with sepsis, rabies (serophobia in the period of the second day of admission). The child was referred to hospital on 3/22/02. Exitus on 3/23/02. Concomitant medication: Calforan 1gm q 8 hrs, i.v., 3/21/02 for covering CNS infection. Assessment: seriousness-criteria: death, hospitalization. Causality: not related. Addendum 10/24/02: we received additional info: A 7 year old received post exposure treatment with PCEC rabies vaccine in the 8 site intradermal post exposure schedule. Four days after administration of the second dose of intradermal injection she complained about headache and became febrile, in the evening that day the pt''s consciousness became cloudy. The girl was hospitalized. Furthermore the following symptoms were reported: pain in left ear, facial nerve palsy, restlessness, spasms of arms, visual hallucinations, agitation, inappetence and vomiting. On 3/22/02 the pt became comatose and she died on 3/23/02, 15 days after being attacked. Rabies was diagnosed due to the pt''s history, symptoms and physical findings. A publication has been submitted to the CID journal. Assessment: unchanged. Causality: not related. Reported on 03/20/2003: "Addendum 03/03/2003: We received additional information. The child received the second vaccination on 03/15/2002. The girl was bitten at two sites; on her face (near nose) and on her left arm. The wound was bleeding and abrasive. There is a possibility of re-exposure because of the dog owner, living as a neighbour of the victim, had said that the girl was usually playing and feeding her snack to the puppies. And the owner did not know when the puppy was infected by rabies. Therefore, the girl might have died from exposure which had taken place before the last time (which would be evidenced obviously), but the previous exposure had not been noticed or informed. After the victim died, other puppies and their mother died. One dog was killed in order to prove rabies infection. The result of the laboratory examination confirmed that the dog was rabies positive. The would treatment was delayed more than an hour after the recorded exposure because the victim was taken to a traditional magic man for treatment. Finally, her relative was advised to get a treatment at the hospital. There was no immediate wound treatment after the bites. Assessment unchanged. Addendum 09/03/2003: The case was also published in: Sriaroon C. et al. Rabies in a Thai child treated with eight-site post-exposure regimen without rabies immune globulin, Vaccine (2003), 21: pp. 3525-3526. Additional info: The pt had incurred a 1 cm deep scratch above her left eyebrow, a 3 cm transdermal abrasion of her left cheek, and a superficial abrasion of her left arm. The mother of the puppy had died recently of an undiagnosed illness. Puppy had acted strangely prior to the attack and died the day after the attack after falling into a coma. Wound was irrigated and Betadine solution applied almost immediately after arrival at hospital on the day of the attach (03/08/2002). The first 8 intraderml Rabipur injections (0.1 ml each) occurred on that day; the 2nd course of 4 intradermal injections on 03/15/2002 (day 7). On 03/19/2002 pt complained of headache, became febrile and vomited. On 03/20/2002 her consciousness became clouded. She was hospitalized; her temperature on admission was 39.4 degrees Centigrade. On 03/21/2002 she complained of severe pain over her left ear (same side as dog bites). Evidence of lower motor neuron left facial nerve palsy was noted. During the same day, she developed restlessness, arm spasms in response to air currents (aerophobia), visual hallucinations, agitation and she refused to eat and drink (hydrophobia). That night, she became comatose, and died on 03/23/2002 of circulatory failure, 15 days post bite. Company assessment: unchanged.


VAERS ID: 191070 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Male  
Location: Foreign  
Vaccinated:2002-08-12
Onset:2002-08-16
   Days after vaccination:4
Submitted: 2002-10-02
   Days after onset:47
Entered: 2002-10-08
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABAVERT) / NOVARTIS VACCINES AND DIAGNOSTICS - / 3 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Dyskinesia, Encephalitis, Headache, Insomnia, Malaise, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dyskinesia (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: 2002-08-17
   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: NONE
Current Illness: UNK
Preexisting Conditions: Dog bite
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20020580

Write-up: A 4 year old male child suffered from 3rd degree dog bite on upper lip and was administered immediately. Rabipur after proper cleansing of wounds. Rabipur was administered IM on 8/5/02, 8/8/02 and 8/12/02. HRIG was given after 28 hours (infiltrated inside the wound). When the child was brought in the reporting doctor on 8/16/02 he showed signs of hydrophobia, fever, malaise, headache, vomiting and sleeplessness. Muscle jerks on plantar flexor did occur. The child died on 8/17/02. The cause of death is unknown as autopsy was not done. The possibility of encephalitis was not ruled out by the reporting doctor.


VAERS ID: 191401 (history)  
Form: Version 1.0  
Age: 1.5  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2002-11-11
Entered: 2002-10-17
   Days after submission:25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Drug ineffective, Meningitis, Otitis media, Pyrexia
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: HIV InfectionCDC Group IV subgroup C1
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: HQ4576509OCT2002

Write-up: Follow-up information received from the physician on 10/14/02 included a revision of the patient''s age and sex. mediucal history was also provide. A physician reported that an 18 month old male with a history of HIV infection/AIDS received her first dose of Prevnar on an unspecified date. Four days post-vaccination the patient presented to an emergency room with a fever, otitis and subsequently developed pnuemococcal meningitis. The patient died as a result of the meningitis on an unspecified date. This report was received from a foreign manufacturer. Follow up info received from the physician on 11/5/02 included additiona levent details. A physician reported that an 18 month old male with a hisotry of HIV infection/AIDS received his first dose of Prevnar on an unspecified date. Four days post vaccination, the child presented to an ER with a fever and otitis. He was prescribed unspecified antibiotics and sent home. "Some days later," the child developed a septic infection and pneumococcal meningitis. He was hospitalized. The child reportedly died on an unspecified date as a result of the meningitis. According to the reporter, the child''s physicians did not consider the death to be related to Prevnar administration.


VAERS ID: 192483 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Male  
Location: Foreign  
Vaccinated:1994-10-13
Onset:0000-00-00
Submitted: 2002-10-30
Entered: 2002-11-05
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1037W / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autism, Gastrointestinal disorder, Hydroureter, Psychomotor hyperactivity
SMQs:, Anticholinergic syndrome (broad), Retroperitoneal fibrosis (narrow), Dementia (broad), Akathisia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (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: WAES0210USA02146

Write-up: Information has been received regarding a case in litigation concerning a male child who on 10/13/94, at the age of 12 months was vaccinated with a dose of MMR II (lot 609861/1037W; batch 850672). It is alleged that following the vaccination the pt developed Asperger''s syndrome and bowel problems. Upon internal review the pt''s Asperger''s syndrome and bowel problems were considered to be other important medical events (OMIC). No further info is available. A 15-day follow up report received 3/10/2003 adds: Information has been received concerning a 13 month old male child with mild asthma, mild hydroureteronephrosis and a medical history of clicking hips, bilateral ureteric reflux, and meconium staining of the liquor during during, who on 10/13/1994 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (Lot #609861/1037W: Batch #950672 (diluent)). It is alleged that following the vaccination the pt developed Asperger''s syndrome, Attention Deficit Disorder with Hyperactivity, and Lymphoid Nodular Hyperplasia in the terminal ileum. Additional info was received and indicted that the pt was crying, screaming and writhing about on one afternoon during the week post vaccination. This was unusual, as the pt never behaved like this before. Within 6 weeks post vaccination, the pt began to pick up his toys one after the other, look at them and then throw them away. He was no longer playing appropriately with them. Also the pt was extremely restless. He was not seeking out the company of adults as he had done before. He started to throw heavy objects around the house. Also within 8 weeks, his speech patterns had changed and from conversational cadences to being less talkative and expressing himself in a kind of gibberish that did not sound like conversational attempts. Within 3 to 4 months, his sleep patterns completely changed. He now needed little sleep, during which he was restless and twitchy. Within approximately 6 months, the pt had developed an obsession with the same audio and videocassettes. He would play then 30 or 40 times over and over again. If they were turned off, he would scream for hours. Within 6 months, the pt was displaying many typical autistic traits. He had gradually begun hand wringing and having temper tantrums. He had also lost all of his eye contact gradually in the 6 months post vaccination. He did not want to be near familiar people and developed a severe dislike of strangers. He would arch his body and go completely rigid if he was somewhere that he was uncomfortable with. In February 1997, the pt was seen by a pediatrician and was diagnosed as having attention deficit disorder with hyperactivity. He was prescribed methylphenidate (RITALIN) which made his condition worse and so he was brought off it after 3 months. On 05/07/1998, the pt was diagnosed with Asperger''s syndrome. Following continuous bouts of constipation for a period of around 12 months, the pt was seen and referred by a general practitioner on 06/16/1999. The pt underwent a colonoscopy on 05/16/2000 and the specialist in pediatric gastroenterology made a diagnosis of Grade 2 lymphoid nodlar hyperplasia in his terminal ileum with loss of vascular pattern up to the transverse colon. During the same appointment, the pt underwent an OGD (oesophagogastroduodenoscopy) that showed normal oesophagus, minimal antral erythema and duodenal erythema in ''D1''. In an assessment performed on 05/01/1997, at the age of 3.5 years old, a physician indicated that the pt''s mother had non-insulin dependent diabetes and needed insulin during pregnancy. The pt was born vaginally at 40 weeks without problems after an induction. He was an easy baby, slept a lot and was breast-fed until 8 months. He began verbalizing at about a year old and had a few words by the age 0f 2. He was talking in sentences now. His parents could not remember when the pt began to sit, crawl, stand, or walk but felt that they were within normal limits. He was an affectionate child. The pt was currently on methylphenidate (RITALIN) 5mg ''mane''. None at weekends. His parents indicated that his behavior was very destructive and had general motor over-activity. He would go around touching everything. He would interrupt others constantly and found it difficult to listen. They reported that he was generally quite easily distractible but with certain tasks, such as sitting with a book, using the computer or watching videos, he was able to maintain concentration. Mealtimes were also difficult in getting him to sit down and eat. His mother felt that the pt was more amenable since starting methylphenidate (RITALIN) with less tantrums and was more settled. His father felt that it made little difference. The pt appeared to have quite a number of ritualistic, almost obsessional behaviors. For istance, the pt insisted that he must eat this breakfast while wearing his dressing gown. He insisted that many tasks are done in a specific order and also had his own ''special tasks'' such as putting lids on bottles or putting fruit into plastic bags in the supermarket. He also appeared to have a compulsive need to touch things. He had a particular interest in books of any kind and will sit and ''read'' a book from cover to cover. He would throw a tantrum, lasting for an hour or so, if he were not allowed to finish the task. Recently, the pt had been experiencing night terrors. Toileting is another main problem. Toilet training had begun last summer and he was dry during the day to the point where he was able to wear ordinary pants but was still soiling. He appeared to be retaining his feces but constipation was ruled out as a possible cause and laxatives were of little help as he was producing small amounts often. Currently, he refused to use a pot; he said, ''I can''t''. He was back to wearing nappies full time now. He played quietly and appropriately with toys on his own for most of the interview. He seemed placid and happy. Although the pt did seem to have some of the features of ADHD (attention-deficit hyperactivity disorder), in general his behavior did not seem to have the pervasiveness that one would expect with such a diagnosis. Medication appeared to have helped with some of his behavior, but then it can also bring about improvements in concentration and ability to settle to tasks in children without such a diagnosis. Regarding his problems of soiling, if constipation has been ruled out as a cause, then it might be a behavioral expression over issue of control. A behavioral approach was suggested for toileting problems. In an assessment performed on 08/13/1997, a physician indicated that the pt was born at 40 weeks following induction. There was meconium staining of the liquor. Chicking hips were diagnosed at birth that resolved spontaneously. Bilateral ureteric reflux was also diagnosed early. Motor milestones were achieved without difficulty and the pt was walking by his first birthday. Theh 18-month check highlighted concerns about the pt''s hearing because of his speech was not making expected progress. He was starting to talk at about 2 years old. His vocabulary grew satisfactorily and sentences developed at the expected time. It was the content of his speech that was of concern and has continued to do so. The pt has no history of ENT (ear, nose, throat) problems; he recently had undergone a full audiological assessment. His inappropriate use of language such as I hungry. I''d better go to bed has been of concern. His mother suspected that he learned and recited verbatim and everything he did was parrot-fashion. He tended to find inappropriate uses for whatever he was given to play with. Formal assessment was not completed. He sat for a short while and attempted a number of tasks successfully. He then decided to get down from the table and left the room. Based on observation, his gross locomotor skills were probably age appropriate. He was a physically active, strong and energetic boy. Cognitive development appeared to be age appropriate. His personal/sociall skills were an area of concern. He dressed himself independently. He had an aversion to using the toilet and would hide when he needed to go. He could relate to other children but did not see the need for them. He paid no attention to visiting children and was very good at amusing himself. He was a messy eater. He was constantly up and down from the table during a meal and always had to dissect his sandwiches. He could use a spoon and fork independently. Hearing was within normal limits. There had been some discussion of language development earlier and of the pt''s sometimes-inappropriate use of language. He actively avoided fine motor tasks. He disliked drawing and avoided using a pencil as much as possible. In an assessment performed on 07/08/1996, a pediatrician indicated that the pt was diagnosed as having mild hydroureteronephrosis which was currently just being monitored and had no overt clinical effects. He had very mild asthma, which was well controlled. He used budesonide (PULMICORT) two puffs at night through a spacer. This was increased to two puffs in the jmorning and at night if he became wheezy. He also required albuterol (VENTOLIN) two puffs through a spacer if he became wheezy. There were no concerns about his vision but he has not had formal testing to date. He seemed to pick up very tiny details of things both near and far. He always had a problem with stool retention but was improving with a behavioral program of going to the toilet every evening. He wore diapers at night and had an occasional accident but in general his toileting during the day was problem free. Due to his disinterest, he needed help with dressing and washing.The pt was receiving help with social communication and developing his imagination. He had an exceptional memory and tended to learn language often by rote. His ability with language made him sound very mature but if asked to give an account of an event, he might provide a disjointed account. He had difficulties with conversations as he made literal interpretations and found difficulty with turn taking. His abstract understanding was also likely to be impaired, although his understanding of physical concepts such as shape, size, and color might well be ahead of his peers. He had a little concept of fear or danger and needed to be supervised. He was recently started a trial of a gluten-free diet. An immunization history indicated that the pt was vaccinated with diphtheria, pertussis, tetanus toxoid, polio and haemophilus B conjugate on 11/11/1993, 12/07/1993 and 01/11/1994. Upon internal review the pt''s Asperger''s syndrome, Attention Deficit Disorder with Hyperactivity, and Lymphoid Modular Hyperplasia in the terminal ileum were considered to be other important medical events. No further information is available. A copy of the pt''s complete medical records is available upon request.


VAERS ID: 192649 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2002-10-28
Onset:2002-10-30
   Days after vaccination:2
Submitted: 2002-11-18
   Days after onset:19
Entered: 2002-11-06
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS 208H4 / UNK - / -
TD: TD ADSORBED (NO BRAND NAME) / UNKNOWN MANUFACTURER 40130 / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Depressed level of consciousness, Headache, Nausea, Pharyngitis, Pyrexia, Rash, Rhinitis
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Agranulocytosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-10-30
   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: UNK
Preexisting Conditions: Nicotine abuse
Allergies:
Diagnostic Lab Data: Temperature 10/29/02 - 40C, 38.4C, 38.5C, 39.8C; Cannula inserted in the vein; Cooling of the calf of the legs with compresses.
CDC Split Type: D0039721A

Write-up: A physician reported the death of a 18 year old male who was vaccinated with hepatitis A and B vaccine (Twinrix adult) for prophylaxis. No current medical conditions and no concurrent medications were reported. On 10/28/02, the subject, a soldier of the German armed forces, received the second dose of hepatitis A and B vaccine, lot number HAB208H4. Concomitantly, tetanus-diphtheria vaccine was administered. One day post vaccination, on 10/29/02, the subject developed symptoms of a common cold, headache, nausea, and fever. At 3PM, the subject consulted the medical officer, was transferred to the bed unit and was symptomatically treated with paracetamol, cooling of the calf of the legs with compresses, metoclopramide hydrochloride and dipyrone. Fever decreased to 39.8C. At 6:30PM, body temperature was 40 C (axillary measured). Therefore, a cannula was inserted in the vein and Ringer''s solution, sodium chloride solution and dipyrone were administered and the subject received paracetamol. Fever decreased to 38.4 C. At 10pm, fever was 38.5C and the subject was responsive, awake and oriented. The night from 10/29/02 to 10/30/2002 was uneventful. On 10/30/02 in the morning, at 6:30AM, the subject showed severe clouded consciousness and small exanthema on truck, neck and head, which could not be pressed away. There was no exanthema on the extremities. The subject was responsive and showed reaction to pain stimulus. The subject received sodium chloride solution. At 7AM, the subject was transferred to the nearest hospital. During the transportation, the subject had to be reanimated. The patient died in the hospital after two hours of reanimation. An autopsy was announced. The public prosecutor will be involved.


VAERS ID: 193471 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Foreign  
Vaccinated:2002-05-07
Onset:2002-06-30
   Days after vaccination:54
Submitted: 2002-11-15
   Days after onset:138
Entered: 2002-11-19
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 477175 / 1 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Dehydration, Diarrhoea, Drug ineffective, Laboratory test abnormal, Multi-organ failure, Pyrexia, Sepsis, Shock
SMQs:, Anaphylactic reaction (narrow), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), 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), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-06-30
   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: Zinnat, Aldactone, Inderal, Lasix, Konakion, and Spartocine.
Current Illness:
Preexisting Conditions: Hepatitis fulminant; Portal hypertension; Malnutrition NOS
Allergies:
Diagnostic Lab Data: Blood culture negative-blood culture negative Jul/2002; culture NOS positive-peritoneal fluid culture positive for penumococci Jul/2002; neutrophil count-peritoneal fluid 95% PMNs Jul/2002; white blood cell count peritoneal fluid 7,700 Jul/2002
CDC Split Type: HQ4163211SEP2002

Write-up: Information has been received from an investigator concerning a 24 month old male who received his first dose of Prevnar on 5/7/02 at 22 months of age as part of the post-marketing study entitled, "Conjugated Heptavalent Pneumococcal Vaccine Administered Before or After Transplantation in Children with Liver Disease." The child''s medical history included fulminant hepatitis; protal hypertension with ascites and esophagal varices; and malnutrition. Concomitant medication included Zinnat, Aldactone, Inderal, Lasix, Konakion, and Spartocine. On 7/1/02, the child was admitted to a hospital for fever, diarrhea, and dehydration with signs of sepsis and shock of 24 hrs duration. A peritoneal fluid WBC count was 7,000 with 95% PMNs. A peritoneal fluid culture was positive for pneumococci. A blood culture was negative. The child died within 24 hrs of hospitalization due to sepsis and multi-organ failure. The investigator reported that the diarrhea and sepsis (expected as per the US package insert) and the dehydration, positive peritoneal culture, and multi-organ failure (unexpected as per the US package insert) were not related to Prevnar administration. The medical reviewer considered the events to be possibly related to Prevnar administration.


VAERS ID: 193721 (history)  
Form: Version 1.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2002-08-28
Onset:2002-09-10
   Days after vaccination:13
Submitted: 2002-11-18
   Days after onset:69
Entered: 2002-11-21
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABAVERT) / NOVARTIS VACCINES AND DIAGNOSTICS - / 4 - / IM

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2002-09-11
   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: NONE
Current Illness: UNK
Preexisting Conditions: Unspecified Protein-Calorie Malnutrition; Dog bite
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20020685

Write-up: A 40 year old malnourished man was bitten by a dog on 8/14/02. He received four doses of Rabipur IM 8/14/02, 8/17/02, 8/21/02 and on 8/28/02. On 9/10/02 he developed rabies-like symptoms and expired on 9/11/02. The cause of death as reported, looks to be rabies. Autopsy was not don. HRIG was not given.


VAERS ID: 194092 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2002-11-25
Entered: 2002-11-27
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Bone marrow depression
SMQs:, Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Myelodysplastic 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: UNK
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0285415A

Write-up: This report describe the occurrence of fatal medullary aplasia in a female child (unknown age) vaccinated with an unspecified hepatitis B vaccine for prophylaxis. This report was made from a radio station broadcast and was not medically confirmed. The patient''s medical and drug history was unknown. At an unspecified time time, she developed a medullary aplasia. The outcomes of the event was fatal. No follow-up is expected for this report. A duplicate check could not be accurately performed due to the lack of information.


VAERS ID: 194093 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2002-11-25
Entered: 2002-11-27
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Bone marrow depression
SMQs:, Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Myelodysplastic 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: UNK
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0285418A

Write-up: This report describes the occurrence of fatal medullary aplasia in a male child (age unknown) vaccinated with an unspecified hepatitis B vaccine for prophylaxis. This report was made from a radio station broadcast and was not medically confirmed. The patient''s medical and drug history was unknown. At an unspecified time, the patient was vaccinated with an unspecified hepatitis B vaccine. After an unknown time, he developed a medullary aplasia. The outcome of the event was fatal. No follow-up is expected for this report. A duplicate check could not be accurately performed due to lack of information.


VAERS ID: 194354 (history)  
Form: Version 1.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2000-08-15
Onset:2000-09-26
   Days after vaccination:42
Submitted: 2002-11-21
   Days after onset:786
Entered: 2002-12-02
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS 571 / 2 - / -

Administered by: Other       Purchased by: Other
Symptoms: Cardiac arrest, Infection, Nervous system disorder, Respiratory arrest
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 (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2000-09-27
   Days after onset: 1
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:
Preexisting Conditions: Protein-calorie malnutrition, dog bite
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20020699

Write-up: A 56 year old lady, with known disturbed metabolism and malnutrition, was bitten in her leg by a dog on 8/12/00. She was given anti-rabies serum along with Rabipur (batch no. 526) in an anti-rabies clinic the same day. The second dose (batch no. 571) was given on 8/15/00. According to narration of the case the deceased was given full course of Rabipur (no. of doses and dates not known). Upon deterioration on 9/26/00, the pt was taken to hospital, where she was diagnosed with dumb rabies and referred to infectious disease hospital. The pt was brought home instead, where she died of cardiac and respiratory arrest on 9/27/00. We are awaiting further information.


VAERS ID: 194584 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Foreign  
Vaccinated:2002-11-21
Onset:2002-11-21
   Days after vaccination:0
Submitted: 2002-12-03
   Days after onset:12
Entered: 2002-12-05
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 20H194 / 3 - / -
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME) / UNKNOWN MANUFACTURER 20H194 / 3 - / -

Administered by: Other       Purchased by: Other
Symptoms: Apnoea, Coma, Pallor, Pyrexia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-11-22
   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: Regurgitation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0286020A

Write-up: This case was reported by a physician and describes the death of a 5 month old male who received Infanrix Quinta for prophylaxis. Concurrent medical condition included regurgitation. On 21 Nov. 2002, in the afternoon, the subject received an injection fo Infanrix Quinta (third injection). At night, the subject experienced paleness reported by the mother. The subject was sleeping face down. On 22 Nov. 2002, at 5am, the mobile emergency unit certified that the death has occurred. Reported on 01/28/2003: The subject had no history of allergy. Concurrent medical condition included gastroesophageal reflux treated with meteelopranide (Primperan). Concurrent medication included paracetamol, dextxopropoxitene (Diantalvic) taken by the mother on 11-21-2002 at 10am. The subject received breast feeding only at 9:30pm. On 09-13-2002, the subject received his first injection of Infanrix Quinta and experienced within an unspecified delay, fever (98.5 Celsius degree) and was grumpy. On 10-14-2002, the subject received his second injection of Infanrix Quinta. After the injection the subject was grumpy. On 11-23-2002 at 3:30pm, the subject received the third injection of Infanrix Quinta. At 5:00pm the subject received ibuprofen (Nureflex) for fever prophylaxis. At 5:30pm, the subject was nervous. Breast feeding was incomplete and the subject felt asleep. At 11:30pm, the subject woke up, he was still nervous and received breast feeding. He felt asleep around midnight. At this time he had no fever (36.6 Celsius degree). On 11-22-2002, at 3:00am the subject woke up and was grumpy. He had no fever (37.1 Celsius degree) and felt asleep around 4:00am. The subject was sleeping face down. At 5:30am the mother reported paleness while sleeping. At 7:50 am the mother found her son turned to white and without breathing. She did a heart massage. The mobile emergency unit certified that the death had occurred, the child presented stiffness. The laryngoscopy was normal. Five to six hours later, pulmonary and skeleton X ray were normal. Leokocyte count was at 38000/mm3. Blood culture was negative. Lumbar puncture was sterile. Bronchial aspiration showed 10''7 Stroptocoucus B and myncynial respiratory virus research was negative. A viral infection was found in ear nose and throat area. On 11-29-2002, the autopsy revealed no abnormality. The physician specified that the post mortem exam did not evidence renal insufficiency nor transaminases disorder. Regarding bronchial bacteriological finding the hospital peodiatrician suspected an alveolitis which could explain the increased white blood cell count. Histological pulmonary analysis showed an ear nose and throat viral infection. At the time of the report and according to the pediatrician, the subject experienced a viral and bacterial co-infection which lead to an important release of pyrogen toxins. This release lead to the subject''s death by apnea. It was reported by the mother that the subject experienced two to three episodes of paleness with bruxian without loss of consciousness several weeks or months before. The physician''s causality assessment for Infanrix Quinta was unlikely.


VAERS ID: 194799 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2002-12-06
Entered: 2002-12-11
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABAVERT) / NOVARTIS VACCINES AND DIAGNOSTICS - / 3 - / -

Administered by: Other       Purchased by: Other
Symptoms: Nervous system disorder, Paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: NONE
Current Illness: UNK
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20020735

Write-up: A 11 year old male child was vaccinated with three doses of Rabipur (days 0, 3, 7). The child died after the vaccination of neuroparalysis. The patient was vaccinated as a prophylactic measure by a local doctor, as his mother had died of suspected rabies seven days ago. The boy himself did not suffer from dog bite. No information on application of rabies specific immunoglobulin. The vaccination schedule used refers to post exposure treatment. We are awaiting further information.


VAERS ID: 196758 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Male  
Location: Foreign  
Vaccinated:2002-04-12
Onset:2002-07-12
   Days after vaccination:91
Submitted: 2003-01-22
   Days after onset:194
Entered: 2003-01-24
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (HEXAVAC) / SANOFI PASTEUR - / UNK - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 3 - / 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: 2002-07-12
   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:
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: DE9402020JAN2003

Write-up: Information has been received from a local study concerning a 7 month old male participant in a study entitled surveillance of infections and risk factors in children <2 after immunization. On 4/12/02 the pt received his third dose of Prevnar for immunization including a dosage of 0.5ml. Concomitant therapy included Hexavac (diphtheria/tetanus/pertussis vaccine/poliomyelitis/hep B vaccine/haemophilus influenzae B). The pt experienced sudden infant death syndrome on 7/12/02. According to police info of 7/12/02 an exogenic etiology of pt''s death could be ruled out. The investigator''s assessment of relatedness between sudden infant death syndrome and Prevnar was probably not related.


VAERS ID: 197466 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2003-01-07
Onset:2003-01-07
   Days after vaccination:0
Submitted: 2003-02-05
   Days after onset:29
Entered: 2003-02-10
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPH: DTAP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / 2 - / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pyrexia, Sepsis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-01-07
   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: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0301USA02403

Write-up: Information has been received from a health professional concerning a 8 week old male who on 1/7/03 was vaccinated in the right thigh with a second dose of hepatitis B vaccine recombinant. Concomitant therapy that day included a first dose of diphtheria toxoid (+) haemophilus B conjugate vaccine (+) pertussis vaccine (+) tetanus toxoid, a first dose of meningococcal protein conjugate, and a first dose of poliovirus vaccine. The reporter indicated that following vaccination it was detected that the baby had a fever. On 1/7/03 the baby was hospitalized and died the same day. The suspected diagnosis was sepsis by streptococcus agalactiea. The report stated that the physician considers that there is no relationship between the vaccine administration and the adverse event. Additional information has been requested.


VAERS ID: 197506 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2003-01-27
Onset:2003-01-28
   Days after vaccination:1
Submitted: 2003-02-06
   Days after onset:9
Entered: 2003-02-11
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (TRITANRIX) / GLAXOSMITHKLINE BIOLOGICALS 15894A3 / UNK - / -
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS 749A47 / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Crying, Irritability, Mydriasis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? 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: UNK
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0290874A

Write-up: This report was received from a physician and describes the occurrence of a sudden death in a 3 month old boy receiving diphtheria tetanus whole cell pertussis, hepatitis B vaccine (Tritanrix Hep B) mixed with hemophilus influenza vaccine (Hiberix) for prophylaxis. Concomitant drugs included a dose of BCG, oral Polio and hepatitis B vaccine given at birth, a dose of Act Hib and a dose of Tritanrix Hep B given at the age of 45 days. Tolerance for these vaccines was not reported. On 1/27/03, at around 19:00, a dose of Tritanrix Hep B (lot # 1589A3) mixed with Hiberix (lot # 749A47) in one syringe was given. After vaccination, the boy remained for about 15 minutes at the hospital and there was no manifestation of any allergic reaction. Later on the same day, the baby developed unusual crying and irritability and his parents had difficulties in quieting him. This lasted until midnight. On 1/28/03 at 08:00, he was noted to have mild fever for which he was given paracetamol. The boy was put to bed and at around 10:00 the parents found that the child was very quiet and motionless. They were alarmed and brought the child to the hospital. The child was dead on arrival. There was no heart beat detectable and pupils were dilated. Resuscitation measures included chest compression and ventilation with bag and mouth were instituted. Intra cardiac adrenalin was given, but there was no response. The baby was declared dead. The reporter did not assess a causal relationship. Additional information has been requested. A 15-day follow up report received 9/17/2003 adds: No additional info could be obtained and this case has been closed.


VAERS ID: 197848 (history)  
Form: Version 1.0  
Age: 6.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2003-02-11
Entered: 2003-02-19
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (IMOVAX) / SANOFI PASTEUR - / 2 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Drug ineffective
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:
Current Illness:
Preexisting Conditions: PT was recruited into the study "Safety and immunogenicity of pre-exposed rabies vaccination in HIV-infected children", starting on 4/2/97.
Allergies:
Diagnostic Lab Data:
CDC Split Type: F200300266

Write-up: A 6 y.o. perinatally HIV-infected Thai girl was admitted to a hospital because of Pneumocystis carinii pneumonia, cervical lymphadenopathy, oral candidiasis and a I-y history of lymphocytic interstitial pneumonitis. She had a CD4 + T-cell count of 44 cells/mm3 (4%) and polyclonal hypergammaglobulinemia. Pediatric AIDS, category C3, was diagnosed. A regimen of zidovudine plus didanosine was prescribed, which was eventually changed to zidovudine plus lamivudine. Funding for more conventional triple-drug therapy was not available. The PT was recruited into the study "Safety and immunogenicity of pre exposed rabies vaccination in HIV-infected children", starting on 4/2/97. One ML of human diploid cell rabies vaccine (HDCV) with an antigen content of 9.3 IU/ml was injected IM in the deltoid area on days 0, 7 and 28. Plasma HIV-RNA remained at levels between 5 and 6 log copies/ml from day 0 to day 570 post-vaccination. Plasma CD4 + T-cell levels were assayed during the first 4 weeks of vaccination, no significant differences being found. Geometric mean titers of rabies-neutralizing antibodies were below the detectable level (<0.04 IU/ml) from day 0 to day 90, except for a specimen on day 60 which contained 0.08 IU/ml, i.e. lower than the protective level ($g0.15 IU/ml) recommended by the CDC. On 4/13/98, the girl was bitten on her left foot and calf by a domestic dog. The history of rabies vaccination of this dog was unknown but it was still alive 2 weeks later and was therefore presumably not rabid. On 6/9/98, the girl was examined at a medical center and 0.1 ml of purified vero cell rabies vaccine (PVRV) was injected IM at 4 sites on days 0, 3, and 7 at 2 sites on days 30 and 90. On 5 occasions, from 3 to 90 days after the start of post-exposure vaccination, antibody titers were consistently <0.07 IU/ml. She died at home in early 99, probably due to AIDS and pulmonary complications. No rabies disease was reported. This article described low titers of rabies-neutralizing antibodies (in an HIV infected subject), which does not correspond to the definition of a "vaccine failure".


VAERS ID: 197850 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2002-11-26
Onset:2002-12-03
   Days after vaccination:7
Submitted: 2003-02-12
   Days after onset:71
Entered: 2003-02-19
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Meningitis, Pyrexia, Sensation of heaviness
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious meningitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-12-08
   Days after onset: 5
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: Hydrocephalus; meningoencephalitis
Allergies:
Diagnostic Lab Data: Serum measles IgG antibody on 12/8/02, comment: no results reported, measles; Serum measles IgM antibody on 12/8/02, comment: no results reported, measles; Serum mumps IgG antibody on 12/8/02, comment: no results reported, mumps; Serum mumps IgM antibody on 12/8/02, comment: no results reported, mumps; Serum rubella IgG antibody on 12/8/02, comment: no results reported, rubella; Serum rubella IgM antibody on 12/8/02, comment: no results reported, rubella; Autopsy: big, swollen, fluid-filled and slightly asymmetric brain with thick membrane and compressed under side, content of stomach found in air pathways,
CDC Split Type: WAES0302USA00230

Write-up: Information has been received from a health authority concerning a 12 year old female who on 11/26/02 was vaccinated with a dose of MMR II. It was noted that the pt had a history of "intern hydrocephalus and signs of meningioencephalitis," but the onset of these is unclear. There was no concomitant medication. Eight days after vaccination, on 12/3/02 the pt developed a fever. On 12/8/02 the pt died (cause of death not reported). Follow up information from the health authority indicated that on 12/3/02 the patient developed numbness in her arms and legs. On 12/7/02 the patient developed a fever up to 40.3C. After contact with a doctor, the patient received penicillin treatment (tablets). On 12/8/02 the patient continued to complain about the pain in her legs and arms, and she was vomiting. The patient''s temperature decreaed to 37.3C. The patient was examined by a doctor 1/2 hour before her death. The doctor said that the patient was able to walk in her room and one could talk to her. The results of the autopsy showed, big, swollen, fluid-filled and slightly asymmetric brain with thick membrane and compressed under side. The content of the stomach has been found in the air pathways. There were no other findings. Clinical examinations showed in both lungs insignificant presence of bacteria type haemophilus haemoliticus. Intestinal bacteries type pseudomas aeruginosa was present in the normal range. Antigen examination did not show presence of meningococs type A, B, and C or pneumococcal polysaccharide. The presence of borelia IgG and IgM had not been shown. Examinations of antibody against MMR viruses showed the presence of IgG and IgM against measles and IgM against mumps but not IgG. IT was not founded any signs or acute or earlier infections with measles virus or reaction on this infection. Neuropathological examinations showed chronic changes in the brain membrane as a result of coalescence of the frontal lobe with brain membrane and brain surface reminding inflamed cell infiltration. The pattern of cell infiltration occurred along cavity forms the typical glial scar. It was reported that the chances in the brain membrane had started at least a half hear ago or for several years ago. The health authority assessment indicated that the results of the autopsy and other examinations showed that compression of the brain causes death from lack of breathing or heart stop. The changes in the brain membrane indicated that earlier cerebrospinal memingitis resulted in the formation of a cavity. The assessment noted, it is unclear if the increased fluid content in the brain was the result of MMR vaccinatoin or infection, possible influenza. However, the results of the examinations showed that the most likely, the increased fluid in the brain and resulted compression of the brain was the consequence of virus infection during earlier cerebrospinal meningitis resulting in formation of cavity in the brain. Follow up information, in the form of an autopsy report, indicated that the patient developed afever and felt well on 12/3/02 on her way home from school. The family took it to be influenza, as a number of families had had it. On 12/8/02 the patient continued to get worse, vomiting and still complaining of a sensation of heaviness and pains in her arms and legs. Post mortem findings were: stomach contents found to have been sucked down into the airways, and an large, swollen, fluid-filled and slightly asymmetrical brain with thickened meninges and signs of pressure on the underside. No pathological changes otherwise. Additional examinations indicated that a full bacteriological examination was carried out, indicating only isolated bacteria of the type haemophilus haemoliticus in both lungs, and these were not attributed any significance. Cultures were taken for pathogenic intestinal bacteria, indicating the presence of naturally occurring pseudomonas aeruginosa. No antibodies were found for rubella. It was noted that the results for mumps antibodies were consistent with a recently administered vaccination, and no previous infection with rubella, or sign of reaction ot the administered vaccine was demonstrated. The neuropathological examination revealed chronic changes, with a thickened meninx and subsequent coalescence of the frontal lobes and attaching of the meninges to the surface of the brain, plus the presence of small inflammatory cell infiltrates. Isolated inflammatory cell infiltrates were observed around the vessels and along their cavities, plus the presence of scar tissue in the form of so-called gliosis. The changes were interpreted as an existing result of a previous inflammation in the meninges and brain tissue, which had taken place at least 5 years ago, or possibly more. Brain atrophy was demonstrated and an enlarged brain cavity wsa noted. Acute fluid accumulation was also found in the brain, with signs of the cerebrum having been pressed down around the brain stem. The conclusion was that, cause of death may be assumed to be respiratory and cardiac arrest resulting from downward pressure on the brain. It was noted that changes found in the brain indicated a past meningeal and brain inflammation, with a subsequently enlarged brain cavity. It was further noted that of relevance is the finding of pronounced fluid accumulation and subsequent downward pressure from this. The extent to which fluid accumulation in the brain was caused by MMR vaccine or an infection, possibly influenza, cannot be determined with certainty, but based on antibody determinations and culture results, it is most likely that fluid accumulation and subsequent downward pressure on the brain arose due to a viral infection in either the previously inflamed meninges or brain (which had occasioned an enlarged brain cavity), in an already weakened 12 year old girl. It was noted that the pt was examined for IgG and IgM for measles, mumps and rubella, but no results were reported. Additional information is not expected. Case closed.


VAERS ID: 199294 (history)  
Form: Version 1.0  
Age: 1.08  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2003-03-07
Entered: 2003-03-12
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Coma, Convulsion, Haemorrhage intracranial, Hypotonia, Thrombocytopenia, Vomiting
SMQs:, Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Haemorrhagic central nervous system vascular conditions (narrow), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Imaging studies revealed subdural hemorrhage; physical examination flaccid and unresponsive; platelet count 50x10 to the 9/L
CDC Split Type: WAES0302CAN00126

Write-up: Information has been received from three physicians publishing an article titled "Thrombocytopenia after immunization of children, 1992 to 2001" concerning a 13 month old male who was vaccinated between 1992 to 2001 with MMR II. Subsequently the pt experienced thrombocytopenia and was hospitalized 6 days post therapy with MMR II. The authors reported that the pt was previously well but had fallen down a few stairs three days prior to hospitalization. On the day of admission the pt had vomited and had a seizure. A physical examination was done that revealed the pt to be flaccid and unresponsive. Subsequently, imaging studies of his head revealed a subdural hemorrhage and a blood platelet count of 5x10 to the 9/1. The pt was treated with four units of platelets, one dose of hydrocortisone and two doses of IV immunoglobulin. Within a few hours of being hospitalized the pt died. The authors felt that the cause of death was intracranial haemorrhage nos. No further info is available.


VAERS ID: 201462 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Female  
Location: Foreign  
Vaccinated:2003-02-11
Onset:2003-03-31
   Days after vaccination:48
Submitted: 2003-04-11
   Days after onset:10
Entered: 2003-04-15
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / 3 - / -

Administered by: Other       Purchased by: Other
Symptoms: Infection, Laboratory test abnormal, Meningitis, Pyrexia, Rhinorrhoea
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious meningitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-04-01
   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: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Sample taken on 04/01/03: Hematology; Hemoglobine: 9,6g% (NV: 10, 0-13, 5); Leucocyte: 22700/mcL (NV: 7000-16000); Formula; Neutrophil: 40% (10-30); Presence of reactional lymphocyte; Neutrophylia abs.: 9080/mm3 (NV: 700-4800); Platelet: (x1000) 84/mcL (NV: 130-400); No microcoagulation seen; Electrolyte; Potassium: 16,61mM/L (NV: 3, 70-5,70); Sodium 123mM/L (NV: 135-145); Chlore: 93mM/L (NV: 98-108); CO2: 15mM/L (NV: 23-30); Enzyme; GOT (ASAT): 154 U/L (NV: <37); GPT (ALAT) 43 U/L (NV: <41); Proteins; Proteins: 62,0 g/L (NV: 57,9-69,6); IgG: 7,62 g/L (NV: 3,50-11,80); IgG2: 0,72 g/L (NV: 0,215-4,40); IgG3: 0,43 g/L (NV: 0.134-0,694); CRP: 283 mg/L (NV: <10);
CDC Split Type: E200300216

Write-up: It is reported that a 5.5 months old female presented with like cold symptoms on 3/31/03 at the day nursery: she experienced fever and running nose on the afternoon. During the night she experienced another fever episode. A physician was called but did not find any alarming symptoms. On the next morning the baby was found dead in her bed. She was taken to the emergencies where meningitis due to Haemophilus influenzae was diagnosed. The serotype is not yet defined. According to the parents the baby received the three first doses of the primary vaccination of Hib. More info is expected. A 15-day follow up report received 04/21/2003 adds: Follow up on 04/10/2003. The serotype of Haemophilus influenzae was b. More info is expected. Follow up on 05/05/2003 It is confirmed that the baby received the 3 first doses of the primary vaccination of Hib (Act-HIB): P1 on 12/02/2002, P2 on 01/02/2003, P3 on 02/11/2003. The 3 doses were administered IM; P1 and P2 by MD, P3 by the GP. The sites of administration and the lot numbers are not reported. More info is expected. A 15-day follow up report received 6/24/2003 adds: Follow up on 06/13/2003: It is confirmed that the baby received the first 3 doses of the primary vaccination of diphtheria-tetanus-acellular pertussis-inactivated polio vaccine (TETRAVAC) comcomitantly with the Hib vaccination (lot numbers not reported), both vaccines mixed together. On 11/02/2002 she also received the first dose of the hepatitis b thiomersal free vaccination (HEVAXPRO) in another site; the site and the route of administration and the lot number are unknown. More info is expected. Follow up on 02/09/04: "It is confirmed that the baby received the first 3 doses of the primary vaccination of Hib (Act-Hib): P1 on 02/12/02, P2 on 02/01/03, P3 on 11/02/03. The 3 doses were administered IM; P1 and P2 by Kind an Gexin, P3 by the GP. The sites of administration and the lot numbers are not reported. More information is expected. Follow up on 06/13/03: It is confirmed that the baby received the first 3 doses of the primary vaccination of diphtheria-tetanus-acellular pertussis-inactivated polio vaccine (Tetravac) concomitantly with the Hib vaccination (Lot #''s not reported), both vaccines mixed together. On 11/02/03 she also received the first dose of the hepatitis B thimomersal free vaccination (Hevaxpro) in another site; the site and the route of administration and the lot number are unknown. More information is expected. Follow up on 01/27/04: The result of the anti-PRP antibodies has been received: <0.15ug/ml. According to the normal values this result has to be considered as negative. It is precised that the testing has been done by two different technicians, in duplicate (pure serum) and with successive dilutions from 1/2 to 1/500. More information will be asked. Follow up on 03/03/04: Lab data have been received. It is reported that the spinal fluid sample and the blood sample were taken on 04/01/03 and kept in good conditions. No more information is expected. Case is closed. Follow up on 04/07/04: "The result of the anti-PRP antibodies has been received: <0.15ug/mL. According to the normal values this result has to be considered as negative. It is precised that the testing has been done by two different technicians, in duplicate (pure serum) and with successive dilutions from 1/2 to 1/500. More information will be asked."


VAERS ID: 201528 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Female  
Location: Foreign  
Vaccinated:2001-02-28
Onset:2003-03-01
   Days after vaccination:731
Submitted: 2003-04-11
   Days after onset:40
Entered: 2003-04-15
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 14959A9C / UNK - / -
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS 14959A9C / UNK - / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER 14959A9C / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Cyanosis, Sudden infant death syndrome
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-03-01
   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: UNK
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Post-mortem examination
CDC Split Type: B0296577A

Write-up: This report received from a foreign regulatory authority describes the occurrence of a sudden infant death syndrome in a 7 month old girl receiving diphtheria tetanus acellular pertussis inactivated polio vaccine and haemophilus influenza type B vaccine for prophylaxis. The child was previously healthy. Two days prior to vaccination, she had high fever. On 2/28/01, she had slight airway difficulties and she was a little bit gurgling. The doctor listened to her heart and did not find anything wrong. The same day, she was vaccinated. In the evening, she was well. The day after, in the morning, she was found laying dead on her stomach in her bed. She was already cold and stiff with blue spots on her face. (Approximately 1.5 weeks earlier, her whole family had similar influenza disease). A post-mortem examination was performed and did not find any signs of infection in brain or salivary gland (brain was swollen with microglia knots and there was inflammation changes and inclusion bodies that by CMV infection in salivary glands.) The findings were concluded in the post-mortem report that it probably has been a generalized virus infection and that this infection might have caused the death. The death was classified as sudden infant death syndrome. There were no causal relationship between the death and the vaccination. The case has been closed.


VAERS ID: 202594 (history)  
Form: Version 1.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2003-05-01
Entered: 2003-05-06
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Ecchymosis, Petechiae, Platelet disorder, Renal failure, Sepsis, Shock
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Haematopoietic thrombocytopenia (broad), Haemorrhage terms (excl laboratory terms) (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), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: Splenectomy
Allergies:
Diagnostic Lab Data: Diagnostic lab tests; Blood culture. Chest X-ray: no abnormalities; Pulse Oximetry: 70%; Ultrasound: Echography revealed well-filled v. cava inferior with no indications of cardiac temponade/hemothroax; Arterial Blood HCO (3): 3.6 mmol/L; Arterial Blood pCO (2): 2.2 kPa; Arterial Blood pH: 6.95; Body temperature: Fever; Serum Potassium: 7.5 mmol/L, hyperkalemia; Vital Sign: 40/minute, respiratory rate; Blood base excess measurement: -27 mmol/L; Blood culture: see narrative
CDC Split Type: WAES0304USA02260

Write-up: Information has been received from a literature article. One pt was a 41 year old female with a history of splenectomy who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. The other previously splenectomized 41 year old female pt was not vaccinated. Both pts were admitted to intensive care unit due to fulminant sepsos. Upon admission, petechiae and ecchymosis characterized the clinical presentation of both pts. Laboratory testes revealed the presence of renal insuffunciency and thrombocytopenia with disseminated intravascular coagulation. Streptococcus pneumoniae with serotypes (24 and 38) not included in the current polyvalent pneumocaccal vaccine were found in blood cultures from both pts. One pt died as a result of a refractory septic shock. The other pt, who had never been vaccinated with pneumococcal vaccine 23 polyvalent, survived the sepsis. The authors concluded that the clinical course of a fulminant Streptococcus pneumonia sepsis in both pts underlines the importance of vaccination. No further information is available. Received on 06/17/2003: "This report has been amended with additional information received in the English translation of the article. This report has been corrected as amended. A copy of the original article and the English translation are attached as further documentation of the patient''s experience.


VAERS ID: 205279 (history)  
Form: Version 1.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2003-04-01
Onset:2003-05-29
   Days after vaccination:58
Submitted: 2003-06-19
   Days after onset:21
Entered: 2003-06-24
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-05-29
   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: Mental disorder NOS
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0306NZL00011

Write-up: Information has been received concerning a 36 year old male with mental disorder NOS who on approximately 4/1/03 was vaccinated with his first dose of hep B vaccine. On approximately the 5/29/03 the pt received his second dose of hep B vaccine in the morning. He then went to work. In the afternoon around 1pm his colleagues noticed he was not looking well and he left work. At approximately 3 pm the pt was witnessed crashing his car down a bank. He was then seen walking away from the vehicle. Later that day the pt died of internal injuries as seen in a post mortem. The cause of death was internal injuries caused by a motor vehicle accident. Additional info has been requested. A 15-day follow report received 7/7/2003 adds: In the returned correspondence administering doctor wrote "Given routinely 10 micrograms of hepatitis B virus vaccine rHBsAg (yeast) into R deltoid at 10:30 am. Waited the accepted 10-15 minutes - was observed through this time and left well". Additional info is not expected.


VAERS ID: 205364 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Female  
Location: Foreign  
Vaccinated:1982-10-01
Onset:1983-06-01
   Days after vaccination:243
Submitted: 2003-06-20
   Days after onset:7324
Entered: 2003-06-25
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MU: MUMPS (MUMPSVAX II) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Encephalopathy, Lung disorder, Respiratory failure
SMQs:, Anaphylactic reaction (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), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1983-06-01
   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: UNK
Current Illness:
Preexisting Conditions: Encephalopathy; Immunization; Brain damage
Allergies:
Diagnostic Lab Data: Clinical serology test
CDC Split Type: WAES0306USA01724

Write-up: Information has been received from two health professionals concerning a 27 month old female with early childhood brain damage of unexplained origin and a history of measles encephalopathy in approximately 2/82, who eight months later, in approximately 10/82, was vaccinated with mumps virus vaccine live. In 10/82, twelve days post vaccination, the patient developed a typical picture of encephalitis. Virus serology gave no evidence of other cause, only seroconversion for mumps. In June 1983, the patient died. The cause of death was pulmonary and central respiratory insufficiency. The authors indicated that the child was vaccinated eight months post measles encephalopathy and she should not have had a mumps vaccination after this short vaccination interval. The fact that encephalitic symptoms repeatedly occurred here would be compatible with the clinical picture of recurrent encephalitis, which may also be triggered by vaccinations and administration of serum. Upon internal review, encephalitis was considered to be an other important medical event. No further information is available.


VAERS ID: 205367 (history)  
Form: Version 1.0  
Age: 1.6  
Sex: Female  
Location: Foreign  
Vaccinated:1982-01-05
Onset:1982-01-09
   Days after vaccination:4
Submitted: 2003-06-20
   Days after onset:7831
Entered: 2003-06-25
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MM: MEASLES + MUMPS (MM-VAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Convulsion, Electroencephalogram abnormal, Encephalitis, Laboratory test abnormal, Loss of consciousness, Mydriasis, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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: 1982-01-14
   Days after onset: 5
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: Assisted ventilation; EEG: severe general alterations; Intubation; Spinal tap unremarkable and 145/3 cells; Measles antibody negative, mumps antibody negative; Mycoplasma pneumoniae titer 1:16;Lymphatic structure biopsy: echo virus type V; Other virus titers negative; Body temp: fever; Clinical serology test: narrative; Body temp: 40C; Diagnostic lab test: othre virus titers negative; Autopsy: meningoencephalitis of middle grade extension; Diagnostic lab test: mycoplasma pneumoniae titer: 1:16; Lymphatic structure biopsy: Echo virus type V; Spinal tap: 145/3 cells; Intubation; EEG: severe general alterations; Spinal tap: unremarkable;
CDC Split Type: WAES0306USA01727

Write-up: Information has been received from two health professionals concerning a 19 month old female who in May 1982, was vaccinated with measles (+) mumps virus vaccine live. In May 1982, on the day of vaccination, the patient had serous rhinitis, but was in good general health. On the 6th day, the patient had a fever (value not reported). On the 7th day, the patient''s fever was 40 degrees C. On the 8th day, the patient developed unconsciousness with convulsions. The lumbar puncture was unremarkable. Subsequently, the patient developed deep coma. Her EEG noted severe general alterations. The patient required intubation and was placed in a respirator. On the 9th day, her pupils were fixed and dilated with muscular hyptonia. The lumbar puncture indicated 145/3 cells, virus serologic findings were negative. Subsequently, the patient died. A lymph node biopsy specimen detected Echo virus type V. The measles and mumps antibodies were negative as well as all other virus titers examined. The mycoplasma pneumoniae titer 1:16 section noted moderately distinct meningoencephalitis, signs of central death. The outcome of the meningoencephalitis was not reported. Upon internal review, meningoencephalitis was considered to be immediately life-threatening and an other important medical event (OMIC). No further information is available. A 15-day follow up report received 10/31/2003 adds: Additional info was received which reported the vaccination date as 01/05/1982. In addition, the pt was reported as a 15-month old female pt, with a slight respiratory infection and acute rhinopharyngitis, who was vaccinated with measles virus vaccine live (+) mumps virus vaccine live vaccine, 0.5 ml, subcutaneous administration. Concomitant medications included "analgesics/antirheumatics". Additional pt info included that the pt suffered from brain edema and subsequently, the pt was hospitalized. The date of death was reported as 01/14/1982. The autopsy revealed meningoencephalitis was considered to be immediately life-threatening and an other important event. In addition, the article discussed the experiences of 28 other patients (WAES #0305USA00689, WAES #0306USA01721 through WAES #0306USA01725 and WAES #0306USA01727 through WAES #0306USA01748). No further info is available. This article was identified during a review of the literature for MMR II. A copy of the English translation has been provided. A 15-day follow up report received 10/31/2003 adds no new info. Follow up on 01/09/04: "This is an amended report. The date of vaccination now reads 01/05/1982 instead of 01/05/1985."


VAERS ID: 205516 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2003-05-01
Onset:2003-05-01
   Days after vaccination:0
Submitted: 2003-06-23
   Days after onset:53
Entered: 2003-06-27
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0285M / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arteriosclerosis, Infection, Loss of consciousness, Obesity, Pneumonia
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), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-05-01
   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: Gliclazide; Acetaminophen (+) proproxyphene napsylate; Ibuprofen
Current Illness:
Preexisting Conditions: Diabetes mellitus; obesity; pain; smoker
Allergies:
Diagnostic Lab Data: Body weight 128kg
CDC Split Type: WAES0306USA01829

Write-up: Information has been received from a health authority concerning a 53 year old male with obesity, diabetes mellitus, a cigarette smoker, and pain who on 5/1/03 was vaccinated IM with a dose of pneumococcal vaccine 23 polyvalent (lot # 643164/0285M)(batch # HS31780). Concomitant therapy included 80mg of gliclazide daily for diabetes mellitus since 2001, 400mg of ibuprofen when required for pain since 2000, and acetaminophen (+) propoxyphene napsylate when required for pain since 2000. It was reported that the patient felt unwell within 24 hours of vaccination due to chest infection. The patient was admitted to the hospital where he improved. The patient was ready to come home when he suddenly collapsed and died. Bronchopneumonia was reported as a diagnosis. The probably causes of death were reported as bronchopneumonia and artherosclerosis. A post-mortem was not carried out to determine the cause of death. No further information is expected. The case is closed. Follow up info received on 7/14/03 indicated that the pt felt unwell within 24 hrs with flu-like symptoms. The pt''s chest was clear. Three days later, the pt was very much worse. The diagnosis was basal crepitations and chest infection. The pt was given azithromycin 500mg daily for 3 days. Three days later, the pt was no better and was admitted to the hospital. In the hospital, the pt improved and was ready to come home when he suddenly collapsed and died. No further info is expected. The case is closed.


VAERS ID: 205838 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Foreign  
Vaccinated:2001-01-01
Onset:2001-01-27
   Days after vaccination:26
Submitted: 2003-07-02
   Days after onset:885
Entered: 2003-07-07
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 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: Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-01-27
   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:
Current Illness: UNK
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: D0041251A

Write-up: A physician reported the occurrence of sudden death in an unknown patient who was vaccinated with diphtheria tetanus pertussis poliomyelitis/haemophilus influenza B vaccine and hepatitis B vaccine for prophylaxis. The event occurred during a study conducted between 1998 and 2001, financed by foreign authorities concerning sudden infant deaths following vaccination. Details regarding anamnesis were missing. Only information received was that there was no mention of a history of convulsions. On an unknown date, the subject received a dose of both diphtheria tetanus pertussis poliomyelitis/haemophilus influenzae B vaccine and hepatitis B vaccine. Twelve or less days post vaccination, the subject suddenly died. Information received did not report the subject to show brain edema. The reporting physician and especially the leader of the study centre, who was in contact to the vaccinating pediatrician, did not consider the death of the subject to be related to vaccination with diphtheria tetanus pertussis poliomyelitis haemophilus influenzae b vaccine and hepatitis B vaccine. Hence this case has not formally been reported to the foreign regulatory authority. However, since there is a contact between the reporting physician and the PEI is aware of the number of lethal cases occurring in this study. For the time being, details have not been exchanged because of the missing consent of the parents. However, further information has been requested. Through requested study leaver was not willing to provide more details for this case. But he confirmed again that there was no causal relationship between SIDS and the vaccination.


VAERS ID: 206349 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2002-10-05
Onset:0000-00-00
Submitted: 2003-07-16
Entered: 2003-07-18
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-05-06
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: There was a suggestion that septicaemia was brought about by a urinary tract infection (no details provided).
Allergies:
Diagnostic Lab Data:
CDC Split Type: E200301403

Write-up: A 76 year old female patient received pneumococcal and influenza immunizations on 10/5/02. She is reported to have had pneumonia from which she did not recover. She is also reported to have had Septicaemia. Severity of the conditions is stated as unknown. However, the outcome was fatal (date of death 5/6/03). Post mortem was performed. Sudden death was discounted. Probable cause of death was Septicaemia and Pneumonia. Reaction text states "No definite cause of death was evident at autopsy, but the histology findings suggested that the patient died of pneumonia brought about by septicaemia. It was suggested that the septicaemia was brought about by a urinary tract infection (no details are provided). No further information is expected. Case is closed.


VAERS ID: 206407 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2003-07-16
Entered: 2003-07-21
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Drug ineffective, Immunoglobulins decreased, Sepsis
SMQs:, Lack of efficacy/effect (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? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Spelenectomy; IgA deficiency; Thrombocytopenia purpura
Allergies:
Diagnostic Lab Data: Serum Immunoglobulin A test: <0.05 g/L; "gammaglobulins" were normal; "complement fractions" were normal.
CDC Split Type: WAES0307USA01325

Write-up: It was reported in a published article that a 25 year old female patient with a medical history of IgA deficiency, autoimmune thrombocytopenic purpura since 1995 and a splenectomy in 1996 for persistent thrombocytopenia who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently, the patient developed vaccination failure. Diagnostic lab data included: IgA <0.05g/L. It was noted that the patient experienced 1 episode of septicemia in 1998 with purpura fulminans, and a fatal outcome was reported. The reporter also mentioned two other patients who developed vaccination failure after receiving pneumococcal vaccine 23 polyvalent. Upon internal medical review, septicemia was considered an other important medical event (OMIC). No further information is expected. A copy of the published article is attached as further documentation of the patient''s experience. A copy of an English translation will be provided, when available. Follow up on 12/31/2003: "This is an amended report. The date received by manufacturer of the previous report was 11/14/2003 and has been corrected to 09/05/2003." Follow up on 12/04/03: "A copy of the published article is attached as further documentation of the pt''s experience. A copy of an English translation is attached." Follow up on 02/13/04: "On 01/28/04 information was received through a letter from the author that noted that he had only little complementary information compared to the publised article. According to this letter, "2 among the 3 pt''s died". The cause of death was not reported and the concerned pt''s were not identified. To the author''s knowledge no pneumococcal serotyping was performed in the 3 pt''s. They were all under oracillin prophylaxis (between 1 and 2 million units/day). No further information is expected. The case is closed."


VAERS ID: 206467 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2002-10-05
Onset:0000-00-00
Submitted: 2003-07-15
Entered: 2003-07-22
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-05-06
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: no definite cause of death; Post-mortem study: sudden death discounted; Diagnostic pathological examination: suggest patient died of pneumonia brought about by septicemia.
CDC Split Type: WAES0307USA01189

Write-up: Information has been received from a health authority concerning a 76 year old female patient who on 10/5/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Concomitant vaccination included a dose of influenza virus vaccine. Subsequently, the patient developed pneumonia from which she did not recover. The patient also developed septicemia. The severity of the conditions was unknown, however, the outcome was fatal (date of death: 5/6/03). A post mortem study was performed. Sudden death was discounted. Probable cause of death was Septicemia and Pneumonia. (Outcome of Septicemia Fatal, associated direct or indirect). No definite cause of death was evident at autopsy, but the histiology findings suggested that the patient died of pneumonia brought about by septicemia. It was suggested that the septicemia was brought about by a urinary tract infection. The case is closed. Additional information is not expected.


VAERS ID: 207625 (history)  
Form: Version 1.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:1998-03-15
Onset:1998-07-01
   Days after vaccination:108
Submitted: 2003-08-08
   Days after onset:1864
Entered: 2003-08-11
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 1909A6 / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Difficulty in walking, Hernia, Thermal burn
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), 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:
Current Illness: UNK
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: In October 1998: CT scan and MRI were performed and a cervical hernia was evoked.
CDC Split Type: B0305876A

Write-up: This case was reported by a foreign regulatory authority and described the occurrence of amyotrophic lateral sclerosis in a 46 year old female subject who was vaccinated with Engerix B for hepatitis B prophylaxis. Concurrent vaccinations included four injections of GenHevac B at 20mcg received on 1/8/92, 2/6/92, 3/11/92 and in March 1993. On 3/15/98 the subject received an IM injection of Engerix B at 20mcg. On 7/1/98, the subject presented with dysesthesia of lower limbs with burning sensation and walking troubles. In October 1998, CT scan and MRI were performed and a cervical hernia was evoked. A first surgery was carried out and then a second one in November 1998. In 3.99, no improvement was noticed and amyotrophic lateral sclerosis was diagnosed. In March 2001, events went worsening until the subject''s death. It is unknown whether an autopsy was performed. According to the agency, the events were unlikely related to Engerix B vaccine and to Genhevac vaccine. Follow up on 01/23/04: "In 10/98: CT scan and MRI were performed and a cervical hernia was evoked."


VAERS ID: 207696 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2002-11-27
Onset:2002-12-02
   Days after vaccination:5
Submitted: 2003-08-07
   Days after onset:247
Entered: 2003-08-12
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 MO / PO
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Asphyxia, Sudden infant death syndrome
SMQs:, Acute central respiratory depression (narrow), Hostility/aggression (broad), Neonatal disorders (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-12-02
   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: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: HQWYE904905AUG03

Write-up: Information has been received from a regulatory authority concerning a 3 month old male patient who received an injection of Prevnar on 11/27/02. Concomitant vaccines included diphtheria/tetanus toxoid/acellular pertussis vaccine and hepatitis B and Sabin vaccine. On 12/2/02, the mother found the child not breathing. The infant was diagnosed with possible SIDS. The reporter indicated that these events were possibly related to the administration of the vaccines. No additional information was available at the time of this report. Follow-up received provided death certificate information signed by a pathologist. Information has been received form a regulatory authority concerning a 3-month-old male patient who received an injection of Prevnar (pneumococcal 7-valent conjugate vaccine) on 27-Nov-2002. Concomitant vaccines included diphtheria/tetanus/toxoid/acellular pertussis vaccine and hepatitis B (manufacturer unknown) and (poliovirus vaccine live oral) vaccine. Medical history: Relevant medical history was not provided. Product Details: Indication for Prevnar was immunization. Product was administered on 27-Nov-2002. Dose regimen was one dose (intramuscular). Concomitant Therapy: Concomitant medications wre not reported. Event Details: On 02-Dec-2002, the mother found the child not breathing. A death certificate stated the cause of death was asphyxia (asphyxia) and sudden infant death syndrome (suddent infant death syndrome). A postmortem examination was apparently performed but the detailed report was not provided. The reporter stated that the infant''s mother was a heavy smoker. The reporter considered these events to be "possibly related" to the administration of the vacines. This report was received from Australia (Ref No. 182403). Reg Authority Ref Num- 207696-1.


VAERS ID: 208218 (history)  
Form: Version 1.0  
Age: 6.0  
Sex: Female  
Location: Foreign  
Vaccinated:2002-08-22
Onset:2002-09-06
   Days after vaccination:15
Submitted: 2003-08-21
   Days after onset:349
Entered: 2003-08-25
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIE-VAX) / SANOFI PASTEUR - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Agitation, Diarrhoea, Drug ineffective, Headache, Infection, Injury, Photophobia, Pyrexia, Salivary hypersecretion, Vomiting
SMQs:, Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2002-09-04
   Days after onset: 2
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: F200300138

Write-up: It was reported that a 5 year-old child was bitten by a dog and dead approximately 15 days after treatment. A serum might have been used for the treatment. File to be completed. Follow-up on January 22, 2003. In fact, a 6 year old girl was bitten on 22 AUG 02 by a dog in the city. The wounds were on cheek, forehead and right shoulder. On the same day of exposure she received on dose of Verorab lot T1316-3 plus 450IU of human antirabies immuneglobulins lot 015898/01. The second does was given on 25 AUG 02. On 26 AUG 02, the wound on the cheek was sutured in a hospital. The third and fourth doses of vaccine were injected on 29 AUG and 04 SEP 02. The little girl complained of headache and was hospitalized on 05 SEP with agitation, photophobia, hydrophobia, vomiting, salivation, fever, and diarrhea. The pt died on 06 SEP 02 and examination of the brain tissue by FAT confirmed rabies. The parents of the girl received full course of post exposure vaccination. Additional information received on August 12, 2003: It was reported that Rabies virus vaccine was isolated by mouse inoculation test, on 06 SEP 02. It was also reported that the pt''s brother, a 12 year old boy was bitten on the knee at the same time and by the same dog. He was transferred with his sister to a health center, on the day of the accident; he was treated against rabies by HROG and five doses of Vero rabies vaccine. He is quite health. Further information will be requested regarding the brother''s outcome.


VAERS ID: 209012 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2003-08-21
Onset:2003-08-24
   Days after vaccination:3
Submitted: 2003-09-05
   Days after onset:12
Entered: 2003-09-10
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER W0861 / UNK - / -
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. W0861 / UNK - / -
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. W0861 / UNK - / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER W0861 / UNK - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
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: 2003-08-24
   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:
Current Illness:
Preexisting Conditions: Premature baby. Gastroesophageal reflux disease. Birth weight 2160 g
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: DEWYE281203SEP03

Write-up: Information regarding Prevnar injection was received from a healthcare professional regarding a 3 month old female pt who experienced death and vomiting. The pt received a dose on 8/21/03. The girl was born premature in the 35 week of gestation as a twin. Indication for Prevnar was immunization. Product was administered on 8/21/03. Dose regimen was one dose IM. Concomitant therapy included Hexavac. The other twin (also girl) was vaccinated on the same day with the same vaccines. The pt experienced vomiting and death on 8/24/03. The mother found her dead in her bed, after mother fed and put her in bed in prone position. Vomit was found in and around the mouth. No additional info was available at the time of this report. Follow-up information was received regarding the change of an event, demographic data and autopsy result. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diptheria crm197 protein) injection) was received from a healthcare professional regarding a 3-month-old female patient who experienced sudden infant death syndrome and vomiting. The patient received a dose on 21-Aug-2003. Medical history: The girl was premature in the 35 week of gestation as a twin (born by caeserean section, birth weight 2160 g; APGAR score 9/10/10). The patient''s concurrent illnesses include gastroesophageal reflux disease. Product details: Indication for Prevnar was immunisation. Product was administered on 21-Aug-2003. Dose regiment was one dose (intramuscular). Concomitant Therapy: Concomitant therapy included Hexavac (diptheria/tetanus/pertussis vaccine/poliomyelitis/hepatitis b vaccine/ haemophilus influenzae b). The other twin (also a girl) was vaccinated on the same day with the same vaccines. Event Details: The patient experienced vomiting (vomiting NOS) and sudden infant death syndrome (sudden infant death syndrom) on 24-Aug-2003. The mother found her dead in her bed, after mother fed and put her in bed in prone position. Vomit was found in and round the mouth. The father tried to resuscitate her and she was taken to a hospital where resuscitation was stopped because it was unsuccessful. An autopsy was performed and the cause of death was sudden infant death syndrome. No additional information was available at the time of this report. Follow up on 02/05/04: "The pt experienced vomiting (vomiting NOS) and sudden infant death syndrome (SIDS) on 08/24/03. The mother found her dead in her bed, after mother fed and put her in bed in prone position. Vomit was found in and around the mouth. The father tried to resuscitate her and she was taken to a hospital where resuscitation was stopped because it was unsuccessful. An autopsy was performed and the cause of death was sudden infant death syndrome. It was started in the report that no signs of mechanical violence were detected. Furthermore "textural changes of an agonal nature. Consequence of means taken to resuscitation or expression of an immunoreaction, e.g. after immunization". No additional information was available at the time of this report."


VAERS ID: 209467 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2003-09-17
Entered: 2003-09-22
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Gastrooesophageal reflux disease
SMQs:, Gastrointestinal nonspecific dysfunction (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: Premature birth; Gastric disorder
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0309USA00381

Write-up: Information has been from an internet new site concerning a male infant, born prematurely at 28 weeks and suffers from a rare stomach disorder, who was vaccinated with a dose of MMR (second generation) (date unknown). Secondary suspect therapy included poliovirus vaccine inactivated (unspecified) (date unknown). The news report stated that "The patient who was born prematurely at 28 weeks suffered a rare stomach disorder. It meant that highly gastric contents entered his airways. But a top surgeon said that the infant suffered the unfortunate coincidence of undergoing immunization before he died while he was being bottle fed by his mother. A consultant neurosurgeon at a hospital, said he believed the immunization could have depressed the patient''s natural instinct to attempt to reject the milk. A pathologist from a hospital, said he was sceptical about any links between jabs and the death. But he said that the consultant neurosurgeon was better qualified to evaluate the risk than himself. On Tuesday, the Coroner recorded a verdict of accidental death after the patient, inhaled some gastric contents. She added: "I was thinking about recording the proximity of the immunization but probably it is too uncertain for me to say that. "But obviously, it is something important that health care practitioners will want to consider. File to be completed. Additional information is not expected.


VAERS ID: 209664 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2002-03-26
Onset:0000-00-00
Submitted: 2003-09-24
Entered: 2003-09-26
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
DTPHIB: DTP + HIB (DTP + ACTHIB) / SANOFI PASTEUR - / UNK RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-03-31
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: Patient history: A 3.5 month old baby developed cough, fever difficult breathing, indrawing beginning two days before vaccination.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200301978

Write-up: This case has been reported after completion of the clinical study ("A randomized, controlled clinical trial of the effect of Haemophilus Influenzae type B (HIB) vaccine on pneumonia and meningitis in children living in a foreign country". This study was conducted between 1998 and 2002. It was a randomized, controlled, double-blind trial comparing pneumonia and meningitis outcomes among children <2 yeas of age who were immunized according to the schedule with DTP or DTP PRP T vaccine. The primary outcome was radiologically confirmed alveolar infiltrate based on standard criteria. Preliminary results: 55,073 children were enrolled. DTP PRP T had a large effect on meningitis outcomes but prevented a small portion, of any, of measured pneumonia outcomes. More data on mortality rates are awaited. Patient history: A 3.5 month old baby developed cough, fever difficult breathing, indrawing beginning two days before vaccination. Taken to doctor but nurse did not treat or refer to hospital. Comments of the study physician: likely acute respiratory illness death. Unblinding of the clinical trial: the patient has been exposed to study vaccine: DTP HIB. A 15-day follow up report received 10/15/2003 adds: Additional info on 09/25, from principal investigator stating that the deaths were not related to vaccination and that infant mortality rate in that area before the study was 100/1000. Follow up information received on 10/27/2003 reported that the manufacturer for OPV ws Biofarma and not AvP.


VAERS ID: 209665 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2002-06-08
Onset:0000-00-00
Submitted: 2003-09-24
Entered: 2003-09-26
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
DTPHIB: DTP + HIB (DTP + ACTHIB) / SANOFI PASTEUR - / UNK RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pyrexia
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: 2002-06-09
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: Patient history: Following vaccination, a 4 month old baby developed fever.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200301972

Write-up: This report has been reported after completion of the clinical study. This study was conducted between 1998 and 2002. It was a randomized, controlled, double blind trial comparing pneumonia and meningitis outcomes among children < 2 years of age who were immunized according to the schedule with DTP or DTP-PRP-T vaccine. The primary outcome was radiologically confirmed alveolar infiltrate based on standard criteria. Preliminary results: 55,073 children were enrolled. DTP PRP T had a large effect on meningitis outcomes but prevented a small proportion, if any, of measured pneumonia outcomes. More data on mortality rates are awaited. Patient history: Following vaccination, a 4 month old baby developed fever. He died at home one day after receiving study vaccine without being seen by medical staff. Comments from study physician: Data insufficient to assign cause of death. Unblinding of the clinical trial: the patient has been exposed to study vaccine: DTP HIB. A 15-day follow up report received 10/15/2003 adds: Additional info on 09/25, from principal investigator stating that the deaths were not related to vaccination and that infant mortality rate in pt''s area before the study was 100/1000. Follow up on 11/05/2003: "Follow up information received on 10/27/2003 reported that the manufacturer for OPV was Biofarma and not AvP."


VAERS ID: 209666 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2002-06-06
Onset:2002-06-07
   Days after vaccination:1
Submitted: 2003-09-24
   Days after onset:474
Entered: 2003-09-26
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
DTPHIB: DTP + HIB (DTP + ACTHIB) / SANOFI PASTEUR - / UNK RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-06-07
   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: Patient history: A 3 month old baby developed fever and cough one day after receiving study vaccine.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200301967

Write-up: This case has been reported after completion of a clinical study. This study was conducted between 1998 and 2002. It was a randomized, controlled double blind trial comparing pneumonia and meningitis outcomes among children < 2 years of age who were immunized according to the schedule with DTP or DTP PRP T vaccine. The primary outcome was radiologically confirmed alveolar infiltrate based on standard criteria. Preliminary results: 55,073 children were enrolled. DTP PRP T had a large effect on meningitis outcomes but prevented a small proportion, if any, of measured pneumonia outcomes. More data on mortality rates are awaited. Patient history: A 3 month old baby developed fever and cough one day after receiving study vaccine. Parents thought baby had met a ghost, so they took her to the dukun. Baby died at home 4 days after vaccination without being seen by medical staff. Comments from study physician: Data insufficient to assign cause of death. Unblinding of the clinical trial: The patient has been exposed to study vaccine: DTP HIB. Follow up on 10/01/2003: "Additional information on 09/25, from principal investigator stating that the deaths were not related to vaccination and that infant mortality rate before the study was 100/1000." Follow up on 11/05/2003: "Follow up information received on 10/27/2003 reported that the manufacturer for OPV was Biofarma and not AvP."


VAERS ID: 209667 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2002-09-23
Onset:2002-09-27
   Days after vaccination:4
Submitted: 2003-09-24
   Days after onset:362
Entered: 2003-09-26
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
DTP: DTP (NO BRAND NAME) / SANOFI PASTEUR - / UNK RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chest pain, Cough, Pneumonia, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), 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: 2002-09-27
   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: Patient history: A female baby was admitted to hospital at 3 months of age with a diagnosis of pneumonia 4 days after receiving study vaccine. On admission, she had a respiratory rate of 55, a temperature of 37.5, chest retractions, cough, krakles, and an oxygen saturation of 70%. Hemoglobin was 4.4, WBC count was 7,000 with 52% segs. She was treated with ampicillin and gentamycin. X-ray was read as abnormal.
Allergies:
Diagnostic Lab Data: Hemoglobin = 4.4; WBC 7,000 with 52% segs.
CDC Split Type: 200301982

Write-up: This case has been reported after completion of the clinical study. This study was conducted between 1998 and 2002. It was a randomized, controlled, double-blind trial comparing pneumonia and meningitis outcomes among children < 2 years of age who were immunized according to the schedule with DTP or DTP RPR T vaccine. The primary outcome was radiologically confirmed alveolar infiltrate based on standard criteria. Preliminary results: 55, 073 children were enrolled. DTP PRP T had a large effect on meningitis outcomes but prevented a small proportion, if any, of measured pneumonia outcomes. More data on mortality rates are awaited. Patient history: A female baby was admitted to hospital at 3 months of age with a diagnosis of pneumonia 4 days after receiving study vaccine. On admission, she had a respiratory rate of 55, a temperature of 37.5, chest retractions, cough, krakles, and an oxygen saturation of 70%. Hemoglobin was 4.4, WBC count was 7,000 with 52% segs. She was treated with ampicillin and gentamycin. X-ray was read as abnormal. She died 1 day after admission. Comments from study physician: Pneumonia death complicated by severe anemia. Unblinding of the clinical trial: the patient has not been exposed to study vaccine but he has received D30 P T60 absorbed. A 15-day follow up report received 10/15/2003 adds: Additional info on 09/25 from principal investigator stating that the deaths were not related to vaccination and that infant mortality rate in pt''s area before the study was 100/1000. Follow up information received on 10/27/03 reported that the manufacturer for OPV was Biofarma and not AvP.


VAERS ID: 209668 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2002-04-11
Onset:2002-04-15
   Days after vaccination:4
Submitted: 2003-09-24
   Days after onset:527
Entered: 2003-09-26
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
DTP: DTP (NO BRAND NAME) / SANOFI PASTEUR - / UNK RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pallor, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-04-15
   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:
Current Illness:
Preexisting Conditions: Patient history: Baby died at home 4 days after vaccination. Parents reported no symptoms except fever, pale color, and vomiting.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200301965

Write-up: This case has been reported after completion of the clinical study. This study was conducted between 1998 and 2002. It was a randomized, controlled, double-blind trial comparing pneumonia and meningitis outcomes among children < 2 years of age who were immunized according to the schedule with DTP or DTP PRP T vaccine. The primary outcome was radiologically confirmed alveolar infiltrate based on standard criteria. Preliminary results: 55,073 children were enrolled. DTP RPR T had a large effect on meningitis outcomes but prevented a small proportion, if any, of measured pneumonia outcomes. More data on mortality rates re awaited. Patient history: Baby died at home 4 days after vaccination. Parents reported no symptoms except fever, pale color, and vomiting. Comments from study physician: Data are insufficient to assign cause of death, and the diffierential diagnosis is large. Unblinding of the clinical trial: the patient has not been exposed to study vaccine but he has received D30 P T60 absorbed. A 15-day follow up report received 10/15/2003 adds: Additional info on 09/25, from principal investigator stating that the deaths were not related to vaccination and that infant mortality rate in pt''s area before the studay was 100/1000. Follow up information receoved on 10/27/03 reported that the manufacturer for OPV was Biofarma and not AvP.


VAERS ID: 209716 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2003-08-02
Onset:2003-09-07
   Days after vaccination:36
Submitted: 2003-09-23
   Days after onset:16
Entered: 2003-09-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (TRITANRIX) / GLAXOSMITHKLINE BIOLOGICALS 15105284 / UNK - / -
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS 789A84 / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Crying, Eye movement disorder, HIV test positive, Irritability, Pneumonia, Pyrexia, Salivary hypersecretion, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-09-15
   Days after onset: 8
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: UNK
Preexisting Conditions: Fever; Gaseous distension; Mouth ulcer; Twitch
Allergies:
Diagnostic Lab Data: Alkaline phosphatase 1150IU/L; Body temp 39C; HIV positive; Hemoglobin 8.5g/dl; Platelet count 98X10E9/L; X-ray - pneumonia.
CDC Split Type: B0308985A

Write-up: This report was received from a physician and describes the bronchoneumonia inducing death in a 2 month old boy receiving diphtheria tetanus whole cells pertussis and hepatitis B and haemophilus influenza type B vaccine for prophylaxis. Concurrent medical condition included mouth ulcer and gaseous abdominal distension. On 8/2/03, a 1st dose of Titanrix hep B and Hiberix were given. On 8/6/03, 4 days after vaccination, the boy developed irritability, temperature. He also cried a lot and vomited. His mother brought him to hospital where he was given Paracetamol. On 9/4/03, a 2nd dose of Tritranrix hep B and Hiberix were given. The mother claimed that the child foamed at the mouth and rolled his eyeballs, suggestive of convulsions secondary to fever. The doctor did not see anything remarkable and thought that it was an adverse drug reaction. On 9/7/03, his mother brought him again to hospital; the child had dyspnean dullness, poor feeding, dull grunting and his respiratory rate was 60. The doctor''s impression was bronchopneumonia. On 9/8/03, he was admitted to hospital where lab tests were performed and showed increase of alkaline phosphase and decrease of haemoglobine and platelets count. On 9/13/03, x-ray was performed and revealed a bronchopneumonia. Further investigations indicated that the child was immunosuppresed (HIV positive). The child''s condition deteriorated rapidly, he was intubated and ventilated and on 9/15/03, he died. No autopsy was done. The reporting physician considered the pneumonia and the immunodepression to be the cause of death. Additional information has been requested. A 15-day follow up report received 10/27/2003 adds: No further details will be available and this case has therefore been closed.


VAERS ID: 210536 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2003-10-01
Onset:2003-10-05
   Days after vaccination:4
Submitted: 2003-10-15
   Days after onset:10
Entered: 2003-10-17
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C0838AR / UNK LL / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Convulsion, Haematoma, Haemorrhage intracranial, Pallor
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), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-10-05
   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:
Current Illness:
Preexisting Conditions: Full term normal delivery; was given Vitamin K at birth. No birth trauma, no illness, no bleeding, diathesis. Mom has Thalassemia minor. No bleeding disorders in family. No neurocutaneous syndrome.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302353

Write-up: It was reported through a doctor that a 3 month old male infant died 3-4 days after receiving DTaP vaccination lot # C0838AR and Oral Polio Vaccine, lot not reported. Patient had intra-cranial bleeding 3-4 days after vaccination. He had an acute onset of pallor and a seizure. Patient was found to have large hematoma. An evacuation was performed, but the child could not be weaned off from ventilator. Patient died on 10/5/03. A 15-day follow up report received 10/22/2003 adds no new info.


VAERS ID: 210538 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Unknown  
Location: Foreign  
Vaccinated:2003-08-08
Onset:2003-08-09
   Days after vaccination:1
Submitted: 2003-10-14
   Days after onset:66
Entered: 2003-10-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0930M / UNK - / -
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
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: 2003-08-09
   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: UNK
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Autopsy concluded sudden infant death.
CDC Split Type: WAES0310USA01272

Write-up: Information has been received from a health authority concerning a 12 week old infant with no previous medical history who on Aug 8, 2003 was vaccinated with a dose of hepatitis B virus vaccine (batch #HS56370, lot #644034/0930M). On Aug 8, 2003 the patient was also vaccinated intramuscularly with a dose of diptheria toxoid, HIB conj vaccine, pertussis acellular 2 component vaccine, poliovirus vaccine inactivated, tetanus toxoid (batch #W1470-1). On Aug 9, 2003 the patient died. An autopsy "concluded to a sudden infant death." Results of samples were not reported. Additional information has been requested. The file is to be completed. A 15-day follow up report received 10/28/2003 adds: On 08/08/2003 the pt''s last bottle was given at 2000 and at 2100 she was put in her bed. She was given paracetamol (Doliprane) 1/2 of a suppository. There was no vomiting. On the morning of 08/09/2003 the pt was found dead in her bed on her stomach. The results of an autopsy are as follows: Measurements: 4.670 kg, length from vertex/heel = 58 cm, cranial perimeter = 41.8 cm, thoracic perimeter = 36 cm, abdominal perimeter = 33.5 cm, foot length = 7.5 cm. Macroscopy: slight macrocephalia, harmonious dimensions, pallor, slight cyanosis of some toes and of nails, anterior fontanelle slightly low lying (1.2 cm), no facial dysmorphia, female external genital organ normal. Autopsy: no specific anomaly. Histology: Lungs: edematous lights, atelectasic alveolae, congestive and dilated vessels, no inflammatory reaction, post-mortem germs. Liver: no anomaly. Kidneys: no anomaly. Heart: slight inflammatory polymorphe infiltration not sufficient to conclude to a myocarditis, hypertrophy of left ventricle. Trachea, spleen, pancreas, surrenal glands, stomach, intestine, bone marrow: no abnormality. Thymus: hypertrophy. Esophagus: small area ulcerated. Ovaries: some cyctic bilateral follicles. Bowel: localized lymphoid hyperplasia. Brain: results missing. A hemogram was not interpretable. No samples of urine and CSF were possible. See below for other diagnostic lab tests performed. The autopsy concluded that no elements in the different samples could explain the death. The diagnosis was a probable sudden unexplained infant death. Additional medical history indicated that on 05/05/2003 the pt was first hospitalized in a neonatology unit for respiratory distress and prematurity (etiology not mentioned). Birth weight was 2.21 kg, birth height 45 cm, and head circumference 34 cm. The pt was discharged on 06/02/2003. On 07/25/2003 the pt was hospitalized for the 2nd time for gastroesophageal reflux and difficulty in feeding. The pt was treated wiht omeprazole (Mopral), aluminum hydroxide (+) magnesium trisilicate (+) alginic acid (Gaviscon) and domperidone (Motilium). On 07/28/2003 the pt was discharged. Her weight when discharged was 4.57 kg. It was reported that due to intestinal colic since 07/25/2003, it was recommended that the pt sleep on her stomach. No further info is available. The case is closed.


VAERS ID: 210862 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2003-10-09
Onset:2003-10-12
   Days after vaccination:3
Submitted: 2003-10-21
   Days after onset:9
Entered: 2003-10-23
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPPHIB: DTP + IPV + ACT-HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Brain oedema, Decreased appetite, Hypotonia, Pallor, Somnolence, Sudden infant death syndrome
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-10-12
   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:
Current Illness:
Preexisting Conditions: Jaudice neonatal.
Allergies:
Diagnostic Lab Data: Blood immunoglobulin E normal 14-Oct-2003 < 2 IU/mL. Laboratory test 14-Oct-2003 blood tryptase = 17.5 microg/l
CDC Split Type: FRWYE358320OCT03

Write-up: Information regarding Prevnar was received from a healthcare professional regarding a 4 month old male patient who experienced sudden infant death syndrome. The patient received a dose on 10/9/03. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 10/9/03. dose regimen was 1 dose. Concomitant therapy included Pentavac. One dose administered on the same day as Prevnar and one previous dose 1 month earlier. The patient experienced sudden infant death syndrome on 10/12/03. The cause of death was reported as sudden infant death syndrome and the autopsy results are unknown at present time. No additional information was available at the time of this report. Follow-up information was received on 25-Feb-04 regarding patient''s demographic, product adminstration, event and autopsy results. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional via French regulatory authority (Afssaps) regarding a 4-month old male patient who experienced sudden death. The patient received a dose on 09-Oct-2003. The patient has a past history of moderal neonatal jaundice. Product Details: Indication for Prevnar was immunsation. Product was administered on 09-Oct-2003 by intramuscular route in the left thigh. Dose regimen was 1 dose. Concomitant Therapy: Concomitant included Pentavac (diptheria vaccine/haemophilus influenzae b/acellular pertussis vaccine/poliomyelitis vaccine inactivated/tetanus vaccine). One dose adminstered by intramuscular route in the right thigh on the same day as Prevnar and one previous dose on 11-Sep-2003. Event Details: During the two day after vaccination, the patient sleeps more and drunk less than usual (somnolence). It is reported that he was more pale than usual (pallor). On 11-Oct-2003 he had a last meal at 10 pm and was put to bed on a prone position. He was found unanimated and hypotonic (hypotonia) without cyanosis 15 to 20 minutes after. His head was caught beween the mattress and the bedside in a prone posititon. The father and then a resuce team started resuscuitation without sucess and ended at 11:30 om. An autopsy was performed on 14-Oct-2003 with the following results: The weight was 6.01 kg, the height was 67 cm. Body temperature was 30.5 degree Celsius. A cyanosis of hands and nails was reported. No anatomic malformation was found for the skull, skeleton, blood vessels and heart. No traumatism was observed. Samples form liver, kidney, lungs, brain, stools and blood were negative for bacteriological testing. Samples from pharynx and cavum were negative including for mycobacteria. Total IgE were found normal in blood (< U/ml). Tryptase was found slightly elevated (17.5 microg/l) nevertheless this figure seems questionalble with regard to a post-mortem test. The microscopic examinations found a slight inflammation of the upper-airways and a less one of trachea and bronchi. Thymus was normal and no inflammation of lungs was noticed. The liver exhibited feature of shock. A slight edema of brain was noticed without signs of meningitis neither encephalitis. Injection sites wre tested with feature of local hypoderm inflammation withough muscle involvement. The conclusions of the the reporting physician are Sudden death (sudden death) of a 4-month-old boy, which occurred 55 hours after a vaccination (second administration of Pentavac and a first one of Prenar). The information available leads to a multi-factorial event where a post vaccination reaciton might have contribute to an inappropriate reaction against an accidental position (prone position with head caught between the mattress and the bedside).


VAERS ID: 210895 (history)  
Form: Version 1.0  
Age: 0.75  
Sex: Male  
Location: Foreign  
Vaccinated:2003-10-07
Onset:2003-10-08
   Days after vaccination:1
Submitted: 2003-10-22
   Days after onset:14
Entered: 2003-10-24
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR U0725 / UNK - / IM
HIBV: HIB (TETRACOQ) / SANOFI PASTEUR W1086 / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Adrenal insufficiency, Cyanosis, Livedo reticularis, Pallor, Tachycardia, Tachypnoea, Uterine hypotonus
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Infective pneumonia (broad), Dehydration (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: Right side neck lymphangioma, light anaemia, lymphatic hypoplastic diathesis, perinatal CNS pathology; Child of close relatives; Hydrocephaly;
Allergies:
Diagnostic Lab Data: Medical certificate on results of histological study of autopsy material
CDC Split Type: 200302429

Write-up: It was reported by a Russian Health Authorities (Russian MoH, State Sanitary-Epidemiological Surveillance Dpt., ref No 384) through AvP Russian that a 9 month old infant presented with an acute adrenal deficiency as a post vaccination complication with fatal outcome one day after injection of Tetracoq (Lot # @1086-2) associated with Act-Hib (U0725-3). The infant was vaccinated with Tetracoq and Act-Hib on 10/07/2003 (10:15 am) in a therapeutic center "Municipal immuno-allergological consultative-diagnostic clinic" in Tyumen. The onset of illness was on the 10/08/2003: the basic symptoms were hyperthermia 39-40 degrees Celcius, 7-8 hours after vaccination, inertia, marked acrocyanosis, pallor of nasolabial region, mottled skin, tachycardia and tachypnea. The infant was referred to a municipal immuno-allergological consultative-diagnostic clinic on 10/08/2003 (10:00 am). Examination and first aid were followed by the following diagnosis: acute adrenal deficiency, grave systemic reaction to Tetracoq. The patient was hospitalized to Pediatric clinical hospital on 10/08/2003. The infant was intubated and was transferred to the pediatric resuscitation department of a hospital. At the end of the hospitalization, the diagnosis was acute adrenal deficiency, post-vaccination complication. The patient died on 10/08/2003 (11:00 pm). The case is under investigation. File to be completed. Follow up on 10/29/03: Additional drugs were prescribed to the baby after vaccination. Parents didn''t give the drugs to the child. All the vaccines were given by IM route. They were presented in syringe and the storage conditions were respected. It was specified that hyperthermia, inertia, and acrocyanosis occurred 7-8 hours after the vaccination and never stopped. The child was hospitalized in resuscitation department from 10/8/03 12:50 to 10/8/03 22:50. He was treated with lytic mixture, prednisolon IM solution 20mg injected once, resuscitation. Complimentary investigations such as echocardial study, lab examination and US of abdomen were performed (results not reported). File to be completed. Follow up on 12/10/03: "Follow up received on 24 and 11/27/03: Partial conclusion of commision of experts: VL was born by closely-related parents. It was the first pregnancy with slight gestosis and with preschedule surgical childbirth. He had have lymphohypoplastic diathesis, hydrocephaly and lymphangioma of neck. During the first months of life, patient transmitted anemia of mild severity. He had been vaccination earlier without any complication by: BCG, against Hepatitis B, Imovax Polio and Act Hib. On 10/07/03 he was vaccinated by tetracoq and Act-Hib against a background of lymphohypoplastic diathesis and of hydrocephaly. In response to the vaccination there was a hyperergic reaction in the forms of: disseminated intravascular coagulopathy and accompanied by shock a massive hemorrhage into adrenals (into each). The reaction caused the death. Thus the death of the baby ensued from hyperergic reaction in forms of disseminated intravascular coagulopathy and massive hemorrhage into adrenals-in response to the vaccination by Tetracoq and Act-Hib against a background of lymphohypoplastic diathesis and of hydrocephaly. Information from the PV form: the hyperthermia was started at 10/07/03 in the evening. There were four visits of emergency between vaccination and hospitalization. At the beginning there was symptomatic and antiallergic therapy, later, it was reanimation. There was a large description of therapy (in draft conclusion of bureau of forensic medical examination) but it was difficult to interpret correctly. Diagnosis at the time of hospitalization: acute adrenal deficiency and encephalitic reaction, post-vaccination complication. Later: progressive cardiovascular collapse, coma. A death was registered on 10/08/03 22:50. Post-humous diagnosis: disseminated intravascular coagulopathy and massive hemorrhage into adrenals. Case is considered as closed." Follow up on 02/13/04: "On the ground of histological study of the autopsy material taken from the infant, the Institute specialists came to the conclusion that the death of the child was due to fulminant acute respiratory infection (most likely influenza) with marked intoxication. Lung lesion (focused hemorrhagic serofibrinous pneumonia), CNA (oedema and hemorrhage to brain tissues), as well as severe haemodynamic changes in internal organs led to cardiopulmonary decompensation and cerebral oedema, which was the direct cause of the lethal outcome. In view of the above, the claim from Tetracoq, Lot # W1086-2 is recalled. Case is closed."


VAERS ID: 211045 (history)  
Form: Version 1.0  
Age: 0.9  
Sex: Female  
Location: Foreign  
Vaccinated:2003-07-30
Onset:0000-00-00
Submitted: 2003-10-23
Entered: 2003-10-28
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (DTP + ACTHIB) / SANOFI PASTEUR W0198 / UNK - / IM
MNQ: MENINGOCOCCAL CONJUGATE (NO BRAND NAME) / UNKNOWN MANUFACTURER 82560 / UNK - / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER 5126YF / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pneumonia, Sepsis, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-08-03
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: WBC 27000 and chest x-ray.
CDC Split Type: E200302797

Write-up: The company was contacted by defective medicines unit requesting batch information and company pharmacovigilance data for batch W0198-1. This has been requested in connection with a report of a case of a child aged 11.5 months who received DTP-Hib, Act-HIBDTP batch W0198-1, Meningitis C vaccine and Oral Polio vaccine all given on 7/30/03. The child is reported to have had pneumonia and septicaemia and the outcome was fatal. Date of death was 8/3/03. Further info on the case report has been requested. FOllow up 10/27/03: The health authority report was received with further details about the case. The baby was female. 0.5 ml Act-HIB DTP vaccine was given IM. Patient is also reported to have experienced malaise commencing on 7/31/03, the child became very unwell on 7/31/03. Patient became more unwell and was admitted with fever, increased respiratory distress, green nasal secretions and brown fluid leaking at peg (Gastric tube) site. Within two hours respiratory difficulties increased dramatically. Chest x-ray showed increased markings particularly at the left base. In spite of intubation, stabilization, adrenaline and further intensive care, the patient died. A post mortem was done, but the results are awaited. Outcome of the pneumonia was confirmed as the first probable cause of death, described as sudden death, with septicemia as second probable cause of death. To be noted that the patient received Prednisone since 7/30/03 orally (Abidec, Plesmet syrup and prednisone were administered via gastric tube. The milk in the gastric tube was changed on the same day as the vaccinations). Additional information: patient had low tone, absent gag reflex and possible tyrosine hydroxylase deficiency (date of diagnosis not reported). Further information is expected to confirm the circumstances following post mortem results. The case has also been received on 11/3/03 as a duplicate from the health authority. Follow up on 12/02/03: "Follow up on 11/17/03, no further information expected. Case to be considered as closed."


VAERS ID: 211252 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2000-07-06
Onset:0000-00-00
Submitted: 2003-10-28
Entered: 2003-10-30
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
DTPHIB: DTP + HIB (DTP + ACTHIB) / SANOFI PASTEUR - / UNK RL / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Convulsion, Meningitis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: He received the previous study vaccine on 8/6/00
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302609

Write-up: This case has been reported after completion of the clinical study: "A randomized, controlled clinical trial of the effect of Haemophilus influenzae type B vaccine on pneumonia and meningitis in children." This study was conducted between 1998 and 2002. It was a randomized, controlled, double-blind trial comparing pneumonia and meningitis outcomes among children <2 years of age who were immunized according to the World Health Organization schedule with DTP or DTP-PRP-T vaccine. The primary outcome was radiologically confirmed alveolar infiltrate based on standard WHO criteria. Preliminary results: 55,073 children were enrolled. DTP-PRP-T had a large effect on meningitis outcomes but prevented a small proportion, if any, of measured pneumonia outcomes. More data on mortality rates are awaited. Pt admitted at 3 months of age with a diagnosis of meningitis 3 days after receiving study vaccine. On admission, had a temp of 37.2 and convulsion. Treated with ampicillin and gentamycin but died 3 days after admission. Comments from study physician: Child appears to have died of meningitis but CSF not collected. No evidence of relationship with vaccination. Unblinding of the clinical trial: the pt has been exposed to study vaccine: DTP-Hib (liquid). The principal investigator stated that the deaths were not related to vaccination and that infant mortality rate before the study was 100/1000.


VAERS ID: 211253 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2001-03-20
Onset:0000-00-00
Submitted: 2003-10-28
Entered: 2003-10-30
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
DTPHIB: DTP + HIB (DTP + ACTHIB) / SANOFI PASTEUR - / UNK RL / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-03-28
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: He received the previous study vaccine on 2/20/01.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302602

Write-up: This case has been reported after completion of the clinical study: "A randomized, controlled clinical trial of the effect of Haemophilus influenzae type B vaccine on pneumonia and meningitis in children." This study was conducted between 1998 and 2002. It was a randomized, controlled, double-blind trial comparing pneumonia and meningitis outcomes among children <2 years of age who were immunized according to the World Health Organization schedule with DTP or DTP-PRP-T vaccine. The primary outcome was radiologically confirmed alveolar infiltrates based on standard WHO criteria. Preliminary results: 55,073 children were enrolled. DTp-PRP-T had a large effect on meningitis outcomes but prevented a small proportion, if any, of measured pneumonia outcomes. More data on mortality rates are awaited. Often vomiting. The mother thinks her baby died of allergic to her breast milk. Her first child died of fast breathing. Child died at home without being examined by a physician. Comments from study physician: As the child died at home and without a subsequent autopsy, there is insufficient info to determine causality. However, there are no facts in the history-other than a temporal association-to suggest a reasonable causal relationship between death and vaccination given what is currently known about the multiple vaccines the child received. Of note is that symptoms began before vaccine receipt and that child died 8 days, and not 7, post vaccine receipt. Unblinding of the clinical trial: the pt has been exposed to study vaccine: DTP-Hib (liquid). The principal investigator stated that the deaths were not related to vaccination and that infant mortality rate before the study was 100/1000.


VAERS ID: 211254 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:1999-06-17
Onset:0000-00-00
Submitted: 2003-10-28
Entered: 2003-10-30
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
DTPHIB: DTP + HIB (DTP + ACTHIB) / SANOFI PASTEUR S3556 / UNK RL / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Agitation, Fracture, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Osteoporosis/osteopenia (broad), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302600

Write-up: This case has been reported after completion of the clinical study: "A randomized, controlled clinical trial of the effect of Haemophilus influenzae type B vaccine on pneumonia and meningitis in children." This study was conducted between 1998 and 2002. It was a randomized, controlled, double-blind trial comparing pneumonia and meningitis outcomes among children <2 years of age who were immunized according to the World Health Organization schedule with DTP or DTP-PRP-T vaccine. The primary outcome was radiologically confirmed alveolar infiltrates based on standard WHO criteria. Preliminary results: 55,073 children were enrolled. DTP-PRP-T had a large effect on meningitis outcomes but prevented a small proportion, if any, of measured pneumonia outcomes. More data on mortality rates are awaited. High temperature, crying. Local healer assumed baby''s backbone was broken because of falling. Child died at home without being examined by a physician. Comments from study physician: As the child died at home and without a subsequent autopsy, there is insufficient info to determined causality. However, there are no facts in the history-other than a temporal association-to suggest a reasonable causal relationship between death and vaccination given what is currently known about the multiple vaccines the child received. Unblinding of the clinical trial: the pt has been exposed to study vaccine: DTP-Hib (liquid). The principal investigator stated that the deaths were not related to vaccination and that infant mortality rate before the study was 100/1000.


VAERS ID: 211255 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:1999-06-02
Onset:1999-07-04
   Days after vaccination:32
Submitted: 2003-10-28
   Days after onset:1577
Entered: 2003-10-30
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
DTPHIB: DTP + HIB (DTP + ACTHIB) / SANOFI PASTEUR S3556 / UNK RL / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Agitation, Cough, Pallor, Pyrexia, Respiratory rate increased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: 200302597

Write-up: This case has been reported after completion of the clinical study: "A randomized, controlled clinical trial of the effect of Haemophilus influenzae type B vaccine on pneumonia and meningitis in children." This study was conducted between 1998 and 2002. It was a randomized, controlled, double-blind trial comparing pneumonia and meningitis outcomes among children <2 years of age who were immunized according to the World Health Organization schedule with DTP or DTP-PRP-T vaccine. The primary outcome was radiologically confirmed alveolar infiltrates based on standard WHO criteria. Preliminary results: 55,073 children were enrolled. DTP-PRP-T had a large effect on meningitis outcomes but prevented a small proportion, if any, of measured pneumonia outcomes. More data on mortality rates are awaited. Cough, fast breathing, and chest indrawing (all for one day), crying, pale, the body sometimes turned blue, high temp for 2 days. Died one day after receiving the second study vaccine. Child died at home without being examined by a physician. Comments from study physician: As the child died at home and without a subsequent autopsy, there is insufficient info to determine causality. However, there are no facts in the history-other than a temporal association-to suggest a reasonable causal relationship between death and vaccination given what is currently known about the multiple vaccines the child received. Of note is that symptoms began before vaccine receipt. Unbliding of the clinical trial: the pt has been exposed to study vaccine: DTP-Hib (liquid). The principal investigator stated that the deaths were not related to vaccination and that infant mortality rate before the study was 100/1000.


VAERS ID: 211256 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:1999-04-19
Onset:0000-00-00
Submitted: 2003-10-28
Entered: 2003-10-30
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
DTPHIB: DTP + HIB (DTP + ACTHIB) / SANOFI PASTEUR S3556 / UNK RL / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cough, Pyrexia
SMQs:, Anaphylactic reaction (broad), 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302596

Write-up: This case has been reported after completion of the clinical study: "A randomized, controlled clinical trial of the effect of Haemophilus influenzae type B vaccine on pneumonia and meningitis in children." This study was conducted between 1998 and 2002. It was a randomized, controlled, double-blind trial comparing pneumonia and meningitis outcomes among children <2 years of age who were immunized according to the World Health Organization schedule with DTP or DTP-PRP-T vaccine. The primary outcome was radiologically confirmed alveolar infiltrates based on standard WHO criteria. Preliminary results: 55,073 children were enrolled. DTP-PRP-T had a large effect on meningitis outcomes but prevented a small proportion, if any, of measured pneumonia outcomes. More data on mortality rates are awaited. Cough and his temp for a week. Child died at home without being examined by a physician one day after the second study vaccinations. The first vaccination was given on 3/15/99. Comments from study physician: As the child died at home and without a subsequent autopsy, there is insufficient info to determine causality. However, there are no facts in the history-other than a temporal association-to suggest a reasonable causal relationship between death and vaccination given what is currently known about the multiple vaccines the child received. Of note is that symptoms began before vaccine receipt. Unbliding of the clinical trial: the pt has been exposed to study vaccine: DTP-Hib (liquid). The principal investigator stated that the deaths were not related to vaccination and that infant mortality rate before the study was 100/1000.


VAERS ID: 211257 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:1999-11-17
Onset:0000-00-00
Submitted: 2003-10-28
Entered: 2003-10-30
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
DTPHIB: DTP + HIB (DTP + ACTHIB) / SANOFI PASTEUR S3557 / UNK RL / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anorexia, Cough, Feeling cold, Respiratory rate increased
SMQs:, Anaphylactic reaction (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: 200302590

Write-up: This case has been reported after completion of the clinical study: "A randomized, controlled clinical trial of the effect of Haemophilus influenzae type B vaccine on pneumonia and meningitis in children." This study was conducted between 1998 and 2002. It was a randomized, controlled, double-blind trial comparing pneumonia and meningitis outcomes among children <2 years of age who were immunized according to the World Health Organization schedule with DTP or DTP-PRP-T vaccine. The primary outcome was radiologically confirmed alveolar infiltrates based on standard WHO criteria. Preliminary results: 55,073 children were enrolled. DTP-PRP-T had a large effect on meningitis outcomes but prevented a small proportion, if any, of measured pneumonia outcomes. More data on mortality rates are awaited. Fast breathing and chest indrawing for 5 days, didn''t want to brerastfeed, baby''s body was cold. Child died at home without being examined by a physician. Comments from study physician: As the child died at home and without a subsequent autopsy, there is insufficient info to determine causality. However, there are no facts in the history-other than a temporal association-to suggest a reasonable causal relationship between death and vaccination given what is currently known about the multiple vaccines the child received. Of note is that symptoms began before vaccine receipt. Unbliding of the clinical trial: the pt has been exposed to study vaccine: DTP-Hib (liquid). The principal investigator stated that the deaths were not related to vaccination and that infant mortality rate before the study was 100/1000.


VAERS ID: 211258 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:1999-07-17
Onset:0000-00-00
Submitted: 2003-10-28
Entered: 2003-10-30
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
DTPHIB: DTP + HIB (DTP + ACTHIB) / SANOFI PASTEUR S3557 / UNK RL / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cough, Diarrhoea, Pallor, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302584

Write-up: This case has been reported after completion of the clinical study: "A randomized, controlled clinical trial of the effect of Haemophilus influenzae type B vaccine on pneumonia and meningitis in children." This study was conducted between 1998 and 2002. It was a randomized, controlled, double-blind trial comparing pneumonia and meningitis outcomes among children <2 years of age who were immunized according to the World Health Organization schedule with DTP or DTP-PRP-T vaccine. The primary outcome was radiologically confirmed alveolar infiltrates based on standard WHO criteria. Preliminary results: 55,073 children were enrolled. DTP-PRP-T had a large effect on meningitis outcomes but prevented a small proportion, if any, of measured pneumonia outcomes. More data on mortality rates are awaited. Cough for 3 days, diarrhea 4 times/day for three days, high temp for three days, pale face for 2 days. Child died at home without being examined by a physician. Comments from study physician: As the child died at home and without a subsequent autopsy, there is insufficient info to determine causality. However, there are no facts in the history-other than a temporal association-to suggest a reasonable causal relationship between death and vaccination given what is currently known about the multiple vaccines the child received. Of note is that symptoms began before vaccine receipt. Unbliding of the clinical trial: the pt has been exposed to study vaccine: DTP-Hib (liquid). The principal investigator stated that the deaths were not related to vaccination and that infant mortality rate before the study was 100/1000.


VAERS ID: 211259 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Male  
Location: Foreign  
Vaccinated:2000-07-15
Onset:0000-00-00
Submitted: 2003-10-28
Entered: 2003-10-30
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
DTPHIB: DTP + HIB (DTP + ACTHIB) / SANOFI PASTEUR S3649 / UNK RL / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cough, Eye disorder, Pyrexia, Respiratory rate increased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Corneal disorders (broad), Retinal disorders (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302582

Write-up: This case has been reported after completion of the clinical study: "A randomized, controlled clinical trial of the effect of Haemophilus influenzae type B vaccine on pneumonia and meningitis in children." This study was conducted between 1998 and 2002. It was a randomized, controlled, double-blind trial comparing pneumonia and meningitis outcomes among children <2 years of age who were immunized according to the World Health Organization schedule with DTP or DTP-PRP-T vaccine. The primary outcome was radiologically confirmed alveolar infiltrates based on standard WHO criteria. Preliminary results: 55,073 children were enrolled. DTP-PRP-T had a large effect on meningitis outcomes but prevented a small proportion, if any, of measured pneumonia outcomes. More data on mortality rates are awaited. Cough for 2 weeks, fast breathing and high temp for a week, yellow eyes for 3 days, chest indrawing for 2 dyas. Child died at home without being examined by a physician. Comments from study physician: as the child died at home and without a subsequent autopsy, there is insufficient info to determine causality. However, there are no facts in the history-other than a temporal association-to suggest a reasonable causal relationship between death and vaccination given what is currently known about the multiple vaccines the child received. Symptoms history suggest possible pneumonia death. Of note is that symptoms began before vaccine receipt. Unblinding of the clinical trial: the pt has been exposed to study vaccine: DTP-Hib (liquid). The principal investigator stated that the deaths were not related to vaccination and that infant mortality rate before the study was 100/1000.


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