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VAERS ID: 282593 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2002-10-01
Submitted: 0000-00-00
Entered: 2007-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: CSF culture positive, Convulsion, Coordination abnormal, Death, Diplopia, Dysarthria, Dysphagia, Electroencephalogram abnormal, Nuclear magnetic resonance imaging brain abnormal, Posture abnormal, Subacute sclerosing panencephalitis, Varicella
SMQs:, Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Ocular motility disorders (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: electroencephalography ??Oct02 showed continuous slowness with paroxysmal discharges, magnetic resonance imaging ??Oct02 of brain showed discrete hyperintensive lacunar regions subcortically in white matter were found., diagnostic laboratory test ?/Oct02 CSF analysis revealed the IgG synthesis within the CNS with oligoclonal bands of immunoglobulins
CDC Split Type: WAES0706USA03037

Write-up: Information has been received from physicians in a literature article, title above concerning a female who was vaccinated with a dose of MMR II. The patient was born in November 1997 in a normal pregnancy. He was vaccinated regularly with MMR II. The patient developed varicella in October 2002. On the third day of the disease, his mother noted his head dropping on several occassions. The patient was hospitalized and treated with acyclovir intravenously. Then ataxia and monoclonic seizures of the arm and head developed. The treatment with carbamazepine resulted in temporary improvement. Next dyplopia arose accompanied by dysarthia, swallowing difficulties and inability to control sphincters. EEG showed continuous slowness with paroxysmal discharges. CSF analysis revealed the IgG synthesis within the CNS with oligoclonal bands of immunoglobulins. On brain MRI, discrete hyperintensive lacunar regions subcortically in white matter found. On brain MRI, discrete hyperintensive lacunar regions subcortically in white matter were found. During hospitalization he was treated with phenobarbitone and carbamazepine but no improvement was observed. Due to progressive disease, the boy died in December 2003. The authors concluded that is spite of some reports of SSPE occurring after the administration of MMR II vaccines, there is no evidence that the measles vaccine could cause SSPE (no vaccine strain has ever been discovered). This is one of several reports received from the same source. This article also discussed the experiences of a 4 year old female (WAES# 0706USA02457), a 7 year old male (WAES# 0706USA03035) and an 11 year old male (WAES# 0706USA03036) while on therapy with MMR II. No further information is available. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 282852 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2007-05-23
Onset:2007-05-23
   Days after vaccination:0
Submitted: 2007-06-22
   Days after onset:30
Entered: 2007-06-26
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 2 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Crying, Respiratory arrest, Sudden infant death syndrome
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-05-23
   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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: DEWYE882720JUN07

Write-up: Information regarding Prevnar was received from a pediatrician via a regulatory authority regarding a 3-month-old female patient who experienced sudden infant death syndrome. The patient received the second dose on 23-May-2007. Due to information of the department the patient started crying in the evening following vaccination administration and was fetched out of bed. She was calmed down and laid back to bed and placed prone. Shortly later the patient was found without breathing. The patient was diagnosed with sudden infant death syndrome on 23-May-2007. The treating physician questioned the causality relatedness between the death and the vaccinations. The cause of death was reported as sudden infant death syndrome. No additional information was available at the time of this report.


VAERS ID: 283501 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Female  
Location: Foreign  
Vaccinated:2006-11-03
Onset:2006-11-27
   Days after vaccination:24
Submitted: 2007-06-29
   Days after onset:213
Entered: 2007-07-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Crying, Death, Haematochezia, Intussusception, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Depression (excl suicide and self injury) (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-11-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Diarrhoea; Malnutrition
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0706CRI00010

Write-up: Information has been received from a health professional concerning a 4 month old female with a history of diarrhoea and malnutrition who on 03-NOV-2006 was vaccinated with Rotateq. There was no concomitant medication. On approximately 27-NOV-2006 the patient experienced intussusception, crying, hematochezia and vomiting and was hospitalized. The reporter felt that intussusception, crying, hematochezia and vomiting were not related to therapy with Rotateq. Patient died on 27-NOV-06. Additional information is not expected.


VAERS ID: 283624 (history)  
Form: Version 1.0  
Age: 0.75  
Sex: Female  
Location: Foreign  
Vaccinated:2007-05-07
Onset:2007-05-08
   Days after vaccination:1
Submitted: 2007-07-02
   Days after onset:55
Entered: 2007-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (TRITANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Body temperature increased, Death, Dyspnoea, Hyperpyrexia, Mechanical ventilation
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-05-08
   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: Cardiovascular medication
Current Illness: CONGENITAL HEART DISEASE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body temperature 08May2007 41.1Deg C
CDC Split Type: B0476928A

Write-up: This case was reported by a physician via a sales representative and described the occurrence of hyperpyrexia in a 9-month-old female subject who was vaccinated with Tritanrix-HB, GlaxoSmithKline, Hiberix for prophylaxis. Concurrent medical conditions included congenital heart disease. Concurrent medications included Cardiovascular medication. The subject was normal, in good condition. On 7 May 2007, the subject received 3rd dose of Tritanrix-HB (unknown route and injection site), unspecified dose of Hiberix (unknown route and injection site). The lot numbers were not provided. The subject was kept under observation after vaccination. She was normal and was sent back home. On 8 May 2007, 12 hours after vaccination with Hiberix and Tritanrix-HB, the subject experienced hyperpyrexia (41.1 Deg C) with gasping respiration. She was brought to hospital. The subject was treated with mechanical ventilation. On 8 May 2006, 16 hours after vaccination, the subject died, cause of death is not specified.


VAERS ID: 284202 (history)  
Form: Version 1.0  
Age: 0.58  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-07-09
Entered: 2007-07-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Laboratory test, Meningitis pneumococcal, Serology positive, Serology test, Vaccination failure
SMQs:, Lack of efficacy/effect (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: Unknown
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Laboratory test (LLT: Laboratory test) Pneumococcus serotype was determined to be 24F
CDC Split Type: FRWYE969804JUL07

Write-up: Information regarding Prevenar was received from a healthcare professional regarding a 7-month-old female patient who experienced meningitis due to Pneumococcus serotype 24F. The patient received the third dose on an unspecified date. Relevant medical history was not provided. Concomitant medications were not reported. On an unspecified date, the patient died as a result of meningitis due to Pneumococcus serotype 24F (meningitis pneumococcal) (drug ineffective). Laboratory test (results: Pneumococcus serotype was determined to be 24F) was done on an unspecified date. No additional information was available at the time of this report.


VAERS ID: 284964 (history)  
Form: Version 1.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2006-03-13
Onset:2006-03-23
   Days after vaccination:10
Submitted: 2007-07-17
   Days after onset:480
Entered: 2007-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Arrhythmia, Autopsy, Cardiac arrest, Cardiogenic shock, Cardiomyopathy, Cellulitis, Chemotherapy, Death, Discomfort, Eosinophil count, Febrile neutropenia, General physical health deterioration, Hodgkin's disease, Intensive care, Local swelling, Lymphocyte count, Lymphoma, Macrophages increased, Malaise, Mediastinal mass, Metabolic acidosis, Resuscitation, Septic shock, Toxicologic test
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Agranulocytosis (narrow), Angioedema (broad), Haematopoietic leukopenia (narrow), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Toxic-septic shock conditions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (narrow), Cardiac arrhythmia terms, nonspecific (narrow), Chronic kidney disease (broad), Malignant lymphomas (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Haematological malignant tumours (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-03-24
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: CHEMOTHERAPY, HODGKIN''S DISEASE, MEDIASTINAL MASS, POSSIBLE LYMPHOMA, SWOLLEN NECK, THROAT DISCOMFORT, Subject presented to a clinic for vaccination for Hepatitis B on 23 January 2006 when he complained of discomfort in his throat. On 25 January 2006, he was seen by a physician who thought he had a lymphoma and he was subsequently seen on 31 January 2006 when his neck was swollen. The subject was diagnosed with classic Hodgkin''s disease on 01 February 2006, presenting with a large pericardial mediastinal mass. On the same day, he was hospitalized for investigation. A diagnosis of Hodgkin''s disease was confirmed. He received first chemotherapy treatment on 11 February 2006, which was well tolerated and his condition improved. The specific chemotherapy regimen was not specified, but included an anthracycline, which was not determined to have caused any cardiotoxicity. The subject received subsequent chemotherapy treatments on 23 February and 09 March 2006.
Allergies:
Diagnostic Lab Data: External examination showed no trauma to the body. Upon autopsy, it was concluded that the cause of death was cardiogenic shock secondary to interstitial myocardial infiltration with small lymphocytes, polynuclear eosinophils, macrophages and plasmocytes, largely attributable to classic Hodgkin''s disease. Toxicology showed subtherapeutic levels of acetaminophen, lidocaine and lorazepam in the blood, which did not contribute to the cause of death.
CDC Split Type: A0664078A

Write-up: This case was reported by a coroner and described the occurrence of cardiogenic shock in a 40-year-old male subject who was vaccinated with Twinrix for prophylaxis. Previous medical history included the following: the subject presented to a clinic for vaccination for Hepatitis B on 23 January 2006, when he complained of discomfort in his throat. On 25 January 2006, he was seen by a physician who thought he had a lymphoma and he was subsequently seen on 31 January 2006 when his neck was swollen. The subject was diagnosed with classic Hodgkin''s disease on 01 February 2006, presenting with a large pericardial mediastinal mass. On the same day, he was hospitalized and the diagnosis of Hodgkin''s disease was confirmed. The subject received first chemotherapy treatment on 11 February 2006, which was well tolerated and his condition improved. The chemotherapy regimen was not specified, but included an anthracycline, which was not determined to have caused any cardiotoxicity. The subject received subsequent chemotherapy treatments on 23 February and 09 March 2006. On 10 March 2006, a physician authorized the continuation of vaccination for Hepatitis A and B and the subject received unspecified dose of Twinrix on 13 March 2007. On 23 March 2006, ten days after vaccination with Twinrix, when the subject was due for another course of chemotherapy, he experienced febrile neutropenia and cellulitis. The chemotherapy was cancelled and the subject was hospitalized and treated with intravenous antibiotic treatment. On 24 March 2006, he experienced episodes of arrhythmia and signs of septic shock with severe metabolic acidosis. He was not feeling well, his condition was deterioration and he was uncomfortable. The subject was transferred to the intensive care unit where his vital signs stabilized. Approximately, four hours later, he suffered cardiac arrest and attempts at resuscitation were not successful. The death was of natural cause. Upon autopsy, it was concluded that the cause of death was cardiogenic shock secondary to interstitial myocardial infiltration with small lymphocytes, polynuclear eosinophils, macrophages and plasmocytes, largely attributable to classic Hodgkin''s disease. A consultant pathologist was of the opinion "that the vaccination with Twinrix did not contribute to the morbid process, stating that in the Compendum, there were no reported cases of death after this vaccination and this was not noted in clinical trials". The coroner''s conclusion was that the subject died of natural causes. The pathologists were not associating the administration of the Twinrix vaccine with this death. Nevertheless, the coroner''s investigation recommended a copy of the Coroner''s Report and a copy of the Autopsy Report be provided to the manufacturer of Twinrix vaccine so that the circumstances of this death may be documented as adverse effects of this vaccine, if necessary.


VAERS ID: 285304 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2007-06-20
Onset:2007-06-20
   Days after vaccination:0
Submitted: 2007-07-20
   Days after onset:30
Entered: 2007-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-06-20
   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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0479532A

Write-up: This case was reported by a physician and described the occurrence of death nos in a 62-year-old male subject who was vaccinated with Havrix, DTP, Typhim for prophylaxis. On 20 June 2007 the subject received unspecified dose of Havrix (unknown), unspecified dose of DTP vaccine and unspecified dose of Typhim (unknown). On 20 June 2007, on the evening of the vaccination date with Havrix DTP vaccine and Typhim, the subject died, cause of death is not specified.


VAERS ID: 286007 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-07-25
Entered: 2007-07-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: ZAWYE075924JUL07

Write-up: Information regarding Prevenar was received from a healthcare professional regarding a 4-month-old patient who experienced death upon arrival at hospital emergency unit. The patient received a dose on an unspecified date a few weeks before the patient died. The patient experienced death upon arrival at hospital emergency unit (death) in Jul-2007. The autopsy revealed subacute pneumonic changes. No additional information was available at the time of this report. Further information has been requested from the healthcare professional who treated the patient and will be reported once received.


VAERS ID: 287758 (history)  
Form: Version 1.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2007-07-18
Onset:2007-08-01
   Days after vaccination:14
Submitted: 2007-08-09
   Days after onset:8
Entered: 2007-08-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-08-01
   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: Acetaminophen/codeine phosphate 18Oct01 - Cont, allopurinol Jan99 - Cont, amiodarone Jan93-Cont, aspirin 05Mar07 - Cont, atorvastatin Jan99 - Cont, bezafibrate 20Dec02 - Cont, bisoprolol 26Aug04 - Cont, clopidogrel bisulfate 05Mar07 - Cont,
Current Illness: Diabetes mellitus; Hyperlipidaemia; Ischaemic heart disease; Atrial fibrillation; Cardiac ventricular disorder; Renal impairment; Osteoarthritis; Acne rosacea; Hypertension; Gout
Preexisting Conditions: Anterior myocardial infarction
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0708USA00284

Write-up: Information has been received from an investigator concerning a 66-year-old male with diabetes mellitus, hyperlipidaemia, ischaemic heart disease, atrial fibrillation, left ventricular failure, renal impairment, osteoarthritis, acne rosacea, hypertension and gout and a history of anterior myocardial infarction who entered a study. On 18-JUL-2007 the patient was vaccinated intramuscularly in the right arm with a 1.0 ml dose of hepatitis B virus vaccine (modified process). Concomitant therapy included bisoprolol, allopurinol, amiodarone, bezafibrate, spironolactone, acetaminophen/codeine phosphate, clopidogrel bisulfate, doxazosin mesylate, fexofenadine hydrochloride, gliclazide, aspirin, isosorbide mononitrate, furosemide and atorvastatin. On 01-AUG-2007 the patient died suddenly in his home. The cause of death was unknown at the time of this report and an autopsy is awaited. At this time, relationship of death to study therapy is unknown. Attempts are being made to obtain additional information. A 7-day phone call was made on 06-AUG-2007.


VAERS ID: 288133 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2007-08-03
Onset:2007-08-04
   Days after vaccination:1
Submitted: 2007-08-15
   Days after onset:11
Entered: 2007-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Acute myocardial infarction, Death, Hyperglycaemia, Myocardial infarction, Nausea, Respiratory distress, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-08-04
   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: CEREBROVASCULAR INCIDENT (STROKE), HYPERTENSION, INSULIN DEPENDENT DIABETES
Current Illness: CEREBROVASCULAR INCIDENT (STROKE), HYPERTENSION, INSULIN DEPENDENT DIABETES, SENILE DEMENTIA
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0482727A

Write-up: This case was reported by a physician and described the occurrence of myocardial infarction in a 81-year-old female subject who was vaccinated with Fluarix for prophylaxis. Concurrent medical conditions included cerebrovascular stroke sequelae, hypertension, insulin controlled diabetes and senile dementia. On 3 August 2007 the subject received unspecified dose of Fluarix (intramuscular). On 4 August 2007, 1 day after vaccination with Fluarix, the subject experienced hyperglycemia, vomiting, nausea, finally she developed an acute myocardial infarction and, respiratory distress. The subject died at 21:00. The physician considered the events were unrelated to vaccination with Fluarix.


VAERS ID: 288523 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Unknown  
Location: Foreign  
Vaccinated:2007-08-10
Onset:2007-08-10
   Days after vaccination:0
Submitted: 2007-08-20
   Days after onset:10
Entered: 2007-08-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. - / UNK UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Crying, Death, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-08-11
   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:
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0708CHN00019

Write-up: Information has been received from a physician on 11-AUG-2007 concerning a 74 day old patient who in the morning of 10-AUG-2007 was vaccinated with PedvaxHib. Concomitant therapy included poliovirus vaccine. After vaccination, the infant continued crying and experienced fever (details unknown). In the same afternoon, the infant was sent to hospital for further treatment. On 11-AUG-2007, the infant died. The cause of death was unknown. The reporter felt that crying, fever and death were probably not related to PedvaxHib. Additional information has been requested.


VAERS ID: 288760 (history)  
Form: Version 1.0  
Age: 10.0  
Sex: Male  
Location: Foreign  
Vaccinated:1996-10-24
Onset:2007-06-12
   Days after vaccination:3883
Submitted: 2007-08-22
   Days after onset:71
Entered: 2007-08-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (HIBTITER) / PFIZER/WYETH L0305B1 / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Meningitis haemophilus, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-06-12
   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: Unknown
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: GBWYE178915AUG07

Write-up: This is a fatal case. Information regarding Hib-Titer Vaccine was received from a healthcare professional via a regulatory authority regarding a 10-year-old male patient who experienced vaccine failure and Hib meningitis. The patient received the first dose on 24-Oct-1995. The patient experienced Hib meningitis date and was attributed to vaccine failure. The cause of death was reported as vaccination failure and meningitis haemophilus. The reporter stated that Hib-Titer may be contributory to the patient''s death. The patient died on 12-Jun-2007. No additional information was available at the time of this report.


VAERS ID: 289353 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-08-29
Entered: 2007-08-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? 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: aspirin Unk - Unk, blood thinner (unspecified) Unk - Unk
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0708CAN00090

Write-up: Information has been received from a friend concerning a male friend who was vaccinated with Pneumovax 23, lot number not available. Concomitant therapy included aspirin and blood thinner (unspecified). Subsequently the patient experienced blood clot and died. The cause of death was not provided. The friend reported that after the shot the patient said he was in a lot of pain like he was going to die. A few days later, the patient died of a blood clot that would have started in his leg. It was reported that the consumer was unable to provide a time and date of the event and if the event was reported to a healthcare professional (no other details provided). The reporter felt that blood clot was related to therapy with Pneumovax 23. No further information is available.


VAERS ID: 289544 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2007-08-01
Onset:2007-08-01
   Days after vaccination:0
Submitted: 2007-08-30
   Days after onset:29
Entered: 2007-08-31
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-08-01
   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: Unknown
Current Illness: Cardiac disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: DEWYE222127AUG07

Write-up: Information regarding Prevenar was received from a healthcare professional via sales representative regarding a patient (age and gender unknown) who died. The patient received a dose in Aug-2007. After vaccination with Prevenar and Infanrix Hexa the patient died in Aug-2007. Due to the patient''s concurrent chronic cardiac disorder the reporting healthcare professional''s assessment of relatedness between the death and Prevenar and Infanrix was not related. Further information has been requested. The cause of death was reported as death.


VAERS ID: 289951 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2003-01-16
Onset:2006-09-05
   Days after vaccination:1328
Submitted: 2007-09-04
   Days after onset:364
Entered: 2007-09-06
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, Death, Pneumonia pneumococcal
SMQs:, Infective pneumonia (narrow), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-09-08
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: blood culture positive
CDC Split Type: WAES0708AUS00296

Write-up: Information was obtained on request by the Company from the agency via a Line Listing and Public Case Detail Form concerning an 87 year old male who on 16-JAN-2003 was vaccinated with Pneumovax 23. On 05-SEP-2006, 1328 days after vaccination with Pneumovax 23, the patient developed blood culture positive streptococcus pneumonia serotype 7F and was hospitalised. On 08-SEP-2006 the patient died. The cause of death was unknown and unrelated to the blood culture positive pneumonia. The agency considered that blood culture positive for streptococcus pneumonia was possibly related to therapy with Pneumovax 23. The original reporting source was not provided. Additional information is not expected.


VAERS ID: 290870 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2007-09-03
Onset:2007-09-09
   Days after vaccination:6
Submitted: 2007-09-18
   Days after onset:9
Entered: 2007-09-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0709USC00023

Write-up: Information has been received on 10-SEP-2007 from an investigator concerning an 8-week-old male patient who entered a study, title as stated above. The patient was vaccinated with blinded therapy on 03-SEP-2007. Concomitant therapy included diphtheria toxoid (+) hepatitis B virus vaccine (unspecified) (+) Hib vaccine (unspecified carrier) (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown) and poliovirus vaccine live oral (manufacturer unknown). The mother informed the staff that when she awoke on the morning of 09-SEP-2007, the patient was sleeping. When she checked on the patient after doing some housework, the patient had died. The cause of death is unknown at this time. The mother stated that she did not know how the death occurred, as the night before, when they had gone to bed, the patient appeared to be in good health. The mother denied any history of fever, loss of appetite, vomiting or diarrhoea. The reporting investigator considered this event to be of severe intensity and the relationship to the study drug was unknown. Additional information has been requested for the baseline number, relation to study drug, and the cause of death. Additional information was received on 12-SEP-2007 from the investigator stating that there is no known cause of death and that an autopsy will not be performed. No further information is expected. Transmission of 7-day notification to the FDA was made on 17-SEP-2007.


VAERS ID: 291394 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2007-09-13
Submitted: 2007-09-26
   Days after onset:13
Entered: 2007-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TTOX: TETANUS TOXOID (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
YF: YELLOW FEVER (NO BRAND NAME) / UNKNOWN MANUFACTURER 06PVFA1152 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Hepatic failure, Intensive care, Pneumonia, Respiratory failure, Septic shock, Vaccination complication, Visceral oedema
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Angioedema (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 (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: records received 9/27/07-CXR enlargement of cardiac silhouette and alveolar infiltrates most prominent on left side. Thrombocytopenic, myocarditis, liver deficiency. Severe hepatic dysfunction. Cutaneous vascular lesion. Blood culture negative. HIV pending. C4 normal, C2 slightly low, syphilis test, IgM Dengue, Hepatitis C and JBsAg negative.
CDC Split Type:

Write-up: Hospitalized 9/13/07 in ICU for septic shock, pneumonia, acute resp. deficiency, severe liver failure, viscerotropic disease assoc. with yellow fever vaccine. 9/27/07-records received with report-admitted 9/13/07 after 1 week of symptoms high unquantified fever, associated with intense headache, chills, general malaise, muscular pain and articular pain. Two days ago presented with cough and difficult breathing. Intubation and ventilation support. 10/8/07-CDC learned from our contact at the Pan American Health Association that this patient died on 10/4/07.


VAERS ID: 291983 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2007-08-07
Onset:2007-08-07
   Days after vaccination:0
Submitted: 2007-10-04
   Days after onset:58
Entered: 2007-10-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Depressed level of consciousness, Encephalitis, Encephalitis viral, Pain in extremity, Pyrexia, Rabies
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2007-09-13
   Days after onset: 37
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: #1 IMMUNOGLOBULIN HUMAN ANTI-RABIES,: 15-AUG-2007 00:00/ Unknown
Preexisting Conditions: 07-AUG-2007 to Unknown Bitten by dog on left hand (category 3), Unknown Rabid dog eaten
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20071004

Write-up: On 21 SEP 2007 we were informed via Novartis Vaccines that a patient was bitten by a dog and therefore vaccinated with Rabipur and allegedly died. It was also reported that people had eaten meat of a suspected rabid dog (patient?). We are awaiting further information. Preliminary company assessment. Seriousness criterion: death. Causality: pending. Expectedness assessment according to SPC: The reported death is not expected after vaccination with Rabipur. No change in benefit risk-ratio. No measures necessary. Novartis SINA ID S2007PH00200 On 27 SEP 2007 we received the following additional information: On 7 AUG 2007, a 14-year-old male patient, was bitten by a dog on his left hand (category 3) and was given Rabipur 0.1 ml on 7, 10, 14 AUG 2007 and on 6 SEP 2007. Patient was also given HRIG on 15 AUG 2007. Patient was admitted to hospital on 7 SEP 2007 due to high grade fever. It was reported that the patient developed fever, pain on left arm and changes in sensorium on 2 SEP 2007. He was treated with Unacyn (Ampicillin-sodium), Ranitidine (Ranitidine HCl), Ambroxol (Ambroxol-HCl), Clarithromycin and Paracetamol. The physician''s diagnosis was rabies encephalitis. On 13 SEP 2007 at 6:25 a.m. the patient died of "Rabies Paralytic Time". Autopsy was done but the official results will only be released after a month. Company assessment: Seriousness criteria: death, life-threatening, hospitalisation, medically significant Causality: not related. Expectedness assessment according to SPC: The reported symptoms are not expected after vaccination with Rabipur. No change in benefit-risk-ratio. No measures necessary.


VAERS ID: 292365 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-10-08
Entered: 2007-10-05
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Dog bite
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20071029

Write-up: Case Description: On 27 SEP 2007 we were informed via foreign manufacturer that a patient was bitten by a dog and therefore vaccinated with Rabipur and died. We are awaiting further information. Preliminary company assessment. Serious criterion: death Causality: pending. The reported death is not expected after vaccination with Rabipur. No change in benefit risk-ratio. No measures necessary. Novartis SINA ID S2007PH00202


VAERS ID: 293262 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2007-09-25
Onset:2007-09-29
   Days after vaccination:4
Submitted: 2007-10-16
   Days after onset:17
Entered: 2007-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS A20CA316C / UNK LA / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB279AN / UNK LL / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS A20CA316C / UNK LA / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER A20CA316C / UNK LA / IM

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2007-09-29
   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:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: D0054812A

Write-up: This case was reported by a regulatory authority and described the occurrence of sudden infant death syndrome (SIDS) in a 2-month-old male subject who was vaccinated with Infanrix-IPV+Hib (GlaxoSmithKline). Co-suspect vaccination included Engerix-B pediatric (GlaxoSmithKline). On 25 September 2007 the subject received the first dose of Infanrix-IPV+HIB (0.5 ml, intramuscular, right thigh) and the first dose of Engerix-B pediatric (0.5 ml, intramuscular, left thigh), contralaterally. Approximately four days post vaccination with Infanrix-IPV+Hib and Engerix-B pediatric, on 29 September 2007, the subject experienced sudden infant death syndrome (SIDS). The event was considered to be life threatening. The subject died on 29 September 2007 from sudden infant death syndrome (SIDS). It was unknown whether an autopsy was performed. The reporter considered that there might have been only a timely association of sudden infant death syndrome (SIDS) to vaccination with Infanrix-IPV+Hib and Engerix-B pediatric.


VAERS ID: 293389 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2007-10-01
Onset:2007-10-04
   Days after vaccination:3
Submitted: 2007-10-16
   Days after onset:12
Entered: 2007-10-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS A21CA296A / UNK UN / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS A21CA296A / UNK UN / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS A21CA296A / UNK UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER A21CA296A / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 26843 / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Enzyme abnormality, Medium-chain acetyl-coenzyme A dehydrogenase deficiency
SMQs:, Congenital, familial and genetic disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2007-10-08
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: Relevant medical history was not provided.
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: DEWYEG00458607

Write-up: Information regarding Prevenar was received from a healthcare professional via a regulatory authority (PEI) regarding a 3-month-old female patient who experienced suspected medium-chain acetyl-coenzyme A dehydrogenase deficiency. The patient received the first dose on 01-Oct-2007. Three days after vaccination on 04-Oct-2007 the patient was put to bed at 4:30 p.m. one hour later the patient was found lifeless in bed. The situation was considered to be life-threatening. The patient was reanimated and hospitalized. Four days later on 08-Oct-2007 the patient died. Probably the patient''s brain was hypoxically damaged and the patient was diagnosed with suspected medium-chain acetyl-coenzyme A dehydrogenase deficiency. Further results were still pending. The differential diagnosis of SIDS was considered as improbable due to the case history. An autopsy was done but the results were as well still pending. The cause of death was reported as medium-chain acetyl-coenzyme A dehydrogenase deficiency and the autopsy cause of death was unknown as results were still pending. This case is being treated according to the foreign agency.


VAERS ID: 293734 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2007-08-13
Onset:2007-08-13
   Days after vaccination:0
Submitted: 2007-10-18
   Days after onset:66
Entered: 2007-10-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Heart disease congenital, Resuscitation, Screaming
SMQs:, Congenital, familial and genetic disorders (narrow), Hostility/aggression (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-08-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness: The patient''s concurrent illness includes severe congenital atrial septal defect with massive left and right ventricular hypertrophy.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: DEWYEG00465607

Write-up: Information regarding Prevenar was received from a healthcare professional via a regulatory authority regarding a male patient who experienced death and intensive screaming. The patient received a dose on 13-Aug-2007. Infanrix and Prevenar were administered in the morning of 13-Aug-2007. After immunisation, the patient intensively screamed several times. Later he was found and resuscitated by the mother who is a nurse. The patient was hospitalized and death was detected at 9:50 p.m. An autopsy has been performed on unknown date with the result of acute death and congenital heart defect which might basically explain the acute death. As reported, the patient''s heart weight was 75 g at the time of autopsy. The relatedness between death and immunisation was considered doubtful. The autopsy cause of death was death. Further a severe congenital heart defect was detected that might basically explain the death. No additional information was available at the time of this report.


VAERS ID: 293923 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2007-05-10
Submitted: 2007-10-22
   Days after onset:165
Entered: 2007-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (NO BRAND NAME) / UNKNOWN MANUFACTURER 050VFA151Z / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Vaccination complication, Visceroptosis
SMQs:

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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Hospitalzied for possible Yellow Fever Vaccine Associated Viscerotropic illness. Date of hospitalization is given as 8/10/07


VAERS ID: 294374 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:1997-03-25
Onset:2007-03-03
   Days after vaccination:3630
Submitted: 2007-10-24
   Days after onset:234
Entered: 2007-10-25
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, Death, Pneumonia, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-03-10
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: corticosteroids (unspecified) Unk - Unk
Current Illness: Chronic obstructive pulmonary disease; Cardiac failure chronic; Steroid therapy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: blood culture ??Mar07 S. pneumonial serotyped as 19A (vaccine - preventable strain) grown
CDC Split Type: WAES0710AUS00155

Write-up: Information was obtained on request by the Company from the agency via Public Case Detail form and a Case Line Listing form concerning an 82 year old male with chronic obstructive pulmonary disease, chronic cardiac failure and on low-dose steroid. The patient was vaccinated with Pneumovax 23 on 25-MAR-1997 and 20-MAR-2002. Concomitant therapy included corticosteroids (unspecified). On 03-MAR-2007, the patient experienced vaccination failure and pneumonia and was preventable strain. On 10-MAR-2007 the patient died. The cause of death was unknown. The agency considered that vaccination failure and pneumonia were possibly related to therapy with Pneumovax. The agency considered the death was unrelated to Pneumovax 23. The original reporting source was not provided. Additional information is not expected.


VAERS ID: 294449 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-10-25
Entered: 2007-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Encephalitis post immunisation, Guillain-Barre syndrome, Hydrophobia, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (narrow), Demyelination (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20071149

Write-up: Novartis vaccines and diagnostic received the following information from a physician on 29 Sept 2007. The reporter drafted a study report which investigated retrospectively rabies and anti-rabies vaccine in an infectious disease hospital. About 30,000 patients attend the hospital per year to receive post-exposure rabies treatment due to bites and scratches by animals, mainly dogs. About 80 to 90 percent of patients receive a locally manufactured nerve tissue rabies vaccine and 10 to 20 percent received a cell culture manufactured rabies vaccine (Rabipur or Verorab). The author studied 500 cases of rabies infection which occurred during a five-year period. 420 of these patients did not receive a vaccination following exposure to a rabid animal. In 80 cases patients developed rabies despite of vaccination. For nerve tissue vaccine 70 cases of vaccine failure, for Rabipur 9 cases and for Verorab 1 case of vaccine failure were reported. Based on the calculation that 83.3% of patients received nerve tissue vaccine and about 8.3% of patients Rabipur and Verorab respectively, it was concluded that 70 cases of vaccine failure in 125,000 patients results in a rate of 0.56 per 1000 vaccinations, for Rabipur 9 cases per 12,500 patients resulting in 0.72 per 1000 and for Verorab 1 case per 12,500 patients. 140 adverse reactions have been observed during the period under evaluation. About 150,000 patients have been vaccinated. 110 reactions occurred after use of nerve tissue vaccine, mainly Guillain Barre syndrome and most of the patients survived and only "rarely dies". Following use of Verorab 3 patients developed encephalitis and died. Following use of Rabipur 27 patients developed encephalitis and all died. In a table the author provides an overview an advantages and disadvantages of the different vaccines taking also into account the price, the dependency on imports of cell culture vaccine, the vaccination schedule and the currency needed for payment. Regarding the vaccine supply he recommends to stop the import of Rabipur, the increase of production of nerve tissue vaccine, the killing of stray dogs and cats and to shift from nerve tissue vaccine to HDC vaccine with in the next years. Detailed patient information or used batch numbers were not provided. All administered Rabipur vaccine is believed to be produced in a foreign country.


VAERS ID: 294506 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-10-26
Entered: 2007-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Multi-organ failure
SMQs:, 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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

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

Write-up: A 73 or 79 y/o male in Peru received the YF vaccine manufacturerd by Biomanguinhos. He was said to be in good health at the time of vaccination. The cause of death was "multiorgan dysfunction." Dates of vaccination and onset of illness not known.


VAERS ID: 294625 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Foreign  
Vaccinated:2007-08-24
Onset:2007-09-26
   Days after vaccination:33
Submitted: 2007-10-26
   Days after onset:30
Entered: 2007-10-29
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0394F / UNK UN / UN
TBE: TICK-BORNE ENCEPH (NO BRAND NAME) / UNKNOWN MANUFACTURER 076031A / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Brain oedema, Death, Intracranial pressure increased, Pyrexia, Resuscitation
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-09-27
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Injection site reaction; Fever; Reaction to previous exposure to any vaccine
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0710USA04821

Write-up: Information has been received from a health authority, concerning a 29 month old male child with a history of injection site reaction and reaction of fever to previous exposure to any vaccine, who on 24-AUG-2007 was vaccinated with a dose of Pneumovax 23 (lot #654980/0349F; batch NE27420) and a with a dose of concomitant suspect vaccine, Encepur (lot #076031A). On 26-SEP-2007 the child developed a slight fever ("subfebrile temperature"), but continued to play as usual. The family physician visited the child at his home and "declared the child to be okay," That night, the mother awoke "because of her other son," and found her 29 month old son to be lifeless in his bed. The child was transported to the hospital with cardiopulmonary resuscitation required. On 27-Sep-2007, at 1:30 a.m., the child died. An autopsy report revealed a "healthy child, brain oedema, cerebellar pressure cone and elapsed convolutions of the brain." The physician felt that there was a temporal relationship of the events to the vaccines, Pneumovax 23 and Encepur. Other business partner numbers include: E2007-07221 and PEI200709856.


VAERS ID: 294689 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2006-11-06
Onset:2006-11-07
   Days after vaccination:1
Submitted: 2007-10-29
   Days after onset:355
Entered: 2007-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS SAA0753 / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-11-07
   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: Alendronate sodium; Co-codamol; Diazepam; Frusemide
Current Illness: CHRONIC OBSTRUCTIVE PULMONARY DISEASE, HEART DISORDER, HYPERTENSION, OSTEOPOROSIS, PERIPHERAL VASCULAR DISEASE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0493060A

Write-up: This case was reported by a regulatory authority (foreign) # GB-MHRA-ADR 20172206 and described the occurrence of myocardial infarction in a 77-year-old female subject who was vaccinated with Influenza vaccine (GlaxoSmithKline). Concurrent medical conditions included chronic obstructive pulmonary disease, heart disorder, hypertension, osteoporosis and peripheral vascular disease. Concurrent medications included Alendronate sodium (Alendronate), Co-codamol, Diazepam and Frusemide (Furosemide). On 6 November 2006 the subject received an unspecified dose of Influenza vaccine (0.5 ml, intramuscularly). On 7 November 2006, 1 day after vaccination with Influenza vaccine, the subject experienced myocardial infarction. The subject died on 7 November 2006 from myocardial infarction. An autopsy was not performed. Verbatim text received: One day post vaccination, the patient was found dead.


VAERS ID: 295676 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Foreign  
Vaccinated:2007-02-06
Onset:2007-10-08
   Days after vaccination:244
Submitted: 2007-11-05
   Days after onset:28
Entered: 2007-11-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 24135 / 3 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, Brain oedema, CSF culture positive, Death, Meningitis pneumococcal, Pneumococcal sepsis
SMQs:, Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Infective pneumonia (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: Relevant medical history was not provided.
Allergies:
Diagnostic Lab Data: CSF culture (results: pneumococci found, results of determination of serotype pending) and blood culture (results: pneumococci found, results of determination of serotype pending) were done on 09-Oct-2007. The cause of death was reported as meningitis pneumococcal and pneumococcal sepsis.
CDC Split Type: DEWYEG00441907

Write-up: Additional information was received regarding product details, course of event, patient demographics and lab findings, new event brain oedema was included. Information regarding Prevenar was received from a healthcare professional regarding a 14-month-old male patient who experienced pneumococcal meningitis, pneumococcal sepsis and brain oedema resulting in death. The patient received the third dose on 06-Feb-2007. The patient experienced pneumococcal meningitis and pneumococcal sepsis on 08-Oct-2007 and was hospitalized on the same day. On admission he was already in a critical condition. It was also found that the patient experienced brain oedema. Results of blood and CSF culture revealed pneumococci, determination of serotype is still pending. The patient was set on artificial respiration but died on 11-Oct-2007. No additional information was available at the time of this report but have been requested.


VAERS ID: 295875 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-11-07
Entered: 2007-11-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Animal bite, Areflexia, Blood electrolytes, Blood glucose normal, CSF test abnormal, Coma, Computerised tomogram normal, Death, Electroencephalogram abnormal, Encephalitis viral, General physical health deterioration, Hypertonia, Hypotonia, Leukocytosis, Liver function test, Mechanical ventilation, Nuchal rigidity, Nuclear magnetic resonance imaging abnormal, Pharyngolaryngeal pain, Pyrexia, Quadriparesis, Rabies, Radial nerve palsy, Renal function test normal, Salivary hypersecretion, Scan brain, Somnolence, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (narrow), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Hypokalaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: ANIMAL BITE
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20071195

Write-up: On 24 OCT 2007 we received via Vaccine Information Service the following literature article" A 12-year-old boy was brought to the Emergency room with vomiting and drowsiness of one day. He also had a history of fever and sore throat of 6 days. On examination he was febrile (temp: 101F) and drowsy. Vital signs were stable. Pupils were equal and reactive bilaterally. Motor system examination revealed hypertonia of all 4 limbs with Grade IV power. All the DTR were brisk bilaterally. Plantar responses were equivocal. Neck rigidity was present. Fundus was normal. There were no cerebellar signs. Other symptoms were within normal limits. On further questioning, the parents revealed that 4 weeks ago the boy was bitten on the hand, by a neighbour''s unvaccinated dog. He was given 4 doses of chick embryo cell antirabies vaccine, starting from the second day of the bite. Rabies Immunoglobulin was not given. He had complained of sore throat, there was no typical history of hydrophobia or behavioral changes. A provisional diagnosis of rabies encephalitis was made, even though the classical symptoms of rabies were absent. Failure of administration of rabies immunoglobulin after the bite favored this diagnosis. The possibility of vaccine induced ADEM, though rare with the modem cell culture vaccines, was also considered. Laboratory investigations revealed neutrophilic leucocytosis, normal blood glucose, electrolytes, liver and renal function tests, CSF analysis showed a normal cell count, biochemistry and culture was sterile. CFS analysis of Japanese B antibody was negative. EEG showed generalized slow wave forms. CT scan head with contrast was unremarkable, MRI of the brain some subsequently showed bilateral hyperintensities in the basal ganglia, midbrain, pons, thalamus and the hippo campus on the T2 weighted and Fluid attenuation inversion recovery (FLAIR) images. On the tenth day of illness, CSF tested was strongly positive for rabies antigen and immune complexes. An ELISA technique using plates coated with monoclonal antibody to rabies N protein was used for antigen detection. Neutralizing antibodies to rabies virus were detected in both serum and CSF by the standard Rapid Fluorescent Focus Inhibition Test (RFFIT). Within 24 hours of admission, the patient became comatose and was electively ventilated. He developed generalized hypotonia, areflexia and quadriparesis. On the third day of hospitalisation, profuse hypersalivation was noted in the ventilated patient. His condition deteriorated and he succumbed to death on day 16 of hospitalisation. Company assessment: Seriousness criteria: death, hospitalisation. Causality: not related. Rabies encephalitis is no sign of vaccination failure because the boy had got an inappropriate post-exposure treatment after dog bite. Expectedness assessment according to package insert: The reported symptoms, except for fever, are not expected after vaccination with Rabipur. Expectedness assessment according: The reported symptoms, except for fever and vomiting, are not expected after vaccination with Rabipur. On a case level, the case is considered not expected. No change in benefit-risk-ratio. No measures necessary.


VAERS ID: 296056 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Female  
Location: Foreign  
Vaccinated:1994-01-01
Onset:1994-01-01
   Days after vaccination:0
Submitted: 2007-11-08
   Days after onset:5059
Entered: 2007-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Rabies
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown Several wounds on face, bitten by a dog
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20071280

Write-up: On 29 OCT 2007 we received the following literature case from foreign country: In 1994 a girl, age 30 months, received multiple wounds on her face by a dog. Early wound care was given. Wounds were sutured under Ketamine anesthesia. ERIG was then injected one half into wounds and the rest into the gluteal region. The ERIG was not diluted and it is likely that not all wounds were injected. PCEC using the Tai Red Cross-ID regimen was started on day 0 and repeated on days 3 and 7. On day 10, symptoms of furious rabies started and she was managed with comfort care but died on day 17. No necropsy was performed. Company assessment: Serious criterion: death. Causality: not related. This report describes a post-exposure treatment error as not all wounds have been injected with ERIG. Expectedness assessment according to foreign manufacturer package insert: Rabies infection is not expected after vaccination with Rabipur. Vaccine failure is expected after vaccination with Rabipur. No change in benefit-risk-ratio. No measures necessary. Reference cases: 19900956BW 199900955BW MA2004-0560 MA202-0550 MA2006-0877 MA2005-0768


VAERS ID: 296527 (history)  
Form: Version 1.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2004-07-08
Onset:2004-07-08
   Days after vaccination:0
Submitted: 2007-11-13
   Days after onset:1223
Entered: 2007-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS - / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Animal bite, Anxiety, Cellulitis, Death, Diet refusal, Dysphagia, Eating disorder, Fluid intake reduced, Intubation, Local reaction, Musculoskeletal stiffness, Myalgia, Pain in extremity, Paraesthesia, Rabies
SMQs:, Rhabdomyolysis/myopathy (broad), Angioedema (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-07-31
   Days after onset: 23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: 08-JUK-2004 to Unknown Mongoose bite at the left wrist OPEN WOUND
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20040560

Write-up: Case Description: A 57-year old man was bitten by a water mongoose into into left wrist and a second time near the base of his left thumb. It lacerated towards the ulna when he tried to get the mongoose off. It happened at 5:30 a.m. in his house on 06 JUL 2004. The patient received a double dose of Rabipur, batch-no. 321011, into this right deltoid on 08 JUL 2004 shortly after 9:00 a.m. He was then referred to the GP in town where he received immunoglobulin (Rabigam) into the wound. Correct dose was given. Wounds were washed and cleaned with Eusol and dressed with Bactigrass. The patient was also given Augmentin. He complained of severe pain in arm from the first day (08 JUL 2004). He received his second dose of Rabipur on 11 JUL 2004 (day 3). Cellulitis of left arm and severe pain were reported on 13 JUL 2004. A severe local reaction was also reported (date?). The third dose of Rabipur was given on 15 JUL 2004 (day 7) into the right deltoid; the fourth dose on 22 JUL 2004 (day 14) again into the right deltoid. On 24 JUL 2004 the wound bursted open and bled. He complained of severe pain extending into his shoulders and paraesthesia in left arm was hospitalised. On 25 JUL 2004 he was discharged from hospital with sore and stiff arm, severe pain in arm and muscle pain. He was eating well. On 28 JUL 2004 he refused to take fluids, was anxious, unable to swallow, did not eat and was admitted to hospital again. Vaccine failure and high viral load with short incubation were reported. The patient died (date?). Rabies titre were reportedly high. Company assessment: Seriousness criteria: fatal outcome and hospitalisation. Causality: unrelated. Addendum 26 NOV 2004: We received additional information, stating that the patient was declared dead on 31 JUL 2004. He had shown signs of rabies infection. The post mortem showed virus presence in the brain and symptoms in accordance with rabies. Assessment: unchanged. We received on 29 OCT 2007 additional information. The case report was additionally published in a vaccine report. The following new information was provided: The animal was manually removed from the patient. The rest of immunoglobuline (Rabigam), 20 IU/kg, was administered into the deltoid. The author stated that Human Diploid Cell Rabies Vaccine was started i.m. both vaccines were on stock but unclear which was used for the patient and was injected into the deltoid region on days 0,3,7 and 14. On day 14 symptoms of furious rabies started. The patient was intubated and supportive care was provided. He died on day 30. Examination of brain issue was positive by FAT. Company assessment: Seriousness criteria: fatal outcome and hospitalisation. Causality: unrelated. Expectedness assessment according to package insert: Rabies infection is not expected after vaccination with Rabipur (Rabies vaccine). Vaccine failure is expected after vaccination with Rabipur (Rabies vaccine). On a case level, the case is considered not expected. No change in benefit-risk-ratio. No measures necessary. Reference cases: 199900956BW, 19900955BW, MA2007-1280, MA2002-0560, MA2005-0877, MA2005-0768 Comment: Expectedness assessment according to regulatory authority. Expect for severe local reaction, vaccine failure, paraesthesia and muscle pain the symptoms are not expected. On a case level, the case is considered not expected. No change in benefit-risk ratio. No measures necessary.


VAERS ID: 296528 (history)  
Form: Version 1.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:1997-01-01
Onset:1997-01-01
   Days after vaccination:0
Submitted: 2007-11-13
   Days after onset:3968
Entered: 2007-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (IMOVAX) / SANOFI PASTEUR - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Incorrect dose administered, Rabies
SMQs:, Medication errors (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: Dog bite
Allergies:
Diagnostic Lab Data:
CDC Split Type: 199900956BW

Write-up: Case Description: foreign literature case: A 72-year-old woman was bitten by a dog. She incurred one small deep wound on her left cheek. The wound was immediately cleansed, disinfected, and, with use of seven to eight punctures, infiltrated with purified equine RIG (Pasteur Merieux). Purified vero cell rabies vaccine (PVRV: Pasteur Merieux) was then administered intramuscularly into the deltoid muscle and repeated on days 3, 7, and 14, with use of PCEC vaccine instead of PVRV. The patient developed paralytic rabies 20 days after the bite and died 3 weeks later. Rabies antibody titers were 27.26 IU/ml in the serum and not detectable in the CSF 2 days before death. According to the SPC, multiple wounds, especially on the head, should be treated with a double dose of Rabipur on day 0. Assessment: Seriousness criterion: death. Causality: Unrelated. We received on 29 OCT 2007 additional information. The case report was additionally published. This publication states the following new information: The patient developed furious rabies 20 days after the bite. She died on day 21. Post mortum brain tissue was positive for rabies by flourescnet antibody technique (FAT). Company assessment: Seriousness criterion: death Causality: not related Expectedness assessment according to SPC: The described symptoms are unlisted after vaccination with Rabipur. No change in benefit-risk-ratio. No measures necessary. Cross-reference to the following cases, also published in the publication: MA2007-1280, 199900966BW, MA2004-0560, MA2002-0550, MA2005-0877, MA2005-0768


VAERS ID: 296529 (history)  
Form: Version 1.0  
Age: 9.0  
Sex: Male  
Location: Foreign  
Vaccinated:1997-01-01
Onset:1997-01-01
   Days after vaccination:0
Submitted: 2007-11-13
   Days after onset:3968
Entered: 2007-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Incorrect dose administered, Intubation, Rabies
SMQs:, Angioedema (broad), Respiratory failure (broad), Medication errors (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: Rabies Antiserum: 1997/Unknown
Current Illness:
Preexisting Conditions: Dog bite- Injury
Allergies:
Diagnostic Lab Data:
CDC Split Type: 199900955BW

Write-up: Case Description: Foreign Literature case: A 9-year-old boy was bitten by a dog, incurring two minor scratches: one with bleeding on his nose and one on his right cheek with no bleeding. Wounds were immediately washed with soap and water. Thirteen hours later, the wounds were infiltrated with purified equine rabies immune globulin (RIG; Pasteur Merieux) and the remaining RIG was injected intramuscuarly. Purified chick embryo rabies vaccine (PCEC; Behring) was injected into the deltoid muscle on days 1,3,7 and 14. The patient developed paralytic rabies 30 days after the bite, and died 1 week later. According to the SPC, multiple wounds, especially on the head, should be treated with a double dose of Rabipur on day 0. Assessment: Seriousness criterion: death. Causality: unrelated. We received on 29 OCT 2007 additional information. The case report was additionally published . This publication states the following new information: The patient was intubated and supportive care was given. Necropsy was positive for rabies by PCR. Company assessment: Seriousness criterion: death. Causality: not related. Expectedness assessment according to authorities: The described symptoms are unlisted after vaccination with Rabipur. No change in benefit-risk-ratio. No measures necessary. Cross-reference to the following cases, also published in the publication. MA2007-1280, 199900956BW, MA20040560, MA20020550


VAERS ID: 296530 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Male  
Location: Foreign  
Vaccinated:2007-10-16
Onset:2007-10-21
   Days after vaccination:5
Submitted: 2007-11-09
   Days after onset:19
Entered: 2007-11-13
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNC: MENINGOCOCCAL (MENINGITEC) / PFIZER/WYETH - / 2 UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 25126 / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asphyxia, Atelectasis, Autopsy, Blood test, CSF test, Cardiac arrest, Cough, Death, Dyspnoea, Feeding disorder, Histology, Pneumonia aspiration
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-21
   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: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: The patient previously experienced no adverse drug reaction while taking Meningitec and Prevenar on 31-Aug-2007.
Allergies:
Diagnostic Lab Data: Autopsy (results: No evidence of inflammatory lesions to CNS (in particular to meninges). Macroscopic evaluation of all the organs was within normal range, except for both lungs) was done on 23-Oct-2007. Additionally, the following tests were done on an unspecified date: histology (results: to liver, spleen, heart, thymus, encephalus, cerebellum, thyroid and pancreas within normal range); histology (results: Pulmonary parenchyma with evidence of atelectasis due to the presence of hystiocytes and amorphous material (like little drops of exogenous nature) in the alveolar lumen. Microbial flora and granulocytic inflammatory elements.); blood test (results: waiting for results); and CSF test (results: waiting for results). The cause of death was reported as cardiac arrest and the autopsy cause of death was asphyxia and aspiration pneumonia.
CDC Split Type: ITWYEG00560207

Write-up: Follow-up information concerning change of adverse events and results of autopsy has been received and incorporated into the narrative. Information regarding Meningitec was received from a healthcare professional via a regulatory authority regarding a 7-month-old male patient who experienced cardiac arrest, asphyxia, aspiration pneumonia and milk went down the wrong way. The patient received the second dose on 16-OCT-2007. The patient also received the second dose of Prevenar on 16-Oct-2007. The patient experienced cardiac arrest, asphyxia, aspiration pneumonia and milk went down the wrong way on 21-Oct-2007 showing cough and ingravescent and acute dyspnoea. The outcome of the events was reported as fatal. No additional information was available at the time of this report.


VAERS ID: 297029 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2007-10-06
Onset:2007-10-06
   Days after vaccination:0
Submitted: 2007-11-14
   Days after onset:39
Entered: 2007-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Pyrexia, Tremor, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-08
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Associated ''pneumological'' disease.
Allergies:
Diagnostic Lab Data:
CDC Split Type: E200707757

Write-up: Case received from Sanofi Pasteur MSD on 06-Nov-2007 under the reference number RA-011-2007: This case was not medically confirmed and was received from a patient''s relative. An elderly female patient with a history of associated ''pneumological'' disease received the booster dose of (Imovax polio, batch number not reported) on 06-Oct-2007. On 06-Oct-2007 she experienced tremor, vomiting and fever. She died on 08-Oct-2007.


VAERS ID: 297780 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Foreign  
Vaccinated:2007-10-29
Onset:2007-11-11
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2007-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Diarrhoea, Gastroenteritis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0711USC00024

Write-up: Information has been received from an investigator concerning a 17-week-old male, with no relevant medical history, who entered study title as stated above. The patient was vaccinated with his first and second doses of blinded therapy on 28-SEP-2007 and 29-OCT-2007. There was no concomitant medication. Report reached the clinician on 12-NOV-2007 from an aunt who stated that the baby had diarrhoea and fever the night of 10-NOV-2007. On the morning of 11-NOV-2007, the baby died due to acute gastroenteritis while on the way to the hospital. The death was 13 days past dose 2 of study therapy. A Verbal autopsy was to be done. The reporting investigator felt that acute gastroenteritis, an important medical event, was of severe intensity and was possibly related to study therapy. Additional information has been requested.


VAERS ID: 297781 (history)  
Form: Version 1.0  
Age: 0.1  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2007-11-09
Submitted: 0000-00-00
Entered: 2007-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cough, Death, Diarrhoea, Dyspnoea, Malaria, Pneumonia, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-11-11
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0711USC00043

Write-up: Information was received from an investigator concerning a 6-week-old female patient who entered study, titled stated above. On 9-NOV-2007, the patient was admitted to the hospital with difficulty breathing, fever, cough and diarrhoea. The patient was diagnosed with pneumonia and malaria. On 11-NOV-2007, the patient died. No further information was available at the time of this report. The investigator considered the events of pneumonia and malaria to be of severe intensity. Causality was not reported and therefore these events were considered related until further information becomes available. Additional information has been requested for a completed SAE report form.


VAERS ID: 297782 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2007-11-08
Onset:2007-11-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2007-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPH: DTAP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Epistaxis, Pulmonary embolism, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, venous (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-11-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: pyrimethamine (+) sulfadoxine 11/08/2007 - Unk
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0711USC00048

Write-up: Information has been received from an investigator concerning a 10-week-old male with no previous medical history who entered a study. On 11-OCT-2007 and 08-NOV-2007, the patient was vaccinated with the first and second doses of blinded therapy, respectively. Concomitant therapy included diphtheria toxoid (+) hepatitis B virus vaccine (unspecified) (+) Hib vaccine (unspecified carrier) (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown), poliovirus vaccine live oral (manufacturer unknown). and Fansider. The father reporter that upon returning from a meeting on the night of 10-NOV-2007, he found the patient lying by the side of the mother dead with blood stained foamy secretions from the nose. There was no prior history of cough, fever, vomiting, diarrhoea, reduced feeding, or any other symptoms or illnesses. Cause of death was suspected pulmonary embolism or pulmonary oedema. An autopsy was not performed and there was no death certificate. Efforts were being made to contact the patient''s mother for further information. The reporting investigator felt that suspected pulmonary embolism or pulmonary oedema was related to study therapy. Additional information has been requested regarding the event term and any further follow up received from the patient''s mother.


VAERS ID: 297977 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-11-26
Entered: 2007-11-28
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (IMOVAX) / SANOFI PASTEUR - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Antibody test abnormal, CSF test abnormal, Death, Immunoglobulins, Rabies, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Guillain-Barre syndrome (broad), Vasculitis (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient was a soldier and was bitten by a mongoose on the finger.
Allergies:
Diagnostic Lab Data: Neutralizing serum antibody was 1:8 one week after onset of symptoms. CSF antibody titers were not detectable.
CDC Split Type: 200703856

Write-up: From information received on 14 November 2007: This case is described in a literature article. According to the author, "rabies remains a public health problem in many emerging countries. Virtually all is known that should enable us to eliminate this scourge by controlling the disease in canine populations and by diligent provision of WHO recommended post-exposure prophylaxis (PEP). Nevertheless, post-exposure prophylaxis failures do occur. Most common failures are due to deviations from WHO management recommendations and lack of essential biologicals. True failures, were all was done according to WHO recommendations, are fortunately extremely rare. Presented are seven such deaths. Other examples of common management deviations that resulted in deaths are also shown." This article describes a total of 15 cases of failure of post-exposure rabies prophylaxis following the administration of rabies vaccine and immunoglobulines from different manufacturers. Among these cases, ten cases are reported following the administration of vaccine and/or immunoglobulines. Case 2007-03856 corresponds to case 1.8 of the publication. A 19-year-old male patient, who was a soldier, was bitten by a mongoose on the finger. Immediate wound care was given. The wound was injected with 1 mL HRIG, batch number not reported, and the rest of the dose calculated as 20 IU/kg was given intramuscularly in the deltoid region. The patient was started on Verorab (batch number not reported) intramuscularly in the gluteal region which was repeated on days 3, 7, and 14. On day 31, the patient experienced symptoms of furious rabies. He was given a final dose of HDCV. Neutralizing serum antibody was 1:8 one week after onset of symptoms. CSF antibody titers were not detectable. On day 30,k he was given 600 mL of pooled hyperimmune serum intravenously (antibody content unknown). He died on day 37. Necropsy was positive for rabies by FAT. This case is linked with 982450/2, 982450/1, 2007-01202, 200401725, 2006-02765, 2006-01541, 2007-03855, 2007-03857 and 2007-01006.


VAERS ID: 297978 (history)  
Form: Version 1.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-11-26
Entered: 2007-11-28
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (IMOVAX) / SANOFI PASTEUR - / 1 GM / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Incorrect route of drug administration, Rabies
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient was bitten by a dog on the upper lip.
Allergies:
Diagnostic Lab Data: not reported
CDC Split Type: 200703857

Write-up: Information received on 14 November 1997: This case report is described in a literature article. According to the author, "rabies remains a public health problem in many emerging countries. Virtually all is known that should enable us to eliminate this scourge by controlling the disease in canine populations and by diligent provision of WHO recommended post-exposure prophylaxis (PEP). Nevertheless, post-exposure prophylaxis failures do occur. Most common failures are due to deviations from WHO management recommendations and lack of essential biologicals. True failures, where all was done according to WHO recommendations, are fortunately extremely rare. Presented are seven such deaths. Other examples of common manage deviations that resulted in deaths are also shown." This article describes a total of 15 cases of failure of post-exposure rabies prophylaxis following the administration of rabies vaccine and immunoglobulines from different manufacturers. Among these cases, ten cases are reported following the administration of vaccine and/or immunoglobulin. Cases 2007-03857 corresponds to case 1.9 of the publication. A 41-year-old male patient was bitten by a dog on the upper lip. Early wound care was given. On day 2, Favirab (batch number not reported) was given intramuscularly into the gluteal region. He was started on Verorab (batch number not reported) intramuscularly into the deltoid and this was repeated on days 4 and 7. On day 14, the patient experienced symptoms of furious rabies. HDCV was given at 8 sites intradermally. The patient received supportive are and died on day 16. No necropsy was performed. This case is linked with 982450/2, 982450/1, 2007-01202, 2004-01725, 2006-02765, 2006-01541, 2007-03856, 2007-03855 and 2007-01006.


VAERS ID: 298470 (history)  
Form: Version 1.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2007-10-25
Onset:2007-10-26
   Days after vaccination:1
Submitted: 2007-12-03
   Days after onset:38
Entered: 2007-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Antibody test positive, Death, Rash
SMQs:, Anaphylactic reaction (broad), Vasculitis (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-11-26
   Days after onset: 31
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Examinations: Antibody test: Varicella antibody positive
CDC Split Type: D0055317A

Write-up: This case was reported by a physician, via a sales representative, and described the occurrence of death in a 29-year-old female subject who was vaccinated with Boostrix (GlaxoSmithKline) and Priorix. The hospital already included Twinrix (GlaxoSmithKline) given five years before, which was well tolerated. Varicella antibody was positive. On 25 October 2007 the subject received unspecified dose of Boostrix (unknown route and application site) and unspecified dose of Priorix (unknown route and application site). On 26 October 2007, 1 day after vaccination with Boostrix and Priorix, the subject experienced exanthema. Measles post vaccination were suspected first, but excluded on 15 November 2007. The subject was hospitalised for an unknown time. The subject developed possible encephalitis. The subject died on 26 November 2007, cause of death was unknown. An autopsy was performed, but the result was not available to the physician. According to the physician a public prosecutor was informed, who considered this was a natural death. Follow-up information has been requested.


VAERS ID: 299026 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Foreign  
Vaccinated:2007-10-25
Onset:2007-11-19
   Days after vaccination:25
Submitted: 2007-12-06
   Days after onset:17
Entered: 2007-12-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Culture stool negative, Death, Diarrhoea, Eyes sunken, Gastroenteritis, Mucosal dryness, Pyrexia, Rotavirus test negative, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Periorbital and eyelid disorders (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-11-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: acetaminophen 06Nov07 - Unk; dextrose (+) electrolytes (unspecified) 01Nov07 - 13Nov07; herba (unspecified) 04Nov07 - Unk; nystatin 06Nov07 - Unk;
Current Illness: Oral candidiasis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: stool culture 01Nov07 normal flora; stool rotavirus antigen 01Nov07 negative
CDC Split Type: WAES0711USC00063

Write-up: Information has been received from an investigator concerning a 19 week-old female with oral candidiasis who entered a study, title as stated above. On 21-AUG-2007, 24-SEP-2007, and 25-OCT-2007, the patient was vaccinated with her first, second, and third doses of blinded therapy. Concomitant therapy included dextrose (+) electrolytes (unspecified), herba (unspecified), nystatin, and Paracetamol (acetaminophen). On 01-NOV-2007, the patient presented to the study clinic with a 2-day history of diarrhoea and vomiting. The diarrhoea was maximum of 5 times and vomiting was 2 times per day. On examination, the baby was alert and drank normally. She had sunken eyes and dry mucous membranes, but skin turgor was normal. An Elisa for Rota antigen was negative; a culture and sensitivity revealed normal flora. A diagnosis of acute gastroenteritis was made and the patient was sent home on oral rehydration salts. On 04-NOV-2007 after a domestic disagreement, the baby''s mother with her baby moved to her maternal home where the baby''s condition worsened. On 13-NOV-2007, the baby was hospitalized at a nearby health center and was discharged on 16-NOV-2007 upon the mother''s request. On 19-NOV-2007 at 1:00am, the patient died. The cause of death was gastroenteritis. No autopsy was done. No death certificate was obtained. The reporting investigator felt that gastroenteritis was related to study therapy. Gastroenteritis was considered to be an important medical event. Additional information has been requested regarding possible fever, any additional local/traditional or other medications after discharge, HIV sero-status, clarification of culture and sensitivity, clarification of herbal medication, and start date of the event. A 7 day phone call was placed to the FDA on 29-NOV-2007.


VAERS ID: 299027 (history)  
Form: Version 1.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2006-11-28
Onset:2006-11-28
   Days after vaccination:0
Submitted: 2007-12-06
   Days after onset:373
Entered: 2007-12-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-11-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0711USA07130

Write-up: Information has been received from a health care professional concerning a 90 year old female with no pertinent medical history who on 28-NOV-2006 was vaccinated in the arm with a dose of pneumococcal 23v polysaccharide vaccine. On 28-NOV-2006, three seconds post vaccination, the patient had what appeared to be a "cardiac collapse and went cold". There was no wheeze or rash. Adrenaline was administered and the patient was taken to the hospital. On 28-NOV-2006, two to three hours later, the patient died. The cause of death was anaphylactic reaction to pneumococcal 23v polysaccharide vaccine. The reporting health professional felt that anaphylactic reaction was related to therapy with pneumococcal 23v polysaccharide vaccine. No further information is available. Other business partner numbers included E2007-08742 and 62692.


VAERS ID: 299131 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2007-11-05
Onset:2007-11-16
   Days after vaccination:11
Submitted: 2007-12-07
   Days after onset:21
Entered: 2007-12-10
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Crying, Death, Gastroenteritis, Hypotonia, Irritability, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Noninfectious diarrhoea (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-11-17
   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:
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0711USC00051

Write-up: Information has been received from an investigator concerning a 7-week-old male with no previous medical history, who entered a study. On 05-NOV-2007, the patient was vaccinated with the first dose of blinded therapy. Concomitant therapy included poliovirus vaccine (manufacturer unknown), diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, Hib conj vaccine (unspecified carrier) and hepatitis B virus vaccine (unspecified). On 17-NOV-2007, the patient had vomited all day and received drugs of unknown type at home. The patient died on the evening of 17-NOV-2007. The field worker arrived at the patient''s house at noon of the 18-NOV-2007 when the patient was due to receive day 14 home visit, but found the funeral ceremony. The reporting investigator felt that gastroenteritis was of severe intensity and was not related to study therapy. Additional information has been requested about the age of the patient, additional assessment about the cause of death and inclusion of the adverse event term of gastroenteritis and its relationship to the study drug in the narrative. Additional information has been received from the investigator. The investigator updated the patient''s age to 40 days, serious adverse event term to unknown, start date to 16-NOV-2007 and the relationship to study drug was unknown. On 30-NOV-2007, a study coordinator visited the patient''s home and learned that the patient was well until 16-NOV-2007, when he went to bed a bit fussy. The patient cried on and off overnight and was breastfed. The patient had 2 episodes of vomiting, but on, sometime in the afternoon, the mother checked on the patient, who was found in bed and seemed hypotonic. Then, the grandmother was called and she noted that the patient had died. They denied noting any fever, and the patient did not have any diarrhea or convulsions. The patient was never examined by a physician and did not receive any medication as his family did not notice that he was ill. there was no known cause of death. No autopsy was or will be performed. The relationship of this event to study drug was unknown. No further information is expected.


VAERS ID: 299232 (history)  
Form: Version 1.0  
Age: 0.36  
Sex: Male  
Location: Foreign  
Vaccinated:2007-11-29
Onset:2007-11-30
   Days after vaccination:1
Submitted: 2007-12-10
   Days after onset:10
Entered: 2007-12-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-11-30
   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: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: Relevant medical history was not provided.
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: NLWYEG00721007

Write-up: Information regarding Prevenar was received from a healthcare professional regarding a 4-month-old male patient who died. The patient received the second dose of Prevenar on 29-Nov-2007. The patient was vaccinated on 29-Nov-2007 around 4PM. At that time the child was happy and alert. The child was found dead the next morning, 30-Nov-2007. It is unknown whether an autopsy has taken place. The cause of death was reported as unknown. No additional information was available at the time of this report.


VAERS ID: 299377 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2007-09-19
Onset:2007-10-05
   Days after vaccination:16
Submitted: 2007-12-11
   Days after onset:67
Entered: 2007-12-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1475F / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bronchitis, Death, Diarrhoea, Photophobia
SMQs:, Pseudomembranous colitis (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-12
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA01347

Write-up: Information has been received from a gynecologist concerning a 19 year old female with no previous medical history reported, who on 19-SEP-2007 was vaccinated (route and site not reported) with the 1st dose of Gardasil (Batch# NF37120, lot#1475F). On the morning of 12-OCT-2007, the patient was found dead in her bed. One week prior to death the female suffered from diarrhea, treatment without antibiotics. The patient also developed light sensitivity. The evening before the patient died she was out with a girlfriend until 3:00 am in the morning. The reporting physician excluded any drug misuse, as she knew the female as a sportive young woman. Contraception was stopped 3 months before vaccination. No reason for the death was detected in autopsy. The only finding in the autopsy was mild bronchitis and mucus. The reporting physician excluded any connection between vaccination and death. Other business partners numbers include E2007-08849(0). Additional information is not expected.


VAERS ID: 299539 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2007-11-09
Onset:2007-11-30
   Days after vaccination:21
Submitted: 2007-12-12
   Days after onset:12
Entered: 2007-12-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-11-30
   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: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0712USC00024

Write-up: Information has been received from an investigator concerning a 10-week-old male with no previous medical history, who entered a study. On 09-NOV-2007, the patient was vaccinated with the first dose of blinded therapy. There was no concomitant medication. On 06-DEC-2007, the field worker went to patient''s home to remind the parent about the second dose of the study therapy, which was due on 07-DEC-2007, but learned that the patient had died on the morning of 30-NOV-2007. The patient was in good health until 30-NOV-2007. The patient''s family reported that the patient behaved normally the night and morning before he died. At some point, the mother breastfed him, the patient fell asleep, and he was laid in bed on his abdomen. The mother returned shortly (the parent was unable to specify the time elapsed), and noted the patient''s eyes were slightly open and she could see the white of his eyes. The mother picked him up and took him to her sister who noted that he had died. The mother and her sister were on the way to the health center when they ran into a family friend, who suggested that "it was too late to save the infant" and sent them home. The mother denied any abnormal behavior throughout the day, history of seizures, vomiting, diarrhea, or fever. There was no vomitus around the patient when the mother found the patient and he had not been entangled in any sheet or blanket. The investigator considered this event as a severe reaction of unknown cause and its relationship to study drug was unknown. No further information is expected.


VAERS ID: 300019 (history)  
Form: Version 1.0  
Age: 1.5  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-12-14
Entered: 2007-12-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 3 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Meningitis pneumococcal
SMQs:, 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: Concomitant medications were not reported.
Current Illness: The patient''s concurrent illness includes an "immunological problem".
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: CLWYEH01691407

Write-up: Information regarding Prevenar was received from a healthcare professional regarding an 18-month-old patient who developed pneumococcal meningitis. The patient received three doses on unspecified dates. The patient developed pneumococcal meningitis early in Nov-2007. The patient expired on an unknown date in Nov-2007. The cause of death was reported as meningitis pneumococcal. No additional information was available at the time of this report.


VAERS ID: 300244 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-12-17
Entered: 2007-12-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: None provided
CDC Split Type: FRWYEG00759307

Write-up: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding three unidentified patients who experienced death. The patients received a dose in 2007. Relevant medical history was not provided. Concomitant medications were not reported. The reporter has had confirmation by a local mobile emergency unit that three patients had experienced death in 2007 whereas they had previously received a dose of Prevenar. The patients had been transferred for autopsy. The reporter did not obtain the patient''s identification, chronology between vaccination and death, cause of death or any additional information.


VAERS ID: 300360 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Male  
Location: Foreign  
Vaccinated:2007-11-27
Onset:2007-12-11
   Days after vaccination:14
Submitted: 2007-12-17
   Days after onset:6
Entered: 2007-12-19
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR A1125 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-12-11
   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: Not reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 200704219

Write-up: Case received from a health authority on 11 December 2007 under the local reference number SK20070007. A 07-month-old male patient with no reported medical history, died on 11 December 2007, i.e. 14 days after receiving his dose of IPV, batch number A1125 and his dose of DTaP (other MFR), batch number unknown, on 27 November 2007. No further information was provided. In the absence of autopsy report and of details surrounding the death of the patient, no conclusion can be drawn.


VAERS ID: 300790 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2007-11-02
Onset:2007-11-13
   Days after vaccination:11
Submitted: 2007-12-21
   Days after onset:38
Entered: 2007-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA290AE / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Immunisation reaction
SMQs:

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2007-11-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: CVA, Heart Failure
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0500512A

Write-up: This case was reported by a regulatory authority and described the occurrence of death nos in a 80-year-old male subject who was vaccinated with Fluarix for prophylaxis. The subject''s medical history included cva and heart failure. On 2 November 2007 the subject received unspecified dose of Fluarix (.5 ml, intramuscular). On 13 November 2007, at an unspecified time after vaccination with Fluarix, the subject experienced death nos. The regulatory authority reported that the event was life threatening. The subject died on 13 November 2007, cause of death was not reported. It was unknown whether an autopsy was performed. Verbatim Text: Delayed reaction to Flu vaccine. Died suddenly found dead in chair after going for his morning newspaper. Possible connection to flu jab as sudden death.


VAERS ID: 300791 (history)  
Form: Version 1.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2007-11-16
Onset:2007-11-19
   Days after vaccination:3
Submitted: 2007-12-21
   Days after onset:32
Entered: 2007-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA336AA / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-11-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0500508A

Write-up: This case was reported by a regulatory authority and described the occurrence of sudden death in a 56-year-old male subject who was vaccinated with Fluarix for prophylaxis. On 16 November 2007 the subject received unspecified dose of Fluarix (.5 ml, intramuscular). At an unspecified time after vaccination with Fluarix, the subject experienced sudden death. The subject was hospitalized and the regulatory authority reported that the event was . The subject died, cause of death is not specified. It was unknown whether an autopsy was performed. Verbatim Text: Died at home sudden death 3 days after vaccination with Fluarix although waiting by pass operation as well before injection died suddenly 3 days later - possible connection? Reporter Comment: Another patient who had heart disease died following administration fluarix - possible connection?


VAERS ID: 301084 (history)  
Form: Version 1.0  
Age: 1.9  
Sex: Male  
Location: Foreign  
Vaccinated:2006-04-01
Onset:2007-12-08
   Days after vaccination:616
Submitted: 2007-12-26
   Days after onset:18
Entered: 2007-12-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, CSF culture positive, Death, Meningitis pneumococcal, Polymerase chain reaction, Respiratory arrest, Streptococcus identification test positive, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-12-15
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: blood culture, 10-Dec-2007, positive for S. pneumoniae; CSF culture, 10-Dec-2007, positive for S. pneumoniae; polymerase chain reaction, 10-Dec-2007, in CSF positive for S. pneumoniae
CDC Split Type: CHWYEG00800907

Write-up: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) unspec) was received from a healthcare professional regarding a 23-month-old male patient who experienced Streptococcus pneumoniae meningitis, vaccination failure. The patient received a dose in Apr-2006. The patient also received a dose of Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) unspec) in Mar-2006 and Apr-2006. Uneventful medical history. Concomitant medications were not reported. The patient experienced Streptococcus pneumoniae meningitis (vaccination failure) on 08-Dec-2007. The patient was hospitalized and died on 15-Dec-2007. On 10-Dec-2007 test results were: blood culture (results: positive for S. pneumoniae); polymerase chain reaction (results: in CSF positive for S. pneumoniae); and CSF culture (results: positive for S. pneumoniae). The pneumococcal serotype test was pending at the time of this report. The cause of death was reported as respiratory arrest. No additional information was available at the time of this report.


VAERS ID: 301390 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2007-11-29
Onset:2007-11-29
   Days after vaccination:0
Submitted: 2007-12-31
   Days after onset:32
Entered: 2008-01-02
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Diarrhoea, Dyspnoea, Influenza like illness, Malaise, Myocardial infarction
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (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: Unknown
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: autopsy confirmed MI
CDC Split Type: WAES0712USA08345

Write-up: Information has been received from a health authority concerning a 69 year old patient (gender not reported) with no relevant medical history (not known if concomitant medications were being taken) who on 29-NOV-2007 was vaccinated intramuscularly (site not reported) with a dose of Pneumovax 23 (lot# not reported). The patient was concomitantly intramuscurlary vaccinated (site not reported) with an Split Viron (Sanofi Pasteur). On the evening of 29-Nov-2007, the patient developed diarrhoea, shortness of breath, felt unwell and experienced flu-like symptoms. The patient died 3 days later due to myocardial infarction. An autopsy was performed and the cause of death was confirmed as myocardial infarction. Both the reporter and the health authority considered this to be a serious reaction but it is not known if the death was related to the suspected vaccine. The cause of death was myocardial infarction was considered to be immediately life-threatening and disabling. Other business partners numbers include E2007-09353 (0). Additional information is not expected, case is closed.


VAERS ID: 302023 (history)  
Form: Version 1.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2007-02-12
Onset:2007-02-12
   Days after vaccination:0
Submitted: 2008-01-08
   Days after onset:330
Entered: 2008-01-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. NG04160 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthma, Cardio-respiratory arrest, Condition aggravated, Death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Asthma/bronchospasm (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-03-12
   Days after onset: 27
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: (therapy unspecified), Unk - Unk; insulin
Current Illness: Bronchitis asthmatic, diabetes mellitus, hypertension, convulsion
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA09330

Write-up: Information has been received from a physician concerning a 58 year old female patient with an acute exacerbation of bronchial asthma with episodes of convulsion, diabetes mellitus and hypertension who on 12-Feb-2007 at 6:00 pm, was vaccinated IM with a dose of pneumococcal 23v polysaccharide vaccine (Batch #NG04160). Concomitant therapy was reported as an anti-asthmatic medication along with ionotropic support for blood pressure, antihypertensives, "AC trapid" and Insulin. On 12-Feb-2007, the patient experienced sudden cardio-respiratory arrest, "the cause of which was not exactly known", and was hospitalized for 2 days. On 12-Mar-2007 the patient died. The cause of death was terminal cardio-respiratory arrest. Additional information has been requested.


VAERS ID: 302024 (history)  
Form: Version 1.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2007-05-11
Onset:2007-10-31
   Days after vaccination:173
Submitted: 2008-01-08
   Days after onset:69
Entered: 2008-01-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. NG04106 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthma, Cardio-respiratory arrest, Chronic obstructive pulmonary disease, Condition aggravated, Death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Asthma/bronchospasm (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-11-08
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Chronic obstructive pulmonary disease; Bronchitis asthmatic
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA09331

Write-up: Information has been received from a physician concerning a 54 year old female with chronic obstructive pulmonary disease and bronchial asthma who on 11-MAY-2007 was vaccinated with Pneumovax 23 (Lot #NG04160) intramuscularly. On approximately 31-OCT-2007 the patient was hospitalized with chronic obstructive pulmonary disease and exacerbation of bronchial asthma. ON 08-NOV-2007 the patient developed respiratory arrest following prolonged chronic obstructive pulmonary deficits and exacerbation of bronchial asthma. On 08-NOV-2007 the patient died. The cause of death was terminal cardio respiratory arrest. No further information is available.


VAERS ID: 302697 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Unknown  
Location: Foreign  
Vaccinated:2007-08-16
Onset:2007-12-17
   Days after vaccination:123
Submitted: 2008-01-14
   Days after onset:28
Entered: 2008-01-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-12-19
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USC00021

Write-up: Information has been received from an investigator concerning a 23-week-old patient who entered a study, title as stated above. On 16-AUG-2007, 18-SEP-2007 and 23-OCT-2007, the patient was vaccinated with the first, second and third doses of blinded therapy. On 17-DEC-2007, the patient was admitted to the hospital for an unknown event. On 19-DEC-2007, the patient died. The cause of death was unknown at this time as well as the relationship of the event to the study therapy. Additional information has been requested for a completed SAE report form.


VAERS ID: 303005 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2008-01-11
Onset:2008-01-11
   Days after vaccination:0
Submitted: 2008-01-17
   Days after onset:6
Entered: 2008-01-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 28367 / 1 UN / IM

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-01-12
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: None provided
CDC Split Type: KRWYEH02061408

Write-up: Information regarding Prevenar was received from a healthcare professional regarding a 2-month-old male patient who experienced fatal cardiac arrest. The patient received the first dose on 11-Jan-2008. Relevant medical history was not provided. Additional suspect medication included "Firsthib". Concomitant medications were not reported. On 11-Jan-2008, approximately 2 hours after Prevnar and Haemophilus influenzae B therapy, the patient experienced cardiac arrest and was hospitalized. Information regarding treatment was not provided. On 12-Jan-2008, the patient died due to cardiac arrest. No additional information was available at the time of this report.


VAERS ID: 303167 (history)  
Form: Version 1.0  
Age: 0.27  
Sex: Male  
Location: Foreign  
Vaccinated:2008-01-02
Onset:2008-01-02
   Days after vaccination:0
Submitted: 2008-01-21
   Days after onset:19
Entered: 2008-01-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac arrest, Cerebral ischaemia, Death, Hyperthermia, Resuscitation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Accidents and injuries (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-01-03
   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: Unknown
Current Illness: Congenital multiplex arthrogryposis, multiple congenital abnormalities
Preexisting Conditions: Drug exposure during pregnancy
Allergies:
Diagnostic Lab Data: None provided
CDC Split Type: FRWYEG00899208

Write-up: Information regarding Prevenar was received from a healthcare professional via a regulatory authority regarding a 3-month-old male patient who experienced cardiac arrest, hyperthermia and prolonged cerebral anoxia. The patient received a dose on 02-Jan-2008. The patient''s concurrent illnesses include congenital multiplex arthrogryposis and multiple congenital malformations with a past history of drug exposure in utero to Abilify (aripiprazole) and Haldol (haloperidol). Concomitant medications were not provided. The patient received immunization by Prevenar and Infanrix Hexa on 02-Jan-2008 in the morning because a gastrostomy was scheduled. He experienced cardiac arrest on 02-Jan-2008 at 23:00 and hyperthermia at an unspecified time. Despite resuscitation the patient died on 03-Jan-2008 at 18:00 after a prolonged cerebral anoxia. The cause of death was reported as cardiac arrest, cerebral ischaemia and hyperthermia. No additional information was available at the time of this report.


VAERS ID: 303290 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: Foreign  
Vaccinated:2007-12-18
Onset:2008-01-09
   Days after vaccination:22
Submitted: 2008-01-22
   Days after onset:13
Entered: 2008-01-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-01-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0801USC00049

Write-up: Information has been received from a site concerning an 18-week-old patient who entered a study, title as stated above. It was estimated that on 18-DEC-2007, the patient was vaccinated with his third dose of blinded therapy. There was no concomitant medication. On 09-JAN-2008, the patient died at home. The cause of death was unknown. At this time, relationship of the event to study therapy is unknown. Due to political unrest, the site was unable to gather further information at this time. Additional information has been requested for a completed an SAE form.


VAERS ID: 303319 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2007-07-18
Onset:2007-11-29
   Days after vaccination:134
Submitted: 2008-01-15
   Days after onset:47
Entered: 2008-01-23
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Catheter placement, Death, Lower respiratory tract infection, Pneumonia, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-11-30
   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: Lipitor; Nitro-Dur; Norvasc; Plavix
Current Illness: Hypertension; Hypothyroidism; Anaemia; Renal disorder; Benign prostatic hypertrophy; Coronary artery disease; Asthma
Preexisting Conditions: Stroke; Cholecystectomy; Small intestinal obstruction; Transient ischaemic attack
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA01969

Write-up: Information has been received from an investigator concerning a 73-year-old male with hypertension, hypothyroidism, anaemia, benign prostatic hypertrophy, kidney disease, coronary artery disease, asthma, chronic obstructive pulmonary disease, hyperphosphataemia and systolic murmur and a history of stroke, cholecystectomy, transient ischaemic attack, small intestinal obstruction and pancreatitis who entered a study, title as stated above. On 03-JUL-2007, the patient was randomized to the study. On 18-JUL-2007 the patient was vaccinated intramuscularly with a first 40 mcg dose of Recombinvax HB (modified process). Concomitant therapy included nitroglycerin (NITRO-DUR), atorvastatin calcium (LIPITOR), levothyroxine Na, amlodipine besylate (NORVASC), cholestyramine resin, vitamins (REPLAVILE), ferrous gluconate, clopidogrel bisulfate (PLAVIX), metoprolol, terazosin hydrochloride, furosemide, enalapril maleate (MSD) and oxybutynin Cl. On 21-SEP-2008, the patient was hospitalized for insertion of an indwelling catheter due to increase in kidney failure. The patient developed a chest infection while in hospital, developed pneumonia on 29-NOV-2007 and died on 30-NOV-2007. The intensity was regarded as "severe". The investigator has stated that an autopsy was not performed. The study medication was reported to be discontinued, and the relationship to the study vaccine is to follow. The outcome of this event was fatal with a stop date of 30-NOV-2007. The course of treatment for this event is "to be obtained". The subject''s clinical course is also, "to be obtained". The investigator reported the relationship of the pneumonia to be unknown to the study vaccine. Additional information has been requested.


VAERS ID: 303470 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-01-23
Entered: 2008-01-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: None provided.
CDC Split Type: ESWYEG00933308

Write-up: Information regarding Prevnar was received from a healthcare professional regarding a male patient who experienced death. The patient received a dose on an unspecified date. Relevant medical history was not provided. Concomitant medications were not reported. The patient experienced death. The cause of death was not reported as unknown. See related case (s): ES-WYE-G00925608 (adverse event, non-expedited). No additional information was available at the time of this report.


VAERS ID: 303471 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2007-12-10
Onset:2007-12-28
   Days after vaccination:18
Submitted: 2008-01-25
   Days after onset:28
Entered: 2008-01-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB265BI / 1 LA / IM

Administered by: Public       Purchased by: Other
Symptoms: Acidosis, Activated partial thromboplastin time normal, Activated partial thromboplastin time prolonged, Aspartate aminotransferase increased, Atrial flutter, Base excess decreased, Blood glucose decreased, Blood lactate dehydrogenase increased, Blood potassium increased, Cardioversion, Chest X-ray abnormal, Coagulopathy, Death, Dyspnoea, Electrocardiogram abnormal, Fatigue, Haemoglobin decreased, Heart rate increased, Hypotension, Intensive care, Intubation, Lung infiltration, Mechanical ventilation, Oedema peripheral, Oxygen saturation decreased, PCO2 abnormal, Palpitations, Platelet count normal, Prothrombin level increased, Prothrombin time prolonged, Pulmonary oedema, Pyrexia, Rales, Shock, Sputum culture, Supraventricular tachycardia, Tachycardia, Tachypnoea, Thrombocytopenia, Unresponsive to stimuli, Ventricular extrasystoles
SMQs:, Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Lactic acidosis (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (narrow), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-01-11
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: COMBIVIR (ZIDOVUDINE/LAMIVUDINE) 04/20/2007:PRESENT; KALETRA (KALETRA) 09/24/2007:PRESENT
Current Illness:
Preexisting Conditions: HIV POSITIVE
Allergies:
Diagnostic Lab Data: 05-Jan-08 Chest X-ray: Increased heart area; pulmonary infiltrates; 05-Jan-08 ECG: Premature ventricular contractions; 10-Jan-08 ECG: Atrial flutter; 10-Jan-08 pCO2: 26.9 mmHg (ref. range 35-45 mmHg); 10-Jan-08 pO2: 41.9 mmHg (ref. range 83-108 mmHg); 10-Jan-08 Base excess (BE): -13.6 2mEg/L (ref. range +/- 2mEq/L); 10-Jan-08 Prothrombin (PT) test: no coagulation (ref. range 12 sec); 10-Jan-08 Partial thromboplastin time (PTT) test: no coagulation (ref. range 30-45 sec); 11-Jan-08 ECG: Supraventricular tachycardia; 11-Jan-08 Chest X-ray: Bilateral basal infiltrates; Three sputum samples for AFB were negative; Glucose 11Jan2008 7 mg/dl 64-116 NL; Potassium 11Jan2008 6.6 meq/L 3.0-5.6 NL; AST (SGOT) 11Jan2008 1366/ul 115-37 NL; LDH 11Jan2008 1487/ul 100-190 NL; Hemolgobin 11Jan2008 7.8 g/dl 9.4 Unknown NL; Platelets 11Jan2008 27000 Unknown 150000 Unknown NL; Hemoglobin 10Dec2008 10.4 g/dl 9.4 Unknown NL; Platelets 10Dec2008 204000 Unknown 150000 Unknown NL
CDC Split Type: 2008A4000000

Write-up: The patient was enrolled in study ATN 024, a Randomized Open-Label trial. This study is exempt from IND reporting requirements. The patient received a dose of 20 mcg of Engerix B intramuscularly on 10-Dec-07. This was her first dose in a series of three doses. On 04-Jan-08, the patient, a 25 year old female, was hospitalized after a 7-day history of fatigue and a 3-day history of low grade fever (up to 100.4 F), tachycardia, tachypnea, and palpitations. Her physical examination at admission was as follows: heart rate 144 beats/min, respiratory rate 28-32 respiration/min, blood pressure 80/50 mmHg, oxygen saturation 97% on room air. Auscultation showed crackies on the lower left lung area, regular heart rhythm, S3 gallop, no murmurs. No hepatomegaly, splenomegaly, or edema on extremities were noted. The neurological exam was normal. A chest X-ray done on 05-Jan-08 demonstrated increased heart area and pulmonary infiltrates, which were judged to be consistent with pulmonary edema. An ECG from the same day was notable for premature ventricular contractions. Three days later the patient''s tachycardia, tachypnea, and hypotension improved. Her heart rate was 124 beats/min, respiratory rate 28/min, blood pressure 120/80 mmHg, oxygen saturation 97% on room air. Her lungs were clear on auscultation and the rest of her examination remained unchanged. This event is ongoing and a follow-up report is expected. Study vaccine causality has been assessed by the investigator as probably not related to Engerix B. Study vaccine causality has been assessed by the medical monitor as probably not related to Engerix B. Follow-up 11-Jan-08: On 10-Jan-08 the patient''s condition worsened and she was transferred to a larger institution for further management. She had shortness of breath, tachypnea of 32 respirations/min, and tachycardia over 140 beats/min. Her oxygen saturation dropped to 91% on 8 L/min oxygen via mask. A lower extremities edema of 2/4+ was noted. Auscultation revealed bilateral basilar rales and regular heart rhythm was S3 gallop. An ECG showed atrial flutter, and a cardioversion was performed. A chest X-ray one on 11-Jan-08 showed bilateral basal infiltrates. The laboratory values were remarkable for thrombocytopenia, severe acidosis, and markedly abnormal coagulation tests showing no coagulation. Three sputum samples for acid fast bacilli were negative. Later, the patient went into shock, was intubated and maintained on ventilatory support. Treatment with dobutamine, norephinephrine dripping, cefepime, cotrimoxazole, furosemide, H2 blocker, hydrocortizone and vitamin K was started. Follow-up 16-Jan-08: At midnight on 11-Jan-08 the patient was transferred to the ICU, responsive to pain, but not to verbal stimuli. An ECG showed supraventricular tachycardia, dobutamine was suspended and treatment with amidoarone and adenosine was started. The patient''s condition worsened despite the treatment and she expired on 11-Jan-08. An autopsy to determine the cause of death is expected. The causality assessments from the investigator and medical monitor remained unchanged. This event was considered resolved on 11-Jan-08.


VAERS ID: 303908 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2006-02-01
Onset:2008-01-09
   Days after vaccination:707
Submitted: 2008-01-29
   Days after onset:20
Entered: 2008-01-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Meningitis pneumococcal
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-01-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: FRWYEG00948508

Write-up: Information regarding Prevenar was received from a healthcare professional regarding a 27-month-old male patient who experienced meningitis pneumococcal. The patient received the third dose in Feb-2006 (estimated date). The patient had no risk factor for invasive pneumococcal disease. Concomitant medications were not reported. The patient had received a Prevenar primary series with three injections at the age of 2, 3 and 4 months but had not received the booster dose. On 09-Jan-2008, the patient experienced fatal pneumococcal meningitis. The pneumococcal serotype was not identified. The cause of death was reported as meningitis pneumococcal. No additional information was available at the time of this report.


VAERS ID: 304198 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2007-11-29
Onset:2007-11-29
   Days after vaccination:0
Submitted: 2008-02-01
   Days after onset:64
Entered: 2008-02-04
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 3001252 / UNK UN / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Diarrhoea, Dyspnoea, Influenza like illness, Malaise, Myocardial infarction
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-12-01
   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: Unknown
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA05154

Write-up: Information has been received from a health authority concerning a 69 year old female with no relevant medical history reported who on 29-NOV-2007 was vaccinated intramuscularly with a dose of Pneumovax 23 (batch reported as "NB26580") and influenza virus vaccine (manufacturer not reported) (lot 3001252). On 29-NOV-2007, on the evening of vaccination, the patient experienced diarrhea, then flu-like symptom, felt unwell, and had shortness of breath. On 01-DEC-2007, the patient died. The reported cause of death was myocardial infarction. The post mortem report is awaited. The patient had not recovered from other events prior to her death. The health authority and the reporter considered the events to be serious. Other business partner numbers E2008-00549. Additional information has been requested.


VAERS ID: 304397 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2008-01-16
Onset:2008-01-16
   Days after vaccination:0
Submitted: 2008-02-04
   Days after onset:19
Entered: 2008-02-06
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / UN
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR B0213 / 2 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asphyxia, Death, Irritability
SMQs:, Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-01-22
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No concomitant therapy
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200800220

Write-up: Case received from a foreign healthcare professional on 23 January 2008 under the local reference number SK20080002. A 04-month-old male patient with no relevant medical history, experienced fatal suffocation on 22 January 2008, i.e. 6 days after receiving his 2nd intramuscular dose of Imovax Polio, batch number B0213, in the right thigh, concomitantly with his 2nd dose of DTaP on 16 January 2008. The patient was already dead when he arrived at the Emergency Room. The physician confirmed the death around 3:36 pm. The cause of death was suffocation "with no relation". The patient experienced irritability within the 1st two days post-vaccination.


VAERS ID: 304685 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Male  
Location: Foreign  
Vaccinated:2007-12-26
Onset:2007-12-29
   Days after vaccination:3
Submitted: 2008-02-11
   Days after onset:44
Entered: 2008-02-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS - / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Disorientation, Feeding disorder of infancy or early childhood, Inappropriate schedule of drug administration, Kernig's sign, Nuchal rigidity, Pyrexia, Rabies, Respiratory failure, Restlessness
SMQs:, Anaphylactic reaction (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), Akathisia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2007-12-30
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: 10-DEC-2007 to Unknown, Indication Dog bite
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20080104

Write-up: On 28 JAN 2008 we received the following information: A 3-year-old boy had a dog bite on 10 DEC 2007. No record exists on the location and severity of the wound and whether it was cleaned appropriately. He was prescribed Rabipur. Medical history from the parents revealed that he received the first dose on 12 DEC 2007. No information was recorded whether and when a second and third dose was received as planned. On 26 DEC 2007 (^day 14, corresponding to the 4th dose of Essen regimen) a dose of Rabipur was received. No batch number for any vaccination was given. The vaccination was given outside the hospital, not clear where. No RIG was given. On 29 DEC 2007 the child was brought to the hospital with difficulty in feeding and fever. On examination the child was disoriented. He showed no aero- or hydrophobia. Throat and ear were without pathological finding. chest was clear, slight neck rigidity was found and Karnig''s sign was slightly positive. Symptomatic treatment included IV fluids, ceftriaxon, penicillin G, corticosteroids (oradexon), Ranison (ranitidine), Sedil (diazepam). In the afternoon the patient became restless, disoriented and aerophobia was present. On 30 DEC 2007 the boy died at 4.05 a.m. The death certificate states "respiratory failure due to rabies". No autopsy was performed.


VAERS ID: 304735 (history)  
Form: Version 1.0  
Age: 8.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-02-11
Entered: 2008-02-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abnormal behaviour, Affect lability, Amnesia, Apathy, Aphasia, Blood immunoglobulin G increased, CSF cell count, CSF lymphocyte count abnormal, CSF monocyte count, CSF neutrophil count increased, CSF protein increased, CSF test abnormal, CSF virus no organisms observed, CSF white blood cell count increased, Cognitive disorder, Complex partial seizures, Computerised tomogram normal, Death, Decerebration, Electrocardiogram abnormal, Globulins increased, Herpes simplex serology negative, Hypertonia, Lethargy, Muscle rigidity, Mutism, Myoclonus, Opisthotonus, Partial seizures with secondary generalisation, Pleocytosis, Respiratory disorder, Respiratory tract infection, Speech disorder, Subacute sclerosing panencephalitis, Tonic convulsion, Trismus
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Dystonia (narrow), Parkinson-like events (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Malignant lymphomas (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Hypokalaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: electrocardiogram normal; computed axial tomography normal; electrocardiogram high amplitudes; CSF VZV IgG Ab negative; cerebrospinal fluid analysis 29 leukocytes/mm3; 69% neutrophils, 10% lymphocytes; 21% monocytes; 115 mg/dl; globulin 35 mg/dl; immunoglobulin G index cerebrospinal fluid analysis immunoglobulin G 1:80; Herpes simplex virus culture negative;
CDC Split Type: WAES0801BRA00065

Write-up: Information has been received from a physician, author of a literature article, concerning an 8 year old healthy male who was vaccinated with MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) when he was ten months old and five years old. The boy presented at the neurology service with a two-month history of behavioural disturbances, mainly manifested by emotional lability and apathy associated with impairment of educational performance. This clinical picture was followed by complex partial seizures with secondary generalization, with normal interictal EEG and cranial computed tomography (CT). Despite having been treated with gamma-aminobutyric acid, the patient''s condition worsened progressively in the following two months, with amnesia, worsening of behavioural pattern, speech and cognitive impairment. He was hospitalized for further investigations. The patient did not have any prior history of measles infection, his immunization history was normal, including vaccination against measles. His developmental milestones were normal and there was no family background of neurological disorders. Carbamazepine was prescribed due to the onset of generalized myoclonic movements and tonic seizures. Recurrent seizures led to the prescription of valproic acid combined with clonazepam. Another EEG showed generalized periodic high-amplitude sharp waves. CSF analysis showed pleocytosis (29 leukocytes/mm3 with 69% neutrophils, 10% lymphocytes and 21% monocytes) and elevated protein (115 mg/dL) and globulin levels (35 mg/dL). The measles immunoglobulin C titer was over 1:200 on CSF analysis and it was greater than the serum titer (1:80). Polymerase chain reaction for herpes simplex virus (HSV) was negative as well as serum and CSF varicella zoster virus (VZV) serology. The patient became nonverbal and developed trism and an irregular respiratory pattern. Physical examination revealed a lethargic boy with increased muscular tone, diffuse rigidity, semi-opsthotonous position, mutism and decerebration. During his stay in hospital, a respiratory infection led to unsuccessful antibiotic treatment. He died after two months in hospital and after six months of symptom onset. According to the authors, SSPE, subacute sclerosing panencephalitis diagnosis could be acceptable for this case. Also there is no evidence to suggest that the attenuated vaccine virus is responsible for sporadic cases of SSPE. The cause of death was subacute sclerosing panencephalitis. No further information is available. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 304784 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2007-12-17
Onset:2008-01-11
   Days after vaccination:25
Submitted: 2008-02-12
   Days after onset:32
Entered: 2008-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS A20CA308A / 1 UN / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS A20CA308A / 1 UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER A20CA308A / 1 UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 26852 / 1 UN / 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: 2008-01-11
   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: Unknown
Preexisting Conditions: PREMATURE BIRTH
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0507029A

Write-up: This case was reported by a regulatory authority and described the occurrence of sudden infant death syndrome in a 2-month-old male subject who was vaccinated with Infanrix-IPV/Hib and Prevenar for prophylaxis. The subject''s medical history included premature birth (35 5.7 gestation age). On 17 December 2007 the subject received 1st dose of Infanrix-IPV/Hib (intramuscular), 1st dose of Prevenar (intramuscular). On 11 January 2008, 25 days after vaccination with Infanrix-IPV/Hib and Prevenar, the subject (approximately at 2:00 am) was found death in bed. Resuscitation was unsuccessful. Autopsy findings were inconspicuous. The suspect diagnosis was sudden infant death syndrome, however the final autopsy report was pending. The regulatory authority reported that the event was unlikely to be related to vaccination with Infanrix-IPV/Hib and Prevenar.


VAERS ID: 304870 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2007-11-21
Onset:0000-00-00
Submitted: 2008-02-12
Entered: 2008-02-14
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-02-02
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: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0802USC00025

Write-up: Information has been received from an investigator concerning a 15-week-old male with no previous medical history who entered a study. On 21-NOV-2007, the patient was vaccinated with his first dose of blinded therapy. There was no concomitant medication. The infant was reported to have died at home on 02-FEB-2008. The immediate circumstances surrounding the death were not known. The reporting investigator felt that the unknown cause of death was of severe intensity and relationship to study vaccine was unknown. The reporting investigator stated that the family is being contacted to establish the cause of death and circumstances surrounding the event. The site will be contacted immediately for follow up information regarding the event term, onset date, and causality.


VAERS ID: 305098 (history)  
Form: Version 1.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2007-11-21
Onset:2007-11-23
   Days after vaccination:2
Submitted: 2008-02-15
   Days after onset:84
Entered: 2008-02-19
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-12-08
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COMBIVENT, 17Oct07 - Unk; ELLESTE DUET, 01May07 - Unk; SERETIDE, 17Oct07 - Unk; TRAMADOLOR, 13Aug04 - Unk; amitriptyline hydrochloride, 01Sep06 - Unk; dihydrocodeine, 16Feb05 - Unk; etoricoxib, 12Dec04 - Unk; leflunomide, ??Sep07
Current Illness: Rheumatoid arthritis; depression; sleep disorder; pain; hormone replacement therapy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0802USA02226

Write-up: Information has been received from health authority concerning a 48 year old female patient with rheumatoid arthritis, depression, sleep disorder, pain and who took hormone replacement therapy. On 21-NOV-2007 the patient was vaccinated with Pneumovax 23 (batch number, route and site of administration was not reported). Concomitant therapy included leflunomide which started on ??-SEP-2007 for rheumatoid arthritis. Other concomitant therapy included ELLESTE DUET, etoricoxib, amitriptyline hydrochloride, SERETIDE, COMBIVENT and TRAMADOLOR. On 23-NOV-2007 two days post vaccination, the patient developed eosinophilia (no details reported). On 03-DEC-2007 therapy with leflunomide was discontinued. On an unknown date the patient developed pneumococcal septicaemia. On 08-DEC-2007 the patient died. It was not known if an autopsy was performed. The cause of death was listed as pneumococcal septicaemia with eosinophilia. Both the reporter and agency considered this to be a serious reaction. No more information was available. The case was closed. The other business partner number included: 20215577 and E2008-01019.


VAERS ID: 305204 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2008-01-10
Onset:2008-02-05
   Days after vaccination:26
Submitted: 2008-02-19
   Days after onset:14
Entered: 2008-02-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 2 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-02-05
   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: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0802USC00046

Write-up: Information has been received from an investigator concerning a 14-week-old male who entered a study, title as stated above. On 10-JAN-2008, the patient was vaccinated with his second dose of blinded therapy. On 05-FEB-2008, the patient died at home due to an unknown cause. At this time, relationship of the unknown cause of death to study therapy is unknown. Additional information has been requested regarding submittal of an SAE form.


VAERS ID: 305359 (history)  
Form: Version 1.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:1994-07-23
Onset:1994-07-23
   Days after vaccination:0
Submitted: 2008-02-21
   Days after onset:4961
Entered: 2008-02-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abnormal behaviour, Asthenia, Autonomic nervous system imbalance, Back pain, Bedridden, Blindness transient, Borrelia burgdorferi serology negative, Bradyphrenia, Brain stem auditory evoked response abnormal, CSF glucose normal, CSF protein normal, Catheter placement, Cerebellar syndrome, Cognitive disorder, Constipation, Death, Depression, Diplopia, Disorientation, Disturbance in attention, Dysarthria, Dysgraphia, Dyskinesia, Dysphagia, Dysphonia, Dyspnoea, Dysuria, Ear, nose and throat examination, Extensor plantar response, Extrapyramidal disorder, Eye pain, Facial palsy, Fatigue, Gait disturbance, Headache, Hostility, Hyperkinesia, Incontinence, Memory impairment, Mental status changes, Micturition disorder, Multiple sclerosis, Neck pain, Nervous system disorder, Neurological symptom, Nuclear magnetic resonance imaging brain abnormal, Nystagmus, Oedema, Optic neuritis retrobulbar, Pain in extremity, Paraesthesia, Pneumonia, Psychomotor retardation, Respiratory failure, Skin irritation, Somatosensory evoked potentials, Spastic paralysis, Tremor, Urinary incontinence, Vision blurred, Visual acuity reduced, Visual evoked potentials abnormal, Weight increased, Wheelchair user
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Akathisia (broad), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Optic nerve disorders (narrow), Cardiomyopathy (broad), Demyelination (narrow), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (narrow), Hearing impairment (broad), Vestibular disorders (broad), Ocular infections (broad), Ocular motility disorders (narrow), Hypersensitivity (broad), Arthritis (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-08-29
   Days after onset: 2959
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Bilateral foot surgery, Metal allergy, Sclerosis of varices, Skin eruption, Venous insufficiency. No genetic factor of mulitple sclerosis was noticed by the patient (HLA DR2 negative, HLA B5 mild positive) and by the patient''s circle. No viral etilogy was found. Before 1994, the subject had a very active life (NOS). Her vaccination included a dose of Engerix B, given on 05 November 1994.
Allergies:
Diagnostic Lab Data: Auditory evoked potentials 07Jan1999 Abnormal; Cerebrospinal fluid glucose 10DEC1998 Normal; Cerebrospinal fluid protein 10DEC1998 Normal; Ear, nose and throat examination 08Mar2002 Unknown; MRI brain 29Oct1998 Abnormal; Mini mental status examination 17/30; Somatosensory evoked potential 07Jan1999 Abnormal; Visual evoked potentials 07Jan1999 Abnormal; On 29 October 1998, brain MRI: white matter lesions, especially supratentorial periventricular lesions. The lesions, evocative of demyelinating lesions, evoked firstly multiple sclerosis. Urodynamic check up was performed on 21 April 1999 and the result concluded to a moderate spincterial insufficiency. On 28 September 1999, the Lyme disease antibodies were negative.
CDC Split Type: B0508278A

Write-up: This case was reported by a physician, via the GSK legal department and described the occurrence of multiple sclerosis in a 35-year-old female subject who was vaccinated with Engerix B (GlaxoSmithKline). GSK was provided with experts report, hospitlisation report, and information from the patient (letter). Until the end of 1994, the subject had a very active life (NOS) seemed to be in good health according to the expert report. Concurrent medical condition included metal allergy (chromium, nickel), which led to cutaneous eruption. At an unknown date, she underwent unspecified bilateral surgery on feet. Past medical conditions included sclerosis of varix and venous insufficiency. No genetic factor of multiple sclerosis was noticed by the subject (HLA DR2 negative, HLA B5 mild positive) and by the subject''s circle. No viral etiology was found. On 15 March 1994, she underwent ophthalmologic exam (NOS). On 02 May 1994, an orthoptic check up was performed. On 23 July 1994, she was vaccinated with a dose of Engerix B (batch number not available). At an unknown date, in 1994, the subject complained of writing and walking difficulty and asthenia. On 21 September 1994, she underwent a second ophthalmologic exam (NOS). From 04 October 1994 to 09 January 1995, she underwent severe orthoptic sessions (due to eye pain during fixation related to convergence insufficiency). According to a physician, the ocular disorder did not allow to suspect a multiple sclerosis: no retrobular optic neuritis and no oculo-motor paralysis. On 05 November 1994, she received a second dose of Engerix B. At an unspecified date in 1994, the subject presented with micturition disorder with false need. In December 1994, she experienced a blurred vision. On 16 April 1996, there was a prescription of ten physiotherapy sessions of lower limbs (NOS). In September 1998, she presented with a transient blindness for half an hour. In October 1998, the urinary disorder worsened with pressing micturition and incontinence. On 22 October 1998, as writing difficulties worsened for two years, a neurologist was consulted. He noticed static and kinetic cerebellar syndrome, led to writing trouble and a pyramidal irritation. On 29 October 1998, brain MRI was performed and revealed white matter lesions, especially supratentorial periventricular lesions. The lesions, evocative of demyelinating lesions, evoked firstly multiple sclerosis. On 10 December 1998, lumbar puncture showed normal glucose and protein level in cerebrospinal fluid. On 07 January 1999, somatosensory, auditory and visual evoked potentials were abnormal, which evoked a multifocal disorder. on 14 January 1999, diagnosis of multiple sclerosis was made. On 16 January 1999, a treatment with Synacthene was initiated and led to edemas and weight gain (5kg) (non event). For urinary disorder, a treatment with Ditropan was introduced. Due to the events, the subject presented with a depressive state. From 05 to 11 February 1999, she was hospitalized and received treatment with flash of Solumedrol followed by an oral corticotherapy until 30 March 1999. During this hospitalisation, the subject complained of voice dysfunction, exacerbation of walking difficulty, perception and memory disorder. The clinical exam revealed right lower limb motor deficit, a diffuse cerebellar-pyramidal syndrome, a cerebellar dysarthria and a psychomotor slowing. Her anxio-depressive state (non event) was marked. The diagnosis of multiple sclerosis flare up was made. In April 1999, a treatment with Avonex was initiated. Lower limb anaesthesia was reported. on 21 April 1999, urodynamic check up was performed and the results concluded to a moderate spincterial insufficiency. On 28 September 1999, Lyme''s disease antibodies were negative. In May 2000, due to a bad tolerance and efficacy, treatment with Avonex was discontinued. In June or July 2000, she consulted a physician whom wanted neurological advice regarding treatment of the subject''s volitional hyperkinesis. No treatment was initiated. From 19 to 23 September 2000, she was hospitalized. During this hospitalization, she presented with bradypsychia, memory disorder, diffuse cerebellar pyramidal syndrome, predominant on right lower limb and right upper limb dyskinesia. The subject had to use a wheelchair. The subject received several injections of corticoids and Solupred which led to walking improvement. The patient reported headache, eyes, limbs, back and neck pain and tingling. From 16 October to 3 December 2000 and from 08 to 19 December 2000, she was hospitalized due to walking difficulty, sphincterial incontinence, diplopia and total loss of autonomy. During this hospitalisation, she presented with massive lower limbs neurological deficit, predominant on the left side. The muscular strength was normal on upper limbs. She had a reflex tetra pyramidal syndrome, a positive bilateral Babinski sign, a disabling intentional tremor on right upper limb with right kinetic and static cerebellar syndrome, a left diplopia, a decreased of bilateral visual acuity, a bi-sphincterial incontinence, a disorder of memory and executive function. The dependence was total, except feeding. The subject was depressed and suspicious or even hostile (non events). After five bolus of Solumedrol, an improvement was reported. From 03 to 08 December 2000, she was hospitalized in the intensive care unit for acute respiratory insufficiency following a deglutition pneumopathy of the right base (non events). From 19 December 2000 to 30 March 2001, she was transferred to a readaptation centre. In the centre, the subject''s state was bedridden with cerebellar of the four limbs, a decrease of visual acuity, a nystagmus, cognitive disorder, with memory and attention disorder and spastic laugh. The dependence was total. The subject had a urinary catheter. Three weeks after admission, the subject''s state aggravated with severe memory disorder, temporospatial disorientation and a decrease of reasoning ability (MMS 17/30). The subject was in a wheelchair. On 04 April 2001, a physician confirmed that the subject was bedridden. She had a spastic paraplegia with a severe kinetic cerebellar syndrome of the right upper limb, an inferior left facial paralysis, a nystagmus and false passage with liquid. She had a vesical catheter. A treatment with Rivotril and Mysoline were introduced. On 13 November 2001, a progressive functional aggravation was observed with a depressive state. At an unknown date, she began a treatment with Lioresal. On 24 October 2001, it was reported a severe fatigability, a dyspnea, optic neuritis retrobular, constipation and joint retraction. No trouble linked to language was reported. She adapted to a wheelchair with adapted control. From 07 to 28 February 2002, the subject was hospitalized for respiratory distress with inhalation pneumopathy (non event). On 08 March 2002, Due to the severe deglutition trouble and after ENT consultation, all the oral food was not recommended. On unknown date, she took Doliprane, Innohep, anxiolytic and laxative. On 29 August 2002, the subject died (NOS). According to the experts multiple sclerosis quickly evolutive was possibly related to the vaccination with Engerix B according to the French method of imputability.


VAERS ID: 305507 (history)  
Form: Version 1.0  
Age: 88.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2006-11-01
Onset:2006-11-01
   Days after vaccination:0
Submitted: 2008-02-20
   Days after onset:476
Entered: 2008-02-22
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (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: Date of death: ??-Nov-2006
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200812934

Write-up: Report received from a literature article on 19-FEB-2008. An 88-year-old patient (gender unknown) received influenza vaccine (brand unknown) in November 2006. On the same day as receiving the influenza vaccine, the patient died suddenly. No details were provided with regard to medical history or concomitant medications. This was one of four deaths cited by the article. The vaccines given to the four deceased people had been produced by two different producers and were from different batches. The authors comment that the option of a quality defect in the product was considered to be ruled out (however, the brands of vaccine involved and the batches were not mentioned). The authors also comment that medical review concluded that it was highly unlikely that there was a causal association between the deaths and the vaccinations. The authors also mention that three of the four deceased were men.


VAERS ID: 305508 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2006-11-01
Onset:2006-11-01
   Days after vaccination:0
Submitted: 2008-02-20
   Days after onset:476
Entered: 2008-02-22
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-11-01
   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: Unknown
Current Illness:
Preexisting Conditions: Date of death: ??-Nov-2006
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200812933

Write-up: Report received from a literature article on 19-FEB-2008. A 80-year-old patient (gender unknown) received influenza vaccine (brand unknown) in November 2006. On the same day as receiving the influenza vaccine, the patient died suddenly. No details were provided with regard to medical history or concomitant medications. This was one of four deaths cited by the article. The vaccines given to the four deceased people had been produced by two different producers and were from different batches. The authors comment that the option of a quality defect in the product was considered to be ruled out (however, the brands of vaccine involved and the batches were not mentioned.) The authors also comment that medical review concluded that it was highly unlikely that there was a causal association between the deaths and the vaccinations. The authors also mention that three of the four deceased were men.


VAERS ID: 305509 (history)  
Form: Version 1.0  
Age: 58.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2006-11-01
Onset:2006-11-01
   Days after vaccination:0
Submitted: 2008-02-20
   Days after onset:476
Entered: 2008-02-22
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (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: Date of death: ??-Nov-2006
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200812932

Write-up: Report received from a literature article on 19-FEB-2008. A 58-year-old patient (gender unknown) received influenza vaccine (brand unknown) in November 2006. On the same day as receiving the influenza vaccine, the patient died suddenly. No details were provided with regard to medical history or concomitant medications. This was one of four deaths cited by the article. The vaccines given to the four deceased people had been produced by two different producers and were from different batches. The authors comment that the option of a quality defect in the product was considered to be ruled out (however, the brands of vaccine involved and the batches were not mentioned). The authors also comment that medical review concluded that it was highly unlikely that there was a causal association between the deaths and the vaccinations. The authors also mention that three of the four deceased were men.


VAERS ID: 305510 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2006-11-01
Onset:2006-11-01
   Days after vaccination:0
Submitted: 2008-02-20
   Days after onset:476
Entered: 2008-02-22
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (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: Date of death: ??-Nov-2006
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200812930

Write-up: Report received from a literature article on 19-FEB-2008. A 53-year-old patient (gender unknown) received influenza vaccine (brand unknown) in November 2006. On the same day as receiving the influenza vaccine, the patient died suddenly. No details were provided with regard to medical history or concomitant medications. This was one of four deaths cited by the article. The vaccines given to the four deceased people had been produced by two different producers and were from different batches. The authors comment that the option of a quality defect in the product was considered to be ruled out (however, the brands of vaccine involved and the batches were not mentioned). The authors also comment that medical review concluded that it was highly unlikely that there was a causal association between the deaths and the vaccinations. The authors also mention that three of the four deceased were men.


VAERS ID: 306034 (history)  
Form: Version 1.0  
Age: 0.8  
Sex: Female  
Location: Foreign  
Vaccinated:2007-06-25
Onset:2008-02-10
   Days after vaccination:230
Submitted: 2008-02-27
   Days after onset:17
Entered: 2008-02-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Crying, Death
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-02-11
   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:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0802USC00047

Write-up: Information has been received from an investigator concerning a 9-month-old female who entered a study, title as stated above. On 25-JUN-2007, 23-JUL-2007, and 20-AUG-2007, the patient was vaccinated with her first, second, and third doses of blinded therapy. There was no concomitant medication. On 14-FEB-2008, the field worker met the patient''s mother while conducting routine field visits in the area of her home. When the mother was questioned regarding the health of her child, she explained that the patient had died on 11-FEB-2008. At the time of report, the cause of death was unknown. No autopsy was performed. The reporting investigator felt that the death was of severe intensity and not related to study therapy. Additional information has been requested regarding further details surrounding the patient''s death. Additional information was received from the investigator. On 20-FEB-2008, a study doctor visited the patient''s mother. She reported that the patient was well until 10-FEB-2008 when she spent the night crying due to abdominal pain (according to the mother). On the morning of 11-FEB-2008, the patient''s mother took her to a traditional healer who prescribed "some concoctions". That evening, she prepared the concoction and gave a large portion to the infant to drink, washed her in it, and put her to bed. The next morning, she went to check on her and found her dead. The mother reported there were no other symptoms and denied presence of oral lesions, fever, vomiting, and diarrhoea. The investigator reported that given the lack of symptoms, other than abdominal pain, a diagnosis could not be assessed. The cause of death remains unknown and of severe intensity while relationship to study therapy was changed to unknown. No further information is expected.


VAERS ID: 306164 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2008-01-09
Onset:0000-00-00
Submitted: 2008-02-28
Entered: 2008-02-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Body temperature increased, C-reactive protein increased, Death, Pneumonia, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BLOPRESS, 2004 - Unk; NORVASC, 2004 - Unk; PANALDINE, 2004 - Unk
Current Illness: Bronchitis chronic; hypertension; infarction
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: body temp 09Jan08 39degrees Celsius; serum C-reactive protein 14Jan08 11 mg/dL; body temp 16Jan08 38 degrees Celsius
CDC Split Type: WAES0801USA05532

Write-up: Initial and follow-up information has been received from a physician concerning an 86 year old male with chronic bronchitis, hypertension and lacunar infarction (past medical history not reported) who on 09-JAN-2008 was vaccinated with Pneumovax 23 (dose and indication not reported). Concomitant therapy included PANALDINE, BLOPRESS and NORVASC. On 09-JAN-2008 on the night of vaccination, the patient developed pyrexia of 39 degrees Celsius (C). On an unspecified date, the patient developed increased C-reactive protein (CRP). On 14-JAN-2008, intravenous drip infusion of UNASYN 3 gram (g) was given at another hospital. CRP was 11 mg/dL. On 16-JAN-2008, at visit, the patient had persisting pyrexia of 38 degrees C. On 17-JAN-2008, at the time of the report, the patient had not recovered from pyrexia. On an unspecified date, the patient was admitted to another hospital (reason not reported). On an unspecified date, the patient died of pneumonia at another hospital. Autopsy results were not reported. Outcomes of pyrexia and increased CRP were unknown. The reporting physician felt that causal relationship among Pneumovax 23, pyrexia and increased CRP was definitely related. The reporting physician felt that causal relationship between Pneumovax 23 and "die of pneumonia" was definitely not related. The physician considered pyrexia and increased CRP were non-serious. The physician considered that "die of pneumonia" was serious due to death. No further information was available. Follow-up information: The AE terms "increased CRP" and "die of pneumonia" was added. Additional information has been requested.


VAERS ID: 306549 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-01-25
Onset:2008-01-26
   Days after vaccination:1
Submitted: 2008-03-05
   Days after onset:39
Entered: 2008-03-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0725F / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-01-26
   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: hormonal contraceptives (unspecified)
Current Illness:
Preexisting Conditions: Bulimia; Immunisation
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0802USA06387

Write-up: Information has been received from a health authority concerning a 21-year old female with a history of bulimia who on 25-JAN-2008 was vaccinated in the upper arm with a dose of measles virus vaccine (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot # 654825/0725F) (batch # NF00890). Concomitant therapy included hormonal contraceptives (unspecified) for systemic use. On 17-OCT-2007 the patient was vaccinated with a dose of influenza vaccine (unspecified) and three 3 dose of ENGERIX (one dose administered on 05-DEC-2005). The following morning (approximately 26-JAN-2008), after sexual intercourse, the patient was found by her boyfriend lying in bed showing convulsions (sudden death). Resuscitation of the patient by lay persons and later by a physician was unsuccessful. An autopsy on 29-JAN-2008 in a medico-legal department, showed the following findings: vomit was found in nostrils, overall 7 punctures (left neck, and both arms) were detected, the right hypogastrium showed greenish color, a circumscribed neoplasia of tissue (1-2 cm) was found at the right lobe of the liver. Cervical muscles showed circumscribed black red hemorrhages. The patient had a history of bulimia with weight loss of several kilos during the last 6 months. All previous immunizations were well tolerated. Concomitant medication included hormonal contraceptives. In the autopsy report, it was mentioned that the brain is going to be further investigated to exclude i.e. vaccine encephalitis. Further historical, neuropathological and chemical-toxicological examinations are underway. Other company numbers included: E2008-01719. Additional information has been requested.


VAERS ID: 307550 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2008-03-15
Onset:2008-03-15
   Days after vaccination:0
Submitted: 2008-03-20
   Days after onset:5
Entered: 2008-03-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (TRITANRIX) / GLAXOSMITHKLINE BIOLOGICALS AT15B371AF / 2 UN / IM
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER A41CA414A / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Diarrhoea, Pyrexia, Sudden infant death syndrome
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Neonatal disorders (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-03-16
   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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0512476B

Write-up: This case was reported by a physician and described the occurrence of sudden infant death syndrome in a 4-month-old female subject who was vaccinated with ROTARIX, GlaxoSmithKline, combined TRITANRIX HEP B for prophylaxis. The baby had no history of any disease or any medication. She had no history of allergy. Previous vaccination included TRITANRIX HEP B (GlaxoSmithKline; intramuscular; unknown) and ROTARIX (GlaxoSmithKline; oral) given at the age of 2 months. At previous vaccination with ROTARIX AND TRITANRIX HEP B the subject developed low fever and few episodes of diarrhea (for details see case B0512476A). On 15 March 2008, the subject received the 2nd dose of ROTARIX (oral), the 2nd dose of TRITANRIX HEP B (intramuscular, unknown). On 15 March 2008 (at the night time), less than one day after vaccination with the 2nd dose of ROTARIX and the 2nd dose of TRITANRIX HEP B, the subject experienced an episode of diarrhea and low fever. No other abnormal symptoms. On 16 March 2008 morning, after sleeping for 4 hours the parents found that their baby was dead. The subject died on 16 March 2008 from sudden infant death syndrome. On 17 March 2008, the doctor asked the baby''s parents for the autopsy but there was still no answer from the parents. Follow up information received on 18 March 2008: Autopsy was not done, the family refused and funeral will be finished on 19 March 2008.


VAERS ID: 308059 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2007-06-02
Onset:2007-06-17
   Days after vaccination:15
Submitted: 2008-03-25
   Days after onset:282
Entered: 2008-03-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Coma, Confusional state, Death
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-06-20
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Antibiotics, 02-JUN-2007 00:00/Unknown
Current Illness:
Preexisting Conditions: 01-JUN-2007 to Unknown, severe dog bite at arm, animal bite
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20080457

Write-up: On 11 Mar 2008 we received the following information: A female patient was severely bitten by a dog in her arm on 1 JUN 2007. Probable on 2 JUN 2007 the patient was given her first of three vaccinations with rabies vaccine (manufacturer unknown). She also received antibiotics on 2 JUN 2007, but no HRIG was given. On 17 JUN 2007 the patient developed confusion and afterwards she felt comatose and died on 20 JUN 2007. An autopsy was done and an rabies infection was ruled out. Dog was killed. Rabies couldn''t be confirmed. Company assessment: Seriousness criterion: death. Causality: insufficient data. The amount of data is insufficient to finally assess the case.


VAERS ID: 308822 (history)  
Form: Version 1.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2004-06-21
Onset:2004-06-21
   Days after vaccination:0
Submitted: 2008-04-02
   Days after onset:1381
Entered: 2008-04-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Alopecia, Autoimmune disorder, Biopsy bone marrow abnormal, Blood stem cell transplant failure, Body temperature increased, Chemotherapy, Death, Hepatosplenic T-cell lymphoma, Influenza like illness, Laboratory test abnormal, Limb discomfort, No reaction on previous exposure to drug, Sensory loss, Splenectomy, Splenomegaly, Stem cell transplant, Syncope, Weight decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Haematopoietic cytopenias affecting more than one type of blood cell (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Malignant lymphomas (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Haematological malignant tumours (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-03-13
   Days after onset: 1361
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: bone marrow biopsy 21Jul04 rare auto immune illness; peripheral hematopoietic stem cell ??Aug06 alpha beta hepatosplenic t-cell lymphoma was diagnosed; splenectomy 10 x normal size; body weight measurement 01Dec06 16 stone; body weight measurement 01Mar07 11.5 stone
CDC Split Type: WAES0803USA04707

Write-up: Information has been received from a physician concerning a case that was initially reported in a foreign newspaper article on 25 MAR 2008, concerning a 49 year old male who on 21-Jun-2004 was vaccinated with a third dose of Recombivax HB (manufacturer unknown) (batch number not reported). The patient had received the first dose of Recombivax HB (manufacturer unknown) on 25-MAY-2004 and a second dose of Recombivax HB (manufacturer unknown) on an unreported date, as part of a rapid dose schedule, with no adverse events reported. Following the third dose of Recombivax HB (manufacturer unknown) (the exact time to onset not reported) the patient reported knowing that his arm did not feel right. Within five days of the vaccination, the patient displayed a temperature, flu-like symptoms and within ten days was in the hospital. On 21 JUL 2004, one month post vaccination, the collapsed in his garden. The patient managed to drive himself to the local "doctor''s surgery" where he was referred to the "local causality department". Numerous tests were performed including a bone marrow removal, and a very rare auto immune illness was confirmed. The patient''s condition failed to improve. The patient''s spleen enlarged up to ten times the normal size and was subsequently removed. The nerves in the abdomen were severed in order to remove the spleen, which resulted in some loss of feeling in some parts of the body. A stem cell transplant was performed after alpha beta hepatosplenic t-cell lymphoma was diagnosed in August 2006. The stem cell transplant failed, and the patient received a course of rarely used chemotherapy (unspecified), which was very severe. The patient''s weight reduced from 16 stone to 11.5 stone between Christmas 2006 to March 2007. The patient lost his hair, regained it, and lot it again (time internal unspecified). The patient subsequently died on 13 MAR 2008. Additional information is expected.


VAERS ID: 309041 (history)  
Form: Version 1.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2008-01-23
Onset:2008-01-23
   Days after vaccination:0
Submitted: 2008-04-04
   Days after onset:71
Entered: 2008-04-07
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB101BA / UNK RL / IM

Administered by: Other       Purchased by: Other
Symptoms: Exercise electrocardiogram abnormal, Myocardial infarction, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-01-23
   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: Unknown
Preexisting Conditions: Arteriosclerosis, Cardiac Hypertrophy, Coronary Heart Disease, Coronary Stenosis, Exercise Electrocardiogram Abnormal, Family History of Myocardial Infarc, Hypercholesterolemia, Myocardial Infarction
Allergies:
Diagnostic Lab Data: UNK; " EXERCISE ELECTROCARDIOGRAM ABNORMAL"
CDC Split Type: D0056725A

Write-up: This case was reported by a regulatory authority ( # DE-PEI-PEI2008003245) and described the occurrence of sudden death in a 51-year-old male subject who was vaccinated with Twinrix adult (GlaxoSmithKline). The subject''s medical history included myocardial infraction. Concurrent medical conditions included coronary heart disease, cardiac hypertrophy, grade III stenosing coronary heart disease (coronary stenosis) and hypercholesterolemia. The patient had a familiar predisposition for arteriosclerosis and family history of myocardial infraction (subject''s father and brother). Exercise electrocardiogram was unusual. Previous vaccination included Twinrix adult (GlaxoSmithKline, unknown route, unknown upper arm) given on 21 December 2007 together with REVAXIS (Sanofi Pasteur MSD, unknown route, unknown upper arm). On 23 January 2008 the subject received unspecified dose of Twinrix adult (unknown route, unknown upper arm). According to general practitioner, the patient had felt physically extraordinarily good. On 23 January 2008, few hours after vaccination with Twinrix adult, the subject experienced sudden death. According to autopsy report cause of death was possibly recent myocardial infraction as a result of coronary heart disease. The physician considered the events were unrelated to vaccination with Twinrix adult. The subject died on 23 January from myocardial infarct. An autopsy was performed. No further information will be available.


VAERS ID: 309526 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2007-08-07
Onset:2007-11-21
   Days after vaccination:106
Submitted: 2008-04-15
   Days after onset:145
Entered: 2008-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abnormal faeces, Anastomotic complication, Appendicectomy, Blood albumin decreased, Blood calcium decreased, Blood glucose increased, Blood potassium decreased, Blood sodium decreased, Death, Gastrointestinal necrosis, Globulins decreased, Haematochezia, Haematocrit normal, Haemoglobin normal, Ileostomy, Intestinal anastomosis, Intestinal fistula, Intestinal perforation, Intussusception, Pallor, Parenteral nutrition, Peritonitis, Platelet count decreased, Protein total decreased, Pyrexia, Sepsis, Surgery, Vomiting, White blood cell count decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal perforation (narrow), Gastrointestinal haemorrhage (narrow), Biliary system related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Ischaemic colitis (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Noninfectious diarrhoea (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-03-14
   Days after onset: 113
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 25Nov2007, see textunit; Albumin, 29Nov2007, 2.2g/dl; Blood glucose, 29Nov2007, 148mg/dl; Calcium, 29Nov2007, 7.0mg/dl; Globulin, 29Nov2007, 1.0g/dl; Hematocrit, 29Nov2007, 34%; Hemoglobin, 29Nov2007, 11.4g/dl; Leukocyte count NOS, 29Nov2007, 4720mm3; Platelet count, 29Nov2007, 152000mm3; Potassium, 29Nov2007, 2.8mEg/l; Protein total, 29Nov2007, 3.2g/dl; Sodium, 29Nov2007, 117mEg/l
CDC Split Type: B0515998A

Write-up: This case was reported by a physician in a frame of a study and described the occurrence of ileocolic intussusception in a 10-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). When the events started the subject was 6-month-old. On 7 August 2007 the subject received 1st dose of ROTARIX (oral). The 2nd dose schedule which should be given on 07 October 2007 was discontinued. The subject was on no other medication and had no relevant medical history nor allergy. On 21 November 2007, 106 days after vaccination with ROTARIX, the subject presented bloody stool (6-8 times/day), vomiting (6 times/day) and fever. On 25 November the subject was brought to hospital. Subject''s physical examination showed pallor, jelly red stools and abdominal distention. Abdominal x-ray showed distended intestinal loops. The same day the subject underwent a surgery. Intussusception was confirmed and resolved. Also ileostomy (20cm) was performed due to ileal necrosis and prophylactic appendectomy. On 29 November 2007 the subject was transferred to another hospital in bad conditions with persisting bloody stools and abdominal distention. Therefore a 2nd surgery was performed finding generalised peritonitis due to 3 intestinal perforation, 3-termino anastomosis were done. On 03 December 2007 a 3rd surgery was done due to opened anastomosis. On 06 December 2007 the 4th surgery was performed due to intestinal fistula. The subject was treated with total parenteral nutrition due to short intestine syndrome. The subject evolution was bad. The subject was hospitalised and the physician considered the events were disabling and life threatening. The subject was treated with AMPICILLIN, amikacin, clindamycin, metronidazole, Ranitidine, methimazole. The physician considered the events were unrelated to vaccination with ROTARIX. The subject died on 14 March 2008 from sepsis. An autopsy was not performed.


VAERS ID: 310013 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-04-16
Entered: 2008-04-18
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Meningitis pneumococcal
SMQs:, 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: Unknown
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: FRWYEG01400408

Write-up: Information regarding Prevenar was received from a healthcare professional regarding a 7-month-old male patient who experienced pneumococcal meningitis. The patient received the third dose on an unspecified date. Relevant medical history was not provided. Product was administered on unspecified dates. Concomitant medications were not reported. The patient, who had received the three vaccinations of the initial series, experienced pneumococcal meningitis and died in Feb-2008 at 7 months old. The cause of death was reported as pneumococcal meningitis. Pneumococcus serotype was unknown.


VAERS ID: 310014 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-04-16
Entered: 2008-04-18
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Meningitis pneumococcal, Serology test
SMQs:, 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: Unknown
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: FRWYEG01400608

Write-up: Information regarding PREVENAR was received from a healthcare professional regarding an unidentified patient who experienced pneumococcal meningitis. The patient received a dose on an unspecified date. Relevant medical history was not provided. Product was administered on an unspecified date. Concomitant medications were not reported. An unidentified patient, who had received an unspecified number of dose of PREVENAR, experienced pneumococcal meningitis in 2008 and died. The cause of death was reported as meningitis pneumococcal. However, pneumococcal meningitis involved a pneumococcus serotype that was not included in the vaccine. No additional information was available at the time of this report.


VAERS ID: 310099 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-04-18
Entered: 2008-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (TRITANRIX) / GLAXOSMITHKLINE BIOLOGICALS AT15B341AI / 1 UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0516562A

Write-up: This case was reported by a healthcare professional (MOH) and described the occurrence of death (NOS) in a 2-month-old subject of unspecified gender who was vaccinated with Tritanrix HepB (GlaxoSmithKline), Oral polio vaccine. On an unspecified date, the subject received 1st dose of Tritanrix HepB (unknown route and injection site), 2nd dose of Oral polio vaccine (oral). Within 24 to 48 after vaccination with Oral polio vaccine and Tritanrix HepB, the subject experienced death nos. The cause of death is not specified. It was unknown whether an autopsy was performed. This case is the 6th of 6 cases for which the same adverse event occurred. Additional information has been requested.


VAERS ID: 310100 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-04-18
Entered: 2008-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (TRITANRIX) / GLAXOSMITHKLINE BIOLOGICALS AT15B341AI / 1 UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0516561A

Write-up: This case was reported by a healthcare professional (MOH) and described the occurrence of death (NOS) in a 2-month-old subject of unspecified gender who was vaccinated with Tritanrix HepB (GlaxoSmithKline), Oral polio vaccine. On an unspecified date, the subject received 1st dose of Tritanrix HepB (unknown route and injection site), 2nd dose of Oral polio vaccine (oral). Within 24 to 48 after vaccination with Oral polio vaccine and Tritanrix HepB, the subject experienced death nos. The cause of death is not specified. It was unknown whether an autopsy was performed. This case is the 5th of 6 cases for which the same adverse event occurred. Additional information has been requested.


VAERS ID: 310101 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-04-18
Entered: 2008-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (TRITANRIX) / GLAXOSMITHKLINE BIOLOGICALS AT15B341AI / 1 UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0516560A

Write-up: This case was reported by a healthcare professional (MOH) and described the occurrence of death (NOS) in a 2-month-old subject of unspecified gender who was vaccinated with Tritanrix HepB (GlaxoSmithKline), Oral polio vaccine. On an unspecified date, the subject received 1st dose of Tritanrix HepB (unknown route and injection site), 2nd dose of Oral polio vaccine (oral). Within 24 to 48 after vaccination with Oral polio vaccine and Tritanrix HepB, the subject experienced death nos. The cause of death is not specified. It was unknown whether an autopsy was performed. This case is the 4th of 6 cases for which the same adverse event occurred. Additional information has been requested.


VAERS ID: 310102 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-04-18
Entered: 2008-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (TRITANRIX) / GLAXOSMITHKLINE BIOLOGICALS AT15B341AI / 1 UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0516559A

Write-up: This case was reported by a healthcare professional (MOH) and described the occurrence of death (NOS) in a 2-month-old subject of unspecified gender who was vaccinated with Tritanrix HepB (GlaxoSmithKline), Oral polio vaccine. On an unspecified date, the subject received 1st dose of Tritanrix HepB (unknown route and injection site), 2nd dose of Oral polio vaccine (oral). Within 24 to 48 after vaccination with Oral polio vaccine and Tritanrix HepB, the subject experienced death nos. The cause of death is not specified. It was unknown whether an autopsy was performed. This case is the 3rd of 6 cases for which the same adverse event occurred. Additional information has been requested.


VAERS ID: 310103 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-04-18
Entered: 2008-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (TRITANRIX) / GLAXOSMITHKLINE BIOLOGICALS AT15B341AI / 1 UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0516558A

Write-up: This case was reported by a healthcare professional (MOH) and described the occurrence of death (NOS) in a 2-month-old subject of unspecified gender who was vaccinated with Tritanrix HepB (GlaxoSmithKline) and Oral polio vaccine. On an unspecified date, the subject received 1st dose of Tritanrix HepB (unknown route and injection site), 2nd dose of Oral polio vaccine (oral). Within 24 to 48 after vaccination with Oral polio vaccine and Tritanrix HepB, the subject experienced death nos. The cause of death is not specified. It was unknown whether an autopsy was performed. This case is the second of 6 cases for which the same adverse event occurred. Additional information has been requested.


VAERS ID: 310104 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-04-18
Entered: 2008-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (TRITANRIX) / GLAXOSMITHKLINE BIOLOGICALS AT15B341AI / 1 UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0516557A

Write-up: This case was reported by a healthcare professional (MOH) and described the occurrence of death (NOS) in a 2-month-old subject of unspecified gender who was vaccinated with Tritanrix HepB (GlaxoSmithKline), Oral polio vaccine. On an unspecified date, the subject received 1st dose of Tritanrix HepB (unknown route and injection site), 2nd dose of Oral polio vaccine (oral). Within 24 to 48 hours after vaccination with Oral polio vaccine and Tritanrix HepB, the subject experienced death nos. The cause of death is not specified. It was unknown whether an autopsy was performed. This case is the first of 6 cases for which the same adverse event occurred. Additional information has been requested.


VAERS ID: 310265 (history)  
Form: Version 1.0  
Age: 1.3  
Sex: Male  
Location: Foreign  
Vaccinated:2008-03-28
Onset:2008-04-07
   Days after vaccination:10
Submitted: 2008-04-18
   Days after onset:11
Entered: 2008-04-21
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER NE33140 / UNK UN / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 29437 / 3 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac arrest, Death, Loss of consciousness, Pyrexia, Respiratory arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), 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), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-04-07
   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: Unknown
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: DKWYEG01419008

Write-up: The outcome of this report is patient died. Information regarding PREVENAR was received from a healthcare professional via a Regulatory Authority regarding a 15-month-old male patient who experienced febrile reaction, unconscious, respiratory arrest and asystolia. The patient received the third dose on 28-MAR-2008. The patient experienced febrile reaction, unconscious, respiratory arrest and asystolia on 07-APR-2008. The patient was found unconscious in his bed by his parents the 07-APR-2008. The boy''s father started CPR and called for an ambulance. The ambulance continued the life support and the boy was brought to the hospital where advanced life cardiac support was performed without success. The boy died and both parents accept an autopsy. According to both parents the boy had experienced fever the same day but he had been drinking, eating and passing urine. His diapers had been wet. No skin rash observed. The cause of death was reported as respiratory arrest and cardiac arrest. No additional information was available at the time of this report.


VAERS ID: 310348 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Unknown  
Location: Foreign  
Vaccinated:2008-03-03
Onset:2008-03-04
   Days after vaccination:1
Submitted: 2008-04-21
   Days after onset:47
Entered: 2008-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LA / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Cough, Pyrexia, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (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: 2008-03-04
   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:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0517179A

Write-up: This case was reported by a physician and described the occurrence of sudden death in a 2-month-old subject of unspecified gender who was vaccinated with DTP (A or W not known), manufacturer unspecified), Hepatitis B vaccine and Oral polio vaccine. This case was identified on 16 April 2008 during the minutes of the meeting. This case is the 7th case of 7 cases reported by the same physician and for which the same adverse event occurred. On 3 March 2008, the subject received unspecified dose of DTP (A or W not known) (unknown), unspecified dose of Hepatitis B vaccine (unknown), unspecified dose of Oral polio vaccine (unknown). On 4 March 2008, 1 day after vaccination with DTP (A or W not known), Hepatitis B vaccine and Oral polio vaccine, the subject died. The subject suffered from high fever, convulsions and persistent cough. The cause of death was not reported. It was unknown whether an autopsy was performed. At time of reporting, the physician could not judge the cause of death and if it was related to the vaccine or not. He concluded that the agency was conducting a mortality survey in the regions of the reported deaths at that period and taking samples from the vaccines batches for analysis.


VAERS ID: 310479 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Unknown  
Location: Foreign  
Vaccinated:2008-01-25
Onset:2008-01-28
   Days after vaccination:3
Submitted: 2008-04-18
   Days after onset:80
Entered: 2008-04-22
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-01-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: The patient was a premature baby (29 week of pregnancy).
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: DEWYEG01415208

Write-up: Information regarding PREVENAR was received from a healthcare professional regarding a patient who died 2.5 days after the vaccination. The patient received the first dose on 25-Jan-2008. The child was monitored with a heart-breath monitor and died 2.5 days after the vaccination on 28-Jan-2008. The cause of death was unknown. No additional information was available at the time of this report, but it was requested.


VAERS ID: 311020 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2008-04-10
Onset:2008-04-10
   Days after vaccination:0
Submitted: 2008-04-25
   Days after onset:15
Entered: 2008-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Dehydration, Diarrhoea, Enterocolitis, Mucous stools, Pyrexia, Sepsis
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-04-11
   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:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0516922A

Write-up: This case was reported by a physician and described the occurrence of sepsis in a 2-month-old male subject who was vaccinated with Rotarix (GlaxoSmithKline). On 10 April 2008, the subject received 1st dose of Rotarix (oral), lot number not provided. On 10 April 2008, less than one day after vaccination with Rotarix, the subject experienced liquid stools with mucus and fever. On 11 April 2008, the subject was hospitalised due to dehydration. Sepsis was diagnosed and the subject was treated with Cataflam, antibiotics and IV hydration. The symptoms were getting worse. On 11 April 2008, the subject died, cause of death is not specified. An autopsy was performed and revealed enterocolitis. The microbiological tests were performed but the results were not yet available.


VAERS ID: 311254 (history)  
Form: Version 1.0  
Age: 0.7  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2008-04-22
Submitted: 2008-04-29
   Days after onset:7
Entered: 2008-04-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-04-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0804USC00088

Write-up: Information has been received from an investigator concerning a 7-month-old male, medical history unknown, who entered a study. The patient was vaccinated with blinded therapy. On 22-APR-2008, 91 days post dose 3 of study therapy, the patient died while hospitalized. The cause of death was unknown. At this time, the relationship of the patient''s death to study therapy is unknown. Additional information has been requested regarding receipt of the SAE Report Form.


VAERS ID: 311427 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2008-02-05
Onset:2008-02-08
   Days after vaccination:3
Submitted: 2008-05-02
   Days after onset:83
Entered: 2008-05-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR B21341 / 3 UN / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER BC56070 / 3 UN / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR B21341 / 3 UN / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR B21341 / 3 UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA402A / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Ascites, Autopsy, Death, Gastrointestinal necrosis, Haematochezia, Intussusception, Skin discolouration, Small intestinal obstruction, Vomiting
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-02-09
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 08Feb2008, fluid levelsunit
CDC Split Type: B0507296A

Write-up: This case was reported by a healthcare professional and described the occurrence of intussusception in a 3-month-old female subject who was vaccinated with Rotarix (GlaxoSmithKline). Previous and/or concurrent vaccination included Pentaxim, Sanofi Pasteur MSD (intramuscular; left thigh) given on 6 December 2007, 8 January 2008 and 5 February 2008; Heberboivac, Heber Biotec (intramuscular; right thigh) given on 6 December 2007, 8 January 2008; Rotarix (GlaxoSmithKline; oral) given on 8 January 2008. On 5 February 2008 the subject received 2nd dose of Rotarix (oral). The subject was healthy and responded well to previous vaccinations without experienced any adverse event. On 8 February 2008, 3 days after vaccination with Rotarix, the subject developed symptoms of bloody stools and vomiting. The subject was taken to the emergency room as the subject got worse. Relevant test included abdominal x-ray which showed dilated gas-filled bowel loops in central abdomen with fluid levels, gas visible in descending colon, obstruction of ileus, no visible air in bowel walls, heart and lung fields appear normal. The physician advised her admission but the subject''s parents apparently refused it. On 09 February 2008 the subject was taken back to hospital where resuscitation was started but the subject passed away on the same day at 9:00. The autopsy was being planned for the 12th February 2008. The subject died due to intussusception which was probably related to vaccination with Rotarix. Follow up received on 26 February 2008: After a phone communication the subject''s parents did not want to give a copy of the autopsy. The subject''s mother mentioned that all the documentation of the autopsy was frozen. According to the subject''s mother the autopsy report stated that the subject died due to obstruction of the ileum caused by the Rotarix. Follow up received on 22 April 2008: The autopsy report (performed on 12 February 2008) stated: Cause of death included bowel obstruction with intussusception and necrosis of the small bowel. Subject''s age: 3month-old and 17 days. Length: 60 cm. Mass approximately: 5 kg. Subject''s physique under average. Subject''s nutrition good. Secondary postmortem changes: rigor mortis. External appearance of body and condition of limbs: abdominal distention with blue discolouration of skin over abdomen. No external injuries visible. Trachea: no foreign object''s in trachea. Peritoneal cavity: abdominal distention and ascites. Intestine and mesentery: intussusception of small bowel with acute bowel obstruction and necrosis of small bowel. The medical certificate of death stated: Immediate cause: intestinal obstruction. Underlying cause: intussusception.


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