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VAERS ID: 238155 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-05-24
Entered: 2005-05-25
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac failure, Respiratory failure
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: HQWYE771018MAY05

Write-up: Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 3 year old patient (unidentified) who experienced cardiac respiratory shutdown. The patient received the first dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose (intramuscular). Event Details: A pediatrician reported (via a sales rep) that a 3 year old patient died 48 hours after receiving a first dose of Prevnar. The cause of death was due to cardiac respiratory shutdown. Another physician commented that there was no causality between the death and the Prevnar vaccine. This report was received from a manufacturer (Foreign) (Reference no. 20050299). No additional information was available at the time of this report.


VAERS ID: 238983 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Unknown  
Location: Foreign  
Vaccinated:2004-07-07
Onset:0000-00-00
Submitted: 2005-06-02
Entered: 2005-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER S127PF / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Child maltreatment syndrome
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: UNK
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0381813A

Write-up: This case was reported by a consumer and described the occurrence of death in a 4 month old subject of unspecified gender who was vaccinated with poliomyelitis vaccine for prophylaxis. A physician or other healthcare professional has not verified this report. The infant received the first doses of the primary pediatric vaccine schedule at 2 months. Co-suspect vaccinations included DTP and Group C meningococcal vaccine. On unspecified dates, the subject received a dose of DPT and Group C meningococcal vaccine. On 7/7/04, the subject received unspecified dose of Poliomyelitis vaccine. At an unspecified time after vaccination with Poliomyelitis vaccine, the subject died. The cause of death was not specified. It was reported that the infant died at 4 months of age. The death was being investigated as part of a criminal investigation. It was thought that the death may have been caused by shaken baby syndrome.


VAERS ID: 239000 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2005-03-31
Onset:2005-04-01
   Days after vaccination:1
Submitted: 2005-06-02
   Days after onset:61
Entered: 2005-06-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (IMOVAX) / SANOFI PASTEUR W0752 / 3 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Diarrhoea, Gastrointestinal haemorrhage, Hypertension, Injection site pain, Injury, Myasthenic syndrome, Myocardial ischaemia, Pneumonia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Malignancy related conditions (narrow), Gastrointestinal haemorrhage (narrow), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Hypertension (narrow), Eosinophilic pneumonia (broad), Other ischaemic heart disease (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-04-21
   Days after onset: 19
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: Nitro-Dur Patch; Phenol Nitro; Tiazac; Nizatadine; Plavix; Metoprolol; Gabapentin; Domperidone
Current Illness:
Preexisting Conditions: CAD - Non symptomatic, Rheumatoid Arthritis, Lupus, Chronic Renal Disease, Lung Fibrosis, Allergic to Sulpha, Codeine and Zithromax. On 3/24/05, the patient received IM 7mL of Imogam lot # W087 divided between both gluteal areas and also the first dose of Rabies Imovax, lot # W0752 administered IM in the deltoid. Dose 2 of Rabies Imovax, lot # W0752 was administered IM in the deltoid on 3/27/05.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200500989

Write-up: It was reported through a physician that a 72 year old female patient died after receiving the third dose of Rabies Imovax, lot # W0752-2 IM on 3/31/05. The patient was scratched by the family cat on 3/17/05. The cat was destroyed without having rabies testing. Seven days later the patient began Rabies Imovax post exposure series. On 3/24/05, the patient received IM, 7mL of Imogam, lot # W087 divided between both gluteal areas and also the first dose of Rabies Imovax, lot # W0752 administered IM in the deltoid. Dose 2 of Rabies Imovax, lot # W0752 was administered IM in the deltoid on 3/27/05. It was at that time the patient informed them that 24 hours after receiving the Imogam and first dose of Rabies Imovax, she developed very severe pain in both buttocks. By day 7, the patient was unable to walk and the physician made a house call. Dose 3 of Rabies Imovax, lot # W0752 was given IM on 3/31/05. The post exposure series was discontinued. The following day 4/1/05, 8 days following the start of treatment the patient was hospitalized for GI Bleed and valve ischemia. She was discharged from the hospital and readmitted with diarrhea, hypertension, and pneumonia. Patient died on 4/21/05. No post mortem or cause of death reported.


VAERS ID: 239131 (history)  
Form: Version 1.0  
Age: 1.66  
Sex: Female  
Location: Foreign  
Vaccinated:2005-04-29
Onset:2005-05-18
   Days after vaccination:19
Submitted: 2005-06-06
   Days after onset:19
Entered: 2005-06-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Abnormal sleep-related event, Crying, Cyanosis, Hypotonia, Salivary hypersecretion, Screaming, Sudden infant death syndrome
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-05-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions: Gastroenteritis
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0383115A

Write-up: This case was reported by a physician and described the occurrence of sudden unexpected death in infancy in a 20 month old female subject who was vaccinated with hep A vaccine (Havrix) for prophylaxis. The subject was a normal delivery full term born infant. The subject had no abnormalities, no known allergies, nor past surgeries. Concurrent medical conditions included gastroenteritis experienced at 12 month old age. On 29Apr05 the subject received a dose of Havrix. On 17May05, the day before death the child was playful and received normal feeding, she did not experience any sign or symptom. She slept with her mother and sister in the same bed. At midnight the child was whining the mother humidified the child''s head and continued sleeping. Approx 3 hrs later, the child was screaming and was in fetal position biting her tongue with cyanotic and flaccid lips. The mother took the child to a traditional medicine practitioner, which provides a non pharmacological treatment without improvment. The child was taken to a hospital before arrival the child presented abundant salivation and died. The child was dead at arrival to the hospital. Cardio pulmonary resuscitation was performed without success. The subject''s body was takent to the dept of legal medicine. An autopsy was performed, the results were not available at the time of this report. Further information were requested.


VAERS ID: 239570 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-06-09
Entered: 2005-06-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 - / IM

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: HQWYE262806JUN05

Write-up: Information regarding Prevnar was received from a general practice physician, regarding a female patient who, at 8 weeks of age, received a first dose of Prevnar. Four weeks later, she developed pneumococcal disease. At 12 weeks of age, the infant expired. Relevant medical history was unknown. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose (IM).Concomitant medications or vaccines were unknown to the reporter. On an unspecified date, at 8 weeks of age, the patient received a first dose of Prevnar. Four weeks later, on an unspecified date, the infant was hospitalized after developing pneumococcal disease, which was considered to be life threatening. At 12 weeks of age, on an unspecified date, the child expired. The reporter indicated she was not the child''s physician. The reported cause of death was unknown. No additional information was available at the time of this report.


VAERS ID: 240837 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-06-29
Entered: 2005-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Bacterial infection, Drug ineffective
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0385019A

Write-up: This case was reported by a pharmacist and described the occurrence of diphtheria in a child of unspecified age and gender who was vaccinated with absorbed diphtheria, tetanus and acellular pertussis vaccine for prophylaxis. In 2003, the subject received unspecified dose of Infanrix. One week after vaccination Infanrix, the subject experienced diphtheria and died. The post-mortem report stated that cause of death was diphtheria.


VAERS ID: 240966 (history)  
Form: Version 1.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2004-07-17
Onset:2004-09-01
   Days after vaccination:46
Submitted: 2005-06-29
   Days after onset:301
Entered: 2005-07-05
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abortion, Abortion induced, Colposcopy, Drug exposure during pregnancy, Ultrasound scan, Unintended pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Pregnancy (LMP 10/Aug-2004)
Allergies:
Diagnostic Lab Data: colposcopy 17Jul04; ultrasound Sept04 pregnancy confirmed.
CDC Split Type: WAES0409SGP00005

Write-up: Information has been received from a physician concerning a 27 yr old female with a history of 0 pregnancies and 0 live births who on 17Jul04 was vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). In Sept 2004, the pt was diagnosed to be pregnant. Pregnancy was confirmed by an ultrasound. The pt had no other adverse effect and her last menstrual period was on 10Aug04. Subsequently the pt had an elective abortion which the reporter thought might be due to the perceived risk from the vaccine exposure. However, no further information is available. Additional information is not expected.


VAERS ID: 242019 (history)  
Form: Version 1.0  
Age: 0.41  
Sex: Unknown  
Location: Foreign  
Vaccinated:2005-03-01
Onset:2005-03-01
   Days after vaccination:0
Submitted: 2005-08-02
   Days after onset:153
Entered: 2005-08-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 2 - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pyrexia, Respiratory failure
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), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-07-09
   Days after onset: 129
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: Epidermolysis bullosa; Stridor
Preexisting Conditions: Pyrexia; Respiratory failure.
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: DEWYE870701AUG05

Write-up: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 5 month old pt who experienced pyrexia, respiratory insufficiency and death. The pt received the second dose on 01Mar05. The pt''s concurrent illnesses include epidermolysis bullosa and stridor with a past history of pyrexia (after first admin of Prevnar on 17Jan05) and respiratory failure (after 1st admin of Prevnar on 17Jan05). Indication for Prevnar was immunization. Product was admin on 01Mar05. Dose regimen was 1 dose. Concomitant medications were not reported. The pt experienced pyrexia and respiratory insufficiency on 01Mar05. The pt had also experienced pyrexia and respiratory insufficiency after the first immunization with Prevnar on 17Jan05. After second admin of Prevnar on 01Mar05, the reaction was even more severe than after the first admin. The child was treated in an ICU. The outcome of pyrexia and respiratory insufficiency are unk. The child died on 09Jul05. The physician considered death not related to Prevnar. The cause of death was not reported (unk). See related case(s): DEWYE858226JUL05. No additional information was available at the time of this report.


VAERS ID: 242922 (history)  
Form: Version 1.0  
Age: 94.0  
Sex: Male  
Location: Foreign  
Vaccinated:1998-10-26
Onset:0000-00-00
Submitted: 2005-08-12
Entered: 2005-08-16
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Drug ineffective, Sepsis
SMQs:, Lack of efficacy/effect (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0508USA01069

Write-up: Information was reported in a published article and from the primary author which concerned a 94 year old male patient with no reported history, who on 10/26/98 was vaccinated with one dose of pneumococcal 23v polysaccharide vaccine. The patient developed bacteremia and was admitted to the hospital on 11/21/01. The patient''s outcome was fatal (exact date not reported). No further information is available. The case is closed. Other business partner numbers include E200502897 to E200503017 and E200503006. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 242923 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2000-03-17
Onset:0000-00-00
Submitted: 2005-08-12
Entered: 2005-08-16
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Drug ineffective, Sepsis
SMQs:, Lack of efficacy/effect (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0508USA01085

Write-up: Information was reported in a published article and from the primary author which concerned a 73 year old male patient with no reported history, who on 03/17/2000 was vaccinated with one dose of pneumococcal 23v polysaccharide vaccine. The patient developed pneumococcal bacteremia and was hospitalized on 4/02/02. Subsequently, the patient died (exact date was not reported). The outcome of the pneumococcal bacteremia was reported as fatal. Other business partner numbers include E200503015 and E200502987 to E200503017. Additional information is not available. The case is closed. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 242924 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2000-05-16
Onset:0000-00-00
Submitted: 2005-08-12
Entered: 2005-08-16
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Drug ineffective, Sepsis
SMQs:, Lack of efficacy/effect (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0508USA01079

Write-up: Information was reported in a published article and from the primary author which concerned a 70 year old male patient, with no reported history, who on 5/16/00 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The patient developed bacteremia and was hospitalized on 1/23/02. Subsequently, the patient died (exact date not reported). The outcome was reported as fatal. Other business partner numbers include E200502987 to E200503017 and E200503013. Additional information is not available. The case is closed. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 242925 (history)  
Form: Version 1.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:1997-10-03
Onset:0000-00-00
Submitted: 2005-08-12
Entered: 2005-08-16
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Drug ineffective, Sepsis
SMQs:, Lack of efficacy/effect (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0508USA01076

Write-up: Information was reported in a published article and from the primary author that a 91 year old male patient, with no reported history, who on 10/3/97 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The patient developed bacteremia and was hospitalized on 4/20/01. Subsequently, the patient died (exact date not reported). The outcome of the pneumococcal bacteremia was reported as fatal. Other business partner numbers include E200502987 to E200503017 and E200503007. Additional information is not available. The case is closed. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 242926 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2000-03-10
Onset:0000-00-00
Submitted: 2005-08-12
Entered: 2005-08-16
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Drug ineffective, Sepsis
SMQs:, Lack of efficacy/effect (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0508USA01064

Write-up: Information was reported in a published article and from the primary author which concerned a 70 year old male patient, with no reported history, who on 03/10/2000 was vaccinated with one dose of pneumococcal 23v polysaccharide vaccine. It was reported that the patient developed pneumococcal bacteremia and was admitted to the hospital on 5/03/01. Subsequently, the outcome was fatal. The cause of death was pneumococcal bacteremia. No further information is available. The case is closed. Other business partner numbers include E200503001. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 242927 (history)  
Form: Version 1.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-08-12
Entered: 2005-08-16
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Drug ineffective, Sepsis
SMQs:, Lack of efficacy/effect (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0508USA01061

Write-up: It was reported in a published article and confirmed by the primary author, that an 88 year old male, with no reported medical history, who was vaccinated with one dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the patient developed pneumococcal bacteremia and was admitted to the hospital on 5/10/01. Subsequently, the outcome was fatal. The cause of death was pneumococcal bacteremia. No further information is available. The case is closed. Other business partner numbers include: E200502997. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 243432 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2005-07-17
Onset:2005-07-26
   Days after vaccination:9
Submitted: 2005-08-26
   Days after onset:31
Entered: 2005-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS - / 4 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Dysuria, Muscular weakness, Paralysis, Respiratory arrest
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2005-07-29
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20050673

Write-up: A 20 year old female patient was vaccinated with 1ml Rabipur IM on 6/26, 6/29, 7/3, and 7/17/05. On 7/21/05 she developed weakness in both limbs and had difficulties in passing urine. On 7/26/05, the patient died because of respiratory arrest and suspected progression of paralytic rabies. Further information is requested. Per Follow-up: Despite request we did not get any further information.


VAERS ID: 243844 (history)  
Form: Version 1.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:1995-09-07
Onset:2000-10-15
   Days after vaccination:1865
Submitted: 2005-09-06
   Days after onset:1787
Entered: 2005-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood creatine phosphokinase increased, Condition aggravated, Difficulty in walking, Dyspnoea, Fatigue, Laboratory test abnormal, Muscular weakness, Myalgia, Neuropathy, Paraesthesia, Respiratory failure, Skin ulcer, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (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), Parkinson-like events (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-10-22
   Days after onset: 1468
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Mefloquine hydrochloride; Fenofibrate
Current Illness: Essential Hypertension, obstructive Chronic Bronchitis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Creatine phosphokinase Feb 1999 increased, Mar 1999 normal, June 1999 203 iu/L, In Oct 200, SMN mutation (survival motor neuron) and Kennedy test were negative, 12/2002, muscular testing in lower limbs worsened.
CDC Split Type: B0392332A

Write-up: This case was reported by a regulatory authority and described the occurrence of amyotrophic lateral sclerosis in a 61 year old male subject, who was vaccinated with hepatitis B vaccine for prophylaxis. Concurrent medical conditions included essential hypertension and obstructive chronic bronchitis. Co-suspect medication included Mefloquine hydrochloride started on 6/15/97. Concurrent medication included Fenofibrate, discontinued in 1999. On 3/3, in April and on 9/7/95, the subject received three doses of Engerix B (IM injections in unknown sites, batch numbers not available). In April 1996, the subject experienced an episode of left hand tremor. In 1997, during a treatment with Lariam, he complained of myalgia and muscle weakness. In September 1998, the subject developed paresthesia in left foot. In February 1999, creatine phosphokinase level was increased, and then normalized in March 1999 following the discontinuation of Lipanthyl. In June 1999, creatine phosphokinase was at 209 IU/L. In October 2000, 5 years after vaccination with Engerix B, muscle weakness aggravated, predominantly in upper limbs and pectoral girdle. Lesions of motoneuron was noticed (upper motor neurone lesion). SMN mutation and Kennedy tests were negative. The subject was diagnosed with amyotrophic lateral sclerosis. In December 2002, muscular testing to lower limbs worsened, the subject presented with fatigability when walking. In April 2003, the subject developed important breathlessness and a treatment with riluzole and alpha tocopheryn acetate was initiated. In October 2003, the subject developed respiratory insufficiency. In February 2004, the subject presented with severe physical handicap and diaphragmatic respiratory insufficiency. The subject died on 10/22/04. The reporting authority considered that the cause of death was upper neurone lesion. It is unknown whether an autopsy was performed. This case was assessed as medically serious (OMIC). The causality relationship assessment of amyotrophic lateral sclerosis for Engerix B and Lariam was considered unlikely. This case has been closed; no more information will be available.


VAERS ID: 243922 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2005-07-10
Submitted: 2005-09-08
   Days after onset:60
Entered: 2005-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Intracranial aneurysm, Subarachnoid haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-07-16
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0392338A

Write-up: This case was reported by a physician and described the occurrence of ruptured cerebral aneurysm in a 1 month old female subject who was vaccinated with hep B vaccine (Engerix B) for prophylaxis. At an unk date, the subject received a 2nd dose of Engerix B. On 10Jul05, at an unk time after vaccination, the subject developed a ruptured cerebral aneurysm and subarachnoid hemorrhage. The subject was hospitalized. On 16Jul05, the subject died, the cause of death was not specified. An autopsy had been performed, the results were not available at the time of this report. The physician considered the events were unrelated to vaccination with Engerix B. Further information has been requested.


VAERS ID: 244241 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-09-09
Entered: 2005-09-19
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Immune system disorder, Infection
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: SCID
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2005132297NL

Write-up: Clinical events: Disseminated BCG infection (Disseminated Tuberculosis) Narrative: Child was vaccinated with BCG (brand unknown) at 2 days of age for multiple infection in 1993. Patient had a severe immunodeficiency disorder. Patient had concomitant infections and subsequently died. Out come: Fatal


VAERS ID: 244242 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-09-09
Entered: 2005-09-19
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (MYCOBAX) / SANOFI PASTEUR UNK / UNK UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Immune system disorder, Infection
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: SCID, Bone marrow transplant
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2005132292NL

Write-up: Clinical events: Disseminated BCG infection (Disseminated Tuberculosis) Narrative: child was vaccinated with BCG (brand unknown) at birth for multiple infection in 1993. Patient had a severe immunodeficiency disorder. Patient had concomitant infections and subsequently died after bone marrow transplant. Outcome: fatal.


VAERS ID: 244243 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-09-09
Entered: 2005-09-19
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / UNK UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Immune system disorder, Tuberculosis
SMQs:, Infective pneumonia (narrow), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: SCID
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2005132291NL

Write-up: Clinical events: Disseminated BCG infection (Disseminated Tuberculosis) Narrative: child vaccinated with BCG (brand unknown) at 1 day of age for multiple infection in 1993. Patient had a severe immunodeficiency disorder. Patient had concomitant infections and subsequently dies. Outcome fatal.


VAERS ID: 244244 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-09-09
Entered: 2005-09-19
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / UNK UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Immune system disorder, Tuberculosis
SMQs:, Infective pneumonia (narrow), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: IFN-y receptor deficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: 205132289NL

Write-up: Clinical events: Disseminated BCG infection (disseminated tuberculosis). Narrative: child was vaccinated with BCG (brand unknown) at 3 weeks of age for multiple infection in 1993. Patient had an IFN-y receptor deficiency. Patient had concomitant infections and subsequently died. Outcome: fatal.


VAERS ID: 244245 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-09-09
Entered: 2005-09-19
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Tuberculosis
SMQs:, Infective pneumonia (narrow), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: HIV infection
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2005132287NL

Write-up: Clinical events: Disseminated BCG infection (disseminated tuberculosis) Narrative: child was vaccinated with BCG (brand unknown) at 3 days of age for multiple infection in 1993. Patient had a HIV infection. Patient had concomitant infections and subsequently died. Outcome fatal.


VAERS ID: 244246 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-09-09
Entered: 2005-09-19
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Immune system disorder, Tuberculosis
SMQs:, Infective pneumonia (narrow), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: SCID
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2005132270NL

Write-up: Clinical events: Disseminated BCG infection (Disseminated Tuberculosis). Narrative: child was vaccinated with BCG (brand unknown) at 3 days of age form multiple infection in 1993. Patient has a sever immunodeficiency disorder, Patient had concomitant infections and subsequently died. Outcome: fatal.


VAERS ID: 244320 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2003-03-01
Submitted: 2005-09-19
   Days after onset:932
Entered: 2005-09-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Culture Mar 2003 ear swab revealed Streptococcus pneumoniae: serotype 19A.
CDC Split Type: HQWYE460314SEP05

Write-up: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a literature source regarding a 4 month old female participant in an independent study entitled who developed pneumococcal infection after receiving 2 doses of Prevnar. The participant received the second dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose. Concomitant medications were not reported. On an unspecified day in Mar 2003 the pt developed pneumococcal infection after receiving 2 doses of Prevnar. Ear swab culture results revealed Streptococcus pneumoniae, serotype 19A. The pt died; cause not specified. No additional information was available at the time of this report. Literature article is attached. Culture was done in Mar 2003 (ear swab revealed Streptococcus pneumoniae: serotype 19A). The investigator considered pneumococcal infection and drug ineffective possibly related to the study product. See related cases: HQWYE458714SEP05; HQWYE460214SEP05; and HQWYE460414SEP05.


VAERS ID: 244321 (history)  
Form: Version 1.0  
Age: 1.67  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2004-07-01
Submitted: 2005-09-19
   Days after onset:445
Entered: 2005-09-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Anemia hemolytic autoimmune; splenectomy
Allergies:
Diagnostic Lab Data: Blood culture (results: yielded S. pneumoniae serotype 33F) was done in July 2004.
CDC Split Type: HQWYE459514SEP05

Write-up: Information regarding Prevnar was received from a literature source regarding a 20 month old female participant in an independent study who experienced pneumococcal bacteremia (serotype 33F) following receipt of Prevnar. The participant received a dose on an unspecified date. The patient''s concurrent illness includes anemia hemolytic autoimmune with a past history of a splenectomy. The indication for Prevnar was immunization. The product was administered on an unspecified date. The dose regimen was 1 dose. Concomitant medications were not reported. Sometime in July 2004, the child was hospitalized with pneumococcal bacteremia after receiving Prevnar. A blood culture yielded S. pneumoniae serotype 33F. On an unknown date, the child died. No additional information was available at the time of this report. A copy of the article is attached. The investigator considered pneumococcal bacteremia possibly related to vaccine administration. See related cases: HQWYE458814SEP05; HQWYE459314SEP05; HQWYE459414SEP05; DEWYE027919DEB03; DEWYE396211NOV03; DEWYE353719JAN05; DEWYE658111MAY05; HQWYE460214SEP05; HQWYE460414SEP05; HQWYE459814SEP05; HQWYE459814SEP05; HQWYE459914SEP05; HQWYE459614SEP05; HQWYE460314SEP05; HQWYE459714SEP05; and HQWYE458714SEP05.


VAERS ID: 244330 (history)  
Form: Version 1.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2005-03-26
Onset:2005-04-13
   Days after vaccination:18
Submitted: 2005-09-15
   Days after onset:155
Entered: 2005-09-20
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: 13Apr05 Diagnostic lab test: streptococcus pneumoniae, serotype 11A
CDC Split Type: WAES0509AUS00068

Write-up: Information was obtained on request by the Company from the agency via a Public Case Details form concerning a 66 year old male who on 3/26/05 was vaccinated with pneumococcal 23v polysaccharide vaccine, 1 dose, 1 time as a prophylactic vaccination. On 4/13/05 the patient experienced vaccination failure which resulted in him developing pneumococcal meningitis. He was admitted to the intensive care unit of hospital and was diagnosed with streptococcus pneumoniae, serotype 11A, meningitis. The patient was treated with IV antibiotics. On 4/25/05 the patient died from pneumococcal meningitis. The agency considered that vaccination failure and pneumococcal meningitis were possibly related to therapy with pneumococcal 23v polysaccharide vaccine. The original reporting source was not provided. Additional information is not expected.


VAERS ID: 244479 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2005-09-13
Onset:2005-09-16
   Days after vaccination:3
Submitted: 2005-09-21
   Days after onset:5
Entered: 2005-09-23
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A2FA067A / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A85857C / 1 RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Haematemesis, Lung disorder, Oedema, Pulmonary oedema, Salivary hypersecretion, Sudden infant death syndrome, Vomiting
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-09-16
   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: Iron 5 drop 2x per 1 day
Current Illness:
Preexisting Conditions: Premature baby 33 to 36 weeks, Hypospadias.
Allergies:
Diagnostic Lab Data: Autopsy 09/16/2005 lung oedema, Physical examination routine in 4th to 6th week after birth by pediatrician, health infant, developing well, all investigations including cardiac not clinically significant for this age group.
CDC Split Type: DEWYE986619SEP05

Write-up: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a physician in an observational prospective pharmacoepidemiological cohort study regarding a 76 day old male participant in a study who experienced sudden infant death syndrome. The participant received the first dose on Sept 13 2005. The patient has a past history of premature baby (34 gestational week, birth weight 1690g, birth height 43cm, hemoglobin 9.0, open foramen ovalis) and hypospadias. Indication for Prevenar and Infanrix Hexa was immunization. Products were administered on Sept 13 2005. Dose regimen was one dose of each (intramuscular, right thigh). Infanrix Hexa (diphtheria vaccine/tetanus vaccine/acellular pertussis vaccine/polio virus/inactivated/ haemophilus influenzae b/hepatitis b vaccine) is also suspected. Concomitant therapy included Iron. Three days after vaccination of Prevenar and Infanrix Hexa the patient was found dead by emergency doctor on Sept 16 2005. Around the mouth were signs of vomiting and blood tinged froth. An autopsy was performed. No written report was provided. personal communications between physician and emergency doctor report that the cause of death is unknown. A lung oedema was identified on autopsy. it is suspected that the patient experienced sudden infant death syndrome on Sept 16 2005. The cause of death and autopsy cause of death was reported as unknown. Physical examination (results routine in 4th to 6th week after birth by pediatrician, health infant, developing well, all investigations including cardiac not clinically significant for this age group) was done in 2005. Autopsy (results lung oedema) was done on Sept 16 205. The physician considered sudden infant death syndrome possibly related to Prevenar and Infanrix Hexa the study product. No additional information was available at the time of this report.


VAERS ID: 244480 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: Foreign  
Vaccinated:2005-09-02
Onset:2005-09-07
   Days after vaccination:5
Submitted: 2005-09-21
   Days after onset:14
Entered: 2005-09-23
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS UNK / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A85857C / 1 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-09-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: DEWYE962308SEP05

Write-up: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a physician in a study regarding a 10 week old male participant who experienced death. The participant received the first dose on Sept 02 2005. The patient had no concurrent or past medical history. Indication for Prevenar was immunization. Product was administered on Sept 02 2005. Dose regimen was 0.5 ml (intramuscular). Concomitant therapy included Infanrix Hexa (diphtheria vaccine/tetanus vaccine/acellular pertussis vaccine/polio virus inactivated/haemophilus influenzae B/hepatitis B vaccine). The patient was found dead in his bed by an emergency physician on Sept 07 2005. An autopsy is planned. The physician considered death probably not related to Prevenar and Infanrix Hexa.


VAERS ID: 244584 (history)  
Form: Version 1.0  
Age: 6.0  
Sex: Female  
Location: Foreign  
Vaccinated:2005-08-01
Onset:2005-08-04
   Days after vaccination:3
Submitted: 2005-09-23
   Days after onset:50
Entered: 2005-09-27
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 2 - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Infarction, Myocarditis, Pyrexia, Viral infection
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-08-15
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0509USA02665

Write-up: Information has been received from a health professional concerning a 6 year old female with no relevant medical history and no safety problems following previous vaccinations who in approximately August 2005, was vaccinated with a second dose of MMR (batch number not reported). Subsequently, eight to ten days post vaccination, she presented with a fever. Three days after onset of the fever, she suffered from abdominal pain which required medical consultation. Fourteen days after vaccination, she experienced an infarction right-left which occurred within the framework of acute myocarditis (documented through clinical examination and echography). She was hospitalized. The child died fifteen days after vaccination. No autopsy was performed. According to the reporter, the symptomatology evoked a viral like post infection myocarditis. The file is to be completed. Other business partner numbers included E200503659. Additional information has been requested.


VAERS ID: 244923 (history)  
Form: Version 1.0  
Age: 0.46  
Sex: Female  
Location: Foreign  
Vaccinated:2005-09-22
Onset:2005-09-23
   Days after vaccination:1
Submitted: 2005-10-04
   Days after onset:11
Entered: 2005-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B007 / 2 - / -
RAB: RABIES (IMOVAX) / SANOFI PASTEUR K09781 / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-09-23
   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: Colecalciferol, Acetazolamide (Magnesium Aspartate + Potassium Aspartate) Papverine, Theophylline
Current Illness: Bilateral pyramidal syndrome, hydrocephaly, neuropathy of cranial nerves
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0395268A

Write-up: This case was reported by a physician and described the occurrence of a fatal dyspnea in a 5 month old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine, rabies vaccine for prophylaxis. Concurrent medical conditions included bilateral pyramidal syndrome, hydrocephaly and neuropathy of cranial nerves. Concurrent medications included Colecalciferol, Acetazolamide, Asparcam, Papaverine, and Theophylline. On 7/27/05, the subject had received a first dose of Infanrix, with no adverse reaction. On 9/22/05, the subject received a second dose of Infanrix, and a dose of Imovax. On 9/23/05, around 16 to 24 hours after vaccination with Infanrix and Imovax, the subject developed dyspnea. When the ambulance came, the child was dead. The physician considered the event was possibly related to vaccination with Infanrix and Imovax. A legal investigation due to the child''s death has been planned. A final statement regarding the cause of death and causal relationship will be provided. Further information has been requested.


VAERS ID: 244976 (history)  
Form: Version 1.0  
Age: 0.7  
Sex: Female  
Location: Foreign  
Vaccinated:2005-09-07
Onset:2005-09-07
   Days after vaccination:0
Submitted: 2005-10-05
   Days after onset:28
Entered: 2005-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood creatinine increased, Blood urea increased, Condition aggravated, Convulsion, Embolism, Gastrointestinal haemorrhage, Laboratory test abnormal, Platelet disorder, Pyrexia, Red blood cell abnormality, Renal failure, White blood cell disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Haematopoietic leukopenia (broad), Haematopoietic thrombocytopenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ischaemic colitis (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-09-12
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vigabatrin, Diazepam, Valproate sodium
Current Illness: Neurological abnormality
Preexisting Conditions: Epilepsy, seizure
Allergies:
Diagnostic Lab Data: Acid base balance 08Sep05 7.345; Alanine aminotransferase 12Sep05 374U/L; Aspartate aminotransferase 12Sep05 1270U/L; Creatinine 12Sep05 2.7mg/dl; platelet count 08Sep05 445000ml; Platelet count 12Sep05 4000ml; Red blood cell count 08Sep05 3000000ml; Urea 12Sep05 5mg/dl; White blood cell count 08Sep05 27300ml; White blood cell count 12Sep05 6600ml.
CDC Split Type: B0393703A

Write-up: This case was reported by a medical advisor and described the occurrence of fatal seizure in a 8 month old female subject receiving diphtheria tetanus acellular pertussis vaccine (Infanrix) for prophylaxis. medical history included some abnormalities and needed neurological care. The mother was alcohol abused and two sons in orphanages. Concurrent medications included tuberculosis vaccine BCG at birth, diphtheria tetanus acellular pertussis vaccine Infanrix on July 27 2005 after neurological examination. Concomitant medication included valpraate sodium and diazepam due to epilepsy with primary generalized seizure (diagnosis established when she was 4 month old. On Sept 07 2005, at 11:00am , a 2nd dose of Infanrix was given. On the same day, at 12:00 am, 1 hour after vaccination with Infanrix, the subject developed temperature. At 1:00 pm, the subject developed fits episode. At03pm, the subject was hospitalised due to convulsive state. On Sept 08 2005, the child was moved to the intensive care due to worsening. She was treated with anticonvulsants (inj), catecholamine (from 3rd day of residence), anti oedematous medicaments and fresh frozen plasma. She was also administered packed erythrocyte mass due to massive bleeding from gastrointestinal tract. Respiration was controlled. During hosptialisation, the baby experienced acute renal failure and thrombo embolic disorder of lower limb. On Sept 12 2005, at 1pm, irrespective of treatment the baby died. Autopsy will be conducted. The reporter considered the event to be possibly related with Infanrix. Further information has been requested.


VAERS ID: 244979 (history)  
Form: Version 1.0  
Age: 5.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-10-05
Entered: 2005-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK - / IM
TTOX: TETANUS TOXOID (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autonomic nervous system imbalance, CSF test abnormal, Convulsion, Drug ineffective, Encephalitis, Guillain-Barre syndrome, Hypoxia, Laboratory test abnormal, Leukocytosis, Phobia, Pleocytosis, Pneumonia aspiration, Sepsis, Viral infection
SMQs:, Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Demyelination (narrow), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Immunoglobulin Human Rabies
Current Illness:
Preexisting Conditions: Stray dog bite with a flap hanging on front of the left eye.
Allergies:
Diagnostic Lab Data: Negri bodies positive; CSF pleocytosis; Leucocytosis
CDC Split Type: MA20050768

Write-up: A 5 yr old girl presented with a 7 cm laceration with flap hanging in front of the left eye following a stray dog bite. Wound cleansing with povidone iodine and tetanus toxoid administration had been done at a nearby dispensary immediately after the bite. PCEV (Rabipur) was given over deltoid region and 20IU/kg of HRIG was administered (about 50% infiltrated locally and rest IM). Laceration was sutured after 24 hrs because of the high likelihood of a bad scar in the girl child. She was discharged after the 3rd dose of Rabipur on day 7 and received the 4th dose on day 14. On day 17 following the bite she reported with typical features of acrophobia and hydrophobia. Although the diagnosis of rabies was obvious, variants of Guillian Barre syndrome and acute disseminated encephalomyelitis were also considered in view of the supervised vaccination profile. Investigations revealed polymorphonuclear leucocytosis in blood and lymphocytic pleocytosis in the CSF. The child rapidly deteriorated with dysautonomia, aspiration pneumonia, and seizures and died despite mechanical ventilation over the next 36 hrs. Autopsy was positive for Negri bodies and rabies antigen. Seriousness criteria: death, hospitalization, medically significant (OMIC).


VAERS ID: 245050 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2005-09-21
Onset:2005-09-21
   Days after vaccination:0
Submitted: 2005-10-06
   Days after onset:15
Entered: 2005-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-09-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0395975A

Write-up: This case was reported by a physician and described the occurrence of death in a 2 month old male subject who was vaccinated with Infanrix-Polio-Hib, hepatitis B vaccine for prophylaxis. On 21 September 2005 the subject received a dose of Infanrix-Polio-Hib and a dose of hepatitis B vaccine (manufacturer unknown). The same day following vaccination, the subject died. At the time of this report, the cause of death was not reported. It was unknown whether an autopsy was performed. The physician considered the event was possibly related to vaccination with Infanrix-Polio-Hib and Hepatitis B vaccine. Further information has been requested.


VAERS ID: 245137 (history)  
Form: Version 1.0  
Age: 0.54  
Sex: Male  
Location: Foreign  
Vaccinated:2003-11-18
Onset:2005-09-21
   Days after vaccination:673
Submitted: 2005-10-10
   Days after onset:19
Entered: 2005-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS UNK / UNK UN / -
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS UNK / UNK UN / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / UNK UN / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0396120A

Write-up: This case was reported and described the occurrence of a fatal sepsis in a 2 year old male subject who was vaccinated with combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and haemophilus influenzae type B vaccine (Infanrix-polio-Hib) and also with combined diphtheria,tetanus,acellular pertussis and inactivated poliomyelitis,haemophilus influenzae type B vaccine (Pentavac) for prophylaxis. On July 3 2003 the subject received 1st dose of Pentavac. On November 18 2003 and Sept 4 2003 the subject received 3rd dose and 2nd dose of Infanrix polio Hib. On Sept 21 2005, 22 months after the last vaccination with Infanrix Polio Hib, the subject developed sepsis and bacterial infection. The subject died on an unknown date. It was unknown whether an autopsy was performed. The regulatory authority reported that the events were possible related to vaccination with Infanrix polio Hib and Pentavac. Further information have been requested.


VAERS ID: 245427 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2005-09-27
Submitted: 2005-10-14
   Days after onset:17
Entered: 2005-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic shock, Hepatitis A, Viral infection
SMQs:, Liver infections (narrow), Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-10-06
   Days after onset: 9
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: Phytomenadione
Current Illness: UNK
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0396977A

Write-up: This case was reported by a physician and described the occurrence of hep a in a 3 yr old male subject who was vaccinated with hep A inactivated and hep B recombinant vaccine (Twinrix) for prophylaxis. Concurrent medication included Phytomenadione (Konakion). On Oct2004 and April2005 the subject received 1st dose and 2nd dose of Twinrix. On 27-28Sept05, 5 months after 2nd dose, 11 months after 1st dose of Twinrix, the subject experienced fulminant hepatitis A. Some days later he was admitted to hospital where he died on 06Oct05. The final diagnosis was anaphylactic shock due to vitamin K (Konakion). The physician considered the events were possibly related to vaccination with Twinrix. Further information has been requested.


VAERS ID: 245712 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2005-09-21
Onset:2005-09-22
   Days after vaccination:1
Submitted: 2005-10-14
   Days after onset:22
Entered: 2005-10-20
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 - / -
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-09-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0510USA05883

Write-up: Information has been received from a health professional concerning a 9 week old male pt with no reported medical history, who on 21-SEP-2005 was vaccinated with a first dose of hepatitis B vaccine rHBsAg (yeast) (thimerosal free). Other suspect vaccine therapy included a first dose of Infanrix. It was reported that the pt died one day after vaccination (22-SEP-2005). The cause of death was not reported. The outcome is fatal. More information is expected. Other business partner number included E200504002 and RIVM200500843.


VAERS ID: 245713 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-10-14
Entered: 2005-10-20
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0510USA06400

Write-up: Information was received from a law firm as background information for a case in litigation. The law firm created a "fact sheet" which was a review of information from a variety of sources. The fact sheet indicated that a 16 year old male was vaccinated with a dose of MMR (manufacturer unknown). "A few days later", the pt died. The cause of death was not reported. No further information is available.


VAERS ID: 245714 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-10-14
Entered: 2005-10-20
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal discomfort, Abnormal behaviour, Arthralgia, Arthritis, Autism, Cerebral palsy, Crohn's disease, Diabetes mellitus, Encephalitis, Encephalopathy, Epilepsy, Fatigue, Guillain-Barre syndrome, Hearing impaired, Leukaemia, Meningitis, Mental retardation severity unspecified, Multiple sclerosis, Myalgia, Nervous system disorder, Purpura, Rheumatoid arthritis, Thrombocytopenic purpura, Vasculitis, Visual disturbance
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Congenital, familial and genetic disorders (narrow), Convulsions (narrow), Gastrointestinal premalignant disorders (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Demyelination (narrow), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Hearing impairment (narrow), Vasculitis (narrow), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad), 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: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0510USA06386

Write-up: Information was received from a law firm as background information for a case in litigation. The law firm created a fact sheet which was a review of information from a variety of sources. The fact sheet indicated that an unk number of pt''s were vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (manf unk) or a dose of measles virus vaccine live (unspecified) (+) rubella virus vaccine live (unspecified) (manf unk). Following vaccination the following adverse events were reported with the figures in parentheses the number of reported cases: autism (287), Crohn''s disease and other serious chronic stomach problems (136), epilepsy (132), other forms of brain damage (including meningitis, cerebral palsy, encephalopathy, encephalitis) (77), hearing and vision problems (81), arthritis and arthralgia (including crippling juvenile rheumatoid arthritis) (50), behavioral and learning problems in older children (110), myalgic encephalomyelitis and chronic fatigue (41), diabetes (15), Guillain Barre syndrome (9), idiopathic thrombocytopenic purpura and other purpuras (6), Subacute sclerosing panencephalitis (3), Wegener''s granulamatosis (2), leukemia (1), and multiple sclerosis (1). There were 18 reported deaths. The cause of death was unk. It was noted that some of these children had more than one adverse reaction. upon internal review autism, epilepsy, other forms of brain damage (including meningitis, encephalopathy, encephalitis, etc), myalgic encephalomyelitis, Guillain Barre syndrome, Sub Acute sclerosing panencephalitis, leukemia and multiple sclerosis were considered to be other important medical events (OMIC). Crippling juvenile rheumatoid arthritis was considered to be disabling. No further information is available.


VAERS ID: 246058 (history)  
Form: Version 1.0  
Age: 1.5  
Sex: Female  
Location: Foreign  
Vaccinated:2005-07-14
Onset:2005-07-20
   Days after vaccination:6
Submitted: 2005-10-24
   Days after onset:96
Entered: 2005-10-25
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS UNK / UNK UN / -
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX) / GLAXOSMITHKLINE BIOLOGICALS AMTRA056AB / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Bacterial infection, Pyrexia, Sepsis, Toxic shock syndrome
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Toxic-septic shock conditions (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-07-25
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0397483A

Write-up: This case was reported by a physician and described the occurrence of fatal toxic shock syndrome in a 18 month old female subject who was vaccination with measles, mumps and rubella vaccine, live, attenuated (new strain) (Priorix) hepatitis B vaccine (Engerix B) for prophylaxis. On July 14 2005 the subject received a dose of Priorix, and a dose of Engerix B. On July 20 2005,6 days after vaccination with Engerix B and Priorix, the subject developed fever. On July 25 2005, 11 days following vaccination, the subject developed a toxic shock syndrome (streptococcus pyogenes were isolated). The subject died on July 25 2005, the case of death was not reported. It was unknown whether an autopsy was performed. Further information has been requested.


VAERS ID: 246182 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Female  
Location: Foreign  
Vaccinated:2005-10-18
Onset:2005-10-18
   Days after vaccination:0
Submitted: 2005-10-26
   Days after onset:8
Entered: 2005-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / UNK UN / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-10-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0397824A

Write-up: This case was reported by a physician and described the occurrence of death in a 2 month old female subject who was vaccinated with combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and haemophilus influenza b vaccine (Infanrix-IPV+Hib) unknown manufacturer for prophylaxis. It was unknown weather the subject received Diphtheria + tetanus + Pertussis vaccine or Diphtheria + tetanus + pertussis + polio + haemophilus influenzae vaccine. On Oct 18 2005 the subject received 1st dose of Diphtheria + tetanus + pertussis + polio + haemophilus influenzae. The subject was found dead in her bed, within 24 hours following vaccination. The cause of death was not reported. It was unknown whether an autopsy was performed. The physician considered the event was possibly related to vaccination with Diphtheria + tetanus + pertussis + polio + haemophilus influenzae. Further information has been requested.


VAERS ID: 246600 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2005-10-14
Onset:2005-10-14
   Days after vaccination:0
Submitted: 2005-11-01
   Days after onset:18
Entered: 2005-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-10-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Isosorbide; Metoprolol; Lansoprazole; Clopidogrel; Prochlorperazine; Domperidone; Lisinopril; Aspirin; Meloxicam; Bisoprolol; Atorvastatin calcium; Co-amilofruse;
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: B0398395A

Write-up: This case was reported by a regulatory authority and described the occurrence of death NOS in a 74 year old female subject who was vaccinated with pneumococcal vaccine, unspecified (Pneumovax II), influenza virus vaccine (Influenza vaccine) for prophylaxis. Concurrent medications included isosorbide, metoprolol, lansoprazole, clopidogrel, prochlorperazine, domperidone, lisinopril, aspirin, meloxicam, bisoprolol, atorvastatin calcium (Atorvastatin) and co amilofruse. On Oct 14 2005 the subject received unspecified dose of Pneumovax II .5 ml, intramuscular unknown, unspecified dose of influenza vaccine .5 ml intramuscular, unknown. Three hours after vaccination with Influenza vaccine and Pneumovax II, the subject collapsed and died. The subject died on Oct 14 2005, cause of death was not reported. An autopsy was not performed.


VAERS ID: 246786 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-11-04
Entered: 2005-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Viral infection
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Immunoglobulin Human Anti-Rabies
Current Illness:
Preexisting Conditions: Bite of an unknown animal
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20050877

Write-up: A female patient (no further information) was bitten by an unknown animal. The patient was vaccinated with Rabipur and she received also RIG. The patient died due to rabies infection. We are awaiting further information.


VAERS ID: 246916 (history)  
Form: Version 1.0  
Age: 1.33  
Sex: Male  
Location: Foreign  
Vaccinated:2005-10-01
Onset:2005-10-01
   Days after vaccination:0
Submitted: 2005-11-04
   Days after onset:34
Entered: 2005-11-07
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / UNK UN / -
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / UNK UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anaphylactic reaction, Bronchospasm, Cardiac arrest, Cyanosis, Diarrhoea, Dyspnoea, Flushing, Gastroenteritis, Hypotension, Hypoxia, Increased bronchial secretion, Lung disorder, Nasal congestion, Pyrexia, Respiratory distress, Respiratory failure, Sepsis, Shock, Vasodilatation, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200502161

Write-up: Initial report received from a healthcare professional on 23-Oct-05. A 16-month-old male patient, with no relevant medical history, developed respiratory and circulatory distress leading to hospitalization 17 hours after he had received TRIMOVAX vaccination. (lot not reported) as well as a BCG booster (manufacturer, unknown, lot not reported). The patient died. Fever with flushed skin started to appear 1 hour after the vaccination. The patient was given paracetamol which afforded no relief. 5 hours after vaccination, the patient consulted due to persistence of initial symptoms, diagnosed as post-vaccination fever. Patient went home after 4 hrs as signs did not progress and the flushed skin disappeared. About 7 hrs prior to admission, patient had episodes of vomiting and diarrhea at home. Then 5 hours PTA, he developed difficulty breathing and cyanosis. He was brought immediately to hospital and admitted as a case of acute gastroenteritis to consider aspiration pneumonia and was given IV fluids and paracetamol. Prior to transfer, patient was given diphenhydramine and hydrocortisone. He was transferred to another hospital as a case of septic shock. Upon arrival at the pedia ER he was cyanotic and ambubagging by the ambulance physician. Intubation was done and was transferred to PICU and was hooked to mechanical ventilator. He was given ceftriaxone, phenytoin and IV fluids. Later patient arrested and despite resuscitative measures expired 11 hours after admission. Comments: In correlation with the history and clinical course, the gross examination and autopsy findings (details available in autopsy report) are consistent with an acute anaphylactic reaction. A vasodilatation and congestion caused increase in vascular bed capacitance not adequately filled by normal circulating blood volume that would led to hypotension. Release of histamine and chemical mediators caused broncho constriction and spasm within trachea as well as hyper secretion of mucus. These eventually led to obstruction of airways resulting to respiratory failure and eventual the death of patient. 26-Oct-2005 Allergic reactions have been observed following administration of MMR vaccine. Cases of anaphylaxis manifest a variety of symptoms, with some (such as breathing difficulty and cyanosis) being more alarming than others. In this case the patient''s health status fluctuated, going through periods of improvement, which was probably a factor in determining the exact diagnosis and aggressively treating the condition. More information such as hospital records, and results of lab investigation will be helpful in further assessment of this case.


VAERS ID: 247155 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Foreign  
Vaccinated:2005-10-25
Onset:2005-10-25
   Days after vaccination:0
Submitted: 2005-11-04
   Days after onset:10
Entered: 2005-11-09
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. NA23910 / UNK - / -
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
MNQ: MENINGOCOCCAL CONJUGATE (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pyrexia, Sudden infant death syndrome
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Metabolic screening normal 04/29/2005, hypoacusia screening normal 05/1/2005, physical examination 10/25/2005 normal, Autopsy 10/26/2005, Body temp 10/25/2005 fever, head circumference measurement 10/25/2005 43cm
CDC Split Type: WAES0511USA00395

Write-up: Information has been received from a health professional concerning a 6 month old healthy male who was breastfeeding with no relevant history reported who on 10/25/05 was vaccinated with a 5mcg dose of hepatitis B virus vaccine (batch # NA23910). Concomitant therapy that day included a dose of diphtheria toxoid (+) HIB conjugate vaccine (tet toxoid) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid (batch # A20CA094A) and a dose of meningococcal C conjugate vaccine (batch # 2498A). At this visit: weight = 7.380kg; height = 68cm; cranial perimeter = 43cm; skin, mucoses, ear, cardiopulmonary auscultation, abdomen, hip abduction, neurological exploration, and psychomotor development = normal. Family history: parents healthy; "youngs"; no blood relatives; rest of relatives without interest; pregnancy without incidences; delivery at 38+1/7 gestation weeks; newborn weight = 3.70kg; newborn height = 50.5cm; newborn cranial perimeter = 34cm; Apgar = 9-10; blood group B, rH +; metabolic screening performed on 4/29/05 = normal; hypoacusia screening performed on 5/10/05 = normal. On 10/25/05, during the afternoon the patient presented with a fever (not measured). He was treated with paracetamol. On 10/25/05 at 19:35, six hours after vaccination, the baby was carried to the primary care center when he arrived dead. A cardiopulmonary resuscitation was tried for 40 minutes without success. The preliminary performed by the forensic scientist was sudden infant death syndrome. Necropsy was performed on 10/26/05. It was noted that the patient did not have any adverse event with previous vaccinations at 2 and 4 months of age. Details information was not reported. Further information is expected. The case is incomplete. Other business partner numbers included E200504385.


VAERS ID: 247333 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2005-10-14
Onset:2005-10-14
   Days after vaccination:0
Submitted: 2005-11-08
   Days after onset:25
Entered: 2005-11-14
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-10-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Clopidogrel bisulfate, domperidone, isosorbide, lansoprazole, lisinopril, meloxicam, metoprolol, prochlorperazine
Current Illness:
Preexisting Conditions: Angina pectoris;Dyspepsia;Nausea;Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0511USA00541

Write-up: Information has been received from a health authority concerning a 74 year old female with angina pectoris, dyspepsia, nausea and hypertension who on 14-Oct-2005 was vaccinated intramuscularly with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot number not reported). The patient also was vaccinated intramuscularly with a 0.5 ml dose of influenza virus vaccine (batch number not reported). At the time of the vaccination, concomitant therapy included isosorbide for angina pectoris 10mg BD po since 01-Oct-2005, metoprolol for angina pectoris 25 mg TDS po since 01-Oct-2005, lansoprazole for dyspepsia 30mg OD po since 06-Sep-2005, clopidogrel bisulfate 75mg OD po since 01-Oct-2005, prochlorperazine 10 mg TDS po since 06-Sept-2005, domperidone for nausea 10mg TDS 01-Sep-2005, lisinopril for hypertension 10mg OM since 18-Oct-2005, aspirin for angina pectoris 75mg OD since 30-Apr-2005, meloxicam 7.5mg OD since 07-Jul-2004, bisoprolol 5mg OD since 15-Oct-2003, atorvastatin calcium for angina pectoris 10mg OD since 09-Mar-2004, and amiloride/furosemide 5/40 since 09-Mar-2004. Three hours post vaccination, on 14-Oct-2005, the patient collapsed and died. The cause of death was unknown. No PM was performed. The patient''s death was not considered to be a sudden death. Both the authority and the reporter considered this event to be serious. Other business partner numbers included E2005-04391 and ADROIT497693. No further information is available. The case is closed.


VAERS ID: 247486 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2005-10-14
Submitted: 2005-11-14
   Days after onset:31
Entered: 2005-11-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-10-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESWYE131411NOV05

Write-up: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from an investigator in a post marketing surveillance study regarding a male participant. Two years after the Prevenar launch who experienced death. The participant received the first dose on an unspecified date and the second on an unspecified date. Relevant medical history was not provided. Indication for Prevenar was immunisation. Product was administered on an unspecified date. The dose regimen was 1 dose intramuscular and then was 1 dose intramuscular. Concomitant medications were not reported. The patient experienced death on 10/14/2005. The cause of death was reported as unknown. The assessments of the investigator(S) and medical monitor(S) for death were unknown. No additional information was available at the time of this report.


VAERS ID: 247661 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2005-10-10
Submitted: 2005-11-15
   Days after onset:36
Entered: 2005-11-17
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH UNK / 1 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Body temperature decreased, Cerebral infarction, Depressed level of consciousness, Drug ineffective, Ear disorder, Hypoxia, Irritability, Meningitis, Multi-organ failure, Pneumonia, Sepsis, Vomiting
SMQs:, Acute pancreatitis (broad), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Eosinophilic pneumonia (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), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-10-27
   Days after onset: 17
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: UNK
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood culture positive for S pneumoniae results serotype pending done on 10/10/2005, Body temp 35 Deg C done on 10/10/2005
CDC Split Type: ESWYE130911NOV05

Write-up: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from an investigator in a post marketing surveillance study regarding a 1 year old female participant in a study. Two years after the Prevenar launch who experienced pneumococcal meningitis, pneumococcal bacteremia, pneumococcal sepsis, drug ineffective and cerebral infarct. The participant received the fires dose , the second dose, and the third dose and the fourth dose on unspecified dates. past therapies include DPT, Haemophilus influenzae B, Poliomyelitis vaccine Inactivated, MMR, Hep B vaccine and Meningitec (meningococcal group c conjugate vaccine injection. Indication for Prevenar was immunisation. Product was administered on an unspecified date. The dose regimen was 1 dose intramuscular, then was 1 dose intramuscular, then was 1 dose intramuscular and then was 1 dose intramuscular. Concomitant medication were not reported. The patient experienced pneumococcal meningitis, pneumococcal bacteremia, pneumococcal sepsis, drug ineffective, and cerebral infarction on Oct 10 2005. The patient was hospitalized with irritability, vomits, otalgy and consciousness level disorder, The patient had a bad status and a temperature of 35 C. She had also positive meningeal signs. The patient needed ventilation and had multi systemic failure. Specific therapy with 200 mg/kg of cefotaxime during 15 days, 40 mg/kg of vancomycin during 15 days and 0.6 mg/kg of dexamethasone during two days was administered to the patient. Blood culture was positive for S pneumoniae (serotype results are pending). The patient was 17 days in the intensive care unit. On 10/27/2005 the patient died with the diagnosis of pneumococcal meningitis, pneumococcal sepsis and cerebral infarct. The cause of death was reported as meningitis pneumococcal, pneumococcal bacteremia, pneumococcal sepsis, drug ineffective and cerebral infarction. The assessments of the investigator and medical monitor for meningitis pneumococcal, pneumococcal bacteremia, pneumococcal sepsis, drug ineffective and cerebral infarction were unknown. No additional information was available at the time of this report.


VAERS ID: 247751 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2005-09-29
Onset:0000-00-00
Submitted: 2005-11-18
Entered: 2005-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS DFLUA014A / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: B0399618A

Write-up: This male subject was enrolled in the prophylactic double blind study 104438 (FluarixUS-004). On 29 September 2005, he received the dose of influenza vaccine (Fluarix) or placebo (IM U deltoid). The subject received a dose of Fluarix (lot nbr DFLUA014A). On an unknown date, after the 1st dose of blinded vaccine, the subject died, cause of death is unknown. Investigator causality was unknown at the time of report.


VAERS ID: 248227 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2005-10-21
Onset:2005-10-23
   Days after vaccination:2
Submitted: 2005-11-22
   Days after onset:30
Entered: 2005-11-28
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 95381 / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-10-23
   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: Bendrofluazide
Current Illness: Ventricular extrasystoles
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: B0401063A

Write-up: This case was reported by a regulatory authority and described the occurrence of death in a 74 year old female subject who was vaccinated with influenza virus vaccine (manufacturer unspecified) for prophylaxis. Concurrent medical conditions included ventricular extrasystoles. Concurrent medications included bendrofluazide (Bendroflumethiazide). On Oct 21 2005 the subject received unspecified dose of influenza vaccine .5 ml intramuscular. On Oct 23 2005, 2 days after vaccination with influenza vaccine, the subject died, cause of death was not reported. An autopsy was not performed. Verbatim text received. Found dead in bed. Reports to coroner as unexpected. The reporter considered the reaction to be serious for the following reason patient died.


VAERS ID: 248329 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2005-11-03
Onset:2005-11-04
   Days after vaccination:1
Submitted: 2005-11-29
   Days after onset:25
Entered: 2005-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Cardiac disorder, Malaise, Pericarditis, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-11-04
   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: Bendrofluazide, Ramipril, Diclofenac, Orlistat
Current Illness: Gastric ulcer, hypertension, obesity, proteinuria.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: B0401650A

Write-up: This case was reported by a regulatory authority and described the occurrence of pericarditis in a 67 year old male subject who was vaccinated with influenza virus vaccine, manufacturer unspecified, for prophylaxis. Concurrent medical conditions included gastric ulcer, hypertension, obesity and proteinuria. Concurrent medications included bendrofluazide, ramipril, diclofenac and orlistat. On Nov 3 2005 the subject received unspecified dose of Influenza vaccine (unknown). At an unspecified time after vaccination with Influenza vaccine, the subject experienced pericarditis, pulmonary edema and feeling unwell. Relevant test results included lab results hospital investigations. The events were unresolved. The subject died on Nov 4 2005, cause of death was not reported. An autopsy was performed and showed pericarditis and pulmonary edema. Verbatim text received. After receiving the flu vaccine he complained of feeling unwell and confined himself to bed, He was found on his bed and was unresponsive-dead. Post portem results showed cloudy fluid around the heart, acute inflammation around the surface the heart, acute pericarditis and pulmonary edema. Autopsy revealed acute pericarditis. An inquest in being arranged.


VAERS ID: 248488 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-11-30
Entered: 2005-12-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 4 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Drug ineffective, Sepsis
SMQs:, Lack of efficacy/effect (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEWYE172024NOV05

Write-up: Information regarding Prevnar was received from a pediatrician regarding a patient who experienced drug ineffective and pneumococcal sepsis. The patient received the fourth dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was not provided. Product was administered on an unspecified date. Dose regimen was 1 dose (IM). Concomitant medications were not reported. The patient experienced pneumococcal sepsis and died. It is unknown if serotyping was performed. The cause of death was reported as pneumococcal sepsis.


VAERS ID: 248542 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Female  
Location: Foreign  
Vaccinated:2005-11-23
Onset:2005-11-24
   Days after vaccination:1
Submitted: 2005-11-30
   Days after onset:6
Entered: 2005-12-02
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / UNK UN / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Z0035 / UNK UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Haematemesis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-11-26
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200502568

Write-up: Initial report received from the health authorities on Nov 28 2005. A 4 month old female child with no reported medical history, vomited blood and milk while sleeping at 10:00 pm Nov 24 2005, the event occurred the day after the second dose of inactivated polio vaccine (eIPV), Lot Z0035 and DTaP administration, then at an unspecified time, she was moved to a hospital. It was reported that, she fell into the brain death and then died at 10 am on 11/26/2005. Outcome was fatal.


VAERS ID: 248663 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2005-09-30
Onset:2005-10-09
   Days after vaccination:9
Submitted: 2005-12-01
   Days after onset:53
Entered: 2005-12-05
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, 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: 2005-10-22
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 24 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Zyloric, Thyradin, aspirin, Pariet, Sigmart and Dogmatyl.
Current Illness:
Preexisting Conditions: Angina pectoris; Cardiac Failure chronic; Hyperthyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0511USA04264

Write-up: Information has been received from a physician concerning an 87 year old male pt, with angina pectoris, cardiac failure chronic and hyperthyroidism, who on 30-SEP-2005 was vaccinated parenteral with a dose of pneumococcal 23v polysaccharide vaccine (Batch# unknown). Concomitant therapy included Zyloric, Thyradin, aspirin, Pariet, Sigmart and Dogmatyl. The pt was placed on therapy with parenteral nutrition due to small appetite (10% of normal range). On 05-Oct-2005, the pt had a medical consultation at the reporting physician''s hospital. No abnormality was recognized. On 07-Oct-2005, the pt had a medical consultation at the reporting physician''s hospital. No abnormalities were recognized. On 09-Oct-2005, the pt was hospitalized due to pneumonia at the other hospital. On 22-Oct-2005, the family member of the pt reported that the pt died of pneumonia at the hospital. It was also reported that MRSA was detected. The information of an autopsy was not provided. The physician assessed that the adverse event was possibly related to pneumococcal 23v polysaccharide vaccine. The pneumonia was considered to the serious as fatal. The cause of death was pneumonia. The reporter felt that pneumonia was related to therapy with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.


VAERS ID: 249211 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Male  
Location: Foreign  
Vaccinated:2005-11-30
Onset:2005-12-01
   Days after vaccination:1
Submitted: 2005-12-13
   Days after onset:12
Entered: 2005-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB128AS / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Crying, Screaming
SMQs:, Hostility/aggression (broad), Depression (excl suicide and self injury) (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-12-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: B0402506A

Write-up: This case was reported by a physician and described the occurrence of sudden death in a 1 month old male subject who was vaccinated with hepatitis B vaccine (Engerix B adult) for prophylaxis. On Nov 30 2005 the subject received 2nd dose of Engerix B adult (20 mcg, unknown). The physician gave half of an adult dose to this child. The remaining dose was given to another child for which nothing abnormal was reported. On Dec 1 2005, at 4am, he was reportedly crying incessantly, His mother gave him paracetamol syrup to relieve the symptoms. At 9am, he was found dead, His parents took him to the nearby police station to file a case for investigation on the death. The subject died on Dec 1 2005, cause of death was not reported. An autopsy was performed. Preliminary autopsy results did not reveal any abnormalities. A complete review of the batch records could no highlight any deviation that could be linked to the complaint.


VAERS ID: 249914 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2005-11-03
Onset:0000-00-00
Submitted: 2005-12-29
Entered: 2005-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Cardiac disorder, Coma, Inflammation, Malaise, Pericarditis, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Bendrofluazide, Ramipril, Diclofenac, Orlistat
Current Illness: Gastric Ulcer;Hypertension;Obesity;Proteinuria
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: B0404878A

Write-up: This case was reported by a regulatory authority and described the occurrence of pulmonary edema in a 67 year old male subject who was vaccinated with influenza virus vaccine (influenza vaccine, manufacturer unspecified) for prophylaxis. Concurrent medical conditions included gastric ulcer, hypertension, obesity and proteinuria. Concurrent medications included bendrofluazide, ramipril and diclofenac. On Nov 3 2005 the subject received unspecified dose of influenza vaccine (unknown). At an unspecified time after vaccination he complained of feeling unwell and confined himself to bed. He was found on his bed and was unresponsive - dead. An autopsy was performed ans showed cloudy fluid around the heart, acute inflammation around the surface of the heart, acute pericarditis and pulmonary edema. An inquest is being arranged.


VAERS ID: 249921 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2005-12-21
Onset:2005-12-24
   Days after vaccination:3
Submitted: 2005-12-29
   Days after onset:5
Entered: 2005-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-12-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: B0404790A

Write-up: This case was reported by a sales representative and described the occurrence of sudden death in a subject of unspecified age and gender who was vaccinated with Haemophilus influenzae type B vaccine (Hiberix), live attenuated oral poliomyelitis vaccine (OPV, unknown manufacturer), combined diphtheria, tetanus and pertussis (A or W not known) vaccine (Diphtheria tetanus pertussis (A or W not known), unknown manufacturer) for prophylaxis. A physician or other health care professional has not verified this report. On 21 December 2005 the subject received unspecified dose of Hiberix (unknown), unspecified dose of OPV (oral, unknown), unspecified dose of Diphtheria tetanus pertussis (A or W not known) (unknown). On 24 December 2005, 3 days after vaccination with Diphtheria tetanus pertussis (A or W not known), Hiberix and OPV, the subject experienced sudden death. The subject died on 24 December 2005, cause of death was not reported. It was unknown whether an autopsy was performed. Additional information has been requested.


VAERS ID: 249981 (history)  
Form: Version 1.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2005-06-30
Submitted: 2006-01-03
   Days after onset:187
Entered: 2006-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Drug ineffective, Influenza like illness, Myocardial infarction, Pyrexia, Rhinorrhoea
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-07-15
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body temperature June 30 2005 38 deg C
CDC Split Type: B0404722A

Write-up: This case was reported by an unspecified health professional via another manufacturer and described the occurrence of myocardial infarction in a 91 year old female subject who was vaccinated with influenza virus vaccine for prophylaxis. Concurrent medical condition and concurrent medication were unknown. Between Oct 16 2004 and Nov 25 2004, the subject received an injection of Influenza vaccine (0.5 ml, batch not available). On June 30 2005, approximately seven months after vaccination with influenza virus vaccine, the subject experienced influenza disease with fever and rhinorrhea. The highest temperature was 38 celsius degrees and occurred on June 30 2005. The subject was treated with oseltamivir. The influenza stain responsible for the infection was the strain A California 7-2004 derived from a New York 55-2004. This strain was not present in the vaccines formulation Northern Hemisphere in 2004-2005. The events resolved on July 4 2005. On July 15 2005, the subject died from myocardial infarction. It was unknown whether an autopsy was performed. The health professionals causality assessment was unspecified. No more information will be available. This case has been closed.


VAERS ID: 250267 (history)  
Form: Version 1.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2005-12-09
Onset:2005-12-12
   Days after vaccination:3
Submitted: 2006-01-06
   Days after onset:25
Entered: 2006-01-11
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0309P / UNK RA / IM
TD: TD ADSORBED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Dyspnoea, Pallor, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-12-12
   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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0601USA00223

Write-up: Information has been received from a health professional concerning a 95 year old female who on 09-Dec-2005 was vaccinated IM into the right upper arm with a dose of PNEUMOVAX 23 vaccine (lot #649257/0309P, batch # HV63940) and concomitantly IM into left arm with a dose of diphtheria-tetanus toxoid vaccine. During the following days, she went well and showed no local reaction, fever, or allergic symptoms. However, in the morning of 12-Dec-2005, she looked "ashy-pale" and had difficulties in breathing. Her airways were cleaned by suction. Short time later this morning, she was found dead. Reportedly, the cause of death was "respiratory arrest." No autopsy was done. The case is closed. Additional information is not expected. Other business partner numbers include PEI2005005273 and E2005-05584.


VAERS ID: 250331 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-01-11
Entered: 2006-01-13
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Otitis media, Mastoiditis
Allergies:
Diagnostic Lab Data:
CDC Split Type: HQWYE259709JAN06

Write-up: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding an 18 month old child who experienced fatal pneumococcal meningitis (drug ineffective). The patient received the fourth dose on an unspecified date. The patient has a past history of otitis media and mastoiditis in which the child "had been treated." Indication for Prevenar was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. The child was taken to the hospital on an unspecified date with pneumococcal meningitis (meningitis pneumococcal) (drug ineffective). The child died on 24-Dec (year not provided). The serotype has not yet been identified. Culture (results: serotype unknown) was done on an unspecified date. The cause of death was reported as meningitis pneumococcal.


VAERS ID: 251183 (history)  
Form: Version 1.0  
Age: 1.5  
Sex: Male  
Location: Foreign  
Vaccinated:2006-01-20
Onset:2006-01-20
   Days after vaccination:0
Submitted: 2006-02-02
   Days after onset:13
Entered: 2006-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS A20CA176A / UNK UN / -
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS A20CA176A / UNK UN / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER A20CA176A / UNK UN / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-01-20
   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: UNK
Current Illness:
Preexisting Conditions: Marfan''s Syndrome
Allergies:
Diagnostic Lab Data: Body temp increased 1/20/2006 39.2 Deg C.
CDC Split Type: D0048581A

Write-up: This case was reported by forensic pathologist via telephone to regulatory authority and described the occurrence of unknown cause of death in a 18 month old male subject who was vaccinated with combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and haemophilus influenza b vaccine (Infanrix-IPV+Hib) injection for prophylaxis. The subjects medical history included marfans syndrome. In the narrative received from the regulatory authority PEI the vaccine Pentavac was mentioned but not confirmed in the data. On 01/20 2006 the subject received a dose of Infanrix IPV Hib via unknown route into an unknown application site. On 1/20/2006, immediately after vaccination with Infanrix IPV Hib, the subject experienced fever at 39.2 deg C and vomiting. The mother put the child to bed at 00.30pm, on Jan 20 2006, at 2:30pm, the mother found the child lifeless in prone position. The resuscitation from mother was unsuccessful. The cause of death was unknown at the time of reporting. An autopsy was performed. Further information including autopsy report, additional investigations and medical history were requested by the regulatory authority.


VAERS ID: 251198 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2005-02-25
Onset:2005-02-25
   Days after vaccination:0
Submitted: 2006-01-31
   Days after onset:340
Entered: 2006-02-03
   Days after submission:3
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: Stillbirth, Unintended pregnancy
SMQs:, Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (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: Pregnancy NOS (LMP = 21Feb05)
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0503USA04688

Write-up: Information has been received from a health professional concerning an adult female with no reported medical history who on 25-Feb-2005 was vaccinated with a dose of MMR vaccine. Following vaccination, the patient discovered she was pregnant. Her LMP was 31-Jan-2005, therefore, she was in approximately week two of gestation when she received the vaccine. The patient did not experience any adverse event following vaccination. Follow-up information was received which indicated that the patient''s LMP was 21-Feb-2005 and she had no previous pregnancies. The patient delivered on 03-Dec-2005 at 41 weeks by ventouse extraction. The male infant was stillborn at delivery. He weight 3 kg with a head circumference of 36 cm. The case will be followed up. Other business partner numbers include E2005-01130 and E2006-00398.


VAERS ID: 251272 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2006-01-26
Onset:2006-01-28
   Days after vaccination:2
Submitted: 2006-02-06
   Days after onset:9
Entered: 2006-02-07
   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 - / -
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Diarrhoea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), 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: 2006-01-29
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HQWYE625402FEB06

Write-up: Information regarding Prevenar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a Pediatrician regarding a 2 month old male patient who received a dose on 26-Jan-2006. On 28-Jan-2006, the patient developed diarrhea, vomiting and fever. On 29-Jan-2006, the patient died. Relevant medical history was not provided. Indication for Prevenar was immunization. Product was administered on 26-Jan-2006. Dose regimen was 1 dose 1 time per day (intramuscular). Additional suspect medication included "pentavalent vaccine" (diphtheria/tetanus toxoids/pertussis vaccine adsorbed/haemophilus B conjugate/hepatitis B vaccine (manufacturer unknown) and Sabin vaccine (poliovirus vaccine live oral) (manufacturer unknown). Concomitant medications were not reported. On 28-Jan-2006, the patient developed diarrhea (diarrhea), vomiting (vomiting) and fever (pyrexia) which required or prolonged the patient''s hospitalization. On 29-Jan-2006 the patient died. The cause of death was reported as pyrexia, vomiting and diarrhea. This report was received from manufacturer affiliate reference number 3121. No additional information was available at the time of this report.


VAERS ID: 251417 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2005-11-14
Onset:2005-11-15
   Days after vaccination:1
Submitted: 2006-02-10
   Days after onset:87
Entered: 2006-02-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / -
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-11-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Coronary vessel disease, Pulmonary atresia, Vitium cordis.
Allergies:
Diagnostic Lab Data:
CDC Split Type: B0409246A

Write-up: This case was reported by an authority and described the occurrence of sudden death in a 14 month old male subject who was vaccinated with combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and haemophilus influenzae type B vaccine (Infanrix Polio Hib) for prophylaxis. The subjects medical history included coronary vessel disease, pulmonary atresia and vitium cordis for which he had undergone surgery. At the time of the vaccination, he was in a good condition. On 11/14/2005 the subject received unspecified dose of Infanrix Polio Hib (unknown, lot number not provided). On 11/15/2005, 24 hours after vaccination with Infanrix Polio Hib, the subject experienced sudden death. The reporting authority considered the event was possibly related to vaccination with Infanrix Polio Hib. The subject died on 11/15/2005, cause of death was not reported. It was unknown whether an autopsy was performed.


VAERS ID: 252188 (history)  
Form: Version 1.0  
Age: 0.48  
Sex: Male  
Location: Foreign  
Vaccinated:2005-11-17
Onset:2006-02-13
   Days after vaccination:88
Submitted: 2006-02-28
   Days after onset:15
Entered: 2006-03-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / -
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 16261 / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: CSF test abnormal, Convulsion, Drug ineffective, Laboratory test abnormal, Meningitis, Nasopharyngitis, Pyrexia, Sepsis, Shock
SMQs:, Anaphylactic reaction (narrow), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-02-16
   Days after onset: 3
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: Emlapatch (lidocaine hydrochloride/Prilocaine hydrochloride.
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: C reactive protein 355 mg/l and lumbar puncture: cerebrospinal fluid was turbid and contained soluble Pneumococcus antigens) were done on 2/15/2006
CDC Split Type: FRWYE400316FEB06

Write-up: Information regarding Prevenar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding an 8 month old male patient who experienced nasopharyngitis, convulsive fit, pneumococcal meningitis and septic shock. The patient received the third dose on 17-Nov-2005. Past therapies included 2 injections of Infanrix-quinta (diptheria/tetanus/acellular pertussis/poliomyelitis/haemophilus influenza vaccine) and 2 administration of Emlapatch (lidocaine hydrochloride/prilocaine hydrochloride patch), on 01-Sep-2005 and 06-Oct-2005. The patient had no relevant medical history. Indication for Prevenar was immunization. Product was administered on 01-Sep-2005, (lot n 15691), 06-Oct-2005 (lot n 16128) and 17-Nov-2005 (lot n 16261). Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant therapy included Infanrix-quinta (diphtheria/tetanus/acellular pertussis/poliomyelitis/haemophilus influenza vaccine) and Emlapatch (lidocaine hydrochloride/prilocaine hydrochloride patch). In Jan 2006, the patient experienced rheumatic purpura, which resolved (see related case: FRWYE423223FEB06 (adverse event, non-expedited). On 13-Feb-2006, the patient presented with fever (value not specified) and was diagnosed with nasopharyngitis (nasopharyngitis). On 15-Feb-2006, fever increased (value not specified) and the patient experienced a convulsive fit (convulsion). The patient was hospitalized in Pediatric unit. C-reactive protein was found increased at 355 mg/L, and cerebrospinal fluid was turbid and contained soluble pneumococcus antigens. He was diagnosed with pneumococcal meningitis (meningitis pneumococcal; drug ineffective). The patient received vancomycin, Rocephin (ceftriaxone sodium), Amikin (amikacin), Valium (diazepam) and Dilantin (phenytoin sodium). However the patient died on 16-Feb-2006 of septic shock (septic shock) and pneumococcal meningitis. Pneumococcal serotype investigation was scheduled. The outcome of nasopharyngitis was unknown. The cause of death was reported as pneumococcal meningitis and septic shock. No additional information was available at the time of this report.


VAERS ID: 252431 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-03-07
Entered: 2006-03-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anorexia, Asthenia, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Nasopharyngitis (LLT: Cold)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRWYE429024FEB06

Write-up: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from an unconfirmed consumer via a webchat forum regarding a 4 month old male patient who experienced vaccination reaction, fever asthenia, anorexia, and death. The patient received a dose on an unspecified date. The patients concurrent illness includes nasopharyngitis. The indication for Prevenar was immunisation. The product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. Two days after Prevenar injection, at an unspecified date, the patient died. Reportedly, the autopsy revealed that the patient had experienced a vaccination reaction with fever, asthenia and anorexia. The cause of death was not specified and the autopsy cause of death was not specified. The case was not medically confirmed. No additional information was available at the time of this report.


VAERS ID: 252741 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-03-07
Entered: 2006-03-14
   Days after submission:7
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: Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0603USA00586

Write-up: Information has been received from a newspaper article, titled "Secret report reveals 18 child deaths following vaccination" Daily Telegraph (12-Feb-2006), concerning a baby (unknown age and gender) with no reported relevant history who in 2003 was vaccinated with a dose of MMRII vaccine (manufacturer and batch number unknown). In 2003, following vaccination, the patient die due to cot death. Other business partner numbers included: E2006-01127. This report was received by manufacturer on 15-Feb-2006 and forwarded to manufacturer on 03-Mar-2006.


VAERS ID: 252742 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-03-07
Entered: 2006-03-14
   Days after submission:7
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: Brain oedema, Meningitis
SMQs:, Noninfectious meningitis (narrow), 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: 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: none
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0603USA00883

Write-up: Information has been received from a newspaper article, titled secret report reveals 18 child deaths following vaccination Daily telegraph 2/12/2006. concerning an infant unknown age and gender, with no reported relevant history who in 2001 was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3), manufacturer and batch number unknown. In 2004, three weeks after vaccination, the patient experienced meningitis and swelling of the brain. The patient died on an unreported date. Upon internal review, meningitis was considered an other important medical event (OMIC) Other business partner numbers.


VAERS ID: 252743 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-03-07
Entered: 2006-03-14
   Days after submission:7
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: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0603USA00884

Write-up: Information has been received from a newspaper article, titled secret report reveals 18 child deaths following vaccination Daily telegraph 2/12/2006. concerning an infant unknown age and gender, with no reported relevant history who in 2001 was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3), manufacturer and batch number unknown. In 2001, following vaccination, the patient died. The cause of death was unknown. Other business partner. This report was received by Sanofi Pasteur Med on 15-Feb-2006 and forward to Merk and Co, Inc. on 03-Mar-2006.


VAERS ID: 252744 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-03-07
Entered: 2006-03-14
   Days after submission:7
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: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0603USA00885

Write-up: Information has been received from a newspaper article, titled secret report reveals 18 child deaths following vaccination Daily telegraph 2/12/2006. concerning an infant unknown age and gender, with no reported relevant history who in 2001 was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3), manufacturer and batch number unknown. in 2001, following vaccination, the patient died. The cause of death was unknown. Other business partner.


VAERS ID: 252846 (history)  
Form: Version 1.0  
Age: 1.17  
Sex: Unknown  
Location: Foreign  
Vaccinated:2006-01-20
Onset:2006-01-23
   Days after vaccination:3
Submitted: 2006-03-15
   Days after onset:51
Entered: 2006-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS A20CA136A / UNK UN / -
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS A20CA136A / UNK UN / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER A20CA136A / UNK UN / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-01-23
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: B0415399A

Write-up: This case was reported by a regulatory authority and described the occurrence of death NOS in a 14 month old subject of unspecified gender who was vaccinated with combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and haemophilus influenzae type B vaccine (Infanrix-polio-HIB) for prophylaxis. On 20 January 2006, at 1:00 pm, the subject received an unspecified dose of Infanrix-polio-HIB (unknown). During the night to Monday 23 January 2006, 3 days after vaccination with Infanrix-polio-HIB, the subject was found dead. After vaccination, no adverse event was reported. The subject died, cause of death is not specified. It was unknown whether an autopsy was performed. Further information has been requested.


VAERS ID: 252914 (history)  
Form: Version 1.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2005-11-03
Onset:2005-11-03
   Days after vaccination:0
Submitted: 2006-03-17
   Days after onset:134
Entered: 2006-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-11-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: B0415395A

Write-up: This case was reported by a regulatory authority and described the occurrence of sudden death in a 65 year old male subject who was vaccinated with influenza virus vaccine (Influenza vaccine, manufacturer unspecified)for prophylaxis. The subjects medical history included bypass surgery. The subject was therefore in a risk group for developing cardiac illnesses. On 11/3/2005 in the morning, the subject received unspecified dose of influenza vaccine, manufacturer unspecified, unknown, lot number not available. The same morning at 9:30am, the subject went out for a walk. At 13:30 the same day, he was found dead. Cause of death is sudden cardiac death. The autopsy report is not available. Additional information has been requested.


VAERS ID: 252915 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2005-11-01
Onset:2005-11-01
   Days after vaccination:0
Submitted: 2006-03-17
   Days after onset:136
Entered: 2006-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Cardiac failure, Headache, Hepatic failure, Laboratory test abnormal, Malaise, Multi-organ failure, Pain, Pneumonia, Pyrexia, Respiratory failure, Sepsis
SMQs:, Cardiac failure (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), 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), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-11-10
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prochloraperazine; Verapamil hydrochloride; Glibenclamide; Metformin hydrochloride; Methyldopa
Current Illness: Chronic obstructive airways disease; Diabetes; Pleuritis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: C-reactive protein: 179 mg/L.
CDC Split Type: B0414710A

Write-up: This case was reported by a regulatory authority and described the occurrence of heart failure in a 81 year old female subject who was vaccinated with influenza virus vaccine for prophylaxis. Concurrent medical conditions included chronic obstructive airways disease, diabetes, and pleuritis. Concurrent medications included Prochlorperazine, Verapamil hydrochloride, Glibenclamide, Metformin hydrochloride, and Methyldopa. On 11/1/05, the subject received unspecified dose of Influenza vaccine. On 1/11/05, less than one day after vaccination with Influenza vaccine, the subject experienced fever, headache, and pain. On a date as yet unspecified, she developed a pneumonia. The events progressed and the subject developed sepsis; with respiration, liver, and heart failure. The progression of the events did not give any suspicion of an allergic reaction to the vaccine. Blood test showed the CRP at 179 mg/L. The patient died on 11/10/05. The regulatory authority reported that the fever, headache, and pain, as well as the feeling of sickness experienced by the subject the first days after vaccination with Influenza vaccine were possibly related to vaccination with Influenza vaccine. However, the regulatory authority reported that the fatal outcome of multiple organ failure and sepsis was unlikely due to the vaccination with Influenza vaccine. Cause of death is multiple organ failure, More information are expected.


VAERS ID: 252916 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-03-13
Entered: 2006-03-17
   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: Unevaluable event, White blood cell disorder
SMQs:, Haematopoietic leukopenia (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: Asplenia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Antibody titers, white blood cell differential.
CDC Split Type: WAES0603USA01116

Write-up: Information has been received from a published meeting abstract concerning an infant under the age of two years old (sex unknown) with asplenia who was enrolled in a post-marketing study. Thirty two patients diagnosed has having asplenia selected during the past 10 years were enrolled into the study. They were divided into two groups. Group I consisted of 12 infants aged under 2 years old, and Group II was consisted of 20 patients aged 2 years or over. On unspecified date, the infant was vaccinated with pneumococcal 23v polysaccharide vaccine, (dose and indication unknown). Concomitant medication were not reported. Antibody titers were measured by enzyme-like immunosorbent assay before and after the vaccination. Serum immunoglobulin were measured 37 times and white blood cell count (differential count of leukocytes) (WBC CD) were measured 22 times. On an unspecified date, the infant suddenly died. The cause of death was sudden death. Autopsy was not reported. At the time of the report the auctorial physician did not assess the causal relationship between the sudden death and pneumococcal 23v polysaccharide vaccine. The auctorial physician assessed that the sudden death was serious due to fatal. The article also discussed the experience of other under 2 year old infants (sex unknown) while on therapy with pneumococcus vaccine (WAES0603USA01104. Additional information has been requested. A copy of the published abstract is attached as further documentation of the patient''s experience.


VAERS ID: 252917 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-03-13
Entered: 2006-03-17
   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: Cardiac failure, Medication error
SMQs:, Cardiac failure (narrow), Cardiomyopathy (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: Unknown
Current Illness: Asplenia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknwn
CDC Split Type: WAES0603USA01114

Write-up: Information has been received from a published meeting abstract entitled "Discussion regarding phylactic ability in patients with asplenia", concerning an infant under the age of two with asplenia who was enrolled in a post marketing study. Thirty two patients diagnosed as having asplenia selected during the past 10 years were enrolled into the study. They were divided into two groups. Group I consisted of 12 infants aged under 2 years old, and Group II consisted of 20 patients aged 2 years or over. Serum immunoglobulin G.A.M and WBC differential counts were measured. The infant was vaccinated with a dose of Pneumococcal 23 polysaccharide vaccine (manufacturer unknown). An antibody was titrated by enzyme linked immunosorbent assay (result not reported) before and after the vaccination. Subsequently, the patient developed cardiac failure and died. The cause of death was cardiac failure. An autopsy was not reported. The author did not assess the causal relationship between the cardiac failure and the pneumococcal 23v polysaccharide vaccine. Additional information has been requested. this article also discussed the experienced of other under 2 year old infants (sex unknown) while on therapy with pneumococcus vaccine. A copy of the abstract article is attached. A copy of an translation will be provided, when available.


VAERS ID: 252918 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-03-13
Entered: 2006-03-17
   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: Sepsis
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Asplenia
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0603USA01113

Write-up: Information has been received from a published meeting abstract entitled Discussion regarding phylactic ability in patients with asplenia, concerning an infant under the age of two with asplenia who was enrolled in a post marketing study. Thirty two patients diagnosed as having asplenia selected during the past 10 years were enrolled into the study. They were divided into two groups. Group I consisted of 12 infants aged under 2 years old, and Group II consisted of 20 patients aged 2 years or over. Serum immunoglobulin G, A, M were measured totally 30 times and WBC differential counts were measured 22 times. In 10 of 32 patients were administered pneumococcus vaccine, and antibody titers were measured by ELISA enzyme linked immunosorbent assay before and after the vaccination. Of 12 infants in Group I, 7 infants died. One infant died of sepsis, another infant died of cardiac failure and the other 5 infants died of sudden death. Of 20 patients in group II, 10 patients died. Six patients died of cardiac failure, 3 patients died of sudden death and 1 patient died during an operation. No tendency was found in WBC CDs since the CDs were scattering. A significant increase in number of patients having high immunoglobulin was recognized in group II. Some patients who received pneumococcus vaccine showed high antibody titers more than 40 fold, but patients infants around 2 year old did not show marked increase. On an unspecified date, the infant was vaccinated with a dose of PNEUMOVAX 23 vaccine (manufacturer unknown). On an unspecified date, antibody was titrated by enzyme linked immunosorbent assay. On an unspecified date, the infant developed sepsis. Subsequently the infant died. The cause of death was sepsis. An autopsy was not reported. The author did not assess the causal relationship between sepsis and pneumococcal 23v polysaccharide vaccine. Additional information has been requested. A copy of the untranslated literature abstract article has been attached as further documentation of the patients experience. A translation of the literature abstract will be provided, when available.


VAERS ID: 252919 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-03-13
Entered: 2006-03-17
   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: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Asplenia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0603USA01107

Write-up: Information has been received from a published meeting abstract concerning an infant under the age of two years old (sex unknown) with asplenia who was enrolled in a post-marketing study. Thirty two patients diagnosed has having asplenia selected during the past 10 years were enrolled into the study. They were divided into two groups. Group I consisted of 12 infants aged under 2 years old, and Group II was consisted of 20 patients aged 2 years or over. On an unspecified date, the infant was vaccinated with PNEUMOVAX 23 vaccine, (dose and indication unknown). Concomitant medications were not reported. Antibody titers were measured by enzyme-linked immunosorbent assay before and after the vaccination. Serum immunoglobulin (GAM) were measured 37 times and white blood cell count (differential count of leukocytes) (WBC CD) were measured 22 times. On an unspecified date, the infant suddenly died. The cause of death was sudden death. Autopsy was not reported. The article also discussed the experience of other two year old infants (sex unknown) while on therapy with the PNEUMOVAX 23 vaccine (WAES0603USA01104, 0603USA01105, 0603USA01106, 0603USA01113, 0603USA01114, 0603USA01116). At the time of the report, the physician did not assess the causal relationship between the sudden death and PNEUMOVAX 23 vaccine. Additional information was requested. A copy of the untranslated published abstract is attached as further documentation of the patient''s experience. A copy of an English translation will be provided when available.


VAERS ID: 252920 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-03-13
Entered: 2006-03-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: Asplenia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0603USA01106

Write-up: Information has been received from a published meeting abstracting concerning an under 2 year old patient (sex not provided) who on an unspecified date, was vaccinated with pneumococcal 23v polysaccharide vaccine (dose not reported). Concomitant medications were not reported. On an unspecified date, the infant suddenly died. The cause of death was sudden death. Autopsy was not reported. The abstract reads as follows: "Thirty two patients diagnosed has having asplenia selected during the past 10 years were enrolled into the study. They were divided into two groups. Group I consisted of 12 infants aged under 2 years old, and Group II was consisted of 20 patients aged 2 years or over. Serum immunoglobulin G, A, M were measured totally 37 times and WBC CD (differential count of leukocytes) were measured 22 times. In 10 of 32 patients were administered pneumococcus vaccine, and antibody titers were measured with ELISA before and after the vaccination. Of 12 infants in group I, 7 infants died. One infant died of sepsis, another infant died of cardiac failure and the other 5 infants died of sudden death. Of 20 patients in group II, 10 patients died. Six patients died of cardiac failure, 3 patients died of sudden death and 1 patient died during an operation. No tendency was found in WBC CDs since the CDs were scattering. A significant increase in number of patients having high immunoglobulin was recognized in group II. Some patients who received pneumococcus vaccine showed high antibody titers (more than 40 fold), but patients/infants around 2 years old did not show marked increase." At the time of this report, the auctorial physician did not assess the causal relationship between the sudden death and pneumococcus vaccine. Additional information has been requested. The article also discussed the experience of other under 2 year old infants (sex unknown) while on therapy with pneumococcus vaccine. See WAES0603USA01106. A copy of the untranslated published abstract is attached as further documentation of the patient''s experience. A copy of the translated abstract will be provided when available.


VAERS ID: 252921 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-03-13
Entered: 2006-03-17
   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: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Asplenia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0603USA01105

Write-up: Information has been received from a published meeting abstract concerning an infant under the age of 2 with asplenia who was enrolled in a post-marketing surveillance study. Thirty two patients diagnosed has having asplenia selected during the past 10 years were enrolled into the study. They were divided into two groups. Group I consisted of 12 infants aged under 2 years old, and Group II was consisted of 20 patients aged 2 years or over. Serum immunoglobulin G, A, M were measured totally 37 times and WBC CD (differential count of leukocytes) were measured 22 times. In 10 of 32 patients were administered pneumococcus vaccine, and antibody titers were measured by ELISA before and after the vaccination. Of 12 infants in group I, 7 infants died. One infant died of sepsis, another infant died of cardiac failure, and the other 5 infants died of sudden death. Of 20 patients in group II, 10 patients died. Six patients died of cardiac failure, 3 patients died of sudden death and 1 patient died during an operation. No tendency was found in WBC CDs since the CDs were scattering. A significant increase in number of patients having high immunoglobulin was recognized in group II. Some patients who received PNEUMOVAX 23 vaccine showed high antibody titers (more than 40 fold), but patients/infants around 2 year old did not show marked increase. On an unspecified date, the infant was vaccinated with a dose of PNEUMOVAX 23 vaccine. On an unspecified date, the patient suddenly died. The cause of death was sudden death. An autopsy was not reported. The author did not assess the causal relationship between the patient''s sudden death and PNEUMOVAX 23 vaccine. Additional information has been requested. A copy of the untranslated literature abstract has been attached as further documentation of the patient''s experience. A translation of the literature abstract will be provided when available.


VAERS ID: 252922 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-03-13
Entered: 2006-03-17
   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: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Asplenia
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0603USA01104

Write-up: Information has been received from a published meeting abstract concerning an infant under the age of two years old with asplenia who was enrolled in a post-marketing surveillance study. Thirty two patients diagnosed has having asplenia selected during the past 10 years were enrolled into the study. They were divided into two groups. Group I consisted of 12 infants aged under 2 years old, and Group II was consisted of 20 patients aged 2 years or over. Serum immunoglobulin G, A, M were measured totally 37 times and WBC CD (differential count of leukocytes) were measured 22 times. In 10 of 32 patients were administered pneumococcus vaccine, and antibody titers were measured by ELISA before and after the vaccination. On 12 infants in group I, 7 infants died. One infant died of sepsis, another infant died of cardiac failure and the other 5 infants died of sudden death. Of 20 patients in group II, 10 patients died. Six patients died of cardiac failure, 3 patients died of sudden death and 1 patient died during an operation. No tendency was found in WBC CDs since the CDs were scattering. A significant increase in number of patients having high immunoglobulin was recognized in group II. Some patients who received pneumococcus vaccine showed high antibody titers (more than 40 fold), but patients/infants around 2 years old did not show marked increase. On an unspecified date, the infant was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On an unspecified date, the infant died suddenly. The cause of death was sudden death. An autopsy was not reported. The author did not assess the causal relationship between the patient''s sudden death and the pneumococcal 23v polysaccharide vaccine. Additional information has been requested. A copy of the untranslated literature abstract has been attached as further documentation of the patient''s experience. A translation of the literature abstract will be provided when available.


VAERS ID: 252923 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-03-13
Entered: 2006-03-17
   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: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Asplenia
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0603USA01095

Write-up: Information has been received regarding a study from a published abstract concerning an infant pt (age and gender not reported) with asplenia who on an unspecified date was vaccinated with pneumococcal 23v polysaccharide vaccine (manf unk). On an unspecified date, the pt died. The cause of death was death unexplained. The published abstract reads as follows: From 1993 to Jan 2002, 38 cases (boy 22, girl 14, unk 2) were diagnosed with asplenia, of which 7 cases were followed up completely. Pt''s natural history and clinical course including complication of infection and effectiveness of pneumococcus vaccine were assessed retrospectively on the basis of clinical records. Fifteen pts were vaccinated with pneumococcal 23v polysaccharide (manf, vaccination site, date and dose unk), of which after introduction of the vaccination one pt died (younger than 2 years old). The causal relationship between the unk cause of death and the pneumococcal 23v polysaccharide vaccine was not mentioned. The abstract also discussed the experience of two pt''s who experienced adverse events while on therapy with pneumococcal 23v polysaccharide vaccine. Additional information is has been requested. A copy of the published abstract is attached as further documentation of the pt''s experience.


VAERS ID: 252924 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-03-13
Entered: 2006-03-17
   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: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Asplenia
Preexisting Conditions: Asplenia
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0603USA01093

Write-up: Information has been received regarding a study from a published abstract entitled "Clinical Consideration of Asplenia Syndrome" concerning an infant patient (age and gender not reported) with Asplenia who on an unspecified date was vaccinated with PNEUMOVAX 23 vaccine (manufacturer unknown). On an unspecified date, the patient died. The cause of death was death unexplained. Information has been received regarding a study from a published abstract entitled "Clinical Consideration of Asplenia Syndrome" concerning an infant patient (age and gender not reported) with Asplenia who on an unspecified date was vaccinated with PNEUMOVAX 23 vaccine (manufacturer unknown). On an unspecified date, the patient died. The cause of death was death unexplained. The published abstract reads as follows: From 1993 to January 2002, 38 cases (boy 22, girl 14, unknown 2) were diagnosed with Asplenia, of which 7 cases were followed up completely. Patient''s natural history and clinical course including complication of infection and effectiveness of pneumococcus vaccine were assessed retrospectively on the basis of clinical records. Fifteen patients were vaccinated with PNEUM0VAX 23 (manufacturer, vaccination site, date and dose unknown), of which after introduction of the vaccination one patient died (younger than 2 years old). The causal relationship between the unknown cause of death and the PNEUMOVAX 23 vaccine was not mentioned. The abstract also discussed the experience of two patients who experienced adverse events while on therapy with PNEUMOVAX 23 vaccine (WAES#0603USA01062 and 0603USA01095). Additional information is been requested. A copy of the untranslated published abstract is attached as further documentation of the patient''s experience. A copy of an English translation will be provided when available.


VAERS ID: 252925 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-03-13
Entered: 2006-03-17
   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: Sepsis
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Uknown
Current Illness: Asplenia
Preexisting Conditions: Asplenia
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0603USA01062

Write-up: Information has been received regarding a study from a published abstract entitled "Clinical Consideration of Asplenia Syndrome" concerning an infant (age and gender not reported) with Asplenia who on an unspecified date was vaccinated with PNEUMOVAX 23 vaccine (manufacturer unknown). On an unspecified date, the patient developed sepsis. The patient died. The cause of death was sepsis. The published abstract reads as follows: From 1993 to January 2002, 38 cases (boy 22, girl 14, unknown 2) were diagnosed with Asplenia, of which 7 cases were followed up completely. Patient''s natural history and clinical course including complications of infection and effectiveness of pneumococcus vaccine were assessed retrospectively on the basis of clinical records. Fifteen patients were vaccinated with PNEUMOVAX 23 (manufacturer, vaccination site, date and dose unknown), of which six months after vaccination one case died due to sepsis. The reporter associated the causality of the sepsis as "unknown" to PNEUMOVAX 23 vaccine. The article also discussed the experience of two patients (younger than 2 years old, gender unspecified) while on therapy with PNEUMOVAX 23 vaccine (WAES0603USA01093 and WAES0603USA01095). Additional information has been requested. A copy of the untranslated published abstract is attached as further documentation of the patient''s experience. A copy of an English translation will be provided, when available.


VAERS ID: 252930 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2001-04-26
Onset:2005-08-03
   Days after vaccination:1560
Submitted: 2006-03-14
   Days after onset:223
Entered: 2006-03-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-08-08
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0603AUS00053

Write-up: Information was obtained on request by the company from the agency via public case detail form concerning an 80 year old male who on 4/26/2001 was vaccinated with Pneumococcal 23v polysaccharide vaccine. On 5/03/2005 the patient developed vaccination failure and invasive pneumococcal disease bacterium, vaccine preventable strain 19F and was hospitalized. On 8/8/2005 the patient died. The cause of death was vaccination failure and pneumococcal infection. The agency considered that vaccination failure and pneumococcal infection were possibly related to therapy with Pneumococcal 23v polysaccharide vaccine. The agency also reported that the patients outcome was unrelated death. The original reporting source was not provided. Additional information is not expected.


VAERS ID: 252938 (history)  
Form: Version 1.0  
Age: 0.42  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2006-01-01
Submitted: 2006-03-16
   Days after onset:74
Entered: 2006-03-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 3 UN / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Jan2006 - Identified Pneumococcus serotype 19A
CDC Split Type: FRWYE461913MAR06

Write-up: Follow-up information received on 13-Mar-2006 confirmed initial information received on 09-Mar-2006, except for patient''s age which was changed to 5 months, included event details leading to code an additional event but did not provide any dates. Information regarding Prevenar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 5 month old patient who experienced meningitis due to pneumococcus serotype 19A and hemodynamic shock. The patient had received a complete primo-immuization schedule on unspecified dates. Relevant medical history was not provided. Indication for Prevenar was immunization. Product was administered on an unspecified date. Dose regimen was complete primo-immuization schedule. Concomitant medications were not reported. The patient experienced meningitis due to pneumococcus serotype 19A (meningitis pneumococcal) (drug ineffective) in Jan-2006, at an unspecified time after the last Prevenar dose. The patient was hospitalized. The patient experienced hemodynamic shock (shock) and died during the hospitalization. The cause of death was reported as meningitis pneumococcal and hemodynamic shock. Laboratory test (results: identified Pneumococcus serotype 19A) was done in Jan-2006. No additional information was available at the time of this report.


VAERS ID: 253027 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2006-03-06
Onset:2006-03-07
   Days after vaccination:1
Submitted: 2006-03-20
   Days after onset:13
Entered: 2006-03-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC203008BA / UNK - / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS A72CA116B / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-03-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Diarrhea; Influenza
Allergies:
Diagnostic Lab Data:
CDC Split Type: B0414809A

Write-up: This case was reported by a physician and described the occurrence of sudden death NOS in a 4 month old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine, Haemophilus influenzae type B vaccine for prophylaxis. The subject''s medical history included hospitalization at two months of age due to diarrhea. The child was prescribed Babelac for colic, flatulence and stools loose. After that the child seemed to be healthy with a good size and weight. Shortly before vaccination, on 3/3/06, the child had slight influenza. The scheduled vaccine administration was then postponed for 3 days. The child was otherwise healthy. On 3/6/06, the subject received second dose of Infanrix (IM, unknown), second dose of Hiberix (IM, unknown). On 3/7/06, 27 hours after vaccination with Hiberix and Infanrix, the subject died. The subject died, cause of death is not specified. Post mortem results are pending.


VAERS ID: 253277 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2006-03-07
Onset:2006-03-10
   Days after vaccination:3
Submitted: 2006-03-22
   Days after onset:12
Entered: 2006-03-27
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (DTP + ACTHIB) / SANOFI PASTEUR - / UNK - / -
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-03-10
   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: UNK
Current Illness:
Preexisting Conditions: Bronchopulmonary dysplasia
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0603USA02858

Write-up: Information has been received from a health professional concerning a 10 week old female with a history of bronchopulmonary dysplasia who on 07-Mar-2006 was vaccinated with a first dose of hepatitis B virus vaccine rHBsAg (yeast) (thimerosal free) (batch number, route and site of administration were not reported). Concomitant vaccine administered on the same day included a first dose of diphtheria toxoid (+) Hib conj vaccine (tet toxoid) (+) pertussis acellular 5 component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (PEDIACEL). It was reported that the patient was found dead in her bed three days after vaccination, on 10-mar-2006. No further information was available. More information was available. More information is expected. Other business partner numbers include: E200601351 and 200600232.


VAERS ID: 253631 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2003-03-18
Onset:2005-09-16
   Days after vaccination:913
Submitted: 2006-03-31
   Days after onset:196
Entered: 2006-04-04
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-09-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0603AUS00185

Write-up: Information has been received on request by the company from the agency via a public case details from and case line listing. The patient was an 87 year old patient who was vaccinated with pneumococcal 23v polysaccharide vaccine on 3/24/1998 and on 3/18/2003. Subsequently the patient experienced vaccine failure and pneumococcal infection. Streptococcus pneumoniae serotype 9v (a vaccine preventable strain) was isolated on blood cultures collected on 9/16/2005. On 9/16/2005 the patient died. The cause of death was not reported. The agency considered that vaccine failure and pneumococcal infection were possibly related to therapy with pneumococcal 23v polysaccharide vaccine, but the patients death was unrelated. The original reporting source was not provided. Additional information is not expected.


VAERS ID: 253632 (history)  
Form: Version 1.0  
Age: 97.0  
Sex: Male  
Location: Foreign  
Vaccinated:1996-04-20
Onset:2005-09-07
   Days after vaccination:3427
Submitted: 2006-03-31
   Days after onset:205
Entered: 2006-04-04
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / IJ

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-09-07
   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: Cardiac disorder
Allergies:
Diagnostic Lab Data: 08/06/2005 Blood culture: streptococcus pneumoniae 3 isolated.
CDC Split Type: WAES0603AUS00186

Write-up: Information has been received on request by the company from the agency via a public case details from and case line listing. The patient was an elderly male who was vaccinated with Pneumococcal 23v polysaccharide vaccine on 4/20/1996 at the age of 87 years, and on 3/18/2004 st the age of 96 years. Subsequently the patient experienced vaccine failure and pneumococcal infection. Streptococcus pneumoniae 3, a vaccine preventable strain, was isolated on blood cultures collected on 8/6/2005. On 9/7/2005 the patient died at the age of 97 years. The cause of death was not reported. The agency considered the vaccine failure and pneumococcal infection were possibly related to therapy with Pneumococcal 23v polysaccharide vaccine but the patient death was unrelated. The original reporting source was not provided. Additional information is not expected.


VAERS ID: 253633 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:1999-06-06
Onset:2005-09-17
   Days after vaccination:2295
Submitted: 2006-03-31
   Days after onset:195
Entered: 2006-04-04
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / IJ

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Drug ineffective, Pneumonia
SMQs:, Lack of efficacy/effect (narrow), 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: 2005-09-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Blood culture streptococcus pneumoniae serotype 9V
CDC Split Type: WAES0603AUS00187

Write-up: Information has been received on request by the company from the agency via a public case details form and case line listing. The patient was a 73 year old male who was vaccinated with Pneumococcal 23v polysaccharide vaccine on 6/6/1999 and on 7/13/2004. Subsequently the patient experienced vaccine failure. He developed invasive pneumococcal disease manifesting as pneumonia and hospitalised. Streptococcus pneumoniae serotype 9V, a vaccine preventable strain, was isolated on blood culture. On 9/17/2005 the patient died. The cause of death was not reported. The agency considered that vaccine failure and pneumonia were possibly related to therapy with Pneumococcal 23v polysaccharide vaccine but the patients death was unrelated. The original reporting source was not provided. Additional information is not expected.


VAERS ID: 254133 (history)  
Form: Version 1.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2006-02-08
Onset:0000-00-00
Submitted: 2006-04-14
Entered: 2006-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cardiac arrest, Haemoglobin decreased, Haemolytic anaemia, Laboratory test abnormal, Platelet count decreased, Thrombocytopenia
SMQs:, Torsade de pointes/QT prolongation (broad), Haemolytic disorders (narrow), Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-03-03
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: Alfatil LP, Epoetin beta, Amlodipine besylate, Calcium carbonate, Frusemide, Bisoprolol Fumarate, Aspegic, Glycine + Lysine aspirin, Urapidil, Tranexamic acid.
Current Illness:
Preexisting Conditions: Cerebral vascular accident, Hypertension arterial, Renal failure.
Allergies:
Diagnostic Lab Data: Haptoglobin 3/1/2006 <0.07gl, Hemoglobin 2/2006 8.6g/dl, Hemoglobin 2/2006 9.5 g/dl, Hemoglobin 2/2006 decreased, Hemoglobin 2/23/2006 7.1 g/dl, Myelogram 2/23/2006 Abnormal, Plate count 2/8/2006 209000/mm3, platelet count 2/23/2006 2000/mm3, Platelet count 3/3/2006 8000/mm3. On 2/23/2006, myelogram confirmed peripheric thrombopenia.
CDC Split Type: B0419923A

Write-up: This case was reported and described the occurrence of cardiac arrest in a 810year old female subject who was vaccinated with hepatitis B vaccine (Engerix B adult) for prophylaxis. The subjects medical history included ischemic cerebral vascular accident in 2004. Concurrent medical conditions included arterial hypertension and terminal renal failure. Concurrent medications included epoetin Beta (Neorecormon), amlodipine besylate (Amlor), calcium carbonate (Calcidia), Frusemide (Lasilix), bisoprolol Fumarate (Detensiel), lysine acetylsalicylate (Aspegic), Urapidil (Eupreseyl) and tranexamic acid (Exacyl). Co suspect medication included cefaclor (Alfatil LP) At an unknown date, the subject began treatment with Neorecormon, Amlor at two units per day, Calcidia at 3 units per day, Lasilix 40 mg, Detensiel, Aspegic 250 mg and Eupreseyl. Between 1/23/2006 and 1/27/2006, the subject was treated with Alfatil LP at 1000 mg daily (unknown reason). On 2/08/2006, the subject received a 1st dose of Engerix B adult (20 mcg, intramuscular, batch number not available). On 2/8/2006, platelet was normal at 209000/mm3. At an unknown date (before or after the vaccination), in February 2006, hemoglobin count was at 8.6 and 9.5 g/dl. Myelogram was performed and confirmed peripheric thrombopenia. On 3/1/2006, haptoglobin lower than 0.07 g/l. Thus, the subject had hemolytic anemia. On 3/1/2006, the subject was hemodialysed. On 3/3/2006, platelet count was 8000/mm3. The subject was hemodialysed for the second time. During this last hemodialysis, the subject died form cardiac arrest (NOS). It was unknown whether an autopsy was performed. It was considered that the death was unrelated to the events. Causal relationship of the cardiac arrest with the vaccine and Alfatil was unspecified. It was considered the other events as dubiously related to vaccination with Engerix B and co suspect drug (Alfatil LP). No more information will be available. This case has been closed.


VAERS ID: 254203 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-04-11
Entered: 2006-04-18
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Condition aggravated, Sepsis, Spleen disorder
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Arterial bypass operation, Asplenia, Heart disease congential, Pulmonary artery atresia.
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0603USA04665

Write-up: It was reported in a published literature article, title as stated above, that a 15 year old male, with asplenia syndrome, single atrium, single ventricle, atrioventricularis communis, heart disease congenital and pulmonary artery atresia and a history of arterial bypass operation (arteria subclavia pulmonary artery shunt), who at age 12 years and 10 months old was vaccinated with a dose of pneumococcal vaccine (manufacturer unknown). Subsequently, at age 15 years and 10 months old the patient died. The cause of death was sudden death. The abstract of the article stated "Pneumococcal vaccine was inoculated to 10 congenital asplenia syndrome CAS patients ranging from 1y4m to 12y10m and the antibody titers of Immunoglobin Ig and IgG2 subclass were measured 3-4 weeks after vaccination. The patients were divided into two groups, one group A consisted of 6 cases with age 3y8m or older at inoculation, and the other group B consisted of 4 cases around 2y1m. The antibody responses were compared between the two groups. As a result, the post vaccination antibody titre of IgG2 subclass containing anti pneumococcal capsular polysaccharide was significantly lower in group B than that of group A (p<0.05), while no difference was observed for IgG1 antibody. Physiological delay in IgG2 was suspected for the low response in group B. It is reported that postsplenectomy sepsis develops within the first two years after surgery in more than 80% of children, and that splenectomy before the age of 2 is quite risky for infections. Congenital asplenia syndrome is supposed to be vulnerable to pneumococcal infection like splenectomized cases, and the prophylaxis for the infection should be accounted for them. Results indicate that pneumococcal vaccination under 2 years is ineffective as asplenia syndrome, and that other prophylactic procedures such as prophylactic antibiotics and/or intravenous Ig administration should be considered for the asplenia syndrome patient under 2 years. The reporting physician did not assess the causal relationship between the patient''s sudden death and pneumococcus vaccine. The adverse event is considered to be serious because of death. This article also discussed the experience of a 13 year and 5 month old male patient, a 11 year and 3 month old female patient, a 10 year and 3 month old male patient, and a 6 year and 7 month old male patient while on therapy with pneumococcal vaccine (manufacturer unknown) (WAES0603USA04666, WAES0603USA04700, WAES0602USA04701, AND WAES0603USA04702, respectively). Additional information has been requested. A copy of the untranslated literature article has been attached as further documentation of the patient''s experience of an English translation will be provided when available.


VAERS ID: 254204 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-04-11
Entered: 2006-04-18
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Cardiac failure, Sepsis, Spleen disorder
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Asplenia, Heart disease congenital, Pulmonary artery stenosis.
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0603USA04700

Write-up: It was reported in a published literature article, title as stated above, that a 11 year old female, with congential heart disease, asplenia syndrome, single atrium, common atrioventricular valve and univentricular heart, pulmonary artery stenosis who as age 6 years and 10 months old (date unknown) was vaccinated with a dose of pneumococcal vaccine (manufacturer unknown). Subsequently, at age 11 years and 3 months old the patient died. The cause of death cardiac failure. The abstract of the article stated Pneumococcal vaccine was inoculated to 10 congenital asplenia syndrome CAS patients ranging from 1y 4m to 12y 10m and the antibody titers of Immunoglobin Ig and IgG2 subclass were measured 3-4 weeks after vaccination. The patients were divided into two groups, one group A consisted of 6 cases with age 3y 8m or older at inoculation, and the other group B consisted of 4 cases around 2y 1m. The antibody responses were compared between the two groups. As a result, the post vaccination antibody titre of IgG2 subclass containing anti pneumococcal capsular polysaccharide was significantly lower in group B than that of group A (p<0.05), while no difference was observed for IgG1 antibody. Physiological delay in IgG2 was suspected for the low response in group B. It is reported that post splenectomy sepsis develops within the first two years after surgery in more than 80% of children, and the splenectomy before the age of 2 is quite risky for infections. Congenital asplenia syndrome is supposed to be vulnerable to pneumococcal infection like splenectomized cases, and the prophylaxis for the infection should be accounted for them. Results indicate that pneumococcal vaccination under 2 years is ineffective as asplenia syndrome, and that other prophylactic procedures such as prophylactic antibiotics and or intravenous Ig administration should be considered for the asplenia syndrome patient under 2 years. The reporting physician did not assess the causal relationship between cardiac failure and pneumococcus vaccine. The article also discussed the experience of other patients while on therapy with pneumococcal vaccine (WAES0603USA04665, WAES0603USA04666, WAES0602USA04701, And WAES0603USA04702, respectively). Additional information has been requested. A copy of the untranslated literature article has been attached as further documentation of the patients experience. A copy of the English translation will be provided when available.


VAERS ID: 254205 (history)  
Form: Version 1.0  
Age: 10.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-04-11
Entered: 2006-04-18
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 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: Unknown
Current Illness:
Preexisting Conditions: Arterial bypass operation, Asplenia, Heart disease congenital, Pulmonary artery atresia.
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0603USA04701

Write-up: It was reported in a published literature article, title as stated above, that a 10 year old male patient, with asplenia syndrome, congential heart disease, single atrium, single ventricle, atrioventricularis communis, and pulmonary artery atresia and a history of arterial bypass operation (arteria subclavia pulmonary artery shunt), who as age 5 years and 8 months old was vaccinated with a dose of pneumococcal vaccine (manufacturer unknown). Subsequently, at age 10 years and 3 months old the patient died. The cause of death was sudden death (died on Fontan surgery). The abstract of the article stated Pneumococcal vaccine was inoculated to 10 congenital asplenia syndrome CAS patients ranging from 1y 4m to 12y 10m and the antibody titers of Immunoglobin Ig and IgG2 subclass were measured 3-4 weeks after vaccination. The patients were divided into two groups, one group A consisted of 6 cases with age 3y 8m or older at inoculation, and the other group B consisted of 4 cases around 2y 1m. The antibody responses were compared between the two groups. As a result, the post vaccination antibody titre of IgG2 subclass containing anti pneumococcal capsular polysaccharide was significantly lower in group B than that of group A (p<0.05), while no difference was observed for IgG1 antibody. Physiological delay in IgG2 was suspected for the low response in group B. It is reported that post splenectomy sepsis develops within the first two years after surgery in more than 80% of children, and the splenectomy before the age of 2 is quite risky for infections. Congenital asplenia syndrome is supposed to be vulnerable to pneumococcal infection like splenectomized cases, and the prophylaxis for the infection should be accounted for them. Results indicate that pneumococcal vaccination under 2 years is ineffective as asplenia syndrome, and that other prophylactic procedures such as prophylactic antibiotics and or intravenous Ig administration should be considered for the asplenia syndrome patient under 2 years. The reporting physician did not assess the causal relationship between the patients sudden death and pneumococcus vaccine. The article also discussed the experience of other patients while on therapy with pneumococcal vaccine (WAES0603USA04665, WAES0603USA04666, WAES0602USA04700, And WAES0603USA04702, respectively). Additional information has been requested. A copy of the untranslated literature article has been attached as further documentation of the patients experience. A copy of the English translation will be provided when available.


VAERS ID: 254206 (history)  
Form: Version 1.0  
Age: 6.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-04-11
Entered: 2006-04-18
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Heart disease congenital, Pulmonary artery atresia.
Preexisting Conditions: Arterial bypass operation, Asplenia
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0603USA04702

Write-up: It was reported in a published literature article title as stated above that a 6 year old male, with asplenia syndrome, single atrium, single ventricle, atrioventricularis communis,and pulmonary artery atresia and a history of arterial bypass operation (arteria subclavia pulmonary artery shunt), who as age 3 years and 8 months old was vaccinated with a dose of pneumococcal vaccine (manufacturer unknown). Subsequently, at age 6 years and 7 months old the patient died. The cause of death was sudden death. The abstract of the article stated Pneumococcal vaccine was inoculated to 10 congenital asplenia syndrome CAS patients ranging from 1y 4m to 12y 10m and the antibody titers of Immunoglobin Ig and IgG2 subclass were measured 3-4 weeks after vaccination. The patients were divided into two groups, one group A consisted of 6 cases with age 3y 8m or older at inoculation, and the other group B consisted of 4 cases around 2y 1m. The antibody responses were compared between the two groups. As a result, the post vaccination antibody titre of IgG2 subclass containing anti pneumococcal capsular polysaccharide was significantly lower in group B than that of group A (p<0.05), while no difference was observed for IgG1 antibody. Physiological delay in IgG2 was suspected for the low response in group B. It is reported that post splenectomy sepsis develops within the first two years after surgery in more than 80% of children, and the splenectomy before the age of 2 is quite risky for infections. Congenital asplenia syndrome is supposed to be vulnerable to pneumococcal infection like splenectomized cases, and the prophylaxis for the infection should be accounted for them. Results indicate that pneumococcal vaccination under 2 years is ineffective as asplenia syndrome, and that other prophylactic procedures such as prophylactic antibiotics and or intravenous Ig administration should be considered for the asplenia syndrome patient under 2 years. The reporting physician did not assess the causal relationship between the patients sudden death and pneumococcus vaccine. The article also discussed the experience of other patients while on therapy with pneumococcal vaccine. Additional information has been requested. A copy of the untranslated literature article has been attached as further documentation of the patients experience. A copy of the English translation will be provided when available.


VAERS ID: 254207 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-04-11
Entered: 2006-04-18
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Cardiac failure, Sepsis, Spleen disorder
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Asplenia, Heart disease congenital, Univentricular heart, Pulmonary artery atresia.
Preexisting Conditions: Arterial by pass operation
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0603USA04666

Write-up: Information has been received from a published literature article concerning a 13 year 5 month old male, with asplenia syndrome, single atrium, atrioventricularis communis, a single ventricle, pulmonary artery atresia and had a history of arteria subclavia pulmonary artery shunt. On an unspecified date, at the age of 10 year 3 month, the pt was vaccinated with pneumococcus vaccine (manf unk) (dose unk). There was no information on concomitant therapy. On an unspecified date, the pt died at the age of 13 yr 5 month. The cause of death who as age 6 years and 10 months old (date unknown) was vaccinated with a dose of pneumococcal vaccine (manufacturer unknown). Subsequently, at age 11 years and 3 months old the patient died. The cause of death was cardiac failure. The abstract of the article stated Pneumococcal vaccine was inoculated to 10 congenital asplenia syndrome CAS patients ranging from 1y4m to 12y10m and the antibody titers of Immunoglobin (Ig) and IgG2 subclass were measured 3-4 weeks after vaccination. The patients were divided into two groups, one group A consisted of 6 cases with age 3y8m or older at inoculation, and the other group B consisted of 4 cases around 2y1m. The antibody responses were compared between the two groups. As a result, the post vaccination antibody titre of IgG2 subclass containing anti pneumococcal capsular polysaccharide was significantly lower in group B than that of group A (p<0.05). Physiological delay in IgG2 production was suspected for the low response in group B while no difference was observed for IgG1 antibody. It was reported that postsplenectomy sepsis develops within the first two years after surgery in more than 80% of children and that splenectomy before the age of 2 yrs is quite risky for infections. Congenital asplenia syndrome is supposed to be vulnerable to pneumococcal infection like splenectomized cases, and the prophylaxis for the infection should be accounted for them. Results indicate that pneumococcal vaccination under 2 years is ineffective as asplenia syndrome, and that other prophylactic procedures such as prophylactic antibiotics and/or intravenous Ig administration should be considered for the asplenia syndrome patient under 2 years. The reporting physician did not assess the causal relationship between cardiac failure and pneumococcus vaccine. The article also discussed the experience of other patients while on therapy with pneumococcal vaccine (WAES0603USA04665, WAES0603USA04700, WAES0602USA04701,WAES0603USA04702). Additional information has been requested. A copy of the untranslated literature article has been attached as further documentation of the patient''s experience. A copy of the English translation will be provided when available.


VAERS ID: 254412 (history)  
Form: Version 1.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2006-04-10
Onset:2006-04-10
   Days after vaccination:0
Submitted: 2006-04-21
   Days after onset:11
Entered: 2006-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB196AC / UNK UN / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-04-10
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: D0049449A

Write-up: This case was reported by a physician and described the occurrence of death at present cause unknown in an approximately 56 year old female subject who was vaccinated with hepatitis B vaccine (Engerix B adult) for occupational medical prophylaxis. The subjects medical history was normal. The subject was known by the physician since three years. All previous vaccinations with not further specified vaccines have been well tolerated. On 4/10/2006 the subject received an unspecified dose of Engerix B adult 1 ml, unknown. Immediately post vaccination, neither cardiovascular disorder nor an anaphylactic reaction have been observed. On the same day post vaccination with Engerix B adult, on 4/10/2006, the subject suddenly and unexpectedly died from an unknown cause (death at present cause unknown). An autopsy was performed, but the results of autopsy were unknown to the physician. The physician was not informed about the cause of death. The reporting physician verbally considered that the event was unrelated to vaccination with Engerix B adult. The physician also reported that the relatives of the subject considered that the event was related to vaccination with Engerix B adult. Follow up information has been requested.


VAERS ID: 254444 (history)  
Form: Version 1.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-04-19
Entered: 2006-04-24
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arthritis, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arthritis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Unknown
Current Illness:
Preexisting Conditions: General symptoms
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0604USA02421

Write-up: Information has been received from an interview card of a physician concerning a 90 year old female who on an unspecified date in 2005 was vaccinated with PNEUMOVAX 23 vaccine. Concurrent diseases and past medical history were reported to be unknown. No information on concomitant medication was reported. In 2005, 12 days after vaccination of PNEUMOVAX 23 vaccine, the patient complained of pain and arthrocentesis was performed. Subsequently, the patient was hospitalized due to fever resulting from the other cause, not left sided gonarthritis. This was reported as conflicting information since the narrative section of the interview card, the reporting physician commented as above but on the adverse event section the physician marked seriousness due to hospitalization of left sided gonarthritis. The action taken with regard to PNEUMOVAX 23 vaccine was not applicable. It was reported that after a while, the patient died of unspecified concurrent disease. The outcome of left-sided gonarthritis was unknown. Date of death, cause of death, and information on autopsy were not reported. The reporting physician felt that the left-sided gonarthritis was possibly related to PNEUMOVAX 23 vaccine. Left-sided gonarthritis was considered to be serious due to hospitalization. The patient''s concurrent disease, cause of fever, date of death, cause of death, and autopsy were under follow up. The reporter commented that the patient died of underlying disease and the death could not result from PNEUMOVAX 23 vaccine.


VAERS ID: 255427 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-05-09
Entered: 2006-05-15
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEA: MEASLES (ATTENUVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Aspiration, Atelectasis, Atrial septal defect, Bronchospasm, Convulsion, Disseminated intravascular coagulation, Faecal incontinence, Guillain-Barre syndrome, Heart rate increased, Hypertension, Hypoxia, Pneumonia, Sepsis
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Congenital, familial and genetic disorders (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Demyelination (narrow), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: Blood pressure measurement 85/90 mmHg hypertension, echocardiography atrial septal defect, Maximum ventricular rate 140.
CDC Split Type: WAES0605BRA00006

Write-up: Information has been received from a physician, author of literature, concerning a 4 year old male who was vaccinated with measles virus vaccine live. After one year of measles vaccination, Guillain Barre syndrome was diagnosed. Patient was hospitalized for 9 months due to repetition bronchopneumonia, bronchospasms, and atelectasis. The idea was to perform gastrostomy with anti reflux valve placement under general anesthesia to decrease broncho aspiration episodes. At preanesthesic evaluation, patient was admitted to ICU, with tracheostomy and under mechanical ventilation in SIMV with PEEPof 5 cmH2O, support pressure of 15cm H2O and 12F nasogastric tube. At physical evaluation patient was hypertensive, with mean blood pressure of 85/90 mmHg, tachycardic with heart rate around 140bpm, and Echocardiography revealing atrial septal defect. There were also lack of sphincter control and seizures. Patient was under alactone, furosemide, nifedipine, captopril, vancomicin and meropenen. Patient was premedicated with intravenous midazolam 3mg. Patient reffered to the operation room with transport ventilator and was monitored with cardioscopy, pulse oximetry and noninvasive blood pressure, being transferred to the anesthesia machine under mechanical ventilation with tidal volume of 200 ml, PEEP 5 cmH2O, O2 40%, compressed air and sevoflurane maintaining expired concentration between 3% and 4%. Procedure lasted 2 hours, without intercurrence being patient referred to the Pediatric ICU. Patient died on the 60th post operative day due to sepsis and disseminated intravascular coagulation. The cause of death was sepsis and disseminated intravascular coagulation. According to the authors of the literature article vaccines are commonly associated to adverse effects, among them, autoimmune disease. The reporter felt that Guillain-Barre syndrome was related to therapy with measles virus vaccine live. No further information is available. A copy of the published article is attached as further documentation of the patients experiences.


VAERS ID: 255574 (history)  
Form: Version 1.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-05-15
Entered: 2006-05-17
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Fatigue, Headache, Myalgia, Ocular hyperaemia, Pneumonia, Pyrexia, Respiratory disorder, Vaccine positive rechallenge
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Glaucoma (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (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:
Current Illness:
Preexisting Conditions: The pt had a previous history of having a febrile reaction to influenza vaccine. No further information was provided.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200601078

Write-up: Initial report from 01Nov05 received on 09May06. A 72 yr old male pt with previous history of a febrile reaction to influenza vaccination developed red eyes, respiratory symptoms, fever, headache, fatigue and myalgia 12 hrs after receiving the influenza vaccine. The products trade name, manf, lot number, route, site and date of administration was not reported. Per reporter, the pt did not seek medical attention. He remained febrile for eight days and was diagnosed with pneumonia. The pt died 54 days post vaccination due to complications despite medical care. There was insufficient evidence to determine a causal association. Same reporter in case 200601079.


VAERS ID: 255575 (history)  
Form: Version 1.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-05-15
Entered: 2006-05-17
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Dyspnoea, Eye irritation, Pharyngolaryngeal pain, Rhinitis
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Corneal disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200601079

Write-up: Initial report from 01Nov05 received on 09May06. A 66 yr old male pt developed eye irritation, sore throat, rhinitis and difficulty breathing within one day after receiving the influenza vaccine. The product''s trade name, manf, lot number, route, site and date of administration not reported. Per reporter, the pt died suddenly eight days later. There was insufficient evidence to determine a causal association.


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