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VAERS ID: 256005 (history)  
Form: Version 1.0  
Age: 1.58  
Sex: Male  
Location: Foreign  
Vaccinated:2006-04-28
Onset:2006-04-29
   Days after vaccination:1
Submitted: 2006-05-19
   Days after onset:20
Entered: 2006-05-22
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CA193B / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 19042 / UNK LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Nasopharyngitis, Pyrexia, Somnolence, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-05-06
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Infection; birth weight 3kg
Allergies:
Diagnostic Lab Data: Apgar score results 1 min:5, 5 min:7, 10 min:9, was done on 9/28/2004. Body temperature results up to 38C was done on 4/29/2006.
CDC Split Type: DEWYE620615MAY06

Write-up: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional via a regulatory authority regarding a 19 month old male patient who experienced body temperature increased and cold and was found dead. The patient received a dose on 4/28/2006. The patient has a past history of infection (recurrent indication for vaccination). He was bon by elective cesarean section in 41st gestational week after uneventful pregnancy (birth weight 3kg, height 52cm). At time of event the patients sister had a diagnosis of viral infection and a close family friend had an EBV infection. There is a family history of atopic dermatitis and fulminant pollinosis. Indication for Prevnar was immunisation. Product was administered on 4/28/2006. Dose regimen was 1 dose intramuscular. Additional suspect medication included Infanrix Hexa (diphtheria vaccine/tetanus vaccine/acellular pertussis vaccine/polio virus inactivated/haemophilus influenzae B/hepatitis B vaccine) which was administered on 4/28/2006 as well. Previous vaccinations with Infanrix Hexa were tolerated well. Concomitant medications were not reported. The patient experienced body temperature increased on 4/29/2006 and recovered on the next day. The mother reported that on 05/05/2006 the patient had a cold (nasopharyngitis) and slept more than usual. The patient was found dead (death) with vomit in his mouth lying in bed on 5/6/2006. The reporting physician requested an autopsy which was declined by the forensic physician because he did not see a reason for an autopsy. Apgar score results 1 min:5, 5 min:7, 10 min:9, was done on 9/28/2004. Body temperature results up to 38C was done on 4/29/2006. The cause of death was not reported.


VAERS ID: 256716 (history)  
Form: Version 1.0  
Age: 1.75  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-05-25
Entered: 2006-05-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, 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? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRWYE649624MAY06

Write-up: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 21 month old female pt who experienced pneumococcal meningitis. The pt would have received a complete primary immunization series. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The pt developed pneumococcal meningitis in May 2006 and had been hospitalized at the most for one day when she died during the night from 14 to 15May06. It was specified that the pt had received a complete primary immunization series with Prevnar in due time, however dates were not reported. It was unk whether the pt had received the booster dose of Prevnar. Pneumococcus serotype was not reported, however it was reportedly a serotype contained in the vaccine. The cause of death was reported as pneumococcal meningitis. No additional information was available at the time of this report.


VAERS ID: 257084 (history)  
Form: Version 1.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2005-11-07
Onset:2005-11-14
   Days after vaccination:7
Submitted: 2006-05-31
   Days after onset:197
Entered: 2006-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Encephalitis
SMQs:, Noninfectious encephalitis (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: 2005-12-02
   Days after onset: 18
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: B0425016A

Write-up: This case was reported by the regulatory authority and described the occurrence of encephalitis in a 56 yr old female subject who was vaccinated with influenza virus vaccine (manf unspecified) for prophylaxis. On 7Nov05 the subject received unspecified dose of influenza vaccine. On 14Nov05, 7 days after vaccination with Influenza vaccine, the subject experienced encephalitis. The subject died on 02Dec05, cause of death was not reported. An autopsy was performed and showed encephalitis. Verbatim text received: Autopsy showed autoimmune non herpetic acute limbic encephalitis following influenza vaccination. The reporter considered the reaction to be serious for the following reason: pt died due to reaction.


VAERS ID: 257095 (history)  
Form: Version 1.0  
Age: 0.24  
Sex: Male  
Location: Foreign  
Vaccinated:2006-05-15
Onset:2006-05-16
   Days after vaccination:1
Submitted: 2006-05-31
   Days after onset:15
Entered: 2006-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (TRITANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / -
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-05-16
   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: Ampicillin Trihydrate, Gentamicin sulphate
Current Illness: Premature birth
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: B0425452A

Write-up: This case was reported by a physician and described the occurrence of sudden infant death syndrome in a 3 month old male subject who was vaccinated with combined diphtheria, tetanus, whole cell pertussis and hep B vaccine (Tritanrix HB) for prophylaxis. Concurrent medical conditions included premature birth at a gestational age of 30 wks. Birth weight was 1200g. At birth, the baby had jaundice and mild respiratory distress syndrome. He was put on oxygen for 3 days and in incubator for 5 days. He had 1-2 peaks of fever and was treated with antibiotics (ampicillin and gentamycin) for 10 days. He was discharged with a weight of 1800g. After discharge, he was noted to be active and healthy. He was also eating well. Previous and/or concurrent vaccination included live attenuated oral poliomyelitis vaccine (manf unspecified oral) given on 15May06. On 15May06 the subject received 1st dose of Tritanrix HB (unk lot number not provided). The same day, less than one day after vaccination, he developed mild fever. On 16May06, at around 3-4MA, he had irritable crying and fell asleep at 4:45AM. At 6AM he was found dead by his mother. The physician considered the events were unrelated to vaccination with Tritanrix HB. The subject died on 16May06 cause of death was not reported. An autopsy was not performed.


VAERS ID: 257675 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2006-03-22
Onset:2006-03-22
   Days after vaccination:0
Submitted: 2006-06-01
   Days after onset:70
Entered: 2006-06-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal distension, Cardiac arrest, Condition aggravated, Enterocolitis, Hypoxia, Respiratory arrest, Shock, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Arrhythmia related investigations, signs and symptoms (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), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (broad), Respiratory failure (narrow), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2006-03-22
   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: Enterocolitis, inguinal hernia, premature baby
Preexisting Conditions: Enterocolitis, inguinal hernia, premature baby (26 to 32 weeks), birth weight 950g
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRWYE659829MAY06

Write-up: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional via regulatory authority regarding a 2 month old male pt who experienced vomiting, abdominal distension, haemodynamic shock, then died due to cardio respiratory arrest and probable fulminant enterocolitis. The pt received a dose on 22Mar06. The pt''s concurrent illnesses include premature baby (born at 26 wks of gestation + 6 days), enterocolitis grade I since Day 21 of life and inguinal hernia for which surgery was planned. Indication for Prevnar was immunization. Product was administered on 22Mar06 at 12:30. Dose regimen was 1 dose 1 time per day (IM). Additional suspect medication included Infanrix quinta (diphtheria/tetanus/acellular pertussis/poliomyelitis/haemophilus influenza vaccine). Concomitant medications were not reported. On 22Mar06 at 15:40 the pt suddenly experienced vomiting, abdominal distension and haemodynamic shock. Despite a treatment including intubation, ventilation and vascular loading, haemodynamics remained unstable. The events were considered to be life-threatening. A few hours later the pt died due to cardio respiratory arrest and probable fulminant enterocolitis. No additional information was available at the time of this report.


VAERS ID: 258142 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Male  
Location: Foreign  
Vaccinated:2006-04-01
Onset:2006-04-01
   Days after vaccination:0
Submitted: 2006-06-05
   Days after onset:64
Entered: 2006-06-08
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Congenital anomaly, Immune system disorder, Infection
SMQs:, Congenital, familial and genetic 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: Unknown
Current Illness:
Preexisting Conditions: Immunodeficiency congenital
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0605TWN00016

Write-up: Information has been received from an agency concerning a 12 month old male with immunodeficiency congenital who in Apr 2006, was vaccinated with VARIVAX vaccine live. Subsequently in Apr 2006 the pt developed generalized varicella. In May 2006, the pt died. The cause of death was immunodeficiency congenital and varicella. The reporter felt that generalized varicella and immunodeficiency congenital were related to therapy with VARIVAX vaccine live. No further information is available.


VAERS ID: 258143 (history)  
Form: Version 1.0  
Age: 0.13  
Sex: Female  
Location: Foreign  
Vaccinated:2006-05-15
Onset:2006-05-16
   Days after vaccination:1
Submitted: 2006-06-07
   Days after onset:22
Entered: 2006-06-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (TRITANRIX) / GLAXOSMITHKLINE BIOLOGICALS AT15B113AL / UNK UN / UN
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS A72CA156A / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Crying, Dyspnoea, Pain, Screaming, Sudden infant death syndrome
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-05-16
   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:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0426339A

Write-up: This case was reported by a physician and described the occurrence of sudden death in a 50 day old female subject who was vaccinated with Tritanrix Hep B (GlaxoSmithKline), Hiberix. On 15May06 the subject received unspecified dose of Tritanrix Hep B (unk), unspecified dose of Hiberix (unk). On 15May06, less than one day after vaccination with Hiberix and Tritanrix, the subject experienced pain and cried. In the evening the subject cried excessively. On 16May06 at 10:30 the subject was gasping and brought to the hospital where the subject died. The subject died on 16May06, cause of death was not reported. It was unk whether an autopsy was performed.


VAERS ID: 258509 (history)  
Form: Version 1.0  
Age: 0.62  
Sex: Female  
Location: Foreign  
Vaccinated:2006-03-30
Onset:2006-03-30
   Days after vaccination:0
Submitted: 2006-06-15
   Days after onset:76
Entered: 2006-06-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 1 - / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 18856 / 2 LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Lung disorder, Neonatal respiratory distress syndrome, 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), Neonatal disorders (narrow), 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: 2006-04-12
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 14 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: Bronchopulmonary dysplasia
Preexisting Conditions: Neonatal respiratory distress syndrome; Premature baby
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEWYE696807JUN06

Write-up: Information regarding Prevnar was received from a healthcare professional via a regulatory authority regarding a 7 month old female patient who experienced febrile infection with high fever and worsening respiratory insufficiency and died. The patient received the second dose on 3/30/06. The patient''s concurrent illness includes bronchopulmonary dysplasia with a past history of premature baby and neonatal respiratory distress syndrome. Indication for Prevnar was immunization. Product was administered on 3/30/06. Dose regimen was 1 dose (IM). Additional suspect medication included Infanrix Hexa which was administered on 3/30/06. The first dose of both vaccines had been tolerated well in the past. Concomitant medications were not reported. The patient experienced febrile infection with high fever starting directly after vaccination on 3/30/06. Furthermore she experienced worsening respiratory insufficiency and was hospitalized. After 14 days in hospital she died. The cause of death was reported as neonatal respiratory distress syndrome.


VAERS ID: 258510 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-06-15
Entered: 2006-06-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRWYE97707JUN06

Write-up: Information regarding Prevnar was received from a healthcare professional regarding a 7 month old female patient who experienced sudden infant death syndrome. The patient received a dose in 2006. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered in 2006. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The patient experienced sudden infant death syndrome in 2006, 4 days after having received a dose of Prevnar. The cause of death was reported as Sudden Infant Death Syndrome and the autopsy cause of death was Sudden infant death syndrome. No additional information was available at the time of this report.


VAERS ID: 258863 (history)  
Form: Version 1.0  
Age: 1.4  
Sex: Male  
Location: Foreign  
Vaccinated:2006-01-01
Onset:2006-01-11
   Days after vaccination:10
Submitted: 2006-06-23
   Days after onset:162
Entered: 2006-06-27
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anorexia, Eye discharge, Irritability, Malaise, Ocular hyperaemia, Otitis media, Pharyngolaryngeal pain, Pyrexia, Rash, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Glaucoma (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: High temperature; Convulsion
Allergies:
Diagnostic Lab Data: Body temperature: high temperature.
CDC Split Type: WAES0606USA03058

Write-up: It was reported by a journalist and in an national and regional newspaper articles that a 17 month old male patient, who was due to have his first MMR vaccination in September 2005, which was delayed after the patient developed a high temperature, taken to the doctor, and experienced a convulsion in the surgery. The patient was given antibiotics by the doctor and recovered. In January 2006, the patient was vaccinated with a dose of MMR. Approximately 10 days post vaccination, the patient died. At the time of death the patient had signs of a viral infection described by the reporter as a runny nose, cough, and diarrhea. Follow up information indicated that, on an unreported date, the patient experienced a high temperature, spots, loss of appetite, was feeling unwell, a possible sore throat, irritability, an inner ear infection, and red sticky eyes. Vomiting was noted. Ten days post vaccination, in January 2006, the patient was found dead in his cot. It was reported that cot death was ruled out as the patient was over one year of age. The patient was reportedly a healthy toddler at the time of death. The patient''s reaction was considered to be an other important medical event by the reporter. Other business partner numbers include E200603051.


VAERS ID: 258864 (history)  
Form: Version 1.0  
Age: 1.4  
Sex: Female  
Location: Foreign  
Vaccinated:2006-05-01
Onset:2006-05-11
   Days after vaccination:10
Submitted: 2006-06-23
   Days after onset:43
Entered: 2006-06-27
   Days after submission:4
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: Anorexia, Asthenia, Convulsion, Cough, Diarrhoea, Pyrexia, Rhinorrhoea, Skin discolouration, Viral infection
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0606USA03059

Write-up: It was reported by a journalist and in national and regional newspaper articles that a 17 month old female patient on an unreported date was vaccinated with a dose of MMR. Subsequently, 10 days post vaccination, the patient died. At the time of death, the patient had signs of a viral infection described by the reporter as a runny nose, cough, and diarrhea. The cause of death was not reported. Additional information reported that the patient had been exposed to an outbreak of chickenpox in her home village just before her vaccination in approximately May 2006 and had experienced a runny nose. Six days after receiving the MMR vaccine the patient came out in purple spots on her body, lost her appetite, had a high temperature, and lost her energy. In May 2006, nine days post vaccination (previously reported as 10 days post vaccination) the patient was found dead in her cot by her mother who had slept next to the cot. It was reported that she had been fit and well until then. It was reported that cot death was ruled out as the patient was over a year of age and blood was found on the patient''s lips suggested that she had an epileptic type seizure just before death. The patient''s parents considered is possible that their daughter had died as a result of a catastrophic reaction to the vaccine. The reporter considered the events to be other important medical events. Other business partner numbers include E200603055. No further information was provided.


VAERS ID: 259047 (history)  
Form: Version 1.0  
Age: 0.43  
Sex: Male  
Location: Foreign  
Vaccinated:2006-03-16
Onset:2006-06-03
   Days after vaccination:79
Submitted: 2006-06-29
   Days after onset:26
Entered: 2006-06-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CA157C / 2 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 19079 / 2 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-06-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: D-Fluoretten (cholesterol/colecalciferol/sodium fluoride), UNK, UNK, efobacin (Gentamicin sulfate), UNK, UNK
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEWYE768122JUN06

Write-up: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a pediatrician in a post marketing surveillance study regarding a 7 month old male participant who experienced sudden infant death syndrome. The participant received the second dose on 16Mar06. The pt''s parents possibly are smokers. Indication for Prevnar was immunization. Product was administered on 16Mar06. Dose regimen was 1 dose (IM). The third dose of both vaccines had been due for admin on 24Apr06. Due to an acute illness at that time the pt was not vaccinated. Concomitant vaccination included Infanrix Hexa (diphtheria vaccine/tetanus vaccine/acellular pertussis vaccine/polio virus inactivated/haemophilus influenzae b/hep B vaccine) which was administered on 16Mar06. Further concomitant medication included D-Fluoretten tablets (cholesterol/colecalciferol/sodium fluoride) and Refobacin eye drops (gentamicin sulfate). The pt experienced sudden infant death syndrome on 03Jun06. The pediatrician reported that she had not seen the pt since Apr06 when the third dose of both vaccines had been due for administration. Information about the pt''s death was forwarded to the pediatrician by a friend of the subject''s family. The pediatrician has not yet received any further confirmation concerning the pt''s death. According to the information provided the pt was found dead in his bed by the 8 yr older sister in the morning of 03Jun06. At the time of report the pediatrician had not yet contacted the pt''s parents. She will contact the hospital to see if any confirmatory information is available. The cause of death was reported as sudden infant death syndrome. The pediatrician considered sudden infant death syndrome definitely not related to Prevnar or Infanrix hexa. No additional information was available at the time of this report.


VAERS ID: 259409 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2004-11-16
Onset:0000-00-00
Submitted: 2006-07-07
Entered: 2006-07-12
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood creatinine increased, Nephritis, Renal failure acute, Renal failure chronic
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-05-01
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: Renal failure chronic
Preexisting Conditions: Renal failure chronic
Allergies:
Diagnostic Lab Data: serum creatinine ??Sep04 1.5 mg/dL; serum creatinine ??Nov05 2.2 mg/dL; serum creatinine 30Mar06 5.3 mg/dL
CDC Split Type: WAES0607USA00147

Write-up: Information has been received from a physician concerning an 87 year old male with chronic renal failure who on 16-NOV-2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included unknown drug(s). Subsequently, on an unknown date, the patient was brought from a hospital to the reporting physician''s hospital with accelerated nephritis. In May 2006, the patient could not undergo dialysis and died of acute renal failure. It was unknown if an autopsy was performed. The reporting physician felt that the patient''s acute renal failure was not related to pneumococcal 23v polysaccharide vaccine. The reporter further commented that he felt that the patient with renal disease died of renal disease and that he considered the adverse event as not related to vaccination with pneumococcal 23v polysaccharide vaccine. No further information is available.


VAERS ID: 261358 (history)  
Form: Version 1.0  
Age: 0.22  
Sex: Female  
Location: Foreign  
Vaccinated:2006-07-10
Onset:2006-07-23
   Days after vaccination:13
Submitted: 2006-07-28
   Days after onset:5
Entered: 2006-08-10
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 2 UN / IM

Administered by: Public       Purchased by: Public
Symptoms: Agitation, Apnoea, Bacterial infection, Blood alkaline phosphatase increased, Cough, Crying, Hypoxia, Laboratory test abnormal, Nasal congestion, Platelet count increased, Pneumonia, Rash, Wheezing, White blood cell count decreased
SMQs:, Liver related investigations, signs and symptoms (broad), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Haematopoietic leukopenia (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (narrow), Biliary system related investigations, signs and symptoms (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-07-23
   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: 1% hydrocortisone cream, Cotrimoxazole, Vidaylin syrup, Ferro drops, Aqueous cream, Salex, Mycostatin cream
Current Illness: 6/12/06 Prevnar vaccination HIV Infection Axillary and neck lymphadenopathy, Atopic dermatitis face, Congested nasal passage, hepatomegaly, 7/10/06 Prevnar vaccination HIV infection axillary and neck lymphadenopathy, atopic dermatitis, candida diaper rash, slight respiratory wheezing without distress.
Preexisting Conditions: HIV infection birth, Axillary lymphadenopathy, hepatomegaly.
Allergies:
Diagnostic Lab Data: 5/30/06 CD4% 36.8%, CD4 abs cells/mm3 2900 (norm 500-2010), CD8% 39.9%, CD8 abs cells/mm3 3144 (norm 250-990), WBC cells/mm3 15.1 (Norm 5.0-19.5), Hgb g/dl 10.7 (Norm 10.2-18.2), Neut % 30.2%, Neut abs (cells/mm3) 4.26 (Norm 1.2-8.0) Platelets 571 (norm 140-350), ALT 49 (3-54), AST 53 (13-64), Alk Phos 349 (119-304), Cholesterol 2.6 (3-5), Viral load $g750,000 copies ml, 6/12/06, CD4% 30.7%, CD4 abs cells/mm3 22.0 (norm 500-2010), CD8% 46.8%, CD8 abs cells/mm3 3357 (norm 250-990), WBC cells/mm3 17.0 (Norm 5.0-19.5), Hgb g/dl 10.2 (Norm 10.2-18.2), Neut % 34%, Neut abs (cells/mm3) 5.78 (Norm 1.2-8.0) Platelets 555 (norm 140-350), ALT 21 (3-54), AST 32 (13-64), Alk Phos , Cholesterol, 06/26/06 CD4%, CD4 abs cells/mm3 , CD8%, CD8 abs cells/mm3, WBC cells/mm3 21.72 (Norm 5.0-19.5), Hgb g/dl 10.4 (Norm 10.2-18.2), Neut % 37.8%, Neut abs (cells/mm3) 8.21 (Norm 1.2-8.0) Platelets 543 (norm 140-350), ALT , AST , Alk Phos, Cholesterol 07/10/2006 CD4% 38.9%, CD4 abs cells/mm3 2734 (norm 500-2010), CD8% 39.8%, CD8 abs cells/mm3 2797 (norm 250-990), WBC cells/mm3 12 (Norm 5.0-19.5), Hgb g/dl 9.6 (Norm 10.2-18.2), Neut % 29%, Neut abs (cells/mm3) 3.48 (Norm 1.2-8.0) Platelets 555 (norm 140-350), ALT 17 (3-54), AST 32 (13-64), Alk Phos , Cholesterol, Pneumocystis Carinii pneumonia negative, Cytomegalovirus negative, Respiratory syncytial virus negative, Adenovirus negative.
CDC Split Type:

Write-up: The subject was a 94 day old, HIV infected female who was enrolled in a study on 6/12/06 and expired on 7/23/06. The subject was vaccinated with Prevnar on 6/12/06 and 7/10/06, and had not begun taking antiretroviral treatment. On 4/21/06 the subjects mother had a normal vaginal delivery. The birth weight of the subject was 2940 grams and the Apgar scores were 8 and 9. No post natal complications were noted. By 5/30/06 the subject had developed a 10 day history of coughing and an 8 day history of skin rash. A physical examination revealed a liver edge 1cm below the costal margin and lungs were clear without respiratory distress. On 5/30/06 her vital signs were pulse 136, respiratory rate 35, temperature 36.6C, weight 4.63 kg, and height 55cm. Her pulse oxygen saturation level was 96%. By 6/12/06 the subjects coughing had resolved, but her skin rash had worsened. Her vitals were P 136, RR 45, T 36.8C, weight 4.89 and height 56.5cm. The pulse oxygen saturation level of 90%. A respiratory exam revealed diffuse wheezing bilaterally. Nebulizer treatments were given and the subject oxygen sat level improved to 97%. A chest x ray revealed right upper lob consolidation and a diagnosis of right upper lobe pneumonia was made. Her vital signs were P165, RR 65, T 36.9C, weight 5.07kg, and height 57.5cm. The subject was treated with Augmentin and Amoxil. By 7/10/06 the subjects coughing had resolved and the skin rash had improved, but she had congested nasal passages and was being treated for a candida diaper rash. Her vital signs P 144 RR 45 T 36.4C weight 5.75kg and height 58.2cm. On 7/23/06 at 4:00am, the subjects mother noticed that the subject was crying excessively and tried to give her formula which the subject was able to drink. At 7:30am, the mother went to check on the subject and found her not breathing. She was pronounced dead at the hospital the same day and the family refused a post mortem. According to the subjects mother the infant was completely asymptomatic prior to death, apart from the excessive crying. The cause of death is unknown. The subject was also co enrolled in another study but had not started treatment with antiretroviral. Assessment of Relationship: Principal investigator: Probably not related to Prevnar. DAIDS medical officer: probably not related, but cannot rule out relationship to Prevnar, given that the event occurred within a two week window from the administration of the vaccine. The information available is insufficient to conclusively exclude a relationship to the vaccine.


VAERS ID: 261380 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2006-06-27
Onset:2006-06-28
   Days after vaccination:1
Submitted: 2006-08-10
   Days after onset:43
Entered: 2006-08-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 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: 2006-06-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Neonatal Jaundice, Premature baby 26 to 32 weeks
Allergies:
Diagnostic Lab Data:
CDC Split Type: B0433397A

Write-up: This case was reported by a healthcare professional and described the occurrence of sudden unexpected death in infancy in a 2 month old male subject who was vaccinated with combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and haemophilus influenza b vaccine (DTPa-IPV-Hib, manufacturer unspecified) for prophylaxis. The subjects medical history included neonatal jaundice. Concurrent medical conditions included premature baby 28 weeks weighting 715 gr. The subject left pediatric service healthy on further ways. Before being vaccinated the subject was health and quick. On 6/27/06 the subject received 1st dose of Dtpa IVP Hib unknown. On 6/28/06, 1 day after vaccination with DTPa IPV Hib, the subject died, cause of death is not specified.


VAERS ID: 261461 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2006-06-15
Onset:2006-06-27
   Days after vaccination:12
Submitted: 2006-08-14
   Days after onset:48
Entered: 2006-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS - / 4 UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Depressed level of consciousness, Guillain-Barre syndrome, Paralysis, Paraplegia, Phobia
SMQs:, Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-06-28
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Globulin V (immunoglobulin Human normal
Current Illness:
Preexisting Conditions: Bitten by a dog on leg
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20060616

Write-up: A 4 yr old child was bitten by a dog on 01Jun06 into the leg. A schedule with Rapibur was started. The first dose was given on 01Jun06 and the three further doses as per schedule. Pt did not receive HRIG. On 27Jun06 the child developed acute paraplegia and was considered to be clinically suffering from GBS and was treated accordingly with iv globulin. The child progressed to altered sensorium, aerophobia and acute paralysis and was referred to tertiary hospital. The pt expired on 28Jun06.


VAERS ID: 261462 (history)  
Form: Version 1.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2005-10-31
Onset:0000-00-00
Submitted: 2006-08-14
Entered: 2006-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Back pain, Phobia
SMQs:, Retroperitoneal fibrosis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-12-08
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: Equirab
Current Illness:
Preexisting Conditions: Rabid dog bite
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20060617

Write-up: A 60 yr old male pt was bitten by a rapid dog on 29Sep05. He received his first dose of Rabipur at clinic with proper wound management on 01Oct05. On 02Oct05 he was administered immunoglobulin Equirab. Additional vaccinations IM with Rapibur (batch no 1130) on 4, 8, 15, and 31Oct05. It was reported that the pt developed hydrophobia for one day and backache for 4 days. The pt was admitted to hospital on 06Dec05 at 11:15am. The pt expired on 08Dec05 at 10:40am.


VAERS ID: 261799 (history)  
Form: Version 1.0  
Age: 1.5  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-08-17
Entered: 2006-08-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Drug ineffective, Lobar pneumonia, Multi-organ failure, Otitis media, Pleural effusion, Respiratory distress, Tonsillitis
SMQs:, Anaphylactic reaction (broad), Agranulocytosis (broad), Lack of efficacy/effect (narrow), Systemic lupus erythematosus (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), Oropharyngeal infections (narrow), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-08-04
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: Culture pleural fluid 8/4/06 positive for pneumococcus no serotype provided.
CDC Split Type: HQWYE378111AUG06

Write-up: This case was considered medically important (OMIC). Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) and received from a Pediatrician regarding an 18 month old male pt who received a dose of an unspecified date and experienced otitis media, tonsillitis, drug ineffective, pleural effusion and pneumonia due to pneumococcus. The pt died on 8/4/06. Relevant medical history was not provided. On an unspecified date, the pt received a dose of Prevnar. On unspecified date in 2006, the pt developed tonsillitis of a 15 day duration. The pt then presented with otitis media. The reporter noted that these episodes started recently. Treatment for otitis media included Trimetropin sulpha without recovery. The pt developed respiratory distress on an unspecified date and was hospitalized. A diagnosis of lobar pneumonia with pleural effusion was made on 8/1/06. The pts conditions continued to worsen and he was transferred to the ICU. On 8/4/06, a toracostomy was performed and a plural culture was positive for pneumococcus (pneumonia pneumococcal) (drug ineffective). No serotype was reported. Treatment included oxacillin ceftriaxone. The pts condition continued to deteriorate and on 8/4/06 the pt died. The cause of death was reported as multi system organ failure due to a worsening pneumococcal pneumonia. Culture positive for pneumococcus no serotype provided was done on 8/4/06. No additional information was available at the time of this report.


VAERS ID: 261817 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-08-18
Entered: 2006-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Coma, Convulsion, Haemoglobin decreased, Laboratory test abnormal, Metabolic acidosis, Platelet disorder, Pyrexia, Respiratory failure, Urine analysis abnormal, Vomiting, White blood cell disorder
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (broad), Haematopoietic thrombocytopenia (broad), Lactic acidosis (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (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), Convulsions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Methylmalonic Aciduria, Psychomotoric retardation
Allergies:
Diagnostic Lab Data: Laboratory testing showed the following: white blood cell count: 3400/mm3; hemoglobin 6.9 mg/L; platelets 410000/mm3; urine ketone 2+; arterial blood gas analysis: pH 7.223, bicarbonate mmol/L, base excess - 20.4 mmol/L. His urine methylmalonnic acid, 3-hydroxy propionic acid, and methylcitric levels were markedly. X-ray showed a cerebral atrophy.
CDC Split Type: B0434455A

Write-up: This case was reported in a literature article and described the occurrence of acute metabolic acidosis in a 3 month old male subject who was vaccinated with combined diphtheria, tetanus, pertussis (A or W not known) vaccine for prophylaxis. Concurrent medical conditions included methylmalonic aciduria (not identified before vaccination) and psychomotororic retardation. At the age of 3 months, his neck muscles could barely support his head, and muscle tone was decreased. His nutritional status was fair before vaccination and his deep tendon reflexes were normal. On an unspecified date the subject received unspecified dose of Diphtheria tetanus pertussis (A or W not known) (unknown). Ten hours after vaccination with Diphtheria tetanus pertussis (A or W not known), the subject experienced vomiting and fever was well as convulsions. Eventually, he became comatose. Laboratory testing showed the following: white blood cell count: 3400/mm3; hemoglobin 6.9 mg/L; platelets 410000/mm3; urine ketone 2+; arterial blood gas analysis: pH 7.223, bicarbonate mmol/L, base excess - 20.4 mmol/L. His urine methylmalonnic acid, 3-hydroxy propionic acid, and methylcitric levels were markedly. X-ray showed a cerebral atrophy. Because Vitamin B12 treatments were inefficient, intravenous fluid therapy, a protein restricted diet, and L-carnitine supplementation were administered. The patient improved initially, but at an age of 2 years he died from severe fever-induced metabolic acidosis and respiratory failure. The author considered that although the vaccine was not the primary cause of the acute metabolic crisis, the severe acute episode occurred coincidentally.


VAERS ID: 261818 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-08-18
Entered: 2006-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Blood bicarbonate decreased, Blood glucose decreased, Blood sodium decreased, Cardiac arrest, Coma, Dehydration, Enlarged clitoris, Hormone level abnormal, Hyperkalaemia, Hypokalaemia, Hyponatraemia, Laboratory test abnormal, Lethargy, Pneumonia, Skin disorder, Urine analysis abnormal, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (narrow), Infective pneumonia (narrow), Dehydration (narrow), Hypokalaemia (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: 21-Hydroxylase deficiency, acute adrenal insufficiency
Allergies:
Diagnostic Lab Data: The laboratory examination results showed the following: serum potassium 7.0 mmol/L, sodium 118 mmol/L, glucose 3.1 mmol/L, bicarbonate 9.2 mmol/L, urine ketone 2+. Plasma adrenocorticotrophic hormone and 17-hydroxyprogesterone were markedly, paramater that characterise 21-hydroxylase deficiency and adrenal crisis
CDC Split Type: B0434336A

Write-up: This case was reported in a literature article and described the occurrence of acute metabolic acidosis in a 3 month old female subject who was vaccinated with combined diphtheria, tetanus, pertussis (A or W not known) vaccine for prophylaxis. Concurrent medical conditions included 21-hydroxylase deficiency (not identified before vaccination), malnutrition, and acute adrenal insufficiency. At the age of 2 months, the girl developed also anorexia and did not gain weight. She was on no concomitant medication. On an unspecified date the subject received unspecified dose of Diphtheria, tetanus, pertussis (A or W not known) (unknown). Three hours after vaccination with Diphtheria, tetanus, pertussis (A or W not known), the subject experienced recurrent vomiting with lethargy and subsequent coma. A physical examination of the child identified severe dehydration, pigmentation over the breast areola, subaxilla, perineum, and clitoral swelling. The laboratory examination results showed the following: serum potassium 7.0 mmol/L, sodium 118 mmol/L, glucose 3.1 mmol/L, bicarbonate 9.2 mmol/L, urine ketone 2+. Plasma adrenocorticotrophic hormone and 17-hydroxyprogesterone were markedly, paramater that characterise 21-hydroxylase deficiency and adrenal crisis. Her condition improved soon after treatment with intravenous hydrocortisone, glucose and sodium chloride. The treatment was changed from the intravenous drugs to oral hydrocortisone, fluidrocortisone, and sodium chloride 3 days later. At the age of 1 year, he developed a pneumonia and died from hyperkalemia, hyponatremia, and cardiac arrest. Autopsy findings were symmetric foci, cystic cavitations with neuronal loss, and vascular proliferation. The fatal outcome was not connected to the vaccination. The author considered that although the vaccine was not primary cause of the acute metabolic crisis, the severe acute occurred coincidentally.


VAERS ID: 261819 (history)  
Form: Version 1.0  
Age: 0.41  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-08-16
Entered: 2006-08-18
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Blood lactic acid increased, Coma, Convulsion, Encephalopathy, Feeding disorder neonatal, Hypertonia, Laboratory test abnormal, Mental impairment, Metabolic acidosis, Paralysis, Pyrexia, Respiratory disorder, Respiratory failure, Urine analysis abnormal
SMQs:, Anaphylactic reaction (broad), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Convulsions (narrow), Parkinson-like events (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), 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: 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: Hypoglycemia, Leigh''s disease, metabolic acidosis
Allergies:
Diagnostic Lab Data: The laboratory examination results showed the following: marked elevations in urine lactic acid, pyruvic acid, fumaric acid, and blood lactic acid. Blood amino acids and acylcarnitine profiles were normal. Brain magnetic resonance imaging disclosed bilateral basal ganglia damage and atrophy of the brainstem. These parameters also characterize subacute necrotizing cerebrospinal disease.
CDC Split Type: B0434456A

Write-up: This case was reported in a literature article and described the occurrence of acute metabolic acidosis in a 5 month old male subject who was vaccinated with combined diphtheria, tetanus, pertussis (A or W not known) vaccine for prophylaxis. Concurrent medical conditions Leigh''s disease (not identified at the time of the vaccination). The child''s condition had been relatively normal before vaccination. On an unspecified date the subject received unspecified dose of Diphtheria, tetanus, pertussis (A or W not known) (unknown). Seven hours after vaccination with Diphtheria, tetanus, pertussis (A or W not known), the subject experienced fever, convulsions and coma with respiratory difficulties. Routine and biochemical examinations of the of the cerebrospinal fluid were normal. Metabolic acidosis lactic acidemia and pyruvic acidemia were documented. He was diagnosed with an acute encephalopathy and treated with intravenous fluids, manitol and antibiotics. The laboratory examination results showed the following: marked elevations in urine lactic acid, pyruvic acid, fumaric acid, and blood lactic acid. Blood amino acids and acylcarnitine profiles were normal. Brain magnetic resonance imaging disclosed bilateral basal ganglia damage and atrophy of the brainstem. These parameters also characterize subacute necrotizing cerebrospinal disease. He manifested a slight improvement 3 to 7 days after treatment and the fever subsided to normal temperatures and he gained consciousness gradually. However, feeding was difficult and he suffered low intelligence quotient score and generalized palsies. He experienced also hypertonic musculature of the extremities and trunk. Physiotherapy and nutrition treatments were ineffective. His condition improved with administration of thiamine, L-carnitine, coenzyme Q10 and vitamin E. At the age of about 1 to 1 and a half year, the child died of respiratory failure, Post mortem findings were symmetric foci, cystic cavitations with neuronal loss, and vascular proliferation as the typical findings described in Leigh''s syndrome. The author considered that although the vaccine was not the primary cause of the acute metabolic crisis, the severe acute episode occurred coincidentally.


VAERS ID: 261820 (history)  
Form: Version 1.0  
Age: 0.58  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-08-18
Entered: 2006-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Coma, Convulsion, Laboratory test abnormal, Metabolic acidosis, Pyrexia, Respiratory disorder
SMQs:, Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: The laboratory examination results showed the following: marked elevations in urine lactic acid, pyruvic acid, fumaric acid, and blood lactic acid. Blood amino acids and acyclcarnitine profiles were normal. Brain magnetic resonance imaging disclosed bilateral basal ganglia damage and atrophy of the brainstem. These parameters characterize also subacute necrotizing cerebrospinal disease.
CDC Split Type: B0434457A

Write-up: This case was reported in a literature article and described the occurrence of acute metabolic acidosis in a 7 month old male subject who was vaccinated with hepatitis B (manufacturer unspecified) vaccine for prophylaxis. Concurrent medical conditions Leigh''s disease (not identified at the time of the vaccination). The child''s condition had been relatively normal before vaccination. On an unspecified date the subject received unspecified dose of hepatitis B vaccine. Eight hours after vaccination with hepatitis B vaccine subject experienced fever, convulsions and coma with respiratory difficulties. Routine and biochemical examinations of the cerebrospinal fluid were normal. Metabolic acidosis, lactic acidemia and pyruvic acidemia were documented. She was diagnosed with an acute encephalopathy and treated with intravenous fluids, manitol and antibiotics. The laboratory examination results showed the following: marked elevations in urine lactic acid, pyruvic acid, fumaric acid, and blood lactic acid. Blood amino acids and acyclcarnitine profiles were normal. Brain magnetic resonance imaging disclosed bilateral basal ganglia damage and atrophy of the brainstem. These parameters characterize also subacute necrotizing cerebrospinal disease. She manifested a slight improvement 3 to 7 days after treatment and the fever subsided to normal temperatures and she gained consciousness gradually. However, feeding was difficult and she suffered low intelligence quotient score and generalized palsies. She experienced also hypertonic musculature of the extremities and trunk. Physiotherapy and nutrition treatments were ineffective. Here condition improved with the administration of thiamine, L-carnitine, coenzyme Q10 and vitamin E. At the age of about 1 to 1 and a half year, the child died of respiratory failure. Post mortem findings were symmetric foci, cystic cavitations with neuronal loss, and vascular proliferation as the typical findings described in Leigh''s syndrome. The author considered that although the vaccine was not the primary cause of the acute metabolic crisis, the severe acute episode occurred coincidentally.


VAERS ID: 262030 (history)  
Form: Version 1.0  
Age: 0.75  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-08-21
Entered: 2006-08-24
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEA: MEASLES (ATTENUVAX) / MERCK & CO. INC. - / UNK UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acidosis, Anorexia, Blood lactic acid increased, Brain stem syndrome, Coma, Convulsion, Encephalopathy, Hypertonia, Hypoglycaemia, Laboratory test abnormal, Mental impairment, Nervous system disorder, Paralysis, Pyrexia, Respiratory disorder, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Convulsions (narrow), Parkinson-like events (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Plasma NH 3 230 Umol.L normal <60 umol.l, serum carnitine 8.38 umol/l normal range <0.5 umol/l, urine glutamic acid test markedly elevated.
CDC Split Type: WAES0608USA03781

Write-up: It was reported in a published article, that a 9 month old male with no medical conditions before vaccination and no family history, who on an unspecified date was vaccinated with a dose of Measles virus vaccine live, manufacturer unknown. Subsequently, twelve hours after vaccination the pt had a fever, convulsions, and coma with respiratory difficulty, mild to severe. Routine biochemical examination of the cerebrospinal fluid were normal, metabolic acidosis and hypoglycemia were documented. He was diagnosed with acute encephalopathy and treated with IV fluids, mannitol, and antibiotics. He manifested slight improvement 3 to 7 days after treatment. His fever subsided to normal temperatures, and he gained consciousness gradually. However, feeding was difficult and he suffered low intelligence quotient score and generalized palsies, He experienced hypertonic musculature of the extremities and trunk. Physiotherapy and nutrition treatments were ineffective. Lab exam revealed marked elevations in urine lactic acid, pyruvic acid, fumaric acid, and blood lactic acid. Brain magnetic resonance imaging disclosed bilateral basal ganglia damage and atrophy of the brain stem. These parameters also characterize subacute necrotizing cerebrospinal disease, Leigh disease. The pt improved with thiamine, L carnitine, coenzyme Q10, and vitamin E, but he died from respiratory failure between the age of one and one and a half years. Post mortem examinations demonstrated symmetrical foci, cystic cavitations with neuronal loss, and vascular proliferation as the typical findings described in Leigh Syndrome. Upon internal review, the pts experiences were determined to be other important medical events (OMIC). No further information is available. A copy of the published article is attached as further documentation of the pts experienced.


VAERS ID: 262150 (history)  
Form: Version 1.0  
Age: 0.53  
Sex: Female  
Location: Foreign  
Vaccinated:2006-08-09
Onset:2006-08-09
   Days after vaccination:0
Submitted: 2006-08-25
   Days after onset:16
Entered: 2006-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS A20CA184B / UNK UN / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS A20CA184B / UNK UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER A20CA184B / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Agitation, Cardiac failure, Crying, Irritability, Myocarditis, Sudden infant death syndrome, Upper respiratory tract infection
SMQs:, Cardiac failure (narrow), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-08-13
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: B0434214A

Write-up: This case was reported by a physician and described the occurrence of sudden infant death in a 6 month old female subject who was vaccinated with combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and haemophilus influenza b vaccine (Infanrix-IPV+Hib), Hepatitis B vaccine (Engerix B) for prophylaxis. The subjects family history included married parents who lived in a rural area. The medical family history was unknown. The subjects medical history included a caesarian delivery. The subject did not present birth defects, nor fetal distress and she was not breast fed. The subject did not presented any known allergies. No other pre existed disease was known. The subject did not experienced adverse events, following previous vaccination. On 8/9/06 the subject received primary course unspecified dose of Infanrix IPV Hib IM, unspecified dose of Engerix B IM. On 8/9/06, less than one day after vaccination with Engerix B and Infanrix IPV Hib, the presented irritable crying during nighttime. On 8/13/06 the subject died. The circumstance of death were unknown. No autopsy was performed but in the certificate of death was specified that subject presented heart failure, upper respiratory infection and acute myocarditis.


VAERS ID: 262343 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-08-23
Entered: 2006-08-30
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / SC
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / 1 - / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Alanine aminotransferase increased, Anaemia, Aspartate aminotransferase increased, Granuloma, Haemolysis, Hepatosplenomegaly, Laboratory test abnormal, Liver function test abnormal, Lymphadenitis, Lymphadenopathy, Neutropenia, Pallor, Pyrexia, Renal failure, Sepsis, Thrombocytopenia, Viral infection
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Haemolytic disorders (narrow), Agranulocytosis (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (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), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Immunophenotypic analysis flow cytometry abnormally low expression of the alfa chain of the IFN gamma receptor, Serum C reactive protein (high), Serum CMV IgM ab (high) level of IgM class anti CMV reactive antibodies, Serum alanine aminotransferase (elevated). Serum aspartate aminotransferase (elevated). Acid fast bacilli stain test (negative), periodic acid Schiff stain test negative for acid fast bacilli, examination of blood cell morphology anemia, thrombocytopenia.
CDC Split Type: WAES0608POL00005

Write-up: It was reported in a published article, that a 4 month old girl exhibited enlargement of left axillary lymph nodes during a 1.5 month period (year unknown) as a rare complication of antituberculous vaccination. She was a second child of healthy parents, with no family history of genetic disorders or TB. The first dose of BCG and anti hepatic B virus vaccination (unknown product, unknown manufacturer) the pt received the first day of life, followed by vaccination against diphtheria, tetanus, pertussis, poliomyelitis, and the second dose of anti hepatic B virus vaccination (unknown product) after 6 weeks. On hospital admission the pt was in reasonably good condition but pale, with grossly enlarged adjacent left axillary lymph nodes and hepatosplenomegaly. Lab test showed anemia, thrombocytopenia, elevated transaminase activity, a high C reactive protein level. and high level of IgM class anti cytomegalovirus reactive antibodies, flow cytometry measurements 20% lymphocytes expressed CD 119 (IFN gamma receptor outer subunit R1), chest and bone radiographs negative for infection, Ziehl Neelsen and periodic acid Schiff staining-did not show acid fast bacilli. CMV infection was suspected. The pt was administered a 14 day regimen of ganciclovir., Liver function test and blood count normalized, hepatosplenomegaly decreased. However, the lymph nodes continued to enlarge. Diagnostic excision and bone marrow aspiration were performed to exclude a neoplastic process. A histopathologic image of the excised lymph nodes showed caseating granulomas and tuberculous lymphadenitis was suggested. At that time a diagnosis of disseminated BCG infection as a complication of TB vaccination in a presumed immunocompromised pt was proposed. Flow cytometry measurements showed abnormally low expression of the alpha chain of the interferon IPN gamma receptor on peripheral blood lymphocytes. Only 20% lymphocytes expressed CD 119 (IFN gamma receptor outer subunit R1). Three drug anti tuberculos therapy (rifamipin, Isoniazid and Streptomycin) was introduced despite chest and bone radiographs that were negative for infection. No abnormalities were found on fundoscopy and negative results of Ziehl Neelsen staining of lymph node tissue. Despite this therapy the child''s conditions worsened. She exhibited a high temperature, hemolysis and progressive neutropenia, thrombocytopenia, cholestasis and renal failure. Uncontrolled sepsis developed and the child died. A post mortem examination the diagnostic of disseminated BCG infection was made on the basis of multiple TB like granulomas in the lungs, lymph nodes, meninges, liver, spleen and kidney. However direct microbiologic confirmation of BCG infection was lacking because culture were negative and Ziehl Neelsen and periodic acid Schiff staining did not show acid fast bacilli, other bacteria of fungi in these specimens. According to the authors of the article this case represents a rare complication of antituberculous vaccination that is a progressive, disseminated BCG infection in a pt with deficiency of IFN Gamma receptor. Additional information is not available. A copy of the published article is attached as further documentation of the pts experience.


VAERS ID: 262858 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Foreign  
Vaccinated:2006-07-18
Onset:2006-07-21
   Days after vaccination:3
Submitted: 2006-09-05
   Days after onset:46
Entered: 2006-09-12
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21U7211B / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 18956 / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Alanine aminotransferase increased, Apathy, Apnoea, Aspartate aminotransferase increased, Bacterial infection, Blood lactate dehydrogenase increased, Blood lactic acid increased, Blood pressure decreased, Bradycardia, Brain oedema, Coma, Convulsion, Electroencephalogram abnormal, Gaze palsy, Hepatic enzyme increased, Hernia, Hypothermia, Hypoxia, Laboratory test abnormal, Metabolic acidosis, Pyrexia, Sepsis, Tachypnoea
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Acute central respiratory depression (narrow), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-07-24
   Days after onset: 3
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: Zymafluor D (Colecaliferol/Sodium Fluoride), 1 tablet, Continues
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Alanine Aminotransferase 7/21/06 159 IU/L 7/22/06 442 IU/L 7/23/06 618 IU/L 7/24/06 354 IU/L, Ammonia 7/21/06 42 ul/dl 7/23/06 52.8 ug/dl, Aspartate Aminotransferase 7/21/06 511 iu/l 7/22/06 790 iu/l 7/23/06 914 iu/l 7/24/06 179 iu/l, Blood bicarbonate 7/22/06 18.7 mmol/l, Blood culture 7/06 detection of coagulase negative starpylococci, Blood lactate dehydrogenase 7/21/06 681 IU/L 7/22/06 2578 IU/L 7/23/06 2800 IU/L 7/24/06 1238 IU/L, Blood lactic acid 7/21/06 160.2 mg/dl, Blood pressure 7/22/06 114/72 mmHg, Body temperature 7/21/06 39 deg C, C reactive protein 7/21/06 0.5 mg/dl, 7/22/06 0.8 mg/dl 7/24/06 1.3 mg/dl, Echocardiogram 7/23/06 left ventrical with slightly decreased pump function, Electroencephalogram 7/23/06 at 11am isoelectric EEG with ECG typical potentials 7/24/2006 at 11.47am same findings as in previous EEG, Lumbar puncture 7/21/06 17/3 cells, protein 33 mg/dl, glucose 113 mg/dl, lactate 109 mg/dl, Microbiology test 7/21/06 herpes simplex virus in lumbar puncture negative, latex test negative for haemophilus influenzae type b, streptococcus pneumonia, Neisseria meningitis type A-C, Escherichia coli no signs for bacterial or viral meningitis, Ophthalmological examination (eye exam) 7/23/06 wide fixed pupil, signs for vascular stasis, no hemorrhage, Scan brain 7/23/06 at 2am upward and downward tentorial herniation, probably massive brain edema with distinct delay of brain perfusion, Ultrasound doppler 7/23/06 transcranial pendular blood flow as sign of circulatory still stand in arteria cerebri media right side and in carotid siphon transorbital, Ultrasound skull 7/21/06 normal findings, good pulsation with doppler sonographic good flow in arterai cerebri anterior. 7/22/06 at 22:50 hours decreased echoginity, no diastolic flow systolic flow in arteria cerebri anterior with weak pulsation 7/23/06 at 1am, internal cerebrospinal fluid space very narrow, external CSF space not visible, marginal pulsation in arterial circle of Willis Doppler extremely short systolic peak up to 22cm/second, no anterograde diastolic perfusion, 7/24/06 stop of cerebral perfusion with severe brain edema.
CDC Split Type: DEWYE788428AUG06

Write-up: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a health care professional regarding a 5 month old male pt who experienced hepatic enzymes increased, tonic clonic convulsions generalized, fever, tachypnea, metabolic acidosis, septicemia, staphylococcal, hypothermia, apnea, bradycardia, coma and brain edema. The pt received the second dose on 7/18/06. The pt has a past history of normal newborn (born in 39th gestational week 4090g and 50cm). Apart from slight dystrophia the child was health. The pt is the second child of health nonconsanguine parents. The pts older sibling is a two year old healthy girl. Indication for Prevnar was immunisation. Product was administered on 7/18/06. Dose regimen was 1 dose IM. Additional suspect medication included Infanrix Hexa (diphtheria vaccine/tetanus vaccine/acellular pertussis vaccine/polio virus inactivated/haemophilus influenzae B/hepatitis B vaccine) which was administered on 7/18/06. Previous vaccinations with both vaccines had been tolerated well. Concomitant therapy included Zymafluor D (colecalciferol sodium fluoride). On 7/21/06 when the pts mother was carrying him on her arms he experienced tonic clonic convulsions generalized. His eyes were partly open and were turned to the upper right side. He did not react. When an Emergency physician arrived the pt was still apathic and eyes were turned to the upper left side. He had fever. The pt received 5 mg of Diazepam and 125mg Paracetamol (Rectal). Convulsion lasted for 30 minutes. He was hospitalized and admitted to an ICU. During admittance he experienced a second tonic clonic convulsion which stopped after 100 mg of Phenobarbital. Furthermore tachypnea was diagnosed. He received Dexamethasone for prophylaxis of brain edema and Cefotaxime. A lumbar puncture was performed and the results showed septicaemia staphylococcal (staphylococcal sepsis) on 7/22/06. Refobacin (gentamicin sulfate) was added to antibiotic therapy. His condition stabilized. there were no signs for bacterial or viral meningitis. He woke up sometimes and also reacted to pain stimulus. He also started experiencing hepatic enzymes increased on 7/21/06. In the afternoon of 7/22/06 he experienced bradycardia (bradycardia and apnea). Furthermore arterial blood pressure decreased to subnormal values. He received Atropine and was sedated with Etomidate. Nasotracheal intubation was performed and Dopamine was administered constantly. Blood pressure stabilized and reached values of 114/72 mmHg due to which Dopamine was stopped. Due to metabolic acidosis he received sodium bicarbonate. In the late hours of 7/22/06 the pat experienced hypothermia. A sonogram of the skull showed no diastolic flow in arteria cerebri anterior. He received Dexamethasone and Lidocaine. For further treatment he was transferred to a different hospital on 7/23/06 and was admitted to an ICU. Upon arrival at the second hospital he was in a coma. Sonograms showed no perfusion of cerebral vessels and EEG showed no electric potentials. A computerized tomogram of the brain showed tentorial herniation and severe brain (brain oedema) was detected. Furthermore a metabolism disorder (for example LCAT defect) was suspected. Sedation with Thiopental began on 7/23/06 at 2am and was stopped at 10am. Extubation was performed on 7/24/06 at 6:45pm. Exitus letalis was stated at 6:52pm. The cause of death was reported as brain oedema and an autopsy was performed, but results were not provided.


VAERS ID: 262923 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Female  
Location: Foreign  
Vaccinated:2006-09-06
Onset:0000-00-00
Submitted: 2006-09-12
Entered: 2006-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Medication error
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: B0437326A

Write-up: This case was reported by a physician and described the occurrence of death nos in a 3 year old female subject who was vaccinated with hepatitis A vaccine (Havrix adult) for prophylaxis. On 9/6/06 the subject inappropriately received unspecified dose of Havrix adult 1440 Elisa unit, IM. At an unspecified time after vaccination the subject died, cause of death is not specified. Verbatim text received a child received an adult dose.


VAERS ID: 263166 (history)  
Form: Version 1.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2001-10-08
Onset:2006-06-18
   Days after vaccination:1714
Submitted: 2006-09-15
   Days after onset:89
Entered: 2006-09-19
   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, Drug ineffective, Pneumonia, Sepsis
SMQs:, Lack of efficacy/effect (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-06-24
   Days after onset: 6
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, blood culture ans ascitic fluid serotype 19A S. pneumonia. 06/06
CDC Split Type: WAES0609AUS00088

Write-up: Information was obtained on request by the Company via a public case details form concerning a 46 year old female who on 10/08/2001 was vaccinated with pneumococcal 23v polysaccharide vaccine for prophylactic inoculation and vaccination. On 6/18/06 the pt developed pneumococcal infection, vaccination failure and sepsis, described as invasive pneumococcal disease due to serotype 19A blood culture and ascitic fluid overwhelming sepsis. On 6/24/06 the pt died, which was reported by the agency as unrelated death. The agency considered the pneumococcal infection, vaccination failure and sepsis were certainly related to therapy with pneumococcal 23 polysaccharide vaccine. The original reporting source was not provided. Additional information is not expected.


VAERS ID: 263353 (history)  
Form: Version 1.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2005-05-09
Onset:2006-06-14
   Days after vaccination:401
Submitted: 2006-09-18
   Days after onset:96
Entered: 2006-09-21
   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: 2006-06-21
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood culture, isolated streptococcus, pneumoniae serotype 22F vaccine preventable strain.
CDC Split Type: WAES0609AUS00089

Write-up: Information was obtained on requested by the company from the agency via a public case detail form concerning a 95 year old female who on 5/9/05 was vaccination with Pneumococcal 23v polysaccharide vaccine. On 6/14/06 the pt experienced pneumococcal infection and vaccination failure and was hospitalised. Blood cultures collected on 6/14/2006 isolated streptococcus, pneumoniae serotype 22F vaccine preventable strain. On 6/21/06 the pt died. The cause of death was unrelated death. The agency considered that pneumococcal infection and vaccination failure were certainly related to therapy with Pneumococcal 23v polysaccharide vaccine. The original reporting source was not provided. Additional information is not expected.


VAERS ID: 263694 (history)  
Form: Version 1.0  
Age: 1.58  
Sex: Male  
Location: Foreign  
Vaccinated:1997-01-01
Onset:1997-03-05
   Days after vaccination:63
Submitted: 2006-09-26
   Days after onset:3491
Entered: 2006-09-29
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anaemia, Diarrhoea, Disseminated intravascular coagulation, Hepatic enzyme abnormal, Leukopenia, Multi-organ failure, Otitis media, Pneumonia, Purpura fulminans, Pyrexia, Respiratory disorder, Rheumatoid arthritis, Systemic lupus erythematosus, Thrombocytopenia, Vomiting
SMQs:, Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), 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), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (narrow), Sepsis (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Infection, lymphopenia, thrombocytopenia, transaminases increased, respiratory syncytial virus bronchiolitis, bronchitis asthmatic, laryngitis, fever, hospitalization.
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0609USA04315

Write-up: Information has been received from a health professional concerning an approximately 19 month old male with a past medical history of frequent infection during th first year of his life, two infections were also associated with lymphopenia, thrombopenia and increase of transaminases, severe RSV bronchiolitis in Dec 1995, asthmatiforme bronchitis with laryngitis requiring hospitalization from 1/18/1996 until 1/26/1996, asthmatiforme bronchitis with laryngitis requiring hospitalization from 2/18/1996 until 2/19/91996, severe fever, probably infection related requiring hosp from 9/1/96 until 9/11/96 who in approx Jan of 1997, at 15-17 months of age, was vaccinated with a first dose of MMR II. Subsequently, on an unspecified date after vaccination, the pt experienced severe fever associated with Leucopenia, thrombopenia and an increase of transaminase. He was hospitalized and he recovered. In March 1997, the pt developed a severe fever, vomiting, and diarrhea associated with anemia, thrombopenia, leucopenia and increase of the transaminases (second time) requiring hospitalization from 3/5/1997 until 3/14/1997. No bacteriological etiology was found. The different suspected etiologies were an immunological defect, a natural killer cells defect, an organic aciduria, a systemic onset of juvenile rheumatism, other systemic disease like lupus erythematous. In April 1997 the pt developed pneumonia and otitis medic, requiring hospitalization from 4/6/1997 until 4/10/1997. In approx 2002, at the approx age of 7 years the pt presented with and was hospitalized for disseminated intravascular coagulation with purpura fulminans, multi organ failure. He subsequently died (cause of death was not reported). No further information was available. The pts sister (WAES0609USA04289) also had an adverse experience after vaccination with MMR II. Additional information is expected.


VAERS ID: 264532 (history)  
Form: Version 1.0  
Age: 0.58  
Sex: Male  
Location: Foreign  
Vaccinated:2006-09-22
Onset:2006-09-22
   Days after vaccination:0
Submitted: 2006-10-12
   Days after onset:20
Entered: 2006-10-16
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 20219 / 3 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Feeling hot, Irritability, Vomiting
SMQs:, Acute pancreatitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-09-22
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRWYE136205OCT06

Write-up: Information regarding Prevnar was received from a healthcare professional via the regulatory authority regarding a 7 month old male pt who experienced sudden death, grumbling, feeling of warmth to the touch and vomiting. The pt received the third dose on 9/22/06. Past therapies included , doses of Prevnar in 2006. The pt had no relevant medical history. Indication for Prevnar was immunisation. Product was administered on 9/22/06 at 11:30am. Dose regimen was 1 dose 1 time per day IM. Additional suspect medication included Pentavac. Concomitant medications were not reported. On 9/22/06, in the afternoon, the pt was found grumbling (irritability) and warm to the touch (feeling hot), however his body temp was not measured. The pt received one suppository of Doliprane. At 2:30pm, the pt drunk 150 ml of milk and ate one fruit compote, then was lain down on the back in his bed. At 4:00pm, the pt was found dead in the same position (sudden death) with vomiting. Grumbling, feeling of warmth and vomiting were considered non serious with unknown outcome. The pt was transferred to the hospital center where autopsy was planned. Results are pending. The cause of death was reported as sudden death. No additional information was available at the time of this report.


VAERS ID: 264670 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2005-10-14
Onset:0000-00-00
Submitted: 2006-10-13
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / -
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pyrexia, Sepsis, Shock
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (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), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Arteriosclerosis, coronary disease, surgery, cardiac valve disease, type I diabetes mellitus, apoplexy.
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0610USA07430

Write-up: Information has been received from a physician concerning an elderly polypathic male with arteriosclerosis, coronary heart disease (including surgery Nos), valvular heart disease, Type I diabetes mellitus and apoplexy who in 2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant suspect therapy included a dose of influenza virus vaccine (unspecified). Three days post-vaccination, the patient experienced a mild fever. The symptoms worsened and he was hospitalized. Eight days later the patient died because of "septic chock". Other business partner numbers included. No further information is available.


VAERS ID: 264825 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2006-10-09
Onset:2006-10-10
   Days after vaccination:1
Submitted: 2006-10-16
   Days after onset:6
Entered: 2006-10-18
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLWYE188211OCT06

Write-up: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) syringe pre filled) was received from a healthcare professional regarding a 2 month old male pt who died the day after vaccination. The pt received a dose on 10/9/06. Relevant medical history was not provided. Indication for Prevnar was immunisation. Product was administered on 10/9/06. Dose regimen was 0.5ml IM. Additional suspect medication included Infanrix Hexa (diphtheria vaccine/tetanus vaccine/acellular pertussis vaccine/polio virus inactivated/haemophilus influenzae B/hepatitis B vaccine). Concomitant medications were not reported. The pt died on 10/10/2006. The cause of death was not reported. An autopsy will be performed. No additional information was available at the time of this report.


VAERS ID: 265370 (history)  
Form: Version 1.0  
Age: 0.67  
Sex: Female  
Location: Foreign  
Vaccinated:2006-07-01
Onset:2006-10-11
   Days after vaccination:102
Submitted: 2006-10-25
   Days after onset:14
Entered: 2006-10-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 3 - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-10-13
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Autopsy 10/13/06 pending results, bacterial culture 10/13/06 pneumococcus serotyping obtained during autopsy pending results.
CDC Split Type: FRWYE303223OCT06

Write-up: Otitis was considered medically important (OMIC). Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding an 8 month old female pt who experienced otitis, meningitis pneumococcal and drug ineffective. The pt received the third dose in Jul 2006. Relevant medical history was not provided. Indication for Prevnar was immunisation. Product was administered in Jul 2006. Dose regimen was 1 dose 1 time per day IM and the both previous dose, in Jun and May 2006 (estimated dates). Concomitant medications were not reported. The pt was treated by Orelox for otitis (ear infection) since 10/11/06 when she died for meningitis pneumococcal and drug ineffective on 10/13/06. The outcome of otitis was unknown. No additional information was available at the time of this report.


VAERS ID: 265421 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-10-26
Entered: 2006-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Anaemia haemolytic autoimmune, Cardiovascular disorder
SMQs:, Haemolytic disorders (narrow), Systemic lupus erythematosus (broad), Cardiomyopathy (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1997-04-21
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: A0624951A

Write-up: This case was reported by a consumer and described the occurrence of autoimmune hemolytic anemia in a female subject of unspecified age who was vaccinated with influenza virus vaccine (Influenza vaccine unspecified, manufacturer unspecified) for prophylaxis. A physician or other health care professional has not verified this report. In 1990 the subject received unspecified dose of Influenza vaccine unspecified (unknown). At an unspecified time after vaccination with Influenza vaccine unspecified the subject experienced autoimmune hemolytic anemia and aortic valve problem. The subject died on 21 April 1997, cause of death was not reported. It was unknown whether an autopsy was performed.


VAERS ID: 265845 (history)  
Form: Version 1.0  
Age: 1.25  
Sex: Male  
Location: Foreign  
Vaccinated:2006-07-05
Onset:2006-08-07
   Days after vaccination:33
Submitted: 2006-11-01
   Days after onset:86
Entered: 2006-11-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 3 UN / -
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK UN / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-08-07
   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: UNK
Current Illness:
Preexisting Conditions: Respiratory tract infection, wheezing, cough, Dyspnea.
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAWYE325224OCT06

Write-up: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding a 16 month old male pt who experienced death. The pt received the third dose on 7/5/06 and was not ill in the 48 hours after the vaccine according to his mother. The pt had a past history of respiratory tract infection, dyspnoea, cough and wheezing in Oct and Dec 2005. Past therapies included Flovent and Ventolin. Indication for Prevnar was prophylaxis. Product was administered on 7/5/06. Dose regimen was received 3rd dose. Additional suspect medication included Varivax. Concomitant medication were not reported. The pt experienced Death on 8/7/06. The mother reported putting him down for his nap and he did not wake, The mother specified that the child had no been wheezing. The cause of death was reported as unk. No additional information was available at the time of this report, but it is reported that the mother is still waiting to learn the cause of death from the pathologist, who has ordered all types of test (Pathology, virology, metabolic disorder and bacteriology). So far, no abnormal findings. Nothing physically wrong with the child. Organs all normal. Out come Fatal it is reported that the mother has already contacted on of the other manufacturers for Varivax and will get in touch with the other for previous administration of Flovent and Ventolin.


VAERS ID: 266029 (history)  
Form: Version 1.0  
Age: 1.33  
Sex: Male  
Location: Foreign  
Vaccinated:2006-07-05
Onset:2006-08-07
   Days after vaccination:33
Submitted: 2006-10-27
   Days after onset:81
Entered: 2006-11-06
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cyanosis
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-08-07
   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: Flovent, Ventolin
Current Illness:
Preexisting Conditions: Respiratory syncytial virus infection.
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0610CAN00179

Write-up: Information has been received from the mother of a 16 month old pt who on 7/5/06 was vaccinated with Varicella vaccine. Concomitant therapy included Prevnar, Ventolin and Flovent. It was reported that the pt was diagnosed previously with a respiratory syncytial virus infection (no details provided). It was also reported that the pt was taking therapy with albuterol and Fluticasone propionate as needed (when was coughing and wheezing) but not when he was vaccinated with Varicella and Prevnar. On 8/7/06, the child went for a nap and when the parents came to pick him up he was blue. The child was dead. The cause was not reported. No further information is available.


VAERS ID: 266749 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2006-11-07
Onset:0000-00-00
Submitted: 2006-11-14
Entered: 2006-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA196AC / UNK LA / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-11-08
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lansoprazole, Anoreine,, (Carrageenan + Zinc oxide + Bismuth subjallate), Macrogol 3350, Proctolog
Current Illness: Constipation, dental care, hemorrhoids, hypertension arterial, shoulder pain.
Preexisting Conditions: Fatigue
Allergies:
Diagnostic Lab Data:
CDC Split Type: B0445909A

Write-up: This case was reported by a pharmacist and a physician an described the occurrence of death in a 83 year old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The subjects past medical history included a scan for unk indication in June 2006 and fatigue during the summer 2006. Concurrent medical conditions included constipation, hemorrhoids, slight hypertension arterial and shoulder pain. Concurrent chronic treatment included Lanzor, Anoreine suppository, Tansipeg, Protolog topic, Depoject. On 10/30/2006, a treatment with Zithromax, Pyralvex, and Diantalvic was prescribed for three days for dental care (NOS). On 11/7/06 the subject received unspecified dose of Fluarix (batch reference AFLUA196AC). The physician reported that the day vaccination, the subject was in good health condition, except shoulder pain. On 11/8/06 in the morning, less than one day after vaccination, the subject''s son found his mother dead in her bed, peaceful. An autopsy was not performed. The physician and pharmacist causality assessment was unk.


VAERS ID: 266792 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2000-03-28
Onset:2006-09-01
   Days after vaccination:2348
Submitted: 2006-11-09
   Days after onset:69
Entered: 2006-11-15
   Days after submission:6
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? 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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Chronic obstructive airways disease, Chronic renal impairment.
Allergies:
Diagnostic Lab Data: Blood culture S Pneumoniae serotype 7F vaccine preventable strain.
CDC Split Type: WAES0611AUS00022

Write-up: Information was obtained on request by the company from the agency via a public case detail form concerning a 79 year old male with a history of chronic obstructive airways disease and chronic renal impairment who on 3/28/00 was vaccinated with Pneumococcal 23v polysaccharide vaccine. On 3/16/05 the pt was revaccinated with another dose of Pneumococcal 23v polysaccharide vaccine. Subsequently, after re vaccination with Pneumococcal 23v polysaccharide vaccine, the pt developed vaccine failure and was hospitalized. Blood culture were collected on admission which grew S pneumoniae which was sero grouped as 7F vaccine preventable strain. At the time of reporting to the agency on 9/12/06, the pt had died. The cause of death was unk. The agency considered that vaccine failure and pneumococcal infection were possibly related to therapy with Pneumococcal 23v polysaccharide vaccine. the original reporting source was not provided. Vaccine failure and pneumococcal infection were considered to be immediately life threatening. Additional information is not expected.


VAERS ID: 266834 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-11-13
Entered: 2006-11-15
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anaemia, Candidiasis, Dehydration, Diarrhoea, Hepatitis, Hepatosplenomegaly, Hyperkalaemia, Irritability, Laboratory test abnormal, Metabolic acidosis, Neonatal respiratory distress syndrome, Pancytopenia, Pyrexia, Rash, Respiratory failure, Thrombocytopenia, Vomiting
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatitis, non-infectious (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (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), Pseudomembranous colitis (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Neonatal disorders (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Myelodysplastic syndrome (broad), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Dehydration (narrow), Hypokalaemia (broad), Opportunistic infections (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Severe combined Immunodeficiency disease (SCID)
Allergies:
Diagnostic Lab Data: AFB was found in gastric aspirates, urine, blood (Mycobacterium bovis) and CSF. CMV was identified in her urine. Serum IgG and IgM levels were low, as were CD3, CD4, CD8 and CD19 and NK cell count.
CDC Split Type: 200603008

Write-up: A 4 months old female pt died an unspecified period of time after BCG vaccination (unk Manufacturer). Dose, site and route of administration were not reported. The pts concomitant vaccinations prior exposure to BCG vaccine were not reported. The pt had a medical history of severe combined immunodeficiency disease. On an unspecified date, the pt had received BCG vaccination. The objective, case and discussion of this article are detailed below. Objective to review the incidence of TB, disseminated BCG and SCID and discuss how to continue giving BCG vaccine in this high risk group with consideration of possible underlying immunodeficiency ID. Case four month old female pt infant presented with a 2 week history of fever, emesis, irritability and diarrhea. She was dehydrated, had oral thrush and a generalized rash. She also had hepatosplenomegaly and healing BCG scar on the L arm. She was anemic, thrombocytopenic and had metabolic acidosis. AFB was found in gastric aspirated, urine, blood (Mycobacterium bovis) and CSF. CMV was identified in her urine. Serum IgG and IgM levels were low, as were CD3, 4, 8 and 19 and NK cell counts. She received IV cefotaxime initially. Respiratory failure rapidly progressed, requiring intubation and ventilation on the 4th hospital day. Diarrhea and rash progressed, as did clinical hepatitis. Pancytopenia became evident, requiring transfusion. Family history was positive for sever combined Immunodeficiency or SCID. A bone marrow biopsy showed AFB even monocyte macrophages. Fluconazole, Isoniazid, Rifampin, Streptomycin, Ethambutol, Axithromycin and Fluoroquinolone were given. She received a bone marrow transplant from a half sibling on day 9. Clinical course was complicated by ARDS, hyperkalemia and intractable acidosis. Death occurred 9 days post BMT. Autopsy findings confirmed of Disseminated BCG. Therefore the benefits of BCG vaccination must be weight against the risk of administration to ID child.


VAERS ID: 267625 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2006-11-10
Submitted: 2006-11-21
   Days after onset:11
Entered: 2006-11-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / -
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Hypoxia, Pallor, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (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:
CDC Split Type: FRWYE589520NOV06

Write-up: Information regarding Prevnar was received from a healthcare professional regarding a 3 month old male pt who experienced sudden death. The pt received the first dose on 11/09/06. The pt had no medical history, particularly no history of either gastroesophageal reflux, or transient respiratory arrest, his birth was normal and he had no pertinent family history. Indication for Prevnar was immunisation. Product was administered on 11/9/06. Dose regimen was 1 dose (IM). Additional suspect medication included Tetravalent (diphtheria vaccine/haemophilus influenzae B/pertussis vaccine/tetanus vaccine) and Rotarix. Concomitant medications were not reported. The pt experienced sudden death on 11/10/06. The pt was fed by bottle at midday. In the afternoon while he slept on a double bed for an unspecified length of time (several minutes), he was found white and in respiratory arrest. After resuscitation by firemen, heart and respiratory rates reappeared. The pt was admitted in intensive care unit where heart and respiratory rates were artificially maintained by resuscitation. The investigations done for searching and infection were neg. Finally resuscitation was stopped on 11/12/06 and the pt died. Nuclear magnetic resonance imaging results normal was done on 11/10/06. Autopsy pending results was done on 11/12/06. The cause of death was reported as sudden death and an autopsy was performed, but results were not provided. No additional information was available at the time of this report.


VAERS ID: 267874 (history)  
Form: Version 1.0  
Age: 1.33  
Sex: Unknown  
Location: Foreign  
Vaccinated:2006-11-21
Onset:2006-11-22
   Days after vaccination:1
Submitted: 2006-11-27
   Days after onset:5
Entered: 2006-11-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-11-22
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHWYE624422NOV06

Write-up: Information regarding Prevnar was received from a healthcare professional via a regulatory authority regarding a 16 month old pt who experienced death. The pt received a dose on 11/21/06. Relevant medical history was not provided Indication for Prevnar was not provided. Product was administered on 11/21/06. Dose regimen was not provided. Additional suspect medication included Infanrix. Concomitant medications were not reported. The pt experienced death on 11/22/06. No additional information was available at the time of this report.


VAERS ID: 267939 (history)  
Form: Version 1.0  
Age: 0.12  
Sex: Female  
Location: Foreign  
Vaccinated:2006-11-03
Onset:2006-11-06
   Days after vaccination:3
Submitted: 2006-11-29
   Days after onset:23
Entered: 2006-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Blood potassium increased, HIV infection, Haemoglobin decreased, Neutropenia, Platelet count decreased, Pyrexia, Sepsis, Thrombocytopenia
SMQs:, Agranulocytosis (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-11-06
   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: Co-trimoxazole
Current Illness: Fever; Thrombocytopenia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: On 10/26/06, all laboratory test results were either within normal limits or not clinically significant except absolute neutrophils and potassium which measured 0.51x10^9/l (Grade III, normal rage = 2.00 - 8.00) and 6.1 mmol/l (Grade II, normal range = 4.1 - 5.3) respectively. On 10/31/06, hemoglobin was grade I and measured 9.9 g/dl (normal range = 10.0 - 15.0), platelet count was grade II at 46X 10^9/l (normal range = 140 - 350) and neutrophil count was grade I at 1.47X10^9/l (normal range = 2.00 - 8.00). All other tests performed on 10/31/06 were either within normal limits or considered not clinically significant. On 11/3/06, platelet count was grade III at 25 X 10^9/l and neutrophil count was grade II at 1.17 X 10^9/l. All other laboratory tests performed on 11/3/06 were either within normal limits or considered not clinically significant.
CDC Split Type: B0446409A

Write-up: This six week old female subject was enrolled in an open label collaborative study comparing three treatment strategies in infants with perinatally acquired HIV-1 infection diagnosed between 6 and 12 weeks of age. The subject received oral zidovudine at 65 mg twice per day from 11/3/06 to 11/6/06, oral lamivudine at 18 mg twice per day from 11/3/06 to 11/6/06 and oral Kaletra at 1 ml twice per day from 11/3/06 to 11/6/06. Co-suspect medication included the pneumococcal vaccine, Prevnar, which was also administered on 11/3/06 at dose 0.5 ml, diphtheria vaccine and tetanus vaccine and pertussis vaccine. Concomitant medications included Co-trimoxazole. On 11/6/06, three days after the start of zidovudine, lamivudine and Kaletra, the subject died. The cause of death was unknown. Treatment with zidovudine, lamivudine, Kaletra was discontinued on the same day. It was unknown whether an autopsy was performed. The site was informed of the subject''s death on 11/9/06. At the time of reporting no details of the subject''s condition prior to death was available; however, the mother of the subject was due to visit the site on 11/13/06 to provide further details. The investigator reported the death as possibly related to treatment with zidovudine, lamivudine, and Kaletra. The investigator also reported the death as possibly related to the pneumococcal vaccine, Prevnar. The investigator commented that details of the subject''s clinical condition was unknown and that this was a temporary association. The investigator further commented that the subject had also received diphtheria, tetanus and pertussis vaccines on 11/3/06 which are known to cause neurological sequelae. Follow up received on 11/16/06: The child was not taken to any health care facility. The death occurred at home. The mother had put the subject to sleep at 00:00 on 11/6/06 and when she went to check up on the child five hours later, the child had passed away. An autopsy was not performed. The site was aware of the death after the funeral had taken place. Treatment with the study medication was continued until the subject''s death. The subject did not have any pre-existing conditions. A blood test which was performed revealed a grade 3 thrombocytopenia which was not related to study medication (date performed unspecified). The subject had experienced fever with a body temperature of 38.1 degrees C on 11/4/06 and 38.7 degrees C on 11/5/06. The investigator reported that the cause of death was unknown and the association with the study drug was a temporal one. Therefore underlying sepsis could not be ruled out. The investigator further stated that diphtheria, tetanus and pertussis vaccines were administered which have neurological sequelae as part of their side effect profile and are considered co-suspect. Follow up received on 11/23/06: On 10/26/06, all laboratory test results were either within normal limits or not clinically significant except absolute neutrophils and potassium which measured 0.51x10^9/l (Grade III, normal rage = 2.00 - 8.00) and 6.1 mmol/l (Grade II, normal range = 4.1 - 5.3) respectively. On 10/31/06, hemoglobin was grade I and measured 9.9 g/dl (normal range = 10.0 - 15.0), platelet count was grade II at 46X 10^9/l (normal range = 140 - 350) and neutrophil count was grade I at 1.47X10^9/l (normal range = 2.00 - 8.00). All other tests performed on 10/31/06 were either within normal limits or considered not clinically significant. On 11/3/06, platelet count was grade III at 25 X 10^9/l and neutrophil count was grade II at 1.17 X 10^9/l. All other laboratory tests performed on 11/3/06 were either within normal limits or considered not clinically significant. The thrombocytopenia was considered clinically significant; however, onset was prior to the start of treatment with study medication. The investigator was unsure as to whether there was an underlying sepsis - no investigations or clinical examinations were undertaken that revealed sepsis. The subject''s temperature indicated pyrexia, however, the cause was unknown. The investigator further commented that it was not known whether there was a definite relationship between the event and the study drugs. The investigator stated that it was difficult to assess whether a relationship existed between the event and the anti-retrovirals, and the vaccine. The investigator went on to state that the time of initiation of the study drugs was the same, and this may be the only association.


VAERS ID: 268097 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-01
Entered: 2006-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic shock
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: B0448258A

Write-up: This case was reported by a physician and described the occurrence of anaphylactic shock in an adult female subject who was vaccainted with Hep B vaccine (Engerix B) for prophylaxis. A physician reported, that she heard from her boss, that a nurse died from anaphylactic shock after the 7th booster dose of Engerix B. The physician considered the event was possibly related to vaccination with Engerix B. Further information has been requested.


VAERS ID: 268100 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2006-11-20
Onset:2006-11-21
   Days after vaccination:1
Submitted: 2006-12-01
   Days after onset:10
Entered: 2006-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS A20CA270B / UNK LA / -
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS A20CA270B / UNK LA / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER A20CA270B / UNK LA / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-11-21
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: B0447980A

Write-up: This case was reported by a regulatory authority and described the occurrence of sudden death in a 1 year old subject of unspecified gender who was vaccinated with combined Infanrix-Polio-Hib, for prophylaxis. The child was previously healthy. Previous and or concurrent vaccination included pneumococcal vaccine, unspecified, unk, given on an unspecified date. On 11/20/06 subject received unspecified dose of Infanrix-Polio-Hib (unk). Shortly after, the child received also a dose of Prevnar. Within hours following vaccination with Infanrix Polio Hib, the subject was sub febrile and developed marked irritability. Eighteen hours after vaccination, the child died during his sleep. The regulatory authority reported that the events were possibly related to vaccination with Infanrix Polio Hib. The subject died on 11/21/06, cause of death was not reported. A autopsy was performed. The autopsy did not reveal any obvious cause of death such as bronchoaspiration or bacterial meningitis. Macroscopic examination results are pending.


VAERS ID: 268102 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2006-11-06
Onset:2006-11-06
   Days after vaccination:0
Submitted: 2006-12-01
   Days after onset:25
Entered: 2006-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK LA / SC

Administered by: Other       Purchased by: Other
Symptoms: Gastrooesophageal reflux disease, Myocardial infarction, Nausea
SMQs:, Acute pancreatitis (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-11-07
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Brachial plexus palsy, depressive troubles, diabetes mellitus, fibromatous uterus, gonarthrosis, hysterectomy, R mastectomy.
Allergies:
Diagnostic Lab Data:
CDC Split Type: B0447856A

Write-up: This case was reported by the regulatory authority and described the occurrence of myocardial infarctus in a 79 year old female subject who was vaccainted with Fluarix for prophylaxis. The subjects medical history included fibromatous uterus followed by an hysterectomy in 1979 and a right mastectomy. Concurrent medical conditions included right brachial plexus paralysis, depressive troubles, diabetes mellitus and gonarthrosis. Co-suspect medications included diltiazen (monotildiem LP), piribedil (Trivastal LP), insulin lispro (Insulin Humalog Mix) and semisodium valproate (Depakote). On 11/6/06, the subject received an unspecified dose of Fluarix (batch number not available), SC. The same day, she presented with gastroesophageal reflux and nausea. It was uncertain if these events appeared before or after the vaccination. In the evening, she began a treatment with Mopral and Vogalene. The subject died on 11/7/06 at 8:30, one day after vaccination with Fluarix, from a massive myocardial infarctus. It was unk whether an autopsy was performed. Myocardial infarctus was dubiously related to the vaccination with Fluarix and to co suspects medications. Causality relationship for the other events was not assessed. No more information will be available. This case has been closed.


VAERS ID: 268155 (history)  
Form: Version 1.0  
Age: 1.85  
Sex: Male  
Location: Foreign  
Vaccinated:1994-08-01
Onset:1996-03-01
   Days after vaccination:578
Submitted: 2006-11-29
   Days after onset:3925
Entered: 2006-12-04
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK UN / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Hypotonia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0611USA06434

Write-up: Information has been received from a health professional concerning a male who in august 1994, was vaccinated with a first dose of Hep B virus vaccine (manufacturer unk) (batch number not reported). Concomitant therapy that day included a first dose of poliovirus vaccine live oral (manufacturer unk) (batch number not reported) and a first dose of Dtap (batch number not reported). Following vaccination, he presented with severe hypotonia. The pediatrician prescribed a specialist consultation and physical therapy. The pediatrician of the local health unit interrupted vaccination with Dtap, but administered the second doses of Hep B (manufacture unk) (batch number not reported) and Poliovirus vaccine live oral (manufacturer unk) (batch number not reported) on 9/29/1994. The child died after prolonged agony in March 1996, at the age of approx 22 months old. No further information was available.


VAERS ID: 268156 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-01
Entered: 2006-12-04
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 3 UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Angiopathy, 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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRWYE655527NOV06

Write-up: Information regarding Prevnar was received from a healthcare professional regarding a 6 month old male pt who experienced pneumococcal meningitis, drug ineffective, vascular disorder and septicemia. The pt received the third dose in 2006. Relevant medical history was not provided. Indication for Prevnar was immunisation. Product was administered in 2006. Dose regimen was 1 dose. Concomitant medications were not reported. In 2006, the pt was hospitalized due to pneumococcal meningitis, drug ineffective. He then developed septicemia (sepsis), unspecified vascular disorder (angiopathy) and died on an unspecified date. Pneumococcus was provided to be of serotype 22F. The delay between the events and the last injection of Prevnar was not specified. The cause of death was reported as pneumococcal meningitis, sepsis and angiopathy. Lab test results Pneumococcus serotype was 22F was done on 2006. No additional information was available at the time of this report.


VAERS ID: 268706 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2006-11-22
Submitted: 2006-12-11
   Days after onset:19
Entered: 2006-12-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 4 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Coma, Hernia, Meningitis, Nervous system disorder, Pyrexia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Premature baby
Allergies:
Diagnostic Lab Data: 11/22/06 Blood culture negative for streptococcus pneumoniae, body temp high fever, CSF culture neg for streptococcus pneumoniae.
CDC Split Type: ESWYE716301DEC06

Write-up: Information regarding Prevnar was received from a healthcare professional regarding a 2 year old male pt who experienced meningitis bacterial. The pt received the fourth dose on an unspecified date. The pt experienced meningitis bacterial on 11/22/06 and was hospitalised. The pt attended the ER with a high fever, status of coma and due to intensive care unit overloaded was transferred to another hospital. The pt was diagnosed of meningitis bacterial nd chemoprofilactic treatment was administered. The pt died as a consequence of the event and the cause of death was reported as brain herniation. Further information has been requested. No additional information was available at the time of this report.


VAERS ID: 268885 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Malaise
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: B0449781A

Write-up: This case was reported in a literature article and described the occurrence of sudden death in a 75 year old subject of unspecified gender who was vaccainted with influenza virus vaccine, manufacturer unspecified, for prophylaxis. On an unspecified date the subject received unspecified dose of Influenza vaccine as well as an unspecified prescriptions medication. Two days after vaccination with Influenza vaccine, the subject started feeling unwell. Eight days later, the subject died. The author considered the events were related to vaccination with Influenza vaccine and the co administered unspecified medication. the subject died, cause of death is not specified.


VAERS ID: 269006 (history)  
Form: Version 1.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-11
Entered: 2006-12-18
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal discomfort, Alanine aminotransferase increased, Anorexia, Ascites, Aspartate aminotransferase increased, Blood bilirubin increased, Blood creatinine increased, Cholestasis, Coma, Depressed level of consciousness, Fatigue, Hepatic encephalopathy, Hepatic failure, Hepatic fibrosis, Hepatitis, Jaundice, Laboratory test abnormal, Liver disorder, Multi-organ failure, Nausea, Oedema peripheral, Prothrombin level increased, Renal failure, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Hepatitis, non-infectious (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (narrow), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: Renal transplant
Allergies:
Diagnostic Lab Data: Hepatic Biopsy diffused ground glass hepatocytes, cholestasis C infiltration of lymphocytes expand portal fibrosis. Serum creatinine at the time renal transplant was done 1.5 mg/dl 72 months prior to admission 2.5 mg/dl 26 months prior to admission 2.9 mg/dl 8 weeks prior to admission 2.6 mg/dl, Serum hepatitis B surface Ab negative before renal transplant and hepatitis B vaccination, Serum hepatitis B surface Ab positive on admission 400 mIU/ml positive 3 weeks before admission 40 mIU/ml, total plasma bilirubin 3 weeks prior to admission 1.1 mg/dl on admission 20 mg/dl, serum hepatitis b surface antigen test negative before renal transplant and hepatitis B vaccine, serum hepatitis B DNA test positive on admission, plasma hepatitis C RNA test negative on admission, Serum hepatitis E antibody test positive on admission, Serum hepatitis A antibody test negative on admission, serum hepatitis C antibody test negative on admission, prothrombin time on admission 20 sec (control 10-13sec), plasma alanine aminotransferase test about 6 weeks prior to admission 219 u/l, serum hepatitis C antibody test positive 3 weeks before admission, plasma aspartate aminotransferase test on admission 253 IU/l, direct plasma bilirubin test on admission 14.4 mg/dl, plasma alanine aminotransferase test on admission 192 IU/l, serum hepatitis B surface antigen test negative 3 weeks prior to admission, plasma alanine aminotransferase test 3 weeks prior to admission 418 u/l.
CDC Split Type: WAES0611THA00013

Write-up: It was reported in a published article, that a 58 year old male, post kidney transplantation was admitted to hospital because of progressive jaundice and alteration of consciousness. thirteen years ago, he underwent living related KI due to end stage renal disease. He received a kidney graft from his identical HLA typing brother. Prior to the transplantation, the patient had negative testing for HBsAg and anti HBsAb and had received three double dosages (2x20mg) of hepatitis B vaccination. It is unfortune that pre KT HBV markers of the patient were not known. HBV markers of the donor were negative for HBsAg and positive for both anti HBsAb and anti HBcAb. The archieved nadir of serum creatinine since KT was done was 1.5mg/dl. Maintenance immunosuppressions consisted of cyclosporin and prednisolone. Seventy two months prior to admission. His creatinine level was 2.5mg/dl. So the dosage of cyclosporin was reduced by 50% and mycophenolate Mofetil (1.5 gm/day) was added. Twenty six months PTA, his creatinine level was 2.9 mg/dl. Cyclosporin was gradually eliminated and the dose of MMF was increased to 2 gm/day. In addition, Sirolimus (2 mg/day) was added while the dosage of prednisolone was kept at 5 mg/day. Sirolimus level was 5.1 ng/ml. Subsequently, serum creatinine level declined to 2.3 mg/dl. Eight weeks PTA, his creatinine level was 2.6 mg/dl. A few weeks after that, he developed fatigue and had alt of 219 IU/L without jaundice. He denied alcohol drinking, recent new drugs or herbal medicine usage. Three weeks PTA, ALT was 418 IU/L, total bilirubin was 1.1 mg/dl and he felt increasingly fatigued. The HBsAg assay by Ortho Vitros ECi was negative. Anti HbsAb was positive at 40 mIU/ml. Anti HbcIgG was positive as well. All potential hepatotoxic agents and sirolimus were stopped. Cyclosporin and prednisolone were continued as a maintainance immunosuppression. The patient had progressive jaundice, loss of appetite, nausea, vomiting, and abdominal discomfort. On admission physical examination revealed deep jaundice, ascites. bilateral leg edema, and grade II hepatic encephalopathy. Laboratory test showed AST of 253 IU/l, ALT of 192 IU/L, total bilirubin of 20 mg/dl, direct bilirubin of 14.4 mg/dl, and prothrombin time of 20 sec (control 10-13 sec). Anti HbcIgM, anti HAVIgM and antibody to Hepatitis C anti HCV markers were all negative. Anti HBcIgG and anti AbsAb were positive (with the rising of anti HBsAb titer to 400 mIU/ml. HBeAg and anti HBeAb were negative and positive, respectively. HCV RNA was negative but HBV DNA was positive by qualitative polymerase chain reaction. HBV DNA (Amplicor HBV monitor test, Roche Diagnostic systems) was 535,000 copies/ml. Repeated HBsAg by enhanced chemiluminescence assay (Ortho Vitros ECi) was 0.17 signal cutoff (s/c) or negative (i.e. less that 1.00 s/c) but it was positive (0.31 IU/ml cutoff 0.05 IU/ml) by automated chemiluminescent micropatarticle immunoassay (Architech HBsAg QT). Diffused ground glass hapatocytes, cholestasis with some infiltrations of lymphocytes and expanding portal fibrosis was revealed from the liver pathology. Immunohistochemistry examination showed strongly positive staining of HBsAg and HBcAg in hepatocytes. Lamivudine (100 mg/day) was started promptly and fully supportive treatment was given. Nevertheless, his clinical course of fulminant hepatitis deteriorated with the development of hepatic coma and renal failure. He was listed for liver transplantation but the liver organ was not available in time. He expired from multiple organ failure at one month after lamivudine therapy. It is concluded that HBV harboring surface mutant of Hepatitis B surface gene was thought to be the cause of acute fulminant hepatitis despite the presence of proactive immunity to wild type HBV. The patient expired from acute liver failure even though an antiviral drug was started promptly. This is the first case report of liver biopsy suggestive of acute fulminating HBV that developed in a long term kidney recipient despite the presence of high anti HBsAb titer. Additional information is not expected.


VAERS ID: 269422 (history)  
Form: Version 1.0  
Age: 0.26  
Sex: Female  
Location: Foreign  
Vaccinated:2006-11-28
Onset:2006-12-01
   Days after vaccination:3
Submitted: 2006-12-19
   Days after onset:18
Entered: 2006-12-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 23612 / 1 - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-12-01
   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: UNK
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEWYE768607DEC06

Write-up: Information regarding Prevnar was received from a pediatrician regarding a 3 month old female patient who experienced sudden infant death syndrome. The patient received the first dose on 28 Nov 2006. The patient has a past history of normal new born (not a premature baby). The child was healthy and did not have any diseases. The family is socially disadvantaged. At least one of the parents is a smoker. Past therapies included Infanrix Hexa which was administered on 31 Oct 2006 and was tolerated well. The patient experienced sudden infant death syndrome 2 1/2 days after vaccination with Prevnar and Infanrix Hexa on 12/01/2006. The patient died at home. It was reported that the flat was untidy and smelled of cigarette smoke. Death was determined by an emergency physician who had been called. The child was brought to hospital. An autopsy was ordered by the Public Attorney''s office. No abnormal findings were detected. The reporting pediatrician (who did not determine the patient''s death) does not see a causal relationship between vaccination and the child''s death. The cause of death was reported as sudden infant death syndrome and the autopsy cause of death was no findings.


VAERS ID: 269766 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2006-09-22
Submitted: 2006-12-27
   Days after onset:96
Entered: 2006-12-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Bacterial infection, Blood sodium increased, CSF test abnormal, Depressed level of consciousness, Diabetes insipidus, Drug ineffective, Electroencephalogram abnormal, Headache, Laboratory test abnormal, Meningitis, Pneumonia, Polyuria, Pyrexia, Sepsis
SMQs:, Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-09-25
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Encephalopathy, HIV infection.
Allergies:
Diagnostic Lab Data: In Sept 2006 test results were Glasgow coma scale during hospitalization 8, blood culture positive for S pneumoniae serotype 18C, electroencephalogram abnormal absence of electric activity, CSF culture positive for S Pneumoniae serotype 18C, and blood sodium increased during hospitalization. On 22 Sep 2006 test were Glasgow coma scale results 13, otoscopy abnormal, and body temperature 38.5 deg C.
CDC Split Type: ESWYE906120DEC06

Write-up: Information regarding Prevnar was received from an investigator in a post marketing surveillance study regarding a 13 year old male participant. Four years after the Prevnar launch who experienced pneumococcal meningitis, vaccination failure, central diabetes insipidus and pneumococcal sepsis. The participant received the third dose on an unspecified date. The patient experienced pneumococcal meningitis, vaccination failure, central diabetes insipidus and pneumococcal sepsis on 22 Sep 2006 and was hospitalized. The patient was hospitalized with fever, consciousness level altered, meningeal signs negative, average status, not valuable fontanela, abdominal pain and headache. The patient had fever during 4 days and poliuria. The patient was treated with 200 mg/kg of Cefotaxime during four days, 60 mg/kg of Vancomycin during 4 days, 0.6 mg of Dexamethasone during 4 days, 5 mg/kg of Dopamine during two days, 1-2 mg every 8 hours of Dermopresine and hypertonic serum. On 25 Sept 2006 the patient died. The cause of death was reported as meningitis Pneumococcal and pneumococcal sepsis. The assessments of the investigators and medical monitors for meningitis pneumococcal, pneumococcal sepsis, diabetes insipidus and vaccination failure were unknown. No additional information was available at the time of this report.


VAERS ID: 269926 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Female  
Location: Foreign  
Vaccinated:2006-12-13
Onset:2006-12-13
   Days after vaccination:0
Submitted: 2006-12-28
   Days after onset:15
Entered: 2007-01-02
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR Z0602 / UNK LA / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal distension, Agitation, Anorexia, Cardiac disorder, Chromaturia, Coma, Crying, Cyanosis, Dehydration, Diarrhoea, Dysphonia, Dyspnoea, Encephalopathy, Eye disorder, Eye movement disorder, Hepatocellular damage, Hypercapnia, Hypertonia, Hypoxia, Lacrimation decreased, Muscle twitching, Nasal congestion, Neutropenia, Oliguria, Pallor, Peripheral coldness, Pyrexia, Renal disorder, Skin disorder, Somnolence, Staring, Vomiting, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Agranulocytosis (broad), Asthma/bronchospasm (broad), Haematopoietic leukopenia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (narrow), Anticholinergic syndrome (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Lacrimal disorders (narrow), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-12-20
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: The subject''s temperature was 97.6 degrees F, R= 60, P=130, BP=70/33 mmHg, the physical exam showed narcosis, shortness of breath, breath by mouth, looking cyanotic, pale lips, marbling skin, cold peripheral limbs and trunk, poor skin elasticity, depressed anterior fontanelle, hollow eyes, no tears when crying, staring eyes, pupils 2.5 mm, poor light reflex, "nasal ala" flapping obviously, rough sound breath with course rales, regular rhythm, no murmurs, abdominal distention "without absent bowel sound", hypomyotonia, pathological reflex not found. Lab tests revealed WBC= 22.3 x 10^9/L with N= 45.4%, L= 38.4%. Blood chemical indicators were abnormal revealing heart damage, liver damage and renal damage.
CDC Split Type: 200603570

Write-up: A 02 month old female patient, with no medical history reported, experienced toxic encephalopathy, diarrhea and severe dehydration the same day after receiving her 1st intramuscular dose of ActHib, batch number Z0602-1, in the left deltoid, concomitantly with her 1st dose of OPV (other MFR) on 13 December 2006. On 13 December 2006, the patient experienced diarrhea, vomiting and sopor leading to the visit of the local sanitary unit. The pediatrician was absent therefore the patient was hospitalized the same day. The patient''s parents told the physicians that before 2 day i.e. 13 December 2006, the patient had cold and then threw up. Initially those episodes were occasional, however the patient''s condition got worse and she had frequent episodes of vomiting, she could not eat something, she had bowel movements from 3-4 times/day to more than 10 times/day. She also presented with watery stools, oliguria with yellow discoloration of urine, crying hoarse. 1.5 hour later, the patient became soporose and twitch, with poor response and eyes turnover. The situation got worse and the patient was transferred to an other hospital on 16 December 2006. The subjects temperature was 36.4C, R=60, P=130, BP=70/33 mmHg. The physical exam showed narcosis, shortness of breath, breath by mouth, looking cyanotic, pale lips, marbling skin, cold peripheral limbs and trunk, poor skin elasticity, depressed anterior fontanelle, hollow eyes, no tears when crying, staring eyes, pupils 2.5mm, poor light reflex, nasal ala flapping obviously, rough sound of breath with coarse rales, regular rhythm, no murmurs, abdominal distention without absent bowel sound, hypomyotonia, pathological reflex not found. Lab test revealed WBC=22.3x 10^9/l with N=45.4%, L=38.4%. Blood chemical indicators were abnormal revealing heart damage, liver damage and renal damage. The patient received fasting and Oxygen inhalation, monitoring of vital signs and polyparamaters, CEFUROXIME, NS (sodium chloride) to expand blood volume and Sodium bicarbonate to correct acid/base balance. The baby died on 20 December 2006. The diagnosis needed to be confirmed. According to the local doctor, the event might be related to the vaccine.


VAERS ID: 269983 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Unknown  
Location: Foreign  
Vaccinated:2006-11-03
Onset:2006-11-27
   Days after vaccination:24
Submitted: 2007-01-02
   Days after onset:36
Entered: 2007-01-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1109F / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Diarrhoea
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Laxatives (unspecified) Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0612USA04011

Write-up: Information has been received from a health professional concerning a child who was vaccinated with a dose of Rotavirus vaccine. Subsequently the patient developed diarrhea. As was "apparently customary" the patient received laxatives and later died from a combination of those two things. The reporter did not ascribe the death to be due to vaccination with Rotavirus vaccine, rather he felt that the death was due to inappropriate laxative use in association with the child''s diarrhea. No further information was provided. Additional information is not expected.


VAERS ID: 270493 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2006-05-30
Onset:0000-00-00
Submitted: 2007-01-15
Entered: 2007-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS C2389AA / UNK - / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS C2389AA / UNK - / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER C2389AA / UNK - / IM
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER 19193 / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Bronchiolitis, Pneumonia
SMQs:, Interstitial lung disease (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: 2006-06-01
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Paracetamol
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: B0452429A

Write-up: This case was reported by regulatory authority and described the occurrence of bronchiolitis in a 8 week old female patient who was vaccainted with Dtap-IPV-HIB, meningococcal polysaccharide vaccine group C for prophylaxis. Concurrent medications included Paracetamol. On 30 May 2006 the patient received unspecified dose of Dtap-IPV-HIB (1 injection, intramuscular), and an unspecified dose of Meningococcal polysaccharide vaccine group C (1 injection, intramuscular). At an unspecified time after vaccination with Dtap-IPV-HIB, meningococcal polysaccharide vaccine group C, the patient experienced bronchiolitis and bronchopneumonia. However, 5 days prior to vaccination, the patient''s mother reported chesty. The patient''s GP examined the patient and stated that the patient was not unwell enough not to have vaccination. The patient died on 1 June 2006 from bronchiolitis and bronchopneumonia. An autopsy was performed. Reporter comments not sure if paracetamol was given to patient.


VAERS ID: 270494 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: Foreign  
Vaccinated:2006-10-24
Onset:2006-10-25
   Days after vaccination:1
Submitted: 2007-01-15
   Days after onset:82
Entered: 2007-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS A20CA240QB / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 22237 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Laboratory test abnormal, Leukocytosis, Lymphocytosis, Sudden infant death syndrome
SMQs:, Neuroleptic malignant syndrome (broad), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-10-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Paracetamol
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: B lymphocyte count Oct2006 increased, IgA low limit, IgG low limit IgM normal, Leukocyte count NOS 21.82 Giga/L, Protein 75 g/L. A lymphocytic typing was performed and showed B and NK lymphocytosis.
CDC Split Type: B0453212A

Write-up: This case was reported and described the occurrence of sudden infant death in a 4 month old male subject who was vaccinated with Infanrix Quinta and Prevnar for prophylaxis. Concurrent medication included paracetamol. The subject''s mother was 33 years old and was Rhesus A positive. The pregnancy had a normal evolution. The delivery was normal at 41 weeks of amenorrhea. At birth, he weight 3.21 kg with APGAR score at 6-10-10. Then, the subject had a normal height and weight growth and normal development. Past vaccinations included the first dose of Infanrix Quinta (batch number not available) and the first Prevnar, given on 24 September 2006, well tolerated. On 24 October 2006, clinical examination was normal. The subject was in good health. The subject was vaccinated with a 2nd dose of Infanrix Quinta (batch number A20CA204QB, intramuscular) and a 2nd dose of Prevnar (batch number 22237, intramuscular). He ate well and had an usual behaviour. At 21:30, the subject was put to bed on back sleeping position. On 25 October 2006, at 5:00, less than one day after vaccinations, the subjects father discovered his done dead (sudden infant death). No vomiting was noted. The subject presented with rigidity and deathly lividity. An autopsy was performed. No dysmorphy was observed. Liver was palpable ( 2 to 3 cm). No splenomegaly was noted. Anatomo-pathological examination of thoracic and abdominal organs did not reveal a cause of death. Several biological check up were performed. The results showed an increase of proteins at 75 g/l. IgG and IgA level was at lower limit and IgM level was normal. As well, the subject presented with hyperleukocytosis at 21.82 Giga/L. The lymphocytic typing showed B and NK lymphocytosis. It was considered that the events were dubiously related to vaccination with Infanrix Quinta and Prevnar. No more information will be available. This case has been closed.


VAERS ID: 270519 (history)  
Form: Version 1.0  
Age: 0.15  
Sex: Male  
Location: Foreign  
Vaccinated:2007-01-03
Onset:2007-01-04
   Days after vaccination:1
Submitted: 2007-01-12
   Days after onset:8
Entered: 2007-01-16
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cyanosis, Respiratory disorder, Skin warm
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-01-04
   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: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLWYE059008JAN07

Write-up: This case was considered medically important (OMIC). Information regarding Prevnar was received from a healthcare professional regarding an 8-week-old male who experienced breathing irregular and death. The patient received a single dose on 03-Jan-2007. The patient was immunized at 14:30 on 3-Jan-2007 without problems. His skin felt warm at 01:00 AM on 4-Jan-2007, and again upon checking at 09:00 AM. At 09:30 AM (4 Jan ''07), he experienced breathing irregular and cyanosis. The patient was taken to the hospital, where he was found to be dead. The reported mentioned risk factors for SIDS, but did specify which ones and did not report SIDS as a diagnosis. No additional information was available at the time of this report.


VAERS ID: 270524 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Female  
Location: Foreign  
Vaccinated:2007-01-10
Onset:2007-01-11
   Days after vaccination:1
Submitted: 2007-01-15
   Days after onset:4
Entered: 2007-01-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM
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: 2007-01-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEWYE118511JAN07

Write-up: Information regarding Prevnar was received from a healthcare professional regarding a 1 year old patient who experienced death. The patient received the first dose on 10 Jan 2007. The patient was found dead by an emergency physician (death) on 11 Jan 2007. At time of report no further information was available. The cause of death was reported as unk.


VAERS ID: 270765 (history)  
Form: Version 1.0  
Age: 1.51  
Sex: Female  
Location: Foreign  
Vaccinated:2006-12-29
Onset:2006-12-31
   Days after vaccination:2
Submitted: 2007-01-17
   Days after onset:17
Entered: 2007-01-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: CSF test, Drug ineffective, Full blood count, Meningitis pneumococcal
SMQs:, Lack of efficacy/effect (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-01-01
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ceftriaxone, unknown
Current Illness:
Preexisting Conditions: The patient''s concurrent illness includes sickle cell anemia (Patient was taking Folic acid 5mg daily since April 2006) with a past history of adentonsillectomy (Adentonsillectomy was done 2 weeks prior to vaccination with Prevnar).
Allergies:
Diagnostic Lab Data: Lumbar puncture (results still awaiting CSF result from lab) and full blood count (results: still awaiting lab results were done on 01-Jan-2007.
CDC Split Type: ZAWYE110311JAN07

Write-up: Information regarding Prevnar was received from a healthcare professional regarding a 17-month-old female patient who experienced pneumococcal meningitis and ineffective drug 2 days after receiving his first dose of Prevnar on 29-Dec-2006. The patient experienced pneumococcal meningitis on 31-Dec-2006. The cause of death was reported as meningitis pneumococcal. Patient died on 01-Jan-2007. No autopsy was performed. No additional information was available at the time of this report.


VAERS ID: 271486 (history)  
Form: Version 1.0  
Age: 6.0  
Sex: Male  
Location: Foreign  
Vaccinated:2006-04-01
Onset:2006-12-01
   Days after vaccination:244
Submitted: 2007-01-29
   Days after onset:59
Entered: 2007-01-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthma, Brain death, CSF test abnormal, Convulsion, Cough, Culture throat positive, Diabetes insipidus, Encephalocele, Headache, Inappropriate antidiuretic hormone secretion, Influenza, Meningitis pneumococcal, Meningitis viral, Mydriasis, Pupillary reflex impaired, Pyrexia, Rhinitis allergic, Rhinorrhoea, Sinusitis, Streptococcus serology positive, Vaccination failure, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (narrow), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Congenital, familial and genetic disorders (narrow), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: ASTHMA, RHINITIS
Preexisting Conditions: MENINGITIS VIRAL, MENINGITIS
Allergies:
Diagnostic Lab Data: CSF culture 00-Dec-2006 Streptococcus pneumoniae, 03-Jan-2007 no growth Culture throat 00-Dec-2006 positive for influenza type Streptococcal serology 28-Dec-2006 Streptococcus pneumonia serotype 6B in blood and CSF
CDC Split Type: HQWYE114102JAN07

Write-up: Follow-up information was received that provided additional events, medical history, course of illness, treatment, event outcome and death date. This case was considered medically important for the events of influenza, sinusitis inappropriate antidiuretic hormone secretion and diabetes insipidus. Information regarding Prevnar was received from a pediatrician regarding an male patient who received the first dose in Apr-2006 at the age of 5 years. On 19-Dec-2006, at the age of 6 years, the child developed meningitis caused by Streptococcus pneumoniae serotype 63. On an unspecified date in Jan-2007, the patient died. In April-2006, the patient received a dose of Prevnar. On 19-Dec-2006, the child was hospitalized for headache, fever, rhinorrhea, mild cough and vomiting. The patient was initially diagnosed with paranasal sinusitis and allergic rhinitis. Treatment included Augmentin. Due to persistent fever, a throat culture was performed and was positive for influenza type B. On 25-Dec-2006, day 7 of hospitalization, the child experienced a sudden onset of severe headache and was transferred to the intensive care unit for conscious disturbance with pupil dilation and sluggish light reflex. On 28-Dec-2006, streptococcal serology of blood and cerebrospinal fluid samples revealed Streptococcus pneumoniae serotype 6B (vaccination failure) (meningitis pneumococcal). Treatment included vancomycin Claforan, erythromycin, acyclovir and Tamiflu, Mannitol, Decadron and Dilantin were used to treat seizure-like movement. On 03-Jan-2007. day 16 of hospitalization, a follow-up CSF culture showed no growth. On 04-Jan-2007, day 17 of hospitalization, the child was declared "brain" dead. On 06-Jan-2007, day 19 of hospitalization, a DNR was signed, and the parents agreed to have the patient decannulated. On 10-Jan-2007, the patient expired. The cause of death was not reported. Additional diagnoses included right maxillary sinusitis, craniopharyngeal canal with suspected encephalocele, diabetes insipidus and suspected syndrome of inappropriate antidiuretic hormone . See Relevant Tests/Laboratory Data: below. This report was received, reference number. No additional information was available at the time of this report.


VAERS ID: 271602 (history)  
Form: Version 1.0  
Age: 0.42  
Sex: Male  
Location: Foreign  
Vaccinated:2007-01-25
Onset:2007-01-25
   Days after vaccination:0
Submitted: 2007-02-01
   Days after onset:7
Entered: 2007-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (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: 2007-01-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0455719A

Write-up: This case was reported by a sales representative and described the occurrence of sudden death in a 5 month old male subject who was vaccinated with Hiberix, Oral polio vaccine (unknown manufacturer) and Dtpa for prophylaxis. A physician or other health care professional has not verified this report. On 25 January 2007 the subject received unspecified dose of Hiberix (intramuscular, unknown), unspecified dose of Oral polio vaccine (Oral), unspecified dose of Dtpa (unknown). On 25 January 2007, 2 hours after vaccination with Dtpa, Hiberix and Oral polio vaccine, the subject was found dead at home. The subject died on 25 January 2007, cause of death was not reported. It was unknown whether an autopsy was performed.


VAERS ID: 271911 (history)  
Form: Version 1.0  
Age: 1.67  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2006-12-07
Submitted: 2007-02-06
   Days after onset:61
Entered: 2007-02-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 4 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiopulmonary failure, Immunology test normal, Meningitis pneumococcal, Septic shock, Vaccination failure
SMQs:, Cardiac failure (narrow), Lack of efficacy/effect (narrow), Toxic-septic shock conditions (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-12-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Immunology test (results: normal) was done on 07-Dec-2006
CDC Split Type: ESWYE522305FEB07

Write-up: Information regarding Prevnar was received from a healthcare professional regarding a 20 month old male patient who experienced pneumococcal meningitis, drug ineffective, Cardio respiratory failure and septic shock. The patient received the fourth dose on an unspecified date. The patient experienced pneumococcal meningitis, drug ineffective, Cardio respiratory failure, and septic shock on 07-Dec-2006 and was hospitalized. Specific treatment was Cefotaxime, Vancomycin, Fenitoin and Dexamethasone was administered to the patient. On 07-Dec-2006 the patient died. Immunology test (results normal) was done on 07-Dec-2006. The cause of death was reported as meningitis pneumococcal, septic shock and cardiopulmonary failure. No additional information was available at the time of this report.


VAERS ID: 271963 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Female  
Location: Foreign  
Vaccinated:2007-01-09
Onset:2007-01-30
   Days after vaccination:21
Submitted: 2007-02-07
   Days after onset:8
Entered: 2007-02-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0595F / 1 UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-01-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Adaptation abnormal
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA00111

Write-up: Information has been received from a health professional concerning a 12-month-old female with a history of postnatal adaption disorder for which she was monitored for a day without any conspicuousness, who on 09-Jan-2007 was vaccinated subcutaneously into the upper arm with a first dose of MMR II (lot#654236/0595F, batch#NE12410). Secondary suspect vaccination included a booster dose of Infanrix given IM into the other arm. During the night from 30-Jan-2007 the patient was found dead. An autopsy was carried out on 31-Jan-2007, no cause of death was found. It was reported by the fire fighters (the fire brigade had been called) that the girl was completely covered by her blanket when she was found. The reporter did not see a causal relation to the vaccines. All previous vaccinations were well tolerated: Infanrix and Prevnar. Other business partner numbers included: E2007-00732. No further information is available.


VAERS ID: 272187 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Female  
Location: Foreign  
Vaccinated:2006-12-12
Onset:2006-12-14
   Days after vaccination:2
Submitted: 2007-02-12
   Days after onset:60
Entered: 2007-02-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 2 - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Respiratory syncytial virus infection, Unevaluable event
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-12-14
   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: UNK
Allergies:
Diagnostic Lab Data: Autopsy (results: except for Respiratory Syncytial Virus found in the lung, the autopsy returned negative and did not find any etiology explaining the sudden death) was done in Dec-2006.
CDC Split Type: FRWYE564107FEB07

Write-up: Information regarding Prevnar was received from a healthcare professional via a foreign regulatory authority regarding a 4 month old female patient who experienced sudden unexplained death. The patient received the second dose on 12-Dec-2006. The patient had no relevant medical history. Indication for Prevnar was immunization. Product was administered on 12-Dec-2006. Dose regimen was 1 dose 1 time per day. Additional suspect medication included Infanrix-quinta. Concomitant medications were not reported. The patient experienced sudden death on 14-Dec-2006, 48 hours after having received the second doses of Prevnar and Infanrix-quinta. The patient was in good health and had not have any problem until that time. The circumstances of death were not provided. The autopsy returned negative and did not find any etiology explaining the sudden death. The cause of death was reported as unknown. No additional information was available at the time of this report.


VAERS ID: 272257 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2007-02-01
Onset:2007-02-04
   Days after vaccination:3
Submitted: 2007-02-14
   Days after onset:10
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 23832 / 1 - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-02-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Autopsy 05-Feb-2007 unknown
CDC Split Type: DEWYE584108FEB07

Write-up: Information regarding Prevnar was received from a healthcare professional via a regulatory authority regarding a 9 week old male patient who experienced sudden infant death syndrome. The patient received the first dose of 01-Feb-2007. The patient experienced sudden infant death syndrome on 04-Feb-2007. An autopsy was performed on 05-Feb-2007. Results are unknown. Autopsy (results: unknown) was done on 05-Feb-2007. The cause of death was reported as Sudden infant death syndrome and an autopsy was performed, but results were not provided. No additional information was available at the time of this report.


VAERS ID: 272379 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Female  
Location: Foreign  
Vaccinated:2006-12-12
Onset:2006-12-14
   Days after vaccination:2
Submitted: 2007-02-15
   Days after onset:63
Entered: 2007-02-15
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 - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Respiratory syncytial virus infection, Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2006-12-14
   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:
Current Illness: UNK
Preexisting Conditions: The subject had no relevant past medical history.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0457922A

Write-up: This case was reported by the Regulatory Authority and described the occurrence of sudden infant death in a 4-month-old female subject who was vaccinated with Infanrixquinta and Prevnar for prophylaxis. The subject had no relevant past medical history. On 12 December 2006, the subject received a 2nd dose of Infanrixquinta (batch number not available) and a 2nd dose of Prevnar (batch number not available). On 14 December 2006, two days after these vaccinations, the subject died from sudden infant death. No etiology was found. An autopsy was performed. The result was negative except a positive respiratory syncytial virus isolated at lung level. The regulatory authority reported that the events were life threatening and the patient died, and that the events were dubiously related to vaccination with Infanrix Quinta and Prevnar. No more information will be available. This case has been closed.


VAERS ID: 272717 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Female  
Location: Foreign  
Vaccinated:2007-02-02
Onset:2007-02-02
   Days after vaccination:0
Submitted: 2007-02-19
   Days after onset:17
Entered: 2007-02-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0755R / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal distension, Anaphylactic shock, Aspiration bronchial, Bladder sphincter atony, Cardiac arrest, Chest X-ray abnormal, Compartment syndrome, Convulsion, Death, Electroencephalogram normal, Eye rolling, Hypoventilation, Intensive care, Multi-organ failure, Oedema, Oxygen supplementation, Renal failure, Resuscitation, Scan brain, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (broad), Convulsions (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (narrow), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Hypokalaemia (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-02-05
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: chest x-ray 03?Feb07 Comment: Bronchoaspiration, electroencephalopathy 03?Feb07 Comment: plain, computed axial tomography 03?Feb07 Comment: Norma - Brain
CDC Split Type: WAES0702ARG00001

Write-up: Information has been received from a physician concerning a 35 month old female who on 02-FEB-2007 was vaccinated with Pneumovax at 8:00 pm. There was no concomitant medication. On 02-FEB-2007 20 seconds after vaccine application the patient experienced anaphylactic shock and was hospitalized. At 9:30 pm aprox the patient was placed on a pediatric intensive care unit with respiratory assistance, Resuscitation technique and treatment were performed and on 02-FEB-2007 the patient died at 5:00am. The cause of death was anaphylactic shock which generated peritoneal compartment syndrome, renal failure, multi organ failure. The reporter felt the anaphylactic shock was related to therapy with Pneumovax vaccine. Anaphylactic shock was considered to be other important medical event. Additional information is not expected. The following is a translation of an e-mail from the primary report. On Friday 2nd of February 2007, at 08:00pm Pneumovax 23 was administered to a female child in an injectable (a place where injections are applied). Theoretically the vaccine was administered in the buttock (intramuscular? Physician guess so). Her mother was holding her so the male nurse can apply the vaccine. Her mother comments "20 seconds after the vaccine was applied, she looked at me and her small eyed went back and faint". By car she was taken to a clinic. During the way to the clinic, her bladder sphincter relaxed and she could feel her heart beating. According to ER when she arrived she was on cardiac arrest. When trying to give respiratory assistance, the anesthesiologist referred liquid in the larynx. Rescue maneuvers were done. She was administered HC03, adrenaline, atropine and nasogastric probe was set. First she recovered the cardiac rhythm and then the breathing, which was irregular and weak. She was then transferred to the hospital''s intensive care unit with mechanical respiratory assistance, dopa and antibiotics. Analysis performed blood, brain computer tomography (edema), thorax X ray. She had convulsions and oligoanuria with abdominal distention (free liquid was drained from the peritoneal cavity), compartmental syndrome. She entered in multi organ failure and died on February 5, 2007 at 5:00am. The physician diagnosed anaphylactic shock which was the cause of death.


VAERS ID: 272788 (history)  
Form: Version 1.0  
Age: 0.42  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-16
Entered: 2007-02-21
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 3 - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Laboratory test abnormal, Meningitis pneumococcal, Pyrexia, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: 00-Dec-2006 Pneumococcus was identified to be serogroup 3
CDC Split Type: FRWYE666214FEB07

Write-up: Information regarding Prevnar was received from a healthcare professional regarding a 5 month old male patient who experienced meningitis pneumococcal. The patient received the third dose in 2006. The patient was hospitalized due to fever in Dec-2006. He was diagnosed meningitis pneumococcal (drug ineffective) and died in Dec-2006. The cause of death was reported as meningitis pneumococcal. The pneumococcus was identified to be serogroup 3. Laboratory test (results Pneumococcus was identified to be serogroup 3) was done in Dec-2006. No additional information was available at the time of this report.


VAERS ID: 273019 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2006-12-28
Onset:2007-01-04
   Days after vaccination:7
Submitted: 2007-02-16
   Days after onset:43
Entered: 2007-02-26
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 MO / PO
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 3 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood HIV RNA increased, CD4 lymphocytes increased, Death, Dermatitis diaper, Pneumonia, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-01-04
   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: Cotrimoxazole (approx. 3 months)
Current Illness: HIV Infection
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Baseline: CD4 count: 1534 cells/mm3; HIV-1 Viral Load: $g 750,000 cells/ml.
CDC Split Type:

Write-up: The subject was a three month, 22 day old infant female, HIV infected, enrolled in a study, who expired at home on January 04, 2007. The subject received three doses of Prevnar on November 6, 2006, December 4, 2006, and December 28, 2006. At screening, the subject''s CD4 count was 1534 cells/mm3 (28.2%) and HIV-1 viral load was $g 750,000 copies/ml. On December 28, 2006, during the subject''s routine study visit, the investigator found the subject had diaper dermatitis but was otherwise well. The subject was not seen for the next scheduled study visit on January 29, 2007. The site contacted the mother and learned that the subject had died January 4, 2007. According to mother, the subject died as a result of a "chest problem." The mother stated the subject had developed a fever but did not know the exact temperature. The site Principal Investigator stated that the only information available was provided by the mother and that, it is assumed the subject developed pneumonia that resulted in death but no concrete evidence is available to substantiate this. There was no post-mortem examination performed. The site Principal Investigator assessed the relationship as possibly related to the study agent, Prevnar. The DAIDS Medical Officer has deemed the adverse event as probably not related, but cannot rule out relationship to study agent, Prevnar. Concomitant medications included: cotrimoxazole and the subject had also received oral poliovirus vaccine(OPV), hepatitis B and CombAct-HIB vaccines.


VAERS ID: 273020 (history)  
Form: Version 1.0  
Age: 0.92  
Sex: Male  
Location: Foreign  
Vaccinated:2007-01-23
Onset:2007-01-26
   Days after vaccination:3
Submitted: 2007-02-23
   Days after onset:28
Entered: 2007-02-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Dyspnoea, Feeling cold, Sudden infant death syndrome
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-01-27
   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: UNK
Allergies:
Diagnostic Lab Data: None provided
CDC Split Type: GBWYE692215FEB07

Write-up: This case was considered medically important and fatal. Information regarding Prevnar was received from a healthcare professional via a regulatory authority regarding a 48-week-old male patient who experienced difficulty breathing and possible sudden infant death syndrome. The patient received a dose on 23-Jan-2007. The patient was reported to be well at the time of Prevnar vaccination and for two days following immunisation. The patient''s mother noticed that the patient had difficulty breathing on 26-Jan-2007. The patient''s mother decided to soothe the patient that evening and the patient went to sleep. The patient was found cold at 3am, having experienced possible sudden infant death syndrome on 27-Jan-2007. The cause of death was reported as possible sudden infant death syndrome. No additional information was available at the time of this report.


VAERS ID: 273692 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Foreign  
Vaccinated:2007-02-23
Onset:2007-02-24
   Days after vaccination:1
Submitted: 2007-03-08
   Days after onset:12
Entered: 2007-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR C2555AB / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08678F / 3 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0077F / 2 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Base excess negative, Blood bicarbonate, Blood glucose increased, Blood pH decreased, Brain death, Cardiac arrest, Death, Electroencephalogram abnormal, Life support
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-02-26
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: GLUCOSE 500 mg/dl, PH 6.8, HCO3 0,BASE EXCESS -28, EEG SHOWED NO BRAIN ACTIVITY
CDC Split Type:

Write-up: AFTER LESS THAN 24 HOURS OF VACCINE ADMINISTRATION WITH NO PREVIOUS OR ASOCIATED SYMPTOMS CHILD PRESENTED APNEA AND CONSECUENTLY CARDIAC ARREST AS DESCRIBED BY FAMILY''S NURSE WHO PERFORMED BASIC CPR. PATIENT WAS BROUGHT TO ER WHERE RECEIVED ADVANCED CPR. STAYED IN PICU WITH CENTRAL ACCESS AND VENTILATORY SUPPORT. INOTROPIC MEDICATIONS AND ANTIBIOTICS WERE ADMINISTERED. AFTER APROX. 36 HRS BRAIN DEATH WAS DECLARED BY LAW REQUIRED PROCEDURES, WITH 2 EEG CONFIRMATION. PATIENT''S FAMILY ACCEPTED LIVER DONATION. 5/18/07 At request of FDA, manufacturer foreign death case will be opened. 5/18/07 T/C to reporter. Stated no autopsy done per parental request. He signed death certificate which stated COD as SIDS. Per FDA, case will be considered closed & no further investigation will be done.


VAERS ID: 273844 (history)  
Form: Version 1.0  
Age: 0.72  
Sex: Female  
Location: Foreign  
Vaccinated:2007-03-09
Onset:2007-03-09
   Days after vaccination:0
Submitted: 2007-03-12
   Days after onset:2
Entered: 2007-03-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 3 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Irritability, Peripheral coldness, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-03-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: HQWYE288209MAR07

Write-up: Information regarding Prevnar was received from a healthcare professional regarding an 8-month-old female patient who died. The patient received the third dose on 09-Mar-2007. The patient received the third dose of Prevnar about 10:00 on 09-Mar-2007. The baby was sent to her nursery after vaccination and was fed at 12:30. At 14:30, she became irritated. She was left sleeping prone. At 15:00, the baby was found with no response and felt cold. CPR was performed immediately and stopped at 16:01. She was transported by ambulance to the emergency room. Death was pronounced at 16:01. The cause of death was not provided. No additional information was available at the time of this report.


VAERS ID: 273904 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2006-12-01
Submitted: 2007-03-13
   Days after onset:101
Entered: 2007-03-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 3 UN / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-12-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: None provided
CDC Split Type: FRWYE950109MAR07

Write-up: Information regarding Prevnar was received from a healthcare professional regarding a 6-month-old female patient who experienced meningitis pneumococcal. The patient received the third dose in 2006. The patient was hospitalized due to meningitis pneumococcal in Dec-2006 and died. The cause of death was reported as meningitis pneumococcal. No additional information was available at the time of this report.


VAERS ID: 273988 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2007-02-22
Onset:2007-02-26
   Days after vaccination:4
Submitted: 2007-03-14
   Days after onset:15
Entered: 2007-03-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Peripheral coldness, Sudden infant death syndrome, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-02-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: GRWYE844102MAR07

Write-up: Information regarding Prevnar was received from a healthcare professional regarding a 98-day-old female patient who experienced sudden infant death syndrome. The patient received a dose on 22-Feb-2007. On 22-Feb-2007, the infant was administered the first dose of Prevnar for active immunization. As reported by the paediatrician, the infant did not experience any symptoms following the vaccination. On 26-Feb-2007, the baby girl was found cold and unresponsive in her cot and was immediately admitted to hospital. It was diagnosed to have experienced sudden infant death syndrome. At the time of the report, the results of the autopsy were not known yet. As mentioned, the infant was a healthy child with no medical problems in the past. Before the administration of Prevnar, the infant was examined and was absolutely healthy. No concomitant medication was administered. The treating paediatrician considered the event to be unrelated to Prevnar administration. The hospital paediatricians did not correlate the event with Prevnar vaccination. Follow-up, including autopsy results, is anticipated. No additional information was available at the time of this report.


VAERS ID: 274844 (history)  
Form: Version 1.0  
Age: 0.43  
Sex: Female  
Location: Foreign  
Vaccinated:2007-03-06
Onset:2007-03-07
   Days after vaccination:1
Submitted: 2007-03-26
   Days after onset:18
Entered: 2007-03-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B037CB / UNK UN / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-03-07
   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: UNK
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0462618A

Write-up: This case was reported by a physician and described the occurrence of sudden death in a 5-month-old female subject who was vaccinated with Infanrix, Oral polio for prophylaxis. On 6 March 2007, the subject received 3rd dose of Infanrix (intramuscular, unknown injection site) and unspecified dose of Oral polio vaccine (unknown manufacturer). On 7 March 2007, 1 day after vaccination with Infanrix and Oral polio vaccine, the subject experienced sudden death. The subject was normal and went to kingergarden. She slept and did not awake. The physician considered the event was possibly related to vaccination with Infanrix and Oral polio vaccine. The subject died on 7 March 2007 from death (at present cause unknown). It was unknown whether an autopsy was performed. Additional information has been requested.


VAERS ID: 274947 (history)  
Form: Version 1.0  
Age: 0.58  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-03-26
Entered: 2007-03-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood lactic acid increased, Blood pyruvic acid, Brain damage, CSF test normal, Cerebellar atrophy, Coma, Convulsion, Death, Encephalopathy, Feeding disorder of infancy or early childhood, Hypertonia, Hypoglycaemia, Laboratory test abnormal, Mental impairment, Metabolic acidosis, Metabolic disorder, Mitochondrial encephalomyopathy, Nuclear magnetic resonance imaging brain abnormal, Paralysis, Pyrexia, Respiratory disorder, Respiratory failure, Urine lactic acid increased
SMQs:, Anaphylactic reaction (broad), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Congenital, familial and genetic disorders (narrow), Convulsions (narrow), Parkinson-like events (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: magnetic resonance imaging Brain = disclosed bilateral basal ganglia damage and atrophy of brainstem. urine L-lactate test Marked elevation, Pyruvic acid = marked elevation, Fumaric acid = marked elevation, serum L-lactate test Marked elevation
CDC Split Type: WAES0703USA02785

Write-up: It was reported in a published article, title as stated above that an 7-month-old "relatively normal" female with no family history. The patient was vaccinated with a dose of Recombivax HB (manufacturer unknown) at the age of 7 months. Eight hours following vaccination, the patient developed a fever, convulsions, and coma with respiratory difficulty (mild to severe). At that time she was suspected to be suffering from acute metabolic disturbance. Routine and biochemical examinations of the cerebrospinal fluid were normal; metabolic acidosis and hypoglycemia were documented. She was diagnosed with acute encephalopathy and treated with intravenous fluids, mannitol, and antibiotics. She manifested a slight improvement 3 to 7 days after treatment. Her fever subsided to normal temperature and she gained consciousness gradually. However, feeding was difficult, and she suffered low intelligence quotient score and generalized palsies. She experienced hypertonic musculature of the extremities and trunk. Physiotherapy and nutrition treatments were ineffective. Laboratory examinations revealed marked elevations in urine lactic acid, pyruvic acid, fumaric acid, and blood lactic acid. Blood amino acids and acylearnitine profiles were normal. Brain magnetic resonance imaging disclosed bilateral basal ganglia damage and atrophy of the brainstem. These parameters also characterize subacute necrotizing cerebrospinal disease (Leigh disease). The patient improved with thiamine, L-carnitine, coenzyme Q10, and vitamin E, but she died from respiratory failure at approximately age 1 to 1 1/2 years. Postmortem examination demonstrated symmetrical foci, cystic cavitations with neuronal loss, and vascular proliferation as the typical findings described in Leigh syndrome. If the physician had diagnosed the etiologic disorder (Leigh syndrome) and if the physician had treated the patient before vaccinations, the acute cerebral damage may have been prevented. No further information is available. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 274949 (history)  
Form: Version 1.0  
Age: 0.75  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-03-26
Entered: 2007-03-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEA: MEASLES (ATTENUVAX) / MERCK & CO. INC. - / UNK UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood lactic acid increased, Blood pyruvic acid, Brain damage, Cerebral atrophy, Coma, Convulsion, Death, Encephalopathy, Feeding disorder of infancy or early childhood, Hypertonia, Hypoglycaemia, Laboratory test abnormal, Mental impairment, Metabolic acidosis, Metabolic disorder, Mitochondrial encephalomyopathy, Nuclear magnetic resonance imaging brain abnormal, Paralysis, Pyrexia, Respiratory disorder, Respiratory failure, Urine lactic acid increased
SMQs:, Anaphylactic reaction (broad), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Congenital, familial and genetic disorders (narrow), Convulsions (narrow), Parkinson-like events (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: magnetic resonance imaging Brain = disclosed bilateral basal ganglia damage and atrophy of brainstem, urine L-lactate test Marked elevation, Pyruvic acid = marked elevation, Fumaric acid = marked elevation, serum L-lactate test Marked elevation
CDC Split Type: WAES0703USA02786

Write-up: It was reported in a published article, title as stated above that an 9-month-old "relatively normal" male with no family history. The patient was vaccinated with a dose of Attenuvax (manufacturer unknown) at the age of 9 months. Twelve hours following vaccination the patient developed a fever, convulsions, and coma with respiratory difficulty (mild to severe). At the time she was suspected to be suffering from acute metabolic disturbance. Routine and biochemical examinations of the cerebrospinal fluid were normal; metabolic acidosis and hypoglycemia were documented. She was diagnosed with acute encephalopathy and treated with intravenous fluids, mannitol, and antibiotics. He manifested a slight improvement 3 to 7 days after treatment. His fever subsided to normal temperature and he gained consciousness gradually. However, feeding was difficult, and he suffered low intelligence quotient score and generalized palsies. He experienced hypertonic musculature of the extremities and trunk. Physiotherapy and nutrition treatments were ineffective. Laboratory examinations revealed marked elevations in urine lactic acid, pyruvic acid, fumaric acid, and blood lactic acid. Blood amino acids and acylearnitine profiles were normal. Brain magnetic resonance imaging disclosed bilateral basal ganglia damage and atrophy of the brainstem. These parameters also characterize subacute necrotizing cerebrospinal disease (Leigh disease). The patient improved with thiamine, L-carnitine, coenzyme Q10, and vitamin E, but she died from respiratory failure at approximately age 1 to 1 1/2 years. Postmortem examination demonstrated symmetrical foci, cystic cavitations with neuronal loss, and vascular proliferation as the typical findings described in Leigh syndrome. If the physician had diagnosed the etiologic disorder (Leigh syndrome) and if the physician had treated the patient before vaccinations, the acute cerebral damage may have been prevented. No further information is available. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 275518 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Female  
Location: Foreign  
Vaccinated:2002-06-03
Onset:2002-06-03
   Days after vaccination:0
Submitted: 2007-04-02
   Days after onset:1764
Entered: 2007-04-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Carboxyhaemoglobin, Dermatitis diaper, Drug screen, Haemorrhage, Hyperaemia, Lung disorder, Petechiae, Pulmonary oedema, Pyrexia, Seborrhoea, Sudden infant death syndrome
SMQs:, Cardiac failure (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug abuse and dependence (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-06-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: acetaminophen
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0703TUR00006

Write-up: Information has been received from a literature article concerning a 3.5 months old twin girls who on 03-JUN-2002 were vaccinated with Recombivax HB. Concomitant therapy included poliovirus vaccine live oral and acetaminophen. Two days prior to the incident, the twins had received the second dose of oral polio, DPT and the first dose of hepatitis B vaccines and they had fever on the first day of the vaccination and been given teaspoonful of acetaminophen. On 03-JUN-2002 the patient died. The cause of death was sudden infant death syndrome. The mother had given birth to twins at her first pregnancy. She had not allergy or significant medical history. She didn''t smoke. Her grandmother gave birth to 3 sets of twins and 5 of the 6 off-springs had died after birth. Her uncle had twin off-springs and both died after birth due to unknown causes. There was no documented or suggested pathology in control visits during the pregnancy. Delivery was at 39th gestational week by Cesarean section. Blood chemistry of the mother was within normal limits. Twin B: 2110 g and 45 cm at delivery, APGAR score 5 at 1st min and 7 at 5th min, front fontanel measures 3x3 cm2, circumference of the head 33 cm, liver 1 cm palpable, premature membrane rupture (+), presents, meconium (+), Blood typre: B (-) 1/6 systolic murmur (no foci stated). She was healthy and did not face any serious health problems. The twins were breast fed for 40 days. Then, they were fed by formula plus baby biscuits and cow milk. Both twins had seborrhea on the scalp and diaper dermatitis at vulvae and genital regions with erosions and epidermal peeling. Anterior and posterior fontanels were open in both babies. Internal examination revealed that both babies had lungs with incomplete separeted lobes, mild edema and hyperemia. The thymus had petechial hemorrhages. Mucoid content at the lower pharynx and epiglottis was seen. Frothy appearance was seen in trachea and down to the bronchus. Heart had small petechial hemorrhages on the surface. The organ weights were within normal limits. On histopathological examination, heart: immaturity consistent with the age hyperemia. Lungs: Intensive edema, intraalveolar fresh hemorrhage, spilled alveolar epithelial cells, increased light-mild amount of mononuclear cells, hyperemia. Liver: Little mononuclear cell increase in the sinusoidal cells, hyperemia, natural appearence at the parenchyma cells. Kidney: Several mononuclear cell clusters intra capsular, hyperemia. Brain: Hyperemia, the autopsies indicated no macroscopic or microscopic pathological findings to which can be attributed. Systemic toxicological analysis (STA) were performed within lungs, liver, kidney, brain, stomach, and heart. None of the items in the the STA were found in the specimens of pericardial fluid, blood and urine. Other analysis performed were insecticides from the specimens, psychoactive drugs in blood and urine. COHb levels in blood. None of the items in the STA were found in the specimens, 5.2 % COHb was found in the blood. No pathogen organisms were isolated from the blood and tissue cultures in microbiological examinations. As a result of the history, interview, test results and psychiatric evaluation, within present findings, no psycological disorders suggestive of child abuse or neglect were found. No involvement on behalf of the parents in the death was concluded. According to forensic evaluation results, the death scene investigation, judicial investigation, parental assessment, macroscopic and microscopic autopsy findings and the toxicological analysis did not yield any specific cause of death. Likewise, the clinical history of the parents and the infants, the gestational follow up during the pregnancy did not imply any pathological condition the death can be attributed to. The case was referred to a supreme board composed of multidisciplinary medical professionals. The board decided that the available data was consistent with SIDS. A copy of the published literature article is attached as further documentation of the patient''s experience.


VAERS ID: 275519 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Female  
Location: Foreign  
Vaccinated:2002-06-03
Onset:2002-06-03
   Days after vaccination:0
Submitted: 2007-04-02
   Days after onset:1764
Entered: 2007-04-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / 2 UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Carboxyhaemoglobin, Dermatitis diaper, Drug screen, Haemorrhage, Hyperaemia, Lung disorder, Petechiae, Pulmonary oedema, Pyrexia, Seborrhoea, Sudden infant death syndrome, Toxicologic test
SMQs:, Cardiac failure (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug abuse and dependence (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-06-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: acetaminophen
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0703TUR00005

Write-up: Information has been received from a literature article concerning a 3.5 month old twin girls who on 03-JUN-2002 were vaccinated with Recombivax HB. Concomitant therapy included poliovirus vaccine live oral and acetaminophen. Two days prior to the incident, the twins had received the second dose of polio, DPT and the first dose of hepatitis B vaccines and they had fever on the first day of the vaccination and been given teaspoonful of acetaminophen. On 03-JUN-2002 the patient dies. The cause of death was sudden infant death syndrome. The mother had given birth to twins at her first pregnancy. She had no allergy or significant medical history. She didn''t smoke. Her grand mother gave birth to 3 sets of twins and 5 of the 6 off-springs had died after birth. Her uncle had twin off-springs and both died after birth due to unknown causes. There was no documented or suggested pathology in control visits during the pregnancy. Delivery was at 39th gestational week by Cesarean section. Blood chemistry of the mother was within normal limits. Twin A: 1900 g and 44 cm prolapsed umbilical cord present, APGAR score 7 (1st min) and 9 (5th min), front fontanel measures 3x3 cm2, circumference of the head 32 cm, liver 1 cm palpable, no premature membrane rupture present, meconium (-), blood type: A (+). She was healthy and did not face any serious health problems. The twins were breast fed for 40 days. Then, they were fed by formula plus baby biscuits and cow milk. Both twins had seborrhea on the scalp and diaper dermatitis at vulvae and genital regions with erosions and epidermal peeling. Anterior and posterior fontanels were open in both babies. Internal examination revealed that both babies had lungs with incomplete separated lobes, mild edema and hyperemia. The thymus had petechial hemorrhages. Frothy appearance was seen in trachea and down to the bronchus. Heart had small petechial hemorrhages on the surface. The organ weights were within normal limits. On histopathological examination, heart: immaturity consistent with the age hyperemia. Lungs: intensive edema, intraalveolar fresh hemorrhage, spilled alveolar epithelial cells, increased light-mild amount of mononuclear cells, hyperemia. Liver: Little mononuclear cell increase in the sinusoidal cells, hyperemia, natural appearance at the parenchyma cells. Kidney: Several mononuclear cell clusters intra capsular, hyperemia. Brain: Hyperemia, the autopsies indicated no macroscopic or microscopic pathological findings to which can be attributed. Systematic toxicological analysis (STA) were performed within lungs, liver, kidney, brain, stomach and heart. None of the items in the STA were found in the specimens of pericardial fluid, blood and urine. Other analysis performed were insecticides from the specimens, psychoactive drugs in blood and urine, COHb levels in blood. None of the items in the STA were found in the specimens, 5.3% COHB was found in the blood. No pathogen organisms were isolated from the blood and tissue cultures in microbiological examinations. As a result of the history, interviews, test results and psychiatric evaluation, within present findings, no psycological disorders suggestive of child abuse or neglect were found. No involvement on behalf of the parents in the death was concluded. According to forensic evaluation results, the death scene investigation, judicial investigation, parental assessment, macroscopic and microscopic autopsy findings and the toxicological analysis did not yield any specific cause of death. Likewise, the clinical history of the parents and the infants, the gestational follow up during the pregnancy did not imply any pathological conditions the death can be attributed to. The case was referred to a supreme board composed of multidisciplinary medical professionals at the Institute of Forensic Medicine, Ministry of Justice. The board decided that the available data was consistent with SIDS. Additional information is not expected. A copy of the published literature article as attached as further documentation of the patient''s experience.


VAERS ID: 275634 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: Foreign  
Vaccinated:2007-03-22
Onset:2007-03-23
   Days after vaccination:1
Submitted: 2007-04-03
   Days after onset:11
Entered: 2007-04-05
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER 106008 / UNK RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Z0979 / UNK LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-03-23
   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: The patient had received his 1st primary vaccinations with IPV and DTaP on unspecified date and no adverse event occurred.
Allergies:
Diagnostic Lab Data: cardiopulmonary resuscitation and blood sampling were not performed
CDC Split Type: 200700882

Write-up: Case received from a healthcare professional on 23 March 2007 under no local reference number. A 04-month-old male patient with no medical history reported, had received his second intramuscular primary dose of Imovax Polio, (batch number Z0979) in the left thigh (facies anterior lateralis femoris) and his secondary primary intramuscular dose of DTap (other MFR, batch number 106008) in the right thigh (facies anterior lateralis femoris) on 22 March 2007. The patient had received his 1st primary vaccinations with Imovax Polio and DTaP on unspecified date and no adverse event occurred. 17 hours post-vaccination, the patient''s parents found him "laid prone on the bed without breathing". The patient was hospitalized but he was already dead. Therefore, cardiopulmonary resuscitation and blood sampling were not performed.


VAERS ID: 276697 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Female  
Location: Foreign  
Vaccinated:2005-03-01
Onset:2007-04-01
   Days after vaccination:761
Submitted: 2007-04-17
   Days after onset:16
Entered: 2007-04-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 2 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, CSF culture positive, Death, Meningitis pneumococcal, Pneumococcal infection
SMQs:, Infective pneumonia (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Spina bifida
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood culture 00-Apr-2007 detection of pneumococci; CSF culture 00-Apr-2007 detection of pneumococci
CDC Split Type: DEWYE474316APR07

Write-up: Information regarding Prevenar was received from a healthcare professional regarding a 3-year-old (38 months) female who experienced pneumococcal meningitis and died. The patient received the second dose in Mar-2005. The patient''s concurrent illness includes spina bifida. Concomitant medications were not reported. The patient experienced pneumococcal meningitis and died Apr-2007. No information concerning serotype was available. The cause of death was reported as meningitis pneumococcal.


VAERS ID: 276963 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Foreign  
Vaccinated:2007-04-11
Onset:2007-04-12
   Days after vaccination:1
Submitted: 2007-04-19
   Days after onset:7
Entered: 2007-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK RA / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-04-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0466180A

Write-up: This case was reported by a physician and described the occurrence of death nos in a 6-month-old male subject who was vaccinated with Infanrix, Imovax for prophylaxis. Subject''s previous vaccination with Infanrix and Imovax included no adverse event. On April 2007 at noon the subject received 3rd dose of Infanrix (intramuscular, unknown), unspecified dose of Imovax polio (unknown). On 12 April 2007, within hours of vaccination with Imovax polio and Infanrix, at 6 am the subject was not breathing. The subject was brought to the emergency room but he was already death. The subject died on 12 April 2007, cause of death was not reported. An autopsy was performed at the time of reporting.


VAERS ID: 277116 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2007-03-01
Onset:2007-03-01
   Days after vaccination:0
Submitted: 2007-04-19
   Days after onset:48
Entered: 2007-04-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-04-09
   Days after onset: 38
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0704USA02859

Write-up: Information has been received from a physician concerning an 81 year old patient who in March 2007, was vaccinated with a dose of Pneumovax 23. In March 2007, the patient developed pneumonia and was hospitalized. The bacillus which induced pneumonia was under confirmation at the time of the report. On April 9, 2007 the patient died. The cause of death was pneumonia. The result of autopsy was not reported. The reporting physician felt that the causal relationship between the patient''s pneumonia and Pneumovax 23 was unknown. Additional information has been requested.


VAERS ID: 277314 (history)  
Form: Version 1.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2007-04-04
Onset:2007-04-12
   Days after vaccination:8
Submitted: 2007-04-24
   Days after onset:12
Entered: 2007-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS ATYAB012AA / UNK - / IM
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME) / UNKNOWN MANUFACTURER ATYAB012AA / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Left ventricular failure
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-04-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: SMOKER
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0466454A

Write-up: This case was reported by a healthcare professional and described the occurrence of death nos in a 55-year-old male subject who was vaccinated with Hepatyrix for prophylaxis. The subject''s medical history included smoker. On 4 April 2007 the subject received unspecified dose of Hepatyrix (1 injection, intramuscular). On 12 April 2007 at an unspecified time after vaccination with hepatyrix, the subject experienced death. The subject died on 12 April 2007, cause of death was not reported. It was unknown whether an autopsy was performed. This is also a pharmaceutical product complaint. Verbatim text: A nurse reported that a patient received a dose of Hepatyrix and died unexpectedly 8 days later. Follow up received n 17 April 2007; Safety statement stated; Based on available date, it can be concluded that at the moment, there is not evidence for a clinical safety for the Lot ATYAB012AA of hepatyrix vaccine, however this case is closely follow up in order to obtain further details. Received from QA; The practice nurse received the coroner''s report and the cause of death was left ventricular heart failure. The practice nurse and treating health care professional did not believe the patient''s death was related to the hepatyrix and felt confident administering the remaining doses from this particular batch. No complaint sample returned. QA result - substantiated.


VAERS ID: 277467 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Foreign  
Vaccinated:2007-04-11
Onset:2007-04-12
   Days after vaccination:1
Submitted: 2007-04-25
   Days after onset:13
Entered: 2007-04-27
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B030CA / UNK - / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Z1163 / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: When he received first and second primary vaccinations, he did not have any adverse event.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200701206

Write-up: Initial report received from a health care professional on 13 April 2007 with no local reference number. A 6-month-old male subject with no reported medical history had received an intramuscular injection of Imovax Polio, lot number Z1163-1 on 11 April 2007 at noon. Concomitantly, he had also received an intramuscular injection of Infanrix, lot number AC14B030CA. It was the third primary vaccination, he did not have any adverse event. The reporter was informed that the patient had been died but he couldn''t know the patient''s status when he was moved to a hospital. It was performed an autopsy, but reporter did know the result of the autopsy. No information is available concerning health status of the patient at time of vaccination and concerning details of the death. Furthermore no conclusion can be drawn in the absence of autopsy results.


VAERS ID: 277473 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2006-10-05
Onset:2006-10-07
   Days after vaccination:2
Submitted: 2007-04-26
   Days after onset:201
Entered: 2007-04-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Ileus paralytic, Pneumonia aspiration, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-02-24
   Days after onset: 140
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 25 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Alosenn, Ensure, Laxoberon, Tarivid, [therapy unspecified], Azulene
Current Illness: Cerebral infarction; Dementia; Bronchitis asthmatic; Constipation
Preexisting Conditions: Cerebral haemorrhage; Cerebral infarction; Pneumonia; Diabetes mellitus; Alcoholic liver disease
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0704USA03522

Write-up: Information has been received from a physician concerning a 75 year old male with late effects of cerebral infarction, dementia, bronchial asthma and constipation (previously had enterolysis (intestinal infusion) and a history of cerebral haemorrhage, cerebral infarction, alcoholic liver disease, pneumonia and diabetes mellitus who on 05-OCT-2006 was vaccinated SC with a 0.5 ml dose of pneumovax 23. Concomitant therapy included minerals (unspecified) (+) protein (unspecified) (+) vitamins (unspecified) (Ensure), "Tulobuterol", Alosenn, Laxoberon, Tarivid and azulene. On 07-OCT-2006, the patient experienced abdominal pain in the evening. He was transfered to another hospital by ambulance and was hospitalized due to paralytic ileus and aspiration pneumonia. On 25-OCT-2006, the patient became able to have a meal of rice gruel. The patient recovered. On 01-NOV-2006, he was discharged from the hospital. On 24-FEB-2007, the patient died suddenly. The reporter felt that paralytic ileus was definitely related to therapy with pneumovax 23 and that the sudden death was defenititely not related. No further information is available.


VAERS ID: 277640 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Male  
Location: Foreign  
Vaccinated:2007-02-19
Onset:2007-03-11
   Days after vaccination:20
Submitted: 2007-04-23
   Days after onset:42
Entered: 2007-05-01
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anaemia, Blood HIV RNA, CD4 lymphocytes, Crying, Death, Diarrhoea, Gastroenteritis, Vomiting
SMQs:, Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-03-12
   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: Co-trimoxazole (approx. 1 month), lamivudine, lopinavir/ritonavir (Kaletra), and zidovudine
Current Illness: HIV Infection
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Baseline on 02/09/07: HIV-1 Viral load: $g750,000 cells/mL, CD4 count: 2601 cells/mm3 (33.80%)
CDC Split Type:

Write-up: This was a 1-month and 26 days old HIV infected, infant male enrolled in a study on February 19, 2007, who expired on March 12, 2007 on the way home in the taxi. The subject was also co-enrolled in another study. On February 19, 2007, the subject received his first and only dose of study vaccination of Prevnar 0.5ml intramuscularly. Upon initial telephone enquiry by the site personnel when the subject missed the week 4 visit, the site learned that the subject had expired on March 5, 2007, on the way back home from the clinic. He had been seen for a scheduled visit earlier that day and the site personnel was told by his grandmother that he had been well since the previous visit. On physical examination, he was found to be clinically well and his baseline classified as category N, not symptomatic as per agency guidelines. The full blood count was done including T-cells and the results revealed a mild anemia but no evidence of sepsis. The mother later informed the site that he had been crying for the last two nights on March 3 and March 4, 2007, but was otherwise well. There was no history of diarrhea, vomiting, cough, fever or body rashes. On April 20, 2007, a new information was obtained in person from the mother and the grandmother with some changes to the details of the event. According to both of them, the subject did have an episode of diarrhea and vomiting on March 11, 2007. The next day, the grandmother took him to the clinic but returned home because he vomited and died on March 12, 2007 in the taxi. The site also changed the primary adverse event from "Death with cause unknown" to "Presumed gastroenteritis" and the Death Certificate listed the death as "Natural causes." The of death listed on the Death Certificate is March 12, 2007, corroborating the second version of events. On February 9, 2007, baseline Viral load: $g750,000 copies/milliters CD4L 33.80% (2,601 cells/mm^3). Concomitant medications: Co-trimoxazole, lamivudine, lopinavir/ritonavir, and zidovudine. The Principal Investigator assessed this event of Presumed Gastroenteritis as not related to study vaccination of Prevnar. The DAIDS Medical Officer has deemed Presumed Gastroenteritis as probably not related, but cannot rule out relationship to study agent. Prevnar.


VAERS ID: 278275 (history)  
Form: Version 1.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2007-04-04
Onset:2007-04-12
   Days after vaccination:8
Submitted: 2007-05-09
   Days after onset:27
Entered: 2007-05-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTIPV: DT + IPV (FOREIGN) / PASTEUR MERIEUX INST. Z1067 / UNK UN / UN
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-04-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0469395A

Write-up: This case was reported by the regulatory authority and Healthcare products Regulatory Agency and described the occurrence of death nos in a 55-year-old male subject who was vaccinated with Hepatyrix for prophylaxis. Co-suspect medication included Revaxis. On 4 April 2007 the subject received unspecified dose of Hepatyrix. On 12 April 2007, 8 days after vaccination with Hepatyrix, the subject died. Cause of death was unknown and it was unknown whether an autopsy was performed. Verbatim text: 8 days post immunisation, the patient made some gutteral sound and woke his wife from her sleep. The wife called an ambulance and tried to resuscitate him but without success.


VAERS ID: 278966 (history)  
Form: Version 1.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:1999-05-01
Onset:2006-07-15
   Days after vaccination:2632
Submitted: 2007-05-17
   Days after onset:306
Entered: 2007-05-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: blood culture positive for streptococcal pneumonia serotype 7F
CDC Split Type: WAES0705AUS00047

Write-up: Information was obtained on request by the Company from the agency via a Public Case Detail Form and a Case Line Listing concerning an 89 year old female who on 01-MAY-1999, 25-MAR-2003 and 29-MAR-2005 was vaccinated with Pneumovax 23. Subsequently, on 15-JUL-2006, 2632 days after vaccination with Pneumovax 23, the patient developed pneumonia, vaccination failure and suspected lack of efficacy and was hospitalised. Blood culture was done which was found to be positive for streptococcal pneumonia serotype 7F. At the time of reporting to the agency on 28-NOV-2006 it was reported that the patient died from an unknown specific cause. The agency considered that vaccination failure and drug being ineffective were certainly related to therapy with Pneumovax 23. The original reporting source was not provided. Additional information is not expected.


VAERS ID: 279834 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-05-25
Entered: 2007-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Subject''s older brother had suddenly died at the age of 12 weeks.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0472386A

Write-up: This case was reported in a newspaper article and described the occurrence of sudden death in an 8-week-old male subject who was vaccinated with DTP (A or W not known), manufacturer unspecified) for prophylaxis. The subject''s medical history included sudden death in an older brother at 12 weeks of age, and subsequently, the subject''s breathing was monitored. In 1998 the subject received unspecified dose of DTP (A or W not known). In 1998, immediately after vaccination with DTP (A or W nor known), the subject became "unusually dozy" and died approximately 5 hours later. The subject died, cause of death is not specified. It was unknown whether an autopsy was performed. The newspaper commented "(the subject) may have died because of an adverse reaction to the jab" and "the odds against two cot deaths in the same family were 73 million to one."


VAERS ID: 279974 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-05-29
Entered: 2007-05-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEA: MEASLES (ATTENUVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Epstein-Barr virus antibody negative, Lymphadenopathy, Meningitis, Mononucleosis heterophile test negative, Pulmonary haemorrhage, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious meningitis (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Lymphoproliferative disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Epstein-Barr virus antibodies Negative At the time of admission.
CDC Split Type: WAES0705USA03539

Write-up: It was reported in a published article, title stated above that a male child with a lymphoproliferative disorder was vaccinated with a dose of Attenuvax (manufacturer unknown). Subsequently, two weeks after vaccination against measles, the patient was hospitalized for fever, cervical adenopathy and a rash. At the time of admission, monospot testing was negative. The patient died a few days later with meningitis and pulmonary bleeding. The cause of death was meningitis and pulmonary bleeding. It was reported that several of the patient''s relative and lymphoproliferative disease. Additional information is not expected. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 280067 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2007-05-23
Onset:2007-05-23
   Days after vaccination:0
Submitted: 2007-05-29
   Days after onset:6
Entered: 2007-05-31
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER UVA06014 / UNK - / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR Z0789 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-05-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: not reported
Allergies:
Diagnostic Lab Data: not reported
CDC Split Type: 200701884

Write-up: Case received from a healthcare professional on 24 May 2007. Manufacturer is EVX20070524-03. A child (age and gender not reported) died on 23 May 2007, within 24 hours after giving a dose of Act-Hib*, lot Z0789-1 with the first dose of DTP vaccine lot 20905010C and the second dose of Euvax B* vaccine, lot UVA06014.


VAERS ID: 280835 (history)  
Form: Version 1.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2007-02-15
Onset:2007-03-28
   Days after vaccination:41
Submitted: 2007-06-05
   Days after onset:69
Entered: 2007-06-07
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (MENOMUNE) / SANOFI PASTEUR - / UNK - / IM

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: 2007-03-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Savarine (Proguanil, Chloroquine)
Current Illness:
Preexisting Conditions: History of sporadic asthma crisis in 2003 and when her father died when she was 16 years old. Concomitant medication: Proguanil and chloroquine (Savarine) once a day.
Allergies:
Diagnostic Lab Data:
CDC Split Type: E200703464

Write-up: Case initially received by the Health Authorities under the reference number LY0700424/1 and linked to the non-serious case E2007-03468 (same reporter, same product, patients of the same family). Initial report on 31-May-07: A 59-year-old female patient received a dose of Menomune (batch number not reported) via intramuscular route in an unspecified site of administration on 15-Feb-07 in view of a second trip out of the country. On 28-Mar-07, ie 42 days after vaccination and one week after her coming back to another country, she suddenly died without prodome and apparently without bronchospasm whereas she seemed to be very fit. The cause of death was unknown. No autopsy was performed. The patient has a medical history of sporadic asthma crisis experienced when she was 16 years old and also in 2003 when her father died. She was taking Savarine once a day as concomitant medication. The patient''s husband also received a dose of Menomune (batch number not reported) and, on an unspecified onset of time, he presented with a mild dysesthesia. No more information were available. The case is closed.


VAERS ID: 282142 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2007-04-17
Onset:2007-04-17
   Days after vaccination:0
Submitted: 2007-06-15
   Days after onset:59
Entered: 2007-06-18
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 3 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Breath sounds abnormal, Death
SMQs:, Acute central respiratory depression (narrow), Respiratory failure (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: NLWYE835012JUN07

Write-up: Information regarding Prevenar was received from a healthcare professional regarding a 4-month-old male patient who experienced strange sound when breathing and several episodes of apnea and the patient died. The patient received the third dose on 17-Apr-2007. The patient experienced strange sound when breathing on 17-Apr-2007. The child was seen by a physician, who did not find particularities. Three days later the patient experienced several episodes of apnea. He was admitted to hospital where he was resuscitated various times. The patient was then transferred to an academic hospital where he died 2 weeks later in May-2007. The patient had not experienced these events during the previous vaccinations. It is unknown if there were other contribution factors. The cause of death was not reported. No additional information was available at the time of this report.


VAERS ID: 282367 (history)  
Form: Version 1.0  
Age: 1.08  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-06-19
Entered: 2007-06-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Body temperature increased, Bronchoscopy, Candida pneumonia, Candidiasis, Cardiac failure congestive, Cardiac murmur, Chest X-ray abnormal, Crepitations, Death, Gene mutation identification test, Haematemesis, Haemolytic anaemia, Heart disease congenital, Infection in an immunocompromised host, Intubation, Irritability, Laboratory test abnormal, Lethargy, Lung disorder, Lung infiltration, Lymphadenopathy, Measles, Mechanical ventilation, Medication error, Oral intake reduced, Pallor, Pneumonia herpes viral, Pneumonia viral, Pulmonary haemorrhage, Pyrexia, Rash vesicular, Tachycardia, Urine analysis normal, Varicella, Varicella zoster virus serology positive, Vomiting
SMQs:, Cardiac failure (narrow), Haemolytic disorders (narrow), Acute pancreatitis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Congenital, familial and genetic disorders (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (broad), Opportunistic infections (narrow), Immune-mediated/autoimmune disorders (broad), COVID-19 (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, 19 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: DiGeorge''s syndrome; Heart diseasecongenital; Immunosuppression; Cardiac failure congestive; Oral candidiasis recurrent; Fallot''s tetralogy
Preexisting Conditions: Surgical procedure
Allergies:
Diagnostic Lab Data: diagnostic laboratory test Genetic testing at birth: hemizygous 22qll.2 deletion, confirming diagnossisi of DiGeorge syndrome. Physical examination thin, pale, afebrile, but irritable, well perfused, tachycardic with grade 4 holosystolic murmur, diagnostic laboratory test non-immune haemolytic anemia. aspiration (procedure) varicella vaccine strain by PCR. autopsy showed extensive pulmonary damage and haemorrhage and generalized lympadenopathy, diagnostic laboratory test positive for varicella by PCR. Bronchoscopy multiple white plaques on an erythematous base in the bronchi, chest X-ray diffuse infiltrates, diagnostic laboratory tests GMS stains were fungal organisms were negative. body temp febrile, urinalysis negative for measles by PCR, tissue analysis bronchoscopy specimen: suggesting viral pneumonia, bronchial culture Candida tropicals, viral culture immunohistochemistry stains were negative
CDC Split Type: WAES0706CAN00082

Write-up: It was reported in a published article, titled as stated above concerning a 13 month old male full term infant with partial Digeorge''s Syndrome (confirmed by genetic testing at birth which demonstrated a hemizygous 22q11.2 deletion), cardiac failure congestive and complex congenital heart disease and a history of Fallot''s tetralogy (diagnosed at 5 days of age), Rastelli procedure (performed at 10.5 months of age), oral candidasis recurrent during the first three months of life (no other significant infections) and immunosuppression at 8 months of age who despite a recommendation not to administer live vaccines was inadvertently vaccinated with ProQuad at 12 months of age. The patient was admitted to hospital with a one week history of decreased oral intake, lethargy, vomiting, and one episode of haematemesis. On admission the patient''s physical examination revealed a thin, pale, afebrile but irritable child. The patient was well perfused but tachycardic with a grade 4 holosystolic murmur radiating to the back. Respiratory exam revealed and sparse inspiratory crackles bilaterally. The patient''s liver was palpated 4 cm below the right costal margin. No rash was noted. The patient''s initial diagnostic laboratory test revealed a non-immune haemolytic anemia and chest-X-ray demonstrated worsening congestive heart failure. The patient was treated with packed red blood cell transfusion and aggressive diuresis with furosemide was initiated. Subsequently the patient developed a fever and increasing diffuse patchy infiltrates on chest radiographs, a bronchoscopic examination was performed on day 11 of hospitalization and showed multiple white plaques on an erythematous base in the bronchi. The patient''s microscopic examination of the bronchoscopy specimen showed many haemosiderin-laden macrophages and few multinucleated giant cells with nuclear inclusions suggesting viral pneumonia. The culture of the specimen grew Candida tropicals but was otherwise negative for all other infectious aetiologies including varicella by PCR. The patient was treated with 2 weeks of antifungal therapy for possible candidal pneumonia. The patient remained febrile, mechanically ventilated, and on medication to support his blood pressure. On day 19 of hospitalization, 7 weeks post-immunization, he developed five vesicular lesions on his trunk. The lesions were positive for varicella vaccine strain by PCR. The patient''s tracheal aspirates and urine samples were negative for measles by PCR. The rash did not progress and the patient received 10 days of aerosolised and intravenous ribavarin as well as 14 days of intravenous acyclovir to treat possible measles and/or varicella pneumonia. The patient died due to pulmonary haemorrhage at 19 months of age after prolonged intubation for chronic lung disease. Autopsy showed extensive pulmonary damage and haemorrhage and generalized lympadenopathy. No thymic tissue was evident. Specific viral immunohistory stains were negative. VZV was not detected in lung or lymph node tissue by PCR. GMS stains for fungal organisms were negative. The authors felt that the patient''s severely immunocompromised status placed him at low risk for varicella as measles pneumonitis following live viral vaccination. The varicella positive tracheal aspirates likely represented mucosal involvement by the vaccine strain, although the bronchoscopic specimen was negative for varicella by PCR. Although tracheal aspirates and urine samples were negative for measles by PCR, the clustering of nuclear inclusion bodies with giant cells on the bronchoscopy specimen was suggestive for measles. The authors concluded, although live viral vaccines are likely safe in some children with partial DiGeorge syndrome, this patient''s post-immunisation course suggests that caution and further study are needed in DiGeorge syndrome patients with severe immunodeficiency. No further information is available. A literature article is attached as further documentation of the patient''s experience.


VAERS ID: 282372 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2007-06-01
Onset:2007-06-01
   Days after vaccination:0
Submitted: 2007-06-19
   Days after onset:18
Entered: 2007-06-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Loss of consciousness, Resuscitation, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Dental operation
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0706USA02451

Write-up: Information has been received from a gynecologist who was informed of the case from another gynecologist concerning a 17 year old female who in June 2007 (week 23), was vaccinated with a first dose of Gardasil (lot number, injection site and route not reported). During the evening of the same day, the patient was found unconscious (lifeless) by the mother. Resuscitation was performed by the emergency physician but was unsuccessful. The patient subsequently died. The cause of death was sudden death. It was noted that the patient had a dental surgery the day before she was vaccinated. An autopsy was done. The results were not known. Other business partner numbers include E2007-03769. Additional information has been requested.


VAERS ID: 282590 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2002-08-01
Submitted: 2007-06-20
   Days after onset:1784
Entered: 2007-06-21
   Days after submission:1
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: Computerised tomogram normal, Convulsion, Coordination abnormal, Death, Dysarthria, Dyskinesia, Electroencephalogram abnormal, General physical health deterioration, Myoclonus, Subacute sclerosing panencephalitis
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Dyskinesia (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Birth Twin
Preexisting Conditions: Rash morbilliform
Allergies:
Diagnostic Lab Data: electroencephalography showed diffuse paroxysmal discharges accompanied by sharp wave complexes, computed axial tomography of brain was normal, diagnostic laboratory test revealed the IgG synthesis within the CNS with oligoclonal bands og immunoglobulins, computed axial tomography repeated CT showed diffuse atrophic changes
CDC Split Type: WAES0706USA02457

Write-up: Information has been received from physicians in a literature article, title above concerning a female, with a history of morbilliform rash, who was vaccinated (at 18 months of age) with a dose of MMR II. The patient was born in December 1997 in a very high risk twin pregnancy. She was vaccinated with MMR II according to the official immunization schedule. At the age of 6 months, she was hospitalized for morbilliform rash. In August 2002, she developed dysarthia, ataxia, and monoclonal jerks. The electroencephalogram (EEG) showed diffuse paroxysmal discharges accompanied by sharp wave complexes and valproate therapy was started. Computed tomography (CT) of the brain was normal. Because of Because of persistent seizures, the girl was admitted to the hospital. CSF analysis revealed the IgG synthesis within the CNS with oligoclonal bands of immunoglobulins. Repeated CT of the brain revealed diffuse atrophic changes. Despite being on valproate therapy she experienced no improvement. The girl''s condition continued deteriorating. She became soporiferous and tetraparetic. The disease had a fulminant course and the girl died in December 2002. Her identical twin sister also had a morbilliform rash at the age of six months, but she didn''t exhibit any symptoms of SSPE until the end of 2004. The authors concluded that is spite of some reports of SSPE occurring the administration of MMR II vaccines, there is no evidence that the measles vaccine could cause SSPE (no vaccine strain has never been discovered). This is one of several reports received from the same source. This article also discussed the experiences of a 4 year old male (WAES# 0706USA03037), a 7 year old male (WAES# 0706USA03035) and an 11 year old male (WAES# 0706USA03036) while on therapy with MMR II. No further information information is available. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 282591 (history)  
Form: Version 1.0  
Age: 7.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:1995-06-01
Submitted: 2007-06-20
   Days after onset:4402
Entered: 2007-06-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: CSF test abnormal, Computerised tomogram normal, Coordination abnormal, Death, Dysgraphia, Dyslexia, Electroencephalogram abnormal, Febrile convulsion, Infantile spasms, Loss of consciousness, Memory impairment, Mental impairment, Subacute sclerosing panencephalitis
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Rash morbilliform
Allergies:
Diagnostic Lab Data: electroencephalography ??Oct96 showed multifocal EEG discharges, computed axial tomography ??Jul?02 of brain was normal, diagnostic laboratory test ??Jul?02 CSF analysis revealed the IgG synthesis within the CNS with oligoclonal bands of immunoglobulins, electroencephalography ??Jul?02 revealed hypsarrythmia
CDC Split Type: WAES0706USA03035

Write-up: Information has been received from physicians in a literature article, title above concerning a female, with a history of morbilliform rash, who was vaccinated (at 20 months of age/only measles and at age 6 years) with a dose of MMR II. The patient was born in November 1994 in a normal pregnancy. He was vaccinated regularly with MMR II. At the age of 7 months, the boy had a febrile disease with morbilliform rash. During 1995, he was hospitalized on three occasions for febrile convulsion for which he was placed on prophylactic therapy with phenobarbitone. In October 1996, the boy was readmitted to the hospital for relapsing convulsions. Because of multifocal EEG discharges, he was placed on valproate therapy. In September 2001, he entered the primary school. Eight months later, mental deterioration started accompanied by memory dysfunction, dysgraphia and dyslexia. Two months later, he developed ataxia and was admitted to the hospital. EEG revealed hypsarrhythmia, CSF analysis revealed the IgG synthesis within the CNS with oligoclonal bands of immunoglobulins. CT of the brain was normal. A topiramate therapy was started. During the hospitalization, he still occasionally had partial seizures in the extremities accompanied by short losses of consciousness and absences. His condition continued to deteriorating. The patient was unable to sit voluntarily, stopped talking and lost control of the sphincters. As the disease was progressive, the boy died in January-2003. The authors concluded that in spite of some reports of SSPE occurring after the administration of MMR II vaccines, there is no evidence that the measles vaccine could cause SSPE (no vaccine strain has ever been discovered). This is one of several reports received from the same source. This article also discussed the experiences of a 4 year old female (WAES# 0706USA03036) while on therapy with MMR II. No further information is available. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 282592 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2002-03-01
Submitted: 0000-00-00
Entered: 2007-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abnormal behaviour, CSF test abnormal, Computerised tomogram normal, Convulsion, Coordination abnormal, Death, Electroencephalogram abnormal, Nuclear magnetic resonance imaging brain normal, Pyrexia, Respiratory tract infection, Somnolence, Speech disorder, Subacute sclerosing panencephalitis, Varicella
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: unknown
Current Illness:
Preexisting Conditions: unknown
Allergies:
Diagnostic Lab Data: computed axial tomography Mar02 of brain was normal; electroencephalography Mar02 irritative bilateral changes were detected; diagnostic laboratory test Aug02 CSF analysis revealed the IgG synthesis within the CNS with oligoclonal bands of immunoglobulins; magnetic resonance imaging Aug02 of the brain was normal; electroencephalography Aug02 showed generalized dysrrythmic discharges with paroxyms of high-voltarge slow waves and occasional; electroencephlography At age 6 years old-revealed dysrrythmic discharges
CDC Split Type: WAES0706USA03036

Write-up: Information has been received from physicians in a literature article, title above concerning a female who was vaccinated with a dose of MMR II. The patient was born in May 1990 in a normal pregnancy. He was vaccinated with regularly with MMR II. At the age of 6 years, he had the first partial seizure. The EEG revealed dysrrhythmic discharges and a therapy with primidone was started. In March 2002, he was hospitalized for varicella when the first generalized seizure occurred. On an EEG, irritative bilateral changes were then detected. CT of the brain was normal. Five months later, his mother noted changes in his behavior, ataxia and occasionally indistinct speech. The boy was readmitted to the hospital. At the end of August 2002, he developed the signs of milder respiratory infection. The following day he became febrile and markedly somnolent, waking up only at a stronger stimulus. Repeated EEG showed generalized dysrrhythmic discharges with paroxysms of high voltage slow waves and occasional sharp pointed waves. CSF analysis showed the IgG synthesis within the CNS with oligoclonal bands of immunoglobulins. MRI of the brain was normal. On several occasions during the hospitalization, he suffered from generalised convulsions. A therapy with phenobarbitone and carbamazepine produced no improvement. The disease had a progressive course and the boy died in November 2003. The authors concluded that in spite of some reports of SSPE occurring after the administration of MMR II vaccines, there is no evidence that the measles vaccine could cause SSPE (no vaccine strain has ever been discovered). This is one of several reports received from the same source. This article also discussed the experiences of a 4 year old female (WAES0706USA02457), a 7 year old male (WAES# 0706USA03035) and a 4 year old male (WAES#0706USA03037) while on therapy with MMR II. No further information is available. A copy of the published article is attached as further documentation of the patient''s experience.


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