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VAERS ID: 335525 (history)  
Form: Version 1.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2004-03-26
Onset:2004-03-26
   Days after vaccination:0
Submitted: 2008-12-17
   Days after onset:1727
Entered: 2008-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 8047A1 / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Haematemesis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unk
CDC Split Type: A0760422A

Write-up: This case was reported by a nurse via a regulatory authority (Health foreign # V0701800) and described the occurrence of hematemesis in a 35-year-old female subject who was vaccinated with ENGERIX B, GlaxoSmithKline. On 26 March 2004 the subject received unspecified dose of ENGERIX B (unknown). On an unknown date in March 2004, 7 hours after vaccination with ENGERIX B, the subject experienced hematemesis. The subject was hospitalised and later died, cause of death was not specified. It was unknown whether an autopsy was performed.


VAERS ID: 335636 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2008-10-01
Onset:2008-10-17
   Days after vaccination:16
Submitted: 2008-12-18
   Days after onset:62
Entered: 2008-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Anorexia, Bronchiolitis, Cardiogenic shock, Cardiopulmonary failure, Chest X-ray, Computerised tomogram abnormal, Computerised tomogram head, Cough, Death, Hypoventilation, Pyrexia, Respiratory distress, X-ray abnormal
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-10-30
   Days after onset: 13
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Congenital cardiac abnormality; Microcephaly
Preexisting Conditions: Premature birth
Allergies:
Diagnostic Lab Data: Computerized tomogram head, microcephaly; Thorax X-ray, 29Oct2008, cardiopathy
CDC Split Type: B0550456A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of cardiogenic shock in a 3-month-old male subject who was vaccinated with ROTARIX, GlaxoSmithKline. The subject was on no other medication and had no allergy. The subject''s medical history included premature birth at 36 weeks gestation by caesarean. Concurrent medical conditions included congenital cardiac abnormality and microcephaly. On 1 October 2008, the subject received unspecified dose of ROTARIX (oral). Lot number not provided. On 17 October 2008, 16 days after vaccination with ROTARIX, the subject started with cough, fever, respiratory distress and hyporexia. He was treated with Cefalexina, Clorfeniramina, Dextromethorphan at home without clinical recovery. The subject was admitted at ER on 24 October 2008 and showed at physical exam, microcephaly, cardiomegaly and pulmonary hypoventilation. Diagnosis of bronchiolitis and congenital cardiopathy was made. Thorax X-ray showed cardiomegaly, apical bronchial congestion and pulmonary over distention. During hospitalization, the subject was treated with digoxin, Furosemide and Penicillin. On 30 October 2008, the subject needed a venoclysis for medication, after this procedure, he experienced cardiopulmonary failure and death after 15 minutes of cardiopulmonary resuscitation. The subject was hospitalized and the physician considered the events were disabling, life threatening, a congenital anomaly and clinically significant (or requiring intervention). The physician considered the events were possibly related to vaccination with ROTARIX. The subject died on 30 October 2008 from cardiogenic shock. An autopsy was not performed. The primary cause of death was cardiogenic shock, congenital cardiopathy, dysmorphic syndrome and the secondary cause of death was bronchiolitis and microcephaly.


VAERS ID: 335689 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2008-12-09
Onset:2008-12-10
   Days after vaccination:1
Submitted: 2008-12-18
   Days after onset:8
Entered: 2008-12-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (HIBTITER) / PFIZER/WYETH - / 2 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 2 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-12-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HIBTITER, 09Dec08; PREVENAR, 09Dec08
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0812KOR00015

Write-up: Information has been received from a physician and an regulatory agency concerning a 12 week old female who on 09-DEC-2008 was vaccinated with the first dose of ROTATEQ (Lot number 1036X, Expiry date 07-JUN-2010). Concomitant therapy included PREVENAR and HIBTITER. In the afternoon on 12-DEC-2008, the professional sales representative reported that he heard from the business partnership company that the baby who was vaccinated with ROTATEQ was recently dead. The additional information was promptly collected from the business partner company. The regulatory agency received the report that the baby was dead, and the agency will investigate this lot number of ROTATEQ (Lot number 1036X, Expiry date 07-JUN-2010). Therefore the agency requested the business partnership company (in charge of vaccine distribution) to check the distribution status of this lot number. The business partnership company is currently checking the distribution status. On the same day the additional information was collected from the administering doctor. The doctor said that the baby was vaccinated with PREVENAR and HIBTITER on 09-DEC-2008 as well as the first dose of ROTATEQ on 09-DEC-2008, and then the baby was dead on 10-DEC-2008. The doctor was just informed of her death over the phone from her parent, so he did not know the additional information yet. The doctor also said that the autopsy was planned in other hospital on 12-DEC-2008 and there was no cause of death and causal relationship with vaccines reported yet. Information regarding lot number validation of ROTATEQ has been requested. Additional information has been requested. A lot check has been initiated. Adjudication Data Entry


VAERS ID: 335706 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2008-12-09
Onset:2008-12-10
   Days after vaccination:1
Submitted: 2008-12-18
   Days after onset:8
Entered: 2008-12-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (HIBTITER) / PFIZER/WYETH BBS039 / 1 UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 33235 / 1 UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-12-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unk
Allergies:
Diagnostic Lab Data: None provided
CDC Split Type: KRWYEH07166308

Write-up: Information regarding PREVENAR was received from a pediatrician regarding a 2-month-old female patient who experienced death. The patient received the first dose on 09-Dec-2008. The patient also received the first dose of Hib-Titer Vaccine on 09-Dec-2008. On 09-Dec-2008, the patient received the first vaccination of PREVENAR, Hib-Titer and ROTATEQ SOLN. The next day, on 10-Dec-2008, the infant was "no reaction" and was transferred to the hospital and died. An autopsy was performed on an unspecified date. The reporting doctor said that the autopsy result indicates that the death is not related to the products. The direct cause of death is unknown. No additional information was available at the time of this report.


VAERS ID: 335715 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2008-11-01
Onset:0000-00-00
Submitted: 2008-12-19
Entered: 2008-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0551113A

Write-up: This case was reported by a physician and described the occurrence of death NOS in a child subject of unspecified gender who was vaccinated with ROTARIX, GlaxoSmithKline. Near the end of November 2008, the subject received unspecified dose of ROTARIX (unknown route of administration, lot number not provided). On an unspecified date, at an unspecified time (short while) after vaccination with ROTARIX, the subject died. Cause of death was not specified. It was unknown whether an autopsy was performed. The physician considered the event was unrelated to vaccination with ROTARIX.


VAERS ID: 336320 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Male  
Location: Foreign  
Vaccinated:2008-11-24
Onset:2008-11-25
   Days after vaccination:1
Submitted: 2008-12-29
   Days after onset:34
Entered: 2008-12-31
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apathy, Autopsy, Body temperature increased, Brain oedema, Death, Decreased appetite, Disseminated intravascular coagulation, Ear infection, Haemophilus infection, Hepatitis, Hyperaemia, Hyperthermia, Laryngitis, Lymphadenitis, Meningitis, Nephritis, Pneumonia, Respiratory tract infection, Respiratory tract infection viral, Sepsis, Somnolence, Thymus disorder
SMQs:, Acute renal failure (broad), Hepatitis, non-infectious (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Accidents and injuries (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-12-04
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body temperature, 25Nov2008, 38 deg C; Body temperature, 01Dec2008, 39 deg C
CDC Split Type: B0551842A

Write-up: This case was reported by a physician and described the occurrence of sepsis in a 12-month-old male subject who was vaccinated with PRIORIX (GlaxoSmithKline). On 24 November 2008, the subject received unspecified dose of PRIORIX (unknown route, unknown injection site). On 25 NOvember 2008, 1 day after vaccination with PRIORIX, the subject experienced hyperthermia (38 deg C) which resolved spontaneously within 24 hours. On 1 December 2008, the temperature raised again (39C); the child showed apathy and sleepiness, his appetite was decreased. The boy was examined by the physician of ambulance, and a lytic mixture was administered (ANALGIN, NO-SPA, DROTAVERINE and DIMEDROLE), as well as NUROFEN. The diagnosis was acute respiratory viral infection (ARVI). The district pediatrician diagnosed ARVI, also on 2 December 2008, and administered NUROFEN, ARBIDOL and NAPHTIZIN. On 3 December 2008, the child was examined by ear, nose, throat (ENT) doctor and throat hyperemia, acute left-side cattharal otitis, submanibular lymphadenitis were diagnosed. On 4 December 2008, the boy''s condition worsened, the temperature raised above 40 deg C. The doctors of ambulance ascertained biological death at 10:50 a. m., 4 December 2008. The subject was treated with ANALGIN, DIMEDROLE, NUROFEN, NO-SPA and NAPHTHIZINUM. The result of autopsy: Sepsis, septicemia, pneumonia, meningitis, hepatitis, nephritis, ulcerous-necrotic laryngitis, syndrome of disseminated intravascular coagulation, edema-swelling of brain, thymus involution stage 3-4. Bacteriologic analysis showed the growth of Haemophilus parainfluenza in all inoculations from internal organs. The physician considered the first episode of hyperthermia to be possibly related to vaccination with PRIORIX. The causality assessment for the other events was unknown. The subject died on 4 December.


VAERS ID: 336697 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2008-11-10
Onset:0000-00-00
Submitted: 2009-01-06
Entered: 2009-01-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-12-25
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0901USC00001

Write-up: Information has been received from an investigator concerning a male who entered a study. On 08-SEP-2008, 09-OCT-2008 and 10-NOV-2008 the patient was vaccinated with blinded therapy. No concomitant medications were reported. Height and weight measurements were taken on 24-NOV-2008. On the morning of 25-DEC-2008 at approximately 0400, the mother fed the infant on porridge and put him to sleep. The mother woke up at approximately 0600 and found the infant had died. On 27-DEC-2008, the infant was buried. The mother reported that the infant had been well prior to death. At the time of this report, the cause of death and relationship to study therapy were unknown. A study clinician will do a home follow up to conduct a verbal autopsy. Additional information has been requested.


VAERS ID: 337349 (history)  
Form: Version 1.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:2009-01-09
Onset:2009-01-09
   Days after vaccination:0
Submitted: 2009-01-14
   Days after onset:5
Entered: 2009-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS ATYAB016AE / UNK UN / UN
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME) / UNKNOWN MANUFACTURER ATYAB016AE / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Expired drug administered
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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0553257A

Write-up: This case was reported by a nurse and described the occurrence of expired vaccine used in a 41-year-old male subject who was vaccinated with HEPATYRIX (GlaxoSmithKline). On 9 January 2009 the subject received an expired dose of HEPATYRIX (1 injection). On an unspecified date, the subject died, cause of death was unknown. It was unknown whether an autopsy was performed. On the 9th January 2009 a nurse reported that a patient was administered an expired dose of HEPATYRIX vaccine on the 9th January 2009. The nurse had not realised the HEPATYRIX vaccine was beyond its expiration date before administering the vaccine. The expiration of the vaccine was October 2008. The patient has not reported any events to the nurse at the time of reporting.


VAERS ID: 337631 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2008-12-01
Submitted: 2009-01-15
   Days after onset:45
Entered: 2009-01-20
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 4 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, Death, Meningitis pneumococcal, Serology test
SMQs:, 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:
Preexisting Conditions: Unk
Allergies:
Diagnostic Lab Data: Blood culture, detection of pneumococci, serotyp unknown but not a serotyp which is included in PREVENAR
CDC Split Type: DEWYEG02924109

Write-up: Information regarding PREVENAR was received from a healthcare professional via sales representatives regarding a male child who experienced pneumococcal meningitis. The patient received the fourth dose on an unspecified date. The patient received four doses of PREVENAR and in DEC-2008 the patient was hospitalized and died due to meningitis pneumococcal. The cause of death was reported as meningitis pneumococcal. No additional information was available at the time of this report but has been requested.


VAERS ID: 337632 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2008-01-05
Onset:2008-01-05
   Days after vaccination:0
Submitted: 2009-01-16
   Days after onset:377
Entered: 2009-01-20
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2945AA / UNK UN / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR C2945AA / UNK UN / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR C2945AA / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 31635 / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-01-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FRUSEMIDE, unknown, unknown; SILDENAFIL, unknown, unknown; SPIRONOLACTONE, unknown, unknown
Current Illness: Cytogenetic abnormality; Truncus arteriosus persistent; Tracheostomy; Cardiac disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: GBWYEG02932709

Write-up: This is a fatal case. Information regarding PREVENAR was received from a healthcare professional via regulatory authority (reference number 20364829) regarding a male patient who experienced an allergic reaction, cardiac arrest and died. Death was considered to be likely due to underlying cardiac and respiratory conditions. The patient received a dose on 05-Jan-2008. Additional suspect medication included PEDIACEL. The patient, who had complex congenital cardiac condition and multiple genetic abnormalities was administered PREVENAR and PEDIACEL at 14:30 on the 05-Jan-2008. At 17:00 on the same day the patient experienced cardiac arrest and died. It was also reported that the patient experienced an allergic reaction although no other signs of anaphylaxis were present (no cutaneous signs and no bronchospasm noted). It was reported that the death was likely due to underlying cardiac and respiratory conditions. The cause of death was reported as cardiac arrest, cardiac disorder, respiratory disorder and condition aggravated. No further information was provided.


VAERS ID: 337811 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-01-20
Entered: 2009-01-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Brain injury, Convulsion, Death
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), 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)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0901USA01867

Write-up: Information has been received from an article in a newspaper journal published on 12-DEC-2008 concerning a 2 year old female patient with no pertinent medical history reported who in 1998 (date of vaccination not reported) received a dose of MMR II (manufacturer, batch #, route and site not reported). There was no concomitant medication. It was reported that following the vaccination, the patient suffered brain damage and experienced up to fits a day. On an unreported date but just before her third birthday, the patient experienced a violent fit and died. The cause of death was brain damage and convulsion. It was reported that the patient''s parents sought compensation from the vaccine damage unit and the claim was upheld and concluded that the patient was disabled as a result of the vaccination which caused her development to deteriorate. Other business partner numbers include E2009-00225. No further information is available.


VAERS ID: 337916 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2009-01-01
Submitted: 2009-01-21
   Days after onset:20
Entered: 2009-01-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: CSF culture positive, Complement factor normal, Death, Drug ineffective, Immunoglobulins normal, Meningitis pneumococcal
SMQs:, Lack of efficacy/effect (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-01-02
   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: Concomitant medications were not provided.
Current Illness:
Preexisting Conditions: Relevant medical history was not provided.
Allergies:
Diagnostic Lab Data: The following tests were done on an unspecified date: CSF culture (results: Pneumococcal meningitis); immunoglobulins (results: normal); and complement factor (results: normal).
CDC Split Type: ESWYEG02937509

Write-up: Information regarding PREVENAR was received from a healthcare professional regarding a 5-month-old male patient who experienced drug ineffective and pneumococcal meningitis. The patient received the second dose on an unspecified date. Relevant medical history was not provided. The patient experienced drug ineffective and pneumococcal meningitis on 01-Jan-2009 and was hospitalized. On 02-Jan-2009 the patient died due to pneumococcal meningitis. See related case(s): ES-WYE-G02937709 (adverse event, expedited) and ES-WYE-G02937609 (adverse event, expedited). No additional information was available at the time of this report.


VAERS ID: 337961 (history)  
Form: Version 1.0  
Age: 1.4  
Sex: Female  
Location: Foreign  
Vaccinated:2007-11-13
Onset:2007-11-21
   Days after vaccination:8
Submitted: 2009-01-14
   Days after onset:420
Entered: 2009-01-22
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-11-21
   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: Cold, Unknown, Unknown, No; Fever, Unknown, Unknown, No
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: B0553968A

Write-up: This case was reported by a regulatory authority (# NO-NOMAADVRE-FHI-2008-6550) and described the occurrence of sudden infant death in a 17-month-old female subject who was vaccinated with PRIORIX (GlaxoSmithKline). Concurrent medical conditions included cold and fever. On 13 November 2007, the subject received unspecified dose of PRIORIX (parenteral, unknown injection site). Lot number not provided. On 21 November 2007, 8 days after vaccination with PRIORIX, the subject experienced sudden infant death. The regulatory authority reported that the event was possibly related to vaccination with PRIORIX. The subject died on 21 November 2007, cause of death was not reported. It was unknown whether an autopsy was performed. Additional information has been requested.


VAERS ID: 338062 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Foreign  
Vaccinated:2009-01-12
Onset:2009-01-13
   Days after vaccination:1
Submitted: 2009-01-22
   Days after onset:9
Entered: 2009-01-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CA496D / 3 RL / IM
PPV: PNEUMO (PNU-IMUNE) / PFIZER/WYETH 34719 / 2 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-01-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: B0554382A

Write-up: This case was reported by a physician via a GSK sales representative and described the occurrence of unexplained sudden infant death in a 4-month-old male subject who was vaccinated with INFANRIX HEXA (GlaxoSmithKline) and PREVENAR (Wyeth Labs). The subject was followed by the reporting paediatrician since 23 September 2008, without problem observed till occurrence of the event. Vaccinal history included a first dose of INFANRIX QUINTA and PREVENAR (batches and injection sites unknown) on 23 September 2008 and a second dose of INFANRIX QUINTA (no coadministration (batch and injection site unknown) on 28 November 2008. There has been no safety problems with all these vaccinations. On 12 January 2009 around 12H30, the subject received a third dose of INFANRIX HEXA (batch A21CA496D, intramuscular, anterior face of right thigh) and a 2nd dose of PREVENAR (batch 34719, intramuscular, anterior face of left thigh). Vaccination happened without any problem. Physical exam and questioning performed just before the vaccination showed no particular anomaly. During the night from 12 to 13 January 2008, around 12 hours after vaccination with INFANRIX HEXA and PREVENAR, the subject was found lying on belly with vomiting in his bed. At around 02 AM, several intensive care manoevers were unsuccessful at emergency room. According to the reporter, the diagnosis seemed to be an unexplained sudden infant death. At the time of reporting, an autopsy was planned. The physician''s causality relationship was unspecified.


VAERS ID: 338452 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-10-20
Onset:2008-12-30
   Days after vaccination:71
Submitted: 2009-01-27
   Days after onset:28
Entered: 2009-01-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1316U / 2 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-12-30
   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:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0901USA03040

Write-up: Information has been received from a health authority (reference # PEI2009000661) concerning a 15 year old female who on 20-OCT-2008 was vaccinated with the first dose of GARDASIL, lot #1427U (batch #NH15200) IM into the left upper arm. No information regarding toleration was given. On 29-DEC-2008, the patient was vaccinated with a second dose of GARDASIL, lot #1316U (batch #NH45640) IM into the left upper arm. On 30-DEC-2008 the patient died. According to the preliminary report, the autopsy showed no acute or chronic organic disease. The possibility of carbon monoxide intoxication was not yet ruled out. Investigation by public prosecution is ongoing. Lot checks have been requested. Other business partner numbers included: E2009-00404. Additional information has been requested.


VAERS ID: 338561 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-12-27
Onset:2009-01-01
   Days after vaccination:5
Submitted: 2009-01-28
   Days after onset:27
Entered: 2009-01-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arrhythmia, Atrial fibrillation, Autopsy, Blood glucose increased, Body temperature decreased, Body temperature increased, Cyanosis, Death, Drug screen negative, Dyspnoea, Electrocardiogram abnormal, Hyperthermia, Hypothermia, Intensive care, Laboratory test normal, Leukocytosis, Lung disorder, Malaise, Multi-organ failure, Mydriasis, Tachycardia, Tremor, Ventricular hypokinesia, White blood cell count increased, X-ray abnormal
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Dehydration (broad), Sepsis (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: BUSPAR; LEXOMIL; hormonal contraceptives (unspecified); magnesium (unspecified) (+) pyridoxine hydrochloride
Current Illness: Asthenia; Anxiety; Overwork; Psychological disorder NOS
Preexisting Conditions: Cardiac Murmur
Allergies:
Diagnostic Lab Data: electrocardiogram, 03Jan09, arrhythmia with atrial fibrillation; X-ray, 03Jan09, pneumopathy of right middle pulmonary lobe and septal hypokinesia; body temp, 01?Jan09, 38 C; WBC count, 03Jan09, 12.4.103/mm3; body temp, 03Jan09, 33.7 C; blood chemistry, no cocaine and no benzodiazepines; blood glucose, 3.18, increased
CDC Split Type: WAES0901USA03398

Write-up: Information has been received from a specialist and from the health authority, concerning a 20 year old female with asthenia, anxiety/overwork syndrome and psychologic fragility since May 2008 and a history of cardiac murmur during childhood, who in OCT-2008 was vaccinated with the first dose of GARDASIL. The patient had no adverse effects after this dose. Concomitant therapy included BUSPAR, LEXOMIL, magnesium (unspecified) (+) pyridoxine hydrochloride and hormonal contraceptives (unspecified). On 27-DEC-2008 the patient was vaccinated with the second dose of GARDASIL, batch number not reported. It was reported that 3 days after the second dose of GARDASIL, i.e. in JAN-2009 the patient presented with hyperthermia at 38 C associated with breathlessness. After a malaise during shopping on 01-JAN-2009 the patient consulted her general practitioner; she had tremor and tachycardia. Blood analysis was performed on 03-JAN-2009 and revealed a slight hyperleukocytosis (12.4 103/mm3). By the evening on 03-JAN-2009 the patient presented with a malaise again but with no dyspnea and after taking BUSPAR. 2 hours later the intervention of EMUR (emergency medical mobile unit) could lead to recuperate a sinusal rhythm. Continuous arrhythmia with atrial fibrillation was diagnosed. The patient was transferred to medical intensive care service: she presented with bilateral mydriasis, hypothermia at 33.7 C, the result of measure of sugar in her blood was increased at 3.18 and she had cyanosis of face, ears, and extremities. Radiological examinations revealed a pneumopathy of the right middle pulmonary lobe and septal hypokinesia with paradoxical septal. There was no cocaine and no benzodiazepines. The patient presented with multiorgan failure under high dose of amines and then she dies in spite of the cardiopulmonary by-pass and extra corporeal oxygenation assistance. An autopsy was performed (unspecified date) and found no cause of death, also reported as information on autopsy was still awaited. Other business partner numbers include: E2009-00502. Additional information has been requested.


VAERS ID: 338775 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Female  
Location: Foreign  
Vaccinated:2008-12-22
Onset:2009-01-04
   Days after vaccination:13
Submitted: 2009-01-30
   Days after onset:26
Entered: 2009-02-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 MO / PO
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 3 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal distension, Congenital anomaly, Death, Decreased activity, Dehydration, Diarrhoea, Faeces discoloured, Gastrointestinal necrosis, Haematochezia, Intussusception, Lethargy, Nausea, Pallor, Pyrexia, Surgery, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Congenital, familial and genetic disorders (narrow), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-01-08
   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: Malnutrition; prophylaxis
Preexisting Conditions: Scabies infestation; Pediculosis corporis; Immunisation
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0901CRI00001

Write-up: Information has been received from a physician concerning a 19 week old female with malnutrition and a history of lice infestation, scabies infestation and vaccination BCG on 21-Aug-08 who on 24-Oct-2008 received first vaccination of ROTATEQ and second vaccination on 22-Dec-2008. Concomitant vaccine therapy included the first and second doses of PENTAVALENTE and polio given on 24-Oct-08 and 22-Dec-08. On 08-Jan-2009 the patient died. The cause of death was intussusception. Infant started vomiting and nauseas within the 5 previous days (#5 a day) before visiting the hospital. Treated with oral rehydration solution at health care center two days before. Signs and symptoms registered: Diarrhea with mucus, green-colored, no blood (however mother referred bloody stools), twice a day, no abdominal pain. Treated with laxatives by non-medical personnel. Clinical symptoms remained the same for 2 days, then starts fever. Physical Evaluation: FC 160x FR 48 t 39 height 62 cm. Hypoactive, lethargic, dehydration signs, with fever, pale and showing sign of capillary fragility. Capillary refill 4 seconds; abdominal distention = 42 cm, no mass or abdominal pain. Rectum and anus: normal. On January 2009 (day unknown) patient required surgery for intestinal necrosis ileo-colic section. Surgeon stated an intestinal invagination probably associated to congenital malformation of the intestine. Additional information has been request.


VAERS ID: 338997 (history)  
Form: Version 1.0  
Age: 1.2  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-02-03
Entered: 2009-02-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial culture positive, Death, Drug ineffective, Meningitis pneumococcal
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: Relevant medical history was not provided.
Allergies:
Diagnostic Lab Data: Bacterial culture (results: Pneumococcal meningitis, serotype 6B) was done on an unspecified date.
CDC Split Type: NOWYEG02984509

Write-up: Additional information was received regarding patient details. Information regarding PREVENAR was received from a healthcare professional at the foreign health agency regarding a 14-month-old female patient who experienced drug ineffective and pneumococcal meningitis, serotype 6B. The patient received the third dose on an unspecified date. The patient experienced drug ineffective and pneumococcal meningitis, serotype 6B during the second year of life. The patient received three doses which is equivalent to full vaccination programme in foreign country. However the elapsed time between the booster dose and the infection is unknown. The outcome was fatal.


VAERS ID: 339005 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2008-02-29
Onset:2008-03-06
   Days after vaccination:6
Submitted: 2009-02-04
   Days after onset:335
Entered: 2009-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB25411E / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blood test normal, Computerised tomogram normal, Death, Dysarthria, Encephalitis viral, Mental disorder, X-ray normal
SMQs:, Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), 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:
Current Illness: Unknown
Preexisting Conditions: It was reported that the patient was perfectly fit. A post mortem had revealed nothing "out of the ordinary" and stated that the death was "possibly due to a possible drug reaction".
Allergies:
Diagnostic Lab Data: CT scans, X-rays and blood tests on unspecified dates had been provided with ''''all clear'''' results.
CDC Split Type: B0556189A

Write-up: This case was reported by a retired midwife (patient''s mother) and described the occurrence of slurred speech in a 24-year-old male patient who was vaccinated with ENGERIX B (GlaxoSmithKline). On 29 February 2008 and 7 March 2008 the patient received 1st dose and 2nd dose of ENGERIX B (1 injection, unknown). On 6 March 2008, approximately 6 days after vaccination with the first dose ENGERIX B, the patient experienced slurred speech which was diagnosed as a psychiatric problem. The patient was hospitalised. At an unknown time after vaccination with ENGERIX B, the patient experienced viral encephalitis. It was reported that "CT scans, X-rays and blood tests on unspecified dates had been provided with ''all clear'' results". The patient died from viral encephalitis "approximately 3 weeks later". It was reported that "a post mortem had revealed nothing ''out of the ordinary'' and stated that the death was ''possibly due to a possible drug reaction''." Verbatim text received: On 26 January 2009, a retired midwife reported that her 24 year old son was administered ENGERIX B vaccine as the first dose of the 0,7,21 day schedule on 29 February 2008. The patient was then administered the second dose of the schedule on 7 March 2008. The vaccinations were received under military care as the patient was in the military. It was reported that after receiving the first dose of ENGERIX B the patient developed slurred speech on 6 March 2008. It was reported that this had been diagnosed as a ''psychiatric problem'', and the patient was subsequently admitted into a psychiatric ward on an unspecified date. CT scans, X-rays and blood tests on unspecified dates had been provided with ''all clear'' results. Approximately 3 weeks later the patient died due to fatal encephalitis, however it had been reported that the patient was being treated for viral encephalitis prior to his death. A post mortem had revealed nothing ''out of the ordinary'' and stated that the death was ''possibly due to a possible drug reaction''. It was reported that an inquest was due to be held into the patient''s death. No further information was available at the time of the report.


VAERS ID: 339227 (history)  
Form: Version 1.0  
Age: 5.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-02-06
Entered: 2009-02-09
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 2 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-01-01
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: Relevant medical history was not provided.
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: ESWYEG03037609

Write-up: Information regarding PREVENAR was received from a healthcare professional regarding a 5-year-old male patient who experienced pneumococcal meningitis. The patient received a dose on an unspecified date. The patient experienced drug ineffective and pneumococcal meningitis. The cause of death was reported as meningitis pneumococcal. The outcome was fatal, the patient died on 01-Jan-2009. Pneumococcal serotype will be investigated. No additional information was available at the time of this report.


VAERS ID: 339487 (history)  
Form: Version 1.0  
Age: 1.2  
Sex: Male  
Location: Foreign  
Vaccinated:2008-10-31
Onset:2008-11-10
   Days after vaccination:10
Submitted: 2009-02-11
   Days after onset:93
Entered: 2009-02-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / SC
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture negative, Body temperature increased, CSF culture negative, Epstein-Barr virus test positive, Hepatic congestion, Incorrect route of drug administration, Laboratory test abnormal, Microbiology test normal, Pulmonary oedema, Respiratory arrest, Splenomegaly, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (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), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-11-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Diagnostic microbiology test, blood: No growth after 5 days incubation; Diagnostic pathological examination, Frozen sections stained with oil red O showed no excess fat accumulation in the tissue; Diagnostic pathological examination, The brain and spinal cord showed no abnormality; Diagnostic pathological examination, Mononuclear cell infiltrate in portal tracts of the liver; Diagnostic pathological examination, The heart was histologically normal with no evidence of myocarditis; Diagnostic pathological examination, The pancreas, thyroid, pituitary and adrenals were normal; Diagnostic pathological examination, colonies of bacteria in the air spaces; Diagnostic pathological examination, There was no pneumonia; Diagnostic pathological examination, The larynx showed a sub epithelial lymphocytic infiltrate; Diagnostic pathological examination, The thymus showed lymphocyte depletion from cortex in keeping with a chronic stress; Diagnostic pathological examination, some bronchi and bronchioles contained gastric contents; Diagnostic pathological examination, The lungs showed prominent intra-alveolar oedema with peribronchial lymphocytic collections; Diagnostic pathological examination; The conduction system was normal; Diagnostic pathological examination, The spleen showed follicular hyperplasia in the white pulp; Diagnostic pathological examination, Expansion of the paracortex and contained numerous blast cells; Diagnostic pathological examination, The lymph nodes show hyperplasia with numerous germinal centres; Laboratory test, normally growth with no structural abnormality to account for death; Laboratory test, There was evidence of a generalized inflammatory response; Laboratory test, Warthin-Finkeldy cells in the lymph nodes; Laboratory test, Epstein-Barr virus was identified in small amounts in heart tissue; Laboratory test, in situ hybridisation of lymph nodes for EBV showed no positivity; Laboratory test, Normal face, chin, mouth, nose and ears; Laboratory test, Dentition partly erupted 1st premolars upper and lower; Laboratory test, Frenula intact; Laboratory test, No buccal or conjunctival petechiae; Laboratory test, Normal neck and chest and abdomen; Laboratory test, Normal back and base of spine; Laboratory test, Normal male external genitalia; Laboratory test, Intraosseus needle marks in both anterior tibiae; Laboratory test, normal scalp and hair and skull bones; Laboratory test, Fused sutures, normal meninges; Laboratory test, Unremarkable brain ovral pattern; Laboratory test, Spinal cord, arterial circle and cranial nerves normal; Diagnostic microbiology test, CSF: No growth on primary or subculture; Laboratory test, Intact pericardium with 2 ml of clear yellow fluid; Laboratory test, Systemic and pulmonary venous connections normal; Laboratory test, Atrial situs solitus; Laboratory test, Oral fossa is probe patent; Laboratory test, Normal coronary sinus; Laboratory test, Atrioventricular and ventricularterial connections concordant; Laboratory test, Normal valves, right and left ventricle with intact septum; Laboratory test, Dark discolouration of endocardium of left ventricle; Diagnostic microbiology test, Spleen: A scanty growth of staphylococcus aureus; Diagnostic microbiology test, Heart: Adenovirus, Parvovirus B19, Enterovirus and CMV not detected; Diagnostic microbiology test, Lung: No virus detected; Diagnostic microbiology test, Heart: Low levels of EBV detected; Diagnostic microbiology test, Lung: A moderate growth of staphylococcus aureus; Laboratory test, Normal cut surface of myocardium; Laboratory test, Aortic arch branches normal; Laboratory test, Pulmonary arteries normal with closed arterial duct; Laboratory test, Normal great arteries and veins; Laboratory test, Normal nose, nasopharynx and larynx, trachea, lung lobation; Laboratory test, Chest wall, pleurus and diaphragm were normal; Laboratory test, No rig fractures; Laboratory test, Oedematous lung cut surfaces, 2 ml serious fluid in both pleural cavities; Laboratory test, Normal mouth, palate, pharynx, tongue and oesophagus; Laboratory test, Stomach contained moderate quantity of undigested food, no malrotation, normal mesentery and retrope; Laboratory test, The liver was congested; Laboratory test, Gall bladder and bile ducts patent, normal pancreas; Laboratory test, normal kidney with smooth capsular surfaces, cut surfaces congested; Laboratory test, Testes descended in the upper part of the scrotum; Laboratory test, Normal thyroid, pituitary and adrenal glands; Laboratory test, Normal thymus; Laboratory test, Large spleen with prominent white pulp on its cut surface.
CDC Split Type: WAES0902USA00872

Write-up: Information has been received from a health authority concerning a 14 month old male patient who on 31-OCT-2008 was vaccinated subcutaneously with a dose of MMR II (manufacturer and lot# not reported) and a dose of PNEUMOVAX 23 (manufacturer and lot# not reported). On 10-NOV-2008 the patient experienced a temperature of 38.5 degrees, the physician advised the patient should be given CALPOL and his temperature settled. He was put into his cot at 19:30 as usual, at 20:30 the patient''s mother checked him and found him face down in the cot and not breathing. CPR was started and an ambulance called. The patient was declared dead at 21:40. The post mortem results were provided as follows: The patient was normally growth with no structural abnormality to account for death. There was evidence of a generalized inflammatory response. The presence of Warthin-Finkeldy cells in the lymph nodes suggest that this was in part due to the measles virus as is expected in any child following vaccination. Epstein-Barr virus was identified in small amounts in heart tissue but in situ hybridisation of lymph nodes for EBV showed no positivity. There was evidence of systemic inflammatory response to vaccination-the desired effect of vaccination-there was no pathological evidence to link the vaccination to the death, indeed no pathological mechanism was seen to explain the death. The patient was older than a year and falls out with the strict definition of sudden infant death syndrome. The death was categorised as sudden unexpected death in childhood. There was no reason to suspect the death was due to other than natural causes. Rigor mortis was present with most mortem lividity over dependant parts. Normal face, chin, mouth, nose and ears. Dentition partly erupted 1st premolars upper and lower. Frenula intact. NO buccal or conjunctival petechiae. Normal neck and chest and abdomen. Venepuncture marks in left antecubital fossa (x3), dorsum of right hand (x5) and left ankle (x5). Normal back and base of spine, male external genitalia, buttocks and anus, proportioned limbs, hands feet and digits, palmar and plantar creases. Intraosseus needle marks in both anterior tibiae. Nervous system: normal scalp and hair and skull bones. Fused sutures, normal meninges. Unremarkable brain gyral pattern externally in keeping with age. Spinal cord, arterial circle and cranial nerves normal. Cardiovascular system: Intact pericardium with 2 ml of clear yellow fluid. Systemic and pulmonary venous connections normal. atrial situs solitus. Oral fossa is probe patent. Normal coronary sinus. Atrioventricular and ventricularterial connections concordant. Normal valves, right and left ventricle with intact septum. Dark discolouration of endocardium of left ventricle particularly around papillary muscles of the mitral valve. Normal cut surface of myocardium. Aortic arch branches normal. Pulmonary arteries normal with closed arterial duct. Normal great arteries and veins. Coronary arteries arise from facing sinuses of the aortic valve and pursue a normal epicardial course. Respiratory system: Normal nose, nasopharynx and larynx, trachea, lung lobation. Chest wall, pleurus and diaphragm were normal. No rig fractures. Oedematous lung cut surfaces, 2 ml serious fluid in both pleural cavities. Alimentary system: Normal couth, palate, pharynx, tongue and oesophagus. Stomach contained moderate quantity of undigested food, no malrotation, normal mesentery and retroperitoneum. The liver was congested. Gall bladder and bile ducts patent, normal pancreas. Genitourinary system: normal kidney with smooth capsular surfaces, cut surfaces congested. Each is connected by a single ureter of normal callibre to a normal empty bladder. Testes descended in the upper part of the scrotum. Endocrine system: Normal thyroid, pituitary and adrenal glands. Lymphoreticular system: Normal thymus. Large spleen with prominent white pulp on its cut surface. Microbiology: Blood: No growth after 5 days incubation. CSF: No growth on primary or subculture. Lung: A moderate growth of staphylococcus aureus. No virus detected. Spleen: A scanty growth of staphylococcus aureus. Heart: Adenovirus, Parvovirus B19, Enterovirus and CMV no detected. Low levels of EBV detected consistent with presence in blood. Histology: Frozen sections stained with oil red O showed no excess fat accumulation in the tissue. The brain and spinal cord showed no abnormality. Mononuclear cell infiltrate in portal tracts of the liver. The lymph nodes show hyperplasia with numerous germinal centres. Expansion of the paracortex and this region contained numerous blast cells including multinucleate giant cells indistinguishable from Warthin Finkeldy cells-the characteristic cell of measles virus infection. The spleen showed follicular hyperplasia in the white pulp. The heart was histologically normal with no evidence of myocarditis. The conduction system was normal. The pancreas, thyroid, pituitary and adrenals were normal. The lungs showed prominent intra-alveolar oedema with a few peribronchial lymphocytic collections, but this was not a widespread feature. There were colonies of bacterial in the air spaces and some bronchi and bronchioles contained gastric contents. The presence of gastric contents and bacteria was taken to represent introduction at the time of resuscitation and not a primary event. There was no pneumonia. The thymus showed lymphocytic depletion from cortex in keeping with a chronic stress reaction. The larynx showed a sub epithelial lymphocytic infiltrate. Other business partner numbers include: E2009-00975. No further information is available.


VAERS ID: 339546 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2009-02-03
Onset:2009-02-06
   Days after vaccination:3
Submitted: 2009-02-12
   Days after onset:6
Entered: 2009-02-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-02-06
   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: Unknown
Current Illness: Cerebral infarction; Loss of consciousness
Preexisting Conditions: Tracheostomy
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0902USA01558

Write-up: Information has been received from a physician concerning an elderly patient with after effects of cerebral infarction, loss of consciousness and a medical history of tracheostomy who on 03-FEB-2009 was vaccinated with PNEUMOVAX 23 against pneumococcal infection (dose not reported). No information on concomitant medication was provided. On 06-FEB-2009, the patient died in the morning though the patient had not developed pyrexia, rash, anaphylactoid symptoms, etc. after the vaccination. The reporting physician did not mention the relationship of the adverse events (AEs) to PNEUMOVAX 23. The reporting physician considered the AEs to be serious as death. Reporter''s comments: Although it is uncertain that the patient developed pneumonia, acute pneumonia was suggested as tentative diagnosis. There seems to be no relationship of the AEs to PNEUMOVAX 23. No further information is available.


VAERS ID: 340655 (history)  
Form: Version 1.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2009-01-08
Onset:2009-01-31
   Days after vaccination:23
Submitted: 2009-02-25
   Days after onset:25
Entered: 2009-02-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABAVERT) / NOVARTIS VACCINES AND DIAGNOSTICS 1630 / 1 UN / ID

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Animal bite, Autopsy, Biopsy brain abnormal, Death, Diarrhoea, Dysphagia, Foaming at mouth, Headache, Joint stiffness, Muscle spasms, Musculoskeletal stiffness, Pyrexia, Rabies
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Convulsions (broad), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-02-04
   Days after onset: 4
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: BERIRAB P
Current Illness:
Preexisting Conditions: 08-JAN-2009 to Unknown; Dog bite(deep wound at both hands, fingers, leg severity grade III)
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20090288

Write-up: We received from a physician following information on 10 FEB 2009: A male patient (no more information) was bitten on 08 JAN 2009. He received 0.1 ml RABIPUR (batch no. 1630) at two sites intradermally on the same day together with HRIG (dose and batch no. unknown) at a hospital. He received another 2 doses on day 3 and day 7. On 05 FEB 2009 the patient died. Rabies was confirmed in this case. Patient received 3 previous vaccination (no more details). On 16 FEB 2009 we received additional information from the hospital. The 33-year-old male patient, born on 17 DEC 1975, was bitten at right back-hand, knee and fingers by his boss''s dog on 08 JAN 2009. The wound were cleaned and he received RABIPUR together with 1300 IU of BERIRAB P. On 11 JAN 2009 he received the second dose of RABIPUR. On 12 JAN 2009 the patient informed the doctor that the dog died and rabies was confirmed. He received an additional dose of HRIG (1300IU) on 12 JAN 2009. On 15 JAN 2009 he received the third dose of RABIPUR. The patient complained about diarrhea, abdominal pain and headache from 01 FEB 2009 till 03 FEB 2009. In the evening of 03 FEB 2009 he developed difficulty of swallowing, foaming at the mouth and muscle spasm. Finally he died on 04 FEB 2009 (previously reported as 05 FEB 2009). On 19 FEB 2009 we received information about the same case with additional new information. The batch no. of BERIRAB was 05947131 N. RABIPUR was given for the first time. It was reported that he has had deep wounds at both hands, fingers and right leg, severity III. In this form it is reported that diarrhea started on 31 JAN 2009. On 01 FEB 2009 the patient revisited the Police hospital due to diarrhea. On 02 FEB 2009 he experienced fever with severe headache. On 03 FEB 2009 he suffered from stiff neck and was checked in another hospital (admission at 03:00 p.m.). Due to progressive symptom of difficulty to swallow and stiff mandible he was referred to the (Police) hospital again. On 04 FEB 2009 he was referred to hospital and died on the same day at 05:30 p.m. A brain biopsy was done with the result of positive FA technique. CSL no: TH 2009-003. The batch review of the QA department revealed the following result: The batch review cannot conclude the reason for the reported adverse event. On 23 FEB 2009 we received additional information from the physician. A brain autopsy was done, an autopsy report is not available and rabies was confirmed by the brain autopsy. The wounds were not sutured and the 3 previous vaccinations were postexposure vaccinations on 08 JAN 2009, 11 JAN 2009 and 15 JAN 2009. The amount of 1300 IU of HRIG was diluted with NSS and was injected around all of the wounds and the rest of the diluted HRIG was injected to the buttock. The potency of the HRIG is 300 IU/2 ml.


VAERS ID: 341030 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-03-03
Entered: 2009-03-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0902CAN00119

Write-up: Information has been received from an Agency concerning a 14 year old female who was vaccinated with GARDASIL, lot # not available. Subsequently the patient died. The cause of death was unknown. Additional information has been requested.


VAERS ID: 341081 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-03-04
Entered: 2009-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (TRITANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anaemia, Bronchopneumonia, Colitis, Death, Enteritis, Pneumonia
SMQs:, Haematopoietic erythropenia (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific inflammation (narrow), Ischaemic colitis (broad), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0561801A

Write-up: This case was reported in a literature article and described the occurrence of fatal bronchopneumonia in an infant subject of unspecified gender who was vaccinated with TRITANRIX HEPB (GlaxoSmithKline), HIBERIX and ORAL POLIO VACCINE. The literature article described results of a randomized controlled trial carried out to assess the safety and immunogenicity of administering 15 mg retinol equivalent (RE) vitamin A alongside the pentavalent diphtheria-polio-tetanus-Haemophilus influenzae b-hepatitis B vaccine at 6, 10 and 14 weeks of age. The trial took place from June 2004 and was completed in December 2005. It enrolled 1077 infants who were randomized into either the intervention or the control group. On an unspecified date, the subject received unspecified dose of TRITANRIX HEP B (unknown), unspecified dose of HIBERIX (unknown), unspecified dose of ORAL POLIO VACCINE (oral). Less than one month after vaccination with HIBERIX, ORAL POLIO VACCINE and TRITANRIX HEPB, the subject experienced bronchopneumonia, pneumonia, colitis, enteritis and anemia. The subject was hospitalised. The subject died (cause of death unknown/not specified). It was unknown whether an autopsy was performed. There were a total of six deaths (three boys and three girls) reported during the trial, five of which occurred before 14 weeks of age. All the deaths with the exception of one were in the intervention group RR 4.65 (0.55-39.6), p = 0.12. All the infants with the exception of one had been sent to the hospital and diagnosed with bronchopneumonia, pneumonia, enema colitis, enteritis and severe anaemia. The child who was not sent to the hospital was suspected to have been suffering from "failure to thrive" and had been sent to a traditional healer for treatment. Deaths occurred from the start of the trial to the end of follow-up at 18 weeks, 4 weeks after the third dose. The conclusion was the following: The trial demonstrated that the pentavalent vaccine was well tolerated whether or not administered with vitamin A according to the WHO/EPI schedule for infant immunisation at 6, 10 and 14 weeks. There were no serious reactions reported in either the intervention or the control group. There were fewer reports of illnesses and fever reported in the intervention group than the control group. There were only eight reports of bulging of the fontanelle following vaccination, four in each group. There were six deaths in the trial. Although five of these were in the intervention group, the 95% CI for the relative risk was very wide RR 4.65 (0.55-39.5), p = 0.12 and included 1. When the deaths in this study and those from a previous study in which 25,000 IU vitamin A was given to young infants with their DPT vaccines are added, the relative risk of dying after vitamin A has been administered with DPT/pentavalent vaccine is 2.96 (0.95-9.19), (p = 0.048). The authors wished to urge caution in administering 50,000 IU vitamin A to young infants with EPI vaccines at 6, 10 and 14 weeks until it can be proven in larger trials that the observed mortality differences are not a cause for concern.


VAERS ID: 341082 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-03-04
Entered: 2009-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (TRITANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anaemia, Bronchopneumonia, Colitis, Death, Enteritis, Pneumonia
SMQs:, Haematopoietic erythropenia (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific inflammation (narrow), Ischaemic colitis (broad), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0561800A

Write-up: This case was reported in a literature article and described the occurrence of fatal bronchopneumonia in an infant subject of unspecified gender who was vaccinated with TRITANRIX HEPB (GlaxoSmithKline), HIBERIX and ORAL POLIO VACCINE. The literature article described results of a randomized controlled trial carried out to assess the safety and immunogenicity of administering 15 mg retinol equivalent (RE) vitamin A alongside the pentavalent diphtheria-polio-tetanus-Haemophilus influenzae b-hepatitis B vaccine at 6, 10 and 14 weeks of age. The trial took place from June 2004 and was completed in December 2005. It enrolled 1077 infants who were randomized into either the intervention or the control group. On an unspecified date, the subject received unspecified dose of TRITANRIX HEPB (unknown), unspecified dose of HIBERIX (unknown), unspecified dose of ORAL POLIO VACCINE (oral). Less than one month after vaccination with HIBERIX, ORAL POLIO VACCINE and TRITANRIX HEPB, the subject experienced bronchopneumonia, pneumonia, colitis, enteritis and anemia. The subject was hospitalised. The subject died (cause death unknown/not specified). It was unknown whether an autopsy was performed. There were a total of six deaths (three boys and three girls) reported during the trial, five of which occurred before 14 weeks of age. All the deaths with the exception of one were in the intervention group RR 4.65 (0.55-39.6), p = 0.12. All the infants with the exception of one had been sent to the hospital and diagnosed with bronchopneumonia, pneumonia, enema colitis, enteritis and severe anaemia. The child who was not sent to the hospital was suspected to have been suffering from "failure to thrive" and had been sent to a traditional healer for treatment. Deaths occurred from the start of the trial to the end of follow-up at 18 weeks, 4 weeks after the third dose. The conclusion was the following: The trial demonstrated that the pentavalent vaccine was well tolerated whether or not administered with vitamin A according to the WHO/EPI schedule for infant immunisation at 6, 10, and 14 weeks. There were no serious reactions reported in either the intervention or the control group. There were fewer reports of illnesses and fever reported in the intervention group than the control group. There were only eight reports of bulging of the fontanelle following vaccination, four in each group. There were six deaths in the trial. Although five of these were in the intervention group, the 95% CI for the relative risk was very wide RR 4.65 (0.55-39.5), p = 0.12 and included 1. When the deaths in this study and those from a previous study in which 25,000 IU vitamin A was given to young infants with their DPT vaccines are added, the relative risk of dying after vitamin A has been administered with DPT/pentavalent vaccine is 2.96 (0.95-9.19), (p = 0.048). The authors wished to urge caution in administering 50,000 IU vitamin A to young infants with EPI vaccines at 6, 10 and 14 weeks until it can be proven in larger trials that the observed mortality differences are not a cause for concern.


VAERS ID: 341083 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-03-04
Entered: 2009-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (TRITANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anaemia, Bronchopneumonia, Colitis, Death, Enteritis, Pneumonia
SMQs:, Haematopoietic erythropenia (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific inflammation (narrow), Ischaemic colitis (broad), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0561799A

Write-up: This case was reported in a literature article and described the occurrence of fatal bronchopneumonia in an infant subject of unspecified gender who was vaccinated with TRITANRIX HEPB (GlaxoSmithKline), HIBERIX and ORAL POLIO VACCINE. The literature article described results of a randomized controlled trial carried out to assess the safety and immunogenicity of administering 15 mg retinol equivalent (RE) vitamin A alongside the pentavalent diphtheria-polio-tetanus-Haemophilus influenzae b-hepatitis B vaccine at 6, 10 and 14 weeks of age. The trial took place from June 2004 and was completed in December 2005. It enrolled 1077 infants who were randomized into either the intervention or the control group. On an unspecified date, the subject received unspecified dose of TRITANRIX HEPB (unknown), unspecified dose of HIBERIX (unknown), unspecified dose of ORAL POLIO VACCINE (oral). Less than one month after vaccination with HIBERIX, ORAL POLIO VACCINE and TRITANRIX HEPB, the subject experienced bronchopneumonia, pneumonia, colitis, enteritis and anemia. The subject was hospitalised. The subject died (cause death unknown/not specified). It was unknown whether an autopsy was performed. There were a total of six deaths (three boys and three girls) reported during the trial, five of which occurred before 14 weeks of age. All the deaths with the exception of one were in the intervention group RR 4.65 (0.55-39.6), p = 0.12. All the infants with the exception of one had been sent to the hospital and diagnosed with bronchopneumonia, pneumonia, enema colitis, enteritis and severe anaemia. The child who was not sent to the hospital was suspected to have been suffering from "failure to thrive" and had been sent to a traditional healer for treatment. Deaths occurred from the start of the trial to the end of follow-up at 18 weeks, 4 weeks after the third dose. The conclusion was the following: The trial demonstrated that the pentavalent vaccine was well tolerated whether or not administered with vitamin A according to the schedule for infant immunisation at 6, 10, and 14 weeks. There were no serious reactions reported in either the intervention or the control group. There were fewer reports of illnesses and fever reported in the intervention group than the control group. There were only eight reports of bulging of the fontanelle following vaccination, four in each group. There were six deaths in the trial. Although five of these were in the intervention group, the 95% CI for the relative risk was very wide RR 4.65 (0.55-39.5), p = 0.12 and included 1. When the deaths in this study and those from a previous study in which 25,000 IU vitamin A was given to young infants with their DPT vaccines were added, the relative risk of dying after vitamin A has been administered with DPT/pentavalent vaccine is 2.96 (0.95-9.19), (p = 0.048). The authors wished to urge caution in administering 50,000 IU vitamin A to young infants with EPI vaccines at 6, 10 and 14 weeks until it can be proven in larger trials that the observed mortality differences are not a cause for concern.


VAERS ID: 341084 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-03-04
Entered: 2009-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (TRITANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anaemia, Bronchopneumonia, Colitis, Death, Enteritis, Pneumonia
SMQs:, Haematopoietic erythropenia (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific inflammation (narrow), Ischaemic colitis (broad), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0561798A

Write-up: This case was reported in a literature article and described the occurrence of fatal bronchopneumonia in an infant subject of unspecified gender who was vaccinated with TRITANRIX HEPB (GlaxoSmithKline), HIBERIX and ORAL POLIO VACCINE. The literature article described results of a randomized controlled trial carried out to assess the safety and immunogenicity of administering 15 mg retinol equivalent (RE) vitamin A alongside the pentavalent diphtheria-polio-tetanus-Haemophilus influenzae b-hepatitis B vaccine at 6, 10 and 14 weeks of age. The trial took place from June 2004 and was completed in December 2005. It enrolled 1077 infants who were randomized into either the intervention or the control group. On an unspecified date, the subject received unspecified dose of TRITANRIX HEPB (unknown), unspecified dose of HIBERIX (unknown), unspecified dose of ORAL POLIO VACCINE (oral). Less than one month after vaccination with HIBERIX, ORAL POLIO VACCINE and TRITANRIX HEPB, the subject experienced bronchopneumonia, pneumonia, colitis, enteritis and anemia. The subject was hospitalised. The subject died (cause death unknown/not specified). It was unknown whether an autopsy was performed. There were a total of six deaths (three boys and three girls) reported during the trial, five of which occurred before 14 weeks of age. All the deaths with the exception of one were in the intervention group RR 4.65 (0.55-39.6), p = 0.12. All the infants with the exception of one had been sent to the hospital and diagnosed with bronchopneumonia, pneumonia, enema colitis, enteritis and severe anaemia. The child who was not sent to the hospital was suspected to have been suffering from "failure to thrive" and had been sent to a traditional healer for treatment. Deaths occurred from the start of the trial to the end of follow-up at 18 weeks, 4 weeks after the third dose. The conclusion was the following: The trial demonstrated that the pentavalent vaccine was well tolerated whether or not administered with vitamin A according to the WHO/EPI schedule for infant immunisation at 6, 10, and 14 weeks. There were no serious reactions reported in either the intervention or the control group. There were fewer reports of illnesses and fever reported in the intervention group than the control group. There were only eight reports of bulging of the fontanelle following vaccination, four in each group. There were six deaths in the trial. Although five of these were in the intervention group, the 95% CI for the relative risk was very wide RR 4.65 (0.55-39.5), p = 0.12 and included 1. When the deaths in this study and those from a previous study in which 25,000 IU vitamin A was given to young infants with their DPT vaccines are added, the relative risk of dying after vitamin A has been administered with DPT/pentavalent vaccine is 2.96 (0.95-9.19), (p = 0.048). The authors wished to urge caution in administering 50,000 IU vitamin A to young infants with EPI vaccines at 6, 10 and 14 weeks until it can be proven in larger trials that the observed mortality differences are not a cause for concern.


VAERS ID: 341085 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-03-04
Entered: 2009-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (TRITANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anaemia, Bronchopneumonia, Colitis, Death, Enteritis, Pneumonia
SMQs:, Haematopoietic erythropenia (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific inflammation (narrow), Ischaemic colitis (broad), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0561587A

Write-up: This case was reported in a literature article and described the occurrence of fatal bronchopneumonia in an infant subject of unspecified gender who was vaccinated with TRITANRIX HEPB (GlaxoSmithKline), HIBERIX and ORAL POLIO VACCINE. The literature article described results of a randomized controlled trial carried out to assess the safety and immunogenicity of administering 15 mg retinol equivalent (RE) vitamin A alongside the pentavalent diphtheria-polio-tetanus-Haemophilus influenzae b-hepatitis B vaccine at 6, 10 and 14 weeks of age. The trial took place from June 2004 and was completed in December 2005. It enrolled 1077 infants who were randomized into either the intervention or the control group. On an unspecified date, the subject received unspecified dose of TRITANRIX HEPB (unknown), unspecified dose of HIBERIX (unknown), unspecified dose of ORAL POLIO VACCINE (oral). Less than one month after vaccination with HIBERIX, ORAL POLIO VACCINE and TRITANRIX HEPB, the subject experienced bronchopneumonia, pneumonia, colitis, enteritis and anemia. The subject was hospitalised. The subject died (cause death unknown/not specified). It was unknown whether an autopsy was performed. There were a total of six deaths (three boys and three girls) reported during the trial, five of which occurred before 14 weeks of age. All the deaths with the exception of one were in the intervention group RR 4.65 (0.55-39.6), p = 0.12. All the infants with the exception of one had been sent to the hospital and diagnosed with bronchopneumonia, pneumonia, enema colitis, enteritis and severe anaemia. The child who was not sent to the hospital was suspected to have been suffering from "failure to thrive" and had been sent to a traditional healer for treatment. Deaths occurred from the start of the trial to the end of follow-up at 18 weeks, 4 weeks after the third dose. The conclusion was the following: The trial demonstrated that the pentavalent vaccine was well tolerated whether or not administered with vitamin A according to the schedule for infant immunisation at 6, 10, and 14 weeks. There were no serious reactions reported in either the intervention or the control group. There were fewer reports of illnesses and fever reported in the intervention group than the control group. There were only eight reports of bulging of the fontanelle following vaccination, four in each group. There were six deaths in the trial. Although five of these were in the intervention group, the 95% CI for the relative risk was very wide RR 4.65 (0.55-39.5), p = 0.12 and included 1. When the deaths in this study and those from a previous study in which 25,000 IU vitamin A was given to young infants with their DPT vaccines are added, the relative risk of dying after vitamin A has been administered with DPT/pentavalent vaccine is 2.96 (0.95-9.19), (p = 0.048). The authors wished to urge caution in administering 50,000 IU vitamin A to young infants with EPI vaccines at 6, 10 and 14 weeks until it can be proven in larger trials that the observed mortality differences are not a cause for concern.


VAERS ID: 341127 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-03-04
Entered: 2009-03-05
   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: Blood culture positive, Culture positive, Death, Drug ineffective, Pneumococcal bacteraemia, Pneumonia pneumococcal
SMQs:, Lack of efficacy/effect (narrow), 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? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness: Relapsing fever; Diarrhoea; Hypotonia; Developmental delay; Failure to thrive; Microencephaly
Preexisting Conditions: The patient was not a premature baby but suffered from several chronic underlying diseases like relapsing fever, diarrhoea, microencephaly (suspicion of microencephaly syndrome), developmental delay, failure to thrive and hypotonia.
Allergies:
Diagnostic Lab Data: Pleural fluid analysis (results: streptococci pneumoniae of serotype 20) and blood culture (results: streptococci pneumoniae of serotype 20) were done on an unspecified date.
CDC Split Type: DEWYEG03226409

Write-up: Information regarding PREVENAR was received from a healthcare professional regarding a 6-month-old male patient who experienced pneumococcal bacteraemia with focus pneumococcal pneumonia and drug ineffective. The patient received the first dose on an unspecified date at the age of three months. The patient experienced pneumococcal bacteraemia (drug ineffective) with focus pneumococcal pneumonia. A blood culture detected streptococci pneumoniae of serotype 20. The patient did not recover, he died on an unspecified date. The cause of death was reported as pneumococcal bacteraemia and pneumonia pneumococcal. No additional information was available at the time of this report.


VAERS ID: 341407 (history)  
Form: Version 1.0  
Age: 0.1  
Sex: Male  
Location: Foreign  
Vaccinated:2009-02-24
Onset:2009-02-27
   Days after vaccination:3
Submitted: 2009-03-05
   Days after onset:6
Entered: 2009-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (TRITANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 LL / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 LL / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-02-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Human immunodeficiency virus exposure
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: B0562737A

Write-up: This male subject was enrolled in a study. On 24 February 2009, he received the 1st dose of 10-Pn-PD-DiT (IM R thigh) and TRITANRIX-HepB/Hib (IM L thigh). Medical conditions at the time of the event included human immunodeficiency virus exposure (PCR negative on 10 February 2009). On 27 February 2009, three days after the 1st dose of 10PN-PD-Dit, three days after the 1st dose of TRITANRIX-HepB/Hib, this one-month-old subject experienced sudden infant death syndrome. An autopsy was performed. The investigator considered that there was a reasonable possibility that the sudden infant death syndrome may have been caused by 10PN-PD-Dit and TRITANRIX-HepB/Hib and that the event was possibly due to possible aspiration. Investigator comment: No tests/procedures performed. Death was sudden and unexpected and there was no opportunity for medical attendance. Child well prior to sudden death. Informed of death of participant when study staff phoned mother on 02 March 2009 at 16.17 for day 4-6 contact. According to mother (telephonic), infant was well post vaccination. Mother put infant down in bed for sleep on 27 February 2009 and returned later to find infant dead. Infant had blocked nose, but no other symptoms. Child died at home, no medical visit/contact was made. Mother requested a post mortem, result to follow. (Blocked nose noted on examination on 24 February, but not on history). Infant received no Cotrimoxazole prophylaxis. Death has been classified as possibly related to vaccination with investigational product due to the short period (three days) between vaccine administration and death.


VAERS ID: 341594 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-03-10
Entered: 2009-03-12
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: Relevant medical history was not provided.
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: DEWYEG03269609

Write-up: Information regarding PREVENAR was received from a healthcare professional regarding an infant (age and gender unknown) who died due to an unknown reason. The patient received the first dose on an unspecified date. 8 days after the first vaccination with PREVENAR and INFANRIX HEXA the patient died due to an unknown reason. The cause of death was reported as death. No additional information was available at the time of this report.


VAERS ID: 341595 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2009-03-01
Submitted: 2009-03-11
   Days after onset:9
Entered: 2009-03-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood grouping, Blood test abnormal, Death, Drug ineffective, Meningitis pneumococcal, Pyrexia
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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: Relevant medical history was not provided.
Allergies:
Diagnostic Lab Data: Blood grouping (results: Pneumococcal serotype 3) was done in Mar-2009.
CDC Split Type: ITWYEG03260509

Write-up: Information regarding PREVENAR was received from a company representative regarding a 3-year-old male patient who experienced drug ineffective and meningitis pneumococcal. The patient received a dose on an unspecified date. The patient experienced drug ineffective and meningitis pneumococcal in Mar-2009. The patient showed high fever for several days and was treated (unknown therapy) at home. He was hospitalized and the day after died. The cause of death was reported as meningitis pneumococcal. No additional information was available at the time of this report.


VAERS ID: 341784 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-03-13
Entered: 2009-03-16
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

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

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: WAES0903USA01657

Write-up: Initial information has been received from a pharmacist concerning a elderly patient aged 70 or over who on an unspecified date was vaccinated with PNEUMOVAX injection, (dose and indication not reported). No information on concomitant medication was provided. On an unspecified date (three to four months after vaccination of PNEUMOVAX), the patient developed pneumonia and died. Because the patient did not develop fever, the patient''s condition had significantly advanced when it was realized that the patient had pneumonia. Whether pathogen was pneumococcus or not was not investigated. No information on autopsy has been provided. The reporting pharmacist considered that the pneumonia was serious due to death. The reporting pharmacist did not assess the seriousness of the vaccination failure. The reporting pharmacist did not assess the relationship of AEs to PNEUMOVAX. Additional information has been requested.


VAERS ID: 341785 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-03-13
Entered: 2009-03-16
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain upper, Blood culture positive, Brain death, CD4 lymphocytes increased, CSF culture positive, Death, Depressed level of consciousness, General physical health deterioration, Headache, Meningism, Pneumococcal bacteraemia, Pyrexia, Streptococcus identification test positive, Streptococcal infection, Vaccination failure, Viral load, Vomiting
SMQs:, Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), 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? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Concomitant therapy included AGENERASE, LAMIVUDINE and ZIDOVUDINE.
Current Illness: The patient''s concurrent illness includes HIV infection (via vertical transmission).
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: The following tests were done on an unspecified date: CD4 lymphocytes (results: 2,063/mul at age 6 years); viral load (results: 13461 cop/ml at age 6 years); CD4 lymphocytes (results: 1,315/mul at age 10 years); CSF culture (results: Streptococcus pneumoniae, serotype 18 C); CD4 lymphocytes (results: 1,000/mul around age 13 years); viral load (results: 3800 cop/ml around age 13 years); blood culture (results: Streptococcus pneumoniae, serotype 18 C); and viral load (results: 32400 cop/ml at age 10 years).
CDC Split Type: ESWYEH08429209

Write-up: This report includes a fatal event. Information regarding PREVENAR was received from a literature source regarding a 13-year-old male patient who experienced Streptococcus pneumoniae, serotype 18C, detected in blood culture, meningismus, streptococcus pneumoniae serotype 18C, detected in cerebrospinal fluid culture, vaccination with PREVENAR at age 10 and vaccination failure. The patient received a dose on an unspecified date. Additional suspect medication included PNEUMOVAX 23. On an unknown date the child was administered PREVENAR at age 10. On an unknown date, at age 13, the child presented to the emergency department with fever, head and stomach-ache, and vomiting. In the following hours his condition continued to deteriorate and depressed level of consciousness and meningismus were observed. Streptococcus pneumoniae, serotype 18C was detected in both blood and cerebrospinal cultures. Despite appropriate treatment with antibiotics and anti-edema medications, brain-death was confirmed 24 hours after his admittance. The patient died. The cause of death was reported as pneumococcal bacteraemia, vaccination failure and CSF culture positive. No additional information was available at the time of this report. The English translation of the literature article has been requested. English abstract attached.


VAERS ID: 341868 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-03-16
Entered: 2009-03-17
   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: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CAP vitamin a palmitate
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0903USA02210

Write-up: It was reported in a published article, that a patient who in 2003 was vaccinated with a dose of ATTENUVAX (manufacturer unknown) and vitamin A palmitate gelatin capsule PO died 12 days after supplementation, cause of death was not reported. The World Health Organization recommends high-dose vitamin A supplementation at vaccination contacts after 6 months of age. The recommendation is based on several large intervention trials showing VAS to be associated with a 23-30% reduction in overall mortality in children aged 6 months to 5 years of age. It has not been studied whether the effect of VAS on mortality depends on the type of vaccine. We have hypothesized that VAS administered with ATTENUVAX is more beneficial than VAS with DTP. We assessed the effect of VAS administered with different vaccines during national immunization days. In 2003, VAS was distributed during NIDs. Children 6 months or older were given VAS, and if they were missing vaccines, these were often given as well. We compared survival between children who had received VAS alone, VAS with DTP, or DTP + MV (manufacturer unknown), or VAS with MV. We also compared the survival between participants and non-participants. We followed 6- to 17-month old children until 18 months of age and analyzed survival in Cox models. Eight children who developed a measles rash within 2 weeks after supplementation were excluded, since they were considered infected prior to the NIDS. Among them was a recipient of VAS + ATTENUVAX (manufacturer unknown) who died 12 days after supplementation. This is one of several reports from the same source. No further information is available. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 341869 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-03-16
Entered: 2009-03-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
MEA: MEASLES (ATTENUVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CAP vitamin a palmitate
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0903USA02209

Write-up: It was reported in a published article, title stated above that a female patient who in 2003 was vaccinated with a dose of ATTENUVAX (manufacturer unknown) and a dose of DTP and vitamin A palmitate gelatin capsule PO died, cause of death was not reported. The WHO recommends high-dose vitamin A supplementation (VAS) at vaccination contacts after 6 months of age. The recommendations is based on several large intervention trials showing VAS to be associated with a 23-30% reduction in overall mortality in children aged 6 months to 5 years of age. It has not been studied whether the effect of VAS on mortality depends on the type of vaccine. We have hypothesized that VAS administered with ATTENUVAX is more beneficial than VAS with DTP vaccine. We assessed the effect of VAS administered with different vaccines during national immunization days (NIDs). In 2003, VAS was distributed during NIDs. Children 6 months or older were given VAS, and if they were missing vaccines, these were often given as well. We compared survival between children who had received VAS alone, VAS with DTP, or DTP and ATTENUVAX (manufacturer unknown) (MV), or VAS with MV. We also compared the survival between participants and non-participants. We followed 6- to 17-month old children until 18 months of age and analysed survival in Cox models. The results were that twenty of the 982 children, who participated in the national immunization days, died during follow-up. Those who received VAS and no vaccine (no. 730) 12 died (6 males/6 females), those who received VAS and DTP (no. 48) 3 died (2 males and 1 female), those who received VAS and DTP and ATTENUVAX (manufacturer unknown) (no. 88) 5 died (3 males/2 females) and those who received VAS and ATTENUVAX (manufacturer unknown) (no. 118) none died. It was reported that there was a negative effect of receiving VAS with any DTP in contrast to the effect of receiving VAS with ATTENUVAX (manufacturer unknown) alone. The study design does not allow for definite conclusions. However, the results are compatible with our a priori hypothesis that VAS is more beneficial when given with ATTENUVAX (manufacturer unknown) and potentially harmful when given with DTP. Randomized trials testing the impact on mortality of the current WHO policy seem warranted. Based on this study alone, no conclusions regarding the potential interactions between VAS and vaccines can be made. This is one of several reports from the same source. No further information is available. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 341870 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-03-16
Entered: 2009-03-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
MEA: MEASLES (ATTENUVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CAP vitamin a palmitate
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0903USA02208

Write-up: It was reported in a published article that a female patient who in 2003 was vaccinated with a dose of ATTENUVAX (manufacturer unknown) and a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid and vitamin A palmitate gelatin capsule PO died, cause of death was not reported. The World Health Organization (WHO) recommends high-dose vitamin A supplementation (VAS) at vaccination contacts after 6 months of age. The recommendation is based on several large intervention trials showing VAS to be associated with a 23-30% reduction in overall mortality in children aged 6 months to 5 years of age. It has not been studied whether the effect of VAS on mortality depends on the type of vaccine. We have hypothesized that VAS administered with measles vaccine (MV) is more beneficial than VAS with diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (DTP) vaccine. We assessed the effect of VAS administered with different vaccines during national immunization days (NIDs). In 2003, VAS was distributed during NIDs. Children 6 months or older were given VAS, and if they were missing vaccines, these were often given as well. We compared survival between children who had received VAS alone, VAS with diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (DTP), or DTP + ATTENUVAX (manufacturer unknown) (MV), or VAS with MV. We also compared the survival between participants and non-participants. We followed 6- to 17-month old children until 18 months of age and analysed survival in Cox models. The results were that twenty of the 982 children, who participated in the national immunization days, died during follow-up. Those who received VAS and no vaccines (no. 730) 12 died (6 males/6 females), those who received VAS and diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid vaccine (no. 48) 3 died (2 males and 1 female), those who received VAS + diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid and ATTENUVAX (manufacturer unknown) (no. 88) 5 died (3 males/2 females) and those who received VAS + ATTENUVAX (manufacturer unknown) (no. 118) none died. It was reported that there was a negative effect of receiving VAS with any diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid in contrast to the effect of receiving VAS with ATTENUVAX (manufacturer unknown) alone. The study design does not allow for definite conclusions. However, the results are compatible with our a priori hypothesis that VAS is more beneficial when given with ATTENUVAX (manufacturer unknown) and potentially harmful when given with diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid. Randomized trials testing the impact on mortality of the current WHO policy seemed warranted. Based on this study alone, no conclusions regarding the potential interactions between VAS and vaccines can be made. This is one of several reports from the same source. No further information is available. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 341871 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-03-16
Entered: 2009-03-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
MEA: MEASLES (ATTENUVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CAP vitamin a palmitate
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0903USA02207

Write-up: It was reported in a published article, titled stated above that a male patient who in 2003 was vaccinated with a dose of ATTENUVAX (manufacturer unknown) and a dose of DTP (unspecified) and tetanus toxoid and vitamin A palmitate gelatin capsule PO died, cause of death was not reported. The WHO recommends high-dose vitamin A supplementation (VAS) at vaccination contacts after 6 months of age. The recommendation is based on several large intervention trials showing VAS to be associated with a 23-30% reduction in overall mortality in children aged 6 months to 5 years of age. It has not been studied whether the effect of VAS on mortality depends on the type of vaccine. We have hypothesized that VAS administered with ATTENUVAX is more beneficial than VAS with DTP. We assessed the effect of VAS administered with different vaccines during national immunization days (NIDs). In 2003, VAS was distributed during NIDs. Children 6 months or older were given VAS, and if they were missing vaccines, these were often given as well. We compared survival between children who had received VAS alone, VAS with DTP (manufacturer unknown) (MV), or VAS with MV. We also compared the survival between participants and non-participants. We followed 6- to 17-month old children until 18 months of age and analyzed survival in Cox models. The results were that twenty of the 982 children, who participated in the national immunization days, died during follow-up. Those who received VAS and no vaccines (no. 730) 12 died (6 males/6 females), those who received VAS and DTP (unspecified) and tetanus toxoid (no. 48) 3 died (2 males and 1 female), those who received VAS and DTP and tetanus toxoid and ATTENUVAX (manufacturer unknown) (no. 88) 5 died (3 males/2 females) and those who received VAS and ATTENUVAX (manufacturer unknown) (no. 118) none died. It was reported that there was a negative effect of receiving VAS with any DTP and tetanus toxoid in contrast to the effect of receiving VAS with ATTENUVAX (manufacturer unknown) alone. The study design does not allow for definite conclusions. However, the results are compatible with our a priori hypothesis that VAS is more beneficial when given with ATTENUVAX (manufacturer unknown) and potentially harmful when given with DTP and tetanus toxoid. Randomized trials testing the impact on mortality of the current WHO policy seem warranted. Based on this study alone, no conclusions regarding the potential interactions between VAS and vaccines can be made. This is one of several reports from the same source. No further information is available. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 341872 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-03-16
Entered: 2009-03-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
MEA: MEASLES (ATTENUVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CAP vitamin a palmitate
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0903USA02206

Write-up: It was reported in a published article, that a male patient who in 2003 was vaccinated with a dose of ATTENUVAX (manufacturer unknown) and a dose of DTaP (unspecified) and vitamin A palmitate gelatin capsule PO died, cause of death was not reported. The World Health Organization recommends high-dose vitamin A supplementation at vaccination contacts after 6 months of age. The recommendation is based on several large intervention trials showing VAS to be associated with a 23-30% reduction in overall mortality in children aged 6 months to 5 years of age. It has not been studied whether the effect of VAS on mortality depends on the type of vaccine. We have hypothesized that VAS administered with MV is more beneficial than VAS with DTP (unspecified). We assessed the effect of VAS administered with different vaccines during national immunization days. In 2003, VAS was distributed during NIDs. Children 6 months or older were given VAS, and if they were missing vaccines, these were often given as well. We compared survival between children who had received VAS alone, VAS with DTP (unspecified), or DTP + ATTENUVAX (manufacturer unspecified), or VAS with ATTENUVAX. We also compared the survival between participants and non-participants. We followed 6- to 17-month old children until 18 months of age and analysed survival in Cox models. The results were that twenty of the 982 children, who participated in the national immunization days, died during follow-up. Those who received VAS and no vaccines (no. 730) 12 died (6 males/6 females), those who received VAS and DTP (unspecified) (no. 48) 3 died (2 males and 1 female), those who received VAS + DTP (manufacturer unknown) (no. 88) 5 died (3 males/2 females) and those who received VAS + ATTENUVAX (unknown manufacturer) (no. 118) none died. It was reported that there was a negative effect of receiving VAS with any DTP (unspecified) in contrast to the effect of receiving VAS with ATTENUVAX (manufacturer unknown) alone. The study design does not allow for definite conclusions. However, the results are compatible with our a priori hypothesis that VAS is more beneficial when given with ATTENUVAX (manufacturer unknown) and potentially harmful when given with DTP (unspecified). Randomized trials testing the impact on mortality of the current WHO policy seem warranted. Based on this study alone, no conclusions regarding the potential interactions between VAS and vaccine can be made. This is one of several reports from the same source. No further information is available. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 341873 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-03-16
Entered: 2009-03-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
MEA: MEASLES (ATTENUVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CAP vitamin a palmitate
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0903USA02074

Write-up: It was reported in a published article that a female patient who in 2003 was vaccinated with a dose of ATTENUVAX (manufacturer unknown) and a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid and vitamin A palmitate gelatin capsule PO died, cause of death was not reported. The World Health Organization (WHO) recommends high-dose vitamin A supplementation (VAS) at vaccination contacts after 6 months of age. The recommendation is based on several large intervention trials showing VAS to be associated with a 23-30% reduction in overall mortality in children aged 6 months to 5 years of age. It has not been studied whether the effect of VAS on mortality depends on the type of vaccine. We have hypothesized that VAS administered with measles vaccine (MV) is more beneficial than VAS with diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (DTP) vaccine. We assessed the effect of VAS administered with different vaccines during national immunization days (NIDs). In 2003, VAS was distributed during NIDs. Children 6 months or older were given VAS, and if they were missing vaccines, these were often given as well. We compared survival between children who had received VAS alone, VAS with diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (DTP), or DTP + ATTENUVAX (manufacturer unknown) (MV), or VAS with MV. We also compared the survival between participants and non-participants. We followed 6- to 17-month old children until 18 months of age and analysed survival in Cox models. The results were that twenty of the 982 children, who participated in the national immunization days, died during follow-up. Those who received VAS and no vaccines (no. 730) 12 died (6 males/6 females), those who received VAS and diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid vaccine (no. 48) 3 died (2 males and 1 female), those who received VAS + diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid and ATTENUVAX (manufacturer unknown) (no. 88) 5 died (3 males/2 females) and those who received VAS + ATTENUVAX (manufacturer unknown) (no. 118) none died. It was reported that there was a negative effect of receiving VAS with any diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid in contrast to the effect of receiving VAS with ATTENUVAX (manufacturer unknown) alone. The study design does not allow for definite conclusions. However, the results are compatible with our a priori hypothesis that VAS is more beneficial when given with ATTENUVAX (manufacturer unknown) and potentially harmful when given with diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid. Randomized trials testing the impact on mortality of the current WHO policy seemed warranted. Based on this study alone, no conclusions regarding the potential interactions between VAS and vaccines can be made. This is one of several reports from the same source. No further information is available. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 341975 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-11-01
Onset:2009-03-01
   Days after vaccination:120
Submitted: 2009-03-17
   Days after onset:15
Entered: 2009-03-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATENEGINE; Mg oxide; bromocriptine mesylate; lisinopril; nifedipine
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0903USA02201

Write-up: Information has been received from a physician concerning a 78 year old female patient who in Nov 2008 was vaccinated with PNEUMOVAX 23 injection (dose not reported). Concomitant medications included ATENEGINE, bromocriptine mesylate, LOKOPOOL, magnesium oxide and nifedipine. In Nov 2008, the patient was vaccinated with PNEUMOVAX 23 at healthcare facility for the elderly as group vaccination. In Mar 2009, the patient developed pneumonia and was transferred to the hospital. The patient died the day after transportation to hospital. Whether pathogen was pneumococcus or not was not investigated. No information on autopsy has been provided. The reporting physician considered that pneumonia was serious due to death. The reporting physician felt that the pneumonia was definitely related to PNEUMOVAX 23. No further information is available.


VAERS ID: 342006 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2009-02-13
Onset:2009-02-13
   Days after vaccination:0
Submitted: 2009-03-18
   Days after onset:32
Entered: 2009-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB471AA / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Apgar score normal, Autopsy, Blood bilirubin increased, C-reactive protein normal, Fatty acid deficiency, Haemoglobin normal, Hypotonia, Platelet count normal, Sudden infant death syndrome, White blood cell count
SMQs:, Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Biliary system related investigations, signs and symptoms (narrow), Guillain-Barre syndrome (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-02-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Immunoglobulin anti hepatitis
Current Illness: Unknown
Preexisting Conditions: Parents medical conditions included ABO incompatibility. The subject''s mother was positive for hepatitis B virus. The subject had no sibling.
Allergies:
Diagnostic Lab Data: Apgar score, 12Feb2009, 8/10; Apgar score, 12Feb2009, 10/10; Autopsy, 13Feb2009, see lab text; Bilirubin total increased, 13Feb2009, 129; C-reactive protein normal, 13Feb2009, 2.9; Hemoglobin normal, 13Feb2009, 17.7g/dl; Leukocyte count NOS, 13Feb2009, 21 000; Platelet count normal, 13Feb2009, 353 000; On 16 February 2009, autopsy was normal on macroscopic level. In favour of fatty acid autosomal recessive metabolic disease.
CDC Split Type: B0563900A

Write-up: This case was reported by a foreign regulatory authority (PC20090052 and PC0900062) and described the occurrence of sudden infant death in a 1-day-old male subject who was vaccinated with ENGERIX B PEDIATRIC (GlaxoSmithKline). Parents'' medical conditions included ABO incompatibility. The subject''s mother (34-year-old) was positive for hepatitis B virus. The subject had no sibling. There was no relevant disorder during pregnancy. Co-suspect medications included immunoglobulin anti hepatitis B (LBF manufacturer). The subject was born on 12 February 2009 at 16:00, after 37 gestational weeks and three days (breech birth). One minute after birth apgar score was at 8/10, 3 minutes after birth, Apgar score was at 10/10. The subject weighed 3160g. On 13 February 2009, at 09:00 the subject received a first dose of ENGERIX B PEDIATRIC (10 mcg, intramuscular, quadriceps unknown thigh, batch AHBVB471AA (as reported), expiry date June 2010) associated with one dose of immunoglobulin anti hepatitis B (intramuscular, unknown quadriceps, batch 08L05831, expiry date March 2010). The subject experienced no adverse effect at injection site. At 19:00, the subject had his last breastfeed. Ten hours after vaccination with ENGERIX B PEDIATRIC, the subject experienced mild hypotonia. Blood tests evidenced C-reactive protein at 2.9, leukocytes count at 21 000, haemoglobin at 17.7 g/dl, and platelet count at 353 000. Total bilirubin was increased at 129. Fourteen hours after vaccination with ENGERIX B PEDIATRIC, the subject was found dead (coded sudden infant death). There was no regurgitation around his mouth. On 16 February 2009, an autopsy was performed: results were normal on macroscopic level. Autopsy results were in favour of fatty acid autosomal recessive metabolic disease. The agency considered sudden infant death as unlikely related to vaccination with ENGERIX B PEDIATRIC and to treatment with immunoglobulin anti hepatitis B, according to the foreign method of imputability.


VAERS ID: 342007 (history)  
Form: Version 1.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-02-01
Onset:2009-02-19
   Days after vaccination:18
Submitted: 2009-03-18
   Days after onset:26
Entered: 2009-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Coma, Death, Hepatitis A, Impaired work ability, Malaise
SMQs:, Liver infections (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-03-01
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0565179A

Write-up: This case was reported by the subject''s colleague and described the occurrence of acute hepatitis A in a 63-year-old female subject who was vaccinated with TWINRIX adult (GlaxoSmithKline). The reporter believed that the subject had good health and didn''t complain about anything before. In week beginning with 2 February 2009, the subject received unspecified dose of TWINRIX adult (unknown route of administration, lot number not provided) as part of vaccination campaign organized in her company. On 19 February 2009, less than one month after vaccination with TWINRIX adult, the subject felt unwell. She was on sick leave starting 25 February 2009. On 28 February 2009, the subject had emergency hospitalisation and died on 01 March 2009. The reporter has seen discharge summary from hospital with diagnosis of acute hepatitis A with coma. Cause of death was not reported. It was unknown whether an autopsy was performed. Follow up from hospital has been requested.


VAERS ID: 342583 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Foreign  
Vaccinated:2009-03-17
Onset:2009-03-19
   Days after vaccination:2
Submitted: 2009-03-24
   Days after onset:5
Entered: 2009-03-25
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 37338 / 1 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-03-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: The patient was not taking concomitant medications and was not administered concomitant vaccine.
Current Illness:
Preexisting Conditions: The patient''s mother was HIV positive but tests performed since the birth had not showed a patient''s contamination. The patient''s had no relevant personal medical history. Past therapies included three doses of INFANRIX-QUINTA at the age of 2, 3 and 4 months and Hepatitis B Vaccine.
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: FRWYEG03362309

Write-up: Information regarding PREVENAR was received from a healthcare professional regarding a 5-month-old female patient who experienced sudden death. The patient received the first dose on 17-Mar-2009. The patient was in good health when he received the first dose of PREVENAR on 17-Mar-2009. Then, the patient experienced sudden death on 19-Mar-2009 whereas she was at a babysitter house. No adverse event had been reported between 17 and 19-Mar-2009. The reporter did not have any details about the circumstances of death. An autopsy will be probably performed. The cause of death was reported as sudden death. No additional information was available at the time of this report.


VAERS ID: 342677 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Foreign  
Vaccinated:2009-03-17
Onset:2009-03-19
   Days after vaccination:2
Submitted: 2009-03-25
   Days after onset:6
Entered: 2009-03-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B063AB / UNK LA / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 UN / UN
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-03-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0566604A

Write-up: This case was reported by a regulatory authority and described the occurrence of death NOS in a 6-month-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline), IPOL (non-GSK) and HEP B vaccine (non-GSK). On 17 March 2009, the subject received unspecified dose of INFANRIX (unknown route of administration), unspecified dose of IPOL (Non-GSK) (unknown route of administration), 3rd dose of HEP B vaccine (Non-GSK) (unknown route of administration). On 19 March 2009, 2 days after vaccination with INFANRIX, HEP B vaccine (Non-GSK) and IPOL vaccine (Non-GSK), the subject died, cause of death was not reported. It was unknown whether an autopsy was performed.


VAERS ID: 343293 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2008-11-04
Onset:2008-11-25
   Days after vaccination:21
Submitted: 2009-04-01
   Days after onset:126
Entered: 2009-04-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Brain neoplasm, Computerised tomogram abnormal, Computerised tomogram head, Death, Exeresis, Facial palsy, Hydrocephalus, Laboratory test, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain abnormal, Pathology test, Surgery, Ultrasound abdomen normal
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad), Non-haematological tumours of unspecified malignancy (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-01-05
   Days after onset: 41
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Breech presentation
Allergies:
Diagnostic Lab Data: Head computed axial tomography, 28Nov08, abnormal and found hydrocephalus; Magnetic resonance imaging, 28Nov08, cerebellar brain tumor; Abdominal ultrasound, 02Dec08, normal; Magnetic resonance imaging, 22Dec08, abnormal and found remaining tumor tissue; Diagnostic pathological examination, 28Dec08, rhabdoid tumor; Diagnostic laboratory test, 28Dec08, no INI-1 protein
CDC Split Type: WAES0903USA05339

Write-up: Information has been received on 24-MAR-2009 from the health authorities (reference number 200900027) via an investigator concerning a 3 month old male who participated in a study on the impact of immunization campaign of infants hospitalization for rotavirus GEA. Non-interventional study. It was reported that he had a medical history of ceasarean birth (breech presentation at 38 weeks and 6 days; APGAR at 10/10) who had received an injection of ROTATEQ (lot # not reported) per os on 04-NOV-2008. He concomitantly received secondary suspect vaccinations of INFANRIX HEXA and PREVENAR on 04-NOV-2008. On 25-NOV-2008, the patient experienced facial paralysis for 3 days. On 28-NOV-2008, he developed hydrocephalus and brain tumor. He was hospitalized on 28-NOV-2008. Aetiological investigations were performed. On 28-NOV-2008, brain scan was abnormal and found hydrocephalus; brain MRI revealed a cerebellar brain tumor. External derivation was performed on 28-NOV-2008. On 02-DEC-2008, abdominal ultrasound was normal. Surgical intervention was performed on 03-DEC-2008 with partial exeresis. Ablation of derivation was performed on 16-DEC-2008. On 22-DEC-2008 brain MRI was abnormal and found remaining tumor tissue. Palliative care was decided on 22-DEC-2008. On 28-DEC-2008, unspecified histology found rhabdoid tumor; immunohistochemistry found no INI-1 protein. The patient died from brain tumor on 05-JAN-2009. No information on autopsy was provided. At the time of reporting, additional information was expected. The investigator considered that brain tumor was not related; the sponsor considered that brain tumor was unlikely related. Other business partner numbers included: E2009-02635. No further information is available.


VAERS ID: 343529 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Foreign  
Vaccinated:2009-03-17
Onset:0000-00-00
Submitted: 2009-04-02
Entered: 2009-04-06
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR B1133 / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-03-19
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: Not reported
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200901247

Write-up: INITIAL REPORT RECEIVED FROM HEALTH AUTHORITIES IN A FOREIGN COUNTRY ON 24 MARCH 2009 UNDER THE LOCAL REFERENCE NUMBER: SK20090002. A 6-month-old male patient with no reported medical history experienced high fever at an unspecified time and moved to a hospital on 18 March 2009, the day following the simultaneous administration of IMOVAX POLIO, lot no: B1133, INFANRIX (manufacturer GSK) and HEP B (manufacturer unknown) via unspecified route and site at the clinic on 17 March 2009. The patient died on 19 March 2009. No other information was received. Corrective version created in order to code the hepatitis B vaccine (manufacturer unknown) with the company drug dictionary (level 1 / generic name).


VAERS ID: 343530 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Foreign  
Vaccinated:2009-03-17
Onset:2009-03-17
   Days after vaccination:0
Submitted: 2009-04-03
   Days after onset:17
Entered: 2009-04-06
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 3 UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER ULA08002 / 3 UN / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Convulsion, Death, Hypotonia, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-03-19
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient was vaccinated with EUVAX B in October 2008 and IMOVAX and INFANRIX in November 2008 and January 2009. No reported medical history.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 200901325

Write-up: Report received from the Health Authorities on 24 March 2009. Reference number: EVX20090324-01. A 6-month-old male patient, with no reported medical history, had received the 3rd dose of IMOVAX POLIO* lot not reported, the 3rd intra-muscular dose of EUVAX B*, lot ULA08002 and the 3rd dose of INFANRIX* (from GSK), lot not reported on 17 March 2009. On 17 March 2009, after vaccination, the patient experienced fever. On the next day, the doctor treated the patient with antipyretic drug. Flaccidity was noted in the evening and after vomiting and convulsion occurred. The patient was admitted in the emergency room at 4 am on 19 March 2009 and died at 2 pm. The patient has been vaccinated with EUVAX B in October 2008 and IMOVAX and INFANRIX in November 2008 and January 2009. Company comments: "the patient had concomitantly taken three vaccines EUVAX B, IMOVAX and INFANRIX. Although the timing of the serious adverse events in this case matches with the vaccination of the child with EUVAX B; due to lack of adequate objective information and due to the similar report following vaccination with EUVAX B, IMOVAX and INFANRIX, conclusive causality cannot be drawn."


VAERS ID: 343612 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-11-01
Onset:2008-11-26
   Days after vaccination:25
Submitted: 2009-04-06
   Days after onset:130
Entered: 2009-04-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Hypertrophic cardiomyopathy, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Congenital, familial and genetic disorders (narrow), Cardiomyopathy (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-11-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptives (unspecified)
Current Illness: Contraception
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0903AUS00084

Write-up: Information has been received from a physician, via agency, as part of a business agreement (manufacturer control No. GARD 2009 03 27 LS2), concerning a 23 year old female who in November 2008 was vaccinated with GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified) in the form of a vaginal contraceptive ring. On 26-NOV-2008, a few days after vaccination with GARDASIL the patient died suddenly. The cause of death was attributed to hypertrophic cardiomyopathy. It was reported that an autopsy was performed (report not provided). A few days prior to her death, the patient had visited her physician to discuss contraception. She was not taking any other drugs other than contraception and had no underlying conditions or hereditary conditions. The reporter considered that hypertrophic cardiomyopathy was not related to therapy with GARDASIL, stating "I''m sure it was not directly related". Additional information has been requested.


VAERS ID: 343840 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2009-02-27
Onset:2009-03-13
   Days after vaccination:14
Submitted: 2009-04-09
   Days after onset:27
Entered: 2009-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABAVERT) / NOVARTIS VACCINES AND DIAGNOSTICS 1630 / 3 UN / ID

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Drooling, Hydrophobia, Hypoaesthesia, Pain in extremity, Phobia, Pyrexia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-03-14
   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: #1 Favirab (Rabies Ig F), 02-MAR-2009, 00:00 / Unknown
Current Illness:
Preexisting Conditions: 26-FEB-2009 to Unknown, Indication animal bite, dog bite
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20090865

Write-up: We received the following information from a reporter on 02 APR 2009: A male patient was bitten by a stray dog on the right arm on 26 FEB 2009 (category 3 with deep multiple bites). The bitten area was washed thoroughly and patient was given RABIPUR (batch no. 1630 and 1636), 0.1 ml intradeltoidally on 27 FEB 2009, 02 MAR 2009 and 06 MAR 2009. The patient developed high grade fever, pain and numbness at bite site on 13 MAR 2009, 1 p.m. At 6 p.m. the same day, patient suffered from drooling of saliva and aerophobia. On 14 MAR 2009, the patient developed hydrophobia and died in the evening. A batch review for batch 1630 dated 19 FEB 2009 demonstrated that there were no deviations affecting product. Concomitant medication: FAVIRAB (rabies immunoglobulines, intravenous?) on 02 MAR 2009. We received further information on 03 APR 2009: The patient was 13 year old. The stray dog was killed after biting. The reporter is a health care professional (nurse). The patient died in his province, not in hospital, so no hospital report or post-mortem examination is available. FAVIRAB was administered intramuscularly.


VAERS ID: 344474 (history)  
Form: Version 1.0  
Age: 94.0  
Sex: Male  
Location: Foreign  
Vaccinated:2008-11-14
Onset:0000-00-00
Submitted: 2009-04-17
Entered: 2009-04-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Herpes zoster, No reaction on previous exposure to drug
SMQs:, 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: Gabapentin; Fentanyl
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: D0061289A

Write-up: This case was reported by a foreign regulatory authority (# DE-PEI-PEI2009002438) and described the occurrence of herpes zoster in a 94-year-old male subject who was vaccinated with INFLUSPLIT SSW 2008/2009, GlaxoSmithKline. Concurrent medications included Gabapentin and Fentanyl. Previous annual vaccinations with seasonal INFLUSPLIT SSW, GlaxoSmithKline, given on unknown dates, have been well tolerated. On 14 November 2008 the subject received a dose of INFLUSPLIT SSW 2008/2009 (0.5 ml, unknown). At an unspecified time post vaccination with INFLUSPLIT SSW 2008/2009, on an unknown date, the subject experienced herpes zoster. The subject was hospitalised for an unknown period of time. The reporter considered that the event was life threatening. The outcome of the event was fatal. On an unknown date the subject died from herpes zoster. It was unknown whether an autopsy was performed. No further information will be available.


VAERS ID: 344685 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2009-04-14
Onset:2009-04-14
   Days after vaccination:0
Submitted: 2009-04-23
   Days after onset:9
Entered: 2009-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-04-14
   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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0570567A

Write-up: This case was reported in a newspaper article and described the occurrence of death nos in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline), DTPa-IPV-HIB (manufacturer unspecified). On 14 April 2009 at 11:00 the subject received unspecified dose of ROTARIX (unknown route), unspecified dose of DTPa-IPV-HIB (unknown route). Lot numbers not provided. On 14 April 2009, 5 hours after vaccination with DTPa-IPV-HIB and ROTARIX, the subject was found dead by the mother. The subject died on 14 April 2009, cause of death was not reported. An autopsy was performed. According to the preliminary analysis of the forensic physician, asphyxia could be the cause of the death. The suffocation could have occurred due to inhalation of the vomit. No further details were provided.


VAERS ID: 344689 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2009-04-01
Onset:2009-04-02
   Days after vaccination:1
Submitted: 2009-04-23
   Days after onset:21
Entered: 2009-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC378031CC / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Culture negative, Headache, Lymphadenopathy, Pulmonary congestion, Pyrexia, Splenomegaly, Streptococcus identification test negative, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-04-05
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A0779009A

Write-up: This case was reported by a regulatory authority (Health # V0901221) and described the occurrence of sudden death in a 15-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 1 April 2009 the subject received unspecified dose of BOOSTRIX (unknown). On 2 April 2009, 24 hours after vaccination with BOOSTRIX, the subject experienced fever and headache, lasting 2 days. On 04 April 2009 the subject was feeling better. On 05 April 2009 around 11:30am the subject was found dead on his bed. The subject died on 05 April 2009 from sudden. An autopsy was performed and showed cervical adenopathy, lung congestion and splenomegaly. The pathology did not find any evident cause to explain the death. The pathologist was more oriented towards an infectious cause because the teen presented splenomegaly, cervical adenopathy and pulmonary congestion. Culture results were negative for Strep A. Microscopy results were pending.


VAERS ID: 344759 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-04-23
Entered: 2009-04-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: Relevant medical history was not provided.
Allergies:
Diagnostic Lab Data: Laboratory test (results: positive for S. pneumoniae of serotype 19 C) was done in 2009.
CDC Split Type: DEWYEG03548109

Write-up: Information regarding PREVENAR was received from a healthcare professional regarding a 2.5-year-old patient (gender unknown) who died due to pneumococcal meningitis. The patient received a dose on an unspecified date. The patient received an unknown number of doses of PREVENAR and died due to pneumococcal meningitis in Mar-2009. The onset date of the pneumococcal meningitis was unknown. The cause of death was reported as meningitis pneumococcal. No additional information was available at the time of this report but has been requested.


VAERS ID: 345179 (history)  
Form: Version 1.0  
Age: 0.7  
Sex: Female  
Location: Foreign  
Vaccinated:2009-03-28
Onset:2009-03-29
   Days after vaccination:1
Submitted: 2009-04-29
   Days after onset:31
Entered: 2009-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (TRITANRIX) / GLAXOSMITHKLINE BIOLOGICALS AT15B583AE / 1 UN / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS AHIBB929AA / 1 UN / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Body temperature increased, Cyanosis, Death, Dyspnoea, Mechanical ventilation, Pyrexia, Septic shock
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Toxic-septic shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (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: 2009-04-01
   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:
Current Illness: Unknown
Preexisting Conditions: BRONCHITIS
Allergies:
Diagnostic Lab Data: Body temperature, 29Mar2009, 40deg C
CDC Split Type: B0570999A

Write-up: This case was reported by a physician and described the occurrence of septic shock in a 8-month-old female subject who was vaccinated with TRITANRIX HepB (GlaxoSmithKline), HIBERIX and poliomyelitis vaccine live oral (non-GSK). The subject''s medical history included bronchitis for the first five months of her life. The patient was treated with pulverizations and other treatments until 5 days before vaccination. At the time of vaccination, the subject had no concomitant medication. On 28 March 2009, the subject received 1st dose of TRITANRIX HepB (intramuscular, unknown thigh), 1st dose of HIBERIX (intramuscular, unknown thigh), 1st dose of Poliomyelitis vaccine live oral (Non-GSK) (oral). There were the first vaccines administered to the child. She had received no vaccination before. On 29 March 2009, 1 day after vaccination with HIBERIX, Poliomyelitis vaccine live oral (Non-GSK) and TRITANRIX HepB, the subject experienced fever (40 deg C) with cyanosis and dyspnea. The subject was hospitalized and put on a respirator. The subject died on 1 April 2009 from septic shock. It was unknown whether an autopsy was performed. The subject had a twin brother who also suffered from bronchitis in the same time of his sister. He received no vaccine on 28 March 2009 because he had fever that day. And he had no problem. The physician considered the events were almost certainly related to vaccination with TRITANRIX HepB, HIBERIX and Poliomyelitis vaccine live oral (Non-GSK).


VAERS ID: 345447 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-10-17
Onset:2009-04-01
   Days after vaccination:166
Submitted: 2009-05-01
   Days after onset:30
Entered: 2009-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA348A / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-04-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Contact dermatitis or other eczema, Hypertension, Other musculoskeletal system and connective tissue disorder.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: R0004010A

Write-up: This female subject was enrolled in a study. On 17 October 2008, she received one dose of FLUARIX or influenza vaccine adjuvanted with half dose of AS03 (FLU NG). This subject received FLUARIX (lot AFLUA348A). On 01 April 2009, five months after the dose of Blinded vaccine, this 82-year-old subject died, cause of death is unknown. It was unknown whether an autopsy was performed. Investigator causality was unknown at the time of reporting. MEDICAL HISTORY AT STUDY START: Contact dermatitis or other eczema, Hypertension, Other musculoskeletal system and connective tissue disorder.


VAERS ID: 345967 (history)  
Form: Version 1.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2002-10-11
Onset:2002-11-01
   Days after vaccination:21
Submitted: 2009-05-08
   Days after onset:2379
Entered: 2009-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Completed suicide, Dysstasia, Gait disturbance, Injection site atrophy, Injection site pain, Lasegue's test positive, Muscle atrophy, No reaction on previous exposure to drug, Pain, Sciatica, Tenderness, Weight decreased
SMQs:, Peripheral neuropathy (broad), Suicide/self-injury (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Repaglinide
Current Illness: Diabetes mellitus type 2 B; Medical diet
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Examination: 02 December 2002: tenderness of right side, lateral to lumbar column; Lasegue''s sign on right side at 70? positive; no paresis. 12 December 2002: fluent way of walking; muscle power in legs uneventful; no problems when walking on toes or heels; Lasegue''s sign bilateral negative; right side of hip completely flexible.
CDC Split Type: D0040224A

Write-up: A physician reported the occurrence of lumboischialgia in a 71-year-old male who was vaccinated with INFLUSPLIT SSW 02/03. The subject suffered from Diabetes mellitus type IIb which was treated with diet and NOVONORM. Previous vaccinations with INFLUSPLIT SSW 02/03 were well tolerated. On 11 October 2003 the subject received a dose of INFLUSPLIT SSW 02/03. The subject reported that he developed injection site pain approximately five to six days post vaccination, which became worse from day to day. He also reported that he developed muscular atrophy from the injection site to the foot which still became worse so that he hardly was able to walk. He consulted an emergency doctor several times. Analgesics were not successful. The reporting physician stated that the subject consulted an emergency doctor on 01 December 2002 whom he had told that he suffered from pain in the right iliac wing, occasionally radiating to the right leg for about eight days. The emergency doctor diagnosed lumboischialgia. On 02 December 2002 the subject consulted the reporting physician. The subject described pain in the lumbar column radiating to the right leg. Examination revealed tenderness of the right side lateral to the lumbar column and positive Lasegue''s sign on right side at 70?. There was no paresis. The events were treated with diclofenac. On 12 December 2002 the subject again visited the reporter because of ongoing right gluteal pain. The subject complained on walking difficulties and said he was hardly able to stand on his feet because of the pain. This time the subject suspected a causal relationship to the vaccination. Examination of the subject showed a fluent way of walking, muscle power in his legs was uneventful and he had no problems when walking on his toes or heels. Lasegue''s sign was bilateral negative, the right side of his hip completely flexible. The reporter diagnosed lumboischialgia. He suggested referral to a specialist but the subject refused. At the time of reporting the subject was not recovered. He mentioned that he additionally lost 4kg of body weight in the meantime. The reporting physician considered that lumboischialgia was unlikely related to vaccination with antiinfluenza vaccine. He did not mention any muscular atrophy and weight loss and hence he did not specify the causality for these events. Follow-up information was received on 04 May 2009 from the subject''s wife. The wife stated that the patient had committed suicide, because he could not cope with the extreme pain any more. She considered that all was caused by vaccination with INFLUSPLIT SSW in 2003. The subject died from completed suicide. It was unknown whether an autopsy was performed. No further information will be available.


VAERS ID: 346460 (history)  
Form: Version 1.0  
Age: 0.45  
Sex: Male  
Location: Foreign  
Vaccinated:2009-04-30
Onset:0000-00-00
Submitted: 2009-05-15
Entered: 2009-05-18
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 3 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 3 RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Sudden death, Tachypnoea
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-04-30
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: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: Past vaccinations included the first two doses of PREVENAR and INFANRIX HEXA. One of the patient''s siblings died of fulminant cardiomyopathy at the same age. The sibling has received the last vaccination 2.5 months prior to date of death.
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: DEWYEG03616509

Write-up: Additional information was received regarding the events, patient''s demographics, dose details, medical history and outcome. Information regarding PREVENAR was received from a healthcare professional regarding a 5-month-old male patient who experienced tachypnoea and who died of sudden death. The patient received the third dose on 30-Apr-2009. Additional suspect medication included INFANRIX HEXA which was administered in the left thigh on the same time. After vaccination the parents went twice to the doctor with the patient on the same morning. The patient experienced mild tachypnoea. The patient was clinically without severe findings. The second visit to the doctor was approximately three hours after the vaccination and during the visit the doctor decided to hospitalize the patient due to the death of the patient''s sibling. Therefore the patient''s parents took the patient to hospital for monitoring. The way to hospital was without any complications but on arrival at hospital the patient''s condition impaired and the patient received permanent drop infusion for example. 40 minutes after the arrival at hospital the patient''s condition got really worse so that reanimation was performed but without success. The patient died of sudden death on 30-Apr-2009. An autopsy was performed but at the time of report the result was unknown. The reporting physician''s assessment of relatedness between the adverse events and PREVENAR and INFANRIX HEXA was possible related. The cause of death was reported as sudden death. No additional information was available at the time of this report.


VAERS ID: 347169 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-05-22
Entered: 2009-05-26
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0905USA02476

Write-up: Information has been received from a health professional concerning a male patient (age not reported), poorly documented case, no information regarding history was reported, who was vaccinated with a dose of PNEUMOVAX 23 (lot #, injection site and route not reported) approximately 2 to 3 years ago. The patient experienced possibly pneumococcal infection and was hospitalized on unspecified date. The patient died of unexplained death. Unexplained death and pneumococcal infection was considered to be immediately life-threatening. No further information was available. Other business partner numbers include E2009-04199.


VAERS ID: 348129 (history)  
Form: Version 1.0  
Age: 10.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-05-29
Entered: 2009-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS - / 4 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Areflexia, Back pain, Blood electrolytes normal, Blood potassium normal, Blood product transfusion, Blood sodium normal, Bulbar palsy, CSF cell count normal, CSF glucose normal, CSF protein increased, Culture negative, Death, Eosinophil percentage, Gram stain negative, Haemoglobin normal, Heart rate increased, Hypotonia, Liver function test normal, Lymphocyte percentage, Mechanical ventilation, Muscular weakness, Neurological examination abnormal, Neutrophil percentage, Oxygen saturation normal, Paralysis, Platelet count normal, Pyrexia, Rabies, Renal function test normal, Respiratory rate increased, Urinary incontinence, Vomiting, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Dog bite right hand (grade III)
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20091309

Write-up: We received the following literature report (country of origin: foreign). A ten-year-old boy presented with sudden weakness of both lower limbs for two days. He also had a history of fever, vomiting, and back pain for three days. His past history elicited an incident of an unprovoked bite by a street dog in his right hand (grade III) three weeks back. Four doses of purified chick embryo cell antirabies vaccine were administered according to schedule in the deltoid, starting from the day of the bite. Rabies immunoglobulin was not given. The patient had complained of back pain, but there was no typical history of pain, tingling, numbness at the site of the bite, hydrophobia, or behavioral changes. Clinical examination revealed a febrile, alert, and conscious child. His temperature was 39.5 C, pulse rate was 110/min, blood pressure 100/70 mm Hg, respiratory rate 30/min, and SPO2 96%. Neurological examination detected grossly reduced muscle tone and power (lower limb 2/5, upper limb 3/5) with areflexia (both superficial and deep tendon reflexes were absent) in all four limbs and the trunk along with urinary incontinence. There were no features of sensory of cranial nerve involvement. The failure to administer RIG after the grade III bite favored a provisional diagnosis of paralytic rabies was made even though the classical symptoms of rabies were absent. Although rare with the modern cell culture vaccines, the possibility of vaccine-induced GBS was also considered. Laboratory investigations showed hemoglobin: 11.5 g/dL, white cell count: 70000/cu.mm (neutrophil: 58%, lymphocyte: 40%, eosinophil: 2%), platelet count: 1,90000/cu.mm. Cerebrospinal fluid analysis showed cell count: 10/cu.mm (all lymphocytes), protein: 50 mg/dL, and sugar: 60 mg/dL (no albumino-cytological dissociation). Microorganisms were not detected either by gram stain or by culture. The electrophysiological test designed to identify features of demyelination (slowing of nerve conduction velocity with marked prolongation of distal latencies and occasional conduction block), was inconclusive. Serum electrolytes were normal. Na: 136 meq/L, K: 5 meq/L. Liver function, renal function tests, and repeat CSF examination on the 7th day were unremarkable. A serological test for rabies was not possible due to some technical difficulties. Conservative management was started but rapid progression of paralysis occurred over the next two days. There was involvement of respiratory muscles as well as features of bulbar palsy. The patient was put on ventilatory support. Intravenous immunoglobulin (2g/kg/total dose) was given over 12 hours for the sake of caution, but there was no improvement and the patient succumbed on the 10th day of onset of the disease. Due to inadequate stool collection by the AFP surveillance worker, all the documents were sent to the National Expert Committee as a special case. They classified the case as being nonpolio and as paralytic rabies.


VAERS ID: 348130 (history)  
Form: Version 1.0  
Age: 6.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-05-29
Entered: 2009-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS - / 4 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: CSF test abnormal, Death, Myalgia, Oedema, Pyrexia, Quadriparesis, Rabies, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Dog bite right upper arm (grade III)
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20091313

Write-up: We received the following literature report: A six-year-old girl presented with sudden onset of quadriparesis for one day, preceded by fever, myalgia, and vomiting for four days. There was also a history of a dog bite in her right upper arm (grade III bite) three weeks back. The child was given the PCEC vaccine as per schedule in the deltoid and received a total of four doses before the development of any symptoms. In that case also RIG was not given though it was indicated. The patient was treated conservatively, but the clinical features and the progression of disease was similar to the first case, except for the presence of myoedema, a striking feature of rabies. In spite of good supportive measures, she expired on the 12th day of disease onset. Results of laboratory investigations on the 11th day of the illness were also quite similar to the first case. The CSF test was strongly positive for rabies antigen and immune complexes. Neutralizing antibodies to rabies virus were detected in both serum and CSF by the Rapid Fluorescent Focus Inhibition Test (RFFIT). Seriousness criteria: fatal, life-threatening, hospitalisation. Causality: not related. Rabies is an infectious disease and not due to vaccination. Paralytic rabies is not expected after vaccination with RABIPUR. No change in benefit-nsk-ratio. No measures necessary.


VAERS ID: 348217 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-05-28
Entered: 2009-06-01
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, Death, Pneumococcal bacteraemia
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: Concomitant medications were not reported.
Current Illness: The patient''s concurrent illnesses include adipositas per magna, hyperparathyroidism secondary, vitamin D deficiency and psychomotor retardation but the patient was no premature baby.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood culture (results: positive for S. pneumoniae of serotype 15B) was done on an unspecified date.
CDC Split Type: DEWYEG03736409

Write-up: Information regarding PREVENAR was received from a healthcare professional regarding a 58-month-old female patient who experienced pneumococcal bacteraemia without focus. The patient received the second dose on an unspecified date at the age of 19 months. The patient died of pneumococcal bacteraemia. After second vaccination at the age of 19 months and at the age of 58 months the patient experienced pneumococcal bacteraemia without focus. S. pneumoniae of serotype 15B were detected by blood culture. The patient died of pneumococcal bacteraemia on an unknown date.


VAERS ID: 348909 (history)  
Form: Version 1.0  
Age: 0.9  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2009-05-10
Submitted: 2009-06-10
   Days after onset:31
Entered: 2009-06-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal discomfort, Autopsy, Cardiac arrest, Convulsion, Death, Dehydration, Depressed level of consciousness, Diarrhoea, Heart rate decreased, Irritability, Laboratory test, Meningitis pneumococcal, Pyrexia, Restlessness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Akathisia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-05-13
   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: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: Returned from long weekend, on 10-May-2009.
Allergies:
Diagnostic Lab Data: Investigation (results: Tests still outstanding to confirm if any other factors were involved.) was done in May-2009.
CDC Split Type: GBWYEG03792609

Write-up: This is a fatal case. Information regarding PREVENAR was received from a consumer regarding a 11-month-old male patient who experienced pneumococcal meningitis, diarrhoea and died. It was reported that the patient, "had been fully vaccinated with PREVENAR", total number of doses unknown. It was reported by the infant''s parents, that upon return from a foreign country on 10-May-2009 the patient developed a fever, which was put down to teething and he did not settle that evening. The following day he developed a high fever and was fretful all day. He was reported to improve in the evening and ate well and it was thought he may have eaten something he shouldn''t have and had an upset stomach, before having what was described as, "a very difficult night of high fever and various other symptoms", unspecified. It was reported that, in the early morning the patient then "slipped into an almost semi-comatose state where he was barely reactive" and was taken to see the family doctor. A nurse triaged him and because he was taking fluids, was sent home. An hour after being taken home, his family doctor called and requested him to return and be re-assessed and as he was still taking fluids, "he''d be OK". Another appointment was scheduled by his family doctor to see him the following day at 12 noon. It was reported that, that night he developed diarrhoea, and it was almost impossible to get fluids into him and again was very restless all night, "subsequently found out that he was having mild seizures, throughout the early hours". He was taken to an out of hours practice at 07h20, where the on duty doctor decided he was dehydrated due to possible gastroenteritis and he was admitted via a local Accident and Emergency department and started on a drip of fluids. The patient was reported to, "respond a little better" and broad-spectrum antibiotics were prescribed. However, it was reported that due to a hospital delay, antibiotics were only administered at 11h00 and he started having the mild seizures again. The seizures were reported to have increased in intensity and the medical staff were alerted. A coma was induced to stop the seizures and manual respiration was initiated, but at the same time the patient''s heart rate dropped alarmingly and then eventually stopped. It was stated that resuscitation ensued for 30 minutes unsuccessfully and the parents requested the medical team ''let him go'', on 13-May-2009. An autopsy confirmed the cause of death, to be pneumococcal meningitis and that there were still some tests outstanding to confirm if any other factors were involved. The outcome of the diarrhoea, was unknown. It was also stated that a postulation had been raised, that a, "13-valent PnC vaccine would have prevented this happening" and the patient had not presented with the, ''classic'' symptoms of meningitis and had, had no rash whatsoever. No additional information was available at the time of this report.


VAERS ID: 349211 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Unknown  
Location: Foreign  
Vaccinated:2009-06-01
Onset:2009-06-01
   Days after vaccination:0
Submitted: 2009-06-16
   Days after onset:15
Entered: 2009-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0578724A

Write-up: This case was reported by a physician and described the occurrence of sudden infant death in a 2-month-old subject of unspecified gender who was vaccinated with INFANRIX-IPV/HIB (GlaxoSmithKline). In June 2009 the subject received unspecified dose of INFANRIX-IPV/HIB (unknown) lot number not provided. In June 2009, 1 week after vaccination with INFANRIX-IPV/HIB, the subject died (sudden infant death). The subject died, cause of death is not specified. It was unknown whether an autopsy was performed.


VAERS ID: 349790 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2005-11-07
Onset:0000-00-00
Submitted: 2009-06-23
Entered: 2009-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Confusional state, Death, Hallucination, Lethargy
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-12-02
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20091497

Write-up: We received the following information from a health care professional via the Regulatory Agency on 09 JUN 2009: A female patient was vaccinated with either INFLUVAC (batch no. H21) or an influenza vaccine made by Chiron as a single dose on 07 NOV 2005. Within a few days, she was lethargic and remained in bed till at least the 14 NOV 2005. At the same point she became confused and had hallucinations and was admitted to the Accident and Emergency department at hospital. On 02 DEC 2005, the patient died. Regulatory Agency no.: ADR 20432832. Other no.: GB-SOLVAY-00309002515.


VAERS ID: 350228 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-06-09
Onset:2009-06-12
   Days after vaccination:3
Submitted: 2009-06-25
   Days after onset:13
Entered: 2009-06-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1477U / 1 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-06-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptives (unspecified)
Current Illness:
Preexisting Conditions: Asthma bronchial
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0906USA04039

Write-up: Information has been received from a gynaecologist concerning an approximate 14 year old female patient with a history of bronchial asthma, who was vaccinated with a first dose of GARDASIL (lot # not reported) IM into the upper arm on 09-JUN-2009. On 12-JUN-2009, the patient experienced an asthmatic attack of which she died. The patient had no long-term medication for the asthma but only on occasion. Concomitant medication included hormonal contraceptives (unspecified). Reportedly, an autopsy was performed. The result is not yet known. A causal relation to the GARDASIL vaccine was considered unlikely by the vaccinating physician. Follow-up information received on 22-JUN-2009: Exact birth date, initials, height (158 cm) and weight (50 kg) as well as lot # 1477U, batch # NH25390 were provided. Following information gathered by phone from the reporting physician, the girl experienced the asthmatic attack at home and an emergency doctor was called. He was not able to arrest the attack and resuscitation was unsuccessful. Other business partner''s numbers included: E2009-05085.


VAERS ID: 350368 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-06-26
Entered: 2009-06-29
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: Relevant medical history was not provided.
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: NLWYEG03903109

Write-up: Information regarding PREVENAR was received from a healthcare professional regarding a 2-month-old female patient who experienced death. The patient received the first dose on an unspecified date. Additional suspect medication included INFANRIX HEXA. The patient experienced death within 24 hours after the vaccinations. The cause of death was reported as unknown. No additional information was available at the time of this report.


VAERS ID: 350518 (history)  
Form: Version 1.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2008-11-18
Onset:2008-11-18
   Days after vaccination:0
Submitted: 2009-06-30
   Days after onset:223
Entered: 2009-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLLA223AA / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER B0445 / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A0792799A

Write-up: This case was reported by a nurse via a regulatory authority (# V0900342) and described the occurrence of sudden death in a 66-year-old male subject who was vaccinated with FLUVIRAL (GlaxoSmithKline), PNEUMO (non-GSK). On 18 November 2008 the subject received unspecified dose of FLUVIRAL (unknown), unspecified dose of PNEUMO (Non-GSK) (unknown). On 18 November 2008, 5 hours after vaccination with FLUVIRAL and PNEUMO (Non-GSK), the subject experienced sudden death. The subject died from death (unknown cause) (nos). It was unknown whether an autopsy was performed.


VAERS ID: 350680 (history)  
Form: Version 1.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:1997-12-16
Onset:0000-00-00
Submitted: 2009-07-02
Entered: 2009-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK RL / UN

Administered by: Other       Purchased by: Other
Symptoms: Anxiety, Ataxia, Borrelia burgdorferi serology negative, C-reactive protein increased, CSF oligoclonal band present, Cerebellar syndrome, Culture urine negative, Death, Demyelination, Dysuria, Electrophoresis protein normal, Extrapyramidal disorder, Fall, Gait disturbance, Intensive care, Loss of proprioception, Lumbar puncture abnormal, Multiple sclerosis, Neurogenic bladder, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain abnormal, Pain, Paresis, Prostatic specific antigen normal, Quadriparesis, Quadriplegia, Red blood cell sedimentation rate increased, Reflexes abnormal, Superinfection, Syphilis test, Syphilis test positive, Thinking abnormal, White blood cell count increased
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Optic nerve disorders (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-08-20
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Terazosin hydrochloride; Bromazepam; Perindopril erbumine
Current Illness: Asthenia; Chronic glaucoma; Confusion; Depressive syndrome; Hyperleukocytosis; Hypoxia; Opacity lung base; OS sacrum eschar; Oxygen desaturation; Pain; Prostatic adenoma operation; Respiratory insufficiency; Sphincter abnormality; Sweating; Trouble walking; Urethral stenosis; Urinary disorder; Vertebral fracture; Vertebral Hemangioma
Preexisting Conditions: Talniasis; Weight loss
Allergies:
Diagnostic Lab Data: Borrelia burgdorferi serology, Sep1999, negative; C-reactive protein, 10Aug2007, 188; Cerebrospinal fluid oligoclona, Sep1999, 3 to 10 ; Electrophoresis protein, Sep1999, normal; Leukocyte count NOS, 10Aug2007, 15 900; Lumbar puncture, Sep1999, see lab text; Lumbar puncture, 2003, see lab text; Nuclear magnetic resonance ima, Sep1999, see lab text; Nuclear magnetic resonance ima, Dec1999, see lab text; Nuclear magnetic resonance ima, 21Feb2000, unavailable; Nuclear magnetic resonance ima, 2003, see lab text; Prostatic specific antigen, Sep1999, normal; Scan, Sep1999, see lab text; Sedimentation rate increased, 10Aug2007, 115; Syphilis test, Sep1999, see lab text; Urine culture, Sep1999, negative; September 1999: Syphilis serology: TPHA positive, VDRL ++: September 1999 Rachis MRI: C4-C5 intramedullar hypersignals. Severe L1 compression without posterior wall rupture. vertebra hemangioma. December 1999, Brain MRI: 3 to 5 periventricular hypersignals
CDC Split Type: B0580228A

Write-up: This case was reported by an expert physician via GSK Legal Department and described the occurrence of multiple sclerosis in a 56-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject''s medical history included taeniasis and weight loss (about 17 kg) in 1994. Concurrent medical conditions included asthenia and possible walking trouble started in 1994, chronic glaucoma, depressive syndrome, prostatic adenoma operation at the end of 1998 complicated with urethral stenosis, sphincter abnormality and urinary disorder. The patient had L1 vertebral fracture due to clumsy fall, and D9 corporeal vertebral hemangioma. On 17 October 1996, the subject received a first dose of ENGERIX B (injection site and batch unknown). Later on, in 1996 or 1997, on unspecified delay after vaccination with ENGERIX B, a physician reported that the subject would have experienced medullar claudication. On 16 November 1996 and 16 December 1996, the subject received a second and third dose of ENGERIX B. On 16 December 1997 the subject received fourth dose of ENGERIX B (injection site and batch unknown). At the end of 1997, less than one month after last vaccination with ENGERIX B according to the wife of the subject, he experienced trouble walking and falls. In September 1999, the subject was hospitalised. Neurological examination revealed ataxia pyramidal disorder and proprioception disorder. There was also a possible supra medullar attack, sharp face reflex and mild left kinetic cerebellar syndrome. A biological check up was performed during hospitalisation: protein electrophoresis was normal. Lyme serology was negative. Syphilis serology was positive with TPHA at 80 and VDRL at 8. Nelson test was planned but results were not available. Urine culture was negative. Lumbar puncture showed a cerebrospinal fluid with a rich cligoclonal profile with 3 to 10 bands. In September 1999, rachis MRI was also performed and revealed C4-C5 intremedullar hypersigna and severe L1 compression without posterior wall rupture. A scanner confirmed DS vertebral hemangioma. Diagnosis of progressive demyelinating disease was made. Spastic paraparesis was also reported, in addition to central neurogenic bladder. On unspecified date in 1999, the patient was discharged from hospital with an improved status, a treatment with SEROPRAM was initiated. In December 1999, the subject was hospitalised because of worsened troubles: her experienced dysuria associated with lower limbs pyramidal syndrome. Result of MRI showed 3 to 5 peri ventricle hypersignals. Multiple sclerosis was considered as possible diagnosis. The subject was treated with SOLUMEDROL. The subject left the hospital with a treatment including SEROPRAM, BROMAZEPAM, LEXOMIL, XATRAL LP 5 mg, and COVERSYL. A skull MRI was planned for 21 February 2000. Results were not available. On 24 January 2001, the subject was hospitalised for walking trouble associated with central neurogenic bladder. At that moment, the subject also experienced thought disorder and anxiety. He received unspecified dose of SOLMEDROL, well tolerated. Nevertheless, behaviour disorder worsened. A psychiatrist evoked thought disorder and psychosis. A treatment with LOXAPAC was initiated. On 12 February 2003, multiple sclerosis diagnosis was confirmed after MRI and cerebrospinal fluid (local production of oligoclonal immunoglobulin) results. The subject presented quadriparesis. A treatment with METHOTREXATE at 7.5 mg weekly was evoked, but finally not initiated because of important respiratory insufficiency (incidental event). Physiotherapy was initiated. At an unspecified date, right lung opacity was evidenced (NOS-incidental event). In August 2007, the subject was hospitalised because of respiratory distress syndrome with oxygen desaturation, he was hypoxic confused, sweating, and algic (incidental events). He presented with superinfected sacrum eschar (incidental event). Lelukocytes were at 15,900, C-reactive protein was at 188 and sedimentation rate at 115 (incidental events). The subject went to intensive care unit. His status worsened and, on August 2007, the subject died. Regarding the subject medical history the expert physician suggested four hypothases: Pre-existing multiple sclerosis (considering walking trouble in1994), multiple sclerosis appeared after vaccination with ENGERIX B but with unspecified delay (from few months to 18 months), neurosyphilis, and cerico-arthrosic myelopathy. If walking trouble started in 1994, expert physician considered that multiple sclerosis was unrelated to vaccination with ENGERIX B. If walking trouble started in 1996 or 1997, expert physician considered that multiple sclerosis was unlikely to vaccination with ENGENRIX B. According to the expert physician, the patient death would be due to his general status, including pulmonary, infectious and neurological polypathology.


VAERS ID: 350812 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2009-05-01
Onset:0000-00-00
Submitted: 2009-07-06
Entered: 2009-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Death, Diarrhoea, Vomiting projectile
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (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:
Current Illness: Diarrhea; Projectile Vomiting
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unk
CDC Split Type: B0581803A

Write-up: This case was reported by a nurse and described the occurrence of death in sleep in an infant female subject who was vaccinated with ROTAVIRUS vaccine (manufacturer unspecified). This is one of 2 cases reported that resulted in death (see case B0581670A). The subject''s involved came from the same home. Concurrent medical conditions included diarrhea and vomiting. On 1 may 2009 and 1 April 2009 the subject received 2nd dose and 1st dose of Rotavirus vaccine (Oral). In May 2009, less than one month after vaccination with the 2nd dose of ROTAVIRUS vaccine, the subject concurrent conditions (diarrhea more than 4 times a day and projectile vomiting) worsened. The subject was treated with fluid and oral rehydration salts but the subject pass away in her sleep. The health professional reported that the event was possibly related to vaccination with ROTAVIRUS vaccine. The subject died, cause of death is not specified. There was no postmortem done. The body was disposed off by the local council.


VAERS ID: 350976 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2009-07-01
Onset:2009-07-02
   Days after vaccination:1
Submitted: 2009-07-08
   Days after onset:6
Entered: 2009-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS A20CA533A / 2 UN / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS A20CA533A / 2 UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER A20CA533A / 2 UN / IM
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER ASPNA006A / 1 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: HEALTHY BABY
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0582236A

Write-up: This case was reported by a physician and described the occurrence of sudden unexpected death in infancy in a 3-month-old female subject who was vaccinated with SYNFLORIX (GlaxoSmithKline), INFANRIX-IPV/HIB. Before vaccination the subject was examined by the physician. The baby was healthy and there were no contraindications for the vaccination. On 1 July 2009 the subject received 1st dose of SYNFLORIX (intramuscular, unknown thigh), 2nd dose of INFANRIX-IPV/HIB (intramuscular). After vaccination no adverse event was observed by the reporter. On 2 July 2009, 1 day after vaccination with INFANRIX-IPV/HIB and SYNFLORIX, the police officer informed the reporter about the sudden unexpected death in infancy. The reason was unknown. The medical documentation has been protected due to temporary relationship with the vaccination. The subject died, cause of death is not specified. It was unknown whether an autopsy was performed. In the follow up received on 07 July 2009 it was mentioned that on 03 July 2009 the autopsy was performed. The document was kept confidential.


VAERS ID: 351036 (history)  
Form: Version 1.0  
Age: 1.5  
Sex: Female  
Location: Foreign  
Vaccinated:2009-04-29
Onset:2009-05-01
   Days after vaccination:2
Submitted: 2009-07-08
   Days after onset:68
Entered: 2009-07-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 3 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Cardiac arrest, Death, Dyspnoea, Endotracheal intubation, Erythema infectiosum, Feeding disorder, Hypoxia, Polymerase chain reaction, Respiratory disorder, Respiratory tract infection viral, Viral myocarditis, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-05-04
   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: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: The patient has a past history of moderate eczema at the age of 3 months old and roseola at the age of 11 months old. Past therapies included 4 doses of INFANRIX-QUINTA received on unspecified dates. The patient had already received the first two doses of PREVENAR on 16-Apr-2008 and 04-Jun-2008 without any adverse events. The patient had no particular family history. She was born after a full-term pregnancy.
Allergies:
Diagnostic Lab Data: Autopsy (results: Severe myocarditis with presence of DNA of Parvovirus B19 in myocardium and lung determined by PCR.) was done in May-2009.
CDC Split Type: FRWYEG03973109

Write-up: Information regarding PREVENAR was received from a healthcare professional via the foreign regulatory authority regarding an 18-month-old female patient who experienced feeding difficulty, vomiting, viral respiratory tract infection due to Parvovirus B19, hypoxia, viral myocarditis due to Parvovirus B19 and cardiac arrest. The patient received the third dose on 29-Apr-2009. Additional suspect medication included BETAMETHASONE. On 01-May-2009, the patient experienced respiratory discomfort with feeding difficulty and vomiting (non serious events). There was no fever. Then, the patient was hospitalized on 03-May-2009 due to progressive aggravation of dyspnea. She received therapy with CELESTENE, VENTOLINE, CLAMOXYL and RULID. Despite this drug therapy and oxygen therapy, hypoxia appeared on 04-May-2009 (estimated date). The patient finally died on 04-May-2009 due to cardiac arrest during intubation. An autopsy was done and revealed severe myocarditis with presence of DNA of Parvovirus B19 in myocardium and lung determined by PCR. The causes of death were reported as viral respiratory tract infection due to Parvovirus B19, hypoxia, viral myocarditis due to Parvovirus B19 and cardiac arrest. A weakening effect of vaccination was considered.


VAERS ID: 351106 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-05-28
Onset:2009-05-28
   Days after vaccination:0
Submitted: 2009-07-09
   Days after onset:42
Entered: 2009-07-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-05-29
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Hypertension
Preexisting Conditions: Asthma; Respiratory failure
Allergies:
Diagnostic Lab Data: Body temp, 28May09, 38.4 Celsius degree
CDC Split Type: WAES0907USA00373

Write-up: Information has been received from an other health professional concerning a 84 year old female patient with hypertension and medical histories of asthma bronchial and respiratory failure who on 28-MAY-2009 was vaccinated subcutaneously with PNEUMOVAX, 0.5ml once a day for prophylaxis against pneumonia. No information on concomitant therapy was provided. On 28-MAY-2009, the patient was vaccinated with PNEUMOVAX, after vaccination, the patient developed pyrexia. The body temperature was 38.4 Celsius degree. On 29-MAY-2009, the patient developed acute pneumonia and died. The outcome of pyrexia was unknown. The causative pathogen of pneumonia was not identified. The cause of death was acute pneumonia. No information on autopsy has been provided. The reporting other health professional considered that pyrexia was serious due to other important medical event. The reporting other health professional considered that acute pneumonia was serious due to death. The reporting other health professional felt that pyrexia and acute pneumonia were not related to PNEUMOVAX. Reporter''s comments: Because it is thought that the adverse events were caused by accidental infection, the adverse events were not related to PNEUMOVAX. No further information is available.


VAERS ID: 351137 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2009-04-01
Onset:2009-04-11
   Days after vaccination:10
Submitted: 2009-07-10
   Days after onset:90
Entered: 2009-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA707A / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Body temperature increased, Chest discomfort, Death, Dehydration, Diarrhoea, Eye discharge, Hypophagia, Ill-defined disorder, Lethargy, Ocular icterus, Pneumonia, Pyrexia, Rhinorrhoea, Upper respiratory tract infection, Vomiting, Vomiting projectile
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Conjunctival disorders (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-05-03
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body temperature, 14Apr2009, 36.8Deg C; Body temperature, 14Apr2009, 39.5Deg C
CDC Split Type: B0581678A

Write-up: This case was reported by a healthcare professional and described the occurrence of possible pneumonia in a 3-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). This case is one of 2 cases from the same reporter (see case B0581603A). The subject involved came from the same Children''s Home. The subject medical history was unknown as well as the subject family history. On 1 April 2009 and 1 May 2009, the subject received 1st dose and 2nd dose of ROTARIX (oral). On 11 April 2009, 10 days after vaccination with the 1st dose of ROTARIX, the subject experienced upper respiratory tract infection without cough. On 14 April 2009, the subject experienced fever (39.5 Deg C). The subject was treated with intramuscular paracetamol, Gentamycin, AMOXIL and retinol. The same day, the temperature was normalized (36.8 Deg C). No diarrhea and vomiting was observed, but the subject had a severe dehydration. She was treated with IV Darrows solution. On 14 April 2009, the IV fluids were stopped, but Gentamycin), AMOXIL and paracetamol in syrup were still given. On 16 April 2009, the subject condition was improved. She was given hydration therapy (ORS). On 30 April 2009, the subject was hospitalised with chest problem due to a suspected pneumonia. The subject has yellow eyes with eye discharge, snotty nose, acute illness. The subject''s condition had worsen and she was lethargic. At admission, the subject developed vomiting and diarrhea. She had a poor oral feeding. On 1 May 2009, the subject received 2nd dose of ROTARIX (oral). Two days after admission, the subject experienced severe diarrhea with more than 4 stools daily and projectile vomiting which worsened 2 days later, leading to death on 3 May 2009. The healthcare professional explained the symptoms were unlike what one would expect as side effects of the vaccine. The healthcare professional considered the events were possibly related to vaccination with ROTARIX. The subject died on 3 May 2009 from unknown cause of death. An autopsy was not performed. The body was disposed off by the local council.


VAERS ID: 351166 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-06-11
Onset:2009-06-12
   Days after vaccination:1
Submitted: 2009-07-10
   Days after onset:28
Entered: 2009-07-13
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Body temperature increased, Death, Influenza serology negative, Pneumonia, 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), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Chronic respiratory disease
Preexisting Conditions: Amyotrophy
Allergies:
Diagnostic Lab Data: diagnostic laboratory test, 12Jun09, test for influenza: negative; body temp, 12Jun09, 40.1 C
CDC Split Type: WAES0907USA00867

Write-up: Initial information has been received from a nurse concerning an 80 year old female patient with chronic respiratory disease and a history of amyotrophy who on 11-JUN-2009 was subcutaneously vaccinated with PNEUMOVAX 0.5 ml once a day for prophylaxis against for pneumonia. No information on concomitant medications was provided. On 12-JUN-2009, the patient developed pyrexia 40.1 degrees C. The test for influenza was negative. On 13-JUN-2009, the patient developed respiratory failure. On 19-JUN-2009, the patient died of acute pneumonia (the causative microorganism was not specified). The outcome of pyrexia 40.1 degrees C was unknown. The reporting nurse considered that the pyrexia 40.1 degrees C was serious due to other important medical event. The reporting nurse considered that the acute pneumonia was serious due to death. The reporting nurse felt that all events were definitely not related to PNEUMOVAX. Reporting nurse''s comments: All events are considered accidental infection and are definitely not related to PNEUMOVAX. No further information is available.


VAERS ID: 351178 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Female  
Location: Foreign  
Vaccinated:2007-05-22
Onset:2007-12-06
   Days after vaccination:198
Submitted: 2009-07-10
   Days after onset:581
Entered: 2009-07-13
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 24359 / 4 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Anuria, Bacterial test positive, Blood culture positive, Blood gases normal, Blood pressure decreased, Blood sodium decreased, Body temperature increased, C-reactive protein increased, Chest X-ray abnormal, Constipation, Crepitations, Death, Dyspnoea, Endotracheal intubation, Enema administration, Febrile convulsion, General physical health deterioration, Hyponatraemia, Intensive care, Lymphocytosis, Mechanical ventilation, Neutropenia, Oxygen saturation decreased, Pleural effusion, Pneumonia pneumococcal, Pyrexia, Renal failure, Respiratory distress, Respiratory syncytial virus test negative, Septic shock, Tachycardia, Thrombocytopenia, Urine analysis abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Agranulocytosis (broad), Angioedema (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (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 (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Convulsions (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), Hyponatraemia/SIADH (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (narrow), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: Past therapies included three doses of INFANRIX-QUINTA received on 18-Jun-2006, 18-Sep-2006 and 24-Oct-2006 and one dose of PRIORIX received on 22-May-2007. The patient had no relevant medical history.
Allergies:
Diagnostic Lab Data: On 07-Dec-2007 test results were: body temperature (results: 36.4 deg. C.); oxygen saturation (results: Decreased); body temperature (results: 39.3 deg. C.); chest X-ray (results: On admission, showed nearly complete opacity of the lung on the right side and moderate pleural effusion. The left side of the lung was almost free of lesion except a few left retrocardiac opacities.); c-reactive protein (results: 354 mg/L); blood sodium (results: 131 mmol/L); chest X-ray (results: Later on 07-Dec-2007, showed spread of opacities on the right side of the lung); respiratory syncytial virus test (results: Negative); urine analysis (results: Positive pneumococcal antigen in urine); blood culture (results: Positive to pneumococcus, multi-sensitive, serotype 19A); body temperature (results: 41.1 deg. C.); blood pressure (results: Decreased); and blood gases (results: Normal).
CDC Split Type: FRWYEG03981909

Write-up: Information regarding PREVENAR was received from a healthcare professional regarding an 18-month-old female patient who experienced absence of micturition, right pneumococcal pleuropneumonia and positive blood culture to pneumococcus serotype 19A, respiratory distress, febrile convulsion, renal failure and septic shock. The patient received the fourth dose on 22-May-2007. On 06-Dec-2007 at 06:00 p.m. the patient started to experience absence of micturition. On 07-Dec-2007 at 11:00 a.m., she was admitted in the emergency unit for abdominal pain and persistent anuria. Body temperature was at 36.4 C but the patient had taken an antipyretic drug. Physical examination was normal. She was diagnosed with constipation and was prescribed an enema. At 01:00 p.m., on 07-Dec-2007, while the patient was about to come back home, the patient''s general condition reduced as well as respiratory condition: the patient developed dyspnea, fever at 39.3, oxygen saturation decreased and crepitations were heard at auscultation. Chest X-ray revealed nearly complete opacity of the lung on the right side and moderate pleural effusion. The left side of the lung was almost free of lesion except a few left retrocardiac opacities. The patient was hospitalized in a pediatric intensive care unit with respiratory distress. Lab tests revealed neutropenia, lymphocytosis, thrombocytopenia, CRP at 354 mg/L and hyponatremia at 131 mmol/L. Blood gases were normal. Respiratory syncytial virus test was negative, but pneumococcal antigens were found in urine and blood culture was positive for pneumococcus later identified serotype 19A. There was no neurological disorder. A vesicular murmur was heard on the right basis. Antibiotic therapy with CLAFORAN and VANCOMYCIN was introduced. On 07-Dec-2007, 3 hours after admission, body temperature was 41.1 C, blood pressure had decreased, the patient had developed tachycardia and febrile convulsion treated by VALIUM and GARDENAL. She was intubated for ventilation. Repeat chest X-ray revealed spread of right opacities. The patient finally died on 08-Dec-2007 as a result of septic shock with right pneumococcal pleuropneumonia due to serotype 19A and renal failure. The cause of death was reported as pneumonia pneumococcal, septic shock and renal failure. See related case(s): FR-WYE-G03982009 regarding pneumococcal pneumonia in the patient''s brother.


VAERS ID: 351297 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2009-06-16
Onset:2009-06-17
   Days after vaccination:1
Submitted: 2009-07-13
   Days after onset:26
Entered: 2009-07-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CA487A / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Hypotonia, Hypotonic-hyporesponsive episode, Loss of consciousness, Pallor
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-06-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant medications were not used.
Current Illness:
Preexisting Conditions: The patient has no relevant medical history.
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: NLWYEG03978409

Write-up: This case was considered medically important. Information regarding PREVENAR was received from a healthcare professional via a regulatory authority regarding an 8-week-old female patient who experienced hypotonic-hyporesponsive episode and died. The patient received the first dose on 16-June-2009. Additional suspect medication included INFANRIX HEXA. Within 24 hours after the vaccinations the patient was found in bed experiencing a hypotonic-hyporesponsive episode which was characterised by pallor, hypotonia and unconsciousness on 17-Jun-2009. The patient died. The cause of death was reported as death. No additional information was available at the time of this report.


VAERS ID: 351701 (history)  
Form: Version 1.0  
Age: 1.1  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-07-16
Entered: 2009-07-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 4 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: Relevant medical history was not provided.
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: NLWYEG04028509

Write-up: This case is considered medically important. Information regarding PREVENAR was received from a healthcare professional regarding a 13-month-old male patient who experienced death. The patient received the fourth dose on an unspecified date. Additional suspect medication included INFANRIX HEXA. The patient died, more than 2 days after the vaccinations. The cause of death was reported as death. No additional information was available at the time of this report.


VAERS ID: 351971 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-07-20
Entered: 2009-07-21
   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: Convulsion, Death, Mitochondrial cytopathy
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0907USA02465

Write-up: Information has been received from a case of literature, following publication in an article, concerning a female toddler who in an unspecified date in 1998 was vaccinated with a dose of MMR II (lot number, route and site not reported). Details of the patient''s medical history or concomitant medication have not been reported. On an unreported date in 1998, six weeks post vaccination, the patient experienced fits, became clingy and died in the arms of the parents. The patient subsequently discovered that she had a mitochondrial disfunction. This case is one of three patients reported in the article (same vaccine, same event). Other business partner numbers included: E2009-05751. No further information is available.


VAERS ID: 352097 (history)  
Form: Version 1.0  
Age: 1.1  
Sex: Male  
Location: Foreign  
Vaccinated:2007-08-13
Onset:2007-08-13
   Days after vaccination:0
Submitted: 2009-07-20
   Days after onset:707
Entered: 2009-07-22
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS A21CA275E / UNK UN / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS A21CA275E / UNK UN / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS A21CA275E / UNK UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER A21CA275E / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 20495 / 4 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-08-16
   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: Concomitant medications were not reported.
Current Illness: The patient''s concurrent illness includes congenital hydrocephalus (for which a drain) and corrected congenital vitium cordis.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: NLWYEG04068109

Write-up: Information regarding PREVENAR was received from a healthcare professional via a regulatory authority regarding a 13-month-old male patient who experienced vomiting, reacting sick, gavage and death. The patient received the fourth dose on 13-Aug-2007. A few hours after the vaccinations the patient experienced vomiting and reacting sick on 13-Aug-2007. He was hospitalized for gavage on 15-Aug-2007 and died during the night on 16-Aug-2007. The cause of death was reported as death. No additional information was available at the time of this report.


VAERS ID: 352438 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Foreign  
Vaccinated:2009-07-09
Onset:2009-07-09
   Days after vaccination:0
Submitted: 2009-07-24
   Days after onset:15
Entered: 2009-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 3 RA / UN
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / 3 RA / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 RA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-07-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0584293A

Write-up: This case was reported by Institute via sales representative and described the occurrence of sudden infant death in a 5-month-old subject of unspecified gender who was vaccinated with INFANRIX-IPV/Hib (GlaxoSmithKline). On 9 July 2009, the subject received 3rd dose of INFANRIX-IPV/Hib (unknown route of administration). On unspecified date, at an unspecified time after vaccination with INFANRIX-IPV/Hib, the subject experienced sudden infant death. Cause of death was not specified. It was unknown whether an autopsy was performed. Further information has been requested. This case is the 1st case of 3 cases reported by the same reporter (The 3 subjects, from 3 different clinics, received the same batch number). Follow up information received on 17 July 2009: On the day of vaccination in the afternoon, the child has fed and after 1,5 hour (19.00) cyanosis occurred. Ambulance was called and child was taken to the hospital where after resuscitation death was declared at 20:40. The Institute considered the events were possibly related to vaccination with INFANRIX-IPV/Hib.


VAERS ID: 352835 (history)  
Form: Version 1.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2000-10-17
Onset:0000-00-00
Submitted: 2009-07-31
Entered: 2009-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS 18505B9 / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-11-01
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: No relevant medical history
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0585454A

Write-up: This case was reported by a detective constable and described the occurrence of the unexplained death of a 70-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline), BCG (non-gsk), Tuberculosis vaccine, Tetanus vaccine, (non-gsk) (AGRIPPAL) and (non-gsk) PNEUMOVAX. According to notes in the subject''s diary, on 17 October 2000 the subject received unspecified dose of FLUARIX (1 injection, batch number 18505B9), expiry date 31 May 2001). On unspecified dates the subject received an unspecified dose of Tuberculosis vaccine (1 injection), 3 unspecified doses of Tetanus vaccine within a single year (1 injection), an unspecified dose of AGRIPPAL (1 injection) and an unspecified dose of PNEUMOVAX (1 injection). According to the subject''s diary the subject''s partner at the time administered all the vaccinations. There were no records of these vaccinations in the subject''s records from his doctor. In November 2008, at an unspecified time after vaccination with AGRIPPAL, PNEUMOVAX, the Tetanus vaccines and Tuberculosis vaccine, and within years of vaccination with FLUARIX, the subject experienced unexplained death. The subject died from ''natural causes''. It was unknown whether an autopsy was performed. Verbatim text received: A detective constable reported on 23/07/2009 that the police were investigating a case of a deceased 70 year old male patient who had died from ''natural causes'' in November 2008. According to the notes in the patient''s diary, he had received some vaccinations which were administered by his partner at the time (dates unknown) but there were no records of the vaccinations given in the patient''s records from his doctor. These vaccines included tuberculosis vaccine, three tetanus injections in one year, PNEUMOVAX, AGRIPPAL and a flu vaccine (administered on 17/10/2000) with the batch details 18505B9. This batch has been confirmed by GSK Order Services Department to be a FLUARIX vaccine, with expiry 31/05/2001. He had tried to contact the deceased''s general practitioner (GP), however the GP was unavailable. No further information was available at the time of reporting. The enquirer had indicated that the cause of death was unrelated to the flu vaccination.


VAERS ID: 353252 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-08-05
Entered: 2009-08-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Biopsy lymph gland abnormal, Bovine tuberculosis, Death, HIV test negative, Injection site ulcer, Lymphadenopathy, Polymerase chain reaction, Surgery
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Extravasation events (injections, infusions and implants) (broad), Malignant lymphomas (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: see narrative description.
CDC Split Type: 200903283

Write-up: Literature was case received on 30 July 2009. A seven month-old male patient who had received BCG vaccination (manufacturer, batch number, route and site of administration not reported) when three days old, presented with swelling in the left axilla and an ulcer at the site of BCG inoculation of three months duration. Routine investigations were within normal limits and he was HIV negative. Biopsy revealed a matted group of lymph nodes adherent to axillary vessels, which were excised. Pathological findings: Gross examination revealed two gray white tissue masses, larger measuring 5x 3.5x2cm and the smaller measuring 5x2x1 cm. Out surface of the masses were gray white and nodular. No area of necrosis was noted. On light microscopy, the lymph node showed effacement of architecture with proliferation of spindle cells arranged in sheets and fascicles. The cells had indistinct cell borders with eosinophilic granular cytoplasm and round to oval nuclei. These cells were admixed with capillaries, inflammatory cells including small lymphocytes, plasma cells and neutrophils. No multinucleated giant cells, mitotic figures, pleomorphism or necrosis were observed. the ZIEHL NEELSEN stain revealed numerous elongated acid-fast bacilli both within and outside the macrophages. The spindle cells were immunoreactive to CD 68. They were negative for desmin and showed focal positive for S-100 protein. PCR was done on paraffin embedded blocks with two sets of extracts for the IS6110 gene of Mycobacterium tuberculosis complex (includes M. tuberculosis hominis and M. tuberculosis bovis strains). One of the tubes (Phenol-Chloroform extract) was positive by PCR, while the second tube (kit extract) was negative, which was attributed to improper protocol for DNA extraction using the kit. Per the author, proliferation of spindle cells arranged in sheets and fascicles mimicking a spindle cell neoplasm which is one form of pathological pattern for BCG infection associated with immunodeficiency. The immune status of the patient could not be assessed, as the child died 10 days after the surgery.


VAERS ID: 353878 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Foreign  
Vaccinated:2009-07-10
Onset:2009-07-13
   Days after vaccination:3
Submitted: 2009-08-12
   Days after onset:30
Entered: 2009-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK LA / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK LA / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Injection site abscess, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-07-14
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0587232A

Write-up: This case was reported by a regulatory authority and described the occurrence of injection site abscess in a 5-month-old male subject who was vaccinated with INFANRIX-IPV/Hib (GlaxoSmithKline). On 10 July 2009, the subject received unspecified dose of INFANRIX-IPV/Hib (intramuscular, unknown injection site, lot number not provided). On 13 July 2009, 3 days after vaccination with INFANRIX-IPV/Hib, the subject experienced abscess and swelling at the injection site. The regulatory authority reported that the events were possibly related to vaccination with INFANRIX-IPV/Hib. The subject died on 14 July 2009, cause of death was not reported. It was unknown whether an autopsy was performed.


VAERS ID: 354197 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-08-13
Entered: 2009-08-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cyanosis, Death, Insomnia, Mumps, Pallor, Respiratory arrest, Somnolence, Syncope, Toxicologic test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Oropharyngeal infections (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-07-26
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0908USA01673

Write-up: This case was initially reported from articles in five newspapers on 06-AUG-2009. This case is not medically confirmed. This case concerns a four year old female patient. The patient was a healthy child who had not suffered any serious illnesses. The patient received both doses of MMR II (manufacturer, lot number, batch number not reported) on unreported dates. On an unknown date post vaccination, the patient was diagnosed with mumps. The patient had been poorly for a week when she suddenly collapsed. The patient''s mother stated that she seemed to be okay and was eating and even starting to play again but a week later, she was a bit groggy and could not get to sleep so the mother stayed with her on the sofa. Suddenly, her lips went blue and she was pale and still breathing but a few minutes later she stopped. The patient''s mother took her to the hospital where doctors revived her but she died hours later on 26-JUL-2009. Tests were being carried out to determine whether the patient did have mumps or whether another undiagnosed infection caused her death. The cause of death was not yet confirmed and toxicology tests were being carried out. The patient''s parents were told that she may have died due to a rare complication of mumps or she may have contracted another virus while her system was weakened by the illness. Other business partner numbers included: E2009-07866. Additional information has been requested.


VAERS ID: 354208 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-08-13
Entered: 2009-08-14
   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: Death, Injection site haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (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: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: Relevant medical history was not provided.
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: ZAWYEG04184009

Write-up: Information regarding PREVENAR was received from a healthcare professional regarding a 14-week-old patient who experienced unknown cause of death and bleeding at the injection site post-vaccination. The patient received the second dose in 2009. The patient experienced unknown cause of death and bleeding at the injection site post-vaccination in 2009. The cause of death was reported as death. No additional information was available at the time of this report.


VAERS ID: 354340 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-07-23
Onset:2009-07-23
   Days after vaccination:0
Submitted: 2009-08-13
   Days after onset:21
Entered: 2009-08-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-07-23
   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: Concomitant therapy included PARACETAMOL.
Current Illness:
Preexisting Conditions: The patient has a past history of weight gain poor (some concerns about poor weight gain in past - resolved).
Allergies:
Diagnostic Lab Data: None provided.
CDC Split Type: GBWYEG04228309

Write-up: This case was considered medically important and fatal. Information regarding PREVENAR was received from a healthcare professional via a regulatory authority (MHRA ref: 20469393), regarding a 1-year-old female patient who experienced sudden collapse with no other reason except for an anaphylactic reaction and died. The patient received a dose on 23-Jul-2009. Additional suspect medication included MMR. The patient experienced sudden collapse one and a half hours after vaccination, with no other reason except for an anaphylactic reaction, on 23-Jul-2009. Full resuscitation was performed for one hour, but not successful and the patient died, on the same day. The cause of death was reported as anaphylactic reaction and the post mortem revealed inconclusive findings, date unspecified. No additional information was available at the time of this report.


VAERS ID: 354412 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2009-07-21
Onset:2009-07-24
   Days after vaccination:3
Submitted: 2009-08-18
   Days after onset:25
Entered: 2009-08-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS 1615 / 4 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Drooling, Rabies
SMQs:, Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-07-30
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Animal bite, Post-exposure treatment with RABIPUR due to dog bite in left arm (category III)
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20092162

Write-up: We received the following information via Novartis Vaccines and Diagnostics from our local sales representative on 06 AUG 2009: A male patient (born in 1949) was bitten by a dog on 07 JUL 2009 at 04.30 a.m. At 06.30 a.m. on the same day he received the first dose RABIPUR (1 ml rabies vaccine, batch no. 1615) into the deltoid muscle. The patient''s exposure was classified as category III and he was advised to take Human Anti-Rabies Immunoglobulin (HRIG) or Equinus Anti-Rabies Immunoglobulin (ERIG). The patient refused to receive the passive immunisation with HRIG or ERIG and provided a written informed consent form. On 10, 14 and 21 JUL 2009 he received 1 ml RABIPUR into the deltoid, respectively. On 24 JUL 2009 at 09.00 a.m. the patient began to dribble and was sent to hospital. No other obvious symptom was observed. He died on 30 JUL 2009 and was formally clinically diagnosed with rabies (vaccination failure). No laboratory examination was performed, due to lack of capability. On 13 AUG 2009 we received follow-up information via the local sales representative: The patient was bitten into the left arm. He had washed the wound before going to hospital; the physician in hospital did not wash the wound properly. It was confirmed that no autopsy was done. No change in assessment.


VAERS ID: 354572 (history)  
Form: Version 1.0  
Age: 1.2  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-08-18
Entered: 2009-08-19
   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: Death, Drug ineffective, Inappropriate schedule of drug administration, Meningitis pneumococcal, Serology test
SMQs:, Lack of efficacy/effect (narrow), Medication errors (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: Relevant medical history was not provided.
Allergies:
Diagnostic Lab Data: Serology test (results: "pending but serotypes 19F or 19A are suspect") was done in 2009.
CDC Split Type: CAWYEG04252909

Write-up: Information regarding PREVENAR was received from a healthcare professional regarding a 14-month-old patient who experienced drug ineffective and pneumococcal meningitis. The patient received the second dose on an unspecified date. An infectious diseases physician reported via a company representative that she treated a 14-month-old infant who experienced drug ineffective and pneumococcal meningitis in 2009. The child was apparently late for his booster dose. The physician was awaiting the lab results for the serotype, but suspected that the serotype was either "19F" or "19A". The infant subsequently died on an unknown date in 2009. No additional information was available at the time of this report. The cause of death was reported as meningitis pneumococcal. The outcome of the events is fatal.


VAERS ID: 354943 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2009-06-19
Onset:2009-06-24
   Days after vaccination:5
Submitted: 2009-08-21
   Days after onset:58
Entered: 2009-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
TBE: TICK-BORNE ENCEPH (NO BRAND NAME) / UNKNOWN MANUFACTURER 099011A / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Aortic aneurysm, Aortic dissection, Autopsy, Back pain, Blood follicle stimulating hormone, Chest X-ray, Chest pain, Death, Electrocardiogram, Fall, Menopause, Oestradiol decreased, Platelet count increased, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-06-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CANDESARTAN CILEXETIL
Current Illness: Aortic aneurysm; Back pain; Chest pain; Essential thrombocytosis; Polyp of corpus uteri
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood pressure, 19Jun2009, 108/91mmHg; Estradiol, 19Jun2009, less than 1pg/ml; FSH, 19Jun2009, 40U/L; Platelet count, 19Jun2009, 641000/mm3
CDC Split Type: B0589027A

Write-up: This case was reported by a regulatory authority (regulatory authority # 2009-02886) and described the occurrence of syncope in a 52-year-old female subject who was vaccinated with ENGERIX-B (GlaxoSmithKline), ENCEPUR and was under MIRENA, BAYER for polyp of corpus uteri. Concurrent medical conditions included aortic aneurysm of unspecified site without mention of rupture, essential primary hypertension, polyp of corpus uteri and thrombocytosis. On 14 June 2009, the subject experienced chest and back pain. She therefore went to the hospital where she obviously had a chest X-ray and electrocardiogram. The results were not provided. The subject was treated with antibiotherapy and the same evening, she was discharged from hospital. Everything seemed to be resolved. On 15 June 2009, in the morning, the same pain recurred permanently. On 18 June 2009, the subject visited a physician who gave her 3 injections against pain. Concurrent medications included long term ATACAND. On 19 June 2009, the subject visited the gynecologist for the yearly control and received unspecified dose of ENGERIX-B (intramuscular, unknown injection site), unspecified dose of ENCEPUR (intramuscular, unknown injection site). The same day, laboratory tests were performed because menopause was suspected. The results showed platelets count 641000 /mm3, FSH 40 U/L and estradiol less than 1 pg/ml. The blood pressure was 108/91 mmHg. The cause of the thrombocytosis and antihypertensive therapy were unfortunately unknown. The diagnosis of menopause was made. On 24 June 2009, 5 days after vaccination with ENCEPUR and ENGERIX-B, the subject experienced syncope and fell down while she was taking a shower. Ambulance was called and reanimation was performed without success. The regulatory authority reported that the events were unrelated to vaccination with ENGERIX-B and ENCEPUR. The subject died on 24 June 2009 from aortic aneurysm dissection and other ill-defined condition. An autopsy was performed. Additional information has been requested but could not be obtained. This case has therefore been closed.


VAERS ID: 354984 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-05-29
Onset:2009-06-14
   Days after vaccination:16
Submitted: 2009-08-21
   Days after onset:68
Entered: 2009-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHAVB578AO / 2 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-06-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 37 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Coronary Heart Disease; Diabetes Mellitus; Dialysis; Hyperuricemia; Uremia
Preexisting Conditions: Anemia; Decompensation Cardiac; Hepatomegaly; Hypertonia, Steatosis, Stroke
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0588534A

Write-up: This case was reported by a regulatory authority and described the occurrence of death nos in a 74-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject''s medical history included anemia, decompensation cardiac, hepatomegaly, hypertonia, steatosis and stroke. Concurrent medical conditions included coronary heart disease, diabetes mellitus, dialysis 3 times weekly since 20 January 2009, hyperuricemia and uremia. Previous and/or concurrent vaccination included ENGERIX B;GlaxoSmithKline;intramuscular;left deltoid given on 29 April 2009. The subject was hospitalised since 9 May 2009. On 29 May 2009, the subject received unspecified dose of ENGERIX B (intramuscular, left deltoid). On 14 June 2009, 16 days after vaccination with ENGERIX B, the subject died, cause of death was not reported. It was unknown whether an autopsy was performed.


VAERS ID: 355247 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-08-25
Entered: 2009-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (TRITANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anaemia, Bronchopneumonia, Colitis, Death, Enteritis, Failure to thrive, Pneumonia
SMQs:, Haematopoietic erythropenia (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific inflammation (narrow), Ischaemic colitis (broad), Eosinophilic pneumonia (broad), Neonatal disorders (broad), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0589511A

Write-up: This case was reported in a literature article and described the occurrence of death in an infant subject of unspecified gender who was vaccinated with TRITANRIX HepB (GlaxoSmithKline), HIBERIX and Oral polio vaccine. The literature article described results of a randomized controlled trial carried out by the Health Research Centre to assess the safety and immunogenicity of administering 15 mg retinol equivalent (RE) vitamin A alongside the pentavalent diphtheria-polio-tetanus-Haemophilus influenzae b-hepatitis B vaccine at 6, 10 and 14 weeks of age. The trial took place from June 2004 and was completed in December 2005. It enrolled 1077 infants who were randomized into either the intervention or the control group. On an unspecified date, the subject received unspecified dose of TRITANRIX HepB (unknown), unspecified dose of HIBERIX (unknown), unspecified dose of Oral polio vaccine (oral). Less than one month after vaccination with HIBERIX, Oral polio vaccine and TRITANRIX HepB, the subject experienced failure to thrive. The subject was not taken to medical center and had been sent to a traditional healer for treatment. There were a total of six deaths (three boys and three girls) reported during the trial, five of which occurred before 14 weeks of age. The trial took place from June 2004 and was completed in December 2005. It enrolled 1077 infants who were randomized into either the intervention or the control group. On an unspecified date, the subject received unspecified dose of TRITANRIX HepB (unknown), unspecified dose of HIBERIX (unknown), unspecified dose of Oral polio vaccine (oral). Less than one month after vaccination with HIBERIX, Oral polio vaccine and TRITANRIX HepB, the subject experienced failure to thrive. The subject was not taken to medical center and had been sent to a traditional healer for treatment. There were a total a six deaths (three boys and three girls) reported during the trial, five of which occurred before 14 weeks of age. All the deaths with the exception of one were in the intervention group RR 4.65 (0.55-39.6), p = 0.12. All the infants with the exception of one had been sent to the hospital and diagnosed with bronchopneumonia, pneumonia, enema colitis, enteritis and severe anaemia. The child who was not sent to the hospital was suspected to have been suffering from "failure to thrive". Deaths occurred from the start of the trial to the end of follow-up at 18 weeks, 4 weeks after the third dose. The conclusion was the following: The trial demonstrated that the pentavalent vaccine was well tolerated whether or not administered with vitamin A according to the WHO/EPI schedule for infant immunisation at 6, 10 and 14 weeks. There were no serious reactions reported in either the intervention or the control group. There were only eight reports of bulging of the fontanelle following vaccination, four in each group. There were six deaths in the trial. Although five of these were in the intervention group, the 95% CI for the relative risk was very wide RR 4.65 (0.55-39.5), p = 0.12 and included 1. When the deaths in this study and those from a previous study in which 25,000 IU vitamin A was given to young infants with their DT vaccines are added, the relative risk of dying after vitamin A has been administered with DPT/pentavalent vaccine is 2.96 (0.95-9.19), (p = 0.048). The authors wished to urge caution in administering 50,000 IU vitamin A to young infants with EPI vaccines at 6, 10 and 14 weeks until it can be proven in larger trials that the observed mortality differences are not a cause for concern. Vitamin A supplements are well tolerated with the pentavalent vaccine.


VAERS ID: 355834 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-08-28
Entered: 2009-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute disseminated encephalomyelitis, Death, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (narrow), Cardiomyopathy (broad), Demyelination (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: Cardiac therapy: Unknown
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20092273

Write-up: We received the following additional information from the full text article on 18 AUG 2009: The objective of this article was to describe the voluntary reports of adverse events associated with vaccination received by a foreign country in 2004-2006. The total number of reports related to influenza vaccines was slow: 25, 9 and 31, respectively. Most of these reports involved adult patients. Conclusion: it is difficult to assess the causal relationship between vaccine administration and the reported symptoms. The data on possible adverse events related to vaccines found in the database provide no cause to question the safety of vaccines. In 2004 25 adverse effects were reported, thereof 12 considered serious. In some of these cases the minimal criteria were included in the article and therefore further separate cases were created: Miscarriage (see case MA2009-2270), death (n=4) (see cases MA2009-2272-2275), hepatitis (n=1), angina pectoris (n=1), shock (n=1), leukoclastic vasculitis (n=1), acute disseminated encephalomyelitis (ADEM; n=1) (this case). In 2005 nine reports were received, including six serious cases: hepatitis (n=1), serum sickness (n=1), cerebral infarction in combination with rhabdomyolysis (n=1), TIA (n=1), vasculitis in combination with fever (n=1), erythema multiforme (n=1). In 2006 31 reports were received, including 11 serious reports: chest pain and liver function disorder (n=1), GBS with tetraparesis and respiratory insufficiency (n=1), vasculitis (n=1), facial paresis (n=1), septic shock (n=1), cerebrovascular accident (n=1), erythema multiforme (n=1), severe dizziness (n=1), sudden death (n=4). In 2007: one case of sudden death. The outcome, except in the fatal cases, was not reported. Addendum: The co-author inform us on 19 AUG 2009 that all serious events had been reported to the MAHs, and that he cannot provide any further information after so many years. No change in assessment.


VAERS ID: 355835 (history)  
Form: Version 1.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-08-28
Entered: 2009-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Cardiac therapy: Unknown
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20092275

Write-up: We received the following additional information from the full text article on 18 AUG 2009: The objective of this article was to describe the voluntary reports of adverse events associated with vaccination received by a foreign country in 2004-2006. The total number of reports related to influenza vaccines was slow: 25, 9 and 31, respectively. Most of these reports involved adult patients. Conclusion: it is difficult to assess the causal relationship between vaccine administration and the reported symptoms. The data on possible adverse events related to vaccines found in the database provide no cause to question the safety of vaccines. In 2004 25 adverse effects were reported, thereof 12 considered serious. In some of these cases the minimal criteria were included in the article and therefore further separate cases were created: Miscarriage (see case MA2009-2270), death (n=4) (this case, 60-year-old male, see also cases MA2009-2272-2274), hepatitis (n=1), angina pectoris (n=1), shock (n=1), leukoclastic vasculitis (n=1), acute disseminated encephalomyelitis (ADEM; n=1) (see case MA2009-2271). In 2005 nine reports were received, including six serious cases: hepatitis (n=1), serum sickness (n=1), cerebral infarction in combination with rhabdomyolysis (n=1), TIA (n=1), vasculitis in combination with fever (n=1), erythema multiforme (n=1). In 2006 31 reports were received, including 11 serious reports: chest pain and liver function disorder (n=1), GBS with tetraparesis and respiratory insufficiency (n=1), vasculitis (n=1), facial paresis (n=1), septic shock (n=1), cerebrovascular accident (n=1), erythema multiforme (n=1), severe dizziness (n=1), sudden death (n=4). In 2007: one case of sudden death. The outcome, except in the fatal cases, was not reported. Addendum: The co-author inform us on 19 AUG 2009 that all serious events had been reported to the MAHs, and that he cannot provide any further information after so many years. No change in assessment.


VAERS ID: 355836 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-08-28
Entered: 2009-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20092274

Write-up: We received the following additional information from the full text article on 18 AUG 2009: The objective of this article was to describe the voluntary reports of adverse events associated with vaccination received by a foreign country in 2004-2006. The total number of reports related to influenza vaccines was slow: 25, 9 and 31, respectively. Most of these reports involved adult patients. Conclusion: it is difficult to assess the causal relationship between vaccine administration and the reported symptoms. The data on possible adverse events related to vaccines found in the database provide no cause to question the safety of vaccines. In 2004 25 adverse effects were reported, thereof 12 considered serious. In some of these cases the minimal criteria were included in the article and therefore further separate cases were created: Miscarriage (see case MA2009-2270), death (n=4) (this case, elderly male, see also cases MA2009-2272-2273 and -2275), hepatitis (n=1), angina pectoris (n=1), shock (n=1), leukoclastic vasculitis (n=1), acute disseminated encephalomyelitis (ADEM; n=1) (see case MA2009-2271). In 2005 nine reports were received, including six serious cases: hepatitis (n=1), serum sickness (n=1), cerebral infarction in combination with rhabdomyolysis (n=1), TIA (n=1), vasculitis in combination with fever (n=1), erythema multiforme (n=1). In 2006 31 reports were received, including 11 serious reports: chest pain and liver function disorder (n=1), GBS with tetraparesis and respiratory insufficiency (n=1), vasculitis (n=1), facial paresis (n=1), septic shock (n=1), cerebrovascular accident (n=1), erythema multiforme (n=1), severe dizziness (n=1), sudden death (n=4). In 2007: one case of sudden death. The outcome, except in the fatal cases, was not reported. Addendum: The co-author inform us on 19 AUG 2009 that all serious events had been reported to the MAHs, and that he cannot provide any further information after so many years. No change in assessment.


VAERS ID: 355837 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-08-28
Entered: 2009-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Cardiac therapy: Unknown
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20092272

Write-up: We received the following additional information from the full text article on 18 AUG 2009: The objective of the article was to describe the voluntary reports of adverse events associated with vaccination received by the foreign country in 2004-2006. The total number of reports related to influenza vaccines at agency was low: 25, 9 and 31, respectively. Most of these reports involved adult patients. Conclusion by agency: it is difficult to assess the causal relationship between vaccine administration and the reported symptoms. The data on possible adverse events related to vaccines found in the agency database provide no cause to question the safety of vaccines. In 2004-25 adverse effects were reported, thereof 12 considered serious. In some of the cases the minimal criteria were included in the article and therefore further separate cases were created: Miscarriage (see case MA2009-2270), death (n=4) (this case, elderly female, see also cases MA2009-2273-2275), hepatitis (n=1), angina pectoris (n=1), shock (n=1), leukoclastic vasculitis (n=1), acute disseminated encephalomyelitis (ADEM; n=1). In 2005 nine reports were received, including six serious cases: hepatitis (n=1), serum sickness (n=1), cerebral infarction in combination with rhabdomyolysis (n=1), TIA (n=1), vasculitis in combination with fever (n=1), erythema multiforme (n=1). In 2006 31 reports were received, including 11 serious reports: chest pain and liver function disorder (n=1), GBS with tetraparesis and respiratory insufficiency (n=1), vasculitis (n=1), facial paresis (n=1), septic shock (n=1), cerebrovascular accident (n=1), erythema multiforme (n=1), severe dizziness (n=1). In 2007; one case of sudden death. The outcome, except in the fatal cases, was not reported. Addendum: The co-author informed us on 19 AUG 2009 that all serious events had been reported to the MAHs, and that he cannot provide any further information after so many years. No change in assessment.


VAERS ID: 355839 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-08-28
Entered: 2009-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Angina pectoris, Cerebral infarction, Cerebrovascular accident, Chest pain, Dizziness, Erythema multiforme, Facial paresis, Guillain-Barre syndrome, Hepatitis, Leukocytoclastic vasculitis, Liver function test abnormal, Pyrexia, Respiratory failure, Rhabdomyolysis, Septic shock, Serum sickness, Shock, Transient ischaemic attack
SMQs:, Rhabdomyolysis/myopathy (narrow), Liver related investigations, signs and symptoms (narrow), Hepatitis, non-infectious (narrow), Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (narrow), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Demyelination (narrow), Other ischaemic heart disease (narrow), Vestibular disorders (broad), Vasculitis (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20091893

Write-up: We received the following additional information from the full text article on 24 JUN 2009: The objective of this article was to describe the voluntary reports of adverse events associated with vaccination received by a foreign country in 2004-2006. The total number of reports related to influenza vaccines was slow: 25, 9 and 31, respectively. Most of these reports involved adult patients. Conclusion: it is difficult to assess the causal relationship between vaccine administration and the reported symptoms. The data on possible adverse events related to vaccines found in the database provide no cause to question the safety of vaccines. Addendum: We received the following additional information from the full text article on 16 AUG 2009. In 2004 25 adverse effects were reported, thereof 12 considered serious. In some of these cases the minimal criteria were included in the article and therefore further separate cases were created: miscarriage (see case MA2009-2270), death (n=4) (see cases MA2009-2272-2275), hepatitis (n=1), angina pectoris (n=1), shock (n=1), leukoclastic vasculitis (n=1), acute disseminated encephalomyelitis (ADEM; n=1) (see case MA2009-2271). In 2005 nine reports were received, including six serious cases: hepatitis (n=1), serum sickness (n=1), cerebral infarction in combination with rhabdomyolysis (n=1), TIA (n=1), vasculitis in combination with fever (n=1), erythema multiforme (n=1). In 2006 31 reports were received, including 11 serious reports: chest pain and liver function disorder (n=1), GBS with tetraparesis and respiratory insufficiency (n=1), vasculitis (n=1), facial paresis (n=1), septic shock (n=1), cerebrovascular accident (n=1), erythema multiforme (n=1), severe dizziness (n=1), sudden death (n=4). In 2007: one case of sudden death. The outcome, except in the fatal cases, was not reported. Addendum: The co-author inform us on 19 AUG 2009 that all serious events had been reported to the MAHs, and that he cannot provide any further information after so many years. No change in assessment.


VAERS ID: 355933 (history)  
Form: Version 1.0  
Age: 0.1  
Sex: Unknown  
Location: Foreign  
Vaccinated:2009-08-20
Onset:2009-08-21
   Days after vaccination:1
Submitted: 2009-08-28
   Days after onset:7
Entered: 2009-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0590244A

Write-up: This case was reported by an unknown source and described the occurrence of death in a 6-week-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline), PREVENAR and ACTHIB. On 20 August 2009 the subject received unspecified dose of ROTARIX (oral), unspecified dose of PREVENAR (unknown), unspecified dose of ACTHIB (unknown). On 21 August 2009, 1 day after vaccination with ACTHIB, PREVENAR and ROTARIX, the subject died. The subject died, cause of death is not specified.


VAERS ID: 356652 (history)  
Form: Version 1.0  
Age: 0.8  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-09-03
Entered: 2009-09-08
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: Relevant medical history was not provided.
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: NLWYEG04342109

Write-up: This report includes a fatal event. Information regarding PREVENAR was received from a healthcare professional regarding a 10-month-old female patient who experienced death. The patient received the first dose on an unspecified date. Additional suspect medication included INFANRIX HEXA. The patient experienced death one day after receiving the vaccinations. The cause of death was reported as unknown. No additional information was available at the time of this report.


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https://medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=58&PERPAGE=100&DIED=Yes


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