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VAERS ID: 410704 (history)  
Form: Version 1.0  
Age: 0.35  
Sex: Female  
Location: Foreign  
Vaccinated:2010-11-19
Onset:2010-11-20
   Days after vaccination:1
Submitted: 2010-11-30
   Days after onset:10
Entered: 2010-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS A20CA592A / UNK LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-11-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The subject was well, the day of vaccination. During the night from 19 to 20 November 2010, last feeding at 12:00 pm.
Allergies:
Diagnostic Lab Data: Body temperature, 20Nov2010, postmortem at 36
CDC Split Type: B0686111A

Write-up: This case was reported by the foreign regulatory authority (agency reference PB20100813) and described the occurrence of sudden infant death in a 4-month-old female subject who was vaccinated with INFANRIXQUINTA, (GlaxoSmithKline). The subject was well, the day of vaccination. She weighed 6.33 kg and measured 62 cm. On 19 November 2010, the subject received a primary course of INFANRIXQUINTA (batch A20CA592A, intramuscular, injection site unknown). During the night from 19 to 20 November 2010, last feeding was at 12:00 pm. The subject slept on the back with her mother and her 2.5-year-old sister. There were sheet, duvet and blanket on the bed. She was seen at 03:00 am while she was sleeping well. On 20 November 2010, at 06:15 am, she was found dead. Presence of milk was evidenced in pharynx during intubation''s attempt and reported by physician of mobile emergency medical unit. At 07:00, postmortem body temperature was at 36 degrees Celsius. The subject died on 20 November 2010 from sudden infant death. An autopsy was not performed (refused by the family). According to the foreign agency method of assessment, the agency considered the causal relationship between vaccination with INFANRIXQUINTA and sudden infant death as dubious.


VAERS ID: 410938 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2010-10-19
Onset:2010-10-22
   Days after vaccination:3
Submitted: 2010-12-01
   Days after onset:40
Entered: 2010-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB416CA / UNK RA / UN
PNC10: PNEUMO (SYNFLORIX) / GLAXOSMITHKLINE BIOLOGICALS ASPNA021CD / UNK LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Diet refusal, Sudden death, Teething
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: 2010-10-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0686109A

Write-up: This case was reported by a consumer who''s the subject''s mother and described the occurrence of sudden death in a 14-month-old male subject who was vaccinated with SYNFLORIX (GlaxoSmithKline), HAVRIX Junior. A physician or other health care professional has not verified this report. On 19 October 2010, the subject received unspecified dose of SYNFLORIX (left arm), unspecified dose of HAVRIX Junior (right arm). On 22 October 2010, 3 days after vaccination with HAVRIX Junior and SYNFLORIX, the subject was teething and didn''t want to eat. The nanny gave him PANADO and powders for gums. The mother decided to take him to casualty on the 22 October and while waiting for admission, the child died. The mother said the doctor couldn''t find anything wrong with the child at the time, there was no rashes and no fever, the doctor suspected possible poisoning. An autopsy was performed and the results were outstanding.


VAERS ID: 411779 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2010-11-12
Onset:0000-00-00
Submitted: 2010-12-03
Entered: 2010-12-06
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (INFANRIX PENTA) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Haemorrhage, Hepatic failure
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-11-16
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: Obstipation
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2010161203

Write-up: This is a spontaneous report received from the Foreign Agency. Regulatory Authority report number NL-LRB-112369. A contactable physician from the national vaccine programme reported about a 10-week-old female patient that received the first dose of PREVENAR and PEDIACEL on 12Nov2010 at a single dose of 0.5 ml for immunization. Relevant medical history consisted of obstipation, needing specialist care. Relevant concomitant medications were not reported. It was reported that, 1.5 days after the vaccinations, the patient developed liver failure. The patient was transferred to a center that specialized in liver transplantation. However, while awaiting a donor liver, the patient died of massive internal bleeding three days later on 16Nov2010. No follow up attempts possible.


VAERS ID: 411896 (history)  
Form: Version 1.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-11-25
Onset:2010-11-26
   Days after vaccination:1
Submitted: 2010-12-06
   Days after onset:10
Entered: 2010-12-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-11-26
   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: Unknown
Current Illness: Cerebral infarction
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1011USA03764

Write-up: Information has been received from a pharmacist concerning a 89 year old male patient with late effects of cerebral infarction who at 3:00PM on 25-NOV-2010 was vaccinated IM with a 0.5 ml dose of PNEUMOVAX 23. There was no concomitant medication. on 25-NOV-2010, any significant change was not observed at and after the PNEUMOVAX 23 vaccine injection. On 26-NOV-2010, no significant change was observed at 4:30AM. The patient was found to be cardiopulmonary arrest at 5:10AM. The patient was thought to have died between 4:30Am and 5:10AM. The cause of death was unknown. No information on autopsy had been provided. Reporting physician''s comment: There was no change in the patient either at the time of inoculation or after the inoculation. His lifestyle was usual and the only thing different from usual was the vaccination. The causal relationship was not known. The relation to the death and vaccination was unknown. The reporting pharmacist felt that the relationship between death and PNEUMOVAX 23 was unknown. Additional information has been requested.


VAERS ID: 412435 (history)  
Form: Version 1.0  
Age: 3.8  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-12-09
Entered: 2010-12-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 25643 / 4 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, Death, Meningitis pneumococcal, Pneumococcal bacteraemia, Streptococcus test positive
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:
Current Illness:
Preexisting Conditions: Asplenia; Past Drug Event; first dose at the age of 3 months; Asplenia; Past Drug Event; PREVENAR; Drug Indication: Vaccination; Drug Reaction: Pneumococcal meningitis; second dose at the age of 4 months; Past Drug Event; PREVENAR; Drug Indication: Vaccination, Drug Reaction: Pneumococcal meningitis; third dose at the age of 5 months
Allergies:
Diagnostic Lab Data: blood culture (unknown date): positive for S. pneumoniae of serotype 12F
CDC Split Type: 2010161274

Write-up: This is a spontaneous report from a contactable physician. It was reported on a 46-month-old female patient who received four doses of PREVENAR and experienced pneumococcal meningitis and pneumococcal bacteraemia without focus. The patient was no premature baby and did not suffer from any immunodeficiency. Relevant medical history included anatomic asplenia. PREVENAR was administered on unspecified dates at the age of 3 months (first dose), at the age of 4 months (second dose), at the age of 5 months (third dose) and at the age of 12 months (fourth dose). Dose regimen was one single dose each time. Product was administered via intramuscular route. Concomitant medication was not provided by reporter. At the age of 46 months the patient experienced pneumococcal meningitis and pneumococcal bacteraemia without focus on an unspecified date in 2010. S. pneumoniae of serotype 12F were detected by blood culture. On an unknown date the patient died of pneumococcal meningitis and pneumococcal bacteraemia without focus. It was unknown whether an autopsy was performed. No follow-up attempts possible. No further information expected. Case Comment: Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVENAR.


VAERS ID: 412610 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Foreign  
Vaccinated:2010-11-25
Onset:2010-11-26
   Days after vaccination:1
Submitted: 2010-12-10
   Days after onset:14
Entered: 2010-12-13
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR E0770 / 2 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-11-27
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No medical history (including allergy)
Allergies:
Diagnostic Lab Data: not reported
CDC Split Type: 201006754

Write-up: Case received from a healthcare professional through the local affiliate on 29 November 2010 under the local reference number A201000037. A 05-month-old male patient, with no medical history (including allergy), had received his second dose of ACT-HIB (batch number E0770, route of administration unknown, anatomical site of administration not reported) on 25 November 2010 at around 14:00. The patient had no reported concomitant therapies. On 26 November 2010, in the morning, the patient experienced cardio-pulmonary arrest in another hospital. On 27 November 2010, at around noon, the reporter was told that the patient died (information provided by the patient''s mother). The reporting physician had no further information. According to the reporter, this case was serious and related to ACT-HIB. Documents held by sender: none.


VAERS ID: 412757 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2010-02-23
Onset:2010-02-24
   Days after vaccination:1
Submitted: 2010-12-14
   Days after onset:293
Entered: 2010-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (TRITANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Crying, Death, Epistaxis, Mouth haemorrhage, Pallor, Peripheral coldness, Pyrexia, Unresponsive to stimuli
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0688671A

Write-up: This case was reported by another health professional via a regulatory authority (10-02-0751A) and described the occurrence of not responsive in a 2-month-old female subject who was vaccinated with HIBERIX (GlaxoSmithKline), POLIO SABIN, TRITANRIX-HB. On 23 February 2010, the subject received unspecified dose of HIBERIX (route and injection site unknown, batch number not provided), unspecified dose of POLIO SABIN (oral, batch number not provided) and unspecified dose of TRITANRIX-HB (route and injection site unknown, batch number not provided). On 24 February 2010, 1 day after vaccination with HIBERIX, POLIO SABIN and TRITANRIX-HB, the subject experienced not responsive, nose bleed, mouth bleeding, cold feeling, pallor, crying abnormal and fever. The vaccination course with HIBERIX, POLIO SABIN and TRITANRIX-HB was discontinued. The regulatory authority reported that the events were probably related to vaccination with HIBERIX, POLIO SABIN and TRITANRIX-HB. The subject died (not related to vaccine) of unknown cause. It was unknown whether an autopsy was performed. Follow-up information received on 14 December 2010: The regulatory authority reported that the events were unrelated to vaccination with HIBERIX, POLIO SABIN and TRITANRIX-HB. This report was received from the regulatory authority as part of a line-listing of several hundred reports, each containing minimal information. No further information is expected.


VAERS ID: 413013 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2010-11-05
Onset:2010-11-05
   Days after vaccination:0
Submitted: 2010-12-17
   Days after onset:42
Entered: 2010-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, General physical health deterioration
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-11-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Alzheimer''s disease; wheelchair user
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0689002A

Write-up: This case was reported by a regulatory authority (FI-FIMEA-20101818) and described the occurrence of fatal general physical health deterioration in a 86-year-old subject of unspecified gender who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included advanced Alzheimer''s disease and wheelchair user. The subject was living in a homecare. On 5 November 2010, the subject received unspecified dose of FLUARIX (intramuscular, right deltoid). The lot number provided doesn''t match with FLUARIX lot number. On 5 November 2010, less than one day after vaccination with FLUARIX, the subject experienced general physical health deterioration, leading to death. According to the epicrisis and police investigations, after vaccination with FLUARIX, the subject was lied in the bed and was found died later. The subject died on 5 November 2010 from general physical health deterioration. It was unknown whether an autopsy was performed.


VAERS ID: 413271 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-12-11
Onset:2010-12-13
   Days after vaccination:2
Submitted: 2010-12-17
   Days after onset:4
Entered: 2010-12-20
   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
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-12-13
   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: None
Current Illness: Hypertension; Ventricular extrasystoles; Anxiety disorder; Hypercholesterolaemia; Chronic gastritis; Bronchitis asthmatic; Aortic valve stenosis; Bronchitis chronic
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1012USA02420

Write-up: Information has been received from a pharmacist concerning an 87 year old female patient with hypertension, ventricular extrasystoles, bronchitis chronic anxiety disorder, hypercholestrolaemia, chronic gastritis, bronchitis asthmatic and aortic valve stenosis, who on 11-DEC-2010 was vaccinated with PNEUMOVAX vaccine (dose, route, injection site and lot# not reported). There was no concomitant medication. On approximately 13-DEC-2010, police informed the hospital that the patient who received PNEUMOVAX vaccine died this morning. The cause of death was unknown. The exact date and time of the death was unknown. No information on autopsy was provided. The reporting pharmacist''s comment: the patient was an outpatient, so patient''s status after vaccination was not follow-up and the exact date and time of the death was not identified. It was unknown whether the PNEUMOVAX vaccine was related to the death. The reporting pharmacist felt that the relationship between death and PNEUMOVAX vaccine was unknown. Additional information has been requested.


VAERS ID: 413544 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2010-09-16
Onset:0000-00-00
Submitted: 2010-12-23
Entered: 2010-12-27
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: A blood culture (unspecified date) reported to have been conducted on an unspecified date with a positive anymening serotype (unspecified date) reported as 1; Blood culture (unspecified date) indicated bacterial invasive pneumococcal disease.
CDC Split Type: 2010175453

Write-up: This is a spontaneous report from a non-contactable healthcare professional via a company representative. An infant male, received a dose of PREVENAR 13 batch number E32634, on 16Sep2010. The patient was reported to be aged 2 months and 7 days old, at the time of his first vaccination. A second dose was administered on an unknown date. Relevant medical history and concomitant medications were not provided. Details of the patient''s vaccination history were not indicated. At age 3 months and 26 days, the patient developed a bacterial invasive pneumococcal infection and vaccination failure was reported. A blood culture indicated bacterial invasive pneumococcal disease. Serotype was identified as 1. The patient also developed empyema on an unknown date. The patient died (date unknown). The cause of death was not reported. No follow-up attempts possible. No further information expected. Follow-up (21Dec2010): Additional information received included specific infection was bacterial invasive pneumococcal infection, test results, event of empyema added, outcome unknown. The cause of death was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 414170 (history)  
Form: Version 1.0  
Age: 0.27  
Sex: Male  
Location: Foreign  
Vaccinated:2010-12-03
Onset:2010-12-05
   Days after vaccination:2
Submitted: 2011-01-06
   Days after onset:32
Entered: 2011-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK LA / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Blood culture negative, Body temperature decreased, C-reactive protein normal, CSF culture negative, Computerised tomogram normal, Culture urine negative, Cyanosis, Feeling cold, Haemoglobin normal, Haemorrhage, Influenza virus test negative, Lividity, Muscle rigidity, Musculoskeletal stiffness, Petechiae, Platelet count increased, Pulmonary congestion, Pulmonary oedema, Rash macular, Respiratory syncytial virus test negative, Resuscitation, Scan brain, Sudden death, Trismus, White blood cell count normal, X-ray normal
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (narrow), Parkinson-like events (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-12-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: AUTOPSY
Preexisting Conditions: Born at 41 weeks+ 3 days of amenorrhea, birth weight 3.765 kg, apgar scores at 10. Initial maternal feeding. Since birth, the subject slept on belly - Hospitalization from 08 to 11 September 2010 for poor weight increase and bottle feeding with artificial milk was started resulting in normal weight increased. December 2010: Autopsy report: few petechiae on surface of thymus and pleura; slight alveolar edema lesions with minim aspect of diffuse vascular congestion which might be related to a ventilation defect.
Allergies:
Diagnostic Lab Data: Blood culture, 05Dec2010, negative; Body temperature, 05Dec2010, 28deg. Celsius; Brain computerized-tomography, 05Dec2010, normal; C-reactive protein, 05Dec2010, 7.6mg/L; CSF culture, 05Dec2010, sterile; Hemoglobin, 05Dec2010, 17g/dL; Platelet count, 05Dec2010, 650000/mm3; Urine culture, 05Dec2010, negative; White blood cells, 05Dec2010, 8000/mm3; X-ray, 05Dec2010, no bone lesions; 05 December 2010, Direct virus tests: negative for Influenza and respiratory syncytial viruses
CDC Split Type: B0691566A

Write-up: This case was reported by the regulatory authority (agency reference PV20100396) and described the occurrence of sudden unexpected death in a 3-month-old male subject who was vaccinated with combined INFANRIXQUINTA, (GlaxoSmithKline), BCG SSI, (non-gsk) and ROTATEQ, (non-gsk). The subject was born at 41 weeks+ 3 days of amenorrhea with a birth weight of 3.765 kg and apgar scores at 10. He was initially maternal fed. Since birth, the subject slept on belly. From 08 to 11 September 2010, he was hospitalized for poor weight increase. Bottle feeding with artificial milk was started resulting in normal weight increased. On 03 December 2010, during his last pediatric consultation, the subject received unspecified doses of INFANRIXQUINTA (batch, route and injection site unknown), of BCG (batch, route and injection site unknown) and of ROTATEQ (oral, batch unknown). No problem occurred on 04 December 2010. The subject received his last bottle (220-230 ml) at around 22:00. The subject slept in his wooden bed on a thick firm mattress with a body, pajamas and thin blanket in a bedroom at 19-21 degrees Celsius. On 05 December 2010, at 03:30-04:00 he was seen by his mother as he was waking-up. At 10:00, he was found on belly with his head slightly on the side, blue, cold and stiff. There was a small blotch of blood on the bed sheet. Resuscitation procedure (cardiac massage and mouth to nose insufflations) was performed by the father. On mobile emergency medical unit arrival, rectal temperature was at 28 degrees Celsius. No resuscitation procedure was attempted. The subject was transferred to pediatric emergency unit at 11:50. Clinical examination showed lividness, blotchiness, rigidity and trismus. There was no sign of traumatism. Complementary lab tests included x-ray with no bone lesions, normal brain CT-scan, C-reactive protein at 7.6 mg/L, white blood cells at 8000/mm3, hemoglobin at 17 g/dL, platelet at 65000/mm3. CSF culture was sterile. Blood and urine cultures were negative. Direct detections of Influenza and respiratory syncytial viruses were negative. An autopsy was performed. There were few petechiae on surface of thymus and pleura and slight alveolar edema lesions with minim aspect of diffuse vascular congestion which might be related to a ventilation defect. The subject died on 05 December 2010, cause of death was unknown. According to the foreign method of assessment, the agency considered the causal relationship between vaccination with INFANRIXQUINTA, BCG SSI and ROTATEQ and the death as dubious.


VAERS ID: 414458 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2010-12-01
Onset:0000-00-00
Submitted: 2011-01-10
Entered: 2011-01-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / 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: 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: WAES1101USA00059

Write-up: Case of fatal outcome received from a healthcare professional on 28-DEC-2010. This case is poorly documented. Case medically confirmed. A 12 month old patient had received a dose of MMR II (Lot # not reported) on an unspecified date in December 2010. Concomitantly, the patient was vaccinated with a dose of MENINGITEC (Lot # not reported). Subsequently, (exact latency not reported), the patient died. An autopsy was performed and reportedly, no pathologic alterations were found. It was assumed that the child died from sudden infant death syndrome. Other business partner numbers include E2010-080500. No further information is available.


VAERS ID: 414691 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-12-20
Onset:2010-12-22
   Days after vaccination:2
Submitted: 2011-01-13
   Days after onset:22
Entered: 2011-01-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 098618802 / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-12-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Bendroflumethiazide; BETACAP; Calcium carbonate; COCOIS; Isopropyl myristate; Levothyroxine; Nitrofurantoin; Simvastatin;
Current Illness: Osteopenia; Essential hypertension; Hypothyroidism; Melaena
Preexisting Conditions: Hysterectomy; Respiratory arrest
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011027341

Write-up: This regulatory report (initial receipt 04-JAN-2011) concerns a 75 year old female patient, who had a relevant medical history of hysterectomy and respiratory arrest (which caused admission in NOV-2009). At the time of the event the patient concomitantly suffered from essential hypertension, hypothyroidism, melaena and osteopenia. Concomitant medications included bendroflumethiazide, betamethasone valerate, calcium carbonate, coal tar solution; precipitated sulphur; salicylic acid combination, isopropyl myristate; liquid paraffin combination, levothyroxine, nitroflurantoin and simvastatin. On 20-DEC-2010, the patient received ENZIRA (batch number: 098618802) as routine measure. She had not previously had swine flu vaccine last year but did have routine vaccinations annually. On 22-DEC-2010, 3 days after vaccination, the patient was found unconscious in bed. Paramedics failed to resuscitate her and she was certified dead at home. The reporter considered events to be serious (medically significant). Cause of death is unknown. Death Date: 22-DEC-2010.


VAERS ID: 414704 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2010-12-03
Onset:2010-12-05
   Days after vaccination:2
Submitted: 2011-01-13
   Days after onset:39
Entered: 2011-01-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Angiopathy, Autopsy, Blood culture negative, Body temperature decreased, Brain scan normal, C-reactive protein normal, CSF culture negative, Computerised tomogram head, Computerised tomogram normal, Culture urine negative, Cyanosis, Feeling cold, Haemoglobin normal, Haemorrhage, Influenza virus test negative, Livedo reticularis, Lividity, Muscle rigidity, Musculoskeletal stiffness, Petechiae, Platelet count decreased, Pulmonary oedema, Respiratory disorder, Respiratory syncytial virus test negative, Resuscitation, Skeletal survey normal, Sudden death, Trismus, White blood cell count normal
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (narrow), Parkinson-like events (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: X-ray, 05Dec10, Skeleton showed no bone lesions; Head computed axial tomography, 05?Dec10, normal; Diagnostic laboratory test, 05Dec10, Respiratory Syncytial Virus and virus influenzae were negative; Physical examination, 05Dec10, Mottling, lividity, trunk rigidity, trismus and no traumatisms; Diagnostic laboratory test, 05?Dec10, Bacteriological examination of injection site samples is not applicable; Autopsy, 05?Dec10; The autopsy showed a few petechiae at the surface of the thymus and pleurae; Apgar score, ??Sep?10, 10-10-10; WBC count, 05Dec10, 8000 mm^-3; Hemoglobin, 05Dec10, 17 g/dL; Platelet count, 05Dec10, 65,000 mm^-3; Rect T, 05Dec10, 28 degrees celsius; Serum C-reactive protein, 05Dec10, 7.6 mg/L; Cerebrospinal fluid histidine test, 05Dec10, sterile culture; Urine culture, 05Dec10, Negative; Blood culture, 05Dec10, Negative
CDC Split Type: WAES1101USA00542

Write-up: Case received from the Health Authorities on 30-DEC-2010 under the reference number PV20100396. Case medically confirmed. A 12 week old male patient had received a dose of BCG VACCINE SSI (batch number not reported), a dose of ROTATEQ (batch number not reported) and a dose of INFANRIX QUINTA (other manufacturer, batch number not reported) on 03-DEC-2010. No information was available on whether a product was used to prepare the site of injection or if the physician encountered difficulties performing vaccination. He was the first child of non consanguineous parents. He was born at 41 weeks and 3 days of amenorrhoea. His birthweight was 3765 g. He had an Apgar score of 10-10-10. He was breastfed. Since birth he had been put to bed face down. He had been hospitalized from 08 to 11-SEP-2010 for poor weight gain. He gained weight with artificial milk. He was 64 cm tall and he weighed 6.430 kg. On 04-DEC-2010 he had no problems. He received his last 220-230 mL feeding bottle around 10 p.m. He slept in a wooden cot, on a thick and firm mattress. He had a bodysuit and a thin blanket. The room temperature was between 19 and 21 degree celsius. He woke up around 3:30-4:00 p.m., his mother went and saw him and put him back to bed. On 05-DEC-2010 at 10 a.m. the patient was found face down, with his head slightly turned side wards, blue, cold and stiff. A small blood spot was found on the sheet. The patient''s father tried to resuscitate him by mouth to nose method and cardiac massage. The emergency mobile medical team was called in. The patient was found to have a rectal temperature at 28 degree celsius. No resuscitation was performed. He was admitted into the pediatrics emergency unit at 11:50 a.m. Physical examination showed mottling, lividity, trunk rigidity, trismus and no traumatisms. Additional investigations were performed. Skeleton X-ray showed no bone lesions. Cerebral CT-scan was normal. His CRP level was 7.6 mg/L, his white blood cell count was 8000/mm3, his hemoglobin level was 17 g/dL, and his platelet count was 65000/mm3. Cerebrospinal fluid showed sterile culture. Urine culture and hemoculture were negative. Respiratory Syncytial Virus and virus influenzae were negative. The autopsy showed a few petechiae at the surface of the thymus and pleurae, discrete lesions of alveolar oedema with mild aspect of diffuse vascular congestion, which could be related with a ventilation defect. In conclusion unexpected death was reported in a 3 month infant who was put to bed face down and had received vaccination 2 days before. The autopsy showed mild lesions which might be related with ventilation defect. The Health Authorities assessed the causal relationship between the reported reaction and vaccination as doubtful (C1 S1 I1) according to the Foreign method of assessment. Other business partner numbers included: E2010-08103. No further information is available.


VAERS ID: 414808 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Female  
Location: Foreign  
Vaccinated:2011-01-04
Onset:2011-01-04
   Days after vaccination:0
Submitted: 2011-01-14
   Days after onset:10
Entered: 2011-01-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LG / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR D0239 / UNK LG / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-01-12
   Days after onset: 8
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 relevant medical history, unknown concomitant drug(s)
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201100178

Write-up: Report received from the Health Authorities on 13 January 2011, through the local affiliates under the local reference number SK20110003. A 5-month-old female patient, with unknown medical history, was diagnosed with acute myocarditis and encephalopathy after receiving a dose of IMOVAX POLIO (lot number D0239) and a dose of DTAP vaccine from unknown manufacturer (lot number not reported) on 04 January 2011 by IM route, in the antero-lateral aspect of the upper thigh. On 04 January 2011, after vaccination, she developed severe fever. On 05 January 2011, she was admitted to hospital and the diagnosis was acute myocarditis and encephalopathy. She died on 12 January 2011. An autopsy is planned.


VAERS ID: 414931 (history)  
Form: Version 1.0  
Age: 8.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-01-14
Entered: 2011-01-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Beta haemolytic streptococcal infection, Death, Dyspnoea, Influenza, Pneumonia necrotising, Pyrexia, Sepsis, Somnolence, Staphylococcal infection
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: WAES1101USA00662

Write-up: Case received from the Public Health Agency on 04-JAN-2011 in a report with reference: 205021008/2010. Adverse events following immunization under National Vaccination Programme. Case medically confirmed. An 8-year-old male patient had received a dose of MMR II (manufacturer and lot # not reported) and a dose of DTP (manufacturer and lot # not reported) on an unspecified date in Childhood Immunization Programme. The event was reported in 2009. The patient experienced fever, drowsiness, shortness of breath, necrotizing pneumonia and sepsis caused by a group A haemolytic streptococci and staphylococci following Influenza B infection with a latency of 2 days after vaccination. 3.5 days after vaccination, the patient died on an unspecified date. An autopsy was performed. Death was judged not to be caused or hastened by the vaccination. No further information expected. Necrotizing pneumonia and sepsis caused by group A haemolytic streptococci and staphylococci following Influenza B infection was considered to be other important medical events. Other business partner numbers include: E2011-00060.


VAERS ID: 415118 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-12-06
Onset:2010-12-12
   Days after vaccination:6
Submitted: 2011-01-20
   Days after onset:39
Entered: 2011-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Chest pain, Death, Dyspepsia
SMQs:, Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-12-13
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic bronchitis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood pressure, 12Dec2010, normal; Oxygen saturation, 12Dec2010, normal
CDC Split Type: D0070000A

Write-up: This case was reported by a regulatory authority (DE-PEI-PEI2010037292) and described the occurrence of unknown cause of death in a 65-year-old male subject who was vaccinated with seasonal trivalent Influenza vaccine (Influenza vaccine (unspecified) manufacturer unspecified). Concurrent medical conditions included chronic bronchitis. On 06 December 2010 the subject received a dose of Influenza vaccine (unspecified) (0.5 ml, intramuscular, unknown). Approximately six days post vaccination with Influenza vaccine (unspecified), on 12 December 2010, the subject experienced chest pain and heartburn. An emergency physician was called. Blood pressure and oxygen saturation were normal. The emergency physician has not given any medication for the events. Ambulatory follow-up treatment was not necessary. On the next day, on 13 December 2010 at 05.55 in the morning, the subject was found dead. The police have been called. The subject died from unknown cause of death. It was unknown whether an autopsy was performed. At the moment no further information will be available.


VAERS ID: 415151 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2011-01-13
Onset:2011-01-13
   Days after vaccination:0
Submitted: 2011-01-21
   Days after onset:8
Entered: 2011-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS XHIBC043A1 / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Crying, Death, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0693587A

Write-up: This case was reported by a physician and described the occurrence of death for unknown causes in a 2-month-old male subject who was vaccinated with HIBERIX (GlaxoSmithKline). On 13 January 2011 (at 10: 30 am), the subject received unspecified dose of HIBERIX (intramuscular, unknown injection site). On 13 January 2011, less than one day after vaccination with HIBERIX, the subject experienced persistent inconsolable crying. On 14 January 2011 (at about 2 am), 15.5 hours after vaccination with HIBERIX, the subject experienced dyspnea. The subject died after emergency treatment. Cause of death was not specified.


VAERS ID: 415153 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-01-21
Entered: 2011-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B105AA / UNK UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Multi-organ failure, Product quality issue
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-01-11
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: B0693703A

Write-up: This case was reported by a regulatory authority and described the occurrence of multiple organ failure in a 5-month-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline), poliomyelitis vaccine inactivated (non-gsk). On an unspecified date, the subject received unspecified dose of INFANRIX (route and injection site unknown) and unspecified dose of Poliomyelitis vaccine inactivated (Non-GSK) (route and injection site unknown). At an unspecified time after vaccination with INFANRIX and Poliomyelitis vaccine inactivated (Non-GSK), the subject experienced multiple organ failure. The subject died on 11 January 2011 from unknown cause of death. It was unknown whether an autopsy was performed. This case is associated to a product complaint.


VAERS ID: 415260 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2010-09-28
Onset:0000-00-00
Submitted: 2011-01-21
Entered: 2011-01-24
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CA765A / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH E36530 / UNK UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0075Z / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-10-04
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: WAES1101USA01454

Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail concerning an approximately 10 week male child who on 28-SEP-2010 was vaccinated with a dose of ROTATEQ (lot # 665666/0075Z). Other suspect vaccines received on the same date included a dose of PREVENAR (Batch # E36530) and INFANRIX HEXA (Batch # A21CA765A). On 04-OCT-2010 the patient deceased. Staff at medical centre had no knowledge of any problems following vaccination and unaware of any details surrounding death of child. Follow-up - cardiac and respiratory arrest. The patient was treated with adrenaline, atropine, defibrib. Cardiopulmonary resuscitation (CPR) was performed for nil pulse respiration. Received follow-up information. Noted to not be breathing approximately 30 minutes post feed. Previously the child was asymptomatic. Unlikely vaccine related. The agency considered that death was possibly related to therapy with ROTATEQ. The original reporting source was not reported. A lot check has been initiated. No further information is available.


VAERS ID: 415270 (history)  
Form: Version 1.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-11-16
Onset:2010-11-16
   Days after vaccination:0
Submitted: 2011-01-21
   Days after onset:66
Entered: 2011-01-24
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER G9791 / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Lower respiratory tract infection
SMQs:, Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-12-21
   Days after onset: 35
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: 2011027391

Write-up: This medically confirmed health authority report (initial receipt 14-JAn-2011) concerns an elderly female patient with a medical history of frailty. The patient received her first dose of influenza vaccine (batch number G979-1, brand unknown) on 12-NOV-2010. On 16-NOV-2010, 5 days later, the patient received a second dose of influenza vaccine (batch number and brand unknown). On an unknown date after vaccination, the patient developed a chest infection and was reported to have died on 21-DEC-2010, approximately 5 weeks after receiving the second dose of influenza vaccine. Case outcome: fatal. This case was reported by a healthcare professional via another company. The case was considered serious due to fatal outcome. Limited information received, time to onset and brand of vaccine unknown. Case is confounded by elderly age and frail condition of patient. Seriousness: Serious (fatal outcome) Causality: Unassessable Listedness: Unexpected Cause(s) of death: chest infection Death Date: 21-Dec-2010.


VAERS ID: 415677 (history)  
Form: Version 1.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-09-21
Onset:0000-00-00
Submitted: 2011-01-28
Entered: 2011-01-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Asthenia, Death, Feeling hot, Hepatic mass, Myocardial infarction, Ultrasound scan abnormal
SMQs:, Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-01-06
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Type 2 diabetes mellitus; Cardiovascular disorder; Hypertension
Allergies:
Diagnostic Lab Data: Ultrasound scan, Abnormal, Revealed hepatic mass
CDC Split Type: PHHO2011PH00676

Write-up: Initial report received on 07 Jan 2011: This patient was enrolled in a study. The patients medical history included diabetes mellitus, hypertensive cardiovascular disease. The patient received the vaccination on 21 Sep 2010 at 17:24 hrs. On 06 Jan 2011 at 09:50 hrs the patient was died at home. No consultation was done. Autopsy was not performed. The investigator did not suspect a relationship between the event and the study vaccine. Following an internal review performed on 11 Jan 2011 the patient had medical history of diabetes mellitus type 2. Follow-up received on 19 Jan 2011: The cause of death was myocardial infarction. On an unspecified date, the patient developed body weakness and enlargement of the abdomen. An ultrasound scan revealed a hepatic mass. The patient died at home whilst sitting and complaining that she was ''hot''. Death certificate revealed myocardial infarction. The investigator did not suspect a relationship between the myocardial infarction and the study vaccine. In the absence of an investigator''s causality assessment, Novartis has processed the event ''hepatic mass" as suspected for reporting purposes. The case will be reassessed on receipt of follow-up information.


VAERS ID: 415824 (history)  
Form: Version 1.0  
Age: 1.3  
Sex: Male  
Location: Foreign  
Vaccinated:2010-04-01
Onset:2010-11-01
   Days after vaccination:214
Submitted: 2011-01-28
   Days after onset:88
Entered: 2011-01-31
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial test positive, Convulsion, Death, Lumbar puncture abnormal, Meningeal disorder, Meningitis pneumococcal, Shock
SMQs:, Anaphylactic reaction (narrow), Systemic lupus erythematosus (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Dose number 2, PREVENAR; Dose number 1, PREVENAR
Allergies:
Diagnostic Lab Data: Lumbar puncture (Nov2010): revealed pneumococcus of serotype 19A
CDC Split Type: 2011016295

Write-up: This is a spontaneous report from a contactable physician via a Pfizer collaborator. A 9-month-old male patient received the third dose of PREVENAR in Apr2010. Past vaccines included the first dose PREVENAR in Sep2009 at 2 months of age and the second dose in Nov2009 at 4 months of age. Relevant medical history was not provided. It was reported that the patient had no risk factors for invasive pneumococcal disease. Concomitant therapy was not provided. In Nov2010, at 16 months of age, the patient experienced meningeal syndrome leading to hospitalization. Lumbar puncture was performed which revealed pneumococcus of serotype 19A. The patient was diagnosed with pneumococcal meningitis. The patients status quickly worsened with convulsions and shock then patient died. No further follow-up attempts, no additional information available. It was reported that the patient had not received a catch-up dose of PREVENAR 13 after the age of 12 months. Based on the information provided in the case, this individual report would not seem to modify to benefit/risk profile of the suspect product.


VAERS ID: 416136 (history)  
Form: Version 1.0  
Age: 0.9  
Sex: Unknown  
Location: Foreign  
Vaccinated:2010-07-01
Onset:0000-00-00
Submitted: 2011-02-02
Entered: 2011-02-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Culture positive, Death, Pneumococcal infection, Streptococcus test positive
SMQs:, 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:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Culture: (date not specified) Streptococcus pneumoniae, serotype 19A
CDC Split Type: 2011019470

Write-up: This is a spontaneous report from a contactable physician via a company sales representative. The reporter was not the physician of this patient but had heard about this case from Colleagues. A 10-month-old patient received one dose of PREVENAR 13 in Jul2010. Relevant medical history was unspecified. The patient previously received a dose of PREVENAR in May2010. On an unknown date in 2010 the patient experienced unspecified pneumococcal disease due to serotype 19A and died. Case Comment: Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of the suspect product.


VAERS ID: 416222 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-11-06
Onset:2008-11-06
   Days after vaccination:0
Submitted: 2011-02-04
   Days after onset:820
Entered: 2011-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Erythema, Rash, Swelling, T-cell lymphoma
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Malignant lymphomas (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (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: B0696393A

Write-up: This case was reported by a consumer and described the occurrence of t-cell lymphoma in a 69-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 6 November 2008, the subject received an unspecified dose of FLUARIX (intramuscular, administration site unknown, batch number not provided). On 6 November 2008, less than one day after vaccination with FLUARIX, the subject experienced swollen, rash and erythema. In May 2010, 18 months after vaccination with FLUARIX, the subject experienced t-cell lymphoma. On an unspecified date, the subject died, cause of death is not specified. It was unknown whether an autopsy was performed.


VAERS ID: 416228 (history)  
Form: Version 1.0  
Age: 0.8  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-02-03
Entered: 2011-02-04
   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: Culture positive, Death, Pneumococcal infection
SMQs:, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Culture: (date unspecified) pneumococcal infection, serotype 33
CDC Split Type: 2011022571

Write-up: This is a spontaneous report from a contactable mother concerning her 9 month-old daughter. The patient received a dose of PREVENAR vaccine (unknown) on an unknown date. The patient experienced a pneumococcal infection reported as serotype 33 and died within 24 hours. No further information was provided.


VAERS ID: 416297 (history)  
Form: Version 1.0  
Age: 0.9  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2011-01-28
Submitted: 2011-02-04
   Days after onset:7
Entered: 2011-02-07
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / IJ

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Disseminated intravascular coagulation, Lumbar puncture abnormal, Meningitis pneumococcal, Pyrexia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre 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:
Current Illness:
Preexisting Conditions: Dose #1, PREVENAR
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011022747

Write-up: This is a spontaneous report from a contactable physician via a Pfizer sales representative. This reporter, as well as another physician contacted on behalf of the reporter, had heard about this case but they were not the physicians of the patient, so few information was available. An 11-month-old female patient had received a primary series of two doses of PREVENAR at unknown dates. The patient''s medical history and concomitant treatment were not reported. On 28Jan2011 or 29Jan2011, the patient experienced fever and disseminated intravascular coagulation. The patient was transferred to hospital where a lumbar puncture was performed. The patient was diagnosed with pneumococcal meningitis. The serotype identification was unknown. The patient was transferred to another hospital but died.


VAERS ID: 416369 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-10-20
Onset:0000-00-00
Submitted: 2011-02-07
Entered: 2011-02-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / CSL LIMITED 098617501 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Completed suicide, Drowning
SMQs:, Suicide/self-injury (narrow), Accidents and injuries (narrow), Hostility/aggression (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: FERRUS SULPHATE; Dosage was 200 mg BID; LACTULOSE; Dosage was 20 ml, 10-20ml; LORAZEPAM; Dosage was 1 mg TID; CLANZAPINE; Dosage was 5 mg QD; SODIUM PICOSULFATE; Dosage was 5 ml BID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011027523

Write-up: This medically confirmed spontaneous report received from a Coroner''s Officer (initial receipt 31-JAN-2011) concerns a 65 year old patient. The patient was taking the following concomitant medications: Farasulfate, lactulose syrup, lorazepam, olanzapine and sodium picosulphate. On 20-Oct-2010, the patient received ENZIRA with batch number 0986 17501. On an unknown date following vaccination, the patient committed suicide by drowning. The patient added in his suicide note he believed "the injection was not the flu jab". The patient had previously received the ''flu jab'' (influenza vaccine, brands unknown) in 2003, 2004, 2006, 2007 and 2008 with no reported adverse events. The event outcome was fatal. Cause of death is unknown. No autopsy findings.


VAERS ID: 416529 (history)  
Form: Version 1.0  
Age: 0.26  
Sex: Female  
Location: Foreign  
Vaccinated:2010-05-04
Onset:2010-12-01
   Days after vaccination:211
Submitted: 2011-02-09
   Days after onset:70
Entered: 2011-02-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, Death, Pneumococcal sepsis, Pneumonia pneumococcal, Pyrexia, Respiratory disorder, Streptococcus test positive
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-12-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FLIXOTIDE; VENTOLINE
Current Illness:
Preexisting Conditions: Premature baby born at 26 weeks of amenorrhea; Renal insufficiency; Ovarian surgery for ovarian hernia; Bronchopulmonary dysplasia; Birth twin
Allergies:
Diagnostic Lab Data: Blood cultures (unknown date): positive for Streptococcus pneumoniae then identified as serotype 1.
CDC Split Type: 2011022761

Write-up: This is a spontaneous report from a contactable physician via a Company sales representative. An 11-month-old female patient had received the third dose of PREVENAR on 04-May-2010. The patient''s past medical history included premature twin birth at 26 weeks of amenorrhea, hyaline membrane disease, transient renal insufficiency and surgery for ovarian hernia. The patient had concurrent medical history of bronchopulmonary dysplasia. Concomitant medications included FLIXOTIDE and VENTOLINE. On an unknown date, at the end of Dec2010, the patient was hospitalized due to a respiratory disorder. Fever developed 2 or 3 days later. Diagnostic tests were performed. A blood culture (unknown date) was positive for Streptococcus pneumoniae, which was later identified as serotype 1. The patient was diagnosed with Pneumococcal septicemia. Treatment with ROCEPHINE was initiated. Within a few hours after initiation of treatment the patient died. The cause of death was Pneumococcal septicemia.


VAERS ID: 416534 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2011-01-20
Onset:2011-01-23
   Days after vaccination:3
Submitted: 2011-02-09
   Days after onset:17
Entered: 2011-02-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-01-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011025551

Write-up: This is a spontaneous report from a contactable physician via a Pfizer sales representative. An infant (age and gender unknown) received one dose of PREVENAR 13 and a dose of INFANRIX HEXA on 20Jan2011 for vaccination. Route of administration was not provided. Relevant medical history and concomitant medication was not provided. On 23Jan2011, the patient died and sudden infant death was suspected. It was unknown whether an autopsy was performed.


VAERS ID: 416629 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-02-11
Entered: 2011-02-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Intensive care, 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: D0069211A

Write-up: This case was reported by a physician and described the occurrence of sudden infant death syndrome in an infant subject of unspecified gender who was vaccinated with INFANRIX-IPV/HIB (GlaxoSmithKline). Initially unspecified 6-valent vaccine (manufacturer unspecified) and unspecified pneumococcal vaccine (manufacturer unspecified) had been reported. On an unspecified date the subject received unspecified dose of 6-valent vaccine and unspecified dose of pneumococcal vaccine. One day after vaccination with 6-valent vaccine and pneumococcal vaccine, the subject was hospitalised to a pediatric intensive care unit and reanimated, but died from unknown cause. An autopsy was performed. Verbal follow-up information was received on 08 February 2011 from the physician. On a Friday (unspecified date) the subject received unspecified dose of INFANRIX-IPV/HIB and unspecified dose of PNEUMOVAX (non-gsk). One day after vaccination with INFANRIX-IPV/HIB and PNEUMOVAX, on a Saturday the subject suddenly died. The subject probably had been in the parent''s bed. Autopsy result stated the subject died from sudden infant death syndrome. Follow-up information has been requested.


VAERS ID: 416948 (history)  
Form: Version 1.0  
Age: 0.28  
Sex: Male  
Location: Foreign  
Vaccinated:2011-02-02
Onset:2011-02-02
   Days after vaccination:0
Submitted: 2011-02-15
   Days after onset:13
Entered: 2011-02-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E87394 / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-02-03
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: 02-FEB-2011, Body temperature, 40 Centigrade
CDC Split Type: 2011030110

Write-up: This is an initial report obtained from contactable CMPV. A 3-month-old male infant received, on 02FEB2011, PREVENAR 13 when he experienced fever (40 C) that responded to paracetamol, at night he experienced an eruption plus fever and the day after the baby died. The lot number of PREVENAR 13 is: E87394. As concomitant vaccine he took DTC, and ROTARIX. No more information is available. This report is lacking information critical for an independent medical assessment. Clinical evaluation is postponed after receipt of additional information. Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of the suspect product.


VAERS ID: 417326 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-02-18
Entered: 2011-02-22
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Crying, Death, Endotracheal intubation, Mechanical ventilation, Shock
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011033412

Write-up: This is a spontaneous report from a contactable pediatrician. A 3-month-old infant male patient received PREVENAR on an unknown date (Thursday). Relevant medical history was not provided. Concomitant medications included DTC and ROTARIX. On an unspecified date, the patient died. The physician confirmed that the baby was crying at night and the day after (Friday) the mother took the baby to the physician who confirmed that the baby was in shock. The baby was hospitalized and treated with antibiotics. It was reported that the baby seemed reacted to the therapy by antibiotics. On Saturday, the baby was doing bad so he was intubated and ventilated, but died 48 hours later. No follow-up attempts possible. No further information expected. Case closed: (15FEB2011).


VAERS ID: 417414 (history)  
Form: Version 1.0  
Age: 1.07  
Sex: Unknown  
Location: Foreign  
Vaccinated:2010-08-04
Onset:0000-00-00
Submitted: 2011-02-22
Entered: 2011-02-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Pneumococcal infection, Serology positive, Vaccination failure
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:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Serotype (unknown date): 3
CDC Split Type: 2011035053

Write-up: This is a spontaneous report received from a contactable healthcare professional via the Health Protection Agency. A regulatory Authority reference number was not provided. A 17-month-old patient of unknown race and sex received a dose of PREVENAR 13 04Aug2010 for vaccination. The patient had previously received the first dose of PREVENAR On 19May2009, and the second dose on 14Jul2009. No relevant medical history or concomitant medication details for the patient were provided. The patient had a pneumococcal infection identified as serotype 3, based on a specimen that was taken from the patient on 24Dec2010. On an unknown date the patient experienced vaccine failure. The patient died on an unspecified date. The cause of death was unknown. It was unknown if an autopsy was performed. The reporter did not wish to be contacted regarding this event, therefore this case was considered lost to follow-up. No follow-up attempts possible. No further information expected.


VAERS ID: 417501 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Female  
Location: Foreign  
Vaccinated:2011-02-13
Onset:2011-02-13
   Days after vaccination:0
Submitted: 2011-02-23
   Days after onset:10
Entered: 2011-02-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR D0703 / 1 UN / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Crying, Death, Food aversion
SMQs:, Depression (excl suicide and self injury) (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-02-15
   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 parents denied any relevant medical history. Personal medical history: the patient had cough on 13-Feb-2011 before vaccination. No concomitant drugs at the time of vaccination.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201100692

Write-up: Case received on 15 February 2011 through an internal contact and on 17 February 2011 from a Healthcare Professional in a foreign country through local affiliates under local reference number CN2011018. A 2-month-old female patient, with a history of cough on 13 February 2011, had received on 13 February 2011 at about 4:00 pm her first intramuscular dose of ACT-HIB (batch number D0703-1) in the gluteal region and in the evening her oral dose of OPV vaccine (other manufacturer (local manufacturer), tradename unknown, batch number not reported). The OPV vaccine was administered by the parents of the patient. There was no other concomitant therapy. The parents denied any relevant medical history. On 13 February 2011, i.e. the day of immunization, the patient presented with crying. On 14 February 2011, she developed apositia (lack of appetite). On 15 February 2011, the patient went asleep at almost 0:00 am. On 15 February 2011, the patient died at almost 6:00 pm. The patient was not hospitalized nor admitted into the hospital as outpatient. No corrective treatment was reported. Documents held by sender: "Manufacturing investigation" about the packaging and storage.


VAERS ID: 417514 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-02-23
Entered: 2011-02-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, CSF culture positive, Death, Meningitis pneumococcal, Pneumococcal bacteraemia, Pneumonia pneumococcal, Streptococcus test positive
SMQs:, 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 provided.
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Blood culture (unknown date in 2010): positive for S. pneumoniae of serotype 8; CSF culture (unknown date in 2010): positive for S. pneumoniae of serotype 8
CDC Split Type: 2011035177

Write-up: This is a spontaneous report from a contactable physician. A 3-month-old male patient was administered the first dose of PREVENAR 13 for vaccination on an unknown date. The route of administration was not reported. The patient was not a premature baby and was a healthy infant. At 5-months-old, the patient was diagnosed with pneumococcal meningitis and pneumococcal bacteraemia with focus of pneumonia on an unspecified date in 2010. S. pneumoniae, of serotype 8, was detected by blood culture and CSF culture. On an unknown date the patient died of pneumococcal meningitis and pneumococcal bacteraemia with focus of pneumonia. It was unknown whether an autopsy was performed. No follow-up attempts possible. No further information expected. Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of the suspect product.


VAERS ID: 417588 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-02-24
Entered: 2011-02-25
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201100717

Write-up: Case received on 16 February 2011 from a consumer (aunt of the patient) in a foreign country through global website. The local reference number was CN2011019. A 2-month-old female patient, with no medical history reported, had received on an unspecified date her dose of ACT-HIB (batch number, number in series, route and site of administration were not reported). No concomitant therapy was reported. On an unspecified date, the patient died. It was not reported if an autopsy was performed, if the patient was hospitalized or if a corrective treatment was administered. Documents held by sender: none.


VAERS ID: 417903 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2011-01-20
Onset:2011-01-20
   Days after vaccination:0
Submitted: 2011-03-02
   Days after onset:41
Entered: 2011-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME) / SANOFI PASTEUR - / UNK LG / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LG / IM
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LG / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abnormal faeces, Apgar score, Asthenia, Crying, Death, Diarrhoea, Diet refusal, Feeding disorder, Pain, Pyrexia, Rhinorrhoea, Somnolence, Thermal burn, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Biliary system related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-01-21
   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: Apgar score, Oct2010, 9/10/10
CDC Split Type: B0701659A

Write-up: This case was reported by a physician via a sales representative and described the occurrence of fatal diarrhea with foul-smelling stool in a 14-week-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline), Hepatitis B vaccine, pneumococcal 7-valent conjugate vaccine (non-gsk) and DTPa-polio-hib (non-gsk). The subject was delivered normally at term with an APGAR score of 9-10-10. Prior to the vaccination, the subject was healthy. The subject had no previous vaccination reaction and no family history of reaction to vaccination. On 20 January 2011, the subject received unspecified dose of ROTARIX (oral), unspecified dose of Hepatitis B vaccine (intramuscular, unknown thigh), unspecified dose of pneumococcal 7-Valent conjugate vaccine (Non-GSK) (intramuscular, unknown thigh), unspecified dose of DTPa-Polio-HIB (Non-GSK) (intramuscular, unknown thigh). Two injections were given in the right thigh and 1 injection in the left thigh. On 20 January 2011, less than one day after vaccination with DTPa-Polio-HIB (Non-GSK), Hepatitis B vaccine, pneumococcal 7-Valent conjugate vaccine (Non-GSK) and ROTARIX, the subject experienced crying with pain. The mother carried the subject on her back and the subject was sleeping when the mother left the clinic. On arrival at home, the subject was still sleeping. The subject didn''t want to take the afternoon feed. No fever, vomiting or diarrhea was experienced. The subject was weak and sleepy and not feeding. The care giver mentioned that the subject had high temperature on the evening following vaccination. The subject slept throughout the night. On 21 January 2011 morning, the subject was fine without fever and did not need to go to the clinic. The mother bathed the baby to wake him up. The subject experienced loose stool with offensive smell, vomited twice with smelly vomitus and some pieces of flesh like things as if the baby was rotten inside. The subject became more weak, could not cry or suck from the breast. An ambulance was called which arrived when the subject was already dead and an undertaker was then called. The body of the subject was not examined by the doctor who wrote on the death certificate: natural causes as cause of death. When they fetched the subject''s body from mortuary for burial, it was noticed that the subject was burnt around the mouth and a black discharge was coming out from the nostrils. The subject was buried on 26 January 2011. The subject died on 21 January 2011 from death from natural causes. An autopsy was not performed.


VAERS ID: 417952 (history)  
Form: Version 1.0  
Age: 0.11  
Sex: Male  
Location: Foreign  
Vaccinated:2011-02-24
Onset:2011-02-25
   Days after vaccination:1
Submitted: 2011-03-03
   Days after onset:6
Entered: 2011-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-02-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0702848A

Write-up: This case was reported by a physician and described the occurrence of death nos in a 6-week-old male subject who was vaccinated with ENGERIX B pediatric (GlaxoSmithKline). Previous and/or concurrent vaccination included hepatitis B vaccine (non-GSK manufacturer) 1st dose given on an unspecified date. On 24 February 2011 the subject received 2nd dose of ENGERIX B pediatric (intramuscular, unknown injection site). Lot number not provided. On 25 February 2011, 1 day after vaccination with ENGERIX B pediatric, the subject was found dead at 3:00 am. The subject died on 25 February 2011, cause of death was not reported. It was unknown whether an autopsy was performed.


VAERS ID: 417993 (history)  
Form: Version 1.0  
Age: 1.17  
Sex: Male  
Location: Foreign  
Vaccinated:2008-01-21
Onset:0000-00-00
Submitted: 2011-03-03
Entered: 2011-03-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER VNS1A03C / UNK UN / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0446F / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Otitis media, Respiratory tract infection bacterial, Sepsis
SMQs:, Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-02-03
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1102USA03642

Write-up: Case of fatal outcome received from the health authorities (Lareb) on 25-FEB-2011 under the reference number NL-LRB-117632 (reference number: RIVM201001397). Case medically confirmed. Initial source was a physician. Case reported as serious by the Lareb (criterion: death, hospitalization). Upon internal review, the company added the following seriousness criterion: Other medically important event (septicaemia). A 12 month (1 year) old male patient had received the first 0.5 ml dose of MMR II (also reported as rHA) (Batch# NE03580; Lot# 653951/0446F) and a 0.5 ml dose of NEISVAC-C (Lot# VNS1A03C) on 21-JAN-2008. There was no information reported on medical history and on concomitant medication. The patient experienced otitis media, respiratory tract infection bacterial and septicaemia. No latency was reported. The adverse events were respectively reported with the following outcomes: "not recovered", "fatal" and "fatal". All MedDRA LLT have "primary source reaction: death 13 days after the vaccination" (i.e. death on 03-FEB-2008). Other business partner number included E2011-01248. A lot check has been initiated. Additional information is not expected.


VAERS ID: 417999 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-03-03
Entered: 2011-03-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute disseminated encephalomyelitis, Death
SMQs:, Noninfectious encephalitis (narrow), 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:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011040092

Write-up: This is a spontaneous report from a contactable physician via a Pfizer colleague. A physician reported to Pfizer colleague that he had treated a patient (gender, age, race unknown) with acute disseminated encephalomyelitis (ADEM). The patient had died from ADEM on unknown date. The physician had known that the patient had received PREVENAR 13, on unknown date, from another doctor. The case was not reported by the treating physician as he deemed ADEM was not related to PREVENAR 13. However, he did mention this event to Pfizer colleague and had requested some safety data. Based on the information currently available, the company agrees with the assessment of the reporter and does not attribute the event to PREVENAR 13.


VAERS ID: 418073 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2011-02-18
Onset:2011-02-19
   Days after vaccination:1
Submitted: 2011-03-04
   Days after onset:13
Entered: 2011-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death, Haemorrhage, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-02-22
   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: B0701954A

Write-up: This case was reported by a physician and described the occurrence of death nos in a 2-month-old male subject who was vaccinated with HIBERIX (GlaxoSmithKline), poliomyelitis vaccine live oral (non-gsk). On 18 February 2011 the subject received unspecified dose of HIBERIX (intramuscular, unknown injection site), unspecified dose of Poliomyelitis vaccine live oral (Non-GSK) (oral). Lot numbers were not provided. On 19 February 2011, 1 day after vaccination with HIBERIX and Poliomyelitis vaccine live oral (Non-GSK), the subject experienced hemorrhage and vomiting. The subject died on 22 February 2011, cause of death was not reported. It was unknown whether an autopsy was performed.


VAERS ID: 418177 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-03-07
Entered: 2011-03-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER AM009B / 2 UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR E1234 / 2 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 10H01A / 2 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Chronic illness of dexiocardia single ventricle pulmonary atresia.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201100978

Write-up: Case received via a press release from the Ministry of Health on 04 March 2011. A female infant patient 6 months to less than 1 year of age with chronic illness of dexiocardia single ventricle pulmonary atresia, die the following day after receiving a second dose of ACTHIB (lot number E1234), a second dose of DPT (Manufacturer unknown, Lot number AM009B), and a second dose of PREVNAR (Manufacturer Wyeth, Lot number 10H01A). The evaluation of the reporting physician was unknown. Per the release, causal relationship between the vaccination and death, according to the physician who reported it was impossible to evaluate, or it was unknown and the details of investigation was still under investigation. The reporter for this case is the same as for case 2011-00918 and 2011-00977. Documents held by sender: None.


VAERS ID: 418178 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-03-07
Entered: 2011-03-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER AM009B / 1 UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR E1065 / 1 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 10E02A / 2 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Under investigation.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201100977

Write-up: Case received via a press release from the Ministry of Health on 04 March 2011. A female infant (age reported as less than 6 months) received her first dose of ACTHIB (batch number E1065), her first dose of DPT (other manufacturer, batch number AM009B), and her second dose of PREVENAR (other manufacturer, batch number 10E02A) on an unspecified date. The patient died 3 days post-vaccination. Base disease (chronic illness) was reported as "under investigation", and the evaluation of the reporting physician was unknown. A detailed investigation was under investigation. According to the press release, "Concerning the causal relationship between the vaccination and death, according to the physicians who reported them, in either case, it was impossible to evaluate or unknown". Documents held by sender: none.


VAERS ID: 418179 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Foreign  
Vaccinated:2011-02-28
Onset:2011-03-01
   Days after vaccination:1
Submitted: 2011-03-07
   Days after onset:6
Entered: 2011-03-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR E1235 / 1 RA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 LA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Peripheral coldness, Posture abnormal, Resuscitation
SMQs:, Dystonia (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: ONON; HOKUNALIN TAPE; PULMOCORT; HYSERENIN; INTAL; MEPTIN
Current Illness:
Preexisting Conditions: The patient had a medical history of chromosome abnormality (lp36 deletion) since 22 September 2008, ventricular septal defect since 20 September 2008, chronic lung disease since 20 September 2008, bronchial asthma, epilepsy. The patient had underwent a patent ductus arteriosus (PDA) ligation on 28 September 2008. He had no history of adverse drug reaction.
Allergies:
Diagnostic Lab Data: not reported
CDC Split Type: 201100918

Write-up: Case received from a healthcare professional on 02 March 2011 and follow-up information received from the Health Authorities on 03 March 2011 under the reference number HIB-76. The local number was A201100157. Additional information was received via a press released from the agency on 04 March 2011. A 29-month-old male patient, with a medical history and concomitant therapies, had received his first subcutaneous dose of ACTHIB (batch number E1235) in the right upper arm and his first subcutaneous dose of PREVENAR (other manufacturer, batch number not reported) in the left upper arm on 28 February 2011. The patient had a medical history of chromosome abnormality (lp36 deletion) since 22 September 2008, ventricular septal defect since 20 September 2008, chronic lung disease since 20 September 2008, bronchial asthma, epilepsy. He had underwent a patent ductus arteriosus (PDA) ligation on 28 September 2008. He had no history of adverse drug reaction. The patient had received as concomitant therapies pranlukast hydrate, HOKUNALIN TAPE and PULMICORT for asthma bronchitic, HYSERENIN for epilepsy, INTAL and MEPTIN. On 28 February 2011 at 15:30, prior to vaccination, the patient was in good mood and there was no particular cardiopulmonary or abdominal finding. The pharynx was normal. The body temperature was 36.6 degrees C. After vaccination, the patient was spending time normally at home. He was romping around n a good mood until 04:00 on 01 March 2011. He was out to sleep after 04:00 and the patient''s mother confirmed that the patient was asleep before she went to bed. On 01 March 2011 at around 07:00, when the patient''s mother tried to wake up the patient to get him ready for nursery center, the patient was in a prone position and cold. An ambulance was called immediately and cardiopulmonary resuscitation was attempted but unsuccessful. The patient was transported to hospital at which the death was confirmed. On 02 March 2011, an administrative autopsy was under way. The association between the patient''s death and the vaccination was unknown until the results of the administrative autopsy were available. According to the physician, this case was related to ACTHIB. PREVENAR was reported as an alternative explanation. Documents held by sender: none.


VAERS ID: 418242 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Foreign  
Vaccinated:2011-02-04
Onset:2011-02-06
   Days after vaccination:2
Submitted: 2011-03-08
   Days after onset:30
Entered: 2011-03-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 LA / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR E0770 / UNK UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-02-06
   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:
Current Illness:
Preexisting Conditions: The patient had a medical history of cyanosis after birth, cardiopulmonary (clarification requested) and right ventricular hypertrophy, almost normalized at a re-visit in November 2010. The patient had received his second dose of DPT vaccine (manufacturer unknown) on 07 January 2011.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201100993

Write-up: Case received from the Health Authorities on 07 March 2011 under the local number A201100178 (Health Authority''s number HIB-92). A 05-month-old male patient, with a medical history of cyanosis after birth and right ventricular hypertrophy (almost normalized at a re-visit in November 2010), had received his subcutaneous dose of ACTHIB (batch number E0770, site of administration not reported) and his first dose of BCG vaccine (manufacturer unknown, batch number and route of administration not reported) in the left upper arm on 04 February 2011. He had received his third dose of DPT vaccine (manufacturer unknown, batch number, route and site of administration not reported) on 28 January 2011. The patient had received his second dose of DPT vaccine (manufacturer unknown) on 07 January 2011. On 06 February 2011, at around 07:00am, the patient''s mother checked that the patient was asleep. At around 09:00am, she noticed that the patient was in state of cardiopulmonary arrest on his bed. He was transported to hospital. Despite cardiopulmonary resuscitation, the patient''s death was confirmed. According to the physician, the causality between sudden death and ACTHIB was not assessable. No alternative explanation was reported. Documents held by sender: none.


VAERS ID: 418364 (history)  
Form: Version 1.0  
Age: 0.45  
Sex: Female  
Location: Foreign  
Vaccinated:2011-01-26
Onset:2011-01-31
   Days after vaccination:5
Submitted: 2011-03-09
   Days after onset:37
Entered: 2011-03-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR E0897 / UNK UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-01-31
   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: No concomitant drug
Current Illness:
Preexisting Conditions: Born at 25 weeks of gestation, low birth weight, retinopathy, patent ductus arteriosus; "No reported medical history (including allergy)"
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201101018

Write-up: Case received from a healthcare professional through the local affiliate on 08 March 2011 under the local reference number A201100195. A 05-month-old female patient (04-month old was also reported), with "no reported medical history (including allergy)", had received her subcutaneous dose of ACT-HIB, batch number E0897, anatomical site of administration not reported, on 26 January 2011. She had previously received her dose of PREVENAR (other manufacturer, batch number 10E01A, route and anatomical site of administration not reported) on 19 January 2011. The patient was born on 16 August 2010 at 25 weeks of gestation with severe low birth weight, retinopathy and patent ductus arteriosus. She was referred to another hospital. Her condition became stable and she was followed in the other hospital as an outpatient. The patient had no concomitant drug. On 07 January 2011, the patient was referred to the reporter''s hospital for prophylactic vaccination. The patient died on 31 January 2011. No further information was reported at the time of the report. According to the reporting physician, the case was serious. He also stated that the relationship with the vaccine was "unknown" since he did not have any details regarding the patient''s death. Documents held by sender: none.


VAERS ID: 418451 (history)  
Form: Version 1.0  
Age: 1.6  
Sex: Female  
Location: Foreign  
Vaccinated:2011-03-01
Onset:2011-03-02
   Days after vaccination:1
Submitted: 2011-03-10
   Days after onset:8
Entered: 2011-03-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER AC014D / UNK LA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 10G03A / UNK RA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Blood bicarbonate increased, Blood pH decreased, Blood potassium increased, Brain oedema, Cardio-respiratory arrest, Computerised tomogram head, Death, Emphysema, Endotracheal intubation, Laboratory test, Lung infiltration, Lymphadenopathy, Mouth haemorrhage, PCO2 increased, PO2 decreased, Pharyngeal erythema, Pneumonia, Pulmonary oedema, Pyrexia, Spleen disorder, Sputum abnormal, Sputum discoloured, Swelling, Unresponsive to stimuli, pH body fluid
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Lactic acidosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-03-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: 02-MAR-2011, Body temperature, 39 Centigrade; Autopsy: (02Mar2011): Computerized tomography revealed brain oedema and infiltrative shadow on the bilateral lungs. SpO2 showed 4%. As for swelling of lymph node on the intestinal membrane, enlarged lymph node on the spleen, and heart-lung, no special findings except after death was noted. Therefore, a cause of death was unknown. Potassium (Mar2011): result - showed high. JCS (Japan coma scale (02Mar2011): 300; Heart rate (02Mar2011): 0; BP (02Mar2011): -; SpO2 (02Mar2011): -%; Cardiac wave (02Mar2011): asystole; Vital signs at (hospital) arrival (02Mar2011): with BVM (bag valve mask) ventilation, PR: -, SpO2: -%, BP: -, HR: -, JCS:300, pupils: 3.5/3.5, -/-. PH body fluid (02Mar2011): 6.559; PaCO2(A) (02Mar2011): 131.0 mmHg, PaO2(A) (02Mar2011): 4.6 mmHg, SaO2(A) (02Mar2011): 4.9%, ABE(A) (02Mar2011): -33.1 mmol/L, HCO3(A) (02Mar2011): 11.0 mmol/L, ctHb(A) (02Mar2011): 13.6 g/dL, ctO2CDC Split Type: 2011046084

Write-up: This is a spontaneous report obtained from agency (regulatory authority report number PREVENAR 91) and from a contactable physician regarding PREVENAR, A 19-month-old female child received on 01Mar2011 a dose of PREVENAR, (Lot N.: 10G03A) in the right arm and concurrently a dose of DPT (lot N AC014D) in the left arm, both administered subcutaneously at 16:30. On 02Mar2011 at 01:00 the child had fever of 39.0 degrees Celsius. In the morning of 02Mar2011, the child was brought to the clinic where a mild pharyngotonsilar redness was noted; the reporting physician considered that child''s clinical conditions was possibly due to a viral infection or to a transient pyrexia following vaccination. The physician also reported that cefdinir was prescribed as prophylaxis for viral and bacterial infection. According to the parents, on 02Mar2011 the child walked back home in good conditions. At 11:00 am she went to bed. At 13:30, the parents tried to wake her up but she was found unresponsive. At 14:05, while being transferred to the hospital, no cardiac sound was noted. When cardiac massage was started, a large volume of pink-coloured foamy sputum was observed. Intubation was performed, as well as endotracheal administration of epinephrine. However, clinical conditions did not improve despite intravenous administration of epinephrine. Potassium level was 10.6 mmol/L; SpO2 level was 4%. The reporting physician stated that since a fairly long time had elapsed since the child had experienced cardiopulmonary arrest, it was judged that the possibility of a resuscitation was extremely low and therefore resuscitation was abandoned. The child''s death was confirmed at 14:53. Early findings from the autopsy did not reveal a cause of death, but did reveal lung and brain edema and well as swollen lymph nodes in the gut and splenic follicular swelling. Chest CT found extensive infiltrations in the lungs. A physician at the hospital reported that blood had adhered around the child''s mouth at arrival, and a large endotracheal volume of reddish foamy sputum was noted at intubation; however, no airway obstruction occurred. The physician also commended that it was unknown if the infiltrative shadow in the lungs was due to emphysema or to a rapidly progressive pneumonia.


VAERS ID: 418705 (history)  
Form: Version 1.0  
Age: 0.61  
Sex: Male  
Location: Foreign  
Vaccinated:2011-02-15
Onset:2011-02-22
   Days after vaccination:7
Submitted: 2011-03-11
   Days after onset:17
Entered: 2011-03-14
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER AC014D / 2 LA / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR E1201 / 1 RA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Cardio-respiratory arrest, Death, Gastroenteritis norovirus, Histology, Norovirus test positive, Polymerase chain reaction, Resuscitation, Sudden infant death syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Neonatal disorders (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-02-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The weight of the patient was 3780g at birth. The patient had no allergic predisposition. The body temperature was 36.8 degrees C before immunization.
Allergies:
Diagnostic Lab Data: Specimens of stool by PCR: Norovirus detected.
CDC Split Type: 201101041

Write-up: Case received on 10 March 2011 from the Health Authorities under reference number HIB-119, through local affiliates under local reference number A201100217. The case was medically confirmed. A 7-month-old male patient with no allergic predisposition, died on 22 February 2011, i.e. 7 days after receiving simultaneously his first subcutaneous dose of ACT-HIB (batch number E1201) on the right upper arm and his second subcutaneous dose of DPT vaccine (Other manufacturer [Kitasato institute], batch number AC014D) on the left upper arm, on 15 February at 15:30. The patient had no allergic predisposition. The body temperature was 36.8 degrees C before immunization. The weight of the patient was 3780g at birth. On 22 February 2011, at 7:50, the patient was found in cardiopulmonary arrest at home. The patient was transferred to hospital in ambulance. The patient did not respond to cardiopulmonary resuscitation. The death was confirmed at 9:13. A sudden infant death syndrome (SIDS) was suspected (waiting for histological diagnosis). Prognosis: "the outcome was fatal. No probable cause of death was found by an autopsy. Norovirus was detected in specimens of stool by PCR". According to the reporter, the relationship between ACT-HIB and the event was not assessable. Upon internal review, "sudden infant death syndrome" and "cardiopulmonary arrest" were coded. Documents held by sender: none.


VAERS ID: 418816 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2011-02-24
Submitted: 2011-03-15
   Days after onset:18
Entered: 2011-03-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Congenital pulmonary artery anomaly, Death, Pulmonary malformation
SMQs:, Congenital, familial and genetic disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-02-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011048962

Write-up: This is a spontaneous report obtained from the Foreign Regulatory Authority, regarding PREVENAR 13. The Foreign Regulatory Authority confirmed a media report relative to a 3 month-old female infant who had received a dose of PREVENAR on an unspecified date and died at the hospital on 24Feb2011. The Foreign Regulatory Authority also reported that the autopsy result revealed a severe cardiopulmonary malformation: absence of the right pulmonary artery.


VAERS ID: 418842 (history)  
Form: Version 1.0  
Age: 0.8  
Sex: Male  
Location: Foreign  
Vaccinated:2011-02-22
Onset:2011-02-23
   Days after vaccination:1
Submitted: 2011-03-15
   Days after onset:19
Entered: 2011-03-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Faecal vomiting, Gastroenteritis, General physical health deterioration, Intestinal obstruction, Laryngitis, Pyrexia, Resuscitation, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-02-25
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Slight cough at the time of the adverse event; Cough
Allergies:
Diagnostic Lab Data: Body temperature (22Feb2011): fever (value unknown); Body temperature (24Feb2011 at 10:00 pm): no fever
CDC Split Type: 2011048963

Write-up: This is a spontaneous report obtained from the Foreign Regulatory Authority, reference number TO20110392, regarding PREVENAR 13. A 9-month-old male infant received on 22Feb2011 a dose of PREVENAR 13 by intramuscular route; the infant had a slight cough at the time of vaccination. In the evening of the same day the infant had fever. According to his mother a physician explained to her that fever could have been a reaction to vaccination, and advised her to administer an antipyretic drug and to have the infant visited by a general practitioner the following morning. On 23Feb2011 a diagnosis of laryngitis was made by the general practitioner and unspecified drugs were prescribed. On the same day in the afternoon the infant vomited. On 24Feb2011 in the evening, the infant still had vomiting and was brought to an emergency unit. On the same day at 10:00 pm a diagnosis of gastroenteritis was made, the infant had no fever and was discharged. During the night between 24Feb2011 and 25Feb2011, the infants clinical conditions suddenly worsened and he was brought again to the emergency unit. On 25Feb2011 at 04:00 am, resuscitation was attempted without success and infant was pronounced dead. The autopsy report was not provided due to legal procedure for unintentional manslaughter; however, it was reported that the pathologist considered the death as not related to vaccination. According to the parents lawyer, the infant had brown vomiting, suggesting that he vomited fecal content and would have had intestinal obstruction. This case was entered into the National Pharmacovigilance database and the reported event was coded using the MedDRA code digestive disorder NOS.


VAERS ID: 419048 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-03-17
Entered: 2011-03-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D78232 / 4 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, CSF culture positive, Death, Meningitis pneumococcal, Pneumococcal bacteraemia, Streptococcus test positive
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:
Current Illness:
Preexisting Conditions: first vaccination at the age of 3 months, Lot #34876, PREVENAR, No adverse event; second vaccination at the age of 4 months, Lot #34875, PREVENAR, No adverse event; third vaccination at the age of 5 months, Lot #36470
Allergies:
Diagnostic Lab Data: Blood culture (no date provided): detection of Streptococcus pneumoniae, serotype not determined; Cerebrospinal fluid culture (no date provided): detection of Streptococcus pneumoniae, serotype not determined
CDC Split Type: 2011055327

Write-up: This is a spontaneous report from a non-contactable but identifiable physician. A 14-month-old male patient received the fourth dose of PREVENAR (lot # D78232) for vaccination, route of administration was not reported. Previous vaccinations included three doses of PREVENAR administered at the age of 3 months (Lot # 34876), 4 months (Lot # 34875) and 5 months (Lot # 36470). The patient was not a premature baby and did not suffer from any chronic or immunodeficiency diseases. Concomitant medication was not reported. At the age of 25 months, the patient experienced pneumococcal meningitis and pneumococcal bacteraemia. Blood and cerebrospinal fluid cultures revealed Streptococcus pneumoniae, the serotype was not determined. Vaccination dates and event onset were not reported. No information regarding the clinical course was provided. The patient died due to the events. No follow-up attempts possible. No further information expected.


VAERS ID: 419052 (history)  
Form: Version 1.0  
Age: 0.22  
Sex: Female  
Location: Foreign  
Vaccinated:2010-10-08
Onset:2010-10-08
   Days after vaccination:0
Submitted: 2011-03-17
   Days after onset:160
Entered: 2011-03-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS A20CA589F / 1 GM / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E44949 / 1 GM / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-10-09
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Birth weight (18Jul2010): 3150 g; Birth height (18Jul2010): 50 cm; Head circumference (18Jul2010): 35 cm
CDC Split Type: 2011055130

Write-up: This is a spontaneous report from a contactable physician. An 11-week-old female patient received the first dose of PREVENAR 13 (Lot number #E44949) on 08Oct2010 for vaccination. Product was gluteally administered in left side via intramuscular route of administration. Additional suspect medication included the first dose of INFANRIX IPV+HIB (Lot number #A20CA589F) which was gluteally administered on the same day at right side via intramuscular route of administration. The patient''s mother was 23 years old. The patient had no siblings and no relevant family medical history was known. It was also unknown whether the parents had a medical history of nicotine, drug, or alcohol abuse. The patient''s mother has a past medical history of two abortions according to statement of the patient''s aunt. During pregnancy the patient''s mother did not take any medication and no fetal complications occurred. The delivery was normal. The patient was born as calculated with a birth weight of 3150 g, birth height of 50 cm, and head circumferences of 35 cm. The patient did not suffer from any birth defect and her development was normal for her age. It was reported that the patient did not suffer from any relevant medical history. After vaccination the patient did not experience any adverse events or complications. On 09Oct2010 the patient was found dead in the bed. The body position of the patient was unknown. The last feeding was bottle feeding. An autopsy was performed. The reported cause of death was sudden infant death syndrome according to the statement of the patient''s aunt. The autopsy report was not available for the reporting physician. Company Clinical Evaluation comment. Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVENAR 13.


VAERS ID: 419067 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Unknown  
Location: Foreign  
Vaccinated:2011-01-20
Onset:2011-01-20
   Days after vaccination:0
Submitted: 2011-03-17
   Days after onset:55
Entered: 2011-03-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / IM
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abnormal faeces, Asthenia, Crying, Death, Diarrhoea, Diet refusal, Gastrointestinal disorder, Injection site pain, Poor sucking reflex, Pyrexia, Rhinorrhoea, Somnolence, Thermal burn, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Biliary system related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-01-22
   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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011051309

Write-up: This is a spontaneous report of an adverse event involving PREVENAR. A non-contactable consumer reported that 14-week-old baby (gender unknown) was vaccinated with a dose of PREVENAR via intramuscular route of administration on 20Jan2011. The patient also received on the 20Jan2011 a dose of ROTAVIRUS orally, PENTAXIM intramuscularly and HEPATITIS B intramuscularly. The baby was injected with three (3) injections in all, two (2) on the right thigh and one (1) on the left thigh, the baby cried with pain. The mother carried the baby on her back and the baby slept when she left the clinic. On arrival at home, the baby was still sleeping and did not want to take his/her afternoon feed. The patient slept throughout the night. No fever, no vomiting and no diarrhoea were noted, but the patient was weak and sleepy and not feeding. The next morning around 0900, the mother bathed the baby to wake him/her up. The child passed a loose stool with offensive smell and vomited twice (2) with smelly vomitus with some pieces of flesh-like things, as if the baby was rotten inside. The baby became more weak could not cry nor suck from the breast. An ambulance was called, which arrived when the baby was already dead on 22Jan2011. Additional information was received based on police reports. The condition of the baby prior to immunisation was healthy. No previous immunisation reactions noted on the baby, no history of reaction in the family. The father of the baby stated that on arrival to the Doctor with the body of the baby, he asked them what was wrong. He (the doctor) did not examine the body of the baby; he just looked and wrote natural causes on the death certificate. He also stated that the baby was burnt around the mouth, and a black discharge coming out from the nostrils, this was noted when they fetched the baby''s body from mortuary for burial. Baby was buried on the 26Jan2011. The father of the baby wants the baby''s body to be exhumed for thorough examination for the cause of death. The nurse, that immunised the baby, mentioned that the baby had high temperature on the evening following immunisation and the following morning the baby was fine did not need to go to the clinic. The baby''s father is a Traditional Healer; it is assumed that a child was given something before or after clinic visit, although denied on inquiry. Other report from the program coordinator stated that the baby delivered normally at term with an Apgar of 9/10-10/10 was immunised at the clinic. The condition of the baby prior to immunisation according to the mother was good. The clinic has one minus 40 fridge. Vaccines are closely packed and there was no space in between vaccines for circulation of air. No expired vaccines were found. There is no vaccine stock out.


VAERS ID: 419174 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-10-04
Onset:2010-10-07
   Days after vaccination:3
Submitted: 2011-03-18
   Days after onset:162
Entered: 2011-03-21
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac disorder, Condition aggravated, Cough, Death, Haemoptysis, Malaise, Renal disorder
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2010-11-03
   Days after onset: 27
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1103USA00922

Write-up: Information has been received from a physician concerning a 15 year old female patient with longstanding health problems (according to mother) since childhood who on 04-OCT-2010 was vaccinated IM with a second dose of GARDASIL (Lot# not reported). In September 2010, the patient experienced cough and was sick. On 07-OCT-2010, the patient experienced cough and haemoptysis. On 30-OCT-2010, the patient was diagnosed with kidney "problem" and heart "problem". The patient was admitted to hospital. The patient''s mother cannot recall treatment or hospital ID number and had not kept files. On 03-NOV-2010, the patient died. The cause of death was not reported. Cough, sickness, haemoptysis, kidney "problem" and heart "problem" were considered to be immediately life-threatening by the reporter.


VAERS ID: 419234 (history)  
Form: Version 1.0  
Age: 99.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-01-27
Onset:2011-02-10
   Days after vaccination:14
Submitted: 2011-03-21
   Days after onset:38
Entered: 2011-03-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac failure, Death, Incorrect dose administered
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Cardiac hypertrophy; Hypertension; Diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1103USA01959

Write-up: Initial information has been received from a physician concerning a 99 year old female patient who was placed in a nursing home run by reporting physician''s hospital with cardiac hypertrophy, hypertension and diabetes mellitus who on 27-JAN-2011 was vaccinated with 0.5 ml injection of PNUEMOVAX 23 for prophylaxis of pneumonia. No information on concomitant medication has been provided. On 10-FEB-2011, the patient was vaccinated with PNEUMOVAX 23 again by mistake. Subsequently, there was no effect of incorrect vaccination of PNEUMOVAX 23. On 23-FEB-2011, the patient developed cardiac failure. Subsequently, on an unspecified date, the patient was admitted to the reporting physician''s hospital. After a while, the patient showed recovery trend, but died of cardiac failure. No information on autopsy has been provided. The reporting physician felt that cardiac failure was definitely not related to PNEUMOVAX 23. The reporting physician considered that cardiac failure was serious due to death and hospitalization. Reporter''s comment: Based on the inoculator''s background, the physician considered that cardiac failure was not directly related to PNEUMOVAX 23. No further information is available.


VAERS ID: 419323 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2011-03-13
Onset:2011-03-15
   Days after vaccination:2
Submitted: 2011-03-22
   Days after onset:7
Entered: 2011-03-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Cyanosis, Death, Dyspnoea, Lung infiltration, Pulmonary haemorrhage
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-03-17
   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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011058473

Write-up: This is a spontaneous report from a contactable physician of pediatrics via a Pfizer Sales Representative. A 10-week-old male patient, weight of 6.2 Kg, received the first dose of PREVENAR 13 on 13Mar2011, via intramuscular route of administration for Immunisation. The patient had no medical history. He was a normal baby. There were no concomitant vaccines administered on that day. However, previously, in Feb2011, the patient received ENGERIX B for Immunisation. On 06Mar2011, ROTARIX and PEDIACEL were administered for Immunisation. On 15Mar2011, the patient came to the hospital with cyanosis, dyspnea and pulmonary infiltration. He was referred to another hospital and the doctor in this hospital reported that the patient had a pulmonary hemorrhage. The patient died in the morning of 17Mar2011. The cause of death was unknown. An autopsy was ordered and the results were not available at the time of this report. The doctor in the second hospital felt that the patient''s pulmonary hemorrhage was not possibly related to PREVENAR-13.


VAERS ID: 419644 (history)  
Form: Version 1.0  
Age: 0.9  
Sex: Unknown  
Location: Foreign  
Vaccinated:2011-01-18
Onset:2011-02-14
   Days after vaccination:27
Submitted: 2011-03-25
   Days after onset:38
Entered: 2011-03-28
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK UN / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-02-14
   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:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Physical Examination (21Jan2011): No abnormality was noted. The patient was healthy without underlying disease or concurrent disease.
CDC Split Type: 2011058358

Write-up: This is a spontaneous report from a contactable pediatrician through a Pfizer sales representative. A 10-month-old infant (gender not reported) received on 18Jan2011 a dose of PREVENAR and a dose of ACT-HIB both administered subcutaneously. On 21Jan2011, a pediatric checkup revealed no abnormalities; no underlying nor concurrent diseases. On 14Feb2011 the patient died. The cause of death was not reported. The reporting pediatrician considered that the infant''s death was not an adverse event due to the vaccination because about one month had passed since the vaccination. The reporting pediatrician assessed the infant''s death unrelated to PREVENAR. No information was provided on whether an autopsy was performed. No follow-up attempts possible. No further information expected. The company agrees with the assessment of the reporting paediatrician and does not attribute the infant''s death to PREVENAR.


VAERS ID: 420533 (history)  
Form: Version 1.0  
Age: 0.96  
Sex: Male  
Location: Foreign  
Vaccinated:2011-03-25
Onset:2011-03-26
   Days after vaccination:1
Submitted: 2011-04-07
   Days after onset:12
Entered: 2011-04-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CA001A / 3 UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E87109 / 3 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Hyperhidrosis, Hypotonia, Pyrexia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-03-28
   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: PROTOVIT; TACHIPIRINA
Current Illness:
Preexisting Conditions: Perinatal (III grade); convulsions; hypoxic-ischaemic encephalopathy; dysphagia; respiratory distress; Nasogastric tube insertion due to hypoxic-ischaemic encephalopathy
Allergies:
Diagnostic Lab Data: Body temperature (26Mar2011): 38-38.5 degrees centigrade
CDC Split Type: 2011073643

Write-up: This is a spontaneous report received from the Regulatory Authority, Regulatory Authority report number 137473. A hospital physician (contactable through Regulatory Authority only) referred that an 11-month-old male patient (weight reported as 5.6kg at time of events) received the 3rd dose of PREVENAR 13, intramuscular on 25Mar2011 at 10:00 and the 3rd dose of INFANRIX HEXA intramuscular on 25Mar2011 at 10:00, both as vaccination. No relevant past drug history has been provided. The patient had a relevant history of Hypoxic-ischaemic encephalopathy (Perinatal (III grade)), Convulsion, Dysphagia, Respiratory distress and Gastrointestinal tube insertion (Due to hypoxic-ischaemic encephalopathy). Concomitant medications included PROTOVIT and TACHIPIRINA. On 26Mar2011 the patient experienced fever (body temperature (38-38.5 Centigrade). On 27Mar2011 the patient also experienced hypotonia and sweating attack. The outcome of fever, hypotonia and sweating attack was reported as not recovered. The patient died on 28Mar2011 at 07:00. The cause of death was not reported.


VAERS ID: 420695 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-04-08
Entered: 2011-04-11
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Healthy patient
Allergies:
Diagnostic Lab Data: No data
CDC Split Type: 201102033

Write-up: Initial report received from a healthcare professional in a foreign country on 30 March 2011 through the affiliates under the local reference number BR2011-157. A male patient (age and age group not specified), who was healthy, had received an Influenza vaccine (manufacturer, batch number, dose number, route, site and side of administration unknown) on an unspecified date. On an unspecified date, the patient presented complications and died. The reporter stated that he had knowledge of a consumer, whose grandfather, who was healthy, presented complications and died, after receiving the vaccine." No additional information was provided. List of documents held by sender: none.


VAERS ID: 421020 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2011-03-04
Onset:0000-00-00
Submitted: 2011-04-14
Entered: 2011-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB199BD / UNK UN / SC
TD: TD ADSORBED (DITANRIX) / GLAXOSMITHKLINE BIOLOGICALS XC12B023H1 / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Arrhythmia, Death, Rhabdomyolysis, Viral infection
SMQs:, Rhabdomyolysis/myopathy (narrow), Neuroleptic malignant syndrome (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-03-25
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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0712024A

Write-up: This case was reported by a regulatory authority (# ES-AGEMED-728425232) and described the occurrence of rhabdomyolysis in a 23-year-old male subject who was vaccinated with DITANRIX (GlaxoSmithKline), TWINRIX and (non-gsk) MMRVAXPRO. On 4 March 2011, the subject received an unspecified dose of DITANRIX (subcutaneous, administration site unknown) and an unspecified dose of TWINRIX (subcutaneous, administration site unknown). On 14 March 2011 the subject received an unspecified dose of MMRVAXPRO (subcutaneous, unknown). In March 2011, less than one month after vaccination with DITANRIX and TWINRIX, within days of vaccination with MMRVAXPRO, the subject experienced rhabdomyolysis, arrhythmia and viral syndrome. The subject was hospitalised. The subject died on 25 March 2011, cause of death was not reported. It was unknown whether an autopsy was performed. Further information has been expected.


VAERS ID: 421116 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Unknown  
Location: Foreign  
Vaccinated:2011-04-04
Onset:2011-04-05
   Days after vaccination:1
Submitted: 2011-04-14
   Days after onset:9
Entered: 2011-04-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR E5933 / UNK UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-04-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient was in good health condition. The patient was previously vaccinated with BCG vaccine and vaccine against hepatitis B after delivery and with second dose of vaccine against hepatitis B when was 1 month old. No reported concomitant therapy.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201102070

Write-up: Case received from a Healthcare Professional and the agency in a foreign country on 06 April 2011 under the reference number BH-2011-0001. A 02-month-old patient (gender not reported), with no reported medical history and concomitant therapy, had received a dose of ACTHIB (batch number E5933-1, route and site of administration not reported), a dose of DTP (manufacturer unknown, batch number, route and site of administration not reported) and a dose of OPV (manufacturer unknown, batch number, route and site of administration not reported) on 04 April 2011 in the morning. During the night there were some complications and the patient died on 05 April 2011. Results of autopsy were pending. The patient was in good health condition. The patient was previously vaccinated with BCG vaccine and vaccine against hepatitis B after delivery and with second dose of vaccine against hepatitis B when was 1 month old. "According to currently known data, it is probably timely coincidence between the patient''s death and vaccine administration."


VAERS ID: 421454 (history)  
Form: Version 1.0  
Age: 0.12  
Sex: Male  
Location: Foreign  
Vaccinated:2011-03-14
Onset:2011-03-14
   Days after vaccination:0
Submitted: 2011-04-19
   Days after onset:36
Entered: 2011-04-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME) / SANOFI PASTEUR 850556 / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER 9C3310 / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / PFIZER/WYETH ES320 / UNK MO / PO
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH E71415 / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS MCA289AB / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Crying, Death neonatal, Expired drug administered, Incorrect storage of drug, Irritability
SMQs:, Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Respiratory failure (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-03-14
   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:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: physical exam: no signs of sickness before and after the immunisation. The patient was a twin.
CDC Split Type: 2011081977

Write-up: This is a spontaneous report from a contactable consumer who reported that a 6-week-old male baby was vaccinated with a dose of PREVENAR on 14Mar2011 at about 9am. The patient also received on the 14Mar2011 a dose of ROTARIX, DPV, HEPATITIS B and PENTAXIM. All were administered via an unspecified route of administration. No medical history or lab data reported. It is reported that this patient was immunized at the same time as his twin sibling for their 6 week immunisation. Conditionally the babies were OK and there were no signs of sickness before and after the immunisation. The babies were only given the immunisation they were due for which was reported on their files or cards. Nothing else. The mother left with both babies in a stable condition. At night it was reported that the patient (baby) was irritable and crying a lot (outcome unknown). The patient (which was one of a twin) died the same day (14Mar2011). The patient''s death certificate reported cause of death from natural causes. No autopsy was done. Patient already buried within hours of death. Notes from adverse events following immunisation (AEFI) form stated that the patient was not admitted to the OPD or hospital. The patient did not have a previous reaction to immunisation, no allergies reported by the reporter, information was given prior to immunisation. The health status of the patient was assessed before immunisation. No other AEFI reported from this clinic in the last 30 days. Final classification by provincial EPI coordinator in cooperation with national office is unknown. On 16Mar2011 the clinic was visited and the cold chain of the vaccines was inspected. On opening the fridge the temperature was 11 degrees celsius all the VVM''s (vaccine vial monitors) of the polios was expired.


VAERS ID: 421462 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-04-20
Entered: 2011-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) / NOVARTIS VACCINES AND DIAGNOSTICS - / 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: No other medications
Current Illness: Unknown
Preexisting Conditions: Myocardial infarction, 3 months before receipt of the vaccine; Coronary artery disease, Double vessel coronary disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011AU32737

Write-up: Case number PHHY2011AU32737 is an initial literature report received on 15 Apr 2011: Authors described passive surveillance data for adverse events followed by immunisation in 2009. This report refers to a middle aged male patient. He had medical history of inferior myocardial infarction 3 months before vaccination and was diagnosed with double vessel coronary disease. He was vaccinated with pandemic influenza virus vaccine (manufacturer and batch number unknown). He was well when seen approximately 8 hours post-vaccination and no other reactions were observed or reported. He died one day after vaccination which was recorded as temporally associated with receipt of vaccine. The authors concluded that, it was unlikely that the vaccine had any role in this patient''s death.


VAERS ID: 421505 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2011-03-14
Onset:0000-00-00
Submitted: 2011-04-20
Entered: 2011-04-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / SC
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / SC
TD: TD ADSORBED (DITANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arrhythmia, Death, Rhabdomyolysis, Viral infection
SMQs:, Rhabdomyolysis/myopathy (narrow), Neuroleptic malignant syndrome (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1104USA02017

Write-up: Case of fatal outcome received from the Health Authorities in a foreign country on 12-APR-2011 under the reference number: ES-AGEMED-728425232. Case medically confirmed. A 23 year-old male patient had received an injection of MMR II (batch number not reported) via subcutaneous on 14-MAR-2011 and on the same month (MAR-2011, exact date not reported) the patient developed rhabdomyolysis, arrhythmia and viral syndrome. The patient had received previous injections of DITANRIX (batch number not reported) via subcutaneous on 04-MAR-2011 and an injection of TWINRIX (batch number not reported) via subcutaneous on the same day, 04-MAR-2011. The outcome from these adverse events was fatal (date of death not reported). Case reported as serious by the Health Authorities with death and hospital admission (start and stop dates not reported) as criteria. According to the HA''s report further information was expected. Other business partner numbers include E201102348.


VAERS ID: 421686 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-04-25
Entered: 2011-04-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (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: WAES1104USA02941

Write-up: Initial information has been received from a physician concerning a patient (the age and sex not reported) who intramuscularly received PNEUMOVAX 23, 0.5 mg once a day (date of vaccination, indication and injection site not reported, lot# and batch# were not provided). There was no information on concomitant medication. ON an unspecified day, the patient''s body temperature was 36.9 C degree in the morning of the date of vaccination, but the patient was vaccinated with PNEUMOVAX 23, 0.5 mg IM once a day at a physician''s discretion. The patient died of myocardial infarction at that night. No information about autopsy was provided. The reporting physician considered that the myocardial infarction was serious due to death. The reporting physician did not assess the relationship of myocardial infarction to PNEUMOVAX 23. Additional information has been requested.


VAERS ID: 422110 (history)  
Form: Version 1.0  
Age: 1.4  
Sex: Male  
Location: Foreign  
Vaccinated:2003-05-12
Onset:2003-05-24
   Days after vaccination:12
Submitted: 2011-05-02
   Days after onset:2900
Entered: 2011-05-03
   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: Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1104USA03196

Write-up: Case retrieved from the literature/information received from the author on 18-APR-2011. This case was linked with case E2004-00941. A 16 month old male was vaccinated on 12-MAY-2003 with the first dose of MMR II (batch number not reported). On 24-MAY-2003 sudden unexpected death occurred. No further information was available. The case was closed. Abstract BACKGROUND: The signal of an association between vaccination in the second year of life with a hexavalent vaccine and sudden unexpected deaths (SUD) in the two days following vaccination was reported in a foreign country in 2003. A study to establish whether the immunization with hexavalent vaccines increased the short term risk of SUD in infants was conducted in a foreign country. METHODOLOGY/PRINCIPAL FINDINGS: The reference population comprises around 3 million infants vaccinated in the study period 1999-2004 (1.5 million received hexavalent vaccines). Events of SUD in infants aged 1-23 months were identified through the death certificates. Vaccination history was retrieved from immunization registries. Association between immunization and death was assessed adopting a case series design focusing on the risk periods 0-1, 0-7, and 0-14 days after immunization. Among the 604 infants who died of SUD, 244 (40%) had received at least one vaccination. Four deaths occurred within two days from vaccination with the hexavalent vaccines (RR=1.5; 95% CI 0.6 to 4.2). The RRs for the risk periods 0-7 and 0-14 were 2.0 (95% C11.2 to 3.5) and 1.5 (95% CI 0.9 to 2.4). The increased risk was limited to the first dose (RR=2.2; 95% CI 1.1 to 4.4), whereas no increase was observed for the second and third doses combined. CONCLUSIONS: The RRs of SUD for any vaccines and any risk periods, even when greater than 1, were almost an order of magnitude lower than the estimates. The limited increase in RRs found appears confined to the first dose and may be partly explained by a residual uncontrolled confounding effect of age. Other business partner included: E2011-02498. No further information is available.


VAERS ID: 422330 (history)  
Form: Version 1.0  
Age: 0.39  
Sex: Female  
Location: Foreign  
Vaccinated:2011-04-14
Onset:2011-04-14
   Days after vaccination:0
Submitted: 2011-05-05
   Days after onset:21
Entered: 2011-05-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21FA980A / 2 UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E57714 / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac arrest, Death, Electroencephalogram normal, Hypertonia, Neurological examination normal, Nuchal rigidity, Peripheral coldness, Pyrexia, Resuscitation, Staring, Status epilepticus, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Parkinson-like events (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-04-25
   Days after onset: 11
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 experienced fever with the first dose of PREVENAR 13; The patient experienced fever with the first dose of INFANRIX HEXA; PREVENAR 13; Drug Indication:Vaccination, Drug Reaction: Fever; The patient experienced fever with the first dose of PREVENAR 13
Allergies:
Diagnostic Lab Data: 14-APR-2011, Body temperature, $g39 Centigrade; Neurological examination (15Apr2011): patient was vigil, reactive, without deficit; EEG (15Apr2011): without irritative abnormalities, theta predominance
CDC Split Type: 2011093460

Write-up: This is a spontaneous report from a physician (contactable through Regulatory Authority only) via the foreign Regulatory Authority. Regulatory Authority report number 139520. A 4-month-old female patient received the second dose of PREVENAR 13 intramuscularly on 14Apr2011 at 15:00 along with the second dose of INFANRIX HEXA intramuscularly, both for vaccination. No relevant medical history and concomitant medication had been provided. Relevant past product history included fever with the first doses of PREVENAR 13 and INFANRIX HEXA. On 14Apr2011, the patient developed fever with a body temperature of greater than 39 degrees Centigrade and recovered on 15Apr2011. On 15Apr2011, after the afternoon sleep, the patient was unresponsive to stimuli and, therefore, the patient went to the Emergency Room where she was found to have cold extremities, hypertonia and nuchal rigidity with normotensive fontanel and was staring. On an unspecified date, the patient recovered. The patient underwent neurological examination, which showed the patient was vigil and reactive without deficit, and an EEG, which was without irritative abnormalities and theta predominance. An EEG was scheduled for 19Apr2011 but the family did not come. On 23Apr2011, the patient developed cardiac arrest and was treated by the Emergency Medical Service. After twenty minutes of resuscitation, cardiac activity started again but with irreversible neurological sequelae. The patient died on 25Apr2011. The cause of death was reported as unknown.


VAERS ID: 422466 (history)  
Form: Version 1.0  
Age: 0.16  
Sex: Male  
Location: Foreign  
Vaccinated:2011-04-04
Onset:2011-04-05
   Days after vaccination:1
Submitted: 2011-05-07
   Days after onset:32
Entered: 2011-05-09
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Public       Purchased by: Public
Symptoms: Asphyxia, Autopsy, Brain oedema, Cerebrovascular disorder, Death, Hepatic steatosis, Histology, Increased bronchial secretion, Lung disorder, Pathology test
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Hyponatraemia/SIADH (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-04-05
   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: No
Current Illness: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data: Autopsy, histology, pathology - histology, lack of toxicology analysis of vials, lack of bacteriology analysis, lack of mercury presence analysis
CDC Split Type:

Write-up: Died 14 hours after immunization, suffocation, in airways pink foamy content, split alveolar septs, hyperaemia at oedema cerebri, focal fat infiltrates of hepatocytes.


VAERS ID: 422813 (history)  
Form: Version 1.0  
Age: 0.44  
Sex: Unknown  
Location: Foreign  
Vaccinated:2010-07-12
Onset:2010-07-15
   Days after vaccination:3
Submitted: 2011-05-12
   Days after onset:301
Entered: 2011-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPH: DTAP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS XROLA102A1 / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Anaemia, Arrhythmia, Cardiogenic shock, Death, Fatigue, Gastrointestinal surgery, Haematochezia, Hepatic failure, Insomnia, Intussusception, Pyrexia, Septic shock, Vomiting
SMQs:, Cardiac failure (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Toxic-septic shock conditions (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-07-17
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0718451A

Write-up: This case was reported by a healthcare professional via another manufacturer (Fiocruz) and described the occurrence of intussusception in a 5-month-old subject of unspecified gender who was vaccinated with ROTARIX (Fiocruz). Concurrent vaccination included combined diphtheria, tetanus, acellular pertussis and Haemophilus influenzae type b vaccine (manufacturer unspecified, unknown route of administration) and live attenuated oral poliomyelitis vaccine (manufacturer unspecified, oral), given on 12 July 2010. On 12 July 2010, the subject received also 2nd dose of ROTARIX (oral). On 15 July 2010, 3 days after vaccination with ROTARIX, the subject experienced vomiting (first symptoms of intussusception). The subject was hospitalised for vomiting. On 16 July 2010, in the morning, the subject was discharged but was hospitalised again later in the day due to experience of insomnia and bloody stool. In the evening, the subject underwent a surgical reduction of bowels. On 17 July 2010, by dawn, the subject experienced high fever (unknown body temperature), tiredness and arrhythmia. The subject died on 17 July 2010 from anemia (onset unspecified), cardiogenic shock, intussusception (primary cause of death), liver failure and septic shock (secondary cause of death). It was unknown whether an autopsy was performed.


VAERS ID: 423435 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-05-19
Entered: 2011-05-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / CSL LIMITED 098618802 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Brain injury, Congenital anomaly, Drug exposure during pregnancy, Stillbirth
SMQs:, Congenital, familial and genetic disorders (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (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: 2011028537

Write-up: This health authority report (initial receipt 10-MAY-2011) concerns a neonate. On an unknown date the patient was exposed to 0.5ml of ENZIRA (batch number: 09861818802) via transplacental route. On an unknown date the patient experienced stillbirth at term. There was evidence of an old brain injury, not the cause of death, but suggestion that the reporter needed to exclude chance of vaccine as a cause. The event outcome was fatal. The cause of death was stillbirth. At the time of death, the patient had not recovered from the event ''old brain injury''. The reporter considered events to be serious due to death and congenital abnormality. Batch record review of lot number 098618802 received on 18-MAY-2011 noted that all deviations related to the manufacture of this lot were assessed as having no impact on product quality. All QC testing was satisfactory with no out of specification results reported. There are no outstanding issues related to this lot that would potentially affect product quality. In conclusion, there has been no assignable cause drawn from this investigation that would indicate any association with the adverse event reported.


VAERS ID: 424044 (history)  
Form: Version 1.0  
Age: 0.42  
Sex: Male  
Location: Foreign  
Vaccinated:2011-05-02
Onset:2011-05-03
   Days after vaccination:1
Submitted: 2011-05-25
   Days after onset:22
Entered: 2011-05-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS A20CA589A / 2 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E86514 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood test, Cyanosis, Laboratory test, Listless, Lumbar puncture, Mouth haemorrhage, Respiratory arrest, Resuscitation, Stool analysis, Sudden death, Sudden infant death syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-05-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011108770

Write-up: This is a spontaneous report from a contactable other health care professional received from a foreign Medicines Agency, regulatory authority number NO-NOMAADVRE-FHI-2011-12401. A 5-month-old male patient received the second dose of PREVENAR 13 batch number E86514 and INFANRIX-POLIO+HIB batch A20CA589A on 02May2011. Medical history was reported as Previously health boy, normal development. Both parents smoke. Concomitant medications were not reported. After vaccination, 02May2011, fever was not noted afterwards, a bit listless but otherwise in good condition. On 03May2011, he experienced sudden death; cause of death reported as sudden infant death. The patient went to sleep in his own bed as usual. The patient''s father checked on him at 23:30, and the patient was sleeping calmly. On 03May2011, the father went in to the boy''s room at 07:30 in the morning (the boy usually slept until approximately 08:00). The father noticed that something was wrong as the boy was laying in prone position instead of supine. The boy was not breathing, his face was blue and there was blood in his mouth. Resuscitation was started. When the anesthesiologist came, rigor mortis and postmortem lividity was found and resuscitation was ended. Examination at hospital included: Rigor mortis and postmortem lividity. Petechiae was not seen, nor were any fractures felt, extremities were seen in normal position. No visible external injuries. A little blood in mouth (but difficult to examine mouth due to rigor mortis). Blood samples, lumbar puncture, nasopharynx tests taken. Bladder puncture was not successful. Fecal test taken. Autopsy will be performed. This is a preliminary report. The foreign Institute of Public Health has asked for further information (test results and autopsy report) from the hospital. The foreign medicines Agency assessed the causality as possible." No follow-up attempts possible. No further information expected.


VAERS ID: 424213 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-05-20
Onset:2011-05-20
   Days after vaccination:0
Submitted: 2011-05-27
   Days after onset:7
Entered: 2011-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS YHBVB872AA / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Coma, Death, Irritability
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-05-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0722116A

Write-up: This case was reported by a sales representative and described the occurrence of coma in 3-year-old female subject who was vaccinated with ENGERIX B Pediatric (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject received the first dose of ENGERIX B previously without any adverse event. On 20 May 2011, the subject received 2nd dose of ENGERIX B Pediatric (.5 ml, intramuscular, unknown site of injection). On 20 May 2011, after having received vaccination with ENGERIX B pediatric, the subject went home and felt into sleep till about 4:00 PM. Then she experienced irritability and coma. The sales representative reported that the events were unrelated to vaccination with ENGERIX B pediatric. The subject died on 20 May 2011 before any medical treatment was prescribed. The parents refused the autopsy.


VAERS ID: 424283 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2011-05-16
Onset:2011-05-17
   Days after vaccination:1
Submitted: 2011-05-27
   Days after onset:10
Entered: 2011-05-31
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CB004A / 2 LG / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F08783 / 2 LG / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Otitis media, Peripheral coldness, Resuscitation
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-05-17
   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:
Current Illness:
Preexisting Conditions: PREVENAR 13 1st dose, lot unknown, Drug Reaction: No adverse event; INFANRIX HEXA 1st dose, lot unknown, Drug Reaction: No adverse event
Allergies:
Diagnostic Lab Data: Autopsy result (18May2011): III autopsy diagnosis: plenty passing earwax in the right ear. Evidence of ropy yellow mucus in both middle ears. Cyanosis and blood richness of brain. Littel-spot-shaped bleeding in mucous membranes at the back of heart, in pericard, at the back of lungs as well as mammary gland. Normal organs. No evidence of death-causal traumatization. Focal over blowing of lungs (reanimation consequence). Plenty air filling in stomach. Injection marks at both thighs. IV Cause of death: not identifiable by autopsy. V Mode of death: not clarified. VI During autopsy no hints (macroscopic findings), which allow assessment of cause of death, were found. Evidence-signs of an otitis media were detected. However, exclusion of a relevant toxicologic influence, a microbiological, virological and tissue examination is needed to make a diagnosis. Regarding a possible vaccination reaction a specific examination of possible antibodies is necessary. Results will be reported in final protocol. VII From the forensic point of view corpse was released for burial. VIII Asservates included: parts of all relevant organs for tissue examinations, parts of liver, kidney and brain as well as heart blood, stomach content and urine for chemical-toxicological examinations. Thigh vein blood for determination of alcohol level. Cerebral ventricle fluid for determination of urea and glucose level. Smear for microbiological examinations. If no order for examination or further asservation will follow, asservates will be deleted after 6 months. Dry blood trace. IX The autopsy performer reserved themself a final scientifical valid forensic assessment until completion of investigations and inspection of files.
CDC Split Type: 2011110412

Write-up: This is a spontaneous report downloaded from the web-portal of the foreign Health Authority which involves PREVENAR 13. Regulatory Authority report number DE-PEI-PEI2011016343. A 3-month-old female patient received the second dose of PREVENAR 13 (lot no. F08783) via intramuscular route of administration (thigh) on 16May2011. Additional suspect vaccination included the second dose of INFANRIX HEXA administered on 16May2011 via intramuscular route of administration (lot no. A21CB004A) (other thigh) on 16May2011. Further relevant medical history included the child was always healthy till now and also the 4 siblings have not been seriously ill. Concomitant medication was not provided. Past vaccine history include the first dose of PREVENAR 13 and INFANRIX HEXA, on 14Apr2011 (lot no. unknown), route of administration was not reported for either vaccines. Vaccinations of PREVENAR 13 and INFANRIX HEXA on 14Apr2011 were well tolerated. At 5:02 am on 17May2011 the emergency doctor was contacted by the patient''s parents as the child was found cold and lifeless by the parents. Cardiopulmonary resuscitation was without success (duration of cardiopulmonary resuscitation was 10 minutes after cardiopulmonary resuscitation by layperson). The patient died on 17May2011. Further investigations revealed while vaccination on 16May2011 a mild intestinal infection was current, wherefore special food was given to take home. At midnight the patient''s mother had looked after the child and at that time the child lay inconspicuous and sleeping in the bed. An autopsy was done to assess cause of death. By autopsy (preliminary report) cause of death was not identifiable and mode of death could not be clarified. During autopsy no hints (macroscopic findings), which allow assessment of cause of death, were found. Evidence-signs of otitis media were detected. However, exclusion of a relevant toxicological influence, a microbiological, virological and tissue examination is needed to make a diagnosis (examinations are required). Regarding a possible vaccination reaction a specific examination of possible antibodies was reported to be necessary. The autopsy performer reserved themselves a final scientific valid forensic assessment until completion of investigations and inspection of files. The final autopsy report has been requested. This case is being treated according to the country''s act.


VAERS ID: 424378 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-05-31
Entered: 2011-06-01
   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: WAES1105USA03486

Write-up: Case reported by a consumer and retrieved from a website by a healthcare professional (specialist) who transmitted to agency on 18-May-2011. This case was not medically confirmed. The consumer published an open letter about vaccination on the website, a citizen''s association. This open letter was addressed to an Agency. A 12-year-old female patient was vaccinated with a dose of GARDASIL ( lot and batch number not reported) on a recent date in. It was reported that the patient deceased 2 days after the vaccination. Medical history: It was reported that the patient was in excellent condition before the vaccination. Following to the reporter, the GP had told the parents that the vaccine was very safe but that, unfortunately, the patient had reacted to it. Until now, no other source confirmed the case. The healthcare professional (specialist) wrote to the consumer for more information. Other business partner included E2011-03076. No further information is available.


VAERS ID: 424381 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2011-02-15
Onset:2011-04-03
   Days after vaccination:47
Submitted: 2011-05-31
   Days after onset:58
Entered: 2011-06-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1016Z / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal distension, Abdominal pain, Death
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2011-04-07
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1105USA03118

Write-up: Information has been received from a physician as part of the GARDASIL Access Program concerning a female who entered a HPV vaccine pilot project. On 15-FEB-2011 was vaccinated with 3rd dose of GARDASIL (lot # 666987/1016Z). The patient was admitted to hospital with abdominal pain and distension on 03-APR-2011. The patient died on hospital on 07-APR-2011. The cause of death was abdominal pain and abdominal distension. The reporting physician felt that abdominal pain (grade 5) and abdominal distension (grade 5) were not related to GARDASIL. Abdominal pain (grade 5) and abdominal distension (grade 5) were considered to be immediately life-threatening. A lot check has been initiated. Additional information has been requested.


VAERS ID: 424457 (history)  
Form: Version 1.0  
Age: 1.3  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-06-01
Entered: 2011-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Anaemia, Autopsy, Coombs negative haemolytic anaemia, Coombs test positive, Death, Immunoglobulin therapy, Malaria
SMQs:, Haemolytic disorders (narrow), Haematopoietic erythropenia (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011KE46237

Write-up: Case number PHHY2011KE46237 is an initial literature report received on 26 May 2011. The authors described a randomised, double-blind, Phase IIb, comparator-controlled trial data for FMP1/AS02 candidate malaria vaccine''s safety, immunogenicity, and efficacy in children. Children were randomised in a 1:1 fashion to receive either FMP1/AS02 (50 mg) or RABIPUR. Four hundred children were randomised in the order of presentation to the clinic on the days of first vaccination; 200 received FMP1/AS02 and 200 (comparator group) received RABIPUR. This report refers to a 15-months-old male patient. This patient in the comparator group, presented with malaria 24 days after his third vaccination, and developed severe anaemia four days into antimalarial treatment. The child was hospitalised and transfused several times for a recurrent Coombs negative, haemolytic anaemia that was refractory to transfusion. No haemoglobinopathy was identified. He received antimalarial treatment for four days and died 38 days later. Autopsy showed no specific etiology. It was also stated that three of his brothers had died of anaemia in early childhood.


VAERS ID: 424824 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Male  
Location: Foreign  
Vaccinated:2011-05-17
Onset:2011-05-26
   Days after vaccination:9
Submitted: 2011-06-02
   Days after onset:7
Entered: 2011-06-06
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARILRIX) / GLAXOSMITHKLINE BIOLOGICALS A70CB757A / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood glucose decreased, Blood pH decreased, Blood pressure immeasurable, Blood sodium increased, Corneal reflex decreased, Death, Heterophoria, PCO2 normal, PO2 decreased, Pulse absent, Pyrexia, Respiratory failure, Resuscitation, Sepsis, Skin disorder, Tachycardia, Tachypnoea
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Lactic acidosis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), 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), Corneal disorders (narrow), Eosinophilic pneumonia (broad), Ocular motility disorders (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (narrow), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-05-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Neurological deficit; Visual impairment; Mental retardation; Epilepsy; Meningitis
Allergies:
Diagnostic Lab Data: Blood glucose, 26May2011, 30 Units; Blood glucose, 26May2011, 104mg/dl; Body temperature, 26May2011, 41.5deg.C; Oxygen saturation, 26May2011, 63%; Partial arterial pressure of carbon dioxide, 26May2011, 33Units; Partial arterial pressure of oxygen, 26May2011, 40Units; Sodium, 26May2011, 166Units; pH, 26May2011, 7.22Units
CDC Split Type: B0722914A

Write-up: This case was reported by a regulatory authority (141629) and described the occurrence of sepsis in a 3-year-old male subject who was vaccinated with VARILRIX (GlaxoSmithKline). The subject''s medical history included meningitis. Concurrent medical conditions included epilepsy, mental retardation, neurological deficit and visual impairment. These medical conditions were consequences of meningitis. On 17 May 2011, the subject received an unspecified dose of VARILRIX (administration site and route unknown). On 26 May 2011, 9 days after vaccination with VARILRIX, the subject experienced sepsis, respiratory failure, tachycardia, tachypnea, skin patches, cataphoria and fever (41.5 deg.C). Oxygen saturation was 63%. The subject was arrived at the first aid accompanied by his father at 7.53 am. Blood gas analysis was performed. Ph: 7.22, partial arterial pressure of carbon dioxide: 33, partial arterial pressure of oxygen: 40, sodium: 166, glucose: 30, blood pressure was not detectable. An intraosseous access was performed. The subject was treated with cardiopulmonary resuscitation, Glucose, SOLUCORTEF, Adrenalin and atropine. From 8.10 am to 8.37, during 27 minutes, a cardio-pulmonary resuscitation was performed without success. There was an absence of corneal reflexes and cardiac activity. The regulatory authority reported that the events were possibly related to vaccination with VARILRIX. The subject died on 26 May 2011 from sepsis. It was unknown whether an autopsy was performed.


VAERS ID: 424962 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2010-09-28
Onset:0000-00-00
Submitted: 2011-06-07
Entered: 2011-06-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CA765A / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH E36530 / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS 0075Z / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-10-04
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:
CDC Split Type: 2011119243

Write-up: This is a literature report from the Prescriber. The article reported that a search of the Therapeutic Goods Administration''s (TGA) Adverse Drug Reactions Database using the terms PREVENAR (medicine trade name) and death or death maybe drug (outcome) identified five cases. For these five reports, the age at death ranged from two to four months, the dates of death from 2002 to 2010, and concomitant vaccine was administered in all cases INFANRIX (and/or rotavirus vaccine). Further information, including hospital records (discharge summary) and coroners reports, was collected for each of these cases by contacting the initial reporter of the event. A causal association between PREVENAR and the adverse event of death was determined to be unlikely for four of the five cases. These assessments were based on the length of time between vaccination and event, the detailed description of the circumstances surrounding the event, coroners'' report and past medical history. For the remaining case, the initial description suggested that causality was unlikely. The article also reported that the TGA had concluded that there was no evidence of a causal association between PREVENAR and deaths in children. Follow up (02Jun2010): New information reported from the Therapeutic Goods Administration (TGA), Office of Product Review (OPR) includes: Regulatory Authority report number 275295. A 9-week-old male patient received a dose of PREVENAR (route of administration not specified) (batch number E36530), along with a dose of INFANRIX HEXA (route of administration not specified) (batch number A21CA765A) and a dose of ROTARIX orally (batch number 0075Z) on 28Sep2010. All three vaccines were reported as suspected drugs. Relevant medical history and concomitant medication was not provided. On an unknown date the previously asymptomatic infant was noted to have stopped breathing approximately 30 minutes post feed (unlikely to be vaccine related). Therapeutic measures taken as a result of this included cardiopulmonary resuscitation (CPR). On an additional follow-up, cardiac and respiratory arrest was reported. At the hospital the infant received adrenaline and atropine, a defibrillator was used for nil pulse and CPR was administered. The infant deceased on 04Oct2010. The staff at the medical centre had no knowledge of any problems following vaccination and was unaware of any details surrounding the death of the infant. It is unclear if the infant was seen only in the emergency department or was admitted to the hospital. Outcome for the events was death. A report on 06Jun2010 reported outcome as death maybe drug. Causality was reported as possible by the Regulatory Authority. Follow-up attempts completed. No further information expected.


VAERS ID: 425073 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-05-17
Onset:0000-00-00
Submitted: 2011-06-09
Entered: 2011-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthma, Bronchopneumonia, Cardiac arrest, Cardiopulmonary failure, Chest X-ray abnormal, Condition aggravated, Cough, Cyanosis, Death, Dyspnoea, Eosinophil count normal, General physical health deterioration, Haematocrit decreased, Haemoglobin decreased, Lung infiltration, Monocyte count normal, Nasopharyngitis, Neutrophil count, Platelet count increased, Pneumonia, Pyrexia, Respiratory disorder, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Asthma/bronchospasm (narrow), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-05-27
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Asthma, Progression of concomitant disease bronchial asthma severe; Pneumonia
Preexisting Conditions: Febrile convulsion; Simple febrile seizure secondary to pneumonia and urinary tract infection; Urinary tract infection; Simple febrile seizure secondary to pneumonia and urinary tract infection
Allergies:
Diagnostic Lab Data: 05/26/2011, Chest X-ray, abnormal, bronchopneumonia, lung infiltrates, both lungs; 05/26/2011, Eosinophil count, 4; 05/26/2011, Haematocrit, 96; 05/26/2011, Haemoglobin, 29; 05/26/2011, Monocyte count, 5; 05/26/2011, Platelet count, 576; 05/26/2011, White blood cell count, 25.5, Leukocytes: 37
CDC Split Type: PHHO2011PH09115

Write-up: Case number PHHO2011PH09115, is an initial report received on 27 May 2011, from clinical study. This 2-year-old female subject was enrolled in a study. The subject''s medical history included pneumonia, simple febrile seizure secondary to pneumonia and urinary tract infection and on 13 Jan 2011 the subject was diagnosed with asthma. The subject started the study vaccination on 17 May 2011 at 19:49. On 22 May 2011 (4 days after commencing the study vaccine), the subject experienced cough and colds without fever. No medications were given. On 25 May 2011, the subject experienced a persistent cough and colds with severe fever and difficulty in breathing. The subject was treated with 3 doses of salbutamol nebuliser in the ER and the subject experienced slight relief. The subject was advised for admission but her parents refused. The subject experienced an acute episode of tight air entry and cyanosis. With further explanation from the physician, the subject''s mother opted for hospital admission on 26 May 2011. The same day (in the night), the subject experienced another episode of tight air entry with cyanosis and the physician suggest for intubation but the subject''s relatives refused for it. However, the subject''s mother and grandmother refused and secured a waiver. The same day, the subject underwent a chest x-ray which showed lung infiltrates in both lungs. The diagnosis was bronchopneumonia. The subject received treatment with cefuroxime, hydrocortisone, nebulisation with salbutamol. COMBIVENT, paracetamol and an aminophylline drip was started. The subject''s laboratory tests were as follows: hemoglobin 9, hematocrit 20, WBC (white blood cell), 25.5, ''segmented'' 53, lymphocytes 37, monocytes 5, eosinophil 4 and their platelet count was 576. On 27 May 2011 around 5 AM, the subject experienced another episode of cyanosis and tight air entry. The subject''s condition deteriorated and eventually went into cardiac arrest at 06:05 AM. The subject died. An autopsy was not performed. The subject''s final diagnosis was cardiorespiratory failure secondary to pneumonia with bronchial asthma severe in acute exacerbation. The investigator stated that ''the subject was suffering from recurrent pneumonia. The first episode was on 13 Jan 2011 and was completely treated. The second episode was on 06 Mar 2011 and was also completely treated. The last episode was on 25 May 2011 and she died on 27 May 2011''. The investigator indicated that a possible contributory factor to the event was progression of concomitant disease bronchial asthma severe. The seriousness criterion for bronchopneumonia was death. The investigator reported that the events were suspected to treatment with the study vaccine and the rationale was the occurrence of signs and symptoms within 1 week from the time of vaccination. Follow up received on 03 Jun 2011: Asthma med history and diagnosis date, no autopsy, recurrent pneumonia info., labs. Follow up received on 08 Jun 2011, prior to circulation of previous follow up: Medical history updated, rationale for causality, treatments updated, hospitalisation details, causality for bronchopneumonia and seriousness.


VAERS ID: 425110 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-06-09
Entered: 2011-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / ID

Administered by: Other       Purchased by: Other
Symptoms: Bronchopulmonary aspergillosis, Death, Obliterative bronchiolitis
SMQs:, Interstitial lung disease (narrow), Eosinophilic pneumonia (broad), Infective pneumonia (narrow), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Lung transplant
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0724903A

Write-up: This case was reported in a literature article and described the occurrence of pulmonary aspergillus in an adult subject of unspecified gender who was vaccinated with FLUVIRAL (GlaxoSmithKline). Concurrent medical conditions included lung transplant. In 2008, the subject received an unspecified dose of FLUVIRAL (intradermal, administration site unknown, batch number not provided). 141 days after vaccination with FLUVIRAL, the subject died from aspergillus lung infection and bronchiolitis obliterans syndrome. It was unknown whether an autopsy was performed. The subjects of this study had receive FLUVIRAL or MUTAGRIP. It was not specified which vaccines was administered in this subject. Summary of the literature article: In this study, the authors compared the immunogenicity of influenza vaccine administered intradermally to the standard intramuscular vaccination in lung transplant recipients. The patients were randomized to receive the trivalent inactivated seasonal 2008-9 influenza vaccine containing either 6 ug (intradermal) or 15 ug (intramuscular) of hemagglutinin per viral strain. Immunogenicity was assessed by measurement of geometric mean titer of antibodies using the hemagglutination-inhibition (HI) assay. Vaccine response was defined as a 4-fold or higher increase of antibody titers to at least one vaccine antigen. Eighty-five patients received either the intradermal (n = 41) or intramuscular (n = 44) vaccine. Vaccine response was seen in 6 of 41 patients (14.6%) in the intradermal vs 8 of 43 (18.6%) in the intramuscular group (p = 0.77). Seroprotection (HI greater than or equal to 1:32) was 39% for H1N1, 83% for H3N2 and 29% for B strain in the intradermal group vs 28% for H1N1, 98% for H3N2 and 58% for B strain in the intramuscular group (p =0.36 for H1N1, p = 0.02 for H3N2, p less than 0.01 for B). Mild adverse events were seen in 44% of patients in the intradermal group and 34% in the intramuscular group (p = 0.38). The authors'' conclusion stated that the immunogenicity of the 2008-9 influenza vaccine given intradermally or intramuscularly was overall poor in lung transplant recipients. Novel strategies for influenza vaccination in this population are needed.


VAERS ID: 425126 (history)  
Form: Version 1.0  
Age: 0.11  
Sex: Male  
Location: Foreign  
Vaccinated:2010-06-03
Onset:2010-06-06
   Days after vaccination:3
Submitted: 2011-06-07
   Days after onset:366
Entered: 2011-06-09
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CA672A / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D02112 / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA09 / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asphyxia, Autopsy, Cardiac arrest, Coma, Coma scale abnormal, Death, Endotracheal intubation, Hypoxic-ischaemic encephalopathy, Mechanical ventilation, Myoclonus, Respiration abnormal
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-06-07
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Glasgow Coma Scale (06Jun2010): 3; Autopsy results (unspecified date): Hypoxic brain damage consistent with positional asphyxia
CDC Split Type: 2011119149

Write-up: This is a literature report from an article. The article reported that a search of the agency''s database using the terms PREVENAR (medicine tradename) and death or death maybe drug (outcome) identified five cases. For these five reports, the age at death ranged from two to four months, the dates of death from 2002 to 2010, and concomitant vaccine was administered in all cases (INFANRIX and/or rotavirus vaccine). Further information, including hospital records (discharge summary) and coroners'' reports, was collected for each of these cases by contacting the initial reporter of the event. A causal association between PREVENAR and the adverse event of death was determined to be unlikely for four of the five cases. These assessments were based on the length of time between vaccination and event, the detailed description of the circumstances surrounding the event, coroners'' report and past medical history. For the remaining case, the initial description suggested that causality was unlikely. The article also reported that the agency had concluded that there was no evidence of a causal association between PREVENAR and deaths in children. Follow up (02Jun2010): The agency reported further information. Regulatory authority report number 272553. A 6-week-old male patient, received a dose of PREVENAR (route of administration not specified) along with a dose of INFANRIX HEXA (route of administration not specified) and a dose of ROTARIX orally on 03Jun2010. On 06Jun2010, the patient developed cardiac arrest and was admitted to the hospital. The patient had a Glasgow Coma Scale (GCS) score of 3, intermittent myoclonic jerking consistent with severe hypoxic brain injury, and no spontaneous respiration when extubated. Therapeutic measures taken as a result of the event included treatment with intubation and ventilation. The patient died on 07Jun2010 with death maybe drug as reported. An autopsy was performed and the reported cause of death was hypoxic brain damage consistent with positional asphyxia. Causality was reported as unclear by the regulatory authority and further information stated death was not related to vaccination. This case is one of five cases recently mentioned in the article. This case is related to cases AUWYE355224SEP07, AU-WYE-G06183310, HQWYE904905AUG03 and 2011119243. Follow-up attempts completed. No further information expected.


VAERS ID: 425151 (history)  
Form: Version 1.0  
Age: 0.28  
Sex: Male  
Location: Foreign  
Vaccinated:2011-06-01
Onset:2011-06-01
   Days after vaccination:0
Submitted: 2011-06-08
   Days after onset:7
Entered: 2011-06-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME) / SANOFI PASTEUR G4133 / UNK UN / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER 9C331 / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F12271 / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA245DA / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cyanosis, Death, Peripheral coldness, Pulse absent, Respiratory arrest, Resuscitation
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-06-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011120582

Write-up: This is a Spontaneous report received from a contactable Department of Health official to a Pfizer representative. The Department of Health official received the report from a contactable pharmacist with additional information provided by a nurse and other healthcare professional. A 14-week-old, male patient received a dose of PREVENAR 13, lot number F12271, on 01Jun2011 via intramuscular route of administration for pneumococcal disease. The PREVENAR 13 vaccination schedule was reported as 6 weeks, 14 weeks and 9 months, however, it is unknown which of these the patient had received. Relevant medical history was not provided although it was noted that the patient did not have any allergies and no side effects were noted on previous (unspecified) vaccinations. It was reported that the patient "appeared healthy" prior to immunization. Concomitant suspect vaccines received on 01Jun2011 included: ROTARIX via oral route of administration, PENTAXIM via intramuscular route of administration and a Hepatitis B vaccine (manufacturer unspecified), unspecified route of administration, also administered on 01Jun2011. It was additionally reported that "other vaccines are all not yet specified". Concomitant medications were not provided. On 01Jun2011, the patient presented at the clinic and received the vaccines. Two hours later, (01Jun2011) the patient returned to the clinic. The patient was cyanotic - lips were blue with cold hands and not breathing. The patient had no heartbeat on auscultation and no pulse on palpation. Active resuscitation was initiated but was proven unsuccessful. The patient experienced death 2 hours post-vaccination. The seriousness criteria for this event was fatal. The outcome of the event at the time of the report was fatal. The cause of death was not yet known. A post-mortem is to be conducted. Death occurred after the patient received a dose of PREVENAR 13. In addition, it was reported that 8 other children received doses from the same batch at the site with no ill effect. Based on the information available in the case, the Company considers this individual report would not modify the benefit/risk profile of the suspect drug.


VAERS ID: 425263 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2011-06-03
Onset:2011-06-04
   Days after vaccination:1
Submitted: 2011-06-10
   Days after onset:6
Entered: 2011-06-13
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR G1134 / 1 LA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 10J02A / 1 RA / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-06-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No relevant medical history; No concomitant therapy; The patient''s body temperature was 36 degrees C and he had eye discharge and slight cough before the vaccination; The patient had no underlying diseases.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201103211

Write-up: Case received from the Health Authorities in a foreign country on 06 June 2011 under the local number A201100405 (HA''s number HIB-180). A 02-month-old male patient, with no medical history and concomitant therapy, had received his first subcutaneous dose of ACTHIB (batch number G1134) in the left upper arm and his first subcutaneous dose of PREVENAR (other manufacturer, batch number 10J02A) in the right upper arm on 03 June 2011 at 10:50 am. The patient''s body temperature was 36 degrees C and he had eye discharge and slight cough before the vaccination. The patient had no underlying diseases. On 04 June at 02:00 am, the patient had breast-feeding. No abnormal finding was observed at that time. Around 07:30 am, his family member found the patient was in cardio-respiratory arrest. The patient was transported to an emergency care hospital, where he was confirmed dead. Administrative autopsy was performed in university hospital and the diagnosis was sudden infant death syndrome. Physician''s comment: The patient died after receiving the vaccinations with ACTHIB and PREVENAR. He had no underlying diseases. According to the physician, this case was serious and the causality assessment between the event and ACTHIB was not assessable.


VAERS ID: 425460 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2011-06-04
Onset:2011-06-06
   Days after vaccination:2
Submitted: 2011-06-14
   Days after onset:8
Entered: 2011-06-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 915573A / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-06-06
   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:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011124937

Write-up: This is a spontaneous report from a contactable nurse and from physicians communicated to a Pfizer sales representative. It was reported that a female child (unspecified race, age, weight and height) received on 04Jun2011 the second dose of PREVENAR-13, lot 915573A, expiration date 30Jun2012, via intramuscular route of administration. It was not informed if patient had relevant medical history or if she was taking concomitant medications. Patient suffered sudden death on 06Jun2011. No additional information was available at the time of this report. Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVENAR 13.


VAERS ID: 425535 (history)  
Form: Version 1.0  
Age: 0.8  
Sex: Male  
Location: Foreign  
Vaccinated:2011-06-09
Onset:2011-06-09
   Days after vaccination:0
Submitted: 2011-06-15
   Days after onset:6
Entered: 2011-06-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEA: MEASLES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Pyrexia, Resuscitation
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: 2011-06-10
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011127057

Write-up: This is a spontaneous report of from a contactable physician reported to a medical information specialist. A 9-month-old male infant was administered a dose of PREVENAR 13 on the 09Jun2011, via an unknown route of administration. A dose of MEASLES VIRUS VACCINE via unknown route of administration, was also administered on 09Jun2011. Medical history was not reported. Concomitant medications were not reported. In Family history there was nothing major to report. The baby developed a fever and the parents took him to the Emergency Room on 09Jun2011. A EMPAPED (dose unknown) was administered as treatment. On the morning of 10JUN2011, the baby went to day care center. Then he had to be taken to the hospital again, but was dead on arrival. Resuscitation was tried but failed. The physician reported that she arrived on call as resuscitation was being performed and therefore had no further information to report. The physician did not believe the event was due to the PREVENAR. The outcome of the event was Fatal. Based on the limited currently available, the company agrees with the assessment of the reporting HCP and does not attribute the event fatal fever to PREVENAR 13.


VAERS ID: 425561 (history)  
Form: Version 1.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2011-03-04
Onset:2011-03-05
   Days after vaccination:1
Submitted: 2011-06-16
   Days after onset:102
Entered: 2011-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (INFANRIX TETRA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Arrhythmia, Autopsy, C-reactive protein increased, Cardiac arrest, Cardiac death, Cytogenetic analysis normal, Death, Diarrhoea, Fatigue, General physical health deterioration, Myositis, Pain, Pulseless electrical activity, Pyrexia, Resuscitation, Troponin I increased, Unresponsive to stimuli, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Pseudomembranous colitis (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), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-03-06
   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: C-reactive protein, 06Mar2011, 38units; Troponin I, 06Mar2011, 43units
CDC Split Type: B0726357A

Write-up: This case was reported by a physician via a regulatory authority (NO-NOMAADVRE-FHI-201-12505) and described the occurrence of cardiac arrest in a 42-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline), DTP-IPV. On 4 March 2011, the subject received unspecified dose of TWINRIX (parenteral, injection site unknown, batch number not provided) and unspecified dose of DTP-IPV (parenteral, injection site unknown, batch number not provided). On 5 March 2011, 1 day after vaccination with DTP-IPV and TWINRIX, the subject experienced tiredness, body pain, diarrhea and fever. On 6 March 2011, the following night, 2 days after vaccination with DTP-IPV and TWINRIX, the subject had strange sounds and was unwakable. Cardiac arrest occurred when the paramedics arrived and confirmed the ventricular fibrillation. The subject received cardiopulmonary resuscitation, varying between pulseless cardiac electrical activity and ventricular fibrillation, resuscitation was continued at the hospital. Relevant tests performed showed following results: C-reactive protein 38 and troponin I 43. The subject died on 6 March 2011 from cardiac death at the hospital. An autopsy was performed and showed inflammation cell infiltrated in the heart muscle, but no certain injury of the heart muscle fibres. These were only documented in autopsies from the right ventricle. Genetic study on arrhythmogenic right ventricular-cardiomyopati was negative. Cause of death is believed to be a sudden heart rhythm disturbance, most likely due to small areas of inflammatory changes in heart muscle. The inflammatory changes had an unusual character. The regulatory authority reported that the body pain, diarrhea, fever and tiredness were possibly related to vaccination with TWINRIX and DTPA-IPV. Because of information about vaccination in connection with planned charter travel and subsequent symptoms of fever and impaired general condition, one could not exclude that there was an unusual complication of vaccination.


VAERS ID: 425582 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-06-10
Entered: 2011-06-16
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Acute respiratory failure, Bronchiolitis, Death, Leukopenia, Malaise, Mechanical ventilation, Neutropenia, Pyrexia, Stridor, Viral test negative
SMQs:, Anaphylactic reaction (broad), Agranulocytosis (broad), Angioedema (broad), Haematopoietic leukopenia (narrow), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: viral test, negative
CDC Split Type: PHHY2011AR50175

Write-up: Case number PHHY2011AR50175 is a combined initial and follow-up spontaneous report received from the health authority respectively on 07 Jun 2011 and 09 Jun 2011. This report refers to a 2 year old boy. He was vaccinated with AGRIPPAL (batch number: unknown) on an unspecified date. One day after vaccination, the child presented with fever, malaise, and stridor and was taken to the emergency room. Viral tests were performed and the results were negative. He was diagnosed with bronchiolitis. After 24 hours, the child was hospitalized with acute respiratory failure, fever, leucopenia and severe neutropenia. Mechanical ventilation was difficult and the child died within 24 hours. The events were reported as not-related to the INFLUENZA vaccine.


VAERS ID: 426065 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Female  
Location: Foreign  
Vaccinated:2010-03-30
Onset:2010-12-15
   Days after vaccination:260
Submitted: 2011-06-23
   Days after onset:189
Entered: 2011-06-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E29298 / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, Death, Pneumococcal infection, Streptococcus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), 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:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Blood culture (15Dec2010): positive for pneumococcal infection serotype 3
CDC Split Type: 2011133441

Write-up: This is a spontaneous report received from the foreign Health Protection Agency. Regulatory Authority report number was not provided. This reporter reported similar events for 7 patients. This is the second report of seven. A 4-month-old female patient of unknown race received the second dose of PREVENAR 13 on 30Mar2010 (Lot number: E29298) for vaccination. The patient received the first dose of PREVENAR 13 on 28Jan2010 (Lot number: Lot D91952) at 2 months of age for vaccination. Relevant medical history, past product history and concomitant therapy were not provided. On 15Dec2010, at the age of 12 months, the patient underwent a blood culture which was positive for pneumococcal infection serotype 3 which was indicative of vaccine failure. Therapeutic measures were not reported. The outcome of the event was unknown at the time of reporting. However, it was reported that the patient died on an unspecified date. The cause of the patient''s death was not specified. No follow-up attempts possible. No further information expected.


VAERS ID: 426641 (history)  
Form: Version 1.0  
Age: 0.09  
Sex: Male  
Location: Foreign  
Vaccinated:2008-10-16
Onset:2008-10-16
   Days after vaccination:0
Submitted: 2011-07-04
   Days after onset:991
Entered: 2011-07-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER UNREGISTERED / 2 AR / IJ

Administered by: Public       Purchased by: Public
Symptoms: Central nervous system lesion, Death, Hypotonia, Spinal muscular atrophy
SMQs:, Peripheral neuropathy (broad), Congenital, familial and genetic disorders (narrow), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-01-01
   Days after onset: 77
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Kvit, Sinacillin Adrianol nose drops,
Current Illness: before second vaccination caught cold,
Preexisting Conditions: born 7 days before,
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: born healthy, received Hep B in first day of life, 100% disability and death, hypotonia, very heavy neural lesion, the level of spinal cord, spinal muscular atrophy type 1, corpus callosum, three adverse events: first: after first 7 days after HepB1 he didn''t use his arm, second: after 30 day he didn''t hold his head, noticed on the occasion of pediatric examination before HepB 2, third: death after HepB2


VAERS ID: 426644 (history)  
Form: Version 1.0  
Age: 0.16  
Sex: Male  
Location: Foreign  
Vaccinated:2011-04-04
Onset:0000-00-00
Submitted: 2011-07-04
Entered: 2011-07-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPPHIB: DTP + IPV + ACT-HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER UNREGISTERED / 1 AR / -

Administered by: Public       Purchased by: Public
Symptoms: Asphyxia, Autopsy, Bloody airway discharge, Brain oedema, Cerebrovascular disorder, Death, Diffuse alveolar damage, Hepatic steatosis, Histology, Pathology test
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Hyponatraemia/SIADH (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-04-05
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BCG 02/24/2011, Hep B 02/03/2011,03/09/2011, DTPr polio +HIB 04/04/2011
Current Illness: no
Preexisting Conditions: no
Allergies:
Diagnostic Lab Data: autopsy, histology, pathology-histology, lack of toxicological analysis of vials, lack of bacteriological analysis, lack of mercury presence analysis,
CDC Split Type:

Write-up: born healthy, received Hep B in first day of life, died 14 hours after immunization, suffocation, in air ways pink foamy content, splitted alveolar septs, hyperaemia a t oedema cerebri, focal fat infiltrates of hepatocytes,


VAERS ID: 426801 (history)  
Form: Version 1.0  
Age: 0.28  
Sex: Female  
Location: Foreign  
Vaccinated:2011-07-01
Onset:2011-07-01
   Days after vaccination:0
Submitted: 2011-07-05
   Days after onset:4
Entered: 2011-07-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Depressed level of consciousness
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-07-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0730358A

Write-up: This case was reported by a physician via a sales representative and described the occurrence of death nos in a 3-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject''s sister, who was 6 years old, was treated with antiepileptics for 5 years. The subject was fine, playful and normal on examination before vaccination. On 1 July 2011, at 11:15 am, the subject received 1st dose of ROTARIX (oral). Lot number not provided. After vaccination, the subject was well and took feeds normally. The subject fell asleep at 5:00 pm. On 1 July 2011, between 7 and 8 pm, hours after vaccination with ROTARIX, the subject could not be aroused from sleep despite several attempts. The baby was brought dead to the emergency the same evening. The subject died on 1 July 2011, cause of death was not reported. An autopsy was performed but the results were pending. Relationship between vaccine and cause of death cannot be ascertained as per the reporting doctor. Additional information has been requested.


VAERS ID: 426774 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-04-19
Onset:2010-08-05
   Days after vaccination:108
Submitted: 2011-07-04
   Days after onset:333
Entered: 2011-07-06
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UH072AC / UNK RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Aphasia, Blood test normal, Chorea, Computerised tomogram head, Computerised tomogram normal, Convulsion, Death, Dyskinesia, General physical health deterioration, Influenza like illness, Lumbar puncture normal, Nuclear magnetic resonance imaging brain normal
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Dementia (broad), Convulsions (narrow), Dyskinesia (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-09-12
   Days after onset: 38
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: Measles in April 2010, characterized by severe generalized rash and fever. No previous history of adverse event to a vaccine or a drug.
Allergies:
Diagnostic Lab Data: CT scan of the brain, MRI of the brain, blood tests and lumbar puncture revealed no abnormalities.
CDC Split Type: 201005637

Write-up: Case received from a healthcare professional in a foreign country on 01 October 2010 under the local reference number 71/2010. A 13-year and 05-month-old male patient, with a reported medical history and no concomitant therapy, had received his dose of ROUVAX (batch number, route and anatomical site of administration not reported) in May 2010. It was administered in the context of a mass campaign. The patient had also received his dose of H1N1 (manufacturer, batch number, route and anatomical site of administration not reported) on an unspecified date. The patient had a medical history of Measles in April 2010, characterized by severe generalized rash and fever. He had no previous history of adverse event to a vaccine or a drug. On 05 August 2010, the patient experienced flu-like symptoms and unvoluntary movement of the right hand and leg. He was hospitalized the same day. The patient then developed 10 episodes of seizures and became aphasic. CT scan of the brain, MRI of the brain, blood tests and lumbar puncture revealed no abnormalities. He was transferred to another hospital on 10 August 2010 where his condition deteriorated. The patient died on 12 September 2010. His family declined the request for an autopsy to be carried out. Additional information received from the local affiliate on 01 December 2010: Chorea, i.e. unvoluntary, jerky, repetitive and rapid movements was previously reported but was illegible. Follow-up information received from the reporter through the local affiliate on 31 January 2011: The patient had received his intramuscular dose of ROUVAX (batch number E5001-1) in the right deltoid on 19 April 2010. The patient had also received his intramuscular dose of H1N1 (manufacturer not reported, batch number UH072AC) in the right deltoid on 26 July 2010. There was no information regarding the patient''s resuscitation. Follow-up information received from the reporter through the local affiliate on 22 June 2011: The reporter stated that the H1N1 vaccine was manufactured by sanofi pasteur (no further details provided).


VAERS ID: 426844 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Male  
Location: Foreign  
Vaccinated:2009-01-20
Onset:2009-01-25
   Days after vaccination:5
Submitted: 2011-07-06
   Days after onset:891
Entered: 2011-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS - / 4 UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, CSF glucose increased, CSF protein increased, Death, Endotracheal intubation, Immunology test, Immunology test abnormal, Inappropriate schedule of drug administration, Laboratory test abnormal, Lyssavirus test positive, Microscopy, Muscular weakness, Nervous system disorder, Ophthalmological examination normal, Pain, Polymerase chain reaction, Pyrexia, Quadriplegia, Rabies, Respiratory paralysis, Resuscitation, Smear test, Somnolence
SMQs:, Rhabdomyolysis/myopathy (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (broad), Respiratory failure (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-01-28
   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: No other medications
Current Illness: Unknown
Preexisting Conditions: 01/06/2009, Animal bite, lacerated wound of size 2cm x 2.5cm
Allergies:
Diagnostic Lab Data: CSF protein, 110mg%; Immunology test, Abnormal, Confirmed the diagnosis of rabies; Microscopy, Abnormal, Intracytoplasmic inclusion bodies indicative of Negri bodies were detected by microscopic examination.; Polymerase chain reaction, Abnormal, Confirmed the diagnosis of rabies
CDC Split Type: PHHY2011IN59068

Write-up: Case number PHHY2011IN59068 is an initial literature report received on 02 Jul 2011: The authors presented a case of fatal rabies despite post-exposure prophylaxis. This report refers to a 3-year-old boy. He was bitten by a stray dog which had rabies symptoms, on right thigh on 06 Jan 2009. The wound was not washed properly with the water. He was vaccinated with day 0 dose of RABIPUR (batch number: unknown) post exposure series, on 07 Jan 2009. However, he was not given rabies immunoglobulin. Second, third, and fourth doses of RABIPUR (batch numbers unknown) were given on 12 Jan 2009, 17 Jan 2009 and 20 Jan 2009 (day 5, 11 and 14) respectively. He developed fever, pain and weakness over the right lower limb on 25 Jan 2009 and was hospitalized. On admission, he was febrile and drowsy with stable vital signs. There was no sign of neck rigidity, no cerebral signs and the ophthalmic examinations was within normal limits. Cerebrospinal fluid (CSF) examination revealed slightly increased protein of 110 mg%. CSF sugar was 80 mg%, which was within the normal range. The weakness initially involving the right lower limbs progressed to involved the left lower limb, followed by the upper limbs over the next 2 days. Finally, he developed quadriplegia. However, the classical symptoms of rabies, i.e. hydrophobia and aerophobia, were not present any time during his illness. He developed respiratory paralysis on 27 Jan 2009. The patient was intubated and cardiopulmonary resuscitation was given. However, he died on 28 Jan 2009. To confirm the diagnosis, an autopsy was performed giving more attention to the brain. On gross examination, the brain was mildly congested. Eight impression smears from the hippocampus of the brain were taken and four were stained with Sellers stain. Intracytoplasmic inclusion bodies indicative of Negri bodies were detected by microscopic examination. Half of the brain was collected in 50% glycerol-saline for further confirmation. Direct immunofluorescence test was performed on the remaining impression smears. Reverse transcriptase polymerase chain reaction was performed on the collected brain tissue, which confirmed the diagnosis of rabies. The authors concluded that the patient developed rabies despite vaccination due to not receiving immunoglobulin, not washing the wound after dog bite and not maintaining proper schedule of vaccination as recommended by the WHO.


VAERS ID: 426855 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Male  
Location: Foreign  
Vaccinated:2011-05-31
Onset:2011-05-31
   Days after vaccination:0
Submitted: 2011-07-04
   Days after onset:34
Entered: 2011-07-06
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME) / SANOFI PASTEUR - / 1 UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER 9C311 / 2 UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH F06967 / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apgar score normal, Autopsy, Death, Histology abnormal, Increased upper airway secretion, Pneumonia, Pulmonary congestion, Pulmonary mass, Resuscitation, Rhinorrhoea, Salivary hypersecretion
SMQs:, Cardiac failure (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: 2011-05-31
   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: Apgar score, (21May2011), 9/10 and 10/10; Report on Medico-legal Post mortem examination (02Jun2011): Reputed age of body: 2 months; Date of death: 31May2011 at 20h10; Chief post mortem findings: congestion of both lungs which pneumonia; Tissue sent for histology; Cause of death: probably pneumonia (further investigation is being conducted); External appearance of clothing described by medical examiner; External appearance of body and condition of limbs: -watery fluid expelled from nose and mouth; -resuscitation plasters (x2) on chest (left); -no new or old injuries observed; skull-scalp normal and no fractures; Intracranial contents: normal; orbital, nasal and aural cavities: Normal, no phlegm and fluid observed in nasal cavities mouth, tongue and pharynx: Normal with fluid noted for mouth and gums neck structures: normal thoracic cage and diaphragm: Normal; mediastinum and oesaphagus: normal; Trachea and bronchi: mucus membrane normal with phlegm noted in trachea and bronchi pleura and lungs: -right: chest cavity and hilium of the lung are normal, visceral surface darker than normal, lung tissue congested with phlegm and heavier indicated pneumonia, lung mass=72g; -left: chest cavity, hilium are normal. Visceral surface is darker. Lung tissue congested with phlegm and heavier indicated pneumonia, lung mass=60g; urinary bladder and ureters: normal; pelvic walls: normal; genital organs; Male: normal; spinal column; normal; spinal chord: not examined; heart, lung, kidney, liver, brain tissue specimens retained
CDC Split Type: 2011144873

Write-up: This is a spontaneous report via a Pfizer employee from a contactable Department of Health employee who received the report via a pharmacist and post mortem results from a physician. A 2-month-old male patient received the second dose of PREVENAR (Suspension for injection), the second dose of Hepatitis B vaccine and the first dose of PENTAXIM on 31May2011. Past vaccine history included a dose of oral polio vaccine (OPV) and BCG VACCINE administered on 21Mar2011 and a dose of oral polio vaccine (OPV), hepatitis b vaccine, PREVENAR and ROTARIX on 04May2011. The patient has been exclusively breastfed. The patient was born via normal vaginal delivery with Apgar scores of 9/10 and 10/10. On 31May2011, the patient visited the clinic for second immunisation but also was administered the second dose of PREVENAR accidentally. The mother of the patient was informed and a note was made for the vaccine to be given again at 14/52. The patient was healthy and fine at departure from clinic. Later that day, the patient passed away due to possible pneumonia (cause of death according to post mortem findings by physician). Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVENAR.


VAERS ID: 427283 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Male  
Location: Foreign  
Vaccinated:2011-07-06
Onset:2011-07-07
   Days after vaccination:1
Submitted: 2011-07-12
   Days after onset:5
Entered: 2011-07-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME) / SANOFI PASTEUR 137K0002C / UNK UN / UN
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR G0084 / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-07-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient was healthy.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201104207

Write-up: Case received in a foreign country on 07 July 2011 from a healthcare professional through local affiliates under local reference number IN2011-037. A 45-day-old male patient, who was healthy, had received on 06 July 2011, at 12:00, his dose of IMOVAX POLIO (batch number G0084-2, number in series, route and site of administration not reported) and his dose of PENTAVAC PFS (other manufacturer, diphtheria, tetanus, whole cell pertussis, hep B and hib vaccine, batch number 137K0002C, number in series, route and site of administration not reported). On 07 July 2011, the patient died. The adverse event was reported as "unknown". On 07 July 2011, the patient was brought dead to the hospital at 05:00am. The same vaccines with same batch number were administered to the twin sister of the patient who was fine. No other associated adverse event like pain or fever was reported in either of the patients. Documents held by sender: none.


VAERS ID: 427347 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2001-05-14
Onset:2001-05-14
   Days after vaccination:0
Submitted: 2011-07-14
   Days after onset:3713
Entered: 2011-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Public       Purchased by: Public
Symptoms: Bronchitis, Bronchopneumonia, Cardiopulmonary failure, Cough, Hypotonia, Posture abnormal, Respiratory disorder
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Dystonia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-09-22
   Days after onset: 131
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: no
Current Illness: no
Preexisting Conditions: no
Allergies:
Diagnostic Lab Data: BCG 05/14/2001, DTPr polio 03/09/2001
CDC Split Type:

Write-up: hypotonia, 20 days later severe respiratory problems- cough, doesn''t keep a head, insuffitientio cardiorespiratoria, bronchitis obstructiva, sy flaccid child, broncho pneumoniae confluens lat.dex.


VAERS ID: 427477 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-07-01
Onset:2011-07-08
   Days after vaccination:7
Submitted: 2011-07-13
   Days after onset:5
Entered: 2011-07-15
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 3 UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bradycardia, Cardio-respiratory arrest, Chest X-ray normal, Computerised tomogram abdomen normal, Endotracheal intubation, Nuclear magnetic resonance imaging brain normal, Sudden death, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-07-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MIYA BM
Current Illness:
Preexisting Conditions: Food allergy; Vomiting; Atopic dermatitis; Enteropathic E.coli
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011153557

Write-up: This is a spontaneous report obtained from a contactable pediatrician based on the information obtained through agency (Ministry of Health) under the I.D. PREVENAR 261. A 1-year-old patient (gender unknown) received PREVENAR injection at 0.5mL subcutaneously for meningitis pneumococcal as the third inoculation on 01Jul2011. Relevant medical history included allergy to milk products, allergy to eggs, newborn vomiting, atopic dermatitis and infection with Enteropathic E.coli. Concomitant medication includes MIYA BM when she had fecal aggravation. The patient experienced vomiting on unknown date, and then experienced sudden death on the morning of 08Jul2011. According to the reporting physician, intratracheal intubation and intratracheal administration of BOSMIN were performed to treat the patient on 08Jul2011; however, the patient became in the states of bradycardia and cardio-respiratory arrest, and then her death was confirmed at 9:47AM on 08Jul2011. The reporting physician commented that magnetic resonance imaging (MRI) of the head, chest X-ray and abdominal computed tomography (CT) scan were performed at the time when the patient died; however, nothing abnormal were detected. The reporting pediatrician assessed the events, vomiting and sudden death, as unrelated to PREVENAR.


VAERS ID: 427655 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-07-18
Entered: 2011-07-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 3 UN / IJ

Administered by: Unknown       Purchased by: Unknown
Symptoms: Beta haemolytic streptococcal infection, Death
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011159165

Write-up: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 7-month-old patient received the third dose of PREVENAR 13 (injection) on an unknown date. Past vaccine history included the first and second dose of PREVENAR 13 (injection) on unknown dates. Relevant medical history and concomitant medications were not reported. On an unknown date, at the age of 7 months, approximately 6 weeks ago and one week after being administered the third dose of PREVENAR 13, the baby died. The cause of death was reported as Streptococcus Pyogenes Group A infection. Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVENAR 13.


VAERS ID: 428089 (history)  
Form: Version 1.0  
Age: 0.46  
Sex: Female  
Location: Foreign  
Vaccinated:2010-11-29
Onset:0000-00-00
Submitted: 2011-07-25
Entered: 2011-07-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Cardiac failure, Death, Decreased appetite, Pneumonitis, Respiratory failure
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Interstitial lung disease (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-12-01
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: Premature baby 26 to 32 weeks
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0734681A

Write-up: This case was reported by a physician via a regulatory authority (NO-NOMAADVRE-FHI-2011-12714) and described the occurrence of pneumonitis in a 6-month-old female subject who was vaccinated with INFANRIX-IPV/HIB (GlaxoSmithKline), (non-GSK) PREVENAR. The subject''s medical history included premature baby at 26 weeks. On 29 November 2010, the subject received 1st dose of INFANRIX-IPV/HIB (parenteral, injection site unknown, batch number not provided) and 1st dose of PREVENAR (parenteral, injection site unknown, batch number not provided). In 2010, within days after vaccination with INFANRIX-IPV/HIB and PREVENAR, the subject experienced appetite lost and pulmonary changes which might be consistent with chronic pneumonitis in infancy. The regulatory authority reported that the events were possibly related to vaccination with INFANRIX-IPV/HIB and PREVENAR. The subject died on 1 December 2010 from heart failure and pulmonary failure. An autopsy was performed.


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