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Found 146 cases where Vaccine is MEN or MENB or MENHIB or MNC or MNQ or MNQHIB and Patient Died and Submission Date on/before '2015-09-30'

Case Details

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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: 435637 (history)  
Form: Version 1.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-09-13
Entered: 2011-09-22
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IJ
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Abdominal pain upper, Abdominal rigidity, Abdominal tenderness, Acute abdomen, Biopsy bronchus abnormal, Biopsy lung, Bronchoscopy abnormal, C-reactive protein increased, Chemotherapy, Chest pain, Computerised tomogram abdomen abnormal, Computerised tomogram abnormal, Computerised tomogram thorax abnormal, Conjunctival pallor, Death, Dizziness, Gastrointestinal sounds abnormal, Haemoglobin decreased, Histology abnormal, Intensive care, Laparotomy, Lung adenocarcinoma stage IV, Lung consolidation, Lung neoplasm malignant, Lymphadenopathy mediastinal, Malaise, Mechanical ventilation, Metastases to bone, Metastasis, Muscle rigidity, Musculoskeletal pain, Neutrophil count increased, Non-small cell lung cancer metastatic, Palliative care, Pallor, Pleural effusion, Pulmonary hilum mass, Rales, Shock, Splenic haematoma, Splenic haemorrhage, Splenic rupture, Surgery, Transfusion, Vomiting, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (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), Malignancy related therapeutic and diagnostic procedures (narrow), Parkinson-like events (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Conjunctival disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Non-haematological malignant tumours (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: penicillin V
Current Illness: Malaise; Dizziness; Vomiting; Chest pain; Musculoskeletal pain; Tobacco User, Approximately 40 pack per year; Blood pressure decreased; Abdominal pain upper; C-reactive protein increased; Acute abdomen, Generalized abdominal tenderness with guarding, rigidity and absent bowel sounds, consistent with an acute abdomen; Pallor; Haemoglobin decreased; Splenic rupture; Conjunctival pallor; Haemorrhage
Preexisting Conditions: Computerised tomogram abnormal, Computer tomography scan of her thorax and abdomen, which showed a left hilar mass with extensive mediastinal adenopathy, bibasal small effusions and consolidation, and a large splenic hematoma with high attenuation suggestive of active bleeding. There was a lytic area affecting her T9 vertebra, which likely represented metastases rather than wedge fracture; Laparotomy, On examination of her internal organs at laparotomy, other than hemorrhage and rupture of her spleen, there was no other gross abnormality and no evidence of disease in her other intra-abdominal organs
Allergies:
Diagnostic Lab Data: Biopsy bronchus, Significant, Confirmed invasive adenocarcinoma; Bronchoscopy, Significant, Trans bronchial needle aspiration revealed numerous malignant nodes consistent with non-small cell carcinoma; Computerised tomogram abnormal, Significant, Bone metastases found on CT
CDC Split Type: PHHY2011GB80735

Write-up: Case number PHHY2011GB80735 is an initial literature report received on 08 Sep 2011: The authors presented a case of acute abdomen due to spontaneous splenic rupture (SSR) as the first presentation of lung malignancy. This case refers to a 61-year-old female patient. There was nothing in the history to suggest a recent viral or other infective process including human immunodeficiency virus or acquired immune deficiency state and no history of any trauma or injury. She had no significant previous medical or surgical history and was not taking any medications. There was no background or family history of cancer, hematologic or clotting disorders. She was a smoker of approximately 40 pack per year and had unlimited exercise tolerance. She presented with a three day history of feeling generally unwell with dizziness, vomiting, abdominal, left lower chest pain and shoulder pain and hospitalized. She denied any sore throat, feeling feverish or other symptoms suggestive of an influenza-like illness. She was ill-looking, conscious and orientated with a blood pressure 89/49mmHg, heart rate of 72 beats per minute, saturations 97% on a non-rebreather mask and temperature of 36.9 degree Celsius. The admission examination revealed normal cardiac examination and bibasal inspiratory crepitations with left upper quadrant and epigastric tenderness on abdominal examination. Her blood work-up on admission showed a hemoglobin level of 11.4g/L, white blood cell count of 19*10^9/L with neutrophils of 17*10^9/L and a C-reactive protein of 7mg/L. Hemodynamic stability was achieved following rehydration with intravenous fluids. However eight hours after admission into the hospital, she developed an acute abdomen with clinical signs of shock. Her blood pressure was 88/52mmHg and heart rate 105 beats per minute. Further to that her oxygen saturations were 91%. Inspection revealed skin and conjunctival pallor. Clinical examination revealed new abdominal signs of generalized abdominal tenderness with guarding, rigidity and absent bowel sounds, consistent with an acute abdomen. A repeat test showed her hemoglobin level had dropped to 5.0g/L. She was stabilized with multiple blood transfusions and underwent an urgent computer tomography scan of her thorax and abdomen, which showed a left hilar mass with extensive mediastinal adenopathy, bibasal small effusions and consolidation, and a large splenic hematoma with high attenuation suggestive of active bleeding. There was a lytic area affecting her T9 vertebra, which likely represented metastases rather than wedge fracture, but there were no abnormalities or neoplastic disease affecting the intra-abdominal organs. She was vaccinated with meningococcal vaccine (manufacturer and batch number: unknown) and pneumococcal vaccine (manufacturer and batch number: unknown) on an unspecified date. She was then promptly taken for laparotomy. On examination of her internal organs at laparotomy, other than hemorrhage and rupture of her spleen, there was no other gross abnormality and no evidence of disease in her other intra-abdominal organs. She spent two days being ventilated in intensive care unit and subsequently made a fully recover from the surgery. She was commenced on life-long penicillin V and was subsequently discharged home a week after admission, fully mobile and independent in terms of her activities of daily living. Her splenic histology was negative for hematologic or other malignancy and no other pathology was identified. She then underwent a bronchoscopy; trans bronchial needle aspiration revealed numerous malignant nodes consistent with non-small cell carcinoma. Histology of bronchial biopsies confirmed invasive adenocarcinoma. This was consistent with likely stage IV in view of the likely bone metastases found on CT. She was referred to the local oncologist. In view of the diagnosis and staging, a palliative treatment pathway was agreed from the outset and she received palliative chemotherapy. She died five months after her presentation., It was possible that this patient had two concurrent, unrelated pathologies: bronchial adenocarcinoma and a true SSR. However, given the well-described association between neoplastic disease and SSR, this case reports linking the two conditions and the rarity of true spontaneous splenic rupture, it was likely that the two conditions were linked with the former precipitating the latter. The authors concluded that lung cancer could potentially precipitate SSR; it could even present itself as SSR as in this patient.


VAERS ID: 444081 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-11-30
Entered: 2011-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Blood culture positive, Death, Depressed level of consciousness, Haemodynamic instability, Infection in an immunocompromised host, Intensive care, Meningococcal sepsis, Neisseria test positive, Pyrexia
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (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: mycophenolate; prednisone
Current Illness: systemic lupus erythematosus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: blood culture, significant, NmX was isolated in the blood cultures
CDC Split Type: PHHY2011ES103853

Write-up: Case number PHHY2011ES103853 is an initial spontaneous report received on 24 Nov 2011: The authors have analyzed a case of invasive meningococcal disease due to Neisseria meningitidis serogroup X (NmX) sepsis in an immunocompromised patient. This report refers to a 15-year-old female patient. She was diagnosed with systemic lupus erythematosus In 2005 and was receiving mycophenolate (an immunosuppressor that inhibited inosine monophosphate dehydrogenase) and oral prednisone (40 mg/day). She was vaccinated with MENVEO INN (manufacturer and batch number was unknown) on an undetermined date. She did not receive any antibiotic prophylaxis during immunosuppressive therapy. After vaccination she developed invasive meningococcal disease due to NmX. She presented to the hospital with fever and abdominal pain on an unspecified date after vaccination. A few hours later, lowering of the level of consciousness and abrupt hemodynamic deterioration were observed. The patient died in less than 24 hours, despite support measures in the intensive care unit (ICU). NmX was isolated in the blood cultures of this patient. Later on, it was identified that, these isolated causing fatal episodes belonged to the ST-750 clonal complex. The authors concluded that foreseeable frequent use of conjugate meningococcal vaccine for serogroups A, C, Y and W135, with a powerful effect on pharyngeal carriage could favor the dissemination of serogroup X strains.


VAERS ID: 444082 (history)  
Form: Version 1.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-11-30
Entered: 2011-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Blood culture positive, Death, Dyspnoea, Infection in an immunocompromised host, Intensive care, Meningococcal infection, Meningococcal sepsis, Neisseria test positive, Petechiae, Pyrexia, Respiratory failure, Septic shock
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: eculizumab; rivaroxaban
Current Illness: Paroxysmal nocturnal haemoglobinuria
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: blood culture, significant, NmX was isolated in the blood cultures
CDC Split Type: PHHY2011ES103631

Write-up: Case number PHHY2011ES103631 is an initial spontaneous report received on 24 Nov 2011: The authors have analyzed a case of invasive meningococcal disease due to Neisseria meningitidis serogroup X (NmX) sepsis in an immunocompromised patient. This report refers to a 27-year-old male patient with a history of paroxysmal nocturnal hemoglobinuria under treatment with eculizumab (a monoclonal antibody that targeted complement fraction 5) and rivaroxaban (a factor Xa inhibitor). He was vaccinated 16 months before the episode of invasive meningococcal disease sepsis with a MENVEO INN (manufacturer and batch number: unknown) on an undetermined date, but the vaccine might not provide protection from meningococcal X infection and no antibiotic prophylaxis was done during treatment with eculizumab. On 04 April 2010 he presented with high fever and breathlessness and developed severe respiratory failure, generalized petechiae and septic shock a few hours later. The patient died in the intensive care unit (ICU) on the same day. NmX was isolated in the blood cultures of this patient. Later on, it was identified that, these isolates causing fatal episodes belonged to the ST-750 clonal complex. The authors concluded that foreseeable frequent use of MENVEO INN, with a powerful effect on pharyngeal carriage could favor the dissemination of serogroup X strains.


VAERS ID: 450047 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2012-02-03
Submitted: 2012-02-21
   Days after onset:18
Entered: 2012-02-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (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: 2012-02-03
   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: Not reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201201714

Write-up: Case received from a consumer (Lay Media) in a foreign country on 10 February 2012 under the reference number BR2012-255. The article was retrieved in the newspaper. A 02-month-old female patient, with no reported medical history and concomitant therapy, died on 03 February 2012 after receiving a dose of DTP-HIB vaccine (manufacturer, batch number, route and site of administration unknown), a dose of OPV (manufacturer, batch number, route and site of administration unknown), a dose of Meningococcal vaccine (manufacturer, batch number, route and site of administration unknown) and a dose of Pneumococcal vaccine (manufacturer, batch number, route and site of administration unknown) on an unspecified date. The cause of death was unknown. Results of the autopsy report from the Legal Medical Institute were expected within 30 to 40 days.


VAERS ID: 457497 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-06-15
Entered: 2012-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Death, Vaccination failure, Waterhouse-Friderichsen syndrome
SMQs:, Lack of efficacy/effect (narrow), Sepsis (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2012-06-06
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2012DE051035

Write-up: Case number PHHY2012DE051035 is an initial combined spontaneous report received from a physician on 14 Jun 2012. This report refers to a 16-years-old female patient. Her medical history included no immunodeficiency. Her vaccination history and concomitant medications were not reported. She was vaccinated with meningococcal vaccine (manufacturer and batch number: unknown) through an unknown route and site of an unspecified date (3 to 4 years ago). On an unknown date, she developed meningococcal infection of serotype C. On 06 Jun 2012, she died due to Waterhouse-Friderichsen syndrome, a complication of the meningococcal C infection. Vaccination failure was suspected. The causality was not assessed. No further information was available.


VAERS ID: 470717 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2012-10-13
Submitted: 2012-10-17
   Days after onset:4
Entered: 2012-10-22
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-10-13
   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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2012BR092128

Write-up: Case number PHHY2012BR092128 is an initial and spontaneous report received from a consumer on 15 Oct 2012. This report refers to a female patient who was less than 18-year-old. Her medical history and concomitant medications were not reported. She was vaccinated with meningococcal vaccine ACWY (manufacturer and batch number: not reported, hence conservatively taken as MENVEO INN) on an unspecified date. According to the reporter, on 13 Oct 2012 the patient died. The cause of death was not reported. No other information was available.


VAERS ID: 475079 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2012-06-01
Onset:0000-00-00
Submitted: 2012-11-21
Entered: 2012-11-26
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Meningococcal infection, Purpura fulminans
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-10-31
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2012FR105871

Write-up: Case number PHHY2012FR105871 is an initial spontaneous report received from a physician on 16 Nov 2012: This report refers to a 23-year-old male patient. No concomitant medication was reported. He was vaccinated with MENVEO (batch number: unknown) on an undetermined date in Jun 2012. After vaccination the patient died on 31 Oct 2012 from fulminans purpura which was secondary to invasive meningococcal infection due to serogroup W135. No further information was provided.


VAERS ID: 490877 (history)  
Form: Version 1.0  
Age: 0.39  
Sex: Male  
Location: Foreign  
Vaccinated:2013-04-17
Onset:2013-04-28
   Days after vaccination:11
Submitted: 2013-05-03
   Days after onset:5
Entered: 2013-05-06
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME) / SANOFI PASTEUR - / UNK UN / IM
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / IM

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: 2013-04-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013135829

Write-up: This is a report from a Non-Pfizer sponsored interventional study source. A 5 month-old male patient received, at the age of 4 months, PREVENAR 13, MENJUGATE and PEDIACEL, all received intramuscularly at 0.5ml single doses on 17Apr2013. The subject had no medical history and was receiving no concomitant medications. There were no relevant tests/laboratory data. On 28Apr2013, the baby died at home due to suspected sudden infant death syndrome. The death was not expected as the baby appeared to be well at the last study visit and outreach midwives were planning to stop visiting the baby. It was not reported if an autopsy was performed. The neonatal outreach midwives who visited the baby had no details of causality at this time. The investigator considered the relationship between PREVENAR 13, MENJUGATE and PEDIACEL and the event to be not assessable. The case is managed as if the investigator''s assessment was that a reasonable possibility exists that the event was related to the study product, as a cautionary measure and for reporting purposes. This is a preliminary report for notification of a fatal event.


VAERS ID: 495781 (history)  
Form: Version 1.0  
Age: 1.01  
Sex: Female  
Location: Foreign  
Vaccinated:2011-12-05
Onset:0000-00-00
Submitted: 2013-07-02
Entered: 2013-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / 4 UN / SYR
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / SYR
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / SYR
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 4 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Apoptosis, Autopsy, Cardiac arrest, Coxsackie virus test negative, Culture throat positive, Death, Dehydration, Diarrhoea, Inflammation, Morbillivirus test positive, Muscle necrosis, Myocarditis, Pericardial drainage test normal, Pharyngitis, Pyrexia, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Agranulocytosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Pseudomembranous colitis (broad), Oropharyngeal infections (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body temperature, Dec 2011, 36Deg. C; Physical examination, Dec2011, Dehydrated
CDC Split Type: B0811004A

Write-up: This case was reported by a paediatrician and described the occurrence of fatal myocarditis in a 13-month-old female subject who was vaccinated with PRIORIX, HIBERIX (GlaxoSmithKline), PREVENAR 13 (non-GSK) and NEISVAC-C. On an unspecified date, the subject received unspecified dose of PRIORIX (unknown route of administration, unknown site of injection, batch number not provided). 8 days after vaccination with PRIORIX, the subject experienced fatal myocarditis. The subject died, the cause of death was fatal myocarditis. It was unknown whether an autopsy was performed. No further information was expected. Follow-up information received on 27 August 2012: Despite several attempts, no further information could be obtained. Therefore, this case has been closed. Follow-up information received on 28 June 2013 from a paediatrician via public health representative: The subject had no relevant medical history. On 5 December 2011, the subject received 4th dose of HIBERIX, 1st dose of PRIORIX, 4th dose of PREVENAR 13 and 1st dose of NEISVAC-C (unknown routes and injection sites, batch numbers not provided). In December 2011, 14 days after vaccination with HIBERIX, NEISVAC-C, PREVENAR 13 and PRIORIX, the subject experienced fever and pharyngitis. The subject was treated with antibiotics. 2 days later, the subject experienced vomiting and diarrhea. She was admitted to hospital. She was assessed to be moderately dehydrated and commenced on nasogastric tube fluids. The subject was afebrile (body temperature at 36 Deg. C). The physician considered the events were possible related to vaccination with HIBERIX, PRIORIX, PREVENAR 13 and NEISVAC-C. Approximately 2 hours after admission, the subject experienced cardiac arrest and died from myocarditis. An autopsy was performed and showed severe transmural chronic inflammation with associated myocyte necrosis and apoptosis. There was also noted to be inflammation in the epicardium. A throat swab at autopsy was vaccine strain measles (Genotype A) and Coxsackie A9 virus from a right tonsil swab. Pericardial fluid and myocardial samples were reportedly negative for measles virus (vaccine and wild type) and Coxsackie Ap virus. This case was identified as duplicate B0903851A. Case B0903851A was voided and all the future correspondence will be added int he present case which stands as case of record for this subject.


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