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VAERS ID: 356987 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Foreign  
Vaccinated:2009-07-21
Onset:2009-07-24
   Days after vaccination:3
Submitted: 2009-09-10
   Days after onset:48
Entered: 2009-09-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / 3 UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / 3 UN / UN
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Coma, Death, Pyrexia, Septic shock, Viral upper respiratory tract infection
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Toxic-septic shock conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-07-27
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported; The patient was healthy during the routine medical exam in the family physician''s office prior to the vaccination. The patient had previously received her doses of TETRAXIM + ACTHIB at 2 and 4 months of age.
Allergies:
Diagnostic Lab Data: not reported
CDC Split Type: 200903838

Write-up: Case received from a healthcare professional on 04 September 2009 under no local reference number. A 06-month-old female patient, with no reported medical history, had received her 3rd primary doses of TETRAXIM + ACTHIB (batch numbers, routes and sites of administration not reported) on 21 July 2009. The patient was healthy during the routine medical exam in the family physician''s office prior to vaccination. The patient had previously received her doses of TETRAXIM + ACTHIB at 2 and 4 months of age. On 24 July 2009, i.e. 3 days post-vaccination, the patient was seen again in the family physician''s office since she presented with fever at 37.7-38.0 degrees C. The patient underwent medical exam and was prescribed NUROFEN and PANADOL. On 25 July 2009, the patient was seen in the hospital since she developed fever at 38 degrees C and more. The diagnosis was upper respiratory tract viral infection. She received a supplementary prescription with AUGMENTIN and was sent home. On 27 July 2009, the patient presented with coma. Her parents brought her to the hospital, however the patient died a few hours later. According to the family physician, "the vaccines administered have nothing in common with the baby''s death". According to the forensic physician, the patient died due to toxic-septic status.


VAERS ID: 357322 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Foreign  
Vaccinated:2009-08-27
Onset:2009-08-27
   Days after vaccination:0
Submitted: 2009-09-11
   Days after onset:15
Entered: 2009-09-15
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER KOMB0089 / UNK UN / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER KOMB0089 / UNK UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER KOMB0089 / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 35821 / 1 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-08-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant therapy included SABRILEX, MOVICOL and CELESTONVALERAT.
Current Illness: The patient''s concurrent illness includes congenital hypothyroidism.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: None provided
CDC Split Type: DKWYEG04414109

Write-up: This case was serious due to the criteria death. Information regarding PREVENAR was received from a healthcare professional via a foreign regulatory authority regarding a 6-month-old male patient who experienced respiratory arrest. The patient received the first dose on 27-Aug-2009. The patient experienced respiratory arrest, in the evening on 27-Aug-2009 and died. It is unknown if autopsy was done. The patient had no acute illness prior to the vaccination. Several examinations, not further specified, were done to reveal a diagnosis. The reporting physician do not believe that there is a correlation between PREVENAR and the death. The cause of death was reported as respiratory failure. Additional information is pursued.


VAERS ID: 357653 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-09-18
Entered: 2009-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK RA / IJ

Administered by: Other       Purchased by: Other
Symptoms: Antineutrophil cytoplasmic antibody positive, Biopsy kidney abnormal, Death, Dialysis, Glomerulonephritis, Pneumonia, Vasculitis, Wegener's granulomatosis
SMQs:, Acute renal failure (narrow), Interstitial lung disease (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Eosinophilic pneumonia (broad), Vasculitis (narrow), Chronic kidney disease (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Biopsy kidney, Abnormal
CDC Split Type: B0592682A

Write-up: This case was reported in a literature article and described the occurrence of Wegener''s granulomatosis in a 70-year-old male subject who was vaccinated with INFLUENZA vaccine (manufacturer unspecified). The subject was referred to the hospital with a suspected rapidly progressive glomerulonephritis. The renal biopsy showed diffuse extracapillary pauci-immune glomerulonephritis and circulating C-ANCA (antineutrophil cytoplasmic antibodies) directed against antisense proteinase 3 (PR3) could be detected. Wegener''s granulomatosis with severe renal involvement was diagnosed and treatment with immune suppressant drugs as IV pulse of glucocorticoids and oral cyclophosphamide instituted. The diagnosis of ANCA associated vasculitis was confirmed by clinical, serological and histopathological methods. Three weeks earlier the subject has received an influenza vaccination by his general practitioner. Despite therapy, the subject became dialysis dependent and acquired severe bilateral pneumonia which finally took a fatal course. The subject died, cause of death is not specified. It was unknown whether an autopsy was performed.


VAERS ID: 357776 (history)  
Form: Version 1.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-09-18
Entered: 2009-09-21
   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: Blood pressure decreased, Body temperature increased, Death, Depressed level of consciousness, Diarrhoea, Endotracheal intubation, Intensive care, Multi-organ failure, Nausea, Pancreatitis acute, Peripheral circulatory failure, Pneumococcal sepsis, Shock, Vaccination failure, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (narrow), Angioedema (broad), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Pseudomembranous colitis (broad), 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), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Hepatitis C; Hepatic cirrhosis
Preexisting Conditions: Splenectomy
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0909USA01698

Write-up: It was reported in an unpublished meeting abstract. Information has been received from a physician concerning a 58 year old female patient with a history of splenectomy due to hepatitis C and hepatic cirrhosis two years ago who was vaccinated with PNEUMOVAX after the splenectomy (dose and indication not reported). No information on concomitant therapy was provided. The patient presented to a doctor as an emergency with a chief complaint of nausea, vomiting and diarrhea. Body temperature was 40.3 degrees Celsius, but other vital signs were stable. At first she was hospitalized for suspected pancreatitis acute. The patient developed depressed level of consciousness 5 hours after hospital visiting. She exhibited shock vital signs and underwent tracheal intubation for artificial respiration. Administration of catecholamine was started. Pneumococcus was confirmed by blood culture and she was diagnosed with severe sepsis. She was transported to the ICU and treated with an increased dose of catecholamine, an infusion, Continuous Hemodiafiltration (CHDF) and Endotoxin Absorption Therapy. Although steroid administration, AT-III replacement therapy, etc. was also performed, blood pressure was decreased and peripheral circulatory failure was remarkable. Three days after the disease onset, she died of multi-organ failure. The cause of death was the pneumococcal sepsis and the multi-organ failure. No information on autopsy has been provided. The reporting physician considered that the pneumococcal sepsis and the multi-organ failure were serious due to death. The reporting physician did not assess the seriousness of the vaccination failure. The reporting physician did not assess the relationship between vaccination failure and PNEUMOVAX. The reporting physician felt that the pneumococcal sepsis and the multi-organ failure were not related to PNEUMOVAX. Reporter''s comment: Pneumococcal infection after splenectomy has a high mortality rate, and the patient have a fulminant course. Therefore it is important to prevent the infection and to detect and treat it at an early stage with a multidisciplinary approach. The appropriate timing of vaccination also should be considered. Additional information is not expected.


VAERS ID: 358151 (history)  
Form: Version 1.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2009-09-21
Onset:2009-09-21
   Days after vaccination:0
Submitted: 2009-09-23
   Days after onset:2
Entered: 2009-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA445AA / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Dyspnoea, Groin pain, No reaction on previous exposure to drug, Resuscitation
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Osteonecrosis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-09-21
   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: Hypertension Arterial
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood pressure, 150/100mmHg
CDC Split Type: D0062951A

Write-up: This case was reported by an occupational physician via a sales representative and described the occurrence of death - at present cause unknown - in a 54-year-old male subject who was vaccinated with INFLUSPLIT SSW 2009/2010 (GlaxoSmithKline). Concurrent medical conditions included hypertension arterial. Latest value of blood pressure determined was 150/100 mmHg. Otherwise, the subject has no known underlying or concurrent medical conditions or other risk factors. Previous vaccinations included seasonal trivalent influenza vaccine, manufacturer not specified, given annually since years. On 21 September 2009 in the morning the subject received a dose of INFLUSPLIT SSW 2009/2010 (0.5 ml, unknown). Less than one day post vaccination with INFLUSPLIT SSW 2009/2010, on 21 September 2009 at around 22:00, the subject returned from work and was complaining about groin pain and dyspnea. An emergency physician was called. Less than one day post vaccination with INFLUSPLIT SSW 2009/2010, in the night from 21 September 2009 to 22 September 2009, the subject died. At present the cause of death was unknown. Resuscitation, performed by the emergency physician, was without success. It was unknown whether an autopsy was or will be performed. According to information provided by the sales representative the physician considered that the events might be unrelated to INFLUSPLIT SSW 2009/2010. Follow-up information has been requested.


VAERS ID: 358423 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Male  
Location: Foreign  
Vaccinated:2009-09-03
Onset:2009-09-03
   Days after vaccination:0
Submitted: 2009-09-25
   Days after onset:22
Entered: 2009-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Heart sounds abnormal, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-09-03
   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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0593948A

Write-up: This case was reported by a physician and described the occurrence of fatal syncope in a 7-month-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The physician was informed of the adverse event by a journalist. The information was pressed in a local newspaper. It was unspecified if any adverse event had occurred after vaccination with the 2 previous doses of ENGERIX B. On 3 September 2009, the subject received 3rd dose of ENGERIX B (unknown route and injection site), lot number not provided. After vaccination, no adverse event had occurred. On 3 September 2009, less than one day after vaccination with ENGERIX B, the subject experienced syncope and died on the way to the hospital. According to the newspaper, at auscultation before the vaccination, the pediatrician had noticed pathologic heart sounds. The subject died on 3 September 2009, cause of death was not reported. It was unknown whether an autopsy was performed.


VAERS ID: 358621 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-09-29
Entered: 2009-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Antineutrophil cytoplasmic antibody positive, Biopsy kidney abnormal, Death, Dialysis, Glomerulonephritis, Pneumonia, Wegener's granulomatosis
SMQs:, Acute renal failure (narrow), Interstitial lung disease (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Eosinophilic pneumonia (broad), Vasculitis (narrow), Chronic kidney disease (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20092519

Write-up: We received the following literature report on 17 SEP 2009: Whether autoimmune or rheumatic disease may be precipitated after vaccination is controversially discussed among experts. Here the authors describe four cases of new onset or relapsing antineutrophil cytoplasmic antibodies associated vasculitis occurring in timely association with Influenza vaccination. In the literature different subtypes of vasculitis have been repeatedly reported after influenza vaccination. Several trials in patients with preexisting auto-immune disease failed to indicate an increased risk for disease recurrence after influenza vaccination but these investigations might be underpowered to detect this very rare but relevant side effect. Although this report does not prove a causal association between vaccination and vasculitis, It seems possible that in rare cases vaccination might induce vasculitic disease. This case refers to one of four patients (see also ref. cases MA2009-2517, -2518 and 2520). A 70-year-old male patient was referred to the hospital with suspected rapidly progressive glomerulonephritis. Renal biopsy showed diffuse extracapillary pauci-immune glomerulonephritis, and circulating CANCA directed against PR3 could be detected. Wegener''s granulomatosis with severe renal involvement was diagnosed and treatment with IV pulse glucocorticoids and cyclophosphamide p.o instituted. Three weeks earlier this patient has received an influenza vaccination by his general practitioner. Despite therapy the patient became dialysis dependent and acquired severe bilateral pneumonia which finally took a fatal course. Addendum: We received follow-up information from one of the authors on 21 SEP 2009: Batch numbers are not available as patients were not vaccinated from the authors. Cases occurred about five to ten years ago. The author only sees a temporal relationship to the vasculitic disease, not a causal one. No new events. No change in assessment.


VAERS ID: 359617 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2005-03-24
Submitted: 2009-10-05
   Days after onset:1655
Entered: 2009-10-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, Blood glucose decreased, Blood glucose increased, Body temperature increased, C-reactive protein increased, Death, Hypoxia, Oxygen saturation decreased, Petechiae, Pneumococcal bacteraemia, Sepsis, Shock, Vaccination failure, White blood cell count normal
SMQs:, Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (narrow), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-03-25
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Heart disease congenital
Preexisting Conditions: Asplenia
Allergies:
Diagnostic Lab Data: WBC count, 24Mar05, 7.49 10^9/l; blood glucose, 24Mar05, 1.5 mmol/l; blood glucose, 24Mar05, 1.06 mmol/l; blood glucose, 24Mar05, 12.67 mmol/l; blood glucose, 24Mar05, 14.5 mmol/l; body temp, 24Mar05, 39.7 C; serum C-reactive protein, 24Mar05, 39 mg/l; blood culture, 24Mar05, Streptococcus pneumoniae
CDC Split Type: WAES0909TWN00010

Write-up: Information has been received from a physician concerning a 4 year and 5 month old female with heart disease congenital and a history of congenitally asplenia who was vaccinated with PNEUMOVAX 23. On 24-Mar-2009 at the emergency room, she had shock, generalized petechiae, and severe hypoxemia (oxygen saturation 37%, her usual saturation being 80% due to congenital heart disease with an intracardiac shunt). Blood culture result showed Streptococcus pneumoniae. Vancomycin and ceftazimide were prescribed for the patient''s fulminant septicemia. On 25-Mar-2005 the patient died. The cause of death was pneumococcal bacteraemia. The reporter felt that vaccination failure and pneumococcal bacteraemia were related to therapy with PNEUMOVAX 23. No further information is available. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 361119 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2009-10-06
Onset:2009-10-08
   Days after vaccination:2
Submitted: 2009-10-15
   Days after onset:7
Entered: 2009-10-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (CSL)) / CSL LIMITED - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Aneurysm, Back pain, Chest pain, Death
SMQs:, Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-08
   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: Atenolol, dosage 25 mg QD, oral; SERITIDE, dosage 250mg BID; SPIRIVA; VENTOLIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2009020904

Write-up: Report received from a foreign regulator on 14-OCT-2009. A 77-year old male patient (initials unknown, date of birth: 16/4/1932) received PANVAX H1N1 (batch unknown) intramuscularly on 06-OCT-2009. The patient was taking concomitant atenolol (25 mg daily), Seretide accuhaler (250 mcg twice daily), Spiriva and Ventolin. Approximately 30 hours after vaccination on 08-OCT-2009, the patient had terrible back pain which continued through the night and then commenced chest pains. The patient was advised by the surgery to attend hospital immediately. The patient attended hospital, and died of an aneurysm on 08-OCT-2009. No autopsy results were provided. The regulatory assessed the causality as possible.


VAERS ID: 361120 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-09-30
Onset:2009-10-01
   Days after vaccination:1
Submitted: 2009-10-15
   Days after onset:14
Entered: 2009-10-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (CSL)) / CSL LIMITED - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac arrest, Cardiac death, Influenza like illness
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: 2009-10-02
   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: cerebral palsy; intellectual disability; epilepsy; foetal alcohol syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2009020903

Write-up: Report received from a foreign regulatory on 14-OCT-2009. A 24-year old female patient (initials and date of birth unknown) received PANVAX H1N1 (batch unknown) intramuscularly on 30-SEP-2009. The patient had a history of cerebral palsy, intellectual disability, epilepsy and foetal alcohol syndrome. On 01-OCT-2009, 1 day after PANVAX vaccination, the patient developed flu-like illness. On 02-OCT-2009, the patient developed a cardiac arrest and dies out of hospital. Apart from flu-like illness, pre-arrest clinical information was not known. Full results of a coronial enquiry are expected in 6-12 months. The regulator assessed the causality as possible, and noted the patient was admitted to hospital. The company assessed the event causality as possible in relation to the suspect drug, given the time to onset. However, the company also notes that the patient''s history classified the patient at high-risk of death regardless of vaccine administration and the influenza-like illness may have been indicative of a concomitant viral infection. Information derived from this AE report does not change the safety profile of the product. History of cerebral palsy, intellectual disability, epilepsy and foetal alcohol syndrome. Influenza-like illness may have been indicative of an intercurrent viral infection. No autopsy details available.


VAERS ID: 361121 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-10-15
Entered: 2009-10-16
   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: WAES0910USA00977

Write-up: Information has been received from a nurse practitioners'' patient who heard on radio that "HPV vaccine killed someone in the country". The cause of death was unknown. The reporter was not sure if the vaccine was GARDASIL or CERVARIX. Attempts are being made to verify the existence of an identifiable patient. Additional information has been requested.


VAERS ID: 361191 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2009-08-03
Onset:2009-08-03
   Days after vaccination:0
Submitted: 2009-10-16
   Days after onset:74
Entered: 2009-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS XHIBB964DI / UNK RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Encephalitis brain stem, Pneumonia
SMQs:, Noninfectious encephalitis (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-08-07
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0597406A

Write-up: This case was reported by a sales representative and described the occurrence of encephalitis in a female subject of unspecified age who was vaccinated with HIBERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 3 August 2009, the subject received unspecified dose of HIBERIX (intramuscular, unknown injection site). On 3 August 2009, less than one day after vaccination with HIBERIX, the subject experienced brainstem encephalitis and pneumonia. The sales representative reported that the events were unrelated to vaccination with HIBERIX. The subject died on 7 August 2009, cause of death was not reported. It was unknown whether an autopsy was performed.


VAERS ID: 362042 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2008-11-11
Onset:2008-11-13
   Days after vaccination:2
Submitted: 2009-10-20
   Days after onset:340
Entered: 2009-10-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 098612001 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Guillain-Barre syndrome, Influenza like illness
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-01-08
   Days after onset: 56
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: Amlodipine; ASPIRIN ARROW; BIMATOPROST; Bisoprolol; Omeprazole; Simvastatin
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2009020947

Write-up: Report received via a regulator. A male patient (patient initials, date of birth and age : unknown) received ENZIRA (influenza vaccine) on 11-NOV-2008. The batch number used was 098612001. Concomitant medications included amlodipine 5 mg taken orally daily for hypertension started on 27-NOV-2008, aspirin 75 mg taken orally daily started on ??-???-2007, bimatoprast for ophthalmic use indicated for glaucoma started on ??-???-2005, bisoprolol, 1.25mg taken orally daily started on ??-???-2007, omeprazole 20 mg taken orally daily for gastric ulcer prophylaxis started on 06-OCT-2008 and simvastatin 40 mg taken orally daily started on ??-???-2007. It is unknown if the patient had any other relevant medical conditions. On 13-NOV-2008, 2 days after ENZIRA was received, the patient developed a flu-like illness. On 28-NOV-2008, 17 days after ENZIRA was administered, the patient developed GUILLAIN BARRE Syndrome. The reaction duration specified for GUILLAIN BARRE Syndrome was 41 days with a recovery time of 58 days. The patient was admitted to hospital. The patient died on 08-JAN-2009, just under two months after vaccination. The patient was treated with amoxycillin 500 mg three times daily and cefadroxil 500 mg twice daily for the flu-like symptoms. The reporter considered this case serious due to death and that the cause of death was due to GUILLAIN BARRE Syndrome. No other details were provided regarding patient death. The company considered events as possible in relation to ENZIRA administration. Information derived from this AE report does not change the current safety profile of the product. Cause(s) of death: GUILLAIN BARRE syndrome. Death Date: 08-Jan-2009.


VAERS ID: 362177 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2009-10-06
Onset:2009-10-06
   Days after vaccination:0
Submitted: 2009-10-21
   Days after onset:15
Entered: 2009-10-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CA561A / 1 UN / IM
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER ASPNA007AG / 1 UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0255Y / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0910USA02244

Write-up: Information has been received from a Health Authority (documentation # 31822) concerning a 2 month old female patient (healthy child, no previous diseases, no medication) who on 06-OCT-2009 was vaccinated P.O with the second dose of ROTATEQ ( lot # 663714/0255Y), the first dose of INFANRIX HEXA (batch # A21CA561A, IM, site not reported) and the first dose of pneumococcal vaccine (unspecified) ( batch ASPNA007AG, intramuscular; site not reported) at about 11:00 am. It was reported that the mother found the infant at about 11 pm exanimated. In hospital the infant was unsuccessfully reanimated and died. A lot check has been requested. Other business partner numbers included: E2009-0960. Additional information has been requested.


VAERS ID: 362840 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2009-10-13
Onset:2009-10-14
   Days after vaccination:1
Submitted: 2009-10-23
   Days after onset:9
Entered: 2009-10-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Liver transplant
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0910USA02253

Write-up: Information has been received from a health care professional concerning a male patient of unspecified age who had a medical history of liver transplant. The patient received a dose of PNEUMOVAX and a dose of influenza vaccine (manufacturer, batch number, route and site of administration have not been reported). According to the reporter the vaccination may have taken place on 13-OCT-2009. The patient died the day after vaccine administration (it may occurred on 14-OCT-2009). No other information has been reported. Additional information has been requested. Other business partner numbers include E2009-09634.


VAERS ID: 363249 (history)  
Form: Version 1.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2009-10-07
Onset:2009-10-09
   Days after vaccination:2
Submitted: 2009-10-26
   Days after onset:17
Entered: 2009-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Acute myocardial infarction, Autopsy, Death
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: ARTERIOSCLEROSIS; DRUNKEN STATE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0598551A

Write-up: This case was reported by a healthcare professional in the frame of an SDE agreement and described the occurrence of death due to acute myocardial infarction in a 59-year-old male subject who was vaccinated with influenza virus vaccine Influenza vaccine (Green Cross Corporation). Concurrent medical conditions included arteriosclerosis. The subject had no concomitant medication. On 7 October 2009 the subject received unspecified dose of Influenza vaccine (intramuscular, unknown injection site). Lot number not provided. On 9 October 2009, 54 hours after vaccination with Influenza vaccine, the subject experienced death due to acute myocardial infarction. The subject was in a drunken state. The subject died on 9 October 2009, cause of death was myocardial infarction. An autopsy was performed and showed serious arteriosclerosis. The healthcare professional and the manufacturer considered the event was unrelated to vaccination with Influenza vaccine. No further information has been requested, the case has been closed.


VAERS ID: 363051 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-09-28
Onset:2009-09-28
   Days after vaccination:0
Submitted: 2009-10-27
   Days after onset:29
Entered: 2009-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA043BB / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cardiac arrest, Circulatory collapse, Death, Malaise, Neoplasm malignant, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Respiratory failure (broad), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-09-28
   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: Propranolol hydrochloride; Lansoprazole; Sumatriptan succinate
Current Illness: Unknown
Preexisting Conditions: No known allergies. Was being treated for migraines with propranolol (unknown dose or presentation) but this has not been confirmed by patient''s GP or family.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0595286A

Write-up: This case was reported by a physician and described the occurrence of death nos in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On the morning of the 28 September 2009 the patient received unspecified dose of CERVARIX (1 injection). On 28 September, within 30 minutes after vaccination with CERVARIX, the patient experienced a possible anaphylactic reaction (not confirmed). The patient collapsed and had to be administered an adrenaline injection. The patient had to be resuscitated by the paramedics and was taken to accident and emergency where they made another attempt to resuscitate the patient. The attempt was not successful and the patient was declared dead on 28 September 2009. It was unknown whether an autopsy was performed. Verbatim text: On the 28th September 2009 a public health consultant reported that a 14 year old female patient was administered a dose of CERVARIX ( Batch: AHPVA043BB, expiry: 09/2010) at school, in the morning of the 28th September 2009 as part of a school immunization program. The consultant reported that within 30 minutes after the administration of the CERVARIX the patient experienced what they believed was an anaphylactic reaction (not confirmed). The patient collapsed and had to be administered an adrenaline injection, she had to be resuscitated by paramedics and was taken to accident and emergency where they made another attempt to resuscitate the patient but it was not successful and the patient was declared dead. There was no further information available at the time of reporting. Follow-up information received via regulatory authority on 30 September 2009: The patient was taking CERVARIX for the prevention of premalignant cervical lesions and cervical cancer. The patient had no known allergies. She was being treated for migraines with propranolol (unknown dose or presentation) but his has not been confirmed by patient''s GP or family. The patient received her first dose of CERVARIX (Batch Number: A1-IPVA043BB) at 10:45 on Monday 28th September 2009 and following complaining of being unwell, had collapsed at approximately 12:00. Paramedics performed CPR on the patient but could not revive her and following further unsuccessful resuscitation attempts at the local acute trust Emergency Care Department, was pronounced dead. The patient died on 28 September 2009 from anaphylaxis. Follow-up information received on 8 October 2009: On 28 September 2009 the subject experienced circulatory collapse. The cause of death was unknown. Follow-up information received on 9 October 2009: Concurrent medications included lansoprazole and sumatriptan succinate. On the morning of the 28 September 2009 the subject received an unspecified dose of CERVARIX (1 injection, intramuscular). The reporter stated that it was not possible to confirm whether the subject was actually administered a dose of sumatriptan succinate prior to vaccination with CERVARIX. The regulatory authority reported that the subject ''received the vaccination, collapsed approximately 60 minutes later, VF, then asystolic arrest. No external signs of anaphylaxis.'' The cause of death was reported to be anaphylaxis. Follow-up information received on 16 October 2009: On an unknown date the subject experienced a malignant neoplasm. The outcome of the malignant neoplasm was fatal. The cause of death was reported to be malignant neoplasm. Post mortem results were pending.


VAERS ID: 363369 (history)  
Form: Version 1.0  
Age: 0.21  
Sex: Male  
Location: Foreign  
Vaccinated:2006-01-09
Onset:2006-01-20
   Days after vaccination:11
Submitted: 2009-10-27
   Days after onset:1375
Entered: 2009-10-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CA094A / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 15619 / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-01-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: The patient''s mother suffered from epilepsy and had been treated with KEPPRA during about the first three months of the pregnancy. The rest of the pregnancy and birth were inconspicuous, expect for a clavicula fracture. The patient was an agitated and whiny baby.
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: DEWYEG04711109

Write-up: Information regarding PREVENAR was received from a healthcare professional via a regulatory authority regarding a 2-month-old male patient who died of unknown reason. The patient received a dose on 09-Jan-2006. Additional suspect medication included INFANRIX HEXA which was administered on the same day. 11 days after vaccination the patient died on 20-Jan-2006. The cause of death was unknown. It was unknown whether an autopsy was performed. The cause of death was reported as unknown cause of death.


VAERS ID: 363731 (history)  
Form: Version 1.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2009-10-23
Onset:2009-10-23
   Days after vaccination:0
Submitted: 2009-10-29
   Days after onset:6
Entered: 2009-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA502AE / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cerebrovascular accident, Computerised tomogram abnormal, Death, Haemorrhagic stroke, Hypertension, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), 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), Hypertension (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-25
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood pressure, 23Oct2009, High; Computerized tomogram, 23Oct2009, Stroke
CDC Split Type: B0599740A

Write-up: This case was reported by a physician and described the occurrence of stroke in a 50-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). The subject was reported to be hypertensive. No information on medication taken. On 23 October 2009 at about 2-4 pm, the subject received unspecified dose of FLUARIX (intramuscular, unknown injection site). The subject was observed (kept) for 30 minutes. Doctor and nurse did not notice anything wrong with him. Afterwhich, no information on whereabouts of the subject. It was reported that the vaccination was part of vaccination program for employees of a petroleum company. About 40 other patients received the vaccine on the same time. On 23 October 2009 at 5:30 pm, within hours of vaccination with FLUARIX, the subject went to the hospital alone via public transport (motor vehicle/TukTuk). The subject had high blood pressure. He fainted at hospital. He showed signs of stroke and was brought for CT Scan. The subject was admitted at hospital and was diagnosed to have stroke (AVC hemorrhagic) based on CT scan result. On 24 October 2009, condition of subject deteriorated. Family decided to bring him home. The subject died on 25 October 2009 (morning) at home, cause of death was not reported. It was unknown whether an autopsy was performed. The physician considered the events were unrelated to vaccination with FLUARIX.


VAERS ID: 364957 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2009-10-23
Submitted: 2009-11-03
   Days after onset:11
Entered: 2009-11-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR - / 3 UN / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Intensive care
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: WAES0910USA04218

Write-up: Information has been received from a healthcare professional on 26-OCT-2009 (no reference number reported) concerning a 6 month old male who in 2009 was vaccinated with a dose of PNEUMOVAX 23. Secondary suspect therapy included PENTACEL given in 2009. 23-OCT-2009 it was notified that the patient had been sent to a child intensive care in very critical situation 1.5h after the third dose of PENTACEL and PNEUMOVAX 23. The patient died between 23-OCT-2009 and 26-OCT-2009 (exact date of death not reported). Batch numbers and manufacturers were unknown. Other business partner numbers included: E2009-09995. Additional information has been requested.


VAERS ID: 365673 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Foreign  
Vaccinated:2009-10-21
Onset:2009-10-21
   Days after vaccination:0
Submitted: 2009-11-05
   Days after onset:15
Entered: 2009-11-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER C3154AB / UNK UN / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER C3154AB / UNK UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER C3154AB / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D66977 / 3 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Crying, Death, General physical health deterioration, Intensive care, Mechanical ventilation, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), 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), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-24
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: The patient has a past history of premature baby (born at 31 weeks gestation). The patient is one of a triplet. 1 of the triplet has died. The mother had a spontaneous pregnancy. The boy has not been sick upfront. The parents are smoking.
Allergies:
Diagnostic Lab Data: Phenylalanine screen (results: questionable Congenital hypothyroidism (CH) result) was done in 2009. Autopsy (results: Macroscopically there were no abnormalities to be seen. The microscopic results are pending) was done in Oct-2009.
CDC Split Type: NLWYEG04726609

Write-up: Information regarding PREVENAR was received from a healthcare professional regarding a 5-month-old male patient who was crying strangely, found lifeless, in a very critical condition and died. The patient received the third dose of PREVENAR and PEDIACEL on 21-Oct-2009. Additional suspect medication included PEDIACEL. On 21-Oct-2009, approximately 90 minutes after receiving the third dose of PREVENAR and PEDIACEL the mother of the patient heard the patient crying strangely. She went to see the boy, after she had prepared a bottle for him. The patient was found lifeless in a very critical condition (unresponsive to stimuli) (general physical health deterioration) and was resuscitated. The child was hospitalised at the pediatric ICU and treated with mechanical ventilation, which was stopped on 24-Oct-2009, at the parents request. On 24-Oct-2009 the patient died. The cause of death was reported as unknown. The child was vaccinated according to 3+1 vaccination schedule as used. The indicated that there were no signs of high fever or serious infection and suspected sudden infant death syndrome as the cause of death. Two additional cases were received reporting death post-PREVENAR vaccination: NL-WYE-G04726709 (adverse event, expedited) and NL-WYE-G04771009 (adverse event, expedited). No additional information was available at the time of this report. QA Results: Quality assurance results were within specification.


VAERS ID: 365680 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2009-10-05
Onset:2009-10-16
   Days after vaccination:11
Submitted: 2009-11-05
   Days after onset:20
Entered: 2009-11-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21AC530A / 3 UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D66977 / 3 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness: The patient''s concurrent illness includes infantile spitting up (not on the day the patient died).
Preexisting Conditions: The patient is of descent. The patient was born at term (at 40 2/7 weeks gestation), policlinically. She had an Apgar score of 9/10. She is the 5th child of the family. The child often lies face down. She gets honey and a pacifier. The patient was not sick in the days prior to her death.
Allergies:
Diagnostic Lab Data: X-ray (results: Babygram: no abnormalities), physical examination (results: post-mortem examination: unimpaired child; normal nutritional state, no external injuries or petechiae) and fundoscopy (results: not possible due to blurred vitreous body) were done in Oct-2009.
CDC Split Type: NLWYEG04726709

Write-up: Information regarding PREVENAR was received from a healthcare professional regarding a 4-month-old female patient who turned blue and died. The patient received a third dose of PREVENAR and INFANRIX HEXA on 05-Oct-2009. Additional suspect medication included INFANRIX HEXA. On 16-Oct-2009, 11 days after receiving the third dose of PREVENAR and INFANRIX HEXA, the patient was brought to bed at 02:00 hours pm. At 04:30 hours pm she was found by her sister and she had turned blue. The mother has tried to resuscitate. The GP and the ambulance arrived. Resuscitation was stopped because the girl had died. The girl had a small amount of food left in her mouth. The body temperature of the patient was not measured prior to death. The child was transferred to the hospital. There the girls was examined by a pediatrician, who did not find abnormalities. The parents refused to have an obduction done and there were no grounds for a judicial autopsy. Indicated that the death was suspected of being sudden infant death syndrome and that there probably was aspiration. The cause of death was reported as unknown. Two additional cases were received reporting death post-PREVENAR vaccination: NL-WYE-G04726609 (adverse event, expedited) and NL-WYE-G04771009 (adverse event, expedited). No additional information was available at the time of this report. QA results: Quality Assurance results were within specification.


VAERS ID: 365684 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2009-10-21
Onset:2009-10-23
   Days after vaccination:2
Submitted: 2009-11-05
   Days after onset:13
Entered: 2009-11-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CA530A / 2 UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D66977 / 2 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: The parents of the girl is from a foreign country. During the pregnancy there were no abnormalities. The girl was born at term at 41 weeks gestation. The birth weight was 2720 g and the length at birth was 47 cm. The apgar-score was 9/10. The father smokes outside of the house. The mother is not smoking. Both the mother and a sister of the girl have the Turner syndrome. The girl was sleeping during the whole night sine the age of 2 months.
Allergies:
Diagnostic Lab Data: Post mortem examination was done by a pediatrician in Oct-2009 (results: no abnormalities).
CDC Split Type: NLWYEG04771009

Write-up: Information regarding PREVENAR was received from a healthcare professional regarding a 11-week-old female patient who died. The patient received a second dose of PREVENAR and INFANRIX HEXA on 21-Oct-2009. Additional suspect medication included INFANRIX HEXA. The patient received the first dose of PREVENAR on an unspecified date in 2009/ lot D66977. The child received the last bottle feeding on 22-October at 22.00 hours. Her mother put her in bed on her side. The next morning she was found lying face down, with her face in the mattress. The patient died 36 hours after receiving second dose of PREVENAR and PEDIACEL during the night of 22 to 23 of October 2009. The cause of death was unknown. Following the vaccinations, the child did not have a fever or any other symptoms. No additional information was available at the time of this report. Two additional cases were received reporting death post-PREVENAR vaccinations: NL-WYE-G04726609 (adverse event, expedited) and NL-WYE-G04726709 (adverse event, expedited). Quality Assurance results were within specification.


VAERS ID: 365933 (history)  
Form: Version 1.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:1998-08-29
Onset:0000-00-00
Submitted: 2009-11-06
Entered: 2009-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Balance disorder, CSF protein increased, CSF test abnormal, Death, Fatigue, Gait disturbance, Lumbar puncture abnormal, Lung adenocarcinoma, Multiple sclerosis, Nervous system disorder, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain abnormal, Visual evoked potentials abnormal
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Optic nerve disorders (narrow), Demyelination (narrow), Vestibular disorders (broad), Hypoglycaemia (broad), Non-haematological malignant tumours (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-04-11
Permanent Disability? Yes
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: Bronchial Adenocarcinoma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Cerebrospinal fluid protein, 2006, 0.78; Lumbar puncture, 2006, see text; Nuclear magnetic resonance ima, see text; Visual evoked potentials, 2006, see text; 2006, Cerebral MRI: seven hypersignals in periventricular and subcortical white matter without contrast enhancement; Medullar MRI: multiple T2 and flair hypersignals; Lumbar puncture: oligoclonal profile with elevated cervicospinal fluid proteins; Evoked potentials: increased of latency at left eye level.
CDC Split Type: B0600873A

Write-up: This case was reported by the regulatory authority (numbers CF20090296 and CF0900323) and described the occurrence of multiple sclerosis in a 29-year-old female subject who was vaccinated with (ENGERIX B, GlaxoSmithKline). The subject belonged to the association under the reference 2377. The patient had a family history of multiple sclerosis (brother) and ALZHEIMER''S disease (mother). Previous vaccination included two doses of (ENGERIX B, GlaxoSmithKline) given on 21 November 1997 and 21 December 1997 (batch and injection site unknown, intramuscular). On 29 August 1998, the subject received 3rd dose of ENGERIX B (batch and injection site unknown, intramuscular). First symptoms appeared after last ENGERIX dose, in 1998. On unspecified dates, the subject presented with general fatigue, neurological troubles and balance disorder. In August 2006, the patient was admitted to hospital for investigation of gait disturbance. Cerebral MRI showed seven hyper signals in periventricular and subcortical white matter without contrast enhancement. Medullar MRI showed multiple T2 and flair hypersignals (MRI abnormal). Lumbar puncture revealed an oligoclonal profile with elevated cervicospinal fluid proteins at 0.78 (cerebrospinal fluid abnormal). Evoked potentials showed an increased of latency at left eye level. Multiple sclerosis was diagnosed. The subject was treated with COPAXONE. On 11 April 2009, the patient died of bronchopulmonary adenocarcinoma (death not related to the event according to regulatory authority). The regulatory authority reported that the events were disabling. The agency assessed the causal relationship of ENGERIX B with the event as dubiously according to the method of assessment.


VAERS ID: 366648 (history)  
Form: Version 1.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-11-04
Onset:2009-11-07
   Days after vaccination:3
Submitted: 2009-11-10
   Days after onset:3
Entered: 2009-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER AB1CA061A / UNK LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Heart rate decreased, Pallor, Respiratory rate decreased, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AMLODIPINE; BUSOPROLOL; VALSARTAN; DICLOFENAC; PANTOPRZOLE
Current Illness: Hyperlipidemia; Hypertension arterial; Polyarthrosis; Reduced physical ability; Renal insufficiency
Preexisting Conditions: Prosthesis implantation; Reduced blood pressure; Strumectomy; Syncope (recurrent)
Allergies:
Diagnostic Lab Data: Heart rate, 07Nov2009, low
CDC Split Type: D0063628A

Write-up: This case was reported by a physician and described the occurrence of death - at present cause unknown - in a 92-year-old female subject who was vaccinated with PANDEMRIX H1N1 (GlaxoSmithKline) and INFLUSPLIT SSW 2009/2010 (GlaxoSmithKline). The subject''s medical history included prosthesis implantation (total endoprosthesis) in 2007 and strumectomy. Relevant recent medical history included recurrent syncope with reduced blood pressure, last episode in May 2009, possibly associated with wrong intake of antihypertensive drug(s). Concurrent medical conditions included hyperlipidemia, arterial hypertension since years, polyarthrosis and renal insufficiency grade I. The subject suffered from reduced physical ability but was mentally fit. The subject lived with her son and was cared for by a nursing service. Concomitant medications included AMLODIPIN, BISOPROLOL, PROVAS, DICLOFENAC and PANTOPRAZOL. On 03 November 2009 the subject received a dose of INFLUSPLIT SSW 2009/2010 (0.5 ml, unknown). On 4 November 2009 the subject received the first dose of PANDEMRIX H1N1 (0.5 ml, unknown). The subject has tolerated both vaccinations well and experienced no adverse events. In the morning of the date of death, on 07 November 2009, the subject was completely well without experiencing any complaints. Approximately three days post vaccination with PANDEMRIX H1N1 and approximately four days post vaccination with INFLUSPLIT SSW 2009/2010, on 07 November 2009, in the afternoon post afternoon nap, the subject was hardly responsive to verbal stimuli and experienced pallor, low pulse rate and decreased respiration rate. The nursing service called for an emergency physician on 07 November 2009 at around 16:00. The subject received no treatment for the event because of living will/advance directive. The subject was transferred to a hospital. Some time later at the hospital, on the same day, on 07 November 2009, the patient died. The cause of death was considered to be unknown. Therefore an autopsy has been ordered by a public prosecutor/district attorney. The results of autopsy were unknown. The reporting physician considered that death and preceding adverse events were unrelated to vaccination with PANDEMRIX H1N1 and/or INFLUSPLIT SSW 2009/2010, because post vaccinations the subject experienced no adverse events at all. Follow-up information has been requested.


VAERS ID: 366656 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-11-10
Entered: 2009-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (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: 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: A0815500A

Write-up: This case was reported by a consumer and described the occurrence of death in an elderly male subject who was vaccinated with influenza vaccine trivalent (seasonal Influenza vaccine unspecified, manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of seasonal Influenza vaccine unspecified (unknown). At an unspecified time after vaccination with seasonal Influenza vaccine unspecified, the subject experienced death. It was reported that the elderly man died after receiving the flu shot a few years ago. The subject died from death nos. It was unknown whether an autopsy was performed.


VAERS ID: 367162 (history)  
Form: Version 1.0  
Age: 0.28  
Sex: Male  
Location: Foreign  
Vaccinated:2009-10-05
Onset:2009-10-05
   Days after vaccination:0
Submitted: 2009-11-13
   Days after onset:39
Entered: 2009-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Bacterial test positive, Bronchopneumonia, Enterobacter infection, Histology abnormal, Staphylococcal infection, Sudden infant death syndrome
SMQs:, Eosinophilic pneumonia (broad), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2009-10-05
   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:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Autopsy, 2009, see lab text; Autopsy: Anatomical and cytopathological examinations were normal without identifiable facial dysmorphism or external malformation. Histological examination of lungs evidenced lesions of acute bronchopneumonia. Bacteriological lab tests showed presence of low amount of staphylococcus aureus and enterobacteria in lungs and several staphylococcus aureus in nasopharyngeal secretions.
CDC Split Type: B0602020A

Write-up: This case was reported by the regulatory authority (numbers MP20090746 and MP0900757) and described the occurrence of sudden infant death in a 3-month-old male subject who was vaccinated with INFANRIXQUINTA (GlaxoSmithKline). The subject weighted 4,7 kg. On 05 October 2009, the subject received an unspecified dose of INFANRIXQUINTA (intramuscular, batch and injection site unknown). On 05 October 2009, four to five hours after vaccination with INFANRIXQUINTA, a sudden death was reported. An autopsy was performed. Anatomical and cytopathological examinations were normal without identifiable facial dysmorphism or external malformation. Histological examination of lungs evidenced lesions of acute bronchopneumonia. Bacteriological lab tests showed presence of low amount of staphylococcus aureus and enterobacteria in lungs and several staphylococcus aureus in nasopharyngeal secretions. The serious criteria, hospitalisation and life threatening, were ticked. Causal relationship of vaccination with INFANRIXQUINTA and sudden death was assessed as "dubiously" according to the method of imputability.


VAERS ID: 367587 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-11-06
Entered: 2009-11-16
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A22CA593A / 2 UN / IJ
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 2 UN / IJ

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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: B0601431A

Write-up: This case was reported by a healthcare professional and described the occurrence of death NOS in a 3-month-old female subject who was vaccinated with INFANRIX HEXA (GlaxoSmithKline), PREVENAR (non-GSK). On an unspecified date, the subject received 2nd dose of INFANRIX HEXA (unknown route of administration), 2nd dose of PREVENAR (unknown route of administration). On an unspecified date, at an unspecified time after vaccination with INFANRIX HEXA and PREVENAR, the subject died, cause of death was not specified. It was unknown whether an autopsy was performed. No active follow-up possible.


VAERS ID: 367628 (history)  
Form: Version 1.0  
Age: 48.0  
Sex: Male  
Location: Foreign  
Vaccinated:2009-10-28
Onset:2009-10-31
   Days after vaccination:3
Submitted: 2009-11-13
   Days after onset:13
Entered: 2009-11-16
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (CSL)) / CSL LIMITED 090201401 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, Death, Septic shock, Staphylococcal bacteraemia, Staphylococcal sepsis
SMQs:, Toxic-septic shock conditions (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-12
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: End stage renal failure, home haemodialysis
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2009021359

Write-up: Report received from a hospital via an adverse event surveillance organisation on 12-Nov-2009. A 48 year-old male patient (initials unknown, date of birth 30-Jan-1961) received PANVAX H1N1 (batch 090201401) on 28-Oct-2009 at 12:30pm. The patient had a medical history of end stage renal failure since March 2009, and was undergoing home haemodialysis. Concomitant medications unknown. On 31-Oct-2009 (3 days post-vaccination), the patient visited the emergency department and presented in septic shock. The patient was admitted to hospital on 2-Nov-2009. A blood culture was positive for Staph aureus and the patient was diagnosed with staph sepsis. The patient died on 12-Nov-2009, 15 days after the suspect drug was administered. Cause of death is unknown. The case was reported as serious because the outcome was fatal. The company considered events to be possibly related to the suspect drug. Information derived from this AE report does not change the current safety profile of the product. Cause of death is unknown.


VAERS ID: 367645 (history)  
Form: Version 1.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2008-01-01
Onset:0000-00-00
Submitted: 2009-11-13
Entered: 2009-11-16
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Inappropriate schedule of drug administration, Myelodysplastic syndrome, Pallor, Platelet count decreased, Red blood cell count decreased, White blood cell count decreased
SMQs:, Haematopoietic cytopenias affecting more than one type of blood cell (broad), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Blood premalignant disorders (narrow), Hypotonic-hyporesponsive episode (broad), Myelodysplastic syndrome (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Radiation exposure
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0911USA01855

Write-up: Initial information has been received from the patient''s family concerning a 91 year old male patient, an atomic bomb survivor, who in December 2007 (dose and indication not reported) and January 2008 (indication not reported) was vaccinated with PNEUMOVAX 23. No information on concomitant therapy was provided. On an unspecified date, the patient developed complexion ill after the second inoculation of PNEUMOVAX 23. In the fall of 2008, the patient developed red blood cell count, white blood cell count and platelet count decreased. In February 2009, the patient developed myelodysplastic syndrome and died. At the time of this report, the outcome of complexion ill and red blood cell count, white blood cell count and platelet count decreased were unknown. The reporter (patient''s family) considered that the myelodysplastic syndrome was serious due to death. The reporter did not assess the seriousness of the complexion ill and the red blood cell count, white blood cell count and platelet count decreased. The reporter felt that the causal relationship of the complexion ill, the red blood cell count, white blood cell count and platelet count decreased and the myelodysplastic syndrome to PNEUMOVAX 23 was unknown. No further information is available. The comment of patient''s family: I didn''t know the cause of death but I became concerned due to inappropriate vaccination and telephoned.


VAERS ID: 368158 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2009-10-20
Onset:2009-10-20
   Days after vaccination:0
Submitted: 2009-11-17
   Days after onset:28
Entered: 2009-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB692DD / 1 AR / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Culture negative, Death, Intensive care, Microbiology test normal, Poor peripheral circulation, Respiratory disorder, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-22
   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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0604627A

Write-up: This case was reported by a physician and described the occurrence of respiratory insufficiency in a 2-day-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline), (non-GSK) BACILLUS CALMETTE-GUERIN. The subject was born with an appropriate gestational age, newborn infant, with apgar score of 9/9. The pregnancy and delivery was with no intercurrences. On 20 October 2009, when he was 6 hours of life, the subject received 1st dose of ENGERIX B (unknown), 1st dose of BACILLUS CALMETTE-GUERIN vaccine (unknown). On 20 October 2009, 2 hours after vaccination with BACILLUS CALMETTE-GUERIN vaccine and ENGERIX B, the subject experienced low peripheral perfusion and respiratory disorder. He was transferred to newborn intensive care unit. The patient''s clinical condition evolved to respiratory insufficiency and she died with 48 hours of life. According to the physician, the exam results were inconclusive, the microbiological cultures were negatives. The injection sites were clean, with no signs of inflammation or infection. The subject died on 22 October 2009 from respiratory insufficiency. An autopsy was performed and the results were pending.


VAERS ID: 368421 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-11-16
Entered: 2009-11-18
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Antineutrophil cytoplasmic antibody positive, Biopsy kidney abnormal, Death, Dialysis, Glomerulonephritis, Pneumonia, Wegener's granulomatosis
SMQs:, Acute renal failure (narrow), Interstitial lung disease (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Eosinophilic pneumonia (broad), Vasculitis (narrow), Chronic kidney disease (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: 2009021366

Write-up: Report received via the medical literature on 11-NOV-2009. Four case reports are included in the paper, this report refers to case 3. The other cases in the paper are reported as CSL cases 2009021367, 2009021368 and 2009021369. A 70 year-old male patient (initials and date of birth unknown) received influenza vaccine (unknown brand) on an unknown date. Patient''s medical history and concomitant medications unknown. Three weeks after the administration of the suspect drug the patient developed rapidly progressive glomerulonephritis. Renal biopsy showed diffuse extracapillary pauci-immune glomerulonephritis, and circulating CANCA directed against PR3 could be detected. Wegener granulomatosis with severe renal involvement was diagnosed and treatment with IV pulse glucocorticoids and CYC po instituted. The patient became dialysis dependent and acquired severe bilateral pneumonia. The patient finally died on an unknown date of pneumonia. The case was reported as serious because of the fatal outcome. The company considered events to be possible in relation to the suspect drug. Information derived from this AE report does not change the current safety profile of the product. Cause of death is unknown.


VAERS ID: 369535 (history)  
Form: Version 1.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-11-09
Onset:0000-00-00
Submitted: 2009-11-23
Entered: 2009-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER E0542 / UNK LA / IJ

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Arthralgia, Chest discomfort, Chills, Death, Influenza like illness, Mouth ulceration, Pain, Pruritus, Swollen tongue
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Systemic lupus erythematosus (broad), Dementia (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Arthritis (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? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Simvastatin
Current Illness: Insulin-dependent diabetes mellitus
Preexisting Conditions: Took antihistamine, paracetamol, ibuprofen. IDDM
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0604342A

Write-up: This case was reported by the regulatory authority (# GB-MHRA-FLU 00027480) and described the occurrence of death (nos) in a 49-year-old female patient who was vaccinated with influenza virus vaccine (manufacturer unspecified). Concurrent medical conditions included insulin-dependent diabetes mellitus. Previous and/or concurrent vaccination included influenza virus vaccine (manufacturer unspecified; unknown) given on an unspecified date. Concurrent medications included Simvastatin. On 09 November 2009 the patient received a dose of Influenza virus vaccine (1 injection, unknown). At an unspecified time after vaccination with Influenza virus vaccine, the patient experienced flu like symptoms, joint pain, chest tightness, pain, itching, swelling of tongue, mouth ulcer and rigors. The regulatory authority reported that the events were disabling. The reaction severity was bad enough to affect every day activities. The patient was treated with Antihistamines, Paracetamol and Ibuprofen. At an unspecified time after vaccination with Influenza virus vaccine, the patient died from unknown cause of death. It was unknown whether an autopsy was performed. Verbatim Text : Reaction Severity: Bad enough to affect every day activities, Caused death.


VAERS ID: 370527 (history)  
Form: Version 1.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-10-09
Onset:2009-10-09
   Days after vaccination:0
Submitted: 2009-11-25
   Days after onset:47
Entered: 2009-11-30
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (CSL)) / CSL LIMITED - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Brain injury, Condition aggravated, Death, Dyspnoea, Hypoxia, Intensive care, Mechanical ventilation, Respiratory arrest, Resuscitation
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Morbid obesity; asthma; recent respiratory infection.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2009021502

Write-up: Report received from a regulator on 20-NOV-2009. A 59 year old female patient (initials: unknown, DOB: 17-JAN-1950) received PANVAX H1N1 via intramuscular route on 09-OCT-2009. Batch number and expiry for the vaccine is unknown. The patient had a medical history of morbid obesity, asthma and a recent respiratory tract infection. It is unclear if the patient was well at the time of vaccination. The patient''s general practitioner stated that the patient was well at the time of vaccination whilst history from the hospital indicated that she and her husband suffered from cold and flu symptoms in the last few days prior to vaccination. At the time of vaccination, the patient appeared well and stable with no temperature and stated that she was alright. The patient had no immediate local or systemic reactions and was monitored for 15 minutes at the general practitioners surgery and was well when she left the surgery. She also had recently ceased a course of antibiotics. Details of concomitant medications are unknown. On 09-OCT-2009, three and a half hours after PANVAX H1N1 was administered, the patient developed dyspnoea and hypoxia. The patient then suffered respiratory arrest and significant hypoxic brain injury. Resuscitation was performed following hypoxic respiratory arrest. The patient was admitted to the intensive care unit where she was ventilated. These events resulted in a fatal outcome. The patient died on an unknown date after PANVAX H1N1 was administered. Cause of death was reported as possible to the administration of PANVAX H1N1. Investigations into this case are ongoing. The reporter considered events possible to PANVAX H1N1 administration. This case was reported as serious because due to fatal outcome. The company considered events possible to PANVAX H1N1 due to time to onset relationship and other possible confounding factors. Information derived from this AE report does not change the current safety profile of the product. Cause of death is unknown.


VAERS ID: 370600 (history)  
Form: Version 1.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-11-30
Entered: 2009-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The subject had gone to see her physician 2 weeks prior to vaccination with the Pandemic vaccine H1N1 unspecified and seasonal Influenza vaccine unspecified and was "completely healthy".
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A0825039A

Write-up: This case was reported by a consumer and described the occurrence of hemorrhage in a 43-year-old female subject who was vaccinated with PANDEMIC VACCINE H1N1 (unspecified, manufacturer unspecified), influenza vaccine trivalent (seasonal Influenza vaccine unspecified). A physician or other health care professional has not verified this report. Relevant medical history included that the subject had gone to see her physician 2 weeks prior to vaccination with the PANDEMIC VACCINE H1N1 unspecified and seasonal Influenza vaccine unspecified and was "completely healthy". In 2009 the subject received unspecified dose of PANDEMIC VACCINE H1N1 unspecified (unknown), and unspecified dose of seasonal Influenza vaccine unspecified (unknown). On an unspecified date in 2009, less than one week after vaccination with PANDEMIC VACCINE H1N1 unspecified and seasonal Influenza vaccine unspecified, the subject experienced hemorrhage. The subject died from hemorrhage. It was unknown whether an autopsy was performed.


VAERS ID: 370770 (history)  
Form: Version 1.0  
Age: 0.27  
Sex: Male  
Location: Foreign  
Vaccinated:2009-09-29
Onset:2009-10-02
   Days after vaccination:3
Submitted: 2009-11-25
   Days after onset:54
Entered: 2009-12-01
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-02
   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: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: Relevant medical history was not provided.
Allergies:
Diagnostic Lab Data: Body temperature (results: 39.4 deg. C.) was done on 02-Oct-2009.
CDC Split Type: DEWYEG04907609

Write-up: Information regarding PREVENAR was received from a healthcare professional via a regulatory authority regarding a 3-month-old male patient who experienced fever of 39.4 C and died due to an unknown cause. The patient received a dose on 29-Sep-2009. Additional suspect medication included INFANRIX HEXA that was administered the same day. The patient died on 02-Oct-2009. An autopsy did not reveal any pathological finding that could explain the death. It was also reported that an emergency medical service was involved who determined the patient''s body temperature as 39.4 C. No further symptoms were reported after vaccination. Therefore the temporal relationship between the vaccinations and patient''s death was considered coincidental. The reported and autopsy causes of death were unknown cause of death. No additional information was available at the time of this report.


VAERS ID: 371292 (history)  
Form: Version 1.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-10-30
Onset:2009-11-02
   Days after vaccination:3
Submitted: 2009-12-02
   Days after onset:30
Entered: 2009-12-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 092302A / UNK RA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0688X / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arrhythmia, Atrial fibrillation, Blood creatinine increased, C-reactive protein increased, Cerebrovascular accident, Chest X-ray normal, Crepitations, Death, Disorientation, Electrocardiogram abnormal, Eye movement disorder, Febrile infection, General physical health deterioration, Granulocyte percentage, Haematocrit decreased, Haemoglobin normal, Heart rate irregular, Hemiparesis, Lymphocyte percentage decreased, No reaction on previous exposure to drug, Rales, Red blood cell count decreased, Somnolence, Unresponsive to stimuli, Urine analysis normal, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (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: CONCOR; KALINOR; PANTOZOL; REMERGIL; carbimazole; furosemide
Current Illness:
Preexisting Conditions: Multimorbidity
Allergies:
Diagnostic Lab Data: physical examination, 02Nov09, irregular heart beat; physical examination, 02Nov09, crackling pulmonary rales right basal; physical examination, 02Nov09, right sided hemiparesis; physical examination, 02Nov09, mild ocular deviation to the left; chest X-ray, 02Nov09, pneumonia was ruled out; electrocardiogram, 02Nov09, absolute arrhythmia in the scope of atrial fibrillation; WBC count, 02Nov09, 19.7/nl; hematocrit, 02Nov09, 0.343 l/l; hemoglobin, 02Nov09, 11.9 g/dl; lymphocyte count, 02Nov09, 7%; serum C-reactive protein, 02Nov09, 254 mg/l; serum creatinine, 02NOv09, 1.28 mg/dl; urinalysis, 02Nov09, normal results; red blood cell count, 02Nov09, 3.88/pl; blood granulocyte count, 02Nov09, 87%; WBC count, 04Nov09, 10.6/nl; hematocrit, 04Nov09, 0.305 l/l; hemoglobin, 04Nov09, 10.3 g/dl; serum C-reactive protein, 04Nov09, 282 mg/l; red blood cell count, 04Nov09, 3.37/pl
CDC Split Type: WAES0911USA04792

Write-up: Information has been received from a health authority in a foreign country on 23-Nov-2009 (PEI200925841) concerning a multimorbid 90 year old patient with history of previous vaccination with FLUAD on 03-Nov-2009 reported as well tolerated. On 30-OCT-2009 the patient was vaccinated with PNEUMOVAX 23 (Lot # 662312/0688X) (Batch # NJ23660) intramuscularly into her left upper arm. Secondary suspect vaccine included FLUAD (Lot # 092302A) administered intramuscularly into her right arm on the same day. Concomitant therapy included CONCOR, carbimazole, REMERGIL and PANTOZOL, KALINOR and furosemide. (These drugs were listed in the hospital report as "recent medications", no exact indications were provided.) It was reported that in the morning of 02-NOV-2009, the patient was somnolent and did not respond to verbal stimuli, general condition was reduced and the patient was hospitalized the same day. Physical examination showed an irregular heartbeat, crackling pulmonary rales right basal, right sided hemiparesis and mild ocular deviation to the left. The patient was awake but disoriented (recovered from somnolence). Electrocardiography on 02-NOV-2009 showed absolute arrhythmia in the scope of atrial fibrillation. Inflammatory lab parameters were remarkably increased. Relevant laboratory for 02-NOV-2009 included: HB (blood hemoglobin test): 11.9; hematocrit (whole blood hematocrit): 0.343; erythrocytes (red blood cell count): 3.88; leucocytes (white blood cell count): 19.7; CRP (serum C-reactive protein test): 254; creatinine (serum creatinine test): 1.28; granulocytes (blood granulocyte count): 87; lymphocytes (blood lymphocyte count): 7. Cystitis could be ruled out by urinalysis on 02-NOV-2009 which showed normal results. Pneumonia was ruled out by chest x-ray on 02-NOV-2009. Relevant laboratory for 04-NOV-2009 included: HB (blood hemoglobin test): 10.3; hematocrit (whole blood hematocrit): 0.305; erythrocytes (red blood cell count): 3.37; leucocytes (white blood cell count): 10.6; CRP (serum C-reactive protein test): 282. Febrile infection on unknown origin and suspicion of apoplexy was diagnosed. Treatment with AUGMENTIN was started. On 06-NOV-2009 the patient was transmitted to a nursing home for further treatment. On the reporting form outcome of the reaction was reported to be fatal (verbatim PEI: febrile infection, reduced general condition and unknown cause of death). cessation date of febrile infection was reported to be 13-NOV-2009. However, the exact date of death was not reported (NOV-2009). Other business partner numbers include E200910777., A lot check has been initiated. File is closed. No further information is available.


VAERS ID: 371298 (history)  
Form: Version 1.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2009-11-03
Onset:2009-11-05
   Days after vaccination:2
Submitted: 2009-12-02
   Days after onset:27
Entered: 2009-12-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, No reaction on previous exposure to drug
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-05
   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:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0911USA04803

Write-up: Information has been received from health authority (HA) under HA reference no. PEI2009025843 concerning a 60-year-old previously healthy male patient who was vaccinated with an unspecified dose of PNEUMOVAX (lot #, injection route and site not reported) on 03-NOV-2009. Two days post vaccination the patient died "out of full health". An autopsy was not carried out. Vaccination with FLUAD on 15-OCT-2009 was well tolerated. File is closed. Other business partner numbers include E2009-10860.


VAERS ID: 371554 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-10-07
Onset:0000-00-00
Submitted: 2009-12-03
Entered: 2009-12-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Drooling, Increased upper airway secretion, Nasopharyngitis, Pneumonia aspiration
SMQs:, Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DOMPERIDONE; DIGOXIN; LANSOPRAZOLE; OXYBUTYNIN; EASPRIN; DILTIAZEM; BENDROFLUAZIDE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2009021595

Write-up: Report received from a physician on 1-Dec-2009. An 87 year-old female patient (date of birth 14-Jul-1922) received ENZIRA intramuscularly on 7-Oct-2009. Concomitant medications included domperidone 10mg three times daily, digoxin 75 micrograms once daily, lansoprazole 30mg once daily, oxybutynin 5mg twice daily, aspirin 75mg once daily, diltiazem 60mg three times daily and bendrofluazide 2.5mg once daily, all taken orally for the CVE (cardiovascular event). An unknown time after administration of ENZIRA, the patient developed mild catarrh and phlegm/mucous/saliva running down side of mouth. Treatment details are unknown, but the reporter indicated that the symptoms were mild and the patient recovered from this event. However, on the 23-Oct-2009, 16 days after the administration of the suspect drug ENZIRA, the patient died. The cause of death was reported as aspiration pneumonia. The reporter stated that he was reporting the event on behalf of the family and that he personally did not consider that the event was an adverse reaction to the ENZIRA. The reporter did not consider the event serious. The case was reported as serious because the patient outcome was fatal. The company considered events to be unlikely in relation to the suspect drug. Information derived from this AE report does not change the current safety profile of the product. Cause of death is unknown. Follow-up: Case 2009021595 is a duplicate of case 2009021548. Case 2009021595 has been nullified in our database as case 2009021548 contains all information regarding the patient and event.


VAERS ID: 371840 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2009-11-12
Onset:2009-11-16
   Days after vaccination:4
Submitted: 2009-12-04
   Days after onset:18
Entered: 2009-12-07
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CA530A / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D91963 / 2 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: Relevant medical history was not provided.
Allergies:
Diagnostic Lab Data: Toxicologic test (results: unknown) and autopsy (results: no abnormalities found yet) were done in Nov-2009.
CDC Split Type: NLWYEG04976409

Write-up: Information regarding PREVENAR was received from a healthcare professional regarding a 3-month-old male patient who died. The patient received the second dose of PREVENAR and INFANRIX HEXA on 12-Nov-2009. Additional suspect medication included INFANRIX HEXA. The patient was found dead on 16-Nov-2009, four days after the vaccinations. According to the media, he was found dead in his bed at the day care center. The police started an investigation to find the cause of death. Obduction has not shown any abnormalities yet and results of a toxicological investigation are still awaited, as stated in the media. The cause of death was reported as death. No additional information was available at the time of this report.


VAERS ID: 372544 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-12-10
Entered: 2009-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / IJ

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Arthralgia, Blood product transfusion, Cerebral haemorrhage, Condition aggravated, Death, Diarrhoea haemorrhagic, Glomerulonephritis, Lung neoplasm, Purpura, Skin ulcer, Vasculitis cerebral
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Vasculitis (narrow), Chronic kidney disease (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological tumours of unspecified malignancy (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Deoxyspergualin; CORTICOSTEROIDS
Current Illness: Wegeners Granulomatosis
Preexisting Conditions: Glomerulonephritis due to Wegeners Granulomatosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20095562

Write-up: We received the following information from the above mentioned literature article on 3 DEC 2009. A male patient, born in 1984, was diagnosed at the age of 12 years with PR3-ANCA-associated glomerulonephritis due to Wegener''s Granulomatosis. He was treated with cyclophosphamide, methylprednisone and azathioprine. In 2004, the patient developed a biopsy-proven renal relapse. Deoxyspergualin, an antiproliferative drug with effects on lymphocyte and macrophage function and neutrophil production, was started in combination with high dose steroids. Because haematuria and proteinuria persisted, the kidney was re-biopsied and showed persistently active glomerulonephritis with new necrotizing and crescentic lesions. The fourth and fifth cycle went uncomplicated. In the sixth cycle, our patient received an influenza vaccination (manufacturer and batch no. unknown). Shortly after this vaccination, a severe relapse occurred with purpura, arthralgias, new nodular lung lesions and active glomerulonephritis. Deoxyspergualin was stopped, and mycophenolate mofetil (2 g/day) in combination with high-dose corticosteroids and plasma exchange was given. Despite this therapy, he developed severe ulceration of the legs, abdominal pain with bloody diarrhoea and intracerebral haemorrhage due to cerebral vasculitis resulting in death. The patient experienced a fatal relapse occurring shortly after influenza vaccination. Vaccination was done while our patient had active glomerulonephritis suggesting that (further) activation of the vasculitic process after influenza vaccination was caused by so-called bystander activation [4] in which vaccination resulted in activation of antigen presenting cells expressing the autoantigen proteinase 3.


VAERS ID: 372910 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-09-18
Onset:2009-09-22
   Days after vaccination:369
Submitted: 2009-12-10
   Days after onset:79
Entered: 2009-12-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 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: 2009-09-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Herpes virus infection
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0912USA00953

Write-up: Information has been received from the agency via Case Line listing via CSL, as part of a business agreement, concerning an 18 year old female patient with disseminated herpes viral disease who on 17-MAR-2009 was vaccinated with the third dose of GARDASIL (batch #NJ11440, lot# 1283U). The second suspect therapy included DEPO-PROVERA which was administered IM, 600 mg yearly, from 2007 October to 2009 January. On 22-SEP-2009 the patient developed sudden death (severe). It was unknown if the patient sought medical attention. A lot check has been initiated. No further information is available.


VAERS ID: 372912 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Female  
Location: Foreign  
Vaccinated:2008-12-01
Onset:2008-12-01
   Days after vaccination:0
Submitted: 2009-12-11
   Days after onset:375
Entered: 2009-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK LG / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK RA / UN

Administered by: Other       Purchased by: Other
Symptoms: Acute lymphocytic leukaemia, Asthenia, Death, Decreased appetite, Ear infection, Haematology test abnormal, Neuritis
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Haematological malignant tumours (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-09-01
   Days after onset: 273
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: Hematology test, 11Jan2009, Abnormal
CDC Split Type: B0612568A

Write-up: This case was reported by a physician via a sales representative and described the occurrence of fatal acute lymphoblastic leukemia in a 8-month-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). Previous and/or concurrent vaccination included poliomyelitis vaccine inactivated (non-gsk) ;non-GSK manufacturer; given in December 2008. In December 2008, the subject received unspecified dose of INFANRIX (unknown route and injection site), lot number not provided. In December 2008, 2 weeks after vaccination with INFANRIX, the subject experienced acute otitis. She was treated with AUGMENTIN and was recovered 7 days later. On 1st January 2009, the subject developed appetite lost and weakness. On 10 January 2009, the diagnosis of neuritis of nervus facialis was made and the subject was hospitalised. On 11 January 2009, the hematology test performed revealed an acute lymphoblastic leukemia. The physician considered the acute lymphoblastic leukemia was probably related to vaccination with INFANRIX. The subject died in September 2009, cause of death was not reported. It was unknown whether an autopsy was performed. Additional information has been requested but could not be obtained as the reporter has refused to be contacted. This case has therefore been closed.


VAERS ID: 373157 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Female  
Location: Foreign  
Vaccinated:2009-07-02
Onset:2009-07-12
   Days after vaccination:10
Submitted: 2009-12-10
   Days after onset:151
Entered: 2009-12-14
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR - / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 3 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-07-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant medications were not used.
Current Illness:
Preexisting Conditions: There was no relevant medical history.
Allergies:
Diagnostic Lab Data: None provided
CDC Split Type: NLWYEG05057809

Write-up: Information regarding PREVENAR was received from a healthcare professional via a regulatory authority regarding a 5-month-old female patient who died in her sleep. The patient received the third dose on 02-Jul-2009. Additional suspect medication included PEDIACEL. The patient died in her sleep on 12-Jul-2009. The cause of death was reported as death. No additional information was available at the time of this report.


VAERS ID: 373183 (history)  
Form: Version 1.0  
Age: 0.41  
Sex: Female  
Location: Foreign  
Vaccinated:2009-12-10
Onset:2009-12-10
   Days after vaccination:0
Submitted: 2009-12-11
   Days after onset:1
Entered: 2009-12-14
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR D0616 / 1 AR / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Crying, Death, Dysphoria, Feeding disorder neonatal
SMQs:, Depression (excl suicide and self injury) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-12-11
   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 "other" relevant history, no concomitant drugs
Allergies:
Diagnostic Lab Data: not reported
CDC Split Type: 200905449

Write-up: Case received from a healthcare professional on 11 December 2009 under the local reference number NC2009133. A 05-month-old female patient, with no "other" relevant history, had received her 1st intramuscular dose of ACT-HIB, batch number D0616-2, in the deltoid, on 10 December 2009 at about 14:00. On 10 December 2009, at about 18:00, the patient experienced dysphoria and crying. The patient''s parents did not care about these symptoms. Then, the patient went to sleep. On 11 December 2009, at about 04:00am, she was found with abnormal breast-feeding. She was then sent to the hospital and died on 11 December 2009 at her arrival in the hospital. List of documents held by sender: none.


VAERS ID: 373578 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2009-11-18
Onset:2009-11-29
   Days after vaccination:11
Submitted: 2009-12-15
   Days after onset:16
Entered: 2009-12-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Altered state of consciousness, Death
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant 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: 2009-12-02
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: [therapy unspecified]
Current Illness: Idiopathic thrombocytopenic purpura
Preexisting Conditions: Splenectomy
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0912USA01535

Write-up: Information has been received from a physician concerning a 73 year old male patient with idiopathic thrombocytopenic purpura and a history of splenectomy who on 18-NOV-2009 was vaccinated with PNEUMOVAX 23 (dose and indication not reported). Other concomitant medications are shown in THERAPY INFORMATION. On 29-NOV-2009, the patient was admitted to hospital because of consciousness disturbed. On 2-DEC-2009, the patient died. The reporting physician did not report the relationship of consciousness disturbed to PNEUMOVAX 23. The reporting physician considered that the consciousness disturbed was serious due to death. Additional information has been requested. The reporting physician''s comment: It was considered that the level of antibody may not have risen or the patient may have been infected with pneumococcus other than 23 types.


VAERS ID: 374084 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2009-11-17
Onset:2009-11-24
   Days after vaccination:7
Submitted: 2009-12-18
   Days after onset:24
Entered: 2009-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Atelectasis, Computerised tomogram abnormal, Death, Electromechanical dissociation, Endotracheal intubation, General physical health deterioration, Multi-organ failure, Pneumonia, Renal failure, Sciatica, Sepsis, Septic shock, Spinal X-ray abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Angioedema (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2009-11-26
   Days after onset: 2
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:
Current Illness: Diabetes mellitus type 2; Glaucoma; Metabolic disorder; Myocardial insufficiency
Preexisting Conditions: Urinary bladder carcinoma
Allergies:
Diagnostic Lab Data: unk
CDC Split Type: D0064872A

Write-up: This case was reported by a physician and described the occurrence of basal pneumonia in an 84-year-old male subject who was vaccinated with Seasonal Influenza Vaccine) manufacturer unspecified). According to the vaccinating physician the subject has not received PANDEMRIX H1N1 (GlaxoSmithKline), as reported initially, but has received Influenza vaccine 2009/2010 (manufacturer unspecified). On 17 November 2009 the subject received a dose of PANDEMRIX H1N1 (unknown). Approximately seven days post vaccination with PANDEMRIX H1N1, on 24 November 2009, the subject experienced pneumonia. The subject was hospitalised for 3 days. Approximately eight days post vaccination with PANDEMRIX H1N1, on 25 November 2009, the subject experienced renal failure and needed intubation. Approximately eight days post vaccination with PANDEMRIX H1N1, on 26 November 2009, the subject died. Follow-up information was received on 30 November 2009 from the reporting physician. Approximately seven days post vaccination with PANDEMRIX H1N1, on 24 November 2009, the subject was hospitalised for reduced general condition and lumboischialgia. Thoracic X-ray and computed tomogram showed basal pneumonia with atelectasis. The subject died on 26 November 2009 from electromechanical dissociation and multiorgan failure post septic shock and pneumonia. An autopsy was not performed. The reporting physician considered fulminant course of the events and that the events were possibly related to vaccination with PANDEMRIX H1N1. Follow-up information was received on 07 December 2009 from the reporting physician. The subject''s medical history included urinary bladder carcinomas. Concurrent medical conditions included diabetes mellitus type 2, glaucoma and myocardial insufficiency. On 17 November 2009 the subject received the first dose of PANDEMRIX H1N1 (intramuscular, unknown). Approximately one week post vaccination post PANDEMRIX H1N1, on 24 November 2009, the subject experienced basal pneumonia and sepsis. The subject was hospitalised on 24 November 2009 for three days. The reporting physician considered that the events were life threatening. In hospital the subject experienced remarkable foudroyant coursed of sepsis with multiorgan failure and death. Approximately nine days post vaccination with PANDEMRIX H1N1, on 26 November 2009, the subject died from electromechanical dissociation due to septic shock. An autopsy was not performed. The reporting physician considered that the events were possibly related to vaccination with PANDEMRIX H1N1. On 15 December 2009 the same case was reported by the regulatory authority (# DE-PEI-PEI2009028753). This information was identical to data previously received on 07 December 2009 from the reporting physician. Follow-up information was also received on 15 December 2009 from the reporting physician. The subject has not received PANDEMRIX H1N1 (GlaxoSmithKline), but Influenza Vaccine 2009/2010, (manufacturer unspecified). The vaccinating physician has never vaccinated any subject with PANDEMRIX H1N1. The reporting physician considered that the events were unrelated to vaccination with Influenza virus vaccine 2009/2010. Follow-up information has been requested.


VAERS ID: 374343 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-12-03
Onset:0000-00-00
Submitted: 2009-12-18
Entered: 2009-12-21
   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: Autopsy, Death, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: ADVAIR
Current Illness:
Preexisting Conditions: Interstitial lung disease
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0912USA01663

Write-up: Information has been received from a hospital pharmacist concerning an 83 year old female with a history of interstitial pneumonia and no problem for receiving inoculation according to the package insert who on 03-DEC-2009 was vaccinated with PNEUMOVAX 23 (dose, route and inoculation site were not provided). Concomitant therapy included ADVAIR. On 09 or 10-DEC-2009, the patient developed respiratory arrest. On 10-DEC-2009 in the morning, the patient was found that her breath had stopped. She died. Information on autopsy was not reported. The reporting pharmacist considered that respiratory arrest was serious due to death. The reporting pharmacist felt that the relationship between respiratory arrest and PNEUMOVAX 23 vaccine was unknown. Additional information has been requested.


VAERS ID: 374505 (history)  
Form: Version 1.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2009-11-06
Onset:2009-11-07
   Days after vaccination:1
Submitted: 2009-12-21
   Days after onset:44
Entered: 2009-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (GSK)) / GLAXOSMITHKLINE BIOLOGICALS A81CA067A / UNK UN / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Drug level increased
SMQs:, Drug abuse and dependence (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Phenytoin; Zonisamide; Ipratropium bromide; Salbutamol sulphate; Ramipril; Citalopram
Current Illness: Chronic obstructive pulmonary disease; Epilepsy
Preexisting Conditions: At review in June 2009 he was having 2-3 fits a month and was being treated with Phenytoin and Zonisemide 300mg. His weight (45kg) was recorded in November 2008.
Allergies:
Diagnostic Lab Data: The dose of phenytoin was reduced in September 2009 by 25mg as his phenytoin levels were found to be too high (26).
CDC Split Type: B0603336A

Write-up: This case reported by a regulatory authority (# GB-MHRA-FLU 00026877) and described the occurrence of death unexplained in a male subject who was vaccinated with PANDEMRIX H1N1 (GlaxoSmithKline), inactivated influenza vaccine (Sanofi Pasteur). Concurrent medical conditions included epilepsy. The patient had previously received annual influenza vaccine for several years. On 6 November 2009 the subject received unspecified dose of PANDEMRIX H1N1 (1 injection, intramuscular), unspecified dose of Inactivated influenza vaccine. On 7 November 2009, 1 day after vaccination with Inactivated influenza vaccine and PANDEMRIX H1N1, the subject experienced death unexplained. The subject died on 7 November 2009 from death unexplained. At the time of reporting a post mortem had been awaited. Pt given H1N1 PANDEMRIX and inactivated influenza vaccine (sanofi pasteur) on Friday 6/11/09, previously received annual influenza vaccine for several years, history epilepsy pt emergency admission early hours saturday morning 7/11/09 now deceased, currently awaiting post mortem. Case updated 10/11/2009: Brand name updated to PANDEMRIX, dates from text entered and reaction amended to death unexplained. Changes identified at signal detection meeting. Follow-up information received on 14 December 2009: Concurrent medication included Phenytoin, zonisemide, ipratropium, salbutamol, ramipril and citalopram. Concurrent medical conditions included chronic obstructive pulmonary disease. On 07 November 2009, in the early hours, the 52 year-old subject was hospitalised. At review in June 2009 he was having 2-3 fits a month and was being treated with Phenytoin and zonisemide 300mg. The dose of phenytoin was reduced in September 2009 by 25mg as his phenytoin levels were found to be too high (26). His weight (45kg) was recorded in November 2008. The brand of the H1N1 vaccine was confirmed as PANDEMRIX and not CELVAPAN. He was vaccinated with both PANDEMRIX and seasonal flu vaccine on 6th November. Admitted to hospital in the early hours of 7th November where he died. He has a medical history of COPD and epilepsy. At review in June 2009 he was having 2-3 fits a month and was being treated with Phenytoin and zonisemide 300mg. The dose of phenytoin was reduced in September 2009 by 25mg as his phenytoin levels were found to be too high (26). His weight (45kg) was recorded in November 2008. No information on weight since then. Other medications - ipratropium, salbutamol, ramipril and citalopram. Post mortem results are awaited. The patient was taking PANDEMRIX for: Epilepsy.


VAERS ID: 374780 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-12-21
Entered: 2009-12-22
   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: Autoimmune disorder, Death
SMQs:, Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0912USA02326

Write-up: Information was reported in a newspaper article that a 14 year old female patient who on an unspecified date was vaccinated with a dose of GARDASIL vaccine (lot number, date, route and site not reported). Subsequently the patient experienced auto-immune symptoms and died 21 months later. The article also discussed the multiple sclerosis of other 5 patient while on therapy with GARDASIL vaccine (WAES 0912USA01664, WAES 0912USA02322, WAES 0912USA02323, WAES 0912USA02324, and WAES 0912USA02325, WAES 0912USA02639, WAES 0912USA02640, WAES 0912USA02641, WAES 0912USA02642 and WAES 0912USA02643. No further information is available.


VAERS ID: 374862 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-11-27
Onset:2009-11-28
   Days after vaccination:1
Submitted: 2009-12-23
   Days after onset:25
Entered: 2009-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (GSK)) / GLAXOSMITHKLINE BIOLOGICALS AFLSA117AA / UNK UN / UN
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-28
   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: Carbon Dioxide narcosis; decompensation cardiac; respiratory insufficiency
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0619049A

Write-up: This case was reported by a regulatory authority (# DHH-N2009-49347) and described the occurrence of death in a 67-year-old female subject who was vaccinated with PANDEMRIX H1N1 (GlaxoSmithKline), ALPHARIX. Concurrent medical conditions included 5 carbon dioxide narcosis in one month with cardiac decompensation and terminal respiratory insufficiency. On 27 November 2009, the subject received unspecified dose of PANDERIX H1N1 (unknown route, unknown injection site), unspecified dose of ALPHARIX (unknown route, unknown injection site, lot number not provided). On 28 November 2009, 1 day after vaccination with ALPHARIX and PANDEMRIX H1N1, the subject experienced death without prodromes or symptoms. The subject died during the night of 28 to 29 November 2009, cause of death was not reported. It was unknown whether an autopsy was performed.


VAERS ID: 375036 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2007-05-22
Onset:2007-07-11
   Days after vaccination:50
Submitted: 2009-12-23
   Days after onset:896
Entered: 2009-12-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0859F / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Osteitis
SMQs:, Osteonecrosis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-07-15
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: VALETTE
Current Illness:
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0912USA02946

Write-up: Information has been received from a physician concerning a previous healthy 17 year old female patient with no relevant medical history who on 22-MAY was vaccinated intramuscularly with her first dose of GARDASIL (Lot # 654740/0859F) (Batch # NE29660) (Injection site was not reported). Concomitant therapy included VALETTE. On 11-JUL-2007 the reporter was informed by the patient''s mother that her daughter was hospitalized due to bone inflammation. On 15-JUL-2007, approximately 7 weeks post vaccination, the patient died of unknown cause. An autopsy was carried out, but the result was not known to the reporter up to the time of reporting. A lot check has been initiated. Other business partner numbers include E2009-11667. Additional information has been requested.


VAERS ID: 375703 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-12-31
Entered: 2010-01-04
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Splenectomy
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0912USA03607

Write-up: Information has been received as part of a business agreement (manufacturer report number A200905627) via a physician concerning a 4 year old patient with a history of splenectomy who on an unspecified date was vaccinated with PNEUMOVAX 23. No information on concomitant medication was provided. On an unspecified date, the patient developed meningitis pneumococcal and died. The reporting physician felt that the meningitis pneumococcal was definitely not related to PNEUMOVAX 23. The reporting physician considered that the meningitis pneumococcal was serious due to death. The report physician''s comment: The pneumococcal vaccine did not cause death. All the physician reported is that the patient developed meningitis pneumococcal, although the patient was vaccinated. Additional information is not expected.


VAERS ID: 375855 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-01-05
Entered: 2010-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / IJ

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2009GB59590

Write-up: Initial consumer report received on 24 Dec 2009: On an unreported date the patient was vaccinated by Flu vaccine (batch unknown). The patient felt unwell after being vaccinated. He went home to sleep and in the morning his wife couldn''t wake him up. The patient had passed away (dates unspecified). No further information was received.


VAERS ID: 376411 (history)  
Form: Version 1.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2009-01-12
Onset:2009-02-04
   Days after vaccination:23
Submitted: 2010-01-08
   Days after onset:338
Entered: 2010-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Agitation, Antibody test positive, Areflexia, Biopsy brain abnormal, CSF glucose normal, CSF monocyte count increased, CSF neutrophil count increased, CSF protein increased, CSF white blood cell count increased, Cardiac arrest, Death, Diarrhoea, Dysarthria, Dyskinesia, Dysphagia, Eyelid ptosis, Facial paresis, Fluid intake reduced, General physical health deterioration, Headache, Hyperhidrosis, Leukocytosis, Lumbar puncture abnormal, Muscle spasms, Muscular weakness, Neutrophil percentage increased, Oropharyngeal pain, Photophobia, Pleocytosis, Pyrexia, Rabies, Restlessness, Saliva analysis normal, Salivary hypersecretion, Speech disorder, Sudden death, Trismus, Urine analysis, Viral test negative, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Akathisia (broad), Dyskinesia (narrow), Dystonia (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vasculitis (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Hypersensitivity (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: 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: Rabies immune globulin, Human
Current Illness: Laceration; Wound
Preexisting Conditions: Animal bite
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2010TH00795

Write-up: Initial literature report received on 02 Jan 2010: This patient, with an unknown medical history experienced dog bites on his hands and right knee on 08 Jan 2009 and had a 1-cm laceration on his right thumb that penetrated deep into the nail bed. He also had two puncture wounds (width, 0.2 cm) on his left hand and bleeding scratch wounds on his right knee. The dog was owned but never vaccinated the dog died three days later and was proven to be rabid by fluorescent antibody test of brain specimens at an Institute. The patient underwent prompt local wound care at a nearby public health center and was vaccinated with RABIPUR (batch 1630; potency, 8.94 IU/dose; expiration date, June 2012) intradermally within six hours using schedule (modified TRC-ID regimen; 2-site intradermal injections on days 0, 3, 7, and 28). The entire calculated dose of human rabies immunoglobulin (HRIG; 1300 IU per 8.7 mL; Berirab P; CSL; potency, 150-300 IU/mL; expiration date, Sep 2010) was infiltrated into and around all wounds at the same time as the first vaccination in spite of much pain, this was also done to the wound at the nail bed. The patient had Tetanus immunization one year before, so booster injection was not given. RABIPUR was continued on days 3 and 7 scheduled. The patient also received another dose of HRIG (1300 IU) injected into the wounds on 12 Jan 2009 after positive results of the fluorescent antibody test of dog brain specimens became unknown. He became symptomatic 24 days after being bitten. The patient was hospitalized on 03 Feb 2009 and at the time of admission the patient was fully conscious and had a temperature of 39.6 degrees Celsius. He had sore throat, headache, and watery diarrhea. He refused to drink water and avoided exposure to light and dark. He had rigidity of the masseter muscles and slurred speech. He had difficulty eating and drinking and was noted to have excessive salivation. Brief episodes of agitation alternating with lucid calm were noted. Laboratory studies were unremarkable except for leukocytosis (white blood cell count, 12,200 cells/mL, with 85% neutrophils). Lumbar puncture revealed a pleocytosis level of 1120 cells/mm3 (82% monocytes, 18% neutrophils), a protein level of 95 mg/dL, and a sugar level of 70 mg/dL. Examination of cerebrospinal fluid (CSF), saliva, and urine specimens and hair follicles using a previously described method of the detection of rabies viral RNA yielded negative results. The patient remained febrile and was restless, with profuse sweating during the second day. Trismus became more severe, and he was unable to open his mouth and speak. Intermittent spasms of the neck and back muscles were noted, but without rigidity of the axial musculature. He remained fully alert and oriented. Left facial weakness of the upper motor neuron type with bilateral incomplete ptosis was detected. Pupils were 5 mm, equally reactive to light. External squint of the right eye was shown on primary gaze. Limited adduction of the left eye was noted but without accompanying abducting nystagmus of the right eye on performing right lateral gaze. Convergence was impaired. Corneal reflexes and other cranial nerve functions were normal. There was no demonstrable weakness. Sensation was normal in all modalities. Deep tendon reflexes were 4+. Plantar responses were flexor, and clonus was absent. Conditions deteriorated rapidly 3 hours later. Proximal muscle weakness of both arms, of Medical Research Council muscle strength grading system grade 3/5, was demonstrated while it was preserved in the lower limbs. Deep tendon reflexes became all absent. He remained rational and arousable until developing sudden cardiac arrest on 04 Feb 2009. Brain tissue necropsy via a transorbital needle biopsy approach confirmed rabies by fluorescent antibody test and detected rabies viral RNA. The incubation period was 24 days, and survival time after onset was 4 days. The outcome of the events was that the patient suddenly died on an unspecified date.


VAERS ID: 376561 (history)  
Form: Version 1.0  
Age: 0.22  
Sex: Male  
Location: Foreign  
Vaccinated:2010-01-05
Onset:2010-01-05
   Days after vaccination:0
Submitted: 2010-01-11
   Days after onset:6
Entered: 2010-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER ASPNA007CK / 1 UN / IJ
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA961A / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unk
CDC Split Type: B0623802A

Write-up: This case was reported by a consumer and described the occurrence of death in a 12-week-old male subject who was vaccinated with SYNFLORIX (GlaxoSmithKline), ROTARIX. Previous and/or concurrent vaccination included combined diphtheria, tetanus-acellular pertussis, hepatitis B, inactivated poliomyelitis and Haemophilus influenzae type b vaccine; GlaxoSmithKline; given on 27 November 2009. On 5 January 2010, the subject received 1st dose of SYNFLORIX (unknown route and injection site), 1st dose of ROTARIX (oral). On 5 January 2010, less than 3 hours after vaccination with SYNFLORIX and ROTARIX, the subject was found died in his bed by his parents. The subject died on 5 January 2010 from unknown cause of death. It was unknown whether an autopsy was performed.


VAERS ID: 376711 (history)  
Form: Version 1.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-01-13
Entered: 2010-01-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) / NOVARTIS VACCINES AND DIAGNOSTICS - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthma, Death, Influenza
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2010-01-10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Lung disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2010IL01204

Write-up: Initial report received from a newspaper on 11 Jan 2010: This patient, with a history of pulmonary disease, was vaccinated for the first time with Influenza virus vaccine H1N1 INN on an unspecified date (reported as 8 days ago). The patient had a severe asthma attack on an unspecified date and was taken to the emergency room. The patient was diagnosed with H1N1 virus infection. He received a respiratory (unspecified) treatment along with PERAMIVIR (unknown). The patient''s condition deteriorated and he passed away on 10 Jan 2010. The causality assessment by the foreign health regulatory authority was stated as there was no relation between the vaccine and the death.


VAERS ID: 376712 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2010-01-09
Submitted: 2010-01-12
   Days after onset:3
Entered: 2010-01-12
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, Loss of consciousness
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? Yes
Birth Defect? No
Died? Yes
   Date died: 2010-01-09
   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: No other medications
Current Illness: Unknown
Preexisting Conditions: Severe congenital diseases
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2010IL01167

Write-up: Initial report received from a newspaper on 11 Jan 2010: This patient had a medical history of severe congenital diseases. The patient was vaccinated with H1N1 flu vaccine (Influenza virus vaccine, unknown), on an unspecified date (reported as a month before). The boy lost his consciousness after administration of the vaccine and was hospitalized and died on 09 Jan 2010. The agency claimed that there was no relation between the vaccine and the death.


VAERS ID: 376753 (history)  
Form: Version 1.0  
Age: 0.36  
Sex: Male  
Location: Foreign  
Vaccinated:2009-12-07
Onset:2009-12-19
   Days after vaccination:12
Submitted: 2010-01-13
   Days after onset:25
Entered: 2010-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0624597A

Write-up: This case was reported by a regulatory authority and described the occurrence of sudden death in a 4-month-old male subject who was vaccinated with INFANRIX-IPV/HIB (GlaxoSmithKline). On 7 December 2009 the subject received unspecified dose of INFANRIX-IPV/HIB (unknown). On 19 December 2009, 12 days after vaccination with INFANRIX-IPV/HIB, the subject experienced sudden death. The subject died, cause of death was not specified.


VAERS ID: 377842 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2010-01-07
Onset:2010-01-09
   Days after vaccination:2
Submitted: 2010-01-21
   Days after onset:12
Entered: 2010-01-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthma, Cardiac failure, Condition aggravated, Death, Decreased appetite, Urine output decreased
SMQs:, Acute renal failure (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Retroperitoneal fibrosis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-12
   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: CORINAEL L; GASMOTIN; LAC-B; SAXIZON; benazepril HCl; famotidine; pravastatin Na; sodium ferrous citrate; theophylline; tulobuterol
Current Illness: Asthma
Preexisting Conditions: Oxygen supplementation; Pneumonia aspiration
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1001USA01362

Write-up: Information has been received from a physician concerning a female inpatient with asthma and a history of pneumonia aspiration who on 07-JAN-2010 was vaccinated with a dose of PNEUMOVAX 23 (dose not reported, it was her initial inoculation). Other concomitant medications included theophylline, tulobuterol, SAXIZON, CORINAEL L, benzepril HCl, pravastatin Na, GASMOTIN, famotidine, LAC-B and sodium ferrous citrate. On 30-OCT-2009, the patient was hospitalized for rehabilitation from a pneumonia aspiration. The patient did not take asthma remedies and had no obvious symptoms of asthma. On an unspecified date, the patient developed one episode of breathlessness but recovered on the day. On 07-JAN-2010, the patient was vaccinated with the first dose of PNEUMOVAX 23 as described above. On 09-JAN-2010, the patient developed asthmatic attack. Theophylline and tulobuterol were administered. The symptom subsided with 1L oxygen inhalation and was not so serious. On 11-JAN-2010, the patient was unable to eat and developed urine output decreased. SAXIZON 500mg was administered. On 12-JAN-2010, the patient took a sudden turn for the worse and died at 2:00 am. The immediate cause of death was considered to be the occurrence of cardiac failure. The patient had no blood pressure reductions or disturbance of consciousness. The reporting physician considered that the cardiac failure was serious due to death and the asthmatic attack was non-serious. The reporting physician did not assess the seriousness of unable to eat and the urine output decreased. The reporting physician felt that the relationship between asthmatic attack and PNEUMOVAX 23 was unknown. The reporting physician did not assess the relationship of cardiac failure, unable to eat and the urine output decreased to PNEUMOVAX 23. Additional information has been requested.


VAERS ID: 378321 (history)  
Form: Version 1.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2009-12-02
Submitted: 2010-01-25
   Days after onset:54
Entered: 2010-01-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN
PER: PERTUSSIS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac failure, Death, Resuscitation
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-12-02
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2010021945

Write-up: Report received from a consumer on 22-JAN-2010. A 51 year old male patient received PANVAX H1N1 influenza vaccine in late NOV-2009. The patient''s medical history was unknown as the patient was adopted and had no family history. The patient was noted as previously fit and was an aviation firefighter. The reporter was not aware that the patient was on any medications. The patient was not ill at the time of vaccination. The patient received pertussis vaccination on the same day as receiving PANVAX. On 02-DEC-2009, approximately 1 week after administration with PANVAX, the patient had heart failure at the gym. The patient was resuscitated for 45 minutes which was unsuccessful. The event outcome was fatal on 02-DEC-2009 and currently awaiting Coroner''s report. The case was reported as serious due to fatality. The company considered the event to PANVAX conditional to further information. Information derived from this AE report does not change the current safety profile of the product. Cause of death is unknown. Death Date: 02-Dec-2009.


VAERS ID: 378500 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-10-14
Onset:2009-10-15
   Days after vaccination:1
Submitted: 2010-01-27
   Days after onset:104
Entered: 2010-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA050AG / 2 AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, General physical health deterioration, Headache, Impaired work ability, Loss of consciousness, Malaise, Pain in extremity, Pyrexia, Respiratory failure, Snake bite
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (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) (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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-02
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Joint pain
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0628298A

Write-up: This case was reported by a physician and described the occurrence of respiratory failure in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s medical history included joints pain. Previous and/or concurrent vaccination included CERVARIX ;GlaxoSmithKline;intramuscular;unknown deltoid given on 9 September 2009. On 14 October 2009, the subject received 2nd dose of CERVARIX (intramuscular, unknown deltoid). The subject was put under observation during 30 minutes after both vaccinations. No adverse event had occurred. On 15 October 2009, 1 day after vaccination with CERVARIX, the subject experienced a low grade fever and headache. She visited an homeopathy center where she was prescribed treatment with paracetamol, Liv 52 and RANTAC. The subject was advised to come back to the center for follow-up after 2 days of treatment. The events resolved and the subject restarted her daily chores. On 1st November 2009, the subject informed her parents that an insect has bitten her during the field work. She was not feeling well and complained about leg pain. Post noon, the subject didn''t go to work and rested at home. Overnight, her condition deteriorated. On the morning of the 2nd November 2009, an ambulance was called. The subject''s vital signs recorded at the time of shifting were poor. On the way to hospital, she became unconscious and her vital signs were not recordable. The cardio pulmonary resuscitation provided was unsuccessful. At hospital, she was declared dead due to a respiratory failure. Autopsy was rejected by the family. The physician considered the events were unrelated to vaccination with CERVARIX and so, no follow-up was necessary. The subject died on 2 November 2009 from a suspected snake bite. An autopsy was not performed.


VAERS ID: 378581 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-01-27
Entered: 2010-01-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR D323 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Convulsion, Death, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: No "other" relevant history, no "other" concomitant drug
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201000648

Write-up: Case received from a healthcare professional on 24 January 2010 under the local reference number CN2010016. A 06-month-old female patient, with no "other" relevant history and no "other" concomitant drug, had received her dose of ACT-HIB (batch number D323-1, route and site of administration not reported) on an unspecified date. The patient died 2 days post-vaccination. The diagnoses were high fever and convulsion. List of documents held by sender: none.


VAERS ID: 378725 (history)  
Form: Version 1.0  
Age: 6.0  
Sex: Male  
Location: Foreign  
Vaccinated:2009-11-16
Onset:2009-11-20
   Days after vaccination:4
Submitted: 2010-01-29
   Days after onset:70
Entered: 2010-01-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / 1 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Autopsy, Bacterial test positive, Blood product transfusion, Death, Histiocytosis haematophagic, Liver function test abnormal, Parasitic test positive, Parvovirus infection, Platelet count increased, Pyrexia, Rash, Serum ferritin increased, Viral test positive, White blood cell count increased
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-12-21
   Days after onset: 31
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Nil
Preexisting Conditions: Nil
Allergies:
Diagnostic Lab Data: 50 bacteria and viral/ parasites test with the autopsy shows parvovirus-related hemophagocystic diseases
CDC Split Type:

Write-up: rashes starting from extremities follow with fever up to 39C 4 days later and elevation of WBC/ Platelets/ liver functions/ ferritin/ Antibiotic and antiviral/ IVIG given together with NSAIS''s


VAERS ID: 378772 (history)  
Form: Version 1.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-12-24
Onset:2010-01-16
   Days after vaccination:23
Submitted: 2010-01-28
   Days after onset:12
Entered: 2010-01-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR E5925 / UNK UN / UN
FLUX: INFLUENZA (SEASONAL) (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: Chills, Coma, Coronary artery disease, Death, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Other ischaemic heart disease (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-17
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: medical history of diabetes mellitus
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201000446

Write-up: Case received from lay media and foreign Health Authority on 18 January 2010 through the company representative under the reference number HKG-2010-009. A 60-year-old female patient with a medical history of diabetes mellitus had received an injection of PANENZA (batch number not mentioned, should be E5925) on 24 December 2009, a shot of seasonal influenza vaccine (Mfr unknown) on 02 November 2009 and a shot of pneumococcal vaccine (Mfr unknown) on 02 November 2009. On 16 January 2010, i.e. 23 days after the injection of pandemic influenza vaccine and 75 days after seasonal influenza vaccine and pneumococcal vaccine, the patient had complained of chills and vomiting. She was sent to the hospital on 17 January 2010. She was found to be in a coma and was certified dead on 17 January 2010. The patient had received an unknown kind of injection several days before the death. According to the government official statement, there was no evidence showing the death is related to the vaccination. At the time of the report, further examination by forensic pathologists was pending. Additional information received on 25 January 2010: according to the local Centre for Health Protection, the patient died of coronary heart disease and the death was not related to the vaccination.


VAERS ID: 379570 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-07-20
Onset:2009-09-06
   Days after vaccination:48
Submitted: 2010-02-04
   Days after onset:151
Entered: 2010-02-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Drowning, Fall
SMQs:, Accidents and injuries (narrow), Hostility/aggression (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1001USA03763

Write-up: Information has been received from from a physician concerning a 12 year old school going girl of class eight of a village. On 20-JUL-2009, the patient received first dose of GARDASIL in the school. During the process of community mobilization for second dose of GARDASIL, the female health worker was informed that on 06-SEP-2009, the patient accidentally fell in open well (granite quarry filled with water), drowned and expired. This event occurred 49 days of receiving first dose of GARDASIL. The female health worker informed the Medical Officer in-charge, which was then communicated to District Immunization Officer. The medical officer in-charge investigated the death and completed first information report and determined that death was not related to the vaccine.


VAERS ID: 379744 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2010-01-25
Onset:2010-01-25
   Days after vaccination:0
Submitted: 2010-02-04
   Days after onset:10
Entered: 2010-02-08
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / 2 UN / UN
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / 2 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Coma, Death, Peripheral coldness, Pyrexia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-26
   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: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: Relevant medical history was not provided.
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: HKWYEH13293110

Write-up: This case was considered medically important for coma and coldness of limbs. Information regarding PREVENAR was received via a newspaper article from a consumer regarding a 4-month-old male patient who experienced pyrexia, coma, death and coldness of limbs. The patient received the second dose on 25-Jan-2010. The patient also received the second dose of QUADRACEL on 25-Jan-2010. On 25-Jan-2010, the patient received PREVENAR and QUADRACEL. The patient experienced pyrexia after the vaccination and was seen by a doctor who prescribed oral medication (unspecified). The child slept with the parents and was found in a coma with coldness of limbs the next morning. The patient was sent to the emergency department for treatment, however the child died on 26-Jan-2010. A pediatrician noted in the newspaper report "that infants aged 2-4 months have a high risk of sudden death, congenital disease, such as brain or respiratory system diseases and man-made factors should be included in the causes of infant''s sudden death." The report noted that the cause of death will be confirmed after an autopsy. No additional information was available at the time of this report.


VAERS ID: 379777 (history)  
Form: Version 1.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-01-08
Onset:2010-01-08
   Days after vaccination:0
Submitted: 2010-02-08
   Days after onset:31
Entered: 2010-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IJ
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / IJ

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-08
   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:
Current Illness: Heart disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0630716A

Write-up: This case was reported by a foreign regulatory authority (GB-MHRA-FLU 00037862) via a consumer and described the occurrence of heart attack in a 72-year-old male subject who was vaccinated with PANDEMIC VACCINE H1N1 (manufacturer unspecified), influenza virus vaccine. Concurrent medical conditions included heart disorder. Previous and/or concurrent vaccination included influenza virus vaccine; manufacturer unspecified; unknown given on an unspecified date. On 8 January 2010 the subject received unspecified dose of PANDEMIC VACCINE H1N1 unspecified (1 injection, unknown), unspecified dose of Influenza virus vaccine (1 injection, unknown). On 8 January 2010, less than one day after vaccination with Influenza virus vaccine and PANDEMIC VACCINE H1N1 unspecified, the subject experienced heart attack. The subject died on 8 January 2010 from a heart attack. It was unknown whether an autopsy was performed. Verbatim Text: Reaction Severity: Caused death. Reaction Description: unknown.


VAERS ID: 379874 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-07-16
Onset:2009-08-29
   Days after vaccination:44
Submitted: 2010-02-08
   Days after onset:163
Entered: 2010-02-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 LA / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Completed suicide, Death, Poisoning
SMQs:, Suicide/self-injury (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2009-08-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1001USA03762

Write-up: Information has been received from a physician concerning a 14 year old school going girl (ID#: -3/09) who received the first dose of GARDASIL in left deltoid, on 16-JUL-2009. Concomitant therapy included indigo. During the process of community mobilization for second dose, the female health worker was informed that the patient committed suicide on 29-AUG-2009 by consuming insecticide. The postmortem was performed on 30-AUG-2009. This event occurred after 45 days of receiving first dose of GARDASIL. The female health worker informed the medical officer in charge, which was then communicated to Immunization Officer. The medical officer in charge investigated the death and completed first information report as per guidelines and determined the death was not related to the vaccine and so no further investigations were done. No further information is available.


VAERS ID: 379876 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-07-19
Onset:2010-01-21
   Days after vaccination:186
Submitted: 2010-02-08
   Days after onset:18
Entered: 2010-02-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Completed suicide, General physical health deterioration, Poisoning deliberate
SMQs:, Suicide/self-injury (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1002USA00379

Write-up: Information has been received from a physician concerning a 13 year old school going girl (ID#: -104/09) of class eight. On 19-JUL-2009, patient received first dose of GARDASIL left deltoid (lot#876, manufacturing date June 2008). Patient successfully completed her second dose on 13-OCT-2009. She was due with her third dose. On 21-JAN-2010, she was reported to have consumed poison around 9:00 am. She was taken to the area hospital and provided preliminary emergency treatment. She was provided DECADRON injection 2 cc, injection dopamine 1 amp. in 5% dextrose 10-12 drops/min, injection deriphylline I.V 8 hourly, injection diazepam 1 amp. IV, Ryle''s tube aspiration and stomach wash. It was advised to record her temperature, pulse, respiration, and blood pressure half hourly and had oxygen inhalation. High risk consent was taken. As her condition started to deteriorate she was shifted to another hospital by ''108 emergency service'' for further evaluation and management. On the way to the hospital, it was reported to have expired around 2:00 pm on 21-JAN-2010. The hospital noted the case was "brought dead". The postmortem was performed on 22-JAN-2010 and the results are awaited. The medical officer in charge investigated the death and completed first information report and determined the death could be suicide (due to poison intake) and not related to the vaccine. This report was part of a post-marketing surveillance program.


VAERS ID: 380081 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-07-17
Onset:2009-08-08
   Days after vaccination:22
Submitted: 2010-02-05
   Days after onset:181
Entered: 2010-02-12
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Coma, Death, Dyspnoea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2009-08-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: RANTAC; acetaminophen, aminophylline; chloroquine
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1001USA03765

Write-up: Information has been received from a physician concerning a 13 year old school girl studying in class nine of health center. On 17-JUL-2009, patient received first dose of GARDASIL left deltoid. Concomitant medications included chloroquine, RANTAC, paracetamol, "IV fluids RL" and aminophyline drip. During the process of community mobilization for second dose of GARDASIL the multipurpose health worker was informed that the patient developed fever on 01-AUG-2009 and was treated by local registered medical practitioner (RMP). The patient did not recover and was admitted to the hospital on 08-AUG-2009. On the same day, GENTAMYCIN was given. She developed dyspnoea and went into coma and so was referred and was shifted to another hospital where she expired on 08-AUG-2009 at around 9:00 pm. The cause of death was determined as "death due to viral fever". The information was provided from patient''s maternal grandparents as she was staying with them. This event occurred after 23 days of receiving first dose of GARDASIL. The female health worker informed the medical officer in charge and he investigated the death and completed the first information report as per AEFI guidelines. The case sheet mentions as "pyrexia of unknown origin". This information was then communicated to district immunization officer, who determined that the death was not related to the vaccine and so a decision was taken to close the investigation.


VAERS ID: 380130 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2010-01-28
Onset:2010-01-28
   Days after vaccination:0
Submitted: 2010-02-12
   Days after onset:15
Entered: 2010-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS AHIBC028CA / UNK UN / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER AOPVB680AA / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Agitation, Asphyxia, Autopsy, Cardio-respiratory arrest, Crying, Loss of consciousness, Pupil fixed, Resuscitation, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (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), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-28
   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: B0631343A

Write-up: This case was reported by a physician and described the occurrence of sudden death in a 3-month-old male subject who was vaccinated with HIBERIX (GlaxoSmithKline), Oral polio vaccine and DTP (a or w not known) (non-gsk). On 28 January 2010, the subject received 2nd dose of HIBERIX (intramuscular, unknown injection site), 2nd dose of Oral polio vaccine (oral), unspecified dose of DTP (a or w not known) (non-GSK) (unknown route and injection site). After vaccination, the subject was kept in observation in the ambulance during 30 minutes without any specific signs. On 28 January 2010, less than one day after vaccination with HIBERIX, Oral polio vaccine and DTP (a or w not known) (non-GSK), the subject experienced strident crying and agitation. The subject was nursed and fell asleep for 30 minutes, then he woke up with crying. The mother gave him paracetamol and covered the injection site with St-John''s wart. He fell asleep and about 3 hours and a half later, the parents tried to wake him up without success. Fifteen minutes later, the subject was brought to the emergency ward. At examination, the subject was unconscious, without spontaneous motoric reactions, pupils were equal and nonreactive, and cardio-pulmonary arrest was noticed. Cardiopulmonary resuscitation was tried with administration of adrenaline and methylprednisolone without success. The subject died on 28 January 2010 from suffocation. An autopsy was performed but official results were not communicated due to foreseen investigations.


VAERS ID: 380200 (history)  
Form: Version 1.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2007-05-08
Onset:2009-07-25
   Days after vaccination:809
Submitted: 2010-02-11
   Days after onset:201
Entered: 2010-02-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, Culture positive, Death, Drug ineffective, Escherichia infection, Influenza, Influenza serology positive, Nocardiosis, Pneumonia, Pneumonia streptococcal, Septic shock, Treatment noncompliance
SMQs:, Lack of efficacy/effect (narrow), Toxic-septic shock conditions (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), 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? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Alcoholic
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Nasal aspirate influenza A H1N1 RNA, 03Jul09, positive; blood culture, 25Jul09, streptococcal pneumonia-serotype 23F and E. Coli blood culture positive
CDC Split Type: WAES1002USA00714

Write-up: Information has been received was obtained on a request by the Company from the agency via a Public Case Detail form concerning a 47 year old female with excessive alcohol intake who on 08-MAY-2007 was vaccinated SC with a dose of PNEUMOVAX 23 (lot number not reported). In June 2009, the patient developed norcardia pneumonia and had poor compliance with antibiotic medication. On 03-JUL-2009, H1N1 was positive. On 25-JUL-2009 (also reported as one month after vaccination), the patient developed streptococcal pneumonia-serotype 23F and E. Coli blood culture positive and septic shock and was hospitalized. The patient was deceased within 24 hours of onset of septic shock. The reporter felt that drug ineffective and septic shock was possibly related to therapy with PNEUMOVAX 23. The original reporting source was not provided. No further information is available.


VAERS ID: 380608 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-02-17
Entered: 2010-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / 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: Bleomycin; Granulocyte col. stim. fact; Cytotoxic agent
Current Illness: Seminoma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A0843851A

Write-up: This case was reported by a physician and described the occurrence of death nos in an adult male subject, around 69 or 70 years of age, who was vaccinated with PANDEMIC VACCINE H1N1 (unspecified, manufacturer unspecified), influenza vaccine trivalent (seasonal Influenza vaccine unspecified). Concurrent medical conditions included seminoma. Concurrent medications included Bleomycin, Granulocyte colony stimulating factor (GCSF) and Cytotoxic agent "PVB" (Unknown cancer therapy drug). On an unspecified date, at the same time, the subject received unspecified dose of PANDEMIC VACCINE H1N1 unspecified (unknown), unspecified dose of seasonal Influenza vaccine unspecified (unknown). At an unspecified time after vaccination with PANDEMIC VACCINE H1N1 unspecified and seasonal Influenza vaccine unspecified, the subject experienced death nos. The internist felt it was not related to vaccination with PANDEMIC VACCINE H1N1 unspecified and seasonal influenza vaccine unspecified but due to the bleomycin. She felt there was not enough of a dose of bleomycin to cause death, however, was unsure of the true cause. The subject died from death nos. It was unknown whether an autopsy was performed.


VAERS ID: 380868 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2008-01-01
Onset:0000-00-00
Submitted: 2010-02-18
Entered: 2010-02-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Pneumonia streptococcal
SMQs:, Infective pneumonia (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: Sickle cell anaemia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1002USA01758

Write-up: Information has been received from a health care professional, via health care agency (90375). This case concerns a female patient of unknown age. The patient had a history of sickle cell anemia. The patient was due to have received PNEUMOVAX 23 (lot # and batch # not reported) in January 2008. The reporter stated that although the vaccination was scheduled the patient probably did not attend. It was also stated that the patient may have been vaccinated in 2003. On an unreported date the patient died. The post mortem results stated the cause of death as streptococcal pneumonia type B. Other business partner numbers include E2010-00927. No further information is available.


VAERS ID: 380973 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-02-19
Entered: 2010-02-22
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: 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: WAES1002USA02410

Write-up: It was reported in the newspaper in an article that a female patient (age not reported) on an unreported date, received MMR II (manufacturer, batch number, route and site not reported). Details of the patient''s medical history and concomitant medication have not been reported. On an unreported date, following the vaccination the patient died. This report is not medically confirmed. Other business partner numbers included E2010-00874. No further information is available.


VAERS ID: 381177 (history)  
Form: Version 1.0  
Age: 0.9  
Sex: Male  
Location: Foreign  
Vaccinated:2008-12-01
Onset:2009-01-01
   Days after vaccination:31
Submitted: 2010-02-23
   Days after onset:418
Entered: 2010-02-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 31933 / 4 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: Relevant medical history was not provided.
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: NLWYEG05583110

Write-up: Information regarding PREVENAR was received from a healthcare professional regarding a 11-month-old male patient who experienced death. The patient received the fourth dose in Dec-2008. Additional suspect medication included PEDIACEL. The patient died in Jan-2009, one month after the fourth dose of PREVENAR and PEDIACEL. The cause of death was reported as death. No additional information was available at the time of this report.


VAERS ID: 381418 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-02-25
Entered: 2010-02-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abnormal behaviour, Blood gases normal, Blood immunoglobulin G increased, Blood thyroid stimulating hormone normal, Body temperature normal, Brucella serology negative, CSF electrophoresis abnormal, CSF lactate normal, CSF measles antibody positive, CSF oligoclonal band present, CSF test normal, Cerebellar syndrome, Ceruloplasmin normal, Coma, Computerised tomogram normal, Cytomegalovirus antigen, Death, Dementia, Demyelination, Dysarthria, Dysgraphia, Educational problem, Electroencephalogram abnormal, Epstein-Barr virus antibody negative, Full blood count normal, Gastrostomy, HIV antibody negative, Laboratory test normal, Measles antibody positive, Mental disability, Muscle rigidity, Myoclonus, Nuclear magnetic resonance imaging abnormal, Nystagmus, Polymerase chain reaction, Posture abnormal, Streptococcus identification test negative, Stupor, Subacute sclerosing panencephalitis, Toxicologic test normal, Toxoplasma serology negative, Viral test negative
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (narrow), Dystonia (broad), Parkinson-like events (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Optic nerve disorders (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypersensitivity (broad), Hypoglycaemia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Measles
Allergies:
Diagnostic Lab Data: Electroencephalography, paroxysm with pattern of acute and slow high voltage waves, in left frontotemporal and R. temp. lobe; blood pressure measurement, 112/50 mmHg; diagnostic laboratory test, anthropometric measures: were among normal limits; diagnostic laboratory test; polymerase chain reaction: among normal limits; diagnostic laboratory test, cerulopalsmin: among normal limits; diagnostic laboratory test, toxicological study with no findings; diagnostic laboratory test, hepatotropic virus: negative; computed axial tomography, normal; magnetic resonance imaging, demyelinating lesion located in the left parietal lobe; diagnostic laboratory test, PCR for rubella, measles, parvovirus B19, herpes virus and enterovirus: negative; diagnostic laboratory test, ASLO: among normal limits; CSF protein electrophoresis, oligloclonal bands detected, high levels of anti-measles antibodies; Epstein-Barr virus antibodies, negative; HIV antibody screen (EIA), negative; blood chemistry, among normal limits; body temp, 36.9 degrees C; cytomegalovirus antigen, negative; serum Brucella Ab, negative; serum TSH, among normal limits; serum measles Ab, 100.000 detected by enzyme immunoassay: very high; serum protein electrophoresis, oligoclonal bands detected, high levels of anti-measles antibodies; complete blood cell count, among normal limits; metabolic marker test, no findings; Toxoplasma antibody screen, negative; cerebrospinal fluid analysis, lactate and biochemistry: among normal limits; arterial blood gas measurement, among normal limits; total heartbeat count, 85 bpm
CDC Split Type: WAES1002USA02941

Write-up: Information has been received from a published literature article titled as stated above. In December 2002, an 11 year old male patient was brought to the emergency room presenting a behavioural change and loss of intellectual abilities that had been going on for one year. Having been one of the best students in his class he began to present inability to do simply calculus or articulate long sentences, he did not answer sequaciously and could not write properly. No intake of drugs, toxic substances nor were any alterations in the level of consciousness reported. Noteworthy in his personal medical history is the fact that he had measles at 8 months of age. He received the correct vaccines for his age, including the measles vaccine at 15 months of age. The patient''s parents were healthy, not being blood related; the patient''s maternal uncle was epileptic. The physical exploration revealed a temperature of 36.9 degrees centigrades, an arterial pressure of 112/50 mm/Hg and a heart frequency 85 bpm. The anthropometric measures were among the normal limits. He presented affective flattening, bradypsychia, and emotional lability, connecting with this environment with no comprehensive verbal communication. The motor-skills coordination tests were deficient, his patellar reflex was symmetrically exalted, presenting reactive isochoric pupils with a mild nystagmus and a discrete dysmetria. 48 hours after admission, the patient presented sudden and symmetrical myoclonus in both upper and lower limbs, which lasted 7 seconds, with a bad response to dyphenylhydantoin, valproic acid and diazepam; afterwards, treatment with acyclovir, valproic acid and corticosteroids was initiated, no improvement from the patient was observed. Among the complementary exploration results from the tests performed during admission, they found the following: hemogram, biochemistry, gasometry, ASLO, PCR, cerulopalsmin, thyroid hormones, lactate and biochemistry of CSF were among normal limits, metabolic and toxicological study with no findings. Serology for HIV, hepatotropic virus, toxoplasm, Epstein-Barr virus, brucella and cytomegalovirus were negative; PCR for rubella, measles, parvovirus B19, herpes virus and enterovirus were negative; normal computerized tomography; the eye fundus was normal during admission and during the evolution of the illness; in the initial EEG the patient showed paroxysm with a pattern of acute and slow high voltage waves, predominantly in the left frontotemporal and right temporal lobe, over a well organized background activity, with an unfavourable evolution, 10 days later he presented Rademecker complex, defined by periodic discharge of slow and acute high voltage (100-180mV) waves followed by low voltage alpha activity; the MRI during admission showed a demyelinating lesion located in the left parietal lobe. In the electrophoresis serum, oligoclonal banding appeared in the gamma region, with an increase in the IgG. The electrophoresis of the cerebral spinal fluid with oligoclonal banding in the gamma region, showed an elevation of the IgG of 24.60 mg/dL and an increase in the total CSF protein of 90.40 mg/DL, with an unscathed hematoencephalic barrier (albumin ICR/serum ration was normal). Several blood samples and CSF samples were sent to a laboratory in order to determine the amount of measles antibody titers being that subacute sclerosing panencephalitis was suspected (medical history of measles as a child, suggestive symptomatology and intrathecal IgG synthesis). The measles antibody titers (100.000 detected by enzyme immunoassay were very high in serum and CSF (usually they are undetectable), what confirms the SSPE diagnosis. Myoclonic episodes were resistant to different anticonvulsives (valproic acid, benzodiasepine, pirrolidone, levetirazetam, diphenylhydantoin, carbamazepine), with torpid evolution, the patient was given a gastrostomy in order to receive nourishment and rehabilitation care. After the SSPE diagnosis, isoprinosine 100 mg/kg/day was ruled, but no evidence of improvement was observed in the patient. Finally, the patient entered a dementia phase, stupor and coma, with rigidity of limbs and decorticate posture. The patient died 2 years and 5 months after the diagnosis was established. Other company numbers included: E201001107. Additional information has been requested.


VAERS ID: 381972 (history)  
Form: Version 1.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-02-20
Onset:2010-02-20
   Days after vaccination:0
Submitted: 2010-03-05
   Days after onset:13
Entered: 2010-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (GSK)) / GLAXOSMITHKLINE BIOLOGICALS AFLSA125AA / UNK UN / UN
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 15801 / UNK UN / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. NK270501627X / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Mydriasis, Resuscitation, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-02-20
   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: Asthma; cardiomyopathy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0636089A

Write-up: This case was reported by the foreign regulatory authority (GB-MHRA-FLU 00039643) and described the occurrence of collapse unspecified in a 34-year-old female subject who was vaccinated with PANDEMIC H1N1 unspecified, (GlaxoSmithKline), (non-gsk) PNEUMOVAX II and Seasonal Influenza vaccine. Concurrent medical conditions included asthma and cardiomyopathy. On 20 February 2010 the subject received unspecified dose of PANDEMIC H1N1 unspecified, and unspecified dose of PNEUMOVAX II and an unspecified dose of Seasonal Influenza vaccine. On 20 February 2010, less than one day after vaccination with PANDEMIC vaccine H1N1 unspecified. PNEUMOVAX II and Seasonal Influenza vaccine, the subject was found early evening collapsed with dilated pupils. Paramedics were called and resuscitation attempted. The subject was pronounced dead on arrival at the hospital. The subject died on 20 February 2010 from collapse unspecified. It was unknown whether an autopsy was performed. After vaccination in the morning the patient was well. The patient''s husband found the patient in the early evening collapsed with dilated pupils. Paramedics were called and resuscitation attempted. The patient was pronounced dead on arrival at the hospital.


VAERS ID: 382201 (history)  
Form: Version 1.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-11-09
Onset:2010-01-28
   Days after vaccination:80
Submitted: 2010-03-09
   Days after onset:40
Entered: 2010-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (GSK)) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, C-reactive protein increased, Carbon dioxide decreased, Chest X-ray abnormal, Continuous positive airway pressure, Cyanosis, Death, Feeling abnormal, Fibrosis, Intensive care, Livedo reticularis, Loss of consciousness, Oxygen saturation decreased, PCO2 decreased, Respiration abnormal, Respiratory distress, Respiratory rate decreased, Tachypnoea
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-28
   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: Alendronate sodium; acetylcysteine; cyclophosphamide; prednisolone; furosemide; spironolactone; CALCICHEW-D3
Current Illness: Aortic stenosis; Pulmonary fibrosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood carbon dioxide, 6.9; Blood carbon dioxide, 5.0; C-reactive protein, 20; C-reactive protein, 186; C-reactive protein, 91; Chest X-ray, fibrosis; Pulse oximetry, 85-90%; Pulse oximetry, 29%; Pulse oximetry, 50-60%; Pulse oximetry, 50-70%; Respiratory rate, 35-40bt%min
CDC Split Type: B0637780A

Write-up: This case was reported by a regulatory authority (# 100285) and described the occurrence of death in a 71-year-old female subject who was vaccinated with PANDEMRIX H1N1, (GlaxoSmithKline), FLUARIX. Concurrent medical conditions included aortic stenosis and pulmonary fibrosis. Concurrent medications included alendronate sodium, acetylcysteine, SENDOXAN, prednisolone, LASIX, spironolactone and CALCICHEW-D3. On 9 November 2009, the subject received 1st dose of PANDEMRIX H1N1 (unknown route and injection site, batch number not provided). At an unknown moment after 1st vaccination of PANDEMRIX, the subject felt infected but it was transient. On 16 December 2009, the subject received 2nd dose of PANDEMRIX H1N1 (intramuscular, unknown injection site, batch number not provided) and unspecified dose of FLUARIX (unknown route and injection site, batch number not provided). A few days later the patient felt that the respiration gradually deteriorated. She came to hospital on 27 December 2009 with severely affected breathing. Tests were performed : pulse oximeter (POX) 50-70%, increasing to 85-90% on 4 liters of oxygen. Pulmonary X-ray showed fibrosis where consolidation could not be excluded. The patient was nursed initially at ICU, without respirator treatment. She was given treatment with cefotaxime and high-dose cortisone. CRP was measured : 91 (<5 mg / L) when admitted, two days later increased to a maximum of 186 and then decreased gradually to 20. The patient still required oxygen treatment. She was discharged to home on 18 January. At that time she presented tachypnoeic and weakness but was eager to go home. She was given oxygen treatment at home. On 26 January 2010, There was a sudden worsening of breathing. When the ambulance arrived the patient showed severe respiratory distress, had cyanotic on the lips and was discretely marbled on the underside of the thighs. Tests : POX 29%, respiratory rate 35-40. Upon arrival at the emergency room somewhat improved oxygen saturation, POX 50-60%. Abdominal respiration. Blood gas showed signs of carbon dioxide retention with pCO2 6.9 (4.4 - 6.0 kPa) and PO2 5.0 (10.6 - 13.8 kPa). Received VENTOLINE, ATROVENT, and BETAPRED. She was admitted to the ICU and was given antibiotics and cortisone. She did not tolerate CPAP-treatment (Continuous Positive Airway Pressure) so she was given high doses of oxygen via mask. There was a deterioration during the day. It was decided that further ICU treatment was not appropriate, was moved to the ward. There was further deterioration in the evening of 27 January 2010. She was Unconscious. The subject died on 28 January 2010 from unknown cause of death. It was unknown whether an autopsy was performed.


VAERS ID: 382392 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-03-10
Entered: 2010-03-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 28943 / 4 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, Death, Pneumococcal bacteraemia, Pneumonia pneumococcal
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 reported.
Current Illness:
Preexisting Conditions: The patient was no premature baby and was a healthy infant.
Allergies:
Diagnostic Lab Data: Blood culture (results: positive for S. pneumoniae of serotype 3) was done on an unspecified date.
CDC Split Type: DEWYEG05711210

Write-up: Information regarding PREVENAR was received from a healthcare professional regarding a 35-month-old female patient who died of pneumococcal bacteraemia with focus of pneumonia. The patient received the fourth dose on an unspecified date at the age of 15 months. At the age of 35 months the patient died of pneumococcal bacteraemia with focus of pneumonia. S. pneumoniae of serotype 3 were detected by blood culture. The patient died on an unknown date. The cause of death was reported as pneumococcal bacteraemia with focus of pneumonia pneumococcal.


VAERS ID: 382620 (history)  
Form: Version 1.0  
Age: 1.1  
Sex: Male  
Location: Foreign  
Vaccinated:2010-01-21
Onset:2010-01-23
   Days after vaccination:2
Submitted: 2010-03-12
   Days after onset:48
Entered: 2010-03-15
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Staphylococcal sepsis
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-23
   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: Unknown
Current Illness: Impetigo
Preexisting Conditions: sickness
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1003USA00999

Write-up: Information has been received from the Health Authorities (reference number DHH-N2010-50353) (Primary source not reported) concerning a 13 month old male patient (weight: 11 kg, height: 79 cm), with a medical history of frequent illness, with no known allergies and presenting a facial impetigo who was vaccinated with a dose of MMR II (batch number not reported) subcutaneously and a dose of PREVENAR (batch number not reported) intramuscularly on 21-JAN-2010. 36 hours after vaccination, on 23-JAN-2010, the patient experienced sepsis due to a multi-resistant staphylococcus aureus strain. Duration of the reaction was reported as 10 hours after which the patient died. Link with vaccination according to the primary source: unknown. Other business partner numbers include: E2010-01382. No further information is available.


VAERS ID: 382899 (history)  
Form: Version 1.0  
Age: 1.13  
Sex: Female  
Location: Foreign  
Vaccinated:2010-03-01
Onset:2010-03-05
   Days after vaccination:4
Submitted: 2010-03-17
   Days after onset:11
Entered: 2010-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-03-05
   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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0639243A

Write-up: This case was reported by a physician and described the occurrence of sudden infant death in a 7-week-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline), INFANRIX HEXA. On 1 March 2010, the subject received unspecified dose of ROTARIX (oral), unspecified dose of INFANRIX HEXA (intramuscular, right thigh). Lot numbers not provided. On 5 March 2010, 4 days after vaccination with INFANRIX HEXA and ROTARIX, the subject experienced sudden infant death. The subject died on 5 March 2010, cause of death was not reported. It was unknown whether an autopsy was performed.


VAERS ID: 382971 (history)  
Form: Version 1.0  
Age: 10.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-10-09
Onset:2009-10-29
   Days after vaccination:20
Submitted: 2010-03-18
   Days after onset:140
Entered: 2010-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA050AG / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Basophil percentage decreased, Blood smear test abnormal, Death, Eosinophil percentage, Haemoglobin decreased, Headache, Lymphocyte percentage, Malaria, Monocyte percentage decreased, Neutrophil percentage increased, Pyrexia, White blood cell count increased
SMQs:, Haematopoietic erythropenia (broad), Haematopoietic leukopenia (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-30
   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: Basophils, 30Oct2009, 0%; Blood smear test, 30Oct2009, Positive; Eosinophils, 30Oct2009, 1%; Hemoglobin, 30Oct2009, 4g/dl; Lymphocytes, 30Oct2009, 28%; Monocytes, 30Oct2009, 0%; Neutrophils, 30Oct2009, 71%; White blood cell count, 30Oct2009, 46200/mm3
CDC Split Type: B0639818A

Write-up: This case was reported by a healthcare professional and described the occurrence of malaria in a 10-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included CERVARIX; GlaxoSmithKline; intramuscular; left deltoid given on 2 September 2009. On 9 October 2009, the subject received 2nd dose of CERVARIX (intramuscular, left deltoid). No adverse event was reported during the observation period of 30 minutes after each dose of CERVARIX. The subject migrated to another village with her parents. She was in good condition and doing well. On 29 October 2009, 1 month after vaccination with the 2nd dose of CERVARIX, the subject experienced severe headache and fever. She visited a private local clinic for treatment as an outdoor patient. The subject was given an injection of an unspecified drug in the right upper arm by the physician. Malaria was suspected and a blood test was prescribed. Unspecified medication was also provided by the physician. On 30 October 2009, the subject was brought to the hospital in critical condition. The laboratory test on blood showed low hemoglobin level 4g/dl which is only 27.58% of a normal level, white blood cells 46200/mm3 with 71% neutrophils, 28% lymphocytes, 1% eosinophils, 0% monocytes and 0% basophils. The thin and thick blood smear analysis revealed many rings of trophozoites and schizont of plasmodium Vivax. The diagnosis of malaria was made. The subject was sent to the community health center where a treatment was started. Around 1 hour later, the subject was declared dead. The subject died on 30 October 2009 from malaria. An autopsy was not performed.


VAERS ID: 382988 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-03-17
Entered: 2010-03-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Condition aggravated, Death, Episcleritis, Histiocytosis, Ophthalmological examination abnormal, Paraesthesia, Polymerase chain reaction, Rash macular, Spinal myelogram abnormal, Uveitis
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Optic nerve disorders (broad), Corneal disorders (broad), Scleral disorders (narrow), Ocular infections (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: azathioprine; corticosteroids (unspecified)
Current Illness: Letterer-Siwe disease; Histiocytosis
Preexisting Conditions: Letterer-Siwe disease
Allergies:
Diagnostic Lab Data: unknown
CDC Split Type: WAES1003BRA00029

Write-up: Information has been received from a published literature titled as stated above concerning an 11-year-old male who on an unreported date was vaccinated with VARIVAX (manufacturer unknown). The reporters noted that the "11 year old was diagnosed since his first year of life with histiocytosis of Letterer-Siwe ;and he has been regularly monitored in the departments of hematology and dermatology. He was in remission with the use of systemic steroids and azathioprin, and he presented with an eritematomacular rash, prickly, in the face and scalp with involvement of the left eye consistent with varicella. History of VARIVAX. Ophthalmologic evaluation revealed episcleritis and anterior uveitis in the left eye. Polymerase chain reaction detects particles of VARIVAX. Received antivaricella zoster immunoglobulin without improvement, and developed relapse of Ilistiocptosis and death". The author''s discussion: "In our report, a child had a 10-year diagnosis of histiocytosis of Letterer-Siwe, with Birbeck granules seen in electron microscopy and immunohistochemistry with S100/CDIA+. He was hospitalized with a severe form of histiocytosis with involvement and infiltration of various organs, including bone marrow confirmed by myelogram with the finding of histiocytic cells, and died within less than a month. The varicella was the first sign of severity and relapse of the disease, aggravating the process. Since his outbreak in 2007, the incidence of varicella has increased with atypical presentations and raised the possibility of mutation of varicella-zoster virus." No further information is available. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 382997 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2009-10-17
Onset:2009-10-17
   Days after vaccination:0
Submitted: 2010-03-17
   Days after onset:151
Entered: 2010-03-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (CSL)) / CSL LIMITED - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Facial palsy, Guillain-Barre syndrome, Headache, Paraesthesia, Paralysis, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (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 (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-31
   Days after onset: 106
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: DIABEX (METFORMIN HYDROCHLORIDE)
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2010022225

Write-up: Report received from a consumer on 10-Mar-2010. A male patient (details unknown) received the PANVAX on an unknown date. The medical history and concomitant medication are unknown. On an unknown date after receiving PANVAX, the patient developed a 10 week long illness that was diagnosed as Guillain Barre Syndrome. Subsequently, the patient died recently. No further information was provided. The reporter states that the ''two may not be linked''. This case was reported as serious because of a fatal outcome. The company considered events conditional to the suspect drug, PANVAX until further information is received. Information derived from the AE report does not change the current safety profile of the product. Follow-up information was received from a consumer on 15-Mar-2010. A 60 year old male patient received PANVAX H1N1 influenza vaccine 0.5 ml on 17-Oct-2009. The patient has a medical history of Type 2 diabetes that was only diagnosed a few months earlier. Concomitant medications included unspecified blood pressure medications, cholesterol medications and low dose DIABEX. The patient was also self dosing with anti-flu decongestant (day/night) tablets just prior to the adverse events. Other relevant medical history is not listed. On 17-OCT-2009 at night, the patient experienced headaches. Over the next few days, he also experienced pins and needles in his hands and feet. On 25-NOV-2009, the patient was admitted to the emergency department with total loss of muscle use in the calves of his legs. This progressed upwards to his shoulders on the same day, however he was still able to shrug his shoulders (he was not able to move muscles below shoulders). By 26-Nov-2009, the patient was totally paralysed through to his face. He was transferred to another Hospital on 26-Nov-2009. The patient was put onto a respirator on an unknown date and received INTRAGAM once at one hospital and twice over his weeks at another hospital. The patient died on 31-Jan-2010. Cause of death was reported as related to GBS, respiratory failure and Type 2 diabetes. The reporter consided the case as serious. The company considered events possible to the suspect drug given the time to onset and additional information. Information derived from this AE report does not change the current safety profile of the product. Cause(s) of death due to disease: Type 2 diabetes mellitus, Respiratory failure. Death date: 31-Jan-2010.


VAERS ID: 383082 (history)  
Form: Version 1.0  
Age: 0.1  
Sex: Male  
Location: Foreign  
Vaccinated:2010-03-10
Onset:2010-03-11
   Days after vaccination:1
Submitted: 2010-03-19
   Days after onset:7
Entered: 2010-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 RA / UN

Administered by: Other       Purchased by: Other
Symptoms: Cardiac failure, Cyanosis, Death
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-03-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0640709A

Write-up: This case was reported by a physician and described the occurrence of heart failure in a 1-month-old male subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). Previous and/or concurrent vaccination included bacillus calmette-guerin vaccine (non-GSK) (manufacturer unspecified) given on 4 February 2010. On 10 March 2010, the subject received 2nd dose of Hepatitis B vaccine (unknown manufacturer, unknown route of administration, unknown injection site, lot number not provided). On 11 March 2010, 1 day after vaccination with Hepatitis B vaccine, the subject experienced heart failure and cyanosis. The subject was hospitalised. The subject died on 11 March 2010 from heart failure. It was unknown whether an autopsy was performed. The responsible physician did not know if the patient had cardiopathy.


VAERS ID: 383583 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-03-23
Entered: 2010-03-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Ascites, Bone disorder, Bovine tuberculosis, Death, Laboratory test abnormal, Nervous system disorder
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had personal immunodeficiency disorders; chronic granulomatous disease. The patient had no family history of immunodeficiency, no consanguinity.
Allergies:
Diagnostic Lab Data: Immune defect tests showed CGD.
CDC Split Type: 201001574

Write-up: Foreign literature article received on 12 March 2010 involving 11 case reports. This case is linked with cases 2010-01562, 2010-01575, 2010-01576, 2010-01577, 2010-01578, 2010-01579, 2010-01580, 2010-01581, 2010-0582, 2010-01583. This case will described adverse event on case number 2. The aim of this prospective study was to determine the role of immunodeficiency disorders in exciting disseminated BCG infection in patients with disseminated BCG infection following immunization at birth with BCG sub strain Pasteur vaccine. Through 2 years all infants with BCG adenitis or other complications of this vaccine that had suspicious BCG infection were referred to a hospital and health center. Evaluation of immune system and in some cases genetic survey was performed in infants with evidence of histopathologic demonstration of acid-fast bacilli. Then frequency of infants who had disseminated BCG infection with immunodeficiency was defined. Clinical manifestations and hematological and immunologic changes were compared between two different groups of cases: Patients (who are children with disseminated BCG infection) and control group (who are children with complications of BCG vaccination but without disseminated BCG infection). Then frequency of patients with disseminated BCG infection who had immunodeficiency was reported. From 122093 BCG vaccinated children through 24 month period, 48 infants with BCG lymphadenitis, within range of 2-62 months (mean + - SD: 9.9 +- 9.85) were selected. 28 infants were male (58.3%) and 20 infants were female (41.7%). Onset age was between 1-21 months (mean +- SD: 6.36 +- 4.62). Twenty four cases had multiple lymphadenitis near to BCG incubation such as cervical, axillary, and supraclaviculs, 11 cases had suppurative lymphadenitis with fistula and abscesses and 5 cases had ulcer of BCG incubation. Osteomyelitis due to BCG vaccination was detected in 2 cases and disseminated BCG infection in 11 cases (22.9%) with multi organ involvement and systemic symptoms was detected. Family history of BCG infection or immunodeficiency was positive in 22.9% if control group and the rate of consanguineous marriage in the parents of them was 37.5% (18 cases). Disseminated BCG infection was diagnosed in 11 cases with multi organ involvement and systemic symptoms, almost all of whom had immunodeficiency. Definitive immunodeficiency was detected in approximately all of children with disseminated BCG infection including: SCID in 7 cases with homozygous mutation and homozygous polymorphism in Rag2 in one patient with heterozygous for the Rag2 mutation and polymorphism in the both parents of him and exclusion of Rag1, Rag2 and Artemis defect in another patient. Other cases were CGD, IL12RB1 deficiency and MSMD. In one cases of MSMD we could exclude in IL12RB1 deficiency. So he had a normal expression of IL12RB1on cell surface with two different antibodies. HIV was not identified in any of the cases. Overall, the mortality rate was 72.8% (8 cases). Consanguineous was found in more than half (7 cases) of patients and family history of disseminated BCG infection or immunodeficiency was found in nearly one third (3 cases) of patients. A chi-square test comparing the clinical manifestations in children with disseminated BCG infection with control group showed statistically significant differences for the two groups of children. Comparison of immunologic markers showed that significant differences were seen between two groups of children. The mean value of CD3 in patients was (P = 0.005) in comparison with control group and the mean value of CD4 in patients was (P < 0.001) in comparison with control group (Table 3). Although antimycobacterial regimens used for the treatment of patients with 4 drugs, but 8 of the patients died despite aggressive management. Case report #2: A 03-year-old male patient had a disseminated BCG infection after immunization at birth with BCG sub strain Pasteur vaccine (Manufacturer and batch number unknown) The patient had personal immunodeficiency disorders: chronic granulomatous disease (CDG). The patient had no family history of immunodeficiency, no consanguinity. The patient were referred to hospital. The sites of dissemination were bone, central nervous system (CNS) and ascites. The patient died.


VAERS ID: 383596 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-03-23
Entered: 2010-03-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bovine tuberculosis, Death, Laboratory test abnormal, Liver disorder, Lymphadenopathy
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had personal immunodeficiency disorders: SCID (severe combined immunodeficiency). The patient had a family history of immunodeficiency and of consanguinity.
Allergies:
Diagnostic Lab Data: Immune defect tests showed SCID Rag2 deficiency T-B-NK+
CDC Split Type: 201001575

Write-up: Literature article from a foreign country received on 12 March 2010 involving 11 case reports. This case is linked with cases 2010-10574, 2010-01562, 2010-01576, 2010-01577, 2010-01578, 2010-01579, 2010-01580, 2010-01581, 2010-0582, 2010-01583. This case will described adverse event on case number 3. The aim of this prospective study was to determine the role of immunodeficiency disorders in exciting disseminated BCG infection in patients with disseminated BCG infection following immunization at birth with BCG sub strain Pasteur vaccine. Through 2 years all infants with BCG adenitis or other complications of this vaccine that had suspicious BCG infection were referred to hospital and health centers. Evaluation of immune system and in some cases genetic survey was performed in infants with evidence of histopathologic demonstration of acid-fast bacilli. Then frequency of infants who had disseminated BCG infection with immunodeficiency was defined. Clinical manifestations and hematological and immunologic changes were compared between two different groups of cases: Patients (who are children with disseminated BCG infection) and control group (who are children with complications of BCG vaccination but without disseminated BCG infection). Then frequency of patients with disseminated BCG infection who had immunodeficiency was reported. From 122093 BCG vaccinated children through 24 month period, 48 infants with BCG lymphadenitis, within range of 2-62 months (mean +- SD: 9.9 +- 9.85) were selected. 28 infants were male (58.3%) and 20 infants were female (41.7%). Onset age was between 1-21 months (mean +- SD: 6.36 +- 4.62). Twenty four cases had multiple lymphadenitis near to BCG incubation such as cervical, axiliary, and supraclaviculs, 11 cases had suppurative lymphadenitis with fistula and abscesses and 5 cases had ulcer of BCG incubation. Osteomyelitis due to BCG vaccination was detected in 2 cases and disseminated BCG infection in 11 cases (22.9%) with multi organ involvement and systemic symptoms were detected. Family history of BCG infection or immunodeficiency was positive in 22.9% of control group and the rate of consanguineous marriages in the parent of them was 37.5% (18 cases). Disseminated BCG infection was diagnosed in 11 cases with multi organ involvement and systemic symptoms, almost all of whom had immunodeficiency. Definitive immunodeficiency was detected in approximately all of children with disseminated BCG infection including: SCID in 7 cases with homozygous mutation and homozygous polymorphism in Rag2 in one patient with heterozygous for the Rag 2 mutation and polymorphism in the both parents of him and exclusion of Rag1, Rag2 and Artemis defect in another patient. Other cases were CGD, IL12RB1 deficiency and MSMD. In one cases of MSMD we could exclude an IL12RB1 deficiency. So he had a normal expression of IL12RB1 on cell surface with two different antibodies. HIV was not identified in any of the cases. Overall, the mortality rate was 72.8% (8 cases). Consanguineous was found in more than half (7 cases) of patients and family history of disseminated BCG infection or immunodeficiency was found in nearly one third (3 cases) of patients. A chi-square test comparing the clinical manifestations in children with disseminated BCG infection with control group showed statistically significant differences for the two groups of children. Comparison of immunologic markers showed that significant differences were seen between two groups of children. The mean value of CD3 in patients was (P = 0.005) in comparison with control group and the mean value of CD4 in patients was (P < 0.001) in comparison with control group (Table 3). Although antimycobacterial regimens used for the treatment of patients with 4 drugs, but 8 of the patients died despite aggressive management. Case report #3: A 04-month-old male patient had a disseminated BCG infection after immunization at birth with BCG sub strain Pasteur vaccine (Manufacturer and batch number unknown). The patient had personal immunodeficiency disorders: SCID (severe combined immunodeficiency). The patient had a family history of immunodeficiency and of consanguinity. The patient was referred to hospital. The sites of dissemination were distal lymph node and liver. The patient died.


VAERS ID: 383598 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-03-23
Entered: 2010-03-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bone disorder, Bovine tuberculosis, Death, Immunology test abnormal, Liver disorder, Omenn syndrome, Pericardial disease
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Congenital, familial and genetic disorders (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had personal immunodeficiency disorders. The patient had no family history of immunodeficiency. Family history of consanguinity
Allergies:
Diagnostic Lab Data: Immune defect tests showed: OMEN syn T+B-NK+
CDC Split Type: 201001576

Write-up: Literature article from a foreign country received on 12 March 2010 involving 11 case reports. This case is linked with cases 2010-01574, 2010-01575, 2010-01562, 2010-01577, 2010-01578, 2010-01579, 2010-01580, 2010-01581, 2010-0582, 2010-01583. This case will describe adverse event on case number 4. The aim of this prospective study was to determine the role of immunodeficiency disorders in exciting disseminated BCG infection following at birth with BCG sub strain Pasteur vaccine. Through 2 years all infants with BCG adenitis or other complications of this vaccine that had suspicious BCG infection were referred to hospital and health centers. Evaluation of immune system and in some cases genetic survey was performed in infants with evidence of histopathologic demonstration of acid-fast bacilli. Then frequency of infants who had disseminated BCG infection with immunodeficiency was defined. Clinical manifestations and hematological and immunologic changes were compared between two different groups of cases: Patients (who are children with disseminated BCG infection) and control group (who are children with disseminated BCG infection). Then frequency of patients with disseminated BCG infection who had immunodeficiency was reported. From 122093 BCG vaccinated children through 24 month period, 48 infants with BCG lymphadenitis, within range of 2-62 months (mean +- SD: 9.9 +- 9.85) were selected. 28 infants were male (58.3%) and 20 infants were female (41.7%). Onset age was between 1-21 months (mean +- SD: 6.36 +- 4.62). Twenty four cases had multiple lymphadenitis near to BCG incubation such as cervical axiliary, and supraclaviculs, 11 cases had suppurative lymphadenitis with fistula and abscesses and 5 cases had ulcer of BCG infection or immunodeficiency was positive in 22.9% of control group and the rate of consanguineous marriages in the parents of them was 37.5% (18 cases). Disseminated BCG infection was diagnosed in 11 cases with multi organ involvement and systemic symptoms, almost all of whom had immunodeficiency. Definitive immunodeficiency was detected in approximately all of children with disseminated BCG infection including: SCID in 7 cases with homozygous mutation and homozygous polymorphism in Rag2 in one patient with heterozygous for the Rag2 mutation and polymorphism in the both parents of him and exclusion of Rag1, Rad2 and Artemis defect in another patient. Other cases were CGD, IL12RB1 deficiency and MSMD. In one cases of MSMD we could exclude an IL12RB1 deficiency. So he had a normal expression of IL12RB1 on cell surface with two different antibodies. HIV was not identified in any of the cases. Overall, the mortality rate was 72.8% (8 cases). Consanguineous was found in more than half (7 cases) of patients and family history of disseminated BCG infection or immunodeficiency was found in nearly one third (3 cases) of patients. A chi-square test comparing the clinical manifestations in children [Due to memory limitations, the remainder of this text could not be compared.] hildren with disseminated BCG infection with control group showed statically significant differences for the two groups of children. Comparison of immunologic markers showed that significant differences were seen between two groups of children. The mean value of CD3 in patients was (P=0.005) in comparison with control group and the mean value of CD4 in patients was (P< 0.001) in comparison with control group. Although antimycobacterial regimens used for the treatment of patients with 4 drugs, but 8 of the patients died despite aggressive management. A 04-month-old male patient had a disseminated BCG infection after immunization at birth with BCG sub strain Pasteur vaccine (Manufacturer and batch number unknown). The patient had Omenn Syndrome (to be verified) with T+B+NK+. The patient had no family history of immunodeficiency. Family history of consanguinity. The patient was referred to hospital. The sites of dissemination were bone, pericardia and liver. The patient died.


VAERS ID: 383599 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-03-23
Entered: 2010-03-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bovine tuberculosis, Death, Gastric disorder, Immunology test abnormal, Lymphadenopathy
SMQs:, Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had personal immunodeficiency disorders: severe combined immunodeficiency (SCID) T-B-NK+. The patient had no family history of immunodeficiency, no consanguinity
Allergies:
Diagnostic Lab Data: Immune defect tests showed SCID T-B-NK+
CDC Split Type: 201001577

Write-up: Foreign literature article received on 12 March 2010 involving 11 case reports. This case is linked with cases 2010-01562, 2010-01574, 2010-01575, 2010-01576, 2010-01578, 2010-01579, 2010-01580, 2010-01581, 2010-0582, 2010-01583. This case will describe adverse event on case number 5. The aim of this prospective study was to determine the role of immunodeficiency disorder in exciting disseminated BCG infection in patients with disseminated BCG infection following immunization at birth with BCG sub strain Pasteur vaccine. Through 2 years all infants with BCG adenitis or other complications of this vaccine that had suspicious BCG infection were referred to a hospital and health centers. Evaluation of immune system and in some cases genetic survey was performed in infants with evidence of histopathologic demonstration of acid-fast bacilli. Then frequency of infants who had disseminated BCG infection with immunodeficiency was defined. Clinical manifestations and hematological and immunologic changes were compared between two different groups of cases: Patients (who are children with disseminated BCG infection) and control group (who are children with complications of BCG vaccination but without disseminated BCG infection). Then frequency of patients with disseminated BCG infection who had immunodeficiency was reported. From 122093 BCG vaccinated children through 24 month period. 48 infants with BCG lymphadenitis, within range of 2-62 months (mean +- SD: 9.9 +- 9.85) were selected. 28 infants were male (58.3%) and 20 infants were female (41.7%). Onset age was between 1-21 months (mean +- SD: 6.36 +- 4.62). Twenty four caseshad multiple lymphadenitis near to BCG incubation such as cervical, axiliary, and supraclaviculs, 11 case had suppurative lymphadenitis with fistula and abscesses and 5 cases had ulcer of BCG incubation. Osteomyelitis due to BCG vaccination was detected in 2 cases and disseminated BCG infection in 11 cases (22.9%) with multi organ involvement and systemic symptoms was detected. Family history of BCG infection or immunodeficiency was positive in 22.9% of control group and the rate of consanguineous marriages in the parents of them was 37.5% (18 cases). Disseminated BCG infection was diagnosed in 11 cases with multi organ involvement and systemic symptoms, almost all of whom had immunodeficiency. Definitive immunodeficiency was detected in approximately all of children with disseminated BCG infection including: SCID in 7 cases with homozygous mutation and homozygous polymorphism in Rag2 in one patient with heterozygous for the Rag2 mutation and polymorphism in the both parents of him and exclusion of Rag1, Rag2 and Artemis defect in another patient. Other cases were CGD, IL12RB1 deficiency and MSMD. In one cases of MSMD we could exclude in IL12RB1 deficiency. So he had a normal expression of IL12RB1 on cell surface with two different antibodies. HIV was not identified in any of the cases. Overall, the mortality rate was 72.8% (8 cases). Consanguineous was found in more than half (7 cases) of patients and family history of disseminated BCG infection or immunodeficiency was found in nearly on third (3 cases) of patients. A chi-square test comparing the clinical manifestations in children with disseminated BCG infection with control group showed statistically significant differences for the two groups of children. Comparison of immunologic markers showed that significant differences were seen between two groups of children. The mean value of CD3 in patients was (P = 0.005) in comparison with control group and the mean of CD4 in patients was (P < 0.001) in comparison with control group (Table 3). Although antimycobacterial regimens used for the treatment of patients with 4 drugs, but 8 of the patients died despite aggressive management. Case report # 5: A 06-month-old female patient had a disseminated BCG infection after immunization at birth with BCG sub strain pasteur vaccine (Manufacturer andbatch number unknown) The patient had personal immunodeficiency disorders: severe combined immunodeficiency (SCID) T-B-NK+ The patient had no family history of immunodeficiency, no consanguinity. The patient was referred to hospital. The sites of dissemination were distal lymph node and gastric aspirate. The patient died.


VAERS ID: 383601 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-03-23
Entered: 2010-03-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Immunology test abnormal, Liver disorder, Lymphadenopathy
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Hypersensitivity (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had personal immunodeficiency disorders of severe combined immunodeficiency (SCID). The patient had a family history of immunodeficiency and consanguinity.
Allergies:
Diagnostic Lab Data: Immune defect tests showed T-B-NK+ SCID
CDC Split Type: 201001578

Write-up: Literature article received on 12 March 2010 involving 11 case reports. This case is linked with cases 2010-01562, 2010-01574, 2010-01575, 2010-01576, 2010-01577, 2010-01579, 2010-01580, 2010-01581, 2010-01582, 2010-01583. This case will describe adverse event on case number 6. Through 2 years all infants with BCG adenitis or other complications of this vaccine that had suspicious BCG infection were referred to hospital and health centers. Evaluation of immune system and in some cases genetic survey was performed in infants with evidence of histopathologic demonstration of acid-fast bacilli. Then frequency of infants who had dissmeninated BCG infection with immunodeficiency was defined. Clinical manifestations and hematological and immunologic changes were compared between two different groups of cases: Patients (who are children with disseminated BCG infection) and control group (who are children with complication of BCG vaccination but without disseminated BCG infection). Then frequency of patients with disseminated BCG infection who had immunodeficiency was reported. From 122093 BCG vaccinated children through 24 month period, 48 infants with BCG lymphadenitis, within range of 2-62 months (mean + SD: 9.9 + 9.85) were selected. 28 infants were male (58.3%) and 20 infants were female (41.7%). Onset age was between 1-21 months (mean + SD: 6.36 + 4.62). Twenty four cases had multiple lymphadenitis near to BCG incubation such as cervical, axiliary, and supraclaviculs, 11 cases had suppurative lymphadenitis with fistula and abscesses and 5 cases had ulcer of BCG incubation. Osteomyelitis due to BCG vaccination was detected in 2 cases and disseminated BCG infection in 11 cases (22.9%) with multi organ involvement and systemic symptoms was detected. Family history of BCG infection or immunodeficiency was positive in 22.9% of control group and the rate of consanguineous marriages in the parents of them was 37.5% (18 cases). Disseminated BCG infection was diagnosed in 11 cases with multi organ involvement and systemic symptoms, almost all of whom had immunodeficiency. Definitive immunodeficiency was detected in approximately all of children with disseminated BCG infection including: SCID in 7 cases with homozygous mutation and homozygous polymorphism in Rag2 in one patient with heterozygous for the Rag2 mutation and polymorphism in the both parents of him and exclusion of Rag1, Rag2 and Artemis defect in another patient. Other cases were CGD, IL12RB1 deficiency and MSMD. In one cases of MSMD we could exclude an IL12RB1 deficiency. So he had a normal expression of IL12RB1on cell surface with two different antibodies. HIV was not identified in any of the cases. Overall, the mortality rate was 72.8% (8 cases). Consanguineous was found in more than half (7 cases) of patients and family history of dissmeninated BCG infection or immunodeficiency was found in nearly one third (3 cases) of patients. A chi-square test comparing the clinical manifestations in children with disseminated BCG infection with control group showed statistically significant differences for the two groups of children. Comparison of immunologic markers showed that significant differences were seen between two groups of children. The mean value of CD3 in patients was (P = 0.005) in comparison with control group and the mean value of CD4 in patients was (P < 0.001) in comparison with control group (Table 3). Although antimycobacterial regimens used for the treatment of patients with 4 drugs, but 8 of the patients died despite aggressive management. Case report # 6: A 05-month-old female patient had a disseminated BCG infection after immunization at birth with BCG sub strain Pasteur vaccine (Manufacturer and batch number unknown). The patient had personal immunodeficiency disorders of severe combined immunodeficiency (SCID), T-B-NK+. The patient had a family history of immunodeficiency and consanguinity. The patient was referred to hospital. The sites of dissemination were distal lymph node and liver. The patient died.


VAERS ID: 383602 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-03-23
Entered: 2010-03-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Ascites, Bovine tuberculosis, Death, Immunology test abnormal, Liver disorder, Lymphadenopathy
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had personal immunodeficiency disorders: severe combined immunodeficiency (SCID), The patient had a family history of immunodeficiency. History of consanguinity
Allergies:
Diagnostic Lab Data: Immune defect tests showed SCID - T-B+NK+
CDC Split Type: 201001580

Write-up: Literature article received on 12 March 2010 involving 11 case reports. This case is linked with cases 2010-01562, 2010-01574, 2010-01575, 2010-01576, 2010-01577, 2010-01578, 2010-01579, 2010-01580, 2010-01581, 2010-01582, 2010-01583. This case will describe adverse event on case number 8. The aim of this prospective study was to determine the role of immunodeficiency disorders in exciting disseminated BCG infection in patients with disseminated BCG infection following immunization at birth with BCG sub strain Pasteur vaccine. Through 2 years all infants with BCG adenitis or other complications of this vaccine that had suspicious BCG infection were referred to hospital and health centers. Evaluation of immune system and in some cases genetic survey was performed in infants with evidence of histopathologic demonstration of acid-fast bacilli. Then frequency of infants who had disseminated BCG infection with immunodeficiency was defined. Clinical manifestations and hematological and immunologic changes were compared between two different groups of cases: Patients (who are children with disseminated BCG infection) and control group (who are children with complications of BCG vaccination but without disseminated BCG infection). Then frequency of patients with disseminated BCG infection who had immunodeficiency was reported. From 122093 BCG vaccinated children through 24 month period, 48 infants with BCG lymphadenitis, within range of 2-62 months (mean +_ SD: 9.9 +_ 9.85) were selected. 28 infants were male (58.3%) and 20 infants were female (41.7%). Onset age was between 1-21 months (mean +_ SD: 6.36 +_ 4.62). Twenty four cases had multiple lymphadenitis near to BCG incubation such as cervical, axiliary, and supraclaviculs, 11 cases had suppurative lymphadenitis with fistula and abscesses and 5 cases had ulcer of BCG incubation. Osteomyelitis due to BCG vaccination was detected in 2 cases and disseminated BCG infection in 11 cases (22.9%) with multi organ involvement and systemic symptoms was detected. Family history of BCG infection or immunodeficiency was positive in 22.9% of control group and the rate of consanguineous marriages in the parents of them was 37.5% (18 cases). Disseminated BCG infection was diagnosed on 11 cases with multi organ involvement and systemic symptoms, almost all of whom had immunodeficiency. Definitive immunodeficiency was detected in approximately all of children with disseminated BCG infection including: SCID in 7 cases with homozygous mutation and homozygous polymorphism in Rag2 in one patient with heterozygous for the Rag2 mutation and polymorphism in the both parents of him and exclusion of Rag1, Rag2 and Artemis defect in another patient. Other cases were CGD, IL12RB1 deficiency and MSMD. In one cases of MSMD we could exclude an IL12RB1 deficiency. So he had a normal expression of IL12RB1 on cell surface with two different antibodies. HIV was not identified in any of the cases. Overall, the mortality rate was 72.8% (8 cases). Consanguineous was found in nearly one third (3 cases) of patients. A chi-square test comparing the clinical manifestations in children with disseminated BCG infection with control group showed statistically significant differences for the two groups of children. Comparison of immunologic markers showed that significant differences were seen between two groups of children. The mean value of CD3 in patients was (P=0.005) in comparison with control group and the mean value of CD4 in patients was (P<0.001) in comparison with control group (Table 3). Although antimycobacterial regimens used for the treatment of patients with 4 drugs, but 8 of the patients died despite aggressive management. A 06-month-old female patient had a disseminated BCG infection after immunization at birth with BCG sub strain Pasteur vaccine (manufacturer and batch number unknown). The patient had personal immunodeficiency disorders of severe combined immunodeficiency, T-B+NK+. The patient had a family history of immunodeficiency and a history of consanguinity. The patient was referred to hospital. The sites of dissemination were ascites, liver, distal lymph node. The patient died.


VAERS ID: 383604 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-03-23
Entered: 2010-03-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bovine tuberculosis, Death, Disseminated tuberculosis, Eye disorder, Immunology test abnormal, Lymphadenopathy
SMQs:, Corneal disorders (broad), Retinal disorders (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (broad), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had personal immunodeficiency disorders of severe combined immunodeficiency (SCID). The patient had no family history of immunodeficiency and history of consanguinity.
Allergies:
Diagnostic Lab Data: Immune defect tests showed T-B-NK+ (exclusion of Rag1, Rag2 and Artemis defect)
CDC Split Type: 201001579

Write-up: Literature article received on 12 March 2010 involving 11 case reports. This case is linked with cases 2010-01562, 2010-01574, 2010-01575, 2010-01576, 2010-01577, 2010-01578, 2010-0582, 2010-01583. This case will describe adverse event on case number 7. The aim of this prospective study was to determine the role of immunodeficiency disorders in exciting disseminated BCG infection in patients with disseminated BCG infection following immunization at birth with BCG sub strain Pasteur vaccine. Through 2 years all infants with BCG adenitis or other complications of this vaccine that had suspicious BCG infection were referred to hospital and health centers. Evaluation of immune system and in some cases genetic survey was performed in infants with evidence of histopathologic demonstration of acid-fast bacilli. Then frequency of infants who had disseminated BCG infection with immunodeficiency was defined. Clinical manifestations and hematological and immunologic changes were compared between two different groups of cases: Patients (who are children with disseminated BCG infection) and control group (who are children with complications of BCG vaccination but without disseminated BCG infection). The frequency of patients with disseminated BCG infection who had immunodeficiency was reported. From 122093 BCG vaccinated children through 24 month period, 48 infants with BCG lymphadentitis, within range of 2-62 months (mean + SD: 9.9 + 9.85) were selected. 28 infants were male (58.3%) and 20 infants were female (41.7%). Onset age was between 1-21 months (mean SD: 6.36 + 4.62). Twenty four cases had multiple lymphadentitis near to BCG incubation such as cervical, axilliary, and supraclaviculs, 11 cases had suppurative lymphadentitis with fistula and abscesses and 5 cases had ulcer of BCG incubation. Osteomyelitis due to BCG vaccination was detected in 2 cases and disseminated BCG infection in 11 cases (22.9%) with multi organ involvement and systemic symptoms was detected. Family history of BCG infection or immunodeficiency was positive in 22.9% of control group and the rate of consanguineous marriages in the parents of them was 37.5% (18 cases). Disseminated BCG infection was diagnosed in 11 cases with multi-organ involvement and systemic symptoms, almost all of whom had immunodeficiency. Definitive immunodeficiency was detected in approximately all of children with disseminated BCG infection including: SCID in 7 cases with homozygous mutation and homozygous polymorphism in Rag2 in on patient with heterozygous for the Rag2 mutation and polymorphism in the both parents of him and exclusion of Rag1, Rag2 and Artemis defect in another patient. Other cases were CGD, IL12RB1 deficiency and MSMD. In on cases of MSMD we could exclude an IL12RB1 deficiency. So he had a normal expression of IL12RB1 on cell surface with two different antibodies. HIV was not identified in any of the cases. Overall, the mortality rate was 72.8% (8 cases). Consanguineous was found in more than half (7 cases) of patients and family history of disseminated BCG infection or immunodeficiency was found in nearly one third (3 cases) of patients. A chi-square test comparing the clinical manifestations in children with disseminated BCG infection with control group showed statistically significant differences for the two groups of children. Comparison of immunologic markers showed that significant differences were seen between two groups of children. The mean value of CD3 in patients was (P =0.005) in comparison with control group and the mean value of CD4 in patients was (P < 0.001) in comparison with control group (Table 3). Although antimycobacterial regimens used for the treatment of patients with 4 drugs, but 8 out of the patients died despite aggressive management. Case report #7: A 4/5 month-male patient had a disseminated BCG infection after immunization at birth with BCG sub strain Pasteur vaccine (Manufacturer and batch number unknown). The patient had persona immunodeficiency disorders of severe combined immunodeficiency (SCID). T-B-NK+ exclusion of Rag1, Rag2 and Artemis defect. The patient had no family history of immunodeficiency and history of consanguinity. The patient was referred to hospital. The sites of dissemination were eye, distal lymph node and lung (miliary). The patient died.


VAERS ID: 383634 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-03-23
Entered: 2010-03-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bovine tuberculosis, Death, Immunology test abnormal
SMQs:, Hypersensitivity (broad), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had personal immunodeficiency disorders: The patient had a family history of immunodeficiency.
Allergies:
Diagnostic Lab Data: Immune defect tests showed SCID - T-B+NK+
CDC Split Type: 201001583

Write-up: Literature article received on 12 March 2010 involving 11 case reports. This case is linked with cases 2010-01562, 2010-01574, 2010-01575, 2010-01576, 2010-01577, 2010-01578, 2010-01579, 2010-01580, 2010-01581, 2010-0582. This case will describe adverse event. The aim of this prospective study was to determine the role of immunodeficiency disorders in exciting disseminated BCG infection in patients with disseminated BCG infection following immunization at birth with BCG sub strain Pasteur vaccine. Through 2 years all infants with BCG adenitis or other complications of this vaccine that had suspicious BCG infection were referred to hospital and health centers. Evaluation of immune system and in some cases genetic survey was performed in infants with evidence of histopathologic demonstration of acid-fast bacilli. Then frequency of infants who had disseminated BCG infection with immunodeficiency was defined. Clinical manifestations and hematological and immunologic changes were compared between two different groups of cases: Patients (who are children with disseminated BCG infection) and control group (who are children with complications of BCG vaccination but without disseminated BCG infection). Then frequency of patients with disseminated BCG infection who had immunodeficiency was reported. From 122093 BCG vaccinated children through 24 month period, 48 infants with BCG lymphadenitis, within range of 2-62 months (mean plus or minus SD: 9.9 plus or minus 9.85) were selected. 28 infants were male (58.3%) and 20 infants were female (41.7%). Onset age was between 1-21 months (mean plus or minus SD: 6.36 plus or minus 4.62). Twenty four cases had multiple lymphadenitis near to BCG incubation such as cervical, axiliary, and supraclaviculs, 11 cases had suppurative lymphadenitis with fistula and abscesses and 5 cases had ulcer of BCG incubation. Osteomyelitis due to BCG vaccination was detected in 2 cases and disseminated BCG infection in 11 cases (22.9%) with multi organ involvement and systemic symptoms was detected. Family history of BCG infection or immunodeficiency was positive in 22.9% of control group and the rate of consanguineous marriages in the parents of them was 37.5% (18 cases). Disseminated BCG infection was diagnosed in 11 cases with multi organ involvement and systemic symptoms, almost all of whom had immunodeficiency. Definitive immunodeficiency was detected in approximately all of children with disseminated BCG infection including: SCID in 7 cases with homozygous mutation and homozygous polymorphism in Rag2 in one patient with heterozygous for the Rag2 mutation and polymorphism in the both parents of him and exclusion of Rag1, Rag2 and Artemis defect in another patient. Other cases were CGD, IL12RB1 deficiency and MSMD. In one cases of MSMD we could exclude an IL12RB1 deficiency. So he had a normal expression of IL12RB1 on cell surface with two different antibodies. HIV was not identified in any of the cases. Overall, the mortality rate was 72.8% (8 cases). Consanguineous was found in more than half (7 cases) of patients and family history of disseminated BCG infection or immunodeficiency was found in nearly one third (3 cases) of patients. A chi-square test comparing the clinical manifestations in children with disseminated BCG infection with control group showed statistically significant differences for the two groups of children. Comparison of immunologic markers showed that significant differences were seen between two groups of children. The mean value of CD3 in patients was (P = 0.005) in comparison with control group and the mean value of CD4 in patients was (P < 0.001) in comparison with control group (Table 3). Although antimycobacterial regimens used for the treatment of patients with 4 drugs, but 8 of the patients died despite aggressive management. Case report: A 04-month-old female patient had a disseminated BCG infection after immunization at birth with BCG sub strain Pasteur vaccine (Manufacturer and batch number unknown). The patient had personal immunodeficiency disorders as severe combined immunodeficiency (SCID) T-B+NK+. The patient had a family history of immunodeficiency and a history of consanguinity. The patient was referred to hospital. The sites of dissemination were urine and liver. The patient died.


VAERS ID: 384205 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-04-02
Entered: 2010-04-05
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Headache, Vaccine positive rechallenge
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: WAES1003USA04772

Write-up: Information has been received from a nurse practitioner concerning a 13 year old female patient who on unspecified dates was vaccinated with three doses of GARDASIL at the nurse practitioner''s previous practice. The patient experienced headache after getting first and second dose of GARDASIL. The patient sought unspecified medical attention. After the third dose of GARDASIL the patient experienced headache and died on the same day. The cause of death was not reported. Additional information has been requested.


VAERS ID: 384216 (history)  
Form: Version 1.0  
Age: 0.55  
Sex: Male  
Location: Foreign  
Vaccinated:2010-03-23
Onset:2010-03-24
   Days after vaccination:1
Submitted: 2010-04-01
   Days after onset:8
Entered: 2010-04-05
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 37392 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Oropharyngeal blistering
SMQs:, Severe cutaneous adverse reactions (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-03-25
   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: Concomitant medications were not reported.
Current Illness: The patient''s concurrent illness includes Ebstein''s anomaly.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: CNWYEG05865110

Write-up: Information regarding PREVENAR was received from a consumer via a regulatory authority regarding a 6-month-old male patient who experienced oral mucosa white blister and death. The patient received a dose on 23-Mar-2010. He died on 25-Mar-2010. The patient with Ebstein''s anomaly received a dose of PREVENAR for immunization on 23-Mar-2010. Then he experienced oral mucosa white blisters next day. The patient died on 25-Mar-2010. On the morning of 30-Mar-2010, the parents reported it to the outpatient department of the hospital where the infant received the vaccination. On the same day around 10 am, District Center for Disease Control and Prevention informed Wyeth sales representative this affair after the healthcare professional in the hospital reported it to be the center. The cause of death was reported as unknown. No additional information was available at the time of this report.


VAERS ID: 384960 (history)  
Form: Version 1.0  
Age: 1.8  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-04-12
Entered: 2010-04-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Haemorrhage intracranial, Idiopathic thrombocytopenic purpura
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Haemorrhagic central nervous system vascular conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1004USA00761

Write-up: Information has been received from a published article, title as stated above. The report summarizes passive surveillance data for adverse events following immunization reported to the Administration for 2008, and describes reporting trends over the 9-year period 2000 to 2008. A 22 month old patient on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (lot number, route and site not reported). 10 days after receipt of the vaccine, the patient was diagnosed with idiopathic thrombocytopenia. 18 days after vaccination, the patient died. The cause of death was reported to be intracranial haemorrhage secondary to idiopathic thrombocytopenia. While temporally related to vaccine administration, no causal relationship had been established. Upon internal review, idiopathic thrombocytopenia was considered to be an other important medical event. Additional information is not expected. The article also discussed some experiences of a 1-year-old child while on therapy with hib conj vaccine and MMR II (WAES # 1004USA00762). A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 384961 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-04-12
Entered: 2010-04-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. - / UNK UN / UN
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: Brain oedema, Death, Encephalitis
SMQs:, Noninfectious encephalitis (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1004USA00762

Write-up: Information has been received from a published article. The report summarizes passive surveillance data for adverse events following immunisation (AEFI) reported for 2008, and describes reporting trends over the 9-year period 2000 to 2008. It reported death of a 12 month old patient who had PEDVAXHIB (manufacturer unknown) (lot number not reported), meningococcal C and MMR II (Lot number not reported). The cause of death was reported to be cerebral oedema due to encephalitis 12 days after receipt of the vaccine, with onset of illness 10 days after vaccination. According to the treating neurologist and pediatrician it was unlikely to be vaccine related. Upon internal review, encephalitis was considered to be an other important medical event. Additional information is not expected. The article also discussed the experience of a patient while vaccinated with varicella vaccine. (WAES #1004USA00761). A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 385407 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Unknown  
Location: Foreign  
Vaccinated:2009-10-01
Onset:2009-10-05
   Days after vaccination:4
Submitted: 2010-04-19
   Days after onset:196
Entered: 2010-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death, Intussusception, Similar reaction on previous exposure to drug, Surgery
SMQs:, Gastrointestinal obstruction (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-05
   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:
Current Illness: Unknown
Preexisting Conditions: INVAGINATION OF INTESTINE
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0647700B

Write-up: This case was reported by a physician and described the occurrence of invagination of intestine in a 4-month-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). Previous vaccination included 1st dose of ROTARIX (GlaxoSmithKline; oral) given on 29 July 2009. After vaccination with 1st dose of ROTARIX, the subject experienced first episode of intestinal invagination (See case B0647700A). On 1 October 2009, the subject received 2nd dose of ROTARIX (oral). On 5 October 2009, 4 days after vaccination with 2nd dose of ROTARIX, the subject experienced a second episode of intestinal invagination. The subject was hospitalised. Surgery was performed and the subject died on the same day at 9:45 PM. The subject died from intestinal invagination caused by vaccination. It was unknown whether an autopsy was performed. The physician considered the event was almost certainly related to vaccination with ROTARIX.


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