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VAERS ID: 428104 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2007-10-29
Onset:2007-11-08
   Days after vaccination:10
Submitted: 2011-07-25
   Days after onset:1354
Entered: 2011-07-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Adverse reaction, Death, General physical condition abnormal, Myopathy, Polymyositis
SMQs:, Rhabdomyolysis/myopathy (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: 2009-03-05
   Days after onset: 483
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1107USA02547

Write-up: Information has been received regarding a case in litigation from a lawyer concerning a 53 year old male who was vaccinated on 29-OCT-2007 with the first dose of HBVAXPRO (lot/batch number not reported). Approximately ten days post vaccination he presented with severe symptoms that lead to hospitalization on 10-JAN-2008; he was discharged on 30-JAN-2008 with diagnosis of myopathy. On 04-SEP-2008 due to aggrevation of his condition, the patient was again admitted to the hospital from which he was discharged with diagnosis of polymyostitis. Successively the patient''s condition kept progressively aggravating requiring further hospitalizations. Patient''s date of death reported 05-MAR-2009 (no further information reported). It was reported that the outcome of the event of polymyostitis was fatal. Case was medically confirmed. No further information is expected.


VAERS ID: 428516 (history)  
Form: Version 1.0  
Age: 0.11  
Sex: Female  
Location: Foreign  
Vaccinated:2011-07-04
Onset:2011-07-04
   Days after vaccination:0
Submitted: 2011-08-01
   Days after onset:28
Entered: 2011-08-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME) / SANOFI PASTEUR 6155 / 1 LL / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER 90380 / 1 RL / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER 65155 / 1 MO / PO
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 RL / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA304RR / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Blood test normal, Bronchopneumonia, Death, HIV test negative, Immediate post-injection reaction, Polymerase chain reaction, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-07-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: cough; crying; distressed; illness; oral thrush; sunken fontanelle
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood test, 04Jul2011, HIV negativeunit; polymerase chain reaction, 04Jul2011, HIV negativeunit
CDC Split Type: B0735986A

Write-up: This case was reported by a representative via a healthcare professional (nurse) and described the occurrence of fatal bronchopneumonia in a 6-week-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline), Hep B vaccine (non-GSK), OPV (non-GSK), (non-GSK) (PREVENAR) and PENTAXIM (non-GSK). The mother''s latest HIV results was positive (test taken during pregnancy). Previous vaccination included BCG vaccine (non-GSK) (unknown route, right arm) and OPV (non-GSK), given on 23 May 2011. The day before vaccination, the infant was very sick and experienced cough, crying, distressed, oral thrush and sunken fontanelle. The subject was taken to a traditional doctor, but it was not clear if any medication was given but on the day of vaccination a strong smell of herbal medication was coming out the baby''s mouth. On 4 July 2011, before the vaccination, the nurse was aware that the infant was not well the day before but the subject was clinically well, so she received 1st dose of ROTARIX (oral), 1st dose of Hep B vaccine (Non-GSK) (intramuscular, right thigh), 1st dose of OPV (Non-GSK) (oral), 1st dose of PREVENAR (unknown, right thigh) and 1st dose of DTPa-Polio-HIB (Non-GSK) (intramuscular, left thigh). On 4 July 2011, immediately after vaccination with ROTARIX, the infant vomited milk from the mouth and nostrils. The baby was not feverish, chest was clear, there was no sign of dehydration and no nasal flaring was observed. A blood test was performed in order to make a polymerase chain reaction test for HIV which was negative. PANADOL and erythromycin were prescribed to treat cough. Herbal medication was given by health education. An half hour later, the mother and the subject left the clinic, the subject was in a satisfactory condition. On 04 July 2011, the subject was discovered dead on arrival at home. Based on the death certificate, the subject died from bronchopneumonia. The healthcare professional considered the events were unrelated to vaccination with ROTARIX, Hep B vaccine (Non-GSK), OPV (Non-GSK), PREVENAR and DTPa-Polio-HIB (Non-GSK). An investigation was opened and the conclusion reached was that death was a coincidence, as the child was experiencing bronchopneumonia.


VAERS ID: 428523 (history)  
Form: Version 1.0  
Age: 0.11  
Sex: Male  
Location: Foreign  
Vaccinated:2011-07-20
Onset:2011-07-21
   Days after vaccination:1
Submitted: 2011-08-01
   Days after onset:11
Entered: 2011-08-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CA972B / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA366CA / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-07-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0735723A

Write-up: This case was reported by a consumer and described the occurrence of death unspecified in a 6-week-old male subject who was vaccinated with INFANRIX HEXA (GlaxoSmithKline), ROTARIX and (non-GSK) PREVENAR 13. A physician or other health care professional has not verified this report. On 20 July 2011, the subject received unspecified dose of INFANRIX HEXA (administration site and route unknown), an unspecified dose of ROTARIX (route unknown) and an unspecified dose of PREVENAR 13 (unknown). On 21 July 2011, 14 hours after vaccination with INFANRIX HEXA, PREVENAR 13 and ROTARIX, the subject experienced death unspecified. The subject died on 21 July 2011, cause of death was not reported. An autopsy was performed. Autopsy results are not yet available. Further information has been expected.


VAERS ID: 428541 (history)  
Form: Version 1.0  
Age: 0.36  
Sex: Female  
Location: Foreign  
Vaccinated:2010-11-05
Onset:2011-01-28
   Days after vaccination:84
Submitted: 2011-07-28
   Days after onset:180
Entered: 2011-08-02
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E48783 / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Meningitis pneumococcal, Streptococcus test positive
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-01-30
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: 30-AUG-2010, first dose at the age of 2 months;Lot number E45165, No adverse event
Allergies:
Diagnostic Lab Data: Pneumococcal serotype identification (date unknown): Serotype 22F
CDC Split Type: 2011033863

Write-up: This is a spontaneous report from a contactable physician via a Pfizer sales representative, with follow-up from the same contactable physician. A 7-month-old female patient received two doses of PREVENAR 13, the first dose at the age of 2 months of age on 30Aug2010, and the second dose on 05Nov2010, at 4-months-old. Relevant medical history was not reported. Concomitant medication was none. On 28Jan2011, the patient visited the doctor''s office. He sent her to the Emergency Unit. A diagnosis of pneumococcal meningitis was made at the hospital on 29Jan2011. On 30Jan2011, at the age of 7 months, the patient died from pneumococcal meningitis. Afterwards, (date unknown) the pneumococcal serotype was identified as 22F, which is not contained in PREVENAR 13. Follow-up received from the reporting physician included: Patient demographics, patient had no relevant medical history, patient was not taking concomitant medications, dates of vaccinations, lot numbers, course of illness, onset date, serotype results. Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of the suspect product. The follow-up information received does not alter the previous company clinical causality evaluation.


VAERS ID: 428955 (history)  
Form: Version 1.0  
Age: 0.27  
Sex: Female  
Location: Foreign  
Vaccinated:1999-03-22
Onset:1999-03-22
   Days after vaccination:0
Submitted: 2011-08-08
   Days after onset:4521
Entered: 2011-08-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Public       Purchased by: Public
Symptoms: Childhood disintegrative disorder, Cyanosis, Death, Dysstasia, Laboratory test, Muscle spasticity, Obliterative bronchiolitis
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Dystonia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1999-03-27
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BCG on 12/14/1998, DTPr 03/22/1999
Current Illness: no
Preexisting Conditions: no
Allergies:
Diagnostic Lab Data: only histogram and bio chemical report
CDC Split Type:

Write-up: died five days after the immunization, diagnosis on 03/26/1999 Bronchiolitis in obs. spastica, her lower part of body was bluish, she coundn''t stay on her legs any more although she stood regularly before, she stopped to smile,


VAERS ID: 429030 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-08-05
Entered: 2011-08-08
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011176609

Write-up: This is a spontaneous regulatory from the foreign Regulatory Authority Monitoring of Adverse Reactions Committee (MARC) meeting minutes. Regulatory Authority number 82290. A patient (age and gender unspecified) received a dose of PREVENAR and a dose of INFANRIX-HEXA on an unspecified date. Relevant medical history, past product history and relevant concomitant medications were not provided. On the unspecified date, the patient suddenly died. Relevant tests were unspecified.


VAERS ID: 429065 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-08-08
Entered: 2011-08-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Bed sharing, Death neonatal, Drug exposure before pregnancy, Drug exposure during pregnancy
SMQs:, Acute central respiratory depression (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-05-27
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MALARONE; Folic acid; Prednisolone; Steroid
Current Illness: Unknown
Preexisting Conditions: Post mortem lab tests showed, Blood results: Sodium at 152, Potassium at 14.2, urea at 6.2, Creatinine at 68, Hb at 2.6, WBC at 3.9, Platelets at 27, MCV at 132, Neutrophils at 1.8%, Carboxyhaemoglobin at 1.2%, Plasma glucose at 18.7, Lactate at 30.5, 3-OH butyrate at 903, Free fatty acids at 208. It was reported that Acycarnitines awaiting, Serum and plasma saved and Toxicology awaiting. Culture results; CSF was blood stained, WBC was 415, Neutrophils 10%, Lymphocytes 90%, red cells 192000, CSF culture Coagulase negative staph, Glucose 2.2 unsuitable protein analysis, Blood cultures no growth, NPA negative for RSV, Influenza A, Influenza B and swine flu, Throat swab normal respiratory tract organisms, Stool negative for culture and parasites, Viral PCR on CSF awaited. It was stated in the department of Paediatrics report that "I presume the raised glucose is a stress response. Baby also received 15 mls of 10% dextrose during resuscitation. The CSF glucose is a little low. We do not know what the resting glucose was in the baby. I wonder if all tests are negative at the conclusion of the PM, including metabolic screens, whether it would be worth considering doing genetic for glut 1 deficiency. Although this is unlikely the phenol of glut 1 is expanding. I spoke to the consultant paediatric neurologist and he would agree even if just a slim possibility. Skin was sent for fibroblast culture so could possibly be used for genetics. These are all post mortem samples so it makes it very difficult to interpret results. The blood acylcarnities and the Guthrie will probably be the most reliable. We also await toxicology. Local report of skeletal survey was normal."
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0679750B

Write-up: This prospective pregnancy case was reported by a physician and described the occurrence of death unknown cause in a 2 day old female neonate who was exposed to MALARONE transplacentally over a unspecified period when her mother was treated for malarial prophylaxis. The neonate was also exposed to HEPATYRIX transplacentally. Concurrent medications included unspecified oral steroids and prednisolone. On 12 July 2010 the 38 year old mother of the neonate was vaccinated with unspecified dose of HEPATYRIX (1 injection: intramuscular). On 19 September 2010 the neonate''s mother started taking MALARONE at 1 tablet daily. The mother''s date of last menstrual period was 11 September 2010 and estimated date of delivery was 17 June 2011. The Neonate was exposed to MALARONE during the first week of gestation, and before conception for HEPATYRIX. On 25 May 2011 at full term (37-42 weeks gestation) the neonate was delivery via normal vaginal delivery. The neonate''s birth weight and APGAR scores were not known. No birth defects were noted. On 27 May 2011 the neonate died cause of death was unknown. This case was assessed as medically serious by GSK. It was reported that on 27 May 2011 the neonate was in bed with mother after a feed and when the mother woke up the neonate had died. The neonate was taken to hospital and pronounced dead at 03:34 on 27 May 2011. It was reported that no specific cause of death could be identified. A post mortem was performed to which some of the results were available. The reporter stated that "I think it unlikely this very sad event was related to exposure to MALARONE in the first week of pregnancy." Post mortem lab tests: Blood results: Sodium at 152, Potassium at 14.2, Urea at 6.2, Creatinine at 68, Hb at 2.6, WBC at 3.9, Platelets at 27, MCV at 132, Neutrophils at 1.8%, Carboxyhaemoglobin at 1.2%, Plasma glucose at 18.7, Lactate at 30.5, 3-OH butyrate at 903, Free fatty acids at 208. It was reported that the Acycarnitines awaiting, Serum and plasma saved and Toxicology awaiting. Culture results; CSF was blood stained, WBC was 415, Neutrophils 10%, Lymphocytes 90%, red cells 192000, CSF culture Coagulase negative staph, Glucose 2.2 unsuitable protein analysis, Blood cultures no growth, NPA negative for RSV, Influenza A, Influenza B and swine flu, Throat swab normal respiratory tract organisms, Stool negative for culture and parasites, Viral PCR on CSF awaited. It was stated in the department of Paediatrics report that "I presume the raised glucose is a stress response. Baby also received 15 mls of 10% dextrose during resuscitation. The CSF glucose is a little low. We do not know what the resting glucose was in the baby. I wonder if all tests are negative at the conclusion of the PM, including metabolic screens, whether it would be worth considering doing genetic for glut 1 deficiency. Although this is unlikely the phenol of glut 1 is expanding. I spoke to the consultant paediatric neurologist and he [Due to memory limitations, the remainder of this text could not be compared.] d he would agree even if just a slim possibility. Skin was sent for fibroblast culture so could possibly be used for genetics. These are all post mortem samples so it makes it very difficult to interpret results. The blood acylcarnities and the Guthrie will probably be the most reliable. We also await toxicology. Local report of skeletal survey was normal." This case is linked to B0679750A (Mother case).


VAERS ID: 429116 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-08-02
Entered: 2011-08-08
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Activated partial thromboplastin time, Antineutrophil cytoplasmic antibody positive, Autopsy, Biopsy artery abnormal, Biopsy skin abnormal, Blood fibrinogen increased, Condition aggravated, Cryptococcosis, Cytomegalovirus infection, Death, Fatigue, General physical health deterioration, Haemoglobin decreased, Headache, Mean cell volume, Microscopic polyangiitis, Platelet count, Pneumocystis jiroveci pneumonia, Pulmonary vascular disorder, Pyrexia, Red blood cell count, Renal impairment, Temporal arteritis, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Pulmonary hypertension (broad), Optic nerve disorders (broad), Vasculitis (narrow), Skin tumours of unspecified malignancy (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (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: No other medications
Current Illness: Renal failure chronic
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Activated partial thromboplastin time, 86.4%; Antineutrophil cytoplasmic antibody, Positive; Biopsy skin, Abnormal, Revealed microscopic polyangiitis with pulmonary involvement and the presence of myeloperoxidase specific anti-neutrophil cytoplasmic antibodies; Blood fibrinogen, 692.7 mg/dL; Haemoglobin, 8.6 g/dl; Mean cell volume, 91.5%; Platelet count, 30.8x10^4; Red blood cell count, 295x10^4/ul; White blood cell count, 6600/ul
CDC Split Type: PHHY2011JP68029

Write-up: Case number PHHY2011JP68029 is an initial spontaneous literature report received on 27 Jul 2011. The authors presented a case of microscopic polyangiitis and giant cell arteritis after influenza vaccination. This report refers to a 67 year old female patient. Her medical history included chronic kidney disease. She was vaccinated with influenza vaccine (strain, manufacturer and batch number: unknown. So, conservatively coded as influenza virus vaccine-unknown INN) on unspecified date. She experienced fever and headache after vaccination. She also presented with worsening of renal function. Temporal artery and skin biopsy were performed and she was diagnosed with giant cell arteritis and microscopic polyangiitis with pulmonary involvement and presence of myeloperoxidase-specific anti-neutrophil cytoplasmic antibodies (MPO-ANCA) were diagnosed. She was treated with prednisolone and symptoms improved. However, 2 months later she presented with general physical weariness. She was diagnosed with pneumocystis pneumonia, cytomegalovirus infection and cryptococcosis. Despite intensive treatment, she died and an autopsy was performed. The authors commented that influenza vaccination can cause different types of vasculitis, microscopic polyangiitis and giant cell arteritis.


VAERS ID: 429117 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-08-08
Entered: 2011-08-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS - / 4 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Fear, Foaming at mouth, Immunoglobulin therapy, Rabies
SMQs:, Convulsions (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Generalised convulsive seizures following immunisation (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-08-05
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Immunoglobulin human anti-rabies
Current Illness: Animal bite
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011CN70402

Write-up: Case number PHHY2011CN70402 is a combined initial and follow-up spontaneous report received from a health care professional on 05 Aug 2011. This report refers to a four and a half years old male patient. He was bitten by a dog 14 days ago and had endured wound around the eye. He was sent to CDC for post exposure treatment after bites where the wound was washed and sterilized. He was immediately vaccinated with the post exposure 5 dose procedure series of RABIPUR vaccine (batch number: unknown) intramuscularly and he also received 800 international units (IU) of immunoglobulin human anti-rabies (HRIG). He had already received three doses of RABIPUR vaccine and was due for the fourth dose of the vaccine on 05 Aug 2011 which could not be administered. On 05 Aug 2011, he was brought to the clinic in the morning by his parents, where he presented with symptoms of scare and foaming at the mouth and died at 5.00 a.m. The doctors diagnosed this reaction as Rabies, however no causality assessment was provided by the reporter.


VAERS ID: 429129 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-08-08
Entered: 2011-08-09
   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: Chemotherapy, Crying, Death, Histiocytosis haematophagic, Life support, Malaise, Measles, Mumps, Pain, Pyrexia, Rash generalised, Respiratory arrest, Rubella, Withdrawal of life support
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Oropharyngeal infections (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Respiratory failure (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1108USA00450

Write-up: This case was identified in a newspaper on 29-JUL-2011 in an article. This case is not medically confirmed. The initial information was reported by a consumer. A male patient (age not reported) received MMR II (manufacturer and batch number not reported) route and site not reported on an unreported date. On an unreported date, one week post vaccination, the patient fell ill with a high temperature and rash over his body which led to hospitalisation. The patient was taken to hospital where the doctors started running tests. The parents were informed that the patient had developed measles, mumps and rubella. They were informed that this was very rare and they were trying to find out how it had happened. The patient was given chemotherapy to try and fight the disease. He was crying in pain. Subsequently, the patient was diagnosed with Hemophagocytic lymphohistiocytosis (HLH) syndrome a rare condition which meant that the patient had virtually no immune system. Even a tiny vaccination could take over his body because he had no way of fighting it. The patient was dying. Two months later, the patient stopped breathing and was put on a life support machine. The doctor informed the parents that he was unlikely to recover. The father decided to have the life support machine turned off and the patient died in his mother''s arms. Other business partner numbers include E2011-04734. No further information is available.


VAERS ID: 429154 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-08-08
Entered: 2011-08-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011176452

Write-up: This is a spontaneous from the foreign Regulatory Authority, Monitoring of Adverse Reactions Committee (MARC) meeting minutes. Regulatory Authority report number 87446. A patient (age and gender unknown) received a dose of PREVENAR and a dose of INFANRIX HEXA on an unspecified date. Relevant medical history, relevant past product history and relevant concomitant medications were not provided. The patient experienced sudden infant death syndrome on an unspecified date. Relevant tests were unspecified. The outcome was fatal. The committee considered the causal association with PREVENAR and INFANRIX HEXA to be unlikely for sudden infant death syndrome.


VAERS ID: 429355 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-08-10
Entered: 2011-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TTOX: TETANUS TOXOID (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Autonomic nervous system imbalance, Death, Intensive care, Muscle spasms, Musculoskeletal stiffness, Nosocomial infection, Opisthotonus, Tetanus, Trismus, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (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:
Current Illness: Abrasions-Arm
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0737949A

Write-up: This case was reported in a literature article and described the occurrence of generalized tetanus in a 78-year-old female subject who was vaccinated with tetanus vaccine (manufacturer unspecified). The subject had recently suffered a superficial right arm abrasion after a fall on her driveway. On an unspecified date, the subject received booster dose of tetanus vaccine (unknown route of administration, unknown site of injection, batch number not provided). It was reported that the subject received appropriate tetanus prophylaxis. More than 10 years after have vaccination with her previous tetanus vaccine booster, the subject experienced trismus, stiff neck and opisthotonos. She was diagnosed clinically with generalized tetanus. Despite appropriate initial management, included documented post-exposure prophylaxis with tetanus vaccination following her fall, the subject had a long protracted intensive care unit admission characterized by intractable muscle spasms, autonomic instability and serial nosocomial infections. Care was withdrawn after 10 week hospitalization given to the subject extremely poor prognosis. The subject died from generalized tetanus. Summary of the literature article: This case marks the first death in the country since 1997. Since the 1970''s, the incidence of tetanus has been less than 10 cases per year. The epidemiology in the developed world is changing such that half of the cases now occur in patients over 65 years. Tetanus immunity is known to wane with age; this case emphasizes the importance of receiving regular tetanus boosters during adulthood in accordance with guidelines. Elderly subjects represent an emerging risk group for tetanus in the developed world. Unanswered questions arising from this case include why there was an apparent vaccination failure and why the clinical course appeared irreversible. Improved public health promotion of maintaining up to date tetanus vaccination in this elderly age group is necessary to prevent future cases of tetanus.


VAERS ID: 430682 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2011-07-29
Onset:2011-08-10
   Days after vaccination:12
Submitted: 2011-08-22
   Days after onset:12
Entered: 2011-08-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS 1898 / 1 UN / IJ

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-08-12
   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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011CN73718

Write-up: Case number PHHY2011CN73718 is a combined initial and follow-up spontaneous report received from a health care professional on 18 Aug 2011. This report refers to a male child. He was bitten by a dog on 29 Jul 2011 and was immediately taken to hospital for post exposure prophylaxis. After cleaning the wounds he was vaccinated with day zero dose of post exposure series of RABIPUR (batch number: 1898) on 29 Jul 2011 according to the protocol. He was later vaccinated with day three and day seven doses of the RABIPUR (batch number 1898) on unspecified dates. At 12 days after first vaccination, he presented with rabies symptoms. He was sent to a local infectious disease. At day 14 after vaccination, he died. No causality assessment was provided by the reporter.


VAERS ID: 430726 (history)  
Form: Version 1.0  
Age: 0.31  
Sex: Female  
Location: Foreign  
Vaccinated:2011-07-09
Onset:2011-07-11
   Days after vaccination:2
Submitted: 2011-08-23
   Days after onset:43
Entered: 2011-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME) / SANOFI PASTEUR - / UNK - / -
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH - / UNK - / -

Administered by: Unknown       Purchased by: Other
Symptoms: Bacterial test negative, Brain injury, Coma, Death, Flatulence, Intensive care, Laboratory test normal, Life support, Pyrexia, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-07-26
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: NO
Allergies:
Diagnostic Lab Data: Meningitis-Negative No salmonella She was not found to have any illness
CDC Split Type:

Write-up: Baby stopped breathing in her sleep and was rushed to the hospital and put on life support. She was in ICU for 16 days. Swollen flatulence, brain damage due to the lack of oxygen, high fever. She was in a Coma.


VAERS ID: 431084 (history)  
Form: Version 1.0  
Age: 0.09  
Sex: Female  
Location: Foreign  
Vaccinated:2011-08-17
Onset:2011-08-17
   Days after vaccination:0
Submitted: 2011-08-24
   Days after onset:7
Entered: 2011-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER 11028A / 1 AR / ID
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB901CD / 2 AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Epistaxis, Mouth haemorrhage, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-08-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding
Preexisting Conditions: Previous vaccination with ENGERIX B pediatric at birth, uneventfully.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0740293A

Write-up: This case was reported by a pharmacist and described the occurrence of sudden death in a 1-month-old female subject who was vaccinated with ENGERIX B PEDIATRIC (GlaxoSmithKline) and (non-gsk) BCG vaccine. Initial and follow-up information received on 17 August 2011 and 18 August 2011 respectively, was summarized together. The subject had no medical history and no relevant family history. The neonate was breastfed (exclusive maternal breastfeeding). Previous vaccination included ENGERIX B PEDIATRIC at birth, uneventfully. Co-suspect vaccination included (non-gsk) BCG vaccine. On 17 August 2011, prior to the vaccination, the clinical examination was unremarkable. At about 9:00 - 9:30 am, the subject received 2nd dose of ENGERIX B PEDIATRIC (intramuscular, unknown arm, batch number AHBVB901CD) and 1st dose of BCG vaccine (batch number 11028A, intradermal, unknown arm). Then she came back home. One and a half hour after receiving the vaccination, the subject was found dead in her sleep (coded sudden death) by her parent, an important mouth and nose bleeding was noticed. No autopsy will be performed. At the time of reporting, investigations were ongoing. Results were pending. The pharmacist considered sudden death was unlikely to be related to vaccination with ENGERIX B PEDIATRIC.


VAERS ID: 431419 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Male  
Location: Foreign  
Vaccinated:2010-12-30
Onset:2011-03-25
   Days after vaccination:85
Submitted: 2011-08-25
   Days after onset:153
Entered: 2011-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS QROLA175A / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Computerised tomogram, Constipation, Death, Intestinal dilatation, Intussusception, Septic shock, Surgery
SMQs:, Acute pancreatitis (broad), Toxic-septic shock conditions (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-04-04
   Days after onset: 10
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: Computerized tomogram, 2011, see text units
CDC Split Type: B0741901A

Write-up: This case was reported by a healthcare professional via another manufacturer (Fiocruz) and described the occurrence of septic shock in a 4-month-old male subject who was vaccinated with ROTARIX (Fiocruz). On 30 December 2010, the subject received unspecified dose of ROTARIX (oral). On 25 March 2011, 85 days after vaccination with ROTARIX, the subject experienced abdominal distension and stop of stool elimination. There was no vomiting. The subject underwent surgery with intussusception reduction, with no bowel perforation. The RX showed an important bowel distension. The subject was treated with ampicillin, GENTAMICIN, metronidazole and surgery. The subject died on 4 April 2011 from septic shock. It was unknown whether an autopsy was performed.


VAERS ID: 431484 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2011-05-17
Onset:0000-00-00
Submitted: 2011-08-25
Entered: 2011-08-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E62906 / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Biopsy lung, Death, Laboratory test, Pneumococcal infection, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Biopsy of lung (unknown date): No results provided. Serotyping (unknown date): 6C
CDC Split Type: 2011193313

Write-up: This is a spontaneous report from a healthcare professional. A 2-month-old male infant patient of unknown race received a dose of PREVENAR 13 as preventive dose 1 on 17May2011 and first SD on 20May2011 (batch/lot number E62906, SN: 2350, sero2: 6C, invac1: 3, InttoVacc1:3). The patient was aged 2 months at onset of Pneumococcal infection. The serotype was determined to be 6C. The patient experienced vaccine failure and died on an unknown date, with no cause of death reported. Biopsy from lung was performed. No results were provided.


VAERS ID: 432269 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2011-07-08
Submitted: 2011-08-26
   Days after onset:49
Entered: 2011-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Death, Gastrointestinal necrosis, Ileectomy, Ileostomy, Intussusception, Peritonitis, Rectal haemorrhage, Septic shock, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Toxic-septic shock conditions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal perforation (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-07-15
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0741808A

Write-up: This case was reported by a healthcare professional via another manufacturer (Fiocruz) and described the occurrence of fatal ileocolic intussusception in a 2-month-old male subject who was vaccinated with rotavirus vaccine (manufacturer unspecified). On an unspecified date, the subject received unspecified dose of rotavirus vaccine (oral). On 8 July 2011, at an unspecified time after vaccination with rotavirus vaccine, the subject experienced vomiting, abdominal distension and rectal bleeding, which was diagnosed as ileocolic intussusception. On 11 July 2011, the subject had ileostomy with resection. After it, the subject experienced septic shock, peritonitis and intestinal necrosis. The subject died on 15 July 2011, cause of death was not reported. It was unknown whether an autopsy was performed.


VAERS ID: 431802 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-08-18
Onset:2011-08-18
   Days after vaccination:0
Submitted: 2011-08-26
   Days after onset:8
Entered: 2011-08-29
   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: Cardiac failure acute, Death, Endotracheal intubation, Respiratory arrest, Sputum retention
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-08-18
   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: Dementia Alzheimer''s type; hypothyroidism; fracture; gastrostomy tube insertion; hospitalisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1108USA02832

Write-up: Initial information has been received from a pharmacist concerning an 80 year old female inpatient with Alzheimer dementia, hypothyroidism, fracture and percutaneous endoscopic gastrostomy (PEG) tube insertion who on 18-AUG-2011 was vaccinated with PNEUMOVAX 23 (route, site, dose and indication not reported). No information on concomitant medication was provided. The patient had originally been in another facility. On an unspecified date, the patient was admitted in the reporting pharmacist''s hospital for short term for the change of PEG tube. On 18-AUG-2011, at 11:00, PNEUMOVAX 23 was vaccinated at the patient''s request. Thereafter, her blood pressure was measured at around noon, which showed no abnormality. At 18:00, sputum sticking sensation was confirmed. At 19:30, sputum sticking sensation was confirmed again. At 20:30, she was found not breathing. At 20:40, respiratory arrest was confirmed. At 21:00, the patient was intubated but there was no response. At 21:30, the patient died of cardiac failure acute. The cause of her death was cardiac failure acute. It was unknown whether autopsy was performed or not. The reporting pharmacist''s comment: The primary physician may not know much about the patient, as it was a short-term hospital admission. The causal relationship is honestly unknown. The reporting pharmacist considered that cardiac failure acute was serious due to death. The reporting pharmacist felt that the causal relationship between cardiac failure acute and PNEUMOVAX 23 was unknown. Additional information has been requested.


VAERS ID: 432925 (history)  
Form: Version 1.0  
Age: 3.2  
Sex: Unknown  
Location: Foreign  
Vaccinated:2011-07-22
Onset:2011-08-22
   Days after vaccination:31
Submitted: 2011-08-31
   Days after onset:9
Entered: 2011-09-02
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK UN / SC
JEVX: JAPANESE ENCEPHALITIS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-08-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011198323

Write-up: This is an initial spontaneous report from a contactable pediatrician through a Pfizer sales representative. A 38-month-old patient (gender unknown) received a single dose of PREVENAR (injection) at 1 DF subcutaneously for immunization on 22Jul2011. The patient also received a single dose of ACT-HIB and a single dose of Encephalitis vaccine both at 1 DF subcutaneously for immunization on 22Jul2011. All drugs were reported as suspect drugs. Relevant medical history was unknown. The patient experienced sudden death on 22Aug2011. The patient died from suspicion of viral myocarditis. The reporting pediatrician classified the event as serious (fatal) and assessed it as unrelated to PREVENAR. Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVENAR.


VAERS ID: 433276 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2011-08-01
Onset:2011-08-01
   Days after vaccination:0
Submitted: 2011-09-06
   Days after onset:36
Entered: 2011-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB907AG / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death neonatal, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Neonatal disorders (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0743541A

Write-up: This case was reported by a health inspector via a foreign Institute and described the occurrence of sudden death in a 3-day-old male subject who was vaccinated with ENGERIX B PEDIATRIC (GlaxoSmithKline) and BCG (non-GSK). The neonate was born at normal term. Concurrent vaccination included BCG (non-GSK) (unknown route of administration) given in August 2011. In August 2011, the subject received 1st dose of ENGERIX B PEDIATRIC (unknown route of administration). In August 2011, 3 days after vaccination with ENGERIX B PEDIATRIC, the neonate was fed by breast-feeding, put to sleep and then died from sudden death. This case was reported with another one (B0743542A). Both male babies, from the same small city, died from sudden death. One on 23 August 2011 and the other on 27 August 2011. At the time of reporting, it was unknown which one died which day. Both were fed by breast-feeding and then were put to sleep and then died. One of them died in bed between the parents. An autopsy of both babies will be made, the SSI will provide follow-up information to GSK as soon as possible. Clarifications obtained on 06 September 2011: In August 2011, the subject received 1st dose of ENGERIX B PEDIATRIC (unknown route of administration) and 1st dose of Tuberculosis vaccine (unknown route of administration, batch number not provided). Both vaccines were reported as suspect.


VAERS ID: 433278 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2011-08-01
Onset:2011-08-01
   Days after vaccination:0
Submitted: 2011-09-06
   Days after onset:36
Entered: 2011-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB907AG / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death neonatal, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Neonatal disorders (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0743542A

Write-up: This case was reported by a health inspector via a foreign Institute and described the occurrence of sudden death in a 3-day-old male subject who was vaccinated with ENGERIX B PEDIATRIC (GlaxoSmithKline) and BCG (non-GSK). The neonate was born at normal term. Concurrent vaccination included BCG (non-GSK) (unknown route of administration) given in August 2011. In August 2011, the subject received 1st dose of ENGERIX B PEDIATRIC (unknown route of administration). In August 2011, 3 days after vaccination with ENGERIX B PEDIATRIC, the neonate was fed by breast-feeding, put to sleep and then died from sudden death. This case was reported with another one (B0743542A). Both male babies, from the same small city, died from sudden death. One on 23 August 2011 and the other on 27 August 2011. At the time of reporting, it was unknown which one died which day. Both were fed by breast-feeding and then were put to sleep and then died. One of them died in bed between the parents. An autopsy of both babies will be made, the SSI will provide follow-up information to GSK as soon as possible. Clarifications obtained on 06 September 2011: In August 2011, the subject received 1st dose of ENGERIX B PEDIATRIC (unknown route of administration) and 1st dose of Tuberculosis vaccine (unknown route of administration, batch number not provided). Both vaccines were reported as suspect.


VAERS ID: 433552 (history)  
Form: Version 1.0  
Age: 0.16  
Sex: Male  
Location: Foreign  
Vaccinated:2011-07-26
Onset:2011-07-27
   Days after vaccination:1
Submitted: 2011-09-07
   Days after onset:42
Entered: 2011-09-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME) / SANOFI PASTEUR G5418 / 1 UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER 9C2911 / 1 UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER G5276 / 2 MO / PO
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH F12271 / 1 UN / UN
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER AROLA245AA / 1 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Bronchopneumonia, Death, Death neonatal, Hypotonia, Increased upper airway secretion, Lung consolidation, Petechiae, Premature baby, Pulmonary oedema, Renal fusion anomaly, Small for dates baby, Subarachnoid haemorrhage neonatal
SMQs:, Cardiac failure (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-07-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Prematurity, Born at 27 weeks and 6 days, Rh negative, normal vaginal delivery, Apgar: 9/10
Allergies:
Diagnostic Lab Data: 29May2011: Apgar score 9/10/10; 25Jun2011: KMC score 20/20; Developmental screening (26Jul2011): general appearance is premature. Skin and eyes, mouth and palate, sucking, genitalia, testes, hips, feet, limb movements, posture, neck, trunk, limbs tone, moro reflex-all reported as normal. Both parents and child born with normal hearing. Child responds to sound. Fixes (birth) and follows (6weeks). Child smiles at caregiver. Observation: caregiver interacts well with child. Caregiver is coping. According to the post mortem (significant findings noted only): Chief findings made by forensic officer on the body: small for age, no external injuries and consolidation of the lungs. The cause of death on the 27Jul2011 at 06g46: bronchopneumonia and prematurity was due to a natural manner. Old subarachnoid hemorrhages of the frontal and temporal lobes infero-medially and the cerebellum superiorly on the left with brown discolouration was probably from the birth process. Small amount of old, brown blood found in the ventricles. Trachea and bronchi contained a small amount of mucus. Visceral surfaces of the right and left lung showed multiple subpleural petechial haemorrhages, no adhesions. The lung tissue of both lungs showed a mottled lower lobe, consolidation of the lower lobe and moderate oedema. A single horse shoe kidney present which appears normal on section.
CDC Split Type: 2011205040

Write-up: This is a spontaneous report received from the Department of Health via a Pfizer employee with additional reporters (nurse, physician) providing information. An 8-week-old male patient received the first dose of PREVENAR (batch number F12271) at 0.5mL, the first dose of PENTAXIM (batch number G5418) at 0.5mL, the first dose of HEPATITIS B VACCINE (batch number 9C291/1) at 0.5mL, the first dose of ROTAVIRUS VACCINE (batch number Arola245AA) at 1.5mls and the second dose of ORAL POLIO VACCINE (batch number G5276) 2 drops oral on 26Jul2011. Relevant past vaccine history included the first dose of BCG VACCINE (batch number 110018A) and the first dose of ORAL POLIO VACCINE (batch number G5276) on 11Jul2011. No concomitant medications were reported. The patient had no previous history of reaction after immunization; it is unknown if there was a history of any allergies in this child''s immunization. The health status of the child was assessed before immunization. There ere no other AEFI''s (adverse events following immunisation) reported from this clinic in the last 30 days (its day 1). Relevant medical history includes: the patient was born premature at 27 weeks and six days and was hospitalized from 29May2011 until 25Jul2011. The weight at birth was 1060g. The weight at discharge was 1540g, length of 41cm and head circumference of 30.5. Developmental screening on day of discharge from hospital (26Jul2011): general appearance is premature. Skin, eyes, mouth and palate, sucking, genitalia, testes, hips, feet, limb movements, posture, neck, trunk, limbs tone, Moro reflex - all reported as normal. Both parents and child were born with normal hearing. Child responds to sound. Fixes (birth) and follows (6weeks). Child smiles at caregiver. Observation: caregiver interacts well with child. Caregiver is coping. On 27Jul2011 at 0600 hours, the mother found the baby flabby/flaccid. The cause of death on 27Jul2011 at 0646 hours was bronchopneumonia, prematurity due to a natural manner. According to the post mortem (significant findings noted only): Chief findings made by forensic officer on the body: small for age, no external injuries and consolidation of the lungs. The cause of death on the 27Jul2011 at 06g46: bronchopneumonia and prematurity was due to a natural manner. Old subarachnoid hemorrhages of the frontal and temporal lobes infero-medially and the cerebellum superiorly on the left with brown discolouration was probably from the birth process. Small amount of old, brown blood found in the ventricles. Trachea and bronchi contained a small amount of mucus. Visceral surfaces of the right and left lung showed multiple subpleural petechial haemorrhages, no adhesions. The lung tissue of both lungs showed a mottled lower lobe, consolidation of the lower lobe and moderate oedema. A single horse shoe kidney present which appears normal on section. Conclusion of report: No evidence of adverse events following immunisation (AEFI) and the medical cause of death was reported as Pneumonia. The seriousness criteria for this event were fatal. The outcome of the event at the time of the report was fatal.


VAERS ID: 434127 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2011-09-01
Onset:2011-09-01
   Days after vaccination:0
Submitted: 2011-09-12
   Days after onset:11
Entered: 2011-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Pneumonia aspiration, 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: 2011-09-05
   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: B0746201A

Write-up: This case was reported by a physician and described the occurrence of fatal aspirative pneumonia in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). In September 2011 (3 days before reporting time), the subject received 2nd dose of ROTARIX (.5 ml, oral). On the same day, the subject also received combined diphtheria, tetanus, whole cell pertussis, hepatitis B and Haemophilus type b vaccine (manufacturer unspecified, vaccine given intramuscularly), live attenuated oral poliomyelitis vaccine (manufacturer unspecified, vaccine given orally) and PREVENAR (non-GSK, given intramuscularly). Less than one week after vaccination with ROTARIX, the subject started to experience fever. His parents brought him to the hospital and the subject died before the arrival. The subject died on 5 September 2011 from aspirative pneumonia. An autopsy was performed and revealed the cause of death. The physician considered the event of aspirative pneumonia was unlikely to be related to vaccination with ROTARIX.


VAERS ID: 434190 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-09-09
Entered: 2011-09-13
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Condition aggravated, 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: Inferior myocardial infarct; Double vessel coronary disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011029706

Write-up: This literature report (initial receipt 30-Aug-2011) concerns a middle aged male patient. The patient had suffered an inferior myocardial infarct 3 months before receipt of the vaccine and was diagnosed with double vessel coronary disease. In 2009, the patient was vaccinated with pH1N1 vaccine. The patient was well when seen approximately 8 hours post vaccination and no other reactions were observed or reported. One day post vaccination, the patient died. The event outcome was fatal. This one report of death was recorded as temporally associated with receipt of pH1N1 vaccine. It is regarded as unlikely that the vaccine had any role in this patient''s death. Cause of death is unknown.


VAERS ID: 434755 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-06-07
Onset:2011-06-07
   Days after vaccination:0
Submitted: 2011-09-16
   Days after onset:101
Entered: 2011-09-19
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-06-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: CHF (chronic heart failure) with LV (left ventricule) dysfunction
Allergies:
Diagnostic Lab Data: No data
CDC Split Type: 201108593

Write-up: Initial report received from the Health Authorities on 13 September 2011 through the company under the reference number GPO-MBP-11-007. Case linked with case 2011-08595, case 2011-08596 and 2011-08598 (same source reporter, INFLUENZA vaccine). A 70-year-old female patient with a medical history of chronic heart failure with left ventricule dysfunction died on 07 June 2011, the day she had received a seasonal INFLUENZA vaccine (manufacturer unknown, batch number, route and administration site not reported) on 07 June 2011. No information was provided on the origin of the seasonal flu vaccine. However, the INFLUENZA vaccine manufactured by GPO-MBP was routinely used in the national vaccination programme. On 07 June 2011, the patient was found lying dead. The physician diagnosed a sudden cardiac arrest. This case was investigated by the regional AEFI committee and was concluded as unlikely related to the vaccine.


VAERS ID: 435057 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: Foreign  
Vaccinated:2011-09-05
Onset:2011-09-07
   Days after vaccination:2
Submitted: 2011-09-16
   Days after onset:9
Entered: 2011-09-21
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CB094A / 1 LG / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F22933 / 1 LG / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Rash macular, Ultrasound scan abnormal
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2011-09-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BEN-U-RON; D-FLUORETTEN
Current Illness:
Preexisting Conditions: 08-JUL-2011, Neonatal jaundice; 08-JUL-2011, Screaming
Allergies:
Diagnostic Lab Data: 08-JUL-2011, Weight, 4 kg; 09-AUG-2011, Weight, 5.43 kg; Audiometry childhood (08Jul2011): without any findings; routine examination (09Aug2011): nutrition Formula Beba Pre, no complications during pregnancy or delivery, good general and nutritional condition, normal development of height, weight and head circumference; skin, heart, lung, pharynx, ear drum, abdomen: without any findings, no hepatosplenomegaly, mild hydrocele right $g left, fixed with eyes, bilateral equal spontaneous motor function, normal muscle tone, Vojta without any findings, traction reaction without any findings, normal head control; BMI (09Aug2011): 16.7; head circumference (09Aug2011): 39 cm; hip sonogram (09Aug2011): left type lla, right la, control examination necessary; physical examination (05Sept2011): small white blotches at mucosa of mouth left, mostly no thrush; hip sonogram (05Sep2011): bilateral type l
CDC Split Type: 2011213588

Write-up: This is a spontaneous report downloaded from the web-portal of the foreign Health Authority. Regulatory Authority report number DE-PEI-PEI2011029271. A 2-month-old male patient received the first dose of PREVENAR 13 (lot number F22933) and the first dose of INFANRIX HEXA (lot number A21CB094A) for vaccination on 05Sep2011. Both vaccines were administered in the thigh via intramuscular route of administration. Relevant medical history included neonatal jaundice which was diagnosed on 08Jul2011. Restlessness was excluded on 08Jul2011. Allergies were not known as family medical history. The patient was completely breastfed and screamed a lot on 08Jul2011. On 09Jul2011, hip dysplasia was excluded. However, on 09Aug2011 hip sonogram revealed left type IIa, right type Ia. A control examination was performed on 05Sep2011 which showed bilateral type I. The mother and a foster mother cared for the patient together because the mother (born on 27Feb1991) was very unsure. Concomitant medications included BEN-U-RON (75mg, frequency unknown), "BENE SUP" (dose regimen unknown) and cholesterol, colecalciferol, BEN-U-RON (dose regimen unknown). On 07Sep2011, the patient died. The cause of death was unknown. An autopsy was performed but the examination was not yet complete and the results were not provided. Other relevant lab test included: Audiometry childhood (08Jul2011): without any findings, routine examination (09Aug2011): nutrition Formula Beba Pre, no complications during pregnancy or delivery, good general and nutritional condition, normal development of height, weight and head circumference; skin, heart, lung, pharynx, ear drum, abdomen: without any findings, no hepatosplenomegaly, mild hydrocele right$g left, fixed with the eyes, bilateral equal spontaneous motor function, normal muscle tone, Vojta without any findings, traction reaction without any findings, normal head control; BMI (09Aug2011): 16.7; head circumference (09Aug2011): 39 cm and physical examination (05Sep2011): small white blotches at mucosa of mouth left, mostly no thrush. No further details were available. This case is being treated according to the foreign Act. No follow-up attempts needed, follow-up automatically provided by PEI.


VAERS ID: 435140 (history)  
Form: Version 1.0  
Age: 0.46  
Sex: Female  
Location: Foreign  
Vaccinated:2010-11-29
Onset:2010-12-01
   Days after vaccination:2
Submitted: 2011-09-16
   Days after onset:288
Entered: 2011-09-21
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Cardiac failure, Cardiomegaly, Constipation, Decreased appetite, Feeling hot, Lung disorder, Malaise, Pneumonitis, Respiratory disorder, Respiratory failure, Resuscitation, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Interstitial lung disease (narrow), 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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-12-01
   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: Premature baby 26 to 32 weeks, Premature, born in 26th week; CPAP and on respirator; Infection after birth
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011215059

Write-up: This is a spontaneous report from a contactable physician via a foreign Medicines Agency, regulatory authority number NO-NOMAADVRE-FHI-2011-12714. A 5-month-old female girl born 14Jun2010 received the first vaccination dose of PREVENAR and INFANRIX-POLIO+HIB on 29Nov2010. Relevant medical history included: She was a premature baby, born in 26th week. Weight at birth was 795 g, and for the first four weeks she needed breathing assistance in form of a respirator and continuous positive airway pressure (CPAP). Except from treatment for an infection after birth, she had been healthy and showed good development by the age of three weeks. Concomitant medications were not reported. A couple of hours after the injections she felt warm. During the next 24 hours, she became increasingly unwell, lost the appetite and the parents suspected that she was constipated. Early night time approximately 36 hours after vaccination, her respiration became irregular. Heart failure, pulmonary failure, sudden death, heart enlarged, pneumonitis and appetite lost were reported as events. It was reported that she had pulmonary changes which might be consisted with chronic pneumonitis in infancy. She died on 01Dec2010 after resuscitation. Cause of death as per post mortem report: death probably due to heart/lung failure. The foreign Medicines Agency assessed the causality between the two suspect products and death as possible. The reporter noted lung disease without association to vaccine could have caused heart failure. Premature infants with additional diseases could be particular susceptible to apnea after vaccination, but should still follow the same vaccination program as full term-born infants. No additional information is available at this time. No follow-up attempts possible. No further information expected.


VAERS ID: 435253 (history)  
Form: Version 1.0  
Age: 9.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-04-28
Onset:2011-05-05
   Days after vaccination:7
Submitted: 2011-09-21
   Days after onset:139
Entered: 2011-09-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3785AA / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Alanine aminotransferase increased, Anuria, Aspartate aminotransferase increased, Blood alkaline phosphatase normal, Bronchospasm, Cough, Dyspnoea, Full blood count, Nausea, Ocular icterus, Pneumonia, Pyrexia, Respiration abnormal, Respiratory failure, Sepsis, Sudden death, Swelling, X-ray
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conjunctival disorders (narrow), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-05-05
   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:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201108735

Write-up: This case report is part of a batch of several hundred reports associated with different products, that was received on 13 September 2011 by sanofi pasteur affiliate in a foreign country, from the "foreign Ministry of Health" (local case reference number BR-BT2011-3685). A 09-year-old female patient, whose medical history and concomitant therapies were not reported, had received her dose of FLUZONE (batch number U3785AA, route and anatomical site of administration not reported) on 28 April 2011. On 05 May 2011, i.e. 7days post-vaccination, the patient experienced sudden unexpected death (intensity classification: severe). The patient presented with dry cough, bronchospasm, chest indrawing, abdominal pain, nausea, fever ($g38 degrees C), difficulty in breathing, "total swelling", conjunctival jaundice and anuria (SIC). The report did not present any information from before or after the vaccination, only about three days before the patient''s death, which occurred in the hospital. Transaminase exams showed GOT 86, GPT 129 and Alkaline Phosphatase 88. Further tests (complete blood count) and X-Ray report were awaited at the time of the report. This event was temporally associated to the vaccine. The death diagnoses were respiratory Failure + Pneumonia + Sepsis. The case was assessed as serious by the Ministry of Health. The patient was hospitalized on unspecified dates. The Ministry of Health classified the adverse events on Coincidence (temporal association). The "causality classification" was inconclusive (the Ministry of Health assessed the causal relationship to the vaccine as unknown). Documents held by sender: none.


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

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

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

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


VAERS ID: 436104 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2011-05-03
Onset:2011-05-04
   Days after vaccination:1
Submitted: 2011-09-26
   Days after onset:145
Entered: 2011-09-28
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3960AA / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anaphylactic reaction, Arthralgia, Completed suicide, Conjunctivitis, Death, Depression, Eye irritation, Face oedema, Headache, Pain in extremity
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Suicide/self-injury (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Corneal disorders (broad), Depression (excl suicide and self injury) (narrow), Conjunctival disorders (narrow), Ocular infections (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201108827

Write-up: This case report is part of a batch of several hundred reports associated with different products, that was received on 13 September 2011 by sanofi pasteur affiliate in a foreign country, from the "foreign Ministry of Health" (local case reference number BR-BT2011-3795). A 62-year-old male patient (born on 08 December 1948), whose medical history and concomitant therapies were not reported, had received his dose of FLUZONE (batch number U3960AA, route and anatomical site of administration not reported) on 03 May 2011. On 04 May 2011, i.e. 24 hours post-vaccination, the patient experienced anaphylaxis with facial oedema, joint pain in the left upper limb, burning eyes, conjunctivitis and moderate headache (intensity classification: not severe). Improvement was seen after receiving antihistamines. On 09 June 2011, the patient''s wife stated that the patient had depression and committed suicide. The Ministry of Health assessed this case as serious. The patient was not hospitalized. The Ministry of Health classified the adverse events on AEFI (Adverse Event Following Immunization). The "causality classification) was confirmed (the Ministry of Health assessed the adverse events as related to the vaccine). Documents held by sender: none.


VAERS ID: 436109 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-05-12
Onset:2011-05-18
   Days after vaccination:6
Submitted: 2011-09-26
   Days after onset:131
Entered: 2011-09-28
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3960AA / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abscess, Cellulitis, Death, Local reaction, Localised infection, Pain, Septic shock, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Toxic-septic shock conditions (narrow), Cardiomyopathy (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-05-22
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported; The patient had underwent an uneventful cardiac catheterization 10 days prior to the vaccination.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201108841

Write-up: This case report is part of a batch of several hundred reports associated with different products, that was received on 13 September 2011 by sanofi pasteur affiliate, from the "Ministry of Health" (local case reference number BR-BT2011-3791). A 77-year-old female patient, whose medical history and concomitant therapies were not reported, had received her dose of FLUZONE (batch number U39601AA, route and anatomical site of administration not reported) on 12 May 2011. The patient had underwent an uneventful cardiac catheterization 10 days prior to the vaccination. On 18 May 2011, the patient experienced severe local reaction with local pain, progressing to local abscess and cellulitis (intensity classification: severe). She developed then septic shock and died on 22 May 2011. The patient initially only received pain medication. When her symptoms worsened, she also received oral antibiotics. This case was still under investigation at the time of the report. A probable local contamination was evoked. Sudden unexpected death was also mentioned. The case was assessed as serious by the Ministry of Health. The patient was hospitalized on unspecified dates. The Ministry of Health classified the adverse events on AEFI (Adverse Event Following Immunization). The "causality classification" was confirmed (the Ministry of Health assessed the adverse events as related to the vaccine). Documents held by sender: none.


VAERS ID: 436272 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2011-05-04
Onset:2011-05-04
   Days after vaccination:0
Submitted: 2011-09-28
   Days after onset:147
Entered: 2011-09-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3829AA / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-05-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Vaccination records showed "7 doses of vaccines (not specified) and one dose of influenza H1N1 vaccine", with no report of adverse reactions. The patient had a medical history of severe arterial hypertension without medical supervision.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201108746

Write-up: This case report is part of a batch of several hundred reports associated with different products, that was received on 13 September 2011 by sanofi pasteur affiliate in a foreign country, from the "foreign Ministry of Health" (local case reference number BR-BT2011-3712). A 65-year-old male patient (born on 20/01/1946), whose medical history and concomitant therapies were not reported, had received a dose of FLUZONE (batch number U3829AA, route and anatomical site of administration not reported) on 04 May 2011. Vaccination records showed "7 doses of vaccines (not specified) and one dose of influenza H1N1 vaccine", with no report of adverse reactions. The patient had a medical history of severe arterial hypertension without medical supervision. On 04 May 2011, one hour post-vaccination, the patient experienced severe malaise and was taken to hospital. He arrived without life. The autopsy was performed but unfortunately "the material could not be analyzed because it arrived contamined" (the Death Verification Service). The cause of death was diagnosed as sudden death of natural causes. The case was assessed as serious by the Ministry of Health. The patient was not hospitalized. The Ministry of Health classified the adverse events as Coincidence (temporal association). The "causality classification" was inconclusive (the Ministry of Health assessed the causal relationship to the vaccine as unknown). Documents held by sender: none.


VAERS ID: 436278 (history)  
Form: Version 1.0  
Age: 0.38  
Sex: Male  
Location: Foreign  
Vaccinated:2011-09-15
Onset:2011-09-15
   Days after vaccination:0
Submitted: 2011-09-28
   Days after onset:13
Entered: 2011-09-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR E1277 / 2 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-09-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient was vaccinated with a first dose of IPV two months ago; no adverse events.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201108726

Write-up: Initial report and follow-up were received through the local affiliate in a foreign country on 19 September 2011 under the local reference number CN2011105, who received the report from a physician. A 4-month-old male patient had received a second dose 0.5 mL intramuscular injection of IMOVAX POLIO, lot number E1277-1 (site of administration not reported) and a first dose of DTP (manufacturer unknown, lot number, route and site of administration not reported) in the morning 15 September 2011. The patient was dead at night on 15 September 2011. The parents refused to take autopsy. Diagnosis and therapy were not reported. The patient had previously received a first dose of IPV two months ago with no adverse events. The patient had no other relevant history and had not received any other concomitant drugs. Outcome: the patient died on 15 September 2011. Documents held by sender: None.


VAERS ID: 436320 (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: 2011-09-29
   Days after onset:585
Entered: 2011-09-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 15801 / UNK UN / UN
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER AFLSA125AA / UNK UN / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1627X / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1109USA02574

Write-up: This fatal case was received from the health authority on 20-SEP-2011 under the reference number GB-MHRA-FLU21073156. This case was medically confirmed. A 34 year old female patient with an unreported medical history and concomitant medication received a dose of PNEUMOVAX 23 (lot#663861/1627X, and batch number NK27050) route and site not reported on 20-FEB-2010. The patient also received a dose of H1N1 influenza vaccine (unspecified) (other manufacturer, batch number AFLSA125AA) and a dose of influenza virus vaccine (unspecified) (other manufacturer, batch number 15801) route and site not reported on 20-FEB-2010. On 20-FEB-2010, the same day as the vaccinations the patient died after she experienced collapse and dilated pupils. After the 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. It was unknown if an autopsy was done. Other business partner numbers include E201105587. No further information is available. A lot check has been initiated.


VAERS ID: 436956 (history)  
Form: Version 1.0  
Age: 0.38  
Sex: Male  
Location: Foreign  
Vaccinated:2011-09-20
Onset:2011-09-21
   Days after vaccination:1
Submitted: 2011-10-04
   Days after onset:13
Entered: 2011-10-06
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CB094A / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F08782 / 2 RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Circulatory collapse, Death, Intensive care, Shock
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: 23-AUG-2011 to 23-AUG-2011, received 1st dose of PREVENAR 13 administered on 23Aug2011, no adverse event. 23-AUG-23-AUG-2011, received 1st dose of INFANRIX-HEXA administered on 23Aug2011, no adverse event
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011229589

Write-up: This is a spontaneous report from a foreign Health Authority. Regulatory Authority report number DE-PEI-PEI2011030856. A 4-month-old male, born on 03May2011, was vaccinated with a second dose of PREVENAR 13 (lot number F08782) intramuscularly into the right thigh along with a second dose of INFANRIX HEXA (lot number A21CB094A) intramuscularly into the left thigh, both vaccines administered on 20Sep2011 for prophylactic vaccination. The patient had received the first doses (in vaccine series) of PREVENAR 13 and INFANRIX HEXA on 23Aug2011, which were well tolerated. Relevant medical history and concomitant medications were not provided. Twenty hours post-vaccination (21Sep2011), the child developed shock with circulatory failure. The events were considered life-threatening. An emergency physician was called and subsequently the child was admitted to the intensive care unit of a hospital. Despite intensive care (treatment not specified), the child died 10 hours after symptom onset (Sep2011, exact day not provided). The reported cause of death was noted as shock and circulatory failure. An autopsy will be performed. Follow-up information has been requested.


VAERS ID: 437104 (history)  
Form: Version 1.0  
Age: 0.09  
Sex: Female  
Location: Foreign  
Vaccinated:2011-08-30
Onset:2011-08-31
   Days after vaccination:1
Submitted: 2011-10-06
   Days after onset:36
Entered: 2011-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS BHBVB720AD / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-08-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Poor hygiene
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0751501A

Write-up: This case was reported by a regulatory authority and described the occurrence of sudden infant death syndrome in a 1-month-old female subject who was vaccinated with ENGERIX B PEDIATRIC (GlaxoSmithKline). Concurrent medical conditions included bad social and hygienic circumstances. She was born on 37th weeks from an uncontrolled pregnancy (7th child). No other illness, she was healthy. On 2 August 2011, the subject was discharged from hospital in good condition, however the mother was quite negligent. Concurrent vaccination included bacillus calmette-guerin vaccine (non-gsk); non-GSK manufacturer; unknown given on 1 August 2011; hepatitis B vaccine recombinant; GlaxoSmithKline; unknown given on 30 July 2011. On 30 August 2011, the subject received 2nd dose of ENGERIX B PEDIATRIC (administration site and route unknown). On 31 August 2011, 1 day after vaccination with ENGERIX B PEDIATRIC , the subject experienced sudden infant death syndrome. She went to sleep at 11pm and she was found dead at 11am. When the physician arrived on 31 August 2011 to the death baby, death marks already shown, he diagnosed the cause of death as sudden baby death. The regulatory authority reported that the event was unrelated to vaccination with ENGERIX B PEDIATRIC. The police autopsy confirmed that the cause of death was sudden baby death, no organs defect or any abnormality detected.


VAERS ID: 437885 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-11-01
Onset:0000-00-00
Submitted: 2011-10-11
Entered: 2011-10-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute disseminated encephalomyelitis, Anaesthesia, Brain stem syndrome, C-reactive protein increased, CSF lymphocyte count abnormal, CSF monocyte count negative, CSF neutrophil count increased, CSF protein increased, CSF test normal, CSF white blood cell count increased, Central nervous system lesion, Cytology normal, Death, Dysarthria, Encephalopathy, Endotracheal intubation, Extensor plantar response, Fatigue, General physical health deterioration, Headache, Hemiparesis, Hemiplegia, Hiccups, Incontinence, Laboratory test normal, Lymphocyte percentage decreased, Malaise, Monocyte percentage, Muscle spasticity, Nausea, Nervous system disorder, Neurological examination abnormal, Neutrophil percentage increased, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal cord abnormal, Plasmapheresis, Pleocytosis, Pneumonia, Quadriplegia, Reflexes abnormal, Respiratory failure, Rheumatoid factor negative, Spinal cord disorder, VIth nerve paralysis, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Haematopoietic leukopenia (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), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Demyelination (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Ocular motility disorders (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Malignant lymphomas (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Past medical history included non-insulin dependent diabetes mellitus type 2, dyslipidemia, hypertension, hypothyroidism and a seronegative arthropathy. She had no other recent illness, history of tuberculosis, or travel history in the preceding 24 months. She had never previously received influenza vaccination.
Allergies:
Diagnostic Lab Data: MRI of the brain and spine: a long segment of T2 hyperintensity extending from the caudal medulla down the entire length of the cervical cord terminating at T6. Spinal cord expansion was present throughout this segment, maximal at C5/C6. Skip lesions were also present through the rest of the spinal cord down into the conus medullaris. Patchy enhancement was present on postgadolinium sequences throughout. The remainder of the brain MRI was within normal limits for her age (non-specific white matter changes). Cerebrospinal fluid (CSF): lymphocytic pleocytosis (white blood cell count of 208/uL), comprised 56% neutrophils, 29% lymphocytes and 15% monocytes, and elevated protein of 911 mg/L. CSF cytology was negative for malignant cells. Comprehensive parainfectious workup and rheumatologic panel were negative apart from an elevated CRP of 37.4 mg/L.
CDC Split Type: 201109459

Write-up: Initial report received on 27 September 2011 via a search of the scientific literature in a foreign country. ABSTRACT: Introduction: Approximately 5% of cases of acute disseminated encephalomyelitis (ADEM) are preceded by vaccination within 1 month prior to symptom onset. This occurs rarely following influenza immunization. Methods: Case presentation and literature review. Results: A 75-year-old woman developed acute disseminated encephalomyelitis within 3 weeks of receiving the seasonal influenza vaccine. The patient subsequently passed away, despite treatment with methylprednisolone and plasma exchange therapy. Conclusions: The literature on post-influenza vaccination encephalomyelitis is limited. The majority of published cases had favourable outcomes following treatment with intravenous methylprednisolone. Given the limited number of cases, no incidence estimates have been published. CASE PRESENTATION: A 75-year-old woman presented in November 2008 with a 20 day history of headache, malaise, fatigue, intractable hiccups, nausea and vomiting. Symptoms began evolving 2 days following receipt of the inactivated seasonal influenza vaccine. The patient developed left hemiparesis 20 days post-immunization (PI) and by 29 days PI had progressed to hemiplegia and hemianesthesia of the left side. She then became encephalopathic and developed brainstem involvement with a left abducens palsy, dysarthria, right hemiparesis, and incontinence. Her neurological exam demonstrated bilateral spastic tone, brisk reflexes and extensor plantar responses. Her past medical history included non-insulin dependent diabetes mellitus type 2, dyslipidemia, hypertension, hypothyroidism and a seronegative arthropathy. She had no other recent illness, history of tuberculosis, or travel history in the preceding 24 months. She had never previously received influenza vaccination. Magnetic resonance imaging (MRI) of the brain and spine demonstrated a long segment of T2 hyperintensity extending from the caudal medulla down the entire length of the cervical cord terminating at T6. Spinal cord expansion was present throughout this segment, maximal at C5/C6. Skip lesions were also present through the rest of the spinal cord down into the conus medullaris. Patchy enhancement was present on postgadolinium sequences throughout. The remainder of the brain MRI was within normal limits for her age (non-specific white matter changes). Her cerebrospinal fluid (CSF) demonstrated lymphocytic pleocytosis (white blood cell count of 208/uL), comprised 56% neutrophils, 29% lymphocytes and 15% monocytes, and elevated protein of 911 mg/L. A comprehensive parainfectious workup and rheumatologic panel were negative apart from an elevated CRP of 37.4 mg/L. CSF cytology was negative for malignant cells. Her clinical and radiologic findings fulfilled published criteria for ADEM. Despite treatment with broad-spectrum antibiotics, acyclovir, methylprednisolone and plasma exchange (7 treatments in 14 days), the patient continued to deteriorate to quadriplegia and required intubation secondary to hypercapneic respiratory failure. She developed pneumonia and passed away 70 days PI. This literature report also contained a table of reported cases of post-influenza vaccination encephalomyelitis/ADEM published since 1982. The cases contained a possible sanofi pasteur influenza vaccine are reported in the following cases: E2005-00990, 2010-00355, 2011-09595, 2011-09626, and 2011-09627.


VAERS ID: 437971 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-10-12
Entered: 2011-10-13
   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: WAES1110USA01164

Write-up: Information has been received from a physician (Local reference # ISR-015-OCT11) who stated that there was a publication approximately two months ago (approximately in August 2011) on a journal concerning 4 patients who were vaccinated with a dose of GARDASIL (dose, route, lot # were not specified). Subsequently, on an unspecified date the patients died (cause of death was unspecified). The physician stated that it was reported on the journal that GARDASIL was withdrawn from the market due to the 4 cases of death. The physician also reported that he also obtained information from a website. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.


VAERS ID: 438638 (history)  
Form: Version 1.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-09-21
Onset:2011-09-22
   Days after vaccination:366
Submitted: 2011-10-17
   Days after onset:25
Entered: 2011-10-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Sepsis
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011DE90135

Write-up: Case number PHHY2011DE90135 is an initial spontaneous report received from a health care professional via a foreign Health Authority (reference number: DE-PEI-PEI2011032831) on 11 Oct 2011. This case refers to a 46-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with influenza virus vaccine (manufacturer and batch number: unknown) on 21 Sep 2010. She developed septicemia on 22 Sep 2011 and died (exact date of death not reported). The event lasted for 3 days. An autopsy was performed. The reporter stated that according to the autopsy report the cause of the death was septicemia, a causal relationship to the vaccination could not be excluded, and poisoning was excluded as cause for the death. The foreign authorities stated that they requested follow up information.


VAERS ID: 438723 (history)  
Form: Version 1.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-09-21
Onset:2010-09-22
   Days after vaccination:1
Submitted: 2011-10-17
   Days after onset:390
Entered: 2011-10-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Sepsis
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2010-09-24
   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: D0073016A

Write-up: This case was reported by a foreign regulatory authority (# DE-PEI-PEI2011032831) and described the occurrence of septicaemia in a 45-year-old female subject who was vaccinated with seasonal Influenza vaccine 2010/2011 ((unspecified), manufacturer unspecified). Information concerning the subject''s medical history and concomitant medication was not provided. Previous vaccination with not further specified vaccines have been well tolerated. On 21 September 2010 the subject received the first dose of seasonal Influenza vaccine 2010/2011 (unspecified) (0.5 ml, unknown). Approximately one day post vaccination with seasonal Influenza vaccine 2010/2011 (unspecified), on 22 September 2010, the subject experienced septicaemia. The reporter considered that the event was life threatening. After three days, on or around 24 September 2010, the subject died from sepsis. An autopsy was performed but the autopsy report was not provided. Poisoning had been excluded. According to autopsy the possibility of a causal relationship of septicaemia and vaccination with seasonal Influenza vaccine 2010/2011 (unspecified) could not be excluded. The foreign regulatory authority has requested further information. At the moment no further information was available.


VAERS ID: 439272 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Foreign  
Vaccinated:2011-10-01
Onset:2011-10-02
   Days after vaccination:1
Submitted: 2011-10-19
   Days after onset:17
Entered: 2011-10-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER AM010C / UNK UN / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK UN / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 10L03A / UNK UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acidosis, Altered state of consciousness, Ammonia increased, Blood glucose increased, Blood test abnormal, Death, Febrile convulsion, Hyperammonaemia, Hyperglycaemia, Pyrexia, Status epilepticus, Sudden infant death syndrome
SMQs:, Liver related investigations, signs and symptoms (narrow), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-10-12
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Blood Test (02Oct2011): revealed mixed acidosis, hyperammonemia, and hyperglycemia. Blood Test (02Oct2011): blood ammonia and glucose levels showed improvement. Blood Test (03Oct2011): acidosis improved 24 hours after visit.
CDC Split Type: 2011245703

Write-up: This is a spontaneous report from a contactable physician through the agency under the Authority I.D. # of PREVENAR 371. A 6-month-old male patient received a dose of PREVENAR (Lot #10L03A) subcutaneously, a dose of DPT subcutaneously, and a dose of ACTHIB subcutaneously on 01Oct2011. Relevant medical history and concomitant medications were not provided. On 02Oct2011, it was suggested that the patient had experienced status epilepticus based on an episode, as well as mixed acidosis, hyperammonemia, and hyperglycaemia indicated by a blood test. Because of these findings, the patient was hospitalized for further examination and treatment on the same day. The patient''s consciousness level gradually improved. The patient had clear consciousness and usual oral feeding was resumed four hours after his visit. Blood ammonia and glucose levels showed improvement in the blood test 12 hours after his visit and acidosis improved 24 hours after his visit. The patient was maintained without worsening of general conditions thereafter, and had successful oral feedings. On 04Oct2011, the patient was discharged from the hospital. The final outcome of the status epilepticus was unknown. On 12Oct2011, the patient experienced sudden death. The cause of the sudden death was not reported. No information was provided regarding whether an autopsy was performed. The reporting physician assessed the events status epilepticus and sudden death as possibly related to PREVENAR. The physician commented as follows: The status epilepticus could be febrile convulsion induced by pyrexia due to the simultaneous vaccinations of PREVENAR, DPT, and ACTHIB or could be a direct adverse reaction to the vaccines. Possible exanthema subitum was considered based on the patient''s age, but without exanthema. Additionally, there was low possibility of convulsion of gastroenteritis origin, since gastroenteritis symptoms were not observed. No follow-up attempts possible. No further information expected.


VAERS ID: 439445 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2011-10-11
Onset:2011-10-14
   Days after vaccination:3
Submitted: 2011-10-20
   Days after onset:6
Entered: 2011-10-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR G1231 / 2 UN / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 10L02A / 2 UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-10-14
   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:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011245679

Write-up: This is an initial spontaneous report based on the information obtained through the agency under the authority ID # of 370 from a contactable paediatrician. A 3-month-old male patient received subcutaneously the second single dose of PREVENAR and ACT-HIB 11Oct2011. On 14Oct2011, the patient developed cardio-respiratory arrest, which resulted in fatal outcome (death). The clinical course was as follows: At 6:30 a.m. of 14Oct2011, the patient''s mother breast-fed the patient. From 7:30 t0 7:40, the mother found the patient not breathing because his nose and mouth were covered with his sister''s body. The patient was taken to the reporting paediatrician''s hospital by ambulance. Although life-saving measure was taken, the patient''s spontaneous circulation did not return. At 8:29 a.m. the reporting paediatrician confirmed the patient''s death. No information was provided whether autopsy was performed. The reporting paediatrician classified the event as serious (death), but the causal relationship was not reported. No follow-up attempts possible. No further information expected.


VAERS ID: 440323 (history)  
Form: Version 1.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-10-24
Entered: 2011-10-26
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK LA / SYR

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Blood culture positive, Body temperature increased, C-reactive protein increased, Chest X-ray abnormal, Clostridial infection, Clostridium test positive, Crepitations, Culture tissue specimen positive, Death, Dysarthria, Gas gangrene, Gastrointestinal disorder, Heart rate increased, Malaise, Microbiology test abnormal, Musculoskeletal pain, Nausea, Oedema, Procalcitonin increased, Pyrexia, Respiratory distress, Septic shock, Skin discolouration, Soft tissue infection, Soft tissue necrosis, Speech disorder, Subcutaneous emphysema
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Toxic-septic shock conditions (narrow), Dementia (broad), Pseudomembranous colitis (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (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? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: lithium; pantoprazole
Current Illness: depression; oesophageal stenosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood pressure, 100/70 mmHg, significant; Body temperature increased, 38.2 degrees C, high; chest x-ray, significant, showed extensive subcutaneous emphysema; c-reactive protein, 305 mg/ml, significant; heart rate, 120 beats/min, high; procalcitonin, 52.7 ng/ml, significant
CDC Split Type: PHHY2011NL91897

Write-up: Case number PHHY2011NL91897 is an initial literature report received on 18 Oct 2011. Authors presented a case of fatal Clostridium septicum gas gangrene in an individual who received the H1N1 influenza vaccine. This report refers to a 71-year-old female patient. Her medical history revealed a depressive disorder and oesophageal stenosis as a result of corrosive ingestion. Her medication comprised only lithium and pantoprazole. She was vaccinated with H1N1 influenza vaccine (manufacturer and batch number: unknown) into her left forearm on an unspecified date. She started feeling unwell one day after receiving the vaccine, complaining of abdominal pain and nausea (without vomiting). Three days after vaccination, she presented to the emergency department of the hospital. During presentation at the hospital. She developed fever, rapidly progressive pain in the left shoulder and blurred speech. At presentation in the emergency room, she was severely ill with a blood pressure of 100/70 mmHg, a pulse rate of 120 beats/min and a temperature of 38.2 C. The patient was in severe respiratory distress. Although the physical examination of her left shoulder region by her general practitioner, two hours before presentation was unremarkable, in the ER she was found to have oedematous, discoloured skin and crepitus, extending from the left shoulder. Laboratory analysis revealed a procalcitonin of 52.7 ng/ml and a C-reactive protein of 305 mg/l. Chest X-ray showed extensive subcutaneous emphysema. The presence of septic shock manifestations and rapidly progressive skin changes raised the suspicion of necrotising soft-tissue infection. Antibiotic therapy was immediately initiated with flucloxacillin, clindamycin and ciprofloxacin. The diagnosis was confirmed during an acute surgical exploration, indicating extensive soft tissue necrosis spreading from the left arm to the back and the contralateral side. Complete debridement was judged impossible. Because of progressive septic shock and lack of treatment options, therapy was discontinued. She died several hours after presentation. Microbiological examination of blood and tissue cultures identified Clostridium septicum as the sole aetiological microorganism. Authors stated that life-threatening skin and soft-tissue infections (SSTIs) are infrequent and difficult to diagnosis. Among gas-forming SSTIs, the pathogens most frequently responsible are Clostridium species. The patients history was unremarkable, apart from the depressive disorder. Particularly, there was no evidence of colorectal cancer or a compromised immune system. Although the initial abdominal pain and nausea in this patient might suggest an intestinal focus, it was more likely that they result from release of clostridial toxins, which had been related to gastrointestinal symptoms. In this patient, fatal gas gangrene of the left shoulder developed three days after intramuscular injection of the H1N1 influenza vaccine in the left forearm, suggesting a causative association. This report emphasized the fulminant evolution of gas gangrene and added influenza vaccination to the list of conditions associated with the risk of gas gangrene development. At the same time, this was the first report on fatal C. septum gas gangrene in an individual who received the H1N1 influenza vaccine.


VAERS ID: 440835 (history)  
Form: Version 1.0  
Age: 1.5  
Sex: Male  
Location: Foreign  
Vaccinated:2010-08-01
Onset:0000-00-00
Submitted: 2011-10-28
Entered: 2011-10-31
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E29195 / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Culture positive, Death, Pneumonia streptococcal, Streptococcus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), 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:
Current Illness:
Preexisting Conditions: Cardiomyopathy chronic; metabolic disorder glycosylation defect; Infantile spasms; developmental delay; AUG-2010 to AUG-2010, therapy regimen changed, the patient previously received three doses of PREVENAR, third dose of PREVENAR (lot number E29195), OCT-2009 to OCT-2009, second dose of PREVENAR (lot number D75997), SEP-2009 to SEP-2009, first dose of PREVENAE (lot number 37658)
Allergies:
Diagnostic Lab Data: Culture (unknown date): Streptococcus pneumoniae, serotype 2
CDC Split Type: 2011260735

Write-up: This is a spontaneous report from a healthcare professional via the contactable Health Protection Agency. A 12-month-old, male patient received the third dose of PREVENAR 13 in Aug2010. Relevant medical history included chronic cardiomyopathy, glycosylation defect, infantile spasms and development delay. The patient was not born prematurely, was born at 40 weeks gestation, and had no history of immunosuppression, malignancy, cerebral spinal fluid leakage, chronic respiratory disease, renal or liver disease, diabetes, cochlear implants, or coeliac disease. Concomitant medications were not reported. Past vaccine history included three doses of PREVENAR with the first dose in Sep2009 (lot number 37658), second dose in Oct2009 (lot number D75997), and third dose on an unspecified date (lot number E29195). On an unspecified date, at the age of 17 months, the patient developed a Streptococcus pneumoniae infection of serotype 2. Vaccination failure was reported. The outcome was unknown. On an unspecified date, the patient died from an unspecified cause. No follow-up attempts possible. No further information expected.


VAERS ID: 440836 (history)  
Form: Version 1.0  
Age: 1.5  
Sex: Female  
Location: Foreign  
Vaccinated:2010-07-01
Onset:0000-00-00
Submitted: 2011-10-28
Entered: 2011-10-31
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E32633 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Cardiac arrest, Cardiomegaly, Chest X-ray abnormal, Condition aggravated, Congenital coronary artery malformation, Culture positive, Death, Heart disease congenital, Pneumococcal infection, Pneumonia, Resuscitation, Streptococcus test positive, Vaccination failure
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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:
Current Illness:
Preexisting Conditions: Heart disease congenital, identified post mortem - Anomalous left coronary artery from the Pulmonary Artery; AUG-2009 to AUG-2009, 1st dose of PREVENAR (D63079); OCT-2009 to OCT-2009, 2nd dose of PREVENAR (D66960); 3rd dose of PREVENAR; Therapy regimen changed, patient previously received three doses of PREVENAR
Allergies:
Diagnostic Lab Data: X-ray (unspecified date) showed some amount of pneumonia and an enlarged heart; culture: serotype 3
CDC Split Type: 2011260759

Write-up: This is a spontaneous report received from a contactable healthcare professional via the health protection agency. A 17-month-old female patient received PREVENAR 13 on an unspecified date in Jul2010 (lot number E32633). Relevant medical history included therapy regimen changed (patient previously received three doses of PREVENAR). Concomitant medications were not provided. Relevant past product history included three previous doses of PREVENAR with dose schedule as follows: 1st dose on Aug2009 (batch number: D63079), 2nd dose on Oct2009 (batch number D66960), 3rd dose received on an unspecified date. The patient was not born prematurely, was born at 39 weeks gestation, no history of immuno suppression or malignancy. There had not been a cerebral spinal fluid leakage, no chronic respiratory disease, no renal or liver disease, no diabetes, no cochlear implants, no coeliac disease. At the age of 17.8 months the patient experienced an pneumococcal infection, serotype 3 reported as vaccination failure. The patient was admitted on an unspecified date with cardiac arrest and was declared dead after failed resuscitation. An x-ray showed an enlarged heart and some amount of pneumonia. The post mortem revealed the patient died from an undiagnosed congenital heart failure of ALCAPA (Anomalous origin of left coronary artery from pulmonary artery). No follow-up attempts possible. No further information expected.


VAERS ID: 440912 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Foreign  
Vaccinated:2011-09-14
Onset:2011-09-20
   Days after vaccination:6
Submitted: 2011-10-31
   Days after onset:41
Entered: 2011-11-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21FA972B / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F04764 / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1392Z / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-09-20
   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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1110USA03947

Write-up: Information was obtained on a request by the company from the agency via a Public Case Detail (local reference # AUS/11/1455, OPR # 289653) concerning a 6 month old male baby who on 14-SEP-2011 was vaccinated with the 2nd dose of ROTATEQ (batch #1392Z, lot # 669077/1392Z) orally, the 2nd dose of INFANRIX HEXA (batch # A21FA972B) intramuscularly in right leg, and the 2nd dose of PREVNAR 13 (batch # F04764) intramuscularly in left leg. Post vaccination mother stated baby was well. No vomiting, diarrhoea or fevers. The child presented by ambulance to hospital on 20-SEP-2011 but was deceased. Sudden infant death syndrome (SIDS) 6 days post vaccinations. The agency assessed the causality as possible. The original reporting source was not provided. The lot check has been initiated. Additional information has been requested.


VAERS ID: 441149 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-10-10
Onset:2011-10-10
   Days after vaccination:0
Submitted: 2011-11-02
   Days after onset:23
Entered: 2011-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA643AA / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Pallor, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-10-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Nutritional supplement
Current Illness: Unknown
Preexisting Conditions: Dementia; Frailty; Pressure sore; No known drug allergies.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0757933A

Write-up: This case was reported by a foreign regulatory authority (# GB-MHRA-ADR 21310327) and described the occurrence of unexplained death in a 78-year-old female subject who was vaccinated with FLUARIX. The subject''s medical history included dementia, frailty and pressure sore. Concurrent medications included unspecified nutritional supplement (Dietary supplement). On 10 October 2011 the subject received an unspecified dose of FLUARIX (0.5 ml, subcutaneous, Batch number AFLUA643AA). On 10 October 2011, on that same day after vaccination with FLUARIX, the subject experienced pallor and was unresponsive to stimuli. It was reported this was not a typical anaphylaxis reaction. Approximately 6 hours after vaccination with FLUARIX, the patient died from an unspecified cause. An autopsy was performed. At the time of reporting the results of the post-mortem examination were unknown. Verbatim Text: Flu jab administered. Family reported patient became pale and lifeless following this. Died 6 hours later. Not typical anaphylaxis reaction. Awaiting results of post-mortem examination to identify definite cause of death.


VAERS ID: 441365 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-10-25
Onset:2010-11-03
   Days after vaccination:9
Submitted: 2011-11-03
   Days after onset:365
Entered: 2011-11-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 AR / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute leukaemia, Cerebral haemorrhage, Coma scale abnormal, Computerised tomogram abnormal, Death, Effusion, Haemoglobin decreased, Headache, Hypertension, Hypokinesia, Hypotension, Intensive care, Mydriasis, Pain in extremity, Platelet count decreased, Purpura, Somnolence, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Haematological malignant tumours (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-11-06
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Computed axial tomography, 04Nov10, Numerous effusions; WBC count, 04Nov10, 500000; WBC count, 04Nov10, 426000; hemoglobin, 04Nov10, 9.5; hemoglobin, 04Nov10, 7; platelet count, 04Nov10, 51000; platelet count, 04Nov10, 45000; Glasgow coma scale, 04Nov10, 13; Glasgow coma scale, 04Nov10, 8
CDC Split Type: WAES1110USA04403

Write-up: Case received from a physician on 24-OCT-2011 and medically confirmed. A 15-year-old female patient received the second dose of GARDASIL (batch number not reported) via intramuscular route in the arm on 25-OCT-2010. On 03-NOV-2010, the patient was seen due to pain in calf and purpuric spots on both legs. The patient was not athletic and had been participating orienterring race the day before, and the physician thought it was a muscle strain. Blood count and differential white count was prescribed. On 04-NOV-2010, the patient experienced headaches and felt drowsy while being in classroom. Her mother picked her up and she remained at home. In the afternoon, her mother had difficulties waking her up. The patient was slow and had difficulties moving. EMU (Emergency Mobile Unit) was called and the patient was led to hospital on 04-NOV-2010. On admission diffuse hemorrhage cerebral and acute leukemia were discovered. White blood cells count was at 500 000. Hemoglobin was at 9, 5 and platelets at 51000. The patient was transferred to intensive care unit where her Glasgow coma scale quickly fell down from 13 to 8. Hemoglobin was at 7, platelets at 45000, white blood cells count at 426000. There was no adenopathy, no tumor. Liver and spleen were normal. CT scan showed numerous effusions. During the night, she experienced an episode of hypertension treated with EUPRESSYL and then hypotension and mydriasis. The patient died on 06-NOV-2010. To be noted that no clinical sign or symptom had been noticed prior to this episode. The patient used to be in good health and was not very often sick. She had received the first dose of GARDASIL via intramuscular route in the arm on 25-AUG-2010 which had been well tolerated. To be noted that the patient''s mother felt guilty and needed to "hold onto" something, including the vaccine. The hospital staff told her that there was no link between the vaccine and the events. Psychological follow-up was still ongoing. It was noteworthy that the general practitioner did not report any link with vaccination. Other business partner numbers included: E2011-06493. No further information is available.


VAERS ID: 441366 (history)  
Form: Version 1.0  
Age: 1.9  
Sex: Male  
Location: Foreign  
Vaccinated:2006-11-01
Onset:2007-01-01
   Days after vaccination:61
Submitted: 2011-11-03
   Days after onset:1766
Entered: 2011-11-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Brain oedema, Death, Infection, Meningitis pneumococcal, Neutrophil function disorder, Pneumococcal infection, Streptococcus test positive, Vaccination failure, Ventriculo-peritoneal shunt
SMQs:, Lack of efficacy/effect (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Immunosuppression, Immune deficiency associated with major neutrophil function defect. Recurrent infections. Extracorporeal membrane oxygenation for severe respiratory distress at birth. Neutrophil function disorder, major neutrophil function defect. Immune system disorder, Immune deficiency.
Allergies:
Diagnostic Lab Data: Sample (Jan2007): Serotype 9V
CDC Split Type: 2011260963

Write-up: This is a spontaneous report from a healthcare professional via the contactable Health Protection Agency. A 23-month-old male patient received the first dose of PREVENAR in Nov2006 (age approximation 21-months). Relevant medical history identified that the patient was included in more than one developmental health risk group. The patient had immunosuppression of immune deficiency associated with major neutrophil function defect, recurrent infections and had received extracorporeal membrane oxygenation for severe respiratory distress syndrome at birth. The patient was not born prematurely. The patient had no homozygous disease. Concomitant medications were not provided, however it was noted that the patient also received prophylaxis antibiotics. At 23-months of age (approximately Jan2007) the patient developed invasive pneumococcal disease (IPD) which was reported as vaccine failure. The patient received 1 vaccine dose prior to IPD. The IPD was listed as serotype 9V in Jan2007. The action taken with PREVENAR in response to the event, was unknown. On an unknown date, it was reported the patient died. The post-mortem stated "VP Shunt" (not further specified). Patient had recurrent Pseudomonas meningitis, EVD inserted, neutrophil function defect, marked cerebral oedema and pneumococcal Meningitis. The reporter noted, the patient''s death may have been attributable to PREVENAR. The reporter stated that this case is a follow up report. However, after extensive duplicate searches of both Argus and S3, this case could not be located in either database and is therefore being treated as an initial report. For this reason, this may be a duplicate of a previously submitted report.


VAERS ID: 441373 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-11-03
Entered: 2011-11-04
   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: Condition aggravated, Death, Pneumonia
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Pneumonia
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1110USA04538

Write-up: Initial information has been received from a family of a patient (sex and age not reported) with a history of pneumonia who was vaccinated with pneumococcal vaccine (indication, injected date, dose and site not reported). No information on concomitant medication was provided. On an unspecified date, the patient developed pneumonia once, and five days after hospital discharge, he/she developed pneumonia again after having received pneumococcal vaccine and died. No information on autopsy was provided. The patient''s family did not assess the causal relationship between pneumonia and pneumococcal vaccine. The patient''s family considered pneumonia to be serious due to death. No further information is available.


VAERS ID: 441374 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Female  
Location: Foreign  
Vaccinated:2008-02-01
Onset:2008-03-01
   Days after vaccination:29
Submitted: 2011-11-03
   Days after onset:1341
Entered: 2011-11-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac arrest, Culture positive, Death, Pneumococcal infection, Pneumonia, Pyrexia, Sepsis, Streptococcus test positive, Vaccination failure, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Congenital abnormality NOS; Polydactyly; Umbilical hernia; Corneal disorder NOS; Ventricular septal defect; Pulmonary stenosis; Chest infection, recently hospitalized; Cleft palate, nasogastrically fed
Allergies:
Diagnostic Lab Data: Culture (Mar2008): Streptococcus pneumoniae, Serotype 6B.
CDC Split Type: 2011260819

Write-up: This is a spontaneous report from a healthcare professional via the contactable Health Protection Agency. A 3-month-old female patient received the second dose of PREVENAR in Feb2008. Relevant medical history included the patient was of the chronic heart disease developmental health risk group and was not born premature. The patient had congenital abnormalities of cleft palate and was nasogastrically fed at home. The patient was also polydactyl, had an umbilical hernia, and a cloudy cornea. Patient also reportedly had ventricular septal defect with mild pulmonary stenosis. The patient was not on antibiotics. Patient had recently been in hospital with chest infection. Patient had small ventricular septal defect, was found in bed vomiting. Concomitant medications were not provided. Past product history included the first dose of PREVENAR in Dec2007. In March of 2008 (at the age of 5-months-old), the patient developed invasive pneumococcal disease (IPD), serotype 6B, reported as vaccine failure. The outcome of pneumococcal infection was unknown. On an unknown date, it was reported the patient developed septicemia, was pyrexial, "chesty", vomiting, and "b/c venous." In April of 2008, the patient died from cardiac arrest. The cause of death was also reported as pneumonia and multiple congenital abnormalities. It was noted that the patient''s death was not attributable to PREVENAR. No follow-up attempts possible. No further information expected. The reporter stated that this case is a follow-up report. However, after extensive duplicate searches of both Argus and S3, this case could not be located in either database and is therefore being treated as an initial report. For this reason, this may be a duplicate of a previously submitted report.


VAERS ID: 441545 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2011-01-12
Onset:2011-10-22
   Days after vaccination:283
Submitted: 2011-11-04
   Days after onset:13
Entered: 2011-11-07
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / IJ

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-10-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Dialysis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1110USA03615

Write-up: Initial information has been received from a physician concerning a 79 year old patient (sex not reported) receiving dialysis who on 12-JAN-2011 was vaccinated with PNEUMOVAX 23, injection drug (injection site and dose not reported), and on 20-OCT-2011 was revaccinated PNEUMOVAX 23, injection drug, 0.5 ml once a day (injection site not reported). No information on concomitant medication was provided. Around 22-OCT-2011 (also reported as 22-OCT-2011), the patient died 2-3 days after vaccination. The cause of death was unknown. No information on autopsy had been provided. The reporting physician considered that the death was serious due to death. The reporting physician did not assess the relationship of death to pneumococcal vaccine. Additional information has been requested.


VAERS ID: 442224 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-11-10
Entered: 2011-11-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Acute respiratory distress syndrome, Death, Influenza, Influenza A virus test positive, Influenza like illness, Live birth
SMQs:, Interstitial lung disease (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Normal pregnancy conditions and outcomes (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Polymerase chain reaction, Positive, H1N1 influenza virus infection
CDC Split Type: PHHY2011TR098288

Write-up: Case number PHHY2011TR098288 is an initial literature report received on 04 Nov 2011. The authors discussed about maternal deaths associated with H1N1 influenza virus infection. This report refers to an adult female patient. She was vaccinated with H1N1 pandemic vaccine (manufacturer and batch number: unknown) on unspecified date. It was unknown that whether the patient was pregnant at the time of vaccination. She delivered a full term live infant on unspecified date. The patient experienced influenza like symptoms within one week after vaccination (after delivery). She was diagnosed with confirmed H1N1 influenza virus infection using reverse transcriptase-polymerase chain reaction. The patient later developed acute respiratory distress syndrome/illness and died on unspecified date. The medical record/death certificate listed H1N1 influenza as an underlying cause of death. The authors commented that H1N1 vaccines become effective only after 21 days after vaccination. This 3-week interval between vaccination and an effective immune response to H1N1 influenza may explain the death of the patient who is only vaccinated 1 week prior to onset of the symptoms.


VAERS ID: 442626 (history)  
Form: Version 1.0  
Age: 0.22  
Sex: Female  
Location: Foreign  
Vaccinated:2011-10-13
Onset:2011-10-21
   Days after vaccination:8
Submitted: 2011-11-15
   Days after onset:25
Entered: 2011-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Diarrhoea, Pyrexia, Sepsis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-10-21
   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: Cold; Premature birth
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0762668A

Write-up: This case was reported by a pharmacist and by another health professional and described the occurrence of fever in a 3-month-old female subject who was vaccinated with INFANRIX HEXA (GlaxoSmithKline), ROTARIX and PREVENAR (non-gsk). The subject was a premature baby. Concurrent medical conditions included cold. On 13 October 2011, the subject received 1st dose of INFANRIX HEXA (route and injection site unknown, batch number not provided), 1st dose of ROTARIX (route unknown, batch number not provided) and 1st dose of PREVENAR (route and injection site unknown, batch number not provided). On 21 October 2011, 8 days after vaccination with INFANRIX HEXA, PREVENAR and ROTARIX, the subject experienced fever and diarrhea. The subject was hospitalised. The subject died in the night 21 and 22 October 2011 from septicemia. It was unknown whether an autopsy was performed. The subject''s twin sister had received the same vaccination without problem.


VAERS ID: 443557 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-11-22
Entered: 2011-11-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Bladder cancer, Death
SMQs:, Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: acute coronary syndrome
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011TH100690

Write-up: Case number PHHY2011TH100690 is an initial literature case received on 15 Nov 2011. Authors stated that INFLUENZA vaccination reduces cardiovascular events in patients with acute coronary syndrome. They did a prospective randomized open with blinded endpoint (PROBE) study in patients who had been admitted due to acute coronary syndrome (ACS) within 8 weeks during Nov 2007 to Oct 2008. Total of 439 patients (age: 65 +/- 9 years) were recruited into this study, of which 221 patients were randomized to vaccine group and 218 patients were randomized to the control group. The median time of follow-up was 360 (range 3-365) days. All patients received standard ACS care, including coronary revascularization, as determined by the primary cardiologist. This case refers to a patient of unknown age and gender who was randomized to vaccine. group. The patient''s medical history included acute coronary syndrome (ACS). The patient was vaccinated with single-dose intramuscular injection of split, inactivated INFLUENZA (manufacturer and batch number: unknown) at a dose of 0.5 mL on an unknown date. On an unknown date the patient died of bladder carcinoma. Authors concluded that this study demonstrated a significant reduction in major adverse cardiovascular event (MACE) in ACS patients receiving the INFLUENZA vaccine compared with controls. It was also stated that addition of INFLUENZA vaccination to standard treatment for an acute coronary syndrome reduced major cardiovascular events.


VAERS ID: 444068 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Female  
Location: Foreign  
Vaccinated:2011-11-17
Onset:2011-11-19
   Days after vaccination:2
Submitted: 2011-11-24
   Days after onset:5
Entered: 2011-11-30
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 11B01A / UNK UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-11-19
   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:
Preexisting Conditions: Weight gain poor, noted at the 1 month old check-up
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011283697

Write-up: This is a spontaneous report obtained from a contactable pharmacist through a Pfizer sales representative. A 2-month-old female patient received a dose of PREVENAR injection (lot number 11B01A) subcutaneously for immunization on 17Nov2011. Past vaccine history included a dose of ACT-HIB subcutaneously for immunization on 10Nov2011. Relevant medical history included poor weight gain noted at the 1 month of age check-up. Concomitant medications were not provided. On 19Nov2011, the patient experienced cardio-respiratory arrest. The patient was subsequently carried to the reporting hospital for resuscitation for over 1 hour but died due to asphyxia from regurgitated matter. The reporting pharmacist classified the event cardio-respiratory arrest as serious (fatal) and assessed it as possibly related to PREVENAR. The information available in this report is limited, and does not allow a medically meaningful assessment of the case. Additional information has been requested. Clinical evaluation is postponed after receipt of follow-up information. The impact of this report on the benefit/risk profile of PREVENAR is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


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

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Blood culture positive, Death, Depressed level of consciousness, Haemodynamic instability, Infection in an immunocompromised host, Intensive care, Meningococcal sepsis, Neisseria test positive, Pyrexia
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (narrow), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: mycophenolate; prednisone
Current Illness: systemic lupus erythematosus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: blood culture, significant, NmX was isolated in the blood cultures
CDC Split Type: PHHY2011ES103853

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


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

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

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

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


VAERS ID: 444263 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Foreign  
Vaccinated:2011-11-18
Onset:2011-11-18
   Days after vaccination:0
Submitted: 2011-12-01
   Days after onset:13
Entered: 2011-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IJ
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Adrenal haemorrhage, Agonal rhythm, Autopsy, Blood pressure decreased, Cardiac arrest, Coma, Corneal light reflex test normal, Cyanosis, Death, Diarrhoea, Disseminated intravascular coagulation, Heart rate increased, Hyperthermia, Mechanical ventilation, Meningitis, Meningococcal bacteraemia, Nausea, Neisseria test positive, Nephrogenic anaemia, Peripheral coldness, Pupillary light reflex tests normal, Purpura, Rash generalised, Resuscitation, Toxic shock syndrome, Vomiting, Waterhouse-Friderichsen syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Toxic-septic shock conditions (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-11-19
   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: Unknown
Preexisting Conditions: Acute rhinitis; Atopic dermatitis
Allergies:
Diagnostic Lab Data: Body temperature, 18Nov2011, 38Deg. C; Heartbeats increased, 19Nov2011, 160beats/min; Pressure arterial decreased, 19Nov2011, 0mm Hg; Pupillary light reflex tests, 19Nov2011, positive; Respiratory rate, 19Nov2011, 60movement/min
CDC Split Type: B0764819A

Write-up: This case was reported by a physician from a distributor company and described the occurrence of toxic shock infection in a 24-month-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). The subject''s medical history included acute rhinitis (mild course) and atopic dermatitis of alimentary genesis (mild course). Concurrent medications included OPV (Non-GSK). On 18 November 2011 at 11:00 AM, the subject received unspecified dose of INFANRIX (0.5 ml, unknown injection site). On 18 November 2011 at 3:00 PM, 4 hours after vaccination with INFANRIX, the subject experienced hyperthermia (38 Deg. C). The subject was treated with NUROFEN. At 06:00 PM, 7 hours after vaccination with INFANRIX, the subject experienced nausea and vomiting. Body temperature diminished and the subject fell asleep. Within unspecified hours of vaccination with INFANRIX, the subject experienced acute meningococcemia. On 19 November 2011 at 02:10 AM, 15 hours after vaccination with INFANRIX, the subject experienced diarrhea and body rash. At 03:00 AM, 16 hours after vaccination with INFANRIX, an ambulance came: the body temperature was 36 Deg. C, the frequency of heartbeats was 160 per minute, the frequency of respiratory movements was 60 per minute, arterial pressure was 0 mm Hg, pupillary reflex was positive, corneal reflexes were normal, the meningeal symptoms were negative. The terminal status was coma. The subject experienced cyanosis of skin, cold skin and massive polymorph haemorrhagic rash on the body (legs, arms, buttocks). Heart sounds were dull. At 04:00 AM, 17 hours after vaccination with INFANRIX, the subject was admitted to the infective department of the hospital. The status was agonal and the diagnosis was a meningococcal infection: meningococcemia, meningitis, infective-toxic shock stage III, Waterhouse-Friderichsen syndrome, disseminated intravascular clotting syndrome and brain coma. At 04:07 AM, the subject experienced cardiac arrest. Resuscitation was done and the child was under pulmonary artificial ventilation. At 04:32 AM, the subject was biologically dead. The preliminary conclusion of the group of operative reaction (health professionals) was: the acute meningococcemia with fulminant course in post-vaccinal period was temporarily concordant with vaccination and was not related with vaccination. On 14.11.2011 parents celebrated subject''s birthday. 12 guests were present. All contact persons were investigated now. Follow-up information received on 28 November 2011: The subject died on 19 November 2011 from meningococcemia, toxic shock infection and Waterhouse-Friderichsen syndrome. An autopsy was performed and the results were: the skin was clean, with total acrocyanosis with singular haemorrhagic elements on the feet, legs and in trigonum inguinale. The expressed blood filling of spleen was without pulp scrap. Expressed blood filling of piramides and anemia of renal cortex. Massive haemorrhages in adrenal glands without differentiation of layers. Bacteriologic investigation of the autopsy material from the nasopharynx found Neisseria meningitides, and this result was proved with the investigation with microbiologic analyser. The causes of the death were Infectional-toxic shock, Waterhouse-Friderichsen syndrome and Acute meningococcemia. The fulminant course of the disease, the results of autopsy, positive results of meningococcemia and positive results for Neisseria meningitides during bacteriologic investigation of members of family were the evidences of meningococcemia in the subject which concurred with the same time of vaccination. The cause-effect relation between the subject''s death and vaccination was absent.


VAERS ID: 444237 (history)  
Form: Version 1.0  
Age: 0.26  
Sex: Female  
Location: Foreign  
Vaccinated:2011-11-12
Onset:2011-11-13
   Days after vaccination:1
Submitted: 2011-11-28
   Days after onset:15
Entered: 2011-12-02
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Depressed mood, White blood cell count normal
SMQs:, Depression (excl suicide and self injury) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-11-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical history included a cough before vaccination (on date reported as "13-Feb-2011"). No concomitant medications.
Allergies:
Diagnostic Lab Data: 13-NOV-2011: WBC 16x10^9/L
CDC Split Type: 201111529

Write-up: Initial report received on 14 November 2011 from a health professional (physician) via a local affiliate under the reference number CN2011130. A 3-month-old female patient, whose medical history included a cough before vaccination (on date reported as "13-Feb-2011") and who had no concomitant medications, received a first 0.5 ml dose of ACT-HIB (lot number not reported) on 12 November 2011. On 13 November 2011, the patient experienced "low spirit". The patient died at almost 10:00 p.m. on 13 November 2011 while in the hospital. Lab test results included WBC 16x10^9/L (ref. 4-10x10^9/L) and Pulse 170/min on 13 November 2011. No other information was provided. Documents held by sender: None.


VAERS ID: 444238 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2011-11-10
Onset:2011-11-19
   Days after vaccination:9
Submitted: 2011-12-01
   Days after onset:12
Entered: 2011-12-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-11-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No medical history (including allergy); No concomitant drug
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201111390

Write-up: Case received from the Health Authorities through the local affiliate on 21 November 2011 under no reference number (local reference number A201100671). A 02-month-old female patient (body weight 3.488 kg), with no medical history (including allergy) and no concomitant drug, had received her subcutaneous dose of ACT-HIB, batch number unknown, on 10 November 2011. She had also received her dose of PREVENAR (other manufacturer, batch number unknown) on 17 November 2011. On 19 November 2011, the patient was brought to the hospital due to cardio-respiratory arrest. She received resuscitation for more than 1 hour, however she died on 19 November 2011. To be noted that an inadequate weight gain was noted at the 1 month check-up. Physician''s comment: Although this case is probably considered to be unrelated to the vaccinations, the physician reported it because the cause of death was unclear. According to the reporting physician, the case was serious and not related to ACT-HIB. Documents held by sender: none.


VAERS ID: 444240 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-12-01
Entered: 2011-12-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / IM
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cyanosis, Death, Pyrexia, Rash generalised
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Nasopharyngitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011291526

Write-up: This is a spontaneous report from a consumer/non-healthcare professional (a local television news agency reported via the agency''s website). A 2.5-month-old female patient received a dose of PREVENAR 13 (Unknown), a dose of INFANRIX and a dose of ROTARIX in mid Oct2011. Relevant medical history included the patient had nasopharyngitis ongoing. Concomitant medications and past product history were not reported. Three days after the vaccinations the patient experienced high fever and was hospitalized. During the night the patient died. The cause of death was unknown. It was reported the whole body was covered with blue spots. The outcome of pyrexia and body covered with blue dots was unknown. It is unknown whether an autopsy was performed. An investigation is ongoing.


VAERS ID: 445105 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-12-08
Entered: 2011-12-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Death, General physical health deterioration, Hyperpyrexia, Malaise
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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011IT106515

Write-up: Case number PHHY2011IT06515 is an initial spontaneous report received from a health care professional on 02 Dec 2011. This report refers to 53-year-old male patient. He was vaccinated with INFLUENZA (manufacturer and batch number: unknown) on an unspecified date. After vaccination, he developed sudden malaise and hyperpyrexia from an unknown date. He was hospitalized in the infective ward of a local hospital. His condition worsened and he died after a few days. Cause of death was not reported. The causality was not reported.


VAERS ID: 445404 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-11-16
Onset:2011-11-23
   Days after vaccination:7
Submitted: 2011-12-13
   Days after onset:20
Entered: 2011-12-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1577Z / UNK UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-11-23
   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: MOHRUS
Current Illness: Osteoporosis; Hypertension
Preexisting Conditions: Craniotomy
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1112USA01111

Write-up: Information has been received from a physician concerning a 78 year old female patient with hypertension, osteoporosis and a history of craniotomy who on 16-NOV-2011 was subcutaneously vaccinated with a dose of PNEUMOVAX 23 (batch number: 9MN01R; lot number: 670142/1577Z) (injection site and dose not reported). Concomitant medications included MOHRUS TAPE (There was a possibility that other medications had been prescribed by a neurosurgery hospital). On 23-NOV-2011, the patient was found dead at home. No information on autopsy was provided. An autopsy seemed to have been performed after her death but details were unknown because the autopsy was not performed at the reporting physician''s institution. There was no further information. The reporting physician felt that sudden death was definitely related to PNEUMOVAX 23. The reporting physician considered sudden death to be serious due to death. A standard lot check investigation has been finalized. All in-process quality checks for lot number 670142/1577Z were satisfactory. The lot met the requirements of the Center for Drug Evaluation and Research and was released. Additional information has been requested.


VAERS ID: 445745 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-11-01
Onset:2011-11-06
   Days after vaccination:5
Submitted: 2011-12-16
   Days after onset:40
Entered: 2011-12-19
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1577Z / 1 UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-11-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Hypertension; Dementia Alzheimer''s type
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood pressure measurement, 01Nov11, 135 mmHg, systolic pressure; Blood pressure measurement, 01Nov11, 72 mmHg, diastolic pressure; Body temp, 01Nov11, 35.1 C; Total heartbeat count, 01Nov11, 73 /min
CDC Split Type: WAES1112USA01110

Write-up: Information has been received from a physician concerning an 83 year old female patient. She had hypertension (blood pressure levels: fluctuated between 100/50 and 148/85, and no accompanying symptoms such as renal disorder and cerebrovascular disorder) and dementia Alzheimer''s type (because the patient was living by herself and had considerably progressed dementia, her drug compliance was not good and her neighbor was supporting her hospital visit and daily living) but had no specific health problems and was very well. On 01-NOV-2011 the patient visited the hospital for vaccination and was subcutaneously vaccinated with the first 0.5 ml dose of PNEUMOVAX 23 (lot number 670142/1577Z, batch number 9MN01R) once a day (injection site not reported). Influenza vaccine was injection in 2010 but there was no record of receiving vaccine in 2011 and there was no other vaccine injected at the same time or in recent days. There was no other concomitant medication. The patient was prescribed ARICEPT and AMLODIPIN on 29-JUN-2011 but was not taking them, therefore, there was a possibility that blood pressure control was poor (the prescription was not covered until November, so the patient did not take the medication but there was no specific problem). On 01-NOV-2011 blood pressure on the day of PNEUMOVAX 23 was 135/72, pulse was 73, body temperature was 35.1 degree C and no arrhythmia, etc. (measured by devices). No problem was found on preliminary examinations and PNEUMOVAX 23 was injected. The patient was followed up for 30 minutes after injection but no symptoms such as urticaria or anaphylaxis appeared. On 06-NOV-2011 the patient, who was living along but had good relationship with neighbors and contacted each other on the previous day as well, was found dead at home on this day. Since sushi took on the previous day was left untouched there was also a possibility that she had poor health condition from the previous day. No information on autopsy was provided. An autopsy seemed to have been performed after her death but details were unknown because the autopsy was not performed at the reporting physician''s institution. There is no further information about patient''s background and no further information about cause of her death could be obtained either. Physician''s comment: The cause of death is unknown but since outdoor temperature suddenly cooled down, there is a possibility of myocardial infarction. Another patient also died about one week after vaccination, which gave me feeling of uneasiness. The causal relationship is unknown. The reporting physician felt that the causal relationship between sudden death and PNEUMOVAX 23 was unknown. The reporting physician considered sudden death to be serious due to death. A standard lot check investigation had been finalized. For details refer to the Form for lot check results. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.


VAERS ID: 445893 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-12-19
Entered: 2011-12-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (CSL)) / CSL LIMITED - / UNK UN / UN
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011030534

Write-up: This literature report (initial receipt 10-Dec-2011) concerns patients who were vaccinated with H1N1 or seasonal influenza vaccines (WAVES 2011030535) from 01-Jul-2009 through 31-Jan-2010 and reported to VAERS (Vaccine Adverse Event Reporting System). There were 42 deaths reported following H1N1 vaccine. Of these, 18 (43%) were male, median age was 49.5 (range 1 - 94) and the median onset interval from vaccination to adverse event was 3 days (range 0 - 55). There were 7 death reports where the patient also received season influenza and H1N1 vaccination on the same day. The reported cause of death category after inactivated vaccine record review were cardiac (20), infectious (8), multiple systems (5), neurologic (4), motor vehicle accident (1), pregnancy complication (1), respiratory (1) and unknown (2). Underlying medical conditions and risk factors for cardiovascular disease were present among 94% (45/48) of the patients who died following live attenuated and inactivated H1N1 vaccination. In some cases the cause of death was clearly unrelated to vaccination (e.g. meningococcal sepsis, ruptured aortic aneurysm). No deaths from anaphylaxis were reported. There were 99 verified reports of GBS (Guillain-Barre syndrome) reports, 86 following inactivated and 12 following live, H1N1 vaccinations (1 unknown type). Of the 99 verified GBS reports, 93 had symptom onset within 42 days following vaccination; the distribution by onset interval (day of vaccination to onset of symptoms) was: 26, week 1 (22 on day 0-4); 27, week 2; 12, week 3; and 28, weeks 4 - 6. Twenty-four of the verified GBS cases had received seasonal influenza vaccine on the same day or within 30 days of the H1N1 vaccine. Reporting rate of verified GBS reports within the 42 day window were .42 and 1.75 per million H1N1 vaccinations for age <25 years and age $g or = 25 years, respectively. Of the 86 GBS reports following inactivated H1N1 vaccinations, 48 (56%) were male, median age was 55 years (range 1 - 83). Of these 86 reports, median onset interval from H1N1 vaccination to GBS was 13.5 days (range 0 - 71). Thirteen (15%) of the 86 cases had same day seasonal influenza and H1N1 vaccination. The author also verified 117 reports of anaphylaxis, 101 following inactivated and 15 following live, attenuated H1N1 vaccinations (1 unknown type). Sixty-nine (60%), 34 (29%) and 13 (11%) occurred <1, 1 - 4 and 5 - 24 hours following vaccination, respectively (1 unknown). The reporting rate for verified anaphylaxis was 1.4 per million H1N1 vaccinations (1.6 per million inactivated and 0.9 per million live, attenuated vaccines). Of the 101 anaphylaxis reports following inactivated H1N1 vaccinations, 31 (30%) were male, median age was 30 years (range 1 - 82). Of these 101 reports, median onset interval from H1N1 vaccination to anaphylaxis was 0 day (range 0, 0). Fifteen (15%) of the 101 cases had same day seasonal influenza and H1N1 vaccination. The event outcome was not reported.


VAERS ID: 446452 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2011-10-06
Submitted: 2011-12-29
   Days after onset:84
Entered: 2011-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Gestational hypertension, Intra-uterine death, Maternal exposure during pregnancy
SMQs:, Hypertension (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0770833A

Write-up: This retrospective pregnancy case was reported by the Agency (# GB-MHRA-EYC 00077010) and described the occurrence of intrauterine death in a neonate subject of unspecified gender whose mother was vaccinated with influenza virus vaccine during pregnancy. On an unspecified date the subject''s 29 year old mother received unspecified dose of Influenza virus vaccine. The date of the mother''s last menstrual period was 2 January 2011; the estimated date of delivery was unknown. The neonate was exposed to Influenza virus vaccine at an unknown number of week''s gestation. On 6 October 2011, at an unspecified time after exposure to Influenza virus vaccine, the subject experienced intrauterine death. It was reported that the neonate was "slightly small for gestational age". It was also reported that the neonate was "term". The regulatory authority reported that the event was congenital anomaly. The neonate died, cause of death is not specified. It was stated that post mortem showed gestational hypertension. Verbatim Text: Patient raised this as a possible cause for her stillbirth. The baby was at term, was slightly small for gestational age and the mother had mild gestational hypertension. Serious consequences for the parents.


VAERS ID: 446703 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2011-12-21
Onset:2011-12-21
   Days after vaccination:0
Submitted: 2012-01-03
   Days after onset:13
Entered: 2012-01-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR G0478 / 1 AR / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac arrest, Death, Feeling cold, Mydriasis, Peripheral coldness, Unresponsive to stimuli
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), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-12-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient was vaccinated with one dose of BCG and two doses of Hepatitis B with no adverse events.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201112498

Write-up: Case received from a health professional through the local affiliate on 22 December 2011 under the local reference number CN2011136 (HA number 410181-2011-0004). A two-month-old male patient, with no reported medical history, no concomitant medications and was previously vaccinated with dose one of BCG and two doses of Hepatitis B with no adverse events, had received at 15:03 on 21 December 2011 his 1st 0.5ml intramuscular deltoid injection of IMOVAX POLIO, lot number G0478-1 (side of administration not reported). According to the report, before vaccination the patient was sleeping. The mother stated that the baby had fallen asleep "just now". After vaccination, the patient did not have any response and did not wake up with the "weaving of the mother". The vaccinating doctor found that the hands of the patient were very cold and did not hear a heartbeat when auscultated. The parents and the doctor took the patient to the nearest hospital which took about one and a half minutes. The emergency doctor found the patient "mydriasis, cardiac arrest and general cold at about 15:10. After routine rescue for 30 minutes, the patient was announced dead at about 15:40 on 21 December 2011. Documents held by sender: none.


VAERS ID: 447022 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2011-12-27
Onset:2011-12-27
   Days after vaccination:0
Submitted: 2012-01-06
   Days after onset:10
Entered: 2012-01-09
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0820Z / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Coronary artery occlusion, Death, Expired drug administered
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-12-30
   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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Autopsy, died due to coronary artery occlusion
CDC Split Type: WAES1201USA00274

Write-up: Information has been received from a nurse (local reference number CA-12-000077) concerning an 80 year old male who on 27-DEC-2011 was accidentally vaccinated with an expired dose of PNEUMOVAX 23 (lot number 667404/0820Z, expired on 16-DEC-2011). The patient''s chart did not indicate whether he had ever received this vaccine in the past or not (i.e. prior to his being placed in this care centre). The patient passed away on 30-DEC-2011. The cause of death as determined by the coroner was coronary artery occlusion. Administration of expired vaccine was not determined to be cause of death or to have caused patient any harm. As per this nurse, the coroner looked into this death because at the time the home was under a respiratory outbreak so in such cases, all deaths were looked into by the coroner. A lot check has been initiated. Additional information has been requested.


VAERS ID: 447157 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2011-12-15
Onset:2011-12-22
   Days after vaccination:7
Submitted: 2012-01-10
   Days after onset:19
Entered: 2012-01-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER AM011B / 2 UN / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 11B02A / 3 UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Aspartate aminotransferase normal, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Blood lactate dehydrogenase increased, Brain natriuretic peptide increased, C-reactive protein normal, Cardiac imaging procedure, Death, Electrocardiogram, General physical health deterioration, Heart sounds abnormal, Laboratory test, Myocarditis, White blood cell count normal, X-ray
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-12-22
   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:
Preexisting Conditions: 1 st dose of PREVENAR; 2 nd of PREVENAR; 1 st dose of DPT; 1 st dose of ACT-HIB; 2 nd dose of ACT-HIB
Allergies:
Diagnostic Lab Data: 22-DEC-2011, Aspartate aminotransferase, 41 IU/l; 22-DEC-2011, Blood creatine phosphokinase, 309 IU/l; 22-DEC-2011, Blood creatine phosphokinase MB, 56.0 ng/ml; 22-DEC-2011, Blood lactate dehydrogenase, 306IU/l; 22-DEC-2011, C-reactive protein, 0.04 mg/dl; 22-DEC-2011, White blood cell count, 12970 cells/mm3; Brain natriuretic peptide (22Dec2011): 3459.9 pg/ml; Electrocardiogram (22Dec2011): results not provided; Roentgen (22Dec2011): results not provided; Ultrasonic cardiogram (22Dec2011): results not provided
CDC Split Type: 2012003968

Write-up: This is a spontaneous report obtained from a contactable pediatrician under the authority I.D. of # PREVENAR 416. A 4-month-old female patient received the third dose of PREVENAR injection at 0.5 ml subcutaneously (Lot number: 11B02A) on 15Dec2011. Co-suspect vaccines included the third dose of ACT-HIB at 0.5 ml subcutaneously (Lot number: G1330) on 07Dec2011 and the second dose of DPT at 0.5 ml subcutaneously (Lot number: AM011B) for immunization on 15Dec2011. The patient did not have any underlying disease, concomitant disease, past medical history or concomitant medications. On 22Dec2011, the patient experienced fulminant myocarditis. The patient, however, died on 22Dec2011. Thus the outcome of the event was "death". No information was given whether autopsy was performed or not. The reporting pediatrician classified the event as serious due to death. The reporting pediatrician assessed the causality with PREVENAR as unknown. The causality with the co-suspect drugs DPT and ACT-HIB were also assessed as unknown by the reporting pediatrician. According to the reporting pediatrician, the patient received the third inoculation of ACT-HIB on 07Dec2011. On 15Dec2011 the patient received the third dose of PREVENAR and the second dose of DPT. On 22Dec2011 at 12:00 PM, the patient visited the reporting pediatrician for inoculation of BCG. Abnormalities in heart sounds were noted and an electrocardiogram, roentgen and ultrasonic cardiogram were performed (results not provided). The patient was diagnosed with fulminant myocarditis. Lab results performed on 22Dec2011 were as follows: Aspartate aminotransferase (41 IU/I); Blood creatine phosphokinase (309 IU/l); Blood creatine phosphokinase MB (56.0 ng/ml); Blood lactate dehydrogenase (306IU/l); C-reactive protein (0.04 mg/dl); White blood cell count (12970 cells/mm3) and Brain natriuretic peptide (3459.9 pg/ml). After securing the line, the patient was hospitalized. Although INOVAN, DOBUTREX and MILRINONE were started, the patient''s condition sharply deteriorated around 15:00 on the same day. Cardiac massage was performed, and BOSMIN as well as CALCICOL and MEYLON were administered to the patient. The patient, however, had a poor response. About an hour after sudden deterioration, it was confirmed that the patient died. The reporting pediatrician commented that the patient in this case died after having a fulminant course. And thus this case was reported as immunization performed within a month before developing the event. As for the causal relationships, they were completely unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 447410 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-01-13
Entered: 2012-01-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1201USA01121

Write-up: Initial information has been received from a published literature article. The authors reported that "It is not known how long children with PEDVAX HIB (manufacturer unknown) failure retain protective Hib antibody levels after infection. This study aimed to determine anti-polyribosylribitol phosphate (PRP) antibody concentrations in children several years later Hib infection and to identify risk factors for low antibody levels. The method used by the authors was that "the families of children with PEDVAX HIB (manufacturer unknown) failure diagnosed between 1992 and 2005 were asked to complete a questionnaire and a blood sample was obtained from the child". The results were: of 323 families approached, 260 (80.5%) returned a completed questionnaire and 175 (54.2%) children provided a blood sample. The median age at follow-up was 8.4 years (IQR 6.2-15.4 years) and median follow-up time was 4.1 years (IQR, 3.5-9.7 years). Twenty seven children (16.1%) had been born prematurely and/or had underlying disease and eighteen (10.8%) had immunoglobulin deficiency. The median anti-PRP antibody concentration was 0.70 ug/ml. Overall, 95 children (56.9%) had anti-PRP levels <1.0 ug/ml, while 27 (16.2%) had anti-PRP levels <0.15 ug/ml. All three children with Down''s syndrome and 42% (10/24) of children aged <5 years at follow-up had Hib antibody levels < 0.15 ug/ml. An antibody level < 0.15 u/ml was independently associated with underlying conditions, young age at Hib disease and shorter time interval between Hib disease and follow-up. The authors concluded that "over half the children with PEDVAX HIB (manufacturer unknown) failure had antibody concentrations below those considered to confer long-term protection, suggesting that they might be at further risk and so benefit from another dose of Hib conjugate vaccine. Follow up information has been received from another published literature article, concerning previous 323 cases of PEDVAX HIB (manufacturer unknown) failure. The objective of this study was to estimate the prevalence of immunoglobulin deficiency in children with PEDVAX HIB (manufacturer unknown) failure several years after developing invasive Hib disease and to determine the risk of serious infections in those who were found to be immunoglobulin deficient. This case concerns 9 children with Hib vaccine (manufacture unknown) failure who had died of the Hib infection. Briefly, 388 children with PEDVAX HIB (manufacturer unknown) failure diagnosed between October 1992 and December 2005 were identified through national surveillance. The families of 9 children who had died of the Hib infection were excluded from the study, as were 55 families who could not be located (n = 42), had moved abroad (n = 2), or whose General Practitioner (GP) did not respond to the invitation letter (n = 1) or had considered it inappropriate to contact the family because 4 children with malignancy and relapsed recently, 2 had parents with psychiatric problems, 2 were in foster care, 2 had suffered a recent family tragedy and 1 had died of an unrelated illness. Therefore, 323 families received an invitation letter to participate in the study, which involved completion of a questionnaire by a parent or legal guardian and obtaining a blood sample from the child. A serious infection was defined as any infection considered to be severe enough to warrant hospital admission, as recalled by the children''s parents. Of 323 families approached, a bloody sample was collected from 175 (54.2%) children and 170 samples provided sufficient sera for immunoglobulin measurement. There was no difference in age at Hib disease, gender, ethnicity, geographic location, presence of underlying conditions or clinical presentation between children who provided a blood sample and those who declined (data not shown). The median ages at Hib disease and follow-up were 2.3 years and 8.4 years, with a median duration of follow-up of 4.2 years, equivalent to 1035 child-years of follow-up after the episode of Hib disease. Around half the cases presented with Hib meningitis (52.4%), a quarter with epiglottitis (27.1%), a tenth with bacteremia (11.2%) and other clinical presentations (9.4%). Eighteen children (10.6%) had an underlying medical condition, including malignancy (five cases), Down syndrome (three cases), multiple congenital abnormalities (three cases), severe quadriplegic cerebral palsy (two cases), complex congenital heart disease (two cases), metabolic disorders (two cases, congenital adrenal hyperplasia and diabetes insipidus) and primary immune deficiency (one case). Although none of the families reported antibody deficiency in the questionnaire, 19 children (11.2%) were found to have a low immunoglobulin concentrations at follow-up, including IgA (12 cases), IgM (5 cases) and all three immunoglobulin classes (2 cases). A higher proportion of children with immunoglobulin deficiency were aged <2 years at their original presentation with Hib disease, compared to those with normal immunoglobulin concentrations. There were no significant differences between the two groups in clinical presentation, underlying medical conditions, premature birth, severity of infection (as determined by requirement for intensive care, presentation with convulsions or development of long-term sequelae), risk of other serious infections requiring hospitalization or Hib antibody concentrations at follow-up. However, both of the children with low Ig concentrations for all 3 classes developed at least 2 other serious infections, compared with one of five children with IgM deficiency and none of the 12 with IgA deficiency. Immunoglobulin deficiency was not associated with known behavioral/environmental risk factors (i.e. breastfeeding in infancy [any durational], attending a nursery or play group in early childhood (any duration), number of siblings, parental smoking) or social risk factors (i.e. parental employment status, size or ownership of accommodation, family access to a car) (date not shown). There was, however, an association between immunoglobulin deficiency and parental reporting of their child receiving more than two antibiotic courses per year in the first 2-3 years of life (OR = 4.0; 95% CI = 1.4-11.7; P = 0.004). In a logistic regression model, after adjusting for age at presentation with Hib disease, age at follow-up and the presence of an underlying medical condition, children who had received multiple antibiotic courses in early childhood were 3.8 times (95% CI, 1.4-10.6; P = 0.01) more likely to be immunoglobulin deficient at follow-up. Results were available for 57 children who had immunoglobulin concentrations measured during their initial Hib disease episode and also completed the long-term follow-up study. At the time of the initial Hib infection, 17 (29.8%) had Ig deficiency, including 11 cases of Ig class deficiency (19%) and 6 cases of Ig subclass deficiency (11%). There were no differences in clinical presentation, other serious infections requiring hospital admissions, long-term complications after invasive Hib disease and Hib antibody concentrations at follow-up when compared with the 40 children who had normal Ig concentrations measured during the original episode, although sample sizes were relatively small for statistical comparison. Repeat Ig concentrations at long-term follow-up were available for 45 of these children (median follow-up period, 11 years; range, 7-14 years), of whom 11 originally had Ig deficiency and 34 normal Ig concentrations. Of these 11 children, 8 now had normal Ig concentrations at follow up while 3 children (all with IgA deficiency) (27%) still had low IgA concentrations. None of these three children, however, had developed any other serious infection during the follow-up period. Of the 34 children with normal Ig concentrations originally, 5 (15%) now had Ig deficiency, including IgA (n = 3) and IgM (n = 2) deficiencies, of whom two (both with IgM deficiency) had had one other serious infection during the follow-up period, namely bacterial cellulitis and varicella pneumonitis. In conclusion, at a median of 4 years after infection, the prevalence of Ig deficiency in children with PEDVAX HIB (manufacturer unknown) failure is half that reported in the first few months after Hib infection. Ig deficiency at follow-up was associated with young age at Hib disease and frequent antibiotic use suggesting recurrent minor infections in early childhood, but not with serious infections requiring hospitalisation. Taken together with previous studies, these findings suggest that some children with PEDVAX HIB (manufacturer unknown) failure may have a maturational delay in producing antibody against encapsulated antigens and, in some cases, this is associated with a delay in the development of normal immunoglobulin concentrations. In a small proportion of cases, however, Ig deficiency may persist, while others may develop Ig deficiency later in childhood, even if they had normal Ig concentrations at the time of the initial Hib infection. Clinicians should have a lower threshold for assessing young children with PEDVAX HIB (manufacturer unknown) failure for immune deficiency (including measurement of Ig concentrations) particularly if the child had received multiple antibiotic courses in early years. Although not a statistically significant finding in this analysis (perhaps due to small numbers), it would also be prudent for PEDVAX HIB (manufacturer unknown) failure cases who subsequently develop another serious infection to also be assessed for immune deficiency, even if their initial Ig concentrations were normal. This is one of several reports received from the same source. No further information was available.


VAERS ID: 447453 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2012-01-09
Onset:2012-01-10
   Days after vaccination:1
Submitted: 2012-01-13
   Days after onset:3
Entered: 2012-01-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Death, Epistaxis, Pallor
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-01-10
   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: UNK
CDC Split Type: B0774506A

Write-up: This case was reported by a physician and described the occurrence of death in a 2-month-old male subject who was vaccinated with HIBERIX (GlaxoSmithKline). On 9 January 2012, the subject received unspecified dose of HIBERIX (unknown route of administration, unspecified injection site, lot number not provided). On 10 January 2012, 1 day after vaccination with HIBERIX, the subject experienced facial pallor and nose bleed in the morning. The subject was hospitalised and died soon after his admission, from unknown cause of death. It was unknown whether an autopsy was performed.


VAERS ID: 447484 (history)  
Form: Version 1.0  
Age: 0.12  
Sex: Male  
Location: Foreign  
Vaccinated:2011-12-20
Onset:2011-12-20
   Days after vaccination:0
Submitted: 2012-01-17
   Days after onset:28
Entered: 2012-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME) / SANOFI PASTEUR G1495 / UNK LL / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER 9C461 / 1 RL / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER G5276 / 1 MO / PO
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER F36239 / 1 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA334AB / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Crying, Death, Feeling abnormal, Night sweats
SMQs:, Dementia (broad), Depression (excl suicide and self injury) (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-12-21
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin B; FERRO
Current Illness: Unknown
Preexisting Conditions: Prematurity
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0775162A

Write-up: This case was reported by a healthcare professional and described the occurrence of death (unknown) in a 6-week-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). poliomyelitis vaccine live oral (non-gsk), hepatitis b vaccine (non-gsk) and pneumococcal vaccines (non-gsk). The subject''s medical history included prematurity. Before vaccination, the subject was healthy. Body temperature: 36 deg.C. Concurrent vaccination included dtpa-polio-hib (non-gsk); Sanofi; intramuscular; left thigh given on 20 December 2011. Concurrent medications included Vitamin B and Ferro. On 20 December 2011, the subject received 1st dose of ROTARIX (oral), 1st dose of Poliomyelitis vaccine live oral (Non-GSK) (oral), 1st dose of Hepatitis B vaccine (Non-GSK) (intramuscular, right thigh) and 1st dose of Pneumococcal vaccines (Non-GSK) (intramuscular, right thigh). On 20 December 2011, less than one day after vaccination with Hepatitis B vaccine (Non-GSK), Pneumococcal vaccines (Non-GSK), Poliomyelitis vaccine live oral (Non-GSK) and ROTARIX, the subject experienced crying, bad feeling and sweating all night. On 21 December 2011, at 12.50, due to persistent crying, the mother took her baby to the emergency room. A nurse told her to back home. The subject died on 21 December 2011 in the afternoon, the cause of death was not reported. An autopsy was performed. The results were not yet provided.


VAERS ID: 447546 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2011-12-15
Onset:2011-12-22
   Days after vaccination:7
Submitted: 2012-01-17
   Days after onset:26
Entered: 2012-01-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER AM011B / 2 UN / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 11B02A / 3 UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Aspartate aminotransferase normal, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Blood lactate dehydrogenase increased, Brain natriuretic peptide increased, C-reactive protein normal, Death, Echocardiogram abnormal, Electrocardiogram abnormal, General physical health deterioration, Heart sounds abnormal, Myocarditis, White blood cell count normal, X-ray abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 medical history including allergy
Allergies:
Diagnostic Lab Data: On 22/Dec/2011: CRP 0.04; WBC 12970; AST 41; LDH 306; CK 309; CK-MB 56.0; BNP 3459.9; Electrocardiogram, X-ray and echocardiography performed
CDC Split Type: 201200243

Write-up: Case received from Health Authorities (reference number HIB-313) in a foreign country on 6 January 2012, through local affiliates under local reference number A201200004. Case medically confirmed. A 4-month-old female patient, with no medical history including allergy, had received on 07 December 2011 her third subcutaneous dose of ACTHIB (batch number G1330). On 15 December 2011, she had also received her third subcutaneous dose of PREVENAR (other manufacturer, batch number 11B02A) and her second subcutaneous dose of DPT (other manufacturer, batch number AM011B). On 22 December 2011, abnormalities in heart sounds were detected when she visited the hospital for BCG vaccination, and a diagnosis of myocarditis fulminant was made after conducting electrocardiogram, X-ray and echocardiography. Lab tests showed CRP at 0.04; WBC at 12970; AST at 41; LDH at 306; CK at 309; CK-MB at 56.0 and BNP at 3459.9. After blood sampling and venous route establishment, although the patient was hospitalized and treatment with INOVAN, DOBUTREX and MILRINON was started, the general state of the patient aggravated at 15:00. Despite the cardiac compression and administration of BOSMIN, CALCICOL and MEYLON, the patient was less responsive to these treatments and death was confirmed approximately 1 hour after the sudden deterioration. The physician''s comment: "Since this is a dead case with fulminant course, vaccinations performed within 1 month before onset of disease were reported in case. The causality is absolutely unknown. (Therefore, most probable suspected drug could not be checked.)" Documents held by sender: none.


VAERS ID: 447621 (history)  
Form: Version 1.0  
Age: 0.62  
Sex: Male  
Location: Foreign  
Vaccinated:2012-01-16
Onset:2012-01-16
   Days after vaccination:0
Submitted: 2012-01-19
   Days after onset:3
Entered: 2012-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS YHIBB542AA / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Diarrhoea, Parasite stool test negative, Stool analysis normal, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-01-18
   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: Stool analysis, 2012, see text
CDC Split Type: B0776252A

Write-up: This case was reported by a physician via a sales representative and described the occurrence of death nos in a 7-year-old male subject who was vaccinated with HIBERIX (GlaxoSmithKline). No relevant medical history reported. Previous vaccinations included BCG, OPV, Hepatitis B and DTP. No adverse event reported before. On 16 January 2012, the subject received unspecified dose of HIBERIX (intramuscular, unknown injection site). On 16 January 2012, less than one day after vaccination with HIBERIX, the subject experienced diarrhea and vomiting. The subject was treated with smectite and other medication but the events did not improve. On 17 January 2012, vomiting was resolved. The subject was found dead in the morning of 18 January 2012. The cause of death was unspecified. The parents refused that an autopsy was performed. An anal swab was performed. The test results are: oil globule positive. Red blood cell, pus globule, mold, roundworm spawn, hookworm spawn and whipworm spawn were negative. No other test was performed. Since the subject already died when he was sent to the hospital, only vomiting and diarrhea were reported.


VAERS ID: 447783 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2012-01-09
Onset:2012-01-11
   Days after vaccination:2
Submitted: 2012-01-20
   Days after onset:9
Entered: 2012-01-23
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21FB171A / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F49241 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Altered state of consciousness, Aspiration, Cardiac arrest, Death, General physical health deterioration, Hypoxia, Intensive care, Procedural complication, Resuscitation, Shock, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), 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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-01-12
   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: Premature baby, 36 weeks; Ductus arteriosus patent, small ductus arteriosus; Foramen ovale patient (Atrial septal defect), patent foramen ovale with the small left to right shunt
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012011668

Write-up: This is a spontaneous report received from a foreign Regulatory Authority. Regulatory Authority report number 156366. A hospital physician (contactable through Regulatory Authority only) reported that a 2-month-old male infant received a dose of PREVENAR 13 intramuscularly and a dose of INFANRIX HEXA intramuscularly both for immunisation on 09Jan2012. The infant was born prematurely (36 weeks) with a small ductus arteriosus and patent foramen ovale with a small left to right shunt. Concomitant medications were not provided. On 11Jan2012, the infant presented two episodes of vomiting and was hospitalized. The infant was admitted to the intensive care unit on 12Jan2012 at 12:15 showing a serious state of shock, hypossiemia and altered states of consciousness. Despite the prompt hemodynamic and respiratory care, the infant''s condition went worse until cardiac arrest, which, despite the cardiopulmonary resuscitation maneuvers led to death at 14:40. During the respiratory assistance, from the tracheal tube was aspirated milky abundant material, which was presumably a result of inhalation of food material complicating a bronchopneumonic process in progress. The infant''s death was considered not related to the administered vaccines. At the time of this report, it was unknown if an autopsy had been performed.


VAERS ID: 448375 (history)  
Form: Version 1.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-01-30
Entered: 2012-01-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anaemia, Azotaemia, Butterfly rash, Death, Fatigue, Haematuria, Hypocomplementaemia, Immunoglobulin therapy, Lymphadenopathy, Nephritis, Pallor, Pyrexia, Thrombocytopenia, Transaminases increased
SMQs:, Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Systemic lupus erythematosus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0777429A

Write-up: This case was reported in a literature article and described the occurrence of active nephritis in a 58-year-old female subject who was vaccinated with human papilloma vaccine (manufacturer unspecified). Concurrent medical history included systemic lupus erythematosus that had been in remission for 8 years. On an unspecified date, the subject received 2nd dose of Human papilloma vaccine (unknown route of administration, unknown site of injection, batch number not provided). 3 months after vaccination with Human papilloma vaccine, the subject she was admitted to emergency because of malar and scalp rashes, fever, easy fatigability, cervical lymph nodes, gross hematuria and pallor. Work up disclosed severe anemia and thrombocytopenia, azotemia, transaminitis, hypocomplementemia, and active nephritis, with SLEDAI score of 15. Despite aggressive management which included methylprednisolone pulse therapy, blood component transfusions, and intravenous immunoglobulin (IVIG), the subject died 1 day after hospital admission. Summary of the literature article: The link between autoimmunity and infectious agents has been strongly suggested by reports of lupus or lupus-like syndromes following immunization. This article describes three patients with either newly diagnosed systemic lupus erythematosus (SLE) or SLE flare, following vaccination for human papilloma virus (HPV). A protective role of infectious agents is exemplified by the significant improvement in healthcare following immunizations using vaccines. However, vaccines which represent a prototype of infectious antigens have been reported to trigger systemic autoimmune disorders following exposure. Systemic lupus erythematosus (SLE) is an autoimmune disease brought about by the interplay of genetic susceptibility and triggers from environmental factors (e.g. infectious agents, drugs, sun exposure and stress). The spectrum of disease development following infectious triggers varies depending on the infectious agent and the genetic susceptibility of an individual. The complex relationship between genetic susceptibility and infection has been intensively investigated to search for the possible etiologies of the evolution and/or exacerbation of an existing autoimmune disease (AID), particularly SLE. In these three cases, besides the individual genetic differences of each patient and variability in antecedent illnesses and clinical presentation (i.e. naive SLE, RA evolving into SLE, and severe SLE flare following a long disease quiescence), a common factor seemed to be the history of HPV vaccination administered 2 to 4 months prior to the current SLEP episode. It thus becomes tempting to speculate on the role of infectious agents and vaccines in the induction of autoimmune diseases. Findings of significant high titers of infectious antigens in cohorts of SLE patients have strengthen the link between SLE and infection. Vaccines, like infection, have been reported to induce AIDs by stimulating the immune system through a number of immunomodulatory processes. Though there has been no direct evidence confirming the association between vaccination and AID, vaccines are likely to trigger autoimmune reactions in a similar manner to infectious agents in genetically susceptible individuals. Such reactions are usually rare and transient. Quadrivalent human papilloma virus (gHPV) types 6, 11, 16 and 19 recombinant vaccine has been approved for young women for prevention of cervical cancer, showing 90-100% efficacy in the prevention of precancerous cervical, vaginal and vulvar lesions and genital warts. Reported serious adverse events include Guillain-Barre'' syndrome (GBS), transverse myelitis, pancreatitis, venous thromboembolism (VTE), and 51 cases of autoimmune diseases, including SLE in 18, RA in 13, mixed connective tissue disease in four, and Sjogren''s, dermatomyositis, and scleroderma in one patient each. Additional substances included in the vaccine, such as adjuvants, preservatives, and stabilizers, may also be considered as potential inducers of autoimmunity. Adjuvants are substances added to vaccines to boost immunogenicity. The adjuvant effect is achieved through various mechanisms that affect both the innate and adaptive immune systems. Current HPV and HBV vaccines further contain a novel adjuvant system, AS04, which is composed of 3-O-desacyl-40 monophosphoryl lipid A and aluminum salts. A rare autoimmune disease called macrophagic myofasciitis (MMF) has been reported following intramuscular injection of vaccines with aluminum hydroxide. 16, 17. Reports on adverse events and safety of AS04 adjuvanted HPV 16/18, HSV, and HBV vaccines showed a total of 362 participants having at least one autoimmune event. Hypothyroidism was the most common AID, followed by musculoskeletal disorders (SLE, RA, Sjogren''s, dermatomyositis, erythema nodosum) and neuroinflammatory disorders (GBS, optic neuritis, multiple sclerosis, myasthenia gravis). In this analysis of over 68,000 participants who received AS04 adjuvanted vaccines or controls, there was a low rate of autoimmune disease, with no increase in relative risk associated with the former. On the other hand, a recent study showed that the quadrivalent HPV vaccine was effective and safe in patients with inactive SLE. Studies further showed that SLE patients had a higher frequency of HPV infection and were at a heightened risk of developing cervical cancer. Immunosuppressive agents used in these SLE patients also increase the susceptibility to HPV infections, mainly by inhibition of adaptive immune responses which play a crucial role in blocking papillomavirus infection. Conclusion: these cases narrate instances of the onset or exacerbation of lupus following HPV immunization suggesting adjuvant-induced autoimmunity. On the other hand, there are reports of higher incidence of HPV infection in SLE, with the infection per se possibly contributing to disease activity. Thus, the benefit of HPV immunization may still outweigh the risk among these individuals.


VAERS ID: 448396 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2005-10-13
Onset:2011-12-12
   Days after vaccination:2251
Submitted: 2012-01-30
   Days after onset:49
Entered: 2012-01-31
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0092R / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood test normal, Death, Intensive care, Laboratory test, Medical induction of coma, Multi-organ failure, Pneumonia
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: diagnostic laboratory test, 05Dec11, there was nothing in the results that would indicate a possible catastrophic event
CDC Split Type: WAES1201USA03483

Write-up: This case was received from a consumer (the patient''s husband) on 18-JAN-2012. The case was not medically confirmed. A female patient of unknown age received dose one of PNEUMOVAX 23 (batch number NB26520, lot number 650909/0092R) on 13-OCT-2005. It was administered at the same time as the patient had an influenza vaccine (manufacturer and batch number not reported). On 12-DEC-2011, 6 years post vaccination, the patient died in intensive care of total organ failure brought on by pneumonia. The patient had blood tests (unspecified) on 05-DEC-2011 but the reporter stated that the general practitioner said there was nothing in the results that would indicate a possible catastrophic event. The patient was put into a induced coma during the night of 06-DEC-2011 and she died whilst still in the coma. The reporter stated that nobody had tole him why his wife died, only what she had died from. Other business partner numbers include E2012-00374. A lot check has been initiated. No further information is available.


VAERS ID: 448745 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-02-01
Entered: 2012-02-02
   Days after submission:1
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: Unknown       Purchased by: Unknown
Symptoms: Death, Disease complication, Fallot's tetralogy, Hypoxia
SMQs:, Asthma/bronchospasm (broad), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No medical history reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201201097

Write-up: Case retrieved from the literature on 23 January 2012. Unique worldwide case ID: MX-SP-2012-01002. In a foreign country, the database corresponding to the event temporarily associated with vaccination (ETAV) associated with influenza (A [H1N1] and seasonal) immunization reported between December 2009 and June 2010 was analyzed. Patients who displayed at least one ETAV after the administration of H1N1 vaccine and/or seasonal influenza vaccine were included. Cases were considered to be probable vaccine-related if they met the temporality criterion, i.e., appearance of the event within 52 days after vaccination, including immediate hypersensitivity reactions. In terms of association and biological plausibility, a causal ETAV is the one that appears after the administration of the vaccine and requires demonstration through clinical, epidemiological and laboratory findings. It would imply that the vaccine caused the event directly and undoubtedly. When causality cannot be demonstrated, the event is defined as a coincidental ETAV, which refers to medical incidents that would have taken place in the same manner, with or without the application of the vaccine. During the study period, a total of 27,048,330 vaccine doses against H1N1 and 18,442,171 doses against seasonal influenza were applied across the country. A total of 597 ETAV corresponding to the application of the anti-H1N1 and/or anti-seasonal influenza vaccine were reported. A total of 57 events considered serious were reported during the period analyzed. 48 cases could be linked with sanofi pasteur product (manufacturer unknown). All of these cases were linked with the case 2012-01002, considered as the case of reference. A 01-year-old female patient, with no reported medical history and concomitant therapy, had received a combination of vaccine against H1N1 (manufacturer unknown, batch number, number in series, route and site of administration not reported) and of vaccine against seasonal influenza (manufacturer unknown, batch number, number in series, route and site of administration not reported) on an unspecified date. It was not notified if vaccines contain adjuvent. On an unspecified date, the patient developed hypoxic crisis (reported as final diagnosis). The initial diagnosis was Tetralogy of Fallot. The hypoxic crisis was secondary to Tetralogy of Fallot. Complications were considered the cause of death. It was not specified if the patient was hospitalized. No corrective treatment was reported. This interval was reported as 3h. the patient died on an unspecified date. According to the author, the event was considered as "CNR" (coincidental not related). According with the author, this case was assessed as serious due to medically important condition. Documents held by sender: none.


VAERS ID: 448748 (history)  
Form: Version 1.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-02-01
Entered: 2012-02-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No medical history reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201201141

Write-up: Case retrieved from the literature on 23 January 2012. Unique worldwide case ID: MX-SP-2012-01002. The database corresponding to the events temporarily associated with vaccination (ETAV) associated with influenza (A [H1N1] and seasonal) immunization reported between December 2009 and June 2010 was analyzed. Patients who displayed at least one ETAV after the administration of H1N1 vaccine and/or seasonal influenza vaccine were included. Cases were considered to be probable vaccine-related if they met the temporality criterion, i.e., appearance of the event within the 52 days after vaccination, including immediate hypersensitivity reactions. In terms of association and biological plausibility, a causal ETAV is the one that appears after the administration of the vaccine and requires demonstration through clinical, epidemiological and laboratory findings. It would imply that the vaccine caused the event directly and undoubtedly. When causality cannot be demonstrated, the event is defined as a coincidental ETAV, which refers to medical incidents that would have taken place in the same manner, with or without the application of the vaccine. During the study period, a total of 27,048,330 vaccine doses against H1N1 and 18,442,171 doses against seasonal influenza were applied across the country. A total of 597 ETAV corresponding to the application of the antiinfluenza A (H1N1) and/or anti-seasonal influenza vaccine were reported. A total of 57 events considered serious were reported during the period analyzed. 48 cases could be linked with sanofi pasteur product (manufacturer unknown). All of these cases were linked with the case 2012-01002, considered as the case of reference. A 92-year-old female patient, with no medical history nor concomitant therapy reported, had received on an unspecified date her dose of vaccine against seasonal influenza (manufacturer unknown, batch number, number in series, route and site of administration not reported). The vaccine was without adjuvant. On an unspecified date, the patient developed pneumonia (reported as initial and final diagnosis). It was not specified if the patient was hospitalized. No corrective treatment was reported. The patient died on an unspecified date. This interval was reported as "8" (no unit reported). According to the author, the event was considered as "CNR" (coincidental not related). Documents held by sender: none.


VAERS ID: 448767 (history)  
Form: Version 1.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-02-01
Entered: 2012-02-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Pneumonia, Septic shock
SMQs:, Toxic-septic shock conditions (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 medical history reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201201139

Write-up: Case retrieved from the literature on 23 January 2012. Unique worldwide case ID: MX-SP-2012-01002. In a foreign country, the database corresponding to the event temporarily associated with vaccination (ETAV) associated with influenza (A [H1N1] and seasonal) immunization reported between December 2009 and June 2010 was analyzed. Patients who displayed at least one ETAV after the administration of H1N1 vaccine and/or seasonal influenza vaccine were included. Cases were considered to be probable vaccine-related if they met the temporality criterion, i.e., appearance of the event within 52 days after vaccination, including immediate hypersensitivity reactions. In terms of association and biological plausibility, a causal ETAV is the one that appears after the administration of the vaccine and requires demonstration through clinical, epidemiological and laboratory findings. It would imply that the vaccine caused the event directly and undoubtedly. When causality cannot be demonstrated, the event is defined as a coincidental ETAV, which refers to medical incidents that would have taken place in the same manner, with or without the application of the vaccine. During the study period, a total of 27,048,330 vaccine doses against H1N1 and 18,442,171 doses against seasonal influenza were applied across the country. A total of 597 ETAV corresponding to the application of the anti-H1N1 and/or anti-seasonal influenza vaccine were reported. A total of 57 events considered serious were reported during the period analyzed. 48 cases could be linked with sanofi pasteur product (manufacturer unknown). All of these cases were linked with the case 2012-01002, considered as the case of reference. A 46-year-old female patient, with no medical history nor concomitant therapy reported, had received on an unspecified date her dose of vaccine against seasonal influenza (manufacturer unknown, batch number, number in series, route and site of administration not reported). It was not specified if the vaccine contains adjuvant. On an unspecified date, the patient developed pneumonia (reported as final diagnosis). The initial diagnosis was septic shock. It was not specified if the patient was hospitalized. No corrective treatment was reported. The patient died on an unspecified date. This interval was reported as "0" (no unit reported). According to the author, the event was considered as "CNR" (coincidental not related). Documents held by sender: none.


VAERS ID: 448768 (history)  
Form: Version 1.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-02-01
Entered: 2012-02-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No medical history reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201201140

Write-up: Case retrieved from the literature on 23 January 2012. Unique worldwide case ID: MX-SP-2012-01002. The database corresponding to the events temporarily associated with vaccination (ETAV) associated with influenza (A [H1N1] and seasonal) immunization reported between December 2009 and June 2010 was analyzed. Patients who displayed at least one ETAV after the administration of H1N1 vaccine and/or seasonal influenza vaccine were included. Cases were considered to be probable vaccine-related if they met the temporality criterion, i.e., appearance of the event within the 52 days after vaccination, including immediate hypersensitivity reactions. In terms of association and biological plausibility, a causal ETAV is the one that appears after the administration of the vaccine and requires demonstration through clinical, epidemiological and laboratory findings. It would imply that the vaccine caused the event directly and undoubtedly. When causality cannot be demonstrated, the event is defined as a coincidental ETAV, which refers to medical incidents that would have taken place in the same manner, with or without the application of the vaccine. During the study period, a total of 27,048,330 vaccine doses against H1N1 and 18,442,171 doses against seasonal influenza were applied across the country. A total of 597 ETAV corresponding to the application of the anti-influenza A (H1N1) and/or anti-seasonal influenza vaccine were reported. A total of 57 events considered serious were reported during the period analyzed. 48 cases could be linked with sanofi pasteur product (manufacturer unknown). All of these cases were linked with the case 2012-01002, considered as the case of reference. A 54-year-old male patient, with no medical history nor concomitant therapy reported, had received on an unspecified date his dose of vaccine against seasonal influenza (manufacturer unknown, batch number, number in series, route and site of administration not reported). The vaccine was without adjuvant. On an unspecified date, the patient developed pneumonia (reported as final diagnosis). The initial diagnosis was pneumonitis. It was not specified if the patient was hospitalized. No corrective treatment was reported. The patient died on an unspecified date. This interval was reported as "1" (no unit reported). According to the author, the event was considered as "CNR" (coincidental not related). Documents held by sender: none.


VAERS ID: 448901 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-02-01
Entered: 2012-02-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Guillain-Barre syndrome, Paralysis flaccid
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Apparently healthy
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201201039

Write-up: Case retrieved from the literature on 23 January 2012. Unique worldwide case ID: MX-SP-2012-01002. In a foreign country, the database corresponds to the events temporarily associated with vaccination (ETAV) associated with H1N1 and seasonal immunization reported between December 2009 and June 2010 was analyzed. Patients who displayed at least one ETAV after the administration of H1N1 and/or seasonal influenza vaccine were included. Cases were considered to be probable vaccine-related if they met the temporality criterion, i.e., appearance of the event within the 52 days after vaccination, including immediate hypersensitivity reactions. In terms of association and biological plausibility, a causal ETAV is the one that appears after the administration of the vaccine and requires demonstration through clinical, epidemiological and laboratory findings. It would imply that the vaccine caused the event directly and undoubtedly. When causality cannot be demonstrated, the event is defined as a coincidental ETAV, which refers to medical incidents that would have taken place in the same manner, with or without the application of the vaccine. During the study period, a total of 27,048,330 vaccine doses against H1N1 and 18,442,171 doses against seasonal influenza were applied across the country. A total of 597 ETAV corresponding to the application of the H1N1 and/or anti-seasonal influenza vaccine were reported. A total of 57 events considered serious were reported during the period analyzed. 48 cases could be linked with sanofi pasteur product (manufacturer unknown). All of these cases were linked with the case 2012-01002, considered as the case of reference. A 02-year-old male patient, apparently healthy, had received on an unspecified date his dose of vaccine against H1N1 (manufacturer unknown, batch number, number in series, route and site of administration not reported). The vaccine was without adjuvant. No concomitant therapy was reported. On an unspecified date, the patient developed GBS (Guillain Barre syndrome) (reported as initial and final diagnosis). it was not specified if the patient was hospitalized. No corrective treatment was reported. The patient died on an unspecified date, due to acute flaccid paralysis complications. This interval was reported as "4" (no unit reported). According to the author, the event was considered as "CNR" (coincidental not related). Fourteen confirmed cases of GBS according to Brighton Criteria were reported. All were ruled as unrelated coincidental events, given that vaccination against H1N1 as an antecedent occurred in seven cases (50%); immunization against seasonal influenza occurred in four cases (28.5%), and the joint administration of both vaccines occurred in three cases (21.4%). Documents held by sender: none.


VAERS ID: 448994 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-02-01
Entered: 2012-02-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Neurological infection, Status epilepticus
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No medical history reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201201146

Write-up: Case retrieved from the literature on 23 January 2012. Unique worldwide case ID: MX-SP-2012-01002. In a foreign country, the database corresponding to the event temporarily associated with vaccination (ETAV) associated with influenza (A [H1N1] and seasonal) immunization reported between December 2009 and June 2010 was analyzed. Patients who displayed at least one ETAV after the administration of H1N1 vaccine and/or seasonal influenza vaccine were included. Cases were considered to be probable vaccine-related if they met the temporality criterion, i.e., appearance of the event within the 52 days after vaccination, including immediate hypersensitivity reactions. In terms of association and biological plausibility, a causal ETAV is the one that appears after the administration of the vaccine demonstration through clinical, epidemiological and laboratory findings. It would imply that the vaccine caused the event directly and undoubtedly. When causality cannot be demonstrated, the event is defined as a coincidental ETAV, which refers to medical incidents that would have taken place in the same manner, with or without the application of the vaccine. During the study period, a total of 27,048,330 vaccine doses against H1N1 and 18,442,171 doses against seasonal influenza were applied across the country. A total of 597 ETAV corresponding to the application of the antiinfluenza H1N1 and/or anti-seasonal influenza vaccine were reported. A total of 57 events considered serious were reported during the period analyzed. 48 cases could be linked with sanofi pasteur product (manufacturer unknown). All of these cases were linked with the case 2012-01002, considered as the case of reference. A 26-year-old female patient, with no medical history nor concomitant therapy reported, had received on an unspecified date her dose of vaccine against seasonal influenza (manufacturer unknown, batch number, number in series, route and site of administration not reported). It was not specified if the vaccine contains adjuvant. On an unspecified date, the patient developed neuroinfection (reported as final diagnosis). The initial diagnosis was SE (status epilepticus). It was not specified if the patient was hospitalized. No corrective treatment was reported. The patient died on an unspecified date. This interval was reported as "7" (no unit reported). According to the author, the event was considered as "CNR" (coincidental not related). Documents held by sender: none.


VAERS ID: 448749 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-02-01
Entered: 2012-02-03
   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: Death, Hypersensitivity, Immediate post-injection reaction, Pneumonia
SMQs:, Angioedema (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No medical history reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201201142

Write-up: Case retrieved from the literature on 23 January 2012. Unique worldwide case ID: MX-SP-2012-01002. In a foreign country, the database corresponding to the event temporarily associated with vaccination (ETAV) associated with influenza (A [H1N1] and seasonal) immunization reported between December 2009 and June 2010 was analyzed. Patients who displayed at least one ETAV after the administration of H1N1 vaccine and/or seasonal influenza vaccine were included. Cases were considered to be probable vaccine-related if they met the temporality criterion, i.e., appearance of the event within 52 days after vaccination, including immediate hypersensitivity reactions. In terms of association and biological plausibility, a causal ETAV is the one that appears after the administration of the vaccine and requires demonstration through clinical, epidemiological and laboratory findings. It would imply that the vaccine caused the event directly and undoubtedly. When causality cannot be demonstrated, the event is defined as a coincidental ETAV, which refers to medical incidents that would have taken place in the same manner, with or without the application of the vaccine. During the study period, a total of 27,048,330 vaccine doses against H1N1 and 18,442,171 doses against seasonal influenza were applied across the country. A total of 597 ETAV corresponding to the application of the anti-H1N1 and/or anti-seasonal influenza vaccine were reported. A total of 57 events considered serious were reported during the period analyzed. 48 cases could be linked with sanofi pasteur product (manufacturer unknown). All of these cases were linked with the case 2012-01002, considered as the case of reference. A 78-year-old female patient, with no medical history nor concomitant therapy reported, had received on an unspecified date her dose of vaccine against seasonal influenza (manufacturer unknown, batch number, number in series, route and site of administration not reported). The vaccine was without adjuvant. On an unspecified date, the patient developed pneumonia (reported as initial and final diagnosis). It was not specified if the patient was hospitalized. No corrective treatment was reported. The patient died on an unspecified date. This interval was reported as "7" (no unit reported). According to the author, the event was considered as "CNR" (coincidental not related). Documents held by sender: none.


VAERS ID: 448751 (history)  
Form: Version 1.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-02-01
Entered: 2012-02-03
   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: Death, Pneumonia
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No medical history reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201201143

Write-up: Case retrieved from the literature on 23 January 2012. Unique worldwide case ID: MX-SP-2012-01002. In a foreign country, the database corresponding to the events temporarily associated with vaccination (ETAV) associated with H1N1 and seasonal immunization reported between December 2009 and June 2010 was analyzed. Patients who displayed at least one ETAV after the administration of H1N1 vaccine and/or seasonal influenza vaccine were included. Cases were considered to be probable vaccine-related if they met the temporality criterion, i.e., appearance of the event within the 52 days after vaccination, including immediate hypersensitivity reactions. In terms of association and biological plausibility, a causal ETAV is the one that appears after the administration of the vaccine and requires demonstration through clinical, epidemiological and laboratory findings. It would imply that the vaccine caused the event directly and undoubtedly. When causality cannot be demonstrated, the event is defined as a coincidental ETAV, which refers to medical incidents that would have taken place in the same manner, with or without the application of the vaccine. During the study period, a total of 27,048,330 vaccine doses against H1N1 and 18,442,171 doses against seasonal influenza were applied across the country. A total of 597 ETAV corresponding to the application of the anti-H1N1 and/or anti-seasonal influenza vaccine were reported. A total of 57 events considered serious were reported during the period analyzed. 48 cases could be linked with sanofi pasteur product (manufacturer unknown). All of these cases were linked with the case 2012-01002, considered as the case of reference. A 60-year-old female patient, with no medical history nor concomitant therapy reported, had received on an unspecified date her dose of vaccine against seasonal influenza (manufacturer unknown, batch number, number in series, route and site of administration not reported). The vaccine was without adjuvant. On an unspecified date, the patient developed pneumonia (reported as initial diagnosis). The final diagnosis was not notified. It was not specified if the patient was hospitalized. No corrective treatment was reported. The patient died on an unspecified date. This interval was reported as "13" (no unit reported). According to the author, the event was considered as "CNR" (coincidental not related). Documents held by sender: none.


VAERS ID: 448912 (history)  
Form: Version 1.0  
Age: 8.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-02-01
Entered: 2012-02-06
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute myeloid leukaemia, Bicytopenia, Death, Intraventricular haemorrhage
SMQs:, Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Myelodysplastic syndrome (broad), Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No medical history reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201201042

Write-up: Case retrieved from the literature on 23 January 2012 dealing with 48 serious cases. The unique worldwide case ID is MX-SP-2012-01002. In a foreign country, the database corresponding to the events temporarily associated with vaccination (ETAV) associated with H1N1 and seasonal immunization reported between December 2009 and June 2010 was analyzed. Patients who displayed at least one ETAV after the administration of H1N1 vaccine and/or seasonal influenza vaccine were included. Cases were considered to be probable vaccine-related if they met the temporality criterion, i.e., appearance of the event within the 52 days after vaccination, including immediate hypersensitivity reactions. In terms of association and biological plausibility, a causal ETAV is the one that appears after the administration of the vaccine and requires demonstration through clinical, epidemiological and laboratory findings. It would imply that the vaccine caused the event directly and undoubtedly. When causality cannot be demonstrated, the event is defined as a coincidental ETAV, which refers to medical incidents that would have taken place in the same manner, with or without the application of the vaccine. During the study period, a total of 27,048,330 vaccine doses against H1N1 and 18,442,171 doses against seasonal influenza were applied across the country. A total of 597 ETAV corresponding to the application of the anti-H1N1 and/or anti-seasonal influenza vaccine were reported. A total of 57 events considered serious were reported during the period analyzed. 48 cases could be linked with sanofi pasteur product (manufacturer unknown). All of these cases were linked with the case 2012-01002, considered as the case of reference. An 08-year-old male patient, with no medical history nor concomitant therapy reported, had received on an unspecified date his dose of vaccine against H1N1 (manufacturer unknown, batch number, number in series, route and site of administration not reported). The vaccine was without adjuvant. On an unspecified date, the patient developed AML (Acute myeloblastic leukemia, type M2) (reported as final diagnosis), complicated by intraventricular hemorrhage. The initial diagnosis was bicytopenia. It was not specified if the patient was hospitalized. No corrective treatment was reported. The patient died on an unspecified date. Complications of the disease was considered the cause of death. This interval was reported as "1" (no unit reported). According to the author, the event was considered as "CNR" (coincidental not related). Documents held by sender: none.


VAERS ID: 449427 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2011-12-01
Submitted: 2012-02-09
   Days after onset:70
Entered: 2012-02-13
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 2 UN / UN
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apathy, Asthenia, Autopsy, Brain death, Computerised tomogram abnormal, Computerised tomogram head, Crying, Multi-organ failure, Posture abnormal, Respiratory arrest, Rib fracture, Subarachnoid haemorrhage, X-ray abnormal
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (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), Dementia (broad), Dystonia (broad), Acute central respiratory depression (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Depression (excl suicide and self injury) (broad), Osteoporosis/osteopenia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-12-26
   Days after onset: 25
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: PREVENAR 13 Drug Reaction: Nasopharyngitis, Dose 1 at 2 months of age
Allergies:
Diagnostic Lab Data: CT scan (date unknown): revealed broken bones and subarachnoid haemorrhage; x-ray (date unknown): revealed broken bones and subarachnoid haemorrhage; Autopsy (Dec2011): results pending
CDC Split Type: 2012031281

Write-up: This is a spontaneous report from lay media (a newspaper article). This is the second of four reports. This is one of the two serious reports. The two additional case are non-serious. This report is for the baby boy twin regarding the second administration of PREVENAR 13. This is a report based on information received by Pfizer from another facility. A 4-month-old male twin patient of an unspecified ethnicity received the second dose of PREVENAR 13 and the second dose of rotavirus vaccine on an unknown date. Past vaccine history included the first dose of PREVENAR 13 and a dose rotavirus vaccine on an unknown date at the age of 2 months. After being administered these vaccines, the patient experienced nasopharyngitis. The patient was conceived via in vitro fertilization (IVF) treatments. He was delivered via Caesarian section with a normal weight of more than 2 kg. Examinations after birth determined that the patient was completely healthy. The baby was not breastfed. Concomitant medications were not reported. One week after the second dose, at around 20:00 hours, the patient experienced multi-system failure. According to the father, he heard the baby crying. It was an unusual cry so he picked him up and saw that the baby was apathetic. Suddenly, he became very weak and his head dropped. The ambulance was called and the patient was rushed to the hospital. On the way to the hospital, the baby stopped breathing and respiration was performed in the ambulance. At the hospital, the parents were asked to bring the baby girl as well. CAT Scan (CT) and X-ray tests showed that the patient suffered from broken ribs and had an subarachnoid haemorrhage. On 26Dec2011, the baby was diagnosed with brain death. An autopsy was performed and the samples were sent out. The parents are now being investigated by the police in a suspicion of physical abuse in the twins. No follow-up attempts possible. No further information expected.


VAERS ID: 449323 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-02-14
Entered: 2012-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No reported concomitant therapy; The patient had a medical history of Myasthenia Gravis
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201201396

Write-up: Case received from a Healthcare Professional on 30 January 2012 under the reference number MX-2012-001. A patient (initials, gender and date of birth unknown), with a medical history of myasthenia gravis and no reported concomitant therapy, had received a dose of influenza vaccine (manufacturer, batch number, route and site of administration unknown) on an unknown date. The patient died on an unspecified date. Corrective version created to add a source/reporter screen with health care professional as the source and physician as the qualification of the reporter in order that the box "health professional" is ticked on the CIOMS form.


VAERS ID: 449620 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-02-14
Entered: 2012-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Breast pain, Cough, Death, Decreased appetite, Dehydration, Hypotension, Hypothermia, Injection site pain, Pain, Pneumonia, Septic shock, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Toxic-septic shock conditions (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Lipodystrophy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (narrow), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-05-02
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown medical history and concomitant therapy
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201201655

Write-up: Case received from a Healthcare Professional via the local affiliate on 07 February 2012 under the reference number BR-BT2012-0352. A female patient (age not reported), with an unknown medical history and concomitant therapy, had received a dose of influenza vaccine (manufacturer, batch number, route and site of administration unknown) on an unspecified date. One day post-vaccination, the patient experienced lack of appetite, pain the body and pain at the injection site. On 29 April 2011, the patient had dehydration, hypotension, hypothermia, vomiting and weakness. She was taken to hospital and was treated with intravenous hydration and IM PLASIL. She was discharged from hospital on the same day. On 30 April 2011, the symptoms persisted and she developed cough and pain in breast. She was admitted to hospital on 30 April 2011. The patient died on 02 May 2011. The death diagnosis was septic shock and community-acquired pneumonia.


VAERS ID: 449632 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2011-11-23
Onset:2011-11-24
   Days after vaccination:1
Submitted: 2012-02-14
   Days after onset:82
Entered: 2012-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0160AA / UNK UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-12-03
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1202USA01156

Write-up: Information has been received from Health Authority (case n. 157817) (local case n. IT064/12). Initial report received on 02-FEB-2012. Case medically confirmed. An 80 year old male patient was vaccinated on 23-NOV-2011 with one dose of PNEUMOVAX 23 (batch # G003886, Lot # 670686/0160AA) SQ. It was also reported that on 17-NOV-2011 the patient was vaccinated with one dose of INFLEXAL V, Mfr. Crucell, (batch # not reported); this vaccine was not reported as suspect by the reporter or Health Authority. On 24-NOV-2011 he presented with persistent fever and acute bronchopneumopathy. He was treated with paracetamol and imipenem and gentamicin. The patient passed away on 03-DEC-2011. The outcome was fatal. The vaccine might have contributed. The case was closed. Other business partner numbers included: E2012-00718. A lot check has been initiated. No further information is available.


VAERS ID: 449683 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2012-01-19
Onset:2012-01-20
   Days after vaccination:1
Submitted: 2012-02-15
   Days after onset:26
Entered: 2012-02-16
   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 lactate dehydrogenase increased, Cardio-respiratory arrest, Fatigue, Glycosylated haemoglobin increased, Loss of consciousness, Sudden death, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-01-20
   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: AMARYL; AMLODIN; ASTOMIN; BENET; HUMALOG MIX; LASIX; MEDET; MUCODYNE; PREDONINE; SM Powder; TAKEPRON
Current Illness: Diabetes mellitus; Hypertension; Alcohol use; Non-smoker; Interstitial lung disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood pressure measurement, temporarily 78/58; WBC count, 16Dec11, 12500 /UL; serum LDH, 16Dec11, 408 IU/L; whole blood hemoglobin A1c, 16Dec11, 10.4 %;
CDC Split Type: WAES1202USA01772

Write-up: Initial information has been received from the agency regarding a case provided by a physician concerning a 79 year old male patient with interstitial pneumonia, diabetes mellitus, hypertension, alcohol intake (one bottle of beer), no history of smoking and no adverse drug reaction history who on 19-JAN-2012 was vaccinated with a dose of PNEUMOVAX 23, 0.5 mL once a day. Concomitant therapy included PREDONINE, AMARYL, TAKEPRON, MEDET, LASIX, AMLODIN, BENET, ASTOMIN, MUCODYNE, SM POWDER, and (injection) HUMALOG MIX. On 19-JAN-2012, at 11:43 am the patient received subcutaneous injection of PNEUMOVAX 23 (as stated above). There was no specific change in the evening. On 20-JAN-2012, on arising at around 7:30 a.m., after walking about 1 meter to go to the bathroom, he felt tiredness, sat down on the chair and then he lost his consciousness. At 8:00 a.m., the patient had cardio-respiratory arrest when ambulance arrived. At 8:20 a.m., the patient was transported to another hospital. The blood pressure was temporarily 78/58 with cardioactive drug but the patient gradually developed cardiac arrest. At 10:16 a.m., the patient''s death was confirmed. The cause of the patient''s death was unknown. No information on autopsy was provided. The reporting physician considered that sudden death was serious due to death. The reporting physician felt that sudden death was definitely related to PNEUMOVAX 23. Reporter''s comment: The patient was under oxygen therapy at home because of pre-existing interstitial pneumonia and also the control of diabetes mellitus was poor. The patient was lost for follow-up after the visit on 16 December. He visited the hospital only for the vaccination on 19 January. At this time, the patient''s condition seemed to be the same as usual. According to the family member, the patient''s condition had been poorly lately; although worsening of primary disease might be the cause, the physician was reporting this case because the causal relationship with PNEUMOVAX 23 cannot be ruled out. No further information is available.


VAERS ID: 449803 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-02-10
Entered: 2012-02-17
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Death, Guillain-Barre syndrome
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: 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: PHHY2012KR011042

Write-up: Case number PHHY2012KR011042, is an initial literature report received on 06 Feb 2012: The authors discussed about serious adverse events following receipt of trivalent inactivated influenza vaccine, between 2003 and 2010. This report refers to unknown age and gender patient. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on unspecified date (between 2003 and 2010). After vaccination, the patient experienced Guillain-Barre syndrome and died on unspecified date. The authors reported that the event was potentially associated (definite/probable/possible) to the influenza vaccination.


VAERS ID: 449804 (history)  
Form: Version 1.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-02-13
Entered: 2012-02-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: CD4 lymphocytes, CD8 lymphocytes, Cough, Cytomegalovirus test positive, Death, Dyspnoea, Epstein-Barr virus test positive, H1N1 influenza, Influenza virus test positive, Karnofsky scale, Lower respiratory tract infection, Mechanical ventilation, Polymerase chain reaction, Pyrexia, Rales, Respiratory failure, Rhinorrhoea, T-lymphocyte count, Upper respiratory tract infection, Vaccine virus shedding, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Hypokalaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 90 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prednisone
Current Illness: Acute myeloid leukaemia; Diabetes mellitus; Nephropathy; Lung disorder; Stem cell transplant; Graft versus host disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: CD4 lymphocytes, 121 micro liter, Baseline; CD8 lymphocytes, 691 micro liter, baseline; Karnofsky scale, 70, Significant; Viral test positive, H1N1 positive, Significant, Positive for H1N1. Co pathogens included CMV and EBV.
CDC Split Type: PHHY2012CH011571

Write-up: Case number PHHY2012CH011571 is an initial literature case received on 08 Feb 2012. Authors described the clinical features and outcome of H1N1 after allogenic hematopoietic stem cell transplant (allo-HSCT) patients who were vaccinated with seasonal/pandemic influenza vaccine. This case refers to a 40-year-old male patient with the history of acute myeloid leukemia, and was in complete remission. His medical history also included of diabetes, renal and pulmonary disease. He underwent allo-HSCT from a HLA identical sibling donor. He received a partial T-cell depleted transplant by myeloblative conditioning regimen. He was pretreated heavily before allo-HSCT as post-transplant maintenance therapy. He had GvHD and was receiving immunosuppressive drugs and prednisone equivalent 30mg/day. His Karnofsky score was at 70. His baseline CD3/CD4/CD8 cells were at 861/121/691 micro liters respectively. He had been vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on an unspecified date. He experienced fever, cough, rhinorrhea, and dyspnea on unspecified date. Abnormal physical findings included wheezes/rales on pulmonary auscultation. He also had upper and lower respiratory tract infections. Samples for H1N1 virus testing were taken that included nasopharyngeal swabs and broncho-alveolar lavage. The H1N1 virus was detected in samples using a real-time reverse transcription-PCR assay in accordance with the protocol from US Centers for Disease Control and Prevention. The patient was diagnosed with H1N1 infection. Co-pathogens included Cytomegalovirus and Epstein-Barr virus. These H1N1 virus isolates were analyzed to determine the presence of H275Y NA and the result was positive. He had symptomatic viral shedding for the period of 21 days. He was treated with oseltamivir at a dose of 75 mg twice daily. The patient developed an oseltamivir resistant strain, 7 days after oseltamivir initiation. He was then treated with intravenous ZANAMIVIR for twenty days. He was hospitalized for 90 days and was under mechanical ventilation for 70 days. He subsequently died of respiratory failure within 94 days of symptoms onset. Authors stated that close contact with children less than or equal to 12 years or adolescents in the previous 7 days was the most frequently suspected mode of transmission. In conclusion, although most allo-HSCT recipients had mild symptoms from H1N1 infection as does the general population, high immunosuppression and emergence of oseltamivir-resistant strains were responsible for a substantial number of deaths in the allo-HSCT setting. Complications included higher rates of LRTI, prolonged viral shedding and respiratory failure. This study strongly supports the need for vaccination and monitoring of family households, especially children.


VAERS ID: 449994 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: Foreign  
Vaccinated:2012-02-13
Onset:0000-00-00
Submitted: 2012-02-17
Entered: 2012-02-21
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CB047C / 1 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F53386 / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Resuscitation
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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012040224

Write-up: This is a spontaneous report from a contactable physician. This report was received via a sales representative. A 2-month-old male patient of an unspecified ethnicity received a first dose of PREVENAR 13, via an unspecified route of administration on 13Feb2011 and a first dose of INFANRIX HEXA, via an unspecified route of administration on 13Feb2012 for immunisation. Relevant medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced "exitus letalis" of unknown cause on the night of either 13 or 14Feb2012. Reanimation was unsuccessful. Causality was reported as related to both PREVENAR 13 and INFANRIX HEXA. An autopsy was planned.


VAERS ID: 450047 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2012-02-03
Submitted: 2012-02-21
   Days after onset:18
Entered: 2012-02-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-02-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201201714

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


VAERS ID: 450448 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Male  
Location: Foreign  
Vaccinated:2010-05-13
Onset:2010-08-15
   Days after vaccination:94
Submitted: 2012-02-24
   Days after onset:558
Entered: 2012-02-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E29194 / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Biopsy lung abnormal, Cardiac arrest, Death, Pneumococcal infection, Resuscitation, Streptococcus test positive
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Interstitial lung disease (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-08-15
   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: Lung Biopsy (20Aug2010): Streptococcus pneumoniae, serotype 19F.
CDC Split Type: 2012047848

Write-up: This is a spontaneous report from the contactable Foreign Agency. A 2-month-old, male patient received the first dose of PREVENAR 13 (Lot Number E29194). It was noted that the patient did not have the second PREVENAR 13 vaccination due to his age in Jul2010. Relevant medical history was reported as the patient did not belong to any of the following risk groups: premature birth, homozygous sickle cell disease or other haemoglobinopathy, history of previous invasive bacterial disease, asplenia or splenic dysfunction, immunosuppressive condition or drug, malignancy, congenital abnormality, conditions associated with CSF leakage, chronic respiratory disease (including asthma), cardiac disease, renal disease, liver disease, diabetes mellitus, cochlear implants, coeliac disease or any other condition. Concomitant medications were unknown. On 15Aug2010, at the age of 5-months-old, the patient experienced cardiac arrest. The patient died the same day despite resuscitation attempts and prior to the arrival to the hospital. It was reported that "res-specialty was given." A lung biopsy specimen taken on 20Aug2010 revealed pneumococcal infection, serotype 19F. No empyema or cerebral abscess was reported. The agency did not provide a causal relationship assessment between the patient''s death and the event of pneumococcal infection. No follow-up attempts possible. No further information expected.


VAERS ID: 450450 (history)  
Form: Version 1.0  
Age: 0.31  
Sex: Female  
Location: Foreign  
Vaccinated:2011-06-30
Onset:2012-01-24
   Days after vaccination:208
Submitted: 2012-02-24
   Days after onset:31
Entered: 2012-02-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E62905 / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, Death, Depressed level of consciousness, Pneumococcal infection, Sepsis, Streptococcus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Infective pneumonia (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:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Blood culture specimen (24Jan2012): identified serotype 19F infection with acute sepsis.
CDC Split Type: 2012047853

Write-up: This is a spontaneous report from a non-contactable healthcare professional. A 3-month-old female patient of unknown race received the second dose of PREVENAR 13, lot number E62905 and Expiry date Apr2013 on 30Jun2011. The patient received the first dose of PREVENAR 13 on 05May2011 (lot number E62905, Expiry date Apr2013). Relevant medical history and concomitant medications were not provided. On 24Jan2012 at the age of 10 months, the patient experienced vaccine failure. Blood culture revealed invasive pneumococcal disease, serotype 19F. The patient had acute sepsis, was obtunded and critically ill and died on an unknown date. The outcome of the event of obtundation was unknown. The reporter did not wish to be contacted therefore this case is considered lost to follow-up. No follow-up attempts possible. No further information expected.


VAERS ID: 450488 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-05-06
Onset:2011-05-08
   Days after vaccination:2
Submitted: 2012-02-24
   Days after onset:292
Entered: 2012-02-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 090629801 / UNK UN / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Myocardial infarction, Pneumonia, Renal failure acute, Sepsis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Myocardial infarction (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), Embolic and thrombotic events, arterial (narrow), Eosinophilic pneumonia (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prednisolone; Roxithromycin; Oxybutynin; Multivitamin and mineral supplement
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012031208

Write-up: This health authority report (initial receipt: 14-Feb-2012) concerns a 86 year old female patient. Concomitant medications included prednisolone, roxithromycin, oxybutynin and nutritional supplements. On 06-May-2011 the patient received 0.5mL dose of influenza virus vaccine inactivated (batch number: 090629801) intramuscular. On the same day she also received 0.5 mL dose of PNEUMOVAX-23 intramuscularly. On 08-May-2011 the patient developed pneumonia, sepsis, acute renal failure and myocardial infarction. The event outcome was death. Predisposing condition was chronic obstructive pulmonary disease. Upon dechallenge the events did not show improvement. No rechallenge was performed. The suspect drugs were not reduced. The reporter considered events to be serious (due to death) and unlikely in relation to the suspect drugs. The reporter stated that the death was "unrelated to drug". Cause of death is unknown.


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