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VAERS ID: 406234 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-10-29
Entered: 2010-11-01
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1337Y / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1010USA02515

Write-up: Information has been received from a pharmacist concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX (Lot #664653/1337Y). Subsequently the patient died. The cause of death was unknown. A priority lot check has been initiated. This is one of several reports received from the same source. Additional information has been requested.


VAERS ID: 406289 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Michigan  
Vaccinated:2010-08-06
Onset:2010-08-19
   Days after vaccination:13
Submitted: 2010-11-02
   Days after onset:75
Entered: 2010-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0640Z / 2 LA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Grand mal convulsion, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-08-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: seizure~HPV (Gardasil)~1~19.42~Patient
Other Medications:
Current Illness:
Preexisting Conditions: Autism
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient had her first Gardasil shot on 02/15/2010. On 02/19/2010, she had a Grand Mal seizure. She had her 2nd shot on 08/06/2010. She died on 08/19/2010. Medical Examiner listed cause of death as Sudden unexpected death associated with Seizure Disorder.


VAERS ID: 406577 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Male  
Location: Louisiana  
Vaccinated:2009-10-20
Onset:2009-11-10
   Days after vaccination:21
Submitted: 2010-10-18
   Days after onset:341
Entered: 2010-11-02
   Days after submission:15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3207AA / 2 LA / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Death, Dysphagia, Gastrointestinal tube insertion, Laboratory test, Paraesthesia, Sensory disturbance
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-08-31
   Days after onset: 293
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: LA101002

Write-up: Approximately 3-4 weeks after flu shot began to have tingling of face and arm. Symptoms progressed to lower extremities Experienced sensory problems - unable to swallow/had feeding tube. 1) Hospitalized - family states multiple tests were done. 2) Released and went to neurology clinic in another state for second opinion. 3) Admitted to another hospital and then transferred to a rehab facility in another state. 4) Family had him brought back to original hospital.


VAERS ID: 406908 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Female  
Location: California  
Vaccinated:2010-10-22
Onset:2010-10-24
   Days after vaccination:2
Submitted: 2010-11-03
   Days after onset:10
Entered: 2010-11-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT3621GA / UNK UN / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0632Y / UNK UN / IM

Administered by: Other       Purchased by: Private
Symptoms: Blood creatine phosphokinase increased, Blood urea increased, Chest X-ray, Dysaesthesia, Full blood count, Hypoaesthesia, Metabolic function test, Muscular weakness, Pain in extremity, Paraesthesia, Red blood cell sedimentation rate increased, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-11-09
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: HCTZ; Atenolol; Lisinopril; Zolpidem; Simvastatin; Nortriptyline
Current Illness: None
Preexisting Conditions: PCN -allergy; HTN; Diabetes
Allergies:
Diagnostic Lab Data: 10/31/10 CXR done CBC; WBC 14.0; CMP with CK of 263; BUN -29; Sed Rate 53; Transferred to hospital - higher level of care with dx of R/o Guillian Barre Syndrome
CDC Split Type:

Write-up: Numbness, pain bilateral lower extremities progressive weakness, tingling, dyesthesias in soles of feet - started on 10/24 seen at clinic on 10/26 - started on LYRICA d/t hx of diabetes seen in ER on 10/31 - with dyesthesias in hands and fingers - transferred to different hospital.


VAERS ID: 406922 (history)  
Form: Version 1.0  
Age: 0.58  
Sex: Female  
Location: New Hampshire  
Vaccinated:2010-04-30
Onset:2010-05-02
   Days after vaccination:2
Submitted: 2010-11-04
   Days after onset:186
Entered: 2010-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3600AA / 3 UN / UN
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1275Y / 3 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E44433 / 1 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1588Y / 3 UN / UN

Administered by: Private       Purchased by: Public
Symptoms: Cardiac arrest, Congenital torticollis, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (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), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Ocular motility disorders (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-05-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SYNERGIS
Current Illness: none
Preexisting Conditions: NKA
Allergies:
Diagnostic Lab Data:
CDC Split Type: NH11042010

Write-up: Preterm; congenital torticollis presented unresponsive, cardiac arrest.


VAERS ID: 406994 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Male  
Location: Kentucky  
Vaccinated:2010-11-03
Onset:2010-11-04
   Days after vaccination:1
Submitted: 2010-11-06
   Days after onset:2
Entered: 2010-11-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3558AA / 1 RL / UN
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 04852 / 2 RL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 914274 / 1 LL / UN

Administered by: Public       Purchased by: Public
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-11-04
   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: None reported
Current Illness: None reported or noted
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Child was seen at County Health Center on 110310 for initial immunizations. Child was alert without any problems noted or voiced.


VAERS ID: 406995 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Colorado  
Vaccinated:2006-08-03
Onset:2010-10-19
   Days after vaccination:1538
Submitted: 2010-11-03
   Days after onset:15
Entered: 2010-11-05
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U1784AA / UNK UN / IJ

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Meningococcal infection
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-10-20
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient''s medical history was not reported.
Allergies:
Diagnostic Lab Data: Not reported.
CDC Split Type: 201006291

Write-up: Initial report received from a health care professional on 02 November 2010. A female patient (age not specified) received an injection (route and site not provided) in 2006 of MENACTRA, lot number not reported. On an unspecified date one and a half weeks ago, the patient died from group C meningococcal disease. No further information was available. Documents held by sender: None.


VAERS ID: 407037 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: Michigan  
Vaccinated:2010-10-08
Onset:2010-10-11
   Days after vaccination:3
Submitted: 2010-11-05
   Days after onset:25
Entered: 2010-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT3580CA / 5 LA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Chest X-ray normal, Condition aggravated, Convulsion, Influenza A virus test positive
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-10-20
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Is on: Trilepta Albuterol Pulmicort
Current Illness: No
Preexisting Conditions: Developmental Delay Obstructive Sleep Apnea Seizure Disorder Prior History of Aspiration Pneumonia Dysphasia
Allergies:
Diagnostic Lab Data: Nasal Washing showed positive for Influenza A
CDC Split Type:

Write-up: Mom states patient had 2 minute seizure and then another one a little bit later that lasted about 5 minutes. She states she hasn''t had a seizure for about 4 to 5 months. Took her into ER per ambulance at 2:30am. Left ER 5:30am. Called ambulance again when she had a 35 minute seizure around 9:30am. Had chest x-ray earlier which was clear. Her Trilepta dosage was increased and she was sent home again.


VAERS ID: 407253 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Female  
Location: Alaska  
Vaccinated:2009-10-03
Onset:2009-10-04
   Days after vaccination:1
Submitted: 2010-11-08
   Days after onset:400
Entered: 2010-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U318AA / UNK RA / UN

Administered by: Public       Purchased by: Public
Symptoms: Cerebrovascular accident, Hemiplegia, Pulmonary congestion
SMQs:, Cardiac failure (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Infective pneumonia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 45 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: I do not know if this also included the H1N1 vaccine, but I believe it did. In addition, her doctor may or may not have submitted her to an additional flu vaccination while being hospitalized, within 1-2 weeks of the original vaccine. The
Current Illness: no. (I do not know what time of day the vaccination occurred!)
Preexisting Conditions: She had a permanent enterococcous infection from the hospital hip surgery rec''d four years prior.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: (actual time unk) 1 day after vaccine severe lung congestion. 5 days after vaccine total paralyzation on right side of body, diagnosed as "stroke."


VAERS ID: 407287 (history)  
Form: Version 1.0  
Age: 85.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2010-10-22
Onset:2010-10-25
   Days after vaccination:3
Submitted: 2010-11-08
   Days after onset:14
Entered: 2010-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFUA602AB / UNK LA / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Back pain, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-11-11
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 16 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vaccinated on 10/22/10. Reports back pain and muscle weakness increasing through weekend. Admitted on 10/27/10.


VAERS ID: 407754 (history)  
Form: Version 1.0  
Age: 0.85  
Sex: Male  
Location: Michigan  
Vaccinated:2010-11-08
Onset:2010-11-08
   Days after vaccination:0
Submitted: 2010-11-10
   Days after onset:2
Entered: 2010-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3744AA / 2 RL / IM

Administered by: Other       Purchased by: Public
Symptoms: Blood glucose increased, Cardiac arrest, Death, Endotracheal intubation, Gastrointestinal tube insertion, Pulse absent, Respiration abnormal, Resuscitation, Unresponsive to stimuli, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant 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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-11-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Diaper rash
Allergies:
Diagnostic Lab Data: Blood sugar 137
CDC Split Type:

Write-up: Previously healthy baby taken to ER by EMS unresponsive, with no pulse, no respirations. Details of what occurred prior to EMS arrival to apartment are unknown. One report is that the baby was in the bath with an older sibling, or mom was in the bathroom with another child, heard something in another room and then went and found the baby unresponsive. Mom started CPR, it took 5 - 10 minutes before the fire department arrived and continued CPR, the EMS arrived and found the baby on the floor with vomitis in hair, continued CPR, intubated, were unsuccessful in placing an IV line and administered Epinephrine via the ET. Upon arrival to the ER the baby was asystolic, IV started, 3 rounds of Epinephrine and Atropine administered via the IV and one dose of Na Bicarb, the ET tube was removed and another one placed, NG tube placed. All attempts were unsuccessful. The baby was pronounced at 10:48 PM. Medical Examiner to handle case.


VAERS ID: 407788 (history)  
Form: Version 1.0  
Age: 47.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2010-10-26
Onset:2010-10-26
   Days after vaccination:0
Submitted: 2010-10-29
   Days after onset:3
Entered: 2010-11-10
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U3051AA / 1 RA / IM

Administered by: Other       Purchased by: Public
Symptoms: Arrhythmia, Cardiac disorder, Death, Mitral valve prolapse, Palpitations, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-10-27
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: NONE
Preexisting Conditions: asthmatic (well - controlled); cardiac
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: On 10/26/10, Pt was given TDAP 12:30pm; no contra indications to vaccine per health screening. Later that evening, pt experienced palpitations and called a physician to schedule appointment. 10/27/10, 06:00 am, pt collapsed at home after walking her dog. 911 called and EMS transported to ER. Pt died at 0820. Coroner reports cause of death as cardiac arrhythmia due to mitral valve prolapse and state pt had extensive cardiac problems. Death reportedly unrelated to TDAP vaccine. Pt did not disclose cardiac condition.


VAERS ID: 409289 (history)  
Form: Version 1.0  
Age: 63.0  
Sex: Female  
Location: Kansas  
Vaccinated:2010-11-15
Onset:2010-11-16
   Days after vaccination:1
Submitted: 2010-11-17
   Days after onset:1
Entered: 2010-11-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3665CA / 1 RA / UN

Administered by: Private       Purchased by: Private
Symptoms: Death, Resuscitation
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-11-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Multiple
Current Illness: Chronically ill, not acutely.
Preexisting Conditions: Diabetes (not controlled); obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Received INFLUENZA vaccine approx 5 pm 11-15-10. Did not awaken from sleep 11-16-10 -$gEMS-$gpulseless electrical activity-$g CPR -$g Emergency Dept. Multiple attempts at resuscitation failed. Pt expired 11-16-10.


VAERS ID: 409766 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2010-10-21
Onset:2010-10-30
   Days after vaccination:9
Submitted: 2010-11-23
   Days after onset:24
Entered: 2010-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA610AA / UNK LA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Asthenia, Borrelia test negative, CSF glucose increased, CSF protein normal, CSF white blood cell count negative, Death, Dysstasia, Guillain-Barre syndrome, Lumbar puncture abnormal, Muscular weakness, Polymerase chain reaction
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-11-11
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Cadue, Prilosec, Multi vit, Vit C, Aspirin, Calcium +D, Fish Oil, Arimidex, Xanax
Current Illness: no
Preexisting Conditions: HTN, Hemochromotosis, breast ca (s/p chemo & XRT) NIDDM, depression, hyperlipidemia
Allergies:
Diagnostic Lab Data: Lumbar Puncture-$gGlucose=118, protein=44, wbc 0, lyme dna pcr neg
CDC Split Type:

Write-up: Sudden onset of weakness (back and neck)progressed to lower extremities described as "gel legs", difficulty standing DX with Guillain-Barre Syndrome


VAERS ID: 409831 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Indiana  
Vaccinated:2010-11-01
Onset:2010-11-02
   Days after vaccination:1
Submitted: 2010-11-11
   Days after onset:9
Entered: 2010-11-23
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR 3C665AA / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 914275 / 1 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CB058A / 1 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Apnoea, Death
SMQs:, Acute central respiratory depression (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-11-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SYNAGIS IM
Current Illness:
Preexisting Conditions: 31 week preemie; Hx nec; s/p surgery nec pt with ostomy
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt was a 31 week preemie with hx of NEC D/C from NICU 3 weeks prior to event. He was on O2 NC; ostomy bag; NG feeds on AB monitor 24 hours after vaccination Pt became apneic at home and was pronounced dead at local ER.


VAERS ID: 410054 (history)  
Form: Version 1.0  
Age: 0.01  
Sex: Male  
Location: New Hampshire  
Vaccinated:2010-07-21
Onset:2010-11-15
   Days after vaccination:117
Submitted: 2010-11-24
   Days after onset:9
Entered: 2010-11-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS BVB789A55 / 1 RL / UN

Administered by: Private       Purchased by: Public
Symptoms: Circumcision, Laboratory test normal
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-11-15
   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: none
Preexisting Conditions: NKA
Allergies:
Diagnostic Lab Data: WNL
CDC Split Type: NH11242010

Write-up: Patient had acetaminophen 20 mg prior to circumcision.


VAERS ID: 410080 (history)  
Form: Version 1.0  
Age: 9.0  
Sex: Male  
Location: Idaho  
Vaccinated:2010-11-19
Onset:2010-11-21
   Days after vaccination:2
Submitted: 2010-11-24
   Days after onset:3
Entered: 2010-11-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3574BA / 1 LA / IM

Administered by: Public       Purchased by: Other
Symptoms: Death, Urticaria, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-11-22
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Hives, pucking, then DEATH


VAERS ID: 410132 (history)  
Form: Version 1.0  
Age: 0.53  
Sex: Male  
Location: Unknown  
Vaccinated:2007-10-04
Onset:0000-00-00
Submitted: 2010-11-24
Entered: 2010-11-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF211AA / 3 RL / IM

Administered by: Other       Purchased by: Other
Symptoms: Altered state of consciousness, Apnoea, Autopsy, Bacterial infection, Bacterial test, Basophil count decreased, Blood culture positive, Blood electrolytes normal, Blood immunoglobulin A, Blood immunoglobulin G, Body temperature increased, Bradycardia, Brain oedema, CSF culture positive, CSF glucose, CSF lymphocyte count, CSF monocyte count decreased, CSF neutrophil count, CSF protein, CSF test abnormal, CSF white blood cell count increased, CSF white blood cell count positive, Chronic sinusitis, Clostridium test negative, Computerised tomogram head, Computerised tomogram normal, Corynebacterium test positive, Crying, Decreased eye contact, Diffuse axonal injury, Effusion, Endotracheal intubation, Gram stain negative, Gram stain positive, Grand mal convulsion, Haemophilus test positive, Hemiparesis, Humoral immune defect, Hypokinesia, Hypophagia, Hypotonia, Immunodeficiency, Influenza virus test negative, Intensive care, Lethargy, Liver function test normal, Lumbar puncture abnormal, Meningitis haemophilus, Mental status changes, Muscular weakness, Musculoskeletal stiffness, Neurological examination abnormal, Neutrophil count decreased, Nuclear magnetic resonance imaging brain abnormal, Otitis media, Pachymeningitis, Partial seizures, Pupil fixed, Pyrexia, Red blood cells CSF positive, Resuscitation, Scan brain, Sepsis syndrome, Sinus disorder, Subdural empyema, Subdural hygroma, Tardive dyskinesia, Toxicologic test normal, Tremor, Tympanic membrane disorder, Tympanic membrane hyperaemia, Ultrasound abdomen normal, Urine output, Varicella virus test negative, Vomiting, White blood cell count, White blood cell count increased, X-ray
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Agranulocytosis (broad), Angioedema (broad), Haematopoietic leukopenia (narrow), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-07-24
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: Autopsy, see text; Basophils, 0.02; Blood culture, see text; Blood culture, Hib sensitive to; Blood electrolytes, normal; Blood pressure, 81/62mmHg; Body temperature, 102F; Body temperature, 38.8deg.C; Brain computerized tomography, see text; CSF WBC, 0.064 x 10^9/L; CSF WBC, 3.45 x 10^9/L; CSF culture, Hib sensitive to; CSF neutrophil count, 0.11; Cerebrospinal fluid glucose, 0.66612mmol/L; Cerebrospinal fluid glucose, 3.94121mmol/L; Cerebrospinal fluid lymphocyte, 0.77; Cerebrospinal fluid protein, 1.14g/L; Cerebrospinal fluid protein, 2.98g/L; Computerized tomogram, see text; Computerized tomogram head, normal; Diphtheria toxin antibody, 0.20IU/ml; Gram stain, gram-negative ro; Gram stain, see text; Heart rate, 96/min; Heart rate, 133b/min; IgA, 0.36g/L; IgG, 4.91g/L; Leukocyte count NOS, 3x10^9/L; Liver function test, normal; Lumbar puncture, cloudy CSF; Lymphocytes, 0.11; Monocytes, 0.06; Neurological examination, see text; Neutrophils, 0.81; Neutrophils, 0.23; Nuclear magnetic resonance ima, see text; Physical examination, see text; Pulse oximetry, 99%; Pulse oximetry, 97%; Red blood cells in cerebrospin, 1 x 10^9/L; Red blood cells in cerebrospin, 0.017 x 10^9/L; Respiratory rate, 24breaths/min; Respiratory rate, 28/min; Tetanus antibody, 0.08IU/ml; Ultrasound abdomen, normal; white blood cells, 24.7 x10^9/L; X-ray, see text
CDC Split Type: B0684669A

Write-up: This case was reported in a literature article and described the occurrence of Hib meningitis in a 15-month-old male subject who was vaccinated with Hib (manufacturer unspecified). No relevant medical history. His 3-year-old brother had reactive airways disease. Previous and/or concurrent vaccination included DTaP; manufacturer unspecified; unknown given on an unspecified date; PREVNAR (non-gsk); Wyeth Labs; unknown given on an unspecified date; varicella virus vaccine; manufacturer unspecified; unknown given on an unspecified date. Immunizations were up-to-date (3 DTaP and Hib vaccinations, with the last being 9 months ago) except for VARIVAX. On an unspecified date, the subject received an unspecified dose of Hib (administration site and route unknown, batch number not provided). 9 months after vaccination with Hib, the subject experienced fever (102 F), lethargy, decreased oral intake, vomiting and urine output. The physician diagnosed otitis media and referred him to the Emergency Department because of a concern for the level of consciousness. On arrival to the ED, vital signs were as follows: temperature, 36.5 deg.C; heart rate, 133 beats per minute; blood pressure, 81/62 mm Hg; respiratory rate, 24 breaths per minute; and pulse oximetry, 97% on room air. Physical examination revealed a child with a weak cry who did not maintain eye contact with the examiner. Stiffness of his neck was noted with flexion and extension. The right tympanic membrane was erythematous and bulging. Pulses and perfusion were normal. Leukocyte count was 3 x10^9/L white blood cells (0.23 segmented neutrophils and 0.55 bands) with Dohle bodies and vacuolization noted on the smear. Two 20-mL/kg saline boluses were given with no improvement in mental status. A blood culture was obtained before ceftriaxone 100 mg/kg was given intravenously. Soft tissue radiographs and computed tomographic (CT) scans of the neck ruled out retropharyngeal abscess but revealed opacification of both maxillary sinuses. Cloudy cerebrospinal fluid (CSF) was obtained from lumbar puncture. Immediately after the procedure and before laboratory results, vancomycin was given. Cerebrospinal fluid had the following: white blood cell count, 3.45 x10^9/L (0.59 neutrophils); red cell count, 1 x10^9/L; glucose, 0.66612 nmol/L, and protein, 2.98 g/L; CSF was also positive by the Phadebact Haemophilus Co-Agglutination Test. When the Gram stain showed gram-negative rods, meropenem was added. The hospital microbiology laboratory serotyped the organism as type b, which was confirmed by the state laboratory. The patient was admitted to the pediatric intensive care unit (PICU) with a diagnosis of meningitis and sepsis. Mental status improved on day 2. Dexamethasone was started, and antibiotics were switched to ceftriaxone alone when blood and CSF cultures returned positive for Hib sensitive to ampicillin. Evaluation for the immunologic response to Hib and immunodeficiency was initiated on day 3, but results were not available during the hospital stay. The patient was transferred to the floor after results of CT scan of the head were normal on day 4. A lumbar puncture was planned on day 7, but the parents refused the procedure. Day 8 was the last day that fever (Tmax, 38.8 deg. C) was present. Blood and urine cultures were sent; vancomycin was added for a possible central venous line infection. Magnetic resonance imaging on day 9 demonstrated a thin subdural hygroma over the left cerebral convexity that measured approximately 4 mm in thickness but normal brain parenchyma. Abdominal ultrasound as part of immunodeficiency evaluation demonstrated a normal spleen for age. On day 12 of hospitalization, vancomycin was discontinued. The patient was discharged after 13 days of antibiotics with appointments scheduled with neurology and immunology. The pediatrician was to arrange audiologic evaluation and early intervention; further immunologic evaluation was also planned. The patient returned to the ED 48 hours after discharge with focal seizure activity. On the day of admission, the patient was afebrile and was more active than in previous days. Parents described right side shaking that lasted several minutes. After the seizure, he was noted to have decreased movement of the right upper and lower extremities. Vital signs in the ED included the following: temperature, 37.9 deg.c; heart rate, 96 beats per minute; respiratory rate, 28 breaths per minute; pulse oximetry, 99% on room air (no blood pressure was recorded). Physical examination revealed an awake child in no immediate distress. Anterior fontanelle was open and flat; pupils were equally round and reactive. No papilledema was noted, and extraocular eye movements were intact. Neurological examination was significant for flaccid right lower extremity and a weak right upper extremity with normal reflexes and sensation. The remainder of the physical examination was unremarkable. There was improvement of the right hemiparesis during his ED stay. Workup in the ED included CT scan of the brain, which demonstrated a left-sided hygroma without midline shift. He then underwent a lumbar puncture that obtained clear fluid with an opening pressure of 17 cm H2O. Results of analysis were as follows: white blood cells, 0.064x 10^9/L (0.11 neutrophils and 0.77 lymphocytes); red blood cells, 0.017 x10^9/L; glucose, 3.94121 mmol/L; and protein, 1.14 g/L. Gram stain demonstrated rare white blood cell count and no organisms. Bacterial antigen panel was negative as was the final culture. White blood cell count was 24.7 x10^9/L with 0.81 neutrophils, 0.11 lymphocytes, 0.06 monocytes, and 0.02 basophils. Electrolytes and liver function profile were normal. Urine toxicology was negative. Neurology and infectious disease consultations were obtained. Ceftriaxone was given intramuscularly per recommendation of the infectious disease specialist because intravenous access was not obtained immediately. Shortly after the lumbar puncture was completed, the patient had generalized tonic-clonic seizure characterized by lip smacking for which he received 1 mg of lorazepam and 15 mg/kg of fosphenytoin intravenously with resolution. During transport to the PICU, he had recurrence of seizure activity. On transfer to the PICU bed, he became apneic and bradycardic. At that time, his pupils were fixed and dilated. Cardiopulmonary resuscitation was initiated, and his trachea emergently intubated. Mannitol was given along with additional doses of lorazepam and resuscitation medications. Hypertonic saline was infused for presumed cerebral edema. The pediatric neurosurgeon performed a ventricular tap that produced 7 mL of purulent CSF. A ventricular catheter was then placed and yielded 40 mL of CSF, but resuscitation was unsuccessful. The subject died from Hib meningitis. An autopsy was performed and showed brain edema, leptomeningitis, pachymeningitis and subdural empyema. Autopsy demonstrated severe acute and chronic diffuse leptomeningitis described as multilayer exudates with neutrophils, lymphocytes, and proliferating capillaries. There was subdural empyema with organizing pachymeningitis of the left frontal region and diffuse brain edema with acute neuronal injury. No evidence of herniation was noted at autopsy. Immunologic workup from the first hospitalization included quantitative immunoglobulins with an IgG of 4.91 g/L (range, 6.81Y16.48 g/L) and IgA of 0.36 g/L (range, 0.40Y2.50 g/L) both at the lower end of normal for age. No significant tetanus antitoxoid antibodies at 0.08 IU/mL (reference, 0.16 IU/mL) or Hib antibodies at 0.13 mg/L (reference, 0.15 mg/L) were detected. Diphtheria antitoxoid antibodies were present at 0.20 IU/mL (reference, 0.10 IU/mL). Varicella IgG was also negative at 0.81 mg/L (reference, 0.90 mg/L) with vaccination occurring approximately 3 weeks before assessment. There were only 2 increased pneumococcal antibody IgG serotypes despite the receipt of his fourth PREVNAR 4 months before presentation. In vitro mitogen and antigen stimulation studies, which were planned by the Immunologist on an outpatient basis, were never completed. The bandemia and low absolute polymorphonuclear count in our patient were indicative of a sepsis syndrome not septic shock. Because the subject was afebrile, the site of the effusion was small, and the patient was clinically improving, a diagnostic paracentesis was not deemed necessary. Magnetic resonance images were planned as outpatient follow-up for the subject. Our case presented was of a child who not only had unvaccinated contacts but, in addition, had no immune response to the Hib vaccine. We cannot definitely state that the child was immunodeficient because additional testing was needed, but the finding of chronic sinusitis on his initial CT on presentation was consistent. Overall, however, despite the need for some upcoming booster vaccinations, we do think that his profile was suspicious for an immune deficiency considering the fact that he lacked protective responses to a number of previous vaccinations. A defect of his humoral immune system was most likely noting that an X-linked Bruton agammaglobulinemia would be unlikely given a normal number of B cells. It would be presumptuous to diagnose the subject with a specific immune deficiency without additional testing. In vitro mitogen and antigen stimulation studies were also planned with his next laboratory assessment. Additional information would be important as one appreciates that select dysfunctions of cellular, humoral, and even innate immunity would allow one to narrow the diagnosis. The poor outcome may be related to the patient''s immunologic deficiency, which, perhaps, did not completely eradicate the organism despite an adequate course of antibiotics, allowing ongoing inflammation and release of cytokines that may have irritated the patient''s brain, although this cannot be documented because of the absence of a repeat lumbar puncture during the first course of treatment and the negative CSF chemistries obtained on the second ED visit. This was a subject who did not maintain protective responses to select vaccines (including strong immunogens, like tetanus) that he received according to the recommended vaccination schedule. He was a child who needed boosters; therefore, omission of the booster dose of Hib for him probably did increase his susceptibility to the organism. The sudden demise of our patient with seizures, apnea, bradycardia, and fixed pupils was most consistent with a neurologic cause despite the absence of herniation on autopsy. The author considered the events were related to vaccination with Hib.


VAERS ID: 410265 (history)  
Form: Version 1.0  
Age: 1.3  
Sex: Male  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-11-25
Entered: 2010-11-29
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 4 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Antibody test negative, Apnoeic attack, Autopsy, Bacterial test, Bacterial test negative, Band neutrophil count decreased, Basophil count decreased, Blood culture positive, Blood electrolytes normal, Blood glucose normal, Blood immunoglobulin G increased, Body temperature increased, Bradycardia, Brain oedema, CSF culture positive, CSF glucose, CSF lymphocyte count, CSF neutrophil count positive, CSF protein, CSF test abnormal, CSF white blood cell count positive, Catheter placement, Central nervous system inflammation, Cerebral hygroma, Clostridium test negative, Computerised tomogram abnormal, Computerised tomogram head, Computerised tomogram normal, Corynebacterium test positive, Crying, Death, Decreased eye contact, Depressed level of consciousness, Diffuse axonal injury, Endotracheal intubation, Eye disorder, Gram stain negative, Grand mal convulsion, Haemophilus test positive, Heart rate normal, Hemiparesis, Hypokinesia, Hypophagia, Hypotonia, Immunoglobulin therapy, Immunology test abnormal, Intensive care, Lethargy, Liver function test normal, Lumbar puncture abnormal, Lymphocyte count decreased, Meningitis, Meningitis haemophilus, Mental status changes, Microbiology test abnormal, Monocyte count decreased, Muscular weakness, Musculoskeletal stiffness, Mydriasis, Nervous system disorder, Neurological examination abnormal, Neutrophil count, Neutrophil count decreased, Neutrophil morphology abnormal, Nuclear magnetic resonance imaging abnormal, Otitis media, Pachymeningitis, Partial seizures, Protein total, Pupil fixed, Pyrexia, Red blood cells CSF positive, Resuscitation, Scan brain, Sepsis, Sinus disorder, Subdural empyema, Subdural hygroma, Tardive dyskinesia, Toxicologic test normal, Tympanic membrane disorder, Tympanic membrane hyperaemia, Ultrasound abdomen normal, Urine analysis normal, Urine output decreased, Varicella virus test negative, Vomiting, White blood cell count decreased, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Acute pancreatitis (broad), Agranulocytosis (broad), Angioedema (broad), Haematopoietic leukopenia (narrow), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Arthritis (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No significant past medical history.
Allergies:
Diagnostic Lab Data: Immunologic workup from the first hospitalization included quantitative immunoglobins with an IgG of 4.91 g/L (range 0.40-2.50 g/L) both at the lower end of normal for age. No significant tetanus antitoxoid antibodies at 0.08 IU/mL (reference, 0.16 IU/mL) or Hib antibodies at 0.13 mg/L (reference, 0.15 mg/L) were detected. Diphtheria antitoxoid antibodies were present at 0.20 IU/ML (reference, 0.10 IU/mL). Varicella IgG was also negative at 0.81 mg/L (reference, 0.90 mg/L) with vaccination occurring approximately 3 weeks before assessment. There were only 2 increased pneumococcal antibody IgG serotypes despite the receipt of his fourth PREVNAR 4 months before presentation.
CDC Split Type: 201006457

Write-up: Initial report retrieved from the scientific literature on 15 November 2010. It is a case report taken from the following source: The following is verbatim from the article: "A 15-month with no significant past medical history presented to the emergency department for 2 days Tmax of 102 degrees F, lethargy and decrease oral intake and urine output. There was vomiting the day before admission. He was seen by his physician who diagnosed otitis media and referred him to the ED because of a concern for the level of consciousness. Immunizations were up-to date (3 DTap and Hib vaccinations, with the last being 9 months ago) except for VARIAVX which he did not receive secondary to a manufacturer shortage. Family history included a 3-year-old brother with reactive airways disease. Social history was notable for attendance at a church daycare where many children were not immunized. On arrival to the ED, vital signs were as follows: temperature, 36.5 degrees C; heart rate, 133 beats per minute; blood pressure, 81/62 mm Hg; respiratory rate, 24 breaths per minutes; and pulse oximetry, 97% on room air. Physical examination revealed a child with a weak cry who did not maintain eye contact with the examiner. Stiffness of his neck was noted with flexion and extension. The right tympanic membrane was erythematous and bulging. Pulses and perfusion were normal. Leukocyte count was 3 x 10E9/L white blood cells (0.23 segmented neutrophils and 0.55 bands) with Dohle bodies and vacuolization noted on the smear. Two 20-mL/kg saline boluses were given with no improvement in mental status. A blood culture was obtained before ceftriaxone 100 mg/kg was given intravenously. Soft tissue radiographs and computed tomographic scans of the neck ruled out retropharyngeal abscess but revealed opacification of both maxillary sinuses. Cloudy cerebrospinal fluid was obtained from lumbar puncture. Immediately after the procedure and before laboratory results, vancomycin was given. Cerebrospinal fluid had the following: white blood cell count, 3.45 x 10E9/L (0.59 neutrophils); red cell count, 1 x 10E9/L; glucose, 0.6612 mmol/L, and protein, 2.98 g/L; CSF was also positive by Phadebact Haemophilus Co-Agglutination test, manufactured by BOULE Diagnostics, Foreign. When the Gram stain showed gram-negative rods, meropenem was added. The hospital microbiology laboratory serotyped the organism as type b, which was confirmed by the state laboratory. The patient was admitted to the pediatric intensive care unit with a diagnosis of meningitis and sepsis. Mental status improved on day 2. Dexamethasone was started, and antibiotics were switched to ceftriaxone alone when blood and CSF cultures returned positive for Hib sensitive to ampicillin. Evaluation for the immunologic response to Hib and immunodeficiency was initiated on day 3, but results were not available during the hospital stay. The patient was transferred to the floor after results of CT scan of the head were normal on day 4. A lumbar puncture was planned on day 7, but the parents refused the procedure. Day 8 was the last day that fever (Tmax, 38.8 degrees) was present. Blood and urine cultures were sent; vancomycin was added for a possible central venous line infection. Magnetic resonance imaging on day 9 demonstrated a thin dural hygroma over the left cerebral convexity that measured approximately 4mm in thickness but normal spleen for age. On day 12 of hospitalization, vancomycin was discontinued. The patient was discharged after 13 days of antibiotics with appointments scheduled with neurology and immunology. The pediatrician was to arrange audiologic with appointments scheduled with neurology and immunology. The pediatrician was to arrange audiologic evaluation and early intervention; further immunologic evaluation was planned. The patient returned to the ED 48 hours after discharge with focal seizure activity. On the day of admission, the patient was afebrile and was more active than in previous days. Parents described right side shaking that lasted several minutes. After the seizure, he was noted to have decreased movement of the right upper and lower extremities. Vital signs in the ED included the following: temperature, 37.9 degrees C; heart rate, 96 beats per minute; respiratory rate, 28 breaths per minute; pulse oximetry, 99% on room air (no blood pressure was recorded). Physical examination revealed an awake child in no immediate distress. Anterior fontanelle was open and flat; pupils were equally round and reactive. No papilledema was noted, and extraocular eye movements were intact. Neurological examination was significant for flaccid right lower extremity and a weak right upper extremity with normal reflexes and sensation. The remainder of the physical examination was unremarkable. There was improvement of the right hemiparesis during his ED stay. Workup in the ED included CT scan of the brain, which demonstrated a left-sided hygroma without midline shift. He then underwent a lumbar puncture that obtained clear fluid with opening pressure of 17 cm H20. Results of analysis were as follows: white blood cells, 0.064 x 10E9L (o.11 neutrophils and 0.77 lymphocytes)l red blood cells, 0.017 x 10E9/L; glucose, 3.94121 mmol/L; and protein, 1.14 g/L. Gram stain demonstrated rare white blood cell count and no organisms. Bacterial antigen panel was negative as was the final culture. White blood cell count was 24.7 x 10E9/L with 0.81 neutrophils, 0.11 lymphocytes, 0.06 monocytes, and 0.02 basophils. Electrolytes and liver profile were normal. Urine toxicology was negative. Neurology and infectious disease consultations were obtained. Ceftriaxone was given intramuscularly per recommendation of the infectious disease specialist because intravenous access was not obtained immediately. Shortly after the lumbar puncture was completed, the patient had generalized tonic-clonic seizure characterized by lip smacking for which he received 1 mg of lorazepam and 15 mg/kg of fosphenytoin intravenous with resolution. During transport to the PICU, he had recurrence of seizure activity. On transfer to the PICU bed, he became apneic and bradycardiac. At that time, his pupils were fixed and dilated. Cardiopulmonary resuscitation was initiated, and his trachea emergently intubated. Mannitol was given along with additional doses of lorazepam and resuscitation medications. Hypertonic saline was infused for presumed cerebral edema. The pediatric neurosurgeon performed a ventricular tap that produced 7 mL of purulent CSF. A ventricular catheter as then placed and yielded 40 mL of CSF, but resuscitation was unsuccessful. Autopsy demonstrated severe acute and chronic leptomenigitis described as multilayer exudates with neutrophils, lymphocytes, and proliferating capillaries. There was subdural empyema with organizing pachymeningitis of the left frontal region and diffuse brain edema with acute neuronal injury. No evidence of herniation was noted at autopsy. Immunologic workup from the first hospitalization included quantitative immunoglobulins with an IgG of 4.91 g/L (range, 0.40-2.50 g/L) both at the lower end of normal for age. No significant tetanus antitoxoid antibodies at 0.08 IU/mL (reference, 0.16 IU/mL) or Hib antibodies at 0.13 mg/L (reference, 0.15 mg/L) were detected. Diphtheria antitoxoid antibodies were present at 0.20 IU/ML (reference, 0.10 IU/mL). Varicella IgG was also negative at 0.81 mg/L (reference, 0.90 mg/L) with vaccination occurring approximately 3 weeks before assessment. There were only 2 increased pneumococcal antibody IgG serotypes despite the receipt of his fourth PREVNAR 4 months before presentation. In vitro mitogen and antigen stimulation studies, which were planned by the Immunologist on an outpatient basis, were never completed. DISCUSSION: The poor outcome may be related to the patient''s immunologic deficiency, which, perhaps, did not completely eradicate the organism despite and adequate course of antibiotics..." Documents held by sender: None


VAERS ID: 410690 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Male  
Location: Florida  
Vaccinated:2009-10-20
Onset:2009-11-06
   Days after vaccination:17
Submitted: 2010-11-30
   Days after onset:389
Entered: 2010-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LA / IM
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / 1 RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Blood test, Death, Guillain-Barre syndrome, Intensive care, Laboratory test, Lumbar puncture, Nuclear magnetic resonance imaging, Paralysis, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (broad), Respiratory failure (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2009-12-19
   Days after onset: 43
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 36 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: no
Allergies:
Diagnostic Lab Data: spinal taps, blood tests, MRI scans, etc
CDC Split Type:

Write-up: Almost 6 weeks in ICU with paralysis, respiritory arrest, death from Guillain Barre Syndrome


VAERS ID: 411487 (history)  
Form: Version 1.0  
Age: 0.01  
Sex: Male  
Location: Unknown  
Vaccinated:2010-09-18
Onset:2010-11-15
   Days after vaccination:58
Submitted: 2010-12-03
   Days after onset:18
Entered: 2010-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB842BA / 1 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-11-15
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NH12032010

Write-up: Dob 9-16-10 dod 11-15-10 received ENGERIX B 9/18/10.


VAERS ID: 411968 (history)  
Form: Version 1.0  
Age: 41.0  
Sex: Male  
Location: Texas  
Vaccinated:2010-10-20
Onset:2010-11-21
   Days after vaccination:32
Submitted: 2010-12-07
   Days after onset:16
Entered: 2010-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 501057P / UNK NS / IN

Administered by: Military       Purchased by: Military
Symptoms: Activities of daily living impaired, Atelectasis, Chills, Computerised tomogram abnormal, Cough, Dyspnoea, Insomnia, Pleural effusion, Pneumonia, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-11-30
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unfortunately, no vaccine information available
Current Illness: Unknown
Preexisting Conditions: NKDA
Allergies:
Diagnostic Lab Data: Bilateral pneumonia versus atelectasis with associated pulmonary effusion shown on chest CT; no PE seen.
CDC Split Type:

Write-up: Pt states shortness of breath started 2 weeks ago when he received Flu mist. symptoms mild at that time. he began to have activity limiting symptoms on 19Nov, unable to take a deep breath or sleep because of symptoms. He becomes very SOB with ambulation. Has cough that is only present when he takes a deep breath (nonproductive). Fever and chills over the last 2 weeks, had fever of 102.2 on presentation to emergency room, and satting 91% on room air.


VAERS ID: 412247 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-08-01
Onset:0000-00-00
Submitted: 2010-12-07
Entered: 2010-12-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Adverse event, Convulsion, Death, Fatigue, Hypoaesthesia, Initial insomnia, Mood altered, Ovarian cyst, Paraesthesia, Respiratory arrest, Syncope, Urinary tract infection
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1012USA00781

Write-up: Information has been received from a physician via a consumer who provided the physician with a link to a forum. The information was received from the patient''s mother, from the link, concerning her healthy 14 year old daughter who in August 2007, January 2008, and June 2008, was vaccinated with a first, second and third dose of GARDASIL (lot # not provided). It was reported that the patient experienced several symptoms including numbness and tingling in her fingers and toes, fatigue, a really hard time falling asleep, urinary tract infections, ovarian cyst, moody, trouble getting out of bed and seizures. The patient had had upwards of 150 seizures following her third shot in June 2008. During her seizures she stopped breathing for periods of 30 to 40 seconds. The patient was diagnosed with Neurocardiogenic syndrome and seizures. It was reported that the patient died due to ovarian cyst. The reporter felt that the patient''s symptoms were related to vaccination with GARDASIL. Upon internal review, the seizures were considered to be other important medical events "seizures" as an other important medical event. No further information is available.


VAERS ID: 412282 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-12-08
Entered: 2010-12-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1011USA03821

Write-up: Information has been received from a nurse practitioner, who mentioned a magazine''s article concerning 70 young female patients who, on an unspecified date, were vaccinated with a dose of GARDASIL (lot #, expire date and route not reported), 0.5 ml. On an unspecified date the patients died from "neurological causes" after being given GARDASIL. "Neurological disorders" were considered to be immediately life-threatening and disabling by the nurse practitioner. Additional information has been requested. This is one of two reports from the same source. Attempts are being made to verify the existence of identifiable patients. This is one of two reports from the same source.


VAERS ID: 412768 (history)  
Form: Version 1.0  
Age: 0.43  
Sex: Female  
Location: Missouri  
Vaccinated:2010-11-10
Onset:2010-11-10
   Days after vaccination:0
Submitted: 2010-12-14
   Days after onset:34
Entered: 2010-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3788AA / 1 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH O14313 / 2 LL / UN

Administered by: Unknown       Purchased by: Other
Symptoms: Death, Decreased appetite, Diarrhoea, Insomnia, Malaise, Pyrexia
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)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-11-18
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Patient received her four month shots within the "four weeks" question above. Without her medical records infront of me, I do not know the date or the names of the vaccines. I can get the information, if needed.
Current Illness: No, patient was very healthy.
Preexisting Conditions: No, patient was very healthy.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient started getting sick around 9 hours after receiving the vaccine. Patient had never been sick before, not even a cold. Her symptoms included fever, diarrhea, loss of appetite & not sleeping very well.


VAERS ID: 413092 (history)  
Form: Version 1.0  
Age: 9.0  
Sex: Female  
Location: Nevada  
Vaccinated:2010-12-17
Onset:2010-12-18
   Days after vaccination:1
Submitted: 2010-12-18
   Days after onset:0
Entered: 2010-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR 713639DA / UNK LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-12-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: unknown manufacturer, report completed by ED doctor. Detailed vaccine information unavailable. Please contact family
Current Illness: uk
Preexisting Conditions: Sickle Cell
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: respiratory and cardiac arrest resulting in death


VAERS ID: 413215 (history)  
Form: Version 1.0  
Age: 5.0  
Sex: Female  
Location: Virginia  
Vaccinated:2010-11-01
Onset:2010-12-06
   Days after vaccination:35
Submitted: 2010-12-20
   Days after onset:14
Entered: 2010-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 501049P / 2 NS / IN

Administered by: Public       Purchased by: Public
Symptoms: Blindness, Death, Headache, Intensive care, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2010-12-16
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: VA10020

Write-up: On 12/6/10, developed fever & headache. Treated with Advil until 12/9/10; went to PMD; patient vomiting, 12/10/10, vision loss, adm. to E.R. 12/11/10, transferred to PICU. Expired 12/16/10.


VAERS ID: 413389 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Female  
Location: Alabama  
Vaccinated:2010-10-21
Onset:2010-11-23
   Days after vaccination:33
Submitted: 2010-12-21
   Days after onset:28
Entered: 2010-12-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3730AA / UNK LA / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Balance disorder, Bradyphrenia, Feeling abnormal, Gait disturbance, Irritability, Mobility decreased, Nausea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-01-17
   Days after onset: 1881
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Swelling~Pneumo (no brand name)~UN~0.00~Patient|Injection site mass~Pneumo (no brand name)~UN~0.00~Patient
Other Medications: Prednisone; blood pressure pill; Vitamin B12
Current Illness:
Preexisting Conditions: History of increased blood pressure, and temporal arteritis (3 years). Additionally, the patient reported that 5 years earlier she had experienced "swelling and a hard knot" following vaccination with pneumonia vaccine.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201007010

Write-up: This case was initially reported by a consumer, who is also the patient, on 15 December 2010. A 79-year-old female patient received an INFLUENZA VACCINE (manufacturer reported as "possibly Sanofi Pasteur", lot not reported) in the left arm on 22 November 2010. The patient had a history of increased blood pressure and temporal arteritis (for past 3 years); she had previously experienced swelling and a hard knot at the site of a pneumococcal vaccine, and had received numerous influenza vaccines in the past. Concomitant medications included prednisone, a blood pressure pill, and Vitamin B12 1000mg. According to the patient, approximately 6 hours post-vaccination she began experiencing fever, nausea, vomiting, and difficulty in moving. Approximately 12 hours post-vaccination, she had a fever of 103 degrees and was unable to get out of bed. She was seen by a physician the day after vaccination, at which time she complained of difficulty walking and "brain function problem", described as fuzziness, slow thinking process, and balance problems when walking. The patient noted that she had been seen by a "brain doctor". Outcome was not reported.


VAERS ID: 413591 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: Kentucky  
Vaccinated:2010-12-07
Onset:2010-12-14
   Days after vaccination:7
Submitted: 2010-12-15
   Days after onset:1
Entered: 2010-12-28
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B254BA / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1246Z / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH E87535 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0982Z / 1 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-12-14
   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: None
Preexisting Conditions: None; Late PNC (No PNC until 6 mo gestation); Had not been to MD until 2 mo of age.
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: None stated.


VAERS ID: 413664 (history)  
Form: Version 1.0  
Age: 88.0  
Sex: Male  
Location: Rhode Island  
Vaccinated:2010-11-03
Onset:2010-11-17
   Days after vaccination:14
Submitted: 2010-12-28
   Days after onset:41
Entered: 2010-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA622AA / UNK LA / UN

Administered by: Public       Purchased by: Other
Symptoms: Asthenia, Cerebrovascular accident, Death, Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-12-02
   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: NONE NOTED
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: No record available.
CDC Split Type:

Write-up: After 2 weeks SP immunization Resid - Began to c/o increased weakness & numbness. Sat -$g MD. Apt with MD. Started on neurontin 11/20. Sat on floor. L/T increased weakness. 11/21 -$g hosp with signs & sx of CVA.


VAERS ID: 413697 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-12-28
Entered: 2010-12-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1012USA02761

Write-up: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with the second dose of GARDASIL (lot number not provided). The physician was visiting his dentist and was talking to the dental hygienist about GARDASIL. The dental hygienist said she had a friend whose daughter died after getting the second dose of GARDASIL. It was unknown if the patient sought medical attention. The reporter considered death to be disabling and life-threatening. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination, lot number, date of event, hospital name (if applicable), and healthcare provider name and contact information. Additional information has been requested.


VAERS ID: 413836 (history)  
Form: Version 1.0  
Age: 95.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2010-11-01
Onset:2010-12-20
   Days after vaccination:49
Submitted: 2011-01-02
   Days after onset:13
Entered: 2011-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Decreased appetite, Full blood count normal, Haemoglobin decreased, International normalised ratio decreased, Melaena, Nausea, Platelet count decreased, White blood cell count decreased
SMQs:, Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-01-07
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Lisinopril; Aspirin; Omeprazole; Diltiazem
Current Illness: None
Preexisting Conditions: Hypertension; Chronic kidney disease; Neurogenic bladder; Allergies: codeine, sulfa
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: May of 2010, CBC plt were normal. Dec of 2010, WBC count of 2.5 - hemoglobin = 7.0 - plt = 14 - no schistocystes or RBC fragments to suggest consumptive coagulopathy, no teardrop cells, plts appear nl, INR = 1.29. Patient complaining of melanic stools, abdominal pain, nauseam decreased appetite, for since December 20, 2010.


VAERS ID: 413868 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: New York  
Vaccinated:2010-07-09
Onset:0000-00-00
Submitted: 2010-12-28
Entered: 2011-01-03
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB711AA / 1 LA / IM
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. 0695Z / 1 LA / SC

Administered by: Private       Purchased by: Private
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: 2010-12-11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Scleroderma
Allergies:
Diagnostic Lab Data: Au at hospital. Not available to me.
CDC Split Type:

Write-up: GUILLAIN BARRE Syndrome Dx 10/2010 by Dr. Tx at hospital.


VAERS ID: 413980 (history)  
Form: Version 1.0  
Age: 0.35  
Sex: Male  
Location: Louisiana  
Vaccinated:2010-12-16
Onset:2010-12-17
   Days after vaccination:1
Submitted: 2011-01-03
   Days after onset:17
Entered: 2011-01-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3739AA / 2 LL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 915065 / 2 LL / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FB096A / 2 MO / PO

Administered by: Private       Purchased by: Unknown
Symptoms: Autopsy, Cardiac arrest, Death, Irritability
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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-12-17
   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: None
Preexisting Conditions: s/p repair of duodenal perforation
Allergies:
Diagnostic Lab Data: autopsy - grossly normal
CDC Split Type:

Write-up: Became fussy with feeds 24 hours after vaccines given then went into cardiac arrest.


VAERS ID: 414023 (history)  
Form: Version 1.0  
Age: 0.27  
Sex: Unknown  
Location: New Hampshire  
Vaccinated:2010-10-08
Onset:2010-10-27
   Days after vaccination:19
Submitted: 2011-01-04
   Days after onset:69
Entered: 2011-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB807CA / 2 RL / UN
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3670AA / 2 RL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH E57643 / 2 RL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. D07962 / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-10-27
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NH01042011

Write-up: Pt got birth dose of Hep B 7/31/10 SIDS baby.


VAERS ID: 414065 (history)  
Form: Version 1.0  
Age: 0.38  
Sex: Female  
Location: Ohio  
Vaccinated:2010-11-01
Onset:2010-11-16
   Days after vaccination:15
Submitted: 2011-01-05
   Days after onset:50
Entered: 2011-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B099BA / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0524Z / 2 MO / PO

Administered by: Private       Purchased by: Other
Symptoms: Bacterial test negative, Brain oedema, Cardiac arrest, Computerised tomogram abnormal, Respiratory arrest, Scan brain, Viral test negative
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2010-11-17
   Days after onset: 1
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: No
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Patient was tested for viral and bacterial infections, all results were negative. CT showed significant swelling of the brain but no evidence of trauma or bleed.
CDC Split Type:

Write-up: Cessation of respiration, cardiac arrest


VAERS ID: 414074 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Male  
Location: Colorado  
Vaccinated:2010-08-09
Onset:2010-08-10
   Days after vaccination:1
Submitted: 2011-01-05
   Days after onset:148
Entered: 2011-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3614AA / 2 LL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBV833DA / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E46124 / 2 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-08-10
   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:
Current Illness: No
Preexisting Conditions: gastroesophageal reflux treated with ranitidine
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death


VAERS ID: 414096 (history)  
Form: Version 1.0  
Age: 0.97  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2010-12-30
Onset:2010-12-31
   Days after vaccination:1
Submitted: 2011-01-04
   Days after onset:4
Entered: 2011-01-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT3574CA / 2 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-12-31
   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: Robinol; Hydrocortisone; Phenobarbital; KEPPRA; PREVACID; ATIVAN PRN; TYLENOL
Current Illness:
Preexisting Conditions: Holoprosencephaly; Diabetes Insipidus; seizure; adrenal insufficiency; FT
Allergies:
Diagnostic Lab Data: Coroner performing autopsy 1/4/11
CDC Split Type:

Write-up: Details unknown. I was notified by agency that pt expired 12/31/10.


VAERS ID: 414136 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2009-09-14
Onset:2010-05-01
   Days after vaccination:229
Submitted: 2011-01-01
   Days after onset:245
Entered: 2011-01-06
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 97846P2A / UNK LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Condition aggravated, Death, Herpes zoster, Living in residential institution, Neuropathy peripheral
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-10-26
   Days after onset: 178
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: many
Current Illness: no
Preexisting Conditions: COPD - died from COPD but the shingles amplified her condition.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: My mom received shingles vac. on 7/15/09. In May she developed a very intense case of shingles & developed severe neuropathy in her left leg & abdomen. She was hospitalized for about 6 weeks had to move to assisted living, never fully recovered & died 10/26/10.


VAERS ID: 414262 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Ohio  
Vaccinated:2011-01-03
Onset:2011-01-04
   Days after vaccination:1
Submitted: 2011-01-07
   Days after onset:3
Entered: 2011-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3668AA / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E69593 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0508Z / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-01-04
   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: Unknown
Current Illness: None recorded or verbalized by Mother.
Preexisting Conditions: None recorded or verbalized by Mother
Allergies:
Diagnostic Lab Data: Autopsy.
CDC Split Type:

Write-up: To ER. Deceased. Details unavailable. Coroners case. Autopsy performed. Information from Coroner - preliminary shows no cause of death.


VAERS ID: 414511 (history)  
Form: Version 1.0  
Age: 7.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2010-11-08
Onset:2010-12-19
   Days after vaccination:41
Submitted: 2011-01-11
   Days after onset:23
Entered: 2011-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 501013P / UNK NS / IN

Administered by: Private       Purchased by: Private
Symptoms: Acute disseminated encephalomyelitis, Coma, Confusional state, Death, Lumbar puncture, Nuclear magnetic resonance imaging, Pyrexia, Subacute sclerosing panencephalitis
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Demyelination (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-01-02
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 14 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Peg Infron; Isoprinosine
Current Illness: SSPE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: MRI & LP at Clinic and Hospital
CDC Split Type:

Write-up: ADEM secondary to agency from administration of live virus flu vaccine to patient following interferon confusion, fever, coma, death. Contact hospital doctor for details.


VAERS ID: 414719 (history)  
Form: Version 1.0  
Age: 0.15  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2011-01-11
Onset:2011-01-12
   Days after vaccination:1
Submitted: 2011-01-14
   Days after onset:2
Entered: 2011-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3582AA / 1 LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0657Z / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 914515 / 1 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FB110A / 1 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Death, Irritability, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-01-13
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DIGOXIN; ASA; LASIX; POLYVISOL w/Iron
Current Illness: fussy per parents day before vaccines
Preexisting Conditions: Double outlet right ventricle; mitral atresia; pulmonary atresia; s/p aortopulmonary shunt 11/19/2010
Allergies:
Diagnostic Lab Data: Not available
CDC Split Type:

Write-up: Day after vaccines pt. sleepy, fussy. Two days after vaccines pt died.


VAERS ID: 414753 (history)  
Form: Version 1.0  
Age: 36.0  
Sex: Male  
Location: Utah  
Vaccinated:2010-12-13
Onset:2010-12-16
   Days after vaccination:3
Submitted: 2011-01-15
   Days after onset:30
Entered: 2011-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA595AA / UNK LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Abdominal distension, Cardiac arrest, Death, Depressed level of consciousness, Dyspnoea, Headache, Hyperhidrosis, Increased bronchial secretion, Nasopharyngitis, Nausea, Pain, Pulse abnormal, Resuscitation, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (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), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-12-20
   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: Fentanyl patch 100 mcg 1 patch every 2 days Oxycodone 30 mg 1 q 3 hrs prn pain Midodrine 10 mg 1 q d Captopril 12.5 mg 1/2 tab q 8 hrs Fludrocortisone 0.1 mg 1 q d Omeprazole 40 mg 1 q d Paxil 40 mg 1 q d Clonazepam 1 mg 1-2 q hs prn insomn
Current Illness: Cellulitis, abdomen, at PEG tube site. Afebrile
Preexisting Conditions: Chronic illnesses: Muscular Dystrophy, Limb girdle type Quadriplegia Dysphagia requiring feeding tube Chronic respiratory failure requiring ventilator support. Chronic hypoxemia. Chronic right pleural effusion. History of recurrent pneumonia. Congestive heart failure Chronic pain requiring chronic Chronic anemia Chronic depression and anxiety
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 12/16/2010. Patient''s wife called to report that he developed nausea, headache, sweats, aching, cold two days ago (1 day after the flu vaccine was administered). On 12/15/10 he had more difficulty breathing but didn''t mention this on 12/16/10 although he still had body aches. I recommended that he receive ibuprofen 800 mg tid until the symptoms subsided. Go to ER for increased difficulty breathing. 12/20/10. Hospital ED physician called to report that patient was found by his wife in the morning to be difficult to arouse. His abdomen was distended and he had nausea with increased secretions. 911 was called. They found his pulse to be thready and while being transported to the ER went into ventricular fibrillation and then asystole. A full code was done in the ER but they were unable to resuscitate him and he died.


VAERS ID: 414974 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Male  
Location: Illinois  
Vaccinated:2010-09-22
Onset:2010-12-26
   Days after vaccination:95
Submitted: 2011-01-19
   Days after onset:24
Entered: 2011-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U3602AA / 1 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Death, Guillain-Barre syndrome, Malaise
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: 2011-01-06
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Per patients daughter, he developed Guillain Barre Syndrome. He fell ill on 12/26/2010, was admitted to Medical Center and passed away on 1/6/2011.


VAERS ID: 415383 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Female  
Location: Florida  
Vaccinated:2010-10-20
Onset:2010-10-21
   Days after vaccination:1
Submitted: 2011-01-25
   Days after onset:96
Entered: 2011-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3558AA / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E44433 / 1 RL / IM

Administered by: Unknown       Purchased by: Public
Symptoms: Death, Inappropriate schedule of drug administration
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-10-21
   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: PREMI
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: NONE


VAERS ID: 415725 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: Indiana  
Vaccinated:2011-01-13
Onset:2011-01-16
   Days after vaccination:3
Submitted: 2011-01-21
   Days after onset:5
Entered: 2011-01-28
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3748AB / 1 RL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB833CA / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 915192 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0526Z / 1 MO / PO

Administered by: Public       Purchased by: Public
Symptoms: Autopsy, Death, Respiratory arrest, Sudden infant death syndrome, Toxicologic test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Neonatal disorders (narrow), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-01-16
   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: Clubfoot; tongue-tie
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt. received vaccinations at at 10:00am on 1-13-11 - no problems noted after receiving vaccinations. Infant found not breathing at 0930 on 1-16-11 by parents. Had been sleeping in car seat (not strapped in)- in living room. Unable to resuscitate. Pronounced dead at hospital. Autopsy listed cause of death SUIDS - Sudden Unexplained infant death. Awaiting toxicology reports/results.


VAERS ID: 416107 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2005-07-12
Onset:2011-01-13
   Days after vaccination:2011
Submitted: 2011-02-03
   Days after onset:21
Entered: 2011-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U1639AA / 1 LA / IM

Administered by: Unknown       Purchased by: Other
Symptoms: CSF culture positive, Death, Endotracheal intubation, Gram stain, Hypoaesthesia, Lacrimal haemorrhage, Meningitis, Meningococcal bacteraemia, Neisseria test positive, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow), Lacrimal disorders (narrow), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2011-01-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No medications
Current Illness: Unknown
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Neisseria meningitidis serogroup C confirmed by culture in cerebrospinal fluid sample. Cause of death: meningococcemia and meningitis.
CDC Split Type: 473442WI00010

Write-up: Non-specific symptoms began 1/12/2011, progressed to rash, fever, numbness in arms/legs 1/13. Taken to Emergency Department, experienced blood in tears, was intubated and crashed within 2 hours of arrival to hospital. Cerebrospinal fluid was collected and showed Gram-negative diplococci. Culture later tested positive for Neisseria meningitidis serogroup C.


VAERS ID: 416374 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2009-08-17
Onset:2011-01-21
   Days after vaccination:522
Submitted: 2011-02-04
   Days after onset:14
Entered: 2011-02-08
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2818AA / UNK LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Blood culture positive, Death, Intensive care, Meningococcal sepsis, Petechiae, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: 2011-01-23
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201100459

Write-up: Initial case received from a physician on 01 February 2011. A 17-year-old male patient received an intramuscular injection of MENACTRA (lot number U2818AA) on 17 August 2009. On 21 January 2011 he presented to the emergency room with fever, vomiting, and petechia, and was diagnosed with meningococcal septicemia. He was transferred to the intensive care unit in critical condition, and died on 23 January 2011. Per the reporter, the patient had undergone blood cultures which were positive for meningococcal strain C. No medical history or concomitant medications were reported; the patient was not ill at the time of vaccination. Documents held by sender: None.


VAERS ID: 416456 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2010-10-18
Onset:2010-11-20
   Days after vaccination:33
Submitted: 2011-02-09
   Days after onset:81
Entered: 2011-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT3579BA / UNK LA / IM

Administered by: Public       Purchased by: Other
Symptoms: Abasia, Electromyogram, Hypoaesthesia, Laboratory test, Lumbar puncture, Muscular weakness, Nuclear magnetic resonance imaging, Scan, X-ray
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (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, 12 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Fish oil, Centrum silver, Baby aspirin, Decadron, Testosterone, folic acid, lasix, Nexium, Toprol-XL, Zocor, Ambien, Levaquin, Neurontin, Rephresh eyedrops, Colace Lortab, coumadin, IVIG
Current Illness: peripheral vascular disease
Preexisting Conditions: colon polyps, Benign prostatic hyperplasia, osteoarthritis, atherosclerotic peripheral vascular disease, history CVA, pituitary adenoma with right partial third nerve palsy, hyperlipidemia, hypertension, peripheral neuropathy, organic health disease with atrial fibrillation and cardiomegaly
Allergies:
Diagnostic Lab Data: Was sent to Nursing Home after discharge from hospital. MRI, scans, lumbar puncture, EMG, xray, lab
CDC Split Type:

Write-up: 6 wks after receiving the vaccine began having progressive weakness and numbness in legs and fingertips. Few days prior to admission to hosptial 1/26/2011 unable to walk.


VAERS ID: 416893 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Female  
Location: Colorado  
Vaccinated:2011-02-02
Onset:2011-02-07
   Days after vaccination:5
Submitted: 2011-02-15
   Days after onset:8
Entered: 2011-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3665AA / 2 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0285Z / 1 RL / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0834Z / 1 RL / SC

Administered by: Public       Purchased by: Public
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-02-07
   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: denied by parent
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: apparently found dead in bed by parent


VAERS ID: 416930 (history)  
Form: Version 1.0  
Age: 32.0  
Sex: Male  
Location: Delaware  
Vaccinated:2010-11-02
Onset:2010-11-25
   Days after vaccination:23
Submitted: 2011-02-16
   Days after onset:83
Entered: 2011-02-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3486AA / 1 LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Cardioversion, Convulsion, Death, Hypoxic-ischaemic encephalopathy
SMQs:, Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (narrow), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-12-04
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 9 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: seizure resulting in defribrilation resulting in anoxic brain injury. treated at Hospital.


VAERS ID: 417137 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2011-01-04
Onset:2011-02-02
   Days after vaccination:29
Submitted: 2011-02-08
   Days after onset:6
Entered: 2011-02-18
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0096Z / 2 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3432AA / 1 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-02-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NORINYL
Current Illness: none
Preexisting Conditions: Hay fever; Animal fur
Allergies:
Diagnostic Lab Data:
CDC Split Type: TN1101

Write-up: Patient deceased within 30 days of vaccine administration.


VAERS ID: 417195 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Female  
Location: Florida  
Vaccinated:2011-02-09
Onset:2011-02-10
   Days after vaccination:1
Submitted: 2011-02-18
   Days after onset:8
Entered: 2011-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3771AA/C3613AA / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 914515 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0525Z / 1 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Apnoea, Death, Hypoxia, Resuscitation
SMQs:, Asthma/bronchospasm (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-02-16
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Synagis given on 1/17/2011
Current Illness: No
Preexisting Conditions: History of prematurity
Allergies:
Diagnostic Lab Data: Please refer to hospital records.
CDC Split Type:

Write-up: Baby was found apneic in bed with parents. She was resuscitated, but died of complications of hypoxia.


VAERS ID: 417551 (history)  
Form: Version 1.0  
Age: 89.0  
Sex: Female  
Location: California  
Vaccinated:2011-02-17
Onset:2011-02-19
   Days after vaccination:2
Submitted: 2011-02-24
   Days after onset:5
Entered: 2011-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / SANOFI PASTEUR U2591AA / UNK LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Asthenia, Dysphagia, Muscle spasms
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2011-02-26
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt. suffered a fall about 2 weeks ago and had abrasion and received tetanus vaccine and about 48 hours post vaccination she became extremely weak with dysphagia and increased muscle spasm.


VAERS ID: 417625 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2010-12-03
Onset:2011-02-04
   Days after vaccination:63
Submitted: 2011-02-25
   Days after onset:21
Entered: 2011-02-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB207AC / 3 UN / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER E0204 / UNK UN / -
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR U786AA / UNK UN / -

Administered by: Military       Purchased by: Military
Symptoms: CSF test abnormal, Death, Meningococcal infection, Neisseria test positive
SMQs:, Guillain-Barre syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-02-05
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Menactra Made by Sanofi Pasteur. Pt started antibiotics after vaccination but before death.
Current Illness: All recruits screened by Recruit Medical Readiness (RMR) staff. No evidence of illness during screening.
Preexisting Conditions: No known illness.
Allergies:
Diagnostic Lab Data: CSF tested by SC medical centers resulted as N. meningitidis. Serotype Y.
CDC Split Type:

Write-up: No known adverse event at tim eof the vaccination. Pt died on 02/05/2011.


VAERS ID: 417899 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Male  
Location: D.C.  
Vaccinated:2011-02-23
Onset:2011-02-24
   Days after vaccination:1
Submitted: 2011-03-02
   Days after onset:6
Entered: 2011-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3815AA / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 915704 / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1269Z / 1 MO / PO

Administered by: Other       Purchased by: Public
Symptoms: Apnoeic attack, Condition aggravated, Death, Endotracheal intubation, Hypopnoea, Pulse absent, Respiratory rate decreased, Resuscitation, Vomiting
SMQs:, Acute pancreatitis (broad), Angioedema (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-02-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZANTAC; POLY-VI-SOL
Current Illness: none
Preexisting Conditions: Prematurity (25 wks); GERD; apnea; BPD; ichthyosis; pulm valve stenosis
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Threw up after a feed, then apnea monitor kept alarming. To ED - found to have slow, shallow respirations. Became apneic/pulseless - unable to resuscitate despite intubation/CPR. Time of death 4:31 PM.


VAERS ID: 418006 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Male  
Location: Idaho  
Vaccinated:2010-11-30
Onset:2010-11-30
   Days after vaccination:0
Submitted: 2011-03-01
   Days after onset:91
Entered: 2011-03-04
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT3773BA / 4 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-11-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none at present time
Preexisting Conditions: COPD; Reflux; HTN; Gout; Allergy to salmon
Allergies:
Diagnostic Lab Data:
CDC Split Type: ID11003

Write-up: Pt. came into clinic for annual flu shot. Was non-ill appearing. Wife received same flu shot at the same time with no adverse rxn. Pt. then went home and later passed away in house (residence).


VAERS ID: 418081 (history)  
Form: Version 1.0  
Age: 50.0  
Sex: Female  
Location: Unknown  
Vaccinated:2010-10-01
Onset:2010-10-01
   Days after vaccination:0
Submitted: 2011-03-04
   Days after onset:154
Entered: 2011-03-07
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2010-10-01
   Days after onset: 0
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: COUMADIN
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1102USA03152

Write-up: Information has been received from a doctor of pharmacy concerning a female patient in her 50''s, who in October 2010, was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot # not reported). Concomitant therapy included COUMADIN. The pharmacist reported that the patient received a shot of the ZOSTAVAX (Merck) and then was rushed to the hospital with a hematoma. After being admitted to the hospital the patient passed away, in October 2010, "a week after her shot". The pharmacist was not sure if it was due to the ZOSTAVAX (Merck) or not, and she was also not sure of the length of time between the patient getting the ZOSTAVAX (Merck) and being to the hospital. The pharmacist considered that the hematoma and that the patient "passed away" to be life threatening. Additional information has been requested.


VAERS ID: 418246 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Massachusetts  
Vaccinated:2011-01-19
Onset:2011-02-28
   Days after vaccination:40
Submitted: 2011-03-03
   Days after onset:3
Entered: 2011-03-09
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3756AA / 1 LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0319Z / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 914514 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0912Z / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-02-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NUTRAMIGEN Lipid with ENFLORA LGG
Current Illness: None
Preexisting Conditions: Allergy to milk products; Esophageal Reflux
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Infant was immunized 1/19/11 DTaP, Hib, IPV, HepB, PCV13, Rotavirus. Infant died ? SIDS.


VAERS ID: 418362 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: D.C.  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-02-25
Entered: 2011-03-10
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Influenza
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions: Patient presumed to be an active employee.
Allergies:
Diagnostic Lab Data: Endemic H1N1 isolated from the bronchioles
CDC Split Type: MEDI0012732

Write-up: A serious spontaneous report of INFLUENZA has been received from a non-healthcare professional concerning a male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient was presumed to be an active employee. On an unknown date, the patient received FLUMIST. Five weeks after receiving FLUMIST, the patient developed symptoms of INFLUENZA. On an unknown date, the patient died. An autopsy was performed. Endemic H1N1 was isolated from the bronchioles. The cause of death was reported as INFLUENZA. The outcome of the event of INFLUENZA was fatal.


VAERS ID: 418868 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Male  
Location: Montana  
Vaccinated:2011-02-10
Onset:2011-02-10
   Days after vaccination:0
Submitted: 2011-03-16
   Days after onset:33
Entered: 2011-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52BO67GA / 1 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Chills, Death, Malaise, Nausea, Pain, Pneumonia, Pyrexia, Respiratory tract congestion
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2011-02-20
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Pradaxa 150 mg daily Lipitor 10 mg daily Lisinopril 20 mg daily Diltiazem 180 mg daily Hctz 12.5 mg daily Zyrtec 10 mg daily
Current Illness: None reported by the patient
Preexisting Conditions: Hyperlipidemia Chronic Lymphoid Leukemia Hypertension Atrial Fib Chronic allergic Rhinitis
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Tdap vaccine was givin in the clinic. The patient called on 2/15/2011 and reported that within 2-3 hours of the injection he was feverish, chilled, nauseated, had body aches, and chest congestion and overall felt very ill. Patient died on 2/20/2011 of an unusual strain of pneumonia.


VAERS ID: 418984 (history)  
Form: Version 1.0  
Age: 0.21  
Sex: Female  
Location: Virginia  
Vaccinated:2011-02-16
Onset:0000-00-00
Submitted: 2011-03-11
Entered: 2011-03-17
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3773AA / 1 UN / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB97 / 1 UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 915704 / 1 UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0917Z / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-02-23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: SIDS.


VAERS ID: 419237 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-03-21
Entered: 2011-03-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1103USA02079

Write-up: Information has been received from a website concerning thousands of other young girls who on unspecified dates were vaccinated with a dose of GARDASIL (lot # not reported). The girls have experienced "life-destroying side effects" or death following their HPV vaccines. Life-destroying side effects were considered to be immediately life-threatening. This is one of two reports from the same source. No further information is available.


VAERS ID: 419371 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Illinois  
Vaccinated:2011-03-16
Onset:2011-03-17
   Days after vaccination:1
Submitted: 2011-03-23
   Days after onset:6
Entered: 2011-03-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3774AA / 3 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E55587 / 3 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Cardiac arrest, Death, Pulse absent
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: 2011-03-17
   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: none
Current Illness: Stuffy nose x 3 days
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Arrived at hospital ER at 1:59AM pulseless, in asystole.


VAERS ID: 419564 (history)  
Form: Version 1.0  
Age: 5.0  
Sex: Male  
Location: Vermont  
Vaccinated:2011-02-07
Onset:0000-00-00
Submitted: 2011-03-25
Entered: 2011-03-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (KINRIX) / GLAXOSMITHKLINE BIOLOGICALS AC20B172AA / 1 RA / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1272Z / 1 RA / UN

Administered by: Private       Purchased by: Public
Symptoms: Condition aggravated, Death, Epilepsy, Status epilepticus, Unresponsive to stimuli, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-02-08
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin B; LAMICTAL; KEPPRA; TOPAMAX
Current Illness: None
Preexisting Conditions: Epilepsy; Right hemiparesis; GERD; Strabismus; Cerebral Palsy
Allergies:
Diagnostic Lab Data: Known left middle cerebral artery infarct with right hemiplegia and epilepsy.
CDC Split Type:

Write-up: DTaP/IPV and VARIVAX given at 14:30 on 2/7/11 as health care maintenance. Patient found unresponsive with vomit in bed around 6 am on 2/8/11. Pronounced deceased on arrival to the ED on 2/8/11. Presumed cause of death is status epilepticus in this patient with known and worsening epilepsy. Medical Examiner involved, and no autopsy performed.


VAERS ID: 420013 (history)  
Form: Version 1.0  
Age: 0.84  
Sex: Male  
Location: Unknown  
Vaccinated:2010-10-12
Onset:2011-03-15
   Days after vaccination:154
Submitted: 2011-03-30
   Days after onset:15
Entered: 2011-03-31
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C368AA / 2 UN / UN
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT3575DA / 1 UN / UN
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB24CA / 3 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 914274 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Cardiac arrest, Cardiomegaly, Convulsion, Culture tissue specimen positive, Death, Meningitis pneumococcal, Neurological infection, Pyrexia, Viral myocarditis, Vomiting, X-ray abnormal
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-03-15
   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? Yes
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: X-ray (14-MAR-2011) results: showed he had an enlarged heart; Autopsy - brain tissue culture (15Mar2011) revealed: pneumococcal meningitis
CDC Split Type: 2011066068

Write-up: This is a spontaneous report from a Pfizer sales representative on behalf of a contactable physician. A 15-month-old male (at the time of death) received the first dose of PREVNAR 13 on an unknown date in JUL2010 at 0.5ml, and the second dose on an unknown date in Oct2010, to prevent against pneumococcal disease. Relevant medical history was unknown. The relevant concomitant medications were unknown. The infant had only been administered two doses of PREVNAR 13 instead of four doses. On 11MAR2011, he was taken to the Emergency Room and diagnosed with neural infection. Treatment was not reported. On 13MAR2011, the patient was taken to the Emergency Room again, but did not see the doctor came back home. On 14MAR2011, the patient was taken to the physician''s office, where he presented with fever, vomiting, and neural infection, because of which he was hospitalized. On 14MAR2011, while in the hospital, he had seizures. An x-ray was performed which revealed an enlarged heart. The patient then had cardiac arrest. On 14MAR2011, the patient was transferred to a hospital where they have found viral myocarditis. Treatments in response to the events were not reported. On 15MAR2011, the infant died. An autopsy was performed on brain tissue culture on 15MAR2011, which showed that he died due to pneumococcal meningitis. The clinical outcome of the reported event of pneumococcal meningitis (per autopsy results) was fatal, and the outcome of the other events was unknown. Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVNAR 13.


VAERS ID: 420044 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: Unknown  
Vaccinated:2010-04-30
Onset:2010-05-13
   Days after vaccination:13
Submitted: 2011-02-14
   Days after onset:277
Entered: 2011-03-31
   Days after submission:44
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C3139A / 1 UN / IJ
HIBV: HIB (ACTHIB) / SANOFI PASTEUR D0870 / 1 UN / IJ
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR D0304 / 1 UN / IJ
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH E15306 / 1 UN / IJ

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal distension, Acquired diaphragmatic eventration, Aerophagia, Autopsy, Bronchopulmonary dysplasia, Cardiac output decreased, Cardiopulmonary failure, Cardiovascular disorder, Condition aggravated, Crying, Death, Flatulence, Gastrointestinal oedema, Hypoxia, Inguinal hernia, obstructive, Intestinal haemorrhage, Intra-abdominal pressure increased, Pulmonary arteriopathy, Pulmonary hypertension, Renal impairment, Respiratory disorder, Resuscitation, Right ventricular hypertrophy, Unresponsive to stimuli, Vascular resistance systemic increased, Venous insufficiency
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: The subject, according to the autopsy report, had a medical history which included premature birth (25 weeks gestation) with intrauterine growth restriction (395 g birth weight) ascribed to maternal chronic hypertension with super-imposed pre-eclampsia/atypical HELLP syndrome. The infant had a prolonged hospital course with morbidity including respiratory distress with apnea, retinopathy, patency of the ductus arteriosis with attempted surgical closure, right ventricular hypertrophy, pulmonary hypertension, hepatic dysfunction and metabolic derangements, and inguinal and umbilical hernias. The infant was discharged to home n 9 May 2010 at a "corrected" gestational age of 42.5 weeks. Repair of his inguinal hernias was planned for around 50 weeks corrected age. The patient received dose 1 of PEDIARIX on 07 March 2010, lot number AC21B208BA.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201005539

Write-up: Initial report received on 28 September 2010 from an investigator participating in a study under the reference number M5A11. An infant male subject who born with an incarcerated inguinal hernia on 29 December 2009. The investigator reported that at 4 months of age the infant received the following vaccines on 30 April 2010: first injection of DAPTACEL, lot number C3139AA; first injection site of ACTHIB, lot number D0870 (UF739AA); first injection of IPOL, lot number D0304; and first injection of pneumococcal vaccine (PNCV7), Wyeth, lot number E15306; and died 15 days post-vaccination. According to the autopsy report, the infant''s medical history included premature birth (25 weeks gestation) with intrauterine growth restriction (395 g birth weight) ascribed to maternal chronic hypertension with super-imposed pre-eclampsia/atypical HELLP syndrome. The infant had a prolonged hospital course with morbidity including respiratory distress with apnea, retinopathy, patency of the ductus arteriosis with attempted surgical closure, hepatic dysfunction and metabolic derangements, and inguinal and umbilical hernias. The infant was discharged to home on 9 May 2010 at a "corrected" gestational age of 42.5 weeks. Repair of his inguinal hernias was planned for around 50 weeks corrected age. On 13 May 2010, the infant became unresponsive following a period of inconsolable crying after a feeding. He could not be resuscitated despite efforts by parents, EMS, and attendings in the ED. The most striking finding in the ED and at autopsy was massive abdominal distension that was not relieved by removal of copious milk from the stomach via NG tube. The large volume of air in the highly distended intestine was sufficient to elevate the diaphragm and increase the intra-abdominal pressure; thus predisposing the infant to reduced cardiac output, increased renal and systemic vascular resistance, decreased venous return to the heart, reduced visceral blood flow, and altered respiratory dynamics. The origin of the intestinal air was most likely a combination of vigorous crying and resuscitative efforts (which included 10 minutes of bag-mask ventilation). Hypertrophy of the right ventricle and pulmonary arterial changes further predisposed him to hypoxia and low cardiac output if venous return were reduced. Obstruction of the terminal ileum in the hernia would be worsened by the intra-abdominal pressure, which would prevent egress of intra-intestinal air. Autopsy internal examination found right inguinal hernia contains 8 cm loop of congested dilated edematous distal-most ileum, along with its hemorrhagic appearing mesentery. There is egress of approximately 10 cc blood tinged clear fluid when the right hernia is reduced (with difficulty). The left hernia contains 8 cm loop of sigmoid colon, which is mildly edematous and mildly dusky and relatively easily reduced. Death was considered multifactorial: acute incarceration of right inguinal hernia, with crying, swallowing of air, and abdominal distension resulting in cardiorespiratory compromise against a background of chronic lung disease with pulmonary hypertension and right ventricular hypertrophy. According to the investigator, the event was not related to the study vaccine. Follow-up information was received on 14 October 2010 from a investigator participating in a trial under the reference number M5A11. The start date of the SAE was changed to the probable date of aggravation of congenital condition (incarceration of inguinal hernia). The start date for the incarcerated inguinal hernia was changed to 13 May 2010 (previously reported as 29 December 2009). According to the investigator, the event remained not related to the study vaccine. Documents held by sender: Autopsy report.


VAERS ID: 420077 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Unknown  
Vaccinated:2009-05-18
Onset:0000-00-00
Submitted: 2011-03-31
Entered: 2011-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS X79P45I1U / 1 LG / IM

Administered by: Other       Purchased by: Other
Symptoms: Activated partial thromboplastin time prolonged, Alanine aminotransferase increased, Arachnoid cyst, Aspartate aminotransferase increased, Autopsy, Blood albumin decreased, Blood alkaline phosphatase normal, Blood bicarbonate decreased, Blood bilirubin decreased, Blood chloride increased, Blood culture, Blood glucose increased, Blood lactic acid normal, Blood potassium increased, Blood sodium increased, Blood urea normal, Bronchitis, Cardiac arrest, Circulatory collapse, Congenital anomaly, Contusion, Death, Endotracheal intubation, Epistaxis, Febrile convulsion, Foaming at mouth, Gaze palsy, Haemoglobin decreased, International normalised ratio, Lipase increased, Lymphadenopathy, Lymphoid tissue hyperplasia, Microscopy, Neurological examination abnormal, Platelet count normal, Protein total decreased, Prothrombin time prolonged, Pyrexia, Respiratory tract congestion, Resuscitation, Skin haemorrhage, Subdural haemorrhage, Syncope, Tonic clonic movements, Unresponsive to stimuli, Upper respiratory tract infection, White blood cell count normal
SMQs:, Torsade de pointes/QT prolongation (broad), Liver related investigations, signs and symptoms (narrow), Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Haematopoietic erythropenia (broad), Lactic acidosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (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), Congenital, familial and genetic disorders (narrow), Convulsions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Tubulointerstitial diseases (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-08-18
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: Activated partial thromboplastin time, 99.5 sec; Alanine aminotransferase, 40 ul; Aspartate aminotransferase, 72 ul; Blood albumin, 1.8 g/dl; Blood alkaline phosphatase, 189 ul; Blood bicarbonate, 8 meq/L; Blood bilirubin, <0.1 mg/dL; Blood chloride, 112 meq/L; Blood culture, unknown, anaerobic blood culture had insufficient quantity; Blood glucose, 542 mg/dL, 337; Blood lactic acid, 19.1 mg/dL; Blood potassium, 7.1 meq/L; Blood sodium, 146 meq/L; Blood urea, 9 mg/dL; Haemoglobin, 6.7 g/dl; International normalised ratio, 2.7; Lipase, 252 ul; Microscopy, unknown; Microscopic comment: Summary of sections: 1. left anterior descending coronary artery, anterior papillary muscle, ductus x 2; 2. circumflex coronary artery, posterior papillary muscle, right atrium; 3. right coronary artery, septal base of heart, horizontal segment of septum; 4. right lung x 2; 5. right lung, larynx, edematous arytenoid cartilage; 6. liver x 2, spleen, pancreas, pituitary; 7. thymus; 8. rectum, small bowel, cecum; 9. bladder, prostate, paraesophageal lymph node, dark purple lymph node; 10. deep scalp hemorrhage; AA. right parietal white matter; BB. left hippocampus; CC. right hippocampus; DD. midbrain, cerebellum; EE. left temporal and parietal cortex at arachnoid cyst; FF. dura; Cardiovascular: Two sections of ductus arteriosus are 95-99% closed by fibrointimal thickening and calcification. Sections of coronary arteries and papillary muscles are unremarkable. Wavy fibers and edema are seen in the section of right atrium. The septal base section includes the bundle of His and is unremarkable. The horizontal section of the mid-septum has no disarray. Respiratory: The mucosal edema at the arytenoid cartilage noted grossly is not confirmed microscopically in section "E". Moderate submucosal inflammation is present with mild mucosal edema and lymphatic infiltrates submucosal glands. The sections of the right lung are well-expanded and have congestion, edema and hemorrhagic edema. Mild submucosal edema and lymphatic infiltrates are seen in the bronchi with focal eosinophils also seen in the submucosa of the bronchus. Sections of the left lung are similar but have less inflammation in the bronchi. Liver: Congestion. Hematologic: Spleen - congestion, follicular hyperplasia. Pancreas: Unremarkable. Genitourinary: Kidney - congestion, otherwise unremarkable. Bladder - unremarkable. Prostate - infantile and unremarkable. Endocrine: Thyroid gland - unremarkable. Adrenal gland - unremarkable, no fetal cortex remains (age-appropriate). Pituitary gland - unremarkable. Neurologic: Slight thickened leptomeninges are seen in all cortical sections and are most present in "EE" at the collapsed arachnoid cyst. No inflammatory infiltrates are seen. Perineural spaces are seen with vacuolated neurophil in the section of the left hippocampus in "BB". The right hippocampus section had a few extravasated red cells but is otherwise unremarkable. Vacuolation of cortex and white matter is seen in the section of right parietal love in "AA". No gray matter nodules are identified. The section of midbrain has subependymal nodules at the aqueduct but is otherwise unremarkable. The section of dura has a subdural membrane composed of loose connective tissue with focal extravastated red cells. An iron stain is negative with approximate control. A trichrome stain confirms the more pale-staining loose connective tissue of the membrane and the control is appropriate. Immunologic: The thymus has a markedly contracted cortex with slight starry sky appearance. The medulla has crowded Hassall corpuscles. Focal interstitial hemorrhage is seen. Sections of lymph nodes has prominent follicular hyperplasia. Gastrointestinal: Marked follicular hyperplasia is seen in Peyer patches in the cecum and rectum. The Peyer patches in the small bowel are less prominent. No mucosal abnormalities are seen. Musculoskeletal: A section of deep scalp has hemorrhage with focal fibrosis. Neurological examination, unknown; Brain weight - 1099 gram; Other than the previously described injuries the scalp is unremarkable. The skull is asymmetric. The fossae measure as follows: anterior 4.3/4.8, middle 4.5/4.8, posterior 5.3/5.8 cm right and left respectively. Other than the previously described injury the dura is unremarkable. The leptomeninges are glistening and translucent. Excess cerebrospinal fluid is seen at the base of the brain and an arachnoid cyst of approximately 2.5 cm is seen at the inferior temporal lobe. The tip of the left temporal lobe appears somewhat smaller than the right temporal lobe. The cerebral and cerebella hemispheres, brainstem, and proximal cervical spinal cord have no other gross abnormalities. The brain is fixed in formalin for further examination at a later date. The brain is re-examined at a later date. The dural hemorrhage is again identified as a red-brown focal stain of 2.5 cm at the left parietal surface. The arachnoid cyst seen at autopsy is collapsed and appears only as redundant leptomeninges at the inferior surface of the left temporal lobe. Multiple coronal sections of the brain reveal multiple gray matter foci of 0.4 x 0.3 cm in the posterior parietal lobe at deep sulci. Otherwise the sections are unremarkable, including the caudate nucleus, thalamus, basal ganglia and the cerebral ventricles which to do extend anterior to the tips of the temporal lobes. Immunologic system: Thymus weight - 45.1 grams; The thymus is pale pink with a few petechiae. The visualised lymph nodes are pink/gray and slightly enlarged. A 2.5 x 0.5 x 0.5 pale pink paraesophageal lymph node is seen. The mesenteric lymph nodes measure up to 1.8 cm. Physical examination, unknown; Body condition: intact. Rigor: complete. Livor: faint purple. Hair: approximately 1/4 inch curly-kinky head hair, no beard or moustache noted. Eye: closed, conjunctivae pale, irides brown, pupils 3 mm, one petechial hemorrhage of less than 1 mm at right eye. Teeth: natural and in good repair. The body is that of a normally developed, normally nourished child, appearing older than the stated age of 17 months, of average build, with no significant abnormalities of head, trunk, extremities and genitalia. The mucous membranes are pale. The body is clad in a disposable diaper which is discarded. The length is greater than 97%-ile for age. The weight is approximately 78%-ile for age. The weight for length is 35%-ile. Evidence of medical intervention consists of an endotracheal tube secured in the mouth, intravenous access and arm board with 0.6/L sodium chloride in right arm, intraoseous catheter with 0.9/L sodium chloride in right lower leg, and needle puncture marks on the left inner arm and left hand. Injuries: 1. A slight fresh abrasion is present at the upper lip. A small hemorrhage is seen at the right side of the tongue near the tip. (The child had been intubated and the tube is seen). 2. No other external injuries are identified. Internal examination reveals a right parietal deep scalp hemorrhage of 5/8 x 1/4 inch, and two small deep scalp hemorrhages of 1/4 x 1/8 at the midline and left parietal scalp. Continued internal examination reveals an intact skull, a focus of subdural blood of 1 inch diameter, and no additional injuries of the brain or it''s coverings. 3. No other injuries are seen. Internal examination: Body cavities: The right and left pleural cavities each contain 20 ml of serious fluid. The pericardial cavity contains 5 ml of serious fluid. The peritoneal cavity contains no significant accumulation of fluid. The surfaces are smooth and glistening. Cardiovascular system: The heart is not grossly enlarged. The weight is not recorded. The epicardial surface is unremarkable. The coronary arteries have right dominant distribution. The fossa ovalls measures 1.2 cm and is closed. The myocardium is medium tan-pink with no focal lesions and the free walls measure 0.2 and 0.8 cm, right and left respectively. The interventricular septum measures 0.7 cm. The circumferences of the cardiac valves measure: tricuspid 7.2, pulmonic 4.6, mitral 6.2 and aortic 3.7 cm. The aorta and the remainder of the vascular system are unremarkable. Respiratory system: Right lung weight - 190 grams. Left lung weight - 171 gram. The soft tissue at the arytenoid cartilage is slightly edematous. The larynx is otherwise unremarkable as is the trachea with light pink mucosa and frothy edema fluid. The hyoid bone and laryngeal cartilages are intact. The pleural surfaces of the lungs are light pink anteriorly and are dark purple posteriorly. The lungs are subcrepitant to the palpitation and soft on section. The cut surfaces are purple-red, congested and edematous. The distal airways contain edema fluid. The pulmonary vessels are unremarkable. Gastrointestinal system: The esophagus is remarkable. The gastroesophageal junction is sharply defined. The stomach contains 150 ml of pale, slightly translucent liquid, french fries and unrecognisable food particles. No hemorrhage is present in the proximal gastrointestinal tract. The distal bowel is hyperemic and congested with dark purple contents. The colon is slightly congested. Peyer''s patches are prominent. The appendix is present. Liver: Liver weight - 514 grams. The liver is purple-red, of soft consistency on palpation and on section. The hepatic architecture is unremarkable. The gallbladder contains less than one ml of dark yellow bile and no stone. The extrahepatic biliary trees is patent. Spleen: Spleen weight - 33 grams. The splenic capsule is dark purple. The spleen is soft on section and the cut surface is dark purple with prominent white pulp. Pancreas: The pancreas is unremarkable. Urinary: Right kidney weight - 52.1 grams; Left kidney weight - 50.6 grams. The renal capsules strip with ease. The kidneys retain fetal lobulation. The bladder contains scant bloody urine. Reproductive: The male internal organs are infantile and grossly unremarkable. Endocrine: The thyroid gland and adrenal glands are grossly unremarkable. No abnormalities are present in the pituitary gland. Platelet count, normal; Normal "hi norm"; Protein total, 3.5 g/dl; Prothrombin time, 28.9 sec; White blood cell count, 8.4 k/mm3
CDC Split Type: PHHO2010US12589

Write-up: Initial report received on 19 Aug 2010: This patient was enrolled in study to evaluate the safety of Novartis MENACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants. Study vaccination was commenced on 18 May 2009. The patient received the second dose on 20 Jul 2009, the third dose on 21 Sep 2009 and the fourth on 22 Mar 2010. On 18 Aug 2010, the patient died. No further information was available. In the absence of the investigator causality, Novartis has processed the case as suspected for reporting purposes. The case will be further reassessed upon receipt of follow-up information. Follow up received on 20 Aug 2010: At the time of death, the child (patient) was in the custody of a friend of the father. They were in a car and the friend pulled over because the child did not look right. They then went to the emergency department. The mother stated that the child was already deceased by the time she got to the emergency department. The investigator assessed the event as not suspected to be related to the study vaccine. Follow up received on 20 Aug 2010: On 13 Aug 2010, the patient was seen in the emergency department (ED) for possible seizure with congestion and fever. The patient''s eyes rolled up in his head and had foaming at the mouth. The patient experienced generalized tonic-clonic movements which lasted 30 seconds to a minute. The patient was diagnosed with upper respiratory infection (URI) and fever. The patient received treatment with MOTRIN. The patient was discharged after around 4 hours in good condition with an impression of febrile seizure. On 18 Aug 2010, the patient was in the seat in a car next to ''step mother'' and experienced sudden syncope episode and cardiac arrest. The report also stated the patient experienced sudden epistaxis. The patient was intubated and given drugs (atropine and epinephrine). Cardiopulmonary resuscitation (CPR) was performed en route to the ED. The patient died at 17:38. Follow up received on 24 Aug 2010 prior to previous follow up circulation: The investigator assessed all events as not suspected to be related to the study vaccine. Follow-up received on 13 Dec 2010: The cause of death was not yet received by the investigator. Follow-up received prior to circulation of previous follow-up on 14 Dec 2010: The patient was presented with upper respiratory tract infection on 09 Aug 2010 and was seen in ER. The patient was discharged in 4hrs after observation. The patient developed febrile seizure on 13 Aug 2010 at 16:30 hrs. The investigator did not suspect a relationship between the event and the study vaccine. Batch review report (reference number 78559) received from quality assurance department on 12 Jan 2011: Based on the document review, it was stated that the concerned MENACWY batch number X79P45I1U was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received on 24 Mar 2011: on 18 Aug 2010, after resuscitation had started, the patient also had blood coming from his mouth. The patient''s diagnoses on the autopsy examination were as follows, focal deep scalp hemorrhage, very focal, 2.5 cm area of organising subdural blood at left parietal dura; left temporal lobe arachnoid cyst of approximately 2 cm; mild laryngeotracheobronchitis with follicular hyperplasia of lymph nodes, Peyer''s patches and spelenic white pulp; perimortem laboratory studies during resuscitative effort consistent with history of prolonged hypoxic-ischemic condition. No other significant pre-existing disease or injury was identified. The autopsy examination revealed a slightly asymmetric skull and an arachnoid cyst at the left temporal lobe, small deep scalp hemorrhages and a very small focus of subdural blood. The investigator stated that the arachnoid cyst is a congenital condition, which is usually identified as an incidental finding rather than a lesion causing death; the leptomeningeal thickening seen microscopically is related to the cyst and is not related to the study vaccine. Furthermore the investigator stated that febrile seizures are usual benign conditions, rarely the children of parents who have experienced febrile seizures are found unresponsive after sleep. The circumstances of this patient''s death are different and no history of parental febrile seizures in childhood are known. Microscopic findings were consistent with the history of recent respiratory illness but were not sufficient to account for the history of sudden unresponsiveness or death. The abnormal laboratory results obtained during the resuscitative attempt were nonspecific and consistent with the prolonged cardiovascular collapse documented in the medical records. The small organising subdural blood and the small deep contusions were not sufficient to cause death, how they occurred was unclear. Toxicologic examination revealed only the drug atropine used in resuscitation. The investigator concluded that based on the scene circumstances and autopsy findings, as well as review of medical records and law enforcement investigation, the cause of death is undetermined. The Novartis medical safety physician has assessed arachnoid cyst and bronchitis as non serious. In the absence of causality assessment for hemorrhage, arachnoid cyst, laryngeotracheobronchitis, follicular hyperplasia of lymph nodes, Peyer''s patches and spelenic white pulp, Novartis has processed the case as suspected for reporting purposes.


VAERS ID: 420242 (history)  
Form: Version 1.0  
Age: 1.01  
Sex: Female  
Location: New Jersey  
Vaccinated:2011-02-25
Onset:2011-03-05
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2011-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 1510Z / 1 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 91497Z / 4 UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1321Z / 1 UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Death, Lethargy, Nasopharyngitis, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-03-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received her shots on Feb 25, 2011. On Thursday March 3rd patient seemed like she was coming down with a cold. We bathed her and she ended up throwing up what little food she ate for dinner. On Friday March 4th patient seemed OK during the day according to her daycare, but at home that night she seemed lethargic and was running a 100.4 fever. Was given a little infants ADVIL and was put to bed at 8:15pm, checked her at 10:15pm, and then at 3:15 am when she had already passed in her sleep.


VAERS ID: 420337 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: Florida  
Vaccinated:2011-03-30
Onset:2011-03-31
   Days after vaccination:1
Submitted: 2011-04-05
   Days after onset:5
Entered: 2011-04-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B256CA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH254AA / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 915192 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1074Z / 1 MO / PO

Administered by: Public       Purchased by: Public
Symptoms: Cold sweat, Death, Hypophagia, Hypotonia, Respiratory arrest, Skin warm, Somnolence, Yellow skin
SMQs:, Cholestasis and jaundice of hepatic origin (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-03-31
   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: none
Current Illness: well baby
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 4-1-2011 mother presents to clinic requesting child, immunization record. Mother reports that her baby died 3-31-2011 at approximately 10:50 am. She reports the following: On 3-30-11 at 12:30pm she brought patient to the CHD for a routine well baby visit and immunizations. The child was done with the visit and receiving his shots by about 1pm. The rest of the day the child was sleepy and ate about 2 oz of formula vs his normal 7 oz at a time. At 11:30 pm she performed his routine diaper change and feeding. At that time he was moist to touch, but not running a fever (she never took his temperature but he felt warm to touch). 3-31-11 2AM; the baby accompanied the family to the ER for another child''s scraped knee. They returned at 4AM, in which the mother reports she fed the baby 2 oz and did a diaper change. 10:40 AM the mother woke up and checked the baby, the baby was sleeping on his stomach. She reports that she does not believe in putting the baby on his back, because she thinks the baby will choke, she admits that she was trained by the provider, he should be on his back for sleeping. She then went out to the garage to have a cigarette. She returned at 10:50 am to get the baby up. The babies arm was flopped out and looked yellow, she checked the baby for breathing, and he was not breathing, then called 911. I gave the mother a copy of the child''s immunization record. Offered Healthy Start bereavement services, she declined, stating she has enough family support for that.


VAERS ID: 420445 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Male  
Location: Unknown  
Vaccinated:2010-04-01
Onset:2010-04-01
   Days after vaccination:0
Submitted: 2011-04-06
   Days after onset:370
Entered: 2011-04-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Herpes simplex, Herpes zoster, Simplex virus test positive
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-12-01
   Days after onset: 244
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: Hydrocortisone
Current Illness: Leukopenia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: herpes simplex virus, Confirmed it was the oka strain
CDC Split Type: WAES1103USA03961

Write-up: Information has been received from a physician concerning a 75 year old male with "chronic leukopenia" who in April 2010, was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported). Concomitant therapy included hydrocortisone (manufacturer unknown). In May 2010, the patient developed shingles spread to his face. In October 2010, the patient was admitted to hospital with dissemination. Acyclovir IV was given for two weeks then Acyclovir oral for 2 weeks for the treatment of the adverse event. In December 2010, the patient was admitted again to the hospital and died three weeks later. On unspecified date, lab study was performed on the ZOSTAVAX (Merck) which confirmed it was the oka strain. Additional information has been requested.


VAERS ID: 420450 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-04-06
Entered: 2011-04-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 4 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Pneumonia staphylococcal
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: First dose PREVNAR, No adverse event; Second dose PREVNAR, No adverse event; Third dose PREVNAR, No adverse event.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011072311

Write-up: This is a spontaneous report from a contactable nurse via a Pfizer Sales Representative. A male patient received the fourth dose of PREVNAR on an unknown date. Relevant medical history, drug history and concomitant medications or vaccines were unknown. Vaccines taken within the last four weeks were unknown. On an unspecified date, the patient developed staphylococcal pneumonia disease. It was unknown if the patient was hospitalized. In Nov2010, the patient died. The cause of death was staphylococcal pneumonia disease. At the time of the report, it was unknown if an autopsy was performed. Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVNAR.


VAERS ID: 421048 (history)  
Form: Version 1.0  
Age: 1.51  
Sex: Female  
Location: California  
Vaccinated:2010-10-15
Onset:2010-11-08
   Days after vaccination:24
Submitted: 2011-04-14
   Days after onset:156
Entered: 2011-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT3566BA / 1 LL / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB444BA / 1 LL / IM

Administered by: Private       Purchased by: Private
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: 2010-11-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: None~ ()~~0.00~Patient|None~ ()~~0.00~Sibling
Other Medications: none
Current Illness: none
Preexisting Conditions: H/O possible febrile seizure 2/2010.
Allergies:
Diagnostic Lab Data: 7 above, per medical examiner report.
CDC Split Type:

Write-up: Sudden unexplained death.


VAERS ID: 421094 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Female  
Location: New Hampshire  
Vaccinated:2011-02-01
Onset:2011-03-03
   Days after vaccination:30
Submitted: 2011-03-03
   Days after onset:0
Entered: 2011-04-15
   Days after submission:42
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3613AA / 1 LL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB977AA / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 915192 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0948Z / 1 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-03-03
   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: Acyclovir at birth 25 mg IV Q 6 Hrs.
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NH04151101

Write-up: Mother had + HSV, gestational diabetes and protein S deficiency.


VAERS ID: 421096 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: North Carolina  
Vaccinated:2011-04-07
Onset:2011-04-08
   Days after vaccination:1
Submitted: 2011-04-11
   Days after onset:3
Entered: 2011-04-15
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3872AB / 1 LL / UN
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1520Z / 2 LL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E63641 / 1 RL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1135Z / 1 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-04-10
   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: TRI-VI-SOL; SIMPLY THICK; SYNAGIS
Current Illness: None
Preexisting Conditions: Prematurity, 31 weeks
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None stated.


VAERS ID: 421121 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-02-28
Entered: 2011-04-15
   Days after submission:45
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, Influenza
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011US01363

Write-up: Initial literature report received on 03 Jan 2011: This literature was about cases of pediatric influenza-associated deaths. To further investigate the bacterial organisms that may have contributed to death, the authors systematically collected information about bacterial cultures collected at non-sterile sites and about timing of Staphylococcus aureus specimen collection relative to hospital admission. The authors performed a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007/2008 season. This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee On Immunization Practices) criteria. This child was vaccinated with INFLUENZA (manufacturer unknown, batch number: unknown) during 2007/2008 season. This child was vaccinated completely as per schedule. This child presented with influenza which later lead to death on unknown date. The causality was not reported. The authors commented that influenza-associated mortality among children is a rare event; however, healthcare providers should be mindful of the severe outcomes associated with influenza in children, especially those with high-risk medical condition. Critically ill children should be promptly treated with anti-viral medications, unless contraindicated, upon influenza diagnosis or suspicion. Because isolation of S. aureus potentially representing co-infection was identified in a substantial proportion (19%) of children with influenza-associated mortality within three days of hospital admission, healthcare providers should consider administering antimicrobial agents active against locally circulating strains of S. aureus when empirically treating children with influenza-like illness and severe respiratory illness.


VAERS ID: 421122 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-02-28
Entered: 2011-04-15
   Days after submission:45
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, Inappropriate schedule of drug administration, Influenza
SMQs:, Medication errors (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011US01364

Write-up: Initial literature report received on 03 Jan 2011: This literature was about cases of pediatric influenza-associated deaths. To further investigate the bacterial organisms that may have contributed to death, the authors systematically collected information about bacterial cultures collected at non-sterile sites and about the timing of Staphylococcus aureus specimen collection relative to hospital admission. The authors performed a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007/2008 season. This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on Immunization Practices) criteria. This child was vaccinated with INFLUENZA (manufacturer unknown, batch number: unknown) during 2007/2008 season. The patient was partially vaccinated and did not complete vaccination schedule. The child presented with influenza which later lead to death on unknown date. The causality was not reported. The authors commented that influenza-associated mortality among children is a rare event; however, healthcare providers should be mindful of the severe outcomes associated with influenza in children, especially those with high-risk medical condition. Critically ill children should be promptly treated with anti-viral medications, unless contraindicated, upon influenza diagnosis or suspicion. Because isolation of S. aureus potentially representing co-infection was identified in a substantial proportion (19%) of children with influenza-associated mortality within three days of hospital admission, healthcare providers should consider administering antimicrobial agents active against locally circulating strains of S. aureus when empirically treating children with influenza-like illness and severe respiratory illness.


VAERS ID: 421123 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-02-28
Entered: 2011-04-15
   Days after submission:45
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, Inappropriate schedule of drug administration, Influenza
SMQs:, Medication errors (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011US01333

Write-up: Initial literature report received on 03 Jan 2011: This literature was about cases of pediatric influenza-associated deaths. To further investigate the bacterial organisms that may have contributed to death, the authors systematically collected information about bacterial cultures collected at non-sterile sites and about the timing of Staphylococcus aureus specimen collection relative to hospital admission. The authors performed a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007/2008 season. This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on Immunization Practices) criteria. This child was vaccinated with INFLUENZA (manufacturer unknown, batch number: unknown) during 2007/2008 season. The patient was partially vaccinated and did not complete vaccination schedule. The child presented with influenza which later lead to death on unknown date. The causality was not reported. The authors commented that influenza-associated mortality among children is a rare event; however, healthcare providers should be mindful of the severe outcomes associated with influenza in children, especially those with high-risk medical condition. Critically ill children should be promptly treated with anti-viral medications, unless contraindicated, upon influenza diagnosis or suspicion. Because isolation of S. aureus potentially representing co-infection was identified in a substantial proportion (19%) of children with influenza-associated mortality within three days of hospital admission, healthcare providers should consider administering antimicrobial agents active against locally circulating strains of S. aureus when empirically treating children with influenza-like illness and severe respiratory illness.


VAERS ID: 421124 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-02-28
Entered: 2011-04-15
   Days after submission:45
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, Influenza
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011US01347

Write-up: Initial literature report received on 03 Jan 2011: This literature was about cases of pediatric influenza-associated deaths. To further investigate the bacterial organisms that may have contributed to death, the authors systematically collected information about bacterial cultures collected at non-sterile sites and about the timing of Staphylococcus aureus specimen collection relative to hospital admission. The authors performed a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007/2008 season. This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on Immunization Practices) criteria. This child was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: unknown) during 2007/2008 season. The child presented with influenza which later lead to death on unknown date. The causality was not reported. The authors commented that influenza-associated mortality among children is a rare event; however, healthcare providers should be mindful of the severe outcomes associated with influenza in children, especially those with high-risk medical condition. Critically ill children should be promptly treated with anti-viral medications, unless contraindicated, upon influenza diagnosis or suspicion. Because isolation of S. aureus potentially representing co-infection was identified in a substantial proportion (19%) of children with influenza-associated mortality within three days of hospital admission, healthcare providers should consider administering antimicrobial agents active against locally circulating strains of S. aureus when empirically treating children with influenza-like illness and severe respiratory illness.


VAERS ID: 421125 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-02-28
Entered: 2011-04-15
   Days after submission:45
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, Influenza
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011US01348

Write-up: Initial literature report received on 03 Jan 2011: This literature was about cases of pediatric influenza-associated deaths. To further investigate the bacterial organisms that may have contributed to death, the authors systematically collected information about bacterial cultures collected at non-sterile sites and about the timing of Staphylococcus aureus specimen collection relative to hospital admission. The authors performed a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007/2008 season. This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on Immunization Practices) criteria. This child was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: unknown) during 2007/2008 season. The child presented with influenza which later lead to death on unknown date. The causality was not reported. The authors commented that influenza-associated mortality among children is a rare event; however, healthcare providers should be mindful of the severe outcomes associated with influenza in children, especially those with high-risk medical condition. Critically ill children should be promptly treated with anti-viral medications, unless contraindicated, upon influenza diagnosis or suspicion. Because isolation of S. aureus potentially representing co-infection was identified in a substantial proportion (19%) of children with influenza-associated mortality within three days of hospital admission, healthcare providers should consider administering antimicrobial agents active against locally circulating strains of S. aureus when empirically treating children with influenza-like illness and severe respiratory illness.


VAERS ID: 421126 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-02-28
Entered: 2011-04-15
   Days after submission:45
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, Influenza
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011US01351

Write-up: Initial literature report received on 03 Jan 2011: This literature was about cases of pediatric influenza-associated deaths. To further investigate the bacterial organisms that may have contributed to death, the authors systematically collected information about bacterial cultures collected at non-sterile sites and about the timing of Staphylococcus aureus specimen collection relative to hospital admission. The authors performed a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007/2008 season. This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on Immunization Practices) criteria. This child was vaccinated with INFLUENZA (manufacturer unknown, batch number: unknown) during 2007/2008 season. The child presented with influenza which later lead to death on unknown date. The causality was not reported. The authors commented that influenza-associated mortality among children is a rare event; however, healthcare providers should be mindful of the severe outcomes associated with influenza in children, especially those with high-risk medical condition. Critically ill children should be promptly treated with anti-viral medications, unless contraindicated, upon influenza diagnosis or suspicion. Because isolation of S. aureus potentially representing co-infection was identified in a substantial proportion (19%) of children with influenza-associated mortality within three days of hospital admission, healthcare providers should consider administering antimicrobial agents active against locally circulating strains of S. aureus when empirically treating children with influenza-like illness and severe respiratory illness.


VAERS ID: 421127 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-02-28
Entered: 2011-04-15
   Days after submission:45
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, Influenza
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011US01353

Write-up: Initial literature report received on 03 Jan 2011: This literature was about cases of pediatric influenza-associated deaths. To further investigate the bacterial organisms that may have contributed to death, the authors systematically collected information about bacterial cultures collected at non-sterile sites and about the timing of Staphylococcus aureus specimen collection relative to hospital admission. The authors performed a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007/2008 season. This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on Immunization Practices) criteria. This child was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: unknown) during 2007/2008 season. The child presented with influenza which later lead to death on unknown date. The causality was not reported. The authors commented that influenza-associated mortality among children is a rare event; however, healthcare providers should be mindful of the severe outcomes associated with influenza in children, especially those with high-risk medical condition. Critically ill children should be promptly treated with anti-viral medications, unless contraindicated, upon influenza diagnosis or suspicion. Because isolation of S. aureus potentially representing co-infection was identified in a substantial proportion (19%) of children with influenza-associated mortality within three days of hospital admission, healthcare providers should consider administering antimicrobial agents active against locally circulating strains of S. aureus when empirically treating children with influenza-like illness and severe respiratory illness.


VAERS ID: 421128 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-02-28
Entered: 2011-04-15
   Days after submission:45
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, Influenza
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011US01355

Write-up: Initial literature report received on 03 Jan 2011: This literature was about cases of pediatric influenza-associated deaths. To further investigate the bacterial organisms that may have contributed to death, the authors systematically collected information about bacterial cultures collected at non-sterile sites and about the timing of Staphylococcus aureus specimen collection relative to hospital admission. The authors performed a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007/2008 season. This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on Immunization Practices) criteria. This child was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: unknown) during 2007/2008 season. The child presented with influenza which later lead to death on unknown date. The causality was not reported. The authors commented that influenza-associated mortality among children is a rare event; however, healthcare providers should be mindful of the severe outcomes associated with influenza in children, especially those with high-risk medical condition. Critically ill children should be promptly treated with anti-viral medications, unless contraindicated, upon influenza diagnosis or suspicion. Because isolation of S. aureus potentially representing co-infection was identified in a substantial proportion (19%) of children with influenza-associated mortality within three days of hospital admission, healthcare providers should consider administering antimicrobial agents active against locally circulating strains of S. aureus when empirically treating children with influenza-like illness and severe respiratory illness.


VAERS ID: 421129 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-02-28
Entered: 2011-04-15
   Days after submission:45
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, Influenza
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011US01356

Write-up: Initial literature report received on 03 Jan 2011: This literature was about cases of pediatric influenza-associated deaths. To further investigate the bacterial organisms that may have contributed to death, the authors systematically collected information about bacterial cultures collected at non-sterile sites and about the timing of Staphylococcus aureus specimen collection relative to hospital admission. The authors performed a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007/2008 season. This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on Immunization Practices) criteria. This child was vaccinated with INFLUENZA (manufacturer unknown, batch number: unknown) during 2007/2008 season. It was unknown if the patient was vaccinated completely as per schedule. The child presented with influenza which later lead to death on unknown date. The causality was not reported. The authors commented that influenza-associated mortality among children is a rare event; however, healthcare providers should be mindful of the severe outcomes associated with influenza in children, especially those with high-risk medical condition. Critically ill children should be promptly treated with anti-viral medications, unless contraindicated, upon influenza diagnosis or suspicion. Because isolation of S. aureus potentially representing co-infection was identified in a substantial proportion (19%) of children with influenza-associated mortality within three days of hospital admission, healthcare providers should consider administering antimicrobial agents active against locally circulating strains of S. aureus when empirically treating children with influenza-like illness and severe respiratory illness.


VAERS ID: 421130 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-02-28
Entered: 2011-04-15
   Days after submission:45
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, Influenza
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011US01359

Write-up: Initial literature report received on 03 Jan 2011: This literature was about cases of pediatric influenza-associated deaths. To further investigate the bacterial organisms that may have contributed to death, the authors systematically collected information about bacterial cultures collected at non-sterile sites and about the timing of Staphylococcus aureus specimen collection relative to hospital admission. The authors performed a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007/2008 season. This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on Immunization Practices) criteria. This child was vaccinated with INFLUENZA (manufacturer unknown, batch number: unknown) during 2007/2008 season. It was unknown if the patient was vaccinated completely as per schedule. The child presented with influenza which later lead to death on unknown date. The causality was not reported. The authors commented that influenza-associated mortality among children is a rare event; however, healthcare providers should be mindful of the severe outcomes associated with influenza in children, especially those with high-risk medical condition. Critically ill children should be promptly treated with anti-viral medications, unless contraindicated, upon influenza diagnosis or suspicion. Because isolation of S. aureus potentially representing co-infection was identified in a substantial proportion (19%) of children with influenza-associated mortality within three days of hospital admission, healthcare providers should consider administering antimicrobial agents active against locally circulating strains of S. aureus when empirically treating children with influenza-like illness and severe respiratory illness.


VAERS ID: 421131 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-02-28
Entered: 2011-04-15
   Days after submission:45
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, Influenza
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011US01360

Write-up: Initial literature report received on 03 Jan 2011: This literature was about cases of pediatric influenza-associated deaths. To further investigate the bacterial organisms that may have contributed to death, the authors systematically collected information about bacterial cultures collected at non-sterile sites and about the timing of Staphylococcus aureus specimen collection relative to hospital admission. The authors performed a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007/2008 season. This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on Immunization Practices) criteria. This child was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: unknown) during 2007/2008 season. It was unknown if the patient was vaccinated completely as per schedule. The child presented with influenza which later lead to death on unknown date. The causality was not reported. The authors commented that influenza-associated mortality among children is a rare event; however, healthcare providers should be mindful of the severe outcomes associated with influenza in children, especially those with high-risk medical condition. Critically ill children should be promptly treated with anti-viral medications, unless contraindicated, upon influenza diagnosis or suspicion. Because isolation of S. aureus potentially representing co-infection was identified in a substantial proportion (19%) of children with influenza-associated mortality within three days of hospital admission, healthcare providers should consider administering antimicrobial agents active against locally circulating strains of S. aureus when empirically treating children with influenza-like illness and severe respiratory illness.


VAERS ID: 421334 (history)  
Form: Version 1.0  
Age: 0.82  
Sex: Male  
Location: New Hampshire  
Vaccinated:2010-12-09
Onset:2011-01-27
   Days after vaccination:49
Submitted: 2011-04-19
   Days after onset:81
Entered: 2011-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3732AA / 3 UN / UN
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT3645AA / 2 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E80083 / 3 UN / UN

Administered by: Private       Purchased by: Public
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-01-27
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 04192011

Write-up: None stated.


VAERS ID: 421371 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Male  
Location: New Hampshire  
Vaccinated:0000-00-00
Onset:2011-04-01
Submitted: 2011-04-15
   Days after onset:14
Entered: 2011-04-19
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2158AA / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Influenza like illness, Meningitis meningococcal, Neisseria test positive, Oropharyngeal pain, Pain, Rash macular, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-04-06
   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:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Relevant diagnostic tests/laboratory data was reported as positive.
CDC Split Type: 201102140

Write-up: Initial report was received on 08 April 2011 from a consumer and the following electronic lay press article. A 23 year-old male patient (also reported as 21 year-old) with no reported past medical history had received possibly in 2007 MENOMUNE A/C/Y/W-135 (lot number, route, site and date of administration not reported) and "on Friday" (01 April 2011) developed a sore throat, was achy and had flu-like symptoms that lasted through the weekend. He was evaluated by his physician on Tuesday and it was thought "it was just a regular virus". Later on Tuesday, the patient complained of being in the "worse pain of his life", he appeared swollen and had "bruise-like blotches" on his body. The patient was taken to the hospital and then transferred to another hospital. He was diagnosed with N-Meningitis serogroup unknown. Relevant diagnostic tests/laboratory data was reported as positive. Treatments were not reported. No further information was available at the time of the report. The patient''s outcome was fatal. The cause of death was reported as bacterial meningitis on 06 April 2011 (also reported as 05 April 2011). Documents held by sender: none.


VAERS ID: 421495 (history)  
Form: Version 1.0  
Age: 0.1  
Sex: Male  
Location: New Hampshire  
Vaccinated:2010-10-14
Onset:2010-11-01
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2011-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1483Y / 2 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-11-01
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NH04201103

Write-up: 10-14-10 Merck 1483Y.


VAERS ID: 421582 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Male  
Location: Unknown  
Vaccinated:2010-11-01
Onset:2010-11-01
   Days after vaccination:0
Submitted: 2011-04-21
   Days after onset:171
Entered: 2011-04-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Sudden cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1104USA02226

Write-up: Information has been received from a nurse practitioner concerning a patient''s nephew, a 17 year old male consumer who she "thought" was vaccinated with a dose of GARDASIL (lot number not provided) in November 2010. The nurse practitioner stated that two weeks after the patient received the dose of GARDASIL, approximately November 2010 (also reported as "two weeks ago" on approximately 01-APR-2011), the patient died of sudden cardiac death on the lacrosse field. Unspecified medical treatment was given. It was unspecified if any lab diagnostic test were performed. The cause of death was sudden cardiac death. Sudden cardiac death was considered to be immediately life-threatening and disabling by the reporting nurse practitioner. Additional information has been requested.


VAERS ID: 422085 (history)  
Form: Version 1.0  
Age: 0.16  
Sex: Female  
Location: Arizona  
Vaccinated:2011-04-22
Onset:2011-04-24
   Days after vaccination:2
Submitted: 2011-04-29
   Days after onset:5
Entered: 2011-05-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3740AA / 1 RL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB960DB / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E80081 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1477Z / 1 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Chest X-ray abnormal, Death, Lung disorder
SMQs:, Cardiomyopathy (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-04-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: D-VI-SOL 400 u/mL liquid
Current Illness: None known
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Chest x-ray showed diffuse, hazy, bilateral granular opacities throughout both lungs, worse on the right.
CDC Split Type:

Write-up: Death.


VAERS ID: 422268 (history)  
Form: Version 1.0  
Age: 0.82  
Sex: Male  
Location: Texas  
Vaccinated:2011-02-17
Onset:2011-02-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2011-05-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC20B172AA / 4 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 915192 / 4 UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Crying, Death, Decreased appetite, Infantile spitting up, Pyrexia, Somnolence
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-02-23
   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:
Current Illness: Ear infection
Preexisting Conditions: Immunology problems undiagnosed
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: He was administered the shot and by the next day started having fevers & spitting up his food. His fever got worse and his appetite also. He was sleeping & crying for the most part and his fever was being stabilized by MOTRIN and TYLENOL.


VAERS ID: 422403 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: California  
Vaccinated:2008-11-05
Onset:2008-11-08
   Days after vaccination:3
Submitted: 2011-05-08
   Days after onset:910
Entered: 2011-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 88805 / UNK RA / IJ

Administered by: Other       Purchased by: Private
Symptoms: Asthenia, Death, Guillain-Barre syndrome, Lumbar puncture abnormal, Malaise, Mechanical ventilation, Paraesthesia, Paralysis, VIIth nerve paralysis
SMQs:, Peripheral neuropathy (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (broad), Respiratory failure (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2009-05-20
   Days after onset: 192
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations: None~ ()~~0.00~Patient
Other Medications: Arthritis Medication (Unknown)
Current Illness: None
Preexisting Conditions: Lumbar area fused in the 1980''s. Metal rod in wrist in the early 90''s due to job related accident.
Allergies:
Diagnostic Lab Data: Spinal Tap revealed Guillain Barre.
CDC Split Type:

Write-up: Started complaining of not feeling well a few days after the injection onto pin and needles effect in hands & feet. Bells palsy on one side of face then onto the other side onto Severe weakness throughout entire body to being on a ventilator severly paralyzed for over 6 months until death on 5/20/08


VAERS ID: 422585 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Texas  
Vaccinated:2011-05-09
Onset:2011-05-10
   Days after vaccination:1
Submitted: 2011-05-10
   Days after onset:0
Entered: 2011-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3882AA / 1 RL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0230AA / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 915371 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0259AA / 1 MO / PO

Administered by: Unknown       Purchased by: Private
Symptoms: Death, Epistaxis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-05-10
   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: Fluconazole prescribed for thrush.
Current Illness: Thrush
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Autopsy to be performed.
CDC Split Type:

Write-up: Pt noted to be lifeless on awaking in morning. Epistaxis reported by father.


VAERS ID: 422660 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Male  
Location: Unknown  
Vaccinated:2010-09-03
Onset:2011-04-18
   Days after vaccination:227
Submitted: 2011-05-10
   Days after onset:22
Entered: 2011-05-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Balance disorder, Blood pressure decreased, Botulism, CSF glucose increased, Computerised tomogram head, Computerised tomogram normal, Death, Dizziness, Headache, Intensive care, Lumbar puncture, Muscular weakness, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging spinal cord abnormal, Protein total normal, Quadriparesis, Quadriplegia, Respiratory paralysis, Spinal myelogram
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Respiratory failure (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-04-21
   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: Simvastatin
Current Illness: Unknown
Preexisting Conditions: Hyperlipidaemia; Breast cancer
Allergies:
Diagnostic Lab Data: 04/18/2011, Blood pressure dropped, abnormal; 04/18/2011, Computerised tomogram head showed no evidence of acute cranial or intracranial abnormality, normal; 04/18/2011, CSF culture, glucose level was increased, abnormal; 04/18/2011, Nuclear magnetic resonance imaging showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation, abnormal.; 04/18/2011, Nuclear magnetic resonance imaging brain revealed moderate microvascular disease, abnormal.
CDC Split Type: PHHO2011US07292

Write-up: Case number PHHO2011US07292, is an initial report received on 26 Apr 2011, from a clinical study. This 70-year-old male subject was enrolled in a study. The subject''s medical history included hyperlipidemia and cancer of left breast. Concomitant medications included Simvastatin. The subject received the study vaccine on 03 Sep 2010 at 13:15. On 18 Apr 2011, the subject was taken to the hospital for evaluation of dizziness and headaches. The same day, the subject experienced botulism and quadriparesis. The subject was unsteady on their feet and was weak in the upper extremities. The subject experienced progressive weakness and quadriplegia. The subject was seen by a neurosurgeon and neurologist. The subject underwent an MRI scan which showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation. The investigator stated that per the neurosurgeon, did not cause the quadriparesis. An MRI scan of the brain revealed moderate microvascular disease. A CT scan of the head showed no evidence of acute cranial or intracranial abnormality. The subject was treated with Aspirin and DECADRON and some improvement in status was noted. The subject was placed on ''JV'' for atypical presentation of Guillain-Barre syndrome. The subject was started on Doxycycline. The subject had a CT myelogram, a lumbar puncture and their antibody cultures were collected. The patient''s protein was normal. In the subject''s CSF fluid it was noted that their glucose level was increased (assessed as not clinically significant by the investigator). On 21 Apr 2011, the subject was transferred to ICU and signed a DNR (do not resuscitate). The subject refused to be intubated and refused a N16 and foley catheter placement. The subject''s condition deteriorated with desaturation 100% and blood pressure dropped. The subject was started on a dopamine drip, maximum dose. The subject experienced respiratory muscle paralysis. On 21 Apr 2011, at 03:38am, the subject died. An autopsy was performed, and results are pending. The seriousness for botulism as life threatening and fatal, quadriparesis was disability and respiratory muscle paralysis was fatal. The outcome of the quadriparesis was condition deteriorating. The investigator suspected a relationship between the botulism, quadriparesis and respiratory muscle paralysis and the study vaccine. Follow up received on 04 May 2011: Patient''s sex corrected, lab tests updated, events updated, death details updated, treatments provided, causalities updated.


VAERS ID: 422773 (history)  
Form: Version 1.0  
Age: 0.37  
Sex: Female  
Location: Alabama  
Vaccinated:2011-04-27
Onset:2011-05-03
   Days after vaccination:6
Submitted: 2011-05-12
   Days after onset:9
Entered: 2011-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3800 / 2 UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 914972 / 2 UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1653Z / 1 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Respiratory arrest, Sudden infant death syndrome, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

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

Write-up: SIDS. Was found not breathing and unresponsive in crib after nap.


VAERS ID: 422775 (history)  
Form: Version 1.0  
Age: 0.36  
Sex: Male  
Location: Alabama  
Vaccinated:2011-05-02
Onset:2011-05-12
   Days after vaccination:10
Submitted: 2011-05-12
   Days after onset:0
Entered: 2011-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3800AA / 1 UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH A15252 / 2 UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 16602 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-05-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: 1.)28 week premie twin, sole survivor 2.)survived in utero twin-twin transfusion 3.) apnea medicated in hospital but sent home without any, just an apnea monitor 4.)bilateral hydroceles
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: SIDS


VAERS ID: 423815 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Illinois  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-05-20
Entered: 2011-05-23
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: WAES1105USA02330

Write-up: Information has been received from a physician concerning a male patient who "quite some time ago", was vaccinated with a dose of PNEUMOVAX 23 (route and lot number not reported). On an unknown date "quite some time ago", the patient experienced cellulites like reaction around the injection site after receiving the PNEUMOVAX 23, "it got really red and swelled up". The physician reported that the patient had deceased and stated that it was unrelated to the PNEUMOVAX 23 vaccine. It was unknown if the patient sought medical attention. Outcome of cellulites like reaction around the injection site was unknown. Additional information has been requested.


VAERS ID: 424063 (history)  
Form: Version 1.0  
Age: 5.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-05-24
Entered: 2011-05-26
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Nonspecific reaction
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 for the patient.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201102909

Write-up: Initial report received from a consumer on 18 May 2011. This case is not medically confirmed. A 5-year-old male patient had received a dose of DTP vaccine (trade name, manufacturer name and lot number unknown) on an unspecified date and had a reaction and died 24 hours later. The reporter declined to provide any further information regarding the event. She declined to provide any other contact information for follow-up, and she did not wish to be contacted any further. No further information is expected. The reporter for this case is the same as for case 2011-02908. Documents held by sender: None.


VAERS ID: 424300 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Male  
Location: Kentucky  
Vaccinated:2011-05-18
Onset:0000-00-00
Submitted: 2011-05-25
Entered: 2011-05-31
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME) / SANOFI PASTEUR C3548AA / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 915706 / 2 LL / IM

Administered by: Public       Purchased by: Public
Symptoms: Asphyxia, Autopsy, Death, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-05-20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: Born addicted to drugs. Weaned off morphine & phenobarbital.
Allergies:
Diagnostic Lab Data: none
CDC Split Type:

Write-up: No known vaccine adverse reactions; parents report father rolled over on infant found unresponsive per mother; preliminary autopsy: asphyxiation per suffocation.


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