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VAERS ID: 320885 (history)  
Form: Version 1.0  
Age: 0.8  
Sex: Female  
Location: New Mexico  
Vaccinated:2008-07-22
Onset:2008-07-26
   Days after vaccination:4
Submitted: 2008-07-30
   Days after onset:4
Entered: 2008-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C951BA / 3 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C65934 / 3 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-07-26
   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: Tylenol
Current Illness: None
Preexisting Conditions: Former 24 week premie/C-section/5 day intubation
Allergies:
Diagnostic Lab Data: Check with Medical Examiner. Labs and Diagnostics: CBC with increased WBCs. Blood glucose and K+ were high upon arrival in ED
CDC Split Type:

Write-up: Pt deceased on 07/26/08. Currently case remains open at Medical Examiners office. Pt had no positive signs of illness at time of exam, normal PE. 10/20/2008 Autopsy received. COD Sudden Infant Death Syndrome. Infant found by parent cold and unresponsive. Resuscitation efforts were unsuccessful. No significant anatomic, circumstantial or toxicologic findings on Autopsy.


VAERS ID: 320909 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-07-30
Entered: 2008-07-31
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Fatigue, Injection site pain, Viral infection
SMQs:, Extravasation events (injections, infusions and implants) (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: WAES0807USA04740

Write-up: Information has been received from a physician concerning a 22 year old female who on an unspecified date was vaccinated with her third dose of GARDASIL. Subsequently the patient experienced soreness at the injection site and fatigue. The outcome of soreness at the injection site and fatigue was not reported. Two months after receiving her third dose of GARDASIL, the patient died. The cause of death was "viral insult to the heart". Unspecified medical attention was sought. Follow-up information was received via telephone call from the physician. The patient was a family member. She did not have the vaccination dates or lot numbers since she did not give them. The physician reported that the patient''s mother thought that the patient died related to GARDASIL. She did not have the cause of death. The physician refused to provide patient information, information was gave to the coroner. The physician considered "viral insult to the heart" to be immediately life-threatening and disabling. Additional information has been requested.


VAERS ID: 320910 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-07-30
Entered: 2008-07-31
   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
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: WAES0807USA04504

Write-up: Information has been received from a physician concerning his patient''s daughter who on an unspecified date was vaccinated with a dose of GARDASIL. The patient''s mother told to the physician that her daughter died in her dorm room 4 days after receiving the dose. The physician did not have much information because he did not administer the vaccine and the patient''s daughter was not his patient. The reporter did not know the name of the physician who administered the vaccine. The physician considered the event to be life threatening. Additional information has been requested.


VAERS ID: 321130 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Texas  
Vaccinated:2008-07-22
Onset:2008-07-24
   Days after vaccination:2
Submitted: 2008-08-01
   Days after onset:8
Entered: 2008-08-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B153AA / 2 LL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF263AB / 2 RL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C80884 / 2 LL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1928U / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-07-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Tox screens were neg.
CDC Split Type:

Write-up: Patient received shots 48 hours prior to death. 9/30/08 Autopsy states COD as sudden unexpected death of an infant. Manner of death undetermined. Report also states patient found unresponsive, face down on comforters, in bed surrounded by pillows.


VAERS ID: 321297 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Male  
Location: Alaska  
Vaccinated:2008-07-24
Onset:2008-07-24
   Days after vaccination:0
Submitted: 2008-07-25
   Days after onset:1
Entered: 2008-08-05
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2572AA / 1 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2864AA / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-07-24
   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: None
Current Illness: None
Preexisting Conditions: Allergy to erythromycin
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: This young man was seen at the clinic where the itinerant Public Health Nurse administered the 2 injections. Later in the early evening he was found outside hanging by the neck - apparent suicide. 2/4/09-Medical Examiner report: COD Hanging.


VAERS ID: 321634 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Washington  
Vaccinated:2008-06-20
Onset:2008-07-27
   Days after vaccination:37
Submitted: 2008-08-08
   Days after onset:12
Entered: 2008-08-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B148AA / 1 LL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF259AA / 1 LL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C65934 / 1 RL / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-07-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: amoxicillin Rx started 7/18
Current Illness: Under tx for (R) OM/URI Sx 7/18
Preexisting Conditions: known in utero cocaine exposure
Allergies:
Diagnostic Lab Data: pending autopsy
CDC Split Type:

Write-up: Unexpected death at 4 1/2 months age (current coroner''s case Medical Examiner''s Office). 9/26 Autopsy report states COD as undetermined in infant w/cocaine in bloodstream. Manner of death is undetermined. Report also states: metabolic screening (-); cardiomegaly; hepato/splenomegaly. Patient placed on back & found face down in adult size bed. Born precipitously at home & admitted to hospital 16 days prior to death. Mother tested (+) for cocaine during pregnancy & hair testing of infant at birth (+) for cocaine. Dx w/Influeza A 5/08 & right OM 7/08. Tox screen at autopsy (+) for cocaine. Was not breast fed.


VAERS ID: 321696 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Missouri  
Vaccinated:2008-03-31
Onset:2008-04-03
   Days after vaccination:3
Submitted: 2008-08-08
   Days after onset:127
Entered: 2008-08-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1487U / 2 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Cardiac arrest, Computerised tomogram, Convulsion, Cough, Death, Dyspnoea, Fall, Headache, Hypotonia, Laboratory test, Loss of consciousness, Respiratory tract congestion, Syncope, Tremor, Upper respiratory tract congestion, X-ray
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (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), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-04-07
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: 3/31 ROCEPHIN; 3/31 ZITHROMAX
Current Illness: Sore throat
Preexisting Conditions: Hx of pharyngitis; Bacterial Meningitis at 17 mons
Allergies:
Diagnostic Lab Data: lab work, Cat scans, X-rays
CDC Split Type:

Write-up: To Whom It May Concern: My daughter went to our nurse practitioner at Health Care Center on March 31, 2008 for a sore throat. She complained of her throat for about two days prior. Pt would get pharyngitis and strep about twice a year since she was 13. She received a shot of ROCEPHIN in the office on March 31st as well she was given a prescription for ZITHROMAX (Z-PAK) at the same time. I''m not sure exactly what time her appointment was it was around 11:00 am. that day. She dropped off her prescription at the pharmacy and I picked up on my way home. She took her first dose of ZITHROMAX on the 31st. She stayed home from school the next two days. She slept late both days which is not abnormal for her. In the evenings we played rummy, she was congested and coughing a little. She complained of a headache the next night and I gave her some ibuprofen. On Wednesday April 3rd she went to school, (school gets out at 3:05 p.m.) after school she went to tract practice. Her tract practice was a short one, I know she ran but I''m not sure how much. She stopped at a convenience store on the way home from school and got a Red Bull. She went home and changed clothes for work. She called me between 4:30 and 5:00 p.m. on her way to work to tell me about the road being blocked due to rain where we live. She parked her car and was walking the short distance into where she works she collapsed and started seizing. A lady in the drive through told the owner that she had fallen and he went out immediately. He said she was shaking, the employees inside called 911 and then me. The owner told me she stopped shaking and took a few strained breaths and then went limp. The police officer arrive within three minutes, he was a first responder. He did not check for a pulse or attempt CPR (I am in the process of getting a police report as well). Just as I got there an off duty paramedic arrived and started CPR. It took quite awhile before the ambulance arrived; she had been down too long. I later learned that they did not get her heart started until just before the ambulance arrived at the hospital. Pt officially died on April 7th, the decision was made on April 6th that she become an organ donor. My daughter was a very healthy, vibrant, and beautiful person! Any other information you need I will do my best to provide. I STILL have not received the autopsy report. I did talk to them Friday and they said it would be within the next two weeks. Sincerely, pt''s mother 9/19/08 Autopsy report states COD as apparent cardiac rhythm disturbance of undetermined etiology. Report states pathologic findings of: hx of sudden fall & cardiac arrest; subgaleal hemorrhage, fontoparietal scalp; tongue abrasions c/w tooth marks; hx of recent illness; agonal seizures; bilateral cerebral edema; catecholamine induced myotoxicity; bilatreral lobar pneumonia; organ & tissue harvesting.


VAERS ID: 322250 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-08-14
Entered: 2008-08-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0808USA01968

Write-up: Information has been received from a registered nurse (R.N.) concerning a 22 year old female (a relative of another employee) who was vaccinated with a third dose of GARDASIL. Subsequently the patient died. The cause of death was unknown. Additional information has been requested.


VAERS ID: 323037 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Female  
Location: Unknown  
Vaccinated:2002-09-26
Onset:0000-00-00
Submitted: 2008-08-16
Entered: 2008-08-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR U0296AC / 5 RL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA745AA / 4 - / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0010 / 2 RA / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 2 LA / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Congestive cardiomyopathy, Deafness, Death, Developmental delay, Mutism
SMQs:, Psychosis and psychotic disorders (broad), Cardiomyopathy (narrow), Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-12-05
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 15 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: PMH: hearing loss x 4 yrs, verbal skills & coordination loss & dx w/autism.
Allergies:
Diagnostic Lab Data: Autopsy: Coroners case no. 2007-08810 Hospital LABS: ESR 95 (H), Hep A (+), blood culture (-). ANA (-). Urine c/s (+). Echocardiogram abnormal w/ejection fraction 35%, severe mitral regurgitation & tricuspid regurgitation, dilated cardiomyopathy. EKG w/conduction abnormalities.
CDC Split Type:

Write-up: Child developed mutism, deafness, developmental delay and diluted cardiomyopathy possibly following vaccination several years before death. 10/3/08 Autopsy states COD as idiopathic dilated cardiomyopathy & contributing condition of chronic sequelae of encephalomyelitis. 9/26/08 Reviewed hospital medical records of 11/20-12/05/2008. FINAL DX: dilated cardiomyopathy, pulmonary edema, cardiac arrest. Records reveal patient experienced cough, DOE, weakness, extreme fatigue, excessive sleeping, rhinorrhea, sore throat & 1 day of diarrhea x 1 week w/newly dx cardiomegaly on CXR at outlying hospital. Weight loss over 1 month noted by family. Exam showed holosystolic heart murmur. Felt to have had dilated cardiomyopathy worsened by or caused by myocarditis. Tx w/IVIG empiracally for viral myocarditis. During intubation attempt in cardiac cath lab, had cardiac arrest & expired despite attempted resuscitation.


VAERS ID: 323339 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2008-05-30
Onset:2008-05-31
   Days after vaccination:1
Submitted: 2008-08-26
   Days after onset:87
Entered: 2008-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2620AA / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Blood test, Decreased appetite, Fatigue, Laboratory test, Pyrexia, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-06-22
   Days after onset: 22
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: We did not notice any obvious illness on 5/30/2008 until next day we found patient had fever
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: autopsy, and lab test for tissue of heart and blood, but no results 9/2/08-records received-Histology report no significant pathology. Tox panel negative.
CDC Split Type:

Write-up: Patient had Minengitis vaccine on 5/30/2008 to meet the requirement of joining a tour this summer. He had fever for two days. On 6/1 his fever was above 100. The next few days temperature had been reduced, but he looked very tired all the time. His appetite also reduced tremendously. On the morning of 6/22/08 he suddenly and unexpectedly passed away during his sleep. Medical Examiner could not find any cause of the death so far. 9/2/08-cardiac arrhythmia of undetermined etiology.


VAERS ID: 323430 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Utah  
Vaccinated:2007-07-13
Onset:2008-04-01
   Days after vaccination:263
Submitted: 2008-08-26
   Days after onset:147
Entered: 2008-08-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / SMITHKLINE BEECHAM AHAVB143AA / 1 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0522U / 1 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2734AA / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Amyotrophic lateral sclerosis, Asthenia, Intensive care, Motor neurone disease, Muscle contractions involuntary, Muscular weakness, Respiratory failure
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dystonia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-08-21
   Days after onset: 142
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 15 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: therapy unspecified
Current Illness:
Preexisting Conditions: None 11/28/2007 - Received Twinrix, IM, RA, lot# AHABB100AA PMH: purpura fulminans age 5 or 8 s/p chickenpox. Pulmonary HTN in childhood. Underweight at birth & Nissen surgery w/G-tube as newborn for 1st year of life, repair of pectus excavatum age 17. Oral contraceptives, hypothyroidism. Allergic sulfa. Family hx of seizures
Allergies:
Diagnostic Lab Data: None LABS: EMG/NCS abnormal. Brain MRI abnormal; c-spine MRI WNL. CSF WNL. West Nile IgG (+), IgM (-)but testing done s/p IVIG. ANA (+). Echocardiogram WNL, SPI-C MRI. Muscle biopsy (+) marked neurogenic changes. CXR (+) for possible aspiration pneumonia. EKG abnormal showing ST depression, tachycardia. CSF: RBC 8, WBC 1, glucose 57, protein 33, c/s neg, oligo bands neg. ESR 13. MRI & CT scans of spine & brain reported as WNL. CXR abnormal w/mild edema vs effusions..
CDC Split Type: WAES0808USA03969

Write-up: Information has been received from a neurologist concerning a 21 year old female previously in good health who in March 2008, was vaccinated with the first dose of GARDASIL (lot# not provided). Concomitant medication included several other vaccinations (not including MENACTRA). Subsequently, the patient developed motor neuron disease consistent with amyotrophic lateral sclerosis (ALS). Her progressive clinical course began in April 2008. The patient had not received a second dose of GARDASIL or any other vaccines since onset of symptoms. She developed upper extremity weakness which had become generalized and much more severe. She had been hospitalized in intensive care for several weeks with respiratory failure. Her condition deteriorated despite treatment with immunoglobulin. She had upper and lower motor neuron features with fasciculations. There is no sensory loss. Diagnostic workup included cerebrospinal fluid analysis (CSF) and muscle biopsy that ruled out other conditions (such as Guillain Barre) and clinical picture is consistent with amyotrophic lateral sclerosis. Antineuronal antibodies were pending. A Superoxide dismutase (SOD) was pending and Stathmin (SMN) test will be ordered if SOD was normal. The reporting physician did not believe that illness was related to GARDASIL. Additional information has been requested. This is one of several reports from the same source. 9/9/08 Autopsy states COD as unclassified neurologic process, clinically presumed to be atypical GBS vs bulbar varient of ALS. FINAL DX 8/17-8/21/08 admission: amyotrophic lateral sclerosis & death by respiratory collapse. Developed cough, difficulty breathing, difficulty swallowing, poor oral intake, constipation, lack of energy 6 days prior to admit; had received Depo-Provera & outpatient IVIG prior to admit w/o any improvement. Admitted to ICU. Gradually worsened over the hospital stay, had NGT for feeding but refused PEG tube placement or tracheostomy. Referred to hospice & expired. FINAL DX 7/28-8/1/2008 admission: axonal motor neuropathy vs neuro neuropathy. UE weakness had progressively worsened until unable to even brush her teeth. Had facial weakness, unable to lift arms above the [[name]] or off the bed, difficulty lifting [[name]] off bed, poor neck flexion, ataxia, hyperreflexia, pain. Muscle biopsy done. Tx w/repeat IVIG. Improved & d/c to home w/outpatient neuro, PT/OT f/u. Neurology Clinic notes of 7/18 & 7/22/08 FINAL DX: Guillain Barre syndrome Records reveal patient experienced stable course s/p hospitalization except for weak voice, HA, tiredness, poor appetite. RTC 7/22 w/improved [[name]] weakness but difficulty standing & marked UE & neck weakness. Very slow progress led to depression. Started on antidepressants. FINAL DX 7/2-7/7/08 admission: actonel motor neuropathy vs neuro neuropathy. Records reveal patient experienced weakness in approx 4/08 after having fall & hit her [[name]]. Approx 3 [[name]] after the fall, patient had severe muscle weakness while exercising. Had been out of state for 7 months until 11 days prior to admit. Weakness progressed & hospitalized. Tx w/IVIG. Rheum, Neuro consulted. Responded well to IVIG. D/C to home w/PT & outpatient clinic f/u. 11/18/08 Reviewed hospital medical records of 7/1-8/26/2008. FINAL DX: neuromuscular weakness, respiratory insufficiency Records reveal that patient experienced fall & hit her [[name]] w/o LOC. Had neck & shoulder discomfort. 3 [[name]] later was unable to raise arms above her [[name]] & had muscle soreness. Seen by out of state chiropractor & orthopedist, c-spine films done. Bilateral UE weakness continued to progress w/SOB. reduced PFTs & admitted 7/1/08 for GBS w/u. Had mild swallowing difficulty & dysarthria. Neuro consult done but not included in records received. No d/c summary available. Have OT/PT notes from 7/9-7/28/08. Seen in ER on 7/28/08 for continued neuromuscular weakness, nausea & dehydration & subsequently transferred to higher level of care.


VAERS ID: 323433 (history)  
Form: Version 1.0  
Age: 0.1  
Sex: Male  
Location: Maryland  
Vaccinated:2008-08-14
Onset:2008-08-15
   Days after vaccination:1
Submitted: 2008-08-25
   Days after onset:10
Entered: 2008-08-27
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (FOREIGN) / MERCK & CO. INC. 1884U / 2 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-08-16
   Days after onset: 1
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: None
Current Illness: None
Preexisting Conditions: PPHN at birth requiring prolonged NICU stay & high level support
Allergies:
Diagnostic Lab Data: autopsy/coroners case pending 9/22/08-records received-WBC 19,700. CT scan revealed diffuse loss of gray-white differentiation consistent with cerebral edema. Global hypox ischemic injury resulting in cerebral edema.
CDC Split Type:

Write-up: Unexplained death at age 6 weeks about 24 hrs after Hepatitis B #2 dose. Autopsy pending. 9/22/08-records receivd for DOS 8/15-/16/08-transferred after cardiopulmonary arrest and severe hypoxic-ischemic encephalopathy. Found unreponsive and pulseless on couch following nap. Received unresponsive with fixed and dilated pupils, hypothermic core temperature 32.6 rectally. Coarse bilateral breath sounds. Intubated, mechanical ventilation. 1/12/09-Autopsy report received-COD Asphyxia. Undetermined cause.


VAERS ID: 323493 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Unknown  
Location: California  
Vaccinated:2008-04-09
Onset:2008-07-10
   Days after vaccination:92
Submitted: 2008-08-27
   Days after onset:48
Entered: 2008-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood cholesterol increased, Death, Myocardial infarction
SMQs:, Dyslipidaemia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Lipodystrophy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-07-10
   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: COPD
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Subject in pneumococcal vaccine trial, with severe COPD, died on 7/10/2008 in home due to myocardial infarction and high cholesterol. Vaccination took place on 4/9/07. According to the physician, the relationship to treatment is ''None". We would be happy to forward the Study''s SAE Report Form upon request.


VAERS ID: 323510 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Female  
Location: Oklahoma  
Vaccinated:2008-08-25
Onset:2008-08-26
   Days after vaccination:1
Submitted: 2008-08-27
   Days after onset:1
Entered: 2008-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B143AA / 3 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF439AA / 3 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C86142 / 3 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0302X / 3 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-08-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: RUNNY NOSE, PARENT DENIED FEVER OR ACUTE ILLNESS
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: PATIENT DIED 10/27/08-autopsy report received-COD undetermined. No injuries or natural causes identified. Toxicology, histology, culture, electrolyte, renal and metabolic screens non-contributory. History of co-sleeping with adult. Evidence of resuscitation attempt. krk


VAERS ID: 323512 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: California  
Vaccinated:2008-08-21
Onset:2008-08-22
   Days after vaccination:1
Submitted: 2008-08-27
   Days after onset:5
Entered: 2008-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (FOREIGN) / MERCK & CO. INC. 1884U / 1 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cyanosis, Heart rate decreased, Hypotonia, Oral intake reduced, Pallor, Resuscitation, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-08-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: 8/17/2008: Discharged from NICU stable; discharged home with diagnosis of: o Transient tachypnea of the newborn resolved o Sepsis left pneumothorax, resolved o Anemia at birth
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: 8/22/2008: 17:17 Mother brought baby to Urgent Care with complaints of baby not feeding for 5 hours, baby pale and limp. During triage it was noted that baby was limp, dusky blue and non-responsive. o 1720PM: Oxygen applied - Heart rate 87 o 1721PM: 911 was called o 1723PM: Heart rate deteriorated and CPR was initiated o 1728PM: 911 transport arrived o 1736PM: Baby transferred to gurney and CPR continued during transfer o 1737PM: Paramedics en route to hospital 12/1/08-autopsy report received-COD Sudden infant death associated with acute gastrointestinal illness of unknown etiology. History of vomiting x 2 days unable to keep feeds down. Abdundant loose stoll within small bowel.


VAERS ID: 323974 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Kentucky  
Vaccinated:2008-07-29
Onset:2008-08-07
   Days after vaccination:9
Submitted: 2008-08-26
   Days after onset:19
Entered: 2008-09-03
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B150AA / 1 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF329AF / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C68310 / 1 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Death, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-08-07
   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: None
Current Illness:
Preexisting Conditions: Twin gestation 33 5/7 week gestation
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 8/7/08 received phone call from patient''s mother that he had stopped breathing. She called EMS and he was taken to hospital and he was pronounced dead.


VAERS ID: 324002 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Ohio  
Vaccinated:2008-02-26
Onset:2008-03-12
   Days after vaccination:15
Submitted: 2008-09-03
   Days after onset:175
Entered: 2008-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1266U / 3 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-03-12
   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: none
Current Illness: none noted
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: Full Autopsy done. Immediate cause of death was massive pulmonary embolus. Secondary was Type 1 Diabetes (previously undiagnosed). Vitreous Humor glucose was 767 9/4/08-records received- Vitreous glucose 767.
CDC Split Type:

Write-up: Sudden death occured on 3/12/2008. 9/4/08-records received-Cause of Death:cardiovascular collapse as a consequence of pulmonary emboli, dehydration and diabetic ketacidosis.


VAERS ID: 324291 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Ohio  
Vaccinated:2008-08-27
Onset:2008-08-30
   Days after vaccination:3
Submitted: 2008-09-02
   Days after onset:3
Entered: 2008-09-05
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B149AA / 2 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF366AB / 2 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C87340 / 2 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Autopsy, Cardiac arrest, Pulse absent, Resuscitation, 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), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-08-30
   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: none
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: post mortem exam pending LABS: Tox screen & x-rays neg.
CDC Split Type:

Write-up: Baby brought to ED by squad. Found unresponsive at home with no pulse. Remained in asystole throughout resuscitation attempt. 10/24/2008 Autopsy report states COD as Undetermined, not c/w SIDS; manner of death undetermined. Report also states pathological diagnoses: pulmonary edema, mild; minor skin injuries to face; small for developmental age by weight & head circumference; and terminal aspiration of gastric contents.


VAERS ID: 324474 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Michigan  
Vaccinated:2008-09-02
Onset:2008-09-03
   Days after vaccination:1
Submitted: 2008-09-08
   Days after onset:5
Entered: 2008-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B142AA / UNK LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF362AA / UNK LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C68310 / UNK RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0207X / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-09-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: nystatin oral triple paste
Current Illness: thrush
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Mom GBS (+). Baby at birth had 7-10 days abx. LABS: Tox screen neg.
CDC Split Type:

Write-up: According to ME office next day after 7 AM bottle baby found dead. Post showed no trauma. 10/24/08 Autopsy report states COD as sudden unexpected death in infancy. Manner of death is undetermined. Report also states patient found unresponsive supine in bassinet.


VAERS ID: 324830 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Utah  
Vaccinated:2007-11-28
Onset:2008-04-04
   Days after vaccination:128
Submitted: 2008-09-02
   Days after onset:151
Entered: 2008-09-11
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB100AA / 1 UN / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Death, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-08-21
   Days after onset: 139
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Levoxyl .08 mcs; Birth control
Current Illness: None
Preexisting Conditions: Hypo-thyroid
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: April 2008, started experiencing symptoms of muscle weakness in arms and neck, they progressed to her throat and breathing muscles. She died 08-21-08.


VAERS ID: 324934 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Male  
Location: Ohio  
Vaccinated:2008-07-15
Onset:2008-08-12
   Days after vaccination:28
Submitted: 2008-09-10
   Days after onset:29
Entered: 2008-09-12
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2951BA / 1 LL / UN
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0475X / 2 RL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF362AA / 1 LL / UN
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR A0996 / 1 LL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C45721E / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0142X / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Blood culture positive, Body temperature increased, CSF culture positive, Death, Drug ineffective, Irritability, Meningitis pneumococcal, Nystagmus, Pyrexia
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-08-28
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: Unknown 10/16/08-records received-PMH: Two weeks prior hospitalized for viral illness which consisted of vomiting. Left orchiectomy at one week of age.
Allergies:
Diagnostic Lab Data: Blood culture, 08/25/2008, positive for Pneumococcus; Body temperature, 08/25/2008, fever; CSF culture, 08/25/2008, positive for Pneumococcus; Reported cause of death, Meningitis pneumococcal, pneumococcal meningitis. 9/25/08-records received-Urine turbid with RBC present. Blood culture positive streptococcus pneumoniae. Urine culture no growth. Abdominal x-ray mildly abnormal nonspecific bowel gas pattern. Lymph percentage increased 51.8. 10/16/08-records received-CSF cloudy 150 red blood cells, 99 white blood cells, 91% neutrophils, protein 257.9, CSF gram positive cocci in pairs. WBC 3.1, platelets 700,000, fibrinogen 950, potassium 6.9, CT normal. MRI brain abnormal consistent with leptomeningeal infiltration and meningitis secondary complications of compromise of vasculature. EEG abnormal, seizure activity.
CDC Split Type: USWYEH05894708

Write-up: Information regarding PREVNAR was received from a pediatrician regarding a 15-week-old male patient who experienced Pneumococcal meningitis. At 15 weeks of age, the patient received the first dose on 15-Jul-2008. He also received the first doses of HIB (manufacturer unknown), Poliomyelitis Vaccine Inactivated (manufacturer unknown), DTaP and ROTATEQ (Merck & Co Inc) on 15-Jul-2008. Relevant medical history was not provided. Concomitant therapy included Hepatitis B Vaccine, HIB, ROTATEQ, DTaP and Poliomyelitis Vaccine Inactivated. On 25-Aug-2008, the patient presented with nystagmus, irritability and fever. He was hospitalized and diagnostic tests were performed (see test results), however serotyping was not performed. The blood culture and cerebral spinal fluid culture were positive for Pneumococcus. The patient was diagnosed as having Pneumococcal meningitis drug ineffective on 25-Aug-2008. Treatments were not reported. The patient died on 28-Aug-2008. The physician considered PREVNAR to be ineffective in preventing Pneumococcal meningitis, but stated that she realized that only receiving one dose in the series did not confer immunity to the disease. No further information was available at the time of this report. The cause of death was reported as meningitis Pneumococcal. On 25-Aug-2008 test results were: blood culture (results: positive for Pneumococcus); body temperature (results: fever); CSF culture (results: positive for Pneumococcus). 9/16/08-office notes received-8/12/08-well visit normal exam. C/O fussy and will not take bottle. Daycare provider was ill day prior to office visit. 8/25/08-fever and seizure. 9/25/08-records received-urgent care center visit 8/12/08-C/O irritability and vomiting without fever. Sent to ED. Presented to ED with vomiting and screaming. Large projectile emesis times 3, decreased oral intake. Admitted overnight. Returned to ED on 8/25/08-fever began day prior of 103.3. In ED pulse oximeter decreased to mid 80''s. Transferred to another facility. 10/16/08-records received for DOS 8/25-8/28/08-Expired 8/28/08 06:35. Fever, eyes deviating from neutral position. Right pupil dilated, right side of face droopy. Symptoms began on 8/24/08 with temperature of 100.6. Respiratory difficulty and perioral cyanosis. Irritable, agitated. 11/06/08-records received-Cause of death:meningitis due to pneumoccal meningitis.


VAERS ID: 325016 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Unknown  
Vaccinated:2008-09-04
Onset:2008-09-07
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2008-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B137AA / 2 LL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF488AA / 2 RL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C35170 / 2 RL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1620U / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-09-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Not available (?)
CDC Split Type:

Write-up: On SUN 9-7-08 pt passed away/diagnosed with S.I.D.S "most likely" no other info available at this time. 1/12/09 Autopsy report states COD as Sudden unexplained death in infancy. Manner of death undetermined. Report also states that patient found unresponsive on her side in crib by parent in AM. Patient had been fed & placed on side in crib approx 1.5 hrs prior to being found unresponsive. Parent reported cold s/s since vaccinations received on 9/4.


VAERS ID: 325063 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Kansas  
Vaccinated:2008-07-24
Onset:2008-08-01
   Days after vaccination:8
Submitted: 2008-09-12
   Days after onset:42
Entered: 2008-09-15
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1740U / 1 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-08-04
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: erythromycin
Current Illness: Acne
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown LABS: WBC 10.3(H). Troponin greater than 100(H) & CPK 5492(H), CKMB 313.1(H) c/w infectious myocarditis, possibly viral. TSH 0.09(L). CRP 38.3(H). BNP 533(H). ANA neg. ASO 200(+). CXR abnormal w/water bottle appearing heart. Sodium 132(L), potassium 3.7(L), bicard 18(L), BUN 29(H), creatinine 1.3(H). AST 832(H), ALT 211(H). Urine drug screen neg. Blood c/s neg. MRSA screen neg.
CDC Split Type: WAES0809USA00837

Write-up: Information has been received from a physician concerning a 17 year old female with acne who on 24-JUL-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included erythromycin, solution, topical. On 04-AUG-2008, the patient experienced abdominal pain, chest pain and aching everywhere and was hospitalized. On 05-AUG-2008, the patient experienced myocarditis and died. Diagnosis was myocarditis but the doctor said it was not related to GARDASIL. The last time she was seen in this office was 2005. No additional information at this time. Additional information has been requested. 10/01/08 Death certificate states COD as myocarditis & CHF as contributing factor. 9/22/08 Reviewed PCP medical records. Reveals patient experienced abdominal pain, chest pain & aching everywhere. Expired 8/5/08 w/viral infection of the heart. Concomitant med was erythomycin topical solution for acne. Patient noted to be in good health on day of vaccination. 4/2/09 Received hospital medical records for 8/3-8/4/2008. FINAL DX: deceased secondary to severe nonischemic cardiomyopathy secondary to viral myocarditis Records reveal patient experienced fever, chills, feeling unwell x 2-4 days. Presented to ER w/abdominal & chest pain, weakness, dizziness, hypotensive, tachycardia, SOB, respiratory distress w/hypoxemia, azotemia, shocklike symptoms. EKG w/diffuse ST changes & ST elevations. Dx w/acute anteroseptal MI Emergent cardiac cath revealed EF 23% & balloon pump placed. Intensive care, deteriorated, V-tach, decompensation, extensive resuscitation efforts failed.


VAERS ID: 325271 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: California  
Vaccinated:2008-07-10
Onset:2008-07-12
   Days after vaccination:2
Submitted: 2008-09-15
   Days after onset:65
Entered: 2008-09-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B156DA / 1 LL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF402AB / 1 RL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C68310 / 1 RL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0018X / 1 MO / PO

Administered by: Public       Purchased by: Unknown
Symptoms:
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-07-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Details NA. 12/17/08-records received-Sudden death in a 2 month old child. Undetermined causes.


VAERS ID: 325385 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: California  
Vaccinated:2008-07-16
Onset:2008-07-29
   Days after vaccination:13
Submitted: 2008-09-17
   Days after onset:50
Entered: 2008-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B142AA / 1 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF370AA / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C42993 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0975U / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-07-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Congestion due to fires in area that the child lived in
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: No adverse effects at the time of injection. But patient died of Sudden infant death syndrome at a later date 07/29/2008 9/22/08-autopsy report received;COD-Asphyxia due to overlay due to co-sleeping with older sibling and parents in same bed. Petechiae of eyes.


VAERS ID: 325544 (history)  
Form: Version 1.0  
Age: 50.0  
Sex: Male  
Location: Unknown  
Vaccinated:2008-01-28
Onset:2008-08-14
   Days after vaccination:199
Submitted: 2008-09-18
   Days after onset:35
Entered: 2008-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: 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? No
Birth Defect? No
Died? Yes
   Date died: 2008-08-14
   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: COPD
Preexisting Conditions: PMH: CAP, SVT, COPD, exacerbation, colon adenoma, obstructive sleep apnea, chronic stasis edema, depression, polycythemia, COPD, cateracts, Ankylosing Spondylitis, probable
Allergies:
Diagnostic Lab Data: Labs and Diagnostics: Echo (+) for pulmonary hypertension. CT (+) for pulmonary hypertension.
CDC Split Type:

Write-up: Subject in pneumococcal vaccine trial, with severe COPD, found dead in his room at home on 8/14/08. Cause of death listed as Sudden cardiac death due to cor pulmonale due to COPD due to cigarette smoking. Vaccination took place on 1/28/2008. According to the physician, the relationship to treatment is ''None''. We would be happy to forward the Study''s SAE Reporting Form upon request. 9/19/08 Case notes received from reporter. Pt had recently been hospitalized for Community Acquired Pneumonia and COPD exacerbation. During admission noted to have signs of CHF. Tx with abx and steroids with return to baseline. Seen 8/6/08 for f/u. PE (+) for 2+ lower extremity edema. Pulse ox 91%. Encouraged to wear O2 supp 24/7. Pt found dead 8/14/08. Nasal cannula off. COD listed by PCP as sudden cardiac death due to cor pulmanale due to COPD due to cigarette smoking. 1/23/2009 Death Cert received from ME. COD: sudden cardiac death due to cor pulmanale due to COPD due to cigarette smoking. .


VAERS ID: 325648 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Oklahoma  
Vaccinated:2008-09-05
Onset:2008-09-08
   Days after vaccination:3
Submitted: 2008-09-19
   Days after onset:11
Entered: 2008-09-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B160BA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF232AD / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C80884 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0208X / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-09-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Trans pos great Vess Noc 745.19
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None. Pt sch for autopsy 1/12/09 Autopsy report states COD as: dTGA s/p arterial switch 7/8/08; ventricular hypertrophy; extensive pericardial adhesions; mineralized foreign body w/giant cell reaction; para aortic nodule w/suture; trachea & distal mainstem bronchi discoloration w/frothy exudates. Report also states patient had history of transposition of great vessels comlicated by single intramural coronary arter. Autopsy revealed nodule located anterior to ascending aorta & posterior to right pulmonary artery. Histology revealed fragments of mineralized foreign body w/marked inflammatory response of corresponding foreign body giant cell reaction of uncertain significance. 12/23/08 Reviewed hospital medical records of 7/2-7/21/3008. FINAL DX: transposition of great vessels; maternal hx of herpes on Valtrex; PROM; arterial switch procedure 7/8/08; relative adrenal insufficiency resolved; suspected left clavicle fracture; s/p delayed sternal closure; relative lymphopenia resolved.


VAERS ID: 325680 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Louisiana  
Vaccinated:2008-09-17
Onset:0000-00-00
Submitted: 2008-09-18
Entered: 2008-09-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B167AA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF488AA / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C65929 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0143X / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-09-18
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: LA080903

Write-up: Death 4/29/09 Autopsy Report states COD as sudden unexpected death in infancy (SIDS); & acute interstitial pneumonitis; & manner of death as natural. Report also states recently diagnosed w/heart murmur & had been born a preemie twin.


VAERS ID: 325794 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2007-02-15
Submitted: 2008-09-22
   Days after onset:584
Entered: 2008-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Agitation, Amnesia, Antinuclear antibody negative, Arthralgia, Ataxia, Back pain, Balance disorder, Blood immunoglobulin G, Blood immunoglobulin M, Borrelia burgdorferi serology, Borrelia burgdorferi serology negative, Chest X-ray abnormal, Cognitive disorder, Computerised tomogram normal, Death, Dehydration, Dementia with Lewy bodies, Depressed level of consciousness, Dizziness, Electroencephalogram abnormal, Epstein-Barr virus antibody negative, Epstein-Barr virus antibody positive, Failure to thrive, Fatigue, General physical health deterioration, Headache, Hypersomnia, Hypoaesthesia, Hypoxia, Immunology test, Influenza like illness, Lethargy, Lyme disease, Malnutrition, Musculoskeletal stiffness, Myalgia, Mycoplasma serology positive, Nuclear magnetic resonance imaging brain normal, Paraesthesia, Pneumonia aspiration, Polymerase chain reaction, Rash, Sepsis, Single photon emission computerised tomogram normal, Visual acuity reduced, Weight decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Retroperitoneal fibrosis (broad), Dementia (narrow), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Neonatal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Arthritis (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-02-15
   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? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Coronary artery bypass graft, diabetes, hypertension, lyme disease, tick bite. The subject''s past medical history, concurrent medical conditions, and concurrent medications were not reported.
Allergies:
Diagnostic Lab Data: Antinuclear antibody, 11Sep2003, negative; Diagnostic tests: 03 June 2003: Lyme IgG and IgM Western Blot positive. B. microti IgM less than 1:20 titer. B. microti IgG 1:160 titer. Human monocytic IgM and IgG both less than 1:40 titer. Human granulocytic IgM and IgG both less than 1:40 titer. 11 September 2003: Epstein Barr virus (EBV) VCA IgM negative, EBV early antigen Ab IgG positive (99, positive), EBV nuclear antigen Ab IgG negative. Bartonella species panel by PCR negative; Mycoplasma general by qualitative PCR positive. Lyme IgM Western Blot positive. Lyme IgG Western Blot equivocal. B. microti IgM and IgG both less than 1:20 titer. Human monocytic IgM and IgG both less than 1:40 titer. Human granulocytic IgM and IgG both less than 1:40 titer. 11 February 2004: Chest x-ray showed hypertrophic degenerative changes present in the dorsal spine. 16 May 2004: Magnetic resonance imaging of brain without contrast due to clinical history of dementia showed 1) no acute intracranial abnormality, 2) cortical atrophy, 3) microangiopathic changes, 4) lipoma involving the right frontal scalp. 05 January 2005: Human ehrlichiosis/human monocytic IgM and IgG both less than 1:40 titer. B. microti IgM less than 1:20 titer. B microti IgG 1:160 titer. Lyme IgG and IgM Western blot positive. 30 January 2006: C6 ELISA B. burgdorferi: 0.09 (negative). Lyme IgM Western Blot negative. Lyme IgG Western Blot positive. 31 January 2006: Mycoplasmia hominis by real time PCR, Bartonella henselae by qualitative PCR, Mycoplasma fermentans by qualitative PCR, Mycoplasma penetrans by qualitative PCR, Mycoplasma pneumoniae by qualitative PCR, Babesia microtri by qualitative PCR, and Babesia microti IgG by ELISA all negative. 20 February 2006: Lyme IgM Western Blot negative. Lyme IgG Western Blot positive. 25 March 2006: Computed tomography of the head without contrast showed no acute intracranial change. 20 April 2006: Brain SPECT (TC99M Neurolite) showed normal findings with no evidence of Lyme''s encephalopathy. 03/04 August 2006: Digitrace 24 hour ambulatory computer-monitored electroencephalograph resulted in a clinical interpretation of sleep disorder such as hypersomnolence or narcolepsy; no epileptiform activity. 01 November 2006: Genomic B. burgdorferi: negative; Plasmid B. burgdorferi: negative. Lyme IgG Western Blot positive. B. henselae-PCR (whole blood) negative.
CDC Split Type: A0730259A

Write-up: This case was reported by a lawyer and described the occurrence of rheumatological symptoms in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). According to the statement of injuries, at an unspecified time after vaccination with LYMERIX the subject experienced "joint pain, flu-like symptoms, fatigue, rashes, tingling in extremities, headaches, memory loss, cognitive dysfunction, muscle pain, numbness, imbalance, weight loss, and decreased activities of daily life". The statement of injuries also alleged that the subject experienced "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism all caused by vaccination with LYMERIX including but not limited to those set forth above." At the time of reporting the outcome of the events was unspecified. Follow up information was received on 08 September 2008 via medical records. On an unspecified date during or prior to 2004, the subject was diagnosed with dementia. On 09 January 2004 and 09 February 2004, the subject reported increasing joint problems/joint pain. On 30 March 2005, he reported decreased memory. In August 2006, the subject underwent ambulatory electroencephalogram monitoring due to hypersomnolence, memory loss, agitation, joint pain and Lyme disease. The subject was diagnosed with dementia on an unspecified date. On 10 January 2007, the subject''s wife contacted his health care provider to inform that the subject was hospitalized and "they stated he doesn''t have Lyme". In January 2007, the subject was experiencing end-stage dementia and was going into a nursing home. On 22 January 2007, the subject''s internist was consulted and it was noted that the physician had been managing the subject''s "chronic Lyme disease" and was reportedly "unaware of the wife''s concern that this is demyelinating polyneuropathy secondary to the Lyme vaccine". The internist noted that the subject had been ambulating a few months prior to the date of evaluation "and that this rapid deterioration could not be secondary to dementia alone". A trial of ROCEPHIN was recommended. He was admitted to a nursing home for end stage dementia. On 01 February 2007 he was noted during a neurology examination of have a history of Lyme disease "with tick bite and bull''s eye rash in the late 1990''s. He was reportedly "given vaccine" two years later and developed symptoms including dizziness, ataxia, back pain, poor vision, stiff neck, and weight loss. He was noted to have "dementia with Lewy Bodies", with gradual memory and cognitive decline. The subject was hospitalized on 04 February 2007 due to progressive lethargy, dehydration, and sepsis. He was obtunded upon admission and remained so throughout admission. He was admitted to the intensive care unit due to hypoxemia, aspiration risk, and "feeling that he was heading toward worsening and respiratory failure:" Initially he was "a full code as it was his wife''s feeling that this was all secondary to Lyme disease and not Lewy body dementia". Treatment included intravenous fluids and antibiotics without change, and he was moved to a medical floor and the family made the decision to "do not resuscitate" (DNR). He progressed in a downward fashion until he expired under comfort care measures on 15 February 2007. The specific cause of death was not provided. Diagnoses were 1) end state Lewy body dementia, 2) chronic failure to thrive, 3) history of Lyme disease, 4) aspiration pneumonia, 5) dehydration, 6) protein malnutrition. 9/24/08-death certificate received-COD-Sepsis. Lewy Body Dementia


VAERS ID: 325998 (history)  
Form: Version 1.0  
Age: 44.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2008-07-31
Onset:2008-09-05
   Days after vaccination:36
Submitted: 2008-09-24
   Days after onset:19
Entered: 2008-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / ID

Administered by: Military       Purchased by: Military
Symptoms: Arteriosclerosis, Autopsy, Cardiac arrest, Death, Dermatitis allergic, Dyspnoea, Rash pruritic
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 (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-09-05
   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: ZOCOR 40 MG PO Q PM
Current Illness: Unknown
Preexisting Conditions: Medical records did indicate a bee sting allergy for which he carried an Epipen. No known drug/medication allergies. Hx of Hyperlipidemia, Started on ZOCOR for treatment in 2007. Tobacco abuse: smokes 1/4-1/2 PPD of cigarettes. No birth defects. 1/30/08-records received- PMH: high cholesterol. Former smoker.
Allergies:
Diagnostic Lab Data: See summary
CDC Split Type:

Write-up: 44 y/o male with a history of Tobacco abuse and Hypercholesterolemia, developed dyspnea and progressed to a cardiac arrest on the morning of 5 Sept 08 towards the end of a several mile run and after performing a wind sprint. Member unsuccessfully given CPR and ACLS (at the scene and EMS/ED) and declared deceased at Emergency Department. Subject 2/5 cardiac risk factors: tobacco use and hyperlipidemia; autopsy results support severe atherosclerotic disease with final cardiac examination for myocarditis pending at this time. Member was seen in ED on 25 Aug 2008 (per wife) for a reported "allergic skin rash". Wife reported the SM had the rash as a result of the Smallpox vaccination he had received earlier. Symptoms: Dyspnea (shortness of breath), Cardiac Arrest, Rash, pruritic. 1/30/09-records received-sudden death while performing PT. Previously lived in foreign country until 8/4/08. Received small pox vaccine on 7/31/08. Presented to clinice on 8/25/08 with C/O pruritic skin rash, pimples on legs and stomach and C/O itching, treated with Keflex, hydrocortisone cream and Benadryl. On 9/4/08 C/O feeling tired. During PT collapsed, difficulty breathing. No C/O chest pain. Stopped breathing. 4/6/09-Medical examiner report received-Probable cause of death:Ischemic heart disease. Contributing conditions:hypertension. hypercholesterolemia.


VAERS ID: 326199 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Texas  
Vaccinated:2008-09-19
Onset:2008-09-19
   Days after vaccination:0
Submitted: 2008-09-25
   Days after onset:6
Entered: 2008-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B160BA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF466AA / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C27701 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0923X / 1 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture negative, Cardio-respiratory arrest, Computerised tomogram abnormal, Culture urine negative, Lumbar puncture, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-09-22
   Days after onset: 3
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, presented to ambulatory clinic for two month well child visit and immunizations.
Preexisting Conditions: Colpocelphaly, as well as abnormality on chromosome 16, ASD, and VSD
Allergies:
Diagnostic Lab Data: Negative blood culture, negative urine culture, head CT demonstrating colpocephaly.
CDC Split Type:

Write-up: Infant presented to emergency room with fever approximately 12 hours after vaccinations. Admitted and started on empiric antibiotics. Two days later, lumber puncture attempted with subsequent cardio-respiratory arrests. 4/7/09 Autopsy report states COD as complications of multiple congenital abnormalities & manner of death as natural. Report also states multiple congenital abnormalities of: normal pressure hydrocephalus; patent foramen ovale; VSD; mildly atretic right dominant coronary artery system. Also had UTI w/enterococcus faecalis, sepsis & lobar pneumonia. Tox screen neg.


VAERS ID: 326269 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: New York  
Vaccinated:2008-07-31
Onset:2008-08-05
   Days after vaccination:5
Submitted: 2008-09-05
   Days after onset:31
Entered: 2008-09-26
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2798AA / 1 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF397AA / 1 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR A0836 / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C80881 / 1 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-08-05
   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: Cardiac murmur
Allergies:
Diagnostic Lab Data: Post mort- revealed no reason for death
CDC Split Type:

Write-up: Pt. received vaccines on 7/31/08 and was then brought to the local emergency room unresponsive, without vital signs. They attempted resuscitation but he did not survive. 2/20/09 Autopsy report states COD as SIDS; perimembranous atrial septal defect. Manner of death undetermined. Report also states patient had seen PCP & slight heart murmur detected. referred to peds cardiologist but expired prior to appt.


VAERS ID: 326811 (history)  
Form: Version 1.0  
Age: 1.1  
Sex: Female  
Location: Indiana  
Vaccinated:2008-04-16
Onset:2008-08-17
   Days after vaccination:123
Submitted: 2008-10-01
   Days after onset:45
Entered: 2008-10-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C49916 / 4 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abnormal behaviour, Autopsy, Blood culture positive, Body temperature increased, Chest X-ray abnormal, Death, Drug ineffective, Irritability, Pneumococcal bacteraemia, Pneumococcal infection, Pyrexia, Sepsis, Tachypnoea
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), 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: 2008-08-19
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: Unknown PMH: eczema, URI, bilateral OM, viral syndrome, viral exanthem. Birth hx: NSVD, losse x 1 nuchal cord, hyperbilirubinemia.
Allergies:
Diagnostic Lab Data: Blood culture, 08/19/2008, revealed S. pneumoniae; Serotype 33F; Body temperature, 08/17/2008, fever, 08/19/2008 afebrile; Chest X-ray, 08/19/2008, revealed pneumonia; Autopsy results not reported; Reported cause of death, Sepsis, Pneumococcal infection, Invasive Pneumococcal Disease; Sepsis
CDC Split Type: USWYEH06121908

Write-up: Information regarding PREVNAR was received from a pediatrician regarding a 16-month-old female patient who experienced Invasive Pneumococcal Disease - drug ineffective, pneumococcal bacteremia and sepsis. The patient died. The patient received the fourth dose on 16-Apr-2008. No significant medical history. Concomitant medications were not reported. The patient was seen at the doctor''s office on 17-Aug-2008. She was fussy and clingy and had a temperature. The child returned to the office on 19-Aug-2008, at which time, she was afebrile and tachypnic. The physician sent her to the ER for diagnostic tests (see test results) and treatment. The child died in the ER. It was determined that the patient experienced Invasive Pneumococcal Disease - drug ineffective on 17-Aug-2008, pneumococcal bacteremia, and sepsis on 19-Aug-2008. The physician stated that IPD was due to serotype 33F, which was not covered by PREVNAR. An autopsy was performed, however results were not available. No additional information was available at the time of this report. The cause of death was reported as sepsis and pneumococcal infection and the autopsy cause of death was not reported. Body temperature (results: fever) was done on 17-Aug-2008. On 19-Aug-2008 test results were: body temperature (results: afebrile); chest x-ray (results: revealed pneumonia); and blood culture (results: revealed S. pneumoniae; Serotype 33F). 10/17/08 Autopsy report states COD as acute lobar pneumonia complicating CHF following viral myocarditis. 10/17/08 Reviewed autopsy report, death certificate & extensive hospital & PCP medical records received for coroner. Records reveal patient experienced fever & difficulty breathing x 2 days. Seen by PCP & sent for admission. Tx w/IV antibiotics. Became tachypneic, tachycardic & intubated for impending respiratory failure. Developed bradycardia. CPR & transcutaneous pacing initiated. Transported to higher level of care for PICU. Upon arrival, had blood in ETT & was acidotic & despite continued resuscitative efforts expired. FINDINGS at Autopsy: severe viral myocarditis w/marked patchy myofibrillar nectosis; chronic lymphocytic bronchitis; acute bilateral pan-lobar pneumonia; acute passive visceral congestion; pleural & pericardial effusions; ascites; mild focal lymphocytic meningeal infiltrates; early neuronal anoxic changes; acute splenitis.


VAERS ID: 326872 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Michigan  
Vaccinated:2008-08-26
Onset:2008-09-15
   Days after vaccination:20
Submitted: 2008-10-01
   Days after onset:16
Entered: 2008-10-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2958AA / 2 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF493AA / 2 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR A0491 / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C69205B / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0642X / UNK MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Autopsy, Electroencephalogram abnormal, Epilepsy, Nuclear magnetic resonance imaging brain normal
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Generalised convulsive seizures following immunisation (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-09-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None known
Preexisting Conditions: Possible seizure disorder PMH: born @ 36 wks, c-section for breech presentation, perinatal hypoglycemia, tube feeding & NICU. Initially was underweight even for a preemie but steadily gained.
Allergies:
Diagnostic Lab Data: 7/1/08 - EEG - abnormal (focal epileptiform activity); 7/21/08 - MRI brain - normal LABS: MRI brain revealed possible mild delay in myelination which was thought to be WNL for a preemie.
CDC Split Type:

Write-up: Patient had likely seizure 8 days after 2 month imms that included DTaP, Hep B, PCV, Hib & rotavirus vaccines (on 6/20/08). Death possibly secondary to seizure, autopsy in progress. 11/07/08 Autopsy report states COD as sudden death & manner of death as undetermined. Report also states patient was in crib in supine position w/vomitus stains around head but no aspiration on autopsy. 10/21/08 Reviewed PCP medical records of 5/1-7/21/2008 including birth records & vaccination records. FINAL DX: Records reveal patient experienced seizure activity x 1 on 6/28/08 during sleep when stiffened & shook arms/legs, unresponsive w/eyes open & deviated. Episode lasted approx 1 min, then pt cried out, had bowel movement & went to sleep Tx w/diastat but not routine antiseizure meds unless had 2nd seizure. .


VAERS ID: 326958 (history)  
Form: Version 1.0  
Age: 0.1  
Sex: Male  
Location: New York  
Vaccinated:2008-09-25
Onset:2008-09-26
   Days after vaccination:1
Submitted: 2008-09-29
   Days after onset:3
Entered: 2008-10-03
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB452AA / 2 LL / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-09-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HBIG 8/21/08
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Newborn screen NYSDOH negative 9/4/08
CDC Split Type:

Write-up: Infant found unresponsive at home on 9/26/08, pronounced dead in ER. Patient had been seen on 9/25/08 in our practice, normal exam, no issues other than mother Hep B (+). Received Hep B dose #2 on 9/25/08 at our practice.


VAERS ID: 326959 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: New York  
Vaccinated:2008-09-03
Onset:2008-09-06
   Days after vaccination:3
Submitted: 2008-09-28
   Days after onset:22
Entered: 2008-10-03
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B192BA / 1 LL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF474AA / 1 LL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C86140 / 1 RL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0414X / 1 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Autopsy, Blood glucose increased, Cardiac arrest, Crying, Haemoglobin normal, Heart rate increased, Intestinal ischaemia, Pain, Pallor, Small intestinal perforation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (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), Gastrointestinal perforation (narrow), Acute central respiratory depression (broad), Ischaemic colitis (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-09-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Autopsy - true bust in small intestine, entire small bowel ischemic.
CDC Split Type:

Write-up: On morning of 9/6/08 pt crying with different cry "painful". On way to office pt noted to be pale. In office HR 110-increased to 190 in 10 mins, Hgb 10.6, Glu 320. Ambulance called. En route to ER had asystole. Code X 30 min but no HR. Autopsy showed entire bowel ischemia and true knot in small intestine.


VAERS ID: 327331 (history)  
Form: Version 1.0  
Age: 1.1  
Sex: Male  
Location: New York  
Vaccinated:2008-10-01
Onset:2008-10-02
   Days after vaccination:1
Submitted: 2008-10-03
   Days after onset:1
Entered: 2008-10-07
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0428U / 1 UN / SC

Administered by: Private       Purchased by: Public
Symptoms: Computerised tomogram abnormal, Death, Haemorrhage intracranial, Respiratory arrest, Resuscitation, Scan brain, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-10-03
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Polyvitamins with fluoride
Current Illness: No
Preexisting Conditions: Ex 31 wk preemie, patent foramen ovale
Allergies:
Diagnostic Lab Data: Intracranial bleed on head CT
CDC Split Type:

Write-up: Pt found unresponsive & not breathing after nap. Resuscitated by EMS & in ER, never regained consciousness & later died in PICU at hospital. Intracranial bleed on head CT. 10/9/2008 Forensic Autopsy Summary Sheet received, COD pending further studies. Infant found unresponsive and transported to ER & dx with subdural hematoma. Transferred to higher level of care. Despite resuscitation efforts, infant pronounced dead. Autopsy findings of 2 small abraded contusions to L side of head, subdural hematoma overlying the L temporal lobe. Marked brain edema and pulmonary edema. Otherwise unremarkable


VAERS ID: 327500 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Female  
Location: Montana  
Vaccinated:2008-07-30
Onset:2008-08-05
   Days after vaccination:6
Submitted: 2008-10-08
   Days after onset:64
Entered: 2008-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2952AA / 2 RL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF439AA / 2 RL / UN
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR A0491 / 2 LL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C65046 / 2 LL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0305X / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-08-05
   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: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: As per hospital death on 8-5-08. 10/15/08-autopsy report received-cause of death:Sudden Infant Death Syndrome.


VAERS ID: 328396 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: New York  
Vaccinated:2008-08-18
Onset:2008-10-02
   Days after vaccination:45
Submitted: 2008-10-13
   Days after onset:11
Entered: 2008-10-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2958AA / 2 LL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF461AA / 2 RL / UN
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR AC0491 / 2 LL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C69255 / 2 RL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0413X / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-10-03
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown 10/30/08-records received-Pathology report acute abdomen, abdominal compartment syndrome. Omental tissue with foci of acute inflammation and fibrinous exudate. CAT scan no evidence of intussusception.
CDC Split Type: WAES0810USA01805

Write-up: Information has been received from a physician concerning a patient younger than 6 months who was vaccinated with a dose of oral ROTATEQ. There was no concomitant medication. Subsequently, the patient died after receiving a dose of ROTATEQ. The cause of death has not been reported. Unspecified medical attention was sought. No product quality complaint involved. Additional information has been requested. 10/30/08-records received for DOS 10/2-10/3/08-presented with fever 103 and lethargy, developed abdominal distention and occult blood positive stool. Decreased urine output. Exploratory laparotomy, drainage of peritoneal fluid, omentectomy, appendectomy. Intubation and ventilation and resuscitation. Profound metabolic acidosis. Right pleural effusion. Necrotic omentum. Acute renal failure. 12/1/08-provisional autopsy report received-Provisional clinical diagnosis: suspected abdominal compartment syndrome. Emergency laparotomy with appendectomy, omentectomy and placement of peritoneal drain. Postoperatively developed severe thrombocytopenia and prolong APTT and INR. Hypotensive secondary to suspected ventricular fibrillation. Resuscitation unsuccessful. Pathologic examination of appendix revealed suppurative acute appendicitis with focal transmural necrosis and extensive periappendicitis. 4/6/09-final autopsy report received. Clinical Diagnosis:fever and lethargy. Abdominal distention and hem positive stool with currant jelly appearance. Acute passive hepatic congestion. Congestive splenomegaly. Bilateral renal medullary congestion. Hypotension due to suspected ventricular fibrillation. Postoperative severe thrombocytopenia and abnormal coagulation profile. krk


VAERS ID: 328445 (history)  
Form: Version 1.0  
Age: 89.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2008-10-03
Onset:2008-10-04
   Days after vaccination:1
Submitted: 2008-10-14
   Days after onset:10
Entered: 2008-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN

Administered by: Other       Purchased by: Private
Symptoms: Cold sweat, Heart rate increased, Hypotension
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-10-04
   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: Lorazepam; Fluoxetine hydrochloride; Lortab; Omeprazole; Sucralfate
Current Illness: Atrial fibrillation, CVA, Dementia
Preexisting Conditions: The subject has no known drug or food allergies. She has previously received flu vaccines and has no history of reactions following previous flu or other vaccines.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A0751873A

Write-up: This case was reported by a healthcare professional and described the occurrence of death-unknown cause in a 89-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included atrial fibrillation, cva and dementia. Concurrent medications included ATIVAN, PROZAC, LORTAB, PRILOSEC and CARAFATE. On 3 October 2008 at 17:15 the subject received a dose of FLULAVAL at 0.5 ml in the right arm. On 4 October 2008, approximately 21 hours after vaccination with FLULAVAL, the subject felt cool and clammy, had increased pulse and low blood pressure. Within 5 minutes, the subject experienced death-unknown cause. She was DNR (do not resuscitate). The healthcare professional considered the events were life threatening. The subject died on 4 October 2008, cause of death was not reported. It was unknown whether an autopsy was performed. 1/6/09-records received-Cause of Death-Sudden Cardiac Death. Cerebrovascular Disease. No autopsy performed.


VAERS ID: 328577 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Male  
Location: Texas  
Vaccinated:2008-10-13
Onset:2008-10-13
   Days after vaccination:0
Submitted: 2008-10-15
   Days after onset:2
Entered: 2008-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2802AA / UNK LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-10-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Post Knee replacement
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was vaccinated on 10/13/2008 in the AM. He ate lunch then went to Physical Therapy for rehabilitation following knee replacement surgery. He died during his PT appointment. 5/5/09-death certificate received-Final COD cardio pulmonary arrest.


VAERS ID: 329267 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-10-21
Entered: 2008-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Children with high risk condition (asthma, seizure disorder, neuro/vesicular disorder)
Preexisting Conditions: One child without any risk conditions.
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20082210

Write-up: We received the following information from the above mentioned literature article on 06 OCT 2008: During the 2004-2007 influenza seasons, influenza-associated pediatric deaths were analysed. Of 90 children who were recommended for influenza vaccination, only 5 (6%) were fully vaccinated. 18 children were at least partially vaccinated more than or equal 14 days before illness onset per season, respectively. One child who was partially vaccinated did not have either an age related or ACIP defined high-risk condition recommended for vaccination. The reason for death was not reported for individual cases. Influenza-associated pediatric mortality and/or bacterial coinfection were suspected. The author will be contacted for details. Children with high risk condition (asthma, seizure disorder, neuro/vesicular disorder). One child without any risk conditions. Causality not related. Causes of death for individual cases not identifiable, complications of influenza and bacterial coinfections were mentioned. Expectedness assessment according to product information: Partial vaccination is unexpected. Vaccination failure is expected. Bacterial coinfections and influenza complications are unexpected after vaccination with FLUVIRIN, BEGRIVAC, FLUAD and AGRIPPAL. On a case level, the case is considered unexpected. No change in benefit-risk-ratio. No measures necessary.


VAERS ID: 329869 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Texas  
Vaccinated:2008-04-22
Onset:2008-04-22
   Days after vaccination:0
Submitted: 2008-10-20
   Days after onset:181
Entered: 2008-10-24
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B139AA / UNK LL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF330AA / UNK LL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C45893 / UNK RL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1371U / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-04-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: PMH: uncomplicated term delivery, 40wk gestation. Normal growth, no congenital anomalies.
Allergies:
Diagnostic Lab Data: LABS: bacterial & viral c/s neg. Metabolic screening neg. Acetaminophen (H). Vitreous creatinine(H).
CDC Split Type:

Write-up: 2 month old died following routine vaccinations. Medical examiner was Dr. 10/28/08 Autopsy report states COD & manner of death as undetermined. 10/28 Autopsy report also states patient found lying on side unresponsive in adult bed 2 hrs s/p laid down for nap. Had fever s/p vaccination & received tylenol. Findings at autopsy included viscous bronchial mucus & chronic cystitis.


VAERS ID: 330032 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Male  
Location: Unknown  
Vaccinated:2008-10-10
Onset:2008-10-10
   Days after vaccination:0
Submitted: 2008-10-17
   Days after onset:7
Entered: 2008-10-24
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Dyspnoea, Pneumonia, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-10-13
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: PMH: atherosclerosis; chronic kidney disese; allergic rhinitis; temporal arteritis syndrome, giant cell arteritis, chronic renal insufficiency, osteoporosis, HTN, nephrolithiasis, B12 deficiency due to pernicious anemia; peripheral neuropathy, GERD, remote oral cancer, psoriasis. Allergy: penicillin & quinine. Ex-smoker.
Allergies:
Diagnostic Lab Data: LABS: ESR peak 137 down to 51 on 10/10. CT chest revealed ground glass opacification. Echocardiogram revealed bicuspid aortic valve, mitral aortic insufficiency, LVH & normal ejection fraction. ABG: pO2 62(L), pCO2 38, pH 7.35. ECG abnormal. WBC 8.8, H/H 8.7/26(L), plts 86K. Sodium 132(L), BUN/creatinine 30/2.2. Troponin 0.12.
CDC Split Type:

Write-up: Friday 10/10/2008: Patient was in good shape when I took him to MD - for a review of his blood test results. He was advised to get a flu shot. They were available in the lobby with a paper from the Dr. He got the flu vaccines shot. Saturday 10/11/2008: He sounds as if he has a hard time breathing. -7 P.M. - Saturday 10/11/2008: Patient goes to hospital via ambulance. 911. Sunday 10/12/2008: Patient called me to advise me that he is in the hospital. Monday 10/13/2008: I visit patient in hospital and he is non-responsive and barely alive. Monday 10/13/2008: Patient died from pneumonia. Prior to the flu vaccine he was in good health. I believe the vaccine should not have been advised as it killed him. 10/28/08 Death certificate states COD as respiratory failure w/pneumonia & myelodysplasia as contributing causes. 10/28/08 Reviewed hospital medical records of 10/12-10/13/2008. FINAL DX: CHF; A-fib w/RVR; acute respiratory failure; acute exacerbation of COPD; acute exacerbation of chronic renal insufficiency & failure; malnutrition. Records reveal patient experienced SOB, bilateral leg edema, atrial fibrillation w/rapid ventricular response. Cardioverted & admitted to ICU. Developed acute respiratory failure, agitation, confusion worsened & placed on BiPAP. Tx w/IV antibiotics. Pt was DNR, no intubation. 11/25/08 Reviewed PCP medical records Office record of 8/20/08 reveals pt disoriented s/p ER visit for visual disturbance, HA & temporal arteritis. Had been started on steroids. RTC 9/19/08 s/p ER visit after fall w/o sequelae. RTC 9/29 w/fatigue. RTC 10/10 stating felt better. No record of flu shot, was given by unknown company in lobby of physician office building.


VAERS ID: 330055 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Arkansas  
Vaccinated:2008-10-20
Onset:2008-10-20
   Days after vaccination:0
Submitted: 2008-10-21
   Days after onset:1
Entered: 2008-10-27
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B192BA / 2 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF450AB / 2 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C71571 / 2 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-10-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None - Started Prosobee at mom''s request.
Allergies:
Diagnostic Lab Data:
CDC Split Type: AR0841

Write-up: Received call from nurse at medical center that infant had died at ER around 4 PM the date of vaccination. The infant appeared well and healthy at the time of vaccination. 6/16/09 6/16/09 Autopsy report states COD as undetermined & manner of death as undetermined. Autopsy report also states pt given antipyretic & put down for nap after vaccination. Found lying face down. Examination revealed mild chronic inflammatory cell infiltration of lungs & no evidence of anaphylaxis.


VAERS ID: 330148 (history)  
Form: Version 1.0  
Age: 0.8  
Sex: Male  
Location: Colorado  
Vaccinated:2008-10-21
Onset:2008-10-22
   Days after vaccination:1
Submitted: 2008-10-27
   Days after onset:5
Entered: 2008-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UA2828AA / 1 LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Laboratory test
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-10-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None noted at well child check done at time of visit.
Preexisting Conditions: Previous UTI, VCUG done with normal results, and hernia (resolved)
Allergies:
Diagnostic Lab Data: Per pathologist unsure of cause of death at this time, lab work being done ? SIDs, also noted no erythemia or swelling at injection site.
CDC Split Type:

Write-up: Patient received Fluzone on Monday 10.21.08, and died on Tuesday pm on 10.22.08 12/18/08 Autopsy report states COD as sudden unexplained infant death. Manner of death is undetermined. Report also states patient getting over cold w/runny nose & cough, no fever, on day of vaccination. Had been put to sleep on back & found on stomach in crib.


VAERS ID: 330245 (history)  
Form: Version 1.0  
Age: 71.0  
Sex: Male  
Location: Unknown  
Vaccinated:2007-01-31
Onset:2007-02-25
   Days after vaccination:25
Submitted: 2008-10-27
   Days after onset:609
Entered: 2008-10-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. 0981F / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cardiac arrest, Cerebrovascular accident, Death, Electrocardiogram T wave abnormal, Electrocardiogram abnormal, Peak expiratory flow rate, Ventricular tachycardia
SMQs:, Torsade de pointes/QT prolongation (narrow), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), 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), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Other ischaemic heart disease (broad), Respiratory failure (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-02-25
   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: [therapy unspecified], mg; atenolol, mg; vardenafil, mg
Current Illness: Chronic obstructive pulmonary disease; Prediabetes; Hypothyroidism; Hypertension; Ex-smoker
Preexisting Conditions: PMH: HTN, Pre-diabetes, hypothyroidism, COPD, former smoker. 1/9/08-records received- Pre-existing conditions:pre-diabetes. Smoking.
Allergies:
Diagnostic Lab Data: electrocardiogram, 02/25/07, left axis deviation, QRS axis -31 to -90, VT, rate 118, since 2/4/05 VT now present; physical examination, well-developed, elderly, male, in no apparent distress, comfortable; peak expiratory flow, 210; electrocardiogram, 02/25/07, frontal axis: mean QRS -77, frontal axis: terminal - 77, frontal axis: ST 90, frontal axis: T 85; electrocardiogram, 02/25/07, severity: T abnormal ECG; electrocardiogram, 02/25/07, QRS interval 89, QT interval 298, QT corrected 417, frontal axis: initial -81; vital sign, within normal limits Labs and Diagnostics: EKG abnormal.
CDC Split Type: WAES0810USA04106

Write-up: Information has been received from an investigator during a study concerning a 71 year old male with hypothyroidism (since 2006), hypertension (since 2006), chronic obstructive pulmonary disease (2001), prediabetes (2007), ex-smoker and occasional drinker who did not use recreational or street drugs, who on 31-JAN-2007 was vaccinated with ZOSTAVAX (Oka/Merck) (lot # 652936/0981F) at routine healthcare visit, including blood pressure and routine testing. Patient did not have concomitant vaccines. No complaints or concerns at this visit. Vitals on exam were within normal limits and on general exam patient was a well-developed, elderly, male, in no apparent distress, comfortable. Concomitant therapy included atenolol 50mg/d, therapy unspecified "LT4" 0.025mg/d and vardenafil 20mg/prn. On 25-FEB-2007 the patient presented at a facility and was noted as having a CVA and cardiac arrest. At this facility the patient had an EKG which was T-abnormal. The EKG impression included: QRS interval 89, QT interval 298, QT corrected 417, frontal axis initial -81, frontal axis mean QRS -77, frontal axis terminal -77, frontal axis ST 90, frontal axis T 85, left axis deviation, QRS axis -31 to -90; ventricular tachycardia, rate 118; since 2/4/05 VT now present. At the same day, the patient died. The cause of death was reported as cerebrovascular accident. At this time, relationship of CVA and cardiac arrest to study therapy is unknown. Upon internal review, cardiac arrest was determined to be an other important medical event. A lot check has been requested. This is one of several reports from the same source. Additional has been requested. 11/5/2008 Note received from FDA. Pt presented 2/25/07 and DX''d with CVA and cardiac arrest. 1/9/09-death certificate received-COD-Cardiac arrest.Ischemia of heart. Hypertension.


VAERS ID: 330246 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-04-17
Onset:2007-05-01
   Days after vaccination:14
Submitted: 2008-10-27
   Days after onset:545
Entered: 2008-10-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. 0329U / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Abdominal tenderness, Anion gap increased, Atrial fibrillation, Blood bicarbonate decreased, Blood calcium decreased, Blood creatinine increased, Blood lactic acid decreased, Blood urea increased, Chest X-ray abnormal, Computerised tomogram abnormal, Death, Endotracheal intubation, Haemodialysis, Heart rate increased, Hypocalcaemia, Hypotension, Hypoxia, Intensive care, Liver function test normal, Mechanical ventilation, Oedema peripheral, Pleural effusion, Renal failure acute, Renal tubular necrosis, Respiratory failure, Respiratory rate, Sepsis, Urine analysis normal, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Lactic acidosis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Renovascular disorders (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (narrow), Tubulointerstitial diseases (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-05-15
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 13 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes mellitus; Hypertension; Hyperlipidaemia; Chronic back pain; Osteopenia
Preexisting Conditions: hx of chronic back pain, hx of osteopenia. 1/9/09-records received- Pre-existing conditions:hyperlipidemia, diabetes mellitus, hyptertension.
Allergies:
Diagnostic Lab Data: blood pressure, 142/5; physical examination, significant for some moderate tenderness to palpation in the epigastric region as well as the right; abdominal computed, 05/02/07, pancreatitis, possibly hemorrhagic w/ enlarged pancreatic head; chest X-ray, significant pleural effusions; abdominal computed, 05/02/07, peripancreatic R anterior pararenal space & R paracolic gutter effusions of high density; total heartbeat count, 88; urinalysis, normal; arterial blood HCO(3), 05/02/07, decreased from initial 23 to 16 with anion gap of 22; serum creatinine, 05/02/07, 1.3; serum L-lactate test, 05/02/07, 4; total heartbeat count, 130s; serum L-lactate test, 05/15/07, 9.4; serum creatinine, previously had been 1; serum creatinine, continued to increase; serum creatinine, 05/03/07, 0.8; serum calcium, 05/02/07, low; WBC count, 05/02/07, initially had been 24,000 and was 20,000; serum blood urea, 05/02/07, 33, elevated; serum creatinine, 1.2; WBC count, 24,00; serum blood urea, 28; hepatic function tests, normal; respiratory rate, 19 Labs and Diagnostics: BUN 28. Creatinene 1.2. WBCs 24K. CT scan abd (+) for pancreatitis, possibly hemorrhagic. Stools guaiac (+).
CDC Split Type: WAES0810USA04107

Write-up: 11/5/08 Death Summary received from FDA. Pt had been admitted 5/2/08 with severe pancreatitis-epigastric abdominal pain and N&V. Tachycardic on admission. PE (+) for abd tenderness and lower extremity edema. Pt became hypoxic eventually requiring intubation and acute renal failure. Pt also developed Atrial Fibrillation and anemia requiring 4 units of PRBCs. Family consented to comfort care and pt was extubated 5/15/07 and expired. Dx at TOD: Severe pancreatitis with probable necrotizing pancreatitis of unclear etiology. Septic shock due to gram (-) rod bacteremia, Acute renal failure on hemodialysis, Respiratory Failure, DM, HTN, Hyperlipidemia, hx of chronic back pain, hx of osteopenia. Labs and Diagnostics: BUN 28. Creatinene 1.2. WBCs 24K. CT scan abd (+) for pancreatitis, possibly hemorrhagic. Stools guaiac (+)./Information has been received from an agency concerning a 70 year old female with diabetes mellitus, hypertension, hyperlipidaemia, chronic back pain and osteopenia who on 17-APR-2007 was vaccinated with ZOSTAVAX (Oka/Merck) (lot # 656861/0329U). This report was part of a study. Concomitant therapy included Td vaccine. The patient presented to the emergency room with complaint of abdominal pain on the evening prior to admission, occurring 30-45 minutes after dinner. In the emergency room, she was afebrile with a blood pressure or 142/51, heart rate 88 and respiratory rate 19. Her abdominal exam was significant for some moderate tenderness to palpation in the epigastric region as well as the right lower quadrant region. She had trace lower extremity edema. Her initial labs showed normal liver function tests and normal urinalysis. Her chemistry panel was remarkable for BUN 28 and elevated creatinine of 1.2 from her prior baseline. White blood count was 24,000. A CT scan of the abdomen at the time of admission showed pancreatitis, possibly hemorrhagic with an enlarged pancreatic head and peripancreatic right anterior pararenal space and right paracolic gutter effusions of high density were also noted. On 02-MAY-2007, She was admitted to the medical surgical floor with the diagnosis of pancreatitis. The patient was kept NPO for severe pancreatitis; however, in the morning, her electrolytes showed her bicarbonate decrease from initial 23 to 16 with an anion gap of 22, BUN was elevated at 33 and her creatinine was 1.3. White blood cell count initially had been 24,000 and was 20,000. STAT lactate level was obtained, which was 4, and patient''s status was subsequently changed from medical/surgical to intensive care unit. She was treated with empiric imipenem. Her calcium level was noted to be low, and she subsequently was repleted. On 03-MAY-2007, patient became increasingly hypoxic and was subsequently intubated, developing respiratory failure. She required LEVOPHED for blood pressure support. Chest x-rays revealed significant pleural effusions, most likely from the aggressive IV fluid hydration. She was intubated as indicated above and ventilation was managed by the intensivist. Patient developed acute renal failure, which was most likely due to ATN. Patient''s creatinine on May 2nd was 1.3 when it had previously been 1. After some aggressive IV fluid hydration the following day on May 3rd it was 0.8. However, it continued to increase, most likely due to hypoperfusion to the kidneys, as she did become hypotensive and required LEVOPHED. Nephrology was consulted on May 3rd, and the nephrologist continue to follow. She was started on hemodialysis after failing a LASIX trial and hemodialysis continued. On 05-MAY-2007 the patient was noted to have an episode of atrial fibrillation. She was started on an AMIDARON drip and converted back into sinus rhythm where she remained during her hospital course. The patient was placed on intensive insulin drip for diabetes mellitus, which was titrated off, and for the rest of her course was on a sliding scale insulin with close monitoring of her blood sugars. The patient developed hypocalcemia which was due to severe pancreatitis. This was monitored closely and repleted. As of 15-MAY-2007, the pancreatitis appeared to be significantly worse overnight. She had required increased LEVOPHED support and her lactate on the morning of 15-MAY-2007 increased to 9.4. The patient was also requiring increased ventilator support with 15 of PEEP, which had increased overnight, as well as the fact that she remained in atrial fibrillation at a heart rate of 130s despite being on an AMIODARONE drip. After conversation with the intensivist, who had been following the patient, it was decided to have a family meeting regarding the patient''s poor prognosis, and it was decided at that time to focus on comfort care. Pressor support was withdrawn, the patient was extubated, and she expired shortly after on 15-MAY-2007. The cause of death was reported as sepsis and pancreatitis. A lot check has been requested. This is one of several reports from the same source. Additional information has been requested. 11/5/08 Death Summary received from FDA. Pt had been admitted 5/2/08 with severe pancreatitis-epigastric abdominal pain and N&V. Tachycardic on admission. PE (+) for abd tenderness and lower extremity edema. Pt became hypoxic eventually requiring intubation and acute renal failure. Pt also developed Atrial Fibrillation and anemia requiring 4 units of PRBCs. Family consented to comfort care and pt was extubated 5/15/07 and expired. Dx at TOD: Severe pancreatitis with probable necrotizing pancreatitis of unclear etiology. Septic shock due to gram (-) rod bacteremia, Acute renal failure on hemodialysis, Respiratory Failure, DM, HTN, Hyperlipidemia, 1/9/09-COD-Necrotizing pancreatitis, etiology unknonw.


VAERS ID: 330247 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: Unknown  
Vaccinated:2007-06-18
Onset:0000-00-00
Submitted: 2008-10-27
Entered: 2008-10-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. 1476F / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cardiac failure congestive, Chronic obstructive pulmonary disease, Condition aggravated, Death, Hospice care, Hypertension, Peripheral vascular disorder
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Hypertension (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-07-22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Dementia Alzheimer''s type; Cardiac failure congestive; Smoker; Peripheral vascular disorder; Hypertension; Hyperlipidaemia; Glaucoma; Chronic obstructive pulmonary disease; Gastrooesophageal reflux disease; Chronic renal insufficiency
Preexisting Conditions: Shingles; Appendicectomy; Total hip replacement; Endarterectomy; Intestinal obstruction; Cataract operation. COPD exacerbation with probable bronchitis. HTN-out of control. Hyperlipidemia. Alzheimer''s dementia. Chronic renal insufficiency. Cigarette addiction.
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0810USA04108

Write-up: Information has been received from an investigator concerning a 77 year old male with chronic obstructive pulmonary disease, Alzheimer''s dementia, hypertension, congestive heart failure, peripheral vascular disease, hyperlipidaemia, glaucoma, gastrooesophageal reflux disease, shingles, chronic renal insufficiency and cigarette addiction and previous surgeries of appendicectomy, total hip arthroplasty, cataract surgery, bowel obstruction and right endarterectomy in July 1995 who on 18-JUN-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (lot # 656412/1476F). This report was part of a study. The patient was hospitalized in May of 2008. On 12-JUN-2008, he was referred for Hospice care. On 10-JUL2008, he as admitted to a skilled nursing facility for Hospice care and died 34 days after vaccination, on 22-JUL-2008. The cause of death was COPD, HTN, PVD and CHF. A lot check has been requested. This is one of several reports received from the same source. Additional information has been requested. 1/9/09-death certificate received- COD-cardiopulmonary arrest. chronic obstructive pulmonary disease.


VAERS ID: 330248 (history)  
Form: Version 1.0  
Age: 64.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-01-25
Onset:2007-03-04
   Days after vaccination:38
Submitted: 2008-10-27
   Days after onset:602
Entered: 2008-10-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. 0981F / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cardiac arrest, Cardiogenic shock, Death
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), 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: 2007-03-04
   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
Current Illness: Osteoporosis; Blood pressure increased; Back injury; Dyspnoea; Hyperlipidaemia
Preexisting Conditions: Atrial fibrillation. PMH: Osteoporosis, elevated BP, hyperlipidemia, atrial fibrillation and dyspnea of uncertain etiology. Recent back injury.
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0810USA04109

Write-up: Information has been received from an investigator during a study concerning a 64 year old female with a history of osteoporosis, elevated blood pressure, hyperlipidemia, atrial fibrillation in the past and recurrent dyspnea of uncertain etiology who on 25-JAN-2007, was vaccinated with ZOSTAVAX (Oka/Merck) (Lot# 652936/0981F). The patient did not have concomitant vaccines. The patient had sustained a recent lower back injury at work and was being seen by occupational medicine. She was not anticoagulated. She was last seen by her medical provider on 25-JAN-2007, the day of vaccination, and was doing well. The patient suddenly expired on 04-MAR-2007. Her death certificate gives cause of death as cardiac arrest and cardiogenic shock. A lot check has been requested. This is one of several reports received from the same source. Additional information has been request. 11/5/2008 Death Cert and note received from FDA. Pt expired suddenly on 3/04/2007. COD Cardiac Arrest and Cardiogenic Shock.


VAERS ID: 330249 (history)  
Form: Version 1.0  
Age: 71.0  
Sex: Male  
Location: Unknown  
Vaccinated:2007-02-14
Onset:2007-02-25
   Days after vaccination:11
Submitted: 2008-10-27
   Days after onset:609
Entered: 2008-10-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. 0032U / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Angiogram cerebral abnormal, Anticoagulant therapy, Aortic arteriosclerosis, Apnoea, Areflexia, Arteriosclerosis, Asthenia, Blood creatinine normal, Blood glucose increased, Brain herniation, Cardiac enzymes normal, Cerebral artery embolism, Cerebral infarction, Cerebrovascular accident, Cheyne-Stokes respiration, Computerised tomogram abnormal, Condition aggravated, Death, Depressed level of consciousness, Dysarthria, Echocardiogram abnormal, Ejection fraction, Electrocardiogram normal, Gastrointestinal tube insertion, Glomerular filtration rate abnormal, Haematocrit normal, Haemorrhage intracranial, Hemiplegia, Intensive care, Ischaemic stroke, Neurological examination abnormal, Oxygen supplementation, Pupillary reflex impaired, Pupils unequal, Renal failure chronic, Sensory loss, Somnolence, Ultrasound Doppler, Unresponsive to stimuli
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (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: 2007-03-01
   Days after onset: 4
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: None
Current Illness: Benign prostatic hypertrophy; Chronic kidney disease
Preexisting Conditions: PMH: BPH, chronic kidney disease stage II
Allergies:
Diagnostic Lab Data: head computed axial, an acute infarct of the right pons and thalamus w/o extension, intracranial hemorrhage or dissection; carotid artery, no significant stenosis of the internal carotid arteries on either side; neurological, no significant changes; electrocardiogram, negative; angiography, distal R cerebral artery patent secondary to communicating arteries; echocardiography, 02/26/07, there was some aortic sclerosis without stenosis; carotid artery, bilateral antegrade vertebral flow; angiography, occlusion of R proximal post. cerebral artery along P1 segment; diagnostic laboratory, 02/25/07, NIH stroke scale was 15 on admission; echocardiography, 02/26/07, an ejection fraction of 50-65% with normal LV function and no cardioembolic source; cardiac enzyme panel, negative; hematocrit, stable; glomerular filtration, approximately 78 consistent with chronic kidney disease; serum creatinine, remained stable; fasting blood glucose, elevated. Labs and Diagnostics: Head CT (+) for acute infarct of the R pons and thalamus. MRI/MRA (+) for acute infarct of R midbrain and pons.
CDC Split Type: WAES0810USA04105

Write-up: Information has been received from an investigator concerning a 71 year old male with benign prostatic hypertrophy and chronic kidney disease stage 2 who on 14-FEB-2007 was vaccinated with ZOSTAVAX (Oka/Merck) (lot#: 656608/0032U). This report was part of a study. The patient was admitted on 25-FEB-2007 for slurred speech and found to have an ischemic bilateral lacunar cerebrovascular accident, and transferred to the Intensive Care Unit secondary to a second cerebrovascular accident involving the right mid brain, pons and with extension to the right thalamus. On the second hospital day, he was found to be unresponsive. A repeat head CT demonstrated an acute infarct of the right pons and thalamus without extension, intracranial hemorrhage or dissection. There was atherosclerosis of the vertebral and aortic arch. The right vertebral artery was found to be smaller than the left and there was also age-related cortical atrophy. Atherosclerosis of the vertebral artery was thought to be the likely embolic source for this second event. A CT angiogram demonstrated occlusion of the right proximal posterior cerebral artery along the P1 segment although the distal right cerebral artery was patent secondary to communicating arteries. Because of this, he was started on anticoagulation with heparin. Carotid ultrasound was obtained which demonstrated no significant stenosis of the internal carotid arteries on either side, and there was bilateral antegrade vertebral flow. The NIH stroke scale was 15 on admission upon evaluation by the neurologist. He was given permissive hypertension and oxygen initially. He was also continued on full dose aspirin which was started upon admission to the hospital since he was not taking that at home. In addition, he was given lovastatin 40 mg p.o. daily. The patient had no significant changes in his neurological examination after admission to ICU. He was hemiplegic on the left side with significant sensory deficit and weakness. He was able to move his right upper and right lower extremities spontaneously against gravity and withdrew to noxious stimuli in all four extremities. However, he had no gag reflex and was very somnolent on examination, at times difficult to arouse. His pupils were bilaterally unequal with the right pupil approximately 4 mm and the left pupil approximately 2 mm, sluggishly reactive bilaterally as well. In addition, on 2/27/2007 he was found to have apneic episodes with Cheyne-Stokes breathing pattern, worrisome for central apnea. The patient was ruled out for myocardial infarction with negative enzymes per protocol, in addition to negative electrocardiogram. Echocardiogram on 2/26/2007 demonstrated an ejection fraction of 50-65% with normal LV function and no cardioembolic source. There was some aortic sclerosis without stenosis. He was given aspirin as above in addition to the statin as above. The patient had no history of diabetes but did have elevated fasting glucose on admission so he was given an insulin sliding scale and his fingerstick glucose was checked. He was also given D5 normal saline since he was not eating. Because his fingersticks remained stable, the insulin sliding scale and fingerstick checks were later discontinued. The patient had a baseline glomerular filtration rate of approximately 78 consistent with chronic kidney disease Stage 2. His creatinine remained stable during hospitalization and electrolytes were repleted as needed. He was given aggressive intravenous hydration given that multiple doses of contrast were given. The patient had no active issues and his temperature and white blood cell count were monitored without any significant signs of infection. The patient was made NPO and a nasogastric tube was initially placed to low intermittent suction. This was later changed to CORPAK in order to initiate tube feeding. He was given GI prophylaxis with famitodine (MSD). Patient was placed on heparin drip secondary to the thrombus as above. His hematocrit was assessed as stable. He was continued on SCD for prophylaxis and also given aspirin as above. The patient was diagnosed with status post bilateral lacuna cerebrovascular accident, status post right mid brain pontine thalamic cerebrovascular accident and chronic kidney disease, Stage 2. The patient died on 01-MAR-2007 at 20:50. The cause of death was haemorrhagic intracranial with likely herniation secondary to left mid-brain pontine and possibly thalamic stroke. Additional information has been requested. 11/5/08 Death Summary received from FDA. Pt admitted 2/25/07 for slurred speech and found to have an Ischemic bilateral lacunar CVA. Found unresponsive on hospital day#2 and dx with acute CVA. Pt hemiplegic with significant sensory defecits and weakness. Apneic episode with Cheyne-Stokes breathing worrisome for central apnea. Gag reflex absent-place on aspiration precautions. NG tube placed for feeds. Place on comfort care only. Pt expired 3/1/07 with COD Intracranial hemorrhage with likely herniation 2'' to left midbrain pontine and possibly thalamic stroke. 1/9/09-death certificate received-COD intercerebral hemorrhage,non-traumatic. acute ischemic stroke.posterior cerebral artery occulsion, etiology unknown.


VAERS ID: 330396 (history)  
Form: Version 1.0  
Age: 55.0  
Sex: Female  
Location: Maryland  
Vaccinated:2007-09-19
Onset:2008-09-13
   Days after vaccination:360
Submitted: 2008-10-28
   Days after onset:45
Entered: 2008-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-09-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: COPD
Preexisting Conditions: PMH: COPD, bipolar disorder.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Subject in pneumococcal vaccine trial, with severe COPD, died at patient''s fathers home on 9/13/28. Vaccination took place on 9/19/07 and death took place on 9/13/08. According to the physician, the relationship to treatment is ''None''. We would be happy to forward the Study''s SAE Report Form upon request Subject ID A100099. 6/1/09 Death certificate states COD as acute respiratory failure & severe COPD & hyperlipidemia as contributing factors. 11/4/08 Reviewed SAE form which reveals patient experienced multiple exacerbations of COPD during study participation making death most likely COPD related. No autopsy was done & there was no hospitalization. Patient died at home.


VAERS ID: 330558 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Male  
Location: Maine  
Vaccinated:2008-10-13
Onset:2008-10-25
   Days after vaccination:12
Submitted: 2008-10-27
   Days after onset:2
Entered: 2008-10-29
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 500536P / UNK NS / IN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood alkaline phosphatase normal, Blood potassium increased, Blood sodium increased, Eosinophil count increased, Lymphocyte count increased, Neutrophil count decreased, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Agranulocytosis (broad), Haematopoietic leukopenia (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-10-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: 11/3/08-records received-completed prednisone taper day prior after Flumist.
Preexisting Conditions: Asthma, Nuts 11/3/08-records received- PMH-Multiple allergies. Asthma. Lung disease.
Allergies:
Diagnostic Lab Data: K, 5.2; Na, 150; Cl, 108; Alk phos, 157; Lymp, 45.3; Neut, 35; EOS, 10
CDC Split Type:

Write-up: 515 Child not breathing at home - brought to ED by POV. 525 Arrived in ED, full arrest at that time. Vitals monitor. 0544 ETT placed, Epi. 11/3/08-records received from ED for DOS 10/25/08-presented to ED dyspnea, unresponsive ventricular fibrillation. At home acutely SOB 6/23/09-death certficate and autopsy report received-COD Status asthmaticus. Lymphocytic bronchitis.


VAERS ID: 331191 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-11-03
Entered: 2008-11-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 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: WAES0810USA04770

Write-up: Information has been received from a study conducted concerning a patient (age and gender not reported) who was vaccinated with a dose of MMR II (date, dose, route and lot #''s not reported). Concomitant suspect vaccine therapy included a dose of VARIVAX (date, dose, route and lot #''s not reported). It was reported that the patient died within 30 days of receiving the vaccines (date and cause of death not reported). This is one of several reports from the same source. No further information is available.


VAERS ID: 331192 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-11-03
Entered: 2008-11-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 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: WAES0810USA04771

Write-up: Information has been received from a study conducted concerning a patient (age and gender not reported) who was vaccinated with a dose of MMR II (date, dose, route and lot #''s not reported). Concomitant suspect vaccine therapy included a dose of VARIVAX (date, dose, route and lot #''s not reported). It was reported that the patient died within 30 days of receiving the vaccines (date and cause of death not reported). This is one of several reports from the same source. No further information is available.


VAERS ID: 331193 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-11-03
Entered: 2008-11-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 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: WAES0810USA04772

Write-up: Information has been received from a study conducted concerning a patient (age and gender not reported) who was vaccinated with a dose of MMR II (date, dose, route and lot #''s not reported). Concomitant suspect vaccine therapy included a dose of VARIVAX (date, dose, route and lot #''s not reported). It was reported that the patient died within 30 days of receiving the vaccines (date and cause of death not reported). This is one of several reports from the same source. No further information is available.


VAERS ID: 331194 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-11-03
Entered: 2008-11-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. - / 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: WAES0810USA04773

Write-up: Information has been received from a study conducted concerning a patient (age and gender not reported) who was vaccinated with a dose of PROQUAD (date, dose, route and lot #''s not reported). It was reported that the patient died within 90 days of receiving the vaccine (date and cause of death not reported). This is one of several reports from the same source. No further information is available.


VAERS ID: 331195 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-11-03
Entered: 2008-11-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0810USA04769

Write-up: Information has been received from a study concerning a patient (age and gender not reported) who was vaccinated with a dose of PROQUAD (date, dose, route not reported). It was reported that the patient died due to drowning (date not reported). This is one of several reports from the same source. Additional information has been requested.


VAERS ID: 331196 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-11-03
Entered: 2008-11-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Body temperature increased, Febrile infection, Pyrexia, Sudden death, Toxicologic test normal
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: diagnostic laboratory, toxicology: negative except for amantadine; body temp, 103, two days of fever
CDC Split Type: WAES0810USA04584

Write-up: Information has been received from a study, concerning a patient who was vaccinated with a dose of PROQUAD (Merck) (date, dose, route, lot # not reported). It was reported that 18 days after PROQUAD (Merck) was administered the patient developed a febrile illness. The subject had two days of fever up to 103 and was found dead (twenty days after PROQUAD (Merck) (date not reported) in the crib. The toxicology screen was negative except for amantadine. The chief adjudicator indicated possible viral infection (febrile) as the cause of death. According to the autopsy report, the cause of death was sudden unexpected death in childhood associated with history of febrile illness. This is one of several reports from the same source. No further information is available.


VAERS ID: 331269 (history)  
Form: Version 1.0  
Age: 64.0  
Sex: Male  
Location: Maryland  
Vaccinated:2008-10-21
Onset:2008-10-22
   Days after vaccination:1
Submitted: 2008-11-04
   Days after onset:13
Entered: 2008-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA181AA / UNK RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Malaise, Mechanical ventilation, Pneumonia
SMQs:, Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-11-13
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 14 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Multivitmin
Current Illness: Upper respiratory symptoms, fatigue
Preexisting Conditions: HX OF MACROCYTIC ANEMIA/1988/SEEN BY HEMATOLOGIST 2002/WAS TO HAVE BONE MARROW BX HX OF SMOKING/1 PPD X 44 YEARS/WEARING PATCH HX OF (L) HIP PAIN ASSOCIATED WITH PRIOR TORN LIGAMENT WHICH HAS CALCIFIED/S/P PT AND CORTISONE INJECTIONS #2 2001 HX OF FATIGUE WEARS H/F RESPIRATOR APPROX. 2 X PER YEAR WHEN WORKING WITH AIRHANDLER''S EXHAUST FUMES HX OF LOW HDL''S S/P LUMBAR LAMINECTOMIES 3/25/03 (L3,4,5) S/P THORACIC NERVE PROBLEM 12/03/SENT FOR MRI/DDD AND SPURS FOUND/SEES PT 2 X PER WEEK (1 1/2 MONTHS)/WILL CONTINUE WITH HOME EXERCISES Quit smoking entirely 12/2005 Full cardiac workup in 2006 including Cardiolyte Stress Test - normal, CXR. Workup done d/t mild intermittent chest symptoms, fatigue PMH: COPD, DM type 2, GERD, spinal stenosis s/p laminectomy, squamous cell carcinaoma of ear. NKDA
Allergies:
Diagnostic Lab Data: Labs and Diagnostics: Chest CT (+) for opacity superimposed on severe pulmonary fibrosis, later (+) for PE. Doppler (+) for DVT. Head CT (-). HIT antibody (+). Bonchoscopy (+) for diffuse alveolar hemorrhage and severe pulmonary fibrosis. CT abd/pelvis suggestive of inflammatory or infectious colitis.
CDC Split Type:

Write-up: Employee presented in the occupational Health clinic on 10/21/08 for a influenza vaccination. He told the RN that he had a mild URI illness but no fever and he consented to getting Flulaval after a brief discussion about postponing it until he felt well. The following day he was admitted to Hospital from home with possible pneumonia. Within days he was transferred by helicopter to Medical System where he remains in treatment. The information we have comes via his supervisor. He is reportedly on a ventilator and receiving steroids. We have provided the hospital with the employee medical record. 12/22/2008 MR received for DOS 10/24-11/13/2008 with D/C DX: Acute interstitial pneumonitis, respiratory failure, pulmonary embolism, acute renal failure and death. Pt transferred from local hospital (admitted 10/22/08)for hypoxemic respiratory failure following 6 months of progressive dyspnea and evaluation for lung transplant. On admission T=96.5''F, intubated and sedated with O2 sat of 96%, coarse bilateral breath sounds and tachycardic. Tx for pneumonia but developed DVT with PE which was symptomatic on 11/10/08. Started on heparin but unable to be aroused from sedation. Platelet count dropped. Pt suffered a PEA arrest on 11/13/08 with restoration of BP and heartrate with CPR however BP difficult to maintain despite high dose pressors. Life support withdrawn and pt died at 10:41 on 11/13/08. Autopsy reports COD as Pulmonary Fibrosis due to a combination of acute pneumonia and organizing diffuse alveolar damage superimposed on a background of chronic interstitial lung disease and emphysema.


VAERS ID: 331589 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Nebraska  
Vaccinated:2008-11-04
Onset:2008-11-05
   Days after vaccination:1
Submitted: 2008-11-06
   Days after onset:1
Entered: 2008-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2955BA / 2 RL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF373AB / 2 RL / UN
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR AU836 / 2 LL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C80901 / 2 LL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0502X / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-11-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data: Autopsy (P)
CDC Split Type:

Write-up: Pt. was found dead in the crib at daycare the following afternoon. 2/18/09-autopsy report received-COD Sudden Infant Death Syndrome.


VAERS ID: 331645 (history)  
Form: Version 1.0  
Age: 56.0  
Sex: Female  
Location: Ohio  
Vaccinated:2008-10-21
Onset:0000-00-00
Submitted: 2008-11-03
Entered: 2008-11-07
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2997AA / 1 RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Death, Upper respiratory tract infection
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-10-30
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: Unknown
Preexisting Conditions: Unknown PMH: insomnia, OA, myalgia/fibromyalgia, sinusitis, depression, postmenopause. Allergy: penicillin & sulfa.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Course of illness prior to death unknown. Aware she did have URI and could not attend school. 1/27/09 Autopsy report states COD as acute bronchopneumonia due to acute intoxication by hydrocodone. Also states additional anatomic dx: mod hepatocellular fatty metamorphosis & early postmortem decomposition. 11/11/08 Reviewed PCP medical records of 10/27/2008. FINAL DX:COPD, cough, acute rhinitis, chronic sinusitis Records reveal patient experienced cough & body pain, no fever. Dx w/COPD & acute bronchitis. Tx w/antibiotics & cough med.


VAERS ID: 332724 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Female  
Location: Utah  
Vaccinated:2008-10-23
Onset:2008-10-23
   Days after vaccination:0
Submitted: 2008-11-18
   Days after onset:26
Entered: 2008-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2805AA / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Hypersensitivity, Oedema peripheral, Rash, Vasculitis
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vasculitis (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-11-13
   Days after onset: 21
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: liptor, spironolactone, lanoxin, allopurinol, macrobid, plaquinil, hydrochlorthiazide, quinapril
Current Illness:
Preexisting Conditions: Rheumatoid arthritis, osteoperois, gout, chronic UTI, hyperlipid, chf. 12/29/08-records received-PMH: rheumatoid arthritis. status post mitral valvle replacement. status post left mastectomy for breast cancer. chronic UTI. osteoporosis.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: she presneted 10/23 for a blood pressure check up and in the course of that we did an annual flu shot for her. See the flu shot note: 10/23/08 The following questions were answered by the patient: Are you currently ill with a moderate or severe illness? No Temperature: __ Are you allergic to eggs or egg products? No Have you ever been paralyzed by Guillain Barre Syndrome? No Have you ever had a severe allergic reaction after getting the flu vaccine? (difficulty breathing, aiway swelling, hives, etc.) No Patient was given the opportunity to ask questions prior to immunization and have them answered to their satisfaction: _Yes Manufacturer: Aventis Lot #: U2805AA Expiration Date: 06/30/2009 Preservative Free _No Vaccine information sheet given: Yes VIS Pub. Date: 07/24/08 Dose: 0.5 ml Site: left deltoid She then reproted on 10/31 with swelling in hands and feet and rash. It looked like allergic reaction. she was not ill so we treated her as an out patient. she called a few days later and was getting worse. I had her admitted to hospital. I have not received a formal report. One of the diagnosis that was on the top of the list was influenza vaccine vasculitis. she was not getting better. The Dr. that was caring for her reported that her dau, a hospice nurse talked to her about what was going on and patient decieded to not have any more needle pokes or evaluation. She was sent to nursing home and died the next day. 12/29/08-records received for DOS 11/3-11/12/08-DC DX: likely vasculitis. acute renal failure, resolving. Presented with C/O weakness, seen 3 days prior with swelling in fingertips and lower extremities. Hyperkalemic. Dehydrated. Hyponatremia. Purpura of feet and lower extremities. 11/21/08 Death certificate states COD as acute renal failure with vasculitis & immunologic reaction as contributing factors.


VAERS ID: 333075 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Texas  
Vaccinated:2008-11-12
Onset:2008-11-14
   Days after vaccination:2
Submitted: 2008-11-20
   Days after onset:6
Entered: 2008-11-24
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B156DA / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C94097 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0310X / 1 MO / PO

Administered by: Public       Purchased by: Public
Symptoms: Dehydration
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-12-08
   Days after onset: 24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 23 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None Noted
Preexisting Conditions: Unknown PMH: Family hx epilepsy, liver & kidney disease, DM.
Allergies:
Diagnostic Lab Data: LABS: Head CT & MRI c/w significant cerebral edema.EEG abnormal. Rhinovirus, EBV, CMV IgG & adenovirus c/s (+). CXR abnormal. Abdominal US abnormal. LABS: CO2 11.0(L); calcium 7.4(L); protein 4.1(L); bilirubin total 2.3(L); AST 22,409(H); ALT 11,903(H); alk phos 436(H). Lactic acid 6.4(H); ammonia 232(H). WBC 5.2(L), H/H 6.8/18.8(L), plts 95(L), segs 69%(H), lymphs 20%(L). CRP <0.5. PT $g100(H), PTT 12.6(H), fibrinogen 65(L), INR 12.6. UA w/large amount blood, protein $g300. CXR revealed pulmonary edema & ascites. Echocardiogram WNL. CT head WNL. Abdominal US abnormal & revealed ascites w/pericholecystic fluid. Blood, urine c/s neg.
CDC Split Type:

Write-up: It was reported that infant was taken to local clinic on 11-14-08 and seen by a private physician. It was reported that the infant had been vomiting and was dehydrated, no fever. Infant was treated and sent home. Infant returned to local ER on 11-15-08 and was transferred to hospital. From there infant was transferred to another hospital. 1/12/09 Death certificate states COD as Liver failure & trisomy 21. 1/12/09 Reviewed hospital medical records of 12/3-12/8/2008. FINAL DX: severe metabolic syndrome including trisomy 21, renal failure, kidney failure, coagulopathy & cerebral edema. Records reveal patient had steady downhill course after transfer & expired 12/8/08. Death certificate included w/medical records. 1/7/09 reviewed hospital medical records of 11/16-12/2/2008. FINAL DX: idiopathic fulminant hepatic failure; multiorgan failure including liver & kidney''s; encephalopathy; coagulopathy. Records reveal patient experienced vomiting day after vaccinations then irritable & continued vomiting next day & became lethargic. Family tx w/Tylenol in correct dosing regimen. Unable to tolerate feedings & taken to outlying hospital ER on 11/14. Dx w/seizure & glucose of 15. Tx & transferred to outlying hospital. Glucose & liver enzymes remained high. Dx w/fulminant hepatic failure, anemia & coagulopathy. Tx w/IVF, insulin drip, PRBCs & blood products. Developed respiratory failure & was intubated. Transferred to higher level of care. On admission had anasarca, jaundice & elevated ammonia. TPN & continuous venovenous hemodialysis started. GI, metabolic, neuro consults done. Mitochondrial disorder suspected. Liver & right thigh muscle biopsy revealed metabolic disorder & necrosis. Deemed not a candidate for transplant. Dialysis stopped, extubated & transferred as DNR to hospital closer to family. 12/5/08 Received hospital medical records of 11/16-12/2/08 which consisted only of operative report & labs. Operative report indicates patient w/fulminant hepatic failure, coagulopathy, renal failure, cerebral edema & gen weakness. Had open liver biopsy & left thigh muscle biopsy on 11/24/08. 12/2/08 Reviewed hospital medical records of 11/15/2008. FINAL DX: no d/c summary available; H&P states respiratory failure, anemia & severe metabolic acidosis; severe coagulopathy. Records reveal patient experienced projectile vomiting, weakness, lethargy x 4 day. Seen in outlying ER, dx w/dehydration & tx w/oral rehydration. Worsened w/increased weakness, diet refusal, moaning & returned to same ER. Seizure noted in ER at that time secondary to hypoglycemia (BS=15) then rebound hyperglycemia (BS$g500). Transferred to higer level of care for PICU. Intubated on arrival, pale, tachycardic, chest retractions, abdominal distention & tenderness, decreased BS, NGT w/bloody & coffee grounds aspirate, hypotonia, areflexic. Transfused PRBCs & FFP. Tx w/antibiotics. Transferred to higher level of care.


VAERS ID: 333284 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Male  
Location: Florida  
Vaccinated:2008-11-06
Onset:2008-11-13
   Days after vaccination:7
Submitted: 2008-11-25
   Days after onset:12
Entered: 2008-11-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLLA209AA / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Confusional state, Disorientation, Encephalitis, Intensive care
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-12-20
   Days after onset: 37
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 37 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Cozaar, Lipitor, Flomax
Current Illness: None
Preexisting Conditions: Hypertension, hyperlipidemia, benign prostatic hypertrophy PMH: obesity, kidney stones,
Allergies:
Diagnostic Lab Data: LABS: Brain biopsy. CSF: WBC 141( H), lprotein 135(H), glucose 161(H), c/s (+) strep grp B & S. simulu. Initial CT brain scan, MRI brain & CXR WNL. Later CT brain revealed bilateral SDHs. Paracentesis fluid: WBC 1822(H), lymphs 5%(H), polys 95%(H), c/s (+) candida. CBC, ammonia, B12, folic acid, ESR, TSH WNL. LFTs (H). Sodium 133. UA abnormal. Blood c/s (+)E.faecal, E. coli, S. Eeider, candida. Urine c/s (+) E. coli & candida. Sputum c/s(+) psuedomonas & Strep Grp B. EEG c/w diffuse encephalopathy, no seizures. CT abdomen & renal US (+) multiple nonobstructing bladder & kidney stones. US doppler of LEs neg.
CDC Split Type:

Write-up: Started with confusion and disorientation abou 3-4 days afterwards which developed into a full bown encephalitis. Presently in an intensive care unit at Medical Center. 1/6/09 Received hospital medical records of 11/13/08-12/20/2008 FINAL DX: No d/c summary dictated. Consults mention multisystem organ failure, fever, cellulitis, UTI, acute renal failure, syncope Records reveal patient being treated for UTI x approx 1 week. Developed confusion, weakness, malaise, dizziness, fever, fall w/amnesia, lethargy, rash mostly over LEs. Fever 101.5 in ER. ID, Neuro, Uro, Nephro, Pulmo, Heme consults done. Developed diabetes, dysphagia, hypernatremia, drug induced thrombocytopenia, liver encephalitis, polymicrobial sepsis w/feeding tube disruption, intra-abdominal infection & acute respiratory distress. Admitted ICU & intubated. LP done. Tx w/IV antibiotics, antivirals, antiseizure meds, steroids, PEG tube feeding, plasmapheresis, dialysis. Continued downhill course & transferred to hospice on 12/20/08.


VAERS ID: 333713 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Male  
Location: West Virginia  
Vaccinated:0000-00-00
Onset:2008-11-27
Submitted: 0000-00-00
Entered: 2008-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Aggression, Confusional state, Fungal infection, Irritability, Local swelling, Pain, Pyrexia, Rash erythematous, Rash generalised, Rash macular, Stomatitis, Swelling face
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (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: 2008-12-06
   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:
Current Illness:
Preexisting Conditions: 12/3/08-records received-PMH: hypoglycemia, Alzheimer''s, diabetes, chronic renal failure, seizure disorder, coronary artery disease, atrial flutter. Coronary artery bypass graft. Pacemaker implantation.
Allergies:
Diagnostic Lab Data: Why keep this drug on the market. It''s already banned in a foreign country. 12/3/08-records received-Developed acute leukopenia with WBC 2.4. EEG normal. 1/14/09-records received-Renal ultrasound showed renal cysts without hydronephrosis. Blood culture gram positive cocci.
CDC Split Type:

Write-up: Extreme red splotches that ran together. Extreme pain and became giant splotches covered from head to toes. Groin area very swollen, face swollen, fungal infection in mouth & on mouth. Extreme irritability, close to combative, face some swollen, confusion. ETC, fever 103.9 first day 11/27/08. 12/3/08-records received-11/27/08-admitted with diffuse rash all over after taking Bactrim and hypoglycemic episode. DX: Stevens-Johnson syndrome due to mostly likely Bactrim. 1/13/09-Discharge summary received for DOS 11/27-12/6/08-DC DX: Primary Cause of Death-Toxic epidermal necrolysis secondary to either Bactrim or Dilantin. Other diagnoses: Acute renal failure/chronic renal failure. Diabetes mellitus. Coronary artery disease. Atrial fibirllation. Patient expired 12/6/08. 3/10/09-death certificate received-COD-toxic epidermal necrolysis. Exposure to either Bactrim or Dilantin. other significant conditions:Acute and chronic renal failure, CAD, A fibrillation. Diabetes Mellitus.


VAERS ID: 333759 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2008-11-21
Onset:2008-11-26
   Days after vaccination:5
Submitted: 2008-11-28
   Days after onset:2
Entered: 2008-12-03
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B198AA / 3 LL / UN
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U22787CA / 1 RL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D03125 / 3 RL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 09688 / 3 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-11-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zantac
Current Illness: Minimal URI
Preexisting Conditions: "Snoring" per ENT; No sleep apnea; GERD 3/9/09-records received-per parent patient suffered from sleep apnea from birth and sometimes snore when sleeping. Antibiotic therapy for recent throat problem. Born 4 weeks premature.
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: 5 days after vaccines administered pt was found face-down in crib not breathing. Resuscitation not successful. No other signs of illness. Presumed SIDS vs suffocation. 3/9/09-autopsy report received-COD Sudden Infant Death Syndrome.


VAERS ID: 334041 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Colorado  
Vaccinated:2008-10-02
Onset:2008-10-28
   Days after vaccination:26
Submitted: 2008-12-04
   Days after onset:37
Entered: 2008-12-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR - / 3 UN / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / 3 UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D05881 / 3 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 3 MO / PO

Administered by: Private       Purchased by: Other
Symptoms: Antibody test positive, Apnoea, Band neutrophil percentage, Blood culture positive, Body temperature increased, Bradycardia, Brain scan abnormal, CSF culture positive, Cerebral infarction, Chest X-ray normal, Convulsion, Culture negative, Culture urine negative, Death, Decreased appetite, Endotracheal intubation, Gram stain positive, Head circumference normal, Lymphocyte percentage, Meningitis pneumococcal, Monocyte percentage, Neutrophil percentage, Pneumococcal bacteraemia, Pupil fixed, Pyrexia, Red blood cell sedimentation rate increased, Respiratory disorder, Subdural effusion, White blood cell count increased
SMQs:, Angioedema (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vasculitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-11-14
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ZANTAC
Current Illness: Unknown
Preexisting Conditions: Premature Baby 33 to 36 weeks
Allergies:
Diagnostic Lab Data: Antibody test, 11/05/2008, Anti-T antibodies - positive; Band neutrophil percentage, 10/28/2008, 6%; Blood culture, 10/28/2008, Strep pneumo; Body temperature, 10/27/2008, 101.8 deg. F, 11/05/2008, 97.9 deg. F; CSF culture, 10/28/2008, pneumococcus (Gram stain many G+ cocci in chains); Chest X-ray, 10/27/2008, Normal chest; Culture, 11/05/2008, fluid from subdural effusions - negative; Culture urine, 10/27/2008, no organisms; Lymphocyte percentage, 10/28/2008, 26%; Monocyte percentage, 10/28/2008, 4%; Neutrophil percentage, 10/28/2008, 64%; Physical examination, 10/02/2008, Weight - 17 lb, 6-1/2 inches.; height - 27-3/4 inches; head circumference, 47.5 cm; language/speech, emotional/social, fine/gross motor skills, cognitive thinking, physical growth, developmental milestones - all normal range; Red blood cell sedimentation rate, 10/27/2008, 72; Scan brain, 11/03/2008, stable mild diffuse ventriculomegaly, bilateral subdural collections with the left larger than right, and signal abnormality within the brains as above, compared to MRI performed two days ago; multi-focal infarcts, mild ventriculomegaly, and bilateral subdural fluid collections that stable in comparison to a 03/11/2008 scan.; White blood cell count, 10/28/2008, 5.8; 10/31.2008, 21.9; 11/05/2008, 10.0; Reported Cause of Death, Meningitis pneumococcal, Streptococcus pneumoniae meningitis
CDC Split Type: USWYEH06608908

Write-up: Additional information was received that provided patient details, medical history, concomitant therapy, laboratory results, event details including updated and additional events, and a fatal outcome. Information regarding PREVENAR was received from a healthcare professional regarding a 6-month-old female patient who received a third dose on 02-OCT-2008 along with a third dose of ACT-HIB (Aventis), a third dose of TRIPEDIA (Aventis), and third dose of ROTATEQ (Merck & Co Inc) and experienced pneumocococcal bacteremia, Streptococcus pneumoniae meningitis, apnea requiring intubation, multiple infarcts of brain, bradycardia and fluid collection around the brain. The patient has a past history of being a premature baby (36 weeks) (delivered by cesarean section, was in the neonatal intensive care for 2 days). Has a twin. Concomitant therapy included ACT-HIB, TRIPEDIA, ROTATEQ and Zantac. On 20-OCT-2008, the patient was hospitalized after a brief history of several days with respiratory symptoms, low grade fever and decreased appetite and was diagnosed with meningitis pneumococcal and pneumococcal bacteraemia. A blood and cerebrospinal fluid culture was performed showing Streptococcus pneumoniae (serotype not reported). Treatment included KEFLEX, dexamethasone, vancomycin, rifampin, ceftriaxone, Cefotaxime and mannitol. During the course of hospitalization, additional laboratory tests and brain scans were performed which showed multi-focal infarcts with bilateral subdural fluid collections. Initially, the patient''s clinical condition stabilized but then was complicated by seizures, apnea requiring intubation, multiple cerebral infarction with subdural effusion and bradycardia. As of 05-Nov-2008, a hospital record indicated the patient''s pupils were fixed and dilated. On 14-NOV-2008, it was reported that the patient died. The cause of death was reported as meningitis pneumococcal. Physical examination (results: Weight-17 lb, 6-1/2 inches, height-27-3/4 inches, head circumference 47.5 cm, language/speech, emotional/social, fine/gross motor skills, cognitive thinking, physical growth, developmental milestones - all normal range was done on 02-Oct-2008. On 27-Oct-2008 test results were: chest X-ray (results: Normal chest); red blood cell sedimentation rate (results:72); body temperature (results: 101.8 deg. F.); and culture urine (results: no organisms). On 28-Oct-2008 test results were neutrophil percentage (results: 64%); Band neutrophil percentage (results: 6%); blood culture (results: Strep pneumo); white blood count (results: 5.8); CSF culture (results: pneumococcus (Gram stain stain many G+ cocci in chains)); monocyte percentage (results: 4%); and lymphocyte percentage (results: 26%). White blood cell count (results: 21.9) and scan brain (results: stable extra-axial fluid collections) were done on 31-Oct-2008. Scan brain (results: stable mild diffuse ventriculomegaly, bilateral subdural collections with the left larger than the right, and signal abnormality within the brain as above, compared to MRI performed two days ago) was done on 03-Nov-2008. On 05-Nov-2008 test results were: body temperature (results: 97.9 deg. F.); scan brain (results: multi-focal infarcts, mild ventriculomegaly, and bilateral subdural fluid collections - stable in comparison to a 03-Nov-2008 scan.); white blood cell count (results: 10.0); antibody test (results: Anti - T antibodies - positive); and culture (results: fluid from subdural effusions - negative). No additional information was available at the time of this report.


VAERS ID: 334270 (history)  
Form: Version 1.0  
Age: 88.0  
Sex: Male  
Location: California  
Vaccinated:2008-10-29
Onset:2008-11-14
   Days after vaccination:16
Submitted: 2008-12-03
   Days after onset:19
Entered: 2008-12-09
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Dyspnoea, Heart rate decreased
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-11-20
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Allopurinol; ALTACE; Prednisone; Amiodarone; Furosemide
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 2 hours after shot, he was short of breath - he said he need some oxygen - went to hospital - said pulse rate was too low 33-34. Was in hospital 3 days and pulse didn''t go up. 6/19/09 Death certificate received. Cause of Death: Urosepsis-secondasry COD Dehydration, dementia, renal failure.


VAERS ID: 334606 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: South Carolina  
Vaccinated:2008-11-14
Onset:2008-11-20
   Days after vaccination:6
Submitted: 2008-12-09
   Days after onset:19
Entered: 2008-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2768AA / UNK LA / IM
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR UF307AB / UNK RA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Antibody test negative, Asthenia, Blood culture negative, Computerised tomogram normal, Confusional state, Cytomegalovirus test negative, Death, Dyspnoea, Ehrlichia serology, Endotracheal intubation, Haemodynamic instability, Herpes simplex serology negative, Hypotension, Intensive care, Malaise, Mechanical ventilation, Multi-organ failure, Nausea, Polymerase chain reaction, Pyrexia, Renal failure, Respiratory failure, Sepsis syndrome, Septic shock, Tachycardia, Tachypnoea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-12-03
   Days after onset: 13
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: 1. Avandaryl 4/2. 2. Triamterene 37.5/25. 3. Tricor 145 mg p.o. daily. 4. Zocor 40 mg q.h.s. 5. Precose 300 mg q.a.c. 6. Metformin 1000 mg p.o. b.i.d. 7. Coumadin 2.5 daily, was not taking at the time of this DVT developing. 8. Hydr
Current Illness: Also see #7 1.Hypertension. 2. Diabetes mellitus type 2. 3. Diverticulosis with hemorrhage. 4. Hyperlipidemia. 5. Bright red blood per rectum. 6. DVT in July 2004.FL 5 def
Preexisting Conditions: also see #7 ALL: NKDA 12/3/09 records received-PMH:DVT/PE,DM, HTN, factor V Leiden.
Allergies:
Diagnostic Lab Data: Yellow fever serum RT PCR: negative,LEPTOSPIRA ANTIBOD. neg, HSV 1/2 QUALITATIVE, PCR- neg,CMV DNA- neg, ehrlichia- neg, Blood cultures neg, CT head, abd, pelvis, brain - negative 2/3/09-records received-MRI brain no evidence of acute intracranial lesions. MRI spine multi level degenerative disease. 2/11/09-laboratory reports received-YF IgM antigen positive. YF arboviral nucloic acid negative.
CDC Split Type:

Write-up: Patient is a 77-year-old male with a history of factor V Leiden, hyperlipidemia, prior history of DVTs, and diabetes mellitus type 2, who presented to the hospital on 11/21/2008 complaining of 2 days of fever, nausea, and generalized weakness and malaise. Pt had Yellow Fever vaccination on 11/14/08 prior to his planned trip abroad. Pt has been otherwise in good health prior to admission. Influenza vaccine was given on 10/30/08. HOSPITAL COURSE: The patient quickly progressed to hemodynamic instability and sepsis syndrome exhibited by tachypnea, tachycardia, hypotension and confusion. Therefore, he was transferred to the MICU on 11/22/2008. The patient was intubated for airway protection at that time and increased work of breathing. The patient required vasopressor support for his blood pressure and was started on broad-spectrum antibiotics. The patient subsequently developed multiorgan system failure, including respiratory failure requiring ventilator support, and oliguric renal failure requiring hemodialysis support. Multiple cultures were sent to try and determine the etiology of the patient''s symptoms and reason for septic shock. It was noted the patient was on broad-spectrum antibiotic, antiviral and antifungal coverage. No specific infection inciting these symptoms was ever identified. The only cultures that were positive were drawn from the patient''s access lines, which grew out Candida albicans. Infectious Disease was following along with the patient the entire time of his stay in the MICU. Over the ensuing days, the patient failed to progress and actually worsened from 12/02 and 12/03 as exhibited by increased tachypnea and work of breathing, hypotension with continued pressor support, and oozing from some of his lines and orifices. At this time, the patient''s family requested that the patient be made DNR and that supportive measures be withdrawn. Therefore, these steps were undertaken on the afternoon of 12/03/2008. The patient passed away officially at 1425 on 12/03/2008. Physical exam was performed to confirm the patient''s death. The family was offered autopsy and declined. 2/3/09-records received for DOS 11/21-12/03/08-C/O Presented to ED with C/O malaise, weakness, nausea, fever and fatigue. Mechanical ventilation. Sepsis. Metabolic acidosis. Septic encephalopathy. 3/30/09-COD multi-organ failure. Septic shock.


VAERS ID: 334611 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Illinois  
Vaccinated:2008-11-26
Onset:2008-12-08
   Days after vaccination:12
Submitted: 2008-12-10
   Days after onset:2
Entered: 2008-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 500569P / UNK - / -
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0070X / 3 LA / -
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2730AA / UNK RA / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-12-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None known. ?? oral contraceptive or an antibiotic for acne.
Current Illness: None.
Preexisting Conditions: Acne. PMH: PCN allergy. Acne. On OCs (Yaz). 12/10/2008 Recived records from health center via CDC. Seen 11/3/08 with c/o sore throat, cough, muscle aches and nasal d/c. PE (+) for pharyngeal erythema, purulent nasal drainage, nasal turbinate changes, and lymphadenopathy. Assessment: Probable viral URI with ? sinusitis. Tx: Biaxin.
Allergies:
Diagnostic Lab Data: Autopsy performed 12-9-08 was unrevealing per family verbal report to me; no signs of intracranial bleed, meningitis, cardiomyopathy, trauma. Toxicology report still pending at this time. Post-mortem tox screen (-).
CDC Split Type:

Write-up: Patient, a previously healthy 19 year-old female college freshman died suddenly yesterday, approximately 10 days after receiving Gardasil & menningococcal vaccines. Vaccines were administered by a medical provider in her hometown while she was home for the Thanksgiving holiday, sometime around 11-28-08. She had a medical appointment pending for 12-8-08 (the day of her death) with the Student Health Service; medical clerk had entered "possible seizure" as the reason for making the appointment. Patient had no history of epilepsy. She complained of a headache and not feeling well in the 24 hours prior to her death. She went to bed at 10:30 PM on 12-7-08, in her dorm room with a roomate. She appeared to still be sleeping the next morning when her roomate left for class. Her body was discovered still in bed around 5 PM that day (12-8-08) with rigor mortis. No history of substance abuse, alcohol intake, or depression or other mental health issues. She was a happy, achieving student. This report is filed by a friend of patient''s parents, who is a physician (board certified internal medicine & geriatrics). Report also filed online today with the FDA. Patient''s mother can be reached at home for additional details. Memorial service & funeral 12-12-08 and 12-13-08. Only known past medical history requiring physician attention was facial acne. 12/10/2008 Recived records from health center via CDC. Seen 11/3/08 with c/o sore throat, cough, muscle aches and nasal d/c. PE (+) for pharyngeal erythema, purulent nasal drainage, nasal turbinate changes, and lymphadenopathy. Assessment: Probable viral URI with ? sinusitis. Tx: Biaxin. Received from CDC via email: The patient had no previous health problems. She was a freshman and was seen at the college health clinic only once on 11/3/08 for sinusitis. She was on Yaz birth control pills and a topical acne medication. After the death, police questioned her roommate who said that the pt did go out on the evening of 12/6/08 and had a few alcoholic drinks, but not an excessive amount. She had a HA the next day and thought it was from the alcohol. She had a PCN allergy and was a non smoker. 12/11/2008 Records received from PCP. HPV#1 1/18/2008. HPV#2 3/28/2008. Vaccines deferred 7/29/2008 2'' to oral prednisone usage for acne (with Bactrim). Seen 8/15/08 for sore throat, runny nose. DX: Pharyngitis s/p steroid tx. Returned for vaccines 11/26/2008 in good health with normal exam. Additional record also received from health center for scheduled appt on 12/8/08. Pt reported 2 episodes (one 1 month ago and one on the day of death) of waking up in a cold sweat, having urinated in the bed, feeling the urge to vomit, dizzy with trouble reading. Appt made for ? seizure. Pt did not arrive for appt. 3/3/09 Autopsy report received. COD: Unable to ascertain after autopsy, microscopic, toxicologic and chemical evaluation.


VAERS ID: 334930 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Massachusetts  
Vaccinated:2006-12-14
Onset:2006-12-18
   Days after vaccination:4
Submitted: 2008-11-30
   Days after onset:713
Entered: 2008-12-11
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B069AA / 1 UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF001AA / 2 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08657H / 1 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1037F / 1 UN / UN

Administered by: Private       Purchased by: Other
Symptoms: Coagulopathy, Death, Hypovitaminosis, Liver disorder, Ocular hyperaemia, Respiratory arrest
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (narrow), Haemorrhage laboratory terms (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Glaucoma (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-12-21
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Jaundice
Allergies:
Diagnostic Lab Data: Vitamin deficiency; Liver disease; blood coagulation disorder
CDC Split Type:

Write-up: Stopped breathing/death. Blood(redness ) in both eyes, (began 12/15). 2/18/09 Death certificate states COD as hypoxic-ischemic encephalopathy due to whiplash shaking injuries of head & spinal cord.


VAERS ID: 335226 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Washington  
Vaccinated:2008-11-13
Onset:2008-11-13
   Days after vaccination:0
Submitted: 2008-12-13
   Days after onset:30
Entered: 2008-12-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR - / 1 UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Brain injury, Death, Decreased appetite, High-pitched crying, Hypotonia, Irritability, Respiratory arrest, Retinal haemorrhage, Skin warm, Sleep disorder, Somnolence
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Retinal disorders (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-11-17
   Days after onset: 4
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: none
Current Illness: i had taken to the same neighborhood health clinic about 2 weeks prior as a walkin for symtoms of a cold they had told me to use sayline drops for congestion and that if things got worse to bring her back in i wanted to but there was nothing they could do but just wait and see if it would get worse or get better and sent us home and also on her 2 week check up on august 22 2008 she was not back up to birth weight and the doctor was not even concerned the 2 week check up was the only time her docotor had seen her the other 2 only a nurse had seen her
Preexisting Conditions: none. PMH:URI 10/18/08
Allergies:
Diagnostic Lab Data: none at this time allegations are retinal hemorrhage she had passed away on Sunday November 16 2008 in hospital. Labs and Diagnostics: CBC with 19.3 WBCs-24% lymphs, 24% bands, 1 metamyelocyte. K+ 7.7. Head CT (+) for cerebral edema and diffuse loss of gray-white differentiation-no intracranial hemoorhage or skull fx. Bone scan (+) for sutural diastasis. No fractures. Arterial gases abnormal. APTT 52. Fibrinogen 225 (L). D dimer $g20. Thrombin time 21. UC (+) for Enterobacter and E. coli. Blood cx (-). Metabolic panel (+) for elevated 17 hydroxyprogesterone
CDC Split Type:

Write-up: I would like some help to find out if my daughters death was caused by a Vaccine Induced Reaction. This all started on November 13 2008. This is the day the i took my daughter to the clinic. She was supposed to be seen for her 2 month well child exam which she was was not. The primary doctor had only seen her once and this was on her 2 week well child exam. When we went in for her 2 month checkup we had seen a nurse practitioner. The doctor never came into see her not even once on this day nor did the nurse weigh her do any of the measurements of check to make sure that everything was growing normally. She had me sign for 2 vaccines when after all this i found out that she was given for 2 that i didn''t know about. We were sent home right after the vaccines were given and told to come back in 4 weeks for more and to expect drowsiness, fussiness, low appetite, not sleeping, irritability, that''s what had happened Thursday night. She slept most that afternoon and evening with very little to eat. Friday morning she was a little fussier then usual. Later on into the day we had noticed her to be warm to the touch but i had checked and it was normal a few more hours into the night. She developed a fairly high pitched cry and it seemed like she had a belly ache but yet eating very much. She was up about every 30 min during that Friday night and she usually was a really good sleeper through the night. On saturday morning i had gotten up to feed her i made a 6 oz bottle she still had about 2 oz left. When she was finished i burped her changed her she was still really fussy so i laid her down on a u shaped pillow and put her on her belly and i laid down beside her and patted her on her bottom and i fell back asleep next to her and was woke up by her father that had just gotten out of bed and told me to make sure the baby is breathing. I grabbed her and her body was limp but still warm to touch. I held her close to my body and ran across the street to the police station where the ambulance had responded and took us to the hospital. They were able to resuscitate her but she could not breath on her own nor did she have any brain function. They then air lifted us to the hospital. After being there for 24 hours the doctor had told us that our baby was not going to live and they see retinal hemorrhaging in the back of the eyes and the only 2 ways were a car wreck or some body had to of shaken her. Well i know that that is not what happened and i have research about these vaccines and all the signs start the day she was vaccinated. Thank you for your time. 01/08/2009 MR received for DOS 11/15-16/2008. Pt presented to ER following parent finding infant unresponsive and not breathing. CPR and intubation initiated at local fire station. Upon arrival, infant was pulseless, pink, hypoxic and hyperthermic. Epi administered with return of pulse but BP fluctuations. Pt acidotic with dilated, unresponsive pupils, asymmetric lung sounds, fungal diaper rash. Trasfered to higher level of care s/p cardiorespiratory arrest, now acidotic and hyperthermic with epi dependent BP. Upon arrival infant was hypothermic with T=35 with shivering, unresponsive to stimulation. Pupils non-reative, (+) retinal hemorrhages, areflexia, flaccid tone. (+) respiratory and metabolic acidosis. Assessment: hypoxic brain injury. Prognosis poor. No brain activity. Ventilator support withdrawn. Pt expired. . 1/14/09 Autopsy report received with COD Anoxic Encephalopathy of unknown etiology. Bilateral Retinal Hemorrhages. Metabolic panel (+) for elevated 17 hydroxyprogesterone. No evidence of physical injury. Manner of death undetermined.


VAERS ID: 335284 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Male  
Location: Maryland  
Vaccinated:2008-08-16
Onset:2008-11-01
   Days after vaccination:77
Submitted: 2008-12-12
   Days after onset:41
Entered: 2008-12-15
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (MENOMUNE) / SANOFI PASTEUR UE489AA / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-11-17
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: PMH: meningococcal meningitis 10 years prior to admission. Allergy: ceclor, cleocin.
Allergies:
Diagnostic Lab Data: LABS: Blood c/s (+) for Neisseria meningitidis serogroup Y. CXR c/w ARDS. EEG abnormal c/w severe diffuse encephalopathy. Creatinine 4.34(H), potassium 5.9, CO2 14(L), anion gap 21(H), calcium 6.3(L), phosphorous 7.7(H), protein 3.2(L), albumin 1.7(L), bilirubin 3.3(H), alk phosphatase 182(H), AST 8881(H), ALT 5540(H), cpk 2204(H), CKMB 25(H), troponin 1 0.73(H), BNP 892(H), lactic acid 13.2(H), D-Dimer .20000(H), PT/PTT/INR (H). CBC: RBC 2.40, H/H 7.4/20.6, plts 11(all low), WBC 19.2(H). LABS: TEE revealed increased right atrial pressure. Head CT c/w diffuse cerebral edema w/acute hemorrhage & possible septic emboli, IVH, hydrocephalus. Cerebral perfusion scan c/w brain death.
CDC Split Type:

Write-up: Pt with a history of menigitis at 10 yrs old. Vaccinated with MENOMUNE prior to college entrance. Contracted meningitis and passed away at age 19 on 11/20/08. MD stated he will fill out VAERS himself and fax to agency. No further info provided. 1/27/09 Death certificate states COD as disseminated intravascular coagulation w/meningococcemia as contributing factor. DOD corrected to 11/17/2008. 12/31/08 Reviewed hospital medical records of 11/13-11/14/2008. FINAL DX: septic shock w/multiorgan failure, DIC, respiratory failure, acute renal failure, lactic acidosis, metabolic acidosis & suspected meningococcemia Records reveal patient experienced myalgia, malaise, generalized aching, nausea, vomiting, diarrhea, fever, petechial rash, sweating, photophobia, neck stiffness, SOB, abdominal pain, back pain. Taken to hospital. Intubated in ER & admitted to ICU in isolation. Exam revealed tachycardia, hypotension(on pressors), anasarca, fever, thrombocytopenia, coagulopathy. Renal, ID, pulmonary consults done. Tx w/IV antibiotics, pressors, steroids, blood product transfusions & hemodialysis. Transferred to higher level of care. 01/14/09 Reviewed hospital medical records of 11/14-11/17/2008. FINAL DX: meningococcemia; purpura fulminans; multiorgan system failure. Records reveal patient experienced purpura fulminans. Had been transferred from outlying hospital. Noted to have had HA in addition to other presenting symptoms as noted in prior records. Tx w/CVVHD, antibiotics & pressors. Developed atrial fib/flutter & was cardioverted. Developed ARDS, acites & anasarca.


VAERS ID: 335418 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Minnesota  
Vaccinated:2008-12-04
Onset:2008-12-06
   Days after vaccination:2
Submitted: 2008-12-11
   Days after onset:5
Entered: 2008-12-16
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B173AA / 1 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF400AA / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C71975 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0926X / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-12-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Child seen in clinic 12-4-08 - well child visit with vaccines given. Child put to bed 12-6-08 on stomach. Unresponsive two hours later by parents at home.2/20/09-autopsy report received-Sudden unexplained infant death, prone sleeping position. Minute foci of pneumonia.


VAERS ID: 335622 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: Kansas  
Vaccinated:2008-10-16
Onset:2008-10-18
   Days after vaccination:2
Submitted: 2008-12-18
   Days after onset:61
Entered: 2008-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR 2761AA / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Biopsy brain abnormal, Death, Demyelination, Gait disturbance, Hemiparesis, JC virus infection, Laboratory test abnormal, Nuclear magnetic resonance imaging brain abnormal, Progressive multifocal leukoencephalopathy, Speech disorder
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Optic nerve disorders (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypoglycaemia (broad), Opportunistic infections (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-12-11
   Days after onset: 54
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 34 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Albuterol-2 puffs QID, Flovent-1 puff QD, Avapro 150mg PO QD, Calcium Carbonate 1 tablet PO QD, Lasix 40mg PO QD, Asprin 81mg PO QD, Fish Oil 1000mg PO QD, Plavix 75mg PO QD, Prandin 2mg PO QD, Zocor 40mg PO QD.
Current Illness: None
Preexisting Conditions: COPD- well controlled, Diabetes Type 2, wel controlled. PMH: DM, Dyslipidemia, COPD, HTN, ? CHF, Allergies to sulfa, PCN, doxycycline, yellow dye #2.
Allergies:
Diagnostic Lab Data: 11/10/08 MRI: Acute Inflamatory process in both frontal lobes crossing the Corpus Callosum, consistent with encephalitis. On 11/24/08, open brain biopsy showed demyelination consistent with progressive multifocal leukoencephalopathy. On 12/08/08, testing showed the presence of JC Virus. Labs and Diagnostics: MRI brain (+) for possible subacute R frontal stroke, later determined to be acute inflammatory process. Repeat showed progression. MRA (+) for severe focal stenosis. LP showed no sign of infection. Myelin basic protein elevated. Neuron specific enolase (+). EEG (+) for background slowing. PCR and viral tests for HSV, CMV, HZV, West Nile, enterovirus, EBV, Lyme all (-). CXR (+) for atelectasis and possible pleural effusion. Brain bx (+) for JC virus.
CDC Split Type:

Write-up: Pt initally presented to hospital on 10/20-10/26/08 with gait instability, garbled speech and Left sided weakness. Pt was re-admitted to hospital on 11/20-11/23/08 with worsening weakness, increasingly garbled speech and severe gait instability. Pt. transferred to hospital on 11/23/08 for a brain biopsy. Brain Biopsy revealed demyelination consistent with progresive multifocal Leukoencephalopathy. Pt''s neurological status deteriorated until pt expired on 12/11/08. 11/22/2008 MR received for multiple admissions beginning ~10/20/2008. Pt expired 12/11/08 with COD Progressive Multifocal Leukoencephalopathy. Pt presented to local hospital 10/20-26/08 with respiratory distress and admitted for COPD exacerbation and CHF. Also having sx of L sided weakness attributed to possible TIA. Pt d/c but developed increasing L-sided weakness and hemineglect and readmitted 11/10/08 with D/C DX: Immunogenic encephalitis s/p vaccination, Diabetes with hyperglycemia on steroids, COPD. Pt was acting confused with abnormal behavior c/w encephalitis. Started on antiviral and steroids w/o improvement. Pt continued to progress with worsening psychomotor retardation. Pt transferred to rehab for several days and admitted agian 11/19/08 for brain biopsy. D/C DX: Infiltrative bilateral frontal lobe process, extending into the brain stem, possible postvaccinal encephalomyelitis. COPD, Dyslipidemia. Basilar artery stenosis, HTN, DM, DVT risk, morbid obesity. Brain bx (+) for JC virus which lead to dx of PML. Pt with decreasing LOC. Transferred to hospice care. Pt expired 12/11/2008. 2/5/09 Death Cert received. COD: Progressive Multifocal Leukoencephalopathy.


VAERS ID: 335762 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2006-05-01
Onset:2008-06-03
   Days after vaccination:764
Submitted: 2008-12-19
   Days after onset:199
Entered: 2008-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2004AA / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, Death, Meningitis meningococcal, Serology test
SMQs:, Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-06-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood culture was positive for Neisseria meningitidis serogroup C on 6/5/08
CDC Split Type:

Write-up: Patient vaccinated on 5/1/06 with Menactra (lot U2004AA). Culture confirmed meningococcal disease on 6/5/08. Blood culture was positive for Neisseria meningitidis serogroup C. 3/4/09-death certificate received-COD Sepsis. Acute Meningococcemia. 3/8/09-office note received for DOS 5/1/06-well visit-mild scoliosis. 3/19/09-records received for DOS 6/3/08-life flight tranferred in hypotensive state intubated. Lifting weights day before, developed diffuse abdominal painlast evening worsened overnight, this morning developed fever and sweats with vomiting. Mottled, hypotensive and tachycardic. PE: cold, tachycardic febrile and mottled. Bleeding from both eyes. Unresponsive. Purpura, petechiae in eyes. At receiving facility in cardiac arrest resuscitation efforts failed. Pronounced dead.


VAERS ID: 335764 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Male  
Location: Texas  
Vaccinated:2007-06-25
Onset:2007-09-26
   Days after vaccination:93
Submitted: 2008-12-19
   Days after onset:450
Entered: 2008-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / AVENTIS PASTEUR UNK / UNK UN / UN
HEPA: HEP A (HAVRIX) / SMITHKLINE BEECHAM AHAVB139CA / UNK UN / UN
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Y1D302 / UNK UN / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2236AA / UNK UN / UN
TD: TD ADSORBED (NO BRAND NAME) / SANOFI PASTEUR U1962AA / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, Death, Meningitis meningococcal, Serology abnormal
SMQs:, Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-09-27
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood culture positive for Neisseria meningitis serogroup C on 9/26/07.
CDC Split Type:

Write-up: Patient vaccinated with Menactra on 6/25/07 (lot U2236AA). Culture confirmed meningococcal disease on 9/26/07. Blood culture was positive for Neisseria meningitidis serogroup C. 1/6/09-records received-on 9/26/08-Three day history of fatigue, fever, tachycardia, altered mental status, blurry vision and headache. Developed diffuse rash, renal failure, coagulopathy and repiratory failure. 1/6/09-autopsy report received-Neisseria Sepsis. Antemortem blood culture positive for neisseria meningitidis, serogroup C. Bilateral hemorrhagic adrenal necrosis (Waterhouse-Friderichsen syndrome). Diffuse confluent petechial purpuric rash. petechial hemorrhages of left conjunctivia, gingivae, scalp and subgaleal tissue. Small vessel fibrin thromboemboli identified clinically disseminated intravascular coagulopathy (DIC). Neutrophilic pulmonary airspace infiltration consistent with terminal ventilator dependence. Bilateral pleural effusions.


VAERS ID: 336129 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Mississippi  
Vaccinated:2008-12-15
Onset:2008-12-17
   Days after vaccination:2
Submitted: 2008-12-22
   Days after onset:5
Entered: 2008-12-29
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3174AA / 1 LL / UN
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2797CA / 1 LL / UN
HEP: HEP B (FOREIGN) / MERCK & CO. INC. 1719U / 2 RL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C52997 / 3 RL / UN

Administered by: Public       Purchased by: Public
Symptoms: Asphyxia, Autopsy, Death
SMQs:, Acute central respiratory depression (broad), Hostility/aggression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-12-17
   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: Cough congestion
Preexisting Conditions: Reflux
Allergies:
Diagnostic Lab Data: Autopsy - report showed accidental suffocation as COD.
CDC Split Type:

Write-up: Death - Mom discovered infant''s head wedged between pillow and bed Thursday morning. 1/2/09-autopsy report received-COD 1. Compressive asphyxia. Compressive markings of skin of chest, shoulders and sides of face. Pulmonary atelectasis. Dilated heart, hypoxic myocardium. Congested cyanotic brain and viscera. Petechiae in epicardium, pleurae and thymus glad. Aspiration of gastric contents. Bilateral enlarged renal pelves, stenotic ureteropelvic junctions, right more than left.


VAERS ID: 336403 (history)  
Form: Version 1.0  
Age: 60.0  
Sex: Male  
Location: Virginia  
Vaccinated:2008-09-29
Onset:2008-09-29
   Days after vaccination:0
Submitted: 2008-12-23
   Days after onset:85
Entered: 2009-01-05
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR 42762AA / 4 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Chest discomfort, Death, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-09-29
   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: LEVAQUIN; LOPRESSOR; NEURONTIN; ELAVIL
Current Illness: No acute illness
Preexisting Conditions: Pernicious anemia; CAD; MI; Lumbar disc disease; Peripheral neuropathy; Hypothyroidism; Cardiomyopathy; GERD; Cervical disc disease; Nonunion R hip fx-repaired; AODM; BPH; MOTRIN; MYCARDIS; PREVACID; FLOMAX; trimethoprim 1/7/09-records received-PMH: CHF, pancreatitis, UTI, Diabetic, coronary stents. Stroke.
Allergies:
Diagnostic Lab Data: 1/7/09-records received-Chest x-ray infiltrate at left lung base and possible infiltrate right upper lobe.
CDC Split Type:

Write-up: Chest tightness, shortness of breath, and rapid demise to death within 4 hours of receiving vaccine. 1/7/09-records received for ED DOS 9/29/08-presented to ED with C/O chest pain, while enroute to ED became diaphoretic, SOB required cardioconversion, intubation. V fib. DX and COD-Pulmonary embolus. Expired 9/29/08. 2/9/09-COD-pulmonary embolism.


VAERS ID: 336473 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2007-08-07
Onset:2007-09-01
   Days after vaccination:25
Submitted: 2008-12-23
   Days after onset:479
Entered: 2009-01-05
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0804F / 1 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0171U / 1 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2207AA / 1 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2457AA / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Asthenia, Biopsy muscle, Death, Dysphagia, Fatigue, Headache, Immunoglobulin therapy, Muscle atrophy, Myalgia, Nuclear magnetic resonance imaging, Pain in extremity, Weight decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2009-03-23
   Days after onset: 569
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Iron-deficiency anemia
Allergies:
Diagnostic Lab Data: muscle biopsy; MRI separate. Dx clinical myositis
CDC Split Type:

Write-up: Onset increased muscle pain, fatigue, weakness, dysphagia, weight loss. Pt requiring Prednisone IVIG every q monthly. Methotrexate headache, muscle atrophy. 2/6/09 Received PCP medical records of 11/11/08-1/20/09. FINAL DX: polymyositis, likely MCV4 vaccine related; osteomalacia; neuropathy; pernicious anemia; tachycardia; ataxia; Budd-Chiari syndrome; dermatomyositis. Records reveal patient experienced muscle weakness, paresthesias, leg pain. Referred to Neuro & Rheum. Tx w/PT & meds including methotrexate, imuran, steroids, enbrel, bicillin, IVGG. Had to drop out of college due to illness. 04/6/2010 Patient''s condition never improved and she died on 3/23/2009.


VAERS ID: 336654 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: North Carolina  
Vaccinated:2008-12-29
Onset:2008-12-30
   Days after vaccination:1
Submitted: 2008-12-31
   Days after onset:1
Entered: 2009-01-07
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3241AA / 1 LL / IM
HEP: HEP B (FOREIGN) / MERCK & CO. INC. 0725X / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D01075 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0926X / 1 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Asthenia, Death, Frequent bowel movements, Hypophagia, Hypothermia, Lethargy, Mucous stools, Shock
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-12-30
   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: Pt seen 12/27/08 with c/o spitting up blood and sneezing. Dx with thrush and tx with Diflucan. Returned to PCP 12/29/08, impetigo noted
Preexisting Conditions: Prematurity 34 wks. PMH: 34 week premie
Allergies:
Diagnostic Lab Data: State examiner case pending.
CDC Split Type:

Write-up: Pt developed decreased PO intake and increased frequency of stools with mucus on the night of 12/29/08 < 12 hours after immunizations. Next day continued to have poor intake and increased stool and became weak/lethargic. Pt came to evening clinic and was in state of shock and hypothermia. He died at about 10pm. 2/13/09 Autopsy report received with COD Dilated and hypertrophic cardiomyopathy. DX: Left ventricular myocardial hypertrophy and dilitation, marked. Fatty alteration of the liver, moderate to marked. Bilateral hydroceles, R$gL. Pt seen 12/27/08 with c/o spitting up blood and sneezing. Dx with thrush and tx with Diflucan. Returned to PCP 12/29/08, impetigo noted and vax given. Returned 12/30/08 with c/o poor feeding, multiple watery, stringy stools, weakness and pallor. PE notable for grunting, poor color and decreased activity. Transported via EMS to hospital with concern for sepsis. T=96.8''F. HR=170''s. Severly dehydrated on arrival. Infant coded and expired.


VAERS ID: 336777 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Tennessee  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-01-06
Entered: 2009-01-08
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Brain injury, Convulsion, Death
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 200900035

Write-up: Initial report was received 05 January 2008 from another manufacturer, document number 455211201. The initial reporter to this manufacturer had been a consumer, who is the patient''s sister. According to the reporter, her brother received a "DTAP" vaccination (manufacturer unknown, lot number not reported) on an unspecified date and an unspecified amount of time later, "he developed severe seizures and he ended up with severe brain damage". Due to complications, he passed away. No cause of death was reported and no additional information was provided at the time of the report. Documents held by sender: None.


VAERS ID: 336785 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Male  
Location: Illinois  
Vaccinated:2008-12-18
Onset:2008-12-19
   Days after vaccination:1
Submitted: 2009-01-07
   Days after onset:19
Entered: 2009-01-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT2792CA / 1 RL / UN
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB319AB / 1 RL / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1083X / 1 LL / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1317X / 1 LL / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-12-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None, healthy
Preexisting Conditions: Extra digit both hands at birth - tied; H/O drugs use in, child was in D 2/17/09-records received-sickle cell anemia trait
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient seen on 12/18/08, received immunizations, had low grade fever next day and then was brought to ER lifeless. 2/17/09-records received COB bacterial sepsis. Other significant conditions contributing to death but not related to terminal conditions:sickle cell anemia trait. krk


VAERS ID: 336841 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Illinois  
Vaccinated:2008-11-18
Onset:2008-12-04
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2009-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2956AA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF515AA / 1 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR A0836 / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C68309 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0641X / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-12-04
   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 except runny nose
Preexisting Conditions: Prematurity
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient found unresponsive in crib by parents. No symptoms prior - autopsy revealed intussusception. Pronounced dead at ER. 1/23/09 Autopsy report states COD as complications of intussusception. Also states: six areas of IS of small intestine; changes of distant intestine present; early pneumonia; inflammation of lung tissue & small airways. Patient had been found unresponsive in crib after recent history of cold like symptoms with fever.


VAERS ID: 337033 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-01-09
Entered: 2009-01-12
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (FOREIGN) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Upper respiratory tract infection
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: body temp, high fever
CDC Split Type: WAES0901USA00096

Write-up: Information has been received from a case in litigation via a case report concerning a baby who on an unspecified date was vaccinated with a dose of HEPTAVAX (manufacturer unknown). The patient had an upper respiratory infection at the time of vaccination. Subsequently, the patient experienced a very high fever and death. A special Master cited that "each of the two factors (the vaccine and the infection) were a substantial factor in causing the patient''s very high fever and death and, but for the presence of each of these two factors, the baby would not have had the high fever and would not have died." No further information is available.


VAERS ID: 337130 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Texas  
Vaccinated:2008-12-23
Onset:2008-12-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2009-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B204BA / 2 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF517AB / 2 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D16279 / 2 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1169X / 2 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Autopsy
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-12-24
   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: None
Current Illness: None
Preexisting Conditions: 33 week premature twin PMH: 33 week preemie twin, NICU x 3 weeks Family hx: parents w/hypothyroidism & psoriasis; others w/protein S factor deficiency, DM, HTN, asthma
Allergies:
Diagnostic Lab Data: Autopsy - report not available.
CDC Split Type:

Write-up: Pt. examined and vaccinated on 12/23/08 for well visit - normal exam. Pt found by parent in crib morning of 12/24 apneic - SIDS is preliminary cause of death - coroner''s report not available. 2/2/09 Received Autopsy Report which states COD as sudden unexplained death in an infant & manner of death as undetermined. 2/2/09 Autopsy report also states patient experienced cold s/s. Last seen by PCP on 12/23/08 for vaccinations, had been given Tylenol x 3 doses. Was fed & had been placed in crib face down w/head turned to side & 2 blankets on. 2/4/09 Received PCP office & vaccine records. Records reveal patient in good health on 12/23/08 w/only dry patchy areas on legs & back & left eye turning intermittently.


VAERS ID: 337242 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: New Mexico  
Vaccinated:2008-01-14
Onset:2008-11-15
   Days after vaccination:306
Submitted: 2009-01-09
   Days after onset:55
Entered: 2009-01-14
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1060U / 2 RA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-11-15
   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: No medical problems-- no allergies -- No drug use, alcohol or smoking. Had all her medical check ups!!!
Allergies:
Diagnostic Lab Data: 1/29/09-records received-COD-undetermined. krk 6/23/09-pathology report received: autopsy tissues without evidence of an infectious process. 6/26/09 Medical records received DOS 10/29/07 to 1/14/08. LABS and DIAGNOSTICS: PAP Tests (-).
CDC Split Type:

Write-up: My daughter had her 3rd GARDASIL vaccine in Sept. She was a very healthy young lady, she went to take a shower and died. Autopsy report states undermined death. There was no sign of trauma to the body to indicate a fall. She had pointed the shower head away from her and she got down on her knees and put her head on the edge of the tub and passed away. This has been a living nightmare for her family. She is not the only one to have had problems and death from this vaccine. Please I beg you to please take it off until it can be further tested. -not tested long enough to begin with- There will be others that will die if the cause is not found. 1/29/09-records received-COD-undetermined. 6/26/09 Medical records received DOS 10/29/07 to 1/14/08. Assessment: Immunizations and Contraceptive Management. HPV#1 10/29/07 LA Merck Lot# 1062U


VAERS ID: 337243 (history)  
Form: Version 1.0  
Age: 0.44  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2008-12-11
Onset:2008-12-16
   Days after vaccination:5
Submitted: 2009-01-09
   Days after onset:24
Entered: 2009-01-14
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2957AA / 2 UN / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF4U5AA / 2 UN / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR A0836 / 2 UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D01074 / 2 UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0217X / 2 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Death, Encephalopathy, Shock haemorrhagic
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hypovolaemic shock conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-12-18
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol
Current Illness: None
Preexisting Conditions: None. PMH: none.
Allergies:
Diagnostic Lab Data: See attached. Labs and Diagnostics: CBC with 43K WBCs with 20% atypical lymphs. CT brain scan (+) cerebral edema and probable ischemic infarcts. CSF (+) for few PMNs, CSF glucose 105, CSF protein 62. CSF cx (-). EEG abnormal. Rotavirus (+), likely due to shedding. ALT 938-9,480. AST 1,974-12,822. Blood cx (-). UC (-). Hgb 9.2. Platelets WNL on admission down to 105K. Lactate 5.3 on adm up to 10.2. PT 36.3-49.5. INR 3.54-5.22. PTT 42-56. Fibrinogen dropped from 153-137. D-dimer $g 20. CXR (+) for atelectasis. K+ 6.1. CO2 12. Cl- 110. Glucose 55.
CDC Split Type:

Write-up: Patient developed hemorrhagic shock w/ encephalopathy syndrome 5 days after vaccine administration and died. 1/27/2009 MR received for DOS 12/16-18/2008 which was the Date of death. Principal DX: Multisystem organ failure 2'' to Hemorrhagic Shock and Encephalopathy Syndrome (HSES). Pt initially presented with new onset seizures and diarrhea. Pt in usual state of good health a.m. of 1/16/09 except for some recent mild congestion. Later noted to be sweaty and did not respond while parent was changing clothes. Later noted to be eye rolling and making unusual movements. In status epilepticus and metabolic acidosis on arrivial in local ED. Intubated and medicated for seizures and transferred to higher level of care. Cool and mottled on arrival. LFTs elevated. Issues with hypoglycemia, abnormal coags and electrolyte fluctuations with little response to tx. Parents elected to withdraw life support follwing notification of fatal status of illness. 2/12/09 Death Cert received. COD- Multiorgan Failure. Hemorrhagic Shock and Encephalopathy Syndrome.


VAERS ID: 337323 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Nebraska  
Vaccinated:2006-01-04
Onset:2009-01-01
   Days after vaccination:1093
Submitted: 2009-01-14
   Days after onset:13
Entered: 2009-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U1780AA / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Meningitis bacterial
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-01-02
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: 1/21/09-records received-PMH: mononucleosis 2 months ago and several colds since then.
Allergies:
Diagnostic Lab Data: We do not have data. She died at Hosptial. According to the State health dept, the case was meningitis serogroup B. 1/21/09-records received-CT scan catastrophic brain injury, diffuses brain edema with non-visualization of 4th ventricle and basilar cisterns. CSF protein 290, WBC 175, gram negative diplococci. Urine Klebsiella pneumoniae. WBC 29.0, ABS neutrophile 27.6. CKMB 5.1, myoglobin 88. 1/27/09-additional diagnostic reports received-CSF culture Neisseria meningitidis Serotype B., toxicology screen negatove. CT head normal.
CDC Split Type:

Write-up: Provider notified on 1/2/09 that patient was admitted to Hospital (different institution) and prognosis is grim. She died of Bacterial Meningitis later that day. Upon record review, it was noted that she did receive Menactra in January of 2006. Contacted the VAERS number and she indicated I should submit information. 1/21/09-records received for DOS 1/1-1/2/09-Brain death from increased intracranial pressure with transtentorial herniation secondary to meningococcal meningitis. Sudden onset of headache and altered mental status changes. Developed severe hypertension with signs of increased intracranial pressure. Received as a transfer with fixed and dilated pupils and no evidence of any cortical or brain stem fucntion. EEG electrocerebral silence. Intubated. Mechanical ventilator. 3/11/09-probable cause of death-neisseria menengitis.


VAERS ID: 337670 (history)  
Form: Version 1.0  
Age: 0.13  
Sex: Male  
Location: Alabama  
Vaccinated:2009-01-08
Onset:2009-01-10
   Days after vaccination:2
Submitted: 2009-01-12
   Days after onset:2
Entered: 2009-01-16
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B77CA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF496AA / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D05882 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1358X / 1 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Autopsy, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-01-10
   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: None
Current Illness: None
Preexisting Conditions: Heart murmur
Allergies:
Diagnostic Lab Data: Autopsy pending
CDC Split Type:

Write-up: Found by father not breathing approximately 0500 on 1/10. Attempted resuscitation at home via police then EMS. To hospital with resuscitation efforts for approximately 1 hr with no results.


VAERS ID: 337671 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Arkansas  
Vaccinated:2009-01-13
Onset:0000-00-00
Submitted: 2009-01-16
Entered: 2009-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR SPC3230AA / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D0107S / 3 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-01-14
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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt was administered vaccines on 013109. Pt was found deceased on 011409. 10/28/09 Autopsy report received. DOD 11/14/09 Cause of Death: Sudden Unexplained Infant Death. Additional information extracted: Suddent Infant Death Syndrome.


VAERS ID: 337669 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Male  
Location: Michigan  
Vaccinated:2008-11-17
Onset:2008-11-24
   Days after vaccination:7
Submitted: 2009-01-19
   Days after onset:56
Entered: 2009-01-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT2788FA / 1 RL / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB213AA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF222AA / 4 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0807U / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C50457 / 4 RL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1517U / 1 RL / SC

Administered by: Private       Purchased by: Public
Symptoms: Death, Dyspnoea, Hypotonia, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-11-24
   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: None
Current Illness: None - normal
Preexisting Conditions: ? slight allergy 6-10-08; Hx otitis media . PMH: PCP records reveal normal childhood illnesses (OM, URI, bronchits) in 1st yr of life. Excessive wt gain noted at 3 months.
Allergies:
Diagnostic Lab Data: Labs and Diagnostics: CXR (+) for R pneumpthorax, pneumomediastinum, and probable L pneumothorax.
CDC Split Type:

Write-up: Pt given HIB #4; PREVNAR #4; Hepatitis A #1; MMR #1; Varicella #1 and Influenza #1 on 11-17-08. Pt presented one week later "barely breathing"; flacid and unresponsive to verbal-painful stimuli at 1755-transferred-died at local hospital a couple of hours later. 2/12/09 PCP and hospital records received from FDA. Pt with mild fever 11/24/08 put down to nap. Ptfound to be diaphoretic, limp, minimally breathing and non-interactive in crib. Upon arrival of EMS pt noted to be unresponsive to stim, satring with no blink response, pulse 160, RR 32 with rhonchi bilaterally R$gL. Dx with severe croup at local hospital with transport planned to higher level of care. In ER unresponsive in severe respiratory distress, skin mottled, O2 sats 80s-90s on pale toes. Arrived to transfer hospital unresposive to pain, lethargic, initially flaccid then posturing, (+) cervical lymphadenopathy, resp distress with stridor and rhonchi- intubated. Impression- Respiratory Failure. Cardiac arrest. CPR unsuccesful. 3/25/09 Autopsy report received with COD: Community Acquired Pneumonia. Manner of Death: natural. Final DX: 1) Acute hemorrhage pneumonia, multifocal, community acquired- a) Diffusely firm, edematous and hemorrhagic lungs, bilaterally. b) Histologic exam confirms purulent multifocal pneumonia. 2) Moderate Cerebral Edema. 3) Serous Pleural and Peritoneal Effusions.


VAERS ID: 337797 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: New Mexico  
Vaccinated:2007-01-03
Onset:2007-08-31
   Days after vaccination:240
Submitted: 2009-01-21
   Days after onset:509
Entered: 2009-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abnormal behaviour, Fatigue, Headache, Hypersomnia, Menorrhagia, Menstrual disorder, Metrorrhagia, Muscle spasms
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dementia (broad), Dystonia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-08-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: none~ ()~~0.00~Patient|none~ ()~~0.00~Sibling
Other Medications: Nasonex (Pseudovent 400 substituted for Entex 400 120 capsule),Claritan, Triamcinolene Acetonide cream for rash on wrist.
Current Illness: Went in for sinisitus, and had a sore throat. She had bad sinus allergies. But they still gave her the shots.
Preexisting Conditions: Seasonal allergies. None other.
Allergies:
Diagnostic Lab Data: 4/7/09-path report received-multiple tissues with extensive autolysis and bacterial overgrowth. Molecular evidence of a Clostridium sp.
CDC Split Type:

Write-up: Headaches, periods were very erratic. She would have them every 14 days @times, and others just spotting. Very bad cramps and periods were heavier after the 1st Gardasil shot. Wasn''t her normal spunky and happy self. She was very tired and the last few weeks before she passed away, sheslept alot during the day which she never did. Never had any other problems prior to the Gardasil shots. She recieved all three shots in the series. Last shot was 5-2-2007. 2/9/09-autopsy report received-COD-undetermined by autospy and toxicology.3/18/09-records received-well visit C/O contact dermatitis, nasal congestion, itchy sore throat times 2-3days. HPV4 lot#1424 F received 1/3/07 in right deltoid. Lot #0384U received 5/2/07 left deltoid and 12/2/08 lot#0955F left deltoid.


VAERS ID: 338667 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2009-01-27
Onset:2009-01-28
   Days after vaccination:1
Submitted: 2009-01-28
   Days after onset:0
Entered: 2009-01-30
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2810AA / 2 RL / UN
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB274AD / 1 RL / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1369X / 1 LL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 021052 / 4 RL / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1406X / 1 LL / UN

Administered by: Private       Purchased by: Private
Symptoms: Autopsy
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-01-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Autopsy is being performed
CDC Split Type:

Write-up: Sudden death at home morning of 1/28/09. 6/1/09 Autopsy report states COD as sudden unexpected infant death & manner of death as natural. Report also states patient found dead in crib, tox screens & cultures all neg.


VAERS ID: 338821 (history)  
Form: Version 1.0  
Age: 1.01  
Sex: Female  
Location: Washington  
Vaccinated:2009-01-21
Onset:2009-01-22
   Days after vaccination:1
Submitted: 2009-02-02
   Days after onset:11
Entered: 2009-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB258AA / UNK RL / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1120X / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D05879 / UNK UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1389X / UNK UN / UN

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2009-01-22
   Days after onset: 0
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: No concomitant medications were noted in chart by parents. No relevant medical history. No noted adverse events following previous vaccinations. PMH: none
Allergies:
Diagnostic Lab Data: UNK. Labs: Tox screen (-). Blood cx (+) for Strep salivarius (contaminant). Lower respiratory cx (+) for moderate growth of Strep pneumoniae and heavy growth routine resp flora.
CDC Split Type: A0766166A

Write-up: This case was reported by a healthcare professional and described the occurrence of death nos in a 12-month-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline), MMR II (strain not specified), VARIVAX and PREVNAR. On 21 January 2009 at 07:43, the subject received unspecified dose of HAVRIX (.5 ml, unknown, right thigh), unspecified dose of MMR II (unknown), unspecified dose of VARIVAX (unknown), and unspecified dose of PREVNAR (unknown). On 22 January 2009, 1 day after vaccination with HAVRIX, after vaccination with MMR II, PREVNAR, and VARIVAX, the subject experienced death nos. The healthcare professional considered the event was disabling, life threatening and clinically significant (or requiring intervention). The subject died on 22 January 2009 from death nos. It was unknown whether an autopsy was performed. It was reported the subject had "no history of illness or medical problems. Not on medications at time of death. Medical examiner stated undetermined cause of death on death certificate". 3/5/09 Autopsy report received with COD: Undetermined. Manner of Death: Undetermined. Child had presented to PCP earlier on the DOD with fever and URI sx. 4 vax given taht day. Child remained cranky and put down to nap. Approx 1 hour later found face down without pulse or respirations. Resuscitation unsuccessful.


VAERS ID: 339027 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Male  
Location: New Mexico  
Vaccinated:2008-08-27
Onset:2008-08-28
   Days after vaccination:1
Submitted: 2009-02-04
   Days after onset:160
Entered: 2009-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (KINRIX) / GLAXOSMITHKLINE BIOLOGICALS AC20B116AB / 5 RA / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1662U / 2 RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1307U / 2 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Pyrexia, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-08-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Febrile seizures in past 2/17/09-records received-history of febrile seizures. mild asthma
Allergies:
Diagnostic Lab Data: Autopsy found no other cause of death.
CDC Split Type:

Write-up: Patient had fever within 24 hours of vaccine administration. Patient was found unresponsive the next morning. Patient had a history of febrile seizures. 2/17/09-records received-COD died from complications of a seizure disorder. Seizure disorder, clinical history of febrile seizures. Asthma Clinical history of mild asthma. histologic changes in large airways consistent with mild asthma.


VAERS ID: 339152 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Virginia  
Vaccinated:2008-12-11
Onset:2008-12-18
   Days after vaccination:7
Submitted: 2009-02-06
   Days after onset:50
Entered: 2009-02-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C2870AA / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D01074 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0926X / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-12-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: URI
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Baby expired 7 days after immunizations. No cause of death at this time. Case is being handled by Medical Examiner. 3/13/09 Autopsy report states COD as undetermined, associated w/co-sleeping in adult bed w/soft bedding.


VAERS ID: 339587 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Oregon  
Vaccinated:2008-10-30
Onset:2008-10-30
   Days after vaccination:0
Submitted: 2009-02-14
   Days after onset:107
Entered: 2009-02-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2955BA / 2 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF233AA / 2 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR AO169 / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C35174 / 2 LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abnormal behaviour, Autopsy, Depressed level of consciousness, Nasopharyngitis, Pulmonary congestion
SMQs:, Cardiac failure (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-11-04
   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: None
Current Illness: Very healthy 4 month old baby boy.
Preexisting Conditions: None Birth Hx: uncomplicated c-section.
Allergies:
Diagnostic Lab Data: autopsy was performed, SIDS was listed as cause of death. LABS: Micro & tox screens all neg.
CDC Split Type:

Write-up: A few hours after his well child check up he was not himself. I would describe him as having an extremely decreased and inconsistant response to surroundings, sounds, and family members. My sister who he loved could not get him to smile or focus on her. We did not take him to the doctor because this seemed slightly normal after shots. He did perk up a little the next day, then he seemed like he was coming down with a cold, I could hear and feel congestion in his lungs. 3/20/09 Autopsy report states COD as sudden infant death syndrome. Report states patient placed down for nap in crib on stomach on top of baby blanket. Found cold & unresponsive. Patient''s bedroom noted to be very warm on investigation.


VAERS ID: 339724 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Mississippi  
Vaccinated:2008-11-26
Onset:2008-11-30
   Days after vaccination:4
Submitted: 2009-02-17
   Days after onset:79
Entered: 2009-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3174AA / 1 LL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB659AA / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D01074 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0926X / 1 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cough, Death, Depressed level of consciousness, Diarrhoea, Dyspnoea, Poor sucking reflex, Pyrexia, Respiratory tract infection, Swelling, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), 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), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-12-27
   Days after onset: 27
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: none~Hep B (no brand name)~1~0.20~Patient|none~ ()~~2.00~Sibling
Other Medications: Tylenol
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: He had a high fever 4 days after getting the vaccines on 11/26/2008. He was not as alert as he usually was, he had diarrhea, acted as though he didn''t know how to suck a bottle, swelled, 1 week before he died I took him to the hospital on 12/20/2008 for wheezing, hard time breathing, fever, coughing severely. They said it was a respiratory infection. I had taken him to the hospital and doctors office for the same reasons numerous times prior to that last visit. They kept telling me there was nothing wrong with him, but I knew there was. He died 12/27/2008. 7/14/09-autopsy report received-COD-positional asphyxia.


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