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VAERS ID: 302595 (history)  
Form: Version 1.0  
Age: 89.0  
Sex: Male  
Location: Michigan  
Vaccinated:2007-12-12
Onset:2007-12-12
   Days after vaccination:0
Submitted: 2007-12-31
   Days after onset:19
Entered: 2008-01-14
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2525AA / 1 LA / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Burning sensation, Computerised tomogram normal, Dysphagia, Feeling abnormal, Muscular weakness, Pain, Paralysis
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2009-01-16
   Days after onset: 401
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 16 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Prednisone, metoprolol, aspirin, Vicodin, Lasix, lisinopril, K-DUR
Current Illness: None
Preexisting Conditions: Rheumatoid arthritis, degen. disk disease-cerv. neck PMH: RA, spinal deformities, steroid dependent. Polymyalgia rheumatica. HTN. HOH. Compression fx of c-spine. CAD, mitral regurgitation, CHF, cardiomyopathy w/CABG. Ejection fraction 35%.
Allergies:
Diagnostic Lab Data: CAT scan neg. for tumor or bleed LABS: head CT essentially WNL. MRI c-spine revealed severe stenosis w/cord compression
CDC Split Type:

Write-up: 8 hrs after vaccine admin., sudden onset of weakness bilateral arms & legs. Difficulty with speech, swallowing & ineffective cough. Overall sensation of feeling "wet" and "burning" flesh pain & paralysis. Not recovered but some improvements seen. 2/8/08 Reviewed hospital medical records which reveal patient experienced arm & leg pain, slurred speech & right facial droop. Admitted 12/13-12/29/2007. Progressed to paresthesias & then paralysis. Swallowing & urination compromised. Neuro consult done & felt non reversible. Transferred to hospice. FINAL DX: cervical cord compression 2nd to severe spinal stenosis; neuropathic pain in upper & lower extremities 2nd to cord compression. Annual Follow-up Information 18-FEB-2009: There was partial paralysis of the lower extremities that remained - unable to rehab pt. after receiving vaccine. Pt died approx 5 weeks ago (Jan 16) Sepsis due to bladder infection, being bedridden at nursing home and advanced age. Pt. passed away 35 days after receiving this vaccine (Jan 16th 09). His residual symptoms were lower extremity (partial) paralysis. The upper extremity paralysis. Resolved shortly after initial onset but unable to rehab the lower lungs. Spots from bilateral infection had to hi.sdeath


VAERS ID: 302699 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-01-11
Entered: 2008-01-15
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Infection
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: Fever
Preexisting Conditions: Febrile convulsion
Allergies:
Diagnostic Lab Data: Autopsy - MV in lungs, and other infections
CDC Split Type: WAES0801USA01619

Write-up: Information has been received from a lawyer concerning a male child with a history of febrile convulsion who on an undisclosed date was vaccinated with MMR II. Ten days after being vaccinated with MMR II the child was found dead in his cot. It was reported that the general practitioner immunized the child when he had a fever and history of febrile convulsion. The post mortem found "MV" in his lungs and various other infections. No further details were provided.


VAERS ID: 302724 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Minnesota  
Vaccinated:2008-01-11
Onset:2008-01-13
   Days after vaccination:2
Submitted: 2008-01-15
   Days after onset:2
Entered: 2008-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B130AA / 1 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF297AA / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B70145K / 1 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-01-13
   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: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt. died in bed approx. 48 hours after receiving 1st set of 3 immunizations. Records received 3/31/08-final autopsy report. COD: Probably Sudden Infant Death Syndrome. Petechial hemorrhages, epicardial, pleural.


VAERS ID: 302826 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Louisiana  
Vaccinated:2007-12-20
Onset:2007-12-22
   Days after vaccination:2
Submitted: 2008-01-07
   Days after onset:16
Entered: 2008-01-16
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B137AA / 3 LL / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2514AA / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B54016F / 3 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1195U / 3 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Anoxic encephalopathy, Apnoea test, Autopsy, Brain death, Brain scan normal, Cardiac arrest, Computerised tomogram normal, Corneal reflex decreased, Crying, Dyspnoea, Electroencephalogram abnormal, Hypotension, Intensive care, Intubation, Mechanical ventilation, Oxygen saturation decreased, PCO2 increased, Poor peripheral circulation, Pupil fixed, Respiratory disorder, Resuscitation, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Cardiomyopathy (broad), Corneal disorders (narrow), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-12-24
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Unremarkable. There were no previous hospitalizations. She has received the six month immunizations two days before this happened and has been told the baby needed tummy time to develop the trunk tone and that is what she was doing when this happened.
Allergies:
Diagnostic Lab Data: A CT scan done at the emergency room showed no bleeding or edema with normal ventricles. The next day, repeat CT scan still did not show any brain edema or hemorrhage. An EEG was nearly flat that day with no significant cortical activity. Over the next 24 hours, the agonal respirations disappeared. The EEG became completely flat and there were no signs of any brain activity. an apnea test which showed the patient to have no spontaneous respirations despite the PCO2 going up to 77 and the oxygen saturation dropping to below 70. Also, at that point, there was no corneal reflex. The ocular vestibular reflex was negative. There was no gagging or coughing reflex, and there was no response to deep pain in any form including unchanged heart rate and blood pressure. The baby had a brain flow scan shortly after she came to the PICU, and it showed blood flow to the brain. After the apnea test and the rest of the examination for brain death was done, the mother requested a second brain flow study. The brain flow study was equivocal but still showed flow. Despite that, I explained to the mother that the criteria was still met for brain death, especially if the patient had not received any narcotics or any medications that could be impairing the cortical brain stem activity. An autopsy was performed.
CDC Split Type:

Write-up: This is a 6-month old white female who was transferred from the emergency room when she came into cardiac arrest on full code, asystole and was resuscitated and the heart rate was brought back after several minutes. According to the mother, she left the child prone over a blanket that had the four ends secure so it would not fold and left the room. She had heard the baby cry because, according to her, she didn''t like to be prone. She heard the baby cry 5 minutes before she went back into the room and found her completely unresponsive. She started CPR and called the paramedics who arrived in another 5 minutes according to her. They intubated the baby and transferred to the emergency room. From there, the patient was sent to this PICU. The physical examination showed the baby to be unresponsive to stimuli with gasping rhythmic chest movements with no effective ventilation. The pupils were at 5 mm and fixed. The patient was on the respiratory oxygenating well. The capillary refill was fair to poor approximately 4-5 seconds. Air entry was good and the heart was rhythmic with no murmur. The abdomen was soft. There were no bruises on the body or head of the infant. There was no gag reflex. A CT scan done at the emergency room showed no bleeding or edema with normal ventricles. The patient was placed on mechanical ventilation. A femoral line was placed. The baby was also started on Dopamine and Dobutamine for low blood pressure and poor perfusion and responded well to it. The baby also received albumin 5%. Due to the fact there was no cerebral edema, no Mannitol or 3% saline was given. The venous blood gases showed normal oxygenation and ventilation. The next day, repeat CT scan still did not show any brain edema or hemorrhage. An EEG was nearly flat that day with no significant cortical activity. Over the next 24 hours, the patient had at one point, according to some nurses, some very sluggish pupil reaction and even very mild response to deep pain in the lower extremities only. In my examination, basically the pupils were nonreactive and there was no response to pain. Over the next 24 hours, the agonal respirations disappeared. The EEG became completely flat and there were no signs of any brain activity. At that point, the situation was discussed with the parents and they agreed to an apnea test which showed the patient to have no spontaneous respirations despite the PCO2 going up to 77 and the oxygen saturation dropping to below 70. Also, at that point, there was no corneal reflex. The ocular vestibular reflex was negative. There was no gagging or coughing reflex, and there was no response to deep pain in any form including unchanged heart rate and blood pressure. The baby had a brain flow scan shortly after she came to the PICU, and it showed blood flow to the brain. After the apnea test and the rest of the examination for brain death was done, the mother requested a second brain flow study. The brain flow study was equivocal but still showed flow. Despite that, I explained to the mother that the criteria was still met for brain death, especially if the patient had not received any narcotics or any medications that could be impairing the cortical brain stem activity. At that point, I placed a call to another doctor who came and examined the patient and concurred there was brain death. The mother discussed the case with organ donation personnel and decided to donate the daughter''s organs. The care was then transferred to organ donation on 12/24/07. Final diagnosis: 1. acute life threatening event, 2. anoxic encephalopathy, 3. brain death. 9/9/06 Autopsy report states COD as probable apneic event w/history of anoxic encephalopathy, unresponsiveness, resuscitation & hospitalization, neuro delay & no evidence of trauma or injury.


VAERS ID: 303166 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Washington  
Vaccinated:2007-12-12
Onset:2007-12-26
   Days after vaccination:14
Submitted: 2008-01-17
   Days after onset:22
Entered: 2008-01-22
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B130AA / UNK UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR SPUF215AB / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B54013H / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-12-26
   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: Unknown
Current Illness: Infant seen 12/11/07 with hx of cough, runny nose and congestion. Dx''d with bronchilolitis and started on nebs.
Preexisting Conditions: Unknown.
Allergies:
Diagnostic Lab Data: Autopsy results, not reported
CDC Split Type: USWYEH02044108

Write-up: Information regarding Prevenar was received from a Complaint Coordinator from the FDA regarding a 2-month-old male patient who experienced death. The patient received a dose in Dec-2007. On the same day, the patient received a dose of Haemophilus influenzae B (manufacturer unknown) and a dose of Pediarix (GlaxoSmithKline) in Dec-2007. The patient received a dose of Rotarix one day prior to the other vaccines in Dec-2007. Relevant medical history was not provided. Concomitant medications were not reported. Approximately two weeks after receiving Prevnar and three other vaccines the patient died on 26-Dec-2007. No explanation was given for the death. No additional information was available at the time of this report. The cause of death was unexplained and the autopsy cause of death was not reported. 4/15/2008 Per FDA: "The cause of death was SIDS, although we don''t have a copy of the death certificate. I don''t think we need anything else for this case." Lengthy investigative report received from FDA. Infant seen 12/11/07 with hx of cough, runny nose and congestion. Dx''d with bronchiolitis and started on nebs. Infant received Rotovirus vaccine 12/11/07. Seen in F/u next day with improved sx and given Pediarix, Hib, and Prevnar 12/12/07. Infant had fed normally in the early morning hours of 12/26/2007 and gone to sleep in parent''s bed, and when parent awoke the next morning, the infant was dead. DX: SIDS.


VAERS ID: 303172 (history)  
Form: Version 1.0  
Age: 0.41  
Sex: Female  
Location: Unknown  
Vaccinated:2007-12-07
Onset:2007-12-07
   Days after vaccination:0
Submitted: 2008-01-18
   Days after onset:42
Entered: 2008-01-22
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AAC21B084BA / 2 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0064U / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08700D / 2 LL / IM

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Drug screen positive, Malaise
SMQs:, Drug abuse and dependence (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-12-16
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Underweight; Vomiting
Preexisting Conditions: Constipation; Fever
Allergies:
Diagnostic Lab Data: autopsy 12/16?/07 - "there was cocaine metabolized in her hair"
CDC Split Type: WAES0801USA01850

Write-up: Information has been received from a mother concerning her 5 month old underweight daughter who "had been throwing up a lot since around the time she was born and who in August 2007 "was really constipated and had a fever of 103F" who on 24-OCT-2007 was vaccinated with a first dose of PEDVAXHIB. A second dose of PEDVAXHIB was administered on 07-DEC-2007. The mother reported that the patient "was given a lot of other shots" on the same days. The patient was reportedly "really sick" after the second dose of PEDVAXHIB on 07-DEC-2007. The patient was being seen by the health department. Subsequently the patient died on 16-DEC-2007. It was reported that they were awaiting autopsy results but an initial report from the medical examiner that stated "there was cocaine metabolized in her hair." Additional information has been requested. 3/5/08 Autopsy report states COD & manner of death as undetermined. Circumstances suggested smothering & mechanical asphyxia w/blunt force injuries, acute bronchopneumonia RUL.


VAERS ID: 303292 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Connecticut  
Vaccinated:2007-10-23
Onset:2007-11-08
   Days after vaccination:16
Submitted: 2008-01-22
   Days after onset:75
Entered: 2008-01-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B1240B / 2 UN / -
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0436U / 2 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B54007H / 2 LL / -
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0670U / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death, Respiratory tract congestion, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2007-11-10
   Days after onset: 2
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Gastroesophageal reflux PMH: otitis media tx starting 11/8/07.
Allergies:
Diagnostic Lab Data: Unknown ER LABS: ABG pH 6.85 (H). CXR & abdominal x-ray revealed multiple dilated loops of air-filled small bowel & free intraperitoneal air. 4/15/08 Additional labs received from CDC: small intestine w/marked & extensive congestion of submucosa w/hemorrhages & necrosis; congestion of liver & spleen. Adenovirus, Rotavirus & haemophilus all neg.
CDC Split Type: WAES0801USA03508

Write-up: Information has been received from a physician concerning an approximately 5 month old male with a history of "reflux" who in approximately October 2007, was vaccinated orally with a second dose of Rotateq. Two weeks post vaccination, on 08 NOV 2007, the patient was seen "in the office" at which time the patient was "congested with on an off vomiting". The patient presented with "a good bowel movement" and was given amoxicillin and sent home. Approximately 16 hours later the patient was taken to the emergency room (ER). "The child passed away on 10 NOV 2007". The patient''s status was not recovered. The reported cause of death was "necrotic bowel". The adverse events reported were considered to be, Disabling, immediately life threatening by the reporter. Additional information has been requested. 1/25/08 Received vax record which reveal patient also received Pediarix #2 AC21B133AA, Hib #2 Merck lot # 0436U, Prevnar #2 B54007H & Rotateq #2 0670U.. 1/29/08 Reviewed ER medical records of 11/9/07 which reveal patient arrived in cardiopulmonary arrest having been brought to hospital by parent. Had voided & had bloody stool, possibly vomited & had been lethargic prior to coding. Was in severe acidosis, shock, dehydration, hypercarbia, arrhythmia, infection. Resuscitated & transferred to higher level of care ER. FINAL Initial ER DX: abdominal castrophe; respiratory/cardiac arrest; and septic shock. 2/1/08 Reviewed hospital med records which reveal patient transferred from outlying hospital in critical shock condition. Admitted 11/9-11/10/2007 to ICU. Had 36 hour hx of poor feeding, increased crying & developed bilious emesis & bloody stools. Intubated & emergent laparotomy & ileocecectomy was performed in ICU. Finding at surgery: IS extending to hepatic flexure w/small area of necrosis in cecum & entire small bowel w/diffusely involved ischemia thought likely secondary to shock & cardiac arrest. Bowel remained dusky at end of procedure & abdomen left open w/bowel wrapped in order to visulize recovery. developed compartment syndrome of bilateral legs. Deteriorated, developed hepatic failure, DIC, fixed & dilated pupils, seizures & absent reflexes. Defibrillated numerous times & expired 11/10/07. Preliminary autopsy report included w/medical records reveals COD as Intussusception leading to ischemic bowel resulting in sepsis complicated by prolonged cardiac arrest & multiorgan failure. Findings included: ischemic bowel; diffuse alveolar damage,mild; sepsis; hepatic failure; DIC; renal petechiae; gastric mucosal petechiae; bilateral lower extremity ischemic damage; hyperemic lower extremities.


VAERS ID: 304128 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Indiana  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-01-31
Entered: 2008-02-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Guillain-Barre syndrome, Pneumonia
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA05442

Write-up: Information has been received from a nurse concerning an 80 year old male patient who on an unspecified date was vaccinated with a dose of Pneumovax 23, (lot # not reported) (manufacturer unknown). The nurse reported that the patient received the Pneumovax 23 and developed a "Guillain-Barre syndrome" which made him develop pneumonia and the patient died as a result. She reported that the patient was not treated or vaccinated at that practice and was not sure if it was Pneumovax 23, she said it was a pneumonia shot (manufacturer unknown). No further information was reported. Additional information is not expected.


VAERS ID: 304418 (history)  
Form: Version 1.0  
Age: 61.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2007-11-28
Onset:2007-11-28
   Days after vaccination:0
Submitted: 2008-01-30
   Days after onset:63
Entered: 2008-02-06
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR AFLUA316AA / UNK LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Death, Intensive care, Malaise, Mechanical ventilation
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-01-17
   Days after onset: 50
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 30 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Many PMH: depression & anxiety, under psychiatric care. Type 2 DM; recurrent UTIs; hyperlipidemia; LBP w/multiple surgeries; thyroid disease; obesity; memory loss. Hx of pneumonia. Secondhand smoke exposure. Family hx of DM & cardiac disease. Allergy: Multiple meds including PCN, sulfa & vancomycin.
Allergies:
Diagnostic Lab Data: LABS: Admit CBC w/WBC 7/9 (N), H/H 11.2/32.7 (L), neutros 82.1% (H), lymphs 6.9% (L), eos 6.7 (H). Admit Chem: Na 134 (L)CT chest scan revealed bilateral nodular lung inflitrates. CT chest angio r/o pulmonary emboli. Bronchoscopy revealed hemorrhagic secretions. Transbronchial biopsy. Lung biopsy via thoracotomy revealed interstitial pneumonitis. FANA (+) w/titer speckled pattern 1:160 (H). Neut cyto aby IgG <1:20 (H). EKG abnormal. Echocardiogram abnormal w/RV dilation & dysfunction.
CDC Split Type:

Write-up: She was immediately sick. Very sick for 4 more days. Kept getting worse. Dec 20 put in hospital. Dec 25 to ICU. Dec 27 respirator. Died 1/17/08. 2/21/08 Reviewed hospital medical records which included clinic visit & vax record of 11/28/07. Database updated. Patient w/palpitations intermittently when anxious or blood sugar low, 10# wt loss over past several months since the death of parent. H&P indicates patient experienced sinusitis, fever, chills, sore throat, nasal congestion, postnasal drip, swollen cervical lymph nodes & productive cough x 3 wks. Dx w/bronchitis & pneumonia & tx w/oral antibiotics as outpatient w/o increasing fever, SOB & weakness. Admitted 12/20/07-01/17/2008 w/community acquired pneumonia & dehydration. Consults by pulmonogy, surgery & ID. Conditioned worsened & was intubated & transferred to ICU. Developed pneumothorax s/p transbronchial biopsy & had chest tube placed. Developed acute ARDS & was trached 1/8/08. Continued to deteriorate & expired 1/17/2008. FINAL DX: none provided on D/C summary. No autopsy done per med records. Death certificate requested from funeral home. 2/21/08 Reviewed death certificate which states COD as respiratory failure with pneumonia as underlying cause.


VAERS ID: 304505 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: North Carolina  
Vaccinated:2008-01-29
Onset:2008-01-30
   Days after vaccination:1
Submitted: 2008-01-31
   Days after onset:1
Entered: 2008-02-07
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B125BB / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0260U / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B54013D / 1 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: 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: 2008-01-31
   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: NONE
Current Illness: NONE
Preexisting Conditions: Hypospadias; Benign tumors; Strawberry hemangioma PMH: umbilical hernia
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Fever, Death 2/12/08 Received vax record from reporter/provider & confirms as reported. 4/11/08Reviewed autopsy report which states COD as SIDS. Autopsy also states patient was 32 wk preemie & developed fever 104 next day tx w/antipyretic & seen in ER. Patient found cold, breathing arrested & unresponsive on 1/31/08 while co-sleeping w/parents. EMS coded & taken to ER in cardiopulomonary arrest where resuscitation unsuccessful. Accidental overlay could not be completely ruled out.


VAERS ID: 304711 (history)  
Form: Version 1.0  
Age: 58.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2008-01-25
Onset:2008-01-25
   Days after vaccination:0
Submitted: 2008-02-01
   Days after onset:7
Entered: 2008-02-11
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2514AA / 1 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Chest pain, Dyspnoea, Pain, Speech disorder
SMQs:, Anaphylactic reaction (broad), Dementia (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-01-26
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hormones; High BP Pills
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: LA080203

Write-up: 01/25/08 11:00 PM Couldn''t breathe or talk at fist. Then c/o pain in chest - then all over. 11:06 Ambulance called. 11:35 Ambulance arrived. Transported to hospital. 09/08 Had problems with SOB to ER - "Test did not show anything" (info given by daughter). 2/12 /08-myocardial infarction per coroner''s office. no autopsy performed. 4/7/08-ER records received for DOS 1/26/08-cardiac arrest. Prounced 0054.


VAERS ID: 304745 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Michigan  
Vaccinated:2008-01-25
Onset:2008-01-28
   Days after vaccination:3
Submitted: 2008-01-28
   Days after onset:0
Entered: 2008-02-12
   Days after submission:15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B127AA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF292A / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C35169 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1391U / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-01-28
   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:
Current Illness: Bronchiolitis
Preexisting Conditions: PMH: recent RSV infection.
Allergies:
Diagnostic Lab Data: 3/19/08 Autopsy report states microscopic exam of lung tissue revealed interstitial mononuclear inflammatory infiltrates & occasional multi-nucleated giant cells c/w pneumonia of viral etiology.
CDC Split Type:

Write-up: Unexplained death - under investigation. 3/19/08 Autopsy report states microscopic exam of lung tissue revealed interstitial mononuclear inflammatory infiltrates & occasional multi-nucleated giant cells c/w pneumonia of viral etiology.


VAERS ID: 304951 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Female  
Location: Louisiana  
Vaccinated:2008-02-13
Onset:2008-02-14
   Days after vaccination:1
Submitted: 2008-02-14
   Days after onset:0
Entered: 2008-02-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2760AA / 2 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF071AA / 2 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR A0298 / 2 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B701458 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1620U / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-02-14
   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: NONE
Current Illness: NONE
Preexisting Conditions: NONE. CHILD WAS BORN AT 29 WEEKS BY C-SECTION. MOM HAD GESTATIONAL DIABETES, SMOKED DURING PREGNANCY AND TOOK PHENOBARBITAL IN MAY 2007
Allergies:
Diagnostic Lab Data: HEARING AND VISION SCREENING DONE ON SAME DAY. NO LABS.
CDC Split Type:

Write-up: NO ADVERSE REACTIONS AT TIME OF VACCINATION. CHILD WAS EXAMINED BY PHYSICIAN AND DEEMED HEALTHY. CHILD WENT HOME ALERT AND SHOWING NO NEGATIVE SYMPTOMS BUT WE WERE ADVISED BY CORONER''S OFFICE ON FEBRUARY 14, 2008 THAT BABY DIED. CORONER''S OFFICE DOES NOT KNOW CAUSE OF DEATH -- POSSIBLE SIDS. 2/19/08 Reviewed provisional autopsy which states COD as SIDS. Patient co-sleeping w/parents & unresponsive when parent awoke. Both parents smoke in home. Mother w/gestational diabetes. Home unkept & narcotics found in home. 3/13/08 Reviewed autopsy report which is unchanged from prelim autopsy.


VAERS ID: 305043 (history)  
Form: Version 1.0  
Age: 64.0  
Sex: Female  
Location: Colorado  
Vaccinated:2007-11-16
Onset:2007-11-21
   Days after vaccination:5
Submitted: 2008-02-13
   Days after onset:84
Entered: 2008-02-15
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2454AA / 3 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Aphasia, Confusional state, Death, Demyelination, Disorientation, Headache, Memory impairment, Muscular weakness, Myalgia, Mydriasis, Pupil fixed, Unresponsive to stimuli
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Optic nerve disorders (broad), Demyelination (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-11-28
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None at the time of vaccination
Current Illness: Had pneumonia 2 weeks prior and then had a viral illness one week prior.
Preexisting Conditions: Hypertension, dermatitis, pre-diabetes; Allergic to codeine, sulfa, neosporin, and penicillin Capillaritis, post inflammatory hyperpigmentation of LEs, sinusitis, constipation, impaired glucose metabolism. Allergies: congestac, Vioxx, ASA, codeine, bactrim, neosprin.
Allergies:
Diagnostic Lab Data: LABS: CT of head & MRI of brain c/w ADEM. CSF WBCs 789(H), polys 89%. Repeat CT scan revealed worsening demyelination. Blood & CSF c/s neg. Brain biopsy revealed ADEM. WBC 15,500. CT abdomen/pelvis revealed fatty liver & gallbladder distension, both mild. CXR WNL.
CDC Split Type:

Write-up: On 11/21 the husband noticed that patient was having confusion and forgetting little things. The husband notified the PCP who advised him to take the patient to the hospital. Prior to this the patient was treated on 10/24/07 for pneumonia with 7 days of Avelox. On 11/5 the patient came to the clinic complaining of myalgias. This was ruled to be a viral process. On 11/16 the patient recieved the influenza vaccine in the clinic. The morning of 11/21 the patient woke up with a headache and progressively became disoriented with muscle weakness and by 4pm that day could not talk. Once at the hospital the patient was given steroids, antibiotics, and antifungals. The patient improved for two days and then got progressively worse each day after that. The patient became completely unresponsive, pupils fixed and dilated by 11/28. Patient expired on 11/28. Diagnosis was unclear. Patient with definite demylinating process and encephalopathy, so vaccine reaction was in the differential. However some of the symptoms did start prior to receiving the vaccine. 8/26/08 Death certificate states COD as acute disseminated encephalomyelitis. 2/19/08 Reviewed hospital medical records of 11/21-11/28/2007. FINAL DX: acute disseminated encephalomyelitis; hyperlipidemia; pre-diabetes; & HTN. Records reveal patient experienced confusion, disorientation & loss of speech x 1 day Admitted 11/21-11/28/2007 when she expired. Exam revealed inability to speak but was able to mime; cranial nerve exam WNL, general muscle weakness w/reflexes intact. Tx w/antibiotics, steroids, antivirals & prophylactic antiseizure meds. Received IVIG x 2. By hospital day #4, conditioned worsened & was unresponsive w/left side weakness. C/S neg & antibiotics/antivirals were d/c. Continued to deteriorate & on vent. Family decision to withdraw tx as condition contined to worsen & pt expired. 5/2/08 Reviewed pcp medical records which included vax record that confirms as reported. Office note of 11/16/07 was for flu shot only, no pcp note. 10/24 vs for URI s/s x approx 1 week. Runny nose, facial tenderness, lightheadedness, cough, LBP, poor appetite. Apouse had been ill w/viral syndrome. CXR that day revealed patchy RUL infiltrate; CBC WNL. 10/29 visit reveals patient seen in f/u for pneumonia, dermatitis & pain in left shoulder. She had less cough & improved appetite but was still tired. CXR that day revealed near resolution of pneumonia. Records also included some hospital medical records. Neurosurgery & neurology consults done. Patient w/fever on admission.


VAERS ID: 305082 (history)  
Form: Version 1.0  
Age: 0.27  
Sex: Male  
Location: Georgia  
Vaccinated:2008-02-14
Onset:0000-00-00
Submitted: 2008-02-18
Entered: 2008-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B132CA / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0498U / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C35172 / 1 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-02-18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: 11/07 - Heart Murmur heard Birth HX: c-section, no complications.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt was reported dead to us by mom this morning. She stated death was around 4:00 am. 5/9/08 Autopsy report states COD as sudden unexplained death in infancy. Autopsy report also states patient was found in prone sleeping position on soft bedding w/soft pillow partially covering mouth/nose. Had been placed in bassinet on back on a soft pillow. Patient was large for his age weighing 19.6 lbs. Patient had seen PCP approx 11-12 days prior for ear infection & had finished his antibiotibcs. No problems noted on day of vaccination or afterward. PCP had noted that patient was overweight & parents counseled to reduce feeding.


VAERS ID: 305097 (history)  
Form: Version 1.0  
Age: 50.0  
Sex: Female  
Location: Unknown  
Vaccinated:2008-01-28
Onset:2008-02-02
   Days after vaccination:5
Submitted: 2008-02-15
   Days after onset:13
Entered: 2008-02-19
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MU: MUMPS (MUMPSVAX II) / MERCK & CO. INC. 1982U / UNK RA / UN

Administered by: Other       Purchased by: Other
Symptoms: Cardiac arrest, Cellulitis, Cough, Death, Dizziness, Headache, Injection site pain, Injection site swelling, Nausea, Oedema peripheral, Pyrexia, Respiratory failure, Septic shock, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-02-08
   Days after onset: 6
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: [therapy unspecified]; TYLENOL; VICODIN; ROCEPHIN; NALOXONE
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown. Tissue exam lungs (+) for abscess formation, tissue destruction, necrosis and marked acute inflammation as well as adjacent lung tissue with acute inflammation and accumulation of proteinaceous material in alveolar spaces and marked congestion. Skin tissue exam of RUE (+) for edema, hemorrhage in subq fat and inflammation. Bacterial clusters in deep dermis and subq tissue.
CDC Split Type: WAES0802USA02238

Write-up: Information has been received from a pharmacist and a pharmacy tech concerning a 50-year-old female patient with no pertinent medical history, allergies or previous drug reactions, who on 28-JAN-2008 was vaccinated in the right upper arm with a dose of Mumpsvax II (659616/1982U) (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3). Concomitant therapy included TYLENOL, ROCEPHIN, VICODIN, NALOXONE and "afzavelrd". On 02-FEB-2008 the patient experienced nausea, vomiting, headache, light headedness, fever and cough which lasted 4-5 days. On 06-FEB-2008 the patient developed swelling and pain of the right upper extremity at the injection site, and the left lower extremity was swollen. On 08-Feb-2008, the patient was admitted to the hospital with a diagnosis of cellulitis and vomiting. She developed respiratory failure, and became septic, likely due to necrotising and vomiting. She expired after shock and cardiac arrest on 08-Feb-2008. The cause of death was fasciitis. During the hospital stay, the patient was treated with "promethezone", "NS" and "zolprclam". The adverse events were classified as type A (pharmacological) reaction. Naranjo''s Algorithm for Determination of Probability was used to assess the adverse drug reaction, and scored a 2 which indicated that they were a possible reaction to the Mumpsvax II (Jeryl Lynn). The adverse event appeared after administration of the vaccine. The vaccine was not detected in the blood or other fluids in concentrations known to be toxic. It was not known if the patient had a similar reaction to Mumpsvax II (Jeryl Lynn) or similar vaccines. According to Schumocks Criteria for Preventability, it was not considered preventable. The Mumpsvax II (Jeryl Lynn) was not inappropriate for the patient''s condition. The dose, route, and frequency of administration was not inappropriate for the patient''s age, weight, or disease state. There was no required therapeutic drug monitoring necessary or lab tests required. There was no reported drug interaction. A toxic serum of the drug concentration was not documented and there was no poor compliance involved. No product quality complaint was involved. The reporter considered the adverse events to be an other important medical event and life threatening. A lot check has been initiated. Additional information has been requested. 02/25/2008 Autopsy Report received with the following findings: 1) Abscess, Left Upper Lobe of Lung. 2) Apparent Cellulitis, Right Upper Extremity. 3) Congestion and Edema, bilateral Lungs. 4) Pleural Effusion, Left side. 5) Congestion, Liver. 6) Mild Coronary Artery Atherosclerosis. 7) Mild Atherosclerosis, Aorta. 2/27/2008 Tag2 received. 4/21/08 Initial report received from coroner. The deceased developed a high fever x 4 days s/p mumps vax for which pt did not seek treatment. On 2/8/08 pt developed severe pain in arm and leg, and began spitting up blood and was brought to the ER. Pt was admitted to the ICU at 930 am. At 1512 pt went into cardiac arrest and was prounounced dead after CPR was unsuccessful. Attending MD stated victim most likely died of sepsis or severe infection. 07/08/2008 Remainder of Autopsy report received. Final COD Abscess, Left Upper Lobe of Lung (Days). Other significant conditions: Mild Subcutaneous inflammation, skin of Right upper extremity.


VAERS ID: 305606 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: New York  
Vaccinated:2008-02-20
Onset:2008-02-22
   Days after vaccination:2
Submitted: 2008-02-25
   Days after onset:3
Entered: 2008-02-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1968U / 3 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-02-22
   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: Yasmin daily birth control
Current Illness:
Preexisting Conditions: No known drug allergies
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Sudden unattended death. Autopsy results pending (inconclusive 2/25/08). 2/26/08 Reviewed pcp medical records & vax records which reveal patient received HPV#1 0469U 7/16/07 & HPV#2 09300 9/17/07. In 11/20/07, noted to have left sided head pain intermittently along with lightheadedness; dx w/tension HA. HPV#3 was scheduled for 1/16/2008 but postponed due to no parental signature. Returned to office 1/24/08 for left wrist pain from cheerleading injury s/p ER vs for same on 1/19/08. Patient last seen in office by nurse only on 2/20 for HPV #3, no notes for visit. PMH: kicked in face by horse in past (undated) & had contusion on cheek; acne vulgaris, started Yasmin & topicals 4/07 w/improvement after multiple other drug failures; 1/19/08 wrist contusion from cheerleading. 5/2/08 Autopsy report states COD as undetermined. Autopsy states patient had intermittent HAs x 2 mo & had been on BCP x 1 year for acne. Found w/small facial laceration from striking flower pot when fell. The autopsy was neg for all findings. Scene indicated sudden death from collapse & fall. Suspected long QT interval syndrome w/fatal arrhythmia rather than new onset seizure in patient w/no history of either. Suggested testing family members.


VAERS ID: 305832 (history)  
Form: Version 1.0  
Age: 0.1  
Sex: Male  
Location: Idaho  
Vaccinated:2008-01-17
Onset:2008-01-18
   Days after vaccination:1
Submitted: 2008-01-23
   Days after onset:5
Entered: 2008-02-27
   Days after submission:35
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B132AA / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B54015D / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1244U / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-01-18
   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: Synagis; Caffeine
Current Illness: No
Preexisting Conditions: Premi 32wks / H/O Apnea 3/28/08-autopsy report received-3/28/08-autopsy report received-comment:born premature at estimate 32 weeks gestation. Dichorionic twin, had some respiratory problems at birth requiring hospitalization and intubation. Left epididymis cyst.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ID08007

Write-up: Pt died within 24 hours of immunizations 3/28/08-autopsy report received cause of death:sudden unexpected infant death. 3/28/08-autopsy report received-COD: Sudden unexpected infant death.


VAERS ID: 306057 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Female  
Location: South Carolina  
Vaccinated:2005-02-28
Onset:0000-00-00
Submitted: 2008-02-28
Entered: 2008-02-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21A008BA / UNK LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE390AA / UNK RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A79659F / UNK RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-03-02
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: scalp seborrhea
Preexisting Conditions: scalp seborrhea
Allergies:
Diagnostic Lab Data: Autopsy
CDC Split Type:

Write-up: Sudden infant death syndrome occurred on 3-2-05. Immunizations were given on 2-28-05. 2/29/08 Autopsy report states COD & manner of death as Undetermined. Reviewed autopsy report which states patient had been fed & placed in crib on back. Found approx 12 hrs later, on stomach at other end of crib, face to the side. Unable to resuscitate w/CPR at scene & in ER. Fire department did carbon monoxide testing of residence which was neg.


VAERS ID: 306062 (history)  
Form: Version 1.0  
Age: 0.38  
Sex: Male  
Location: Colorado  
Vaccinated:2008-01-30
Onset:0000-00-00
Submitted: 2008-02-28
Entered: 2008-02-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B129AA / 2 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0077U / 2 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B70143B / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1128U / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-02-06
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: Death 2/6/08. 3/18/08 Reviewed autopsy report which states COD as SIDS. Autopsy states patient found face down atop baby blankets on floor. Autopsy findings insufficient to explain death. PMH: viral URI 1/2008. No other recent illlness or sick contacts. Birth history unremarkable.


VAERS ID: 306238 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: California  
Vaccinated:2007-07-31
Onset:2007-09-19
   Days after vaccination:50
Submitted: 2008-02-29
   Days after onset:163
Entered: 2008-03-03
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2605AA / 1 RL / UN
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB341AA / 1 LL / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF104AA / 1 RL / UN
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Z05272 / 1 LL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08692D / 1 LL / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-09-19
   Days after onset: 0
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: [therapy unspecified]
Current Illness: Teething
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: diagnostic laboratory specifics unknown
CDC Split Type: WAES0802USA04488

Write-up: Information has been received from a consumer concerning her 17 week old grandson, who in July 2007, was vaccinated with PedvaxHIB (Lot# "VFIG4AA"). Concomitant suspect vaccination included Comvax. Other concomitant therapies included "five unspecified vaccinations and teething pills." The patient sought unspecified medical attention. Laboratory diagnostics were performed, however the specific were unknown. On 19-SEP-2007 the patient died. The cause of death was unspecified. No product quality complaint was involved. Additional information has been requested. 5/13 Autopsy report state COD as anoxic encephalopathy due to interrupted SIDS. Report states patient found pulseless & apneic followed by successful parental CPR; hospitalized 9/16-9/19/2007 w/supportive care & developed seizures & condition deteriorated; diffuse anoxic encephalopathy; scene & circumstances c/w interrupted SIDS.


VAERS ID: 306283 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Female  
Location: Arizona  
Vaccinated:2008-02-19
Onset:2008-02-21
   Days after vaccination:2
Submitted: 2008-03-03
   Days after onset:11
Entered: 2008-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1382U / 2 UN / SC
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. 1413U / 2 LA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-02-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Coumadin; lisinopril; Digoxin; cholesterol; CRT
Current Illness: Sinusitis. 4/30/2008 Most recent H&P received for DOS 2/19/2008 with DX:Sinusitis, ST (sore throat?), Congestion. Pt presented with hx of a cold which got worse. Pt c/o sinus pain and pressure as well as facial pain. Requested Shingles vax and Pneumovax. PE (+) for reddened turbinates and pharynx and enlarged nodes. Txd with Nasonex& Z-pack.
Preexisting Conditions: Heart valve disease; HTN; increased chol. PMH: Seen by cardiologist 2 months prior. "All good with valves". 5/07/2008 MR received from most recent cardiac eval done 1/31/2008. PMH: Mitral Valve repair 1991, hypertension, chronic atrial fibrillation and hyperlipidemia. Labs and Diagnostics: ECG (+) for A fib and occ PVC. Echo (+) for biatrial enlargement, R ventricular enlargement, EF 45%. Abd US (+) atherosclerotic abdominal aorta, no aneurysmal dilitation. CBC with platelets 105, otherwise WNL. Lipid panel WNL. CMP unremarkable. Impression: As per PMH.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt died in her sleep 48 hrs after receiving vaccinations. I do not think related but close time frame with vaccination. We just wanted to inform you (and family). Autopsy pending. Final COD: Mitral Valve Disease. (no autopsy done).


VAERS ID: 306386 (history)  
Form: Version 1.0  
Age: 0.36  
Sex: Male  
Location: Colorado  
Vaccinated:2008-02-22
Onset:2008-03-01
   Days after vaccination:8
Submitted: 2008-03-04
   Days after onset:3
Entered: 2008-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B132CA / 2 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. UF224AA / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B54015H / 2 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1244U / 2 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Constipation, Diarrhoea, Erythema, Gastrointestinal haemorrhage, Hyperhidrosis, Hypersomnia, Injection site erythema, Muscle rigidity, Opisthotonus, Pyrexia, Screaming, Thymus enlargement
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (narrow), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Dystonia (narrow), Parkinson-like events (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Depression (excl suicide and self injury) (broad), Neonatal disorders (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: death~DTaP + HepB + IPV (Pediarix)~1~0.30~Patient
Other Medications: Tylenol
Current Illness: none
Preexisting Conditions: none BIRTH Hx: NSVD at term w/o complication. Patient & parent positive for THC at birth. Salmonella at 1 mo. Stomach flu w/vomiting, diarrhea & fever 2/12/08 lasting 3-5 days.
Allergies:
Diagnostic Lab Data: swollen and red thymus others still pending
CDC Split Type:

Write-up: Shrill screaming, arched back, fever, excessive sleeping, rigid, cried when touched, red where shots were administered, sweating, constipation/diarrhea resulting in bowel area bleeding all resulting in death. 3/13/08 PCP medical records reviewed which reveal patient subjected to second hand smoke. 1/31/08 vs had nasal congestion, irritability, cough, red throat. No treatment Rx. Returned to office 2/12 w/vomiting, diarrhea, fever, diet refusal. Dx: dehydration & tx w/fluids & antipyretics. Returned to office 2/22/08, found to be healthy & vaccines given. 4/4 Autopsy report states COD as SIDS & manner of death as natural. Report reveals parent was smoker. Patient lived w/single parent & dog. Patient placed in crib in own bedroom on side w/swaddling blanket. Found face down in center of crib, cyanotic & limp w/very small amount of pink tinged sputum 3 hrs later. Ambulance to ER momentarily got vitals but resuscitation ultimately unsuccessful. Investigative notes from PCP indicate patient had period of brief screaming w/rigidity followed by listlessness & lethargy 24-48 hrs after shots.


VAERS ID: 306548 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Missouri  
Vaccinated:2007-10-24
Onset:0000-00-00
Submitted: 2008-03-05
Entered: 2008-03-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B128AB / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF184AA / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08700D / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1152U / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-27
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 PMH: FT previously health infant
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0802USA05956

Write-up: Information has been received from a physician concerning a 2 month old male with no drug allergies who was vaccinated PO with his first 2.0 ml dose of ROTATEQ (no lot# available). Suspect vaccination administered on the same day included a dose of Hib conj vaccine (OMPC) (manufacturer unknown). Concomitant vaccinations administered the same day included a dose of PEDIARIX and a dose of PREVNAR. Three days after vaccination, the patient died (specific date of death unknown). The cause of death was sudden death syndrome. There was no product quality complaint. Additional information has been requested. 4/18 Spoke w/physician who provided corrected patient name, DOB, DOD, date of vaccination & ME contact #. States prelim COD is SIDS. 8/5/08 Autopsy states COD as sudden unexpected death by suffocation & manner of death as accident. Patient found in crib face down w/mouth & nose in full contact w/bedding lying in ''pool'' of blood tinged emesis not breathing. CPR started & EMS responded. Arrived in ER in full arrest & unable to be resuscitated.


VAERS ID: 306563 (history)  
Form: Version 1.0  
Age: 46.0  
Sex: Male  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-03-03
Entered: 2008-03-06
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TTOX: TETANUS TOXOID (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had a history of hepatitis C. The patient had received tetanus vaccination for a "cut."
Allergies:
Diagnostic Lab Data: Relevant diagnostic testing was unknown.
CDC Split Type: 200800633

Write-up: Initial report received on 03 March 2008 from another manufacturer, report number MCN54683. The initial reporter to this manufacturer was a health care professional. "This spontaneous case was received via a company representative, reported by a physician and concerns a 46 year old male patient who had an unexplained death after taking Peg-Interferon Alfa 2A (Pegasys), Ribavirin (manufacturer unknown) for hepatitis C and tetanus vaccine as a prophylaxis. On an unknown date, the patient commenced treatment with Peg-Interferon Alfa 2A and Ribavirin. About a week back, the patient cut himself and went to the hospital. He was administered a tetanus vaccine. The patient died shortly after that due to unknown reason. No further information was available. "


VAERS ID: 306734 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Male  
Location: Idaho  
Vaccinated:2007-12-31
Onset:2008-01-08
   Days after vaccination:8
Submitted: 2008-03-05
   Days after onset:57
Entered: 2008-03-10
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2382BA / UNK LA / UN
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2771AA / UNK RA / UN

Administered by: Private       Purchased by: Private
Symptoms: Alanine aminotransferase normal, Albumin globulin ratio normal, Aspartate aminotransferase normal, Blood alkaline phosphatase normal, Blood bilirubin, Blood creatine phosphokinase normal, Cardiac arrest, Globulin, Hypertrophic cardiomyopathy, Inappropriate schedule of drug administration, Myoglobin blood increased, Sudden death, Troponin, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Cardiomyopathy (narrow), Respiratory failure (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-01-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None PMH: sibling w/VSD repair. PE tubes @3yo.
Allergies:
Diagnostic Lab Data: Globulin 2.3 1.8-3.5 g/dl; ALB/Glob ratio 1.4 1.0-2.7 ratio; Bilirubin, TOT 0.2 <2.0 mg/dl; ALT 21 5-50 u/L; ALK Phos 144 103-429 u/L; AST 30 14-40 u/L; CK, TOT 161 25-287 u/L; Myoglobin 147 (high) LT 65 ng/ml; Troponin-T <0.01 0.00-0.10 ng/ml. LABS: in ER, venous pH 6.94 (L), CO2 16 (L), serum myoglobin 147 (H), anion gap 23 (H), glucose 278 (H), total protein 5.7 (L), albumin 3.3 (L).
CDC Split Type:

Write-up: Sudden death on school playground. 3/11/08 Reviewed medical records that accompanied autopsy report which reveal patient who appeared large for his age was involved in after school snow ball fight w/friends then ran across street approx 50 yards to parent''s vehicle & collapsed over the car. Parent & other bystanders witnessed event & called 911. Parent told ER patient was gurgling, color drained from face & eyes glassed over. Transported to ER where resuscitation unsuccessful. 3/25/08 Reviewed pcp medical records of 12/31/07. Only complaint was of slight pain right knee s/p bike crash. Pt wt 148 lbs, ht 63.5 in, BMI 25.8. BP 100/60. Vax record supplies lot #. Family hx: parent w/HTN.


VAERS ID: 306817 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Male  
Location: Illinois  
Vaccinated:2008-02-23
Onset:2008-02-27
   Days after vaccination:4
Submitted: 2008-03-03
   Days after onset:5
Entered: 2008-03-11
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0808U / 1 LL / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1491U / 1 RL / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-02-27
   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: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None Performed. Labs: Microscopic exam (+) for foci of neutrophils and eosinophils in walls of bronchi and scattered neutrophils in peribronchiolar alveoli; congestion. Otherwise NPC. Blood cx (+) for Enterobacter aerogenes, Enterobacter cloacae, Staph aureus, and Virididans streptococcus group. Blood glucose 132. Creatinine 0.0. K+ 16.0. Cl- 116
CDC Split Type:

Write-up: On 2/23/08 child received MMR and Varicella vaccinations during routine one year check up. No adverse events reported to physician prior to death on 2/27/08. 6/25/2008 Postmortem examination report received. COD-Acute Febrile Illness. DX based on exam: Pale doughy lungs. Bite marks on lower lip. Febrile illness by history. Acute inflammatory cells in walls of bronchi in peribronchial alveoli.


VAERS ID: 306894 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Minnesota  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-03-11
Entered: 2008-03-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: CSF culture positive, Death, Pneumococcal infection, Serology test
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Cochlea implant
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: CSF culture streptococcal pneumoniae serotype 19A; Reported Cause of Death Pneumococcal infection, pneumococcal disease
CDC Split Type: USWYEH02953708

Write-up: Information regarding Prevnar was received from a Physician regarding a female patient who experienced pneumococcal disease. The patient received a dose on an unspecified date. The patient''s concurrent illness includes cochlea implant (had not received Pneumovax). Concomitant medications were not reported. On an unspecified date, the patient experienced pneumococcal disease and died. The cause of death was reported as pneumococcal infection. CSF culture (results: Streptococcal pneumoniae serotype 19A) was done on an unspecified date. No additional information was available at the time of this report.


VAERS ID: 306983 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: North Carolina  
Vaccinated:2007-11-14
Onset:2007-11-20
   Days after vaccination:6
Submitted: 2007-11-21
   Days after onset:1
Entered: 2008-03-13
   Days after submission:112
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B127AA / 1 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0259U / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B087008 / 1 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Blood ethanol normal
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-11-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Neg for ethanol
CDC Split Type:

Write-up: Arrived @ ER in cardiac arrest @ 6pm apparently choked while being fed. Autopsy Dx = SIDS. 3/17/08-Autopsy report received-COD-Sudden Infant Death Syndrome. Apparently had been healthy. Parent had been lying on bed with child feeding it with a bottle when both he and the child apparently went to sleep. The 4 year old sibling noticed child was face down in crook of parent''s arm and turned the child and woke father. Autopsy revealed a normally developed and well cared for appearing child, no evidence of injury, no congential or acquired condition that might explain her death was found. The circumstances raise the possibilty of accidental asphyxia but it does not appear from account available that in the position described the child''s breathing would necessarily be compromised.


VAERS ID: 307009 (history)  
Form: Version 1.0  
Age: 6.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2008-02-27
Onset:2008-02-29
   Days after vaccination:2
Submitted: 2008-03-13
   Days after onset:12
Entered: 2008-03-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB200B / 1 RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1472U / 2 LA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chest X-ray abnormal, Death, Laboratory test abnormal, Mental status changes, Respiratory distress, Viral test positive, Virus culture positive
SMQs:, Anaphylactic reaction (broad), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-03-02
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations: swollen lips~Influenza (Seasonal) (Fluzone)~~0.00~In Patient
Other Medications: Aspirin, Gabapentin, Amoxicillin, Albuterol, Clonazepam and Prevacid
Current Illness: None - Patient has multiple chronic medical issues but was well appearing at time of clinic visit.
Preexisting Conditions: Congenital Heart Disease, Cerbral Palsy, Asplenia PMH: situs invernus; profound developmental delay; cerebral palsy from chronic ischemia; Hypotonia; failure to thrive; non-verbal; GERD; oral motor function; sleep dysfunction. Allergies: apples, milk, strawberries, benadryl, reglan. PMH: heterotaxy syndrome; dextrocardia; single ventricle physiology; asplenia; s/p Fontan completion 2004. G-tube fed & w/c bound. 2006 records reveal patient w/G-tube for several years. Recurrent pneumonias. -Allergic reactions to beef broth & flu vaccine.
Allergies:
Diagnostic Lab Data: Viral studies and Chest xray showed left lower lobe pneumonia LABS: rapid test for influenza B (+). Initial WBC 3,000 & chemistry WNL. CT of brain w/severe cerebral edema & transtentorial herniation. LABS: CXR LLL pneumonia.
CDC Split Type:

Write-up: Patient received Hepatitis A and Varicella vaccines 2 days prior to presenting to the ED with respiratory distress and mental status changes. The patient died 3 days later from influenza B. There is no indication that the vaccines this patient received or any other vaccine could have had any relationship to the outcome, or is there any reason to believe from the history that anything other than the influenza and the patients underlying medical condition (Congential Heart Disease, Asplenia, CP) were related to the death. However, we report all incidents of patients with a serious adverse event temporarily related to vaccine administration, whether or not there is a relationship. 6/2/08 Reviewed hospital discharge/death summary for 2/29-3/2/2008, FINAL DX: overwhelming influenza B sepsis & encephalopathy Records reveal patient experienced labored breathing, altered mental status x 1 day; coughing, rhinorrhea & fever x 2 days. Seen by PCP & dx w/viral illness. Conditioned worsened & became unresponsive at home. Taken to ER by EMT with oxygen saturation 70''s (baseline high 80''s). In ER, noted to have frothy sputum. Tx w/CPAP & nebs. Improved & became responsive. Then after another episode of bradycardia & hypotension, became unreponsive again. Felt to be having sub-clinical seizures. Admitted to PICU, intubated & coded several times. On multiple pressors w/fixed & dilated pupils. Family requested no further resuscitation efforts. ME declined case & family declined autopsy. 6/3/08 Reviewed medical records for 2006 & additional medical records for 2008. Records for 2/15-3/2/2008 reveal patient in usual state of health on day of vaccination. Seen by PCP 2/29 w/fever 103.3 for 1-2 days; had not received flu shot due to prior facial swelling w/flu vaccine in 2006. Dx w/viral illness. Seen in ER later same day for cough, rhinorrhea & fever x 2 days & increased respiratory effort becoming unresponsive. Admitted to PICU w/influenza w/pneumonia; respiratory failure; & congenital heart disease. Neuro & cardio consults done.


VAERS ID: 307156 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Connecticut  
Vaccinated:2008-02-09
Onset:2008-02-25
   Days after vaccination:16
Submitted: 2008-03-11
   Days after onset:14
Entered: 2008-03-17
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B125CB / 1 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0498U / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B540134 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0902U / 1 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Apnoea, Autopsy, Death, Epistaxis, Haemorrhage, Petechiae, Pulse absent, Resuscitation
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-02-25
   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: Synagis; TriViSol Vitamins
Current Illness: None - healthy and thriving
Preexisting Conditions: Former 32 week preemie (she was co-sleeping with mom at time of cardio-pulmonary failure) 4/18/08-autopsy report received-history of co-sleeping with an adult.
Allergies:
Diagnostic Lab Data: Medical Examiner autopsy - report pending - by verbal report - "petechial hemorrhages" and blood in nose
CDC Split Type:

Write-up: On 2/25/08 infant breastfed well at 3 AM. At approximately 6 AM 2/25/08 infant was found with blood in nose, apneic and pulseless; 911 called, fail resuscitation attempted. Infant was declared dead at hospital ED after failed attempt to revive her. She was a former 32 week preemie who slept in same bed with parents. 4/18/08-autopsy report received: Cause of Death:Sudden unexplained infant death in infancy.


VAERS ID: 307157 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Arkansas  
Vaccinated:2008-01-03
Onset:2008-02-14
   Days after vaccination:42
Submitted: 2008-03-14
   Days after onset:28
Entered: 2008-03-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B127AA / 2 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. UF196AA / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B54015L / 2 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0669U / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-02-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: unknown
Preexisting Conditions: unknown
Allergies:
Diagnostic Lab Data: None available. Autopsy pending.
CDC Split Type:

Write-up: Infant reported in paper as deceased. No contact with parents. PHN who gave vaccine had remembered that infant died and had received immunizations from local health unit on 010308. This was triggered by report of another infant in same county who dies at 3 mo. of age and was given same vaccines but with different lot #s of some vaccines.


VAERS ID: 307158 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Arkansas  
Vaccinated:2008-02-20
Onset:2008-02-26
   Days after vaccination:6
Submitted: 2008-03-14
   Days after onset:16
Entered: 2008-03-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B126AA / UNK RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. UF196AA / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B54015C / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1620U / 1 MO / PO

Administered by: Public       Purchased by: Public
Symptoms: Death, Diarrhoea, Vomiting projectile
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-03-12
   Days after onset: 14
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: "fussy" for a few days
Preexisting Conditions: unknown
Allergies:
Diagnostic Lab Data: Deceased - unknown
CDC Split Type:

Write-up: 1st series of vaccines given 022008. T. Call from mother 022608 states in faint having "projectile vomiting and severe diarrhea." PHN called CDNS who rec. infant see private MD STAT and report to nurse outcome. 022708 call from infant''s mother states "her pediatrician told her that"vomiting not due to Rotavirus." That it is OK to give at 4 months old. 031308 Mom called to say baby dies lat PM. Mom states "she was just fussy the past few days."


VAERS ID: 307188 (history)  
Form: Version 1.0  
Age: 0.21  
Sex: Male  
Location: Texas  
Vaccinated:2008-03-03
Onset:2008-03-05
   Days after vaccination:2
Submitted: 2008-03-17
   Days after onset:11
Entered: 2008-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B141AA / 1 RL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR 6F231AA / 1 LL / UN
PPV: PNEUMO (PNU-IMUNE) / PFIZER/WYETH B97283A / 1 LL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1664U / 1 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Death, Hyperventilation, Irritability, Resuscitation, Somnolence
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-03-05
   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: HUMIDIFIER, OCEAN SPRAY NASAL MIST
Current Illness: Patient had a stuffy nose that caused him to have trouble breathing through his nose in the evenings. He was taken to the doctor on several occasions because of this. We were worried he could possibly have a cold or the flu or maybe a sinus infection.
Preexisting Conditions: Patient experienced some grunting after birth. The hospital performed blood tests on him and checked his lungs for any abnormalities. All results were negative for any infections.
Allergies:
Diagnostic Lab Data: An autopsy is currently being done to find out the cause of death. 6/3/08-records received: cause of death-Sudden Infant Death Syndrome. Natural causes.
CDC Split Type:

Write-up: Patient was given the following vaccines: Hep B, HIB, Rotateq, DT/DTAP, IPV, Pneumococcal Conj. on Monday March 3rd, 2008 around 1:45pm. He was fussy after and was given Tylenol at the dr''s instructions and slept most of Monday evening other than waking to eat. Tuesday he was still taking deap breaths as if he just finished crying and was very quiet. Although I still was able to have him coo with me he was very calm and relaxed. Monday morning I got him ready for daycare and dropped him off around 7:30 along with his sister and received a phone call at 4:45 that my baby was lot breathing. Daycare performed CPR until the EMS arrived, then the EMS took over and transferred him to the hospital. At the hospital they tried to revive him for an hour and had to pronounce him dead. 3/31/08-records received from ED for DOS 3/5/08-Presented in cardiopulmonary arrest. Found nonresponsive at daycare. Intubated. No blood pressure, no pulse, asystolic pulse. Patient expired. DX: Cardiopulmonary arrest.


VAERS ID: 307394 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: California  
Vaccinated:2007-03-01
Onset:2007-05-25
   Days after vaccination:85
Submitted: 2008-03-19
   Days after onset:299
Entered: 2008-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0187U / 3 - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Amyotrophic lateral sclerosis, Electromyogram abnormal, Lumbar puncture, Muscular weakness, Nerve conduction studies abnormal, Neuropathy, Nuclear magnetic resonance imaging, Paralysis flaccid, Respiratory failure, Sleep study abnormal, Swelling, Urinary incontinence, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (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), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2009-03-15
   Days after onset: 660
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 24 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none 4/8/08-recor ds received-PMH: attention deficit hyperactivity disorder and congenital strabismus. Migraines. Cognitive delay, developmental delay and motor delay. Allergies:strawberries cause an itch. In May sustained injury with pain in leg which improved but never returned completely to normal. 4/16/08-records received-PMH: Pityriasis lichennoides. Allergy to strawberries causes itching. Attention deficit disorder.
Allergies:
Diagnostic Lab Data: EMG and nerve conduction studies suggest motor neuronopathy vs neuropathy 4/8/09-records received- EEG normal. MRI brain showed slightly prominent cerebellar fissures but otherwise normal. MRI spine normal. West Nile, hepatitis B were negative. Urine organic acids elevated lactic acid. T4 and TSH normal. Heavy metal screen normal. Acylcarnitine profile normal. CSF protein elevated 54, lymphocytes 86 and monocytoid cells 14. CSF amino acids showed nonspecific variations from normal of serine, alanine, citrulline, valine, methionine, beta aminoisobutyric acid, lysine and histidine. triglycerides 429. December 2007 EMG and nerve conduction studies with dignosis of multifocal motor neuropathy. MRI at that time showed nerve root enhancement. 4/16/08-records received-EEG normal. MRI brain and spine normal. Elevated lactic acid level in urine. Sleep study mild obstructive sleep apnea syndrome with one episode of hypoxemia without hypoventilation worse in REM sleep and supine. MRI of lumbar spine mild enhancement of lumbar nerve roots however this was done after a lumbar puncture and findings may be secondary to lumbar puncture. 4/16/08-CPK increased of 313 and slightly elevated anticardiolipin IgM of 20.3. EEG normal. MRI brain and spine normal. Elevated lactic acid level in urine. LP: mildly elevated protein of 46 with normal glucose. MRI of lumbar spine mild enhancement of lumbar nerve roots however this was done after a lumbar puncture and findings may be secondary to lumbar puncture.
CDC Split Type:

Write-up: Progressive muscle weakness resulting in flaccid paresis of all 4 extremities, respiratory insufficiency. 4/8/08-records received for DOS 2/4-2/17/08-DC DX: autoimmune motor neuropathy, provisional. Possible motor neuron disease. Admission 3/14-3/25/08-DC DX: Muscular weakness. Seizures. Received IVIG, treated with plasmapheresis. Admitted with C/O progressive muscular weakness over the 3 weeks prior to admission increased immunomodulation. Seizure after completion of solumedrol. Remained post ictal for several hours. No diagnosis made during this admission. Genetic evaluation for mitrochondrial disease sent to include evaluation for Pompe disease. In May sustained injury with pain in leg which improved but never returned completely to normal. Developed worsening limping and loss of strength in distal left lower extremity. Between August and October of 2007 developed symptoms in right arm. Received IVIG at that time and again January 2008 with improvement in right handed tremor but worsening function status especially in ambulation, stair climbing and standing from seated position. Feb 4-17 2008 hospitalized received plasmapheresis with improved ability to stand for short periods. C/O headaches and nausea. She may have chronic inflammatory demyelinating myopathy versus a multifocal motor neuropathy. After discharge to follow up with specialist in ALS. 4/16/08-records received-for DOS 1/2-1/3/08-DC DX: Multifocal neuropathy versus chronic demyelinating polyneuropathy. LP: mildly elevated protein of 46 with normal glucose. Unable to perform activities of daily living. IVIG treatment. PE: left lower and right upper extremity weakness and atrophy with some mild weakness of right lower extremity. 4/16/08-clinical consult case review template received: CPK increased of 313 and slightly elevated anticardiolipin IgM of 20.3. DX: chronic inflammatory demyelinating polyneuropathy. 1/2/08-urinary incontinence may have been due to her reduced ability to mobilize given her leg weakness. Plasmapheresis. 3/14/08-admitted for progressively worsening weakness and increased immunomodulation. During treatment with IV Solu-Medrol, one seizure and was post-ictal for several hours. Shortness of breath with vital capacity of 48%. Restrictive and obstructive component to her lung involvement. 4/5/08-DX: primary muscular atrophy the syndrome of progressive lower motor neuron loss. Third seizure during sleep study. Currently on a trial of Cytoxan. Impression: ten month history of progressive muscular weakness with lower motor neuron signs and status post multiple different trials of immunosuppressant medications. 4/16/08-records received-for DOS 1/2-1/3/08-DC DX: Multifocal neuropathy versus chronic demyelinating polyneuropathy.Unable to perform activities of daily living. IVIG treatment. PE: left lower and right upper extremity weakness and atrophy with some mild weakness of right lower extremity. 6/17/09 Autopsy report received from CDC - DOS 3/17/09 Clinical Diagnosis: Atypical progressive lower motor neuron disease, ventilator dependence, gastrostomy tube, hypercalcemia, seizures. I. Extensive demyelination, involving the lateral and anterior columns of the cervical, thoracic and lumbar spinal cord, with macrophage and lymphocytic infiltration. Severe loss of motor neurons, cervical, thoracic, and lumbar spinal cord. Rare neurons with amorphous cytoplasmic inclusions, frontal cortex, substantia nigra, locus ceruleus, medulla oblongata, and spinal cord. Neurogenic atropy, skeletal muscle. II. Acute brochopneumonia, lungs. III. Mild steatosis, liver. IV. Gastrostomy tube, stomach, in proper position. Follow-up: Paralysis - involving 4 extremities trunk and possibly the diaphragm given that her FVC = 27%. She also has significant persistent nausea / vomiting, intermittent abdominal pain, and extremity swelling. Her condition continues to deteriorate and now she is on BIPAP.


VAERS ID: 307764 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Male  
Location: California  
Vaccinated:2008-03-10
Onset:2008-03-11
   Days after vaccination:1
Submitted: 2008-03-22
   Days after onset:11
Entered: 2008-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2800AA / 2 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF233AA / 2 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR A0298 / 2 LA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B70145E / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0110X / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-03-11
   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: Tylenol
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Medical examiner identified cause of death as SIDS (verbal report to me).
CDC Split Type:

Write-up: Patient died of Sudden Infant Death Syndrome the day after receiving DTaP, IPV, HIB, PCV7 and Rotateq. 6/13/08 Autopsy report states COD as SIDS. Report also states slight pulmonary edema & petechial hemorrhages on thymus gland, pericardium of heart & pleurae of lungs. Patient had been placed down for nap on his left side in adult bed at daycare provider. Patient found face down & unresponsive approx 45-50 min later. CPR was started & EMS called. PMH: NSVD, no complications. Upper respiratory congestion frequently since birth & seen for cold s/s by PCP on 3/3. Otitis media 2/1 & had mild wheezing. Sibling w/recent cold symptoms. Had to be picked up early from daycare x2 the week before death due to vomiting.


VAERS ID: 308149 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: New Hampshire  
Vaccinated:2008-03-13
Onset:2008-03-14
   Days after vaccination:1
Submitted: 2008-03-20
   Days after onset:6
Entered: 2008-03-25
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B142AJ / 2 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF345AC / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C57536 / 1 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-03-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: State exam - pending
CDC Split Type: NH08

Write-up: Our office was informed 3/14/08 of patients demise - no side effects in office. 5/15/08-records received-Cause of death:Sudden Infant Death Syndrome (SIDS). Manner of death:natural.


VAERS ID: 308500 (history)  
Form: Version 1.0  
Age: 0.37  
Sex: Female  
Location: Massachusetts  
Vaccinated:2005-05-04
Onset:2005-05-04
   Days after vaccination:0
Submitted: 2008-03-28
   Days after onset:1059
Entered: 2008-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR APU1348DA / UNK UN / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE429AA / UNK UN / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR APX1240-2 / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A67186B / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Convulsion, Myoclonus
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-12-02
   Days after onset: 1308
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 180 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: none at the time of vaccinations.
Current Illness: myoclonic jerks
Preexisting Conditions: bilateral sensory hearing loss. PMH: Sensorineural hearing loss, normal development prior to 1st admission. Recent episode of vomiting, loose stools. Family hx of siezure in a paternal 2nd cousin.
Allergies:
Diagnostic Lab Data: Continual testing done over the next 6 months. Labs and Diagnostics: EEGs initially normal then abnormal by 5/2005. Echo (+) for hypertrophic cardiomyopathy. Brain MRI and CT normal. Swallow study failed. Mitochondrial sequencing showed no abnormalities. Muscle and skin bxs showed abnormally shaped and abnormal # of mitochondria which did not corrolate with known disorder. Beta-hydroxybutyric acid (H) at 24.5.
CDC Split Type:

Write-up: Patient stated having myoclonic jerks on 3/28/05. After her 4 month vaccinations, she had uncontrolable seizures that resulted in hospitalization for about six months. She has had numerous testing done at Hospital and results have remained, no known cause. 4/30/2008 MR received for $g10 admissions from 3/29/2005 to 3/09/2008. Initially admitted 3/29/2005 in status epilepticus, progressive in nature since 2pm. Episode started with arm and leg twitching, which progressed to myoclonic jerking of upper and lower extremities with LOC. Admitted multiple times subsequent to this even with DX: Myoclonus for DOS 4/10-22/05. Pt developed refractory seizures of multiple types including generalized tonic-clonic seizures, complex partial seizures as well as myoclonic jerks, eye deviations. Frequent admissions for increased seizures as well as various infections (Candida, Mycobacterium, C.diff). Developmental delay noted by 5/2005 with regression. Hypertrophic cardiomyopathy dxd 6/2005. Suspect metabolic or mitochondrial disorder. G-tube placed after failed swallow study. Ketogenic diet started 2007 with good control of seizure. Poor muscle tone and head control. Assessment 3/11/08 Status epilepticus, Global Developmental Delay, Possible mitochondrial disorder. 4/17/09 F/u received reporting pt''s death in December 2008. 5/14/09 Genetics note recd dated 11/20/08 for eval of genetic testing done. W/U (-) for known disorders. Most likely a mitochondrial d/o, unproven. 6/24/09 Verbal report from ME''s office with COD -hypoxic ischemic encephalopathy complicating probable viral myocarditis in a child with developmental disorder of uncertain etiology. manner of death natural. 8/3/09 Autopsy report received with above COD. Final Dx: Lymphocytic Myocarditis with hypoxic/ischemic encephalopathy. Chronic Bronchopneumonia. Blunt impact injury of the torso-contusion of back. Follow-up: seizures, developmental delay - severe.


VAERS ID: 308577 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-03-28
Entered: 2008-03-31
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Lymphohistiocytosis
SMQs:, Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Death~Varicella (Varivax)~UN~0.00~In Sibling|Lymphohistiocytosis~Varicella (Varivax)~UN~0.00~In Sibling
Other Medications: unknown
Current Illness: Immunodeficiency
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: unknown
CDC Split Type: WAES0803USA04484

Write-up: It was reported in a published article that a patient was vaccinated with a dose of VARIVAX (Oka/Merck). After vaccination, the patient died after receiving a diagnosis of familial hemophagocytic lymphohistiocytosis. It was reported that the patient''s younger sibling died after vaccination with VARIVAX (Oka/Merck) (WAES # 0803USA04454). The article also discussed the experience of two other patients while on therapy with VARIVAX (Oka/Merck) (WAES numbers 0803USA03578 and 0803USA04453). Additional information has been requested. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 308620 (history)  
Form: Version 1.0  
Age: 54.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2007-10-18
Onset:2007-12-01
   Days after vaccination:44
Submitted: 2008-03-27
   Days after onset:116
Entered: 2008-03-31
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFUA05288 / UNK UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Abasia, CSF protein increased, Guillain-Barre syndrome, Hypoaesthesia, Lymphoma, Mechanical ventilation
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Dystonia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (narrow), Demyelination (narrow), Malignant lymphomas (narrow), Respiratory failure (broad), Haematological malignant tumours (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-05-16
   Days after onset: 166
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 30 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: CSF - 153 protein on 2/25/08
CDC Split Type:

Write-up: Patient had influenza vaccine on 10-18-07. Complaints on 1/9/08 of numbness for 1-2 wks in arms/feet. 2/22/08 unable to ambulate. 3/2 Placed on vent. (1/21/08 had malignant lymphoma removed from tonsil). MD diagnosis Guillain barre, 2 lymphoma. 6/24/08 Death certificate states COD as respiratory failure with Guillain-Barre Syndrome & lymphoma. as underlying cause. 6/13/08 Reviewed hospital medical records for 2/23-5/16/2008. FINAL DX: diffuse large B cell lymphoma Records reveal patient experienced paresthesias of hands/feet, sore throat. Had lump on tonsils removed & found to have diffuse large B cell lymphoma. Weakness & paresthesias worsened & dx w/GBS. Had very prolonged extensive hospital course complicated by multiple issues: chronic ventilator dependent respiratory failure; tracheostomy; PEG feeding tube; multiple septic episodes; pulmonary embolism; chemotherapy. Condition worsened, developoed MRSA septicemia, became unresponsive. Family requested comfort measures only, patient was extubated & expired 5/16/2008. Patient had cancer and was undergoing chemo and radiation. This was cause of death.


VAERS ID: 308661 (history)  
Form: Version 1.0  
Age: 7.0  
Sex: Male  
Location: Unknown  
Vaccinated:2007-11-19
Onset:2008-02-01
   Days after vaccination:74
Submitted: 2008-04-01
   Days after onset:59
Entered: 2008-04-01
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, Road traffic accident
SMQs:, Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-02-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20080504

Write-up: We received on 12 FEB 2008 from a healthcare professional the following information: A 7-year-old male patient, born on 21 JUN 2000 was vaccinated with FLUVIRIN (batch no. unknown) on 19 NOV 2007. The patient was killed in an automobile traffic accident on 01 FEB 2008. The subject had participated in a clinical trial sponsored by MedImmune. FLUVIRIN was used in that trial as a control, and Novartis Vaccine & Diagnostics (NVD) has donated the FLUVIRIN, but other than that has not been involved. Although the event did not occur during the duration of the trial, and the investigator did not see any causal relationship to the vaccination with FLUVIRIN, he reported the event to the IRB and NVD because the child had died.


VAERS ID: 308662 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-03-31
Entered: 2008-04-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Intensive care, Pneumonia herpes viral, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (narrow), Hypokalaemia (broad), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0803USA03830

Write-up: Information has been received from a literature article regarding an adult with diabetes, who was admitted for varicella-related pneumonitis and died of respiratory failure after 11 days in an ICU. In the opinion of the author, the data demonstrated the sizeable and continuing reduction in severe varicella-related morbidity with the use of the varicella vaccine since 1995. It was also noted that the data highlighted the fact that the majority of hospitalizations that occurred during this time period were preventable through implementation of existing vaccination-policy recommendations. The author noted that varicella incidence and varicella-related hospitalizations (VRHs) and deaths have decreased substantially since the implementation of the varicella vaccination program. A copy of this published article is attached as further documentation of the patient''s experience.


VAERS ID: 308717 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: North Carolina  
Vaccinated:2008-03-17
Onset:2008-03-23
   Days after vaccination:6
Submitted: 2008-03-24
   Days after onset:1
Entered: 2008-04-01
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U2354AA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF240AB / 1 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR A0342 / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C35172 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1598U / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-03-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Prematurity (34 weeks), twin 6/20/08-records received-PMH:twin born at 34 weeks, hyperbilirubinemia. Threee episodes of choking in which stopped breathing and turned blue. This occurred at about 2-3 weeks of age.
Allergies:
Diagnostic Lab Data:
CDC Split Type: NC08041

Write-up: (Less than 1 week after vaccines ) Death 3/23/08 - found dead in crib 3/23/08 AM by mother. Pronounced dead at the scene. Autopsy pending. Unknown if related to vaccines. 6/20/08-records received-final cause of death:Sudden Infant Death Syndrome. 6/20/08-autopsy report:findings included intrathoracic petechiae, umbilical hernia, tibial subperiosteal new bone formation and right hydrocele.


VAERS ID: 308774 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: New York  
Vaccinated:2008-03-20
Onset:2008-03-25
   Days after vaccination:5
Submitted: 2008-04-02
   Days after onset:8
Entered: 2008-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF241AC / 2 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-03-25
   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: none
Current Illness: none
Preexisting Conditions: Renal dysplasia with concentration defect
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient found cyanotic in crib and dead on 3/25/08 7/10/08-autopsy report received-COD: positional asphyxia. Accident, prone face down positiong on soft bedding in crib.


VAERS ID: 308828 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-04-01
Entered: 2008-04-03
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autism, 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: WAES0803USA04115

Write-up: Information has been received from a consumer concerning her neighbor''s son who on an unspecified date was vaccinated with a dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3). On an unspecified date, post vaccination, the patient developed autism and eventually jumped in a lake and died. A product quality complaint was not involved. The adverse event autism was considered an Other Medically Important Event (OME). Additional information has been requested. 4/4/08 Received via email from FDA & manufacturer: The reporter is a consumer who reported on a neighbor''s child. The reporter refused to provide information beyond what was on the VAERS form . The reporter refused to provide the name and telephone number of the actual parents of the child. This is unevaluable.


VAERS ID: 309085 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Wisconsin  
Vaccinated:2007-07-01
Onset:2007-07-02
   Days after vaccination:1
Submitted: 2008-01-23
   Days after onset:205
Entered: 2008-04-08
   Days after submission:75
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (FOREIGN) / MERCK & CO. INC. 0608F / 1 LL / UN

Administered by: Private       Purchased by: Other
Symptoms: Ascites, Biopsy bone marrow normal, Biopsy liver normal, Biopsy skin normal, Cardiopulmonary failure, Convulsion, Death, Dyspnoea, Encephalopathy, Endotracheal intubation, General physical health deterioration, Hepatosplenomegaly, Multi-organ failure, Oxygen supplementation, Peritoneal dialysis, Platelet count decreased, Platelet transfusion, Pseudomonal sepsis, Pyrexia, Rash, Renal failure, Thrombocytopenia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (narrow), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2007-08-10
   Days after onset: 39
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None. Prenatal and PMH: Mother (+) for Gestational Diabetes. GBS (+)-treated. Mother had febrile illness/GE 10-14 days prior to delivery.
Allergies:
Diagnostic Lab Data: Lab studies showed on DOL #2 showed a normal CBC and differential. <24 hours after the vaccine, showed severe thrombocytopenia which remained low throughout his hospital course despite twice daily platelet transfusions, etc. Labs and Diagnostics: WBCs 21.5. Platelets 9000 on DOL#3 and remained low. HCT and Hgb low. Chemistry abnormal. BUN 75. LFTs abnormal. Hearing test failed. US of head (-) for intracranial hemorrhage. Abd US (+) for enlarged kidneys with increased echo texture, moderate ascites. EEG abnormal. ECG sinus tach. Chromosomal analysis WNL. Urine organic acids (+).
CDC Split Type:

Write-up: Patient was a term infant who had had an uneventful delivery. He did develop a fever in the first 24 hours of life, was treated with IV antibiotics but blood culture was negative so IV abx were stopped after 48 hours. He was monitored for several days and did well. He was scheduled for discharge and received HepB vaccine 24 hour prior to scheduled discharge. 12 hours after immunization, parents report his fevers returned and he developed a skin rash. He also had difficulty breathing requiring supplemental oxygen by nasal cannula. A few days later, he deteriorated dramatically, required endotracheal intubation and started having seizures. He then became encephalopathic and had cardiopulmonary collapse as well as multi-system organ failure. An EXTENSIVE work up was done. No infectious, endocrinologic, hematologic or neurologic cause was found. He developed massive ascites, hepatosplenomagaly and renal failure requiring peritoneal dialysis. He had skin biopsies, liver biopsies, bone marrow biopsies in addition to an exhaustive amount of blood work for common and rare disorders-all were negative. Patient eventually died at 6 weeks of age from Pseudomonal sepsis. Lab studies showed on DOL #2 showed a normal CBC and differential. <24 hours after the vaccine, showed severe thrombocytopenia which remained low throughout his hospital course despite twice daily platelet transfusions, etc. 4/11/2008 Autopsy report and Case Summary received for DOD 8/10/2007. Term infant developed fever (T=103''F), respiratory distress and irritability at 4 hrs of age. Txd with Acyclovir for presumed viral infection, viral cultures (-). Pt later developed macular rash which resolved. Pt developed fever and increasing respiratory distress ultimately requiring intubation on 7/8/07. Infant became edematous and developed thrombocytopenia and seizures. Transfered to higher level of care. Upon admission pt exibited temperature elevations, twitching, rash, throbocytopenia. Sepsis w/u (-). Pt dx: Bone marrow failure with gram-negative sepsis and renal failure. Deeply purpuric rash noted after admission. 6 wk hospital course was dominated by diffuse edema, respiratory distress, thrombocytopenia and renal failure. ID consult suspect Neonatal Onset Multisystem Inflammatory Disease (NOMID). Autopsy revealed anasarca, Pseudomonas pneumonia, multiple hemorrhagic infarcts of the spleen, hypoplastic bone marrow, cholestatic hepatopathy, and marked thymic involution. Presumed COD: Overwhemling sepsis. Contributing COD: Pancytopenia.


VAERS ID: 309233 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-04-27
Onset:2007-06-22
   Days after vaccination:56
Submitted: 2008-04-09
   Days after onset:292
Entered: 2008-04-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0250U / 2 LA / -
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0384U / 2 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Arrhythmia, Brain death, Brugada syndrome, Convulsion, Death, Electrocardiogram, Electrocardiogram QT prolonged, Headache, Life support, Rash
SMQs:, Torsade de pointes/QT prolongation (narrow), Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Congenital and neonatal arrhythmias (narrow), Conduction defects (narrow), Torsade de pointes, shock-associated conditions (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-06-29
   Days after onset: 7
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: LAMICTAL; KEPPRA; vitamins (unspecified)
Current Illness:
Preexisting Conditions: Convulsion; Arrhythmia
Allergies:
Diagnostic Lab Data: electrocardiogram
CDC Split Type: WAES0804USA00429

Write-up: Information has been received from a consumer concerning her 12 year old daughter with a history of seizures and heart arrhythmias, who on 25-JAN-2007 was vaccinated with a first dose of Gardasil. On 27-APRIL-2007 the patient was vaccinated with a second dose of Gardasil. Concomitant therapy included LAMICTAL, vitamins (unspecified) and KEPPRA. Subsequently, the patient began to have seizures, developed a rash on her arm, and was complaining about headaches. On 22-JUN-2007 the patient experienced a heart arrhythmia and was hospitalized. Due to the arrhythmia the patient was placed on life support and died on 29-JUN-2007. The patient''s mother reported that the patient had an electrocardiogram (EKG) about 5 years ago to test for prolonged QT syndrome. The test came back normal. It was reported that at that time the patient was in and out of the emergency room due to having seizures periodically. The patient had been seeing a neurologist and had not had any seizures for about two years until she received the second dose of Gardasil. The patient''s mother reported after her daughter''s death and burial she had received copies of her daughter''s medical records. Throughout the reports it showed that for the past five years the patient had prolonged QT syndrome, and proguda syndrome "which causes seizures and heart arrythmias." The patient''s cause of death was prolonged QT syndrome, brain death, and proguda syndrome. No product quality complaint was involved. The seizures, rash, headaches, heart arrythmias, prolonged QT syndrome, brain death, and proguda syndrome were considered to be other important medical events. Additional information is not available.


VAERS ID: 309368 (history)  
Form: Version 1.0  
Age: 0.28  
Sex: Female  
Location: Virginia  
Vaccinated:2008-04-07
Onset:2008-04-11
   Days after vaccination:4
Submitted: 2008-04-11
   Days after onset:0
Entered: 2008-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B139AA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF219AA/UF154AA / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C45894 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1195U / 1 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Sudden infant death syndrome, 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), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-04-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NO MEDICATIONS AS OF 04/07/08 WHEN SEEN IN OFFICE FOR 2 MONTH WELL CHILD CHECK
Current Illness: NO NOTED ILLNESS WHEN EXAMINED AT 2 MONTH WELL CHILD CHECK ON 04/07/08
Preexisting Conditions: PREMATURE- 32 WEEK GESTATION DUE TO PLACENTAL ABRUPTION. DIAGNOSIS WHILE IN NICU: RESPIRATORY DISTRESS SYNDROME; HYPOTENSION; INTRAVENTRICULAR HEMORRHAGE GRADE 1; DIFFICULT INTRAVENOUS ACCESS; RULE OUT SEPSIS; HYPERBILIRUBINEMIA- INDIRECT; POSSIBLE MATERNAL DRUG USE; FEEDING INTOLERANCE. DISCHARGED FROM NICU ON 01/14/08 AND FOLLOWED UP IN OFFICE ON 01/16/08 FOR WEIGHT AND FEED CHECK- NOTED TO BE GAINING WEIGHT AND FEEDING WELL. SEEN IN OFFICE ON 02/02/08 FOR RECHECK WEIGHT, CONGESTION- NASAL, SLIGHT COUGH, AND SNEEZING. SEEN IN ER ON 02/02/08 FOR QUESTIONABLE APNEA EPISODE WITH CHOKING. EMS CALLED AND PT TAKEN TO ER FOR EVALUATION. NO S/S OF ILLNESS FOUND AT ER VISIT. WHEN SEEN IN OUR OFFICE ON 02/05/08 DIAGNOSED WITH COMMON COLD AND GASTROESOPHOGEAL REFLUX. THEN NOT SEEN AGAIN UNTIL 04/07/08 WHEN SHE WAS GIVEN A 2 MONTH WELL CHILD CHECK AND IMMUNIZATIONS. SHE WAS FOUND AT THAT VISIT TO BE GAINING AND GROWING WELL AND DEVELOPING NORMALLY FOR ADJUSTED AGE FOR PREMATURITY. PMH; c-section secondary to placental abruption, in hospital x 3 wks for respiratory problems.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: ON 04/07/08, THE 2 MONTH IMMUNIZATIONS OF PEDIARIX, PREVNAR, ACT HIB AND ROTATEQ WERE ADMINISTERED TO THIS PATIENT AT HER CURRENT AGE OF 3 1/2 MONTHS. THERE WERE NO ADVERSE EFFECTS NOTED WHILE IN THE OFFICE. THERE WERE NO PHONE CALLS FROM PARENTS REPORTING PROBLEMS AFTER LEAVING THE OFFICE. MEDICAL EXAMINER CALLED THIS MORNING (04/11/08) TO MAKE DR. AWARE THAT PATIENT HAD BEEN FOUND UNRESPONSIVE ON MORNING OF 4/11/08. RESCUE SQUAD WAS UNABLE TO RESCUSITATE THE INFANT. CASE IS BEING INVESTIGATED BY COUNTY SHERIFF''S OFFICE AND IS MEDICAL EXAMINER''S CASE. AUTOPSY WILL BE DONE. AT PRESENT THE PRESUMED DIAGNOSIS IS SUDDEN INFANT DEATH SYNDROME. 6/27/08 Autopsy states COD as sudden unexplained infant death assoc w/prior sibling death, non-standard bedding & prematurity. Autopsy states no evidence of trauma, disease or congenital anomaly.


VAERS ID: 309426 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: New York  
Vaccinated:2008-04-03
Onset:2008-04-06
   Days after vaccination:3
Submitted: 2008-04-08
   Days after onset:2
Entered: 2008-04-14
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B139AA / 1 LL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF232AD / 1 RL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C45893 / 1 RL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 16640 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-04-06
   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: Twin A
Allergies:
Diagnostic Lab Data: All viral PCR tests (-). Drug screen (-). Mass spec shows no underlying metabolic disorder
CDC Split Type:

Write-up: Unexplained death/SIDS 6/12/2008 Autopsy received with COD Sudden Infant Death Syndrome. Manner of Death: Natural. Neuropathology report DX: Gliosis of the Medullary Nuclei.


VAERS ID: 309427 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Minnesota  
Vaccinated:2008-04-07
Onset:2008-04-08
   Days after vaccination:1
Submitted: 2008-04-08
   Days after onset:0
Entered: 2008-04-14
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B133DA / 2 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF255AB / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C49919 / 2 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0141X / 2 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Autopsy, Cardiac arrest, 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: 2008-04-08
   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: Tylenol given
Current Illness: None
Preexisting Conditions: H/O RSV Bronchiolitis - in 2/2004 - Resolved; GERD
Allergies:
Diagnostic Lab Data: Autopsy - pending from medical examiner
CDC Split Type:

Write-up: Note: Pt had no fever. Next day after immunization - Pt found unresponsive during nap at daycare. Asystolic at daycare - unable to be resuscitated by paramedics nor by ED physician. 5/27 Autopsy report states COD as SIDS. All labs WNL. 4/22/08 Reviewed ER medical records of 4/8/2008. Records reveal patient in cardiopulmonary arrest after being found unresponsive by daycare provider. No bystander CPR provided. EMS found patient in v-fib. No defibrillation, just epi , intubation & intraosseous line. Patient in asystole in ER, temp 95 (R), glucose 111, unresponsive & expired.


VAERS ID: 309447 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Female  
Location: Alabama  
Vaccinated:2007-11-07
Onset:2007-11-13
   Days after vaccination:6
Submitted: 2008-04-14
   Days after onset:152
Entered: 2008-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LA / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood pressure decreased, Chest pain, Dizziness, Headache, Palpitations, Pharyngeal oedema, Restlessness, Stomach discomfort
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Akathisia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Oropharyngeal allergic conditions (narrow), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-12-06
   Days after onset: 23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Death~Influenza (Seasonal) (no brand name)~~76.30~Patient
Other Medications:
Current Illness: COPD/Emphysema
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Palpitations, restlessness, stomach discomfort pharyngeal edema, headache, dizziness, chest pain, decreased blood pressure. 7/28/08-death certificate received; COD:respiratory failure. Chronic obstructive pulmonary disease.


VAERS ID: 309495 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Unknown  
Vaccinated:1994-12-21
Onset:1994-12-21
   Days after vaccination:0
Submitted: 2008-04-14
   Days after onset:4862
Entered: 2008-04-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Oedema, Petechiae, Pulmonary congestion, Sudden infant death syndrome
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Neonatal disorders (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1994-12-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0804USA01923

Write-up: Information has been received regarding a case in litigation concerning a 7-week-old female who on 21-DEC-1994 was vaccinated with a dose of Recombivax HB (manufacturer unspecified). On 21-DEC-1994 the patient experienced sudden infant death syndrome (SIDS). The patient death occurred the same day as her 21-DEC-1994 vaccinated at 7 weeks old, which was reported to be too quickly to have been the result of a catastrophic auto-immune reaction called cytokine storm as pustulated by the petitioner. Cerebral Edema: "Reports of cerebral edema following infection of nervous tissue generally are acommpanied by fever and significant symptom development usually requires several days to occur," reported the petitioner. Although the patient received Recombivax HB (manufacturer unspecified) on the same day of her death, the physician opined that a cytokine-induced cerebral edema would have required days to manifest." The cause of death was ruled SIDS by a forensic pathologist in the coroner''s office who noted signs associated with SIDS such as "rare epicardial petechia," pulmonary congestion and edema, the petitioner reporter. And her age was within the accepted temporal window for SIDS. Also the child''s mother during her pregnancy took the antipsychotic haloperidol, which was said to have been associated with "sudden and unexpected death." The reporter felt that sudden infant death syndrome was not related to therapy with Recombivax HB (manufacturer unspecified). Additional information is not expected.


VAERS ID: 309594 (history)  
Form: Version 1.0  
Age: 6.0  
Sex: Female  
Location: Colorado  
Vaccinated:2008-01-11
Onset:2008-01-20
   Days after vaccination:9
Submitted: 2008-04-10
   Days after onset:80
Entered: 2008-04-16
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 500490P / 1 NS / IN

Administered by: Private       Purchased by: Public
Symptoms: Asthenia, Ataxia, Congenital anomaly, Dyspnoea, Expired drug administered, Fall, Gait disturbance, Gene mutation identification test, Mitochondrial encephalomyopathy, Nuclear magnetic resonance imaging abnormal
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Congenital, familial and genetic disorders (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-04-05
   Days after onset: 75
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 20 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Weak prior to vaccination. Two months of respiratory problems at night when asleep described as sudden inspiratory gasp and suddenly relieved.
Preexisting Conditions: 5/1/08-records received- PMH: born at 29 weeks on ventilator for pneumonia. Hospitalized for 3 months. Strabismus repair, PE tubes and adenoidectomy. Rotavirus and hospitalization. Developmental delay. Did not receive 5 year old vaccinations.
Allergies:
Diagnostic Lab Data: Abnormal MRI; Genetic mutation 8993 T-C for mitochondrial disease 5/1/08-records received-EEG negative. MRI 2/08 showed abnormal basal ganglia. Sleep study 3/19/08-hyperventilation and obstructive sleep apnea. G-tube insertion on 3/21/08-Repeat MRI shows further note of worsening of lesions in brain consistent with Leigh syndrome. Blood and wound culture positive for staph.
CDC Split Type:

Write-up: Received FluMist on 1/11/08. Approx 7-10 days later became weak with multiple episodes of falling to ground, difficulty walking, ataxia. Weakness progressive leading to breathing problems. Neurology and genetics diagnosed congenital disease - Leigh''s disease which may have been 1st manifested after this vaccine.Swallowing problems, 5/15/08-death certificate received-final cause of death Leigh''s syndrome. 5/1/08-records received for DOS 3/15-4/5/08-DX: Leigh''s encephalopathy syndrome. Respiratory failure. Sepsis. Presented to ED and subsequently transferred. About 2 months ago received FluMist and since then became weak and wobbly. Weak prior to vaccination but more so after vaccination and was receiving physical and occupational therapy. Starring episodes usually at night. Became more limp. Appears sleepy acts as if drunk. Ataxia. With thes episodes has become unresponsive and starring with them. No clonic seizure acitivity. after surgery remained intubated with mechanical ventilation and required CPAP. Neurologic status became more obtunded and unresponsive. Fever. Fevers secondary to brain inflammation due to Leigh syndrome. Withdrawn from life support and expired.


VAERS ID: 309850 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: West Virginia  
Vaccinated:2008-04-04
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2008-04-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B133CA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF232AD / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C63114 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1828U / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-04-06
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: Patient was DOA at local hospital 3 days after immunes were given. 2/27/09 Autopsy report states COD as sudden unexplained death of infant & manner of death as undetermined. Autopsy report also states patient''s caregiver was smoker; patient co-sleeping w/2 adults who had used alcohol & marijuana. 04/29/08 Reviewed ER medical records of 4/06/08. FINAL DX: full cardiopulmonary arrest & prehospital death of uncertain cause. Records reveal patient arrived in ER asystolic w/pupils fixed & dilated, rigor mortis already present, cyanotic, mottled, early livido w/CPR in progress.


VAERS ID: 310076 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Male  
Location: Florida  
Vaccinated:2006-11-24
Onset:2006-11-29
   Days after vaccination:5
Submitted: 2008-04-18
   Days after onset:505
Entered: 2008-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2650DD / 2 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE9990K / 2 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR 410682 / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08672F / 2 LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Intussusception
SMQs:, Gastrointestinal obstruction (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-11-29
   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: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: My son died 5 days after being vaccinated from an intussusception. 5/13/08 Autopsy report states COD as complications of intussusception. Report states patient had clinical history of abdominal distension & vomiting; IS w/5 in telescoping of ascending into transverse colon beginning at the ileocecal valve;partially reducible telescoping w/colonic infarction & prominent lymph nodes at leading colonic edge; dilated abdomen w/increased abdominal distention; BRB per rectum on autopsy & history of currant jelly stool at home; sepsis w/E.coli cultures from heart blood, spleen & lung'' interstitial pneumonitis w/positive RSV antigen from nasopharynx swab.


VAERS ID: 310262 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2008-04-01
Onset:2008-04-05
   Days after vaccination:4
Submitted: 2008-04-17
   Days after onset:12
Entered: 2008-04-21
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1978U / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-04-05
   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: Unknown
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: autopsy, 04/??/08, ruled out suicide or anything suspicious; diagnostic laboratory, 04/??/08, toxicology results unknown. 7/16/09 Pathology report received Receipt 02/23/09 Sign-out 07/06/09. Single focus of mononuclear inflammation of the epicardium. No molecular evidence of infection with enteroviruses or adenoviruses. Liver shows focal nodular hyperplasia. Lung is congested. Enterovirus group RT-PCR (-) Adenovirus group PCR (-).
CDC Split Type: WAES0804USA02336

Write-up: Information has been received from a physician concerning a 20 year old female with no medical history reported, who on 01-APR-2008 was vaccinated with a dose of Gardasil. On 05-APR-2008, the patient died four days after receiving Gardasil. The patient sought unspecified medical attention. An autopsy was performed which ruled out suicide and anything suspicious. The cause of death is currently unknown and they are performing toxicology tests to try to determine the cause. No product quality complaint was involved. The reportable physician considered death to be immediately life-threatening and disabling. Additional information has been requested.7/14/08-autopsy report received-COD:Undetermined. Died unexpectedly while working as a health aid. Postmortem examination reveals focal nodular hyperplasia in liver; this finding though significant, cannot accoutn for sudden death. There is no evidence of pregnancy. Toxicology analysis negative. Based on history, autopys, and toxicological examination, cause of death is undetermined.


VAERS ID: 310715 (history)  
Form: Version 1.0  
Age: 0.39  
Sex: Female  
Location: Virginia  
Vaccinated:2008-04-17
Onset:2008-04-20
   Days after vaccination:3
Submitted: 2008-04-22
   Days after onset:2
Entered: 2008-04-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 21B133DA / 2 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF341AC / 2 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C45892 / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1702U / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-04-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: sib with holoprosencephaly/optic nerve dysplasia~Vaccine not specified (no brand name)~UN~0.00~Sibling
Other Medications:
Current Illness: none
Preexisting Conditions: 36 wk by C/S; jaundice with phototherapy (16); slow initial weight gain PMH: Birth wt 6.2 lbs & had slow weight gain. 50% for ht & wt at 4 mo. Sibling w/holoprosencephaly w/optic nerve dysplasia.
Allergies:
Diagnostic Lab Data: Autopsy pending LABS: Bacterial & virus c/s were neg, metabolic screening WNL, tox neg. Vitreous glucose of 138.8(H).
CDC Split Type:

Write-up: Presented to ER DOA, autopsy pending. 10/7/08 Autopsy states COD as undetermined. Pathological diagnosis: hyperglycemia, likely related to physiologic stress. 10/7/08 Autopsy report states patient experienced irritability w/teething at time of vaccination. Infant sleeping in car seat within cluttered closet w/door partially closed & baby monitor in closet. Parents bedroom (w/monitor found turned off) on another floor in house. Infant was put to sleep approx midnight but not checked or attempted to be fed until approx 2PM when parent entered closet for clothing. Found unresponsive, damp w/sweat, w/blanket partially over face. DOA in ER w/core temp of 85. Autopsy found no traumatic injury.


VAERS ID: 310806 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Arkansas  
Vaccinated:2007-08-13
Onset:2007-08-18
   Days after vaccination:5
Submitted: 2007-09-07
   Days after onset:20
Entered: 2008-04-24
   Days after submission:230
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B097 / 2 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 007U / 2 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B47300H / 2 LL / IM

Administered by: Private       Purchased by: Other
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: 2007-08-18
   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: unknown
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: May have had done at ER unknown
CDC Split Type: AR0739

Write-up: "a bit of a fever after vaccines 8/13/2007 but cleared up and pt felt fine and ate well day before he died." 12/10/08 Death certificate states COD as SIDS.


VAERS ID: 310807 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Arkansas  
Vaccinated:2007-08-13
Onset:2007-08-18
   Days after vaccination:5
Submitted: 2007-08-23
   Days after onset:5
Entered: 2008-04-24
   Days after submission:245
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B079BA / 2 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE925AA / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08674D / 2 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1033F / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-08-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TYLENOL
Current Illness:
Preexisting Conditions: Dx with Thrush at 1 month check up, "spitting up" 1 mo check up.
Allergies:
Diagnostic Lab Data: Autopsy Pending
CDC Split Type: AR0738

Write-up: Possible SIDS 4/25/08-COD Sudden Infant Death Syndrome


VAERS ID: 310808 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Arkansas  
Vaccinated:2007-08-10
Onset:2007-08-12
   Days after vaccination:2
Submitted: 2007-08-22
   Days after onset:10
Entered: 2008-04-24
   Days after submission:246
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B115CB / UNK LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF101AA / UNK RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B58845C / UNK RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Cyanosis, Death, Oxygen saturation decreased
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-08-12
   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: TYLENOL
Current Illness: none per mom
Preexisting Conditions: 36 weeks premature, Reflux
Allergies:
Diagnostic Lab Data: Failed car seat test x3 (lot 9 days of life); O2 De sats when sitting up
CDC Split Type: AR0737

Write-up: Parents found infant blue, face down in crib around 1145 on 8/12/07. Per Coroner Possibly SIDS. CPR Attempted. Infant Pronounced Dead at 1:30 on 8/12/07. 5/27/08-records received:Cause of death-Sudden Infant Death Syndrome. Manner of death-natural


VAERS ID: 310946 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Male  
Location: Texas  
Vaccinated:2007-10-20
Onset:2007-10-20
   Days after vaccination:0
Submitted: 2008-04-28
   Days after onset:191
Entered: 2008-04-25
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Death, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-20
   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: Hydrocodone; Asthenia inhaler
Current Illness: None
Preexisting Conditions: Adult onset asthma; Allergic to penicillin PMH: high cholesterol.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Sudden loss of consciousness several hours after vaccination. EMT could not revive him. Physical and EKG were normal just 3 days prior at annual exam. 4/29 Autopsy report states COD as atherosclerotic coronary vascular disease. Manner of death is natural. 4/29 Autopsy states patient found unresponsive & cyanotic at bottom of ladder with a drill (no malfunction). ASCVD findings: LAD & circumflex arteries to pinpoint lumen; RCA 80% narrowing; aorta w/ulcerated plaque partly occluding left coronary ostium; previous MI, extensive involving lateral LV w/aneurysmal thinning of ventricular wall.


VAERS ID: 311452 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-01-22
Onset:0000-00-00
Submitted: 2008-05-01
Entered: 2008-05-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08675C / 4 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Bacterial culture positive, Death, Meningitis pneumococcal
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-04-17
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: Nasopharyngitis; Viral infection
Preexisting Conditions: PMH: 32-wk preemie w/several weeks in hospital for RDS, pneumothorax & jaundice. Normal G&D s/p recovery from initial hospitalization. Living w/foster family w/frequent visits from biological mother.
Allergies:
Diagnostic Lab Data: Bacterial culture, 00/00/2008, Streptococcus pneumoniae; 00/00/2008, negative for Haemophilus influenzae, Group B strep, N. meningitides, and E. coli; Autopsy Results, Meningitis pneumococcal; Streptococcus pneumoniae meningitis LABS: CBC abnormal, WBC 27.2(H), lymphs 7% (L), monos 2(L), grans 85 (H). Chemistry, UA, CXR all WNL. Rapid strep & MRSA c/s (-). Blood c/s (+) for streptococcus pneumoniae.
CDC Split Type: USWYEH03818008

Write-up: Information regarding Prevnar was received from a healthcare professional regarding a female patient who received the fourth dose on 22-Jan-2007 at 12 months of age and died from Streptococcus pneumoniae meningitis at the age of 26 months. The patient''s concurrent illnesses included nasopharyngitis or viral infection. Concomitant medications were not reported. On an unspecified date in 2008, the patient developed Streptococcus pneumoniae meningitis. On 17-Apr-2008, the patient died. The autopsy cause of death was meningitis pneumococcal. A serotype was not provided. The reporter noted that the patient had "something going on in her system, such as possibly a cold or another type of viral infection, that weakened her immune system." Bacterial culture (results: negative for Haemophilus infection, Group B strep, Neisseria meningitides, and Escherichia coli) and bacterial culture (results: Streptococcus pneumoniae) were done in 2008. No additional information was available at the time of this report. 6/27/08 Autopsy report states COD as bacterial meningitis & streptococcus pneumoniae. States acute bacterial meningitis: purulent exudate of subarachnoid space & meninges; c/s (+) for alpha hemolytic streptococcus; PCR for herpes simplex & enterovirus (-). 7/8/08 Reviewed hospital medical records of 4/16/2008. FINAL DX: Admitted for viral gastroenteritis. Final Dx: bacteremia. Records reveal patient seen by PCP w/fever, nausea & vomiting x 3 days; diarrhea x 1 day; no oral intake; no further BMs; decreased UO; tired; irritable; excessive sleepiness; minimal nasal congestion. Tx w/IVF. Began to become more alert then found unresponsive, cyanotic & no pulse/respirations later in evening. Resuscitation unsuccessful.


VAERS ID: 311463 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Idaho  
Vaccinated:2008-03-31
Onset:2008-04-24
   Days after vaccination:24
Submitted: 2008-04-29
   Days after onset:5
Entered: 2008-05-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B138BA / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08702C / 3 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0509U / 3 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-04-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: This child had his last set of immunizations on 3-31-08. He did not have any reactions. He died of SIDS on 4-24-08. 6/13 Autopsy report states COD as sudden unexplained death in infancy. Report also states patient had petechiae of thymus & visceral surfaces of lungs; no evidence of injury; normal growth parameters; neg metabolic screen; no evidence of aspiration. Had been placed in crib on back w/propped bottle. Found unresponsive.


VAERS ID: 311686 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Male  
Location: Unknown  
Vaccinated:2007-12-18
Onset:2008-03-05
   Days after vaccination:78
Submitted: 2008-05-05
   Days after onset:60
Entered: 2008-05-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-03-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: diabetes; benign prostatic hyperplasia and hyperlipidaemia
Preexisting Conditions: myocardial infraction (1996) and cataract operation
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0804USC00103

Write-up: Information has been received from an investigator concerning a 68 year old male with diabetes, benign prostatic hyperplasia and hyperlipidaemia and a history of myocardial infarction (1996) and cataract operation who entered a study, title as stated above. On 18-DEC-2007 the patient was vaccinated with blinded therapy. On 08-MAR-2008 the patient died. The cause of death was unknown. At this time, relationship of death to study therapy is unknown. The records for this patient was unblinded on 01-MAY-2008. The patient was treated with Zostavax (Oka/Merck) 0.65 ml. Additional information has been requested. 5/7/08-record received Cause of Death: Cardiac insufficiency. Diabetes. Hypertension


VAERS ID: 311791 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Female  
Location: Unknown  
Vaccinated:2008-02-14
Onset:2008-02-20
   Days after vaccination:6
Submitted: 2008-05-06
   Days after onset:75
Entered: 2008-05-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-04-12
   Days after onset: 51
Permanent Disability? Yes
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: ZOVIRAX; Clorazepate dipotassium
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0804USA06377

Write-up: Information has been received from a nurse practitioner concerning an 83 year old female consumer who on 14-FEB-2008 was vaccinated SQ with a 0.65ml of ZOSTAVAX. Concomitant therapy included acyclovir (ZOVIRAX) and clorazepate dipotassium. Subsequently, on 20-FEB-2008, the patient developed shingles. Unspecified medical attention was sought. It was unspecified if lab studies were performed. It was reported that the patient was treated for shingles (treatment regimen not reported) and made a full recovery. It was also reported that the patient went on vacation and when she returned from vacation she developed pneumonia and died on 12-APR-2008. There was no product quality complaint involved. The cause of death was pneumonia. The nurse practitioner considered the event to be disabling. Additional information has been requested.


VAERS ID: 311987 (history)  
Form: Version 1.0  
Age: 57.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2007-10-16
Onset:2007-11-18
   Days after vaccination:33
Submitted: 2008-05-09
   Days after onset:172
Entered: 2008-05-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 80685 / 3 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blindness, Death, General physical health deterioration
SMQs:, Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-01-21
   Days after onset: 64
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 19 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: none
Preexisting Conditions: none PMH: cranial atherosclerosis, distant history of melanoma excised 15 yrs ago; erectile dysfunction; DJD. Bell''s palsy s/p swine flu shot, resolved. Tennis elbow/bursitis, resolved. Dysuria. Diabetes.
Allergies:
Diagnostic Lab Data: unknown LABS: MRI of orbits revealed bilateral optic nerve enhancement (prechiasmal). Sed rate, CRP, ANA & CBC WNL.
CDC Split Type:

Write-up: information is a verbal report from spouse, onset of illness 32 days after vaccination, treated by primary care MD, thought he had a virus, became blind by 11/21/07, continued deterioration to death. Autospy preformed: found patient had a demylinating process as cause of death. 05/27/08 Autopsy report reviewed which states COD as presumed acute pneumonia (autopsy limited to examination of brain). Report also states clinical hx of acute respiratory failure, febrile illness & staph aureus & e.coli dx on bronchoalveolar lavage 1/14/08. Other contributing conditions included: acute aggressive multifocal demyelinating disease w/white matter lesions multiple areas of the brain including previous biopsy sites & cervical spinal cord; cerebral atrophy & edema. 9/26/08 Reviewed hospital medical records of 1/3-/-19/2008. FINAL DX: multiple CNS lesions w/gadolinium-enhancing CNS lesions; myalgia; hypoxic respiratory failure; dysphagia; poor oral intake; nutrition; possible pneumonia; prophylaxis. Records reveal patient experienced re-admission for brain biopsy which revealed acute demyelinating process. Failed high dose steroids & plasma exchange. Tx w/mitoxantrone treatment & second course of high dose steroids in ICU. Mental & respiratory status deteriorated, significant muscle spasms & pain. Mechanical ventilation. Brain lesions continued to grow & new lesions appeared. Developed decerebrate posturing. Comfort care only decided & transferred to hospital closer to family home. 5/23/08 Reviewed initial eye clinic records of 11/29-11/30/2007 FINAL DX: probable retrobulbar ischemic ACON. Records reveal patient experienced HA x 3 days & blurred vision x 1 day. Patient had viral infection w/fever approx 10 days prior & still has sore eyes & stiff neck. Referred to neuro-ophthal. 6/6/08 Reviewed neuro-optho medical records for 11/30-12/2/2007. FINAL DX: bilateral optic neuritis Records reveal patient seen in clinic 11/30 emergently & admitted to hospital same day. Had used Cialis & noted difficulty reading next AM w/HA. Then developed blurry vision, decreased vision & pain over 3 days. Exam revealed visual acuity hand motion in right eye & 4/200 left eye, IOP WNL, no ptosis, slit lamp WNL, fundus w/1(+) edema of right optic nerve & trace edema left optic nerve. Admitted for stat MRI & IV steroids. No improvement & D/C to home on continued tapering steroids. 7/4/08 Reviewed hospital medical records of 11/30-12/02/2007 which were previously included in clinic records. FINAL DX: bilateral optic neuritis


VAERS ID: 312063 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-05-09
Entered: 2008-05-12
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK UN / UN
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. - / UNK UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / PFIZER/WYETH - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Injury
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: WAES0805USA00079

Write-up: Information has been received regarding a case in litigation concerning a patient who was vaccinated with a dose of Recombivax HB (manufacturer unknown), DTaP, poliovirus vaccine, PedvaxHIB (manufacturer unknown). Subsequently, the patient experienced alleged injuries and died. The cause of death was unknown. No additional information is available.


VAERS ID: 312251 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Unknown  
Location: Pennsylvania  
Vaccinated:2008-01-07
Onset:2008-02-05
   Days after vaccination:29
Submitted: 2008-05-13
   Days after onset:97
Entered: 2008-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-02-10
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: COPD
Preexisting Conditions: PMH: Emphysema/COPD, HTN, hypercholesterolemia, basal cell carcinoma. NKDA. Past hx of smoking-quit 2001.
Allergies:
Diagnostic Lab Data: Labs and Diagnostics: Troponin 0.25, 1.14. Creatinine 1.9. BUN 39 up to 52. EKG sinus tach with PVCs. CBC with WBCs 5.9. Hgb initially 13.1 down to 11.1 CXR with no acute infiltrates (+) emphysematous changes. Stool hemoccult (+).
CDC Split Type:

Write-up: Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized for COPD exacerbation. Vaccination took place on 1/7/2008 and hospital admission was on 2/5/2008. According to the physician, relationship to treatment is ''None''. We would be happy to forward the Study''s SAE Report Form upon request. 5/19/2008 MR received for DOS 2/5-10/2008 with D/C DX: Non-ST segment elevation Myocardial Infarction. Acute on chronic respiratory failure. Acute on chronic renal failure. Atrial Fibrillation with rapid ventricular response. Acute Bronchitis. COPD. Gastrointestinal bleeding. Anemia. Hyperlipidemia. Pt presented to ER with 2 day hx of cough and fever with worsening shortness of breath with diaphoresis. Pt also had diarrhea 1 day prior to ER visit. On admission, troponin was (+). PE (+) for I&E wheezing and decreased breath sounds. Pt developed atrial fib, GI bleeding, and acute on chronic renal failure during hospitalization: multi-system organ failure. Transferred to hospice on 2/10/08 per pt request. Pt expired on 2/11/08.


VAERS ID: 312298 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Female  
Location: Iowa  
Vaccinated:2007-04-25
Onset:0000-00-00
Submitted: 2008-05-08
Entered: 2008-05-14
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. 0015U / 1 UN / UN

Administered by: Private       Purchased by: Other
Symptoms: Biopsy, Herpes zoster, Inflammatory carcinoma of the breast
SMQs:, Breast malignant tumours (narrow), Non-haematological malignant tumours (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-12-18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: blood pressure, cholesterol
Current Illness: NONE-deemed healthy at physical
Preexisting Conditions: blood pressure, cholesterol PMH: HTN, hypercholesterolemia, leg cramps, acid reflux. Seborrheic keratosis removed 10/2005.
Allergies:
Diagnostic Lab Data: LABS: mammogram of 3/23/2007 neg. Pap smear 2006 neg
CDC Split Type:

Write-up: Normal mammogram in 3/07. During physical in 4/07 was given Zostavax-shingles vaccine. Days later developed symptoms on chest. Was told it was shingles-from the vaccine. Did not improve and was biopsied. Diagnosed as Inflammatory Breast Cancer. 5/16/08 Death certificate states COD as metastatic inflammatory breast cancer. 5/16/08 Reviewed PCP medical records of 4/19/07-7/10/2007 which reveal patient experienced good health on 4/19/07 w/a normal breast exam. Returned on 6/15/07 with rash on right breast x 2-3 weeks. Vesicular rash in T8 dermatome that was crusting over but had been pruritic & tender. Dx w/shingles. Returned 7/10/07 because rash was not healing. Exam at that time revealed a keloid type rash over the anterior chest & right breast into the axilla. A biopsy was done & started on antibiotic for surrounding erythema.


VAERS ID: 312543 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Oklahoma  
Vaccinated:2008-04-25
Onset:2008-04-27
   Days after vaccination:2
Submitted: 2008-05-15
   Days after onset:18
Entered: 2008-05-19
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0067U / 2 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-04-27
   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: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Awaiting autopsy report performed 4/28/08 also r/o SIDS mother reports
CDC Split Type:

Write-up: 4/27/08 woke up wasn''t breathing- Blue called 911- Sheriff and paramedics. 6/20/08 Autopsy states COD as undetermined. Report states no injuries or disease; all tests neg; history of co-sleeping w/adult. Found supine & unresponsive in bed w/parent w/numerous pillows arranged to keep patient from rolling. CPR initiated.


VAERS ID: 313132 (history)  
Form: Version 1.0  
Age: 92.0  
Sex: Female  
Location: New Mexico  
Vaccinated:2007-11-29
Onset:2007-12-14
   Days after vaccination:15
Submitted: 2008-05-21
   Days after onset:158
Entered: 2008-05-23
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Dizziness, Herpes zoster, Myocardial infarction, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-01-12
   Days after onset: 29
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: High blood pressure. 6/18/08-records received-PMH: dementia, hypertension. osteoporosis, left hip fracture 11/05.
Allergies:
Diagnostic Lab Data: 6/18/08-records received-Sodium 130, BNP 2460. Troponin 0.04. CXR no acute finidng. Echocardiogram normal. blood culture negative.
CDC Split Type: 200801534

Write-up: This case was received from a consumer in the United Stated on 13 May 2008. A consumer reported that his 92-year-old mother received an injection of Influenza Vaccine (manufacturer and lot number not reported) on 29 November 2007. At the time of vaccination, the subject had high blood pressure. Two days after vaccination, on 01 December 2007, the patient began experiencing dizziness, nausea, and vomiting. She was diagnosed with pneumonia, and admitted to the hospital for 14 days. She later developed shingles on her forehead. She died on 12 January 2008; cause of death on the death certificate was "heart attack" according to the patient''s son. No autopsy was performed. 6/16/08-records received for 12/03/07-presented obtunded and unresponsive. Felt weak and limp, gurgling and wheezing, falling towards left side. Appeared to improved but had sudden listless and fever, delirious and gurgling. ED assessment:CHF exacerbation. Assessment viral versus bacterial community acquired pneumonia. 7/18/08-records received for DOS 12/4-12/7/07-DC DX: Community-acquired pneumonia. Pulmonary edema. Presented to ED less responsive than baseline. PE:rales. 9/24/08-records receivedOD-cardiac arrest. Probable myocardial infarction. Possible aspiration.


VAERS ID: 314113 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Minnesota  
Vaccinated:2008-05-19
Onset:2008-05-29
   Days after vaccination:10
Submitted: 2008-05-29
   Days after onset:0
Entered: 2008-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B156BA / 2 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR U231AB,UF174AA / 2 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C45891 / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0212X / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-05-29
   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: CLOTRIMAZOLE 1 % EX CREA
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient had immunizations on 5-19-08 and was found in bed on back today. 7/18/2008 Autopsy report received with COD: Sudden Unexplained Infant Death. Report states infant had some chest congestion x 2 days for which no medication used for tx. Infant had been acting normally with no other recent c/o. Infant had fed at 1 am and at 4 am parent noted infant was not breathing.


VAERS ID: 314292 (history)  
Form: Version 1.0  
Age: 1.1  
Sex: Female  
Location: Unknown  
Vaccinated:2008-05-05
Onset:2008-05-11
   Days after vaccination:6
Submitted: 2008-05-29
   Days after onset:18
Entered: 2008-05-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C57543 / 4 UN / UN

Administered by: Private       Purchased by: Other
Symptoms: Antimicrobial susceptibility test, Blood culture positive, Brain death, CSF culture positive, Culture urine positive, Death, Intensive care, Pneumococcal bacteraemia, Respiratory failure, Septic shock, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-05-13
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness: Unknown
Preexisting Conditions: The patient had no notable medical history. The child went to daycare. 6/3/08-records received-PMH: Roseola at age 7 months. weight loss.
Allergies:
Diagnostic Lab Data: Antimicrobial susceptibility test (results: unremarkable) was done in May-2008. On 11-May-2008 test results were: culture urine (results: pneumococcal bacteria); CSF culture (results: grew large amount of pneumococcal bacteria in less than eight hours); and blood culture (results: pneumococcal bacteria). 6/3/08-records received-NM brain-no scintigraphic evidence of intracranial flow. CSF milky appearance. Gram stain many gram-positive coccobacilli. Protein 1020. WBC 73 and RBC 103. C-reactive protein 13.9. Hypothermic, hypocalcemia, hypokalemia and hyperglycemia. Metabolic acidosis. EEG: compatible with electrocerebral silence, no evidence of cortical activity. Blood culture positive for gram positive cocci.
CDC Split Type: USWYEH04198908

Write-up: Information regarding PREVNAR was received from a physician regarding a female patient who received the fourth dose on 05-May-2008 at 12 months of age and experienced neurogenic septic shock, neurogenic respiratory failure, brain dead, pneumococcal bacteria in blood, vaccine failure and pneumococcal meningitis at 13 months of age. On 11-May-2008, the patient was admitted to the intensive care unit brain dead and in neurogenic respiratory failure. Laboratory results revealed pneumococcal bacteria in blood and a large amount of pneumococcal bacteria that grew in less than eight hours in CSF culture, which led to the additional diagnosis of pneumococcal meningitis. Serotype testing was not performed. An antimicrobial susceptibility test was unremarkable. The physician felt "like this is a vaccine failure". The patient also developed neurogenic septic shock. Treatment included ROCEPHIN and VANCOMYCIN. On 12-May-2008, the patient died. The cause of death were reported as meningitis pneumococcal, respiratory failure, septic shock, vaccination failure, brain death and pneumococcal sepsis. No additional information was available at the time of this report. 6/3/08-records received for DOS 5/11-5/13/08-Date of Death 5/13/08. Final DX: Meningitis secondary to Streptococcus pneumoniae. Gram-positive coccal bacteremia. Admission neurologic examination consistent with brain death, subsequently confirmed. Brain death confirmed by repeat examination and confirmatory tests through course of hospitalization. Admitted via emergency room previously well child until 3/10/08, warm to touch temperature 101, listless and febrile with temperature as high as 104.4. Vomited. Became limp, feet cold, apneic. CPR initiated at home. Cyanotic. Pupils dilated and nonreactive. GCS 3. Heart rate 170 but not palpable pulses. No spontaneous respirations. Intubation, mechanical ventilation.


VAERS ID: 314404 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2003-12-08
Onset:2004-01-20
   Days after vaccination:43
Submitted: 2008-06-01
   Days after onset:1593
Entered: 2008-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1088AA / 1 LA / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Death
SMQs:, Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-02-17
   Days after onset: 1489
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE. PMH: typanostomy tubes, phimosis, GERD,. Allergy to sulfa.
Allergies:
Diagnostic Lab Data: Labs and Diagnostics: EMG/NCS 1/24/08 showed widespread sensory motor neuropathy significantly worsened since 2004. Swallow study shows mild/moderate aspiration risk. Genetic testing showed several sequence variations of unknown significance. CSF culture (-). CSF glucose 61. CSF protein 47. CSF lactic Acid 1.5. (N). CSF Pyruvic Acid 0.18 (N). ESR 22. Thymidine phosphorylase activity normal.
CDC Split Type:

Write-up: DIAGNOSED WITH CIDP/GUILLIAN BARRE SYNDROME IN MAY 2003 HE RECEIVED THE MENINGITS VACCINE IN NOVEMBER 2002. Confirmed with parent and vax record concurs Flu vaccine given 12/8/2003, not meningococcal. Onset of sx January 2004, not 2003 as originally reported. 7/14/2008 Death Cert received with Immediate COD listed as Chronic Inflammatory Demyelinating Polyneuropathy. 06/03/2008 MR received for DOS 1/23-28/2008 with D/C DX: Neuropathy. 2'' DX: Tachycardia. Respiratory Distress. Pt most recently presented to another facility in December 2007 with GI issues and increasing lower extremity weakness. Pt was discharged and was transferred for further evaluation due to progressive upper extremity weakness and dyspnea, as well as new onset urinary and fecal incontinence, orthostasis, decreased hearing and L hand pain. Pt had initially developed limb weakness and paresthesias 4 years ago. Testing showed widespread sensory motor polyneuropathy. DX: Presumed Chronic Inflammatory Demyelinating Polyneuropathy. Course has been slowly progressing over the years and has had multiple hospitalizations and rehabs. PE (+) for tachycardia, use of accessory muscles for breathing, tachypnea and decreased breath sounds. Bowel sounds decreased. Motor exam showed decreased bulk, tone and strength. Sensation decreased with no proprioception below the elbow. Pt txd with plasmapheresis IVIG over the years without response. Pt now with autonomic dysfunction. BIPAP improved overall energy level. Pt unable to return to rehab facility given questionable prognosis so pt was D/C to home. Per mother pt died at home on 2/17/2008. PMH since 2003: (CIDP dx 2004 with depression, anxiety, osteoporosis. Sural nerve bx, OSA on CPAP, Recent Gastroenteritis.)


VAERS ID: 315005 (history)  
Form: Version 1.0  
Age: 63.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2007-08-02
Onset:2008-05-26
   Days after vaccination:298
Submitted: 2008-06-05
   Days after onset:10
Entered: 2008-06-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
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: 2008-05-26
   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: COPD,
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Subject in pneumococcal vaccine trial, with severe COPD died of respiratory arrest on the way to the hospital. According to the physician, relationship to treatment is ''None''. We would be happy to forward the Study''s SAE Report Form upon request.


VAERS ID: 316231 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: North Carolina  
Vaccinated:2008-06-05
Onset:2008-06-08
   Days after vaccination:3
Submitted: 2008-06-13
   Days after onset:5
Entered: 2008-06-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B149AA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF349AA / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C65049 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0281X / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-06-09
   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: Actigall, Ferrous Sulfate
Current Illness: Cholestatic Jaundice, URI sypmtoms 2 days later
Preexisting Conditions: see #7 please note hep B in NICU is unknown type or lot #
Allergies:
Diagnostic Lab Data: Labs and Diagnostics: CBC 6/9/08 WBC 5.6. Lymphs 75.3% Hgb 8.9, Hct 27.4
CDC Split Type:

Write-up: Ex 29-week premature infant presented for routinue post NICU follow-up on 6/5/08 for 2mo. Relatively nml Pexam (hx of RDS,Apnea, R/o spesis, anemia, hyperbilirubinemia, cholestatic jaundice, murmur, bilat inguinal hernia) Of note only jaundice and murmur were present at time of discharge. Patient recieved 4 vaccines on 6/5/08. Patient presented with URI symptoms on 6/9/08 diagnoses with URI and sent home. The baby reportedly had a cardiac arrest later that evening and did not survive. ****please note submission of similar patient of similar event with ALTE diagnosis and hospitalization (survived). 6/27/08 Link w/317530 per direction of FDA. 9/24/08 ER record received for DOD 6/10/08. DX: Sudden Death. CPR unsuccessful. Infant last seen alive at 1800. EMS on scene at 22:35. Pt found cold, stiff and puple in color. CPR attempted but unsuccessful. Pt in rigor upon arrival in ED and prounounced. PMH: 28 wk premie. In NICU from DOB 3/29/08 until 4/29/08 with DX: Respiratory Distress syndrome. Apnea of Prematurity. R/O Sepsis x3. R/O NEC. Jaundice. Nutritional support. R/O IVH and PVL. Temperature Support. Infant on CPAP and NC O2. Had apnea, bradycardia and O2 desats. 3 episodes of sepsis w/u. Had physiologic jaundice requiring phototherapy. On parenteral feeds with intermittant enteral feeds. D/C on O2 and monitoring./pc 9/29/08 ME''s report received. Probable COD Acute Bronchopneumonia. DX: Acute bronchopnemonia, moderate. Cholestasis. Microscopic exam of the lungs reveals moderate acute bronchopneumonia present w/in the major and minor bronchi and alveolar spaces. Focal atelectasis. Liver shows diffuse cholestasis with bile plugs present. Slight chronic inflammation. Severe autolysis. 10/30/08 PCP records received which include d/c summary for 2+month NICU stay with D/C 6/4/08. Seen in f/u 6/5/08-cholestatic jaundice, anemia, ROP and scrotal masses (hydroceles) noted. Otherwise normal premie exam. Vax given. Seen again 6/9/08 for cough and congestion with Impression URI. RR 60. P ox 95%. Wet cough, wheeze and rhonchi noted (clear A/P/L). Nasal saline and suction as sympromatic care. To f/u in 1-2 days or to ER PRN.


VAERS ID: 316534 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: New York  
Vaccinated:2006-07-06
Onset:2006-07-07
   Days after vaccination:1
Submitted: 2008-06-18
   Days after onset:712
Entered: 2008-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B055AA / 1 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0083F / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08655E / 1 LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Echocardiogram abnormal
SMQs:, Acute central respiratory depression (narrow), Cardiomyopathy (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-07-07
   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: tylenol at time of vaccine, no meds prior to vaccine
Current Illness: Parents state infant had rash, no fever,not nasal congestion, good behavior and appetite, rash was never documented, probable atopic dermatitis
Preexisting Conditions: PMH: mom was pre-eclampsic. C-section due to non reassuring fetal heart rate. Mom w/(+) drug screen for marijuana. Family hx: asthma, DM, heart disease, cervical cancer & HIV.
Allergies:
Diagnostic Lab Data: an echo performed one monthe prior to death and showed ASD/PFO, probably not relevant to death
CDC Split Type:

Write-up: patient was given vaccines onthe date of 7/6/2006 and on the morning of 7/7/2006 was found in the bed (with parents) not breathing, was bought to ER via ambulance and pronounced dead. The autopsy was inconclusive. 8/8/08 Autopsy report states COD as undetermined & manner of death as undetermined. Report also states that patient was co-sleeping w/parents in adult bed. PMH: patent foramen ovale; reducible umbilical hernia 7/11/08 Reviewed PCP clinic records, vax records & hospital medical records. Clinic records reveal patient had congestion & cough, poor weight gain, thrush, umbilical hernia & 2/6 systolic heart murmur. Cardiac consult done for ASD which was felt to be unlikely to cause s/s. Was in usual state of health on day of vaccination. 7/11/08 Hospital medical records of 7/7/2006 reviewed. Patient had been fed approx 4 hours prior to being found unresponsive, cyanotic, asystole, w/jaw clenched. Unable to determine from records if patient was in crib or in bed with parents, reported in varying ways in records. EMS unable to obtain IV access or intubate. ER unable to resuscitate.


VAERS ID: 316952 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Texas  
Vaccinated:2008-05-01
Onset:0000-00-00
Submitted: 2008-05-06
Entered: 2008-06-23
   Days after submission:48
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B142AA / 1 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF238AF / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08702B / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1231F / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-05-05
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZMAX
Current Illness: SINUSITUS
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: INFANT IN BED WITH PARENTS AT TIME OF DEATH. 6/30/08 Autopsy report states COD as SID, pt found unresponsive in bed w/parents.


VAERS ID: 316983 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: New Hampshire  
Vaccinated:2008-05-28
Onset:2008-06-12
   Days after vaccination:15
Submitted: 2008-06-16
   Days after onset:4
Entered: 2008-06-23
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0928U / 1 LA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-06-12
   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:
Preexisting Conditions: Seizures PMH: ''problems w/alcohol''.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death 9/9/08 Death certificate states COD as idiopathic seizure disorder. 8/5/08 Reviewed ER medical records of 6/12/2008. Records reveal patient found unresponsive, prone on her bed when parent went to awake for school. Last seen at bedtime. Pupils fixed & dilated, cyanotic & pale, incontinent of urine, developed pulmonary edema during resuscitation. Unable to resuscitate.


VAERS ID: 316985 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: North Carolina  
Vaccinated:2008-06-11
Onset:2008-06-13
   Days after vaccination:2
Submitted: 2008-06-23
   Days after onset:10
Entered: 2008-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B132CA / 1 LL / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER UF341AC / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C65047 / 1 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-06-20
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: asthma
Allergies:
Diagnostic Lab Data: 6/26/08-records received-. Liver 7-8cm below costal margin. CK 10,248, lactate 10.9. EKG decreased voltages, elevation of ST segments. Initial BUN 35 and total CO2 16. Blood gas 7.36 and pCO2 30, potassium 4.5.
CDC Split Type:

Write-up: ER visit to hospital Friday 6/13/08. 2nd ER visit to hospital on 6/20/08 - transferred to another hospital. I have not received any medical charts. 6/26/08-records received for DOS 6/20-6/21/08-transferred with history of dehydration and metabolic acidosis on 6/14/08 with subsequent ER visit on 6/20 with similar symptoms. Developed difficulty breathing after 6/11/08 immunizations, with grunting and screaming on 6/12/08. In ED with respiratory distress including retractions, tachypnea, heart rate at 153. On 6/19/08 at 2130 passed large diarrheal stool. Evening prior to admission developed limpness and refused p.o. feedings. Pale, gray and cold to touch. In ED with weak cry, heart rate of 200 and unobtainable blood pressure, respirations 60. Electrocardiogram revealed wide complex tachycardia.Intubated, ventilator Resuscitative efforts. Massive pulmonary edema. Expired at 2355. 12/23/08-autopsy report received-acute congestive heart failure with myocarditis probably viral. mild interstitial pneumonitis, hepatomegaly with centrilobular congestion and necrosis. serous effusions. stress changes in thymus. Diffuse cerebral edema and hyopxic ischemic injury.


VAERS ID: 317385 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Texas  
Vaccinated:2008-04-14
Onset:2008-04-16
   Days after vaccination:2
Submitted: 2008-05-16
   Days after onset:30
Entered: 2008-06-25
   Days after submission:40
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B142AA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF215AB / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C65043 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1621U / 1 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Diarrhoea, Laboratory test, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-04-18
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: 0~ ()~~0.00~In Patient|0~ ()~~0.00~In Sibling|0~ ()~~0.00~In Sibling
Other Medications:
Current Illness: WELL AT TIME OF VACCINE
Preexisting Conditions: NO
Allergies:
Diagnostic Lab Data: LABS 4/17
CDC Split Type:

Write-up: VOMITING AND DIARRHEA STARTED 4/16 IMPROVED ON 4/17. NO DEHYDRATION TOLERATED PEDIALYTE WELL. DIED AM OF 4/18 AFTER MOM FELL ASLEEP WHITE FEEDING CHILD. 7/2/08-records received-Undetermined causes, no convincing cause of death could be deteremined. The infant may have asphyxiated by various means, including suffoction or positional asphyxia or may have died of other reasons.


VAERS ID: 317407 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Female  
Location: Michigan  
Vaccinated:2008-03-26
Onset:2008-03-27
   Days after vaccination:1
Submitted: 2008-06-25
   Days after onset:90
Entered: 2008-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B126AA / 2 - / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF229 AA / 2 - / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C49918 / 2 - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-03-27
   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: unknown
Current Illness:
Preexisting Conditions: Child born at 28 weeks gestation. Had hx of RSVP. Had been treated for e-coli & strep infection in past. Low birth wt. Periods of apnea in past. Reported at Child Death Review Meeting of immunizations day before death.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: See box 19 for information. Baby alive at 5:30 AM & died approx. 6:00 AM. 7/7/08-autopsy report received-COD:Sudden Unexplained Infant Death. Complications of Prematurity.


VAERS ID: 317757 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Indiana  
Vaccinated:2008-06-13
Onset:2008-06-15
   Days after vaccination:2
Submitted: 2008-06-27
   Days after onset:12
Entered: 2008-06-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1447U / 1 LA / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiomegaly, Death, Passive smoking, Splenomegaly, Toxicologic test normal
SMQs:, Cardiac failure (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-06-15
   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
Preexisting Conditions: overweight PMH: recurrent colds/sore throat, neg strep.
Allergies:
Diagnostic Lab Data: toxicology and other test came back negative expect trace amount of nicotine (father heavy smoker)
CDC Split Type:

Write-up: Death -coroner says enlarged heart & enlarge spleen 7/4/08 Reviewed PCP medical records of 1999-6/2008 which included vax record. In 8/2007, c/o of tiredness & loss of appetite. Monospot (-). On day of vax, patient was well, weight noted as 237, otherwise no complaints. 7/8/08 Autopsy report states COD as arrhythmia due to cardiomyopathy.States anatomic findings of obesity, pulmonary edema, mild & left ventricular hypertrophy w/myocardial nuclear enlargement. Patient had been found non-responsive by family. EMS found patient cyanotic w/rigor & no further resuscitation was performed. Family reported patient had been well earlier in the evening. Albuterol inhaler was found at scene but no suspicious features at scene.


VAERS ID: 317877 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Kentucky  
Vaccinated:2008-06-09
Onset:2008-06-25
   Days after vaccination:16
Submitted: 2008-06-26
   Days after onset:1
Entered: 2008-06-30
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B143AA / 1 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF348AA / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 858845H / UNK LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 02124 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-06-25
   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: None
Current Illness: None
Preexisting Conditions: Dwarfism-records received 8/29/08- dwarfism; remote SDH; history of c-section;
Allergies:
Diagnostic Lab Data: Dwarfism, Premature at 37 wks
CDC Split Type:

Write-up: Father called 6/25 to cancel appts for August/08 and states baby died of SIDS. 8/29/09 Autopsy report also states: apparently found unresponsive at home in car seat which had been placed in crib;no evidence of acute traumatic injury; post mortem studies all negative. 8/29 Autopsy states COD: no anatomic cause./


VAERS ID: 318120 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Illinois  
Vaccinated:2008-07-01
Onset:2008-07-01
   Days after vaccination:0
Submitted: 2008-07-02
   Days after onset:1
Entered: 2008-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B143AA / 2 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR HF366AA / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C65930 / 2 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0501X / 2 MO / PO

Administered by: Private       Purchased by: Unknown
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: 2008-07-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TYLENOL after inj.
Current Illness: None
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt received immunization at approx 10:15 am. Father found unresponsive @ approx 7:15 pm. 8/21/08-cause of death undetermined. pulmonary vascular congestion. petechiae of epicardium.


VAERS ID: 318491 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-07-07
Entered: 2008-07-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Hypersensitivity
SMQs:, Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Sulfonamide allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0806USA08737

Write-up: Information has been received from a physician who was told by a patient''s mother that a female patient with a sulfa allergy who on an unspecified date was vaccinated with a first dose of GARDASIL (lot number, injection site and route not reported), which was well tolerated. On an unspecified date, the patient was vaccinated with a second dose of GARDASIL (lot number, injection site and route not reported). Subsequently the patient died. The cause of death was reported as allergic reaction to GARDASIL. The physician stated that the patient who died was not her patient and she knew no further details. Follow-up information was received from the physician who reported that a other of one of her patients had said to her, that she "thought" she read this report on the internet. The physician asked the patient''s mother to find out where she read the report. The patient''s mother could not find the report and did not know where to locate the source information. Additional information has been requested.


VAERS ID: 318570 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: New York  
Vaccinated:2008-07-07
Onset:2008-07-08
   Days after vaccination:1
Submitted: 2008-07-09
   Days after onset:1
Entered: 2008-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B156CA / 3 UN / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF366AA / 3 UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C65930 / 3 UN / IM

Administered by: Private       Purchased by: Public
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: 2008-07-08
   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: Poly Vi Flor
Current Illness: None
Preexisting Conditions: s/p inguinal hernia repair
Allergies:
Diagnostic Lab Data: Currently examined by medical examiner
CDC Split Type:

Write-up: vaccine 7/7/08 approx 3 pm. Reportedly child fus til 7/8/08 afternoon nap with mom. When mom awoke child unresponsive -$g died 10/20/08-records received-COD Sudden unexpected infant death. Manner of death-undetermined.


VAERS ID: 318702 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-07-10
Entered: 2008-07-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / 2 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 2 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0501X / 2 MO / PO

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: autopsy, results not yet available
CDC Split Type: WAES0807USA00755

Write-up: Information has been received from an office worker concerning a 4 month old patient who was vaccinated with oral ROTATEQ (lot # 660548/0501X), (therapy date and dose not reported). The baby died the same day ROTATEQ was given to the patient. Per office worker, they had a memo in their office not to give any further vaccines to patients because one 4 month old baby died after receiving ROTATEQ. The office is currently waiting for the autopsy report before they can resume giving vaccines in their office. Per office worker, the patient is not a patient in their office. The Director of Pharmacy from the pharmacy who dispensed ROTATEQ provided the name of the patient''s physician and lot # 0501X. Additional information was received from a pharmacist, indicating that this patient also received second dose of ACTHIB, PREVNAR and PEDIARIX on the same day that a second dose of ROTATEQ was given. It was reported that the patient sought unspecified medical attention, physician. The event was considered life threatening and disabling. A lot check has been requested. Additional information has been requested.


VAERS ID: 318749 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Unknown  
Vaccinated:2008-04-04
Onset:2008-07-02
   Days after vaccination:89
Submitted: 2008-07-11
   Days after onset:9
Entered: 2008-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 RL / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 LL / IM
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Metabolic function test, Neurological examination
SMQs:

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-07-02
   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: LEVETIRACETAM; LANSOPRAZOLE
Current Illness: APNEA ; SEIZURE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: R0000398G

Write-up: This male subject was enrolled in the prophylactic open study 110870 (MenACWY-TT-057). On 4 April 2008, he received the 1st dose of HIB-MENCY-TT (IM L thigh) and of PEDIARIX (IM R thigh). The subject received concomitantly PREVNAR (IM) and ROTATEQ vaccines (po). Medical conditions at the time of the event included apnea and seizure. Concomitant medications included PREVACID and KEPPRA. On 02 July 2008, 89 days after the 1st dose of PEDIARIX, 89 days after the 1st dose of HIB-MENCY-TT, this five-month-old subject died. The event was disabling, life-threatening, clinically significant (or requiring intervention). The subject died on 02 July 2008, cause of death is unknown. An autopsy was performed. The investigator considered that there was a reasonable possibility that the death nos may have been caused by PEDIARIX and HIB-MENCY-TT. Investigator Comments: Site was Notified of report of death on 07-03-2008, records have been requested. All data pending. 07-07-2008. After PI review, cannot completely rule out vaccine related causality, but not probable. Subject on anticonvulsants and has underwent metabolic/neurologic work-up with no significant findings. Possibility of Munchausen by Proxy, but waiting on pending results of physician and ER notes, apnea monitor results and autopsy and toxicology report. 8/22/08 Autopsy states COD as sudden unexpected infant death. Report also states Anatomical diagnosis: same as COD & aspiration of vomitus, terminal/subterminal focal bilateral. Comments: infant had complicated history of seizures, aspiration & apnea which could not be substantiated during multiple hospitalizations & ER visits & Munchausen by proxy was questioned. Autopsy showed only relatively mild terminal aspiration of vomitus. 8/5/08 Reviewed ER medical records of 7/2/2008 submitted by FDA from manufacturer. Records reveal patient well known w/history of recurrent episodes of life-threatening events of possible apnea vs seizure over the prior 2 months w/cyanosis, choking & gagging. Was on apnea/bradycardia monitor at home. Found by parent vomiting & poorly responsive. Started CPR & ACLS by EMS. Arrived in ER in full arrest & unable to resuscitate.


VAERS ID: 318889 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: New Jersey  
Vaccinated:2008-06-25
Onset:2008-06-26
   Days after vaccination:1
Submitted: 2008-07-14
   Days after onset:18
Entered: 2008-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U2397CA / 3 RL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF362AB / 3 LL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C65929 / 3 LL / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-06-26
   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: ZANTAC, lisinopril
Current Illness: None
Preexisting Conditions: Premature at birth, status post intrauterine drug exposure, status post apnea of prematurity. PMH: Prematurity-33wks. Special needs. Birth mother abused ETOH and cocaine
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None stated. 8/11/08 Gross autopsy findings: Visceral congestion. Diaper rash. Full report pending. 10/20/2008 Autopsy received. COD-Sudden unexplained death in infancy. Manner of death natural. Infant found unresponsive with abundant vomitus.


VAERS ID: 319501 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Tennessee  
Vaccinated:2008-05-05
Onset:2008-05-22
   Days after vaccination:17
Submitted: 2008-06-06
   Days after onset:15
Entered: 2008-07-17
   Days after submission:41
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B129AA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF329AA / 1 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-05-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: TN08020

Write-up: Reported to office patient deceased. 9/22/08-autopsy report received-COD sudden unexpected infant death associated with inappropriate sleeping environment. Found dead while sleeping on an adult mattress on floor with pillows and blankets. Anatomical diagnosis:Thymic petechiae. Pulmonary edema. Cerebral edema. Medical intervention. Facial abrasions, mild and tongue contusion.


VAERS ID: 319533 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Maryland  
Vaccinated:2008-06-03
Onset:2008-06-20
   Days after vaccination:17
Submitted: 2008-07-17
   Days after onset:27
Entered: 2008-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0053X / 3 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-06-20
   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: Reported allergy to penicillin and cephid 3/5/09-records received-Allergic to penicillin.
Allergies:
Diagnostic Lab Data: None - apparently healthy young woman 8/22/08-records received-cardiac blood neg for ethanol; urine (+) for ethanol=16 mg/dl; liver (+) for acetaldehyde (incidental finding). 3/5/09-records received-pap smear normal. 2/4/09-records received-CBC WNL, chemistry WNL. 2/12/08 ECG abnormal mild tricuspid regurgitation, 2D Doppler frequent premature ventricular contractions. 4/30/09-records received-lung specimen showed diffuse edema and intraalveolar hemorrhages. Staphylococcus aureus negative.
CDC Split Type:

Write-up: Pt received her 3rd and final dose of HPV vaccine on 6/3/08. Per mother patient was found dead, in bed on 6/22/08, in her dorm room at an out-of-state college. According to the autopsy the patient had been dead for about 48 hours. According to mother autopsy was negative except for splenic inflammation. 8/22/08 Autopsy report also states Final Diagnoses: Cardiac arrest, cause undetermined w/recent history of PAC w/otherwise normal EKG; normal echocardiogram 2/08; no evidence of myocarditis; acute pulmonary edema; slight splenomegaly; cardiac blood neg for ethanol; urine (+) for ethanol=16 mg/dl; liver (+) for acetaldehyde (incidental finding). 3/5/09-records received for DOS 8/22/07-seen for routine visit and first annual pap test..PE normal. First HPV vaccine administered. 2/4/09-records received for DOS 11/20/07-C/O chronic PAC and irregular heart beat.


VAERS ID: 319809 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-07-18
Entered: 2008-07-21
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, 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? 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: WAES0807USA03098

Write-up: Information has been received from a medical assistant concerning a 22 year old female with no known medical history and no known allergies who was vaccinated with GARDASIL. Subsequently the patient experienced an unexplainable death. The mother of the patient found her daughter unresponsive and dead in her bed. It was noted that this death was reported to VAERS and the death was not caused by GARDASIL. It is unknown if medical attention was sought. The medical assistant considered the death to be disabling and life-threatening. No further information is available.


VAERS ID: 319810 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Illinois  
Vaccinated:2007-08-06
Onset:2007-09-20
   Days after vaccination:45
Submitted: 2008-07-18
   Days after onset:302
Entered: 2008-07-21
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0012U / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Death, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2007-09-20
   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: Unknown
Current Illness:
Preexisting Conditions: Unknown. PMH: 1 prior seizure 8/2007. 4/28/09 Additional records received from PCP at CDC''s request. Pt in for OV 1/30/07 with c/o allergy sx and requesting HPV#1-given 0012U. Returned 3/22/07 for HPV#2-given 1427F with Boostrix AC52B012AA. Mild URI 4/25/07. OV 6/12/07 in F/U to ER visit for seizure on 6/11/07. Syncope noted. Sent for tests. OV 6/28/07 Echo and blood work reportedly WNL. Syncope again noted. PE WNL. OV 7/5/07 EEG normal. EIA? Retuned 8/6/07 for HPV#3 given 0012U. PFTs reportedly normal.
Allergies:
Diagnostic Lab Data: Unknown. Labs and Diagnostics: Tox screen (-).
CDC Split Type: WAES0807USA02139

Write-up: Information has been received from a certified medical assistant concerning a 14 year old female who was vaccinated with a first dose of GARDASIL and experienced syncope. She was taken to an emergency room and released. The patient was vaccinated with a second dose of GARDASIL (unspecified time). Subsequently, the patient experienced her first seizure (unspecified time) and was taken to the emergency room (no further details provided). The patient was vaccinated with a third dose of GARDASIL at 15 years old. Approximately 27-JUN-2008, two weeks after the third dose, the patient developed a complication. She was taken to the hospital by ambulance but passed away during the transport from an unknown cause. The physician has asked the mother for the autopsy report. The reporting medical assistant considered the syncope, seizure and "a complication" were considered to be immediately life-threatening and disabling. Additional information has been requested. 2/13/09 Autopsy report received. COD: Seizure Disorder. Summary Diagnoses: Clinical history of seizure disorder. Pulmonary congestion and edema. Passive visceral congestion. 2/20/2009 ER received from CDC. Pt presented to ER via EMS following witnessed seizure activity with fall from standing. Upon EMS arrival pt had agonal respirations and was pulseless in V-fib at 650. Upon arrival in ER unresponsive, pupils fixed and dilated, no cardiac activity. Resuscitation unsuccessful and pt expired.


VAERS ID: 320129 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Illinois  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-07-22
Entered: 2008-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Brain oedema, Confusional state, Death, Emotional distress, Gait disturbance, Hepatomegaly, Incoherent, Malaise, Neurological examination abnormal, Nightmare, Sleep disorder
SMQs:, Liver related investigations, signs and symptoms (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Thyroid
Current Illness: Unknown
Preexisting Conditions: The subject was healthy except for a low thyroid for years. There was no history of adverse events following previous vaccinations. This case, A0738694A, is linked to two other cases from the same reporter. The master case is A0738675A. The other linked case is A0738681A. Cases A0738675A and A0738681A are sibling cases.
Allergies:
Diagnostic Lab Data: The subject failed unspecified neuro exams.
CDC Split Type: A0738694A

Write-up: This case was reported by a healthcare professional and described the occurrence of enlarged liver in a female subject (the aunt of the reporter) aged between 50 and 59 years old who was vaccinated with HEPATITIS B, manufacturer unspecified. Concurrent medications included Thyroid replacement. In 2004 the subject received unspecified dose of HEPATITIS B (unknown). At an unspecified time after vaccination with HEPATITIS B, the subject complained that she was not feeling well or not feeling right (unspecified). She was awakening with horrible dreams and she was distressed. It was observed that the subject was confused. She was in the bathroom saying things that made no sense and stumbling. This was considered to be a systemic reaction. A friend took her to the doctor and the doctor sent her to the hospital. The hospital did a work-up. The subject failed the neuro exams and she was hospitalized. The events were also considered to be life threatening and clinically significant (or requiring intervention). The subject died in the hospital an unknown amount of time later. Initially in the hospital, the subject was thought to have Lyme disease or an inflammatory reaction, possibly an allergic reaction. An autopsy revealed an enlarged liver and brain swelling. Specific events of not feeling well or not feeling right, awakened with horrible nightmares and distress were said to have resolved and were considered probably related to vaccination with HEPATITIS B. This case, A0738694A, is linked to two other cases from the same reporter. The master case is A0738675A. The other linked case is A0738681A. Cases A0738675A and A0738681A are sibling cases.


VAERS ID: 320329 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Texas  
Vaccinated:2008-05-14
Onset:2008-05-15
   Days after vaccination:1
Submitted: 2008-07-18
   Days after onset:64
Entered: 2008-07-24
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B145AA / 2 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF330AA / 2 LA / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C65043 / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1888U / 2 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Autopsy, Death, Life support, Myocarditis, Respiratory arrest, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-05-18
   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? No
Previous Vaccinations:
Other Medications:
Current Illness: None 8/1/08-records received-Congested for past several days. Cough symptoms for approximately 1 week secondary to seasonal allergies.
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Autopsy reports myocarditis as cause of death 8/6/08-records received-EEG:abnormal organic encephalopathy. CT brain-question of diffuse cerebral edema.
CDC Split Type:

Write-up: Pt found 5-15-08 @ 2110 by mother unresponsive, not breathing. He had been fed 4 oz and given TYLENOL for temp at 2040 hrs, then put in his crib, on abdomen with face turned to side, at 2100 she rushed him to ER at local hospital where CPR was performed and pt transferred via helicopter to another hospital. Pt on life support until 5-18-08 when it was stopped and he expired. 8/1/08-records received for DOS 5/16/08-5/18/08-presented in cardiopulmonary arrest, resuscitative efforts included CPR, intubation, mechanical ventilation. Hypothermic on presentation with rectal temperature of 91.6, hypoglycemia with blood sugar 16, metabolic acidosis. Prior to event C/O fussy all day running low grade fever, placed in crib on abdomen, found white, lump with face buried in cover. Drove child to hospital. PE: agonal respirations not compatible with life. Pupils nonreactive to light, fixed. No spontaneous movement of extremities. Deep tendon reflexes absent. 8/11/08-records received-Findings:Myocarditis. Inflammation and necrosis, myocardium. Interstitial edema, epiglottis. Tracheobronchitis, chronic. The inflammatory lesions observed in heart are consistent with either acute viral infection or post-viral syndrome.


VAERS ID: 320407 (history)  
Form: Version 1.0  
Age: 0.38  
Sex: Female  
Location: Michigan  
Vaccinated:2008-07-14
Onset:2008-07-16
   Days after vaccination:2
Submitted: 2008-07-24
   Days after onset:8
Entered: 2008-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B129AA / 2 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1125F / 2 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 808702K / 2 RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Brain injury, Coma, Convulsion, Death, Nuclear magnetic resonance imaging abnormal
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), 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? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-07-23
   Days after onset: 7
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Final MRI results: marked abnormal loss of gray-white differentiation and edema in the frontal and parietaloccipital areas 8/11/08-records received- MRI brain acute anoxic ischememic injury within the bilateral basal ganglia and bilateral occipital lobes, suggests two separate etiologies one would be diffuse hypoxia and the other posterior circulation infarcts from low/slow flow in left vertebral artery. Mild degree of brachycephaly. Marked loss of gray white differentiation with edema involving the frontal and parietoccipital regions.
CDC Split Type:

Write-up: Patient presented to the ED on 7/16/08 with seizure activity that was difficult to contol after starting to have seizures at home. She was finally stabilized then transferred to the PICU at hospital. After being here she had again started to have uncontrolled seizures. She was started on multiple seizure medications (Phenobarbital, Fosphenytoin, Pyridoxine) but still not controlled so placed into a Pentobarbital coma. This was initially weaned with a recurrence of seizures, so placed back into a Pentobarbital coma and Keppra was added. This was again weaned with the recurrence of seizures. Parents then decided that with the amount of brain damage noted on imaging that they would like to withdraw support. The patient then passed a few hours after support was withdrawn. 7/29/08-pending. no significant trauma, no gross natural disease, brain and spinal cord retained for neuropathology exam. 8/11/08-records received for DOS 7/16-7/23/08-presented to ED after seizure, had low grade fever since Monday of last week 2 days after immunizations. Intubation. Bulging pulsating fontanelle, DX:seizure activity with cerebral edema.


VAERS ID: 320559 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-07-25
Entered: 2008-07-28
   Days after submission:3
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? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0806USA08705

Write-up: Initial and follow up information has been received from a physician, who was told by one of his patients, that the mother of a consumer was told by a neurologist that there were 4,400 kids who have died following vaccination with GARDASIL. No product quality complaint was involved. Attempts are being made to verify the existence of patients. Additional information has been requested.


VAERS ID: 320713 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Female  
Location: Oregon  
Vaccinated:2008-07-21
Onset:2008-07-22
   Days after vaccination:1
Submitted: 2008-07-24
   Days after onset:2
Entered: 2008-07-29
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0860U / 1 RA / IM
TTOX: TETANUS TOXOID, ADSORBED (NO BRAND NAME) / SANOFI PASTEUR U2120BA / UNK LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-07-22
   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: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Unknown adverse event. Patient received vaccines and passed away within 24 hrs. Autopsy scheduled 7/24/08. 10/14/08 MR and Death Cert received from PCP. Pt seen 7/21/08 with Assessment: Healthy 70 year old. PE WNL. Pt expired at unknown time 7/22/08 of unknown causes. Autopsy deferred by ME. COD: Unknown causes.


VAERS ID: 320862 (history)  
Form: Version 1.0  
Age: 50.0  
Sex: Female  
Location: Montana  
Vaccinated:2007-09-26
Onset:2007-10-26
   Days after vaccination:30
Submitted: 2008-07-30
   Days after onset:278
Entered: 2008-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 6185U / UNK RA / UN
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2734AA / UNK RA / UN

Administered by: Public       Purchased by: Unknown
Symptoms: Chemotherapy, Death, Diplegia, Fall, Lung neoplasm malignant, Myelitis transverse
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Non-haematological malignant tumours (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-01-06
   Days after onset: 72
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 18 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PPD
Current Illness: None
Preexisting Conditions: HX: Lung cancer 8/11/08-records received-PMH:obesity adenocarcinoma of lung.
Allergies:
Diagnostic Lab Data: Lung cancer 2 years with chemotherapy 8/11/08-records received- NCV abnormal evidence of primary muscle disorder. Glucose elevated, AST and ALT elevation of 144 and 177. MRI normal. CSF leukocytosis. Culture negative. on 1/6/08 began hypotensive with oxygen saturation 82%.
CDC Split Type:

Write-up: Brother states patient developed "Transverse myelitis" from the MMR vaccine then the patient "Fell down and died". Developed paralysis in legs one week after shot. 8/11/08-records received for DOS 12/12/07-1/6/08- DX: Paraparesis secondary to transverse myelitis. Death secondary to pulmonary embolism. Admitted for evaluation of lower extremity weakness for 2-3 weeks, with shooting pain in feet on 12/14/07-balance difficulties noted, tingling in left upper extremity prior to hospitalization Upgoing plantar reflex noted on right side, lower extremity reflex loss at ankles and left patella. Autopsy refused by family.


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