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VAERS ID: 339771 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Illinois  
Vaccinated:2008-04-28
Onset:2008-10-26
   Days after vaccination:181
Submitted: 2009-02-09
   Days after onset:106
Entered: 2009-02-18
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1978U / 3 UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-10-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Bloodclot~HPV (Gardasil)~3~13.00~Patient
Other Medications:
Current Illness:
Preexisting Conditions: 5/7/09-records received-5/7/09-records received-office visit 4/21/00-evaluation for dehydration, vomiting, sore throat and febrile. Impression strep pharyngitis. 9/2/05-routine physical. Assessment:overweight. Office visit 1/4/08-C/O lump in neck noticed in 9/07. Intermittently hurts. Assessment:mild lymphadenopathy.
Allergies:
Diagnostic Lab Data: 3/9/09-records received-WBC 17.3.
CDC Split Type:

Write-up: She developed a pulmonary embolism after having 3 rounds of vaccine GARDASIL. She was a healthy, active teenager. 2/23/09-autopsy report received immediate cause:Massive pulmonary embolism. Mild cardiomegaly. Last several days C/O cough and congestion. 3/9/09-ED records received for DOS 10/26/08-presented in full cardiac arrest after suffering a full and prolonged cardiac arrest, aystole. Expired.


VAERS ID: 339772 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Kentucky  
Vaccinated:2009-01-14
Onset:2009-01-18
   Days after vaccination:4
Submitted: 2009-02-06
   Days after onset:19
Entered: 2009-02-18
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3227AA / 1 RL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D16284 / 1 LL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1168X / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-01-18
   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: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient found in cardiopulmonary arrest at home. 6/29/2009 Autopsy report received with COD Sudden Unexplained Death in Infancy. Pt found face down in crib. Resuscitation unsuccesful. Reportly had be lethargic and not sleeping at night since receiving vax at 3 month check up. No anatomic, metabolic or toxicologic COD, therefore SUDI. ICD9: 798.4


VAERS ID: 340167 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Massachusetts  
Vaccinated:2009-02-18
Onset:2009-02-19
   Days after vaccination:1
Submitted: 2009-02-19
   Days after onset:0
Entered: 2009-02-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3242AA / UNK LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D15050 / UNK RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1267X / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-02-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SYNAGIS, MedImmune, 08A624, upper right thigh, 2 previous doses
Current Illness: Not ill at time of vaccines
Preexisting Conditions: 35 wk preemie; Twin; Reflux (GERD); NB hearing screen (L) ear did not pass
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None stated. 7/20/09 Autopsy report received. COD: Undetermined. Manner of Death: Undertermined. Final dx: Developmentally normal male infant


VAERS ID: 340285 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: California  
Vaccinated:2009-01-08
Onset:2009-01-24
   Days after vaccination:16
Submitted: 2009-02-20
   Days after onset:27
Entered: 2009-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3241AA / 2 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C97890 / 2 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1269X / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-01-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Atopic dermatitis
Preexisting Conditions: History of congestion and runny nose, Atopic dermatitis
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 02/09/09, mother of Pt said that 02/22/09 Pt was taken to ED of medical center for respiratory illness by his father. Pt was arrested in ED and after resuscitation, transferred to a different medical center. Pt passed away 01/24/09. 3/11/09 Autopsy report received with the following DX: Large right pleural empyema-collapse of R lung with no evidence of pneumonia-small R pneumothorax-Gram (+) cocci present in fibrinopurulent coagulum from R pleural space. Multi-focal acute bronchopneumonia of L lung (early?). Focal hemorrhage, base of L lung. Left pleural effusion. Tri-lobed left lung (with normal bronchial branching pattern). Mild cardiomegaly with dilated tricuspid valve. Moderate congestive hepatosplenomegaly. Findings c/w acute physiologic stress: Moderate to marked thymic involution, moderate lipid depletion of adrenal cortex, moderate arrest of rib growth plate. Small pericardial and peritoneal effusions. Small fragment of apparent old blood clot in bladder. Myeloid hyperplasia of bone marrow, with left shift 4/6/09 Coroner''s report received with COD: Acute Respiratory Insufficiency due to Empyema, Sepsis and presumed pneumonia


VAERS ID: 340286 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Male  
Location: California  
Vaccinated:2009-01-23
Onset:2009-02-13
   Days after vaccination:21
Submitted: 2009-02-20
   Days after onset:7
Entered: 2009-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2808AA / 1 UN / IM

Administered by: Private       Purchased by: Public
Symptoms: Chest X-ray abnormal, Cough, Influenza serology positive, Pneumonia, Pyrexia, Staphylococcus identification test positive
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2009-03-21
   Days after onset: 35
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 35 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Staph Aureus; Infl B positive; X ray chest diffuse pneumonia LABS: Admit labs: WBC 0.9(L), plts 41K(L) CRP 26.6(H), RA factor 16(H).Drug screen neg. Head CT WNL. Bone marrow biopsy.
CDC Split Type:

Write-up: Fever, cough. Diffuse bilateral pneumonia. Staph aureus MRSA. 5/12/09 Autopsy report states COD as organizing diffuse alveolar damage w/bronchiectasis; multiple bronchopleural fistulas secondary to influenza B & MRSA infection; extensive pleural adhesions. Autopsy limited to lung only. 4/15/09 Received hospital medical records of 2/16-3/21/2009. FINAL DX: death; influenza B pneumonia w/secondary MRSA pneunonia; ARDS; leukopenia; thrombocytopenia; hyponatremia; coagulopathy; hypotension requiring pressors; high frequency oscillatory ventilation; bilateral pneumothorax; bilateral bronchopulmonary fistulas. Records reveal patient experienced sorethroat, fever, cough, post-tussive emesis x 4-5 days & hemoptysis x 1 day prior to admit w/increased work of breathing. Admitted PICU for severe respiratory distress secondary to bilat pneumonia & leukopenia. Pulm, ID, heme consults done. Patient had long & complicated PICU course while continuously vented, feeding tube, bilateral chest tubes, tracheostomy, multiple blood product transfusions, IV antibiotics & steroids, Tamiflu, IVIG. Progressively declined, extubated per family request & expired shortly therafter.


VAERS ID: 340558 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Indiana  
Vaccinated:2009-01-12
Onset:2009-01-12
   Days after vaccination:0
Submitted: 2009-02-24
   Days after onset:43
Entered: 2009-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3200AA / 1 RL / UN
HEP: HEP B (FOREIGN) / MERCK & CO. INC. 0401X / 2 LL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D06803 / 1 LL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1359X / 1 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Cyanosis, Death, Irritability, Pallor, Skin discolouration, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-01-12
   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-was told to take prior to vaccinations per MD
Current Illness: Chronic bronchitis per pathologist who did the autopsy
Preexisting Conditions: Premature infant, 3 old healing rib fractures found at autopsy PMH: 36 wk preemie.
Allergies:
Diagnostic Lab Data: Autopsy done - LABS: 12/18/08: CBC, BMP, CXR WNL. 1/12/09: LABS: WBC 30.3, segs 9.97% lymphs 16.9%.
CDC Split Type:

Write-up: Received first set of baby shots, left the pediatrician''s office and went to store. Became very fussy. Then in the car on the way home became more fussy before falling asleep. When arrived home, the baby''s skin looked off white and the lips were cold and dark colored and the baby was not arousable. Parents took the baby to the ER where they were unable to revive him and he was pronounced dead after about 45 minutes. The baby had previously been to the ER on 12/18/08 for small size and for congestion. Was put on weight gaining formula and given Albuterol breathing treatment and sent home. Autopsy was done and showed 3 healing rib fractures that were old and the pathologist stated the baby had chronic bronchitis, but the cause of death was undetermined. 2/25/09 Autopsy report state COD as sudden unexplaineed death in infant & manner of death as undetermined. 2/25/09 Received ER records of 12/18/2008. FINAL DX: URI w/tachypnea Records reveal patient experienced SOB, nasal congestion, loose stool x 2 days. Seen in PCP office x 2 for same & sent to ER for eval. Resp rate in ER 64, pulse ox 98%. Remainder of exam WNL. Tx w/nebs & resp rate returned to WNL. 2/27/09 Received vaccine records & PCP office records which reveal patient in good health on 1/12/2009. 3/9/09 Received ER medical records of 1/12/2009. FINAL DX: DOA Records reveal patient brought to ER by parent. Patient gray, limp w/no pulse or respirations after having found unresponsive. Resuscitation attempts failed


VAERS ID: 340925 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Texas  
Vaccinated:2009-01-14
Onset:2009-02-10
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2009-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C2903AA / 3 RL / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT2794CA / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C83143 / 3 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1172X / 3 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-02-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient died of influenza A on 2/10/09. 3/16/09-preliminary anatomic diagnoses received-Influenza A infection with Staphylococcus aureus superinfection and septic shock. Bilateral hemorrhagic bronchopneumonia. Staphylococcus aureus isolated on postmortem lung culture;antibiotic sensitivity pending. Influenza A virus identified by PCR testing on antemortem tracheal aspirate. Bilateral adrenal hemorrhage Waterhouse-Friderichsen syndrome). Coagulopathy widespread glomerular microthrombi. Congestive organomegaly, lungs, liver, kidneys and spleen. Admitted 2/10/09.


VAERS ID: 340971 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Colorado  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-02-27
Entered: 2009-03-03
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None.
CDC Split Type: 200900658

Write-up: Initial report received on 20 February 2009 from a newspaper source. Two children, 2 years and younger, had one of the two doses of vaccine recommended for young children (manufacturer and lot number not reported) and have died of influenza. No further information was provided. List of Documents held by Sender: None.


VAERS ID: 341467 (history)  
Form: Version 1.0  
Age: 52.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2008-03-13
Onset:2008-10-31
   Days after vaccination:232
Submitted: 2009-03-10
   Days after onset:130
Entered: 2009-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Drug toxicity
SMQs:, Anticholinergic syndrome (broad), Drug abuse and dependence (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-10-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: COPD
Preexisting Conditions: PMH: COPD, HTN, CAD, MI, palpitations, stroke, coronary stent placement, OA & joint pain.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Subject in pneumococcal vaccine trial, with severe COPD, died on 10/31/2008 of multiple drug intoxication. Vaccination took place on 3/13/2008. According to the physician, the relationship is ''None''. We would be happy to forward the Study''s SAE reporting form upon request 3/12/09 Death certificate states COD as multiple drug intoxication. SAE & ER medical records from study center reveal patient found asystolic w/o signs of trauma. Patient was not on any know medications.


VAERS ID: 341562 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: California  
Vaccinated:2008-07-22
Onset:2008-07-26
   Days after vaccination:4
Submitted: 2009-03-11
   Days after onset:228
Entered: 2009-03-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (DTP + ACTHIB) / SANOFI PASTEUR C2953AA / 3 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF403AA / 3 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C87339 / 3 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0210X / 3 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-07-29
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: none~ ()~~0.00~Patient
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death 7 days later 4/20/-09-autopsy report received-Final diagnoses:straw colored pericardial effusion and ascites. No antemortem trauma.


VAERS ID: 341593 (history)  
Form: Version 1.0  
Age: 1.1  
Sex: Female  
Location: Indiana  
Vaccinated:2009-01-05
Onset:2009-01-11
   Days after vaccination:6
Submitted: 2009-03-10
   Days after onset:57
Entered: 2009-03-12
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1079X / 1 RL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D16279 / 4 LL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 11924 / 1 RL / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-01-11
   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: None noted
Current Illness: None noted
Preexisting Conditions: Treated for ear infection 12/23/08 amoxicillin x 10 days.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient died 1-11-09. Had received vaccines in our office 1-5-09. Coroner determined cause of death as SIDS after autopsy completed. 3/16/09-autopsy report received-COS Sudden Infant Death Syndrome (SIDS). Manner of death natural. Moderate thymic and pleural petechiae. Pulmonary and visceral congestion.


VAERS ID: 341874 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-03-16
Entered: 2009-03-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEA: MEASLES (ATTENUVAX) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Measles
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: WAES0903USA02000

Write-up: Information has been received from a published article, concerning "a patient who was vaccinated with two doses of ATTENUVAX (manufacturer unknown). In approximately 2004, the patient experienced measles related death. The cause of death was measles." The article also discussed the experience of 1 other patient who died while on therapy with ATTENUVAX (manufacturer unknown) (WAES# 0903USA01794). Additional information has been requested. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 341875 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-03-16
Entered: 2009-03-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEA: MEASLES (ATTENUVAX) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Measles
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: WAES0903USA01794

Write-up: Information has been received from a published article, concerning "a patient who was vaccinated with one dose of ATTENUVAX (manufacturer unknown). In approximately 2004, the patient experienced measles related death. The cause of death was measles." The article also discussed the experience of 1 other patient who died while on therapy with ATTENUVAX (manufacturer unknown) (WAES# 0903USA02000). Additional information has been requested. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 341877 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-03-16
Entered: 2009-03-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0903USA01668

Write-up: Information has been received form a physician who received a "health alert" from the health department concerning an 8 week old patient who was vaccinated with unspecified HIB (manufacturer unknown) (Lot# not reported). 5-6 days after receiving the unspecified HIB (manufacturer unknown), the patient developed invasive HIB disease and died shortly afterward. The adverse events were considered to be immediately life-threatening. It was not reported whether the patient''s sought medical attention. This is one of several reports receive from the same resource. Additional information has been requested.


VAERS ID: 341933 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Female  
Location: California  
Vaccinated:2008-12-04
Onset:2008-12-20
   Days after vaccination:16
Submitted: 2009-03-17
   Days after onset:86
Entered: 2009-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Private       Purchased by: Other
Symptoms: Autopsy, Chest discomfort, Death, Dyspnoea, Eosinophilic myocarditis, Hyperhidrosis, Hypersensitivity, Myocarditis
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (narrow), Hypersensitivity (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: 2008-12-31
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: See clinical report; simvastatin; metformin; ASP; COZAAR
Current Illness: None Known
Preexisting Conditions: see medical records - If I recall she did have other medication allergies 4/27/09-records received-PMH:borderline DM and HTN with DVT. allergies to grass, animals, dust.
Allergies:
Diagnostic Lab Data: See autopsy report opinion and clinical records from clinic.
CDC Split Type:

Write-up: She dies on 12/31/08 - clinicians list hypersensitivity myocarditis of unk etiology - I autopsy case 1-14-09 - confirmed an eosinophilic myocarditis, unk etiology but cannot exclude ZOSTAVAX vaccination given around 12-4-08 - unk where, clinician indicate possible delayed hypersensitivity reaction. (She presented --$g to ER 12-20-08 with diaphoresis, chest tightness, SOB). 4/27/09-records received-COD Eosinophilic myocarditis, etiology not established.


VAERS ID: 341949 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Illinois  
Vaccinated:2009-03-06
Onset:2009-03-11
   Days after vaccination:5
Submitted: 2009-03-17
   Days after onset:6
Entered: 2009-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR 3000AA / 1 UN / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF402HH / 1 UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / PFIZER/WYETH B0009 / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D33126 / UNK UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1472X / 1 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Intestinal resection, Intussusception
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-07-05
   Days after onset: 116
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 117 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: REGLAN
Current Illness: none
Preexisting Conditions: Down''s Syndrome; AV canal; Reflux (G-E); Myeloproliferative disorder 5/19/09-records received-PMH: Down Syndrome with transient myeloproliferative disorder. Congenital heart disease.
Allergies:
Diagnostic Lab Data: 5/21/09-records received-Echo abnormal. Ultrasound diagnosis of intussusception.. LABS and DIAGNOSTICS; Thyroid function tests abnormal. Creatinine levels high. Blood cultures (+). Echocardiogram. ECG - abnormal. CT - Abnormal. Lactic acids. Blood gases. Vascular Doppler - Abnormal. KBU - abnormal. Electrolytes abnormal.
CDC Split Type:

Write-up: Intussusception (ileo-cecal) requiring bowel resection. 5/19/09-records received for DOS 1/2/09 and 3/5/09 -clinic notes for follow-up-3/13/09-seen in clinic after presenting to ED with large bloody stools times 2 days, developed respiratory distress. Transfusions. Intubated. PICU. Impression: rectal bleeding, DIC, leukocytosis. 5/21/09-operative report received for DOS 3/13/09-exploratory laparotomy with right hemicolectomy and ileocolostomy. DX: Intussusception. Presented with C/O abdominal tenderness and distended abdomen, rectal bleeding. Post operatively developed ARDS, ventialtor dependent. Subsequent surgery 5/7/09 Median sternotomy, PDA ligation, pulmonary artery banding, insertion of right femoral arterial line. 5/12/09-subsequent surgery for closure of sternal wound. Failure to wean from ventilator. 8/11/09 Hospital DC summary, ICD-9 codes received DOS 3/11/09 to 7/5/09. Assessment: Intussusception status post bowel resection, ischemic colitis - septic shock, multi organ system dysfunction. Additional clinical data abstracted: 5/28/09 Continued fever. Signs of sepsis. Parental decision to withdraw care on 7/5/09. Patient expired on 7/5/09. ICD-9 Codes: 786.05 Shortness of breath, 560.0 Intussusception, 286.6 Defibrination syndrome, 557.0 Acute vascular insufficiency of intestine, 785.52 Septic shock, 569.83 Perforation of intestine, 038.49 Septicemia due to gram-negative organism, 038.43 Septicemia due to Pseudomonas, 518.5 Pulmonary insufficiency following trauma and surgery, 745.69 Endocardial cushion defect, 747.0 Patent ductus arteriousus, 238.79 Neoplasm of uncertain behavior of other lymphatic and hematopoietic tissue, 995.92 Severe sepsis, 599.0 Urinary tract infection site not specified, 758.0 Down''s syndrome, 427.5 Cardiac arrest.


VAERS ID: 342046 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Oklahoma  
Vaccinated:2009-03-13
Onset:2009-03-17
   Days after vaccination:4
Submitted: 2009-03-18
   Days after onset:1
Entered: 2009-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AX21B143AA / 1 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0818U / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C73459 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0925X / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-03-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Baby died 4 days after vaccines were given, death is under investigation cause of death is still unknown 6/15/09 Autopsy report also states patient had fever since receiving vaccinations. 6/15/09 Autopsy report states COD as unknown./Had been given Tylenol & put down for nap. Found face down between pillow & mesh of playpen. Attempted resuscitation but patient with rigor & unsuccessful. Noted to have dried blood around nose. Skeletal survey, drug & metabolic testing all WNL./


VAERS ID: 342079 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-03-18
Entered: 2009-03-19
   Days after submission:1
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: 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: WAES0903USA02330

Write-up: Information has been received from a consumer concerning a young baby who on an unknown date was vaccinated with a dose of MMR II. Subsequently, the baby died locally. No further information is available.


VAERS ID: 342365 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-03-20
Entered: 2009-03-23
   Days after submission:3
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: 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: WAES0903USA01874

Write-up: Information has been received from a registered nurse who reported what read an article. In the article was reported that a female patient died because of the serious adverse event due to GARDASIL. The patient was not the reporting nurse''s patient and she did not have a copy of the article. This is a unconfirmed report. Attempts are being made to verify the existence of an identifiable patient. Additional information has been requested.


VAERS ID: 342366 (history)  
Form: Version 1.0  
Age: 47.0  
Sex: Female  
Location: Unknown  
Vaccinated:1998-05-20
Onset:0000-00-00
Submitted: 2009-03-20
Entered: 2009-03-23
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Demyelination, Intraocular pressure test, Multiple sclerosis, Neuromyelitis optica, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain normal, Optic neuritis, Vaccination complication, Visual field defect, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Glaucoma (broad), Optic nerve disorders (narrow), Demyelination (narrow), Lens disorders (broad), Retinal disorders (broad), Ocular infections (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Magnetic resonance, 01/25/99, MRI of brain showed negative, abnormal signal in upper cervical spinal cord
CDC Split Type: WAES0903USA01790

Write-up: Information has been received form a lawyer regarding a case in litigation which was reported in a literature article concerning a 47 year old female patient who on 20-MAY-1998 was vaccinated with a second dose of RECOMBIVAX HB (manufacturer unknown). Concomitant medication was not reported. The special master reported that there was a logical sequence of cause and effect in patient''s having received the vaccination and then experiencing optic neuritis, the first symptom of her Devic''s disease of variant of multiple sclerosis (MS). It was reported that two months after getting the second dose of the vaccine the patient noted retro-orbital pressure in her left eye followed by decreased visual function. On July 27, 1998, she noted a curtain over the superior visual field in her left eye. On 25-JAN-2009 she had an magnetic resonance imaging (MRI) scan of brain which was negative, although there was an abnormal signal in the upper cervical spinal cord. The physician diagnosed neurologic syndrome involving her optic nerves and spinal cord. The medical records during the patient''s final hospitalization reflected that she died from demyelinating disease. It was reported that patient had a vaccine injury and her death was also vaccine related. The patient died in May (Year not reported) at age of 47. The reporter felt that Devic''s disease and demyelinating disease were related to the therapy with RECOMBIVAX HB. No other information is available.


VAERS ID: 342393 (history)  
Form: Version 1.0  
Age: 10.0  
Sex: Female  
Location: New York  
Vaccinated:2008-10-10
Onset:2009-02-13
   Days after vaccination:126
Submitted: 2009-03-23
   Days after onset:37
Entered: 2009-03-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR 27A3EA / UNK UN / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Death, Influenza, Influenza serology positive
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-02-15
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Ventral Septal Defect 5/20/09-records received-Clinical history of patent ductus arteriosus and ventricular septal defect. Slit-like communication between atria. One of twins.
Allergies:
Diagnostic Lab Data: Flu A cultured; IVP, brain, heart 5/20/09-records received-CXR negative.
CDC Split Type:

Write-up: Possible vaccine failure. Child expired with Flu A cultured. 5/20/09-autopsy report received-COD-cardiopulmonary arrest. Due to: systemic infection with influenza type A/H1. Sudden onset of muscle and leg cramps on 2/14/09, URI symptoms last day or so including sore throat. Suddenly developed tachypnea fever and diaphoresis within 20n minutes of onset of leg cramps. In ED fever of 107, tachycardia and dyspnea, developed flutter then bradycardia. Intubated, v-tach, coded and expired.


VAERS ID: 343124 (history)  
Form: Version 1.0  
Age: 0.15  
Sex: Male  
Location: South Dakota  
Vaccinated:2009-01-15
Onset:2009-01-30
   Days after vaccination:15
Submitted: 2009-03-31
   Days after onset:59
Entered: 2009-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C32408AA / 1 UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 52779 / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Areflexia, Brain death, Child maltreatment syndrome, Convulsion, Dyspnoea, Endotracheal intubation, Irritability, Mechanical ventilation, Respiratory arrest, Retinal haemorrhage, Subdural haemorrhage, Victim of homicide
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Haemorrhagic central nervous system vascular conditions (narrow), Convulsions (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Retinal disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2009-01-31
   Days after onset: 1
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 9 days
   Extended hospital stay? No
Previous Vaccinations: Stopped Breathing and Poor Feeding~Hep B (no brand name)~1~0.10~Patient
Other Medications: Visad, Aminophylline, 2 types Thrush medication, Am
Current Illness: See Above or we will be happy to approve realese of entire medical history/profile to you.
Preexisting Conditions: Anemic, head was Dolicephellic, Had blood transfusion, Sepsis, Respiratory Distress, Thrush, Digestive Tract problems, possible infetion from PIC Line procedure, feeding problems--took to same Dr''s Pediatric clinic 5 days before 911 call, Had Synagis in hospital but never given 2nd dose as recommended within 30 days of 1st dose, Low birth weight, Smaller of discordant twins born 8 weeks premature, 3 lbs smaller than identical twins brother, medical records indicate "no ACUTE hemmorage" so sounds like their must have been some type of bleeding even if not ACUTE 6/10/09 Hospital records, discharge summary received DOS 1/30/09 to 1/31/09. Premature birth, necrotizing enterocolitis, problems with feeding and weight gain. Choking spell.
Allergies:
Diagnostic Lab Data: See Above....Toxicology test were denied by DR. that help 3 positions in care of child and this was a conflict of interest. 6/10/09 Hospital records, discharge summary received DOS 1/30/09 to 1/31/09. LABS and DIAGNOSTICS: Cranial Ultrasound - brain swelling. Head CT scan - subarachnoid and subdural hemorrhage, cerebral edema. EEG - flat / no evidence of brain activity. Apnea test and ice water calorics. CBC - WBC 17000, 22% Segs, 1% Bands, 73% Lymphs, 4% Monocytes, Hemoglobin 7.1, Hematocrit 21%. CHEM - Sodium 139, Potassium 3.6, Chloride 106, BUN 6 mg, Creatinine 3.5, Glucose 254, Calcium 1.15 . PT 19.1, PTT 67, INR 1.5. Chest X-Ray - Gaseous distention of stomach and bowel.
CDC Split Type:

Write-up: On 1-4-09 patient had Hep B Vaccine in NICU and also this day he had lost weight as he had on several days while in the hospital, he was released on 1-5-09 after several complications. On 1-5-09 he stopped breathing but started so we did not take him to the hospital for his doctor told us while in the NICU that periodic breathing was normal for premature children. On 1-15-09 the same NICU Dr''s nurse practitioner administered a series of 5 vaccines including the DTAP that has been used to cause inflammation of the brain. This was on the same day that he was being treated for a 2nd consecutive visit for thrush. They actually called in the prescription in the wrong twins name and I had to have it corrected for the "right" chart was in the wrong twins folder. This Dr. was in 3 positions as the NICU Doctor, The Pediatrics Doctor and the Medical Examiner (how convenient is this). Other Dr. saw him on 1-15-09 for current Dr. wasn''t in the office this day. We feel he shouldn''t have been given 2 month old vaccines for 3 reasons: One he was losing weight and had thrush, secondly, He was 5 days shy of being legally 2 months old and since he was the smaller of discordant twins born 8 weeks early due to low heart rate and fear of both identical twins boys dying they induced labor he wasn''t physically 2 months old. 15 days later on 1-30-09 he stopped breathing while I was away. I returned home right after the ambulance and emergency response team had arrived. I thought they had the wrong address but then my significant other (patient''s Mother) came out of the house with patient. She indicated he was fussy and she placed him on the bed after changing his diaper to go make a bottle for him. When she returned to the room she indicates he was gasping for air. She panicked and called her mother and there wasn''t an answer, she then reached a friend who advised to call 911. She says she called 911 and they walked her thru CPR efforts. The EMT arrived and right after this I arrived. The police officer took the child and ran to the ambulance. After arriving to the hospital it seemed patient was more stable. The mother arrived before I did and the nurse gave her patient''s shirt. I had a blood stain on it and when asked the nurse indicated it was from the tube the EMT had to shove in his throat as part of the CPR efforts. He was given Sodium Bicarbonate among other medications. He seemed to have been determined as "more stable". Hours later the same Dr. indicated that things did not look good and was ready to pronounce brain death but waited until the following day. An organ donor organization was brought in and he was given medication to preserve the body. It seemed this was more of the process than was keeping him alive. At one point I heard the nurse ask the Dr "20"? I am not sure what medication measurement was being determined but Dr. said, "No, bump it up to 80" The nurse looked at him as if this was unusual procedure that she was accustomed to in this situation. Before being pronounced brain dead he started having seizure activity. At first Drs. were indicating Seizure activity but later recanted this as being possible Clonus activity. Dr. said the best case scenario would be that he would be in a vegetative state and most likely be blind. It was determined that he didn''t have any reflex response and he was kept on a ventilator for he wasn''t breathing voluntarily but his heart was beating all by itself. I am not sure if when the police officer ran from our house and down the alley to the ambulance with patient and/or the CPR efforts given by EMT in additon to too much Sodium Bicarbonate for such a small fragile child could have worsened the retinal and/or subdural bleeding that was caused by the residual and gradual effects of all the medications and series of vaccines or not. This child also was malnutritioned due to sharing the same Placenta as his recipient discordant twins. Patient''s cord was not attached to the Placenta but rather a membrane that was attached to the Placenta. We also lived in an old house that contains lead and the old water pipes probably contained metals as well. He became anemic in the NICU after a "PIC Line" insertion. He also had Heparin flushes and possibly Heparin coated Catheter. He was also given a more dangerous diuretic in combination of other diuretcis. He was on Aminophylline that most doctors don''t use due to safer and more effective newer drugs being available and it indicates in the warnings it should be used at the same time as other medications used for the same purpose. He also on at least 2 occassions in the NICU had his IV placed in his forehead which could alone in such a small fragile child cause or aggrevate bleeding. It seems possible that all of the diuretics were being given to reduce the fluids and swelling of his head. Drs'' NICU medical records indicate one day his head was Dolicephelic. He also indicates one day the sutures were overriding and the next day after his head grew 1 CM his sutures were seperated. This fragile sickly child ONLY weighed 2 lbs 13 ounces compared to his IDENTICAL twin brother''s weight of 4 lbs. At the time of patient''s death he weighed 3 pounds less than his larger and healthier brother. His mother had a very small birth canal and cervix. In addition of patient being born 8 weeks early the mother went to the hospital 6 weeks earlier for she had an infection and was 2 CM dialated. She was given several medications to stop her from going into labor, given antibiotics to fight off infections and then 6 weeks later they induced labor early for thought both babies would die due to patient''s VERY low heart rate....they indicate in identical twin boys that if one passes they normally both pass due to their heart rates being regulated. His head grew more front to back than side to side (left to right) and up and down. He had a red mark in the NICU in a picture we took on 12-14-09 and the mark would go away and reappear. This same mark appeared again on 1-29-09..one day before the 911 call. The only possible conclusion is that either the vaccines, medical issues, medical neglect or a combination of all of these killed our son. After days on life support, the mother finally decided, after Dr. and the hospital staff''s insistance, to discontinue the ventilator. He passed away on 2-8-09 and was pronounced brain dead on 1-31-09. 6/10/09 Hospital records, discharge summary received DOS 1/30/09 to 1/31/09. FINAL DIAGNOSIS: Subdural/subarachnoid hemorrhage, Cerebral edema, Cardiorespiratory arrest Post immunization: Irritable for several day, became pale, dusky, spasmotic respiratory efforts. Unresponsive. Hypotonic. Placed on mechanical ventilation in ED, episodes of hypertension and hypotension, seizure activity, clonic movements, pupils fixed and dilated. Abdomen distended. Reddening over left eyelid. Anterior fontanel tense and full. No spontaneous respiratory efforts. Declared brain dead. Edematous. Life support discontinued.


VAERS ID: 343528 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-04-03
Entered: 2009-04-06
   Days after submission:3
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: Brain injury, Death, Pneumonia
SMQs:, Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0903USA05627

Write-up: Information has been received from a consumer''s niece concerning her uncle whose age was undetermined. The consumer reported that her uncle was "older than me." The patient received a triple vaccine of MMR II. The patient became brain damaged. The patient had been hospitalized. The patient was reported to die from pneumonia "about 4 years ago" in approximately 2005. No further information is available.


VAERS ID: 343777 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Unknown  
Location: Virginia  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-04-08
Entered: 2009-04-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: 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: WAES0904USA00201

Write-up: Information has been received from a physician concerning an 11 year old patient who was vaccinated with GARDASIL (lot number, route and site not reported). Subsequently the patient died. Additional information has been requested.


VAERS ID: 343822 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Unknown  
Location: Alabama  
Vaccinated:2008-04-17
Onset:2009-01-30
   Days after vaccination:288
Submitted: 2009-04-09
   Days after onset:68
Entered: 2009-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-01-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: COPD
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Subject in pneumococcal vaccine trial, with severe COPD died on 1/30/09. Vaccination took place 4/17/2008. According to the physician, the relationship to treatment is ''None''. We would be happy to forward the Study''s SAE Report Form upon request. 3/14/2009 SAE received from reporter. Pt experienced L sided pain and increasing SOB on 1/22/09 x 2 days. Presented to ER where dx with L Pneumothorax and Pneumonia. Unresponsive to tx. Pt died 1/30/09.


VAERS ID: 343825 (history)  
Form: Version 1.0  
Age: 1.18  
Sex: Female  
Location: Indiana  
Vaccinated:1998-01-09
Onset:1998-01-19
   Days after vaccination:10
Submitted: 2009-04-09
   Days after onset:4097
Entered: 2009-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0283E / 1 LL / SC

Administered by: Public       Purchased by: Public
Symptoms: Autopsy, Cough, Death, Heart rate increased, Pharyngitis, Pyrexia, Rash, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal infections (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 1998-02-18
   Days after onset: 30
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: no~ ()~UN~0.00~Patient|no~ ()~UN~0.00~Sibling|no~ ()~UN~0.00~Sibling
Other Medications: none
Current Illness: premature, "hole" in heart that was healed
Preexisting Conditions: PMH: preemie, birth weight 2 lb 8 oz & was hospitalized x 1 mo.
Allergies:
Diagnostic Lab Data: Autopsy was done
CDC Split Type:

Write-up: developed fever and rash approx. 10 to 12 days after mmr was giver on Jan. 1, 1998, after rash was gone they developed cough around Feb 11, 1998. Mother took patient to doctor on Feb 16. Dx w/ pharyngitis and told increase heart rate due to infection. Sent home w/ antibiotic. On Feb 17, patient vomiting, mother called doctor, MD orderde suppository over phone. Mother tried suppository for vomiting, did not work. Patient appeared to be getting worse. By 3:00 am Feb 18 mother took patient to ER. Patient died by 4:ooam. Autopsy ordered. 4/17/09 Autopsy report states COD as acute viral myocarditis & manner of death as natural. Report also states patient had been seen by PCP for cold symptoms on 2/16/1998, dx w/pharyngitis & tx w/antibiotics. Later that day, began vomiting, called clinic & tx w/suppositories. Coughing & vomiting continued & developed fever on 2/18. Presented to ER on 2/18/98 w/very labored respirations & fever. Shortly after arrival, went into cardiopulmonary arrest, resuscitation unsuccessful.


VAERS ID: 343831 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Florida  
Vaccinated:2009-04-08
Onset:2009-04-09
   Days after vaccination:1
Submitted: 2009-04-09
   Days after onset:0
Entered: 2009-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3279AA / 1 LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0726X / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D01074 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1792X / 1 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Pulse absent
SMQs:, 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: 2009-04-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Mild congestion/ cold symptoms
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: Newborn Screen - normal
CDC Split Type:

Write-up: Patient brought in the clinic in the afternoon of April 8, 2009 for check-up and immunization. He had mild congestion only, vital signs were normal, gaining weight, no previous medical problems. Patient was given Pentacel, Hep B, Prevnar and Rotateq. The next day, in AM patient was brought to local ER apneic and pulseless. Patient pronounced dead at about 11:21AM. 8/17/09 Autopsy Report states Probable cause of death: Undetermined. Manner of death: Undetermined. Report additional notes: Preliminary Autopsy Findings - 1. Normally developed infant with height and weight at the 75th and 50th percentile respectively. 2. Rare thymic and epicardial petechia. 3. Bilateral lungs with small perivascular chronic inflammatory collections. 4. Pulmonary hemorrhage. 5. Microscopic mitral valve hemangioma. 6. Negative toxicological, microbiological, and neuropathology evaluations. Other Significant Conditions - Co-sleeping with adult(s), new sleep environment, childhood immunizations within 48 hours of death. 4/17/09 Received ER medical records of 4/9/09. FINAL DX: cardiopulmonary arrest Records reveal patient experienced unresponsiveness, asystole, EMS started CPR & unableto intubate. In ER, remained unresponsive w/fixed pupils, abd distention, pale & possible dependent lividity of back. Intubated in ER but resuscitation efforts were unsuccessful.


VAERS ID: 343839 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Male  
Location: Indiana  
Vaccinated:2009-03-11
Onset:2009-03-11
   Days after vaccination:0
Submitted: 2009-04-07
   Days after onset:27
Entered: 2009-04-09
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. 1511X / 1 UN / SC

Administered by: Private       Purchased by: Unknown
Symptoms: Asthenia, Death, Dyspnoea, Respiratory tract congestion, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-03-12
   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: Lipitor; Altace; Flomax; Coreg; Spironolactone
Current Illness:
Preexisting Conditions: CAD; COPD; HTN; Hyperlipidemia; CHF
Allergies:
Diagnostic Lab Data: Neg
CDC Split Type:

Write-up: Started w/chest congestion/shortness of breath on 3/11/09 PM. Vomiting, weakness on 3/12/09 PM. Death occurred 11PM 3/12/09. 4/16/09 Death Cert received from reporter who stated pt died at home. No Autopsy done. Cause of Death: Cardiac Arrest. Coronary Artery Disease. COPD


VAERS ID: 344158 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Unknown  
Location: Pennsylvania  
Vaccinated:0000-00-00
Onset:2008-02-01
Submitted: 2009-04-14
   Days after onset:437
Entered: 2009-04-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. - / 1 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0904USA00644

Write-up: It was reported in a newspaper article that a 3 year old received one dose of PEDVAXHIB (manufacturer unknown), and had onset of clinical syndrome of meningitis in February 2008, and died. No further information was available.


VAERS ID: 344159 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-04-14
Entered: 2009-04-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0904USA00515

Write-up: It was reported in a newspaper article that a child in who had received the full primary series of PEDVAXHIB (manufacturer unknown) (dates not reported) died of Hib disease, in 2008 a spokeswoman for the Health Department reported. She was unable to provide more details. No further information was available. 4/20/09 FDA spoke with the NJ health authority. The child received 3 doses of HIBV (unknown brand) and died of a brain abscess. The official did not know whether an autopsy had been performed, nor whether the abscess was cultured..


VAERS ID: 344160 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: Georgia  
Vaccinated:2009-03-31
Onset:2009-03-31
   Days after vaccination:0
Submitted: 2009-04-14
   Days after onset:14
Entered: 2009-04-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / SMITHKLINE BEECHAM AHAVB262A / 1 UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0570X / 1 UN / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2670AA / 1 UN / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B029AA / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Blood test abnormal, Death, Pyrexia, Streptococcal bacteraemia, Streptococcus identification test positive
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-04-03
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: sore throat 4/24/09 PCP records received which reveal 11yr WCC 3/31/09 with no medical c/o. Vax given- Hep A, Gardasil, TDaP and MCV4.
Preexisting Conditions: PMH: foot swelling. Sickle-cell trait.
Allergies:
Diagnostic Lab Data: diagnostic laboratory, a group A strep in the blood was found. Labs 4/1/09: CBC with WBCs 11.1 73% segs, 13.1% lymphs, 12.6% monos. UA WNL Labs 4/3/09: CK 116. LDH 389. Na+ 131. K 3.1. Cl 94. CO2 18.6. Anion gap 21.5. Glucose 170. Albumin 3.3. Globulin 4.2. AST 132. ALT 90. Aldolase 22.3. WBCs 8.4 with 16% bands, 12% lymphs. Abnormal RBC morphology. Hgb 11.1. Hct 33.6. MCV 70.3. MCH 23.4 UA (+) for 100 Glucose, urobilinogen 8.0, (+) reducing subst. UC (+). Blood cx (+) Strep pyogenes Group A. CXR ? bronchitis or atypical pneumonia.
CDC Split Type: WAES0904USA01011

Write-up: Information has been received from a physician concerning an 11 year old female who on 30-MAR-2009 (last week) was vaccinated with the first dose of GARDASIL. Concomitant therapy included VAQTA, MENACTRA and DTAP (unspecified) on the same day. Patient complained about sore throat a week prior to vaccination. A week later some kind test was performed and it showed that a group A strep in the blood was found. On approximately 30-MAR-2009, after getting the first dose of GARDASIL the patient experienced fever and pain in the hip after getting the vaccine. The patient died on 03-APR-2009. The patient sought unspecified medical attention. Additional information has been requested. 4/24/09 ER record received for DOS 4/1/09 with dx: Fever. Pediatric Viral syndrome. Pt presented with L hip pain and fever. PE (+) for tenderness over L anterior thigh. Tx with analgesic and d/c. 4/24/09 ER record received for DOS 4/3/09 with dx: Post-vaccination reaction. Pt presented again to ER with fever of 102''F, body aches, inability to walk 2'' to leg pain, nausea, vomiting, rash and polymyagias. PE (+) for extremity pain and swelling, rash, as well as not sleeping and acting differently. Transferred to higher level of care. 4/24/09 MR received for DOS 4/3-4/2009 with Final DX: Necrotizing fasciitis (gram (+) cocci with septic shock). Pt expired 4/4/09. Pt admitted from local facility for eval of fever with difficulty ambulating. Neuro/ortho consults on arrival with probable dx: infectious myositis. Tx with IV abx however IV access was lost and pt became hypotensive and with eveidence of septic shock with cardiovascular instability. Pt intubated and despite extensive resuscitation efforts pt expired. 4/24/09 Autopsy report received with COD: Necrotizing Fasciitis (Gram (+)) with septic shock.


VAERS ID: 344385 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-04-17
Entered: 2009-04-20
   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? 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: WAES0904USA02014

Write-up: Information has been received from an office manager that the physician heard from the physician''s colleague that a 16 year old female colleague''s patient was given an unspecified dose of GARDASIL (Lot not reported) on a Friday and on Monday the patient passed away (specific dates were unknown). The reporter considered the event as disabling and life threatening. Additional information has been requested.


VAERS ID: 344399 (history)  
Form: Version 1.0  
Age: 64.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-04-20
Entered: 2009-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cerebral infarction, Computerised tomogram abnormal, Death, Haemorrhage intracranial, International normalised ratio fluctuation, Rectal haemorrhage, Unresponsive to stimuli
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Warfarin
Current Illness: Unknown
Preexisting Conditions: PMH: on warfarin
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20090925

Write-up: A 64-year-old male patient was admitted to the hospital after becoming unresponsive. The family reported a 2-day history of bleeding from the patient''s rectum prior to admission. He had no recent changes in medical conditions or medication regimen, which included Warfarin for stroke prophylaxis secondary to atrial fibrillation. The patient had received an inactivated influenza vaccine 4.5 weeks prior to presentation, at which time his international normalized ratio (INR) was 2.0. During the 6 months prior to presentation, no medications were changed and no significant changes in the patient''s health were noted. Upon admission, the patient''s international normalized ratio was greater than 15; INR values over the previous 6 months had been relatively stable (range 1.4 to 4.7). A noncontrast computed tomography scan of the head showed a large parenchymal hemorrhagic infarction involving the left temporal, parietal, and occipital lobes. In the emergency department, the patient received a nitroglycerin infusion to maintain systolic blood pressure in the range of 140-160 mm Hg as well as an infusion of 4 units of fresh frozen plasma and 10 mg of vitamin K. Following a neurosurgery evaluation, it was determined that nothing meaningful could be done to alter the patient''s outcome positively, and he died approximately 17 hours after admission. The patient''s significant INR elevation, after being relatively stable for at least 6 months, was thought to be due to an interaction between warfarin and the influenza vaccination. The Horn Drug Interaction Probability Scale indicated a possible interaction between warfarin and the influenza vaccination. The authors also stated that the possibility of an unknown contributor to the INR elevation could not be totally excluded. Seriousness criterion: death. Causality: possible. Causality cannot be excluded as the pathomechanism remains unclear and therefore the temporal relationship cannot be assessed. Expectedness assessment according to agency label: The reported symptoms are expected after vaccination with BEGRIVAC, FLUAD, FLUVIRIN or AGRIPPAL. No change in benefit-risk-ratio. No measures necessary. 4/21/09 Per FDA COD: Intracranial hemorrhage./pc


VAERS ID: 344445 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Georgia  
Vaccinated:2009-03-26
Onset:2009-03-27
   Days after vaccination:1
Submitted: 2009-04-20
   Days after onset:24
Entered: 2009-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B114BB / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF366AB / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C80881 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0212X / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-03-27
   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: Synagis Given 03/26/2009 Left Leg IM Lot#31301568 Manufacturer MedImmune 2 doses previous & Synagis was Given 02/26/2009 IM Left Leg lot#07H609 Manufacter MedImmune 1 doses previous.
Current Illness: NA
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Apparant SIDS/Post Mortem Exam Pending. 9/14/09 Autopsy Report Received DOD 3/27/09 - Sudden unexpected death of infancy while co-sleeping. Manner of death undetermined.


VAERS ID: 344595 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Georgia  
Vaccinated:2009-04-15
Onset:2009-04-15
   Days after vaccination:0
Submitted: 2009-04-21
   Days after onset:6
Entered: 2009-04-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR - / UNK UN / UN
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-04-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0904USA02836

Write-up: Information has been received from a nurse concerning an 8 week old patient without any pertinent medical history who at approximately 11:00 in the morning of 15-APR-2009 was vaccinated with a 0.5 ml/0.5 mcg dose of RECOMBIVAX HB. Concomitant therapy included a dose of PENTACEL. In the afternoon of 15-APR-2009 the patient was found to be dead. It was reported that the patient sought medical attention before death. Additional information has been requested. 9/4/09 Autopsy Received DOD 4/14/09 - Sudden Infant Death Syndrome. Manner of death natural. Addtional information abstracted: Found supine and unresponsive on mattress. Grossly unremarkable 2 month (10 and 3/7th weeks) old male infant. Pulmonary edema. Rare epicardial and pleural and scattered thymic petechia. Simian crease of left palm.


VAERS ID: 344796 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: New York  
Vaccinated:2008-09-02
Onset:2008-09-02
   Days after vaccination:0
Submitted: 2009-04-24
   Days after onset:234
Entered: 2009-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B149AA / 2 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C86145 / 2 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0985X / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Alanine aminotransferase, Aspartate aminotransferase normal, Blood alkaline phosphatase increased, Blood calcium normal, Blood chloride normal, Blood creatinine decreased, Blood culture negative, Blood glucose increased, Blood magnesium normal, Blood pH, Blood phosphorus, Blood potassium normal, Blood sodium normal, Blood urea decreased, CSF culture negative, Carbon dioxide abnormal, Convulsion, Haematocrit decreased, Haemoglobin decreased, Heart rate decreased, Hypophagia, Hypotonia, Intensive care, Mechanical ventilation, PCO2 increased, PO2 increased, Platelet count normal, Respiratory syncytial virus test negative, Unresponsive to stimuli, White blood cell count
SMQs:, Liver related investigations, signs and symptoms (broad), Haematopoietic erythropenia (broad), Peripheral neuropathy (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-09-17
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ocygen, ?
Current Illness: chronic lung disease on oxygen
Preexisting Conditions: Chronic lung disease on oxygen therapy, retinoopathy of prematurity, periventricular leukomalacia, 24 week prematurity
Allergies:
Diagnostic Lab Data: labs on 9/16/08: Hb/HCT 9.7/29, WBC 6.42, platelets 355, sodium 140, potassium 4.2, chloride 101, CO2 31, BUN 4, creatinine <0.2, glucose 93, Alkaline phosphatase 430, ast 39, alt 22, calcium 10, magnesium 2,phosphorus 6.4, ABG - pH 7.37, pCO2 57.7, pO2 102,vancomycin trough 9.2, RSV negative, CSF and blood culture negative
CDC Split Type:

Write-up: about 12 hours after receiving his vaccinations, he developed poor intake of his feeds, and became limp and unresponsive (CPR was initiated). He did not have any fevers, vomiting, or diarrhea. He was admitted to the PICU and placed on nasal CPAP and oxygen. About 2 days before he died, while on the ventilator he had 2 -3 episodes of seizure like activity but remained stable on the ventilator. on the day of his death he had a sudden drop in his heart rate to 40 and was unresponsive. CPR was performed but were never able to obtain a heart rate or rhythm. There were no signs of seizure before this last event. 5/28/09 autopsy report received DOS 9/18/09. FINAL DIAGNOSIS: I. Complications of Prematurity A. Chronic Lung Disease B. Gliosis, Medullary Nuclei. II. History or Maternal Abruptio Placenta and Delivery by Caesarian Section. CAUSE OF DEATH: Compications of Prematurity. MANNER OF DEATH: Natural.


VAERS ID: 344816 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Arkansas  
Vaccinated:2009-04-16
Onset:2009-04-21
   Days after vaccination:5
Submitted: 2009-04-21
   Days after onset:0
Entered: 2009-04-24
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3279AA / 1 RL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0062X / 2 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D24322 / 1 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA693A / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-04-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: AR0912

Write-up: None stated. 6/22/09 Autopsy report received DOS 4/22/09. Cause of Death: Sudden Infant Death Syndrome (SIDS). Manner of Death: Natural.


VAERS ID: 345053 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Male  
Location: Texas  
Vaccinated:2007-10-10
Onset:2007-10-11
   Days after vaccination:1
Submitted: 2009-04-28
   Days after onset:565
Entered: 2009-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLLA037AA / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-11
   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: Lamictal - 100 mg/day as of 9/14/07; Zocor 20 mg/day; also on Vytorin 10/20 p.o. daily ?
Current Illness: none
Preexisting Conditions: artherosclerosis, obesity, mild epilespy, CAD with mildly elevated calcium score
Allergies:
Diagnostic Lab Data: Coroner''s report conludes he died as the result of artherosclerotic and hypersensitive-type cardiovascular disease, with obesity as a contributory condition.
CDC Split Type:

Write-up: Patient (68 year old male) received a flu shot on 10/10/07. He died that night in his sleep of a massive heart attack, presumably in the early morning hours of 10/11/07. Although previously diagnosed with mild artherosclerosis, he had never had a prior heart attack. He had just visited his doctor the previous day and been given a clean bill of health. 5/6/09 Autopsy report states COD as artherosclerotic & hypertensive-type cardiovascular disease w/obesity as contributing condition. Manner of death natural. Report also states 40-50% stenosis of LAD by calcified atherosclerotic plaque; atherosclerosis of aorta; cardiomegaly; obesity, BMI 34; hx of hypercholesterolemia; mild pulmonary edema/congestion; prostatic nodular hyperplasia; hx of seizure disorder.


VAERS ID: 345178 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2009-04-21
Onset:2009-04-23
   Days after vaccination:2
Submitted: 2009-04-25
   Days after onset:2
Entered: 2009-04-29
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3280AA / 1 LL / UN
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB706A / 2 RL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D16279 / 1 RL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1472X / 1 MO / PO

Administered by: Private       Purchased by: Unknown
Symptoms: Brain 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: 2009-04-24
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Wheezing 5/11/09-records received-Seen in ED and PCP office multiple times last visit 4/19/09 for recurrent fever. and croupy cough. Last 2 weeks with RSV and anemia.
Preexisting Conditions: Gastroesophageal reflux; Croup; Dehydration 5/11/09-records received-PMH: GERD. Family history of SIDS approximately 30 years ago.
Allergies:
Diagnostic Lab Data: 5/11/09-records received-H&H 8.6 and 26.7, Na 133, K 10.8, ABG 6.6. CXR severe bilateral airspace disease worse on right, likely reflects diffuse edema, severe bilateral pneumonia or pulmonary hemorrhage are other possibilities.
CDC Split Type:

Write-up: 4-23-09 Child had respiratory arrest @ home. He was life flighted to hospital where he is currently brain dead. Infant was given vaccines 4-21-09. 5/11/09-records received for DOS 4/24/09-presented to outside in ED in cardiac arrest transferrred to facility with PICU. Found in bed unresponsive and blue. Parent initiated CPR, intubated and placed on mechanical ventilator. Down time approximated at one hour or more before spontaneous return of circulation. 6/25/09 Autopsy report received DOS 4/25/09.


VAERS ID: 345318 (history)  
Form: Version 1.0  
Age: 0.1  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2009-04-24
Onset:2009-04-27
   Days after vaccination:3
Submitted: 2009-04-28
   Days after onset:1
Entered: 2009-04-30
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1677X / 2 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-04-27
   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:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None. 10/5/09 Autopsy received. Cause of Death: Sudden Infant Death Syndrome. Additional information abstracted: History of co-sleeping with both parents. Lividity present in anterior and posterior body with areas of blanching on left face and abdomen. Petechial hemorrhages of thymus and lungs. Pulmonary congestion and edema.


VAERS ID: 345435 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-04-30
Entered: 2009-05-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? 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: None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0904USA03499

Write-up: Information has been received via the internet concerning a 21 year old female who was vaccinated with GARDASIL. The patient died 4 days after vaccination. The cause of death was unknown. No further information is available.


VAERS ID: 346137 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-05-11
Entered: 2009-05-12
   Days after submission:1
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: 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: WAES0905USA00539

Write-up: Information has been received from a consumer who stated that he or she knew someone that died soon after receiving the MMR II. Attempts to verify the existence of an identifiable patient and reporter have been unsuccessful. No further information is available.


VAERS ID: 346325 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Ohio  
Vaccinated:2009-05-11
Onset:2009-05-12
   Days after vaccination:1
Submitted: 2009-05-14
   Days after onset:2
Entered: 2009-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3285AA / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D3437 / 2 RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Brain injury, Epistaxis, Life support, Mouth haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2009-05-16
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: 8/14/09 Hospital records received DOS 5/12/09 - 5/16/09. Patent foramen ovale.
Allergies:
Diagnostic Lab Data: 8/14/09 Hospital records received DOS 5/12/09 - 5/16/09. LABS and DIAGNOSTICS: EEG flat and consistant with brain death. Echocardiogram - abnormal, patent foramen ovale. Coagulation studies abnormal. HGB - 2g (L). BUN and Cr increased. CXR - abnomal.
CDC Split Type:

Write-up: Pt was found face down in his crib approximately 30 hours after vaccine administration. Blood was found around his nose and mouth. Pt currently on life support and has no brain activity. It is expected that he will not survive. Cause has not yet been determined. 9/1/09 Autopsy report staes COD as Cardiac arrest of undetermined etiology, four days prior to death on 5/16/09. Autopsy report also states contributory cause of death. History of prone position as found, islet cell hyperplasia of the pancreas, aspiration near the time of initial arrest. 8/14/09 Hospital records received DOS 5/12/09 - 5/16/09. Diagnosis: Cardiopulmonary arrest, seizures. Records reveal patient found by parents face down in bed and blood coming out of his nose and mouth. Parents began CPR. Transported to local hospital by EMS and was in full arrest upon arrival. Coded, pulses returned, and patient transported to this hospital. He was not responsive, pupils were fixed and dilated. Rib fractures. Noted to have abdominal distention and ileus. Became tachycardic, febrile, extremities cool. Poor peripheral perfusion. Agnonal respirations, ventiilator. Shock. Transfusions of FFP and PRBCs Seizure activity. Declared deceased and taken off ventilator.


VAERS ID: 346673 (history)  
Form: Version 1.0  
Age: 37.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2009-05-04
Onset:2009-05-09
   Days after vaccination:5
Submitted: 2009-05-18
   Days after onset:9
Entered: 2009-05-20
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (IMOVAX) / SANOFI PASTEUR 446011A / 1 RA / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Death, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-05-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Imogam Rabies-HT; lot # 26nc8x1 9/1/09 ER records received DOS 5/4/09. Administered Augmentin.
Current Illness: At the time of vaccination, illness was reported as "bitten by a bat".
Preexisting Conditions: The patient had no known allergies and he had not been taking any concomitant medications.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 200902102

Write-up: Initial report received from an assistant coroner on 11 May 2009, with additional information received 13 May 2009 from an emergency room health care professional. A 38-year-old male patient had received at 10AM in the hospital emergency room on 04 May 2009, a first intramuscular right deltoid injection of IMOVAX Rabies, lot number 446011A (also reported as 446601A; both lot numbers are invalid sanofi pasteur lot numbers, manufacturer was reported as Novartis). He also received a first right deltoid injection of Imogam Rabies-HT, lot number 26NC8X1 (invalid sanofi pasteur lot number, manufacturer was reported as Talecris). The sites of administration for the IMOVAX Rabies and Imogam Rabies-HT were also reported as "multiple deltoid, thigh, and buttocks". At the time of the report, there was no record of additional series doses and no record of other lot numbers. The patient had been bitten by a bat on their right index finger on the evening of 03 May 2009 and it was reported that the bat appeared to have been sick. It was unknown if the bat had been captured for testing. An unspecified amount of time after receiving the above vaccinations, the patient developed "continuous" vomiting and was subsequently found deceased on 09 May 2009. No additional information was provided at the time of the report. Documents held by sender: None. 8/28/09 Autopsy report. Cause of Death: Fatty liver. Other significant conditions: Chronic alcoholism. Opinion: The decedent has fatty liver changes and Mallory Weiss Syndrome both of which are consistent with chronic alcoholism. 9/1/09 ER records received DOS 5/4/09. Assessment: Bat Bite, Rabies Prone. Presents at ER with two puncture wounds on right index finger. Bitten by bat that looked sick. Imogram Rabies and Imovax rabies vaccine administered.


VAERS ID: 347042 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Female  
Location: Arkansas  
Vaccinated:2009-05-18
Onset:2009-05-19
   Days after vaccination:1
Submitted: 2009-05-20
   Days after onset:1
Entered: 2009-05-22
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B153AA / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D34438 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0011Y / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-05-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: AR0916

Write-up: Per Coroner mom was in bed with baby between pillow and mother on bed. Sheet & blanket in bed. Baby was on side when found. Mom attempted mouth to mouth then drove infant to ED.


VAERS ID: 347248 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Female  
Location: Florida  
Vaccinated:2009-05-22
Onset:0000-00-00
Submitted: 2009-05-26
Entered: 2009-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B087BA / 4 UN / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR A0491 / 2 UN / SC
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1580X / 1 UN / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0181Y / 1 UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-05-24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Keppra 0.5 mg PO daily
Current Illness: None
Preexisting Conditions: S/P Cardiac arrest; S/P stroke; R hemiparesis; S/P ALTE
Allergies:
Diagnostic Lab Data: Autopsy by Medical Examiners office
CDC Split Type:

Write-up: None noted. Pt was not seen in our office after vaccine administration. Death was reported to our practice on Tuesday AM 5/26/09. 7/10/09 Autopsy report states COD as idiopathic epilepsy. Report also states pt had history of cardiac pacemaker & seizure disorder. Admitted to hospital on 5/23/09 for local reaction w/swelling at injection site, had seizure & cardiac arrest on 5/24/09.


VAERS ID: 347446 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Georgia  
Vaccinated:2009-04-29
Onset:2009-05-05
   Days after vaccination:6
Submitted: 2009-05-18
   Days after onset:13
Entered: 2009-05-27
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3275AA / 1 RL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB659BA / 2 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C52997 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1449X / 1 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Apnoea, Death, Pulse absent, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-05-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None known
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 5/5/09 Pt was brought into ED by EMS. Pt was pulseless and apneic. Pronounced dead in ED. History was that pt was put on sofa for a nap at 7 AM. At 915, EMS was called because pt was not breathing. Pt in foster care. Coroner''s case. Possible SIDS. 9/4/09 Coroner''s Investigative Report DOS 5/5/09. Decedent found on stomach, not breathing by parent. Parent called 9-1-1 and started CPR.


VAERS ID: 348859 (history)  
Form: Version 1.0  
Age: 32.0  
Sex: Male  
Location: Illinois  
Vaccinated:2009-05-26
Onset:2009-05-28
   Days after vaccination:2
Submitted: 2009-06-10
   Days after onset:13
Entered: 2009-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB096AA / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-05-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Hypertension that was currently under control and was not on any medications.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Client received Twinrix vaccination on 5-26-09. Clt''s wife called Health Department 6-9-09 inquiring about services she received and mentioned in passing that her husband passed away on 5-28-09. "No one knows what happened" was quoted by the wife. 7/7/09 Autopsy report received. Cause of death is Diphenhydramine intoxication.


VAERS ID: 348907 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: Unknown  
Vaccinated:2000-06-06
Onset:2001-11-01
   Days after vaccination:513
Submitted: 2009-06-11
   Days after onset:2778
Entered: 2009-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Secondary transmission
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-11-04
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None (in infant)
Allergies:
Diagnostic Lab Data: Blood cultures, #1 Enterobacter cloacae, MND; #2 Klebsiella pneumoniae, MND; #3, Bacillus species, MND (not B. Anthracis); #4, Strep viridians, CWM
CDC Split Type:

Write-up: NOTE: Reported Adverse Event is death of vaccinee''s male infant/NOT VACCINEE. Infant male pronounced dead on 11/04/01 at age 2 months. (Born on 7 Sept 2001.) Autopsy opinion: Cause of death was interstitial pneumonitis and adrenal hemorrhage. Pathological findings include interstitial pneumonitis with intraalveolar extension. Adrenal hemorrhage was noted as well.


VAERS ID: 349339 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-06-16
Entered: 2009-06-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? 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: Coronary artery bypass
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0906USA02086

Write-up: Information has been received from a registered nurse concerning a patient with a history of coronary artery bypass who on an unspecified date was vaccinated with ZOSTAVAX (Merck) (lot number, route and site not reported) after cardiac bypass surgery and then died. It was unknown if the patient sought medical attention. The patient''s death was considered to be disabling. Additional information has been requested.


VAERS ID: 349359 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Iowa  
Vaccinated:2009-05-27
Onset:2009-05-29
   Days after vaccination:2
Submitted: 2009-06-17
   Days after onset:19
Entered: 2009-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3306AA / 1 UN / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1350X / 2 UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D39016 / 1 UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1487X / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-05-29
   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: None
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IA090008

Write-up: Presented to ER -Died 6/26/09 Autopsy report states COD as SIDS & cause of death as undetermined. Report also notes visceral congestion; petechiae of lungs; Simian creases of palms; undescended right testis; diaper dermatitis about anus; posterior neck capillary hemangioma; remote subdural hemorrhage.


VAERS ID: 349360 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Iowa  
Vaccinated:2004-12-21
Onset:2004-12-23
   Days after vaccination:2
Submitted: 2009-06-17
   Days after onset:1636
Entered: 2009-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U1300DA / UNK UN / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1154N / UNK UN / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X1006 / 1 UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A57561E / UNK UN / IM

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: 2004-12-23
   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: None
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IA090009

Write-up: Mom found baby unresponsive 12-23-2004. Went to hospital. 6/22/09 Autopsy report received DOS 12/24/04. Final Cause of Death: Probable encephalitis, Found face down in soft pillow.


VAERS ID: 349653 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Female  
Location: Michigan  
Vaccinated:2008-12-09
Onset:0000-00-00
Submitted: 2009-06-19
Entered: 2009-06-22
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. 1617X / UNK RA / SC

Administered by: Other       Purchased by: Other
Symptoms: Death, Encephalitis post varicella, Herpes zoster, Intensive care, Varicella
SMQs:, Opportunistic infections (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2009-01-18
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: Renal insufficiency; Hypertension; Coronary artery disease
Preexisting Conditions: Diabetes; Asthma; Myocardial infarction
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0906USA01827

Write-up: Information has been received from a physician concerning an 82 year old female patient with renal insufficiency, hypertension, coronary artery disease, a history of "diabetes", asthma, and a previous myocardial infarction (MI) who on 09-DEC-2008 was vaccinated subcutaneously in the right arm with a 0.65 mL dose of ZOSTAVAX (Merck) (lot # 662860/1617X, expiration date 14-MAY-2010). The physician reported that the patient''s husband had shingles and the patient inquired about the vaccine. The physician confirmed that the patient''s husband was not vaccinated with ZOSTAVAX (Merck) prior to developing shingles. Shortly after vaccination within 1 week to 1 month the patient developed an illness. The patient experienced shingles after receiving ZOSTAVAX (Merck). The patient was admitted to the hospital on 09-JAN-2009. She was in the ICU and then transferred to the long term unit prior to passing away. The physician explained that the hospital records mention varicella encephalitis, chickenpox complicated with encephalitis. He indicated that shingles was mentioned in the chart once. The physician did not provide a definitive diagnosis or cause of death. Shingles and pass away due to complication from the shingles were considered to be disabling and immediately life-threatening. Upon international review, the patient''s varicella encephalitis was considered to be other important medical event. A lot check has been requested. Additional information has been requested.


VAERS ID: 349674 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Male  
Location: New Hampshire  
Vaccinated:2009-05-21
Onset:2009-06-11
   Days after vaccination:21
Submitted: 2009-06-22
   Days after onset:11
Entered: 2009-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0601X / 1 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-06-11
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: THERE WERE NO ADVERSE EVENTS THAT WE ARE AWARE OF THE PATIENT DIED 06/11/09 WITH MEDICAL RESULTS PENDING I WAS TOLD I NEEDED TO FILL OUT REPORT REGARDLESS OF LACK OF PROOF THAT VACCINATION CONTRIBUTED WITH HIS DEATH. 8/31/09 Autopsy Report received. DOD 6/11/09 Cause of Death: Sudden Infant Death Syndrome (SIDS). Manner of Death: Natural.


VAERS ID: 349847 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New Hampshire  
Vaccinated:2009-02-19
Onset:2009-02-21
   Days after vaccination:2
Submitted: 2009-06-23
   Days after onset:121
Entered: 2009-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB6 92BA / 1 LL / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-02-21
   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: NONE
Current Illness: NONE
Preexisting Conditions: 34 WEEK PREMATURE DEVELOPED SOME GRUNTING AND SOME RESPIRATORY DISTRESS. JAUNDICE 6/29/09-records received-PMH:born 6 weeks premature.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: UNKNOWN 6/29/09-autopsy report received-COD-Undetermined.


VAERS ID: 350132 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Female  
Location: New Hampshire  
Vaccinated:2009-03-13
Onset:2009-03-23
   Days after vaccination:10
Submitted: 2009-06-25
   Days after onset:94
Entered: 2009-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB569AA / 1 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-03-23
   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: None known
Preexisting Conditions: Preterm twin infant (34 weeks gestation), SGA, hypoglycemia, apnea of prematurity. 7/13/09 DC summary received DOS 2/14/09 to 3/14/09 Discharge Diagnosis: First born twin, small for gestational age, Preterm very low birthweight newborn, Low risk of sepsis, breech presentation, Apnea of prematurity resolved. Born 33-6/7 Week. C-Section. During hospital stay infant was hypoglycemic and had mild apnea. Newborn Intensive care unit.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None known. 7/2/09 Medical Examiner report received. COD - Sudden infant death syndrome (SIDS).


VAERS ID: 350412 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2009-06-15
Onset:2009-06-15
   Days after vaccination:0
Submitted: 2009-06-29
   Days after onset:14
Entered: 2009-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR B0475 / 2 LL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D33501 / 3 LL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0083Y / 3 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-06-15
   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: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Sudden Death. 8/12/09 Autopsy records received. CAUSE OF DEATH - SUDDEN UNEXPLAINED INFANT DEATH. Infant found prone with head between the mattress and netting wall of the porta-crib.


VAERS ID: 350666 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-07-01
Entered: 2009-07-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? 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: WAES0906USA05296

Write-up: Information has been received from a physician concerning his/her daughter''s co-worker''s daughter who on an unknown date was vaccinated with GARDASIL. It was reported that the patient died after receiving a dose of GARDASIL. The cause of death was not reported. Attempts to verify the existence of an identifiable patient and reporter have been unsuccessful. No further information is available.


VAERS ID: 350967 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-07-07
Entered: 2009-07-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0907USA00328

Write-up: It was reported from an article published on 29-JUN-2009 that there were 27 deaths in 2008 said to be associated with GARDASIL. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.


VAERS ID: 351421 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2006-03-22
Onset:0000-00-00
Submitted: 2009-07-14
Entered: 2009-07-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0907USA00699

Write-up: Information has been received from a case in litigation via a case report concerning a child patient who on 22-MAR-2006 was vaccinated with a dose of MMR II (Lot number not reported) and concomitantly on the same day with a dose of poliovirus vaccine inactivated (unspecified) and a dose of DTaP (unspecified). On an unknown date, the patient died. The family member alleged that as a result of the administration of the vaccines on 22-MAR-2006. No further information is available.


VAERS ID: 351889 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: Unknown  
Vaccinated:2007-07-23
Onset:2007-07-28
   Days after vaccination:5
Submitted: 2009-07-20
   Days after onset:723
Entered: 2009-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB080AB / UNK LA / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Z08722 / UNK LA / SC
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR Z04332 / UNK RA / IM
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR UF057AA / UNK RA / SC

Administered by: Other       Purchased by: Other
Symptoms: Cerebrovascular accident, Chills, Computerised tomogram abnormal, Death, Fatigue, Headache, Scan brain, Subdural haematoma, Surgery
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Accidents and injuries (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-08-10
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 12 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Warfarin sodium; Lisinopril; Ascorbic acid; Unknown
Current Illness: Unknown
Preexisting Conditions: Cataract; Hearing loss; Pacemaker (Atrial Fibrillation); Quadruple heart bypass; Vitrectomy. 8/25/09 DC summary outpatient and hospital records received. Service dates 6/28/07 to 08/10/07. Recent malaria prophylaxis. Foot pain, partial colectomy for diverticulosis, ankle surgery, renal dysfunction, hyperplastic polyp. Coronary artery disease, pacemaker, anticoagulants.
Allergies:
Diagnostic Lab Data: 08 August 2007, Computed axial tomography (CAT) scan: diagnosis subdural hematoma of the brain. 8/25/09 DC summary outpatient and hospital records received. Service dates 6/28/07 to 08/10/07. LABS and DIAGNOSTICS: CT - Abnormal, subdural hematoma. Echocardiogram - Abnormal.
CDC Split Type: A0797113A

Write-up: This case was reported by a consumer and described the occurrence of stroke in a 70-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Co-suspect medication included COREG. The subject''s medical history included cataract, hearing loss, pacemaker (atrial fibrillation), quadruple heart bypass and vitrectomy. Previous and/or concurrent vaccination included live attenuated oral poliomyelitis vaccine; manufacturer unspecified; oral given on an unspecified date. Concurrent medications included COUMADIN, PRINIVIL, VITAMIN C and TYSHINI (unknown medication). On an unknown date, the subject started CARVEDILOL (oral) at 3.25 mg twice per day. On 23 July 2007 the subject received unspecified dose of TWINRIX (unknown). On 28 July 2007, five days after vaccination with TWINRIX and while on CARVEDILOL, the subject experienced stroke, subdural hematoma, headache, chills and tiredness. The subject was hospitalised. On 08 August 2007, the subject had Computed axial tomography (CAT) scan and was diagnosed subdural hematoma of the brain. The subject died on 10 August 2007 from stroke. It was unknown whether an autopsy was performed. Vaccine AE template documented during the call, after the call I realized that the patient was also taking COREG at the time of death. Customer stated that the patient received the TWINRIX vaccine on July 23, 2007 and on July 28, 2007 he developed a severe headache, chills, and tiredness that continued to worsen over time. The patient consulted his healthcare provider that recommended a CAT scan because the patient was taking COUMADIN. The CAT scan was performed on 8/8/2007 and a diagnosis of subdural hematoma of the brain was made, the patient was then prepped for surgery which was successful but died on 8/10/2007 due to a stroke. 7/28/09 Death certificate received. Final cause of death: Intracerebral hemorrhage. 8/25/09 DC summary outpatient and hospital records received. Service dates 6/28/07 to 08/10/07. Assessment: Subdural hematoma, atrial fibrillation, hypertension, coronary artery disease, hyperlipidemia, status post craniotomy for evaculation of subdural hematoma, status post right basal ganglia hemmorhage / brain herniation. Patient was complaining of headache. Hematoma evacuated. Brain herniation. Terminal extubation performed and patient expired.


VAERS ID: 351934 (history)  
Form: Version 1.0  
Age: 49.0  
Sex: Male  
Location: California  
Vaccinated:2009-07-02
Onset:2009-07-02
   Days after vaccination:0
Submitted: 2009-07-15
   Days after onset:13
Entered: 2009-07-20
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0424Y / UNK LA / SC
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B040AB / UNK LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-07-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type:

Write-up: Per translator client died 2 to 3 hrs. after receiving vaccines on 7/2/09. Autopsy is pending to determine cause of death. Due to language barrier unable to get more information.7/21/09-Nancy with Med Exam office called with preliminary COD: Coronary Artery Disease with no other significant conditions contributing to death. 8/13/09 Cause of Death: Coronary artery disease. Manner of death: Natural. Autopsy report summary of findings: I. Atherosclerotic cardiovascular disease. A. Calcific coronary artery disease, marked, involving three major vessels and left main. B. Aortic atherosclerosis, mild to moderate. II. Nephrosclerosis. III. Right rib fractures consistent with resuscitation efforts.


VAERS ID: 351970 (history)  
Form: Version 1.0  
Age: 37.0  
Sex: Female  
Location: Unknown  
Vaccinated:2009-05-08
Onset:2009-06-22
   Days after vaccination:45
Submitted: 2009-07-20
   Days after onset:28
Entered: 2009-07-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: AIDS encephalopathy, Acute respiratory failure, Aphasia, Blood HIV RNA increased, Blood pressure fluctuation, Brain death, Brain herniation, Brain oedema, CD4 lymphocytes decreased, CSF culture negative, CSF glucose decreased, CSF protein increased, CSF test normal, Computerised tomogram abnormal, Condition aggravated, Confusional state, Death, Dysarthria, Encephalitis, Endotracheal intubation, HIV antibody positive, HIV infection, Haematocrit decreased, Haemoglobin decreased, Heart rate irregular, Hypoaesthesia, Hyporeflexia, Lumbar puncture abnormal, Lymphocyte count decreased, Lymphocyte percentage decreased, Mental status changes, Migraine, Monocyte percentage increased, Neutrophil percentage increased, Nuclear magnetic resonance imaging brain abnormal, Pleocytosis, Pupil fixed, Red blood cell count decreased, Red blood cell sedimentation rate increased, Unresponsive to stimuli, White blood cell count decreased
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Peripheral neuropathy (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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? Yes
Birth Defect? No
Died? Yes
   Date died: 2009-07-02
   Days after onset: 10
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: None
Current Illness: HIV infection
Preexisting Conditions: Migraine; Amphetamine abuse; Bell''s palsy
Allergies:
Diagnostic Lab Data: head computed axial tomography, 06/22/2009, see narrative; spinal tap, 06/23/2009, see narrative; spinal tap, 06/23/2009, normalization of glucose; magnetic resonance imaging, 06/23/2009, brain: see narrative; head computed axial tomography, 07/02/2009, brain: see narrative; magnetic resonance imaging, diffuse cerebral edema with leptomeningeal enhancement; plasma HIV RNA quantification, 03/17/2009, HIV infected; plasma HIV RNA quantification, 06/12/2009, 45310 copies/ml; blood CD4 count, 06/23/2009, 263 cells/mm3; WBC count, 06/24/2009, 3.3 k/ul, low; blood CD4 count, 06/24/2009, 308 cells/mm3; hematocrit, 06/24/2009, 32.3 %, low; hemoglobin, 06/24/2009, 10.9 g/dl, low; WBC count, 06/25/2009, 2.6 k/ul, low; absolute lymphocyte count, 06/25/2009, 0.9 k/ul, low; absolute neutrophil count, 06/25/2009, low; hematocrit, 06/25/2009, low; hemoglobin, 06/25/2009, low; monocyte count, 06/25/2009, high; red blood cell count, 06/25/2009, 3.65 million/u, low; WBC count, 06/26/2009, 3.1 k/ul, low; hematocrit, 06/26/2009, 30.5 %, low; hemoglobin, 06/26/2009, 10.9 g/dl, low; red blood cell count, 06/26/2009, 3.69 million/u, low; erythrocyte sedimentation rate, 06/26/2009, 47 mm/hr, high; WBC count, 06/28/2009, 3.3 k/ul, low; hematocrit, 06/28/2009, 33.4 %, low; hemoglobin, 06/28/2009, 11.5 g/dl, low; absolute lymphocyte count, 07/01/2009, 0.7 k/ul, low; lymphocyte count, 07/01/2009, 9.2 %, low; neutrophil count, 07/01/2009, 67.6 %, high; lymphocyte count, 07/02/2009, 12.8 %, low; neutrophil count, 07/02/2009, 82.0 %, high; blood CD4 count, 391 cells/mm3
CDC Split Type: WAES0907USA01529

Write-up: Information has been received from an investigator concerning a 37 year old female with HIV and a history of migraine headaches and methamphetamine abuse for 20 years who entered a study. On 08-MAY-2009 the patient was enrolled in A5240 and vaccinated IM with the first dose of GARDASIL, 0.5ml, in deltoid. On 22-JUN-2009 the patient developed the following adverse events: altered mental status grade 3 (dysarthria, anomia, confusion); headache grade 3 (presented to HD 22-JUN-09 with AMS, HA). CT angle of head showed diffuse cerebral edema); left hand numbness grade 2. On 02-JUL-2009 the patient developed decreased neurological reflexes grade 4 (life threatening), pupils fixed and dilated bilaterally grade 4 (life threatening), and death. The report was as follows: The patient presented to emergency department on 22-JUN-2009 with migraine-like headache, left hand numbness, dysarthria and anomia. CT read as normal, patient discharged, the patient returned on 23-JUN-2009 with persistent headache, anomia. At that time, she was not on treatment for HIV and her CD4 count was 263. She was admitted to the neurology service and empirically treated with antibiotics for bacterial and HSV meningitis. Lumbar puncture showed borderline low glucose, elevated protein and a lymphocytic pleocytosis without red blood cells, CSF tests for EBV, HSV, VZV, Cryptococcus, VDRL, AFB smear were negative as well as CSF culture for bacteria, fungus and mycobacteria. CSF cytology was negative, flow cytometry was not performed. JC virus PCR was ordered, but results not reported. Toxoplasma IgG was negative. Blood cultures, coccidioidomycosis titers, serum cryptococcal antigen, RPR were all negative. Prior quantiferon testing in 2004 was positive without subsequent isoniazid treatment chest X ray during admission was negative as were 2 sputum for AFB smear and culture. MRI showed diffuse cerebral edema with leptomeningeal enhancement. Repeated lumbar puncture showed normalization of glucose. During the hospitalization, her symptoms had improved. Discharged to home 29-JUN-2009 with diagnosis of resolving viral meningitis vs. HIV encephalopathy. Initial consideration had been made of TB meningitis but her symptomatic improvement without TB treatment made this less likely. HIV treatment was not started during the hospitalization but was planned pending reevaluation after discharge and final review of all cultures and pending test. Re-presented emergency department on 01-JUL-2009 complained of worsening headache, symptoms and confusion; discharged as it was thought her symptoms were consistent with previous status. Returned to emergency department that night with confusion and altered mental status. At 5 AM on 02-JUL-2009, she acutely became unresponsive in the emergency room, requiring intubation and was noted to have fixed, dilated pupils bilaterally. Emergent head CT revealed diffuse cerebral edema and herniation. Pronounced brain dead of unknown cause on 02-JUL-2009. Post mortem pending, would take up to 8 weeks at this site before results were available. Relevant diagnostic tests conducted at the time of death occurred were as follows: On 22-JUN-2009, computerized tomography (CT, CT Scan, CAT Scan) of head: diffuse cerebral edema: 3 am left ICA aneurysm; bilat symm, optic nerve sheath distention. On 23-JUN-2009, magnetic resonance imaging (MRI) of brain: with contrast, diffuse supratentorial leptomeningeal enhancement, consistent with leptomeningitis. Diffuse sulcal effacement. Vague non enhancing T2/FLAIR hyperintensity multiple sites suggestive of infectious or toxic/metabolic etiology or PML. 02-JUL-2009, computerized tomography (CT, CT Scan, CAT Scan) of brain, profound diffuse sulcal effacement throughout cerebral hemispheres and posterior fossa. Severe downward tonsillar herniation and severe upward transtentorial herniation with compression of brainstem. The reporting investigator felt the event death was not related to study therapy. Study therapy association for the other events was not reported. Follow up information has been received from medical records. The patient had a past medical history significant for migraine headaches and HIV (new diagnosis, not on antiretrovirals, recent CD4 count 263 to 381), substance abuse, recent Bell''s palsy January 2009 and no known drug allergies. She was on no medications upon admission. The patient''s CD4 count on 24-JUN-2009 was 308 and a viral load on 12-JUN-2009 was 45310, diagnosed in March of 2009 and currently not on antiretroviral therapy. She was currently living in a drug rehab facility. The patient also had a history of past methamphetamine abuse and had been sober since March of 2009. The patient also had a questionable psychiatric history with a potential diagnosis of anxiety, borderline personality disorder, and depression. The patient also had a history of migraine disorders. She presented with a headache typical of her migraines but with additional features of left hand numbness, dysarthria, and anomia. The patient underwent a CT scan which was negative in the ED, and was initially sent home, and re-presented the next day with similar headache with anomia without hand numbness. A lumbar puncture was performed in the ED, remarkable for lymphocytic pleocytosis and decreased glucose, as well as elevated protein, and an MRI showed evidence for meningoencephalitis. The patient was admitted to the neurology service for further work up. The patient was hospitalized from 23-JUN-2009 to 28-JUN-2009. She was initially placed on vancomycin, cefapime, acyclovir, and ampicillin for bacterial meningitis treatment and HIV encephalitis treatment. When the results of the lumbar puncture were obtained, the antibiotics were discontinued and the patient remained on acyclovir until her PCR came back as negative. Infectious disease was consulted and upon discussion with them, the most likely differential diagnosis of the patient''s encephalitis was HIV encephalitis. Initially, a diagnosis of possible TB meningitis/encephalitis was entertained given the slightly low glucose. However, given that the glucose normalized on repeat lumbar puncture, the improvement of the patient''s condition throughout the hospitalization, and relatively benign course of the patient''s encephalopathy, it was felt that TB was much less likely. Lymphoma was still a possibility for the patient''s symptoms, and cytology was pending, although this was felt to be a much less likely diagnosis. The patient was discharged back to her program, with plans for close followup: retroviral therapy was to be initiated and she was to be followed up in neurology within 1 to 2 weeks. The discharge diagnosis on 28-JUN-2009 was human immunodeficiency virus (HIV) encephalopathy. Discharge medications included IMITREX, amlodipine, compazine (10 mg PO Q8H, PRN nausea/vomiting), ibuprofen (PRN headache). The patient was hospitalized again on 02-JUL-2009 with acute mental status changes. She was brought to the ED and around midnight or 12:15 on 02-JUL-2009 and it was noted at that time that the patient seemed to again have worsening headache, worsening confusion, as well as progressive acute mental status changes. Neurology was not contacted regarding the patient as the ED felt that the previous work up was satisfactory from a neurological standpoint. Primary medicine evaluated the patient, and it was determined she would be taken to their service. It was noted at 5:30 a.m. that the patient had a CT requested by the primary medicine serve to the ED prior to her transition up to the floor. Subsequently after that, the patient was noted at approximately 6 a.m. to have fixed pupils bilaterally and a change in blood and change in heart rate from an atypical bradycardia in the 40''s to a tachycardia. It was thought that the patient would be unable to protect her airway, and the decision was made to intubate the patient. The patient was subsequently successfully intubated after several tries. She was noted to have an acute decrease in her blood pressure to a hypotension of 50''s/40''s. It was then thought the patient was acutely decompensating, and the decision to place a central line was made in collaboration between the ED and the ICU staff. The ICU staff became involved at approximately 6:20 a.m. during the tail end of the intubation period. Central line was placed in the jugular vein. At the same time, the patient''s systolic blood pressure returned to the 110s. It was then noted that the patient was moving toward hypertension, and her dopamine was weaned from 10 to 5 and subsequently settled to about 8. She was brought to CT scan and subsequently to the floor. The initial read by the on-call radiologist demonstrated what appeared to be some mild edema, but otherwise negative. At approximately 8:30 the patient was being rounded on the ICU by the faculty and staff, and staff had noted dilated pupils bilaterally while in the ED after intubation and presented this to the team. During the examination by the attending physician, the radiology attending came and noted that the original read had missed important information regarding the patient''s clinical status. The attending contributed that the patient, in fact, did demonstrate a herniation of the posterior brain tissue into the spinal cord region. The patient was initially said to have decreased neurological reflexes in the ED, and this was corroborated and simultaneously neurosurgery and neurology were contacted and activated regarding the patient. Stat orders for mannitol and decadron were sent and administered to the patient. After evaluation by neurology and neurosurgery, it was determined that the patient in fact had suffered brain death. Intervention was discontinued around 10 a.m. and subsequently neurological evaluation for brain death commenced and terminated with determination of brain death at 1 p.m. on the afternoon of July 2, 2009. Support was withdrawn at approximately 1 p.m. The patient''s family was present and requested autopsy to be performed. The following laboratory tests were performed during the patient''s hospitalizations: sodium of 136, potassium 4.3, chloride of 95, BUN of 12, creatinase of 0.61 and glucose of 111. The patient had an IMR of 1.1, PT of 29.6, white count 7.9, hemoglobin and hematocrit 12.8 and 37.7 respectively with a platelet count in the upper 200s. The patient had blood cultures drawn that were pending, and urinalysis demonstrated 1+ protein, glucose, and bacteria with 0 to 2 white blood cells and 0 to 2 red blood cells. The patient also had a lumbar puncture from 29-JUN-2009 this showed 30 white blood cells and 3 red blood cells in tube 1 and 25 white blood cells and 2 red blood cells in tube 4 that were both lymphocyte predominant. The patient had several studies done in addition, ALF was 23, ABT 20, alkaline phosphatase 57, and total bilirubin 0.4 with a direct bilirubin of 0.1. The patient''s urine pregnancy was negative, urine was positive for opiates, and the patient had a serology from a previous admission that showed cocci and crypto negative. The patient also had a lactate of 4.6, protein 0.7, albumin 9.4, calcium 9.4, lipase 24. The patient was also noted to have a viral load of hepatitis C less than 3200, but also had positive hepatitis C antibodies. Hepatitis B and hepatitis A were found to be negative. A chest x-ray on the patient failed to demonstrate focal lesions, although there was mild left-sided hilar congestion. A CT scan of the head that was noncontract demonstrated herniation and edema. ECG demonstrated sinus bradycardia. CT neuro angiogram performed 22-JUN-2009, Impression: 1. Diffuse bilateral sulcal effacement of the cerebral hemispheres without herniation. This is suggestive of diffuse cerebral swelling with causes including toxic, metabolic, or infectious etiologies. 2. Bilateral symmetric optic nerve sheath distention without clear elevation of the optic discs suggestive of elevated intracranial pressure (ICP) correlate with fundoscopic exam findings and/or clinical symptoms referable to elevated ICP. 3. Incidentally noted 3 mm left supraclinoid ICA aneurysm, medially directed, may be a carotid cave aneurysm. 4. No acute large vessel territory ischemia or infarct, intracranial hemorrhage or extra-axial collection. There is no abnormal parenchymal or leptomeningeal enhancement. MRI brain scan with contrast performed 23-JUN-2009. Impression: diffuse sulcal effacement suggesting diffuse swelling. There is FLAIR hyperintensity and prominent enhancement within sulci. This may be due to vessel crowding within the narrowed sulci. However, a leptomeningeal process such as meningitis can also look like this. Correlation with CSF analysis is recommended. 2. Vague enhancing T2/FLAIR hyperintensity in the bilateral frontal white matter, left greater than right subinsular white matter, the left brachium pontis, the bilateral medial thalami, bilateral anteromedial temporal lobes. Diagnostic considerations include infectious etiologies such as HIV encephalopathy, herpes encephalitis, progressive multifocal leukoencephalopathy, or toxic/metabolic etiology. All medical records are available upon request. 9/8/09 Autopsy report received. DOD 7/2/09 Acute cerebrovascular event with uncal and tonsillar herniation due to severe and extensive CNS vasculitis. Additional clinical information abstracted: Migraines, history of substance / methamphetamine use, Bell''s palsy, altered mental status, HIV infection. Extensive vasculitis affecting blood vessels in leptomeniniges and throughout the brain and spinal cord. Severe hypoxic ischemic encephalopathy. Chronic meningitis. Heavy and congested lungs. Renal cortical scars, right and left kidneys, suggestive of prior infectious process. Reactive lymphadenopathy of axillary and paraaortic lymph nodes.


VAERS ID: 352162 (history)  
Form: Version 1.0  
Age: 0.21  
Sex: Female  
Location: Nevada  
Vaccinated:2009-07-17
Onset:2009-07-22
   Days after vaccination:5
Submitted: 2009-07-22
   Days after onset:0
Entered: 2009-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B201BA / 1 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF608AA / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D36147 / 1 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA692A / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-07-22
   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:
Allergies:
Diagnostic Lab Data: 7/23/09 Medical records and DC summary received. LABS and DIAGNOSTICS: CT Brain - Frontal hemorrhage. CBC - WBC 2.28 (L) HGB 14.5 (H) HCT 40.3 (H) MCV 88 (H) MCHC 36.2 (H) PLT 76 (L) MONO 2.6% (L) EOS 0.0% (L) NEUT# 0.89 (L) LYMPH# 1.30 (L) MONO# 0.06 (L) EOS# 0.00 (L). Coagulation - Protime 15.7 (H) INR 1.7 (H) PTT 140 (H) D-DIMER 35.20 (H). CHEM - CL 124 (H) Glucose 255 (H) Total Protein 4.5 (L) Albumin 3.2 (L) A/G ratio 2.5 (H) Calcium 7.7 (L) SGOT/AST 162 (H) SGPT/ALT 319 (H) Total Alk Phos 579 (H) Total CK 688 (H) Lactate 9.7 (H). Urine Tox Screen - Benzodiazapines. Urinalysis - color red, cloudy, glucose 100, blood large amt, protein 100, bacteria trace. Urine culture - E. Coli. Tracheal culture - Strep agalactiae, Staph aureus. Blood culture - no growth. Chest X-ray - abnormal, right pneumothorax.
CDC Split Type:

Write-up: The baby died under suspicious conditions this morning. 7/23/09 Medical records and DC summary received. Assessment: Multisystem organ failure, severe traumatic brain injury, acute respiratory distress syndrome, metabolic acidosis, rule out nonaccidental trauma. Patient presents with frontal traumatic brain injury, bilateral pneumothoraces, decreased hemoglobin and hematocrit. Pupils are 4 mm and fixed. Does not move face or extremities. GCS of 6T. Bruising to frontal scalp area, left knee. No corneal (reflex) no gag (reflex), no movement to pain. Diffuse hypotonia. Preretinal hemorrhage. Corneal edema. Anoxic encephalopathy. Depressed brain stem reflexes.


VAERS ID: 352293 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Oklahoma  
Vaccinated:2008-12-23
Onset:2009-02-14
   Days after vaccination:53
Submitted: 2009-07-23
   Days after onset:158
Entered: 2009-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2999A / 2 UN / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF516AA / 2 UN / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR A12292 / 2 UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D03125 / 2 UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1271X / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal distension, Autopsy, Convulsion, Death, Diet refusal, Disturbance in social behaviour, Dyskinesia, Hypersensitivity, Infection, Irritability, Screaming, Somnolence
SMQs:, Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Dyskinesia (narrow), Drug abuse and dependence (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-02-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: decreased level of consciousness~DTaP (Daptacel)~1~0.20~Patient|allergies, asthma, adhd, learning disabilities, language delay,
Other Medications:
Current Illness: None
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Autopsy unknow/undetermined, did not fit SIDS. Planning further review of autopsy by private pathologist, hopedully that specializes in autoimmune disorders.
CDC Split Type:

Write-up: She was born August 22nd, 2008, perfectly healthy, an easy, happy, delicate baby girl. She did not receive any Hep B vaccines. However, at two and four months she received all other vaccines according to the CDC''s schedule. Looking back, I see the downward spiral, but did not know what to look at the time. For this, I am extremely ashamed to admit, being that I have a medical degree. Her 2 month vaccinations were given 10/22/08. She was initially excessively sleepy, at 5 days she was irritable and refused to eat, within the first week her tongue began involuntarily protruding, at 5-6 weeks I believe she suffered a seizure which I did not recognize at the time as being that, she would also have frequent episodes of high pitched screaming. After the 4 month vaccines (12/23/08), similar things took place, however, there was not a seizure episode that I can recall. But she continued to become less interactive (would not respond to a loud blender 2 feet from her, sit quietly in bath chair for an hour, not react to play with siblings), bloated, allergy and infectious symptoms (but never spiked a high fever). I did give her tylenol the first two days after both sets of vaccinations because of the high fevers both my boys spiked with their vaccinations. Patient took a bottle at 6am, was awake til 945a, took another bottle, fell asleep in her papazon swing supine, nothing over her head, she made no sounds, picked her up to change her 45 ming later, and she was lifeless. Autopsy found nothing, unknown/undetermined. I am looking to find the appropriate person to review it and do further testing as indicated.


VAERS ID: 352836 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-07-30
Entered: 2009-07-31
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal tenderness, Autopsy, Back pain, Blood culture positive, Body temperature increased, Chest X-ray abnormal, Chills, Computerised tomogram normal, Death, Disseminated intravascular coagulation, Heart rate increased, Hypotension, Laboratory test abnormal, Metabolic acidosis, Neutrophil count increased, Oxygen saturation normal, Pneumococcal sepsis, Purpura, Pyrexia, Respiratory rate increased, Shock, Vomiting, White blood cell count increased
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Lactic acidosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Asplenia; Pulmonary fibrosis; Chronic alcoholism
Preexisting Conditions: Urinary tract infection; Sepsis; Pneumonia
Allergies:
Diagnostic Lab Data: blood pressure, 100/42 mmHg; chest X-ray, revealed right lung haziness; computed axial, abdomen and pelvis showed no acute intraabdominal process; diagnostic laboratory, showed disseminated intravascular coagulation (DIC) and metabolic acidosis; body temp, 38 degr; total heartbeat count, 113 min; blood culture, showed streptococcus pneumoniae after death; respiratory rate, 26 min; arterial blood O2, 95%, on room air; WBC count, 15.5 10^3; absolute neutrophil, 94%;
CDC Split Type: WAES0907USA03866

Write-up: Information has been received from a published article that an overwhelming postsplenectomy infection (OPSI) is a low-incidence entity with a high mortality rate despite aggressive therapy. Although initial symptoms may be mild and nonspecific, it can progress rapidly to Waterhouse-Friderichsen syndrome with full blown septic shock and disseminated intravascular coagulation (DIC). Overwhelming postsplenectomy infection is known to occur at any time after splenectomy, even in patients who have received pneumococcal immunization and/or chemoprophylaxis. Although the term OPSI gives the impression of a "postsurgical" complication, it has been seen in association with conditions predisposing to functional hyposplenism and in children with congenital asplenia. The physicians reported there had been no previously reported cases of OPSI in a pneumococcal vaccinated adult with congenital asplenia. A 67 year old woman with congenital asplenia presented to the emergency department complaining of chills, fever, severe low back pain, and vomiting of 24 hours of duration. She had a recent history of a treated urinary tract infection and a remote history of sepsis and pneumonia, for which she was hospitalized and treated in other institutions. The patient also had a diagnosis of lung fibrosis of uncertain etiology and was a chronic alcohol user. The patient had received pneumococcal vaccination 1 year prior. On physical examination, she was found to be alert and in no acute distress. Her temperature was 38 degrees C orally; blood pressure, 100/42 mmHg; heart rate, 113/min; respiratory rate, 26/min; and oxygen saturation, 95% on room air. She had mild tenderness to palpation in the right lower abdominal quadrant and positive bowel sounds. Her initial blood workup showed an elevated white blood cell count of 15.5 x 10^3/mm^3 with 94% neutrophils. A chest x-ray revealed right lung haziness. A computer tomographic scan of the abdomen and pelvis documented no acute intraabdominal process. Blood and urine samples were obtained for cultures. Within a few hours of presentation, the patient developed a diffuse purpuric rash with severe hypotension. Cefepime and vancomycin were started. Additional laboratory tests revealed disseminated intravascular coagulation (DIC) and metabolic acidosis. Cortisol levels were within normal limits, although lower than expected considering the patient''s condition. Despite administration of vasopressors agents and intravenous fluids, she developed shock and died in less than 24 hours after presentation. At autopsy a diffuse purpuric rash was noted. There was massive bilateral adrenocortical hemorrhagic necrosis. A recent subdural hemorrhage and scattered focal hemorrhages in the heart and gastrointestinal tract were present. The right lung was extensively fibrotic. Interstitial fibrosis and bronchiectasis were seen bilaterally. There were focci of organizing pneumonia in the right upper lobe and a focus of acute bronchitis in the right middle lobe. The liver showed severe steatosis and findings consistent with chronic alcoholic liver disease. Arterionephrosclerosis was seen in both kidneys. The bone marrow was hypercellular with a few paratrabecular aggregates of monotonous appearing lymphocytes. Asplenia was the only congenital abnormality. Premortem blood cultures reported after death grew Streptococcus pneumoniae sensitive to penicillin and cefotaxime. The urine culture had negative results. Although the patient provided a history of congenital asplenia, the absence of alarming signs at presentation, in addition to an up-to-date pneumococcal vaccination and noncritical initial physical examination and laboratory studies, gave the false impression of a relatively stable patient who could be worked up for a precise diagnosis and subsequent treatment. Prior pneumococcal vaccination should not be reassuring as seen in this patient who in vivo blood cultures grew Streptococcus pneumoniae. The protective role of pneumococcal 23-valent vaccine for adults aged greater than 65 years remains controversial because some older patient do not develop an immune response to the most prevalent serotypes causing invasive disease. In addition, antibody concentrations and response may be lower in elderly patients with comorbid illnesses such as alcoholic cirrhosis, chronic obstructive pulmonary disease, and lymphoproliferative disorders. The 67 year old patient had comorbid illnesses including chronic alcoholic liver disease and severe lung fibrosis. Because OPSI Is a virulent entity with a 50% to 80% case fatality ensuing in less than 48 hours, diagnostic workup should never delay the initiation of empiric antibiotic therapy. As seen in this case, when the initial clinical presentation is mild or nonspecific, physicians may have a false sense of security and attempt to reach a precise diagnosis instead of intervening early with empiric antibiotics. Consequently, this may result in death, even when the delay is only of a few hours. Overwhelming postsplenectomy infection can occur at any time after splenectomy and as demonstrated by this patient should also be considered in adults with congenital asplenia. Additional information is expected. A copy of the published article is attached as further documentation of the patient''s experience. 9/3/09 Per FDA COD=Pneumococcal Sepsis.


VAERS ID: 352838 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-07-30
Entered: 2009-07-31
   Days after submission:1
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: 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: WAES0907USA05047

Write-up: Information has been received from a consumer concerning a fried of the physician''s daughter, who on an unspecified date was vaccinated with a dose of MMR II. Subsequently the patient died. The cause of death was unknown. Attempts are being made to verify the existence of an identifiable patient. This is one of two reports from the same source. No further information is available.


VAERS ID: 353311 (history)  
Form: Version 1.0  
Age: 0.15  
Sex: Male  
Location: Colorado  
Vaccinated:2009-08-05
Onset:0000-00-00
Submitted: 2009-08-06
Entered: 2009-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3277AA / 1 LL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBV663AA / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D24322 / 1 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41DA692A / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-08-06
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: N/A
Preexisting Conditions: N/A
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: none, 9/25/09 Autopsy report received - Cause of Death - Probable Partial Mechanical Obstruction of Airway by Ectopic Thymus. By history baby developed "noisy breathing" by evening. Found prone and unresponsive. Only explanation for abnormal breathing sounds was a benign growth, an extra thymus gland, growing in the wrong place next to his trachea.


VAERS ID: 353395 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: Unknown  
Vaccinated:2009-07-15
Onset:2009-07-19
   Days after vaccination:4
Submitted: 2009-08-07
   Days after onset:19
Entered: 2009-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B173AA / UNK UN / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF569AA / UNK LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D37015 / UNK RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FA782A / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-07-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: 10/5/09 Medical records received w/PMH: left clavicle fx at birth.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A0800503A

Write-up: This case was reported by a healthcare professional, via a GSK representative and described the occurrence of death nos in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included Haemophilus influenza type b vaccine (non-gsk) (non-GSK manufacturer) given on 15 July 2009; PEDIARIX (GlaxoSmithKline) given on 15 July 2009; PREVNAR (non-gsk) (non-GSK manufacturer) given on 15 July 2009. On 15 July 2009 the subject received unspecified dose of ROTARIX (details unknown). On 19 July 2009, 4 days after vaccination with ROTARIX, the subject experienced death nos. The healthcare professional considered the event was possibly related to vaccination with ROTARIX. The subject died on 19 July 2009; cause of death was not specified. It was unknown whether an autopsy was performed. No further details were reported. 8/13/09 Received PCP medical records of 3/24/09- Records reveal patient seen in office on 7/7/09 for wet cough, nasal congestion, rhinitis, eating difficulty. Dx viral URI. Sick family member. RTC 7/9/09 w/vomiting, cough, decreased appetite x 3 days. Dx viral gastroenteritis. RTC 7/15, well child visit w/shots. Immediately after shots had emesis x 1 then perioral cyanosis w/recovery in 5 min. ER records of 7/18/09 included which reveal patient arrived in full arrest approx 9 hr after being put to bed w/Tylenol, in asystole & unable to intubate due to rigor. 10/5/09 ER records received for 7/18/09 which had been previously received.


VAERS ID: 353731 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2009-07-28
Onset:2009-08-03
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2009-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2920AA / 1 LA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-08-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None Known
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pt. committed suicide on 8-3-09. 9/25/09 Autopsy report received - DOD 8/3/09 Asphyxiation due to hanging.


VAERS ID: 354351 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: New York  
Vaccinated:2009-04-01
Onset:2009-05-01
   Days after vaccination:30
Submitted: 2009-08-14
   Days after onset:105
Entered: 2009-08-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. 0131Y / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abasia, Biopsy skin abnormal, Pemphigoid, Rash generalised
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Skin tumours of unspecified malignancy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-11
   Days after onset: 255
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: Neuromuscular disorder (NOS)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: biopsy, 05/??/09, diagnosed with bullous pemphigoid
CDC Split Type: WAES0908USA01901

Write-up: Information has been received from a consumer concerning her 77 year old husband with neuromuscular disorder and no known drug allergies who in April 2009, was vaccinated with a dose of ZOSTAVAX (Merck) (route and lot number not reported). About a month later, in approximately May 2009, he started to develop a rash on his elbow which then spread all over his body. The patient''s wife reported that the patient saw his physician who sent him to a dermatologist who then sent him to have blood test and a biopsy and the patient was diagnosed with bullous pemphigoid. The consumer reported that the patient already had a neuromuscular disorder and was walking with a cane, then to a walker and after receiving ZOSTAVAX (Merck) he could not walk at all and was in a nursing home to do rehab, but because of the rash, the patient could not do the rehab. At the time of reporting, the patient had not recovered from the events. Upon internal review, he could not walk at all was considered to be disabling. No further information is available.


VAERS ID: 354571 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2009-05-30
Onset:2009-06-01
   Days after vaccination:2
Submitted: 2009-08-18
   Days after onset:78
Entered: 2009-08-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0932X / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C68309 / 4 LL / IM

Administered by: Private       Purchased by: Other
Symptoms: Blood culture positive, CSF culture positive, Cerebrovascular accident, Condition aggravated, Death, Discomfort, Eye disorder, Irritability, Meningitis pneumococcal, Pneumococcal sepsis, Pyrexia, Streptococcus identification test positive, Upper respiratory tract infection, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-06-23
   Days after onset: 22
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: Concomitant medications were not reported.
Current Illness: Unknown 9/1/09-records received-Upper respiratory viral infection 2 weeks prior to admission.
Preexisting Conditions: The patient has a past history of wheezing (during the winter of 2008-2009 and 09-Jun-2009 to 13-Jun-2009). The child''s age appropriate immunization schedule included: Diphtheria/Tetanus Toxoids/Acellular Pertussis Vaccine, Hepatitis B Vaccine, Haemophilus Influenzae B and IPOL. Per the treating physician the patient attended daycare and the patient had no significant medical history. 8/24/09 Hospital records received DOS 6/21/09 to 6/23/09. Cough. Wheezing.
Allergies:
Diagnostic Lab Data: CSF culture (results: Positive for Streptococcus pneumoniae) and blood culture (results: Positive for Streptococcus pneumoniae) were done in Jun-2009. 8/24/09 Hospital records received DOS 6/21/09 to 6/23/09. LABS and DIAGNOSTICS: Urinalysis - Dark Yellow, Ketone 80, Protein 300, RBC Many /hpf, Bacteria Many /hpf, Hyaline Cast 10-20 /hpf. Basic Metabolic Profile - CO2 19 mmol/L (L) Glucose 118 mg/dl (H) Phosphorus 2.5 mg/dl (L). CBC - RBC 3.93 /pL (L) HGB 10.6 g/dl (L) HCT 32.3% (L) RDW CV 16% (H) Platelet 24 /nL (L) Monocytes 3.0% (L) Bands 20% (H) Lymphocytes Abs 2.8 (L). Prothrombin Time 20.2 sec (H) Activated PTT 42.8 sec (H) Fibrinogen 539 mg/dl (H). C-Reactive Protein 315.2 mg/L (H). Sed Rate 100 mm/hr (H). Spinal Tap / CSF - Turbid, WBC 167 /UL (H), RBC 15 /UL (H) Lymphocytes 25% (L), glucose <1 mg/dl (L), Total Protein 474 mg/dl (H), gram stain Gram positive cocci, culture Strep pneumoniae. Blood culture - gram positive cocci, Strep pneumoniae. Urine culture - no growth. Vancomycin Trough 57.7 ug/ml (H). Blood gases abnormal. Negative Viral tests.
CDC Split Type: USWYEH10544309

Write-up: Information regarding PREVNAR was received from a healthcare professional regarding a 12-month-old male patient who experienced pneumococcal meningitis, pneumococcal sepsis, upper respiratory infection and stroke. The patient received the fourth dose on 30-May-2009. The patient also received the first dose of VAQTA (Merck) on 30-May-2009. During the winter of 2008-2009 the patient experienced wheezing, treatment unknown. On 09-Jun-2009 the patient was seen in the office with wheezing treated with ORAPRED in addition to PULMICORT and Albuterol inhalation therapy. On 13-Jun-2009 follow-up showed the wheezing resolved. On 20-Jun-2009 the patient presented to the physician with a two day history of fever, fussiness and being uncomfortable per the parents. In the office the child engaged with the staff and was playful. He was afebrile with no cough noted and was diagnosed with an upper respiratory infection, treatment unknown. On 21-Jun-2009 the parents telephoned the office and "seemed nervous which was not normal for them". The physician examined the child and noticed a drooping eye, side unknown, and was diagnosed with stroke. This event was considered medically important. The child was admitted to the local hospital and on an unknown date was transported to another hospital. On 23-Jun-2009 the child died. The cause of death was reported as meningitis pneumococcal and pneumococcal sepsis. Serotype testing was not performed at the time of this report but is being requested by the child''s physician. No additional information was available at this time of this report. 8/24/09 Hospital records received DOS 6/21/09 to 6/23/09. Assessment: Fever. meningitis. Patient earlier this day presented at ED with fever. Seen later for drooping and swelling of right eyelid and vomiting after Advil. Moderate distressed, photophobia, fussiness. Not alert, moaning, hypotonic. 9/1/09-records received for 6/23/09-COD-Pneumococcal meningitis, septic shock, acute respiratory distress syndrome, multiorgan failure, left hemispheric infarct. Transferred from another facility after presenting with febrile illness, progressive lethargy and poor feeding and worsening respiratory distress. Developed respiratory failure intubation and ventilator support, developed shock, multiorgan failure.


VAERS ID: 355056 (history)  
Form: Version 1.0  
Age: 50.0  
Sex: Male  
Location: Florida  
Vaccinated:2009-01-25
Onset:2009-01-25
   Days after vaccination:0
Submitted: 2009-08-24
   Days after onset:210
Entered: 2009-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. UNKNOWN / UNK RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anaphylactic reaction, Anaphylactic shock, Immediate post-injection reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-01-25
   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: List includes PRN meds / standing orders over one month hospital stay:Tylenol PO, Norvasc PO, Bisacodyl PO,chlorpromazine IM, clonidine PO, Cardene IV, fentanyl IV, haldol IM, Primaxin IV, hydralazine IV, labetolol IV, levaquin IV, Ativan I
Current Illness: anaphylaxis (immediate)
Preexisting Conditions: Allergy to ace inhibitors (swollen lips, a sign of angioedema). PMH of hypertension x 14 years.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: anaphylaxis (immediate) 9/10/09 Received hospital medical records of 12/2/08-1/24/2009. FINAL DX: Expired; malignant neoplasm of kidney; pulmonary insufficiency; HTN; hypertensive urgency; pulmonary atelectasis; acute pancreatitis; paralytic ileus; bacteremia; peritoneal abscess; pure hypercholesterolemia; GERD; anxiety; cardiac dysrhythmia; anemia; leukocytosis; psychosis; gastroparesis; hematuria; hypertensive chronic kidney disease Records reveal patient experienced progressively increasing abdominal pain & swelling x 11 mo. Nephrology, Uro, Heme/Onc, gen surgery, Cardio, Pulm, ID consults done. Taken to 12/19 OR for exp lap, radical left nephrectomy, jejunostomy & appendectomy. Developed post op HTN, fever, pancreatitis, ileus, psychosis & OBS. Taken back to OR for re-exploration of bowel obstruction requiring bowel resection & removal of massive adhesions, abdominal wound left open. Chest tube & thoracotomy. Progressed slowly & was ready for d/c to home when he received the vaccine. Patient developed immediate respiratory difficulty, had a seizure & respiratory-cardiac arrest & was unable to be resuscitated. ME refused autopsy but was done in hospital


VAERS ID: 355131 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Female  
Location: Washington  
Vaccinated:2009-08-11
Onset:2009-08-14
   Days after vaccination:3
Submitted: 2009-08-21
   Days after onset:7
Entered: 2009-08-25
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3297AA / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D39015 / 2 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-08-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZANTAC
Current Illness: None
Preexisting Conditions: GERD
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt found dead in crib on 8/14/09. Preliminary autopsy showed no cause of death. 12/29/2009 Autopsy report received. Cause of Death: Sudden Unexplained Infant Death. Additional information abstracted: History of prone sleep position, Intrathoracic petechia (pleural and thymus involvement). Toxicology: acetaminophen (+), carbon monoxide <5 % Sat. Skeletal Survey - Hypoventilatory chest.


VAERS ID: 355219 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Texas  
Vaccinated:2009-03-25
Onset:2009-03-31
   Days after vaccination:6
Submitted: 2009-08-25
   Days after onset:147
Entered: 2009-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Diet refusal, Eosinophilic myocarditis, Feeling cold, Histology, Irritability, Jaundice neonatal, Unresponsive to stimuli, Vomiting
SMQs:, Congenital, familial, neonatal and genetic disorders of the liver (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Congenital biliary disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (narrow), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-04-01
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None, maybe jaundice several days after birth
Allergies:
Diagnostic Lab Data: none besides the histology of the heart.
CDC Split Type:

Write-up: Decedent is a 7 day old neonate who was given the hepatitis B immunization at birth (Energix B). Lot # AHBVB663AA. Decedent discharged on March 27, 2009 without complications. On March 30, 2009 decedent was taken to pediatrician mild jaundice. Labs taken and was told to come back in two weeks. In the evening of March 31, 2009, the decedent was very fussy, vomiting, and not taking formula. The mother tried comforting the baby all evening of March 31, 2009 and in the early morning hours of April 1, 2009. At approximately 6 AM, the mother felt the baby to be cold (the mother was sleeping with the baby in a possibly compromising position). The mother got up with the baby and walked her around and then when she was going to bed again, she saw the neonate take two deep breaths and become unresponsive. Autopsy revealed a normally developed female neonate with extensive necrotizing eosinophilic myocarditis. I did a literature search and found that hepatitis B vaccine maybe associated with this type of myocarditis and that is why I am reporting it. The cause of death for the death certificate reads "necrotizing eosinophilic myocarditis." I am not including the vaccination because I do not believe there is a direct correlation, but I felt I should report the case for potential correlation. The neonate was never given any prescription medications that I am aware of. Not sure if mother gave anything. 8/26/09-autopsy report received-COD-Necrotizing eosinophilic myocarditis.


VAERS ID: 355396 (history)  
Form: Version 1.0  
Age: 63.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2008-09-09
Onset:2008-10-01
   Days after vaccination:22
Submitted: 2009-08-25
   Days after onset:328
Entered: 2009-08-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA155AA / 1 UN / UN

Administered by: Private       Purchased by: Public
Symptoms: Cardiac failure, Death, Hypoaesthesia, Intensive care, Mobility decreased, Muscular weakness, Pain in extremity, Paralysis, Wheelchair user
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (narrow), Peripheral neuropathy (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-10-21
   Days after onset: 20
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 17 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: FLOMAX; ASPIRIN; LOPID; TORSEMIDE; LYRICA; QUINAPRIL; DIOVAN; ZOCOR; CLONIDINE; ZEMPLAR; HUMULIN; Fish oil; Calcium
Current Illness: Diabetes; Renal failure
Preexisting Conditions: Diabetes; Diabetic neuropathy; Renal disease; Stroke. 9/11/09 Hospital records received DOS 10/6/08 to 10/21/08. Known history of recent myocardial infarction. Type 2 Diabetes Mellitus. Diabetic neuropathy and retinopathy. Diabetic nephropathy. Hyperlipidemia. Bilateral ankle surgery. Immobility. History of lumbar degenerative disk disease. Hypertension.
Allergies:
Diagnostic Lab Data: See med. records - too numerous. 9/11/09 Hospital records received DOS 10/6/08 to 10/21/08. LABS and DIAGNOSTICS: CD4/CD8 Ratio - Normal. CSF Oligoclonal Bands (IEF) - Total Protein 133 mg/dL (H) IgG 11.20 mg/dL (H) Albumin 77.7 mg/dL (H) Synthesis Rate 11.3 (H). Serum - IgG 558 mg/dL (L) Albumin 2200 mg/dL (L). No evidence of IgG bands in CSF or serum. CSF - Glucose 94 mg/dL (H) Sodium 146 mmol/L (H) Potassium 5.1 mmol/L (H). CHEM - Potassium 7.5 mmol/L (H) Chloride 113 mmol/L (H) BUN 104 mg/dL (H) Creatinine 3.84 mg/dL (H) Glucose 247 mg/dL (H) ALKPHOS 525 U/L (H) ALT 901 U/L (H) AST 3348 U/L (H) Amylase 191 U/L (H) Bilirubin Direct 1.0 mg/dL (H) LDH 560 U/L (H) Phos 14.1 mg/dL (H) SGGT 189 U/L (H) Uric Acid 9.5 mg/dL (H) CK 73311 U/L (H) CKMB 172.4 ng/mL (H) Troponin 6.38 ng/mL (H). CRP 24.27 mg d/L (H). D-DMR $g1000 ng/mL (H). PT 23.6 drc (H). Parathroid PTH 426.2 pg/mL (H). Thyroid Profile abnormal. HGB A1C 8.2% (H). CBC - HGB 7.4 g/dL (L) HCT 22.5% (L) RBC 2.51 M/mm3 (L) RDW 18.5% (H) Platelets 143 Thou/mm3 (L) Neut 13.7 Thou/mm3 (H) WBC 22.0 Thou/mm3 (H) Sed Rate 110 mm/HR (H). Culture (R) foot - Positive Coagulase Negative Staph. Fecal Occult Blood (+). Urinalysis - Orange, Turbid, Sp Grav 1.033 (H), Protein (+) Glucose (+) Acetone (+) Occult Blood (+) WBC (+) RBC (+) Renal Epith (+). Segnmental BP LE - Abnormal.
CDC Split Type:

Write-up: On 10-01-08 he complained of soreness and unusual weakness and numbness in legs (after physical therapy). Had to have help to & from wheelchair and bed. Much worse Thur, Fri. By Sat. he could not move on his own from chest down. Convinced him to go to ER on Sunday. Paralyzed by PM 10-05-08. Transferred to hospital 10-05-08, put in ICU AM 10-06-08. Code blue (heart failure 10-10-08). See med. reports (Also I kept diary) too numerous. 9/11/09 Hospital records received DOS 10/6/08 to 10/21/08. Assessment: Cardiorespiratory failure. Advanced Guillain-Barre Syndrome. Chronic renal disease with initiation of hemodialysis. Type 2 Diabetes Mellitus with increased rhabdomyolysis. Episode of supraventricular tachycardia. Episode of cardiac arrhythmia. Probable sepsis. Patient transfered to facility after noticing weakness in upper and lower extremity. Plasmapheresus. Renal functioning worsened. Flaccid. Pneumonia. Extubated per patient''s desire. Quickly expired. 10/5/09 Death Cert received with COD=Cardiorespiratory Failure due to End Stage Renal Disease due to Guillain-Barre Syndrome


VAERS ID: 355624 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-08-26
Entered: 2009-08-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 2 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0908USA03961

Write-up: Information has been received from a consumer who reported a female child died after the second dose of MMR II (route and lot number not reported). Attempts to verify the existence of an identifiable patient and reporter have been unsuccessful.


VAERS ID: 356434 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Kentucky  
Vaccinated:2009-07-15
Onset:2009-08-09
   Days after vaccination:25
Submitted: 2009-09-03
   Days after onset:25
Entered: 2009-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B177CA / 1 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF569AA / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D39016 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0571Y / 1 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: 2009-08-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: reflux
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: No known adverse reactions. Aunt reports infant died of SIDS on 8/9/09. 12/29/09 Autopsy report received. DOD 8/09/09. Cause of Death: Consistent with Sudden Unexplained Death in Infancy. Additional Information Abstracted: A. Co-sleeping male infant with parental caregivers. B. Petechia of heart. C. Pulmonary edema. D. No evidence of congenical anomaly. E. No evidence of trauma. F. Postmortem toxicological screen of the postmortem blood negative for drugs and ethanol. II. History of Colic and Thrush per family. A No gross lesions of mouth. III. Therapeutic Procedures. A. Endotracheal intubation. B. Intravascular and intraosseus catheters.


VAERS ID: 356473 (history)  
Form: Version 1.0  
Age: 0.7  
Sex: Female  
Location: Washington  
Vaccinated:2009-07-07
Onset:2009-07-09
   Days after vaccination:2
Submitted: 2009-09-03
   Days after onset:56
Entered: 2009-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3280AA / 3 LL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBNB663AA / 3 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D36147 / 3 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-07-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prevacid; Tylenol
Current Illness: None
Preexisting Conditions: Failure to thrive; GE Reflux; Ht. murmur; Pre-maturity. 9/11/09 Autopsy received DOD 07/09/2009. Born at 37-38 weeks gestational age, small for gestational age.
Allergies:
Diagnostic Lab Data: Autopsy was performed. 9/11/09 Autopsy received DOD 07/09/2009. LABS and DIAGNOSTICS: Negative Radiographic Skeletal Survey. Toxicology Blood - Ethanol (-) No Drugs Detected.
CDC Split Type:

Write-up: Death. 9/11/09 Autopsy received DOD 07/09/2009. Sudden Unexplained Death in Infancy (SUIDI or SIDS). The manner of death is natural. Additional information abstracted: Infant was found dead in crib, positioned supine. No evidence of injury.


VAERS ID: 356603 (history)  
Form: Version 1.0  
Age: 66.0  
Sex: Female  
Location: North Dakota  
Vaccinated:2009-06-22
Onset:2009-06-23
   Days after vaccination:1
Submitted: 2009-09-04
   Days after onset:73
Entered: 2009-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR UF484BA / UNK UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Biopsy lung, Cardiac stress test, Catheterisation cardiac, Computerised tomogram, Death, Dyspnoea, Pulmonary embolism, Pulmonary function test, Right ventricular failure
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-08-19
   Days after onset: 57
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ASACOL; Calcium; Vitamin D; Aspirin
Current Illness: Primary sclerosing cholangitis
Preexisting Conditions: None.
Allergies:
Diagnostic Lab Data: Cardiolyte stress test; chest CT scan; pulmonary function testing; heart catheterization; open lung biopsy.
CDC Split Type:

Write-up: Shortness of breath, initially with exertion. Progressive to dyspnea at rest, pulmonary emboli, right heart failure.


VAERS ID: 356666 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-09-08
Entered: 2009-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Herpes simplex, Liver function test abnormal, Pyrexia
SMQs:, Liver related investigations, signs and symptoms (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: There was no information available regarding concomitant vaccinations, medications or medical history.
Allergies:
Diagnostic Lab Data: Liver function test, abnormal
CDC Split Type: A0798512A

Write-up: This case was reported by a physician and described the occurrence of abnormal liver function tests in an infant subject of unspecified gender who was vaccinated with ENGERIX B (GlaxoSmithKline). There was no information available regarding concomitant vaccinations, medications or medical history. On an unspecified date the subject received 1st dose of ENGERIX B (details unknown) at birth. Less than one week after vaccination with ENGERIX B, the subject experienced abnormal liver function tests and fever. Blood levels were checked 6 days after vaccination with ENGERIX B and abnormal liver function tests were noted, along with fever. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified. No additional information was available. Follow-up information received on 03 September 2009 indicated that the events of abnormal liver function tests were likely secondary to herpes simplex virus type II infection and not ENGERIX B. It was reported that the subject died with cause of death reported as herpes simplex virus type II. An autopsy was performed, however, results were not provided.


VAERS ID: 356938 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Oklahoma  
Vaccinated:2008-07-21
Onset:2008-09-12
   Days after vaccination:53
Submitted: 2009-09-10
   Days after onset:363
Entered: 2009-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 17400 / 3 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chest pain, Death, Dizziness, Dyspnoea, Fatigue, Feeling cold, Headache, Muscle spasms, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-09-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: None~ ()~~0.00~Patient
Other Medications: Yaz until 3/17/08. Femcon beginning 3/17/08. Anaprox as needed.
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None. I do have copies of all medical history from 01/08/2004 to the time of her death that I can provide if needed. The Medical Examiners office will have tissue samples until 4/2010.
CDC Split Type:

Write-up: Headache, Nausea, dizziness, chilling, tiredness, shortness of breath, complained of chest plain, severe cramps. 9/14/09 Received vaccine & PCP medical records which reveal patient seen 12/5/07 & 2/27/08 with sore throat, fever, chills, fatigue, body aches, productive cough w/yellow sputum & HA. Dx both times w/acute bronchitis & tx w/antibiotics & cough syrup. 9/25/09 Autopsy report received DOD 09/12/2008. Acute Cardiac Arrhythmia of Unknown Etiology. Addtional information abstracted: Heart with focal microscopic ischemic changes, pulmonary congestion and edema. Rare petechiae: conjunctival, periorbital and laryngeal. Resuscitation related sternal fracture.


VAERS ID: 357588 (history)  
Form: Version 1.0  
Age: 0.46  
Sex: Male  
Location: Virginia  
Vaccinated:2009-09-01
Onset:2009-09-08
   Days after vaccination:7
Submitted: 2009-09-11
   Days after onset:3
Entered: 2009-09-17
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB780AA / 2 RL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0175Y / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-09-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Spironolactone; Levothyroxine; Chlorothiazide; FeSO4; NaCl; O2
Current Illness: BPD = Hypothyroid:Prematurity
Preexisting Conditions: Hyponatremia
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: NICU graduate (24 5/7 wks) gestation) Brought to office apneic 9/08/09 CPR unsuccessful. Chron. age about 6 mos DOB 3/17/09.


VAERS ID: 357994 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Indiana  
Vaccinated:2009-07-07
Onset:2009-07-07
   Days after vaccination:0
Submitted: 2009-09-22
   Days after onset:77
Entered: 2009-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3188AA / 1 LL / UN
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHB13659AA / 1 RL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 039016 / 1 RL / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abnormal behaviour, Feeding disorder of infancy or early childhood, Injection site erythema, Injection site swelling, Injection site warmth, Insomnia, Lethargy, Pyrexia, Screaming
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-07-17
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: PMH: Living conditions are reportedly very dirty and bug infested.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient had a high fever and screamed most of the time. She wouldn''t eat normally and would sleep very little. Her legs were hot and red and had big swollen bumps on them where she got the vaccines. She was lethargic a lot of the time and not responding like she normally did. She did this for the whole 10 after she got the vaccines. 9/24/09 Autopsy report received DOD 7/17/09 - Sudden Unexplained Infant Death. Anatomic findings noted: Pleural petechia, pulmonary edema and congestion, generalized visceral congestion, sunken anterior fontanelle, mild to moderate tracheitis. Infant reportedly fell off of bed 7/15/09.


VAERS ID: 358002 (history)  
Form: Version 1.0  
Age: 0.35  
Sex: Male  
Location: Washington  
Vaccinated:2009-09-14
Onset:2009-09-19
   Days after vaccination:5
Submitted: 2009-09-22
   Days after onset:3
Entered: 2009-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3297AA / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D59297 / 2 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. O0884 / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-09-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Primary hypotony
Allergies:
Diagnostic Lab Data: Labs & Diags: Brain bx: Focal neuronal ischemic changes, acute, R frontal lobe. No evidence of traumatic brain injury
CDC Split Type:

Write-up: Death of patient. 11/09/09 Medical records received for DOS 9/19. Police dept summary and autopsy report. Final DX: Fibroelastosis, natural death Infant stopped breathing. Father gave CPR until medics arrived. Intubated. Transported. Reintubated in ED. ED not able to resuscitate. Bil retinal hemorrhages. Infant had cold sx and fussiness since vaccine. Got worse. Not sleeping or eating well. Labored breathing. Vomited 3-4x that morning. PMD had wanted recheck for floppy baby syndrome. Autopsy revealed markedly enlarged heart.


VAERS ID: 358388 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Male  
Location: Colorado  
Vaccinated:2007-09-19
Onset:2009-06-02
   Days after vaccination:622
Submitted: 2009-09-25
   Days after onset:115
Entered: 2009-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-06-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: COPD
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Subject in pneumococcal vaccine trial, with severe COPD, died due to respiratory failure secondary to COPD. Vaccination took place 9/19/2007. According to the physician the relationship is ''None''. We would be happy to forward the Study''s SAE reporting form upon request. 10/1/09 PSCC Report DOS 6/2/09 Assessment: Death Due to COPD. Subject died in hospital from respiratory failure secondary to COPD. 10/06/09 Death certificate states COD as COPD w/diabetes mellitus, atril flutter, hypertension & CVA as contributing factors ICD-9 Code: 491.20 10/6/09 Death certificate received. Cause of death: COPD


VAERS ID: 358489 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Montana  
Vaccinated:2009-09-21
Onset:2009-09-28
   Days after vaccination:7
Submitted: 2009-09-28
   Days after onset:0
Entered: 2009-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB737BA / 1 LL / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-09-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None. Drug screen postmortem blood - Caffeine detected. CHEM - Glucose 6 mg/dl (L) Sodium 120 mEq/L (L) Potassium $g10.0 mEqL (H).
CDC Split Type:

Write-up: SIDS death 9-28-09 - went to hospital. 12/4/09 Autopsy report received. DOD 9/28/09. Final Cause of Death: Sudden unexpected death of a neonate while bed-sharing with adults. Additional information abstracted: History that decedent was placed on bed for sleep between his father and mother. That mother found decendent unresponsive when she awoke and that neither parent was covering the decedent. That cardiopulmonary resusitation was performed by parents and EMS. No lethal traumatic injuries. No evidence of a lethal natural disease process. Body weight 10-25th percentile for age; body length 25-50th percentile for age. Organ weights consistent with 3-week-old neonate. No history of medical conditions.


VAERS ID: 358921 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Male  
Location: Unknown  
Vaccinated:1995-07-07
Onset:2000-07-27
   Days after vaccination:1847
Submitted: 2009-09-29
   Days after onset:3351
Entered: 2009-09-30
   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
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-07-27
   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:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0909USA03723

Write-up: Information has been received from a registered nurse concerning her 84 year old father with multiple medical problems who in 1995 was vaccinated with a dose of PNEUMOVAX 23 (lot, route and site of administration not reported). The nurse reported that her father may have had aspiration pneumonia when he died on 27-JUL-2000. Her father was a hospice patient at the time of his death. The registered nurse felt that her father''s death and aspiration pneumonia were not related to therapy with PNEUMOVAX 23. No further information is available. 11/16/09 Certificate of Death received. DOD 7/27/2000. Cause of Death: Alzheimers Disease.


VAERS ID: 359035 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-09-30
Entered: 2009-10-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0909USA03923

Write-up: Information has been received from a group of physicians at an inservice meeting concerning a male patient who on an unspecified date was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot number not reported). The group of physician''s indicated that they had heard of a patient who developed necrotizing lesions after getting ZOSTAVAX (Merck) and died. The physicians didn''t know if it was from the ZOSTAVAX (Merck) but they believed that it was. Necrotizing lesions was considered to be disabling and immediately life-threatening by the reporters. Attempts are being made to clarify the existence of an identifiable patient. Additional information has been requested.


VAERS ID: 359066 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Female  
Location: D.C.  
Vaccinated:2008-10-13
Onset:2008-10-14
   Days after vaccination:1
Submitted: 2009-10-01
   Days after onset:352
Entered: 2009-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 08132 / 5 LA / UN

Administered by: Private       Purchased by: Other
Symptoms: Anaphylactic shock, Angioedema, Blood glucose increased, Death
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-10-25
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NOVOLOG; Insulin; Glypizide; Benazepril, etc.
Current Illness: Diabetes; Hyperlipidemia
Preexisting Conditions: Hypertension; Arteriosclerosis; Anemia; Glaucoma, etc.
Allergies:
Diagnostic Lab Data: Blood sugar - Accucheck 444/424
CDC Split Type:

Write-up: Anaphylaxis shock. Angioedema. Death.


VAERS ID: 359358 (history)  
Form: Version 1.0  
Age: 10.0  
Sex: Female  
Location: Georgia  
Vaccinated:2009-07-20
Onset:2009-07-20
   Days after vaccination:0
Submitted: 2009-09-29
   Days after onset:71
Entered: 2009-10-05
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0246Y / 2 LA / SC

Administered by: Public       Purchased by: Public
Symptoms: Convulsion, Death, Respiratory arrest, Screaming
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-07-20
   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: KEPPRA 100 mg Bid for seizures since 2-14-2009
Current Illness: No
Preexisting Conditions: Epilepsy PMH: Epilepsy Allergies:NKDA
Allergies:
Diagnostic Lab Data: Labs: CBC: Lymphocytes 88 H CMP: Glucose 394 H, SGOT 59 H Total protein 4.5, Albumin 2.5, Calcium 7.9, CO2 17 all Low values Blood gases abnormal, Allen Test positive DX studies/Xrays: CXR abnormal, noting in both lungs diffuse ground glass opacities
CDC Split Type:

Write-up: Received Varicella vaccine around 11:40-12:00 noon. Left here to go to grandmother''s house. They were leaving & child said I think I am having a seizure to her mom. She came out of the seizure & screamed, stopped breathing. Mom started CPR until ambulance got there & took over shocked her. Took to hospital where they told her nothing else they could do for her. 10/23/2009 received hospital records for ED visit 7/20/2009. Patient presents with sx of a seizure which resulted in cessation of breathing. Per ambulance to ED , patient unresponsive, pupils fixed and dilated despite resuscitation efforts. Final DX: Cardiac Arrest 12/8/09 Death Certificate received. DOD 7/20/09. Final cause of death: Cardiac Arrest, Seizure Disorder.


VAERS ID: 359582 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2009-09-23
Onset:2009-09-25
   Days after vaccination:2
Submitted: 2009-10-06
   Days after onset:11
Entered: 2009-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 97848PIC / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Dyspnoea, Influenza like illness, Mechanical ventilation, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-05
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Psoriasis PMH: psoriasis Allergies: PCN
Allergies:
Diagnostic Lab Data: Labs and Diagnostics: H1N1 (-). Labs: Admission: CBC norm, CMP: Na 127, K-3.2, Albumin-1.9 all Low, Creatinine 2.4, BUN-36, AST-158, ALT-81 all HIgh Viral respiratory panel neg, MRSA screening negative, Urine strep pneumonia antigen negative, Mycoplasma IgM AB negative, Urine Legionella antigen negative, Blood and Urine cultures negative Dx studies/Xrays: CXR multilobar pneumonia , Echocardiogram pericardial effusion
CDC Split Type:

Write-up: Flu like symptoms: Fever, SOB. Was admitted to the hospital on 9/25/09 and was diagnosed with H1N1 and deteriorated; was placed on a ventilator and expired on 10/5/09 at approxitmately 1800 hours. 10/9/09 Prelim autopsy report received with the following findings: Multilobar pneumonia (all lobes severely involved). Post mortem bacterial, fungal, acid fast and viral cultures pending. H1N1 (-). Renal failure probably 2'' to acute tubular necrosis. 10/21/2009 hospital records for date 10/1- 10/5/ 2009, patient with 1 week hx of fever, malaise. nausea, vomiting, and chest discomfort. Saw PCP 9/26/2009 and thought to be viral, sx progressed, cough worsened and patient became dyspneic. To hospital 10/1/2009 in respiratory failure. TX: placed on continuous ventilation with nitrous oxide and pressors, IV ABX Zyvox, Clindamycin, Levaquin, Aztreonam, Cleocin, Xigris, Serum Bicarbonate. DC DX''s: Severe Multilobar Pneumonia, Respiratory failure, Renal failure, Metabolic Acidosis. 12/29/09 Autopsy report received. DOD 10/5/2009. Cause of Death: Multilobar pneumonia secondary to Legionella, non-pneumophilia species. Additional information abstracted: Patient developed community-acquired bilateral pneumonia causing severe hypoxia and multiorgan system failure.


VAERS ID: 359602 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2009-09-24
Onset:2009-09-27
   Days after vaccination:3
Submitted: 2009-10-16
   Days after onset:19
Entered: 2009-10-06
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / SANOFI PASTEUR U3192AA / 2 LA / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abasia, Lumbar puncture
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-12
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 14 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: kidney stone issues
Preexisting Conditions: hx polio, prostate ca, hyperlipediemia, smokes, emphesema, diverticulitis, hemmroids, ventral hernia, osteoarthritis, skin ca, no allergies. 10/19/09 Physician fax received for date of service 10/12/09.PMH: Post-Polio syndrome. 12/1/09 ED and Hospital records received. Service dates 9/28/09 to 10/12/09. PMH: Polio with kyphoscoliosis, atrophy (L) lower extremity and arm. Nephrolithiasis. Carcinoma of prostate. Hyperlipidemia. Diverticulosis / Diverticulitis. Hemorrhoids, tosillectomy, ventral hernia, basal cell carcinoma of skin, osteoarthritis.
Allergies:
Diagnostic Lab Data: LP done. 10/19/09 Physician fax received for date of service 10/12/09. Labs and Diagnostics: EMG: Denervation distally. 12/1/09 ED and Hospital records received. Service dates 9/28/09 to 10/12/09. LABS and DIAGNOSTICS: Chest X-ray - Abnormal. EMG - Abnormal. MRI Brain Abnormal. Abdominal US - Abnormal. ECG - Abnormal. CBC - WBC 11.4 (H) RBC 3.47 (L) HGB 11.1 (L) HCT 32.2 (L). CHEM - Glucose 123 (H) Calcium 8.1 (L) ALKPHOSPH 236 (H) AST 171 (H) ALT 287 (H).
CDC Split Type:

Write-up: he had a hard time navigating to the bathroom on 2 separate occasions and is unable to walk on his own. 10/19/09 Physician fax received for date of service 10/12/09. Dx: Death secondary to Guillain-Barre Syndrome. Assessment: Intubated due to GBS. EMG showed denervation distally. Due to increased neuronal injury and poor prognosis (also coupled with post-Polio syndrome) the family decided to extubate the patient. 12/1/09 ED and Hospital records received. Service dates 9/28/09 to 10/12/09. Assessment: Severe Guillian-Barre Syndrome. Patient developed profound, progressive and generalized weakness over the last 24-36 hours. Numbness toes, feet, fingers. Unable to walk on his own. Peripheral edema. Rhonchi bilateral. Intubated. Subdural hematoma. Hematuria with clots. Gallbladder polyp, Renal cyst. Atrial fibrillation. Sinus Bradycardia. Left ventricular hypertrophy. Nonresponsive to voice / touch. DTR''s absent. IVIG Administered.


VAERS ID: 359853 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Female  
Location: Unknown  
Vaccinated:2008-10-16
Onset:2008-12-11
   Days after vaccination:56
Submitted: 2009-10-06
   Days after onset:298
Entered: 2009-10-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA184AA / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Death, Leukaemia, Lymphoma
SMQs:, Malignant lymphomas (narrow), Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-01-01
   Days after onset: 21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 12 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Lymphoma
Preexisting Conditions: Chemotherapy; Radiotherapy 10/13/09 Hospital records and DC summary received for dates 12/11/08 to 12/23/08. PMH: Thrombocytopenia, non-Hodgkin''s lymphoma, pacemaker, myelodysplastic syndrome, hyponatremia. 10/15/09 Medical records received for date of service 10/9/08. PMH: None.
Allergies:
Diagnostic Lab Data: Unknown 10/13/09 Hospital records and DC summary received for dates 12/11/08 to 12/23/08. Diagnostics/Labs: CT abdomen and pelvis?RUQ mass, bilateral pleural effusion. CXR-decreased inspiration w/ basilar effusion/atelectasis. US RUQ - cholecystitis. EKG WNL. Platelet 13(L), HGB 9.8(L), HCT 30.8(L), BUN 28(H), urine culture(+) E-coli.10/15/09 Medical records received for date of service 10/9/08. Diagnostics and Labs: None.
CDC Split Type: WAES0910USA00329

Write-up: Information has been received from a consumer concerning his approximately 78 year old wife with lymphoma diagnosed in February 2007. The patient was underwent chemotherapy and radiation. In December 2007 she experienced a recurrent lymphoma and was prescribed oral chemotherapy from January 2008 to May 2008. In October 2008 she was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported). Several weeks later, she was diagnosed with leukemia and experienced recurrence of lymphoma. On an unspecified date she was hospitalized. She received unspecified treatment which was unsuccessful. The patient died on 01-JAN-2009. The cause of death were Lymphoma and leukemia. No further information is available. 10/13/09 Hospital records and DC summary received for dates 12/11/08 to 12/23/08. DC DX: Lower back pain-resolved, fever-resolved, UTI-resolved, dental abscess, malnutrition. Presenting SX: pt c/o pain in back and both hips. Assessment: Pt found to have fever. Pt treated for current medical conditions and acute conditions and DC to rehab facility. 10/15/09 Medical records received for date of service 10/9/08. Shingles (Zostavax) vaccine administered on 10/9/08. Physician reports that pt. did not call office to report an adverse reaction. 10/21/09 Death Certificate DOD 1/1/2009. Myelodysplastic syndrome. Acute myelogenous leukemia. Anemia.


VAERS ID: 359951 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: California  
Vaccinated:2009-10-02
Onset:2009-10-03
   Days after vaccination:1
Submitted: 2009-10-07
   Days after onset:4
Entered: 2009-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 97844P2 / UNK LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Encephalitis, Mental status changes
SMQs:, Dementia (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-24
   Days after onset: 52
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 51 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: See report
CDC Split Type:

Write-up: 10/3 - started with mental changes 24 hours after influenza vaccine. Dx with encephalitis.


VAERS ID: 360138 (history)  
Form: Version 1.0  
Age: 0.27  
Sex: Male  
Location: Kentucky  
Vaccinated:2009-09-02
Onset:2009-09-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2009-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B208AA / UNK RL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF596AB / UNK LL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D74257 / UNK LL / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FA732A / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood gases, Computerised tomogram, Convulsion, Differential white blood cell count, Dyspnoea, Electroencephalogram abnormal, Full blood count, Herpes simplex serology negative, Intensive care, Metabolic function test, Nuclear magnetic resonance imaging brain, Status epilepticus, Urine analysis
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-05
   Days after onset: 32
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 32 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None Known
Preexisting Conditions: Inguinal Hernia.
Allergies:
Diagnostic Lab Data: CBCw Diff; CMP; ABG; Urinalysis; HSV, Negative; PCS, negative; CT; Brain MRI; EEG, left temporal focus
CDC Split Type:

Write-up: 3 mo old infant received multiple vaccines to include PEDIARIX, HIB, PREVNAR, and ROTARIX during well child visit on September 2nd. On September 3rd. he was brought to Pediatric Clinic by his mother with c/o "trouble breathing". When the physician came into the room, the infant was noted to be seizing. A CBC, CMP, ABG and urine samples were also collected. He was diagnosed with Status Epilepticus and taken to a Hospital where he was admitted to PICU. A CT and brain MRI were completed. EEG demonstrated left temporal focus; HSV PCS & culture were negative; the initial infant screen was insufficient, repeat infant screen, ID & genetic consults are pending.


VAERS ID: 360397 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Male  
Location: New York  
Vaccinated:2009-10-02
Onset:2009-10-02
   Days after vaccination:0
Submitted: 2009-10-02
   Days after onset:0
Entered: 2009-10-12
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 98441P1A / UNK RA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Kidney stones.
Allergies:
Diagnostic Lab Data: None performed
CDC Split Type:

Write-up: Patient to PMD for physical. Was feeling well and received flu vaccine. Upon arriving home minutes later told wife "I don''t feel well" and collapsed. Brought to ED in full cardiac arrest. Unable to resuscitate. 10/19/09 ER records received service date 10/2/09. Assessment: Cardiac Arrest. Patient arrived unresponsive, intubated with CPR in progress. Asystole on monitor with no spontaneous respirations. External trauma to eyes. ICD-9 code 427.5 cardiac arrest. 12/16/09 Death Certificate received. DOD 10/02/09. Cause of Death - Hypertensive and arteriosclerotic heart disease.


VAERS ID: 360527 (history)  
Form: Version 1.0  
Age: 47.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2009-09-22
Onset:0000-00-00
Submitted: 2009-10-09
Entered: 2009-10-12
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR C3202AA / 2 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3249AA / 2 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-03
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: None stated. 11/30/09 Death Certificate Received. DOD 10/03/2009. Final Cause of Death: Acute Methadone Toxicity. Additional Information - Underlying conditions: Constrictive Atherosclerotic Artery Disease.


VAERS ID: 360706 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Female  
Location: Virginia  
Vaccinated:2009-10-02
Onset:2009-10-03
   Days after vaccination:1
Submitted: 2009-10-13
   Days after onset:10
Entered: 2009-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 98431P1 / UNK LA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metformin; Aricept; Coreg; HCTZ; Lexapro; Lisinopril; Synthroid; Namend; Insulin; Simvastatin
Current Illness: Diabetes; HTN; Dementia; hypothyroidism
Preexisting Conditions: NKDA
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt. expired on 10/3/09. Attending MD did not believe immunization was cause of death but reported because of dose temporal proximity. (Pt. expired approx. 24 hrs after receiving the flu vaccine). 10/16/09 Death Certificate: Cardiorespiratory arrest, Diabetes mellitus type 2, Hypertension.


VAERS ID: 360751 (history)  
Form: Version 1.0  
Age: 1.04  
Sex: Male  
Location: Michigan  
Vaccinated:2009-10-01
Onset:2009-10-04
   Days after vaccination:3
Submitted: 2009-10-08
   Days after onset:4
Entered: 2009-10-14
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT3178DA / 1 RL / UN
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB334BA / 1 LL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF673AA / 4 RL / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0554Y / 1 LL / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0731Y / 1 RA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: Seizure disorder; DANDY WALKER syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was seen on 10/1/09. Death reported on 10/4/09. Pt has seizure disorder along with encephalocele. / DANDY WALKER Syndrome. Had received vaccines on 10/1/09.


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