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VAERS ID: 181049 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Ohio  
Vaccinated:2002-01-30
Onset:2002-01-31
   Days after vaccination:1
Submitted: 2002-02-01
   Days after onset:1
Entered: 2002-02-07
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES U054DBA / 2 RL / IM
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES UA648AA / 2 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. U03442 / 2 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 484141 / 2 LL / IM

Administered by: Private       Purchased by: Private
Symptoms: Apnoea, Pulse absent, Sudden infant death syndrome
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Neonatal disorders (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-01-31
   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: Hydrocortisone-topical
Current Illness: NONE
Preexisting Conditions: Eczema
Allergies:
Diagnostic Lab Data: Initial autospy results (-). Final Pending
CDC Split Type:

Write-up: found pulseless, not breathing in bed, resuscitation without success. COD -- SIDS as per autopsy report.


VAERS ID: 181229 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Idaho  
Vaccinated:2002-01-11
Onset:2002-01-12
   Days after vaccination:1
Submitted: 2002-01-14
   Days after onset:2
Entered: 2002-02-12
   Days after submission:29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 527A2 / 3 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1676K / 3 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR T1464 / 3 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 484146 / 3 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Apnoea, Cyanosis, Sudden infant death syndrome
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-01-12
   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: Zantac
Current Illness: Resolving Otitis Media with effusion
Preexisting Conditions: GERD
Allergies:
Diagnostic Lab Data:
CDC Split Type: ID02001

Write-up: Informed on 1/12/02, at 12:30, that the child had died. Cause of death was determined to be SIDS by ER doctor. He called me as a courtesy notification. The child apparently was found blue and not breathing at home. COD as per autopsy report -- SIDS


VAERS ID: 181356 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: New York  
Vaccinated:2002-01-22
Onset:2002-01-22
   Days after vaccination:0
Submitted: 2002-02-12
   Days after onset:21
Entered: 2002-02-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES DPTA524AZ / 1 RL / IM
HBPV: HIB POLYSACCHARIDE (HIBIMUNE) / PFIZER/WYETH 474706 / 1 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T1310 / 1 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 482373 / 1 LL / IM

Administered by: Private       Purchased by: Private
Symptoms: Abnormal sleep-related event, Agitation, Coma, Contusion, Oral intake reduced, Pyrexia, Respiratory disorder
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-01-23
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~Measles + Mumps + Rubella (MMR II)~1~4.00~In Sibling
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: History of Co-sleeping with adult
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Temperature of 102.2F, 2 hours post vax. No appetite and heavy breathing. At 20:00, she was alive in parent''s bed and found at 10:00 on 1/23/02 (legs were black and blue from hip to knee). Unconsolable crying. Per F/U: child being found unresponsive face-down in a bed Co-sleeping with her father.


VAERS ID: 181403 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: New Hampshire  
Vaccinated:2001-06-05
Onset:2001-06-16
   Days after vaccination:11
Submitted: 2002-02-13
   Days after onset:242
Entered: 2002-02-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 986A2 / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA570AA / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 479299 / 1 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Anoxia, Apnoea, Brain oedema, Cardio-respiratory arrest, Encephalopathy, Intestinal infarction, Multi-organ failure, Sudden infant death syndrome
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), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Hyponatraemia/SIADH (broad), Ischaemic colitis (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Neonatal disorders (narrow), Chronic kidney disease (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-06-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Amoxicillin X 10 days completed on 6/4/01
Current Illness: Left Otitis Media 5/26/01
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: No drugs detected per F/U 8/13/02.
CDC Split Type: NH0127

Write-up: SIDS Admitted to hospital through ER with sudden cardiac and respiratory arrest with significan periodic of anoxia/cardiac arrest. Multiorgan system injury and severe anoxic brain injury. COD as per autopsy exam was anoxic encepalopathy due to resuscitated SIDS. Per F/U 8/13/02: Other conditions: Multisystem ischemia. This is a 2 month old white female who was found unresponsive by her babysitter face-down on a water bed. EMT''s arrived and the baby was pulseless but subsequently, on transportation to the ER, a pulse was restored. The infant was transferred to another facility for management of complications of anoxia. It appeared to clinicians that the infant had resuscitated SIDS. At the hospital, the infant showed evidence of severe hypoxic ischemic encephalopathy and subsequently, developed multi-organ failure based upon anoxia. The interval between the initial arrest and death was approx. 2 days. Findings on autopsy: Anoxic encephalopathy with brain swelling; reperfusion infarction of the septum of the heart, hemorrhagic and ischemic infarction of the right colon and transverse colon.


VAERS ID: 181414 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Unknown  
Vaccinated:2001-12-19
Onset:2002-02-07
   Days after vaccination:50
Submitted: 2002-02-13
   Days after onset:6
Entered: 2002-02-15
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (ACEL-IMUNE) / PFIZER/WYETH - / 1 RL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH - / 1 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR - / 1 RL / SC
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Sudden infant death syndrome
SMQs:, Acute central respiratory depression (narrow), Neonatal disorders (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-02-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Coroner''s report-pending
CDC Split Type: HQ0630811FEB2002

Write-up: Information has been received from an investigator regarding a 2 month old male who received his 1st doses of study vaccine; Hib-Titer, IPV and DTAP vaccines on 12/19/01 as part of the study. On 2/7/02, the infant was found by his father in his crib, not breathing. He was seen in a hospital and pronounced dead. A probable dx of SIDS was made, however, the coroner''s report is pending. Both the medical monitor and the investigator agree that SIDS (unexpected per the investigator brochure) was not related to study vaccine administration.


VAERS ID: 181457 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Male  
Location: Illinois  
Vaccinated:2001-10-09
Onset:2001-10-10
   Days after vaccination:1
Submitted: 2001-10-19
   Days after onset:9
Entered: 2002-02-19
   Days after submission:123
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0572EA / UNK LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Bacterial infection, Cardiogenic shock, Chills, Pyrexia
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-10-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: Heart valve replacement; CAD
Allergies:
Diagnostic Lab Data: C & S X 2-reported as staph aureus
CDC Split Type: IL01053

Write-up: We were contacted by HD who received a call from a MD stating pt received flu shot on 10/09/01 and developed rigors and a fever of 103F later that night. He was seen in ER and developed cardiogenic shock and died.


VAERS ID: 181512 (history)  
Form: Version 1.0  
Age: 1.5  
Sex: Male  
Location: Indiana  
Vaccinated:2002-01-17
Onset:2002-01-19
   Days after vaccination:2
Submitted: 2002-02-11
   Days after onset:23
Entered: 2002-02-20
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPH: DTAP + HIB (TRIHIBIT) / SANOFI PASTEUR 3274C / 4 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR U03442 / 3 LA / SC
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1094L / 1 RA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 488175 / 2 LL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1235L / 1 LA / SC

Administered by: Private       Purchased by: Public
Symptoms: Coma, Petechiae
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-01-19
   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: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Autopsy-pending Autopsy states; few petechiae of heart, thymus and lungs; early stage of decompression; no evidence of injuries; cultures are neg for pathologic organisms; blood neg for volatiles, acetaminophen and CO; blood salicylate 11.2ug/ml; urine neg for drugs
CDC Split Type:

Write-up: Informed by mom on 2/8/02 that her child was found dead in bed on 1/19/02 about 33 hours after well child visit and immunizations. No previous by us, last immunizations at 6 months. Mom reports an autopsy is being done. Per coroner''s office no autopsy was done in this county. COD as per autopsy report is undetermined. Info rec''d 4/18/02 states; The decedent was an 18 month old white male who lived with his parents. He was pronounced nonviable by medics at 08:55 upon their arrival at the residence. The child was found by his father around 08:45 to be unresponsive and 911 was called. The child was last seen alive by his mother about 23:00 of the night before when she placed him in bed after returning from a birthday party. The child has a clinic visit on 1/17 when he had 5 immunization shots and treatment for dry skin rash. There was bottles of children liquid cold medicine scattered in the kitchen but according to the mother, the infant had not had any since the last time he was sick, about 2 1/2 weeks ago. COD: undetermined.


VAERS ID: 181623 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Texas  
Vaccinated:2002-02-07
Onset:2002-02-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2002-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardio-respiratory arrest, Pulmonary congestion, Pulmonary oedema, Sudden infant death syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Neonatal disorders (narrow), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-02-08
   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: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: PALS Protocol-2/8/02
CDC Split Type:

Write-up: A 2 month old presents to ER at 06:10 in full cardiopulmonary arrest. Two month immunization given the day before presentation to the ER. Reported to MD. Per F/U 4/16/02: Pulmonary congestion and edema; focal pulmonary hemorrhage (history of vigorous cardiopulmonary resuscitation); no injuries demonstrated. The death therefore falls into the category of SIDS


VAERS ID: 181700 (history)  
Form: Version 1.0  
Age: 39.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2000-06-08
Onset:2001-12-04
   Days after vaccination:544
Submitted: 2002-02-20
   Days after onset:78
Entered: 2002-02-26
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / SMITHKLINE BEECHAM LY128A2 / 2 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Cardiomegaly
SMQs:, Cardiac failure (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-12-04
   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: Claritin prn; Azmacort prn; albuterol prn
Current Illness: NONE
Preexisting Conditions: Asthma; Hayfever
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Unexpected death on 12/4/01, while sleeping. No symptoms. Doubt related to Lymerix vaccine but wife wanted it reported. See autopsy report. COD as per autopsy report -- cardiomegaly with left ventricular hypertrophy


VAERS ID: 181780 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: California  
Vaccinated:2002-02-06
Onset:2002-02-06
   Days after vaccination:0
Submitted: 2002-02-21
   Days after onset:15
Entered: 2002-02-27
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. - / 1 - / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Cardiac arrest, Cardio-respiratory arrest, Cerebrovascular disorder, Coma, Eosinophilia, Injection site inflammation, Injection site nodule, Injection site oedema, Small for dates baby, Strabismus, Sudden infant death syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Ocular motility disorders (narrow), Neonatal disorders (narrow), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-02-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: Low birth weight; Umbilical hernia and supernumerary digits on each hand was tied off and detached; Birthmark on buttocks-Mongolian spots
Allergies:
Diagnostic Lab Data: Autopsy
CDC Split Type:

Write-up: Healthy 2 month old black male received 4 vaccinations, IM, at about noon; fell asleep immediately, taken home, still apparently asleep. Found unresponsive with face down by mother at 18:00. Asystole at the scene. Full term with low birth weight of 4 lbs and 11 oz, NSVD to a 31 year old married G2 P2 with PNC; history of maternal alcohol and marijuana use with first trimester; no maternal disease. Autopsy shows severe eosinophilic infiltrate of muscle at the injection site. Weight at death 9 lbs and 4 oz. Per F/U 5/7/02: COD-SIDS Exam: left thigh injection site showing 2 hemorrhagic puncture defects extending vertically into the deep muscle surrounded by an extensive area of edema and severe acute inflammation composed mostly of eosinophils. Right thigh injection site showing a hemorrhagic puncture defect in the deep muscle and slight focal acute inflammation. Cerebrovascular congestion (mild) and heterotopic neuronal rest, large-cell type, cerebellar white matter; incidental finding. Hospital care facility report states: COD as cardiopulmonary arrest.


VAERS ID: 181781 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:1995-05-17
Onset:1995-08-01
   Days after vaccination:76
Submitted: 2002-02-15
   Days after onset:2390
Entered: 2002-02-27
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Adrenal insufficiency, Bacterial infection, Brain oedema, Cardio-respiratory arrest, Cerebral infarction, Cyst, Diarrhoea, Fatigue, Gastric ulcer haemorrhage, Gastrointestinal haemorrhage, Gastrointestinal ulcer, Hepatic failure, Hepatic necrosis, Jaundice, Lymphadenopathy, Multi-organ failure, Oral intake reduced, Pancreatitis necrotising, Pseudo lymphoma, Pyrexia, Sepsis, Sinusitis, Spleen disorder, Urinary tract disorder, Weight decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Cholestasis and jaundice of hepatic origin (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Acute pancreatitis (narrow), 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), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal ulceration (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1996-02-06
   Days after onset: 189
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: Allergies; S/P liver transplant; small bowel obstruction and exploratory laparotomy was performed 1/24/96; 2/1/96 endoscopy as well as bone marrow aspiration and LP; he required multiple packed red blood cells transfusions; because of decreased immunosuppression, chemotherapy was given; 2/3/96, the pt experienced massive GI hemorrhage followed by sustained cardio-respiratory arrest requiring resuscitation, intubation and inotropic drugs
Allergies:
Diagnostic Lab Data: Tests were done and showed his liver was failing. Per F/U 4/5/02: CT Scan showed lesions consistent with cerebral infarcts. Multiple abdominal adhesions; focus of coagulative necrosis at inferior margin of liver, consistent with infarct; mild centrilobular ischemic change; multiple ulcers in gastro-intestinal tract, mediastinal, mesenteric and cervical lymph nodes; Cerebral edema, right hemisphere
CDC Split Type:

Write-up: After receiving his 2nd Hep-B shot, he seemed tired a lot. In the middle of August, 1995, we noticed his eyes were jaundiced. Within days, he turned completely jaundiced. Test results said his liver was failing. He received a liver transplant on 9/22/95. He died of complications. He was also treated for a sinus infection on 8/11/95 and put on amoxicillin. This family has a lawyer. The doctor denies that this was from the vaccination. COD as per autopsy report: lymphoproliferative disorder, gastrointestinal bleeding, sepis Per F/U 4/5/02-12 year old male S/P orthotopic liver transplant on 9/22/95 for fulminant hepatic failure of unknown etiology who was originally admitted on 1/2/96 for diarrhea, decreased appetite, eating poorly and a 5lb weight loss. The pt developed persistent fevers and was treated with broad spectrum antibiotics, including Gentamicin, Imipenem and Bactrim. The pt was also treated with Flagyl and he had continued problems with heme (+) stools. On admission, exam notable for lymphadenopathy. He had Giardia, lymphoproliferative disorder, Klebsiella sepsis, gastrointestional hemorrhage and cardio-pulmonary arrest. Final autopsy dxs: hemorrhagic bladder mucosa; pleural petechiae; peripancreatic fat necrosis; adrenal atrophy; exceedingly hypocellular bone marrow with hemophagocytosis; splenic infarct; focal mild acute and chronic pneumonitis, right upper lobe of lung; thymic cysts. His mental status deteriorated and CSF showed increased WBC''s and protein. The pt continued to deteriorate had sustained multi-organ failure and expired on 2/5/96.


VAERS ID: 181884 (history)  
Form: Version 1.0  
Age: 9.0  
Sex: Female  
Location: New York  
Vaccinated:2002-01-25
Onset:2002-01-28
   Days after vaccination:3
Submitted: 2002-02-25
   Days after onset:28
Entered: 2002-03-04
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 5292A2 / 1 LA / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0736L / 1 RA / SC

Administered by: Private       Purchased by: Other
Symptoms: Dyspnoea, Heart rate increased, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-02-08
   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: Extensive antibiotics; prednisone
Current Illness: Advanced Cystic Fibrosis
Preexisting Conditions: Cystic Fibrosis; diabetes
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Shots were given on 1/25/02. On 1/28/02, the pt had a temperature of 104F, extreme shortness of breath (requiring 10 liters of oxygen) to help alleviate. Also, had a heart rate of 180 +.


VAERS ID: 182115 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Female  
Location: North Carolina  
Vaccinated:2001-11-29
Onset:2001-12-01
   Days after vaccination:2
Submitted: 2002-02-27
   Days after onset:88
Entered: 2002-03-08
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 5214A2 / 2 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Abnormal sleep-related event, Adrenal haemorrhage, Apnoea, Cough, Nasal congestion, Petechiae, Sudden infant death syndrome
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Acute central respiratory depression (narrow), Neonatal disorders (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-12-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol
Current Illness: nose congestion
Preexisting Conditions: pnenumonia, respiratory distress, jaundice at birth, 3-6 weeks pre-term
Allergies:
Diagnostic Lab Data: autopsy-SIDS
CDC Split Type:

Write-up: Sudden Infant Death preceeded by nasal congestion and dry cough. Per autopsy F/U 3/27/02: The pleural surfaces are smooth and glistening with petechiae (thymic, epicardial and pleural). There is hemorrhage within the periadrenal fat of the bilateral glands. According to the parents, they awaken with the decedent in bed with them and not breathing. They call 911 and began CPR. EMS arrived and CPR continued en route to the hospital. Efforts at resuscitation were continued in the ER, but they were unsuccessful. The infant was pronounced dead at 6:30 AM on 12/1/01.


VAERS ID: 182147 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: Unknown  
Vaccinated:1998-10-20
Onset:1998-10-23
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2002-03-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / MEDEVA PHARMA, LTD. - / UNK - / IM

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PJP200200178

Write-up: A report received on 2/28/02, is concerning a 73 year old male pt who experienced life-threatening tracheobronchitis, for which he was hospitalized, 3 days after receiving Fluvirin vaccine, on 10/20/1998. The pt died subsequently. It is unclear from the report what the cause of death was. The causality was stated to be possibly related. No further information was provided.


VAERS ID: 182148 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Montana  
Vaccinated:2002-02-28
Onset:2002-03-01
   Days after vaccination:1
Submitted: 2002-03-01
   Days after onset:0
Entered: 2002-03-11
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 543A2 / 1 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0657L / UNK RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR T1390 / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 483169 / 1 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Abnormal sleep-related event, Anaemia, Apnoea, Enterocolitis, Metabolic acidosis, Oedema, Petechiae
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haematopoietic erythropenia (broad), Lactic acidosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (narrow), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Noninfectious diarrhoea (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Synagis/Medimmune/GBZ163A/LL/02/27/02/1 previously
Current Illness: NONE
Preexisting Conditions: 30 week preemie; GERD
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt with GERD, showed apnea on monitor. (30 week preemie) Reglan and ranitidine discontinued by mom, 2 weeks ago. Found lifeless at home. EMT''s in ambulance tried resuscitation and this was continued at the ER. No response. COD: undetermined, manner of death: undetermined Per F/U 5/22/01: Lungs show petechiae bilaterally and also in thymus. Also states; child was found unresponsive in bed shared with mother and another individual. Hospital course complicated by necrotizing enterocolitis, anemia, mild hyperbilirubinemia, periodic breathing (treated with caffeine), edema and mild metabolic acidosis. Discharged after birth on caffeine, ranitidine and Reglan. The cause of death could not be determined.


VAERS ID: 182262 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Texas  
Vaccinated:2002-03-01
Onset:2002-03-05
   Days after vaccination:4
Submitted: 2002-03-06
   Days after onset:1
Entered: 2002-03-13
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U0543CA / 1 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 13902 / 1 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR U0422 / 1 LL / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-03-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: SIDS 3/5/02


VAERS ID: 182271 (history)  
Form: Version 1.0  
Age: 60.0  
Sex: Male  
Location: Unknown  
Vaccinated:1998-10-23
Onset:1999-05-29
   Days after vaccination:218
Submitted: 0000-00-00
Entered: 2002-03-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / MEDEVA PHARMA, LTD. - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pneumonia, 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), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PJP200200177

Write-up: The pt received a Fluvirin vaccination on 10/23/98 and on 5/29/99 experienced pneumonia and respiratory failure and subsequently died, as a result the adverse event was considered serious. The reporter assessed the causality as possibly related. No more information has been provided.


VAERS ID: 182418 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Unknown  
Vaccinated:2001-12-28
Onset:2002-01-10
   Days after vaccination:13
Submitted: 2002-03-14
   Days after onset:63
Entered: 2002-03-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 522A2 / 1 RL / IM
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 5216A2 / 1 RL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 480938 / 1 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR T0790 / 1 LA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 484134 / 1 LL / IM

Administered by: Other       Purchased by: Other
Symptoms: Abnormal sleep-related event, Pulmonary congestion, Pulmonary oedema, Sudden infant death syndrome, Thymus hypertrophy
SMQs:, Cardiac failure (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Neonatal disorders (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-01-09
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: HQ1250111MAR2002

Write-up: Information has been received from an investigator regarding a 2 month old male who received his 1st doses of Prevnar, Hib-Titer, Infanrix, IPV and Engerix-B vaccines on 12/28/01, as part of a post-marketing safety trial. On 1/10/02, at 02:00, the mother took the infant into her bed for breast-feeding and the infant remained in bed with her. At 06:00, the mother awoke to find the infant dead. The coroner reported the cause of death as SIDS. The investigator believes that SIDS (expected per package insert) was not related to vaccine administration. The medical monitor''s assessment of relatedness is unknown. This report of a serious labeled event is being submitted in a 15-day time frame, as requested by the FDA. Per F/U 4/1/02: Date of death is reported as 1/9/02 on autopsy report. COD was reported as SIDS (bed-sharing context). There was pulmonary congestion and edema and thymus weight 37 grams (enlarged). Follow up on 01/28/04: "Follow up information received on 01/14/04 provided a change in the event date. Information has been received from an investigator regarding a 2 month old male who received his first doses of Prevnar, Hib-Titer, Infanrix, IPV, and Engerix-B vaccines on 12/28/01 as part of a surveillance trial. On 01/09/02, at 03:00AM, the mother took the infant into her bed for breastfeeing and the infant remained in bed with her. At 6:00AM, the mother awoke to find the infant dead. The coroner reported the cause of death as Sudden Infant Death Syndrome. The investigator and the medical monitor agreed that SIDS (expected per package insert) was not related to vaccine administration. This report of a serious, labeled event is being submitted in a 15-day time frame, as requested by the FDA."


VAERS ID: 182420 (history)  
Form: Version 1.0  
Age: 0.75  
Sex: Female  
Location: Unknown  
Vaccinated:2001-08-22
Onset:2001-10-30
   Days after vaccination:69
Submitted: 2002-03-14
   Days after onset:135
Entered: 2002-03-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 506A2 / 3 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA563AC / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 478325 / 3 RL / IM

Administered by: Other       Purchased by: Other
Symptoms: Apnoea, Lymphadenopathy, Ovarian cyst, Polyp, Pulmonary congestion, Pulmonary haemorrhage, Pulmonary oedema, Sudden infant death syndrome
SMQs:, Cardiac failure (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Acute central respiratory depression (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Neonatal disorders (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-10-30
   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:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: None
CDC Split Type: HQ1249511MAR2002

Write-up: Information has been rec''d from an investigator regarding a pt who rec''d her 3rd doses of Prevnar, Infanrix, and ActHIB vaccines on 8/22/01 as part of a post marketing safety surveillance trial. On 10/30/01, at 9 months of age the infant was found not breathing. Emergency services were called and she was seen in an ER where resuscitation efforts were unsuccessful. The results of an autopsy revealed that the cause of death was Sudden Infant Death Syndrome. The investigator believed that SIDS (expected per package insert) was not related to vaccine administration. The medical monitor''s assessment of relatedness is unknown. This report of a serious, labeled event is being submitted in a 15 day time frame as requested by the FDA. Per F/U 4/17/02: Autopsy states wholly liquified blood within the cardiovascular lumens, pulmonary congestion and a benign large tracheal polyp causing 50% occlusion of the tracheal lumen. The right ovary shows the presence of a cyst. There are enlarged lymph nodes.


VAERS ID: 182421 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Georgia  
Vaccinated:2002-03-11
Onset:2002-03-11
   Days after vaccination:0
Submitted: 2002-03-12
   Days after onset:1
Entered: 2002-03-14
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U0540DA / 2 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 09332 / 2 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR U0179 / 2 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 484132 / 1 RL / IM

Administered by: Public       Purchased by: Public
Symptoms: Petechiae, Sudden infant death syndrome
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-03-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Autopsy
CDC Split Type:

Write-up: Pt received shots on 3/11/02. Pt expired, during sleep, on 3/11/02. COD as per autopsy report: SIDS Per F/U 5/16/02 fo autopsy report: There are florid thymic petechiae.


VAERS ID: 182510 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Unknown  
Vaccinated:2001-11-23
Onset:2002-01-24
   Days after vaccination:62
Submitted: 2002-04-02
   Days after onset:68
Entered: 2002-03-15
   Days after submission:18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 606A2 / 2 LL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 480938 / 2 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR T13902 / 2 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 484134 / 2 RL / IM

Administered by: Other       Purchased by: Other
Symptoms: Apnoea, Atelectasis, Cardiomegaly, Irritability, Oral intake reduced, Petechiae, Pulmonary congestion, Pulmonary oedema, Sudden infant death syndrome, Thymus hypertrophy
SMQs:, Cardiac failure (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Neonatal disorders (narrow), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-01-24
   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:
Preexisting Conditions: Past conditions; Ear infections NOS
Allergies:
Diagnostic Lab Data: Per F/U 4/1/02, the autopsy report states the date of death was 1/27/02 but then in also states it as 1/24/02. The lungs show patchy atelectasis. Serial section reveals congestion and some edema froth. Thymus is enlarged but otherwise normal. There are scattered visceral and parietal pleural petechiae and there are a few petechiae on the epicardium. The thyroid is mildly congested, otherwise normal. Liver and kidneys have moderate congestion. There is dilatation of right heart.
CDC Split Type: HQ1250911MAR2002

Write-up: An investigator reported that a 6 month old male received a 2nd dose of Prevnar vaccine on 11/23/01, as "Post marketing Evaluation of Prevnar Pneumococcal 7-Valent conjugate vaccine (CRM197 protein conjugate); Safety of Prevnar Administered Concurrently with Routine Infant Vaccinations at 2,4 ,6, and 12 to 15 Months of Age." Concomitant medication included Infanrix, Polio vaccine and Hib-Titer. The coroner''s office reported that the infant "hadn''t been feeling good" for 2-3 days, was not eating and fussy while at "sitter''s" house. Sitter said he ate very little. The infant was put down to sleep and 1/2 hours later, was fine. In another 1/2 hour, a blanket was found around the infant''s face and he was found not breathing but with a heartbeat. "911" was called, resuscitation was attempted and the infant was pronounced dead. The pathologist that handled the case, determined the cause of death as SIDS. The investigator noted that a MD at the hospital said he sent the final report to the coroner''s office; however, the coroner''s office said that the hospital would have the workup. The investigator is still attempting to track down the documentation. The investigator and the medical monitor agree that sudden infant death syndrome (expected per local package insert) as "not related" to study vaccine. Additional information received 03/29/02 from investigator. The infant was described as previously healthy, except for recent fussiness related to teething. He was dropped off at the babysitter''s residence at approximately 0700 on 01/24/02. He was not eating well.At 09:00 he took four ounces of Enfamil in the car seat. he was then put to bed in a portable crib and asleep at approximately 09:15. Two months ago he took antibiotics for an ear infection which has now cleared. At approximately 1000 he was checked and seemed to be fine, supine position.At 10:30-1100, he was found with the quilt over his face and unresponsive. 911 was called, He was in full cardiac arrest upon arrival of the paramedics. Coroners'' autopsy report confirmed cause of death as SIDS.


VAERS ID: 182511 (history)  
Form: Version 1.0  
Age: 0.7  
Sex: Male  
Location: Unknown  
Vaccinated:2001-11-08
Onset:2001-12-29
   Days after vaccination:51
Submitted: 2002-08-13
   Days after onset:226
Entered: 2002-03-15
   Days after submission:150
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 501A2 / 3 LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 521142 / 3 RL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 479268 / 3 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 484134 / 3 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-12-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: HQ1245111MAR2002

Write-up: An investigator reported that an 8 month old male received a 3rd dose of Prevnar as a post-marketing safety study. Concomitant vaccines included a 3rd dose of Infanrix, Recombivax-HB and Hib-Titer vaccines. On 12/29/01, the pt expired. The coroner''s office is investigating the death as SIDS; however, confirmation of dx is "still pending receipt of results from toxicology, pathology, etc". The investigator assessed SIDS (expected per local package insert) as "not related" to study vaccine.


VAERS ID: 182513 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Unknown  
Vaccinated:2001-10-05
Onset:2001-10-21
   Days after vaccination:16
Submitted: 2002-03-14
   Days after onset:144
Entered: 2002-03-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 506A2 / 1 LL / IM
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 5205A2 / 2 RL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 479268 / 1 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR T05632 / 1 RA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 482373 / 1 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-10-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: HQ1250311MAR2002

Write-up: Information has been received from an investigator regarding a 2 month old female who received her 1st doses of Prevnar, Hib-Titer, Infanrix, IPV and her 2nd dose of Engerix-B as part of a post-marketing safety study. On 10/21/01, at 3 months of age, the infant died. Autopsy results showed the cause of death to be SIDS. The investigator believed that SIDS (expected per package insert) was not related to study vaccine administration. The medical monitor''s assessment of relatedness in unknown. This report of a serious, labeled event is being submitted in a 15-day time frame, as requested by the FDA. Follow-up info received on 03/13/2002 indicated that the medical monitor agreed with the investigator''s assessment that the event was not related to vaccine administration. Per F/U 4/1/02 autopsy states: The pt has apparent healed rib fractures on the lateral aspect of left ribs 6,7 and 8 and rib 6 on the lateral right chest. The thymus has occasional petechial hemorrhages on both the anterior and posterior surfaces. Sectioning of the lungs reveals moderate congestion and edema.


VAERS ID: 182514 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Unknown  
Vaccinated:2001-11-15
Onset:2001-12-04
   Days after vaccination:19
Submitted: 2002-03-14
   Days after onset:100
Entered: 2002-03-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 506A2 / 1 RL / IM
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 529A2 / 1 RL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 480438 / 1 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR T07902 / 1 LA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 451553 / 1 LL / IM

Administered by: Other       Purchased by: Other
Symptoms: Bronchiolitis, Pulmonary congestion, Pulmonary oedema, Sudden infant death syndrome
SMQs:, Cardiac failure (narrow), Interstitial lung disease (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Neonatal disorders (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-12-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: HQ1247411MAR2002

Write-up: Information has been received from an investigator regarding a 2 month old female who received her 1st doses of Prevnar, Hib-Titer, Infanrix, Engerix-B and IPV vaccines on 11/15/01 as part of a post-marketing safety study. On 12/4/01, the infant was seen in an ER where CPR was attempted. Resuscitation was unsuccessful and the infant died. Autopsy results revealed the cause of death as SIDS. The investigator believed the SIDS (expected per package insert) was not related to vaccine administration. The medical monitor''s assessment of relatedness is unknown. This report of a serious, labeled event is being submitted in a 15-day time frame, as requested by the FDA. Follow-up info received on 03/12/2002 indicated that the medical monitor agrees with the investigator''s assessment that the evnet was not related to vaccine administration. F/U 4/1/02 autopsy states: Pulmonary congestion and edema with mild patchy chronic bronchiolar inflammation; generalized visceral congestion.


VAERS ID: 182530 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Indiana  
Vaccinated:2001-10-29
Onset:2001-10-29
   Days after vaccination:0
Submitted: 2002-03-08
   Days after onset:130
Entered: 2002-03-18
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Apnoea, Bacterial infection, Cardio-respiratory arrest, Encephalopathy, Grand mal convulsion, Hyperbilirubinaemia, Inappropriate antidiuretic hormone secretion, Irritability, Jaundice, Tachycardia
SMQs:, Torsade de pointes/QT prolongation (broad), Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Anaphylactic reaction (broad), Acute pancreatitis (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Acute central respiratory depression (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hyponatraemia/SIADH (narrow), Hostility/aggression (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-11-01
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Multiple
CDC Split Type:

Write-up: The pt was very fussy that night and stopped breathing. He was on life support for 3 days before we let him go. Diagnosis in Hopital was : Acute anoxic encephalopathy, status epilepticus, acute respiratory failure, syndrome of inappropriate ADH secretion. Per F/U states DOB as 10/27/01 not 10/29/01. Per F/U Cardio-respiratory arrest, bacterial infection, jaundiced, electrolytes abn, fine tremors, tongue fasciculations, hypertonic UE and LE. Pt seizuring when 1st examined. Tacycardia, neonatal hyperbilirubinemia.


VAERS ID: 182594 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Maryland  
Vaccinated:2001-12-17
Onset:0000-00-00
Submitted: 2002-03-06
Entered: 2002-03-19
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U05408A / 2 LL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 480839 / 2 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR U0426 / 2 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 483162 / 2 RL / IM

Administered by: Private       Purchased by: Private
Symptoms: Coma, Sudden infant death syndrome
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Neonatal disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-12-21
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: Hemangioma-colic
Allergies:
Diagnostic Lab Data: EKG
CDC Split Type:

Write-up: COD -- SIDS. Per F/U 3/27/02; Reportedly, the decedent was a 4 month old healthy, normal male infant who was found unresponsive in his crib lying on his stomach.


VAERS ID: 182605 (history)  
Form: Version 1.0  
Age: 98.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2001-11-17
Onset:2002-01-01
   Days after vaccination:45
Submitted: 2002-03-15
   Days after onset:73
Entered: 2002-03-19
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUSHIELD) / PFIZER/WYETH 4018038 / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood chloride decreased, Coronary artery disease, Haemoglobin decreased, Influenza, Myocardial infarction, Nasal congestion, Pyrexia, Respiratory tract infection
SMQs:, Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Other ischaemic heart disease (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-01-26
   Days after onset: 25
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: Agitation; Coronary artery disease NOS; Dementia of the Alzheimer''s type NOS; Hypertension NOS; Hypothyroidism; Rami (unspecified) fracture NOS
Allergies:
Diagnostic Lab Data: On 1/23/02, blood chloride 97meq/L (decreased) and haemoglobin 10.5g/dL (decreased); mean cell haemoglobin 31.9pg/cell (increased) and blood thyroid stimulating hormone-pending
CDC Split Type: HQ0814321FEB2002

Write-up: A nurse reported that a 98 year old female resident in a long-term care facility received a dose of Flu Shield ''01-''02 on 11/17/01. In 1/02, the resident developed a "severe" respiratory infection characterized by congestion and fever. On 1/22/02, a dx of influenza A was confirmed by rapid antigen testing. She was treated with Tamiflu (oseltamivir phosphate) and Tylenol (acetaminophen). According to the reporter, the pt "was responding" to these interventions. However, on 1/26/02, the pt died. The pt''s physician indicated that the cause of death was myocardial infarction secondary to coronary artery disease. The physician "didn''t think her death was flu-related" but noted that influenza "may have been a contributory factor but not the primary cause of death". This is 1 of 8 residents from this facility who experienced adverse events following receipt of Flu Shield ''01-''02 (lot 4018038); however, this is the only pt who died. The reporter also noted that 7 employees of the facility experienced adverse events following receipt of Flu Shield ''01-''02 (lot 4018038).


VAERS ID: 182767 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Mississippi  
Vaccinated:2002-03-06
Onset:2002-03-07
   Days after vaccination:1
Submitted: 2002-03-11
   Days after onset:4
Entered: 2002-03-25
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 531A2 / 2 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0659L / 2 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR U0344 / 2 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 482872 / 2 RL / IM

Administered by: Public       Purchased by: Public
Symptoms: Salivary hypersecretion
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-03-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Augmentin and cough syrup
Current Illness: NONE
Preexisting Conditions: Mother reports RSV
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: MS02006

Write-up: Grandmother states "the baby died; that it had foamed at the mouth; gone to sleep and never woke up".


VAERS ID: 182920 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: New Jersey  
Vaccinated:2002-03-04
Onset:2002-03-14
   Days after vaccination:10
Submitted: 2002-03-27
   Days after onset:13
Entered: 2002-03-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U0542BA / 2 - / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1510L / 2 - / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA658AA / 2 - / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR U0425 / 2 - / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 484856 / 2 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Coma, Myocarditis
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), 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: 2002-03-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Cultures are submitted of blood and cerebrospinal fluid. Antigen test for respiratory syncytial virus was performed and was positive.
CDC Split Type:

Write-up: The pt received a 2nd dose of immunizations on 3/4/02 and passed away on 3/14/02. The infant was found unresponsive at his residence. The cause of death is still pending. Per F/U 4/24/02 autopsy; COD-myocarditis.


VAERS ID: 182993 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Male  
Location: California  
Vaccinated:2001-02-01
Onset:0000-00-00
Submitted: 2002-03-29
Entered: 2002-04-01
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Adrenal disorder, Bacterial infection, Cough, Dyspnoea, Epiglottitis, Laryngitis, Lethargy, Pyrexia, Tachypnoea, Tracheitis
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-02-05
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: amoxicillin
Current Illness: UNK
Preexisting Conditions: Per F/U 5/10/02: pt has a history of asthma since 1 month of age on albuterol, via nebulizor at home with multiple admissions. Recent lung infection seen on 1/30/02 and prescribed amoxicillin
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A0363598A

Write-up: This report describes a 7 month old male who died after receiving Infanrix. Medical history, concurrent conditions, and concurrent medicaitons were not specified. On 02/01/2002, the vaccine received an injection of Infanrix. It was not known if he had received previous doses of Infanrix. On an unspecified date post-immunization, the vaccinee died. Per F/U 5/10/02; pt had increased labored respirations and fever of 102.7F. He also had nasal flaring, cough was tachypneic and had a weak cry. He was lethargic. Arrested in ER, medical staff unable to resuscitate. Microscopic report: evidence of viral tracheitis and laryngitis as well as bronchopneumonia. Also has mild lymphocytic epiglottitis. Adrenal gland with increased congestion.


VAERS ID: 183160 (history)  
Form: Version 1.0  
Age: 32.0  
Sex: Female  
Location: California  
Vaccinated:2002-03-21
Onset:2002-03-22
   Days after vaccination:1
Submitted: 2002-03-30
   Days after onset:8
Entered: 2002-04-04
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 13844 / UNK - / SC
TD: TD ADSORBED (NO BRAND NAME) / SANOFI PASTEUR U0519AA / UNK - / IM

Administered by: Private       Purchased by: Private
Symptoms: Respiratory disorder
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2002-05-01
   Days after onset: 39
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: At 17:00 on 3/21/02, she received MMR and Tetanus vaccination. About 12 hours later (05:00 on 3/22/02), she died and was brought back. 05/01/2002 patient expired after being transferred to hospital in Budapest. Records from San Clemente Hospital: Diagnosed with severe anoxic brain injury, probably alpha coma, seizure disorder, staphylococcus aureus bronchitis, ventricular fibrillation arrest, tachycardia, elevated liver enzymes.


VAERS ID: 183183 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Oklahoma  
Vaccinated:2002-02-14
Onset:2002-02-15
   Days after vaccination:1
Submitted: 2002-03-08
   Days after onset:21
Entered: 2002-04-05
   Days after submission:28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 525A2 / 3 LL / IM
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 5228A2 / 4 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR U01792 / 3 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 485048 / 2 LL / IM

Administered by: Public       Purchased by: Public
Symptoms: Coma, Petechiae
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-02-15
   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: UNK
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: OK0158

Write-up: Death certificate received by state health dept on this child. Autopsy is pending. Cause of death unknown. Per F/U autopsy 4/15/02: No anatomic, metabolic or toxicologic cause of death found; thymic and pleural petechiae. The decedent was reportedly found unresponsive in her crib in a supine position with a comforter covering her head on 2/15/02.


VAERS ID: 183208 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Texas  
Vaccinated:2002-03-19
Onset:2002-03-20
   Days after vaccination:1
Submitted: 2002-03-23
   Days after onset:3
Entered: 2002-04-08
   Days after submission:15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 527A2 / 1 LL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 5252A2 / 1 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA618AA / 1 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR T1450 / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 484206 / 1 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Pulmonary congestion, Pulmonary oedema, Respiratory arrest, Sudden infant death syndrome
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Neonatal disorders (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-03-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: TX02043

Write-up: Pt was found by his father at home in full arrest. 911 contacted and taken to the ER. Vaccines were administered on 3/19/02. COD as per autopsy report: SIDS. Per F/U 5/28/02: Pulmonary vascular congestion, bilateral, severe, with mild edema and generalized visceral congestion, moderate.


VAERS ID: 183257 (history)  
Form: Version 1.0  
Age: 1.6  
Sex: Male  
Location: California  
Vaccinated:2001-02-27
Onset:2001-03-01
   Days after vaccination:2
Submitted: 2001-03-12
   Days after onset:11
Entered: 2002-04-09
   Days after submission:392
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1237H / 4 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 473351 / 1 RL / IM

Administered by: Public       Purchased by: Public
Symptoms: Bacterial infection, Brain oedema, Bronchitis, Coma, Cyanosis, Gastrointestinal disorder, Haematoma, Injury, Nervous system disorder, Petechiae, Pyrexia, Renal disorder, Sepsis, Tracheitis, Upper respiratory tract infection
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hyponatraemia/SIADH (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Probable primary site of this child''s infection is an upper respiratory tract infection.
CDC Split Type: CA010144

Write-up: Administered 0.5cc of Prevnar, RT, IM and 0.5cc of Hib, LT, IM per doctor''s orders. Per F/U 4/15/02: Group A Streptococcal Sepsis, tracheitis and bronchitis (chronic); cerebral edema with herniation of brain, temperal lobe; thymic petechiae; S/P attempted resuscitation; Blunt force injury of abdomen-laceration of the gastro-splenic ligament, avulsive, recent; retroperitoneal and perinephric hematoma, left (10ml), recent; hemoperitoneum (35ml); blunt force injury of right leg with contusion of thigh, small, organizing; child''s abdominal injury is inconsistent with resuscitative efforts. The child was reportedly found unresponsive in his crib by his mother on 3/1/01 AM. She and the child''s grandmother are reported to have initiated CPR and called for EMS. EMS found the decedent "unresponsive and cyanotic" at the scene and transported him to the ER. The child''s body temperature (R) was measured at 107.9F at the ER.


VAERS ID: 183258 (history)  
Form: Version 1.0  
Age: 2.5  
Sex: Unknown  
Location: California  
Vaccinated:2001-11-02
Onset:2001-11-02
   Days after vaccination:0
Submitted: 2001-12-10
   Days after onset:38
Entered: 2002-04-09
   Days after submission:119
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 697A2 / 1 LA / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 477553 / 1 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Ascites, Bacterial infection, CSF test abnormal, Cellulitis, Cyanosis, Feeling cold, Gastroenteritis, Haemorrhage, Hypokinesia, Oedema peripheral, Pulmonary congestion, Pulmonary oedema, Purpura, Pyrexia, Skin discolouration, Skin ulcer, Tachycardia, Toxic shock syndrome
SMQs:, Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Toxic-septic shock conditions (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Sepsis (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-11-05
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Blood, CSF and skin scraping from right leg-all positive for group A Beta Hemolytic strept
CDC Split Type: CA010145

Write-up: Per MD, persistent fever, 8 hours post vax. Decreased mobility on 11/4/01. Mosquito bite looking lesion on right lower leg. On 11/5/01, right lower leg discolored and swollen. To ER. On admit to ER, temperature 39.3C, tachycardia and right lower leg cyanotic, purpuric and cold below the knee. Only pulses present in right leg was femoral; others absent. Bleeding profusely from mucous membranes and puncture sites. Rapidly deteriorated and despite very aggressive CPR, reports child expired. Cause of death dx''d as toxic shock syndrome. Per F/U 4/29/02-Pathologic dxs cellulitis on the right lower extremity; petechial rash on the skin of the head, neck, torso and extremities, hospital blood cultures grouwing out beta-hemolytic Streptococcus Group A bacteria, Meningitis due to: Streptococcus pyogenes, Group A, Beta-hemolytic streptococcus; pulmonary congestion and edema; bilateral hydrothraces; ascites; eosinophilic gastroenteritis. COD: Septic Shock and Bacterial Meningitis due to bacteremia due to cellulitis.


VAERS ID: 183362 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Unknown  
Vaccinated:2002-01-01
Onset:2002-01-19
   Days after vaccination:18
Submitted: 2002-02-27
   Days after onset:39
Entered: 2002-04-11
   Days after submission:42
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asphyxia, Condition aggravated, Hepatic fibrosis, Hepatitis, Quadriplegia
SMQs:, Hepatitis, non-infectious (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Hostility/aggression (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Respiratory failure (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: 2002-01-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Hip displasia and thoracic scoliosis; quadriplegia following remote polio vaccination; recurrent pneumonia; remote tracheotomy and ventilator dependence
Allergies:
Diagnostic Lab Data: Hepatitis with moderate fibrosis
CDC Split Type:

Write-up: Decedent received the Oral Polio Vaccine at the doctor''s office on 05/22/2002. Soon after he began developing polio vaccine related quadriplegia. Per F/U 6/20/02: COD-asphyxia due to mechanical ventilator failure dut to polio vaccine related quadriplegia; therapeutic complication.


VAERS ID: 183402 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: North Carolina  
Vaccinated:2001-04-18
Onset:2001-04-27
   Days after vaccination:9
Submitted: 2001-10-01
   Days after onset:157
Entered: 2002-04-12
   Days after submission:193
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 991A2 / 1 LL / -
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / 2 - / -
HIBV: HIB (HIBTITER) / PFIZER/WYETH 474710 / 1 RL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR T0562 / 1 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 475380 / 1 LL / -

Administered by: Private       Purchased by: Private
Symptoms: Bacterial infection, Cardiac arrest, Cerebral atrophy, Coma, Crying, Dementia, Irritability, Nasal congestion, Pharyngitis, Pyrexia, Respiratory syncytial virus infection, Rhinorrhoea
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Agranulocytosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (narrow), Oropharyngeal infections (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-02-27
   Days after onset: 306
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations: ~Measles + Mumps + Rubella (MMR II)~~1.25~In Sibling|~Measles + Mumps + Rubella (MMR II)~~1.25~In Sibling
Other Medications: Tylenol, Mylacon Per F/U 4/15/02: Topomax
Current Illness: Seizure disorder Per F/U 4/15/02, she had been haveing fever and cold symptoms since 2/25/02
Preexisting Conditions: Seizure disorder with growth and developmental delay Per F/U 4/15/02; hospitalized at 10 weeks of age with a dx of viral meningoencephalitis with secondary status epilepticus
Allergies:
Diagnostic Lab Data: MRI''s; EEG; Ultrasounds; blood work. Per F/U 5/13/02; Nasopharyngeal swab (+) for RSV; Lung-bacterial culture: streptococci, alpha hemolytic; CSF-no growth
CDC Split Type: NC02016

Write-up: On 04/27-cold symptoms-cogesting, runny nose, fussy, etc. On 04/28 the symptoms got gradually worse. On 04/30, extremely fussy when eating (very little). On 05/01, in the early morning, the pt started high pitched screams and fever. COD as per autopsy report: Global hypoxic-ischemic brain injury, remote; RSV. Per F/U 5/13/02, At 8:00 AM on 2/27/02, she was found unresponsive. EMS arrived and she was asystolic and unresponsive to resuscitation. She was pronounced dead in the ER. Final DX: Global hypoxic-ischemic brain injury, remote; static encephalopathy due to remote meningoencephalitis (clinically); severe bilater cortical laminar necrosis; bilateral atrophy of cerebral hemispheres with subdural membrane formation; neuronal loss and gliosis of thalamus and basal ganglia; centrolobular cerebellar sclerosis; respiratory syncytial virus (RSV) bronchitis/bronchiolitis.


VAERS ID: 183721 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Male  
Location: New York  
Vaccinated:2001-10-16
Onset:2002-11-01
   Days after vaccination:381
Submitted: 2002-04-16
   Days after onset:199
Entered: 2002-04-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 90659 / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain upper, Alanine aminotransferase increased, Anaemia, Angina pectoris, Aspartate aminotransferase increased, Atrial fibrillation, Blood albumin decreased, Blood alkaline phosphatase increased, Blood calcium decreased, Blood glucose increased, Blood urea increased, Carbon dioxide increased, Cardiomegaly, Enzyme abnormality, Gastrointestinal haemorrhage, Haematocrit decreased, Haemoglobin decreased, Hepatic neoplasm malignant, Hepatomegaly, Hyperbilirubinaemia, Hypertension, Lymphopenia, Platelet count decreased, Red blood cell count decreased, Red blood cell sedimentation rate increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Acute pancreatitis (narrow), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypertension (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Liver malignant tumours (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-12-18
   Days after onset: 318
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lasix; Adalat; Loppressor; Lopid; MT Patch; Axid; Vioxx
Current Illness: NONE
Preexisting Conditions: Per F/U 6/25/02: heart disease, hypertension, diabetes mellitus, tuberculosis, asthma, pneumonia, bronchitis, jaundice, anemia, gall bladder disease, kidney disease, arthritis, veneral disease, mental illness, rheumatic fever
Allergies:
Diagnostic Lab Data: 11/2/01-Glucose 147 (H); CO2-34 (H); Calcium-8.2 (L); Albumin-3.1 (L); Total bilirubin-2.0 (H); AST and ALT-109 (H) and 186 (H)RBC-3.86 (L); HGB-12.2 (L) HCT-35.2 (L); Platelets-121 (L); MPV-6.9 (L); Neutrophil-80.4 (H); Lymphocyte-8.5 (L); ESR-24 (H). On 11/1/01-BUN 30 (H); CO2-33 (H); Total bilirubin-2.1 (H); Direct bilirubin-1.0 (H); ALK phosphatase-124 (H); AST-123 (H); ALT-205 (H); RBC-3.94 (L); HGB-12.1 (L); HCT-36.0 (L); MPV-7.2 (L); SEGS-74.0 (H); Lymphocyte-7.0 (L); MONOCYTE-14.0 (H); Myelocyte-1.0 (H); PT-14.2 (H); INR-1.40 (H); PTT-22.3 (L); Lipase-151 (H); CT lung-liver is enlarged with nodules, multiple lesions compatible with metastic disease of liver; Chest PA-heart enlarged;
CDC Split Type:

Write-up: Patient was under doctor''s care for years. On October 4th, patient had an enzyme test and the numbers were low (45). He had the flu shot on October 16th. November 1st, he had stage 4 liver cancer. His enzymes were over 260. Patient died on 12/18/2001. Diagnosed at hospital with hepatomegally with liver mass, hypertention, GI bleeding/anemia. Also diagnosed with unstable angina. Pt sent to ER by MD for LUQ pain X 1 week per F/U 6/25/02 and afibrillation.


VAERS ID: 184184 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: West Virginia  
Vaccinated:2002-02-12
Onset:2002-02-14
   Days after vaccination:2
Submitted: 2002-03-25
   Days after onset:39
Entered: 2002-05-03
   Days after submission:38
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 532A2 / 1 RL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 477336 / 1 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR T140412 / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 483169 / 1 LL / IM

Administered by: Private       Purchased by: Other
Symptoms: Apnoea, Blood potassium increased, Blood sodium decreased, Cold sweat, Meningitis, Musculoskeletal stiffness, Pulmonary oedema, Pyrexia
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (narrow), Hyponatraemia/SIADH (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Chronic kidney disease (broad), Arthritis (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-02-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Lab-possible meningitis Follow-up autopsy-Brain (multiple sections of the meninges show a dense exudate of acute and chronic inflammatory cells. Gram stain shows large numbers of gram positive cocci mostly in pairs, occasionally short chains, consistent with a streptococcus.) Lungs-pulmonary edema, no inflammation; liver-mild microvesicular fatty change; Minor abrasion to left side of forehead; Potassium-17.6mmol/L (H); Sodium-117mmol/L (L)
CDC Split Type:

Write-up: The vaccination was administered on 02/12/2002 and pt was brought dead to the community hospital on 02/14/2002. Mother stated that she does not know what happened; infant had some fever. Mother woke up around noon, she found baby cold and stiff. She was not breathing. COD as per autopsy report: Bacterial Meningitis


VAERS ID: 184239 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Alabama  
Vaccinated:2002-04-24
Onset:2002-04-27
   Days after vaccination:3
Submitted: 2002-04-30
   Days after onset:3
Entered: 2002-05-07
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U0546BA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA677AA / 1 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR U0824 / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 483177 / 1 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-04-27
   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: Rynatan suspension
Current Illness: Mild nasal drainage/moderately rhonchi in both lungs
Preexisting Conditions: URI 4/9/02
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Sudden Infant Death Syndrome: Child discovered with no pulse or respiration by mom, lying face down around 04:00. Ambulance was called and the pt was taken to the hospital with CPR in progress. At 05:13, the pt was pronounced dead.


VAERS ID: 184302 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Female  
Location: Georgia  
Vaccinated:2002-04-02
Onset:2002-04-02
   Days after vaccination:0
Submitted: 2002-05-06
   Days after onset:33
Entered: 2002-05-08
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pyrexia, Respiratory disorder
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 20 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever and respiratory difficulty. The annual follow up received on 5/23/03 states "she died from vaccine reaction. Pneumovax in pneumonia pt''s may not be safe."


VAERS ID: 184346 (history)  
Form: Version 1.0  
Age: 1.08  
Sex: Female  
Location: California  
Vaccinated:2002-04-04
Onset:2002-04-27
   Days after vaccination:23
Submitted: 2002-05-01
   Days after onset:4
Entered: 2002-05-09
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1379L / 1 RL / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0573L / 1 LL / SC

Administered by: Private       Purchased by: Private
Symptoms: Cardiac arrest, Infection, Multi-organ failure, Respiratory arrest, Shock
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 (broad), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2002-07-16
   Days after onset: 80
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 44 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: RSV Bronchiolitis and pneumonia
Preexisting Conditions: Congenital ichthyosis, failure to thrive,
Allergies:
Diagnostic Lab Data: VZV-DFA (+)
CDC Split Type:

Write-up: Disseminated VZV with multi-organ failure, shock, CV arrest. Diagnosed with Superficial cellulitis, Otitis externa, hepatomegaly. 3/16/05 Autopsy report received which revealed COD to be respiratory arrest and congenital ichthyosis w/Netherton''s syndrome. Patient arrested in pediatrician''s office & unable to be revived/ss


VAERS ID: 184466 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Male  
Location: Louisiana  
Vaccinated:2002-03-05
Onset:2002-03-18
   Days after vaccination:13
Submitted: 2002-05-07
   Days after onset:49
Entered: 2002-05-14
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA610AA / 4 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0160L / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 484209 / 2 RL / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Bacterial infection, Brain oedema, Cerebral haemorrhage, Hypersensitivity
SMQs:, Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-03-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pink throat and slightly enlarged tonsils and stuffy nose per F/U 6/10/02
Preexisting Conditions: Mom reported vomiting and diarrhea that stopped 4 days prior to death; went to ER per F/U 6/10/02, also has history of allergies
Allergies:
Diagnostic Lab Data: Autopsy performed-cause of death; nodular pneumonitis with allergic component
CDC Split Type: LA020501

Write-up: The pt died suddenly at the babysitter''s; dx on death certificate is nodular pneumonitis with allergic component. Mother is concerned that child''s allergic reaction was possibly related to vaccine. Received HIB, MMR, PCV-7 on 3/5/02. Per F/U 6/10/02 also had cerebral edema and congestion, scattered colonies of bacterial-type elements within these nodular areas and intra-alveolar hemorrhage.


VAERS ID: 184511 (history)  
Form: Version 1.0  
Age: 0.22  
Sex: Male  
Location: Maryland  
Vaccinated:2002-04-19
Onset:2002-04-20
   Days after vaccination:1
Submitted: 2002-04-22
   Days after onset:2
Entered: 2002-05-14
   Days after submission:22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 532A2 / 1 LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1521K / 2 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1521K / 1 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR U0179 / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 485043 / 1 RL / IM

Administered by: Public       Purchased by: Public
Symptoms: Apnoea, Sudden infant death syndrome
SMQs:, Acute central respiratory depression (narrow), Neonatal disorders (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-04-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol
Current Illness: Mild URI
Preexisting Conditions: Mild URI, wheezing (one episode)
Allergies:
Diagnostic Lab Data: Autopsy is pending, Medical Examiner expects this to be SIDS, per phone call.
CDC Split Type: MD02002

Write-up: Pt found not breathing at 6am on 04/20/2002. Medical examiner expect from the autopsy to be SIDS. Per F/U autopsy; deceased found unresponsive in bed with an adult. SIDS confirmed. Follow up on 06/19/2002: "Follow up telephone call from manufacturer on 06/03/2002 to Dr at care center for additional information on patient, Dr stated that without patient''s full name she is unable to provide any information. Dr also stated that the administered product was IPOL and not IPV. As per regulatory affairs, the lot # (U0179) that had been originally reported for IPV was that of Yellow Fever. The lot number for the IPOL product was not reported. From faxed correspondence received at the manufacturer, it was reported: "This report was received from Wyeth-Ayerst for Streptococcus pneumoniae vaccine and was assigned manufacturer control number HQ2420023MAY2002. Information has also been received from a physician concerning an 11-week old male patient with a history of one previous episode of wheezing (time not specified, treated with albuterol), no other significant past medical history and no concurrent conditions, who on 04/19/2002 at 15:00 was vaccinated in the right thigh with the first dose (Lot # 152K reported, invalid for the product) of Haemophilus B conjugate vaccine (reported as "Hib(PRP-OMP)). Concomitant therapy that same day at 15:00 included the second dose (illegible lot number reported) in the right thigh of hepatitis B vaccine recombinant vaccine/tetanus toxoid (INFANRIX), and the first dose (Lot # 485-043) in the right thigh of Streptococcus pneumoniae vaccine (PREVNAR). It was reported taht the patient had a mild upper respiratory infection at the time of vaccination, and that the patient did not have any wheezing on the day of vaccination. The patient was not on any medications to the physician''s knowledge. It was noted that the episode of wheezing has not been in the several days prior to the vaccinations. On 04/20/2002, at 06:00 the patient was found not breathing. The patient died on 04/20/2002. The patient had no history of adverse events after prior vaccination. It was reported that an autopsy was done, but that the results were pending." Additional information has been requested.


VAERS ID: 184569 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Illinois  
Vaccinated:2001-02-07
Onset:2001-04-19
   Days after vaccination:71
Submitted: 2002-05-07
   Days after onset:383
Entered: 2002-05-15
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 5166A2 / 3 - / IM

Administered by: Public       Purchased by: Other
Symptoms: Abasia, Headache, Influenza like illness, Leukaemia, Respiratory disorder
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Respiratory failure (broad), Haematological malignant tumours (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Unknown to this reporter.
CDC Split Type:

Write-up: Headache and flu-like symptoms in mid-April, 2001. Went to ER on 4/22/01 and was unable to stand on her own. On 4/24/01, went to ICU on vent. Transferred to another hospital with a dx of Leukemia (AML). Life expectancy unknown. The annual follow up received on 5/29/03 states pt died summer 2002.


VAERS ID: 184895 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: California  
Vaccinated:2002-05-09
Onset:2002-05-12
   Days after vaccination:3
Submitted: 2002-05-14
   Days after onset:2
Entered: 2002-05-21
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 538A2 / 1 RL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1670K / 1 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR T0266 / 1 LL / SC

Administered by: Public       Purchased by: Public
Symptoms: Apnoea, Cyanosis, Petechiae, Pyrexia, Sudden infant death syndrome
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-05-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: Per F/U 7/5/02; during delivery, the pt suffered a decreased heart rate but received no lasting side effects. She was born with thrush and an eye infection.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Per F/U 7/5/02, autopsy DX: SIDS. The pt was last known alive by her mother at 06:45 on 5/12/02. She states she bottle-fed the pt 4 oz of Enfamil with Iron at 06:45. She also gave the pt Children''s Tylenol (dosage unk). She states she fell asleep with the pt resting face up on her chest and wrapped in a receiving blanket. When she awoke at 11:15 and saw the pt''s lips were blue, she yelled to her mother to call the hospital. At 11:16, the pt''s grandmother iniated CPR. EMS responded and arrived at 11:19. The pt was without respirations or discernible heart beat. Pt was given oxygen via bag-valve mask and CPR was continued during transport. Arrived in ER at 11:24. At ER, advanced life support were iniated but unsuccessful. MD made the death decision at 11:47 hours. The pt''s mother was present at the time of death. A low-grade temperature had been present since the immunizations. Final pathologic findings: scattered petechial hemorrhages of the lungs, heart and thymus.


VAERS ID: 184907 (history)  
Form: Version 1.0  
Age: 2.6  
Sex: Male  
Location: Unknown  
Vaccinated:1996-10-17
Onset:1998-11-15
   Days after vaccination:759
Submitted: 2002-05-17
   Days after onset:1278
Entered: 2002-05-21
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 4 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Fungal infection, Gastrointestinal haemorrhage, Haemoglobin decreased, Meningitis, Myeloid leukaemia, Pleural effusion, Pyrexia, Respiratory distress, Sepsis, White blood cell count decreased
SMQs:, Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Noninfectious meningitis (narrow), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Haematological malignant tumours (narrow), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1999-01-04
   Days after onset: 50
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Acute Myeloid leukemia NOS; Immunodeficiency NOS
Preexisting Conditions: Epistaxis episodes since the age of 14 months; Per F/U 5/28/02 history of acute myeloid leukemia; immunodeficiency NOS
Allergies:
Diagnostic Lab Data: Blood culture 11/15/98-specimen revealed penicillin resistant Streptococcus pneumoniae serotype 19F; Culture NOS-(+) right pleural effusion grew Aspergillus; Differential WBC-2.3, 12% neutrophils, 88% lymphocytes; Full blood count 11/10/98-Hgb 10.5, WBC-3.3, 83% neutrophils, 16% lymphocytes and 1 basophil; Platelets-390,000; Blood culture 11/16/98-neg. COD as per death certificate includes myleodysplasia/preleukemia and aspergillus meningitis.
CDC Split Type: HQ1985612JUN2001

Write-up: Information has been received from an investigator concerning a male child with a history of acute myeloid leukemia who received his 4th dose of Prevnar on 10/17/96 as part of a post-marketing safety surveillance trial. Approx. 2 years, post vax, at 31 months of age, he developed sepsis. Culture revealed Streptococcus pneumoniae serotype 19F. Sepsis was considered to be an "Other Medically Important Event". The Medical Monitor and Investigator''s assessment of the relatedness between septicemia streptococcal (expected per the package insert) and Prevnar was unknown. Additional information was received on 5/6/02. The child had a history of bleeding episodes since 14 months of age. A probable dx of acute megaloblastic leukemia was made and the child was treated with standard induction chemotherapy including intrathecal cytarabine. He was re-admitted to the hospital on 11/15/98 for his 2nd course of chemotherapy and was febrile. Blood culture grew penicillin resistant Streptococcus pneumoniae. A repeat blood culture on 11/16/99 was negative. He was afebrile and was started on chemotherapy. "Stormy" hospital course was complicated by Streptococcus viridans sepsis and he was transferred to another facility because of increased respiratory distress. He developed a right pleural effusion which grew Aspergillus. His respiratory condition improved and the child was transferred back to the hospital facility. He was discharged on 1/1/99 and died at home. Both the investigator and medical monitor''s assessments were unknown. Per F/U 5/28/02 autopsy: COD ureteral and GI bleeding, Aspergillos meningitis and pneumonia and myelodysplasia/pre-leukemia.


VAERS ID: 185037 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: California  
Vaccinated:0000-00-00
Onset:2000-10-01
Submitted: 2002-05-20
   Days after onset:596
Entered: 2002-05-22
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Dyspnoea, Lung disorder, Lung neoplasm malignant, Pleural effusion
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-07-22
   Days after onset: 659
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: Spinal cord injury NOS; Cigarette smoking
Allergies:
Diagnostic Lab Data: Lab results included aspiration of pleural cavity revealing fluid with reactive mesothelial cells on 9/28/00; CXR revealing malignant mesothelioma on 11/00; CT revealing malignant mesothelioma and a Thorascopic biopsy-results not specified
CDC Split Type: HQ2372117MAY2002

Write-up: The pt had a legal complaint. An attorney reported that a 57 year old male received Orimune vaccine sometime after 1960, when the pt was over 15 years old. The pt has a medical history of cigarette smoking and spinal injury. On or about 8/00, the pt was dx''d with malignant mesothelioma. He also developed shortness of breath, anatomical changes to his alveoli and other lung damage (not specified). It is alleged that the pt was exposed to the SV40 virus. The pt also alleges asbestos exposure while employed at various organizations. This case was considered "serious" since malignant mesothelioma was considered "Medically Important" (OMIC) for this case. Follow-up information received on 03/10/2005. Follow-up information received from the attorney provided a revised onset date, revised coding and outcome. An attorney reported that a 56-year-old male received Poliovirus vaccine (manufacturer unknown) sometime in the early 1960s. The patient had a medical history of cigarette smoking and spinal injury. On or about October 2000, the patient was diagnosed with mesothelioma. He also developed shortness of breath, anatomical changes to his alveoli and "invariably fatal cancer of the serosal membranes." Lab results included an aspiration of the pleural caviry revealing fluid with reactive mesothelioma. On 22-Jul-2002, the patient subsequently died from mesothelioma. The attorney alleges the decedent contracted, suffered and died form mesothelioma as a result of exposure to both teh SV40 virus in the poliovirus vaccine and to asbestos while employed at various organizations.


VAERS ID: 185418 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Indiana  
Vaccinated:2002-05-01
Onset:0000-00-00
Submitted: 2002-05-20
Entered: 2002-05-28
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 521A2 / 2 RL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1638K / 1 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T1191 / 2 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 484209 / 2 LL / IM

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: 2002-05-07
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type:

Write-up: Pt was given 2nd set of immunizations on 05/01/2002. No adverse reactions at time. None reported later. Pt died on 05/08/2002. Death certificate states "SIDS." Per F/U 5/29/02, death certificate states date of death as 5/7/02 at 5:10 PM


VAERS ID: 185419 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Minnesota  
Vaccinated:2002-05-15
Onset:2002-05-16
   Days after vaccination:1
Submitted: 2002-05-20
   Days after onset:4
Entered: 2002-05-28
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 531A2 / 1 RL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0039M / 1 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR T1464 / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 484856 / 1 LL / IM

Administered by: Private       Purchased by: Other
Symptoms: Bacterial infection, Petechiae, Sudden infant death syndrome
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-05-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Preliminary medical examiners report is SIDS (early AM). Per F/U 7/8/02; Thymic and pleural petechial hemorrhages; Lung culture-mixed bacterial flora


VAERS ID: 185516 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Mississippi  
Vaccinated:2002-04-23
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2002-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 542A2 / UNK RL / -
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0037M / UNK LL / -
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. U0823 / UNK LL / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-04-29
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: Upper respiratory infection
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Found in prone position in crib, covered by blanket. Preliminary cause of death is SIDS as per medical examiner.


VAERS ID: 186046 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Texas  
Vaccinated:2002-05-31
Onset:2002-06-01
   Days after vaccination:1
Submitted: 2002-06-03
   Days after onset:2
Entered: 2002-06-05
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 530A2 / 1 LL / IM
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 5213A2 / 2 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA618AA / 1 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR T1390 / 1 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-06-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Prematurity 31-32 weeks
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Child found dead in bed at 7AM. Fed well at 3AM. Afebrile all evening after immunization. SIDS was COD as per autopsy report.


VAERS ID: 186187 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Female  
Location: New Jersey  
Vaccinated:2002-05-17
Onset:2002-05-31
   Days after vaccination:14
Submitted: 2002-06-03
   Days after onset:3
Entered: 2002-06-10
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U0540BA / 2 LL / -
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1390L / 2 RL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR U0425 / 2 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 484871 / 2 LL / -

Administered by: Private       Purchased by: Private
Symptoms: Blood disorder, Sudden infant death syndrome
SMQs:, Haematopoietic cytopenias affecting more than one type of blood cell (broad), Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-05-31
   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: Polyviflor + Fe, Westcourt Cream
Current Illness: Mild eczema
Preexisting Conditions: Bart''s Hemoglobin
Allergies:
Diagnostic Lab Data: Patient may have Bart''s Hgb
CDC Split Type:

Write-up: Pt received immunizations on 05/17/2002. Was well. No reacting. Put to bed on 05/31/2002. Found cold and dead on 06/01/2002 AM. Medical examiner "SIDS."


VAERS ID: 186274 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Male  
Location: D.C.  
Vaccinated:2002-05-29
Onset:2002-05-29
   Days after vaccination:0
Submitted: 2002-06-10
   Days after onset:12
Entered: 2002-06-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 5230A2 / 3 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-05-29
   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: Inderol, Spironolaetone, Demadol
Current Illness: UNK
Preexisting Conditions: Hypertension, liver failure
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A0370073A

Write-up: Report A0370073A describes a 62 year old male who died following receipt of hep B vaccine recombinant. The medical history included hypertension. The vaccinee was scheduled to received a liver transplant; the condition that caused the pt to require a transplant was not provided. The vaccinee received his first and second injections of Engerix-B on unspecified dates. He had no adverse experiences following these injections. He received his third injection of EngerixB at 14:20 on 05/29/2002. He remained in the physician''s office for observation for 15 mins post-immunization. He stopped breathing in his car as his wife drove him home, approximately 20 mins after leaving the physician''s office. His wife drove directly to the local ER, where he was pronounced dead. The cause of death was unknown at the time of this report.


VAERS ID: 186723 (history)  
Form: Version 1.0  
Age: 0.59  
Sex: Male  
Location: Michigan  
Vaccinated:2002-05-28
Onset:2002-06-01
   Days after vaccination:4
Submitted: 2002-06-11
   Days after onset:10
Entered: 2002-06-19
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 55242 / 1 LL / -
HIBV: HIB (HIBTITER) / PFIZER/WYETH 481568 / 1 RL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR U0614 / 1 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 484871 / 1 RL / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-06-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EES suspension
Current Illness: URI, Left Otitis, Afebrile
Preexisting Conditions: Umbilical granuloma, gastro, otitis media.
Allergies:
Diagnostic Lab Data: Autopsy-pending
CDC Split Type:

Write-up: Died four days after receiving vaccines for us apparent reasons. Autopsy pending. COD ruled as asphyxia, manner of death natural as per autopsy report


VAERS ID: 186861 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2002-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -

Administered by: Private       Purchased by: Unknown
Symptoms: Infection, Influenza like illness, Red blood cell count decreased, White blood cell disorder
SMQs:, Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (broad), Haemorrhage laboratory terms (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1999-03-14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: Decades of undefined anemia (in family)
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Flu shot first week in October 10/98, by 10/12/98 huge infected mass forms on chest rather got flu symptoms immediately after shot. WBC doubled over night and WBC kept rising, RBC falling until dead 5 months later. March 10, 1999 cortizons injected to knee March 14, 1999 dead.


VAERS ID: 187005 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Ohio  
Vaccinated:2002-05-23
Onset:2002-05-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2002-06-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U0547CA / 2 LL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 480695 / 2 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR U0907 / 2 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 484874 / 2 RL / IM

Administered by: Private       Purchased by: Private
Symptoms: Apnoea, Sepsis, Sudden infant death syndrome
SMQs:, Acute central respiratory depression (narrow), Neonatal disorders (narrow), Respiratory failure (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-05-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: Syndactyly L 2nd and 3rd toes.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Sudden unexpected death. No symptoms preceeding discovery of apneic infant. COD - Sepsis due to beta hemolytic strep as per autopsy report.


VAERS ID: 187045 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2002-07-05
Entered: 2002-07-01
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / -
TTOX: TETANUS TOXOID (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Coma, Encephalitis
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), 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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Hospitalization
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0206USA01625

Write-up: Information has been received from a physician concerning a pt who was vaccinated with a dose of MMR II. The reporter "heard" that the pt "may have had a serious adverse event" and requested information regarding MMR II, encephalitis and coma. Unspecified medical attention was sought; however, the reporting physician noted that the pt was "not his pt." The reporter considered the adverse event to be an other important medical event. Additional info has been requested. Follow-up info was received on 06/27/02. The physician revealed that he is acting as a consutant on a legal case concerning this pt. He reported that she went on to develop encephalitis and later died. The reporter considered the encehalitis to be an other important medical event. Additional info has been requested.


VAERS ID: 187233 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: North Carolina  
Vaccinated:2002-06-18
Onset:2002-06-18
   Days after vaccination:0
Submitted: 2002-06-20
   Days after onset:2
Entered: 2002-07-05
   Days after submission:15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER 543A2 / 2 LL / -
HIBV: HIB (HIBTITER) / PFIZER/WYETH 481562 / 2 LL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR U0823 / 2 RL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 485993 / 2 RL / -

Administered by: Private       Purchased by: Other
Symptoms: Decreased appetite, Lethargy, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-06-18
   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: Former 32 week premie with h/o tracheomalcia
Allergies:
Diagnostic Lab Data:
CDC Split Type: NC02055

Write-up: Pt came in mom and dad for 4 month well visit. Was doing well at that time with no illness or temp noted. Pt is former 32 weeks premie who had good weight gain was up to 8#9lb. Shots below were administered. Pt tolerated them well. When parents got home they gave dose of Tylenol at 8pm but stated no temp was noted. They then gave another dose at 12am. Pt acted very lethargic with decreased po intake. Parents awake at 6am and found pt to have passed. No fussiness was ever noted, just increased sleepiness with a decrease in po intake.


VAERS ID: 187789 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Male  
Location: Ohio  
Vaccinated:2002-07-16
Onset:2002-07-17
   Days after vaccination:1
Submitted: 2002-07-18
   Days after onset:1
Entered: 2002-07-22
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 538A2 / UNK LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1697K / UNK RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA546AD / UNK LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR T1128 / UNK RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 484873 / UNK RL / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Apnoea, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-07-17
   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: PPD
Current Illness: NONE
Preexisting Conditions: Congenital spina bifida
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Parents noticed infant was not breathing well, then noticed that he had stopped breathing-called 911- underwent prolonged resuscitation without recovery.


VAERS ID: 187790 (history)  
Form: Version 1.0  
Age: 0.9  
Sex: Male  
Location: Nevada  
Vaccinated:2002-06-27
Onset:2002-06-29
   Days after vaccination:2
Submitted: 2002-07-18
   Days after onset:19
Entered: 2002-07-22
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 488566 / 1 LL / IM

Administered by: Private       Purchased by: Private
Symptoms: Abdominal distension, Adrenal haemorrhage, Ascites, Bacterial infection, Convulsion, Heart rate increased, Hypotension, Platelet count increased, Pleural effusion, Pyrexia, Respiratory rate increased, Sepsis, Tremor
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Pulmicort, Singulair, Kopenex
Current Illness: UNK
Preexisting Conditions: Bronchospasm NOS; Bronchiolitis; Congenital diaphragmatic hernia; Otitis Media NOS; Upper respiratory tract infection NOS
Allergies:
Diagnostic Lab Data: Blood Culture - streptococcus pneumoniae isolated (serotype 22F); WBC - 18,000; Platelet Count - 514,000; UA-wnl; Autopsy pending. Per F/U 7/23/02, BP in ER 42/36; glucose-too low to measure but then f/u accu-chek was 91; Contrast study of abdomen to R/O intestinal obstruction
CDC Split Type: HQ3058102JUL2002

Write-up: Additional information received on 7/12/02 provided the Strep pneumoniae serotype. A pediatrician reported that an 11 month old male, who had a medical history of congenital diaphragmatic hernia, reactive airway disease and numerous colds, received his first dose of Prevnar on 6/27/02. Concomitant therapy included Pulmicort (budesonide), Kopenex (Levalbuterol) and Singulair (montelukast sodium). In 5/02, he was treated for bronchiolitis and otitis media with amoxicillin. Two days post vaccination, on 6/29/02, he was taken to the pediatrician''s office because he was shaking. His temperature was 104.9 deg F; he was transported to the hospital. On admission, it was noted that he had experienced seizures. Laboratory studies yielded the following results: WBC 18,000; platelet count 514,000; blood culture positive for Strep pneumoniae (serotype 22F). A lumbar puncture was not performed. A diagnosis of septic shock was made and intravenous ceftriaxone was administered. He expired later that day following resuscitative efforts. Autopsy results are pending. The reporter submitted this directly to VAERS. Per F/U 7/23/02, on arrival at ER, pulse-198; RR-45; hemorrhaging at IV spots and given fresh frozen plasma and platelets with resolution of his bleeding. He was also given a unit of packed red blood cells. His abdomen became quite distended thoughout this resuscitation attempt. He began to have red frothy sputum from his endotracheal tube and his CXR showed a developed bilateral white-out of his lungs. He was transferred to ICU where his oxygen sats dropped into the 70''s. He remained hypotensive. He died at 18:51. DX: ascites; bilateral pleural effusions; bilateral adrenal hemorrhage.


VAERS ID: 187936 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Texas  
Vaccinated:2002-07-19
Onset:2002-07-22
   Days after vaccination:3
Submitted: 2002-07-22
   Days after onset:0
Entered: 2002-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 546A2 / 1 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0283M / 1 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR V0903 / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 486820 / 1 RL / IM

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: 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: none known
Current Illness: no
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: pending
CDC Split Type:

Write-up: Death- post mortem pending (county medical examiner )


VAERS ID: 187938 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: West Virginia  
Vaccinated:2002-05-08
Onset:2002-05-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2002-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 538A2 / 2 LL / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA676AA / 2 LL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR U0613 / 2 RL / -

Administered by: Private       Purchased by: Public
Symptoms: Fatigue, Irritability, Sudden infant death syndrome
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Neonatal disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-05-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Heart murmur, sibling seizure disorder
Allergies:
Diagnostic Lab Data: Have ER reports then autopsy performed. Waiting for final report
CDC Split Type:

Write-up: Had shots on 05/08. Extremely fussy next day 05/09, more tired than usual. Put to bed 05/09 that night when father called she passed away.


VAERS ID: 188068 (history)  
Form: Version 1.0  
Age: 0.9  
Sex: Male  
Location: South Dakota  
Vaccinated:1984-11-28
Onset:1984-11-28
   Days after vaccination:0
Submitted: 2002-07-24
   Days after onset:6446
Entered: 2002-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / 2 UN / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / PFIZER/WYETH UNKNOWN / 3 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Cerebral palsy, Dyskinesia, Encephalopathy, Neurodevelopmental disorder, Somnolence
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Congenital, familial and genetic disorders (narrow), Dyskinesia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Chronic kidney disease (broad), 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: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: encephalopathy/seizure~DTP (no brand name)~2~0.90~In Patient
Other Medications:
Current Illness:
Preexisting Conditions: diagnosed with mild cerebral palsy at 8 months of age...with good prognosis. Apgar was 9, suspect 2 months shot caused the cp. Second dose of Pertussis resulted in dramatic adverse affects and significant further brain damage and onset of seizures. Administering doctor not aware of patient death 17 years later.
Allergies:
Diagnostic Lab Data: apgar 9 at birth, showing cerebral palsy not present at birth. Mild cerebral palsy as diagnosed by neurologist with no seizures as substantiated by EEG after first Pertussis dose at 2 months of age, and immediately prior to 2nd dose. Within 1 week of 2nd dose, significant loss of motor control and appearance of seizures noted by parents. Within 4 weeks of 2nd dose, severe cerebral palsy with mental retardation and abnormal EEG and seizures officially diagnosed by neurologist. Sudden and unanticipated death (SIDS-like) at age 17, ruled by coroner the result of cerebral palsy.
CDC Split Type:

Write-up: Patient sleepy after shot at 2 months of age. Birth apgar 9, although development delayed after 3 months of age and diagnosed with mild form of cerebral palsy by Dr., neurologist, at 9 months of age. At that time (2 months of age), we did not see a pertussis connection because were told that a bona-fide reaction was marked only by fever. However, at 11 1/2 months of age, Dr. argued with patient''s mother over administration of Pertussis vaccine as mother had learned from other parents of cp victims that Pertussis should never be given to children with neurological problems. Dr. argued that neurologist said it was safe because pt had non-progressive encephalopathy. Another dose of Pertussis was then administered two weeks before patient''s 1st birthday. Pt developed jerking spells within the week after shot and taken to neurologist and diagnosed with infantile spasms. EEG showed no seizure disorder present before the shot was given. Pt could suddenly no longer scoot on floor or smile. He became lethargic and dull in reflexes and cognitive ability. His cerebral palsy immediately became severe, with mental retardation, and remained so until his death at age 17. Since the last pertussis shot, his jerking spasms were uncontrollable by any anti seizure medication on the market.


VAERS ID: 188405 (history)  
Form: Version 1.0  
Age: 0.7  
Sex: Male  
Location: Mississippi  
Vaccinated:2002-07-15
Onset:2002-07-20
   Days after vaccination:5
Submitted: 2002-07-29
   Days after onset:9
Entered: 2002-08-05
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 530A2 / 3 RL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 9372804 / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 4868200 / 3 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-07-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Head cold
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MS02014

Write-up: Came into office with head cold and was behind in immunizations, so MD''s office brought him up-to-date with shots. Pt died on 7/20/02, 5 days, post vax.


VAERS ID: 188464 (history)  
Form: Version 1.0  
Age: 0.7  
Sex: Male  
Location: Indiana  
Vaccinated:2001-05-10
Onset:2001-06-11
   Days after vaccination:32
Submitted: 2002-07-30
   Days after onset:414
Entered: 2002-08-06
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U0357C4 / 2 - / -
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1548K / 2 - / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR T0786 / 2 - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 474724 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-06-11
   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: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Full drug and metabolic post mortum was negative
CDC Split Type:

Write-up: Vaccinated on 05/10/01. Died-apparent SIDS 06/11/01. Was totally normal. Put down to nap and found dead two hours later. Mom requesting VAERS be notified.


VAERS ID: 188465 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2002-08-02
Entered: 2002-08-06
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0207USA02659

Write-up: Information has been received from a consumer concerning a female who was vaccinated on an unknown date with a dose of MMR II (lot not given). The reporter stated "a little girl up the street died after an allergic reaction to MMR." It was also indicated that it was unknown if the pt sought medical attention. Additional info has been requested.


VAERS ID: 188762 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Kentucky  
Vaccinated:2002-06-14
Onset:2002-06-15
   Days after vaccination:1
Submitted: 2002-08-05
   Days after onset:51
Entered: 2002-08-13
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 548A2 / 1 LL / -
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0952L / 1 RL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR U0344 / 1 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 485999 / 1 RL / -

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: 2002-06-15
   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: Nystatin
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: No reaction noted-child died 24 hours after vaccines given. Autopsy neg-states SIDS


VAERS ID: 188844 (history)  
Form: Version 1.0  
Age: 88.0  
Sex: Male  
Location: New York  
Vaccinated:2002-08-06
Onset:2002-08-06
   Days after vaccination:0
Submitted: 2002-08-09
   Days after onset:3
Entered: 2002-08-14
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / SANOFI PASTEUR U0382AA / UNK LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Apnoea, Circulatory collapse
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (narrow), Hypersensitivity (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-08-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Proscar, Docusate, Calcium, Prilosec, Multivitamin, Flomax, Tylenol, Carafate, Reglan, Cozaar, Ferrous sulfate, Lasix 80mg qd and Lasix 40mg qd
Current Illness: NONE
Preexisting Conditions: CHF, Hiatal Hernia, acid reflux, arthritis, hypertension, enlarged prostate, CAD
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: NYS22006

Write-up: Pt was sitting at a table and started to get up, suddenly collapsed and stopped breathing. Pt was a resident of an assisted living facility and was a DNR so facility staff did not attempt CPR. Pt was transported to ER where he was pronounced dead.


VAERS ID: 188967 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2002-04-15
Onset:2002-04-16
   Days after vaccination:1
Submitted: 2002-08-14
   Days after onset:120
Entered: 2002-08-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-04-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: NKA
Allergies:
Diagnostic Lab Data: Co-sleeping with parents
CDC Split Type: HQ3684112AUG2002

Write-up: A physician reported via a company representative that a 2 month old infant received Prevanr vaccine (date not specified) along with three other vaccines (not identified). The following day, the infant died from SIDS. The reporting physician did not think that the vaccines had anything to do with the death. No additional information was available as of the date of this report. This report of a serious, labeled event is being submitted in a 15-day time frame, as requested. Follow up information via telephone contact was obtained from the physician on 10/03/02. She clarified the infant''s age (4 months rather than 2 months) and reported that the child died as a result of co-sleeping with the parents. (Initial report)A physician reported via a company representative that a 2 month old infant received Prevnar (pneumococcal 7-valent conjugate vaccine) vaccine (date not specified) along with 3 other vaccines (not identified).The following day, the infant died from SIDS. The reporting physician did not think the vaccines had anything to do with the death. No additional information was available as of the date of this report.


VAERS ID: 189021 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Oklahoma  
Vaccinated:2002-07-26
Onset:2002-07-26
   Days after vaccination:0
Submitted: 2002-08-01
   Days after onset:6
Entered: 2002-08-19
   Days after submission:18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 542A2 / 1 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0456M / 1 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR U12752 / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 487385 / 1 RL / IM

Administered by: Private       Purchased by: Private
Symptoms: Cardio-respiratory arrest, Pulmonary congestion
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (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), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-07-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: meropenem, Zantac, phenobarbital, vitamins
Current Illness: Desmoplastic infantile astrocytoma (brain tumor) meningitis
Preexisting Conditions: S/P tumor resection, I & D, UPS placement; EUD placement; Per F/U 8/20/02: Edema of right hemisphere with probable focal necrosis of right hemisphere cortex and extensive dural fibrous adhesions
Allergies:
Diagnostic Lab Data: Autopsy pending; Per F/U 8/20/02: CSF, bacterial and viral cultures pending
CDC Split Type: OK0225

Write-up: Pt went into cardiopulmonary arrest after being seen for WCC and receiving immun. Pt with severe pre-existing illness. Death most likely not related to vaccine but occurred in 2 hours after administration therefore is being reported. Autopsy pending. Per F/U 8/20/02: Mild pulmonary congestion.


VAERS ID: 189059 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Louisiana  
Vaccinated:2002-07-09
Onset:0000-00-00
Submitted: 2002-07-12
Entered: 2002-08-20
   Days after submission:39
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Private       Purchased by: Other
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: 2002-07-12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Premature twin
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Mother reported baby received 4 month shots on 7/9/02. Pt seen in Peds; arrived via ambulance for cardiopulmonary arrest. Unknown reason.


VAERS ID: 189147 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Unknown  
Vaccinated:2002-08-06
Onset:2002-08-06
   Days after vaccination:0
Submitted: 2002-08-16
   Days after onset:10
Entered: 2002-08-21
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 537A2 / 1 - / -
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1393L / 1 - / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR U1082 / 1 - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 487390 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-08-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Pierre Robin Syndrome; Probable Moebius'' Syndrome
Allergies:
Diagnostic Lab Data: Autopsy-pending
CDC Split Type:

Write-up: SIDS 30 hours after 2 mos immunizations autopsy pending. DTaP, IPV, Comvax, Prevnar.


VAERS ID: 189239 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: California  
Vaccinated:2001-01-17
Onset:2002-03-07
   Days after vaccination:414
Submitted: 2002-08-21
   Days after onset:166
Entered: 2002-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER NOT REPORTED / 1 - / -

Administered by: Public       Purchased by: Unknown
Symptoms: Myocarditis
SMQs:, 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: 2002-03-15
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ortho-TriCyclen
Current Illness: none
Preexisting Conditions: Mitral Valve Prolapse
Allergies:
Diagnostic Lab Data: no etiology discovered
CDC Split Type:

Write-up: myocarditis


VAERS ID: 189358 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Male  
Location: Nevada  
Vaccinated:2002-04-16
Onset:2002-04-26
   Days after vaccination:10
Submitted: 2002-08-23
   Days after onset:119
Entered: 2002-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0905L / 1 RL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1291L / 1 RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anaemia, Convulsion, Encephalitis, Hepatomegaly, Hypertension, Thrombocythaemia, Viral infection
SMQs:, Liver related investigations, signs and symptoms (narrow), Haematopoietic erythropenia (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (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: 2002-10-25
   Days after onset: 182
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 26 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: LUMBAR PUNCTURE, MRI
CDC Split Type:

Write-up: ENCEPHALITIS STATUS EPILEPTICUI 60 Day follow up states seizures, death. On October 25,2002, pt died as a result of complications of his seizures Discharge Summary received on 9/23/2002 states viral infection, Hepatomegaly, anemia, and thrombocytosis.


VAERS ID: 189360 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Male  
Location: California  
Vaccinated:2002-08-19
Onset:0000-00-00
Submitted: 2002-08-22
Entered: 2002-08-27
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 533C9 / 3 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR 6A636AA / 3 LL / IM

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: 2002-08-20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Allergies; RAD
Allergies:
Diagnostic Lab Data: The autopsy report states SIDS.
CDC Split Type:

Write-up: Actual cause of death unknown. Pending Coroner Report. The autopsy report states SIDS.


VAERS ID: 189597 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Iowa  
Vaccinated:2002-08-13
Onset:2002-08-14
   Days after vaccination:1
Submitted: 2002-08-26
   Days after onset:12
Entered: 2002-09-03
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U0548BA / UNK RL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0283M / UNK LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR U1081 / UNK LL / IM

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: 2002-08-14
   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: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Autopsy-cause of death SIDS.
CDC Split Type:

Write-up: Found unresponsive by father, prone position on pillow.


VAERS ID: 189882 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: New York  
Vaccinated:1997-06-12
Onset:1997-06-12
   Days after vaccination:0
Submitted: 2002-09-03
   Days after onset:1909
Entered: 2002-09-10
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (ACEL-IMUNE) / PFIZER/WYETH 444259 / 4 LL / -
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 2371A2 / 4 - / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0009E / 2 - / -
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / PFIZER/WYETH 0760 / 3 LL / -

Administered by: Private       Purchased by: Other
Symptoms: Chromosome abnormality, Drug administration error, Lethargy
SMQs:, Congenital, familial and genetic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2000-09-25
   Days after onset: 1201
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: Born with a 5mm ventrical septal defect-healed by age 20 mos.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt was given an "extra hep B" shot in error. He became lethargic for three days after the vaccines were administered. Pt died from Adrenoleukodystrophy. His mother was not the carrier, symptoms of ALD began three months after vaccines.


VAERS ID: 189974 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Male  
Location: California  
Vaccinated:2002-09-04
Onset:2002-09-05
   Days after vaccination:1
Submitted: 2002-09-20
   Days after onset:15
Entered: 2002-09-11
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (MENOMUNE) / SANOFI PASTEUR UB295AA / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-09-05
   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: Propecia
Current Illness: NONE
Preexisting Conditions: Family history positive for asthma, patient''s sister has asthma.
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: U200200705

Write-up: From telephone contact received at Aventis Pasteur Inc. on 09/05/2002, it was reported that an 18-year-old male was vaccinated on 09/04/2002 with Menomune A/C/Y/W-135 (lot# UB295AA). On 09/05/2002, patient''s parent called 911 after he collapsed. Patient expired. Autopsy is being performed. Follow-up (#1) telephone call to the Coroner''s Office on 09/17/2002: "No information, no preliminary results" available at this time. Investigator collected 7 doses of fluid and powder. Toxicology results will take 8-12 weeks. Family history positive for asthma. Coroner''s case number is 2002-02746. From additional correspondence received at Aventis Pasteur Inc. on 02/12/2003, it was reported that the patient with no illnesses at time of vaccination and had no pre-existing diagnosis received first dose of MENOMUNE (expiration date 10/22/2003) subcutaneously in the left arm at 15:30 on 09/04/2002. The patient was not responsive on 09/05/2002. No cause of death was determined on the preliminary coroner''s report on 09/06/2002. As per the reporter, a copy of this report has been sent to VAERS on 09/09/2002. Follow-up #2 correspondence received on 02/13/2003: From telephone contact to the Coroner''s office, the toxicology was negative and the cause of death remains undetermined. A copy of the autopsy has been requested. Reported on 03/20/2003: "From follow-up #3 information received at Aventis Pasteur Inc. on 03/07/2003, it was reported that the decendant''s Histological Examination from the autopsy report showed that the heart had few round cells in the epicardium, otherwise non-contributory. Also, on histological exam the thyroid, spleen, kidney, lung, pancreas and the liver were all non-contributory. All toxicology labs were negative. The investigator''s notes showed that the decendant had symptoms of the common cold about 3 months ago and was losing his hair, he was prescribed Propecia. Autopsy on file: Case is closed.


VAERS ID: 190081 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: South Carolina  
Vaccinated:2002-09-05
Onset:2002-09-07
   Days after vaccination:2
Submitted: 2002-09-11
   Days after onset:4
Entered: 2002-09-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 541B9 / 2 LL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 481575 / 2 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR U16452 / 2 RA / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-09-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None, no known adverse event (pt. died 9/7/02-SIDS).


VAERS ID: 190214 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Kentucky  
Vaccinated:2002-08-12
Onset:2002-08-23
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2002-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR 566A7 / 1 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0452M / UNK RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR U0908 / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 589474 / 1 RL / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-08-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: COD is SIDS


VAERS ID: 190451 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Florida  
Vaccinated:2002-06-27
Onset:2002-06-30
   Days after vaccination:3
Submitted: 2002-09-11
   Days after onset:73
Entered: 2002-09-23
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. - / 2 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -

Administered by: Military       Purchased by: Military
Symptoms: Injection site erythema, Injection site mass, Rash, Sudden infant death syndrome
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Neonatal disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-06-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Rash on neck from heat
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: June 27--received shot and developed rash on trunk of body and red lump at injection site. (Husband saw rash). June 28--Saw rash before giving baby (Mother saw rash). June 29--took child to hospital. Doctor mentioned rash but gave no treatment and doctor did not look rash or injection site. SIDS.


VAERS ID: 190452 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2002-09-17
Entered: 2002-09-23
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Pyrexia, Rash morbilliform
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unk
Current Illness:
Preexisting Conditions: Immunodeficiency NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0209USA00733

Write-up: Information has been received from a physician concerning a male (age not given), who was vaccinated on an unknown date with a dose of MMR vaccine live (second generation) (lot # not given). At the time of vaccination the patient had an unknown immune deficiency. Following vaccination, the patient developed a morbilliform rash and fever, got better, then developed another morbilliform rash and fever for 3-4 days, the a serious illness. The patient had been diagnosed on an unknown date with hematophagocytic syndrome, and Epstein Barr virus was found. The patient had also been hospitalized on an unknown date. The patient died (cause unknown) on an unknown date. It was noted that this case took place some years ago, and had to do with a child. Morbilliform rash, fever, serious illness, hematophagocytic syndrome, Epstein Barr virus and the unknown cause of death were considered to be immediately life-threatening. Additional information has been requested.


VAERS ID: 190901 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Georgia  
Vaccinated:2001-10-01
Onset:2002-01-01
   Days after vaccination:92
Submitted: 2002-08-15
   Days after onset:225
Entered: 2002-10-01
   Days after submission:47
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Bacterial infection, Laboratory test abnormal, Sepsis
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-01-01
   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: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Jan 2002- Blood culture positive S. pneumoniae. Autopsy results- Sepsis.
CDC Split Type: HQ3673709AUG2002

Write-up: A physician reported that a 5 month old infant received an initial dose of Prevnar vaccine at 2 months of age along with all recommended immunizations. When the infant was 4 months of age Prevnar was deferred due to decreased product availability. The infant received all other recommended vaccines at this 4 month visit. In Jan 2000, the infant was admitted to the PICU. A blood culture revealed S. pneumoniae. Within 24 hours of admission, the child died of overwhelming sepsis. The reporter noted that by the time he was notified of this case and asked microbiology to subculture the original isolate, the organism had autolysed. The original isolate had been maintained on a culture of media slant, the specimen was not lyophlized or otherwise preserved. No additional information was available as of the date of this report. Additional information received 18-Oct-2002 from reporter contained name and address of a pediatrician that cared for the child. A physician reported that a 5 month old infant received an initial dose of Prevnar (pneumococcal 7-valent conjugate vaccine) vaccine at 2 months of age along with "all recommended immunizations" (immunizations not specified). When the infant was 4 months of age Prevnar was deferred due to decreased product availability. The infant "received all other recommended vaccines" at this 4 month visit (immunizations not specifeid). in Jan-2002, the infant was admitted to the pediactric ICU. A blood culture revealed S. pneumoniae. Within 24 hours of admission the child died of overwhelming sepsis. The reporter noted that by the time he was notified of this case and asked Microbiology to subculture the original isolate, the organism had autlysed. The original isolate had been maintained on a culture of media slant, the specimen was not lyophlized or otherwise preserved. no additional information was available as of the date ofthis report(10/22/2002).


VAERS ID: 191330 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Female  
Location: Florida  
Vaccinated:2002-08-06
Onset:2002-09-06
   Days after vaccination:31
Submitted: 2002-09-13
   Days after onset:7
Entered: 2002-10-16
   Days after submission:33
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 566A2 / 1 RL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0037M / 1 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR T0561 / 1 LL / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-09-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: Unk, Premature twin
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Child was only seen 1 time. Child was a twin. Immunization office found out child died from the mother of child. MOC received our letter advising of 2nd set of shots due 9/6/02 and came in to tell us child had died. Per medical records, ME requested copies of medical records to help with cause of death. Death certificate coy to be sent as soon as received at vital statistics.


VAERS ID: 191503 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Texas  
Vaccinated:2002-10-09
Onset:2002-10-16
   Days after vaccination:7
Submitted: 2002-10-16
   Days after onset:0
Entered: 2002-10-18
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR 552A2 / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA718AA / 1 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR U10822 / 1 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 486003 / 1 RL / IM

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: 2002-10-18
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Autopsy pending
CDC Split Type:

Write-up: Baby seemed fine when she was put down for a nap. When the parents checked her she was dead on 10/15/02. SIDS.


VAERS ID: 191552 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2002-10-15
Onset:2002-10-15
   Days after vaccination:0
Submitted: 2002-10-17
   Days after onset:2
Entered: 2002-10-21
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: Unknown
Symptoms: Skin discolouration
SMQs:, Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-10-15
   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: HTN, DM
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 68 year old male reported to have received two vaccines (flu and "pneumonia"). Ambulance was called. Pt was purple from neck up. Medical examiner declined autopsy.


VAERS ID: 191604 (history)  
Form: Version 1.0  
Age: 90.0  
Sex: Female  
Location: Florida  
Vaccinated:2001-12-13
Onset:2001-12-15
   Days after vaccination:2
Submitted: 2002-10-28
   Days after onset:317
Entered: 2002-10-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 90658 / UNK - / -
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER 90732 / UNK - / -

Administered by: Other       Purchased by: Public
Symptoms: Condition aggravated, Decreased appetite, Haemoptysis, Lethargy
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-12-19
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: Pneumonia
Preexisting Conditions: Alzheimer''s, Alcohol Abuse, Varicose Veins
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pneumonia worsened: lack of appetite, lethargy, coughing blood on 12/15/01 and adm. to hosp.


VAERS ID: 191712 (history)  
Form: Version 1.0  
Age: 30.0  
Sex: Male  
Location: Kansas  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2002-10-10
Entered: 2002-10-23
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS 044 / 3 - / -

Administered by: Military       Purchased by: Military
Symptoms: Completed suicide, Fatigue, Overdose
SMQs:, Suicide/self-injury (narrow), Drug abuse and dependence (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-08-20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Chronic fatigue. Suicide Sept 2002. MD was notified by a former squadrom member. Death due to carbon monoxide toxicity. Autopsy Report received on 7/09/2003 states overdose.


VAERS ID: 192136 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2002-10-23
Entered: 2002-10-30
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Anorexia, Asthenia, Cough, Haemolytic anaemia, Hepatosplenomegaly, Laboratory test abnormal, Lymphadenopathy, Night sweats, Pancytopenia, Pyrexia, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Haemolytic disorders (narrow), Anaphylactic reaction (broad), Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Guillain-Barre syndrome (broad), Chronic kidney disease (narrow), Myelodysplastic syndrome (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prednisone
Current Illness:
Preexisting Conditions: Angiomimmunoblastic (AILD), LgX
Allergies:
Diagnostic Lab Data: Kappa monoclonal gammopathy of 654ng/dl with free kappa chainss in the urine
CDC Split Type: WAES0210USA01752

Write-up: It was reported in a published article that a 75 year old female with a history of angioimmunoblastic lymphadenopathy (AILD), which was currently suppressed, who was vaccinated with a 0.5ml dose of pneumococcal vaccine 14 polyvalent. Prior to the vaccination, the patient presented with fevers, night sweats, cough, anorexia, and weakness, with diffuse lymphadenopathy and hepatosplenomegaly. The patient had a Coombs positive hemolytic anemia and polyclonal gammapothy. Lymph node biopsy confirmed AILD. After a course of chlorambucil, vincristine, and prednisone, the symptoms and physical findings resolved. With the patient''s maintenance therapy of prednisone, the patient''s disease was completely suppressed for 4 months. Three weeks after vaccination, the patient experienced a sudden onset of high fevers, adenopathy, and recurrent organomegaly progressing to renal failure and pancytopenia despite aggressive support and combination chemotherapy. Immonulogical studies before death demonstrated an IgG kappa monoclonal gammapathy of 654 mg/dl with free kappa chains in the urine. Permission for necropsy was refused. No further information is available.


VAERS ID: 192298 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Unknown  
Location: Minnesota  
Vaccinated:2002-09-10
Onset:2002-09-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2002-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0541M / 1 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Dyspnoea, Myalgia, Pneumonia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-10-20
   Days after onset: 39
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: Type 2 D M, HTN
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Myalgias developed 9/11/02. Increase SOB. Seen 9/23/02 with bilat pneumonia. Rx started Levaquin. Got worse. Admitted to hosp 9/24 with ARD''s. No etiol. found despite extensive work-up. Died 10/20/02.


VAERS ID: 192409 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: West Virginia  
Vaccinated:1999-06-25
Onset:1999-06-30
   Days after vaccination:5
Submitted: 2001-09-18
   Days after onset:811
Entered: 2002-11-01
   Days after submission:409
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV: ROTAVIRUS (ROTASHIELD) / PFIZER/WYETH - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Apnoea, Infection, Sepsis
SMQs:, Acute central respiratory depression (narrow), Respiratory failure (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1999-06-30
   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: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: HQ6080218SEP2001

Write-up: A father alleges that his son received a dose of Rota Shield on 6/25/99 and subsequently developed an infection. He was hospitalized where the child died on 6/30/99. The father alleges that his don died as a result of the infection. No further information was available at the date of this report. Death Certificate received on 12/19/2002 indicates respiratory failure and group B strep sepsis as the cause of death.


VAERS ID: 192477 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Washington  
Vaccinated:2002-10-17
Onset:2002-10-21
   Days after vaccination:4
Submitted: 2002-11-01
   Days after onset:11
Entered: 2002-11-05
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0983AA / 3 - / IM
YF: YELLOW FEVER (YF-VAX) / CONNAUGHT LABORATORIES U0253AA / 1 - / SC

Administered by: Military       Purchased by: Military
Symptoms: Multi-organ failure, Shock
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-10-26
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Pathelogy studies at AF17 now
CDC Split Type:

Write-up: Pt died of distributive shock and multisystem organ failure on 10/26/02.


VAERS ID: 192848 (history)  
Form: Version 1.0  
Age: 88.0  
Sex: Female  
Location: Unknown  
Vaccinated:2002-10-01
Onset:2002-10-17
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2002-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES 763353 / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac failure, Hypertrophy
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PJP200200544

Write-up: It was received from a regulatory authority on 10/29/00, concerning an 88 year old pt who experienced cardiac failure and ventricular hypertrophy which led to death 16 days after receiving the Fluvirin vaccine on 10/1/02. The pt had a medical history of dementia, lower respiratory tract infection in June 2002, influenza and anaemia. The pt had been receiving the flu vaccination since 1993. On 10/17/02, 16 days after vaccination, the vaccinee developed an acute cardiac failure following left ventricular hypertrophy and subsequently died. A post mortom examination was performed and cardiac failure was reported as the probable cause of death. The reporter has assessed the relationship of the vaccine to the events as having a direct or indirect association.


VAERS ID: 192915 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Female  
Location: Unknown  
Vaccinated:2002-10-13
Onset:2002-10-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2002-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 763459 / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Myocardial ischaemia
SMQs:, Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PJP200200543

Write-up: It was received from a regulatory authority on 10/29/00, concerning a 76 year old female pt who experienced ischaemic heart disease resulting in death 2 days after receiving the Fluvirin vaccine on 10/13/02. On 10/15/02, two days after vaccination, the pt experienced ischaemic heart disease and died. A post mortem examination was performed and coronary artery disease was reported as the probable cause of death. The reporter has assessed the relationship of the vaccine to the events as having a direct or indirect association.


VAERS ID: 192931 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: Illinois  
Vaccinated:2002-10-18
Onset:2002-10-23
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2002-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0910AA / UNK LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Convulsion, Encephalitis, Headache, Migraine, Upper respiratory tract infection, Vomiting
SMQs:, Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (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: 2002-10-28
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OTC, Afrin, Valine
Current Illness: NONE
Preexisting Conditions: History of recurrent sinusitis. Asthma, Meningoencephaitis Viral
Allergies:
Diagnostic Lab Data: CSF 114 94%, CIE-nl, original nl CT/MRI brain. 10/27 herniation.
CDC Split Type:

Write-up: Administered 10/18/02. Developed URI 10/23 migraines with headache, vomiting. Progressed to encephalitis with hospital admission 10/25. Doing fairly well. Onset seizures 10/26. Transferred to another facility. Recurrent seizures. Herniation brain. Death.


VAERS ID: 193018 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Georgia  
Vaccinated:2002-11-07
Onset:2002-11-08
   Days after vaccination:1
Submitted: 2002-11-11
   Days after onset:3
Entered: 2002-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 574A2 / UNK RL / -
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0250M / UNK LL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0010 / UNK LL / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-11-09
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: Heart murmur, inguinal hernia, problems of prematurity
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Found dead at 5am per family.


VAERS ID: 193157 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Kentucky  
Vaccinated:2002-09-04
Onset:2002-09-08
   Days after vaccination:4
Submitted: 2002-11-04
   Days after onset:57
Entered: 2002-11-13
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 567A2 / 1 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0641M / 1 RL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR U1234 / 1 LL / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-09-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Unsure if done at autopsy
CDC Split Type:

Write-up: Death, unsure if any other did effects prior to death. Autopsy SIDS.


VAERS ID: 193371 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Unknown  
Vaccinated:2002-06-21
Onset:2002-06-21
   Days after vaccination:0
Submitted: 2002-11-05
   Days after onset:137
Entered: 2002-11-18
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 546A2 / 1 - / -
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1475L / 1 - / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR U0614 / 1 - / -

Administered by: Military       Purchased by: Military
Symptoms: Abnormal behaviour, Agitation, Crying, Diarrhoea, Faeces pale, Hyperhidrosis, Irritability, Sudden infant death syndrome
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Psychosis and psychotic disorders (broad), Biliary system related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2002-07-06
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: Mild congestion
Preexisting Conditions: Eczema
Allergies:
Diagnostic Lab Data: Autopsy performed after death
CDC Split Type:

Write-up: June 21-24hrs pt screamed quite loudly when he received his immunizations and whimpered off and on afterward. The most immediate and noticeable change in pt was emotional and metabolic. He was unusually fussy and prone to crying and screaming. His normal stools were deep mustard in color and never runny. After the immunizations his stools were very loose, watery, a pale yellow color with a strong odor and the stools ran out the back of his diaper. He had frequent bowel movements like this throughout each day and they continued in this manner until he died. He was also noticeably sweaty with an oily smelling scalp, like someone who''d done a strenuous workout. This was not normal for pt. He would be bathed and this condition returned very quickly. Before his immunizations, pt enjoyed his baths. After his immunizations he would scream and cry the whole time he was bathed until he was dried off and clothed. The same would happen when he would be washed for a diaper change. He did not even enjoy being powdered anymore and this had been his favorite part of bathing. Mentally, I noticed at one point pt would stare directly in front of him as if in a trance. I would try to get his attention and he would not respond. After a short time pt would come out of this trance-like state and would growl. Pt seemed confused and upset when he came out of this trance-like state. I fully expected pt to be irritable for at least 72 hrs after his shots. Generally speaking this was my experience with my other 3 children after immunization. I also expected him to be very sleepy. To alleviate his discomfort, the Drs. advised the use of Tylenol drops. I medicated my other children in the same way with good success. With pt the Tylenol did not work. He was still very fussy and unhappy. I did not know what to think. But because my husband had cut teeth at 3 mos. of age I believe there was a possibility that pt was cutting teeth. I felt his gums and it was questionable but I thought there could be teeth under the gums. So I gave him teething medication. It seemed to help a little but not for long. He was back to fussing after a short time. I also noticed pt was unusually gassy and I thought this was due to the diarrhea. I thought this might be causing his fussiness. So I gave him gas drops. It seemed to help him pass some gas but it didn''t help with the fussing. June 26 (five days)-We were also in the midst of a move so we also felt there was a change pt was upset because of the change. We had packed out our home and thought his fussiness might be because his things were packed away. While the movers were packing, I carried pt around in a carrier. He was fussy even then and I moved around quite a bit. He just continued not to be himself. June 27 (6 days)-Then when we moved to our temporary living facility, we thought perhaps the strangeness of the surroundings was upsetting pt. Pt''s nature was such that he preferred being home in familiar surroundings, that''s where he was happiest. The following thing were always helpful with pt in the past when he was fussy: nursing, rocking, swinging in his swing, sitting in his bouncy chair, being held, bathing him, and changing his diaper. Some of these thing helped a little after he was immunized but not for very long. Nursing was good until he''d eaten what he needed, then he''d be fussy, gassy and have diarrhea. Nothing we did really seemed to help keep pt content like he once was. Even pt''s most favorite thing, being held, was of little consolation. At this point I was very concerned that we would not be able to keep pt calm long enough to make the plane trip across the ocean of the US. I was sure that people would become annoyed with us for having this very noisy baby. I thought to take pt to see the Dr. but I never took him in because I believed the Drs. would only tell me that I had a colicky child. We started putting pt in an adjoining room during meals because he was just constantly fussing, crying or screaming. I would put him in his bouncy chair and as long as there was constant, vigorous motion he would not scream or cry. When we held him he was no longer happy to be still and held, he had to be in constant motion. The moment we stopped moving he would fuss or cry until he slept. July 5 (14 days)-This was particularly true to the night before his death. Just hours before his death, I needed a break from caring for pt. My husband hand oldest daughter took turns taking pt outside in the fresh air for a walk. He quieted down for that time that they were walking and they would bring him in. But within 5 minutes he would be back to screaming and crying. I tried to nurse pt to which he protested and I also held him as he continued to fuss and scream. This was one evening where we photographed pt. It was very hard to do because he didn''t stop crying for very long. We did snap photos between the shot episodes of relative quiet. I can remember being very frustrated that he continued to fuss and cry no matter what we tried. This night pt''s breathing was unusually noisy and wheezy sounding. But I thought it might be because he''d been having some congestion. The cold to warm weather changes tended to cause our family to get colds. So I just thought that he might have a cold. It was a tremendous relief when he finally slept at 10pm that night. This was also a little earlier than his normal 10:30-11:30pm bedtime. This night was also different again because we had packed away pt''s portable crib that day as we anticipated boarding the plane in a day and a half. We had boxed up the bed to have it shipped through the post office. We made a bed for him on a comforter as we did when traveling and laid pt on the floor and on his stomach as I had done with all my children. I checked on pt at 1am and he seemed to be fine. He fussed at me a little as I adjusted his blanket. July 6 (2 weeks 16/17 hrs)- The next time I checked pt, it was 5 or 6 am on the morning of the 6th of July as he had not woken for his morning sleep. I went in the room which he shared with his 5 year old sister. He was very still and I noticed that he had moved himself to the corner of the room. I thought he looked odd. I could see his face, I picked him up and screamed for my husband. Pt did not move. We hysterically rushed about to the phone which was downstairs to call for help. Our eldest daughter telephoned. I hurried carried pt downstairs, my husband followed, hoping for some instruction which might help pt. We followed their instructions for infant CPR to no avail. The Emergency personnel arrived to took over. The girls and I prayed in the kitchen. The situation did not look hopeful. Pt was transported by ambulance to the ER. My husband I followed soon after in our own car. The doctors worked on pt for what seemed like an eternity. After a time they reported to us what we already feared was true, that pt was dead.


VAERS ID: 193380 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Male  
Location: Unknown  
Vaccinated:2002-10-02
Onset:2002-10-02
   Days after vaccination:0
Submitted: 2002-11-19
   Days after onset:48
Entered: 2002-11-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Pulmonary embolism, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (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: 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: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0211USA00399

Write-up: Information has been received from manufacturer (report number HQ4742722OCT2002) concerning a pt who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently the pt developed a pulmonary embolism. The outcome of the event was unknown. Pulmonary embolism was considered to be an other important medical event (OMIC). This was originally reported by a pharmacist. Additional info has been requested. Follow-up from a pharmacist concerning a 65 year old male with no allergies and a history of COPD, acute renal insufficiency, and diabetes who on 10/2/02 while preparing for discharge from the hospital was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. The pt had been hospitalized on 9/30/02 with a diagnosis of pneumonia. Concomitant medications included levaquin, Zocor, prednisone, insulin and a nebulizer. On 10/2/02, the pt was dressed and ready to be discharged from the hospital when he was administered a dose of the pneumococcal vaccine 23 polyvalent and 10 minute later, the pt had a respiratory arrest, coded and died. It was reported that the preliminary autopsy report stated tha tthe pt did not have an enaphylactic reaction and the report did state that the pt had blood in his lungs. The reporter stated that "they do not known why the pt died and they do not know if it was related to the pneumococcal vaccine 23 polyvalent or not." Additional info has beenr requested.


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