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VAERS ID: 193720 (history)  
Form: Version 1.0  
Age: 42.0  
Sex: Female  
Location: Texas  
Vaccinated:2002-11-01
Onset:2002-11-01
   Days after vaccination:0
Submitted: 2002-11-01
   Days after onset:0
Entered: 2002-11-21
   Days after submission:20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0982AA / UNK RA / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-11-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Rocephin TGM IM, Albuterol, Atrovent, xalatian, Advair, Seravent, Lasix, Ambien, Iron, Zanaflex, Lexapro, Elavil, Respirdol, Potassium, Cipro, Floxin, Penicillin, Levaquin, Adhesive Tape, Naprosyn, Timoptic
Current Illness: Asthma
Preexisting Conditions: Nail-patella syndrome, glaucoma, hematuria, hep C, personaltiy disorder, bipolar, narcotic dependence, asthma, hypercholesterolemia, chronic pain.
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Patient received flu vaccine and a Rocephin injection after office visit. She developed an anaphylactic reaction and subsequently respiratory failure. Despite resuscitation attempts, patient died. Anaphylactic reaction.


VAERS ID: 193771 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Michigan  
Vaccinated:2002-10-17
Onset:2002-10-21
   Days after vaccination:4
Submitted: 2002-11-21
   Days after onset:31
Entered: 2002-11-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0911AA / 1 LL / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Congenital anomaly, Pneumonia, Unevaluable event
SMQs:, Congenital, familial and genetic disorders (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-10-21
   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: 1. Claritin syrup 5 mg once a day. 2. Zantac 9 mg twice a day. 3. Reglan 1 mg 3 times a day. 4. Multivitamin 1 mL 1 times per day. 5. Iron 90 mg 3 times per day. 6. Pulmicort 0.5 mg twice a day. 7. Inhaled tobramycin 300 mg twi
Current Illness: 1. Hypoxic-ischemic encephalopathy. 2. Seizure disorder. 3. Cerebral palsy. 4. Recurrent aspiration. 5. Diffuse lymphad
Preexisting Conditions: 1. Hypoxic-ischemic encephalopathy. 2. Seizure disorder. 3. Cerebral palsy. 4. Recurrent aspiration. 5. Diffuse lymphadenopathy and hepatosplenomegaly of unknown etiology. 7. Chronic urticaria. 8. Failure to thrive, improvement after G-tube placement.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt died 4 days after administration of vaccine


VAERS ID: 193775 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: California  
Vaccinated:2002-10-09
Onset:2002-10-30
   Days after vaccination:21
Submitted: 2002-11-19
   Days after onset:20
Entered: 2002-11-22
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C0725AA / 2 LL / -
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 5358A2 / 2 RL / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA741AA / 2 RL / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER U0823 / 2 LA / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 486002 / 2 LL / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-10-30
   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: Premature baby (26-32 weeks); respiratory failure; neonatal apnoeic attach, bradycardia neonatal; hyperbilirubinaemia neonatal
Allergies:
Diagnostic Lab Data: Autopsy results pending. Autopsy results-10/30/02: petechial hemorrhages, thymus; pulmonary congestion and edema; no external or internal evidence of injury; cause of death SIDS
CDC Split Type: U200201033

Write-up: From faxed correspondence received at manufacturer on 11/15/02 regarding an adverse event, which occurred during a Phase IV study for Daptacel. It was reported that a 4 mt old female received Daptacel. Pneumo Conjugate, IPV, PRP-T, and Hep B vax on 10/9/02. The PT expired on 10/30/02. "Per [a local county gov''t office] provisionally diagnosed as SIDS death pending remaining test results from toxicology, etc." The event is not considered to be related to vax. Follow up info recieved on 12/11/02 included additional pt details, medical history, and atuopsy results. Info has been received from an investigator concerning a 4 month old female who received her second dose of Prevnar along with Tripedia, IPOL, ActHIB, and Engerix B vaccines on 10/9/02 as part of the Post-Marketing Safety Surveillance Trial. THe pt was a twin born prematurely at 31 weeks gestation to a mother with nail-patella syndrome in renal failure. At birth, the infant experienced respiratory insufficiency of prematurity, apnea, bradycardia and hyperbilirubinemia. During a well-child visiton 9/12/02, the infant showed early physical findings suggetive of nail-patella syndrome. On 10/30/02, the infant died. An autopsy was performed. The infant was described as well-nourished and well-developed. Findings included petechial hemorrhages on the thymus as well as pulmonary congestion and edema. There was no external or internal evidence of injury. The autopsy-reported cause of death was SIDS. Both the investigator and the medical monitor considered the SIDS death to be unrelated to Prevnar administration. This report of a serious, labeled event is being submitted in a 15-day time frame as requested by FDA.


VAERS ID: 193776 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Texas  
Vaccinated:2002-11-12
Onset:2002-11-13
   Days after vaccination:1
Submitted: 2002-11-14
   Days after onset:1
Entered: 2002-11-22
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U0846CA / 1 LL / -
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0855M / 1 LL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0197 / 1 RL / -

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: 2002-11-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ayr Nasal Solution
Current Illness: Dry skin
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Baby received the immunizations on 10/12/02 and was found lifeless in early morning of 11/13/02. Autopsy results are pending. Autopsy report received on 12/30/2002 indicates SIDS.


VAERS ID: 193852 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Unknown  
Vaccinated:2002-04-23
Onset:2002-06-06
   Days after vaccination:44
Submitted: 2002-11-21
   Days after onset:168
Entered: 2002-11-25
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 505A2 / 1 RL / -
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 5295A2 / 2 LL / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA646AA / 1 RL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR T0472 / 1 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 484198 / 1 RL / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Gastrointestinal haemorrhage, Intussusception
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (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: Asthma NOS; ear infection NOS; penumonia NOS
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: HQ5402619NOV2002

Write-up: Autopsy report received on 12/19/2002 indicates gastrointestinal hemorrhage and intussusception. Additional info was received on 12/11/02 from an investigator provided medical history, revised event info and coroner''s report. Info has been received from an investigator regarding a 5 month old male with a hisory of asthma and a recent history of ear infection and pneumonia. On 6/6/02, he was found unresponsive and was not breathing. Subsequently, he was taken to the hospital. On 6/8/02, he expired as a result of gastrointestinal hemorrhage due to small bowel intussusception. This was confirmed by the coroner''s report. The investigator considers the intussusception and gastrointestinal hemorrhage to be "not related" to the study product or concomitant vaccine administration. The medical monitor''s assessment is unknown. This case has been expedited per agreement with the FDA.


VAERS ID: 193887 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: California  
Vaccinated:2002-11-12
Onset:2002-11-14
   Days after vaccination:2
Submitted: 2002-11-15
   Days after onset:1
Entered: 2002-11-26
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 575A2 / UNK LA / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0454M / UNK RA / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR U1275 / UNK LA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 487390 / UNK RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-11-14
   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: Mild URI
Preexisting Conditions: 31 week premie. No problems.
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Pt came in for routine PE, Slight stuffy nose, given 2 months shots- went home, expired early morning 11/14 after feeding . No temp. No irritability. The autopsy report states SIDS.


VAERS ID: 194214 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: California  
Vaccinated:0000-00-00
Onset:1998-07-01
Submitted: 2002-11-26
   Days after onset:1609
Entered: 2002-12-02
   Days after submission:6
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, Neoplasm malignant, Pleural mesothelioma
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-05-03
   Days after onset: 672
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: HQ5478422NOV2002

Write-up: A legal complaint was received from an attorney alleging that a male received Orimune vaccine sometime after 1960. As an adult, he was diagnosed with mesothelioma on or about July 1998 and died on 5/3/00. "The decedent has mesothelioma in which SV40 was a substantial factor and therefore one of the causes of his mesothelioma." It is alleged that the "decedent''s exposure to asbestos, asbestos-containing products, and the SV40 virus caused severe and permanent injury to the decedent, included but not limited to breathing difficulties, asbetosis, lung and/or other cancer, mesothelioma, and/or lung damage. The reporter stated that the "Decedent retired from his last place of employment at regular retirement age. He had therefore suffered no disability from his asbestos-related disease as "disability" is defined in Code of Civil Procedure 340.2."


VAERS ID: 194255 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Mississippi  
Vaccinated:2002-11-19
Onset:2002-11-20
   Days after vaccination:1
Submitted: 2002-11-20
   Days after onset:0
Entered: 2002-12-02
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C0812AA / 1 LL / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA649AA / 1 RL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR U12752 / 1 RL / -

Administered by: Private       Purchased by: Public
Symptoms: Pneumonia
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-11-20
   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: Zantac
Current Illness: NONE
Preexisting Conditions: Recent hospitalization-poss GE reflux-on Zantac
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Informed by coroner pt found dead by parents this am.


VAERS ID: 194709 (history)  
Form: Version 1.0  
Age: 94.0  
Sex: Female  
Location: New York  
Vaccinated:2002-10-21
Onset:2002-10-25
   Days after vaccination:4
Submitted: 2002-12-02
   Days after onset:38
Entered: 2002-12-10
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: Unknown
Symptoms: Asthenia, Blood glucose decreased, Cardiac arrest, Cardiomyopathy, Coronary artery disease, Dizziness, Dyspnoea, Hypokinesia, Hypotonia, Infection, Nausea, Pneumonia, Speech disorder
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (narrow), Eosinophilic pneumonia (broad), Other ischaemic heart disease (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (narrow), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-11-15
   Days after onset: 21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 21 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Isosorbide-10mg 3x a day- taken for 5 yrs. Vasotec- 20mg 2x a day- taken for 5 yrs. Norvasc- 5mg- 1 x a day- taken for 5 yrs. Aspirin- 81mg 1 x a day- taken for 5 yrs. Toprol x L- 50mg 1 x a day- new pill- doctor started during 1st hospital
Current Illness: Had supposedly just recovered from pneumonia.
Preexisting Conditions: Had angioplasty 5 yrs ago. Had high blood pressure, but blood pressure was normal during this time. Suffered a stroke. Still has pneumonia.
Allergies:
Diagnostic Lab Data: Blood sugar was 50. Suffered a stroke. Still had pneumonia.
CDC Split Type:

Write-up: Awakened at 6am extremely nauseous, dizzy and weak. in am hour her right arm and leg became limp and her speech was slurred. She could not stand or sit and just toppled over on the bed. Rushed by ambulance to hospital. (note attached)--My mother went into the hospital on 09/27/2002 and was diagnosed with pneumonia and bronchial infection. After 2 weeks i was told by the lung doctor, that it was cleared up, so she was released from the hospital. Her private MD suggested she go to rehab for some physical therapy. She left the hospital on 10/11/2002, and went to rehab. She did great and was very active. While there, with her doctor''s permission, they gave her the flu shot on 10/18/2002 and the pneumonia shot on 10/21/2002. On 10/22/2002 she came home, and had a stroke on 10/25/2002. She died in the hospital on 11/15/2002, gasping for breath. Her blood pressure was normal during both her hospital stays and rehab. During her 3 days back home, she was active and fortunately well. What concerns me in that the pneumonia vaccine may have been given too close to the flu vaccine. (3 days). Also, when she went back to the hospital with the stroke, they said she still had some pneumonia. Maybe she shouldn''t have been given the vaccine if she still had some pneumonia. Also, at this time her blood sugar went out of control reaching between 300-400, without food. i know my mother was old with several conditions. but everyone sent her home with a clean bill of health and much hope, not to have a stroke after 3 days. I was her caregiver, but she was also very independent. Her mind was still functioning very well until the end. Not being able to speak fluently or walk or eat and having strangers change her really broke her spirit and broke my heart. We were very close. I loved and needed her very much, and she loved me so much. She didn''t want that vaccine, but with her doctor''s permission, I encouraged her to take it. That''s why these questions are haunting me. I would appreciate someone helping me understand what happened. Was i


VAERS ID: 194726 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Male  
Location: Oregon  
Vaccinated:2002-10-19
Onset:2002-11-08
   Days after vaccination:20
Submitted: 2002-11-29
   Days after onset:21
Entered: 2002-12-10
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0875AA / UNK - / -

Administered by: Private       Purchased by: Unknown
Symptoms: Balance disorder, Dysphonia, Guillain-Barre syndrome, Hypoaesthesia, Hyporeflexia
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Demyelination (narrow), Vestibular disorders (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2002-12-04
   Days after onset: 26
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death certificate received on 2/5/2003 indicates GBS as the cause of death.


VAERS ID: 194798 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Male  
Location: Washington  
Vaccinated:2002-09-19
Onset:2002-10-03
   Days after vaccination:14
Submitted: 2002-12-02
   Days after onset:60
Entered: 2002-12-11
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U0549AA / 2 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA705AA / 2 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR U08242 / 2 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 485997 / 2 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: 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: 2002-10-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Autopsy negative toxic exposure/cause of death SIDS
CDC Split Type:

Write-up: Two weeks possible post DTaP, IPV, HIB, pneu 7. SIDS event. Five days prior to SIDS seemed fussy. Mom feels baby different post 2nd set shots.


VAERS ID: 194915 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Female  
Location: Arkansas  
Vaccinated:2002-10-30
Onset:2002-11-08
   Days after vaccination:9
Submitted: 2002-11-20
   Days after onset:12
Entered: 2002-12-13
   Days after submission:23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Guillain-Barre syndrome, Paralysis
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2002-12-23
   Days after onset: 45
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: Methadone
Current Illness:
Preexisting Conditions: BMH: chronic back pain-on Methadone program; gastric bypass 1992, left knee surgery 1997, volvulus repair 1994
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt was given flu vaccine 10/30/02 in an outpatient setting. Pt admitted to hospital 11/8/02 with progressive ascending paralysis. Pt diagnosed as having developed Guillain Barr? syndrome. Per aclnowledgement letter: I do not have any way of obtaining this information. pt did not receive the vaccine at our institution. 60 Day Follow up States: Pt expired (exact date unknown) Death affiliated to GBS


VAERS ID: 194961 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Texas  
Vaccinated:2002-12-11
Onset:2002-12-13
   Days after vaccination:2
Submitted: 2002-12-13
   Days after onset:0
Entered: 2002-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR C0889AA / 1 - / -
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER UA742AA / 2 - / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR U1275 / 1 - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 490370 / 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: 2002-12-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: The autopsy report states SIDS.
CDC Split Type:

Write-up: Baby put to bed in good condition; found expired this AM.


VAERS ID: 194964 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Ohio  
Vaccinated:2002-10-24
Onset:2002-10-26
   Days after vaccination:2
Submitted: 2002-11-27
   Days after onset:32
Entered: 2002-12-16
   Days after submission:19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U0846AA / 1 RL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1825K / 1 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0013 / 1 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-10-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Infant found deceased at home in parent''s bed.


VAERS ID: 194965 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2002-12-12
Entered: 2002-12-16
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUSHIELD) / PFIZER/WYETH - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: UNK
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: HQ5595503DEC2002

Write-up: A consumer reported that a male adult received Influenza Virus vaccine, Trivalent, Types A & B (1995-1996 formula) vaccine (date of immunization not identified). Subsequent to immunization he experienced paralysis and the patient died in connection with a flu vaccination. The consumer also reported that this individual experienced adverse events following immunization with smallpox in 1950. See Case ID HQ5610404DEC2002. This report was received from a department at a manufacturer. No additional information was available as of the date of this report.


VAERS ID: 194968 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:2000-05-01
Submitted: 2002-12-12
   Days after onset:955
Entered: 2002-12-16
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Dyspnoea, Lung disorder, Neoplasm malignant, Pleural mesothelioma
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-03-24
   Days after onset: 327
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: HQ5619704DEC2002

Write-up: A legal complaint was received from an attorney alleging that a female received Orimune vaccine. As an adult, she was diagnosed with mesothelioma on or about May, 2000 and died 3/24/01. "The decedent had mesothelioma in which SV40 was a substantial factor, and therefore a cause of decedent''s mesothelioma." It is alleged that the "decedent''s exposure to asbestos, asbestos-containing products, and the SV40 virus caused severe and permanent injury to the decedent, including but not limited to breathing difficulties, asbestosis, lung and/or cancer, mesothelioma, and/or lung damage. The reporter stated that the "Decedent stopped working on 4/27/00, due to her mesothelioma."


VAERS ID: 194971 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Unknown  
Vaccinated:2002-07-17
Onset:2002-08-28
   Days after vaccination:42
Submitted: 2002-12-12
   Days after onset:106
Entered: 2002-12-16
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 553A2 / 1 RA / -
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 522609 / 2 RL / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA675AA / 1 LL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR UA823 / 1 RA / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 484151 / 1 LL / IM

Administered by: Other       Purchased by: Private
Symptoms: Acidosis, Atrioventricular block, Cardiac failure, Cardiomyopathy, Hypotension, Lung disorder, Pneumonia, Respiratory distress
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Conduction defects (narrow), Acute central respiratory depression (broad), Cardiomyopathy (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-08-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: Diaphragmatic paralysis; Lung Disorder, Pylorospasm; Feeding problem in newborn
Preexisting Conditions: Meconium aspiration; Pulmonary hypertension
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: HQ5598004DEC2002

Write-up: Information has been received from an investigator concerning a 3 month old female. On 7/17/02, at 2 months of age, she received her first dose of Prevnar as part of a post-marketing safety surveillance trial. That same day, she also received first doses of DTaP, IPV, and ACT-HIB, with a second dose of Hep B. On 8/28/02, she was hospitalized with acute respiratory distress and a diagnosis of pneumonia was made. Later that day, the child expired due to A/V block complete, acute respiratory failure and heart failure with primary cardiomyopathy and other cardiac dysrhythmias, hypotension, acidosis, and other lung disorders. Resuscitation attempts were unsuccessful. The child''s medical history consisted of diaphragmatic/phrenic paralysis with mechanical ventilation leading to chronic lung disease, meconium aspiration and pulmonary hypertension which required extracorporeal circulation membrane oxygenation, pylorospasm, and feeding problems which required feedings via N-J tube. The investigator''s assessment of relatedness of these events (all except pneumonia, unexpected as per USPI) to the vaccines administered was *not related.* *Add''l info received as result of combining duplicate cases on 12/13/02 provided an investigator''s assessment of NOT RELATED."*


VAERS ID: 195278 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2003-01-17
Entered: 2002-12-20
   Days after submission:28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Infection, Sepsis
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Autopsy results-Pneumococcal sepsis
CDC Split Type: HQ4151110SEP2002

Write-up: A pediatrician reported that a child who received an injection of Prevnar developed pneumococcal sepsis two days post-immunization and subsequently died. No further info was available at the date of this report. *F/UP report on 3/31/03: Add''l info received on 1/14/03 from an MD provided further info about the event. Upon contacting the MD, the MD said that "he heard this story from a PT anecdotally." He had no info about the PT and indicated that he doesn''t even know if this is a true story. The MD advised to disregard this report. No further info was available at the date of this report.


VAERS ID: 195279 (history)  
Form: Version 1.0  
Age: 49.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2002-12-18
Entered: 2002-12-23
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Drug toxicity, Dyspnoea, Lung disorder
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Drug abuse and dependence (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-03-24
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: Toxic effect of asbestos
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0212USA01215

Write-up: Information has been received regarding a case in litigation concerning a 49 year old female with a history of toxic effect of asbestos who sometime in the 1980s was vaccinated with the poliovirus vaccine (site and route not reported). It was noted that from approximately 1967 to approximately 2001, the patient used a blow dryer to dry her hair at least twice a week. The patient was exposed to asbestos, asbestos containing products and the SV-40 virus. The patient felt these exposures caused severe and permanent injury, including but not limited to breathing difficulties, asbestosis, lung and/or other cancer, mesothelioma and or lung damage and death. In approximately 5/00 the patient was diagnosed with mesothelioma and subsequently died on 3/24/01 from mesothelioma, a condition related to exposure to asbestos and asbestos containing products and the SV-40 virus. Additional information has been requested.


VAERS ID: 195314 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Virginia  
Vaccinated:2002-07-16
Onset:2002-09-15
   Days after vaccination:61
Submitted: 2002-10-24
   Days after onset:39
Entered: 2002-12-23
   Days after submission:60
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES - / 3 - / -
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / 3 - / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / 3 - / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / 3 - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 484198 / 3 - / IM

Administered by: Private       Purchased by: Other
Symptoms: Coma, Diarrhoea, Infection, Pharyngitis, Pyrexia, Rhinitis, Sepsis, Vomiting
SMQs:, Acute pancreatitis (broad), Agranulocytosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Oropharyngeal infections (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), 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: 2002-09-18
   Days after onset: 3
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: UNK
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: 9/18/02 blood culture positive-for Streptococcus pneumoniae serotype 19A; lumbar puncture-revealed open pressure, blew tube and stoppe dat 40cm, turbid fluid, protein 250, glucose 20, 8 white cells; white blood cell count 2000; 19/18/02 CSF culture positive-for Streptocuccus penumoniae serotype 19A, blood immunoglubulin G normal, blood immunoglobulin M normal, blood immunoglobulin A normal
CDC Split Type: HQ4485803OCT2002

Write-up: Follow-up info received from the physician on 10/23/02 provided serotype. A physician reported that a 6 month old male received his third dose of Prevnar on 7/16/02. Concomitant therapy included Act-Hib, Tripedia, IPOL and Recombivax-HB. On 9/15/02, at 8 months of age, he developed a fever. On 9/17/02, he was seen by the physician; he had a one week history of a cold and presented with vomiting, diarrhea, and a fever of 103.5 deg F. He was treated with acetaminophen. On the morning of 9/18/02, he was found unresponsive. He was taken to the ER and admitted to the ICU. His temperature ranged from 102.2 to 104 deg F. A white blood cell count was 2000. A spinal tap revealed open pressure, blew tube and stopped at 40cm, turbid fluid, protein 250, glucose 20, 8 white blood cells. A blood cultures and cerebrospinal fluid culture revealed Streptococcus pneumoniae serotype 19A. Serotype results are pending. Later that same day, he died.


VAERS ID: 195346 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Female  
Location: New York  
Vaccinated:2002-10-23
Onset:2002-10-25
   Days after vaccination:2
Submitted: 2002-12-12
   Days after onset:48
Entered: 2002-12-26
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES E35812CA / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anxiety, Gastrointestinal disorder
SMQs:, Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-11-23
   Days after onset: 29
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Paxil, Vioxx, Inderol, Premarin, Norvasc, Ativan
Current Illness: Infected total knee 5/02
Preexisting Conditions: DM, HTN, SIADH, osteoarthritis, malnurishment, bipolar disorder
Allergies:
Diagnostic Lab Data: Leukocytes 19,500, 92 cegs, 4 lymphs, 4 mono K: 5.6 NA: 119 K: 516 BUN 32 CHL 90
CDC Split Type:

Write-up: 12/25/02 at 12 noon; tongue noted to be edematous and unable to swallow food. Given Benadryl and transported to ER c/o throat swelling and erythema to upper arms bilaterally. Dehydrated with hyponatremia. Rx: hydration, antibiotic-steroid IV. Diagnosed Stevens Johnson syndrome to drug reaction.


VAERS ID: 195539 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2002-11-26
Onset:2002-11-29
   Days after vaccination:3
Submitted: 2002-12-20
   Days after onset:21
Entered: 2002-12-27
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 568A9 / 3 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA756AA / 3 RA / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 489473 / 3 RL / IM

Administered by: Private       Purchased by: Private
Symptoms: Screaming
SMQs:, Hostility/aggression (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-11-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: URI; Conjunctivitis
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Abdominal US and X-ray; Autopsy
CDC Split Type:

Write-up: Mother called answering service at 01:56, that baby is screaming in pain. On call doctor referred baby to ER where the baby was coded and passed away at 07:30.


VAERS ID: 195634 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Female  
Location: North Carolina  
Vaccinated:0000-00-00
Onset:2002-10-19
Submitted: 2002-12-26
   Days after onset:68
Entered: 2002-12-30
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Private       Purchased by: Other
Symptoms: Bacterial infection, Herpes zoster, Urinary tract infection, Viral infection
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-11-03
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prednisone, Valtrez, HCTZ, Lexoxyl, Vicodin, Ultram, Proso
Current Illness: Presistant bug of E Coli
Preexisting Conditions: Penicillin
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: MD first saw pt June 04, 2002 Wt 111 1/2 B/P 140/14 Proc. 07/18/2002 Wt 108, B/p 120/76. on 09/05/2002 Wt 106 B/p 132/51 P 92 UTI diagnosis given Cipro Wt 106 1/2 B/P 146/66. p 92 09/19/2002. 10/10/2002 given Flu shot resisted e Coli 10/22/2002 became ill on 10/19/2002, diagnosed with Herpes Zoster Wt 104lbs.


VAERS ID: 195695 (history)  
Form: Version 1.0  
Age: 0.12  
Sex: Female  
Location: Alaska  
Vaccinated:2002-12-17
Onset:2002-12-17
   Days after vaccination:0
Submitted: 2002-12-23
   Days after onset:6
Entered: 2003-01-02
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK RL / -
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. - / UNK LL / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK RL / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-12-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Polyviplor vitamins, Tylenol
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Autopsy negative so far; Carboxyhemoglobin negative; Histiology negative; Lung and CSF cultures negative.
CDC Split Type:

Write-up: Death


VAERS ID: 196173 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Michigan  
Vaccinated:2002-11-26
Onset:2002-12-13
   Days after vaccination:17
Submitted: 2003-01-09
   Days after onset:27
Entered: 2003-01-15
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 572A2 / 1 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1076L / UNK RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. U1275 / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 486809 / 1 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-12-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Na Sulamyd 10% eye gtts
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Autopsy
CDC Split Type:

Write-up: Pt found unresponsive not breathing in crib at nap time. Attempts to resuscitate failed. Pt pronounced dead by sudden infant death.


VAERS ID: 196267 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Ohio  
Vaccinated:2003-01-07
Onset:2003-01-12
   Days after vaccination:5
Submitted: 2003-01-13
   Days after onset:1
Entered: 2003-01-16
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U0846BA / UNK LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA752AA / UNK RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0196 / UNK LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 489834 / UNK 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: 2003-01-12
   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:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received DTaP, HIB, IPV and Prevnar on 1/7. No apparent immediate problems but was found dead at home 1/12 AM. Apparent SIDS; autopsy pending.


VAERS ID: 196292 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Texas  
Vaccinated:2003-01-06
Onset:2003-01-10
   Days after vaccination:4
Submitted: 2003-01-10
   Days after onset:0
Entered: 2003-01-17
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR 575A2 / 1 RL / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR LA772AA / 1 RL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0063 / 1 LL / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-01-10
   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: Pediacare Drops; Erythromycin
Current Illness: Cough and congestion
Preexisting Conditions: Conjunctivitis; URI
Allergies:
Diagnostic Lab Data: Cardiac monitor Asystole
CDC Split Type:

Write-up: Got call on 1/10/03 from ER. Succumbed to SIDS.


VAERS ID: 196293 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2001-07-01
Submitted: 2003-01-13
   Days after onset:561
Entered: 2003-01-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Dyspnoea, Lung neoplasm malignant, Neoplasm malignant
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Non-haematological malignant tumours (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:
CDC Split Type: WAES0301USA00223

Write-up: Information has been received regarding a case in litigation concerning a female who has sustained bystander exposure to inhaled, used, handles or been otherwise exposed to asbestos and asbestos containing products for a substantial length of time. Sometime in the 1950s the pt was vaccinated with poliovirus vaccine (manuf unk) OPV or IPV. In approximately July 2001, the pt was diagnosed with mesothelioma. The reporter stated the exposure to asbestos, asbestos containing products and the SV-40 virus, caused severe and permanent injury including but not limited to breathing difficulties, asbestosis, lung and or other cancer, mesothelioma and or other lung damage including death. Subsequently the pt died. The cause of death was not specified. The reporter also stated the only source of SV-40 the pt could have been exposed to was SV-40 in the polio vaccine. The mesothelioma, asbestosis, dyspnea, lung cancer, lung injury and malignant neoplasm were considered to be other important medical events (OMIC).


VAERS ID: 196486 (history)  
Form: Version 1.0  
Age: 0.75  
Sex: Male  
Location: Alaska  
Vaccinated:2002-12-30
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2003-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 575A2 / 2 LL / -
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0829M / 2 RL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0013 / 2 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 489835 / 2 RL / -

Administered by: Public       Purchased by: Public
Symptoms: Cardiac 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), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-01-07
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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: AK200303

Write-up: Child died 1/2/03. Enclosed is copy of obituary. No cause of death given. Discharge summary received on 4/30/2003 indicates Acute Cardiac Arrest.


VAERS ID: 196540 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Kentucky  
Vaccinated:2003-01-13
Onset:0000-00-00
Submitted: 2003-01-14
Entered: 2003-01-21
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C0584DA / 1 RL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0650M / UNK RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0290 / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 490364 / 1 LL / IM

Administered by: Public       Purchased by: Public
Symptoms: Asphyxia, Coma
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-01-14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Synagis, 1% hydrocortisone cream
Current Illness: NONE
Preexisting Conditions: 34 week premie, anemia of prematurity
Allergies:
Diagnostic Lab Data: Hct 36.6
CDC Split Type: KY2003007

Write-up: Baby was found unresponsive by mom at 8A 1/14/03 (per state police).


VAERS ID: 196572 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2003-01-08
Onset:2003-01-10
   Days after vaccination:2
Submitted: 2003-01-21
   Days after onset:11
Entered: 2003-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR 4020032 / UNK - / -
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR U0704 / 1 - / -
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR UB307AB / 1 - / -

Administered by: Military       Purchased by: Military
Symptoms: Overdose
SMQs:, Drug abuse and dependence (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-01-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE. HIV test done on 1-8-03. Results pending.
Preexisting Conditions: History of IV drug abuse including heroin prior to military enlistment
Allergies:
Diagnostic Lab Data: Autopsy performed by Dr. Results pending. Specimens to be sent to CDC for testing.
CDC Split Type:

Write-up: Pt. died 2 days after receiving vaccines. Autopsy resutls pending. Specimens to be sent to CDC for testing. Autopsy report received on 2/12/2003 indicates overdose.


VAERS ID: 196780 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Maryland  
Vaccinated:2001-08-29
Onset:2001-09-15
   Days after vaccination:17
Submitted: 2003-01-18
   Days after onset:490
Entered: 2003-01-27
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 989A2 / UNK - / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA563AC / UNK - / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR T0909 / UNK - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 489542 / UNK - / -

Administered by: Private       Purchased by: Other
Symptoms: Agitation, Apnoea, Cardiac arrest, Central nervous system neoplasm, Crying, Diarrhoea, Injury, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Non-haematological tumours of unspecified malignancy (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-09-25
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Bleeding in eye
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Autopsy-shaken baby syndrome
CDC Split Type:

Write-up: After administration of shots on 8/29/01, pt experienced high fever, diarrhea, high-pitched screaming. 9/15/01-stopped breathing, cardiac arrest. 9/25/01-life support terminated. Pt died.


VAERS ID: 196956 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Virginia  
Vaccinated:2003-01-02
Onset:2003-01-07
   Days after vaccination:5
Submitted: 2003-01-25
   Days after onset:18
Entered: 2003-01-30
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C0948AA / 2 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA777AA / 2 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0332 / 2 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 49176 / 2 LL / IM

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: 2003-01-07
   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: Reglan, Mylanta, Prilosec
Current Illness:
Preexisting Conditions: Premie (35 weeks) GER
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: SIDS; Autopsy report received on 3/5/2003 indicates that the cause of death was undetermined.


VAERS ID: 197125 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: Mississippi  
Vaccinated:2002-10-09
Onset:2002-10-10
   Days after vaccination:1
Submitted: 2003-01-31
   Days after onset:113
Entered: 2003-02-03
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UO908AA / 7+ LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Chills, Dyspnoea, Lung disorder, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-10-24
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 12 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: prednisone, albuterol,hytrin, xanox,fosomax, axid, icar-c, roxcodore
Current Illness: COPD
Preexisting Conditions: COPD, lung cancer, hypertension
Allergies:
Diagnostic Lab Data: none
CDC Split Type: MS03005

Write-up: Fever greater than 101 degrees F, chills, shortness of breath, Hospitalized 10/11/02 through 10/16/02 and 10/19/02 through 10/24/02. Death certificate received on 2/19/2003 indicates end stage COPD as the cause of death.


VAERS ID: 197251 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Georgia  
Vaccinated:2003-01-28
Onset:2003-02-03
   Days after vaccination:6
Submitted: 2003-02-04
   Days after onset:1
Entered: 2003-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR CO947AA / 1 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0652M / 1 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0332 / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 490894 / 1 RL / IM

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: 2003-02-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: The patient was taken to Medical Center. We do not have any data at this point, other than hearing it was probable SIDS.
CDC Split Type:

Write-up: No adverse symptoms from the shots given on 1/28/03. However patient died from probable SIDS while @ daycare. County investigating.


VAERS ID: 197252 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Minnesota  
Vaccinated:2003-01-17
Onset:2003-01-18
   Days after vaccination:1
Submitted: 2003-02-04
   Days after onset:17
Entered: 2003-02-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 576A2 / UNK - / -
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0694M / UNK - / -
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR W0197 / UNK - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 48957 / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asphyxia, Cardiac arrest, Irritability, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (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: 2003-01-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zantac, Ibuprofen
Current Illness:
Preexisting Conditions: Reflux
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Baby was completely healthy according to the check up on 1/17. Checked him at midnight on 1/18. Had a fever and was fussier than usual. Checked him again at 4:30AM. Was found dead at 8:30AM. Nurse follow up on 10/01/04 states: "Positional asphyxia; cardiac arrest."


VAERS ID: 197323 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: California  
Vaccinated:2003-01-16
Onset:2003-01-17
   Days after vaccination:1
Submitted: 2003-01-29
   Days after onset:12
Entered: 2003-02-06
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 582B2 / 1 LL / -
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 5355A2 / 1 RL / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA749AA / 1 RL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR U1234 / 1 LA / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 489472 / 1 LL / -

Administered by: Private       Purchased by: Other
Symptoms: Aortic valve stenosis, Bradycardia, Hypotension, Respiratory distress, Respiratory failure
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-01-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: Aortic Stenosis
Allergies:
Diagnostic Lab Data: Blood cx neg, urine cx neg.
CDC Split Type:

Write-up: Pt developed severe respiratory distress that led to respiratory failure. Subsequently, despite mechanical ventilation, develped hypotension, bradycardia.


VAERS ID: 197385 (history)  
Form: Version 1.0  
Age: 89.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2003-01-14
Onset:2003-01-14
   Days after vaccination:0
Submitted: 2003-01-17
   Days after onset:3
Entered: 2003-02-07
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES 312026A / 2 RA / IM

Administered by: Other       Purchased by: Public
Symptoms: Anorexia, Cardiac failure, Chills, Lethargy
SMQs:, Cardiac failure (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-01-17
   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: Ascriptin, Lasix, Lanoxin, Flomax, Tylenol
Current Illness: c/o of chills - was in a w/c
Preexisting Conditions: PT was terminally ill, was not expected to live $g Oct. 02. CHF, renal insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt received influenza vaccine on Tuesday and complained of chills and lethargy the following afternoon. Family was instructed to take him to a doctor as he had a terminal illness, but pt refused to go as he feared he would be placed in a nursing home. Nurse contacted family today and again encouraged he go to hospital as he was not eating, bed-bound and less responsive. He died when he got to hospital 1/17/03. Death certificate received on 3/5/2003 indicates CHF as the cause of death.


VAERS ID: 197386 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2003-02-03
Entered: 2003-02-07
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MU: MUMPS (MUMPSVAX II) / MERCK & CO. INC. - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0301USA02037

Write-up: Information has been received from a registered nurse concerning an adult female pt who was vaccinated with a dose of mumps virus vaccine live. The reporter indicated that a doctor told her that the pt died after being vaccinated. The cause of death was not reported. Unspecified medical attention was sought. Additional info has been requested.


VAERS ID: 197504 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Colorado  
Vaccinated:2002-10-29
Onset:2002-10-29
   Days after vaccination:0
Submitted: 2003-02-05
   Days after onset:99
Entered: 2003-02-11
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 7+ RA / IM

Administered by: Private       Purchased by: Public
Symptoms: Abdominal pain, Anorexia, Chest pain, Injection site reaction, Metabolic acidosis, Nausea, Pain, Pyrexia, Shoulder pain, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Arthritis (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-11-23
   Days after onset: 25
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations: Illness~Influenza (Seasonal) (no brand name)~~0.00~In Patient
Other Medications: Advil; Lomotil
Current Illness: NONE
Preexisting Conditions: Topical allergic reactions; Bypass surgery
Allergies:
Diagnostic Lab Data: WBC 20,000 - 40,000; Severe metabolic acidosis; Heart attack; CT Scans negative
CDC Split Type:

Write-up: Within 2 hours, high fever, brown spot size of nickel at injection site, ache all over, stopped eating and drinking. 3 Advil for 3 hours for unrelieved pain. 2 weeks - abdominal pain and nausea. One week - chest pain and right shoulder pain.


VAERS ID: 197704 (history)  
Form: Version 1.0  
Age: 0.1  
Sex: Male  
Location: Hawaii  
Vaccinated:2002-09-28
Onset:2002-10-28
   Days after vaccination:30
Submitted: 2003-02-11
   Days after onset:106
Entered: 2003-02-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -

Administered by: Private       Purchased by: Public
Symptoms: Cerebral haematoma, Constipation, Faeces hard, Hypertension, Injury, Jaundice, Nasopharyngitis, Premature baby, Small for dates baby, Subdural haematoma, Vomiting projectile
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Hypertension (narrow), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-10-30
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Death/ Constipation~Hep B (no brand name)~2~0.00~In Patient
Other Medications: We had given our son Infant Tylenol after the vaccine and two days prior to his death because he displayed signs and symptoms of having a cold
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: There is an on-going autopsy by City and County of Honolulu Medical Examiner Office as this case is unusual from other cases that they have performed regarding a subdural hematoma.
CDC Split Type:

Write-up: My son passed away on October 30, 2002 approxiametly one month after the second Hepatitis B shot was administered. He died from a subdural hematoma with out any other evidence of trauma or stroke activity. My son did display some of the reactions such as low birth weight, prematurity, high blood pressure during pregnancy, labor induction, jaundice, constipation, cold without fever, projectial vomitting. I was also involved in a car accident four weeks prior to delievery and had some loss of ambiotic fluid associated with the accident. We had also talked to his pediatrician regarding his hard, clay like stool and he was constipated two days prior to his death. Follow up per autopsy report: Subdural hematoma, abusive head trauma.


VAERS ID: 197618 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Washington  
Vaccinated:2002-09-05
Onset:2002-09-26
   Days after vaccination:21
Submitted: 2003-02-10
   Days after onset:137
Entered: 2003-02-12
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / UNK - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 486817 / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-09-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Autopsy Results: Sudden infant death syndrome (LLT, SIDS)
CDC Split Type: HQWYE172204FEB03

Write-up: A nurse reported that a male infant received a dose of Prevnar along with DTaP, IPOL and hep B vaccines on 9/5/02 at 4 months of age. On 9/26/02 at 5 months of age, the infant died. SIDS was the reported cause of death. No further info was available at the date of this report. This report of a serious, labeled event is being submitted in a 15-day time frame as requested. Info regarding this event has been forwarded to manufacturer of IPOL vaccine. From initial information received at manufacturer on 03/03/2003 from another manufacturer regarding an event that happened in the U.S. concerning a 4-month-old male patient who received IPOL on 02/05/2002. The lot number and site/route for the vaccination was not reported. The patient died on 09/26/2002 from SUDDEN INFANT DEATH SYNDROME. From additional information received at manufacturer on 04/24/2003, it was reported that the patient also received Prevnar, DTaP and Hepatitis B Vaccine on 09/05/2002. The manufacturer, lot number and route/site were all not reported for Hepatitis B Vaccine and DTaP. Prevnar was given intra-muscular. Autopsy results showed Sudden Infant Death Syndrome (LLT, SIDS) as reported cause of death. From additional information received on 05/13/2003 from manufacturer, it was reported that their manufacturer number be added to WAES 0305USA00241.


VAERS ID: 197619 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2000-11-01
Submitted: 2003-02-10
   Days after onset:831
Entered: 2003-02-12
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Lung neoplasm malignant, Pleural mesothelioma
SMQs:, Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-12-22
   Days after onset: 51
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: Autopsy results: mesothelioma
CDC Split Type: HQWYE230006FEB03

Write-up: An attorney reported that a 57 year old male received either IPV or OPV (manuf unk) sometime in the 1950s or 1960s. He was reportedly diagnosed with mesothelioma on or about November 2000. On 12/22/00, he died from the mesothelioma. It is alleged that, exposure to SV40 in the vaccine was a cause of the pt''s mesothilioma. The reporter also noted exposure to asbestos and asbestos containing products as a cause. No further info was available at the date of this report.


VAERS ID: 197715 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Louisiana  
Vaccinated:2002-01-28
Onset:0000-00-00
Submitted: 2003-02-11
Entered: 2003-02-13
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 532 / 2 LL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 480319 / 2 RA / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR T1446 / 2 LA / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 483171 / 2 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: 2002-01-29
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: Sudden infant death syndrome.


VAERS ID: 198342 (history)  
Form: Version 1.0  
Age: 1.08  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2003-02-14
Onset:0000-00-00
Submitted: 2003-02-19
Entered: 2003-02-26
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA791AA / 4 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 491186 / 3 LL / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Dehydration, Hyperthermia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Accidents and injuries (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-02-17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Synagis
Current Illness: Otitis Media
Preexisting Conditions: Congenital hear disease; FTT; Prematurity
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Child with congenital heart disease, twin gestation and prematurity. G-tube present about 50 hours after administration of vaccines with hyperthermia, dehydration and death.


VAERS ID: 198474 (history)  
Form: Version 1.0  
Age: 1.5  
Sex: Male  
Location: Ohio  
Vaccinated:2002-07-19
Onset:2002-07-22
   Days after vaccination:3
Submitted: 2003-02-15
   Days after onset:208
Entered: 2003-02-28
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 557A2 / 4 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR U0903 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-07-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Cardiac arrest in emergency room x-ray dept. Autopsy related unexplained cardiomyopathy.


VAERS ID: 198580 (history)  
Form: Version 1.0  
Age: 47.3  
Sex: Male  
Location: California  
Vaccinated:2003-02-22
Onset:2003-02-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2003-02-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV066 / 1 LA / -

Administered by: Military       Purchased by: Unknown
Symptoms: Arrhythmia, Cardiomegaly, Diarrhoea, Electrolyte imbalance, Myocardial fibrosis
SMQs:, Cardiac failure (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (narrow), Cardiac arrhythmia terms, nonspecific (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-02-23
   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: UNK
Current Illness: UNK
Preexisting Conditions: NKA
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt was immunized w/arm initial Anthrax vaccination at 7:30 am on 2/22/03. he died late pm of 2/23/03. Autopsy results pending from ME''s office. The autopsy report states cardiac arrhythmia, cardiomegaly, myocardial fibrosis, electrolyte imbalance and diarrhea.


VAERS ID: 198666 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2003-02-27
Entered: 2003-03-04
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Bacterial infection, Drug ineffective
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Penicillin (unspecified)
Current Illness: NONE
Preexisting Conditions: Hb-ss disease with crisis
Allergies:
Diagnostic Lab Data: Diagnostic Laboratory: revealed penicillin sensitive pneumococcus; Body temperature: elevated temperature
CDC Split Type: WAES0302USA02069

Write-up: Information has been received from five authors of a published literature article concerning a patient who participated in a post marketing study involving pneumococcal vaccine 23 polyvalent. The 30 month old patient with hb-ss disease with crisis was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy included penicillin. It was reported that the patient was compliant with penicillin therapy. In 1996 the patient developed severe pneumococcal infection and subsequently the patient died. It was noted that the patient was discharged from the local ER a few hours earlier. The cause of death was pneumococcal infection NOS. Patient developed severe pneumococcal infection was considered to be immediately life threatening. It was reported that two other patient developed pneumococcal infections. At this time, relationship of the patient''s pneumococcal infection to pneumococcal vaccine 23 polyvalent was unknown. Additional information has been requested. Reported on 03/26/2003: "Follow-up information received from the Primary Author revealed that the year of death was December, 1996. The parents reported that the child was on oral penicillin prophylactically. However the child was very non-compliant, and it was questionable as to whether or not the child had ever been vaccinated with pneumococcal vaccine 23 polyvalent, since there were no records of vaccination dates. The childd was seen in a local emergency room and had an elevated temperature (which would have required the child to be admitted and the organism was penicillin sensitive pneumococcus. The child was sent home and was found dead in the AM. No autopsy was performed. Additional information has been requested. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 198667 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2003-02-27
Entered: 2003-03-04
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 2 - / -

Administered by: Other       Purchased by: Other
Symptoms: Bacterial infection, Drug ineffective, Feeling hot, Headache
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Penicillin
Current Illness: NONE
Preexisting Conditions: Bacteremia; Hb-ss disease with crisis
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0302USA02379

Write-up: Information has been received from five authors of a published literature article concerning a patient with a history of bacteremia several years earlier who participated in a post marketing study involving pneumococcal vaccine 23 polyvalent. The 14 year old patient with hb-ss disease with crisis was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy included penicillin. It was noted that the patient was not compliant with penicillin theapy and had recently discontinued penicillin prophylaxis. In 1997, the patient was infected with pneumococcal serotype (18F) and subsequently died. The cause of death was the pneumococal infection. It was also reported that two other patient''s had pneumococcal infections. At this time, relationship of the patient''s pneumococcal infection to pneumococcal vaccine 23 polyvalent was unknown. Patient developed pneumococcal infection that resulted in death was considered to be immediately life-threatening. Additional information has been requested. Reported on 03/26/2003: "Follow up information received from the Primary Author revealed that the patient was almost 15 years old with a history of bacteremia at approximately 6-7 years of age. The first pneumococcal vaccine 23 polyvalant was administered at 2 years 2 months and the 2nd dose just shy of 8 years of age. The child was not on prophylactic penicillin therapy. It was noted that the child had been well and out sledding all day then complained of a headache and felt a little warm. The child was seen in the hospital, was admitted, deteriorated quickly, was sent to the ICU and in the AM died. The child was infected with a Pneumococcal serotype (38f). No autopsy was performed. Additional information has been requested. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 198668 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2003-02-27
Entered: 2003-03-04
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Bacterial infection, Pneumonia
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 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: Penicillin (unspecified)
Current Illness: NONE
Preexisting Conditions: Hb-ss disease with crisis
Allergies:
Diagnostic Lab Data: Diagnostic Laboratory-no serum penicillin; Blood culture-streptococcus pneumonia; hemoglobin-2.7;
CDC Split Type: WAES0302USA02380

Write-up: Information has been received from five authors of a published literature article concerning a patient who participated in a post marketing study involving pneumococcal vaccine 23 polyvalent. The 24 month old patient with hb-ss disease with crisis was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy included penicillin. It was noted that no penicillin was detected in the serum. In 1997 the patient developed a severe pneumococcal infection and subsequently died. The cause of death was pneumococcal infection NOS. It was also reported that two other patient''s developed pneumococcal infections. At this time, relationship of the patient''s severe pneumococcal infection to pneumococcal vaccine 23 polyvalent was unknown. The patient''s severe pneumococcal infection was considered to be immediately life threatening. Additional information has been requested. Reported on 03/26/2003: "Follow up information received from the Primary Author revealed that the patient died in 1997. The child had no previous episodes of sepsis or meningitis. The serotype was unknown. The child presented to the Emergency Room in septic shock with a hemoglobin of 2.7. massive hepatoslenomegaly, DTC, went into Ventrivular Fibrillation and "expired 4 hours after presenting". the parents had reported that the child was taking prophylactic penicillin, however no penicillin was detected in the serum and the blood culture result was Streptococcus pneumonia that was sensitive to Oxacillin. There was no autopsy performed. Additional information has been requested. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 198981 (history)  
Form: Version 1.0  
Age: 57.0  
Sex: Female  
Location: Florida  
Vaccinated:2003-02-27
Onset:2003-02-28
   Days after vaccination:1
Submitted: 2003-03-06
   Days after onset:6
Entered: 2003-03-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020077 / 2 LA / -

Administered by: Public       Purchased by: Unknown
Symptoms: Angiopathy, Atherosclerosis, Circulatory collapse, Cough, Decreased appetite, Dehydration, Diarrhoea, Dizziness, Dyspnoea, Fatigue, Infarction, Lung disorder, Malaise, Myocardial infarction, Nausea, Pain, Pruritus, Pyrexia
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-03-26
   Days after onset: 26
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Norvasc 5mg po qd, Hazaar 50/12.5 one po qd; Evista
Current Illness: NONE
Preexisting Conditions: Hypertension; osteoarthritis; osteoporosis; prior TIA, status post heart cath; L1-5 compression fracture; right carotid endarterectomy; bilateral hip replacement; breast biopsy on the right (bening); heart cath in November of 2002; steroid epidural in December of 2002; smoking; transient ischemic attach.
Allergies:
Diagnostic Lab Data: BP is 113/80, heart rate is 100 and regular, respiratory rate is 20. Autopsy: showed extensive atherosclerosis of the coronary arteries, and a large healing infarct involving the posterior wall of the left ventricle and intraventricular sep. The autopsy report states arteriosclerotic cardio-vascular disease.
CDC Split Type:

Write-up: Pt is a 57 year old white female who presents to the smallpox vaccination follow up dressing clinic status post vaccinia vaccine times six days. She states that, the day following her vaccination, she began to suffer from increasing body aches, fatigue, general malaise, and fever that maxed at 102.6. She complains of nausea without vomiting and inability to eat or drink since that time. She does complain of increasing shortness of breath and productive cough, which is productive in nature with a green sputum. She denies chest pain. She denies ? related complications other than mild itching/pruritis. She denies generalized rash or rash on other parts of her body. She does complain of orthostatic dizziness. She has only taken Tylenol with small sips of water for the preceding five days. Impression: acute exacerbation of chronic obstructive pulmonary disease, dehydration, rule out vaccinia reaction. Follow up letter states: The latest that I was able to gather from - working on AE''s is the following: 57 yof nurse vaccinated 02/27/2003, seen in ER 03/04/2003 for nausea without vomiting, dizziness, shortness of breath. There was no evidence of rash, or fever and no report of diarrhea. Vital signs: 113/80, pulse 100, RR20, PE: Bilateral wheezing, scattered ronchi, no murmur, and normal heart sounds. The pt had a history of HTN, osteoporosis and TIA, no report of COPD. Was on antihypertensives and treatment for osteoporosis. This information comes from the report from the ER, it claims that she was going to be transferred but it is unclear if she was "admitted" or not (it appears to be an overnight ER admission, but this needs to be clarified). They had a requested CXR,ABG''s and were going to treat her as an "acute exacerbation of COPD" with antibiotics, bronchodilators, expectorants, and oxygen. COPD is not determined in past medical history from ER however the pt is a smoker since age 14 (1 ppd x 43 ys). On March 16 while with husband the pt collapsed and was down for 15-20 minutes. EMT''s came, pt was resuscitated in. The autopsy report states arteriosclerotic cardio-vascular disease.


VAERS ID: 198985 (history)  
Form: Version 1.0  
Age: 6.0  
Sex: Female  
Location: California  
Vaccinated:2002-01-04
Onset:2002-01-07
   Days after vaccination:3
Submitted: 2003-03-06
   Days after onset:423
Entered: 2003-03-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 05206A2 / UNK LA / IM
HEPA: HEP A (HAVRIX) / SMITHKLINE BEECHAM 706A2 / UNK RA / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 07422 / UNK LA / SC

Administered by: Public       Purchased by: Public
Symptoms: Cardiac arrest, Headache, Myocarditis, Nausea, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (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: 2002-01-07
   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: PPD
Current Illness: NONE
Preexisting Conditions: 12/12/01 diagnosed scabies cleared on 1/4/02 T 100 oral
Allergies:
Diagnostic Lab Data: Hct/Hgb, with 99.5 NAAC, urine/UC, vision screen, hearing screen
CDC Split Type:

Write-up: Pt initially seen for physical exam on 12/12/01. The physical was wnl except for dental caries, a referral was made to dentist, and a diagnosis of Scabies. The family was given scabies education. A Hct/Hgb, with 99.5 NAAC, urine/UC, vision screen, hearing screen and PPD (all negative results) MMR, HBV and HAV given on 1/4/02.


VAERS ID: 199061 (history)  
Form: Version 1.0  
Age: 0.75  
Sex: Female  
Location: South Dakota  
Vaccinated:2002-11-21
Onset:2002-12-08
   Days after vaccination:17
Submitted: 2002-02-27
   Days after onset:284
Entered: 2003-03-10
   Days after submission:376
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES E33472HA / 1 RL / UN
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 5355A2 / 3 RL / UN

Administered by: Private       Purchased by: Private
Symptoms: Bronchitis acute, Cerebral ischaemia, Cough, Dyspnoea, Laryngitis, Pneumonia, Pyrexia, Stridor
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-02-10
   Days after onset: 301
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Autopsy-laryngotracheitis, bronchopneumonia, ischemic brain changes.
CDC Split Type: 03002

Write-up: Admitted to hospital with difficulty breathing, fever, croupy cough, inspratory stridor, acute bronchitis.


VAERS ID: 199143 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: California  
Vaccinated:2002-11-18
Onset:2002-12-09
   Days after vaccination:21
Submitted: 2003-03-06
   Days after onset:87
Entered: 2003-03-11
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / UNK - / -
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Nasal congestion, Pharyngitis, Rhinitis, Sudden infant death syndrome
SMQs:, Agranulocytosis (broad), Oropharyngeal infections (narrow), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-12-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol Cold Drops
Current Illness:
Preexisting Conditions: Cold/Congestion; upper respiratory tract infection NOS
Allergies:
Diagnostic Lab Data: Postmortem biochemical, bacteriology, micribiology, genetic teting-negative. Blood drug screen negative; virology test negative; nasal aspirate RSV negative
CDC Split Type: U200300078

Write-up: From initial correspondence received at manufacturer as a phase IV study report on 2/27/03, it was reported that an 11 week old male patient received DAPTACEL, IPOL, PRP-T, HEPATITIS B VACCINE and PNEUMO CONJ on 11/18/02. Lot numbers and the site/route for the vaccines were not reported. On 12/7/02, the patient suffered from a cold/congestion and was given Tylenol Cold Drops for infants every 8 hours. Patient''s last dose was on the evening of 12/8/02. on 12/9/02, the decedent was taken to the day care provider at about 8:00 AM. He reportedly was placed down for a nap at 9:30 AM on his side/stomach. He was stirring around 11:00 AM. The day care provider checked on him again at 11:30 and observed the decedent unresponsive. She called the emergency services and the decedent was transported to hospital. Doctor pronounced death at 12:57 PM. Patient died on 12/9/02 from SUDDEN INFANT DEATH SYNDROME. The decedent was brought to the coroner''s office for examination, an autopsy was done on 12/10/02 at 10:00 AM. Pathologic diagnosis: There is clinical history of the decedent being found deceased at the day care (prone sleeping position). No evidence of injury or congenital malformation. Negative post-mortem microbiology, toxicology and genetics testing. Clinical history of recent upper respiratory infection. Post mortem toxicology, bacteriology virology and biochemical testing negative. Cause of Death: Sudden infant death syndrome. Other significant conditions were prone sleeping positions. The manner of death was natural. Report of scene investigation: On Monday 12/9/02 at approximately 1:40 PM, the coroner was contacted at the office by the investigator regarding the death of a 11 week old, currently at hospital. The coroner contacted the investigator via telephone and informed him of the circumstances, agreeing to meet him at the hospital, he departed for the hospital at 1:50 PM. He arrived at the hospital at approximately 8:30 that morning. Four children total, are being cared for by the day care operator. The baby was given approximately 4/10 of a cc of infant Tylenol due to a cold, and was placed face down, at the mom''s request, in a playpen with a blanket covering the child at approximately 9:30 AM. At 11:00 AM, the child was noted to stir, and at 11:45 AM the child was found to be unresponsive. Paramedics were called and the child was transported to hospital. The child is a well-developed, well-nourished appearing male infant. Rigidity is fully developed in the bilateral lower extremities and the right upper extremity but appears to have been broken in the left upper extremity. It is fully developed at the jaw. Lividity is in a somewhat mixed distribution but somewhat heavier over the back, with clearing over pressure points. It blanches with pressure. The hands are clenched. Evidence of medical therapy is present, including a left intraosseous pretibial catheter, a hospital identification bag at the right ankle, multiple EKG pads and defibrillator pads and an endotracheal tube present in the mouth. No signs of injury are noted on the child. The child is wrapped in a blanket and there is a clean appearing disposable diaper appropriately positioned. The genitalia are unremarkable. No intraoral or ocular petechiae noted. The fundi are examined with the ophthalmoscope present in the room, and there is some haziness present, but the vessels are seen in both eyes and no evidence of retinal hemorrhage is appreciated. The anterior fontanel is flat and non-bulging. The head is normocephalic and shows no evidence of trauma. There are also a pair of socks present on the bilateral feet. Photographs are taken and then the infant is undressed and the majority of the medical instrumentation is taken off and additional photographs are obtained. Following his examination, he leaves the baby in the custody of investigator B, waiting for the arrival of investigator R. The coroner then departs the hospital for the scene at 2:40 PM. He arrives at


VAERS ID: 199292 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Texas  
Vaccinated:2003-01-10
Onset:2003-01-11
   Days after vaccination:1
Submitted: 2003-03-04
   Days after onset:52
Entered: 2003-03-12
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 545D9 / UNK - / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA716AA / UNK - / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR 60348 / UNK - / -

Administered by: Private       Purchased by: Public
Symptoms: Agitation, Crying, Irritability, Lethargy, Pyrexia, Sudden infant death syndrome
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-01-17
   Days after onset: 6
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: Mild reflux
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Inconsolable crying, extremely lethargic, fever. Pt received his vaccinations Fr. 1/10/03. In the afternoon. He slept all day Sat. We could not hardly wake him up to feed him. He slept all day Sunday also. Sun evening he was running a low grade fever about 101. During church he started crying and we prayed for him because we thought he just felt bad because of his shot. Fever is a well know side affect. When we left church his fever had subsided. Monday he seemed fussy but not bad. My daughter had a doctors appt which is is about 24 miles from where we live. So she took pt with her. She had been in the doctors office for about 30 minutes when she called me to please come get him she said he had been screaming since she left and she couldn''t get him to quiet down. I drove to pick him up and when I got there one of the girls in the office was holding him and he was screaming. I took him and I couldn''t console him. I had never seen anything like it. I could always get him to quit crying. I left and when we started driving he stopped crying. We went to store and bought a few things and when we started checking out he started screaming again. We left and he screamed most of the way home. He was real fussy that night. I don''t remember about Tuesday but my mom who kept him during the day said that Wed. he was real fussy, and just needed to be held. He was also waking up a lot during the night. Thursday night he seemed fine, I bathed him and took him to see a friend of mine. He was laughing and talking to me. I rocked him to sleep when we got home. The next morning my daughter woke up and found him dead.


VAERS ID: 199295 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: New Hampshire  
Vaccinated:2002-04-10
Onset:2002-04-16
   Days after vaccination:6
Submitted: 2003-03-11
   Days after onset:329
Entered: 2003-03-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 538A2 / 1 - / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR U0613 / 1 - / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR UA662AA / 1 - / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 485048 / 1 - / 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: 2002-04-03
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Nystatin 3/4/02; difucon 4/9/02; Cestriaxone (IM) 4/4/02
Current Illness: Thrush
Preexisting Conditions: Thrush 3/4/02, ear infection 4/4/02
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: NH0303

Write-up: SIDS


VAERS ID: 199296 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: New Hampshire  
Vaccinated:2002-09-30
Onset:2002-10-21
   Days after vaccination:21
Submitted: 2003-03-11
   Days after onset:141
Entered: 2003-03-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 5352A2 / 2 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: 2002-10-21
   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: Polyvifior 0.25, Mylestatin
Current Illness: Thrush 9/30/02
Preexisting Conditions: Similac allergy 9/18/02 formulas to Isomil Fe diarrhea resolved by 9/30/03
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: NH0304

Write-up: SIDS


VAERS ID: 199432 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Massachusetts  
Vaccinated:2003-03-07
Onset:2003-03-07
   Days after vaccination:0
Submitted: 2003-03-12
   Days after onset:5
Entered: 2003-03-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U0849CA / 2 LL / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA736AB / 2 RL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR V0536 / 2 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 490096 / 2 RL / -

Administered by: Private       Purchased by: Public
Symptoms: Irritability, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-03-09
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt received vaccinations on 3/7/03 in am. At 7:22pm pt''s mother called the urgent care dept to report pt had 102.2 fever and was fussy-no rash or redness was present. Pt was seen that evening. On 3/8/03 pt was reported to look better. On 3/9/03 pt was found deceased in crib.


VAERS ID: 199689 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Massachusetts  
Vaccinated:2003-03-04
Onset:2003-03-04
   Days after vaccination:0
Submitted: 2003-03-16
   Days after onset:12
Entered: 2003-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U0583DA / 2 - / IM
HBPV: HIB POLYSACCHARIDE (HIBIMUNE) / PFIZER/WYETH UA712AA / 2 - / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR U0903 / UNK - / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Conjunctivitis, Crying, Cyanosis, Fatigue, Irritability, Sudden infant death syndrome
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Conjunctival disorders (narrow), Ocular infections (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2003-03-09
   Days after onset: 5
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: Umblical hernia
Allergies:
Diagnostic Lab Data: SIDS
CDC Split Type:

Write-up: My fiance recently took our son for his 2 month check up on March 4, 2003. He received three vaccines that day DTP, IPV and Hib. That night he was very fussy, wouldn''t take his bottle and cried all night. Patient usually would go back to sleep in the middle of the night after he ate, but this night was different. It was so bad I stayed home from work to be with him. I didn''t think nothing of it due to the fact he was colic. March 7th I took him to his Doctor because he had conjunctivitis and they gave him a routine check up. The next two nights he wouldn''t sleep much and a little fussy, but not as bad as when he first got the vaccines. Saturday night March 8th I put my baby down to sleep around 12:45am. Patient woke up around 6 am. His daddy tried to feed him but he wouldn''t take his bottle all he did was cry. Finally patient fell asleep from exhaustion. Around 9:30am I woke up and checked on my baby and he was all blue, he died in his sleep. He was rushed to the hospital in the matter of minutes. They worked on him for about a half hour and there was nothing they could do. My angel was gone. The Doctors said they believed it was a case of SIDS. His tissues are still under investigation for the next 6 weeks. I really believe his death had something to do with the vaccines. He was born December 25, 2002 and rec''d the hepatitis vaccine, and agian on Jan.29,2003. I had a healty normal full term pregnancy. The only problem was that I had to get an emergency c-section due to patients heart rate was dropping. I was never informed of all the risks from vaccines. Please help me. --------------------------------------------------------------------------------


VAERS ID: 199645 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Florida  
Vaccinated:2003-02-21
Onset:0000-00-00
Submitted: 2003-03-14
Entered: 2003-03-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U0849CA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA797AA / 1 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0460 / 1 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 491167 / 1 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-02-23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Specimen(s) submitted: Blood and stomach contents; blood in culture bottles; culture swabs of heart, spleen, left lung and right lung.
CDC Split Type:

Write-up: According to the death investigation report, this 2 month old white female infant was transported to the hospital ER at about 21:21. CPR was performed by ER service for 30 minutes. The patient was found unresponsive by her mother at about 20:30 after being put down for a nap on the parent''s bed at about 18:30. The infant was pronounced dead at 21:30 by the doctor. The doctor estimated the length of time that the infant was unresponsive was from 30 minutes to 2.5 hours. The said decedent died of Sudden Infant Death Syndrome. Children in the early months of infancy can often die without any pathological changes seen at autopsy. The only injury seen at autopsy was a very small dot-like purple abrasion of the chin to the left of the midline. This injury was the result of blunt trauma and did not contribute to the patients death. Postmertem blood alcohol test and drug screen were negative. The manner of death is classified as Natural.


VAERS ID: 199646 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Male  
Location: Washington  
Vaccinated:2002-12-11
Onset:2002-12-17
   Days after vaccination:6
Submitted: 2003-03-07
   Days after onset:80
Entered: 2003-03-17
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 566A2 / 3 LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0534M / 3 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA720AA / 3 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Bacterial infection, Coagulopathy, Hepatic failure, Hypoglycaemia, Jaundice, Laboratory test abnormal, Multi-organ failure, Vomiting
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (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), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (narrow), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-01-22
   Days after onset: 36
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: 86 with an INR of 7.6, PTT 85, fibrinogen of 56,000. His AST was 2,900, ALT 3,500. His white count was elevated at 22, hematocrit 35, platelet count 245,000. Ammonia level was 73.
CDC Split Type:

Write-up: Pt previously healthy. Six days after 6 mo WCC and vaccines x 3 (hep B, DTaP, HIB), pt presented with vomiting and jaundice. Transferred to hospital on 12/20/02. Developed fulminant liver failure of unknown etiology and died 1/22/03. Principal diagnosis: idiopathic liver failure. Secondary diagnoses: hypoglycemia. Coagulopathy. Citrobacter freundii bacteremia and line infection. Multiorgan system failure.


VAERS ID: 199647 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: California  
Vaccinated:2003-01-30
Onset:2003-02-08
   Days after vaccination:9
Submitted: 2003-03-12
   Days after onset:32
Entered: 2003-03-17
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / UNK - / -
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Accidental overdose, Cyanosis, Pneumonia, Pulse absent, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Drug abuse and dependence (broad), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-02-08
   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:
Current Illness:
Preexisting Conditions: Born at 26-27 weeks gestation, birth weight 1lb and 15 ounces; Tylenol overdose treated with MucoMist; Treated with Caffeine for apnea and bradycardia; Ventricular septal defect - asymptomatic; Pneumonia treated with Amoxicillin; Diaper Rash.
Allergies:
Diagnostic Lab Data: Autopsy results: External appearance - there is some diaper rash involving the labia majora and the buttocks. There is a ploypoid skin lesion in the anterior neck, and it is not clear whether this represents some residual lesion from neonatal therapy. Internal organs - the pleural cavities contain small serous sanguineous effusions. Lymphoreticular System - no generalized lymphadenopathy. Respiratory system - the larynx, trachea, and main bronchi show is seropurulent exudate, but there are no signs of injury. Both lungs are heavy, and there are areas of hemorrhagic consolidation throughout both lungs. Sections of the right lower lobe show areas of discrete, punched-out, hemorrhagic infarction. Gastrointestinal System - the liver weights 200gm. The cut surface show mild steatosis, but there is no necrosis or cirrhosis. Cardiovascular System - the great veins and arteries, valves, chambers, and myocardium are unremarkable. Central Nervous System: the scal, skull, dura and meninges are unremarkable. Microscopic Description: Lung - sections show evidence of acute and on-going aspiration. Many of the alveoli contained large numbers of lipid-laden macrophages, which are typical of chronic aspiration. In addition, many of the airways and bronchi contain large amount of particulate esosinophilic material, which almost certainly represent gastric content. There is also widespread hemorrhagic infarction of both lungs, but no evidence of viral infection is seen. Bone marrow - the bone marrow shows non-specific hyperplastic reactive changes. There is no evidence of leukemia or any other kind of bone marrow infiltrate. Hospital course: This is a 3 month old that was born at 27 weeks premature, female who was referred to our hospital from poison control after it was found that the mother was giving double the amounts of Tylenol over the course of 3 days. The admission Tylenol level was 104. The baby was asymptomatic at the time. The baby''s liver enzymes were normal throughout the hospitalization as well as clotting studies. She did have a chest x-ray done for cough and this showed a right lower lobe pneumonia for which the baby was treated with Amoxicillin. After admission, the baby was started on Mucomyst through a nasogastric tube. Subsequent Tylenol levels were continuing to drop. The baby''s condition continued to be benign. After approximately 24 hours of Mucomyst, the Mucomyst was discontinued as the Tylenol levels were within normal ranges and there was no evidence of clotting disorder or hepatitis by laboratory studies. Social service was contacted and interviewed the family and felt to be in honest mistake on the mother''s part. She was not intending to hurt the child. The baby was sent home with the parents to have a follow up in the outpatient department. At the time of discharge, the baby''s pulse oximetry readings were 100% with 1/8th L of oxygen by nasal cannula.
CDC Split Type: U200300080

Write-up: From initial information received at manufacturer on 2/28/03, it was reported that a female, date of birth 10/12/02, received Daptacel on 12/17/02 and 1/30/03 as part of a post-marketing phase IV study. She also received IPV, PRP-T, Hepatitis B, and Pneumo Conjugate vaccines on 1/30/03. The patient presented to the ER on 2/8/03 at 13:35 in severe respiratory distress and cyanosis. Her respiratory rate was in the 60''s and oxygen saturation in the low 80''s. Initial capillary refill was greater than three seconds. The labs were consistent with infection, and her chest x-ray showed three large infiltrates. The electrolytes were remarkable for a very high potassium level and the CBC showed a very high white cell count with a picture that was subsequently interpreted by the hematologist as being a leuko-erythromblastic response. She was intubated by an anesthesiologist who reported child was very hard to ventilate. Child then lost pulse and cardiac rhythmn. Resuscitation measures taken including Epinephrine, Normal Saline, Albumin, Calcium Chloride, Atropine, Albuterol, and Vaporephrine. The patient was pronounced dead at 15:35. The pathologist indicates patient had been regurgitating gastric content and aspirating. The event was considered by the investigator as unlikely/not related to the vaccines. The patient was born at 26-27 weeks gestation with a complicated post-natan NICU course for two months. Eventually discharged to home on oxygen and was first tried off oxygen on 12/28/02. Then re-admitted to the hospital on 12/18/02 for pneumonia and was found to have high dose of acetaminophen accidentally, she was given a wrong dose over a one-week duration during febrile illness requiring Mucomist to Detoxify. She had been off of this medication for two weeks prior to this last illness when there was recurrence of viral illness before she expired. Case is closed.


VAERS ID: 199804 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Female  
Location: New Jersey  
Vaccinated:1993-04-30
Onset:1993-05-02
   Days after vaccination:2
Submitted: 2003-03-18
   Days after onset:3607
Entered: 2003-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / SANOFI PASTEUR - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1993-05-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NA
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: My Daughter Died 4 days after shot was given


VAERS ID: 199945 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2002-04-25
Onset:2003-03-05
   Days after vaccination:314
Submitted: 2003-03-19
   Days after onset:14
Entered: 2003-03-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK - / -

Administered by: Private       Purchased by: Unknown
Symptoms: Sepsis
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2003-03-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Lumbar puncture for Streptoccus pneumoniae
CDC Split Type:

Write-up: Pt admitted to hospital for MS change. Had lumbar puncture and transferred to another hospital. Pt had Streptococcal meningitis and died. pt had received 3/4 of Prevnar vaccine.


VAERS ID: 199949 (history)  
Form: Version 1.0  
Age: 42.0  
Sex: Male  
Location: Indiana  
Vaccinated:2003-03-06
Onset:2003-03-06
   Days after vaccination:0
Submitted: 2003-03-18
   Days after onset:12
Entered: 2003-03-20
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / SANOFI PASTEUR 00550AA / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Atherosclerosis, Cardiovascular disorder, Dizziness, Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-03-11
   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: ephedra
Current Illness:
Preexisting Conditions: Patient was a Tetanus plasma donor and had donated a unit of Source plasma (approximately 10 mL on 03/06/2003. He had participated in the Tetanus Immune Plasma program in the past and had donated plasma regularly since 2001 (125 times prior to the 03/06/2003 donation) and each time without incident. Pt had a physical on 02/19/2003 that indicated that he was a healthy and suitable donor. The pt''s health history was unremarkable and showed that the pt had pneumonia in 1979, a tonsil and adenoid removal in 1968, and surgery on his right knee in 1976. Per the pt''s brother, he may have been taking Mini-thins, a dietary supplement containing ephedra, which he had taken in the past and had lost weight due to the fact that he had been walking 2 miles to and from work each day.
Allergies:
Diagnostic Lab Data: Vital signs included pulse-86; BP-153/79; temperature-99.0F; hematocrit-43 and total protein 7.5 were all WNL.
CDC Split Type: U200300083

Write-up: From initial correspondence received at manufacturer, on 03/11/2003 it was reported that a 42-year-old male pt who was a Tetanus Plasma Donor, received a Tetanus Toxoid Adsorbed vaccination, administered IM in the right deltoid on 03/06/2003. The pt was observed for 15 minutes post-vaccination and was fine Pt has no history of allergies to Tetanus. Reportedly the pt passed away on 03/06/2003 or 03/07/2003, this is still under investigation. According to further info received on 03/12/2003 frm reporter it was reported: "The donor (the patient) successfully and without incident donated a unit of Source Plasma on 03/06/2003, was found dead in his bed on either March 6 or 7, 2003. There appears to be no relationship between the donor''s death and his donation of plasma on the previous day. In a telephone conversation with the Coroner''s office this morning, March 12th, Aventis Bio Services were informed that the cause of death in this case was due to severe Atherosclerotic Cardiovascular Disease." "The decedent was a 42-year-old male who was a regular donor. He weighed 166 pounds, and had donated a unit of Source Plasma (approximately 30 mL) on 03/06/2003 between approximately 6:30 AM and 9:30 AM. The donor''s vital signs, including his pulse (86), blood pressure (153/79), temperature (99.0 F), hematocrit (43) and total protein (7.5) were all within acceptable limits. Info obtained during annual physical examinations conducted on this donor on 02/19/2003 indicated that he was healthy and suitable to donate. On 03/10/2003, manufacturer was contacted by the donor''s brother and was informed that when the donor returned home sometime after donating that he complained of lightheadedness and numbness below the elbows in both arms. The brother reported inquiring if medical care was needed but the donor declined and elected to ''lay down for a while and try to feel better.'' The donor''s brother reported that when he tried to wake the donor on either Thursday afternoon or evening or Friday morning, that the donor had passed away. The decedent''s brother speculated that the donor might have taken the dietary supplement ''Minithins'' which contain ephedra since he had known him to take the supplement in the past. An autopsy was performed; a copy of the post-mortem report will be forwarded to manufacturer. The cause of death was reported by the Indiana Coroner''s Office on 03/12/2003 to manufacturer as being due to severe atherosclerotic cardiovascular disease.


VAERS ID: 200177 (history)  
Form: Version 1.0  
Age: 55.0  
Sex: Female  
Location: Maryland  
Vaccinated:2003-03-18
Onset:2003-03-22
   Days after vaccination:4
Submitted: 2003-03-24
   Days after onset:2
Entered: 2003-03-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020077 / 2 LA / ID

Administered by: Public       Purchased by: Public
Symptoms: Coma, Disorientation, Dizziness, Pain, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-03-23
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Atenolol, Diovan, Hydrochlorthiazide, Cardiazem
Current Illness: None
Preexisting Conditions: Hypertension, history of hypoglycemic episodes, intermittent bilateral hand swelling, occasional herpes simplex on arm
Allergies:
Diagnostic Lab Data: None for current illness; autopsy results pending
CDC Split Type:

Write-up: Day 4 after vaccination, disorientation, dizziness, L. arm pain, vomiting Day 5 discovered unresponsive in bed, pronounced dead at hospital. No medical treatment other than normal meds in 24 hours prior to death known.


VAERS ID: 200120 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Male  
Location: New Hampshire  
Vaccinated:2002-12-19
Onset:2002-12-24
   Days after vaccination:5
Submitted: 2003-03-24
   Days after onset:90
Entered: 2003-03-25
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 5286A2 / 1 - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-12-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: NH0305

Write-up: SIDS.


VAERS ID: 200214 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Ohio  
Vaccinated:1995-12-18
Onset:2001-10-01
   Days after vaccination:2114
Submitted: 2003-03-19
   Days after onset:534
Entered: 2003-03-26
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 2 - / -

Administered by: Private       Purchased by: Other
Symptoms: Bradycardia, Circulatory collapse, Pain, Sepsis
SMQs:, Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypersensitivity (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-11-01
   Days after onset: 31
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Sickle Cell SC disease
Allergies:
Diagnostic Lab Data: Holter monitoring-showed no abnormal rhythms. Chest X-ray 11/01/01-Normal. Magnetic resonance (1999?)-no ostructive lesions. Pulse oximetry (11/01/01-slight desaturation-upon admission. Diagnostic procedure (1999?)-no ostructive lesions. Pulse oximetry 11/01/01-significantly desaturated-2 hours after arriving on floor. Body height measurement 11/02/01 - 132 cm. Lab test 11/02/01 - toxicology studies show opiates (morphine and codeine) at therapeutic levels. Body temp 11/01/01-afebrile. Total heartbeat count 11/02/01-bradycardic. Body weight measurement 11/02/01 - 37 kg.
CDC Split Type: WAES0303USA00840

Write-up: Information has been received from a physician concerning a pt with the SC form of sickle cell disease who was vaccinated with the first and second doses of pneumococcal vaccine 23 polyvalent. The child received the first dose at the age of 2 and the second dose at the age of 5 or 6. It was noted that the pt developed pneumococcal infection. In approximately October 2001, the child was admitted to the hospital due to pain. Within 30 minutes, the child collapsed and died. This case was reported while obtaining information from a lead author of a literature article titled "Streptococcus pneumoniae Sepsis and Meningitis During the Penicillin Era in Children with Sickle Cell Disease" (WAES0302USA02380, WAES0302USA02379, WAES0302USA02069). Additional info has been requested. The follow up received on 3/31/03 from a physician indicated that the child presented to the ER complaining of pain in her legs. She was afebrile. It was noted that she had slight desaturation and she was given oxygen by nasal prongs as well as pain medication. A chest x-ray was normal. Her symptoms did not resolve in the ER and so she was admitted to the 23 hour observation status. Approximately 2 hrs after arriving on the floor it was noted that she was becoming significantly desaturated and bradycardic. In very short order she arrested and was noted to be asystolic. CPR was instituted nearly immediately and the pt was intubated and given Narcan and cardiac drugs. Ventricular fibrillation was obtained but defibrillation was unsuccessful and after 25 minutes of resuscitation effort the resuscitation was called. According to the autopsy report, the date of death is reported at 11/1/01. The final anatomic diagnosis were Pneumococcal sepsis, adrenal hemorrhage, hepatic and splenic congestion, acute cerebral anoxic changes, thymic involution, and marrow with erythroid hyperplasia and myeloid left shift. Special studies indicated that toxicology studies showed opiates (morphine and codeine) at therapeutic levels and Streptococcus pneumonia was sensitive to penicillin. Additional info has been requested. A 15-day follow up report received 04/11/2003 adds: This case was reported while obtaining info from a lead author of a literature article titled ''Streptococcus pneumoniae Sepsis and Meningitis During the Penicillin Era in Children with Sickle Cell Disease'' (WAES #0302USA02380, WAES #0302USA02379, WAES #0302USA02069). Additional info has been requested. The follow up received on 5/21/03 received from a physician indicated that the source of the information regarding the penicillin-sensitive pneumococcus was a blood culture obtained in the emergency room at the time of admission approximately 2-3 hours before the pt''s death.


VAERS ID: 200329 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Male  
Location: Florida  
Vaccinated:2002-09-27
Onset:2002-09-29
   Days after vaccination:2
Submitted: 2002-10-21
   Days after onset:22
Entered: 2003-03-27
   Days after submission:157
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (IMOVAX) / SANOFI PASTEUR 305011 / 1 - / -

Administered by: Private       Purchased by: Private
Symptoms: Cerebrovascular accident, Dehydration, Rash maculo-papular, Rhabdomyolysis, Urticaria
SMQs:, Rhabdomyolysis/myopathy (narrow), Anaphylactic reaction (broad), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-10-19
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: Hypertension, ARDS
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Rash varying from urticaria type to maculopapular per doctor''s office nurse administering vaccine and pt''s sister in-law respectively. Pt died due to CVA in brain stem. Dx of rhabdomyolysis given also. F/UP report on 3/28/03: Cause of death was complications of dehydration.


VAERS ID: 200330 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Male  
Location: Unknown  
Vaccinated:2002-10-17
Onset:2002-11-06
   Days after vaccination:20
Submitted: 2003-03-25
   Days after onset:139
Entered: 2003-03-27
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES C072544 / 1 RL / -
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 5353B2 / 2 RL / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA741AA / 1 LL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR U1082 / 1 LA / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 487390 / 1 LL / IM

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: 2002-11-06
   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: UNK
Allergies:
Diagnostic Lab Data: Blood ethanol toxicology report - no ethanol detected in heart blood sample; Blook ketone body toxicology report - no acetone detected in heart blood sample; X-ray - total body x-rays show no recent or healing fractures, bony malformations or projectiles
CDC Split Type: HQWYE140718MAR03

Write-up: An investigator reported that a 2 month old male received his 1st dose of Prevnar on 10/17/02, at 1 month of age, as part of the Prevnar Post-Marketing Safety Surveillance Trial, "Post-Marketing Evaluation of Prevnar-Pneumococcal 7 Valent Conjugate Vaccine: Safety of Prevnar Administerred Cconcurrently with Routine Infanr Vaccinations at 2, 4, 6, and 12 to 15 months of Age." On 10/17/02, the infant also received Tripedia, Polio Vaccine, ActHIB, and Engerix B vaccines. On 11/6/02, 20 days post-immunization, the pt expired due to SIDS. Autopsy findings confirmed the cause of death as SIDS. Post-mortem total body x-rays revealed "no recent or healing fractures, bony malformations or projectiles." Toxicology results from a sample of heart blood were negative for ethanol and acetone. Per the autopsy report: "The presence of lymphocytic inflammatory infiltrates in many of the organs, especially the lungs and CNS, and the lymphoid hypertrophy noted in the GI tract, suggest a viral syndrome, which is considered coincidental. The clinical history and scene investigation do not reveal evidence of an overwhelming infection. The decedent was asystolic and apneic when encountered by paramedics." Both the investigator and the medical monitor assessed the SIDS as "not related" to the study vaccine. This report of a serious (OMIC), labeled event is being submitted in a 15-day time frame, as requested by FDA.


VAERS ID: 200387 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Georgia  
Vaccinated:2001-07-02
Onset:0000-00-00
Submitted: 2003-03-26
Entered: 2003-03-28
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 5178A2 / 3 - / -
MEN: MENINGOCOCCAL (MENOMUNE) / SANOFI PASTEUR UB034AA / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Laboratory test abnormal, Meningitis
SMQs:, Noninfectious meningitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-02-18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood cultures postiive for Meisseria meningitis group C
CDC Split Type:

Write-up: From initial information at manufacturer, it was reported that a 19 year old female patient received Menomune A/C/Y/W 135, UB034AA, on 7/2/01. Route/site were not reported. Patient had cultures sero group C. On 2/15/03, patient had blood cultures and was positive for ? of meningitis group C. Patient was hospitalized for 4 days, then died on 2/18/03.


VAERS ID: 201024 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2003-03-14
Onset:2003-03-25
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2003-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS - / UNK - / -
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH - / UNK - / -

Administered by: Military       Purchased by: Military
Symptoms: Accident, Anaemia, Back pain, Blood lactate dehydrogenase increased, Blood pressure decreased, Chest pain, Collagen disorder, Convulsion, Cough, Dyspnoea, Electrocardiogram abnormal, Laboratory test abnormal, Mental impairment, Nausea, Pleural effusion, Pneumonitis, Pyrexia, Sepsis, Supraventricular tachycardia, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Tylenol; Naproxen
Current Illness: Recent pneumonia
Preexisting Conditions: NONE Information received from transfer summary states Pneumonia. Information received from final discharge summary states rash. msv
Allergies:
Diagnostic Lab Data: CSF Cx, Thoracentesis, Atypical pneumonia serology panel, ANA, Rheumatoid screen Transfer summary states abnormal ECG, anemia, abnormal lab tests. Discharge summary states LDH increased. msv
CDC Split Type:

Write-up: Initially admitted with extreme shortness of breath/pneumonitis and pleural effusions noted after 2-3 week history of illness. Admit 3/27/03. On 4/6/03 Patient had mental status changes, partial complex seizure. Shortly thereafter decreased BP, required ventilation. Transferred to another hospital; later expired. Information received from transfer summary states fever, pain in chest, cough increased, supraventricular tachycardia. Discharge final summary states accident injury, collegen disorder, sepsis, nausea, vomiting and back pain. msv


VAERS ID: 201117 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Ohio  
Vaccinated:2002-09-19
Onset:2002-09-19
   Days after vaccination:0
Submitted: 2003-04-07
   Days after onset:200
Entered: 2003-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U0583AA / 1 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0456M / 1 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0013 / 1 RL / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Convulsion, Irritability, Oral intake reduced, Sepsis, Sleep disorder
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2003-03-18
   Days after onset: 180
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt was normally developing infant. After 1st vaccination series 9/19/02 Pt became fussy and would not sleep or eat well. He was followed by MD for possible colic. After 2nd vaccination series on 11/22/02, fussiness increased and appetite decreased, along with decreased sleeping. Pt was referred to a gastroenterologist; he diagnosed seizure activity and referred to neurologist, MD and to MD (cardiologist). He was placed on ACTH and zonegram. Childs condition worsened over the next several months and he expired on 3/18/03. Dr. reportedly told family that he could not rule out an adverse reaction to immunizations as a cause of the seizure activity.


VAERS ID: 201048 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Kentucky  
Vaccinated:2003-03-17
Onset:2003-03-19
   Days after vaccination:2
Submitted: 2003-04-02
   Days after onset:14
Entered: 2003-04-08
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 583B2 / 1 LL / -
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0641M / UNK RL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0062 / 1 RL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 490364 / 1 LL / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-03-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: Milk Allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient died on 3/19/03. Cause of death SIDS. Death occurred two days after immunizations. No problems reported before or after shots.


VAERS ID: 201354 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Florida  
Vaccinated:1999-01-19
Onset:0000-00-00
Submitted: 2003-04-08
Entered: 2003-04-11
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 2710A2 / 1 RL / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0786H / 2 RL / SC
TD: TD ADSORBED (NO BRAND NAME) / SANOFI PASTEUR C00934600 / 1 LL / -

Administered by: Public       Purchased by: Public
Symptoms: Convulsion, Drooling, Fatigue, Staring, Urinary incontinence
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-10-03
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Client received hep B #1 on 1/19/99, #2 on 4/7/99, #3 on 8/10/99. Parents stated that child started acting strange 24 hrs after first Hp B vaccine. She started staring into space, complained of being tired and grades dropped over period of time. She had the first seizure on 8/6/99 at a friend''s house and fell off the chair. After the second Hp B vaccine, she started drooling and wet the bed twice over a period of time. After the third vaccination, seizures became progressively worse. Child was under the care of the neurologist and medical services. On 10/13/01 child died in her sleep as a result of a "brain seizure."


VAERS ID: 201363 (history)  
Form: Version 1.0  
Age: 0.9  
Sex: Male  
Location: Mississippi  
Vaccinated:2003-03-27
Onset:2003-04-04
   Days after vaccination:8
Submitted: 2003-04-07
   Days after onset:2
Entered: 2003-04-11
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR UO581DA / 3 LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1228L / 2 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR U1233 / 3 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 490897 / 2 RL / IM

Administered by: Public       Purchased by: Public
Symptoms: Coma, Hypotonia
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-04-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: none
CDC Split Type: MS03020

Write-up: HV made to give late immunizations. No problem noted. Patient died 8 days later, had not been ill according to mother. She had gone to town and he was limp and unresponsive when she got home. They took him to MD and was pronounced dead. Autopsy pending. (homicide suspected)


VAERS ID: 201704 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Idaho  
Vaccinated:2003-03-18
Onset:2003-03-19
   Days after vaccination:1
Submitted: 2003-03-25
   Days after onset:6
Entered: 2003-04-18
   Days after submission:23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 586A9 / 1 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0740M / 1 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0334 / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 490531 / 1 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Apnoea, Cardiac arrest, Coma
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-03-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: Mild nasal congestion
Preexisting Conditions: Mongolian spot on back; Periods of Apnea
Allergies:
Diagnostic Lab Data: Radiographic studies-reveals no focal infiltrates, no cardiomegaly.
CDC Split Type: ID03023

Write-up: Child presented to med center ER the next am unresponsive and apneic. Paramedics reported that the baby was found apneic and pulseless at home by the home. Mother was lying beside the child in bed and the last time this child was seen well was about 7:30am this morning. The pt was noted to be asystole in the field. Was given four rounds of epinephrine without any return of spontaneous circulation. The pt then had CPR initiated. The pt was intubated and interosseous line was started. Further review of systems unable to be obtained given the fact that the parents are not here during resuscitation and pt is intubated and too young to give further history of present illness. This 2 month old male with cardiac arrest. At this time presenting apneic and pulseless. The possible etiologies include sudden infant death syndrome. At this time the coroner office was also invovled and will also be exploring any possible other etiologies. At this time pt will undergo a full body x-ray series and will also undergo autopsy. While pt was here in the emergency dept, the pt underwent further resuscitation and received two more doses of epinephrine and CPR was continued for another 10-15 minutes here in the emergency dept. The pt remained in asystole. This is documented in two leads afterwards. After 45 minutes of resuscitative efforts the resuscitation was discontinued given the futility of further intervention. The pt''s care and examination was discussed with MD who is the pt''s primary care physician. The family was also notified of the pt''s recent demise. Diagnostic impression: Cardiac arrest, uncertain etiology. The autopsy result states undetermined cause of death.


VAERS ID: 201705 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: North Carolina  
Vaccinated:2003-03-20
Onset:0000-00-00
Submitted: 2003-04-12
Entered: 2003-04-18
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U0853AA / 1 LL / -
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1031M / 2 RL / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA785AA / 1 LL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0334 / 1 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 490896 / 1 RL / -

Administered by: Private       Purchased by: Public
Symptoms: Abdominal pain, Constipation, Diarrhoea, Hyperhidrosis, Irritability, Rash, Sudden infant death syndrome, Urticaria
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Neonatal disorders (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-04-04
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Thrush medication mother taking antibiotics and breastfeeding
Current Illness: Runny nose
Preexisting Conditions: Premature birth
Allergies:
Diagnostic Lab Data: Autopsy - SIDS?
CDC Split Type:

Write-up: Cranky, colicky, constipated for 2 weeks, 2 days before shot until death. Had 5 dirty diapers day he died; 2 with diarrhea. Noticed a bone in frontal lobe protruding. Hive/Rash on neck, back, chest. Sweating.


VAERS ID: 201926 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2003-02-11
Onset:2003-02-14
   Days after vaccination:3
Submitted: 2003-03-14
   Days after onset:28
Entered: 2003-04-22
   Days after submission:38
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES U0846BA / 1 LL / IM
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES UA757AA / 1 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. W0013 / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 490908 / 1 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: 2003-02-14
   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:
CDC Split Type:

Write-up: Presented to hospital ER-not able to resuscitate suspected SIDS.


VAERS ID: 202332 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Male  
Location: Texas  
Vaccinated:2003-02-01
Onset:2003-02-06
   Days after vaccination:5
Submitted: 2003-04-28
   Days after onset:80
Entered: 2003-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS - / 2 - / -
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / UNK - / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / -
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020071 / 1 - / -
TD: TD ADSORBED (NO BRAND NAME) / SANOFI PASTEUR - / UNK - / -

Administered by: Military       Purchased by: Military
Symptoms: Coma, Hypertrophy
SMQs:, 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: 2003-02-06
   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: See tox screening in box 7.
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: See box 7.
CDC Split Type:

Write-up: Active-duty soldier, 181 cm tall, 180 lbs, found unresponsive in barracks 5-6 days post smallpox vaccination. Post-mortem toxicology positive for methadones (0.26 mg/L), diazepam (0.33 mg/L), nordiazepam (0.22 mg/L), but not temazepam, alprazolam, or dextromethorphan. Autopsy revealed concentric L ventricular hypertrophy, but no myocarditis. Conclusion: Vaccination unrelated to soldier''s death.


VAERS ID: 202346 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Mississippi  
Vaccinated:2003-04-07
Onset:2003-04-12
   Days after vaccination:5
Submitted: 2003-04-23
   Days after onset:11
Entered: 2003-04-30
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR UA849BA / 1 LL / -
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0693M / UNK RL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0332 / 1 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 491577 / 1 RL / -

Administered by: Private       Purchased by: Public
Symptoms: Apnoea, Nasal congestion, 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: 2003-04-12
   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: Pediatex 1/4 tsp QID
Current Illness: Allergic Rhinitis
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Autopsy
CDC Split Type:

Write-up: To clinic 4/7/03 for 2 month check and immunizations. Doing well, only complaints stuffy nose. On 4/12/03 to ER, not breathing and ER was not able to revive her. Preliminary autopsy reports listed as SIDS as cause of death.


VAERS ID: 202583 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Texas  
Vaccinated:2003-02-14
Onset:2003-02-17
   Days after vaccination:3
Submitted: 2003-05-05
   Days after onset:76
Entered: 2003-05-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 572A2 / 1 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0739M / 1 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR U1428 / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 491171 / 1 RL / IM

Administered by: Military       Purchased by: Military
Symptoms: Respiratory distress, Sudden infant death syndrome
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Neonatal disorders (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-02-17
   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: RANITIDINE METOCLOPRAMIDE FERROUS SULFATE
Current Illness: NONE
Preexisting Conditions: GASTROESOPHAGEAL REFLUX
Allergies:
Diagnostic Lab Data: negative autopsy results
CDC Split Type:

Write-up: infant death reported 3 days after 2 mos immunizations; autopsy revealed no etiology for death; reported as SIDS; child a 34 wk preemy growing up with history of respiratory distress; prescribed apnea monitor but unaware of its use at home


VAERS ID: 202592 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2003-04-15
Onset:2003-04-23
   Days after vaccination:8
Submitted: 2003-05-05
   Days after onset:12
Entered: 2003-05-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C1245AA / 1 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1218M / UNK LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0625 / 1 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 491185 / 1 RL / IM

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: 2003-04-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: Murmur
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Probable SIDS.


VAERS ID: 202593 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Wisconsin  
Vaccinated:2003-01-08
Onset:2003-01-10
   Days after vaccination:2
Submitted: 2003-04-29
   Days after onset:108
Entered: 2003-05-06
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 528D9 / 1 RL / -
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0583M / 1 RL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0197 / 1 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 489473 / 1 LL / -

Administered by: Private       Purchased by: Unknown
Symptoms: Hypertension, Lung disorder, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Hypertension (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-03-17
   Days after onset: 66
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 70 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt admitted 01/10/2003 with respiratory distress, eventually diagnosed with primary pulmonary hypertension.


VAERS ID: 202674 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Male  
Location: Florida  
Vaccinated:2003-04-24
Onset:2003-04-24
   Days after vaccination:0
Submitted: 2003-04-29
   Days after onset:5
Entered: 2003-05-07
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 5352A2 / 1 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Apnoea, Epistaxis, Sudden infant death syndrome
SMQs:, 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: 2003-04-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Jaundice
Preexisting Conditions: Premature birth at 34 weeks
Allergies:
Diagnostic Lab Data: The autopsy report states SIDS.
CDC Split Type:

Write-up: 10pm mom noticed child bleeding from nose while breast feeding, she wiped blood away then child turned blue and stopped breathing. She performed CPR dad call 911. Child was taken to hosp via ambulance. Pronounced dead 10:50pm. The autopsy report states SIDS.


VAERS ID: 202753 (history)  
Form: Version 1.0  
Age: 0.16  
Sex: Male  
Location: Alabama  
Vaccinated:2003-04-07
Onset:2003-04-08
   Days after vaccination:1
Submitted: 2003-04-25
   Days after onset:17
Entered: 2003-05-08
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 583B2 / 1 RL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 482355 / 1 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W00132 / 1 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 491572 / 1 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Agitation, Cardio-respiratory arrest, Cardiomyopathy, Eye disorder, Myocardial fibrosis
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (narrow), Corneal disorders (broad), Retinal disorders (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-04-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Multi Vitamins
Current Illness: NONE
Preexisting Conditions: Premature Birth, macrocephaly, sickle cell trait
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Infant brought to ER 04/08/2003 in cardio-pulmonary arrest at 0039. Resuscitation attempted per DR but was unsuccessful. The autopsy report received on 1/28/04 states cardiomyopathy, and subendocardial fibroelastisis. The hospital discharge summary received on 1/28/04 states cranky and eye deviation.


VAERS ID: 202931 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2000-05-01
Submitted: 2003-05-09
   Days after onset:1103
Entered: 2003-05-13
   Days after submission:4
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 neoplasm malignant
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-08-26
   Days after onset: 847
Permanent Disability? Yes
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: Autopsy results: lung cancer
CDC Split Type: HQWYE106008MAY03

Write-up: A legal complaint was received from an attorney regarding an adult male. The plaintiff''s history includes exposure to asbestos and asbestos-containing products. According to the legal complaint, "sometime between 1962 and 1963, plaintiff was administered OPV or IPV." In May 2000, the plaintiff was reportedly diagnosed with lung cancer. The legal complaint states that the "contaminated vaccine products were toxic and carcinogenic" and that the "plaintiff''s exposure to asbestos, asbestos-containing products, and SV40 virus caused severe and permanent injury to the plaintiff, including, but not limited to breathing difficulties, asbestosis, lung and/or other cancer, mesothelioma, and/or other lung damage." On 8/26/02, he died from lung cancer.


VAERS ID: 202932 (history)  
Form: Version 1.0  
Age: 55.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2003-04-16
Submitted: 2003-05-08
   Days after onset:22
Entered: 2003-05-13
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABAVERT) / NOVARTIS VACCINES AND DIAGNOSTICS - / 3 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Cardio-respiratory arrest, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (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), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2003-04-16
   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: NONE
Current Illness: UNK
Preexisting Conditions: Dog Bite
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20030208

Write-up: A 55 year old woman was bitten by a stray dog. She was vaccinated with three doses of Rabipur IM, but rabies immune globulin was not administered. On 4/13/03 (11th day) the pt experienced a loss of consciousness and died due to cardio-respiratory arrest on 4/16/03. An autopsy was not performed.


VAERS ID: 203154 (history)  
Form: Version 1.0  
Age: 55.0  
Sex: Male  
Location: Texas  
Vaccinated:2003-03-20
Onset:2003-03-25
   Days after vaccination:5
Submitted: 2003-05-14
   Days after onset:49
Entered: 2003-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020071 / 2 - / -

Administered by: Military       Purchased by: Military
Symptoms: Cardiac arrest, Cardiomegaly, Cerebral ischaemia, Coma, Coronary artery disease, Hypertrophy, Ventricular fibrillation, Ventricular tachycardia
SMQs:, Torsade de pointes/QT prolongation (narrow), Cardiac failure (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2003-03-27
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Smoker. Hyperlipidemia. Degenerative joint disease.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Found unresponsive in vehicle, CPR initiated within 5 min. Resuscitated from cardiac arrest in ER at Medical Center. Suffered anoxic brain injury. As inpt had ventricular tachycardia, ventricular fib. Post-mortem exam revealed 3-vessel coronary artery disease, left ventricular hypertrophy, cardiomegaly, but no myocarditis. Full records provided to Dr.


VAERS ID: 203186 (history)  
Form: Version 1.0  
Age: 39.0  
Sex: Male  
Location: New York  
Vaccinated:2003-03-05
Onset:2003-04-06
   Days after vaccination:32
Submitted: 2003-05-15
   Days after onset:38
Entered: 2003-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS - / 1 - / -
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020071 / UNK - / -

Administered by: Military       Purchased by: Military
Symptoms: Cardiovascular disorder, Deep vein thrombosis, Muscle spasms, Pulmonary embolism, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Dystonia (broad), Thrombophlebitis (broad), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2003-04-06
   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: Aspirin?
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Heterozygous for Factor V Leiden mutation R506Q, indicating 3-6-fold increase in risk for vein thrombosis.
CDC Split Type:

Write-up: Deep-vein thrombosis of L lower extremity, leading to multiple pulmonary thromboemboli with near complete occlusion of L pulmonary artery. Dilated, tortuous deep veins of both lower extremities. Hypertensive atherosclerotic cardiovascular disease. Preliminary Autopsy Report: Cause of death: Pulmonary Thromboembolism due to DVT. Manner: Natural. Autopsy performed 10 Apr 03. Reports will be faxed. News article, dated 7 Apr 03, asserts "Three days ago, patient had complained of cramps behind his knee. Like most of us journalists "embedded" in the military, he had endured days and nights of working, eating, and sleeping in our vehicles as convoys snaked their way around. He consulted military doctors and described his symptoms over the phone to overseas physicians. They suspected DVT, or deep veinous thrombosis, and advised him to seek proper medical attention. He ignored their advice, swallowed some aspirins, and kept on working."


VAERS ID: 203195 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Kentucky  
Vaccinated:2003-05-08
Onset:2003-05-11
   Days after vaccination:3
Submitted: 2003-05-12
   Days after onset:1
Entered: 2003-05-15
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR 40854AA / 2 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0021N / 2 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0704 / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 492585 / 2 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Apnoea, Skin discolouration, Sudden infant death syndrome
SMQs:, 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: 2003-05-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: mild gastroesphageal reflux (improved)
Allergies:
Diagnostic Lab Data: state medical examiner autopsy pending
CDC Split Type: KY2003067

Write-up: History of mother finding infant blue and not breathing on morning of 5/11/03. Transported code 300 by EMS, resutation unsuccessful. State Medical Examiner, autopsy pending.


VAERS ID: 203239 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2003-04-09
Onset:0000-00-00
Submitted: 2003-04-14
Entered: 2003-05-16
   Days after submission:32
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C0950AB / 1 RL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0453M / 1 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0332 / 1 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 489750 / 1 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-04-13
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
CDC Split Type: PA0315

Write-up: Phone call from county coroner''s office that pt died yesterday (4/13/03). Autopsy pending. 4/16/03 autopsy showed death no relation to immunizations.


VAERS ID: 203265 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: North Carolina  
Vaccinated:2003-04-08
Onset:2003-04-09
   Days after vaccination:1
Submitted: 2003-04-29
   Days after onset:20
Entered: 2003-05-19
   Days after submission:20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U0852CA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA785AA / 1 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0197 / 1 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 491178 / 1 RL / IM

Administered by: Private       Purchased by: Private
Symptoms: Coma, Laboratory test abnormal, Oedema peripheral, Sudden infant death syndrome
SMQs:, Cardiac failure (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Neonatal disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-04-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Infant Tylenol .4ml
Current Illness: NONE
Preexisting Conditions: Hemangioma on left scapula. RSV positive on 2/5/03.
Allergies:
Diagnostic Lab Data: Had an autopsy by medical examiners; RSV-Rapid screen (Nasal)(Final): positive
CDC Split Type:

Write-up: Mom bottle fed at 0330 on 4/9/03. Placed on couch with mom at 0400. Mom fell asleep on couch with him at 0430. She awoke at 0630 to discover he was not moving. Some swelling in lower extremities noticed. CPR started at 0630 and continued until rescue arrived at 0705.


VAERS ID: 203515 (history)  
Form: Version 1.0  
Age: 45.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2003-03-10
Onset:2003-05-18
   Days after vaccination:69
Submitted: 2003-05-21
   Days after onset:3
Entered: 2003-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020076 / UNK LA / ID

Administered by: Public       Purchased by: Public
Symptoms: Atherosclerosis, Cardiac disorder
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-05-18
   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: Meds for HTN - unsure of exact medications
Current Illness: None Reported
Preexisting Conditions: HTN, family history of HD
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Sudden death on 5/18/03. Autopsy results show atherosclerotic heart disease.


VAERS ID: 203521 (history)  
Form: Version 1.0  
Age: 0.35  
Sex: Male  
Location: California  
Vaccinated:2003-02-24
Onset:2003-03-06
   Days after vaccination:10
Submitted: 2003-03-21
   Days after onset:15
Entered: 2003-05-22
   Days after submission:61
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C0948AA / 2 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA786AA / 2 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0332 / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 491190 / 2 LL / IM

Administered by: Private       Purchased by: Private
Symptoms: Anoxia, Encephalitis, Sudden infant death syndrome
SMQs:, Acute central respiratory depression (broad), Noninfectious encephalitis (narrow), Neonatal disorders (narrow), 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: 2003-03-08
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: 34 week 1.925kg birth
Allergies:
Diagnostic Lab Data: Autopsy
CDC Split Type:

Write-up: SIDS death 3/8/03 onset sx 3/6/03. Autopsy Report received on 5/27/2003 states anoxia and encephalitis.


VAERS ID: 203673 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2003-05-22
Entered: 2003-05-27
   Days after submission:5
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, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-10-11
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: Autopsy results: mesothelioma
CDC Split Type: HQWYE216915MAY03

Write-up: A legal complaint was received from an attorney regarding an adult male. The decedent''s history includes exposure to asbestos and asbestos-containing products. According to the legal complaint, sometime in the 1960''s or 1970''s, decedent was administered OPV or IPV. On or about 2002, the decedent was reportedly diagnosed with mesothelioma. The legal complaint states that the decedent''s exposure to asbestos, asbestos-containing products, and the SV40 virus caused severe and permanent injury to the plaintiff, including, but not limited to breathing difficulties, asbestosis, lung and/or other cancer, mesothelioma, and/or other lung damage. On 10/11/02, he died. The death certificate lists the immediate cause of death as respiratory arrest due to mesothelioma.


VAERS ID: 203963 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: Michigan  
Vaccinated:2003-04-10
Onset:2003-04-16
   Days after vaccination:6
Submitted: 2003-05-29
   Days after onset:43
Entered: 2003-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS ENG5305A6 / 1 - / -
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR UB359AA / 1 - / -

Administered by: Private       Purchased by: Private
Symptoms: Headache, Incoherent, Multi-organ failure, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2003-04-18
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Norvasc 5mg qd, Proscar 5mg qd, Toprol 200 mg qd, Lescol 20 mg qd, Elavil 100 mg qd, Ultram 50 mg prn, Valium 10 mg prn
Current Illness: arthritis
Preexisting Conditions: arthritis, other medical conditions unknown
Allergies:
Diagnostic Lab Data: 4/17/03-Platelet count 52,000 ALT 2850 U/L AST 6200 U/L
CDC Split Type:

Write-up: 4/16/03-Patient complained of headache, back and hip pain. 4/17/03-Hospitalized with fever of 103, became incoherent, developed multiple organ system failure. 4/18/03-Died


VAERS ID: 204529 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: New York  
Vaccinated:2003-05-30
Onset:2003-06-03
   Days after vaccination:4
Submitted: 2003-06-04
   Days after onset:1
Entered: 2003-06-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 529A2 / 2 - / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0932L / 2 - / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR T1368 / 2 - / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 468569 / 2 - / IM

Administered by: Public       Purchased by: Public
Symptoms: Asphyxia, Coma, Injury
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (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), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-06-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: A few days post viral illness
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Infant found unresponsive laying on stomach am of 6/3. The autopsy states suffocation.


VAERS ID: 204565 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2003-06-04
Entered: 2003-06-06
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Dyspnoea, Lung neoplasm malignant
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-03-21
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: Autopsy Results: Malignant mesaothelioma
CDC Split Type: HQWYE401029MAY03

Write-up: A legal complaint was received from an attorney regarding an adult female. The decendent''s history includes exposure to asbestos and asbestos-containing products. According to the legal complaint, sometime in the 1960''s, the decedent was administered OPV or IPV (manufacturer unspecified). Sometime on or about January 2001, the decedent was reportedly diagnosed with mesothelioma. The legal complaint states that the decedent''s exposure to asbestos, asbestos-containing products, and the SV40 virus caused severe and permanent injury to the decedent including, but not limited to breathing difficulties, asbestosis, lung and/or other cancer, mesothelioma, and/or lung damage. On 3/21/02, she died.


VAERS ID: 205222 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Male  
Location: New York  
Vaccinated:2002-10-16
Onset:2003-05-09
   Days after vaccination:205
Submitted: 0000-00-00
Entered: 2003-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Laboratory test abnormal, Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-05-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: K-Dur, Enteric coated aspirin, Zaroxolyn, Prevacid, Lasix, Atenolol, Allopurinol, 2 liters of oxygen, Lantus, Humalog, Quinine, Combivent,
Current Illness:
Preexisting Conditions: Type 2 diabetes poorly controlled, Recent HB1C of 8.8; Congestive heart failure felt more to be diastolic with recent ejection fraction of 55% and chronic ascites; Coronary artery disease status post coronary artery bypass grafting; Chronic bilateral leural effusions status post decortication; History of gout; Chronic renal insufficiency, Baseline BUN and creatinine recently 72/2.1; Ventral hernia; Glaucoma; GERD, COPD, Right bundle branch block;
Allergies:
Diagnostic Lab Data: BP: 109/59; Pulse: 81; Respirations 16; Pulse oximetry: 95% on 3 liters; alert and oriented x 3; CT of head: negative for bleed or stroke; ENG: Consistent with atrial flutter with irregular ventricular response ranging from 80-90; Blood glucose: 224; BUN and creatinine: 64/1.8; Sodium: 131; Potassium: 3.3; Chloride: 84; CO2: 37; Alkaline Phosphatase: 341; CK: 34; LDH: 709; Lipase: 301; White count: 14; Hematocrit: 39.7; Platelets: 330,000; Neutrophils: 8.5%; Lymphs and 0.4% eosinophils;
CDC Split Type: 200301034

Write-up: A 68 year old male received RSV vaccine or Placebo and Influenza Vaccine on 10/16/02 and 205 days later died on 5/9/03. Investigator was notified by patient''s family that he died at home. Will speak to family in a couple of weeks. The Investigator assessed the event as unrelated to the study product. Follow up on 07/08/2003: "A 68 year old male received RSV vaccine or Placebo and Influenza vaccine on 10/16/2002 and 205 days later died on May 9, 2003. Investigator was notified by patient''s family that he died at home. Will speak to family in a couple weeks. The investigator assessed the event as unrelated to the study product. Follow up information received 07/01/2003. Investigator spoke with family members regarding death. Death certificate lists CHF as cause of death. Subject went from a lengthy hospitalization to a nursing home where he died approximately 1 week later. Prior hospitalization in File # 2003-00364. The Investigator assessed the event as unrelated to the study product. HISTORY OF PRESENT ILLNESS: The patient is a 68 year old white male well known to me who is being admitted to hospital for acute syncope with resultant facial contusions and left knee contusion. The patient was seen by myself last week in the ofice for his usual followup and also had an episode of either slipping vs. syncope with resultant left facial contusion and left conjuctival hemorrhage. He was back to his baseline status and saw doctor at hospital today who is his cardiologist. He suggested placing him on a Holter monitor because of the facial ontusion and questionable syncopal episode. The patient left the hospital. Apparently, the patient became lightheaded and passed out. He landed on his face and chest and does not recall any events thereafter until he was at the hospital. He was complaning of chest discomfort which he felt was due to contusing his chest but was treated as if it was cardiac in origin with aspirin, Nitroglycerin paste and morphine. He also was placed in a left knee immobilizer. He underwent a CAT scan of his head which was normal. Chest x-ray revealed questionable mild congestive heart failure. His labs are notable for his usual chronic renal insufficiency, hypoatremia, hypoalemia and an elevated white count of 14,000. It was determined that the patient needed to be further evaluated due to his complicated history as well as syncope and possible cardiac issues. He has since been transferred to a other hospital where he is presently complaining left knee discomfort and mild palpable chest discomfort. He is not short of breath and is frustrated with the overall situation.


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