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VAERS ID: 424958 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: New Hampshire  
Vaccinated:2011-04-06
Onset:2011-05-31
   Days after vaccination:55
Submitted: 2011-06-07
   Days after onset:7
Entered: 2011-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3815AA / 1 UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 915702 / 1 UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1525Z / 1 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Death, Premature baby
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-05-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NH06071104

Write-up: Baby was immunized 4/6/11. Baby was born prematurely. Hep B refused.


VAERS ID: 425289 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Female  
Location: Illinois  
Vaccinated:2011-06-10
Onset:2011-06-11
   Days after vaccination:1
Submitted: 2011-06-13
   Days after onset:2
Entered: 2011-06-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3879AA / 1 RL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB972AA / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E55587 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1269Z / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-06-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: unexplained death


VAERS ID: 425334 (history)  
Form: Version 1.0  
Age: 1.66  
Sex: Male  
Location: New Jersey  
Vaccinated:2011-05-05
Onset:2011-05-07
   Days after vaccination:2
Submitted: 2011-06-14
   Days after onset:38
Entered: 2011-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A98669 / 4 UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0813Z / 1 UN / SC

Administered by: Private       Purchased by: Other
Symptoms: Autopsy, Cerebral haemorrhage, Child maltreatment syndrome, Computerised tomogram abnormal, Computerised tomogram head, Cough, Death, Dyskinesia, Mechanical ventilation, Nasopharyngitis, Neurosurgery, Respiratory tract congestion, VIIth nerve paralysis, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Dyskinesia (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-05-13
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: None, just got over a cold prior to vaccine
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Baby had cold symptoms, cough, congestion, a little vomiting. My son came home at 7:20 p.m. On 5/10 to babysitter advising baby was napping from 6 p.m. Patient was face down on bed. My son laid next to him and put his hand on his back and he noticed he wasn''t breathing right. He lifted him and turned him over and his one side of face and mouth was drooping and his right arm and leg kept jolting. No left side movement at all. 911 was immeidately called. CT scan showed bleeding on brain. Three hours later transferred by ambulance to Hospital (not airlifted) was put on respirator at Medical Center. Got to another hospital had another CT scan, bleed was worse underwent neurosurgery and brains was hemorrhaging too bad. Neurosurgeons said bleed was too bad and injuries were consistent with shaken baby syndrome. Patient had no brain activity or breathing capacity at all. Passed away on 5/13 at 10:30 a.m. Initial Autopsy was inconclusive. Undergoing more tests. Patient on 5/5 had PVC (Pneumococcal Vaccine and Varicella Vaccine). It is being treated as a homicide by Prosecutor''s office. A local chiropractor told us about a link with vaccines and brain injuries similar to shaken baby. We wanted to report this since he did get these two recent injections. Awaiting second autopsy. They said brain and eyes were sent to specialist around the country.


VAERS ID: 425476 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-06-15
Entered: 2011-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic reaction, Circulatory collapse, Death, Dyspnoea, Hyperhidrosis, Loss of consciousness, Respiratory arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), 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), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergic rhinitis; Allergy to DAPSONE; Asthma; Coronary artery disease; Dermatitis; Obesity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0726071A

Write-up: This case was reported in a literature article and described the occurrence of anaphylaxis in an adult male subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). Concurrent medical conditions included allergic rhinitis, allergy to DAPSONE, asthma, coronary artery disease, dermatitis and obesity. On an unspecified date, the subject received unspecified dose of Hepatitis B vaccine (unknown route, unknown lot number). 15 minutes after vaccination with Hepatitis B vaccine, the subject experienced anaphylaxis, respiratory arrest, cardiovascular collapse, loss of consciousness, shortness of breath and diaphoresis. The subject was treated with EPINEPHRINE and ATROPINE. The subject died, cause of death is not specified. It was unknown whether an autopsy was performed. The case could have been an acute coronary event. Initial case was retrieved from the scientific literature on 08 June 2011. The National Vaccine Injury Compensation Program (VICP) was established in 1986 in response to vaccine safety concerns. A unique feature is a table of compensable injuries, the Vaccine Injury Table (VIT). Anaphylaxis is a listed adverse event with an interval of 0 to 4 hours for several vaccines. In 2009, the VICP charged the Institute of Medicine with the task of completing a comprehensive review of the medical literature regarding adverse events related to vaccines so that the VIT could be updated. Concurrent with the Institute of Medicine''s review, we undertook a systematic analysis of the VICP''''s anaphylaxis case experience. The VICP administrative database was queried for all cases submitted to the VICP alleging "anaphylaxis or anaphylactic shock" for the 10-year period from January 1, 2000, through December 31, 2009. Cases were categorized as anaphylaxis, possibly allergic-not anaphylaxis, and not anaphylaxis or allergic. The anaphylaxis cases all met the Brighton Collaboration (BC) case definition and were further subdivided into 3 levels of diagnostic certainty using major and minor criteria, with level 1 being the greatest level of certainty. Possibly allergic cases were defined as those for which there were signs and/or symptoms compatible with an allergic reaction occurring within 4 hours of injection but that did not meet any of the BC case definitions for anaphylaxis. All of our anaphylaxis cases met the BC diagnostic certainty and, with an interval of 0 to 4 hours, are consistent with the current VIT. This case was classified at level 1 of certainty. This review represented the first systematic approach in analyzing the VICP experience with anaphylaxis and will be useful when the VIT is updated. This was one of 9 cases reported in the same article and represented 8 different vaccines containing at least 11 different vaccine antigens.


VAERS ID: 425513 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Idaho  
Vaccinated:2011-04-26
Onset:2011-04-28
   Days after vaccination:2
Submitted: 2011-04-29
   Days after onset:1
Entered: 2011-06-16
   Days after submission:48
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0886Z / 1 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1492Z / 2 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-04-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ORTHO CYCLEN
Current Illness: (1) Depression/chronic; (2) ADHD; (3) acne severe
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: None known -suicidal ideation denied at visit 4/26 - known chronic depression she elected to stop her medications when she turned 18. Committed suicide 04/28/11. Hung herself.


VAERS ID: 425598 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-06-16
Entered: 2011-06-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1106USA01652

Write-up: A consumer reported that he/she read an internet concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL (lot # , dose and route not reported). On an unspecified date, the patient died of "clot blood" eight hours after vaccination. This is one of several reports from the same source. No further information is available.


VAERS ID: 425680 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-06-01
Onset:2007-06-01
   Days after vaccination:0
Submitted: 2011-06-17
   Days after onset:1477
Entered: 2011-06-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1106USA01650

Write-up: A consumer reported that he/she obtained the information from internet concerning a 17 years old woman who in June 2007 was vaccinated the first dose of GARDASIL. In the afternoon of the same day, in June 2007, the patient was found unconscious (without signs of life) by her mother. The doctor from the emergency crew attempted resuscitation, but without success. The cause of death was unspecified. This is one of several reports received from the same source. No further information is available.


VAERS ID: 425817 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-06-16
Entered: 2011-06-21
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DT: DT ADSORBED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anaphylactic reaction, Choking, Death, Dyspnoea, Endotracheal intubation complication, Hypotension, Local swelling, Respiratory arrest, Swelling, Swelling face
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), 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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had a history of type 2 Diabetes Mellitus, hypertension (HTN), coronary artery disease (CAD) after coronary artery bypass graft, dementia, and dysrhythmia.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201103324

Write-up: Initial case was retrieved from the scientific literature on 08 June 2011. "The agency was established in 1986 in response to vaccine safety concerns. A unique feature is a table of compensable injuries, the Vaccine Injury Table (VIT). Anaphylaxis is a listed adverse event with an interval of 0 to 4 hours for vaccines containing Td, DPT, DTaP, MMR II, IPV, and HBV. In 2009, the agency charged the Institute with the task of completing a comprehensive review of the medical literature regarding adverse events related to vaccines so that the VIT could be updated. Concurrent with the Institute''s review, we undertook a systematic analysis of the agencies anaphylaxis case experience. The agency administrative database was queried for all cases submitted to the agency alleging "anaphylaxis or anaphylactic shock" for the 10-year period from January 1, 2000, through December 31, 2009." The patient captured in this case was one of 8 noted in the above reference that experienced anaphylaxis after vaccination. A geriatric male patient (age not reported) with a medical history of type 2 diabetes mellitus, hypertension (HTN), coronary artery disease (CAD) after coronary artery bypass graft, dementia, and dysrhythmia, received an injection (route and site not reported) for Diphtheria and Tetanus Toxoids, lot number and manufacturer not reported, on an unknown date. On an unknown date within 30 minutes after receiving the vaccine, the patient developed anaphylaxis with symptoms of choking, shortness of breath, and face/neck/whole body swelling. The Emergency Medical Service (EMS) was unsuccessful in intubation. The patient became hypotensive and went into respiratory arrest. The patient received epinephrine x 3, atropine x 3, and remained an unsuccessful intubation. The patient died (date not reported). The outcome was reported as fatal. The reporter in this case is the same as cases: 2011-03327, 2011-03328, 2011-03329, 2011-03330, 2011-03331, 2011-03332, and 2011-03333. Documents held by sender: None.


VAERS ID: 425873 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Male  
Location: Illinois  
Vaccinated:2011-06-16
Onset:2011-06-20
   Days after vaccination:4
Submitted: 2011-06-22
   Days after onset:2
Entered: 2011-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3911AA / 2 RL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E70195 / 2 LL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0530AA / 2 MO / PO

Administered by: Private       Purchased by: Unknown
Symptoms: Gastrointestinal obstruction, Surgery
SMQs:, Gastrointestinal obstruction (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2011-07-08
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 17 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UGI --$g obstruction
CDC Split Type:

Write-up: Surgical resection.


VAERS ID: 425996 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: California  
Vaccinated:2009-11-12
Onset:2009-12-10
   Days after vaccination:28
Submitted: 2010-05-18
   Days after onset:158
Entered: 2011-06-23
   Days after submission:401
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3385AA / 1 UN / UN
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. AHBVB761CA / 2 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D74804 / 1 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0088Y / 1 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-12-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201002826

Write-up: Initial report received on 18 May 2010 from an investigator participating in the above-mentioned trial under the reference number M5A11. A 3-month-old male subject died 28 days after he received a first dose injection of PENTACEL, lot number C3385AA on 12 November 2009. The subject also received the following vaccines on the same date: a first dose of PREVNAR (lot number D74804), a second dose of RECOMBIVAX HB (lot number AHBVB761CA), and a first dose of ROTATEQ (Lot number 0088Y). The subject was last seen on 12 November 2009 for normal well baby care which was unremarkable. The subject died on 10 December 2009. The reporter had no additional information pertaining to the cause or description of death; therefore the "Event Start Date (Date of onset of symptoms)" was reported as unknown. At the time of the report, the county coroner''s bureau confirmed the death but would not provide preliminary information. The bureau did indicate that the manner of death was determined to be natural causes and autopsy results would be available as soon as they were considered final. According to the investigator, the event was not related to PENTACEL.


VAERS ID: 425997 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: California  
Vaccinated:2009-07-15
Onset:0000-00-00
Submitted: 2010-05-18
Entered: 2011-06-23
   Days after submission:401
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3181AA / 3 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D46873 / 2 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1695X / 2 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Biopsy site unspecified abnormal, Biopsy skin, Blood chloride, Blood creatinine, Blood glucose, Blood potassium, Blood sodium, Blood urea, Brain neoplasm malignant, Brain scan abnormal, Carbon dioxide, Central nervous system mass, Computerised tomogram head, Death, Dehydration, Dilatation ventricular, Disease progression, Drain removal, Emotional distress, Fluid retention, Hydrocephalus, Hypotension, Mass excision, Nausea, Nuclear magnetic resonance imaging abnormal, Otitis media, Pathology test, Posture abnormal, Surgery, Upper respiratory tract infection, Urine output decreased, Ventricular drainage, Vomiting
SMQs:, Acute renal failure (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Dystonia (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Dehydration (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-12-15
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: Subject was born with small pedunculated skin lesion on the left side of the midline at about the T3-T4 region.
Allergies:
Diagnostic Lab Data: Fibroblastic, myofibrotic, myoblastic lesions with mitotic figures: pathology results did not provide a diagnosis. 07 December 2009: Laboratory data included Na=134, K=4.4, CO2=18, CL=101, BUN=7, CR=0.3, RBS=77 (units unspecified). A CT scan showed enlarged ventricles that had increased in size from her initial post-operative scan. An enlarged posterior fossa fluid collection was noted, with no evidence of transependymal edema. Low blood pressure on admission (NBP=94/61).
CDC Split Type: 201002827

Write-up: Initial report received on 18 May 2010 from an investigator under the reference number M5A11. A 10-month-old female subject with a history of cerebellar atypical teratoid rhabdoid tumor (ATRT) died due to disease progression 153 days after receiving a third injection of PENTACEL (lot number C3181AA). The subject also received the following vaccines on the same date: a second dose of PREVNAR(lot number D46873), and a second dose of rotavirus vaccine (lot number 1695X). The subject was born with a small pedunculated skin lesion on the left side of the midline at about T3-T4 region. It was initially the size of a pea, which gradually grew over the next 4-5 months, becoming a pedunculated, multilobulated, cornified, epithelialized lump dangling on the peduncle against the back. She also developed other lesions which were biopsied and described as fibroblastic, myofibrotic, myoblastic lesions with mitotic figures. However, pathology results did not lead to a diagnosis. She behaved normally during this time with the exception of a slight head tilt. An MRI of the neck subsequently indicated that the lesions were related to deeper structures, specifically a large anterior fossa mass, and that the child had significant hydrocephalus. The subject was diagnosed with ATRT on an unspecified date. She underwent a resection with external ventricular drain placed on 30 September 2009. The drain was removed on 07 October 2009. Due to her extremely poor prognosis, the family decided against chemotherapy at that time. She was at home doing well until 05 December 2009, when she developed upper respiratory infection (URI) symptoms and vomiting. She was seen by her primary care physician, diagnosed with otitis media, and treated with amoxicillin. The following date she presented to the emergency department with persistence distress, emesis, and a lack of wet diapers. She was diagnosed with dehydration. Laboratory date included Na=134, K=4.4, CO2=18, CL=101, BCN=7, CR=0.3, RBS=77 (all units unspecified). A CT scan showed enlarged ventricles that had increased in size from her initial post-operative scan. An enlarged posterior fossa fluid collection was noted, with no evidence of transependymal edema. Due to these findings, as well as the dehydration, she was admitted to the hospital on 07 December 2009 for rehydration and possible neurosurgical treatment of hydrocephalus. She had low blood pressure on admission (NBP-94/61), which improved following administration of intravenous fluids (Bolus with normal saline 10 ml/kg, D5NS at 40 ml/hr). In addition, ZOFRAN was prescribed for nausea and vomiting. Diagnostic imaging showed that symptoms had progressed significantly, and the family decided on palliative care only. On 09 December 2009 her code status was changed to "DNR" (do not resuscitate, and she was started on morphine and a transdermal fentanyl patch for pain control. The subject was discharged to home hospice on 14 December 2009, and she expired the following day, on 15 December 2009. No autopsy was performed. According to the investigator, the event was not related to the study vaccine. Documents held by sender: discharge summary, medication records, physician consult.


VAERS ID: 427555 (history)  
Form: Version 1.0  
Age: 44.0  
Sex: Female  
Location: Minnesota  
Vaccinated:0000-00-00
Onset:2008-12-01
Submitted: 2011-07-13
   Days after onset:953
Entered: 2011-07-18
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Areflexia, Axonal neuropathy, Babinski reflex test, Bilevel positive airway pressure, Biopsy lung abnormal, CSF glucose normal, CSF lymphocyte count normal, CSF myelin basic protein increased, CSF protein normal, CSF white blood cell count, Cerebral small vessel ischaemic disease, Condition aggravated, Constipation, Cough, Culture stool positive, Death, Diarrhoea, Dyskinesia, Dyspnoea, Endotracheal intubation, Enterovirus infection, Enterovirus test positive, Fall, Feeling of body temperature change, Hepatic function abnormal, Inspiratory capacity decreased, Interstitial lung disease, Joint sprain, Lower motor neurone lesion, Lung infiltration, Malaise, Muscle spasms, Muscular weakness, Neurological symptom, Neutrophil count increased, Nuclear magnetic resonance imaging spinal cord abnormal, Pain in extremity, Paraesthesia, Paralysis, Paralysis flaccid, Pneumonia, Poliovirus test positive, Pyrexia, Quadriplegia, Reflexes abnormal, Respiratory failure, Rhinitis, Spinal cord disorder, Viral infection, Viral test positive, White blood cell count increased, Withdrawal of life support
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (narrow), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (narrow), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (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 (broad), Hypoglycaemic and neurogenic shock conditions (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Dyskinesia (narrow), Dystonia (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Tendinopathies and ligament disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (narrow), Hypokalaemia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Antibiotics; Prednisone; Immune Globulin
Current Illness:
Preexisting Conditions: The patient had a history of long-standing common variable immunodeficiency, chronic sinusitis, frequent episodes of otitis media, chronic lymphoid interstitial pneumonitis, liver cirrhosis with esophageal varices of grade 1 and 2, spruelike enteropathy, chronic diarrhea and she had a splenectomy in 2006.
Allergies:
Diagnostic Lab Data: MRI of the Spinal cord on hospital day 2 revealed the signal was increased on T(2)-weighted images from the lumbar spine to the seventh thoracic vertebra; on day six focal hyperintensity was seen on T(2)-weighted images in the anterior horns bilaterally, extending from the third through seventh cervical vertebra with mild enlargement of the spinal cord. Cerebrospinal fluid white-cell count was 6 x10(-3)/mm(3) and myelin basic protein on hospital day 1-30 was 17 ng/ml and on days 61-91 was 5.24. Blood white-cell count on hospital days 1-30 was 17.8 x10(-3)/mm(3); on hospital days 31-60 was 22.3 x10(-3)/mm(3); and on hospital days 61-91 was 25.5 x10(-3)/mm(3). Neutrophils on hospital days 1-30 were 17.1 x10(-3)/mm(3); on hospital days 31-60 was 18.7 x10(-3)/mm(3); and on hospital days 61-91 was 23.7 x10(-3)/mm(3).
CDC Split Type: 201104104

Write-up: Initial case was retrieved from scientific literature on 04 July 2011. A 44 year-old female with a history of common variable immunodeficiency and was receiving intravenous immune globulin. The patient experienced sudden paralysis of all four limbs and respiratory muscles, resulting in death. The patient was found, to have Type 2 vaccine-derived poliovirus in her stool. According to the report, the patient was probably infected 11.9 years prior when her child had received the oral poliovirus vaccine. Verbatim from the report: "In March 2009, the Department of Health investigated a case of acute flaccid paralysis associated with a positive stool culture for enterovirus. Case report: In December 2008, cough, purulent rhinorrhea, mild dyspnea, malaise, and a "low-grade fever" developed in a 44-year-old woman with long-standing common variable immunodeficiency; the symptoms, which she assumed were an exacerbation of her chronic sinusitis, resolved after 4 days. Two days later, cramping developed in her left calf and progressed over a period of 5 days to leg weakness, which was associated with a fall and ankle sprain, and the patient was hospitalized. On examination, she was afebrile and her cranial nerves were normal, without meningismus. Upper-extremity muscle strength was normal, and reflexes were "quite brisk". Measurements of lower-extremity muscle strength on the right and left sides, respectively, were as follows: iliopsoas, 3/5 and 1/5; quadriceps, 3/5 and 1/5; dorsiflexors, 2/5 and 1/5; and plantar flexors, 4/5 and 3/5. A trace right-ankle jerk was noted, but all other lower-extremity stretch reflexes were absent. The plantar (Babinski) reflex was downward bilaterally. Sensory responses to a light touch, temperature changes, and pinprick were intact, with severe pain noted in both legs. Common variable immunodeficiency was diagnosed in 1991, with subsequent diagnoses of chronic lymphoid interstitial pneumonia (on lung biopsy), liver cirrhosis with esophageal varices of grade 1 to 2, and spruelike enteropathy (on intestinal biopsy) with chronic diarrhea (which had worsened during the 2 months before the patient''s hospitalization in 2008). She had undergone splenectomy in 2006 owing to portal hypertension. B cells were absent on flow cytometry, expression of Bruton''s tyrosine kinase was normal, and she was heterozygous for an R202H mutation in the transmembrane activator and calcium-modulator and cyclophilin-ligand-interactor (TACI) protein. Frequent episodes of otitis media and sinusitis were treated with antibiotics. She was being treated with prednisone, 20 mg daily, and two different brands of intravenous immune globulin every 3 weeks, with multiple changes in the dose, before the onset of her neurologic symptoms. The only travel of possible relevance was with her family 2 months earlier. By hospital day 2, the weakness had progressed to involve both upper extremities. The patient became constipated and remained afebrile. The cerebrospinal fluid contained 6 white cells per cubic millimeter (51% lymphocytes) and glucose and protein levels were normal. Initial magnetic resonance imaging showed increased T2-weighted signal in the spinal-column parenchyma from T7 to the conus medullaris, without contrast enhancement. When imaging was repeated on hospital day 6, new areas of hyperintensity were noted in C3 through C7, findings that were consistent with anterior horn-cell disease. The patient''s upper-extremity muscle weakness progressed (biceps strength, 3/5 on the right side and 2/5 on the left), and she continued to have severe muscular limb pain. Electromyography and nerve-conduction testing on hospital day 8 were consistent with acute motor axonal neuropathy or motor neuronopathy (anterior horn-cell disease). On hospital days 8 through 38, negative inspiratory force was reduced, and pulmonary infiltrates required noninvasive, bilevel positive airway pressure and intermittent endotracheal intubation. On hospital days 61 through 73, liver dysfunction worsened and pneumonia and respiratory failure ensued. These problems continued, and given the multiple coexisting illnesses and persistent neurologic deficits, the family chose to withdraw support on hospital day 92, and the patient died. No autopsy was performed. Although the initial viral cultures were negative, a stool sample obtained on hospital day 74 was found to contain enterovirus and was sent to the Department of Health for assessment of speciation. Investigators of reportable diseases, including polio, under state statute are classified as public health response, nonresearch by the Department of Health Institutional Review Board." The patient reportedly had received all recommended childhood vaccinations. The patient''s child had received the primary series of oral poliovirus vaccine at 13.0, 12.8 and 12.6 years before the patient''s isolate was collected. The patient had the first nonimported case of paralytic poliomyelitis and the second case of VDPV infection reported since the "discontinuation in 2000 of oral poliovirus vaccinations". The patient''s history of receiving intravenous administration of immune globulin did not "prevent the acquisition of infection, stop the long-term poliovirus infection or prevent the development of paralytic poliomyelitis." Diagnostic and Laboratory findings included: MRI of the Spinal cord on hospital day 2 revealed the signal was increased on T(2)-weighted images from the lumbar spine to the seventh thoracic vertebra; on day six focal focal hyperintensity was seen on T(2)-weighted images in the anterior horns bilaterally, extending from the third through seventh cervical vertebra with mild enlargement of the spinal cord. Cerebrospinal fluid white-cell count was 6 x10(-3)/mm(3) and myelin basic protein on hospital day 1-30 was 17 ng/ml and on days 61-91 was 5.24. Blood white-cell count on hospital days 1-30 was 17.8 x10(-3)/mm(3); on hospital days 31-60 was 22.3 x10(-3)/mm(3); and on hospital days 61-91 was 25.5 x10(-3)/mm(3). Neutrophils on hospital days 1-30 were 17.1 x10(-3)/mm(3); on hospital days 31-60 was 18.7 x10(-3)/mm(3); and on hospital days 61-91 was 23.7 x10(-3)/mm(3). Documents held by sender: journal article.


VAERS ID: 427564 (history)  
Form: Version 1.0  
Age: 0.37  
Sex: Male  
Location: Idaho  
Vaccinated:2011-05-31
Onset:0000-00-00
Submitted: 2011-06-22
Entered: 2011-07-18
   Days after submission:26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3741AA / 2 LL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 915375 / 2 RL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1135Z / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-06-21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None stated.


VAERS ID: 427623 (history)  
Form: Version 1.0  
Age: 0.36  
Sex: Female  
Location: Missouri  
Vaccinated:2011-06-07
Onset:2011-06-07
   Days after vaccination:0
Submitted: 2011-07-18
   Days after onset:41
Entered: 2011-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C384099 / 3 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH C97564 / 3 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1657Z / 2 MO / PO

Administered by: Private       Purchased by: Other
Symptoms: Autopsy, Death, 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: 2011-06-12
   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: I have no idea the manufacturer of the vaccinations.
Current Illness: None
Preexisting Conditions: Lop ear/cup ear. Just cosmetic nothing serious.
Allergies:
Diagnostic Lab Data: Autopsy revealed Re-breathing/SIDS
CDC Split Type:

Write-up: Nothing major just fussy, no temperature. She ate somewhat normal, was a little fussy at the breast at times. Didn''t want to be put down.


VAERS ID: 427909 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Male  
Location: Delaware  
Vaccinated:2004-11-04
Onset:2004-11-05
   Days after vaccination:1
Submitted: 2011-07-10
   Days after onset:2437
Entered: 2011-07-22
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER U1516AA / UNK RA / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0513P / UNK LA / UN

Administered by: Private       Purchased by: Military
Symptoms: Coma, Dyspnoea, Myocardial infarction, Renal impairment, Speech disorder, Sudden death, Thirst
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-08-03
   Days after onset: 270
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: In records
Current Illness: None
Preexisting Conditions: Diabetes
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Coma, Sudden death. Shortness of breath, thirsty, strange conversation, heart attack. Thereafter his medical records have all information. Kidneys were at 13%. That''s why public health said to request this form to see what went on. This adversity was never reported.


VAERS ID: 428369 (history)  
Form: Version 1.0  
Age: 0.23  
Sex: Male  
Location: Tennessee  
Vaccinated:2011-07-25
Onset:2011-07-26
   Days after vaccination:1
Submitted: 2011-07-28
   Days after onset:2
Entered: 2011-07-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3852AA / 1 LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1519Z / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 916007 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1199Z / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-07-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Mom awoke in am to find baby unresponsive. EMS initiated CPR. No response & pronounced in ED. Associated risk factors: bed-sharing, maternal smoking. Autopsy pending.


VAERS ID: 428370 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Georgia  
Vaccinated:2011-06-13
Onset:2011-06-20
   Days after vaccination:7
Submitted: 2011-07-29
   Days after onset:39
Entered: 2011-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB509AA / 2 LL / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1643Z / 2 RA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-06-21
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever & fussy 6/20/11. Fever 6/21/11. Found unresponsive after taking a nap.


VAERS ID: 428488 (history)  
Form: Version 1.0  
Age: 0.16  
Sex: Male  
Location: Minnesota  
Vaccinated:2011-07-25
Onset:2011-07-29
   Days after vaccination:4
Submitted: 2011-08-01
   Days after onset:3
Entered: 2011-08-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3755AA / 1 LL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB972DA / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F13779 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0259AA / 1 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Computerised tomogram abnormal, Death, Electroencephalogram abnormal, Hypoxic-ischaemic encephalopathy, Pallor, Resuscitation, Unresponsive to stimuli, Withdrawal of life support
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-07-31
   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: No
Preexisting Conditions: No - Colicky
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Put down for nap and found by mother 1 hr later - face down. Pale, cold & non-responsive. CPR initiated. 911. Perfusing rhythm re-established in ED at 11:18. Never required any function. EEG - no electrical activity x 2. CT scan - compatible with hypoxic injury. Removed from life support on 7/31/11 at 14:40.


VAERS ID: 428554 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: New Hampshire  
Vaccinated:2011-03-24
Onset:0000-00-00
Submitted: 2011-08-01
Entered: 2011-08-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 04827 / 1 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-03-26
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: NH08011110

Write-up: None stated.


VAERS ID: 429007 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-08-05
Entered: 2011-08-08
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1108USA00348

Write-up: Information has been received from a consumer concerning her daughter who was vaccinated with GARDASIL. The consumer reported that he had nothing to live for because GARDASIL killed his daughter. It was unknown if the patient sought medical attention. No further information is available.


VAERS ID: 429045 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Female  
Location: Guam  
Vaccinated:2011-07-18
Onset:0000-00-00
Submitted: 2011-07-28
Entered: 2011-08-08
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1699Z / 1 LA / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-07-20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Fluoride varnish of teeth done. (DURAFLOR Lt # 32209)
Current Illness: None
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: See autopsy report.


VAERS ID: 429366 (history)  
Form: Version 1.0  
Age: 0.26  
Sex: Male  
Location: Idaho  
Vaccinated:2007-03-05
Onset:2007-03-05
   Days after vaccination:0
Submitted: 2011-08-10
   Days after onset:1618
Entered: 2011-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B070AA / 1 RL / -
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1015F / 1 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08681B / 1 LL / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Crying, Death, Diet refusal, Dyspnoea, Emotional distress, Hyperaesthesia, Immediate post-injection reaction, Middle insomnia, Oedema peripheral, Pain, Self injurious behaviour
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Suicide/self-injury (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-04-10
   Days after onset: 401
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
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''s legs immediately began to swell, much larger than I had seen swell in his older sister. The nurse advised me to administer ibuprofen when we got home. From the time of vaccination, patient screamed a very high pitched scream from 2:00 PM 3/5/07 until midnight -- 10 hours straight. He flinched at the slightest touch and pain was evident. I called my doctor''s office at approximately 3:30, and the nurse told me to administer more ibuprofen and rub the sites where he received vaccination. I did not administer more ibuprofen as I was uncomfortable with giving him another dose, but I did rub his legs -- which proved to be completely excruciating for him to endure. I called my doctor''s office again at 5:00, but the office was closed so I called a "Call A Nurse" from the hospital. She suggested a myriad of ridiculous suggestions from teething to gas. I tried to nurse him several times but he would not nurse and his screams of pain would turn into gasps for air if I touched him. At one point, I laid him on the floor and leaned over the top of him to try and nurse him. He suckled for under a minute and continued crying. He did not sleep or eat for 10 hours. At approximately midnight it seemed like he began to have trouble breathing. Strangely enough, it seemed that this calmed him down, and within a minute his breathing became regular and he fell asleep. I called the "Ask A Nurse" again and talked to a gentleman that said I let him sleep if he''s sleeping and bring him in to the doctor again the following day. Patient slept for 15-30 minutes at a time during the night, waking up often screaming a scream I had never heard from him before. In the morning, I called the doctor''s office and talked to the nurse. I told her what had happened since I talk to her last and she said "That sort of reaction happens often. It might be the Pertussis part of the vaccine because it often gives people trouble. We''ll give him his next round of shots in a couple months, and if this reaction happens again we''ll consider taking out the Pertussis." Patient was not the same baby he was previously to 3/5/07. He cried often and was inconsolable. He always seemed like he was in pain. I discussed my concerns with my doctor and his nurse, and they both assured me it was a normal reaction and that he was not injured or hurt long term. They both urged me to continue vaccinating him. Patient''s behavior for the next 14 months was... odd. He was always "touchy" and cried often as if he was always in pain. I found him many times standing in one spot, hitting his head with his hand. When he was about 14 months, I found him hitting his head with his hand saying "ow ow ow" with every touch to his head. My little boy would have been a different person had he not received those vaccinations. He passed away on 4/10/2008, unrelated to vaccinations.


VAERS ID: 429528 (history)  
Form: Version 1.0  
Age: 1.25  
Sex: Female  
Location: Georgia  
Vaccinated:2011-07-27
Onset:2011-08-06
   Days after vaccination:10
Submitted: 2011-08-11
   Days after onset:5
Entered: 2011-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1643Z / 1 LL / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1705Z / 1 LL / SC

Administered by: Private       Purchased by: Private
Symptoms: Acidosis, Autopsy, Blood gases abnormal, Death, Laboratory test, Pyrexia, Respiratory arrest, Resuscitation
SMQs:, Anaphylactic reaction (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-08-08
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Ex-27wk preemie. RSV requiring hospitalization - 11/10.
Allergies:
Diagnostic Lab Data: ABG at ER showed acidosis. No other testing done at ER due to rapidity of clinical decline. Autopsy inconclusive. Further testing of tissue samples being done by state lab. Results pending.
CDC Split Type:

Write-up: Onset of fever on 8-6-11 up to 102 degrees. Playful when afebrile. Seen in doctor''s office on 8/8. Presented later to ER where resp. arrest occurred during evaluation. CPR and defibrillation with aggressive IV inotropes unsuccessful. (intermittent fever present 8/6-8/8).


VAERS ID: 430811 (history)  
Form: Version 1.0  
Age: 0.63  
Sex: Male  
Location: New York  
Vaccinated:2011-08-16
Onset:2011-08-16
   Days after vaccination:0
Submitted: 2011-08-19
   Days after onset:3
Entered: 2011-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3753AA / 3 RL / ID
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH E23421 / 3 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1199Z / 3 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-08-16
   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:
Current Illness: No
Preexisting Conditions: GERD
Allergies:
Diagnostic Lab Data: Autopsy all organs normal except heart which was not seen by Medical Examiner because it was harvested for valve donation
CDC Split Type:

Write-up: Sudden infant death. Patient received vaccine in the morning. Found dead at around 9pm after he was put in bed at 7pm.


VAERS ID: 430641 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: New Hampshire  
Vaccinated:2010-09-16
Onset:2010-12-02
   Days after vaccination:77
Submitted: 0000-00-00
Entered: 2011-08-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS ENGE10DI14 / 1 LG / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-12-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NH08221113

Write-up: SIDS baby.


VAERS ID: 430780 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: California  
Vaccinated:2011-03-28
Onset:2011-04-11
   Days after vaccination:14
Submitted: 2011-08-23
   Days after onset:134
Entered: 2011-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3741AA / 1 LA / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0565Z / 3 LA / UN

Administered by: Public       Purchased by: Public
Symptoms: Arrhythmia, Autopsy, Blood culture positive, Body fluid analysis, Cardiac failure, Cardiomyopathy, Death, Drug screen negative, Microscopy, Streptococcus test positive, Sudden cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (narrow), Cardiac arrhythmia terms, nonspecific (narrow), Infective pneumonia (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-04-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Mildly overweight; concern for idiopathic scoliosis
Allergies:
Diagnostic Lab Data: Autopsy, including microscopy slides. Heart blood culture showed alpha streptococcus (not Strep. pneumoniae, not enterococcus sp., not Strep. bovis). Femoral blood and vitreous humor samples showed no drugs on complete drug screen. Vitreous panel (Glucose - 32 mg/dL, Sodium - 137 mmol/L, Potassium - 15.2 mmol/L, Chloride - 124 mmol/L, Urea Nitrogen 13 mg/dL and Creatinine - 1.3 mg/dL)
CDC Split Type:

Write-up: Found dead in bed in a.m. by family. Pathologist stated cause of death as consistent with cardiac insufficiency, due to cardiac arrhythmia, due to probable early cardiomyopathy. Child Death Review Team felt this death was consistent with a diagnosis of sudden cardiac death.


VAERS ID: 432081 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-08-26
Entered: 2011-08-30
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011029608

Write-up: This literature report with sparse information (initial receipt: 19-Aug-2011) concerns a male patient who died from Guillain-Barre syndrome after receiving influenza vaccination. Of note, the patient''s daughter experienced a serious adverse event after receiving influenza vaccine (WAVES 2011029570).


VAERS ID: 432209 (history)  
Form: Version 1.0  
Age: 48.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2011-08-25
Onset:0000-00-00
Submitted: 2011-08-30
Entered: 2011-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0103AA / 2 LA / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-08-27
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: NKA
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt. wife reports pt. died.


VAERS ID: 432347 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-08-30
Entered: 2011-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB162AA / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A0942729A

Write-up: This case was reported by a lawyer and described the occurrence of death nos in a male subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received 2nd dose of TWINRIX (details unknown). At an unspecified time after vaccination with TWINRIX, the subject experienced death nos. The subject died due to unknown cause. It was unknown whether an autopsy was performed.


VAERS ID: 432455 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: Maryland  
Vaccinated:2011-08-11
Onset:2011-08-22
   Days after vaccination:11
Submitted: 2011-08-26
   Days after onset:4
Entered: 2011-08-30
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3853AA / UNK LA / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH E63642 / UNK LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Endotracheal intubation, Muscle rigidity, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant 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), Parkinson-like events (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2011-11-09
   Days after onset: 79
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 17 days
   Extended hospital stay? No
Previous Vaccinations: Death/respiratory failure~Vaccine not specified (no brand name)~UN~0.00~Patient
Other Medications: None
Current Illness:
Preexisting Conditions: Ex-36 weeks s/p NICU stay x 2 wks for feeding intolerance.
Allergies:
Diagnostic Lab Data: See attached lab reports
CDC Split Type:

Write-up: Respiratory failure requiring intubation with high flow oscillator due to severe muscle rigidity.


VAERS ID: 432687 (history)  
Form: Version 1.0  
Age: 0.36  
Sex: Male  
Location: California  
Vaccinated:2011-07-25
Onset:0000-00-00
Submitted: 2011-09-01
Entered: 2011-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3931AA / UNK - / -
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0491AA / 2 - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 916598 / UNK - / -

Administered by: Unknown       Purchased by: Other
Symptoms: Pyrexia, Retinal haemorrhage, Subdural haematoma, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Retinal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-08-12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: baby Tylenol, baby Orajel
Current Illness: Cold
Preexisting Conditions: Zithromax
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: fever, vomiting, subdural hematoma, retinal hemorrhage


VAERS ID: 432984 (history)  
Form: Version 1.0  
Age: 63.0  
Sex: Male  
Location: Missouri  
Vaccinated:2011-08-23
Onset:2011-09-01
   Days after vaccination:9
Submitted: 2011-09-03
   Days after onset:2
Entered: 2011-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVC004AA / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-09-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: NO
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: EMPLOYEE RECEIVED HEP B ON 8/23/2011. DONOR PASSED ON 9/1/2011. UNKNOWN IF SHOT ASSOCIATED WITH DEATH.


VAERS ID: 433101 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Oregon  
Vaccinated:1993-10-08
Onset:1993-10-27
   Days after vaccination:19
Submitted: 2011-08-30
   Days after onset:6516
Entered: 2011-09-06
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

Administered by: Private       Purchased by: Other
Symptoms: Death, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1993-10-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Fever~DTP + IPV (no brand name)~1~0.00~Sibling
Other Medications: None
Current Illness:
Preexisting Conditions: Induced early; low birth weight
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Swelling at site.


VAERS ID: 433733 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Pennsylvania  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-09-02
Entered: 2011-09-08
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient worked out and had been fit.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201108152

Write-up: Initial report was received 31 August 2011 from a consumer who was a co-worker of the patient. A female patient (age and date of birth not reported), who was fit and worked out, had received an injection of swine INFLUENZA VACCINE during the 1970s and right before Christmas, she became ill. The patient died two years later. According to the reporter, at first they thought it was GBS (Guillain-Barre Syndrome), but it was found to be "something else" (unknown by the reporter). Per the reporter, she had no additional information to provide regarding this event. The reporter further stated that the business where they worked had been bought and sold several times and had since gone out of business; therefore, there is no one to contact for follow-up. The reporter for this case is the same as for case numbers 2011-08149 and 2011-08150.


VAERS ID: 434287 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Male  
Location: California  
Vaccinated:2009-12-17
Onset:2009-12-25
   Days after vaccination:8
Submitted: 2011-09-13
   Days after onset:626
Entered: 2011-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UP015AA / 1 UN / UN

Administered by: Public       Purchased by: Public
Symptoms: Brain neoplasm, Death, Diplopia, Dysphagia, Fall, Fatigue, Feeling abnormal, Headache, Incontinence, Nuclear magnetic resonance imaging brain abnormal
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Ocular motility disorders (broad), Hypoglycaemia (broad), Non-haematological tumours of unspecified malignancy (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2010-02-14
   Days after onset: 51
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: Terazosin HCL 1 mg; Cyclobenzaprine HCl 10 mg
Current Illness: None
Preexisting Conditions: Diverticulitis-occasional flare ups
Allergies:
Diagnostic Lab Data: MRI
CDC Split Type:

Write-up: Shortly after the vaccine, he started feeling tired, out of sorts, disconnected. In January 2010, he started having headaches, seeing double, difficulty swallowing, eventually lost continence. Would fall and be unable to get up. MRI on 1-29-10 dx 2cm tumor in ponds. Admitted to hospital. Died 2-14-10.


VAERS ID: 434581 (history)  
Form: Version 1.0  
Age: 59.0  
Sex: Female  
Location: California  
Vaccinated:2010-09-29
Onset:2010-10-01
   Days after vaccination:2
Submitted: 2011-09-16
   Days after onset:350
Entered: 2011-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U3082CA / UNK RA / UN

Administered by: Private       Purchased by: Other
Symptoms: Amyotrophic lateral sclerosis, Death, Electromyogram abnormal, Muscle contractions involuntary
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Dystonia (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LAMICTAL; Estradiol; Prometrium, IMITREX
Current Illness: Partial complex SZ
Preexisting Conditions: Partial complex SZ
Allergies:
Diagnostic Lab Data: Abnormal EMG; Exam
CDC Split Type:

Write-up: ADACEL vaccine administered 7/29/10 Occ Health. Fasiculations developed 2 weeks later. Diagnosed with ALS 11/10. Expired Sept 2011.


VAERS ID: 435007 (history)  
Form: Version 1.0  
Age: 0.76  
Sex: Male  
Location: California  
Vaccinated:2011-08-02
Onset:2011-08-07
   Days after vaccination:5
Submitted: 2011-09-20
   Days after onset:44
Entered: 2011-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH E23421 / 2 RL / IM

Administered by: Unknown       Purchased by: Other
Symptoms: Brain oedema, Computerised tomogram abnormal, Computerised tomogram head, Death, Hypotonia, Multi-organ failure, Pallor, Posturing
SMQs:, Peripheral neuropathy (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dystonia (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-08-08
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: His body was limp and pale rush to Hospital where his body was posturing and Cat scan showed swelling of the brain. Organs started to shut down and he died the next day.


VAERS ID: 435682 (history)  
Form: Version 1.0  
Age: 0.02  
Sex: Male  
Location: New Hampshire  
Vaccinated:2011-05-16
Onset:2011-05-28
   Days after vaccination:12
Submitted: 2011-09-12
   Days after onset:107
Entered: 2011-09-22
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 8482Z / 1 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-05-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 08121114

Write-up: Death.


VAERS ID: 435354 (history)  
Form: Version 1.0  
Age: 54.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2011-08-31
Onset:2011-09-07
   Days after vaccination:7
Submitted: 2011-09-23
   Days after onset:16
Entered: 2011-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1100201 / 1 RA / IM

Administered by: Other       Purchased by: Private
Symptoms: Autopsy, Death, Livedo reticularis, Peripheral coldness, Pulse absent, Respiratory arrest, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-09-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: no c/o illness by patient
Preexisting Conditions: Hypertension Type 1 diabetes
Allergies:
Diagnostic Lab Data: I dont have results of postmortum as of today. Still pending.
CDC Split Type:

Write-up: At 12:30 PM patient laid down for a nap he offered no co at that time, at 2 PM I (wife) found patient unresponsive no pulse no respiratory effort. His skin was cold and moteled I dailed 911 and began chest compressions as instructed by 911 operator. I never got a pulse first responders and also worked on patient and transfered him to hospital he was pronounced dead at 2:08 pm on 09/07/2011.


VAERS ID: 435707 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Male  
Location: Washington  
Vaccinated:2011-09-22
Onset:2011-09-25
   Days after vaccination:3
Submitted: 2011-09-26
   Days after onset:1
Entered: 2011-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 501096P / 3 NS / IN

Administered by: Military       Purchased by: Military
Symptoms: Chest pain, Death, Malaise, Resuscitation, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-09-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None noted
Allergies:
Diagnostic Lab Data: Autopsy has been ordered
CDC Split Type:

Write-up: Member was given the Flumist on 09/22/2011. On 09/25/2011, member was feeling chest pain and not feeling well after dinner and going to the Club. Mamber was found down face in vomit by his friends. CPR was started and 911 activated. Paramedics arrived and continued CPR en route to Hospital where CPR was continued unsuccesfully. Member was pronounced dead at 0215 by Dr.


VAERS ID: 435760 (history)  
Form: Version 1.0  
Age: 0.35  
Sex: Male  
Location: Nebraska  
Vaccinated:2011-08-30
Onset:2011-09-09
   Days after vaccination:10
Submitted: 2011-09-26
   Days after onset:17
Entered: 2011-09-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3841AA / 2 LL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E79665 / 2 LL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0776AA / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Rotavirus infection, Rotavirus test positive, Sudden death, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2011-09-14
   Days after onset: 5
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: Unknown
Allergies:
Diagnostic Lab Data: autopsy, positive for rotavirus
CDC Split Type: WAES1109USA01863

Write-up: Information has been received from a physician concerning a 19 week old male patient who on 30-AUG-2011 was vaccinated with his second dose of ROTATEQ (dose two lot # 669764/0776AA) (date of dose #1 unavailable) and died suddenly two weeks later. No problems were reported to the office after administration, child was not symptomatic. On 09-SEP-2011, the child was discovered "unresponsive, at daycare". The child was life-flighted to hospital. On 14-SEP-2011, the child died. Autopsy revealed child was positive for rotavirus. Death certificate stated "positive for rotavirus". "Unresponsive, at daycare" and "positive for rotavirus" and "died suddenly" were considered to be immediately life-threatening. Follow-up information has been received from the physician concerning the patient received concomitantly on 30-AUG-2011 the following vaccinations: PENTACEL and PREVNAR 13. The physician also stated that he had not spoken with the patient''s parents. The patient had been taken from day care to the hospital. He indicated he would send any additional information that he receives concerning the patient. A lot check has been initiated. Additional information has been requested.


VAERS ID: 435871 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2011-08-19
Submitted: 2011-09-23
   Days after onset:35
Entered: 2011-09-27
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABAVERT) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Death, Expired drug administered, Incorrect drug administration duration, Rabies
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-08-31
   Days after onset: 12
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHEH2011US04709

Write-up: Case number PHEH2011US04709 is an initial spontaneous report received from a health care professional on 16 Sep 2011. This report refers to a 24-year-old male patient. He was a soldier and he was bitten by a stray dog on his hand while breaking up a dog fight and had a likely canine exposure three months prior to redeployment on an unspecified date. It was reported that the doctor who treated him stated that he would have given exposed soldier expired rabies vaccine shots (manufacturer and batch number: unknown) on an undetermined date. It was also noted that he received incomplete post exposure schedule of vaccine. Three months after redeployment symptoms began making the overall incubation period of nearly six months. He was admitted for suspected rabies on 19 Aug 2011 and it was confirmed on 21 Aug 2011. Typing was consistent with foreign canine rabies. He expired on 31 Aug 2011.


VAERS ID: 436253 (history)  
Form: Version 1.0  
Age: 5.0  
Sex: Female  
Location: Maryland  
Vaccinated:2011-08-26
Onset:2011-08-26
   Days after vaccination:0
Submitted: 2011-09-29
   Days after onset:34
Entered: 2011-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C3944AA / 5 LL / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH476AC / 1 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR G1083 / 4 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1644Z / 2 LL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1046AA / 2 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-08-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was found dead in bathroom after no obvious reaction.


VAERS ID: 436542 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-09-30
Entered: 2011-10-03
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Neurologic disorder; Pulmonary disease; Chromosomal abnormality or genetic disorder; Congenital heart disease; Cardiac disease; Immunosuppressive condition; Obesity; Endocrine disorder; Mitochondrial disorder; Renal disease; Pregnant.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Group A streptococcus, positive; Staphylococcus aureus, positive; Streptococcus pneumoniae, positive
CDC Split Type: 2011029810

Write-up: This literature report (initial receipt 19-Sep-2011) concerns 17 children. This literature report summarises 115 cases of influenza-associated pediatric mortality reported to CDC (Centre for Disease Control and Prevention) that occurred from 01-Sep-2010 to 31-Aug-2011. A case was defined as a death from a clinically compatible illness confirmed to be influenza by a diagnostic test in a resident aged < 18 years, with no period of complete recovery between illness and death. Confirmatory influenza testing methods include commercial rapid diagnostic tests, viral culture, fluorescent antibody, enzyme immunoassay, reverse transcription-polymerase chain reaction and immunohistochemistry. Information about influenza vaccination was available for 74 children aged 6 months or greater; 17 received influenza vaccine in the appropriate number of doses at least 14 days before illness onset. Of 39 vaccine-eligible children with agency-defined high-risk medical conditions who had vaccination data available, 12 had been vaccinated according to 2010 agency recommendations. Among children who dies from influenza described in the report, 23% were vaccinated. 49% of the children who died had no known agency-defined high-risk medical conditions, 57 children were reported with medical conditions recognised by agency that placed them at increased risk for influenza-related complications and the medical history of two children was unknown. Of the 57 children with at least one agency-defined high-risk condition, 31 had a neurologic disorder, 17 had pulmonary disease, 14 had a chromosomal abnormality or genetic disorder, 11 had congenital heart disease or other cardiac disease, and 11 had asthma or reactive airway disease. Obesity was reported in two of the 57 children. Other types of agency-defined high risk conditions that were reported for children who died from influenza associated illness include immunosuppressive disorder (9 children), endocrine disorder (5 children), mitochondrial disorder (3 children), renal disease (2 children) and pregnancy (1 child). Of the 115 influenza-associated pediatric deaths reported, 72 occurred in males. The median age of patients was 6 years, and 53 cases were in children aged < 5 years. 71 of these cases were associated with influenza A virus infection; 30 cases were 2009 influenza A (H1N1), 21 cases were influenza A (H3N2) and 20 cases were influenza A viruses for which the subtype was not determined. The remaining 44 cases were associated with influenza B virus infections. Of 64 children who had specimens collected for bacterial culture from normally sterile sites (including 58 blood cultures), 25 had positive cultures; staphylococcus aureus was detected in nine patients (six with methicillin-resistant S. aureus, two with methicillin-sensitive S. aureus, and one with unknown sensitivity). streptococcus pneumoniae was detected in six patients, and Group A streptococcus was detected in three. The most frequent complications reported were radiographically confirmed pneumonia (62%), shock or sepsis (40%), and acute respiratory distress syndrome (34%). Encephalopathy or encephalitis was reported in 12 children (14%). Other complications included seizures (13%), hemorrhagic pneumonia/pneumonitis (6%), croup (5%), cardiomyopathy/myocarditis (4%) and bronchiolitis (2%). Of the 47 children who received antiviral therapy, three died in the emergency department and 44 died after being admitted to the hospital. All three children who died in the emergency department received oseltamivir. Of the children who died after being admitted to the hospital, 41 received oseltamivir only, two received oseltamivir and zanamivir and one received zanamivir only.


VAERS ID: 436701 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-09-30
Entered: 2011-10-04
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Laboratory test normal, Pulmonary haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (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:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Pathogenesis of the hemorrhage remained undefined. No CNS lesions were identified.
CDC Split Type: 201109242

Write-up: Initial case retrieved from the scientific literature on 22 September 2011. The authors evaluated clinical-pathological features of 37 infants/children whose parents alleged a relationship between vaccination and death or permanent central nervous system (CNS) damage, and sought compensation through the National Vaccine Injury Compensation Program during the years from 1990 through 1999. CNS tissue was available for evaluation by a pediatric neuropathologist in these 37 cases: 23 males (62%) and 14 females (38%) ranging in age from 1 month to 17 years at the time of death or biopsy. Thirty-three of the 37 patients were dead at the time the case was evaluated. Most commonly implicated vaccines were DTP or DTAP (33 cases), followed by MMR and IPV/OPV (25 cases each). The authors concluded that there was no obvious relationship between type of vaccine (or vaccines simultaneously administered) to time of onset of symptoms, nature of symptoms, or the lesions found. No CNS lesions were found in 5 of 37 cases. There were a variety of CNS lesions amongst the 32 remaining cases, but pathogenesis of the majority was apparent and not considered a complication of vaccination. Of the 37 patients described in the article, the vaccines received by eight of these patients were specified. This case captures one patient; and the other seven patients are captured in case numbers 2011-09243, -09245, -09246, -09247, -09248, -09249 and 2011-09250. An unidentified patient (infant/child, age not reported) had received a DTAP vaccine (manufacturer unknown; lot number, route, site and date of administration not reported) and within three days of vaccination, the patient died. Cause of death was pulmonary hemorrhage (onset not reported) although pathogenesis of the hemorrhage remained undefined. No CNS lesions were identified. Documents held by sender: None.


VAERS ID: 436704 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-09-30
Entered: 2011-10-04
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Cardio-respiratory arrest, Convulsion, Death, Hypoxia, Hypoxic-ischaemic encephalopathy, Myelopathy, Nervous system disorder, Pyrexia, Spinal cord ischaemia, Status epilepticus
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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:
Current Illness:
Preexisting Conditions: The patient had a history of recurrent CNS infections by unidentified agents (which were thought to have been viral), was developmentally delayed and microcephalic.
Allergies:
Diagnostic Lab Data: Post mortem examination disclosed acute hypoxic-ischemic encephalomyelopathy.
CDC Split Type: 201109245

Write-up: Initial case retrieved from the scientific literature on 22 September 2011.The authors evaluated clinical-pathological features of 37 infants/children whose parents alleged a relationship between vaccination and death or permanent central nervous system (CNS) damage, and sought compensation through the National vaccine Injury Compensation Program during the years from 1990 through 1999. CNS tissue was available for evaluation by a pediatric neuropathologist in these 37 cases: 23 males (62%) and 14 females (38%) ranging in age from 1 month to 17 years at the time of death or biopsy. Thirty-three of the 37 patients were dead at the time the case was evaluated. Most commonly implicated vaccines were DTP or DTAP (33 cases), followed by MMR and IPV/OPV (25 cases each). The authors concluded that there was no obvious relationship between type of vaccine (or vaccines simultaneously administered) to time of onset of symptoms, nature of symptoms, or the lesions found. No CNS lesions were found in 5 of 37 cases. There were a variety of CNS lesions amongst the 32 remaining cases, but pathogenesis of the majority was apparent and not considered a complication of vaccination. Of the 37 patients described in the article, the vaccines received by eight of these patients were specified. This case captures one patient; and the other seven patients are captured in case numbers 2011-09242, -09243, -09246, -09247, -09248, -09249 and 2011-09250. A three-year-old female patient (who was one of triplets) and who had a history of developmental delay, microcephalic, and recurrent CNS infections by unidentified agents which were thought to have been viral, had received an INFLUENZA VACCINE (manufacturer unknown; lot number, route, site and date of administration not reported) when she was 3 years 9 months old. Two weeks later, she presented with CNS symptoms similar to those she had had unassociated with vaccination in the past, including fever. The day following hospitalization, she had a seizure which proceeded to status epilepticus and cardio-respiratory arrest. Respirator therapy was terminated on the following day. Postmortem examination disclosed acute hypoxic-ischemic encephalomyelopathy, noted to have been secondary to status epilepticus. Documents held by sender: None.


VAERS ID: 436705 (history)  
Form: Version 1.0  
Age: 0.9  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-09-30
Entered: 2011-10-04
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Central nervous system lesion, Cough, Death, Developmental coordination disorder, Encephalitis viral, Hypoxic-ischaemic encephalopathy, Infarction, Mobility decreased, Musculoskeletal stiffness, Pathology test, Posture abnormal, Pyrexia, Quadriparesis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: CNS lesions consisted of subacute non-demyelinizing viral encephalitis, acute infarctions and acute anoxic encephalopathy.
CDC Split Type: 201109248

Write-up: Initial case retrieved from the scientific literature on 22 September 2011. The authors evaluated clinical-pathological features of 37 infants/children whose parents alleged a relationship between vaccination and death or permanent central nervous system (CNS) damage, and sought compensation through the National Vaccine Injury Compensation Program during the years from 1990 through 1999. CNS tissue was available for evaluation by a pediatric neuropathologist in these 37 cases: 23 males (62%) and 14 females (38%) ranging in age from 1 month to 17 years at the time of death or biopsy. Thirty-three of the 37 patients were dead at the time of the case was evaluated. Most commonly implicated vaccines were DTP or DTaP (33 cases), followed by MMR and IPV/OPV (25 cases each). The authors concluded that there was no obvious relationship between type of vaccine (or vaccines simultaneously administered) to time of onset of symptoms, nature of symptoms, or the lesions found. No CNS lesions were found in 5 of 37 cases. There were a variety of CNS lesions amongst the 32 remaining cases, but pathogenesis of the majority was apparent and not considered a complication of vaccination. Of the 37 patients described in the article, the vaccines received by the eight of these patients were specified. This case captures one patient; and the other seven patients are captured in case numbers 2011-09242, -09243, -09245, -09246, -09247, - 09249 and 2011-09250. A 10-month-old male infant had received DTAP, IPV, HIB (Manufacturers unknown) and Hep B (Other manufacturer) lot numbers, routes, sites and dates of administration not reported. Seven to 10 days post vaccination, the patient developed a stiff neck and fever; he could not sit, roll over or hold this head up, and was quadriparetic. He developed fever and had a cough at 14 months of age, and died at 16 months. CNS lesions consisted of subacute non-demyelinizing viral encephalitis, acute infarctions, and acute anoxic encephalopathy. Pathological diagnosis was unknown. The authors further noted that the two anti-viral vaccines he received, Hep B was a non-neurotropic virus and even natural infection does not cause CNS inflammation. IPV is a killed vaccine (SALK) and on the remote chance that some live virus remained, the CNS pathology was quite different from that cause by polio virus. The authors further noted that the two anti-viral vaccines he received, Hep B was a non-neurotropic virus and even natural infection does not cause CNS inflammation. IPV is a killed vaccine (SALK) and on the remote chance that some live virus remained, the CNS pathology was quite different from that cause by polio virus. Documents held by sender: None.


VAERS ID: 436735 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-10-03
Entered: 2011-10-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Acute disseminated encephalomyelitis, Anaesthesia, Brain stem syndrome, C-reactive protein increased, CSF lymphocyte count increased, CSF monocyte count increased, CSF neutrophil count increased, CSF protein increased, CSF test abnormal, CSF white blood cell count increased, Central nervous system inflammation, Death, Dysarthria, Encephalopathy, Endotracheal intubation, Extensor plantar response, Fatigue, Headache, Hemiparesis, Hemiplegia, Hiccups, Hyperreflexia, Incontinence, Malaise, Muscle spasticity, Nausea, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal cord abnormal, Pleocytosis, Pneumonia, Quadriplegia, Respiratory failure, Rheumatoid factor negative, Spinal cord disorder, VIth nerve paralysis, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (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), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Demyelination (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Ocular motility disorders (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Malignant lymphomas (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Type 2 diabetes mellitus; dyslipidaemia; hypertension; hypothyroidism
Preexisting Conditions: Seronegative arthritis
Allergies:
Diagnostic Lab Data: C-reactive protein increased, high, 37.4mg/l; CSF lymphocyte count, significant, 29%; CSF monocyte count, significant, 15%; CSF neutrophil count, significant, 56%; CSF protein, significant, 911 mg/l; CSF test abnormal, significant demonstrated lymphocytic pleocytosis, abnormal; CSF white blood cell count, 208/micro L; Nuclear magnetic resonance imaging, brain, significant, Magnetic resonance imaging (MRI) of the brain and the spine demonstrated a long segment of T2 hyperintensy extending from the caudal medulla down the entire length of the cervical cord terminating at T6. Spinal cord expansion was present throughout this segment, maximal at C5/C6. Skip lesions were also present through the rest of the spinal cord down into the conus medullaris. Patchy enhancement was present on postgadolinium sequences throughout. Abnormal
CDC Split Type: PHHY2011CA86216

Write-up: Case number PHHY2011CA86216 is an initial literature report received on 27 Sep 2011. Authors presented a case of acute disseminated encephalomyelitis (ADME) following influenza vaccination. This case refers to a 75-year-old female patient. Her past medical history included non-insulin dependent diabetes mellitus type 2, dyslipidemia, hypertension, hypothyroidism and a seronegative arthropathy. She had no other recent illness, history of tuberculosis, or travel history in the preceding 24 months. She had never previously received influenza vaccination. She was vaccinated with an inactivated seasonal influenza vaccine (manufacturer and batch number: Unknown) on an undetermined date in 2008. She presented with a 20 day history of headache, malaise, fatigue, intractable hiccups, nausea and vomiting in Nov 2008. It was reported that the symptoms began evolving 2 days following receipt of vaccination. She developed left hemiparesis 20 days post-immunization (PI) and by 29 days PI had progressed to hemiplegia and hemianesthesia of the left side. She then became encephalopathic and developed brainstem involvement with a left abducens palsy, dysarthria, right hemiparesis, and incontinence. Her neurological exam demonstrated bilateral spastic tone, brisk reflexes and extensor plantar responses. Magnetic resonance imaging of the brain and spine demonstrated a long segment of T2 hyperintensity extending from the caudal medulla down the entire length of the cervical cord terminating at T6. Spinal cord expansion was presented throughout this segment, maximal at C5/C6. Skip lesions were also present through the rest of the spinal cord down into the conus medullaris. Patchy enhancement was presented on postgadolinium sequences throughout. The remainder of the brain MRI was within normal limits for her age (non-specific white matter changes). Her cerebrospinal fluid demonstrated lymphocytic pleocytosis (white blood cell count of 208/micro L), comprised 56% neutrophils, 29% lymphocytes and 15% monocytes, and elevated protein of 911 mg/L. A comprehensive parainfectious workup and rheumatologic panel were negative apart from an elevated CRP of 37.4 mg/L. CSF pathology was negative for malignant cells. Her clinical and radiologic findings fulfilled published criteria for ADEM according to the Brighton Collaboration Encephalitis Working Group. Despite treatment with broad-spectrum antibiotics, acyclovir, methylprednisolone and plasma exchange therapy (7 treatments in 14 days), the patient continued to deteriorate to quadriplegia and required intubation secondary to hypercapneic respiratory failure, she developed pneumonia and passed away 70 days PI. Authors stated that seeing as the patient passed away 70 days PI and did not attain the minimum 3 months follow-up duration required to document a monophasic pattern of illness and fulfill a level 1 of diagnostic certainty, her case meets a level 2 of diagnostic certainty for ADEM. Although CSF findings are not included in the abovementioned diagnostic definition of ADEM, the CSF pleocytosis and elevated protein in this patient are useful indicators of central nervous system inflammation. Authors also stated that brainstem dysfunction may serve as a poor prognostic indicator. When assessing post-vaccination adverse events it is always difficult to separate causality from a temporal coincidence, however, in accordance with the World Health Organization''s causality assessment criteria it is ''very likely'' that in this case disease was caused by the administration of vaccine.


VAERS ID: 436743 (history)  
Form: Version 1.0  
Age: 1.06  
Sex: Male  
Location: Minnesota  
Vaccinated:2011-09-22
Onset:2011-09-23
   Days after vaccination:1
Submitted: 2011-10-04
   Days after onset:11
Entered: 2011-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT4176BA / UNK RL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0404AA / 1 RL / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 916598 / 4 LL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0819AA / 1 LL / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-09-23
   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: none
Current Illness: Cold/URI/ear infection
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Parents found patient blue and not breathing at home. Code Blue to hospital.


VAERS ID: 436818 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-10-03
Entered: 2011-10-05
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Convulsion, Death, Developmental delay, Hypoxic-ischaemic encephalopathy, Laboratory test
SMQs:, Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (narrow), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: CNS tissue - No lesions that might have accounted for the developmental delay were found.
CDC Split Type: 201109243

Write-up: Initial case retrieved from the scientific literature on 22 September 2011. The authors evaluated clinical-pathological features of 37 infants/children whose parents alleged a relationship between vaccination and death or permanent central nervous system (CNS) damage, and sought compensation through the National Vaccine Injury Compensation Program during the years from 1990 through 1999. CNS tissue was available for evaluation by a pediatric neuropathologist in these 37 cases: 23 males (62%) and 14 females (38%) ranging in age from 1 month to 17 years at time of death or biopsy. Thirty-three of the 37 patients were dead at the time the case was evaluated. Most commonly implicated vaccines were DTP or DTaP (33 cases), followed by MMR and IPV/OPV (25 cases each). The authors concluded that there was no obvious relationship between type of vaccine (or vaccines simultaneously administered) to time of onset of symptoms, nature of symptoms, or the lesions found. No CNS lesions were found in 5 of 37 cases. There were a variety of CNS lesions amongst the 32 remaining cases, but pathogenesis of the majority was apparent and not considered a complication of vaccination. Of the 37 patients described in the article, the vaccines received by eight of these patients were specified. This case captures one patient; and the other seven patients are captured in case numbers 2011-09242, -09245, -09246, -09247, -09248, -09249 and 2011-09250. A five-month-old female patient had received a DTP vaccination (manufacturer unknown; lot number, route, site and date of administration not reported) and within 24 hours developed onset of seizures, but later manifested developmental delay. The patient died at seven years of age at which time acute anoxic encephalopathy was found and was most likely a consequence of terminal seizures. No lesions that may have accounted for the developmental delay were found. Documents held by sender: None.


VAERS ID: 436838 (history)  
Form: Version 1.0  
Age: 0.8  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-10-03
Entered: 2011-10-05
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Central nervous system lesion, Cerebral atrophy, Convulsion, Death, Developmental delay, Hypoxic-ischaemic encephalopathy, Laboratory test abnormal, Microcephaly, Nervous system disorder, Periventricular leukomalacia
SMQs:, Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Congenital, familial and genetic disorders (narrow), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Neonatal disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Brain lesions were those of classical perinatal hypoxic-ischemic injury, consisting of periventricular leukomalacia and "status marmoratus"; there was associated atrophy.
CDC Split Type: 201109250

Write-up: Initial case retrieved from the scientific literature on 22 September 2011. The authors evaluated clinical-pathological features of 37 infants/children whose parents alleged a relationship between vaccination and death or permanent central nervous system (CNS) damage, and sought compensation through the National Vaccine Injury Compensation Program during the years from 1990 through 1999. CNS tissue was available for evaluation by a pediatric neuropathologist in these 37 cases: 23 males (62%) and 14 females (38%) ranging in age from 1 month to 17 years at time of death or biopsy. Thirty-three of the 37 patients were dead at the time the case was evaluated. Most commonly implicated vaccines were DTP or DTaP (33 cases), followed by MMR and IPV/OPV (25 cases each). The authors concluded that there was no obvious relationship between type of vaccine (or vaccines simultaneously administered) to time of onset of symptoms, nature of symptoms, or the lesions found. No CNS lesions were found in 5 of 37 cases. There were a variety of CNS lesions amongst the 32 remaining cases, but pathogenesis of the majority was apparent and not considered a complication of vaccination. Of the 37 patients described in the article, the vaccines received by eight of these patients were specified. This case captures one patient; and the other seven patients are captured in case numbers 2011-09242, -09243, -09245, -09246, -09247, -09248 and 2011-09249. A nine-month-old male infant had received a DTP vaccine at six months of age (manufacturer unknown, lot number, route, site and date of administration not reported) and at 9 months of age, developmental delay was noted, along with seizures, complex neurologic dysfunction and eventually microcephaly. The patient died when they were nine years three months of age. At that time, brain lesions were those of classical perinatal hypoxic-ischemic injury, consisting of periventricular leukomalacia and "status marmoratus"; there was associated atrophy. Documents held by sender: None.


VAERS ID: 436852 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-10-03
Entered: 2011-10-05
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Convulsion, Death, Developmental delay, Infarction, Laboratory test abnormal
SMQs:, Systemic lupus erythematosus (broad), Myocardial infarction (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), 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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Multifocal infarctions were found.
CDC Split Type: 201109249

Write-up: Initial case retrieved from the scientific literature on 22 September 2011. The authors evaluated clinical-pathological features of 37 infants/children whose parents alleged a relationship between vaccination and death or permanent central nervous system (CNS) damage, and sought compensation through the National Vaccine Injury Compensation Program during the years from 1990 through 1999. CNS tissue was available for evaluation by a pediatric neuropathologist in these 37 cases: 23 males (62%) and 14 females (38%) ranging in age from 1 month to 17 years at time of death or biopsy. Thirty-three of the 37 patients were dead at the time the case was evaluated. Most commonly implicated vaccines were DTP or DTaP (33 cases), followed by MMR and IPV/OPV (25 cases each). The authors concluded that there was no obvious relationship between type of vaccine (or vaccines simultaneously administered) to time of onset of symptoms, nature of symptoms, or the lesions found. No CNS lesions were found in 5 of 37 cases. There were a variety of CNS lesions amongst the 32 remaining cases, but pathogenesis of the majority was apparent and not considered a complication of vaccination. Of the 37 patients described in the article, the vaccines received by eight of these patients were specified. This case captures one patient; and the other seven patients are captured in case numbers 2011-09242, -09243, -09245, -09246, -09247, -09248 and 2011-09250. A five-month old female infant received a DTP vaccine (manufacturer unknown, lot number, route, site and date of administration not reported) and had onset of seizures within 24 hours post-vaccination. After the seizures, the patient manifested developmental delay. Multifocal infarctions were found when she died seven years later. Documents held by sender: None.


VAERS ID: 437334 (history)  
Form: Version 1.0  
Age: 0.36  
Sex: Female  
Location: Nevada  
Vaccinated:2011-09-28
Onset:2011-10-02
   Days after vaccination:4
Submitted: 2011-10-07
   Days after onset:5
Entered: 2011-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR A4025AA / 1 RL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F13780 / 2 RL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0883AA / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-10-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol; Amoxicillin
Current Illness: Bronchiolitis 9-15-11
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Received shots (PENTACEL/PCV13/ROTATEQ) on 9-28-11. H/o bronchiolitis 9-15-11 --$g better 9-20-11. NL exam on 9-28-11.


VAERS ID: 437391 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Female  
Location: Maine  
Vaccinated:2011-10-04
Onset:2011-10-05
   Days after vaccination:1
Submitted: 2011-10-07
   Days after onset:2
Entered: 2011-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH463AB / UNK LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-10-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEXAPRO; ASA; AMBIEN; Tramadol; LIPITOR; Anagrelide
Current Illness: None
Preexisting Conditions: HTN; Elev. Lipids
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Police reported to us that patient was found dead in her home the day after flu vaccine was administered. We had no communication w/ pt after office visit 10/4.


VAERS ID: 437570 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Female  
Location: Michigan  
Vaccinated:2011-10-06
Onset:2011-10-06
   Days after vaccination:0
Submitted: 2011-10-11
   Days after onset:5
Entered: 2011-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH438AB / UNK LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Alanine aminotransferase increased, Antiphospholipid antibodies, Arrhythmia, Aspartate aminotransferase increased, Atelectasis, Blood albumin decreased, Blood alkaline phosphatase increased, Blood bilirubin increased, Blood calcium increased, Blood chloride increased, Blood count abnormal, Blood creatinine increased, Blood gases, Blood glucose normal, Blood lactic acid normal, Blood magnesium increased, Blood pH decreased, Blood phosphorus normal, Blood potassium normal, Blood sodium increased, Blood urea increased, Bradycardia, Breath sounds abnormal, C-reactive protein, Carbon dioxide decreased, Cardiac arrest, Central venous catheterisation, Chest X-ray abnormal, Clostridium test negative, Compression fracture, Computerised tomogram abdomen abnormal, Computerised tomogram abnormal, Condition aggravated, Cyanosis, Death, Electrocardiogram P wave abnormal, Electrocardiogram abnormal, Endotracheal intubation, Eye movement disorder, Femoral pulse decreased, Gastrointestinal sounds abnormal, Haematocrit normal, Haemodilution, Haemoglobin normal, Heart rate decreased, Hypertension, Hypotension, International normalised ratio normal, Ischaemic hepatitis, Loss of consciousness, Mean cell volume normal, Mechanical ventilation, Mental status changes, Merycism, Neuropathy peripheral, Neutrophil percentage increased, Nodal rhythm, Occult blood positive, Ocular hyperaemia, Oliguria, Osteoporosis, PCO2 normal, PO2 increased, Peripheral coldness, Platelet count normal, Pneumothorax, Protein total decreased, Prothrombin time normal, Pulseless electrical activity, Radial pulse abnormal, Red blood cell sedimentation rate normal, Renal failure acute, Renal tubular necrosis, Resuscitation, Rhonchi, Rib fracture, Sepsis, Septic shock, Somnolence, Spinal compression fracture, Syncope, Troponin normal, Ultrasound Doppler, Ultrasound pelvis abnormal, Unresponsive to stimuli, Urinary sediment present, Urine analysis abnormal, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Hepatitis, non-infectious (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (narrow), Angioedema (broad), Haematopoietic cytopenias affecting more than one type of blood cell (broad), Lactic acidosis (broad), Peripheral neuropathy (narrow), Haemorrhage laboratory terms (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Disorders of sinus node function (narrow), Supraventricular tachyarrhythmias (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Embolic and thrombotic events, venous (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (narrow), Biliary system related investigations, signs and symptoms (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Hypertension (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Osteoporosis/osteopenia (narrow), Renovascular disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Tubulointerstitial diseases (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-10-07
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MEDICATIONS: The patient is on the following medications at home. - Oxycodone one capsules orally p.r.n.. - Voltaren 75 mg orally twice a day. - Gabapentin 400 mg four times a day. - Digoxin 0.125 mg orally every other day. - Amlo
Current Illness: None noted
Preexisting Conditions: PAST MEDICAL HISTORY: Hypertension, neuropathy, atrial fibrillation. Chronic kidney disease stage 3. Depression, anxiety, chronic iron-deficiency anemia, COPD, stable, osteoarthritis and chronic pain syndrome, and history of recurrent falls.
Allergies:
Diagnostic Lab Data: 10/6/11: WBC 21.4, Scr-1.8, BUN-39, LA-7.9, ABG-7.16, troponin-0.01 10/7/11: Wbc-12.2, Neuts-71.1%, scr-2.2, BUN-47, LA-4.6, ABG-7.20, CRP-1.8, sed rate-10mm/hr
CDC Split Type:

Write-up: DATE OF EXAM: 10/07/2011 at 08:20. SUBJECTIVE: The patient is an 80-year-old lady who was brought in to the Emergency Room last night unconscious. I reviewed the reviewed the history in the system as well as reviewed the history from the patient''s family at bedside. The patient''s daughter saw the patient during lunchtime and had lunch with her. She was in her usual state of health. She has not had any fever or chills. No productive cough, no chest pain, no abdominal pain and no diarrhea. She was in her usual state of health without any evidence of an infectious process. After lunch time, the patient was supposed to get her flu shot and was on her way to get her flu shot. The patient''s family believes that she has gotten her flu shot. They were not told otherwise. It is presumed that the patient has received her flu shot. We are at this time unsure of the route it was given if indeed she received it. At around 6:00 after work, the same daughter came to visit the patient to cook her dinner. She was noted to be unconscious, sitting up in her electrical wheelchair. The patient does have episodes of syncope and has had multiple episodes in the past. Normally this is associated with "bowel movement" vasovagal syncope). At this time, the patient was not on the toilet bowl. The patient''s daughter did not smell or see any evidence of bowel or bladder incontinence or any sign that she had tried to move her bowels. The patient''s daughter tried to pick her up, thinking that this was one of her usual episodes of syncope. She asked the nursing staff to help her wake the patient up, but when they could not wake up the patient, EMS was called. When EMS arrived, the patient was noted to have low blood pressure. The patient''s daughter believes that she had taken all of her morning medications since her medication dispenser for that day was empty. The only thing that they are not sure of is whether or not the patient took her "fibromyalgia pill". The patient was then brought to the emergency room. The patient remained unconscious and had to be intubated to protect her airway. She was given IV fluid boluses without good response and started on vasopressor initially with dopamine and subsequently changed to Levophed. While the patient was in the emergency room, the patient was noted to have a pulseless electrical activity. They were not sure how long the patient had pulseless electrical activity and so CPR was performed. The patient sustained some broken ribs as well as mild pneumothorax. I have counseled the patient''s family regarding this and they are aware. The patient remains unresponsive on the vent. Occasionally, she tried to move her upper extremities. She is noted to have some movements of the lower extremity, but is not necessarily consistent with stimulation and not necessary purposeful. Occasionally, she will bite down on her ET tube. She is also noted occasionally to be "ruminating". The patient has guaiac positive stools, but there is no evidence of active bleeding or GI bleed. Blood count remains stable despite aggressive IV fluid hydration. There is some decrease in blood count, but mainly secondary to hemodilution. OBJECTIVE: GENERAL: The patient is mainly unresponsive, intubated, on vent support and vasopressor support. VITAL SIGNS: Most recent vital signs showed blood pressure 114/90, heart rate of 98, respirations of 15-22, temperature 35.4 degrees centigrade. Temperature minimum was 34.7 degrees early this morning. HEENT: Normocephalic and atraumatic. ET and OGT noted. Pupils were 4-5 mm bilaterally and minimally reactive to 3-4 mm bilaterally. Doll''s eyes were equivocal. There is some eye movements, but not entirely consistent with doll''s eye movement. Pink conjunctivae, no icterus. I was unable to fully evaluate the patient''s oral mucosa. NECK: Supple. CHEST: Lungs are symmetrical with good chest expansion. Diminished breath sounds at the bases with occasional scattered rhonchi noted, otherwise no significant wheezing. CARDIOVASCULAR: Normal rate, regular rhythm, S1, S2 noted. I do not appreciate any rubs or gallops. PMI is difficult to palpate secondary to the patient''s low blood pressure. No significant JVD noted. GASTROINTESTINAL: The abdomen is globular very hypoactive bowel sounds, soft, no grimace to palpation, no rebound tenderness. MUSCULOSKELETAL: There is no significant edema of bilateral lower extremities. Pedis pulses are significantly diminished. The patient''s extremities are cold to touch and the left upper extremity appears to be somewhat cyanotic. SKIN: Cool to touch as noted above. No other rash or skin breakdown noted. I am not able to detect any injection site on both of the patient''s deltoid areas. NEUROLOGIC AND PSYCHIATRIC: Examination severely limited secondary to the patient''s mental status. Babinski are equivocal. There are some occasional movements of both upper extremities and left lower extremity as noted above. DIAGNOSTIC RESULTS: Laboratories obtained this morning showed WBC 12.2, hemoglobin 12.5, hematocrit 36.5, MCV of 93, and platelet count 243. PT 11.6, INR 1.1. Sodium 151, potassium 3.6, chloride 113, CO2 18, BUN 47, creatinine 2.2, calcium 7.3, magnesium 3.8, phosphorus 4.4. Lactic acid 4.6, alk phos is 614, total bilirubin 1.6, AST 213, ALT of 84, total protein 5.3, albumin 2.8, glucose of 166. PH is 7.20, pCO2 42, pO2 of 109, CO2 17, oxygen saturation 95% at 60% FIO2. Stools for guaiac came back positive. Stools for Clostridium difficile back negative x2. CT of the abdomen and pelvis obtained, preliminary reading, showed multiple findings without definite evidence of bowel obstruction, left-sided pneumothorax with left-sided rib refracture of the left transverse process at L1-L2. Compression fracture of T12 of indeterminate age with marked compression deformities in retropulsion noted. ASSESSMENT AND PLAN: * Hypotension with mental status change presumed to be secondary to severe sepsis with septic shock. Unclear source at this time. Urinalysis obtained did show some evidence of possible infection; however, this was a contaminated urine with a lot of squamous epithelial cells. So far there is really no other definitive infectious source. We will continue vasopressor support. We will continue IV antibiotics with vancomycin and Zosyn. We will need to ascertain whether the patient did receive a flu vaccine and what route it was given. We might need to know the lot number. I personally spoke with Dr. from Infectious Disease. I recommend continuing IV antibiotics and this might need to be reported, especially once we are certain that the patient did receive a flu vaccine. I will also order a rapid flu test. We will follow the results of blood cultures and urine cultures. * Status post cardiac arrest with pulseless electrical activity requiring chest compression. Initial troponin did come back negative. I will not order further troponins since it is likely this will be elevated secondary to the CPR that was performed at the Emergency Room. We will check digoxin level. The patient was intubated for protection of her airway and from my understanding she did not have any respiratory arrest. * Acute renal failure. I believe this is secondary to acute tubular necrosis (ATN) from the patient''s hypotension. I will repeat urinalysis. We will monitor the patient''s I''s and O''s closely. At this time, it appears that the patient is starting to be oliguric. We will continue IV fluid hydration and will obtain ultrasound of the abdomen. * Probable shocked liver secondary to hypotension with mental status change and hypertension. Continue supportive care. We will continue to monitor the patient''s kidney function including PT and INR. * Osteoarthritis. * Neuropathy. * Hypertension. The patient''s blood pressure is low and needs vasopressor support, so we will hold the patient''s amlodipine and benazepril. Given the patient''s acute renal failure, benazepril is not a good medication for this patient at this time. We will try to obtain old records from the patient''s primary care doctor. * Positive guaiac stools. No evidence of acute bleeding. Hemoglobin and hematocrit remain stable. * GI and DVT prophylaxis. We will continue IV Protonix, but I will increase the dose to q.12 hours given the guaiac positive stools. I will discontinue Lovenox, but I will give low-dose heparin subcutaneous injections instead given the patient''s kidney function and guaiac positive stools. It is easier to reverse the heparin than Lovenox if you do end up needing to reverse it. * Condition is very guarded. Prognosis is poor. * Pending patient''s clinical course and at this time, I will obtain EEG for altered mentation will hold off any sedation until after the EEG done. The patient already has p.r.n. Ativan ordered as well as fentanyl. DISPOSITION: Pending the patient''s clinical course. At this time, I will obtain EEG for the altered mentation. We will hold off any sedation until after the EEG is done. The patient already has p.r.n. Ativan ordered as well as fentanyl. Total critical time spent was 60 minutes including discussion with the patient. The patient''s family has been made aware of the critical nature of their mother''s condition. All of their questions were answered to their satisfaction. DATE OF EXAM: 10/07/2011 at 11:15. SUBJECTIVE: I was called to the bedside because of a rhythm change. I looked at the tele monitor and I was unable to see P-waves. EKG has been ordered. I was unable to find radial pulses right away. Femoral pulses were very faint and were not necessarily correlating with electrode activity on telemetry monitor. Doppler ultrasound was used to monitor the patient''s pulse. The patient''s pulse was noted to be 35 beats per minute, but heart rate on the telemetry monitor showed 70 beats per minute. EKG obtained showed a junctional rhythm. Because of this 1 amp of atropine was given. Prior to this, blood pressure was also in the 70s systolic. The patient''s blood pressure, telemetry heart rate and palpable pulse improved. Repeat blood pressure obtained showed systolic in the 110s. Repeat EKG done after atropine still showed accelerated junctional rhythm with a rate of 75. OBJECTIVE: The patient remains intubated with altered mentation and unresponsive. DIAGNOSTIC RESULTS: New laboratories obtained since the earlier visit with the new ABG obtained showed a pH of 7.27, pCO2 31, pO2 80, and CO2 15. Oxygen saturation 93% at 60% FIO2. Digoxin level 0.7. Repeat chest x-ray, 1 view, obtained today showed bibasilar subsegmental atelectasis. There is a left-sided central venous catheter seen with its tip apparently having been retracted now with appearance in the region opposing the medial clavicle head on the left. No obvious pneumothorax was detected. Reactive CRP was 1.8. ASSESSMENT AND PLAN: * Electrical impulse dissociation presently with a junctional rhythm. The dissociation improved with atropine. At this time, blood pressures are acceptable and heart rate is acceptable. Because of the low pH and electrical rhythm and pulse disassociation, 1 amp of bicarb was given even though pH was only 7.27. Cardiology consultation would be obtained. Echocardiogram has been ordered. * Hypotension. The patient''s Levophed drip was titrated to 27 mcg per minute. * Presumed severe sepsis with septic shock. Again, no focus can be found aside from questionable urinary tract infection, which was contaminated/colonized. Inflammatory CRP is only 1.8, which does not really correlate with a person in septic shock. Continue IV antibiotics for now. * Acute renal failure with acute tubular necrosis. The patient is becoming more and more oliguric. The patient was given 500 mL of normal saline bolus. The patient remains on fluid resuscitation. Kidney ultrasound has been ordered. * Please refer to the previously dictated progress note as well as diagnoses for further details. * Prognosis remains poor. Condition is very critical. * Total critical time spent was another 40 minutes. DATE OF EXAM: 10/07/2011 at 1355 hours. SUBJECTIVE: The case was discussed with cardiologist who recommended the patient will need to be transferred since she might need a pacemaker to be placed. Transfer was arranged. The case was discussed with the intensivist at another Medical Center who accepted the patient in transfer. Medevac was informed, but arrived at approximately 1356 hours, the patient was noted to have a rhythm change and became bradycardic and suddenly asystole. Code blue was called, aside from me 2 other doctors responded. Dr. ran the code according to ACLS protocol. The patient was given 3 rounds of epinephrine and atropine. Rhythms checks were made intermittently. Despite aggressive progressive attempt, the patient remained in asystole. The patient was coded for approximately 15 minutes and the code was called off at 1411 hours. The patient''s family was informed. They were aware when the code blue was called. I spoke to them during the middle of the code, informed them that we will continue to try cardiac resuscitation, will continue on for 15 minutes. They agreed with the plan. They were also notified after the code was called. Patient''s family was informed about the outcome of the code. Because the patient has not been in the hospital for less than 24 hours, the cause of death cannot be ascertain at this time. The case will be forwarded to the medical examiner. Noncritical time spent was 15 minutes.


VAERS ID: 437685 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Male  
Location: Idaho  
Vaccinated:2011-09-28
Onset:2011-10-05
   Days after vaccination:7
Submitted: 2011-10-11
   Days after onset:6
Entered: 2011-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B280BA / 2 RL / UN
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1514Y / 2 LL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 915375 / 2 LL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0204A / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-10-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Our office became aware of the infants death by an acquaintance of the family. This person also states that cause of death was determined to be S.I.D.S.


VAERS ID: 437735 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2011-01-07
Onset:2011-04-01
   Days after vaccination:84
Submitted: 2011-10-11
   Days after onset:193
Entered: 2011-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 - / IM

Administered by: Unknown       Purchased by: Other
Symptoms: Condition aggravated, Death, Differential white blood cell count normal, Ecchymosis, Haematocrit normal, Haemoglobin normal, Haemorrhage intracranial, Idiopathic thrombocytopenic purpura, Mean cell volume normal, Petechiae, Platelet count decreased, Red blood cell morphology normal, White blood cell count normal
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Haemorrhagic central nervous system vascular conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-07-06
   Days after onset: 96
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: Immune thrombocytopenic purpura, diagnosed in 1995 and in remission from 2004 to 2011 following treatment with Rituximab in 2004.
Allergies:
Diagnostic Lab Data: Petechiae and ecchymoses noted by patient and family in early April (exact date not known). CBC on 04/26/2011 included platelet count 5000; WBC 5.4 with normal differential, Hgb 12.8, Hct 37.2, MCV 87.9; normal RBC morphology.
CDC Split Type:

Write-up: Relapse of ITP: 18 year-old female with immune thrombocytopenic purpura, diagnosed in 1995 and in remission from 2004 to 2011 following treatment with Rituximab. Relapse in early April, 2011, followed administration of Gardasil vaccine on 10-26-10 and 1-7-11. Relapse of ITP led eventually to death from intracranial hemorrhage on 07/06/2011.


VAERS ID: 437792 (history)  
Form: Version 1.0  
Age: 0.1  
Sex: Male  
Location: Tennessee  
Vaccinated:2011-09-20
Onset:2011-09-24
   Days after vaccination:4
Submitted: 2011-10-05
   Days after onset:11
Entered: 2011-10-12
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB977CA / 2 UN / IM

Administered by: Private       Purchased by: Public
Symptoms: Bed sharing, Cardiac arrest, Death neonatal, Intensive care, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-09-25
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: PICU treatment
CDC Split Type:

Write-up: Infant reportedly co-sleeping. Found nonresponsive. EMS took to ER - 24 hr in PICU - arrested and died.


VAERS ID: 437999 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Male  
Location: Ohio  
Vaccinated:2011-07-22
Onset:2011-07-27
   Days after vaccination:5
Submitted: 2011-10-12
   Days after onset:77
Entered: 2011-10-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0126AA / UNK UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0841AA / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asphyxia, Completed suicide, Death, Drug screen negative, Toxicologic test normal
SMQs:, Suicide/self-injury (narrow), Acute central respiratory depression (broad), Hostility/aggression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-07-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SEPTRA
Current Illness: Acne
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: diagnostic laboratory, ?/?/11, toxic screen indicated that there were no medications involved in the patient''s death.
CDC Split Type: WAES1110USA00917

Write-up: Information has been received from a physician concerning an 18 year old male patient with acne and no drug allergy or reaction who on 16-MAY-2011 was vaccinated with the first dose of GARDASIL (Lot number 668554/0306AA; Expired date: 10-MAY-2013) and a dose of VAQTA (Lot number: 670377/0126AA; Expired date: 07-DEC-2013, dose in series unknown). On 22-JUL-2011, the patient received the second dose of GARDASIL (Lot number 668262/0841AA; Expired date: 18-APR-2013). Concomitant therapy included SEPTRA. Follow up phone call from the physician was received. The physician reported that the patient had no medical history. The last time he saw the patient was on 22-JUL-2011, when the patient received his second dose of GARDASIL. The physician also reported that there was no indication from the patient that he was troubled. On 27-JUL-2011 the patient committed suicide. The cause of death was asphyxiation by hanging. The death report that the physician received was that the patient had a normal examination. The Toxic screen indicated that there were no medications involved in the patient''s death. The patient''s mother had asked the physician if GARDASIL could have caused her son to commit suicide. The physician reported to the patient''s mother that he did not feel that GARDASIL was the cause of her son''s suicide. The physician stated that he was not aware of any reported deaths by suicide that were related to GARDASIL. Lot checks have been initiated for 668554/0306AA, 668262/0841AA for GARDASIL and 670377/0126AA for VAQTA. Additional information has been requested.


VAERS ID: 438031 (history)  
Form: Version 1.0  
Age: 27.0  
Sex: Male  
Location: Unknown  
Vaccinated:2011-10-01
Onset:2011-10-01
   Days after vaccination:0
Submitted: 2011-10-11
   Days after onset:10
Entered: 2011-10-13
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Blood glucose increased, Death, Diabetic coma
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-10-03
   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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHEH2011US06146

Write-up: Case number PHEH2011US06146 is an initial spontaneous report received from a consumer on 05 Oct 2011: This case refers to 27-year-old male patient. He was vaccinated with FLUVIRIN (batch number: unknown) on 01 Oct 2011. After vaccination his sugar was 1500 because of flu shot. The flu shot raised his blood sugar to a diabetic coma that he did not wake up. The patient received care at hospital. The critical team worked on him for 12-hours and he expired on 03 Oct 2011. No other information was provided.


VAERS ID: 438050 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-10-12
Entered: 2011-10-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Cardio-respiratory arrest, Convulsion, Death, Hypoxic-ischaemic encephalopathy, Pyrexia, Respiratory therapy, Similar reaction on previous exposure to drug, Status epilepticus
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Central nervous system infection; microcephaly
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011US89577

Write-up: Case number PHHY2011US89577 is an initial literature report received on 06 Oct 2011: The authors analyzed clinical-pathological features of 37 infants/children whose parents alleged a relationship between vaccination and death or permanent central nervous system (CNS) damage, and sought compensation through the National Vaccine Injury Compensation Program. This report refers to a female child. She was one of the triplet and her medical history included recurrent CNS infections by unidentified agents, but which were thought to have been viral. She was developmentally delayed and microcephalic. At the age of 3 years and 9 months, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on an unspecified date. Two weeks later, she presented with CNS symptoms similar to those she had unassociated with vaccination in the past, including fever. The day following hospitalization, she had a seizure which proceeded to status epilepticus and cardio-respiratory arrest. Respiratory therapy was terminated on the following day. Postmortem examination disclosed acute hypoxic-ischemic encephalomyelopathy. The authors concluded that provided evidences were not supportive of direct relationship between a given vaccine and a specific CNS complication. Pathogenesis of majority of the cases was apparent and not a complication of vaccination.


VAERS ID: 438069 (history)  
Form: Version 1.0  
Age: 0.51  
Sex: Male  
Location: Massachusetts  
Vaccinated:2011-05-11
Onset:2011-05-13
   Days after vaccination:2
Submitted: 2011-10-07
   Days after onset:147
Entered: 2011-10-13
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3806AA / 3 LL / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER 0979Z / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 915703 / 3 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0184AA / 3 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-05-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Leg pain/Crying~Hep B (no brand name)~0~0.00~Patient|Leg pain/Crying~Rotavirus (Rotateq)~0~0.00~Patient|Leg pain/Cryiing~DTaP +
Other Medications:
Current Illness: Rhinovirus 4/19/11
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient died in crib 48-hours after receiving the series of vaccines identified in Box 13 below. Coroner listed the cause of death as SIDS.


VAERS ID: 438416 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Female  
Location: Washington  
Vaccinated:2011-10-12
Onset:2011-10-12
   Days after vaccination:0
Submitted: 2011-10-14
   Days after onset:2
Entered: 2011-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA678AA / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Crepitations, Death, General physical health deterioration, Oxygen saturation decreased
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-10-12
   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: Novolin 70/30 insulin 13 u sq QPM Novolin 70/30 insulin 45 u sq QAM Celexa 30 mg QD Fosamax 70 mg 1x/wk. Levoxyl 100 mcg QAM Lanoxin 0.125 mg QAM Prilosec 20 mg QD ASA 325 mg QD Lasix 80 mg QD Calcium w/Vit D 600/400 BID KCL 20 meq QD Benad
Current Illness: None
Preexisting Conditions: Diabetes, Hypothyroidism, GERD, Hypercholestrolemia, A. Fib., CHF, COPD, HTN, Vascular Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Sudden onset of decline. Audible, course crackles upper airways. O2 sats 88% on 4L O2, BP 112/70, P90, R24, T98.6. Elevated HOB, nebulizer given. MD immediately informed w/orders, if no improvement w/PRN neb tx or worsening sx''s, transfers to ER for eval. Guardian notified & in agreement w/MD orders. During neb tx, O2 sats decreased to 84% w/audible course crackles, BP 102/78, P89, R34. Ambulance called, arrived & during assessment per ambulance crew, rt. expired at 2145. Ambulance crew informed Co. Sheriff of death. No concerns re: death. Guardian & MD informed of rt.''s passing. Funeral home notified.


VAERS ID: 438770 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Female  
Location: Illinois  
Vaccinated:2011-10-13
Onset:2011-10-13
   Days after vaccination:0
Submitted: 2011-10-14
   Days after onset:1
Entered: 2011-10-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA609AA / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Atrial fibrillation, Confusional state, Death, Dehydration, Fall, Mental status changes, Pallor, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-10-14
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOSAMAX; CALTRATE D; RELAFEN
Current Illness: Rapid H.R.; Weakness; Paleness
Preexisting Conditions: Asthma; Osteoporosis; Prosthetic eye; Osteoarthritis; Breast CA; Allergy = strawberries.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt. had emesis that she vomited on the floor, she then tried getting up & fell. Resident was confused, weak, & had pale color. Sent to ER for evaluation. ER called at 1:22am & said she was admitted with A-fib, dehydration, rapid ventricular response, & mental status changes.


VAERS ID: 438876 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Male  
Location: New York  
Vaccinated:2011-10-03
Onset:2011-10-03
   Days after vaccination:0
Submitted: 2011-10-18
   Days after onset:15
Entered: 2011-10-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH462AC / 1 RA / IM

Administered by: Other       Purchased by: Private
Symptoms: Activities of daily living impaired, Blood culture positive, CSF protein increased, Culture urine positive, Dysstasia, Endotracheal intubation, Escherichia urinary tract infection, Guillain-Barre syndrome, Hypoaesthesia, Hypokinesia, Immunoglobulin therapy, Lumbar puncture, Mechanical ventilation, Paraesthesia, Plasmapheresis, Sensory loss, Sputum culture positive, Staphylococcal infection, Streptococcal bacteraemia, Walking aid user
SMQs:, Angioedema (broad), Peripheral neuropathy (narrow), Dementia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Demyelination (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Infective pneumonia (broad), Sepsis (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2011-10-23
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 18 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: no
Allergies:
Diagnostic Lab Data: LP- positive for protein
CDC Split Type:

Write-up: Pt had numbness and tingling of his finger tips on same evening as recieving flu shot that morning. On next day, Tuesday, he started same numbnes and tingling in his toes. Pt went to family doctor on Wednesday and needed walker to assist him in walking. (Prior to this event the pt was able to ambulate without assistance of any devices, drive a car long distances and grocery shop on own) pcp- sent pt to the ER for evaluation. Pt was diagnosed as having Guillain Barre syndrome from the flu shot. By 9 pm that Wednesday evening he was not able to stand and pt had limited use of his arms. Pt was admitted to hospital. By 9am on Thursday pt had little movement and no feeling in legs. He had very little movement of his arms and was not able to lift his arms to his mouth to feed himself. By Thursday night pt was intubated and placed on ventilation support. By Friday am he was not able to move any extremities and only had movement of his head, mouth and shoulder shrugs. Immunoglobulin administration was started on Wed afternoon and continued for 5 or 6 doses (one each day). No improvement was seen. Pt subsequently developed several infectious processes-e-coli in urine, staph (not MRSA) in his sputum, and strep in his blood. Plasmaphoresis was started every other day times 5 exchanges. (Was have finished 3 exchanges up to this time with no movement of extremities seen.


VAERS ID: 439082 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Washington  
Vaccinated:2011-10-13
Onset:2011-10-13
   Days after vaccination:0
Submitted: 2011-10-19
   Days after onset:6
Entered: 2011-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3931AA / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 916304 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1311AA / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-10-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No medications reported
Current Illness: None described
Preexisting Conditions: None described
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None stated.


VAERS ID: 439084 (history)  
Form: Version 1.0  
Age: 90.0  
Sex: Female  
Location: Michigan  
Vaccinated:2011-09-09
Onset:2011-09-10
   Days after vaccination:1
Submitted: 2011-10-06
   Days after onset:26
Entered: 2011-10-19
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH4398A / UNK LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Chest pain, Dysphonia, Hypokinesia, Pain, Swollen tongue, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Asthma/bronchospasm (broad), Parkinson-like events (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-09-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None (see above dx.)
Preexisting Conditions: (See above)
Allergies:
Diagnostic Lab Data: Heart Disease (CHF); Thyroid; Kidney (4% operating)
CDC Split Type:

Write-up: Received High dose flu shot 9/9/11 within 12 hr had chest pain, hoarseness, wheezing, decreased movement arm/shoulder, decreased movement in face, body ache, tongue swelling. Daughter reporting.


VAERS ID: 439265 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Male  
Location: Florida  
Vaccinated:2011-09-21
Onset:2011-10-07
   Days after vaccination:16
Submitted: 2011-10-17
   Days after onset:10
Entered: 2011-10-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH444AB / 2 LA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-10-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Rectal carcinoma; Delirium
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death.


VAERS ID: 439266 (history)  
Form: Version 1.0  
Age: 66.0  
Sex: Male  
Location: Florida  
Vaccinated:2011-09-12
Onset:2011-10-10
   Days after vaccination:28
Submitted: 2011-10-17
   Days after onset:7
Entered: 2011-10-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH444AB / 2 LA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-10-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Gastric adenocarcinoma; CAD; COPD; Afib; HTN; AVR; Dementia; Seizure disorder; CHF
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death.


VAERS ID: 439267 (history)  
Form: Version 1.0  
Age: 94.0  
Sex: Male  
Location: Florida  
Vaccinated:2011-09-20
Onset:2011-10-14
   Days after vaccination:24
Submitted: 2011-10-17
   Days after onset:3
Entered: 2011-10-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH444AB / 2 LA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-10-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: CAD; HTN; Arthritis; Confusion/delirium
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death.


VAERS ID: 439269 (history)  
Form: Version 1.0  
Age: 92.0  
Sex: Male  
Location: Florida  
Vaccinated:2011-09-19
Onset:2011-10-16
   Days after vaccination:27
Submitted: 2011-10-17
   Days after onset:1
Entered: 2011-10-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH444AB / 2 RA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-10-16
   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:
Current Illness:
Preexisting Conditions: CHF; A fib; CAD
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death.


VAERS ID: 439567 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: Texas  
Vaccinated:2011-10-20
Onset:2011-10-21
   Days after vaccination:1
Submitted: 2011-10-21
   Days after onset:0
Entered: 2011-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B305AA / 1 LL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH344AA / 1 LL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 91660 / 1 RL / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FA902A / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-10-21
   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: None
Current Illness: None
Preexisting Conditions: 35 weeks
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Baby expired around 6AM on 10-21-11 as per the grandmother''s call to the office at 0900 (approx).


VAERS ID: 440304 (history)  
Form: Version 1.0  
Age: 0.16  
Sex: Male  
Location: Kentucky  
Vaccinated:2011-10-20
Onset:2011-10-22
   Days after vaccination:2
Submitted: 2011-10-25
   Days after onset:3
Entered: 2011-10-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C3686AA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR C3806AA / 1 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR C3686AA / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 915383 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1268Z / 1 MO / PO

Administered by: Public       Purchased by: Public
Symptoms: Apnoea, Autopsy, Cyanosis, Death, Pulse absent, Resuscitation, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-10-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Autopsy results pending.
CDC Split Type:

Write-up: Per report received from hospital, Pt. was pulseless, apneic, cyanotic unresponsive upon arrival. Father doing CPR upon EMS arrival. Pt. pulseless per report. Grandmother reported child "was fine" at 1:00 AM.


VAERS ID: 440529 (history)  
Form: Version 1.0  
Age: 57.0  
Sex: Male  
Location: Texas  
Vaccinated:2011-10-17
Onset:2011-10-18
   Days after vaccination:1
Submitted: 2011-10-28
   Days after onset:10
Entered: 2011-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA685AA / UNK RA / IM

Administered by: Other       Purchased by: Private
Symptoms: Death, Intensive care, Multi-organ failure, Septic shock
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2011-10-27
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: None.
Preexisting Conditions: Unknown.
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type:

Write-up: Reported to us that patient received Flu shot on 10/17/2011 and went to ER. Admitted to ICU with septic shock and multiple organ failure.


VAERS ID: 440919 (history)  
Form: Version 1.0  
Age: 1.01  
Sex: Female  
Location: California  
Vaccinated:2011-10-10
Onset:2011-10-20
   Days after vaccination:10
Submitted: 2011-10-25
   Days after onset:5
Entered: 2011-11-01
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4184BB / UNK RL / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS AHIBC291BA / UNK LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0047AA / 1 LL / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 916922 / UNK RL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0338AA / 1 RL / SC

Administered by: Private       Purchased by: Unknown
Symptoms: Asthenia, Brain herniation, Brain oedema, CSF test, Diarrhoea, Endotracheal intubation, Hydrocephalus, Posturing, Pyrexia, Rash, Unresponsive to stimuli, Ventricular cisternostomy, Viral test, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Dystonia (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Seckel syndrome or osteodysplastic primordial dwarfism
Allergies:
Diagnostic Lab Data: California encephalitis panel; CSF
CDC Split Type:

Write-up: Patient with likely osteodysplastic primary dwarfism began to have vomiting, diarrhea, rash, fever on 10/20, became progressively weaker. Seen in urgent care clinic 10/23, became very weak after home on BENADRYL, came to ER. Found to have hydrocephalus (more than previous MRI), decorticate posturing, intubated, ventriculostomy perform, no longer responsive, cerebral edema and herniation.


VAERS ID: 441165 (history)  
Form: Version 1.0  
Age: 95.0  
Sex: Female  
Location: Alabama  
Vaccinated:2011-09-22
Onset:2011-09-30
   Days after vaccination:8
Submitted: 2011-11-02
   Days after onset:33
Entered: 2011-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH468AB / UNK LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Aphasia, Asthenia, Encephalopathy, Fatigue, Gait disturbance, Hypersomnia, Nuclear magnetic resonance imaging brain abnormal, Weight decreased
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-11-13
   Days after onset: 44
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Zinc; Vit D; MICARDIS; Levothyroxine; Vitamin C; PERICOLACE; MVI; Glucosamine; Calcium; PROTONIX
Current Illness: Reflux
Preexisting Conditions: Allergies: ALDOMET, VASOTEC, ZANTAC, MIRALAX, DEXILANT, Sulfa, Mycins; Hypertension; Arthritis; Stroke
Allergies:
Diagnostic Lab Data: MRI - head - possibility of encephalitis could be considered MD diagnosed: Acute post vaccine encephalopathy
CDC Split Type:

Write-up: Pt. admitted to hospital 10/27/11. About 4 wks prior had begun feeling weak, stumbling, fatigued. Has lost 15-20 pounds over past mo. Past 3-4 days family reported no verbal responses. Sleeping 16 or more hrs/day. Treated with Acyclovir IV.


VAERS ID: 441422 (history)  
Form: Version 1.0  
Age: 7.0  
Sex: Male  
Location: Texas  
Vaccinated:2011-10-17
Onset:2011-10-21
   Days after vaccination:4
Submitted: 2011-11-04
   Days after onset:14
Entered: 2011-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH455AD / 5 RA / IM

Administered by: Public       Purchased by: Other
Symptoms: Cardiac disorder, Condition aggravated, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-10-21
   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: UNKNOWN
Current Illness: DENIED
Preexisting Conditions: PER REPORTS CHILD HAD UNDISCLOSED HEART CONDITION
Allergies:
Diagnostic Lab Data: UNKNOWN
CDC Split Type: TX20110081

Write-up: PT WAS VACCINATED ON 10/17. NO DISTRESS IMMEDIATELY FOLLOWING VACCINATION. PER REPORT FROM SCHOOL NURSE, PT COLLAPSED ON PLAYGROUND ON 10/21. REPORTEDLY, CHILD HAD UNDISCLOSED HEART CONDITION.


VAERS ID: 441679 (history)  
Form: Version 1.0  
Age: 61.0  
Sex: Male  
Location: Virginia  
Vaccinated:2011-10-04
Onset:2011-10-11
   Days after vaccination:7
Submitted: 2011-11-07
   Days after onset:27
Entered: 2011-11-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT425AA / UNK UN / IM

Administered by: Public       Purchased by: Public
Symptoms: Abdominal distension, Adenovirus test, Alanine aminotransferase increased, Antibody test negative, Aspartate aminotransferase increased, Asthenia, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Blood creatinine increased, Blood pH increased, Blood phosphorus increased, Borrelia test negative, Brain natriuretic peptide increased, C-reactive protein increased, Carbon dioxide decreased, Cardiac failure, Cardiomegaly, Chest X-ray abnormal, Chills, Cytomegalovirus test, Cytomegalovirus test negative, Death, Dialysis, Dyspnoea, Echocardiogram abnormal, Ejection fraction decreased, Epstein-Barr virus antibody positive, Extracorporeal membrane oxygenation, Fatigue, Feeling abnormal, Fibrin D dimer, General physical health deterioration, HIV test negative, Headache, Hepatitis B core antibody negative, Hepatitis B surface antibody negative, Hepatitis B surface antigen negative, Hepatitis C antibody negative, Influenza, Influenza A virus test negative, Influenza B virus test, Intensive care, Jaundice, Left ventricular dysfunction, Lung consolidation, Myalgia, Myocarditis, Neutrophil percentage increased, PO2 decreased, Pericardial effusion, Pleural effusion, Protein urine present, Pulmonary arterial pressure normal, Pulmonary hypertension, Pulmonary oedema, Red blood cell sedimentation rate increased, Renal impairment, Respiratory syncytial virus test negative, Streptococcus test negative, Toxoplasma serology, Toxoplasma serology negative, Troponin I increased, Ventricular assist device insertion, Weight increased, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Myocardial infarction (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Pulmonary hypertension (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (narrow), Proteinuria (narrow), Tubulointerstitial diseases (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2011-10-27
   Days after onset: 16
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: ASACOL; omega 3s; mvi
Current Illness: Ulcerative colitis well controlled and asymptomatic at the time
Preexisting Conditions: Ulcerative colitis; mild glaucoma
Allergies:
Diagnostic Lab Data: CRP, 25.92 (15 Oct); ESR, 79; 18 Oct labs: WBC, 24.4/87 neuts; Troponin I 12.40; BNP, 55321; CKMB, 63.8; CK, 501; ALT/AST, 2587/3549; creatinine, 2.7; phosphate, 7.9; ABG pH/ PO2CO2, 7.48/63/16.1; Antibody panels: Epstein-Barr virus nuclear Ab IgG serum, $g5.00; Epstein -Barr virus capsid Ab IgG serum, 2.7; Epstein-Barr virus capsid Ab IgM serum, <0.2; Epstein-Barr virus nuclear Ab IgG, $g8.0; Hepatitis B virus surface Ab serum Non reactive; Hepatitis B virus surface Ag serum Non reactive; Hepatitis B virus Core Ab IgM serum Non Reactive; Hepatitis C virus Ab serum Non reactive; nasopharyngeal swab 21 Oct: NO INFLUENZAE A/B, PARAINFLUENZA 1-3, adenovirus, or RSV isolated; HIV negative; Cytomegalovirus Ab IGG/IGM negative; Toxoplasma Ab IGG/IGM negative; Streptolysin O Ab negative; Lyme disease total ab screen negative; ECHO 18 Oct, - overall left ventricular systolic function severely reduced EF < 20%, - small circumferential pericardial effusion present, -mild pulm hypertension w/PA systolic pressure estimated at 40mmHg, - No cardiac tamponade, left ventricular wall thickness normal, LV cavity dimensions normal; CXR as above
CDC Split Type:

Write-up: 61 y/o stated he received injectable INFLUENZA vaccine on 4 Oct 2011. States he has received the flu shot every year with no problems as well as no adverse events with any other vaccinations in his career. PMH includes ulcerative colitis for which he took ASACOL. He developed this condition in the late ''90''s and it has been under good control with no active symptoms. Took ASACOL up until the time of hospitalization but was not given it after admitted. Pt was healthy and active, worked full time and ran 3-4 miles 5x/week and ran the 10 miler on Sunday 9 Oct''11. On Tues, 11 Oct he developed chills in the evening. He went to work the next day but by evening "wasnt feeling right". He stayed home from work on Thurs 13 Oct with chills, myalgias, headache, abdominal bloating and weakness. Denied having chest pain, fever, cough, sob. He got weighed and found he had gained 7 pounds. He continues to feel badly and went into primary care on Fri, 14 Oct where exam was normal, was diagnosed with the flu and was sent home with conservative tx. He went to the ER on Sat 15 Oct when he continued to feel worse: WBC 18 Neutrophils Troponin 3.6 (continuing to rise to current 8.24, BNP 38747, ALT 209, AST 147, CKMB 34.8. He was admitted to CCU with diagnosis of myocarditis with cardiac failure. Labs as of 18 Oct at hospital: creatinine 1.8, D-dimer 2.15, urine protein SSA positive, influenza A & B virus antigen negative via nasopharyngeal swab. Pt was SOB, slightly jaundiced, c/o bloating in abdomen and fatigued. P 94, 113/64 CXR shows enlarged cardiacmediastinal silhouette with bilat pul, consolidations. CXR had evolved to develop pleural effusion, clear evidence of pulmonary edema, and continued cardiomegaly. INPT treatment: LOPRESSOR, NEXIUM, PLAVIX, TAMIFLU, LASIX, O2, piperacillin/tazobactam. Transferred to another hospital on 18 Oct not only to receive dialysis due to worsening renal function, but also due to potential need for ECMO (extra-corporeal membrane oxygenation) as a bridge to LVAD (Left ventricular assist device). Update 21 Oct: pt continued to worsen, on ECMO, receiving steroids, unable to do heart biopsy due to worsening condition. Biventricular assist device inserted on 25 Oct at hospital. Patient died on 27 Oct. Titers/PCR pending on myocardial tissue. Path report returned yesterday showed giant cell myocarditis, no eosinophils. Additional labs pending from hospital to include parvo and coxackie abs.


VAERS ID: 441707 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Female  
Location: California  
Vaccinated:2009-12-22
Onset:2010-01-18
   Days after vaccination:27
Submitted: 2011-11-07
   Days after onset:658
Entered: 2011-11-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) / NOVARTIS VACCINES AND DIAGNOSTICS 102136P1A / UNK LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Chromaturia, Death, Dyspnoea, Haemolytic anaemia, Myocardial infarction, Renal failure, Splenectomy
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Haemolytic disorders (narrow), Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2010-02-01
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Full physical exam prior to vaccination with no negative report.
Preexisting Conditions: No other medical conditions.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 1/18/2010 red color in urine, 1/23/2010 out of breath, 1/24/2010 medical diagnosis was hemolytic anemia, 1/25/2010 condition became worse, 1/25/2010 admitted to hospital, surgery to take out spleen, 1/26-2/1/2010 kidneys failed, heart attack with death on second heart attack.


VAERS ID: 442054 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Missouri  
Vaccinated:2011-10-17
Onset:2011-10-18
   Days after vaccination:1
Submitted: 2011-11-10
   Days after onset:23
Entered: 2011-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B285EA / 1 LL / IJ
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH321AA / 1 RL / IJ
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 916972 / 1 RL / IJ
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS 41CB098A / 1 MO / PO

Administered by: Military       Purchased by: Military
Symptoms: Crying, Cyanosis, Death, Musculoskeletal stiffness, Peripheral coldness, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Arthritis (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-10-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: No illness at the time. Patient was crying after his shots, that was the only reaction he showed. No fevers all day. He went to sleep at his normal time. Woke up around 0230 am and my husband rocked him back to sleep. When my husband went to wake patient up, patient wasn''t breathing, he was blue in the lips and cold and stiff. He was pronounced dead at 0604 am on 10/18/2011.
Preexisting Conditions: n/a
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death


VAERS ID: 442306 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-11-10
Entered: 2011-11-14
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Herpes zoster
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-01-01
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Cardiac disorder
Preexisting Conditions: Hospitalisation
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1111USA00145

Write-up: Information has been received from a physician concerning a "little over 70 years old" male patient with heart disease who either in 2007 or 2008, was vaccinated with a dose of ZOSTAVAX (Merck) (lot number, dose and route not reported). The physician reported that either in 2007 or 2008 the patient developed shingles about 6 days after receiving the vaccine. The patient had some heart issues and had been hospitalized before getting the vaccine. Apparently the ZOSTAVAX (Merck) was given after the patient was released from the hospital but the physician did not know how soon after. Later on an unspecified date about 6 to 12 months after getting the vaccine the patient passed away. The physician reported that he thought the cause of death was the heart disease but he did not know for sure. Additional information has been requested.


VAERS ID: 442402 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Male  
Location: Oregon  
Vaccinated:2011-10-17
Onset:2011-10-17
   Days after vaccination:0
Submitted: 2011-11-14
   Days after onset:28
Entered: 2011-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1262AA / UNK RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4006AA / UNK RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B072EA / UNK RA / IM

Administered by: Private       Purchased by: Public
Symptoms: Death, Pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-10-20
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Depakote, Lyrica, Diazapam, Adderall
Current Illness: No
Preexisting Conditions: Seizure Disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Initial soreness and swelling. Death 10/20/2011.


VAERS ID: 443115 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2011-10-06
Onset:2011-10-28
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2011-11-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0675AA / 2 RA / UN

Administered by: Public       Purchased by: Public
Symptoms: Death, Diarrhoea, Escherichia infection
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2011-11-02
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: DEPAKOTE
Current Illness: None
Preexisting Conditions: Trisomy 21; epilepsy
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Diarrheal illness on 10/28/11 - transferred to hospital on 10/31/11. Died on 11/2/11 - dx with E-coli 0157 Huhs. She was Trisomy 21 (Downs) & epilepsy, well controlled with med.


VAERS ID: 443774 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-11-21
Entered: 2011-11-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Activated partial thromboplastin time prolonged, Ageusia, Asthenia, Biopsy bone marrow abnormal, Biopsy skin abnormal, Blood cortisol normal, Blood electrolytes normal, Blood fibrinogen decreased, Blood follicle stimulating hormone decreased, Blood gonadotrophin decreased, Blood luteinising hormone decreased, Blood osmolarity increased, Blood prolactin normal, Blood sodium increased, Blood thyroid stimulating hormone, Blood triglycerides normal, Cachexia, Colonic polyp, Colonoscopy abnormal, Computerised tomogram abdomen abnormal, Culture urine negative, Cytomegalovirus test negative, Death, Decreased appetite, Diabetes insipidus, Disseminated intravascular coagulation, Dysgeusia, Electrophoresis protein abnormal, Endoscopy gastrointestinal, Endoscopy gastrointestinal normal, Epstein-Barr virus antibody positive, Fatigue, Gastrointestinal haemorrhage, Haemoglobin decreased, Hepatosplenomegaly, Herpes simplex serology negative, High density lipoprotein increased, Histiocytosis haematophagic, Human herpes virus 6 serology negative, Hypergammaglobulinaemia, Hyperplasia, Hypothalamo-pituitary disorder, Influenza like illness, International normalised ratio increased, Iron deficiency anaemia, Laboratory test normal, Leukocytosis, Liver function test normal, Low density lipoprotein decreased, Lymphocyte percentage decreased, Macrophage activation, Marrow hyperplasia, Mean cell volume decreased, Monocyte percentage increased, Multi-organ failure, Neutrophil count normal, Nitrite urine absent, Nodule, Normochromic normocytic anaemia, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain abnormal, Parvovirus B19 test positive, Periarthritis, Platelet count decreased, Pollakiuria, Polydipsia, Polyuria, Protein total decreased, Pyrexia, Rash, Rash maculo-papular, Red blood cell sedimentation rate increased, Red cell distribution width increased, Reticulocyte percentage normal, Sepsis, Serum ferritin increased, Simplex virus test positive, Thirst, Thrombocytopenia, Thyroid function test normal, Thyroxine free normal, Transfusion, Urinary tract infection, Urine leukocyte esterase positive, Urine osmolarity decreased, Urine output increased, Urine sodium decreased, Weight decreased, White blood cell count increased, White blood cells urine positive
SMQs:, Liver related investigations, signs and symptoms (narrow), Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (broad), Dyslipidaemia (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal premalignant disorders (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific inflammation (broad), Hyponatraemia/SIADH (broad), Ischaemic colitis (broad), Skin tumours of unspecified malignancy (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Malignant lymphomas (broad), Arthritis (narrow), Myelodysplastic syndrome (broad), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Dehydration (broad), Hypokalaemia (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: vitamin D; lorazepam
Current Illness: hypertension
Preexisting Conditions: Risedronate sodium for osteoporosis; Alendronate sodium; Two infusions of zoledronic acid, her last one in Oct 2009; Gastric ulcer; Transient ischaemic attack; Computed tomography of the brain without contrast in Jul 2009 revealed small vessel ischemia
Allergies:
Diagnostic Lab Data: Biopsy bone marrow, significant, revealed a markedly hypercellular marrow (near 100% cellularity) with trilinear hyperplasia; biopsy skin, significant, the pathologic findings showed histiocyte collections within the epidermis and papillary dermis that stained positive for CD43; blood cortisol, 22,3 g/dL, high; blood follicle stimulating hormone, decreased low, 44 pg/mL; blood follicle stimulating hormone, decreased, 24.2 mlU/mL; blood luteinising hormone decreased, low, 11.2 mlU/mL; colonoscopy, significant, three non-bleeding polyps; computerised tomogram, significant, computed tomography of the abdomen and pelvis showed hepatosplenomegaly with heterogeneous enhancement suggestive of an infiltrative process; Epstein-Barr virus antibody positive, positive, IgG antibodies to Epstein-Barr virus (EBV) were also found at a low titer in our patient (EBV viral capsid antigen, 1:80; EBV early antigen, 1:20; and Epstein-Barr nuclear antigen, 1:10); haemoglobin, low, 9.1 g/dl; international normalised ratio, high, 1.39; nuclear magnetic resonance imaging, significant, magnetic resonance imaging (MRI) of the pituitary revealed a 4-mm nodular lesion within the left lobe of the pituitary gland, consistent with a possible pituitary micro adenoma; platelet count, significant, 134 x 103/?L; protein total decreased, low, 6.5 g/dl; red blood cell sedimentation rate, significant, 42 mm/hour; simplex virus test positive, positive; urine leukocyte esterase, 3+; urine output, 3990 ml; urine output, 2550 ml; white blood cell count, high, 20, 000/?L; white blood cells urine positive, high, 31
CDC Split Type: PHHY2011US100194

Write-up: Case number PHHY2011US100194 is an initial literature report received on 14 Nov 2011: The authors reported the first case of central diabetes insipidus associated with hemophagocytic lympho-histocytosis following vaccination with H1N1 vaccine. This report refers to a 75-year-old female patient. Her past medical history was significant for osteoporosis treated with risedronate for one year, then alendronate for one year, after which she received two infusions of zoledronic acid, her last one in Oct 2009. She had a history of gastric ulcer at age 60, a possible transient ischemic attack in Jul 2009, and hypertension. Computed tomography of the brain without contrast in Jul 2009 revealed small vessel ischemia. Her only medications were vitamin D, 50,000 IU once a month, and lorazepam, 0.5 mg, for anxiety. She was vaccinated with H1N1 vaccine (batch number and manufacturer: unknown) on an undetermined date in 2010. One month after vaccination she presented with flu-like illness in Mar 2010 and was treated with oseltamivir phosphate. However, within several days of developing this flu-like illness, she began to have polyuria associated with polydipsia and loss of appetite. A urine culture was negative. She was asked to record her urinary volume over a 24-hour period. On two successive days, her 24-hour urinary volumes were 3, 990 mL and 2, 550 mL respectively. An overnight dehydration test was performed, and her morning urine sodium concentration was 22 mEq/L, urine osmolarity was 145 mOsm/kg, serum sodium concentration was 147 mEq/L, and serum osmolarity was 314 mOsm/kg. She continued to complain of generalized weakness, loss of appetite, loss of taste for salt, excessive thirst, and frequent urination. She was found to have iron-deficiency anemia with an elevated erythrocyte sedimentation rate of 42 mm/hour (normal, less than 20 mm/hour). Her fasting serum gastric level was 44 pg/mL (normal, less than 200 pg/mL), serum prolactin level was 16.7 ng/mL (reference range, 1.9 to 25 ng/mL), and serum protein electrophoresis revealed a polyclonal gamma increase. Her follicle-stimulating hormone level was 24.2 mlU/mL (normal postmenopausal, more than 25) and luteinizing hormone level was 11.2 mlU/mL (normal postmenopausal , more than 20 mlU/mL). Thyroid and liver function tests were normal. Magnetic resonance imaging (MRI) of the pituitary revealed a 4-mm nodular lesion within the left lobe of the pituitary gland, consistent with a possible pituitary micro adenoma. In May 2010, she was started on intranasal 1-deamino-8-D-arginine vasopressin (DDAP) supplementation, one puff at bedtime, with marked improvement of her polyuria. A few days later she developed gastrointestinal bleeding and was hospitalized. She was found to have three non bleeding polyps on colonoscopy and had a negative capsule endoscopy. Her polyuria remained improved on DDAVP. In Aug 2010, she was readmitted with intermittent daily fevers that reached 39.5 degree Celsius, a white blood cell (WBC) count of 20, 000/L (reference range, 3, 500 to 9,000/L) with 65% neutrophils, 15% lymphocytes, 17% monocytes, and 3% band forms indicating leukocytosis, and a urinary tract infection (indicated by the presence of 3+ leukocyte esterase, no nitrites, and 31 WBCs on urinalysis). She had progressive fatigue and anorexia and had lost 3.6 kg in the past few months (from 49.5 to 45.9 kg). She appeared cachectic on examination. She was not orthostatic, acromegalic, or Cushingoid and demonstrated full visual fields. Her thyroid was not enlarged. There was a diffuse, maculopapular rash confluent on her torso and abdomen and palpable hepatosplenomegaly. Aside from leukocytosis, admission laboratory results were also notable for normocytic anemia (hemoglobin, 9.1 g/dL (reference range, 12 to 15.8 g/dL); mean corpuscular volume, 79.5 fl (reference range, 79 to 93 fL); red blood cell distribution width, 15.1% (normal, less than 14.5%), with absence of reticulocyte response (1.5%), mild thrombocytopenia (platelet count was 134 x 103/uL, reference rang 165 to 415 x103/uL), an elevated international normalized ratio of 1.39 (reference range, 0.86 to 1.16), and a partial thromboplastin time of 43.4 seconds (reference range, 24.4 to 37.9 seconds). Electrolytes and hepatic function tests were essentially normal with the exception of mildly reduced total protein 6.5 g/dL (reference range, 6.7 to 8.6 g/dL). Results of a fasting lipid panel were as follows: high-density lipoprotein, 3 mg/dL; low-density lipoprotein, 46 mg/dL; and triglycerides, 118 mg/dL. Assessment of the hypothalamic-pituitary-adrenal axis demonstrated a robust 8 am serum cortisol of 22.3 ug/dL (reference range, 5 to 21 ug/dL), normal thyroid function tests thyrotropin, as 2.43 mlU/L (reference range, 0.32 to 4.05 mlU/L) and free thyroxine as 1.09 ng/dL (reference range, 0.7 to 1.24 ng/dL), mildly suppressed gonadotropins for a postmenopausal woman (follicle-stimulating hormone, 10.4 mlU/mL and luteinizing hormone, 6.9 m;U/mL), and a normal prolactin level (22.5 ng/mL). Two MRIs of the brain with focused imaging of the sella region were performed at 1.5 Tesia before and after administration of contrast material. The overall appearance of the brain was unremarkable for a 75-year-old woman with history of mild hypertension. Specifically, no parenchymal brain mass and no abnormal parenchymal or meningeal enhance, enhancement affected the cerebrum, brainstem, or cerebellum. The ventricular size was normal. There was focal thickening of the pituitary infundibulum extending to its insertion into the hypothalamus. This finding was most obvious as plaque like contrast enhancement surrounding the infundibulum. The pituitary gland was of normal size. The posterior pituitary signal intensity was a bit lower and more heterogeneous than normal. The pituitary gland enhanced somewhat heterogeneously post contrast administration, but there was no clear evidence of microadenoma. The sella and the remainder of the hypothalamus were entirely unremarkable. These findings were similar on both MRI exams performed. The patient remained febrile despite the escalation of her antibiotics to treatment with piperacillin and tazobactam. Polydipsia and polyuria remained well-controlled on DDAVP. Dermatology was consulted and performed a skin biopsy; the pathologic findings showed histiocyte collections within the epidermis and papillary dermis that stained positive for CD43. Computed tomography of the abdomen and pelvis showed hepatosplenomegaly with heterogeneous enhancement suggestive of an infiltrative process. Her leukocytosis progressively increased to a WBC count of 93, 800/uL with worsening anemia (hemoglobin, 6.1 g/dL) and thrombocytopenia (platelet count, 12 x 103/uL) requiring transfusions. Oncology was consulted and performed a bone marrow biopsy, which revealed a markedly hypercellular marrow (nearly 100% cellularity) with trilinear hyperplasia. CD68 (PGM1) immunostaining demonstrated florid histiocytosis and hemophagocytosis in the marrow - pathognomonic of hemophagocytic lymphohistiocytosis (HLH) without evidence of malignancy. CD1 a staining for Langerhans cell histiocytosis (LCH) was negative. Herpes simplex virus 1 DNA was detected at a low titer in her serum; herpes simplex virus 2, human herpes virus 6, and cytomegalovirus DNA were not detected. IgG antibodies to parvovirus B19 were present, but there was no evidence of current infection. IgG antibodies to Epstein-Barr virus (EBV) were also found at a low titer in our patient (EBV viral capsid antigen, 1:80; EBV early antigen, 1:20 and Epstein-Barr nuclear antigen, 1:10), as was a very low copy number of EBV DNA by quantitative polymerase chain reaction (100 DNA copies/mL, assay range, 100 10 1 x 10^10 copies/mL). She had an elevated ferritin level. She was started on etoposide and dexamethasone for treatment of HLH, but soon died of multiorgan failure die to sepsis and disseminated intravascular coagulation despite cryoprecipitate and blood product support. Even though the patient had normal fibrinogen levels previously, she had low level (96mg/dL) on the morning of her death. The patient''s family declined a postmortem examination. The authors concluded that the patient demonstrated no evidence of either autoimmunity or malignancy despite her marked leukocytosis, EBV was commonly reported to be associated with secondary HLH, but most herpes viruses had been reported to cause this rare syndrome so it was possible that either EBV or herpes simplex virus 1 might have bee the trigger for macrophage activation in this patient. It was of interest, however, that this patient developed a flulike illness 1 month after receiving the H1N1 vaccine. The authors further commented that HLH should be added to the differential diagnosis in a patient with new onset central diabetes insipidus, especially after febrile illness. Whether this patient''s illness was related to the vaccination or was purely coincidental was speculative, but worth noting.


VAERS ID: 443611 (history)  
Form: Version 1.0  
Age: 5.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-11-23
Entered: 2011-11-28
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011283285

Write-up: This is a spontaneous report from a contactable nurse communicated to a Pfizer sales representative. A 5-year-old patient (gender unknown) received a dose of PREVNAR 13 on an unknown date. Relevant medical history and concomitant medications were not provided. On an unknown date, the patient developed a Streptococcus pneumoniae infection and died. It is unknown if an autopsy was performed. No further information was provided.


VAERS ID: 443669 (history)  
Form: Version 1.0  
Age: 66.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-11-22
Entered: 2011-11-28
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Drug administered to patient of inappropriate age, Dyspnoea, Interstitial lung disease, Pulmonary hypertension
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had several underlying conditions.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201111265

Write-up: This case was retrieved via a search of scientific literature on 11 November 2011. The reporter for this case is the same for case numbers: 2011-11264, 2011-11267, 2011-11271, 2011-11272 and 2011-11371. "Background: TDAP vaccine was not licensed for use in adults aged greater than or equal to 65 years due to lack of sufficient efficacy and safety data. To characterize reports to the Vaccine Adverse Event Reporting System (VAERS) among adults aged greater than equal to 65 years who received TDAP vaccine ''off label'' to assess for potential vaccine safety concerns. We searched VAERS for reports of adverse events (AEs) in subjects aged greater than or equal to 65 years who received TDAP vaccine from 9/1/2005 to 9/08/2010. Medical records were requested for all reports cases as serious (death, hospitalization, prolonged hospitalization, permanent disability, life-threatening illness). Proportional reporting ratio (PRR) was used to assess for higher proportionate reporting for AEs after TDAP compared with Td reports in subjects aged greater than or equal to 65 years. VAERS received 243 reports following TDAP administered to persons aged greater than or equal to 65 years. Eleven (4.5%) reports were serious, including two deaths. Most common AEs were local reactions in 100 (41.2%) reports. Seventy-eight (32.1%) reports contained coding terms that denoted inappropriate administration of vaccine. ''Cough'' was the only term associated with disproportionately higher reporting after TDAP compared with Td. Six of seven Tdap reports containing the term ''cough'' were non-serious. Clinical review of serious reports identified no unusual patterns of AEs. Our VAERS review of the ''off label'' use of TDAP vaccine in adults greater than or equal to 65 years did not find any safety concerns that warrant further study. These date will provide useful baseline information to assist CDC and FDA with monitoring efforts as permissive recommendations for TDAP in older persons are adopted." A 66-year-old female had received DTAP vaccine (manufacture, lot number, route site and date of administration not reported) and two days after vaccination, presented with shortness of breath, which worsened in the following six weeks. The patient died two months after vaccination; the cause of death was indicated to be pulmonary hypertension due to acute interstitial lung disease. Documents held by sender: None.


VAERS ID: 443712 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Male  
Location: Washington  
Vaccinated:2011-11-15
Onset:2011-11-23
   Days after vaccination:8
Submitted: 2011-11-28
   Days after onset:5
Entered: 2011-11-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV294 / 1 UN / UN
SMALL: SMALLPOX (ACAM2000) / SANOFI PASTEUR VV040003A / 1 UN / -
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR B1026 / 1 UN / UN

Administered by: Military       Purchased by: Military
Symptoms: Activated partial thromboplastin time prolonged, Blood creatine phosphokinase increased, Blood creatinine increased, Blood fibrinogen decreased, Body temperature increased, Cardioversion, Disseminated intravascular coagulation, Encephalopathy, Hepatic enzyme increased, Intensive care, Leukocytosis, Loss of consciousness, Pain, Prothrombin time prolonged, Renal failure, Rhabdomyolysis, Thrombocytosis, Troponin I increased
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (narrow), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Liver-related coagulation and bleeding disturbances (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (narrow), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2011-11-28
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None listed and all AHLTA meds not active. Was given doxycycline for malaria prophylaxis on SRP note--but would not have taken it until 2 days prior to deployment.
Current Illness: None recorded
Preexisting Conditions: allergy to primaquine and G6PD deficient
Allergies:
Diagnostic Lab Data: Leukocytosis, thrombocytosis, decreased fibrinogen and prolonged PT/PTT, elevated liver enzymes, Increased Cr, Increased CKs, transient elevated TNIs
CDC Split Type:

Write-up: Per records, patient was in 5 mile run and passed out--HR$g180s and T~102.9 - adenosine and cardioversion with IVF-admitted to ICU-placed on broad spectrum Abx and Cx drawn. Progressive, rhabdomyolysis, DIC, renal failure, pain, and encephalopthy. Tx with cryo, ffp, fluids, pressors and ultimately transferred to another facility.


VAERS ID: 443738 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Missouri  
Vaccinated:2011-11-18
Onset:2011-11-26
   Days after vaccination:8
Submitted: 2011-11-28
   Days after onset:2
Entered: 2011-11-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B315AA / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0487AA / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 916976 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0919AA / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-11-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: eye drops
Current Illness: None (resolving conjunctivitis)
Preexisting Conditions: ? laryngomalacia
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Died of apparent SIDS.


VAERS ID: 444038 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Nevada  
Vaccinated:2011-11-08
Onset:2011-11-11
   Days after vaccination:3
Submitted: 2011-11-30
   Days after onset:19
Entered: 2011-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB441BA / 2 RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Cardiomyopathy, Death, Fatigue, General physical health deterioration, Hepatorenal failure, Laboratory test abnormal, Life support, Multi-organ failure, Nausea, Vomiting
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (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 (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (narrow), Chronic kidney disease (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2011-11-29
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 15 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: NO ILLNESS WAS REPORTED TO MD AT TIME OF IMMUNIZATION VISIT BUT FAMILY LATER REPORTED CONFLICTING AND VAGUE RECOLLECTIONS OF INTERMITTENT FLU LIKE SYMPTOMS AND FATIGUE OVER A 3 WK PERIOD PRIOR TO THE VACCINATION VISIT
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: EXTENSIVE MULTIPLE SYSTEMIC WORKUP / MULTIPLE ORGAN FAILURE: CARDIOMYOPATHY, HEPATO-RENAL FAILURE.
CDC Split Type:

Write-up: ER VISIT C/O VOMITING NAUSEA ALSO REPORTING SIMILAR SYMPTOMS INTERMITTENTLY OVER PAST THREE DAYS-DISCHARGED HOME AFTER UNEVENTFUL ER WORK UP. RETURNED TO CLINIC FOR FOLLOW UP 11/14 AND REPORT OF INCREASING FATIGUE AND SIMILAR SYMPTOMS OVER PREVIOUS THREE WEEKS. ADMITTED TO HOSPITAL. RAPID DETERIORATION AND EMERGENCY XFER BY LIFE FLIGHT TO HIGHER LEVEL OF CARE$g MULTIPLE ORGAN FAILURE $g LIFE SUPPORT $g SUBSEQUENT DEMISE 11/29 AT OTHER HOSP.


VAERS ID: 444090 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2011-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201111326

Write-up: Initial report received on 17 November 2011 via search of the literature. This case involved reports received through 01 March 2010 by the CDC of pregnant women who were vaccinated with the 2009 H1N1 vaccine (trade name, manufacturer name and lot number not reported) during 01 October 2009 through 28 February 2010. Some of these patients (31/294 patients) may have also received a dose of seasonal INFLUENZA vaccine (trade name, manufacturer name and lot number not reported). Non-country reports were excluded. Include in the reports were AEs in neonates of the report indicated their mother had received 2009 H1N1 vaccine during pregnancy. One of those patients was born with congenital anomaly and has been captured in case number 2011-11325. Information regarding that patient''s mother has been captured in case number 2011-11324. Regarding this case: Characteristics of the reports (which included all 294 patients that were vaccinated) were received by the CDC of pregnant women vaccinated 01 October 2009 through 28 February 2010: 60/294 reports were serious; 2/294 involved deaths (1 patient died from ruptured aortic aneurysm, and one patient died from hemorrhagic shock. In both cases the neonates were born alive); median maternal age of patients was 30 years of age (age range 15.0-46.0 years); median onset interval for onset of adverse and serious adverse events was 2 days (range 0-84.0 days); Median gestational age (in weeks) at time of vaccinations was 13 weeks (range 3.0-39.0 weeks) with 133/247 patients in the first trimester of pregnancy, 67/247 in the second trimester and 42.247 in the third trimester. Adverse events that had been reported after vaccinations included: Pregnancy-specific outcomes: SAB (121; 41.2%); Stillbirth (19; 6.5%); preterm delivery (7; 2.4 %); threatened abortion (4; 1.4%); preterm labor (3; 1.0%); maternal death (2; 0.7%); preeclampsia (2; 0.7%); intrauterine growth restriction (2; 0.7%); fetal hydronephrosis (1; 0.3%); fetal tachycardia (1; 0.3%); cleft lip (1:0.3%); neonatal intraparenchymal hemorrhage (1; 0.3%); and intrauterine fetal death (1; 0.3%). Non-pregnancy-specific outcomes included allergic reactions other than anaphylaxis (36; 12.2 %); general or constitutional symptoms (28; 9.5%); local reactions (10; 3.4%); paresthesias (8; 2.7%); Bell''s Palsy (5; 1.7%); syncope (5; 1.7%); dizziness (5; 1.7%); hypoesthesia (3; 1.0%); headache (3; 1.0%); anaphylaxis (1;0.3%); and other (25; 8.5%, which included anxiety, arthralgia, asthenia, arthritis, blurred vision, chest pain, chronic bronchitis, cough, diarrhea, dyspnea, eye swelling, influenza, influenza-like illness, lip injury, nail bleeding, panic attack, shingles, wheezing, tachycardia, tremors, unusual taste, upper respiratory infection, wheezing). Risk factors for the SABs (which were 95) and stillbirths (which were 18) included advanced maternal age, smoking, history of intrauterine fetal death, hypothyroidism, diabetes mellitus, urinary tract infection, alcohol or drug use, obesity, and "other" (which included chlamydia infection and complicated pregnancy, congenital malformations in past pregnancies, uncontrolled diabetes, chronic hypertension, positive Down Syndrome screening, k chronic hypertension, and macrocytic hyperchromic anemia). Recovery status was not reported for any of the patients. The following is verbatim from the published summary of the article regarding all patients: "Background and Objective: In April 2009, H1N1 virus infection( 2009 H1N1) was identified. The Advisory Committee on Immunization Practices recommended that pregnant women (in any trimester) be included as an initial target group for 2009 H1N1 vaccination. Monitoring adverse events (AEs) following 2009 H1N1 vaccine administration in pregnant woman was a priority for the Centers for Disease Control and Prevention (CDC) in collaboration with the Food and Drug Administration (FDA). Raid surveillance was conducted for adverse events reported to Vaccine Adverse Event Reporting System (VAERS) in pregnant women who received H1N1 vaccines to assess for potential vaccine safety problems. Materials and Methods: The VAERS, established in 1990, is jointly administered by the CDC and FDA. VAERS generally cannot assess whether a vaccination caused an AE but can identify possible vaccines safety problems for further investigation. Reports are classified as serious, based on the Code of Federal Regulations, if they result in death, life-threatening illness, hospitalization or prolongation of hospitalization, permanent disability, or congenital anomaly. As part of the federal response to monitor the safety of 2009 H1N1 vaccine, VAERS was enhanced in several ways. VAERS reports received through March 1, 2010, on pregnant women vaccinated with 2009 H1N1 vaccine from Oct.1, 2009, through Feb. 28, 2010 were analyzed. Included were reports of AEs in neonates if the report indicated that their mothers had received the 2009 H1N1 vaccine during pregnancy. All VAERS reports for pregnant cases were manually reviewed. Medical records were requested for all reports that suggested the vaccinee was pregnant at the time of receipt of the 2009 H1N1 vaccine or that concerned infants born to mothers who had received 2009 H1N1 vaccine during pregnancy. Reporting rated of AEs in pregnant women were calculated by dividing the number of AEs by the estimated number of inactivated 2009 H1N1 vaccines doses administered to pregnant women during the time period were covered in this review. RESULTS: From Oct. 1, 2009, through Feb.28, 2010, VAERS received 294 reports; 288 followed inactivated and 6 followed live vaccines. Sixty reports (20.4%) were coded as serious, including 2 maternal deaths. Serious reports corresponded to 59 pregnant women who were hospitalized for any reason and 1 to an infant born with a congenital anomaly. The 2009 H1N1 vaccine was reported as administered mostly during the first (133; 53.9%) or second trimester of pregnancy (67; 27.1%). The most frequent pregnancy-specific AE reported following 2009 H1N1 vaccine administration was spontaneous abortion (SAB) in 121 women (41.2% of reports), followed by stillbirth in 19 women (6.5% of reports). Ninety-five SABs (78.5%) and 18 stillbirths (94.7%) were verified by review of medical records. Five fetal adverse outcomes were reported. Risk factors for SAB were identified in 47 of the 95 verified reports (49.5%). The most common risk factor was maternal age 35 years or older in 25 (26.3%) reports. Of 18 stillbirths with verified diagnosis, 13 (72.2%) had at least 1 maternal risk factor for stillbirth or a pathologic finding that may have contributed to the fetal demise. The overall reporting rate of AEs to VAERS in pregnant women after inactivated 2009 H1N1 vaccine was 118.2 reports per 1 million pregnant women vaccinated. The reporting rates for SABs and stillbirths were 49.2 and 7.8 reports, respectively, per 1 million pregnant women vaccinated. Table of adverse events (presented in the article) were based on main diagnosis following medical chart review. The events included: Pregnancy-specific outcome of SAB (121; 41.2%); stillbirth (19; 6.5%); preterm delivery (7; 2.4%); threatened abortion (4; 1.4%); preterm labor (3; 1.0%); maternal death (2; 0.7%); preeclampsia (2; 0.7%); intrauterine growth restriction (2; 0.7%); fetal hydronephrosis (1; 0.3%); fetal tachycardia (1; 0.3%); cleft lip (1; 0.3%); neonatal intraparenchymal hemorrhage (1; 0.3%); and intrauterine fetal death (1; 0.3%). Non-pregnancy-specific outcomes included allergic reactions other than anaphylaxis (36; 12.2%); general or constitutional symptoms (28; 9.5%); local reactions (10; 3.4%); paresthesias (8; 2.7%); Bell''s Palsy (5; 1.7%); syncope (5; 1.7%); dizziness (5; 1.7%); hypoesthesia (3; 1.0%); headache (3; 1.0%); anaphylaxis (1; 0.3%); and other (25; 8.5%, Includes anxiety, arthralgia, asthenia, asthma, arthritis, blurred vision, chest pain, chronic bronchitis, cough, diarrhea, dyspnea, eye swelling, influenza, influenza-like illness, lip injury, nail bleeding, panic attack, shingles, sneezing, tachycardia, tremors, unusual taste, upper respiratory infection, wheezing). Comment: From October 2009 through February 2010, approximately 3% of reports to VAERS after 2009 H1N1 vaccine were of pregnant women who experienced at least 1 AE after vaccination. Among these 294 reports of AEs, no unusual patterns of adverse maternal or fetal outcomes were observed. The most common pregnancy-specific AE reported was SAB. In the review of medical records, more than an third of women who experienced a SAB had at least 1 risk factor, the most common being advance maternal age. The second most common pregnancy specific AE was stillbirth. Careful review of medical records revealed that 72% of those women had at least 1 risk factor or a pathologic finding in the fetus or placenta, suggesting factors other than vaccination that may have contributed to the fetal demise. SAB is a relatively frequent event in pregnancy, with a rate as high as 22.4% in women aged 34 years or older and 10.4% in women younger than 25 years. Stillbirths occur at a background rate of 0.4% of all pregnancies or 6.22 per 1000 live births and fetal deaths. There is underreporting to VAERS in general and the proportion of AEs following immunization among pregnant women that are reported to VAERS is unknown. Nonetheless, the reporting rates to VAERS for SABs and stillbirths after H1N1 vaccines was several orders of magnitude lower than the expected rates of fetal losses in the general population of pregnant women during a time of heightened awareness about vaccine safety. The VAERS data provided no indication that the occurrence of SAB and stillbirths following INFLUENZA vaccination was higher than in the general population. Other AEs observed in pregnant women were mostly nonserious and were similar to those reported in a preliminary review of the safety of 2009 H1N1 vaccines among the general population. VAERS is a passive surveillance system that may be prone to biased reporting (over-or underreporting) and inconsistency in the quality and completeness of reports. VAERS generally cannot determine whether a vaccine caused an AE. Stimulated reporting can occur following publicity around a potential AE. One important limitation of VAERS is that it collects data only on vaccinated individuals who have experienced an AE. The total vaccinated population is not known with certainty and therefore incidence rates of AE cannot be directly calculated. Review of VAERS reports following 2009 H1N1 vaccination had provided a comprehensive and rapid assessment of the safety of inactivated 2009 H1N1 vaccine among pregnant women during a period when INFLUENZA vaccine coverage during pregnancy was at its highest recorded levels. Clinical Implications: 1) No unusual patterns of adverse maternal or fetal outcomes were observed in pregnant women who received influenza A 2009 monovalent vaccines and who reported to the Vaccine Adverse Event Reporting System (VAERS). 2) The reporting rates of spontaneous abortion and stillbirth were markedly lower than the expected number of fetal losses in the general population of pregnant women, probably because of underreporting in VAERS. 3) VAERS generally cannot assess whether a vaccination caused an adverse event but can identify possible vaccine safety problems for further investigation. 4) Findings in passive surveillance systems such as VAERS need to be interpreted with caution, given their inherent limitations, such as over-underreporting, biased reporting, and inconsistency in quality and completeness of reports." Documents held by sender: None.


VAERS ID: 444950 (history)  
Form: Version 1.0  
Age: 7.0  
Sex: Female  
Location: Vermont  
Vaccinated:2011-12-02
Onset:2011-12-03
   Days after vaccination:1
Submitted: 2011-12-08
   Days after onset:5
Entered: 2011-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH476AD / UNK LA / IM

Administered by: Unknown       Purchased by: Other
Symptoms: Autopsy, Culture negative, Death, Dyspnoea, Influenza like illness, Lethargy, Microscopy, Pain, Pyrexia, Resuscitation, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-12-06
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: no
Preexisting Conditions: no
Allergies:
Diagnostic Lab Data: Gross Autopsy negative. Preliminary cultures negative Pending Microscopic examination
CDC Split Type:

Write-up: Went for well child check 12/2 no issues flu vaccination given. Next day developed flu like illness with fever 102.3, body aches lethargy, treated with Tylenol and Motrin, symptoms waxed and waned got significantly worse Tuesday 12/6/11 with dyspnea. Patient went unresponsive on way to pediatrician emergent resuscitation and died 12/6/11.


VAERS ID: 444965 (history)  
Form: Version 1.0  
Age: 97.0  
Sex: Female  
Location: Idaho  
Vaccinated:2011-11-30
Onset:2011-12-02
   Days after vaccination:2
Submitted: 2011-12-08
   Days after onset:6
Entered: 2011-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4147CA / UNK - / IM

Administered by: Private       Purchased by: Other
Symptoms: Anxiety, Breath sounds abnormal, Cardiac failure congestive, Condition aggravated, Dyspnoea, Oedema peripheral, Rales
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-12-04
   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: Lasix, aldactone, Lanoxin, valproic acid, Senocot, Miralax
Current Illness: End-stage CHF- health declining
Preexisting Conditions: No known allergies
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Exacerbated CHF x 6 weeks with multiple changes in medications. ON continuous O2. 12/2 Extremely dyspnic with anxiety. Crackles right lung, diminished breath sounds. Increased peripheral edema.


VAERS ID: 445440 (history)  
Form: Version 1.0  
Age: 52.0  
Sex: Male  
Location: Vermont  
Vaccinated:2011-11-17
Onset:2011-12-08
   Days after vaccination:21
Submitted: 2011-12-14
   Days after onset:6
Entered: 2011-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB208AA / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Acute hepatic failure, Alanine aminotransferase increased, Analgesic drug level therapeutic, Aspartate aminotransferase increased, Computerised tomogram abnormal, Hepatic steatosis, Hepatitis C antibody positive, International normalised ratio increased, Terminal state, White blood cell count increased
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Liver-related coagulation and bleeding disturbances (narrow), Liver infections (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2011-12-16
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: none that we are aware of
Preexisting Conditions: medical history unremarkable aside from psychiatric disorder
Allergies:
Diagnostic Lab Data: As of 12/14 death is imminent. Hep C IgM positive. On admission: WBC 10,200, INR 10.1, SGOT 7209, SGPT 11359, acetaminophen <10, CT shows diffuse fatty infiltrates.
CDC Split Type:

Write-up: Acute hepatic failure, question etiology, r/o relationship to recent Hepatitis A and Hepatits B vaccinations.


VAERS ID: 445447 (history)  
Form: Version 1.0  
Age: 45.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2011-12-05
Onset:2011-12-06
   Days after vaccination:1
Submitted: 2011-12-14
   Days after onset:8
Entered: 2011-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH476AD / UNK LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-12-09
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown at this time
CDC Split Type: MA1103

Write-up: PT became ill and reported to have gone to the ER.


VAERS ID: 445693 (history)  
Form: Version 1.0  
Age: 1.01  
Sex: Male  
Location: D.C.  
Vaccinated:2011-11-28
Onset:2011-12-02
   Days after vaccination:4
Submitted: 2011-12-16
   Days after onset:14
Entered: 2011-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C39999AA / 4 RL / IM
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 1068AA / 1 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0513AA / 1 RL / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 916921 / 4 LL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0950AA / 1 LL / SC

Administered by: Unknown       Purchased by: Public
Symptoms: Coagulopathy, Epistaxis, Haemoptysis, Peritoneal dialysis, Platelet count decreased, Renal failure acute, Respiratory failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (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), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Pulmicort, Albuterol, Poly-vi-sol with iron, ibuprofen
Current Illness: no
Preexisting Conditions: Prematurity (born at 29 weeks gestation) Hx of thrombocytopenia and hepatitis in NICU - resolved Asthma/chronic lung disease Developmental delay
Allergies:
Diagnostic Lab Data: unknown - evaluation at Hospital
CDC Split Type:

Write-up: Patient traveled to another country on 12/1/11. Following day, began bleeding from his nose and coughing up blood. Found to have low platelets and profound coagulopathy. Subsequently has developed respiratory failure and acute renal failure requiring peritoneal dialysis. No infectious or other etiology identified to date.


VAERS ID: 445775 (history)  
Form: Version 1.0  
Age: 0.42  
Sex: Male  
Location: Texas  
Vaccinated:2011-12-08
Onset:2011-12-12
   Days after vaccination:4
Submitted: 2011-12-19
   Days after onset:7
Entered: 2011-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4083AA / 2 LL / -
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 917737 / 2 RL / -
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1347AM / 2 - / -

Administered by: Private       Purchased by: Private
Symptoms: Death, Pyrexia, Sudden infant death syndrome
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-12-13
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received vaccines in office on 12/08/2011. Patient''s mother stated he ran a low-grade fever of 100-101 that evening and was treated with Tylenol twice. No fever after that. Child passed away on 12/12/2011 of suspected SIDS.


VAERS ID: 445896 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-12-19
Entered: 2011-12-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (CSL)) / CSL LIMITED - / UNK UN / UN
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011030535

Write-up: This literature report (initial receipt 10-Dec-2011) concerns patients who were vaccinated with 2009-2010 seasonal influenza or 2009-H1N1 inactivated or live attenuated (WAVES 2011030534) vaccines from 01-Jul-2009 through 31-Jan-2010 and reported to VAERS (Vaccine Adverse Event Reporting System). There were 48 deaths with reported cause of death category after record review of cardiac, infectious, multiple systems, neurologic, motor vehicle accident, pregnancy complication, respiratory and unknown. Results of clinical review of death, cardiovascular conditions were the most common reported cause of death (22 reports). Underlying medical conditions and risk factors for cardiovascular disease, were present among 94% (45/48) of the patients who died. In some cases the cause of death was clearly unrelated to vaccination (e.g. meningococcal sepsis, ruptured aortic aneurysm). Molecular testing did not identify vaccine strain virus in lung tissue for the three individuals tested and who received live, attenuated 2009-H1N1 vaccine. No deaths from anaphylaxis were reported. There were 8 death reports where the patient also received seasonal influenza and H1N1 vaccination on the same day. There were 99 verified reports of GBS (Guillain-barre syndrome), 24 had received seasonal influenza vaccine on the same day or within 30 days of the 2009-H1N1 vaccine (live attenuated or inactivated). The author also verified 117 reports of anaphylaxis, 15 had received seasonal influenza and H1N1 vaccine (live attenuated or inactivated) on the same day. The event outcome was not reported. The adverse event profile after 2009-H1N1 vaccine in VAERS was consistent with that of seasonal influenza vaccines.


VAERS ID: 446200 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-12-22
Entered: 2011-12-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
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? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Risk factor(s): Advanced maternal age, Smoking, History of Intra-uterine fetal death, Hypothyroidism, Diabetes Mellitus, Urinary tract infection, Alcohol use, Drug use, Obesity, Type 1 diabetes, Type II diabetes, History of gestational diabetes, Chlamydia infection and complicated pregnancy, Congenital malformations in past pregnancies, Uncontrolled diabetes, Chronic hypertension, positive Down''s Syndrome screening, macrocytic hyperchromic anaemia. Pregnant: Yes. Result: STILL BIRTH.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011030537

Write-up: This literature report (initial receipt 14-Dec-2011) concerns VAERS (Vaccine Adverse Event Reporting System) reports received through 01-Mar-2010, on pregnant women who were vaccinated with the H1N1 during 01-Oct-2009 through 28-Feb-2010. Foreign reports were excluded. The author included reports of AEs (adverse events) in neonates if the report indicated that their mothers had received H1N1 during pregnancy. Risk factors for spontaneous abortions included the following; advanced maternal age equal or $g35 years (25 patients), smoking (7 patients), history of intrauterine fetal death (4 patients), hypothyroidism (4 patients), diabetes mellitus type 1 (1 patient), diabetes mellitus type II (1 patient), history of gestational diabetes (1 patient), alcohol or drug use (2 patients), obesity (1 patient) and other (1 patient). ''Other'' risk factors for spontaneous abortions were defined as the following; chlamydia infection with complicated pregnancy. Risk factors for stillbirth included the following; advanced maternal age equal or $g35 years (5 patients), smoking (3 patients), history of intrauterine fetal death (2 patients), diabetes mellitus type 1 (1 patient), history of gestational diabetes (1 patient), alcohol or drug use (4 patients), obesity (3 patients) and other (7 patient). ''Other'' risk factors for stillbirth included the following; congenital malformations in past pregnancies, uncontrolled diabetes, chronic hypertension, positive Down Syndrome screening and macrocytic hyperchromic anaemia. From 01-Oct-2009 through 28-Feb-2010, VAERS received a total of 10,186 reports after H1N1 vaccination; 422 of these reports involved pregnant women. The author excluded 128 pregnancy reports in which no AE was reported after the administration of inactivated or live H1N1. These pregnant women are being followed up prospectively as part of a separate CDC (Centres for Disease Control and Prevention) study that seeks to assess delivery and infant outcomes. Of the remaining 294 reports, 288 followed inactivated and 6 followed live vaccines. Median maternal age was 30 years (range 15 - 46 years). Median onset interval (adverse event onset date and vaccination date) was 2 days (range 0 - 84 days). Median gestational age at time of vaccination was 13 weeks (range 3 - 39 weeks). The H1N1 was reported as administered mostly during the first (133; 53.8%) and second trimester of pregnancy (67; 27.1%). In 31 reports (10.5%), the H1N1 was administered on the same date as the seasonal influenza vaccine (WAVES 2011030539). Sixty reports (20.4%) were coded as serious, including 2 maternal deaths. Serious reports corresponded to 59 pregnant women who were hospitalized for any reason and 1 to an infant born with a congenital anomaly. The most frequent pregnancy-specific AE reported following H1N1 administration was SAB (spontaneous abortion) in 121 women (41.2% of reports), followed by stillbirth in 19 women (6.5% of reports), preterm delivery of 7 women (one case of preterm delivery where the infant of one mother died approximately 1 month after delivery), threatened abortion in 4 women, preterm labor in 3 women, maternal death in 2 women, preeclampsia in 2 women, intrauterine growth restriction in 2 women, fetal hydronephrosis in 1 woman, fetal tachycardia in 1 woman, cleft lip in 1 woman, neonatal intraparenchymal hemorrhage in 1 woman and intrauterine fetal death in 1 woman. Most SAB reports (n = 62) were received in Nov-2009 but reporting rapidly declined thereafter. All stillbirths were reported during Oct-2009 and Nov-2009 with 10 and 9 reports, respectively. In 42.4% of the SAB reports, the onset interval from the day of vaccination to onset of AE was 0-3 days (61 reports with onset of 0-6 days). In 47.4% of stillbirth reports, the onset interval was 0-6 days. The author did not observe any clustering of SAB or stillbirth cases by geographic location or lot number. Ninety-five SABs (78.5%) and 18 stillbirths (94.7%) were verified by review of medical records. Five fetal adverse outcomes were reported: 2 cases of intrauterine growth restriction and 1 case each of hydronephrosis, tachycardia, and cleft lip. The maternal deaths included 1 patient who experienced hemorrhagic shock because of uterine atony following a cesarean section and 1 patient who experienced a ruptured aortic aneurysm, which resulted in cardiac tamponade and subsequent death. A mild fetal hydronephrosis was detected in the patient during an ultrasound exam at 36 weeks'' gestation. However a postnatal ultrasound examination of the infant performed on day 2 of life failed to confirm the presence of hydronephrosis. Cause of death was not reported. Only 1 congenital anomaly was reported to VAERS: a cleft lip in an infant born to a 23 year old woman who was vaccinated at 19 weeks'' gestation. The cleft lip was first detected during a prenatal ultrasound examination at 22 weeks'' gestation. Cause of death was not reported. Because cleft lip was embryologically determined during the first trimester of pregnancy, it is implausible to consider vaccination at 19 weeks'' gestation as a possible causative agent. The most common non pregnancy specific AEs were non anaphylactic allergic reactions (36), constitutional symptoms (28), and local reactions (10). Two hundred thirty-five of the total reports (79.9%) did not require hospitalization. Five cases of Bells'' palsy and 1 case of anaphylaxis (meeting Brighton Collaboration case definition) were reported. No cases of Guillain-Barre syndrome were identified. There were 8 cases of paraesthesia''s, 5 cases each of syncope and dizziness, 3 cases each of hypoesthesia and headache and 25 cases of ''other'' Other events included anxiety, arthralgia, asthenia, asthma, arthritis, blurred vision, chest pain, chronic bronchitis, cough, diarrhoea, dyspnoea, eye swelling, influenza, influenza-like illness, lip injury, nail bleeding, panic attack, shingles, sneezing, tachycardia, tremors, unusual taste, upper respiratory tract and wheezing. One hundred twenty-one cases of SAB after H1N1 vaccination were reported to VAERS (120 after inactivated and 1 after live vaccine), of which 95 were verified. Medical records were not received for 16 reports, and in 10 reports, the available records were not sufficient to confirm the initial diagnosis of SAB. Risk factors for SAB were identified in 47 (49.5%) of the 95 verified reports. Thirty-six women had only 1 risk factor for SAB. The most common risk factor was advanced maternal age (defined as age $g or = 35 years) in 25 reports (26.3%). Nineteen stillbirths were reported to VAERS. Of 18 with verified diagnosis, 13 (72.2%) had at least 1 maternal risk factor for stillbirth (eg, obesity) or a pathological finding that may have contributed to the fetal demise. Fourteen of 18 reports had pathology reports. Pathological/placental or other findings were present in 13 of the 14 reports and included chorioamnionitis in 7 reports and 2 reports each of tight nuchal cord, fetal-maternal hemorrhage, and fetal growth restriction. Of note, the 6 adverse event cases involving live H1N1 included 1 case of spontaneous abortion, 2 cases of general/constitutional symptoms, 1 case each of dizziness, headache, and ''other''. The author estimated that during Oct-2009 through Feb-2010, 2,437,113 (95% confidence interval, 1,865,373-3,008,853) pregnant women were vaccinated with H1N1. The overall reporting rate of AEs to VAERS in pregnant women after H1N1 was 118.2 reports per 1 million pregnant women vaccinated. The reporting rates for SABs and stillbirths were 49.2 and 7.8 reports per 1 million pregnant women vaccinated, respectively. The event outcome was not reported. Reporter comments: Review of reports of VAERS following H1N1 vaccination in pregnant women did not identify any concerning patterns of maternal or fetal outcomes.


VAERS ID: 446207 (history)  
Form: Version 1.0  
Age: 1.25  
Sex: Male  
Location: Unknown  
Vaccinated:2008-04-18
Onset:2011-12-07
   Days after vaccination:1328
Submitted: 2011-12-22
   Days after onset:15
Entered: 2011-12-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Pneumococcal sepsis
SMQs:, Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-12-07
   Days after onset: 0
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011308318

Write-up: This is an initial spontaneous report from a contactable physician communicated to a Pfizer Sales Representative. A 4-year-old patient (gender unknown) received a dose of PREVENAR on an unknown date for an unknown indication (site and time of administration were also unknown). Relevant medical history, concomitant medications, concomitant vaccines or vaccines given within the last four weeks were unknown. On an unknown date, the patient experienced invasive pneumococcal sepsis which resulted in death. Relevant laboratory data was unknown and it was unknown if an autopsy was performed. The cause of death was reported as invasive pneumococcal sepsis.


VAERS ID: 446208 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-12-22
Entered: 2011-12-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011308814

Write-up: This is an initial spontaneous report from a contactable reporter. The reporter reported for a consumer (age, gender and race unknown) who received a dose of PREVNAR on and unknown date for an unknown indication. Relevant medical history and relevant concomitant medications were unknown. The reporter mentioned that the child died on an unknown date due to pneumococcal disease after taking PREVNAR. Therapeutic measures taken in response to the events, if any were unknown. Relevant laboratory data was unknown and it was unknown if an autopsy was performed. The reported cause of death was pneumococcal infection.


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