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VAERS ID: 458862 (history)  
Form: Version 1.0  
Age: 1.11  
Sex: Female  
Location: Unknown  
Vaccinated:2011-04-27
Onset:2011-08-28
   Days after vaccination:123
Submitted: 2012-05-22
   Days after onset:268
Entered: 2012-07-09
   Days after submission:48
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3747AB / 4 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Aspiration, Choking, Death, Respiratory arrest, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MMR, other mfr, D1, 01/JUL/2011
Current Illness:
Preexisting Conditions: The patient had dose one, two and three of PENTACEL on 20 May 2010, 22 July 2010 and 23 September 2010 respectively. The lot number for dose one was C3556AA and the lot number for dose two and three was C3634AA.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201109818

Write-up: Initial report was received on 12 October 2011 from an investigator participating in the study under the reference number M5A11. A 17 month-old female patient with no reported past medical history experienced respiratory arrest due to aspiration (resulting from vomiting) 123 days after receiving dose four of PENTACEL, lot number C3747AB (route and site of administration not reported) on 27 April 2011. Additional vaccine history included a first dose of MMR, lot number 1644Z (route and site of administration not reported) received on 01 July 2011. According to the investigator, a representative from the coroner''s office was told that the "child likely choked on a ravioli as fed by a parent". No autopsy was performed as it was not a coroner''s case. The outcome was fatal. According to the investigator, the event was not related to the trial product. Documents held by sender: none.


VAERS ID: 459278 (history)  
Form: Version 1.0  
Age: 0.27  
Sex: Male  
Location: Illinois  
Vaccinated:1990-05-07
Onset:0000-00-00
Submitted: 2012-07-14
Entered: 2012-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LG / IM
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LG / IM

Administered by: Private       Purchased by: Other
Symptoms: Death, Pulse absent, Pyrexia, Respiratory arrest, Respiratory tract congestion, Resuscitation, Sudden infant death syndrome
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Neonatal disorders (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1990-05-08
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Infant Tylenol
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: On 05/07/1990 patient went to the Doctor and had a physical, which the doctor said he was in good health and doing well for his age and he also received 2 vaccinations MMR and DPT. He was congested and had a fever after receiving his shots. I gave him infant Tylenol during the day and before I put him to sleep. At 7am approximately 12 hours later I found patient in his bed not breathing and without a pulse. I performed CPR but patient died. The coroner determined that the cause of death was SIDS.


VAERS ID: 459500 (history)  
Form: Version 1.0  
Age: 0.46  
Sex: Male  
Location: Oregon  
Vaccinated:2012-06-27
Onset:2012-06-28
   Days after vaccination:1
Submitted: 2012-07-17
   Days after onset:19
Entered: 2012-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C4035AA / 2 RL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH400AA / 2 RL / UN
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR G1145 / 2 LL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F63667 / 2 LL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1846AA / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-06-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Hx of failure to thrive - on NUTRAMIGEN
Allergies:
Diagnostic Lab Data: Autopsy results (P)
CDC Split Type:

Write-up: Pt received vaccines 6/27/12 - found dead in crib (prone) next morning.


VAERS ID: 459641 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Male  
Location: Ohio  
Vaccinated:2012-01-19
Onset:2012-01-28
   Days after vaccination:9
Submitted: 2012-07-13
   Days after onset:166
Entered: 2012-07-19
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVC010AB / 3 LA / UN
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB532AA / 1 RA / UN
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR 11451 / 1 LA / UN
TD: TD ADSORBED (NO BRAND NAME) / SANOFI PASTEUR U3399CA / 1 LA / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0342AA / 1 RA / UN

Administered by: Public       Purchased by: Public
Symptoms: Congestive cardiomyopathy, Death, Excessive exercise, 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), Cardiomyopathy (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-01-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None known
Allergies:
Diagnostic Lab Data: Death certificate - cause of death - dilated cardiomyopathy, excessive exercise on treadmill
CDC Split Type:

Write-up: No previous problems known. Pt was found unresponsive in rec room of home with treadmill running.


VAERS ID: 459685 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Arkansas  
Vaccinated:2012-06-29
Onset:2012-06-30
   Days after vaccination:1
Submitted: 2012-07-19
   Days after onset:19
Entered: 2012-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4195AA / 1 LL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVC044AA / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F56178 / 1 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CBZ68A / 1 MO / PO

Administered by: Public       Purchased by: Public
Symptoms: Death, Endotracheal intubation, Resuscitation, Unresponsive to stimuli
SMQs:, Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-06-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: born 5 weeks premature
Allergies:
Diagnostic Lab Data: Autopsy to be performed. Hospital records will be sent to VAERS via regular mail.
CDC Split Type: AR1216

Write-up: Found unresponsive by parents just after midnight 6/30/12, transported to local hospital with external CPR by EMS. ER able to intubate and establish HR, then transferred to another hospital. Died at 2148 on 6/30/12.


VAERS ID: 460000 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2012-05-01
Submitted: 2012-07-24
   Days after onset:84
Entered: 2012-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS C3947BA / UNK UN / UN
TDAP: TDAP (ADACEL) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death neonatal, Maternal exposure during pregnancy, Neonatal disorder, Ultrasound antenatal screen normal
SMQs:, Acute central respiratory depression (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow), Normal pregnancy conditions and outcomes (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-05-17
   Days after onset: 16
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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: An "ultrasound 7" was performed and showed no evidence of a defect.
CDC Split Type: A0984491B

Write-up: This retrospective pregnancy case was reported by a consumer and described the occurrence of death nos in a female neonate subject who was exposed to BOOSTRIX (GlaxoSmithKline), ADACEL (non-gsk) during pregnancy. A physician or other health care professional has not verified this report. On 6 September 2011, the 31-year-old mother of the subject received unspecified dose of BOOSTRIX (.5 ml, transplacentary) and unspecified dose of ADACEL (transplacentary). The mother''s last menstrual period was on an unknown date and estimated date the delivery was 01 May 2012. The neonate was exposed to BOOSTRIX during an unknown trimester. Examination results of an "ultrasound 7" showed no evidence of a defect. On 1 May 2012, at an unspecified gestation age, the neonate was delivered by unknown method and weight 3.9 kilograms. Apgar score was not provided. The neonate was diagnosed with pulmonary hypertension and arterial venous malformation. The neonate remained hospitalized and died on 17 May 2012, cause of death was not provided. It was unknown whether an autopsy was performed. The outcome of pulmonary hypertension and arterial venous malformation were not specified. Please see report A0984491A for details regarding the mother case. Follow-up information received via the consumer on 17 July 2012 indicated the lot number for BOOSTRIX as C3947BA with expiration date 03 February 2014.


VAERS ID: 460006 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: New Hampshire  
Vaccinated:2012-06-07
Onset:2012-06-28
   Days after vaccination:21
Submitted: 2012-07-18
   Days after onset:20
Entered: 2012-07-24
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4190AA / 1 LL / UN
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVC093AA / 2 LL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F53376 / 1 RL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1710AA / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-06-28
   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: See attached
CDC Split Type: NH072420128

Write-up: 6/28 - Pt. rushed to ER in cardiac arrest.


VAERS ID: 460432 (history)  
Form: Version 1.0  
Age: 1.28  
Sex: Female  
Location: New Jersey  
Vaccinated:2012-07-16
Onset:2012-07-22
   Days after vaccination:6
Submitted: 2012-07-27
   Days after onset:5
Entered: 2012-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 02771AE / 1 UN / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1577 / 1 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E56178 / UNK UN / UN

Administered by: Private       Purchased by: Other
Symptoms: Acidosis, Acute myeloid leukaemia, Anaemia, Aspiration bone marrow abnormal, Bacterial test negative, Bilevel positive airway pressure, Blast cells present, Blood culture, Central venous catheterisation, Culture urine, Death, Diarrhoea, Endotracheal intubation, Full blood count abnormal, Hypercapnia, Leukocytosis, Mechanical ventilation, Oxygen saturation decreased, Postoperative respiratory distress, Pyrexia, Tachycardia, Tachypnoea, Thrombocytopenia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Haematopoietic cytopenias affecting more than one type of blood cell (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (broad), Haematopoietic thrombocytopenia (narrow), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, venous (narrow), Blood premalignant disorders (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Malignant lymphomas (broad), Myelodysplastic syndrome (broad), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-07-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: (all medications received between admission 7/17/12 and death 7/22/12); Aluminum hydroxide suspension; Diphenhydramine; Acetaminophen; Propofol; Allopurinol; Cefepime; Ondansetron; Cytarabine; Morphine; Dexamethasone; Albuterol (inhaled); D
Current Illness: AML
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Autopsy is pending
CDC Split Type:

Write-up: The patient had a screening CBC done the same day as vaccinations (7/16/12) that showed leukocytosis with blasts, anemia and thrombocytopenia. She was admitted to the hospital on 7/17/12. On 7/19/12, she was diagnosed with AML by bone marrow aspirate. She also started having fever and was started on broad spectrum antibiotics. Had surgical placement of CVC on 7/20/12 and received intrathecal cytarabine. She had postoperative respiratory issues, which was treated with high flow nasal cannula oxygen and diuretics. On 7/21/12, she received dexamethasone, cytarabine, daunorubicin and etoposide. Bortezomib (a tyrosine kinase inhibitor) was given per experimental treatment protocol. Beginning 7/21/12, she developed vomiting, diarrhea, tachypnea and tachycardia with worsening desaturations. She progressed over the course of the day on 7/22/12 despite increasing respiratory support from high flow nasal cannula oxygen to bilevel positive airway pressure, to endotracheal intubation with mechanical ventilation. The team caring for her was unable to increase oxygenation, improve carbon dioxide retention or correct acidosis. The patient died on 7/22/12 at 2151. Cultures from blood and urine did not grow bacteria. An autopsy is being done.


VAERS ID: 460993 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Unknown  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-07-31
Entered: 2012-08-03
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Pertussis
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 infant had a premature birth at 28 weeks gestation. No other medical history was reported.
Allergies:
Diagnostic Lab Data: Not reported.
CDC Split Type: 201207246

Write-up: Initial case received via search of scientific literature on 26 July 2012. The following is verbatim from the article abstract: "Objective: In 2010, an area experienced the highest number of pertussis cases in $g60 years, with $g9000 cases, 809 hospitalizations, and 10 deaths. This report provides a descriptive epidemiologic analysis of this epidemic and describes public health mitigation strategies that were used, including expanded pertussis vaccine recommendations. STUDY DESIGN: Clinical and demographic information were evaluated for all pertussis cases with onset from January 1, 2010 through December 31, 2010, and reported to the Department of Public Health. RESULTS: Infants younger than 6 months had the highest disease rates; all deaths and most hospitalizations occurred in infants younger than 3 months. Most pediatric cases were vaccinated according to national recommendations, although 9% of those aged 6 months to 18 years were completely unvaccinated against pertussis. High disease rates also were observed in fully vaccinated preadolescents, especially 10-year-olds. Mitigation strategies included expanded tetanus, diphtheria, and acellular pertussis vaccine recommendations, public and provider education, distribution of free vaccine for postpartum women and contacts of infants, and clinical guidance on diagnosis and treatment of pertussis in young infants. CONCLUSIONS: Infants too young to be fully vaccinated against pertussis remain at highest risk of severe disease and death. Data are needed to evaluate strategies offering direct protection of this vulnerable population, such as immunization of pregnant women and of newborns. The high rate of disease among preadolescents suggests waning of immunity from the diphtheria, tetanus, and acellular pertussis series; additional studies are warranted to evaluate the efficacy and duration of protection of the diphtheria, tetanus, and acellular pertussis series and the tetanus, diphtheria, and acellular pertussis series." The following is verbatim from the article: "The remaining fatality was a 2-month-old infant born prematurely at 28 weeks gestational age who had received the first dose of diphtheria, tetanus, and accelular pertussis (DTaP) vaccine 15 days prior to disease onset." A two-month-old infant (date of birth and gender not reported), who was born at 28 weeks gestation, received dose one injection of DTaP, manufacturer unknown, (lot number, route and site not reported) on an unspecified date. On an unspecified date, 15 days after vaccination, the patient developed Pertussis. Other than premature birth, the patient''s past medical history, concomitant medications or vaccinations were not reported. Hospitalization, laboratory/diagnostic studies, treatments and date of death were not reported. The patient''s outcome was reported as fatal. Documents held by sender: None.


VAERS ID: 462360 (history)  
Form: Version 1.0  
Age: 72.0  
Sex: Male  
Location: Unknown  
Vaccinated:2012-07-19
Onset:2012-07-24
   Days after vaccination:5
Submitted: 2012-08-19
   Days after onset:26
Entered: 2012-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. 1649AA / UNK RA / SC

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2012-07-24
   Days after onset: 0
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Carvedilol; Lisinopril; COUMADIN; Spironolactone
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1208USA005366

Write-up: This spontaneous report was received from a pharmacist refers to a 72 years old male patient with no known drug allergies who was vaccinated subcutaneously into upper left deltoid with a dose of 0.65 ml ZOSTAVAX (lot # 672563/1649AA, expiration date 21-JAN-2013) on 19-JUL-2012. No other co-suspects were reported. Concomitant medications included lisinopril, COUMADIN, spironolactone and carvedilol. Pharmacist stated she read in the local paper and found out that client was died at her home residence on 24-JUL-2012. Cause of death was unknown. It was unknown if autopsy was performed. Pharmacist stated the patient did have health conditions, unspecified, but she wanted to make sure that no problem existed with this ZOSTAVAX lot number. This event (death) was considered to be life-threatening and disabling. This is one of the two reports from the same reporter. Additional information has been requested.


VAERS ID: 462383 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Female  
Location: Georgia  
Vaccinated:2012-05-24
Onset:2012-05-27
   Days after vaccination:3
Submitted: 2012-08-13
   Days after onset:78
Entered: 2012-08-20
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4156AB / 1 LL / UN
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1481AA / 2 LL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 917245 / 1 RL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1540AA / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-05-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: We would like to report that this death occurred within one week of 2 month vaccines. Coroner reported cause of death undetermined - possible SIDS vs. co-sleeping.


VAERS ID: 462902 (history)  
Form: Version 1.0  
Age: 63.0  
Sex: Female  
Location: Unknown  
Vaccinated:2012-04-16
Onset:2012-04-18
   Days after vaccination:2
Submitted: 2012-08-23
   Days after onset:127
Entered: 2012-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. 1649AA / UNK LA / SC

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2012-04-18
   Days after onset: 0
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: acyclovir; PERCOCET; clonazepam; lovastatin; amlodipine
Current Illness: Medical observation normal
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1208USA005076

Write-up: This spontaneous report as received from a pharmacist refers to a 63 years old female patient with no known allergies. The patient was vaccinated subcutaneous into upper left deltoid with 0.65 ml ZOSTAVAX (lot # 672563/1649AA, expiration date 21-JAN-2013) on 16-APR-2012. No other co-suspects were reported. Concomitant medications included acyclovir, acetaminophen, PERCOCET, clonazepam, lovastatin and amlodipine. Pharmacist stated she read the local paper and found out that client was found dead at her home residence on 18-APR-2012, due to natural causes. Pharmacist stated the patient did have health conditions, unspecified, but she wanted to make sure that no problem existed with this ZOSTAVAX lot number. Lot check was requested by the reporter. Event was considered to be disabling and life-threatening. This is one of the two reports from the same reporter. Additional information has been requested.


VAERS ID: 463159 (history)  
Form: Version 1.0  
Age: 60.0  
Sex: Male  
Location: Utah  
Vaccinated:2012-06-12
Onset:2012-06-13
   Days after vaccination:1
Submitted: 2012-08-27
   Days after onset:75
Entered: 2012-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-06-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: DEATH


VAERS ID: 463211 (history)  
Form: Version 1.0  
Age: 0.39  
Sex: Female  
Location: Alabama  
Vaccinated:2012-08-06
Onset:2012-08-15
   Days after vaccination:9
Submitted: 2012-08-17
   Days after onset:2
Entered: 2012-08-27
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3970AA / 2 UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F30921 / 2 UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1540AA / 2 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Cardiac arrest, Intensive care, Respiratory failure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (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), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-08-16
   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: Runny nose; no fever
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 8/15/12 05:51 - presented to ER in full arrest - brought by EMS. Admitted to the PICU with diagnosis of cardiac arrest, respiratory failure.


VAERS ID: 463731 (history)  
Form: Version 1.0  
Age: 0.35  
Sex: Male  
Location: New Hampshire  
Vaccinated:2012-07-11
Onset:2012-08-25
   Days after vaccination:45
Submitted: 2012-08-31
   Days after onset:6
Entered: 2012-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B329BA / 2 UN / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH432AA / 2 UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F56178 / 2 UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CB268A / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-08-25
   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: No
Current Illness: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data: No
CDC Split Type: NH08312012

Write-up: Well child exam on 7-11-12. No problems at birth.


VAERS ID: 463942 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: California  
Vaccinated:2012-08-27
Onset:2012-08-28
   Days after vaccination:1
Submitted: 2012-08-29
   Days after onset:1
Entered: 2012-09-04
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4184AB / 1 LL / UN
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVC109BB / 2 RL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F65441 / 1 RL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0052AE / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-08-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Baby was found dead in parents bed (she sleeps in parents bed). She was on the side with face down in the memory foam mattress. This happened on 8-28-12. Day after she received her 2 months vaccines on 8-27-12. Most probably a case of SIDS.


VAERS ID: 464129 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-08-31
Entered: 2012-09-05
   Days after submission:5
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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Of the 411 diagnosed with probable or confirmed GBS, combined past medical histories included prior episode of GBS, diabetes mellitus, other immune disorder (including liver failure/cirrhosis, thyroid disease, systemic lupus erythematosus, rheumatoid arthritis, sarcoidosis, human immunodeficiency virus/acquired immunodeficiency syndrome, chemotherapy, neuropathy, and receipt of a transplanted organ), and cancer (including solid tumors such as breast, ovarian, and lung cancers, malignant melanoma, and hematologic malignancies).
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201207887

Write-up: Initial report was received via a search of the scientific literature on 23 August 2012. The following information is per the report: Active, population-based surveillance for GBS cases in persons who had an initial health-care encounter between October 1, 2009, and May 31, 2010, was conducted among 44.9 million residents at the 10 sites of the Emerging Infections Program (EIP). Each EIP site established a surveillance network comprised of neurologists and other health-care providers that was queried weekly to stimulate reporting of suspected GBS cases; hospital discharge data were also reviewed (International Classification of Disease, Ninth Revision) to capture additional cases not reported through the provider network. Trained surveillance officers reviewed medical records to gather standardized information on patient characteristics, clinical presentation, and medical history for every suspected GBS case. Suspected cases of GBS were evaluated by surveillance officers according to criteria established by the Brighton Collaboration. Patients with confirmed (Brighton levels 1 and 2) and probable (Brighton level 3) GBS were included in the analysis. Results: Among 44.9 million persons under surveillance from October 1, 2009, to May 31, 2010, study personnel identified 707 suspected GBS cases; 282 (40%) did not meet the Brighton criteria. Among the remaining 425 patients, a total of 411 GBS cases were included in the analysis (349 confirmed and 62 probable); 14 patients with GBS onset dates prior to October 1, 2009, were excluded. Eighty-five percent of GBS cases were aged $g/= 25 years; 52% were male, 15% required mechanical ventilation, and 3% died. Of the 411 total cases of confirmed or probable GBS, 408 patients received pH1N1 vaccine [29 patients (27 confirmed and 2 probable) received pH1N1 vaccine during the 42 days prior to symptom onset; 379 patients received it outside of the 42 day timeframe] and 371 patients received seasonal vaccine [36 patients (30 confirmed and 6 probable) received pH1N1 vaccine during the 42 days prior to symptom onset; 335 patients received it outside of the 42 day timeframe]. Among the 29 patients who received pH1N1 vaccine during the 42 day timeframe, there were 17 cases where 1 or more antecedent events were documented. Also of the 29 cases, 11 patients experienced upper respiratory or influenza-like symptoms, 5 experienced mechanical ventilation, and 1 patient had a medical history of a prior episode of GBS. Among the 36 patients who received seasonal vaccine during the 42 day timeframe, there were 24 cases where 1 or more antecedent events were documented. Also of the 36 cases, 21 patients experienced upper respiratory or influenza-like symptoms and 4 experienced mechanical ventilation. (Specific antecedent events included: upper respiratory or influenza-like symptoms, fever, gastrointestinal symptoms, seasonal influenza vaccine, and noninfluenza vaccination.). There were a total of 11 cases of death. In the group of 408 patients who received pH1N1 vaccine, there was 1 fatal case within the 42 day timeframe and 10 fatal cases outside of the 42 day timeframe. In the group of 371 patients who received seasonal vaccine, there was 1 fatal case within the 42 day timeframe and 8 fatal cases outside of the 42 day timeframe. History of pH1N1 vaccination was ascertained for 408 GBS cases (99%), of whom 67 (16%) received pH1N1 vaccine. Of these 67 patients, pH1N1 vaccine was received during the 42 days prior to GBS onset for 29 (43%), more than 42 days prior to onset for 34 (51%), and after GBS onset for 4 (1%). Fifty-seven patients (85%) received inactivated vaccine, 4 (6%), the vaccine type was unknown. pH1N1 vaccination status was ascertained by means of vaccine administration records, state registries, or administering provider documentation for 79% of cases, with the remainder being ascertained by self-report. History of seasonal vaccination was ascertained for 90% (n=371) of GBS cases, of whom 131 (35%) received seasonal vaccine. Of these 131 patients, seasonal vaccine was received during the 42 days prior to GBS onset for 36 (27%), more than 42 days prior to onset for 90 (69%), and after GBS onset for 5 (4%). Sixty-nine patients (53%) received inactivated vaccine, 1 (1%) received live attenuated vaccine, and vaccine type was unknown for 61 (47%). Seasonal vaccination status was ascertained by means of documented sources for 63% of cases, with the remainder being ascertained by self-report. Five cases received both pH1N1 vaccine and seasonal vaccine during the 42 days prior to GBS onset. Among GBS cases receiving pH1N1 vaccine 1-84 days prior to GBS onset, the median interval between vaccine receipt and disease onset was 27 days. The most likely cluster identified using the scan statistic was 29 cases occurring during days 1-37, but this cluster was not statistically significant (P=0.13). For seasonal vaccine, the median interval was 36 days, and no statistically significant cluster was identified. Generally, demographic characteristics, medical history, and outcomes for GBS cases did not differ by vaccine status, although antecedent events were less common among cases who received pH1N1 vaccine during the 42 days prior to onset than among those who did not (59% vs. 79%; P = 0.02). Examination of specific types of antecedent events showed that upper respiratory or influenza like symptoms were the only category of antecedent event that was significantly less common among cases who received pH1N1 vaccine than among those who did not (38% vs. 67%; P < 0.01). The total number of observed GBS cases in the EIP catchment area (n = 411) was similar to the expected number for the surveillance population (age-adjusted observed/expected ratio = 1.21, 95% confidence interval (CI): 0.78, 1.81), as well as among persons aged <25 years and $g=25 years. Authors estimated that there was less than 1 excess GBS case per million doses of pH1N1 vaccine administered and concluded that given the magnitude of morbidity and mortality associated with influenza infection, these findings provide reassurance that the excess risk of GBS following receipt of the pH1N1 vaccine was small compared with the morbidity and mortality prevented through the widespread use of the vaccine. Documents held by sender: None.


VAERS ID: 464200 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Iowa  
Vaccinated:2011-07-25
Onset:2011-07-25
   Days after vaccination:0
Submitted: 2012-08-30
   Days after onset:402
Entered: 2012-09-06
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3895AA / UNK RL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0732Z / UNK RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 916006 / UNK RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0708Z / UNK MO / PO

Administered by: Private       Purchased by: Unknown
Symptoms: Constipation, Cough, Crying, Death, Decreased appetite, Irritability, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-08-11
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Allergies.~Vaccine not specified (no brand name)~1~0.00~Sibling|Respiratory vomiting issues.~Vaccine not specified (no brand nam
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Cough, fussiness, fever, persistent crying, lack of appetite, cough, constipation, death.


VAERS ID: 464953 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-09-13
Entered: 2012-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / SYR

Administered by: Military       Purchased by: Other
Symptoms: Central nervous system infection, 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1209USA003315

Write-up: Information has been received from a receptionist of the registered nurse, concerning rumor going around that a 19 years old girl who on an unspecified date received the first shot of GARDASIL (dose, route and lot # not reported), developed a brain infection, and passed away. The patient died this summer, June/July 2012. The reporter was not even 100% sure if the patient had had the GARDASIL shot because the nurses found that there was no record of the patient in local registry for GARDASIL patients. They were assuming that she was vaccinated out of state because she had joined the military (unspecified). The patient might have gotten vaccinated by the military. Another part of the rumor that was going around was that "the girl was fine one day, not the next, and it must be the GARDASIL shot that did this". The time from receiving the GARDASIL shot to the time of her death was unknown. It was unknown if she had any adverse experience from the GARDASIL or if it caused the brain infection. Additional information has been requested.


VAERS ID: 465224 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-09-13
Entered: 2012-09-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (MENOMUNE) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial test positive, Death, Meningitis meningococcal, Meningococcal sepsis, Neisseria test positive, Polymerase chain reaction, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Culture, PCR or both: Neisseria meningitidis, serogroup Y
CDC Split Type: 201208248

Write-up: Initial report was retrieved from the scientific literature on 06 September 2012. The following information is verbatim from the abstract: "Meningococci have historically caused extensive illness among members. Three successive meningococcal vaccine types were used from 1971 through 2010; overall disease incidence dropped by $g90% during this period. During 2006-2010, disease incidence of 0.38 (cases per 100,000 person-years) among members was not significantly different from the incidence of 0.26 among the age-matched general population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis serogroup Y. Incidences among 17- to 19-year-old trainees and among others were significantly higher than among comparison populations (p<0.05). No apparent change in epidemiology of meningococcal disease was observed after replacement of quadrivalent polysaccharide vaccine with conjugate vaccine in 2007. The data demonstrate that vaccination with meningococcal vaccine is effective." According to the report, the cases were confirmed by culture, PCR or both. The information included in this case concerns a 20-24-year-old male patient who had received MENOMUNE A/C/Y/W-135 (lot number, route, site and date of administration not reported) and 15 months after vaccination developed meningococcal meningitis and sepsis, year reported as 2008 (Q 4). Neisseria meningitidis serogroup was determined to be serogroup Y. Treatments were not reported. No further information was available at the time of report. The patient''s outcome was fatal. The reporter for this case is the same as for cases 2012-08240, -08241, -08242, -08243, -08244, -08245, -08246, -08247, -08249, -08250, -08251, -08252, -08253, -08254, -08255, and -08256. Documents held by sender: None.


VAERS ID: 465234 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-09-13
Entered: 2012-09-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (MENOMUNE) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Military       Purchased by: Military
Symptoms: Bacterial test positive, Death, Meningitis meningococcal, Meningococcal sepsis, Neisseria test positive, Polymerase chain reaction
SMQs:, Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Serogroup C was confirmed by culture, PCR or both (exactly which test was not reported).
CDC Split Type: 201208240

Write-up: Initial report was retrieved from the scientific literature on 06 September 2012. The following information is verbatim from the abstract: "Meningococcal have historically caused extensive illness among members. Three successive meningococcal vaccine types were used from 1971 through 2010; overall disease incidence dropped by $g90% during this period. During 2006-2010, disease incidence of 0.38 (cases per 100,000 person-years) among members was not significantly different from the incidence of 0.26 among the age-matched general population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis serogroup Y. Incidences among 17- to 19-year-old basic trainees and among were significantly higher than among comparison populations (p<0.05). No apparent change in epidemiology of meningococcal disease was observed after replacement of quadrivalent polysaccharide vaccine with conjugate vaccine in 2007. The data demonstrate that vaccination with meningococcal vaccine is effective." According to the report, the cases were confirmed by culture, PCR or both. The information included in this case concerns a 20-24 year-old male patient who had received MENOMUNE A/C/Y/W-135 (lot number, route, site and date of administration not reported) and 12 months after vaccination developed meningococcal meningitis and sepsis, year reported as 2006 (Q 1). Neisseria meningitidis serogroup was determined to be serogroup C. Treatments were not reported. No further information was available at the time of report. The patient''s outcome was fatal (date of death not reported). The reporter for this case is the same as for cases 2012-08241, -08242, -08243, -08244, -08245, -08246, -08247, -08248, -08249, -08250, -08251, -08252, -08253, -08254, -08255, and -08256. Documents held by sender: None.


VAERS ID: 465345 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-09-14
Entered: 2012-09-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial test positive, Death, Meningococcal sepsis, Neisseria test positive, Polymerase chain reaction
SMQs:, Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Culture or PCR, or both: Neisseria meningitidis, serogroup C
CDC Split Type: 201208244

Write-up: Initial report was retrieved from the scientific literature on 06 September 2012. The following information is verbatim from the abstract: "Meningococci have historically caused extensive illness among members. Three successive meningococcal vaccine types were used from 1971 through 2010; overall disease incidence dropped by $g90% during this period. During 2006-2010, disease incidence of 0.38 (cases per 100,000 person-years) among members was not significantly different from the incidence of 0.26 among the age-matched general population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis serogroup Y. Incidences among 17- to 19-year-old were significantly higher than among comparison populations (p<0.05). No apparent change in epidemiology of meningococcal disease was observed after replacement of quadrivalent polysaccharide vaccine with conjugate vaccine in 2007. The data demonstrate that vaccination with meningococcal vaccine is effective." According to the report, the cases were confirmed by culture, PCR or both. The information included in this case concerns a 17-19-year-old male patient who had received MENACTRA (lot number, route, site and date of administration not reported) and three months after vaccination developed meningococcal sepsis, year reported as 2007 (Q 3). Neisseria meningitidis serogroup was determined to be serogroup C. Treatments were not reported. No further information was available at the time of report. The patient''s outcome was fatal. The reporter for this case is the same as for cases 2012-08240, -08241, -08242, -08243, -08245, -08246, -08247, -08248, -08249, -08250, -08251, -08252, -08253, -08254, -08255, and -08256. Documents held by sender: None.


VAERS ID: 465397 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Missouri  
Vaccinated:2012-08-15
Onset:2012-08-16
   Days after vaccination:1
Submitted: 2012-09-04
   Days after onset:19
Entered: 2012-09-18
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B33CE / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0221AE / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 918242 / 1 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FB288A / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-08-16
   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: Oral NaCl
Current Illness: Nasal congestion
Preexisting Conditions: Pre-term birth; Hyponatremia
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient found at home not breathing, CPR started. EMS continued CPR & brought patient to our ED. Patient still in full cardiopulmonary arrest. Patient never recovered heart rate.


VAERS ID: 465434 (history)  
Form: Version 1.0  
Age: 0.15  
Sex: Male  
Location: Indiana  
Vaccinated:2012-09-14
Onset:2012-09-15
   Days after vaccination:1
Submitted: 2012-09-18
   Days after onset:3
Entered: 2012-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B330CE / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0419AE / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 918246 / 1 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FB288A / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-09-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Child received vaccines on 9/14/12. Parent reported found child unresponsive on 9/15/12. Taken by ambulance to ER and pronounced.


VAERS ID: 465543 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Female  
Location: Florida  
Vaccinated:2012-08-18
Onset:2012-08-18
   Days after vaccination:0
Submitted: 2012-09-11
   Days after onset:24
Entered: 2012-09-19
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Cardiac disorder, Death, Dyspnoea, Gait disturbance, Pain
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2012-08-22
   Days after onset: 4
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: Heart Dr. did not want to see us in 6 months several days earlier.
Allergies:
Diagnostic Lab Data: Coroner assumed it was massive heart failure
CDC Split Type:

Write-up: Severe weakness, severe pain, difficulty breathing. Pain meds, heart meds, aspirin, TYLENOL. Could not walk without assistance.


VAERS ID: 465858 (history)  
Form: Version 1.0  
Age: 0.62  
Sex: Female  
Location: North Carolina  
Vaccinated:2012-08-28
Onset:2012-08-30
   Days after vaccination:2
Submitted: 2012-09-14
   Days after onset:15
Entered: 2012-09-21
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C4186AA / 3 LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0293AE / 3 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0130AE / 3 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR H1330 / 3 LL / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F63665 / 3 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0033AE / 3 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Apnoeic attack, Autopsy, Brain death, Cyanosis, Death, Hypoxic-ischaemic encephalopathy, Intensive care, Multi-organ failure, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant 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), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-09-02
   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: No
Current Illness: No
Preexisting Conditions: Recent otitis media - TM''s normal 8/28/12
Allergies:
Diagnostic Lab Data: Extensive evaluation at hospital
CDC Split Type:

Write-up: Vaccines given 8/28/12, 850am. Catastrophic event about 6pm 8/30/12. Found by family to be apneic, blue, unresponsive. To ER then to Hosp PICU. Hypoxic ischemic encephalopathy & multisystem organ failure. Brain dead & expired 09/02/12. Law enforcement & DSS notified - autopsy pending. No indication that death related to immunizations.


VAERS ID: 465916 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Male  
Location: Texas  
Vaccinated:2012-09-20
Onset:2012-09-21
   Days after vaccination:1
Submitted: 2012-09-21
   Days after onset:0
Entered: 2012-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U4494AA / UNK UN / IM

Administered by: Other       Purchased by: Public
Symptoms: Activities of daily living impaired, Death, Faecal incontinence, Musculoskeletal stiffness, Pain
SMQs:, Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), Noninfectious diarrhoea (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-09-21
   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: Losartan 50mg daily
Current Illness: No chronic disease noted
Preexisting Conditions: Diabetes; Hypertension
Allergies:
Diagnostic Lab Data: Since flu vaccine was adminstered within such a close timeframe, medical examiner thought that we should be aware and report to VAERS, the possible link of the vaccine to the patient''s death.
CDC Split Type:

Write-up: Patient complained of "achiness" around 2:30 to 3:00 pm. His symptoms progressed to stiffness and soreness by bedtime and needed help with his clothing before bed. Around Midnight, there was a loss of bowel control and he passed away.


VAERS ID: 465936 (history)  
Form: Version 1.0  
Age: 0.21  
Sex: Female  
Location: Florida  
Vaccinated:2011-12-14
Onset:2011-12-17
   Days after vaccination:3
Submitted: 2012-09-22
   Days after onset:279
Entered: 2012-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3840AA / 1 LL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVC022DA / UNK RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 916918 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0543AA / 1 MO / PO

Administered by: Unknown       Purchased by: Other
Symptoms: Autopsy, Death, Musculoskeletal stiffness, Respiratory arrest, Resuscitation, Sudden infant death syndrome
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), Neonatal disorders (narrow), Hypersensitivity (broad), Arthritis (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-12-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Amoxicillin for upper respiratory infection; Nystatin oral for thrush; Desitin for diaper rash.
Current Illness: Upper respiratory infection; Rectal prolapse; Premature
Preexisting Conditions: Premature; Rectal prolapse; Lactose
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Woke up to baby face up, she looked fine, when I went to pick her up she was stiff still warm, but stiff, and not breathing, called 911 paramedics arrived and tried to resuscitate, she had been dead approx 12 mins. Med ex. said it was SIDS. Autopsy report cause of death "undetermined" manner of death: "undetermined, prematurity by history"


VAERS ID: 465968 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-09-24
Entered: 2012-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abnormal behaviour, Autopsy, Bacterial test negative, Biopsy brain abnormal, Blood calcium decreased, Blood culture negative, Blood electrolytes normal, Blood glucose normal, Brain death, Brain herniation, Brain neoplasm, Brain oedema, Calcium ionised decreased, Central nervous system lesion, Central nervous system neoplasm, Cerebral haemorrhage, Chromosome analysis normal, Communication disorder, Computerised tomogram abnormal, Computerised tomogram head abnormal, Convulsion, Death, Decreased appetite, Drooling, Electroencephalogram abnormal, Encephalitis post varicella, Encephalitis viral, Epilepsy, Eye pain, Fundoscopy normal, Gaze palsy, Headache, Hemianopia, Hepatic enzyme, Immunohistochemistry, Inflammation, Intracranial pressure increased, Laboratory test normal, Lethargy, Lymphocyte percentage decreased, Mental status changes, Microscopy, Monocyte percentage, Necrosis, Neurological examination abnormal, Neutrophil percentage increased, Nuclear magnetic resonance imaging brain abnormal, Platelet count normal, Polymerase chain reaction, Pupillary light reflex tests abnormal, Pupillary reflex impaired, Pyrexia, Renal function test normal, Somnolence, Tremor, Unresponsive to stimuli, Vaccination failure, Varicella virus test positive, Vasogenic cerebral oedema, Viral test negative, Vomiting, White blood cell count normal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Haematopoietic leukopenia (broad), Lack of efficacy/effect (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Convulsions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (narrow), Optic nerve disorders (broad), Cardiomyopathy (broad), Retinal disorders (narrow), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Non-haematological tumours of unspecified malignancy (narrow), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-02-01
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Sinusitis; Nasal septum perforation with subsequent recurrent sinusitis requiring prolonged courses of antibiotic therapy
Preexisting Conditions: 2008, Hypoparathyroidism; 2008, Convulsion at age 1 year secondary to partial hypoparathyroidism; 2008, Calcium, Convulsion; Antimicrobial, Sinusitis
Allergies:
Diagnostic Lab Data: DiGeorge syndrome workup (at 1 year old) including a fluorescence in situ hybridization test for 22q11 chromosomal deletion was negative. No documentation of T & B cell subsets being performed was found. WBC count: neutrophils 85%, lymphocytes 7%, monocytes 8%. CT brain: showed a discrete enhancing lesion measuring 3x3 cm without ring enhancement in the right posterior parietal lobe with surrounding vasogenic edema, indicating an infectious or inflammatory process. A well-defined abscess was not clearly identified and an underlying mass lesion could not be excluded. MRI: consistent with a primary glial neoplasm with local mass effect. Head CT in 2008 after the hypocalcemic seizure indicated no brain abnormalities. Facial CT scan, approximately 2 weeks before her hospital admission, demonstrated a perforated nasal septum, paranasal sinus opacification, and an enhancing mass suggestive of redundant nasal mucosa, enlarged vomeronasal organ, or nasal glioma. Recommended nasal endoscopy and biopsy were not performed. EEG: revealed strong epileptiform activity in the area of the suspected tumor and subclinical seizures on video EEG monitoring. Head CT (hospital stay 4): indicated no changes. Emergent head CT scan (hospital day 5): indicated an obstruction of the fourth ventricle and evidence of herniation. Cerebral perfusion study: indicated no intracerebral blood flow, consistent with brain death. A postmortem examination (autopsy) was performed. The brain appeared swollen with tissue softening and hemorrhages. No discrete brain lesions was grossly visible. A biopsy of the right side of the brain was performed. Microscopic examination revealed necrosis with inflammation, including clusters of microglia, consistent with encephalitis. No evidence of a tumor was observed. Brain specimens were sent to the Center for Disease Control and Prevention for additional testing. Multifocal encephalitis with viral-like inclusions was seen by hematoxylineosin stain. Extensive multifocal immunohistochemical staining of VZV antigens was seen in association with tissue damage; no evidence of herpes simplex virus or bacterial infection was observed. Polymerase chain reaction (PCR) testing of DNA extracted from specimens was positive for wild-type VZV. VZV encephalitis was determined to be the cause of death. --/--/2011, autopsy, see relevant test; 02/--/2011, blood calcium, 8.6 mg/dl; 02/--/2011, blood culture, negative; 02/--/2011, blood electrolytes, normal; 02/--/2011, blood glucose, normal; 02/--/2011, calcium ionised, 1.07 mmol/L; 02/--/2011, computerised tomogram, see relevant test; --/--/2008, computerised tomogram head, see relevant test; 02/--/2011, computerised tomogram head, see relevant test; 02/--/2011, computerised tomogram head, see relevant test; --/--/2008, diagnostic procedure negative, see relevant test; 02/--/2011, diagnostic procedure, see relevant test; 02/--/2011, electroencephalogram, see relevant test; 02/--/2011, hepatic enzyme, normal; 02/--/2011, nuclear magnetic resonance imaging, see relevant test; 02/--/2011, platelet count, 287x10^9/L; 02/--/2011, renal function test, normal; --/--/2008, white blood cell count; 02/--/2011, white blood cell count, 10x10^9, see relevant test
CDC Split Type: WAES1209USA008559

Write-up: Information has been received from a published article. Encephalitis associated with varicella-zoster virus (VZV), rare among children in the varicella vaccine era, has generally been associated with a rash. Authors reported fatal wild-type VZV encephalitis without a rash in a child who had received 1 dose of varicella. VZV encephalitis should be considered in the differential diagnosis for children neurologic symptoms, even vaccine recipients. In June 2011, a pediatrician notified the that a 4-year-old female patient died of VZV encephalitis. A varicella death investigation was conducted, because varicella is a notifiable disease in the state. The patient was admitted to the hospital in February, 2011, after complaining of sudden severe headache and right eye pain. During the 10 days before admission, she had experienced frequent and intermittent episodes of vomiting, headaches, seizures, lethargy, low-grade fever, mental status changes, poor interaction, and poor appetite. She did not have cough, abdominal pain, diarrhea, or rash. No history of recent travel, or known sick contacts at home or the child care center she attended were noted. She had received 1 dose of varicella vaccine (manufacturer unspecified) at age 13 months and had no history of varicella disease. Her medical history was remarkable for nasal septum perforation with subsequent recurrent sinusitis requiring prolonged courses of antibiotics therapy. Additionally, she had hypocalcemia-related seizures at age 1 year secondary to partial hypoparathyroidism; a DiGeorge syndrome workup including a fluorescence in situ hybridization test for 22q11 chromosomal deletion was negative. No documentation of T & B cell subsets being performed was found. She received calcium supplements and had no more seizures. The patient had no history of chronic medical conditions or immunosuppressive medications, was born full-tern without reported complications, had reached appropriate developmental milestones, and had performed adequately at preschool. On physical examination, the patient was drowsy, drooling, lethargic, and increasingly unresponsive to verbal stimuli. Her vital signs were normal. Neck was supple. Pupillary reflexes and fundoscopy were normal. She had a right gaze preference and probable left hemianopia with some tremors in her extremities. No rash or dysmorphic features were noted. Her general and neurologic examinations were otherwise unremarkable. Laboratory data revealed a white blood cell count of 10x10^9L (neutrophils 85%, lymphocytes 7%, monocytes 8%): platelet count was 287x10^9/L. Total calcium was 8.6 mg/dL (normal, 8.5 10.1) and ionized calcium was 1.07mmol/L (normal, 1.15 1.27). The patient''s electrolyte panel, glucose, liver enzymes, and renal function tests were within normal limits. Blood cultures were negative. Lumbar puncture and cerebrospinal fluid (CSF) tests were not performed. No extensive laboratory evaluation of immunocompetence was performed. A computed tomography (CT) brain scan showed a discrete enhancing lesion measuring 3x3 cm without ring enhancement in the right posterior parietal lobe with surrounding vasogenic edema, indicating an infectious or inflammatory process. A well-defined abscess was not clearly identified and an underlying mass lesion could not be excluded. Follow-up magnetic resonance imaging was consistent with a primary glial neoplasm with local mass effect. A head CT scan in 2008 after her hypocalcemic seizure indicated no brain abnormalities. A facial CT scan in February 2011, approximately 2 weeks before her hospital admission, demonstrated a perforated nasal septum, paranasal sinus opacification, and an enhancing mass suggestive of redundant nasal mucosa, enlarged vomeronasal organ, or nasal glioma. Recommended nasal endoscopy and biopsy were not performed. The patient was given a preliminary diagnosis of primary brain tumor, with mild local mass effect, and treated with supportive measures. No antibiotics or antivirals were administered. The patient''s condition worsened, and during hospital day 4 she developed symptoms of increased intracranial pressure. An electroencephalogram (EEG) revealed strong epileptiform activity in the area of the suspected tumor and subclinical seizures on video EEG monitoring. A head CT scan indicated no changes. During hospital day 5, the patient''s symptoms worsened, and she had no pupillary light reflex. An emergent head CT scan indicated an obstruction of the fourth ventricle and evidence of herniation. She underwent emergenct external ventricular device placement. Intraventricular pressure monitoring beginning at that time revealed extremely elevated pressures. On hospital day 6, the day the patient died, a cerebral perfusion study indicated no intracranial blood flow, consistent with brain death. A postmortem examination was performed. The brain appeared swollen with tissue softening and hemorrhages. No discrete brain lesion was grossly visible. A biopsy of the right side of the brain was performed. Microscopic examination revealed necrosis with inflammation, including clusters of microglia, consistent with encephalitis. No evidence of a tumor was observed. Brain specimens were sent to the Centers for Disease Control and Prevention for additional testing. Multifocal encephalitis with viral-like inclusions was seen by hematoxylineosin stain. Extensive multifocal immunohistochemical staining of VZV antigens was seen in association with tissue damage; no evidence of herpes simplex virus or bacterial infection was observed. Polymerase chain reaction (PCR) testing of DNA extracted from specimens was positive for wild-type VZV. VZV encephalitis was determined to be the cause of death. "To our knowledge, this is the first reported fatal case of VZV encephalitis in a child who had received 1 dose of varicella vaccine. Additionally, the child did not have rash. Two major pathologic mechanisms have been proposed as contributing to the development of VZV encephalitis: direct viral invasion of the brain and an autoimmune process. The findings in this case, including acute presentation, localization of viral antigens in encephalitic lesions, and detection of VZV DNA from brain tissue, suggest direct viral invasion." "Detection of wild-type VZV, and the absence of varicella rash history, indicate this patient had unrecognized varicella, either previously or at the time of this fatal illness. We were unable to determine whether the patient''s encephalitis was because of breakthrough infection or herpes zoster. In healthy vaccinees, breakthrough varicella is usually mild. However, in this patient, we cannot exclude the possibility of an underlying immunocompromising condition, given some features of her medical history that could have led to severe breakthrough. If the patient''s illness was breakthrough, its severity might also be attributable to lack of response to vaccination (i.e. primary vaccine failure)." Additional information has been requested.


VAERS ID: 466002 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Utah  
Vaccinated:2012-06-25
Onset:2012-06-26
   Days after vaccination:1
Submitted: 2012-07-19
   Days after onset:23
Entered: 2012-09-24
   Days after submission:67
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B305 / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0254AA / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH F89912 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0677AA / 1 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Autopsy, Death, Toxicologic test
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-06-26
   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: Dexamethasone 2mg
Current Illness: Viral Croup
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Toxicology pending / autopsy results pending
CDC Split Type:

Write-up: Patient seen in office for well child check, normal healthy child with viral symptoms. Immunizations performed, child tolerated well. Following morning found deceased.


VAERS ID: 466029 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: Florida  
Vaccinated:2012-09-11
Onset:0000-00-00
Submitted: 2012-09-20
Entered: 2012-09-24
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (IMOVAX) / SANOFI PASTEUR H1091 / 1 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Past medical history and illness at time of vaccination was reported as unknown.
Allergies:
Diagnostic Lab Data: Not reported.
CDC Split Type: 201208467

Write-up: Initial report was received from a health care professional on 12 September 2012. A 24-year-old female patient received dose one of an intramuscular injection of ("the rabies series") IMOVAX Rabies, sanofi pasteur SA, H1091-1 (indication and site and side of administration were not reported) on 11 September 2012. According to reporter, the patient did not have any reactions when she went home. The next day, it was reported that the client died during the night. Exact date of death was reported as unknown, either 11 September 2012 or 12 September 2012, as reported "during the night". The medical examiner was called to verify the death, and details were not available at the time of the report. No information was reported at this time on if an autopsy was performed. The patient''s outcome was fatal. Documents held by sender: None.


VAERS ID: 466326 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Male  
Location: Maryland  
Vaccinated:2012-09-10
Onset:2012-09-14
   Days after vaccination:4
Submitted: 2012-09-25
   Days after onset:11
Entered: 2012-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. AH2140 / 1 NS / IN

Administered by: Unknown       Purchased by: Public
Symptoms: Influenza virus test negative, Intensive care, Nasopharyngitis, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-09-20
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Miralax; Dulcolax; Erythromycin (EES); Iron; Poly-Vi-Sol; Lactulose
Current Illness: Mild URI for 1 day with no fever and no respiratory distress
Preexisting Conditions: Prematurity (31-32 weeks); G-tube dependent; Developmental delay; Atrial Septal Defect; Undiagnosed cause for muscle weakness; Constipation
Allergies:
Diagnostic Lab Data: Negative Influenza test result.
CDC Split Type:

Write-up: Respiratory arrest at home after 4 days of worsening cold symptoms. Driven by family auto to Medical Center and then transfered to PICU at another hospital.


VAERS ID: 466962 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-09-29
Entered: 2012-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Biopsy brain abnormal, Blood calcium decreased, Blood culture negative, Blood electrolytes normal, Blood glucose normal, Blood pressure increased, Brain death, Brain neoplasm, Brain oedema, CSF pressure increased, Calcium ionised decreased, Central nervous system lesion, Central nervous system neoplasm, Cerebral haemorrhage, Cerebral hypoperfusion, Chromosome analysis normal, Computerised tomogram head abnormal, Convulsion, Decreased appetite, Drooling, Electroencephalogram abnormal, Encephalitis viral, Epilepsy, Eye pain, Fundoscopy normal, Glioma, Headache, Hemianopia, Hepatic enzyme, Hypocalcaemic seizure, Hyporesponsive to stimuli, Infection, Inflammation, Intracranial pressure increased, Laboratory test abnormal, Left ventricular end-diastolic pressure increased, Lethargy, Lymphocyte percentage decreased, Mass, Mental status changes, Monocyte percentage, Nasal mucosal disorder, Necrosis, Neurological examination normal, Neutrophil percentage increased, Nuclear magnetic resonance imaging abnormal, Oedema, Paranasal sinus discomfort, Platelet count normal, Polymerase chain reaction, Pupillary reflex impaired, Pyrexia, Renal function test normal, Somnolence, Tremor, Unresponsive to stimuli, Varicella post vaccine, Varicella virus test positive, Vomiting, White blood cell count normal
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Haematopoietic leukopenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Haemorrhagic 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), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, arterial (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), 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), Glaucoma (broad), Hypertension (narrow), Optic nerve disorders (broad), Cardiomyopathy (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Non-haematological malignant tumours (narrow), Non-haematological tumours of unspecified malignancy (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Hypoparathyroidism; --/--/2008, Convulsion, at age of 1 year; --/--/2008, Hypocalcaemia, at age of 1 year; Sinusitis; Nasal septum perforation; calcium, Convulsion
Allergies:
Diagnostic Lab Data: Cerebral perfusion study: No intracerebral blood flow, consistent with brain death; Intraventricular pressure: (FEB-2011): Extremely elevated pressure; Postmortem examination: The brain appeared swollen with tissue softening and hemorrhages. No discrete brain lesions was grossly visible. Hematoxylin-eosin stain: Multifocal encephalitis with viral-like inclusions; Fluorescence in situ hybridization test for 22q11 chromosomal deletion: Negative; 02/--/2011, Biopsy brain, Microscopic examination revealed necrosis with inflammation including cluster of microglia consistent with encephalitis. No evidence of tumor was observed; 02/--/2011, Blood calcium, Normal, 8.6 mg/dL; 02/--/2011, Blood culture, Negative; 02/--/2011, Blood glucose, Normal, Within normal limits; 02/--/2011, CSF pressure, Increased; 02/--/2011, Calcium ionised, Normal 1.07 mmol/L; 02/--/2011, Computerised tomogram, Approximately 2 weeks before her hospital admission: demonstrated a perforated nasal septum, paranasal sinus opacification, and an enhancing mass suggestive of redundant nasal mucosa, enlarged vomeronasal organ, or nasal glioma; --/--/2008, Computerised tomogram head, Normal, After her hypocalcemic seizure: indicated no brain abnormalities.; 02/--/2011, Computerised tomogram head, Discrete enhancing lesion measuring 3x3 cm without ring enhancement in the right posterior parietal lobe with surrounding vasogenic edema indicating an infectious or inflammatory process. A well defined abscess was not clearly identified and an underlying mass lesion could not be excluded.; 02/--/2011, Computerised tomogram head, No changes; 02/--/2011, Computerised tomogram head, Obstruction of the fourth ventricle and evidence of herniation.; 02/--/2011, Electrolyte panel, Normal, Within Normal limits; 02/--/2011, Electroencephalogram, Strong epileptiform activity in the area of the suspected tumor and subclinical seizures on video EEG monitoring; 02/--/2011, Fundoscopy, Normal; 02/--/2011, Hepatic enzyme, Normal, Within normal limits; 02/--/2011, Lymphocyte count, 7%; 02/--/2011, Monocyte count, 8%; 02/--/2011, Neurological examination, Otherwise unremarkable; 02/--/2011, Neutrophil count, 85%; 02/--/2011, Nuclear magnetic resonance imaging, Consistent with a primary glial neoplasm with local mass effect; 02/--/2011, Physical examination, Drowsy, drooling, lethargic, and increasingly unresponsive to verbal stimuli; 02/--/2011, Platelet count, 287x1E09 platelets/L; 02/--/2011, Polymerase chain reaction, Positive, Positive for wild-type VZV; 02/--/2011, Pupillary light reflex tests, Negative, No pupillary reflexes, during hospital day 5; 02/--/2011, Pupillary light reflex tests, Normal; 02/--/2011, Renal function test, Normal, Within normal limits; 02/--/2011, White blood cell count, 10x10E9 cells/L
CDC Split Type: WAES1209USA010266

Write-up: Varicella-zoster virus (VZV) causes varicella as primary infection; virus remains latent and can reactivate to cause herpes zoster. Neurologic complications associated with both illnesses, albeit rare, have been reported among both healthy and immunocompromised patients. The patient was admitted to the hospital in February 2011, after complaining of sudden severe headache and right eye pain. During the 10 days before admission, she had experienced frequent and intermittent episodes of vomiting, headaches, seizures, lethargy, low-grade fever, mental status changes, poor interaction, and poor appetite. She did not have cough, abdominal pain, diarrhea, or rash. No history of recent travel, or known sick contacts at home or the child care center she attended were noted. She had received 1 dose of varicella vaccine at age 13 months and had no history of varicella disease. Her medical history was remarkable for nasal septum perforation with subsequent recurrent sinusitis requiring prolonged courses of antibiotic therapy. Additionally, she had hypocalcemia-related seizures at age 1 year secondary to partial hypoparathyroidism; a DiGeorge syndrome workup including a fluorescence in situ hybridization test for 22q11 chromosomal deletion was negative. No documentation of T & B cell subsets being performed was found. She received calcium supplements and had no more seizures. The patient had no history of chronic medical conditions or immunosuppressive medications, was born full-term without reported complications, had reached appropriate developmental milestones, and had performed adequately at preschool. On physical examination, the patient was drowsy, drooling, lethargic, and increasingly unresponsive to verbal stimuli. Her vital signs were normal. Neck was supple. Pupillary reflexes and fundoscopy were normal. She had a right gaze preference and probable left hemianopia with some tremors in her extremities. No rash or dysmorphic features were noted. Her general and neurologic examinations were otherwise unremarkable. Laboratory data revealed a white blood cell count of 10x109/L (neutrophils 85%, lymphocytes 7%, monocytes 8%); platelet count was 287x109/L. Total calcium was 8.6 mg/dL and ionized calcium was 1.07mmol/L. The patient''s electrolyte panel, glucose, liver enzymes, and renal function tests were within normal limits. Blood cultures were negative. Lumbar puncture and cerebrospinal fluid (CSF) tests were not performed. No extensive laboratory evaluation of immunocompetence was performed. A computed tomography (CT) brain scan showed a discrete enhancing lesion measuring 3x3 cm without ring enhancement in the right posterior parietal lobe with surrounding vasogenic edema, indicating an infectious or inflammatory process. A well-defined abscess was not clearly identified and an underlying mass lesion could not be excluded. Follow-up magnetic resonance imaging was consistent with a primary glial neoplasm with local mass effect. A head CT scan in 2008 after her hypocalcemic seizure indicated no brain abnormalities. A facial computed tomography (CT) scan in February 2011, approximately 2 weeks before her hospital admission, demonstrated a perforated nasal septum, paranasal sinus opacification, and an enhancing mass suggestive of redundant nasal mucosa, enlarged vomeronasal organ, or nasal glioma. Recommended nasal endoscopy and biopsy were not performed. The patient was given a preliminary diagnosis of primary brain tumor, with mild local mass effect, and treated with supportive measures. No antibiotics or antivirals were administered. The patient''s condition worsened, and during hospital day 4 she developed symptoms of increased intracranial pressure. An electroencephalogram (EEG) revealed strong epileptiform activity in the area of the suspected tumor and subclinical seizures on video electroencephalogram (EEG) monitoring. A head computed tomography (CT) scan indicated no changes. During hospital day 5, the patient''s symptoms worsened, and she had no pupillary light reflex. An emergent head CT scan indicated an obstruction of the fourth ventricle and evidence of herniation. She underwent emergent external ventricular device placement. Intraventricular pressure monitoring beginning at that time revealed extremely elevated pressures. On hospital day 6, the day the patient died, a cerebral perfusion study indicated no intracerebral blood flow, consistent with brain death. A postmortem examination was performed. The brain appeared swollen with tissue softening and hemorrhages. No discrete brain lesion was grossly visible. A biopsy of the right side of the brain was performed. Microscopic examination revealed necrosis with inflammation, including clusters of microglia, consistent with encephalitis. No evidence of a tumor was observed. Brain specimens were sent to the Centers for Disease Control and Prevention for additional testing. Multifocal encephalitis with viral-like inclusions were seen by hematoxylin-eosin stain. Extensive multifocal immunohistochemical staining of varicella zoster virus (VZV) antigens was seen in association with tissue damage; no evidence of herpes simplex virus or bacterial infection was observed. Polymerase chain reaction (PCR) testing of DNA extracted from specimens was positive for wild-type varicella zoster virus (VZV). VZV encephalitis was determined to be the cause of death. In June 2011, a pediatrician notified the local Department of Health that a four year-old female patient died of varicella zoster virus (VZV) encephalitis. To the reporters knowledge, this is the first reported fatal case of VZV encephalitis in a child who had received 1 dose of varicella vaccine. Additionally, the child did not have rash. Two major pathologic mechanisms have been proposed as contributing to the development of VZV encephalitis: direct viral invasion of the brain and an autoimmune process. The findings in this case, including acute presentation, localization of viral antigens in encephalitic lesions, and detection of VZV DNA from brain tissue, suggest direct viral invasion. Among children who have received varicella vaccine, nonfatal neurologic complications have been reported rarely following varicella or herpes zoster; a few of these were confirmed to be a result of vaccine-strain VZV. Among unvaccinated persons, wild-type VZV is known to cause fatal neurologic complications. Because the patient described in this report had received 1 dose of varicella vaccine and had no recognized evidence of an immunocompromising condition, her clinical presentation raises questions about why the illness was fatal, and we found no conclusive answers. Although, VZV-associated illness generally manifests with rash, encephalitis related to primary VZV infection without a rash in an unvaccinated immunocompetent child was described in one report. Cases of neurologic complications associated with reactivated VZV but without rash (zoster sine herpete) in unvaccinated immunocompetent children have also been reported. Detection of wild-type VZV, and the absence of varicella rash history, indicate this patient had unrecognized varicella, either previously or at the time of this fatal illness. We were unable to determine whether the patient''s encephalitis was because of breakthrough infection or herpes zoster. In healthy vaccinees, breakthrough varicella is usually mild. However, in this patient, we cannot exclude the possibility of an underlying immunocompromising condition, given some features in her medical history that could have led to severe breakthrough. If the patient''s illness was breakthrough, its severity might also be attributable to lack of response to vaccination. Serologic studies have reported that 15%-24% of healthy children lack adequate antibody response after 1 dose of varicella vaccine, and clinical studies have revealed that approximately one-quarter of breakthrough cases have clinical characteristics similar to varicella among unvaccinated persons. Waning of vaccine-induced immunity was suggested by one study but not confirmed by others. In this patient, the reporter also could not exclude the possibility of herpes zoster. Past breakthrough disease, although not reported, could have been missed considering that the presentation is usually mild or atypical. The differential diagnosis between varicella and herpes zoster could be made clinically in most situations by assessing rash, but this patient did not have rash at presentation. No laboratory tests exist to differentiate between the 2 illnesses. Children with acute otherwise unexplained neurologic symptoms may warrant an investigation for encephalitis, and that VZV should be considered as a possible cause of encephalitis, even if rash is not present and varicella vaccine has been received. Available tests include PCR to detect the viral genome in CSF and assays to detect intrathecal immunoglobulin G. Biopsy can also be considered in individual cases and may aid with diagnosis. Early diagnosis improves the chance of successful treatment. For this patient, past varicella vaccination, absence of rash, and atypical neuroimaging did not raise suspicion of VZV encephalitis. To provide protection among children who do not respond adequately to the first dose of varicella vaccine and to further reduce the disease burden of varicella, a second dose of varicella vaccine is recommended for children aged 4-6 years. The fact that this child was appropriately vaccinated for age may prompt consideration of earlier administration of the second dose. A copy of the published article will be provided as further documentation of the patient''s experience. Additional information has been requested.


VAERS ID: 467090 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Male  
Location: Missouri  
Vaccinated:2012-09-24
Onset:2012-09-24
   Days after vaccination:0
Submitted: 2012-10-01
   Days after onset:7
Entered: 2012-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED P58406 / UNK - / IM

Administered by: Other       Purchased by: Public
Symptoms: Diarrhoea
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-09-28
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: None
Preexisting Conditions: None noted
Allergies:
Diagnostic Lab Data: unknown.
CDC Split Type:

Write-up: Pt daughter reported next day that explosive diarrhea occurred. Recommended ER or urgent care.


VAERS ID: 467247 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Male  
Location: New York  
Vaccinated:2012-09-26
Onset:2012-09-27
   Days after vaccination:1
Submitted: 2012-10-02
   Days after onset:5
Entered: 2012-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4482AA / 4 AR / IM

Administered by: Private       Purchased by: Public
Symptoms: Body temperature increased, Death, Moaning, Nasal flaring, Pain, Peripheral coldness, Resuscitation
SMQs:, Neuroleptic malignant syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-09-27
   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: Multivitamin Levetiraceta Phenobarbitol Diazepam
Current Illness: None
Preexisting Conditions: MR/CP, seizure disorder, developmental delay
Allergies:
Diagnostic Lab Data: None. Family waived Medical Examiner review.
CDC Split Type:

Write-up: 11AM-O2 sats @74%, HR 204, temp 97.7, moaning, upper extremities cold. Tylenol given for pain. 1:10PM-nasal flaring, O2 sats @ 74%, HR 82, temp 99.9, RR 42. EMS called and subsequent code blue. Chest compressions and ambu-bagged, epinephrine given. Transferred to hospital. Pronounced dead at hospital.


VAERS ID: 467340 (history)  
Form: Version 1.0  
Age: 49.0  
Sex: Male  
Location: Unknown  
Vaccinated:2012-09-25
Onset:2012-09-26
   Days after vaccination:1
Submitted: 2012-10-03
   Days after onset:7
Entered: 2012-10-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1204901 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Malaise, Myocardial infarction, Nausea
SMQs:, Acute pancreatitis (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-09-27
   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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US019182

Write-up: Case number PHEH2012US019182 is an initial spontaneous report received from a pharmacist on 28 Sep 2012. This report refers to a 49-years-old male patient whose medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1204901, expiry date: May 2013) intramuscularly on 25 Sep 2012. On 26 Sep 2012, he felt sick and nauseous. It was reported that he suffered a heart attack at his work site and expired before the ambulance arrived on 27 Sep 2012. No further information was available.


VAERS ID: 467381 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-10-03
Entered: 2012-10-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US018706

Write-up: Case number PHEH2012US018706, is an initial spontaneous report received from a consumer on 21 Sep 2012 with a follow up information received on 24 Sep 2012: This report refers to a female patient whose age was not reported. She was vaccinated with influenza vaccine (unknown manufacturer and batch number) on an unknown date. On an unspecified date she died following a flu shot. Cause of death was not reported. Causality assessment was not reported. No further information was provided. Follow up information received on 24 Sep 2012: Gender of the patient was updated.


VAERS ID: 468865 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Male  
Location: Ohio  
Vaccinated:2012-10-03
Onset:2012-10-04
   Days after vaccination:1
Submitted: 2012-10-10
   Days after onset:6
Entered: 2012-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1204201 / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-10-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: vitamin D, mirtazapine, omeprazole, hydrochlorothiazide, loratadine, tramadol, docusate
Current Illness: no infectious illnesses at time of vaccination
Preexisting Conditions: NKDA Adult Failure to Thrive Esophageal stricture, HTN, Osteoarthritis, Dementia
Allergies:
Diagnostic Lab Data: Pt had chronic illnesses including being very malnourished, weighing 102# and being 6''2".
CDC Split Type:

Write-up: Per family pt had a good day and eve, no signs of allergic reaction or difficulty. He failed to wake up the next morning. Time of death 10:37 AM.


VAERS ID: 469542 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Female  
Location: Kentucky  
Vaccinated:2012-09-07
Onset:2012-09-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2012-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B323AA / 1 LL / UN
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1070AA / 1 RL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 918242 / 1 RL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0055AE / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-09-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: GER
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient expired on 9/08/2012 at 4:00 AM, in her home.


VAERS ID: 469573 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Male  
Location: New York  
Vaccinated:2012-07-27
Onset:2012-07-30
   Days after vaccination:3
Submitted: 2012-10-11
   Days after onset:73
Entered: 2012-10-15
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4256AA / UNK AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Hypersomnia, Posture abnormal, Resuscitation, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-07-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DEPAKOTE; KEPPRA; KLONIPIN
Current Illness:
Preexisting Conditions: The patient was autistic and had a past medical history of seizures. He had no illness at the time of vaccination.
Allergies:
Diagnostic Lab Data: An autopsy was performed on an unspecified date. No results were provided.
CDC Split Type: 201209473

Write-up: Initial information received on 10 October 2012 from a patient''s parent. An 18-year-old male patient received a dose of MENACTRA (lot number U4256AA) intramuscularly in the arm on 27 July 2012. The patient was autistic and had a history of seizures. Concomitant medications included DEPAKOTE, KEPPRA, and KLONOPIN as needed for seizures. The patient had no illness at the time of vaccination. The patient''s parent reported that her son was very sleepy on 29 July 2012 and slept all day. He went to summer session at regular time the following day, 30 July 2012, and returned home at regular time at 12:30 pm. He went into his room and played computer games. At 3:30 pm the patient was found with his head slumped on his computer. Cardiopulmonary resuscitation (CPR) was initiated and emergency services (911) was called. The patient was transferred to the hospital and CPR continued for 45 minutes before the patient was pronounced dead. An autopsy was completed, but no results were provided at the time of this report. Documents held by sender: none.


VAERS ID: 469713 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: Washington  
Vaccinated:2012-09-18
Onset:2012-09-18
   Days after vaccination:0
Submitted: 2012-10-11
   Days after onset:23
Entered: 2012-10-15
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 12251P / 2 RA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-09-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Recently discharged for CHF exacerbation
Preexisting Conditions: CHF; Peripheral vascular disease; Hyperlipidemia; Atrial fibrillation; Foot amputation
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Resp. Depression, Tachycardia and Cardiac Arrest. Epinephrine 1 MG Other, Dopamine 10 MCG Other.


VAERS ID: 470610 (history)  
Form: Version 1.0  
Age: 59.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2010-09-01
Onset:2010-09-10
   Days after vaccination:9
Submitted: 2012-10-19
   Days after onset:770
Entered: 2012-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Unknown       Purchased by: Other
Symptoms: Chronic fatigue syndrome, Malaise
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-03-23
   Days after onset: 194
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Not sure. She had been taking pain meds, psych meds, and laxatives.
Current Illness:
Preexisting Conditions: Hypothyroidism Bipolar disorder Back pain
Allergies:
Diagnostic Lab Data: My mom died from a small bowel obstruction. I believe the vaccine may have precipitated the mechanical obstruction. As a healthcare worker being forced into the flu vaccine, I am extremely afraid of the effect on me or losing my job as a CRNA.
CDC Split Type:

Write-up: Extreme malaise lasting months. Diagnosed with chronic fatigue syndrome from the flu vaccine.


VAERS ID: 471586 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New Hampshire  
Vaccinated:2012-09-15
Onset:2012-10-07
   Days after vaccination:22
Submitted: 2012-10-26
   Days after onset:19
Entered: 2012-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0293AE / 1 LG / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-10-07
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NH10262012

Write-up: No information.


VAERS ID: 471590 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-10-26
Entered: 2012-10-26
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1210USA012210

Write-up: This spontaneous report as received from a consumer, who learned from a foreign radio channel of fatal cases after GARDASIL vaccination in one country (1210USA012211) and a second country (2 fatal cases, 1210HKG011628) and in a third country (3 fatal cases, this case). The reporter himself experienced serious adverse events (1210HKG011385). This report refers to three patients of unknown age. The patients were vaccinated with GARDASIL (date and route of administration not provided). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patients died. No details for death are available. The relatedness for death is unknown for GARDASIL. Additional information has been requested.


VAERS ID: 471819 (history)  
Form: Version 1.0  
Age: 95.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2012-10-23
Onset:2012-10-24
   Days after vaccination:1
Submitted: 2012-10-26
   Days after onset:2
Entered: 2012-10-29
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH732AA / UNK LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Asthenia, Cardiac failure congestive, Condition aggravated, Nausea
SMQs:, Cardiac failure (narrow), Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-10-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: CHF; Aortic aneurysm; Advanced age
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient hospitalized 10/16-10/21 with CHF exacerbation and increased weakness. Assessment by HH 10/23/12 and vaccine given. Patient developed nausea later in the day. Called EMS morning of 10/24 and patient taken to E.R.


VAERS ID: 472279 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Male  
Location: New Hampshire  
Vaccinated:2012-10-11
Onset:2012-10-13
   Days after vaccination:2
Submitted: 2012-10-26
   Days after onset:13
Entered: 2012-10-31
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED P58306 / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-10-13
   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:
Current Illness:
Preexisting Conditions: Recent massive heart attack; Narcolepsy
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012033702

Write-up: This medically confirmed spontaneous report (initial receipt: 18-Oct-2012) concerns a 62-year-old male patient, who had a medical history of recent massive heart attack and narcolepsy. He had no known drug allergy. He was taking ''a lot of medications'' (type unspecified). On 11-Oct-2012 the patient received AFLURIA (batch number: P58306) injection at a dose of 0.5 mL intramuscularly. On the day of vaccination, the patient did not complain of any symptoms and went home without any adverse events. On 13-Oct-2012 the patient was found dead. The cause of death was still being investigated. According to the pharmacist (reporter), the patient had many health problems including a recent massive heart attack (date unspecified).


VAERS ID: 472319 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Female  
Location: Washington  
Vaccinated:2012-10-25
Onset:2012-10-27
   Days after vaccination:2
Submitted: 2012-10-31
   Days after onset:4
Entered: 2012-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4204AA / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F70997 / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0058AE / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-10-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: SIDS.


VAERS ID: 472525 (history)  
Form: Version 1.0  
Age: 93.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-11-01
Entered: 2012-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? 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: Prednisone
Current Illness: Unknown
Preexisting Conditions: MEDROL
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1210USA013349

Write-up: This spontaneous report as received from an other health professional refers to a female patient of unknown age. The patient was vaccinated with 0.65 ml ZOSTAVAX in 2008. No other co-suspects were reported. Concomitant medications included: PREDNISONE and inhaled corticosteroids (not otherwise specified). The nurse reported that she administered ZOSTAVAX to a patient that had completed a MEDROL Dosepak. The patient completed the MEDROL Dosepak a month prior to the administration of the ZOSTAVAX (administration of the ZOSTAVAX was believed to be in 2008, but nurse was not sure). The nurse reported that the patient had no adverse reaction associated with the administration of the ZOSTAVAX, but then stated that the patient has since died at age 93. On an unknown date the patient experienced death (death). No treatment information was reported. The outcome of death was reported as fatal. The date of death is not known. Nurse did not feel death was associated with ZOSTAVAX vaccination. The nurse asked about using ZOSTAVAX in a patient that is on 10 mg of Prednisone and inhaled corticosteroids. The nurse did not wish to provide additional information at the time of the call and did not wish follow up. Additional information is not expected. It has been determined that case 1210USA013797 is a duplicate of case 1210USA013349. Therefore, case 1210USA013797 is being deleted from our files and the cases consolidated into case 1210USA013349. No new information was reported.


VAERS ID: 473170 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Female  
Location: Hawaii  
Vaccinated:2012-08-01
Onset:2012-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2012-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute disseminated encephalomyelitis, Demyelination, Myelitis transverse, Nuclear magnetic resonance imaging brain abnormal
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Optic nerve disorders (broad), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-10-10
   Days after onset: 70
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: MRI consistent of ADEM.
CDC Split Type: HI1205

Write-up: Transverse myelitis. Region of demyelination in right frontal lobe.


VAERS ID: 473483 (history)  
Form: Version 1.0  
Age: 31.0  
Sex: Male  
Location: Oklahoma  
Vaccinated:2012-10-30
Onset:2012-10-31
   Days after vaccination:1
Submitted: 2012-11-07
   Days after onset:7
Entered: 2012-11-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB566AN / UNK LA / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR H1354 / UNK LA / IM
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF) / BERNA BIOTECH, LTD. 3000128 / UNK MO / PO
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR UH296AB / UNK LA / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-10-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Soma
Current Illness: No
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pronounced dead at home in bed.


VAERS ID: 473692 (history)  
Form: Version 1.0  
Age: 0.15  
Sex: Female  
Location: Arkansas  
Vaccinated:2012-10-30
Onset:2012-11-04
   Days after vaccination:5
Submitted: 2012-11-08
   Days after onset:4
Entered: 2012-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B351AB / 1 LL / UN
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1070AA / 1 RL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 918131 / 1 RL / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FB27BA / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-11-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Fever
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Child passed away 11/4/12. Autopsy pending - cause of death unknown.


VAERS ID: 473737 (history)  
Form: Version 1.0  
Age: 0.35  
Sex: Male  
Location: Kansas  
Vaccinated:2012-05-18
Onset:2012-05-21
   Days after vaccination:3
Submitted: 2012-10-23
   Days after onset:155
Entered: 2012-11-09
   Days after submission:17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4221AA / 2 RL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F89912 / 2 RL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1847AA / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-05-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient died from unknown cause within 3 days of vaccine series. Death deemed SIDS.


VAERS ID: 475000 (history)  
Form: Version 1.0  
Age: 0.35  
Sex: Male  
Location: Virginia  
Vaccinated:2012-11-16
Onset:2012-11-16
   Days after vaccination:0
Submitted: 2012-11-19
   Days after onset:3
Entered: 2012-11-21
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4259AA / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 918131 / 2 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CB291A / 2 MO / PO

Administered by: Public       Purchased by: Public
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-11-19
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Hydronephrosis; Fussy infant/baby
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt. was taken to the hospital for sx''s of high fever. Seen by resident.


VAERS ID: 475174 (history)  
Form: Version 1.0  
Age: 88.0  
Sex: Female  
Location: Unknown  
Vaccinated:2012-09-22
Onset:2012-10-08
   Days after vaccination:16
Submitted: 2012-11-21
   Days after onset:44
Entered: 2012-11-26
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL) / SANOFI PASTEUR UT4466BA / UNK UN / ID

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Drug administered to patient of inappropriate age
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-10-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient''s past medical history was reported as not applicable (n/a) and illness at time of vaccination was reported as none. The patient used home oxygen.
Allergies:
Diagnostic Lab Data: Not reported.
CDC Split Type: 201210777

Write-up: Initial report was received from a consumer on 14 November 2012, and involves a case of misuse, inappropriate age at vaccine administration. An 88-year-old female patient received an injection of FLUZONE Intradermal, sanofi pasteur Inc., (lot number, route, site, side and dose in series not reported) on 22 September 2012, which is indicated for patients 18 to 64 years of age. On 08 October 2012, 16 days post vaccination, the patient was found dead. The patient''s past medical history was reported as not applicable (n/a) and illness at time of vaccination was reported as none. The patient used home oxygen. It was not reported if an autopsy was done. No other details were provided. The patient''s outcome was reported as fatal on 08 October 2012. Documents held by sender: None.


VAERS ID: 475176 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: Washington  
Vaccinated:2012-10-29
Onset:2012-11-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2012-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B351BA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH624AA / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F70997 / 2 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0059AE / 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: 2012-11-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Died of SIDS 2 days after receiving vaccines.


VAERS ID: 475315 (history)  
Form: Version 1.0  
Age: 49.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-11-26
Entered: 2012-11-27
   Days after submission:1
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, Death, Glioblastoma multiforme, Hyporeflexia, Immunoglobulin therapy, Metastases to meninges, Motor dysfunction, Muscular weakness, Myelitis transverse, Nuclear magnetic resonance imaging spinal cord abnormal, Paraesthesia, Respiratory disorder, Viral infection
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Respiratory failure (broad), Non-haematological malignant tumours (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: 2012033954

Write-up: This literature report (initial receipt: 13-Nov-2012) concerns a 49-year-old male patient. The patient had a recent history of viral infection status post flu vaccination (manufacturer, brand name and batch number were not provided). On an unknown date (post viral infection) the patient presented with a 2-week history of bilateral lower extremity weakness and paresthesias starting at the level of the axilla. He was evaluated by Neurology and initially diagnosed with transverse myelitis. He underwent intravenous immunoglobulin and steroid treatment without improvement. The patient''s physical examination revealed 3/5 proximal and 5/5 distal muscle strength in the lower extremities, deep tendon reflexes were 2/4 with no upper motor neuron signs visualized. He was medically stabilized and transferred to inpatient rehabilitation facility. Ten days post admission, the patient experienced acute motor loss (0/5) in bilateral lower extremities and worsening paresthesias, now involving bilateral upper extremities. At 10 days post admission, imaging revealed C7 to T2 diffuse cord expansion and an oval-shaped focus of intramedullary enhancement. Prior to the completion of his medical work-up, the patient passed away due to unclear causes. Death was most likely related to respiratory compromise. Post mortem autopsy results showed histopathological diagnosis of primary glioblastoma multiforme of the spinal cord. Reporter''s comment: This is a rare documented case of primary spinal glioblastoma multiforme in an adult patient. Mean survival time after onset is between 6-16 months. The major cause of death is leptomeningeal spread and cerebral metastasis. Cervical glioblastoma multiforme may have an even poorer outcome because of early involvement of the phrenic nerve nucleus and vasomotor centers.


VAERS ID: 441125 (history)  
Form: Version 1.0  
Age: 1.28  
Sex: Male  
Location: New Hampshire  
Vaccinated:2011-10-28
Onset:2011-10-31
   Days after vaccination:3
Submitted: 2012-11-25
   Days after onset:391
Entered: 2012-12-03
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B136BB / 1 RL / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT4118CA / 1 RL / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS AHIBC263BA / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 916617 / 4 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Death, 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: 2011-10-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Sodium fluoride
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: See medical examiner''s report
CDC Split Type:

Write-up: Was seen for 15 mo well child visit 10/28/2011 received DTaP, HIB, PCV 13 and influenza vaccines approximately 5pm exam was normal. Patient was at daycare 10/31/11 and found to be unresponsive after being put down for a nap. Brought to ER, pronounced dead after unsuccessful resuscitation attempt.


VAERS ID: 476377 (history)  
Form: Version 1.0  
Age: 89.0  
Sex: Female  
Location: New York  
Vaccinated:2012-10-02
Onset:2012-10-14
   Days after vaccination:12
Submitted: 2012-12-04
   Days after onset:51
Entered: 2012-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U4489AA / UNK LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Anaemia, Blood culture, Blood test, Candidiasis, Chest X-ray, Computerised tomogram, Culture urine, Death, Echocardiogram, Fatigue, Full blood count, Hyperhidrosis, Malaise, Pyrexia, Ultrasound scan, Urine analysis
SMQs:, Haematopoietic erythropenia (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-11-30
   Days after onset: 47
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Amlodipine 5mg, Metoprolol ER 25mg, Isosorbide mononitrate 60mg, Fluoxetine 20mg, Hydrocodone/APAP 7.5/500, Omeprazole 20mg, ASA 81mg, Lidoderm patch 5%, Pravastatin 40mg.
Current Illness: None specifically known.
Preexisting Conditions: None known.
Allergies:
Diagnostic Lab Data: Blood cultures, blood analysis (CBC, etc), urine cultures and analysis, CT scans, chest x-rays, sonogram, echo-cardiogram, and possibly more tests were given.
CDC Split Type:

Write-up: Fevers (102.6 max), sweating, fatigue, malaise, anemia, thrush. Adverse effects lasted until day of death.


VAERS ID: 476382 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2012-10-09
Onset:2012-10-12
   Days after vaccination:3
Submitted: 2012-12-04
   Days after onset:53
Entered: 2012-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U4525AA / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Abasia, Biopsy, Biopsy bone marrow, Blood test, Computerised tomogram, Nuclear magnetic resonance imaging, Sensory loss, X-ray
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-12-01
   Days after onset: 50
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 34 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Vasodec, HTZ/lisinopril
Current Illness: None
Preexisting Conditions: Hypertension
Allergies:
Diagnostic Lab Data: CT, MRI, (multiple) biopsies, blood tests, bone marrow biopsy, multiple x rays
CDC Split Type:

Write-up: Started losing all feeling in arms and legs. Unable to walk unassisted.


VAERS ID: 476400 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Florida  
Vaccinated:2012-11-21
Onset:2012-11-21
   Days after vaccination:0
Submitted: 2012-12-04
   Days after onset:13
Entered: 2012-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U4537AA / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chills, Confusional state, Death, Influenza like illness, Malaise, Nausea, Pain, Vertigo
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-11-22
   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: QUINAPRIL 10 mg tablets, 1 oral dose daily; Simvastatin 10 mg tablets, 1 oral dose daily
Current Illness:
Preexisting Conditions: The patient was a male who smoked, had hyperlipidemia, and hypertension. No known allergies to food or other medications were noted in his medical history.
Allergies:
Diagnostic Lab Data: No autopsy was performed as it appeared at the time to be a natural cause of death due to the patients advanced age.
CDC Split Type:

Write-up: Patient died after receiving a HIGH DOSE flu shot on the morning of 11/21/12. The shot was administered at pharmacy. The shot was given to the patient at approximately 11:00 am on November 21, 2012. By late afternoon the patient was experiencing flu-like symptoms; chills, body aches, vertigo, nausea and confusion. The patient spoke with his eldest son late that evening by phone and told his son of his symptoms and the fact that he had been given a flu shot early that day. Patient died after receiving a HIGH DOSE flu shot on the morning of 11/21/12. The shot was administered at pharmacy. The shot was given to the patient at approximately 11:00 am on November 21, 2012. By late afternoon the patient was experiencing flu-like symptoms; chills, body aches, vertigo, nausea and confusion. The patient spoke with his eldest son late that evening by phone and told his son of his symptoms and the fact that he had been giving a flu shot early that day. At approximately 10:30 pm on 11/21/12 the phone conversation ended with the patient stating that he was going to the bathroom because he did not feel well. The next morning the patient did not respond to phone calls or knocking on the door by relatives. Upon gaining entry to the home, the patient was found dead on the floor between his bedroom and bathroom hallway. The patient was naked and face down on the floor when found. The patient had no history of heart problems and had never experienced a heart attack.


VAERS ID: 476687 (history)  
Form: Version 1.0  
Age: 49.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-12-05
Entered: 2012-12-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Glioblastoma multiforme, Immunoglobulin therapy, Motor dysfunction, Muscular weakness, Neurological examination abnormal, Paraesthesia, Respiratory failure, Viral infection
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), 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), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypersensitivity (broad), Respiratory failure (narrow), Non-haematological malignant tumours (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Neurological examination, see text
CDC Split Type: B0849218A

Write-up: This case was reported in a literature article and described the occurrence of glioblastoma multiforme in a 49-year-old male subject who was vaccinated with influenza vaccine unspecified (manufacturer unspecified). On an unspecified date the subject received unspecified dose of Influenza vaccine unspecified (unknown route, unknown lot number). At an unspecified time after vaccination with Influenza vaccine unspecified, the subject presented with a 2-week history of bilateral lower extremity weakness and paresthesia starting at the level of the axilla. The subject had a recent history of viral infection status post flu vaccination. He was evaluated by Neurology and initially diagnosed with transverse myelitis. He underwent intravenous immunoglobulin and steroid treatment without improvement. The subject''s physical examination revealed 3/5 proximal and 5/5 distal muscle strength in the lower extremities, deep tendon reflexes were 2/4 with no upper motor neuron signs visualized. He was medically stabilized and transferred to our inpatient rehabilitation facility. Ten days post admission, the subject experienced acute motor loss (0/5) in bilateral lower extremities and worsening paresthesia, now involving bilateral upper extremities. At 10 days post admission, imaging revealed C7 to T2 diffuse cord expansion and an oval-shaped focus of intramedullary enhancement. Prior to the completion of his medical work-up the subject passed away due to unclear causes. The subject died from glioblastoma multiforme and respiratory failure. Post mortem autopsy results showed histopathological diagnosis of primary glioblastoma multiforme of the spinal cord.


VAERS ID: 477044 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Illinois  
Vaccinated:2012-11-29
Onset:2012-12-01
   Days after vaccination:2
Submitted: 2012-12-07
   Days after onset:6
Entered: 2012-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4293AA / 1 RL / UN
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0384AE / 2 LL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F95942 / 1 LL / UN

Administered by: Private       Purchased by: Private
Symptoms: Autopsy, 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: 2012-12-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Coroners case - post inconclusive, other studies are pending
CDC Split Type:

Write-up: ER informed me 12-1-12 that child brought to ER after being found unresponsive in parent''s bed.


VAERS ID: 477186 (history)  
Form: Version 1.0  
Age: 1.06  
Sex: Female  
Location: Unknown  
Vaccinated:1994-11-01
Onset:1994-11-01
   Days after vaccination:0
Submitted: 2012-12-07
   Days after onset:6611
Entered: 2012-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blindness, Death, Immune system disorder, Pyrexia, Surgery
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 1993, Body temperature, 107-108 F
CDC Split Type: WAES1212USA001673

Write-up: This spontaneous report was received from the patient''s brother refers to a 13 months old female patient with no pertinent Medical History or Drug reactions/allergies who on unspecified date in approximately November 1994 (when the patient was 13 months of age) was vaccinated with MMR II (dose, lot number and route no reported). No other co-suspects were reported. No concomitant medications were reported. The night the patient received the vaccine, the patient developed a high fever (107-108 F) and was sent to an unspecified hospital where she was admitted and treated for an unspecified period of time. On unknown date, the patient had multiple unspecified surgeries, became blind and her "immune system failed." The patient was two years of age when she died (approximately in 1995). The outcome of the events patient developed a high fever (107-108 F), became blind and her "immune system failed" was unknown. The relatedness for the event and MMR II was unknown. Additional information is not expected.


VAERS ID: 478039 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Female  
Location: Texas  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-12-14
Entered: 2012-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Death, Malignant neoplasm progression, Neuroendocrine carcinoma of the skin
SMQs:, Malignancy related conditions (narrow), Skin malignant tumours (narrow), Non-haematological malignant tumours (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Neuroendocrine carcinoma of the skin; Systemic lupus erythematosus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1212USA004903

Write-up: This spontaneous report as received from a licensed practical nurse refers to an approximately 68 years old female patient with lupus and merkel cell carcinoma. About 3 months ago (reported on 12-DEC-2012)(September 2012) the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot number and route were not reported) at an unspecified pharmacy in an unspecified location. No other co-suspects were reported. No concomitant medications were reported. The nurse reported that the patient was given the vaccine even though he had both lupus and merkel cell carcinoma. The nurse reported that after the vaccination, over the following 2 months, the cancer progressed more aggressively (death, medically significant, life threatening and hospitalization). On an unknown date the patient sought medical attention. The patient was admitted to the hospital (date not provided) and died while in the hospital. The patient died about a month ago. (November 2012) and the cause of death was reported as cancer. The patient''s doctor at the hospital told the patient''s family that he believed that the cancer''s progression was caused by ZOSTAVAX. Discrepant information reported in Source Document: patient is referred to as ''female'' in the patient section of the report, but referred to as ''he'' in Narrative. Additional information has been requested.


VAERS ID: 478157 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-12-14
Entered: 2012-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Pertussis
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: Premature baby 26 to 32 weeks
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0852241A

Write-up: This case was reported in a literature article and described the occurrence of death nos in a 2-month-old subject of unspecified gender who was vaccinated with DTP (manufacturer unspecified). The subject was born prematurely at 28 weeks'' gestational age. On an unspecified date, the subject received 1st dose of DTP (unknown route of administration, unknown site of injection, batch number not provided). 15 days after vaccination with DTP, the subject experienced pertussis. The subject died from unknown cause of death. It was unknown whether an autopsy was performed. Summary of literature article: Pertussis is an endemic, underdiagnosed bacterial respiratory tract infection caused by Bordetella pertussis. The incidence of pertussis is cyclical, with peaks every 2-5 years as the proportion of susceptible people in the population who are immunologically naive or have lost immunity grows sufficiently large. The incidence of pertussis reported decreased substantially after extensive childhood immunization, falling from more than 265 000 cases in 1934 to a nadir of 1010 cases in 1976. Subsequently, the number of report cases has increased. During the cyclical peak year of 2005, more than 25 000 cases were reported, including more than 3000 cases; cases included 8 deaths in infants younger than 3 months. Possible explanations for the rising incidence of pertussis include large birth cohorts of susceptible infants, the replacement of more reactogenic whole cell vaccines with less effective acellular pertussis vaccines in the 1990s, more rapid waning of immunity conveyed by acellular pertussis vaccines, and increased detection of cases; and increased detection of cases through greater clinician awareness and the availability of more sensitive polymerase chain reaction (PCR) tests for laboratory confirmation. Pertussis PCR tests have been used since the 1990s and became the predominant testing method in 2004. In 2010, experienced the highest number of pertussis cases in more than 60 years, with more than 9000 cases, 809 hospitalizations, and 10 deaths. This report provides a descriptive epidemiolgic analysis of this epidemic and describes public health mitigation strategies that were used, including expanded pertussis vaccine recommendations. Clinical and demographic information were evaluated for all pertussis cases with onset from January 1, 2010, through December 31, 2010, and reported to the Department of Public Health. A total of 9154 pertussis cases with onset in 2010 were reported: 5482 (60%) confirmed, 1706 (19%) probable, and 1966 (22%) suspect. Of the confirmed cases, most (82%) were laboratory-confirmed by PCR testing, 6% were confirmed by culture, and the remaining 12% were epidemiologically linked to a laboratory-confirmed case. Of the suspected cases, 88% were confirmed by PCR testing and the remaining were epidemiologically linked to confirmed cases. The majority (56%) of reported patients became ill from June through September 2010; the peak month was July. The reported incidence of cases per 100 000 population was 23.4 statewide but varied 0-138.4 by county. Incidence was highest among infants younger than 6 months and lowest in adults 19 years of age and older. Relatively high numbers of cases were observed in fully vaccinated older children and adolescents, with the peak at age 10 years; after age 10, the number of cases declined with age and remained low among those aged 14-18 years. Information was reported for 8028 (88%) cases. Overall, the incidence per 100 000 population. Infants younger than 6 months had the highest case incidence (587.7 per 100 000); however, among young children and adolescents aged 1-18 years, the highest incidence (70.3). A total of 809 (8.9%) patients were hospitalized, of whom 584 (72%) were younger than 6 months and 446 (55%) were younger than 3 months. Sixty-two percent of all 720 infants younger than 3 months were hospitalized. The hospitalization rate among all infants younger than 6 months was 46%. The median age at disease onset among all hospitalized cases was 2.6 months (range less than 1 month to 92 years), and the median length of stay was 4 days (range 1-48 days). Of 1506 patients reported to have undergone radiography or computed tomography of the chest, 285 (18%) had a diagnosis of pneumonia. Nineteen patients had seizures and 3 had acute encephalopathy. Ten fatal cases were reported, all in infants. Nine were previously healthy infants younger than 2 months at illness onset who had not been immunized against pertussis; 7 of these infants were younger than 6 weeks. The remaining fatality was a 2-month-old infant born prematurely at 28 weeks'' gestational age who had received the first dose of DTAP 15 days prior to disease onset. Nine of 10 fatalities were infants. The case-fatality rate among infants younger than 3 months was 1.3%. Seven infants were brought to medical attention for their pertussis illness at least once prior to the visit that led to hospital admission. Five of these 7 infants had multiple prior medical visits; however, only 1 received macrolide antibiotic therapy for pertussis. All had leukocytosis with a median white blood cell count of 78 200 cells/mm3. All deaths occurred in infants with symptom onset in the first 9 months of 2010. Of 4415 (76%) pediatric cases in infants aged 6 months through 18 years with vaccination information, 380 (9%) were completely unvaccinated against pertussis and 1621 (37%) had not received 1 or more recommended pertussis vaccine doses; 745 (46%) of incompletely immunized individuals were 11-18 years old and had not received TDAP. The remaining 2414 (55%) were reported to be fully immunized for their age; most (66%) of these were children aged 7-10 years who had received 5 prior doses of DTAP immunized younger than the recommended age for immunization with TDAP. Among 314 unvaccinated patients aged 6 month to 18 years. Infants younger than 6 months had the highest disease rates; all deaths and most hospitalizations occurred in infants younger than 3 months. Most pediatric cases were vaccinated according to national recommendations, although 9% of those aged 6 months to 18 years were completely unvaccinated again pertussis. High disease rates also were observed in fully vaccinated preadolescents, especially 10-year-olds. Mitigation strategies included expanded tetanus, diphtheria, and acellular pertussis vaccine recommendations, public and provider education, distribution of free vaccine for postpartum women and contacts of infants, and clinical guidance on diagnosis and treatment of pertussis in young infants. In conclusion, infants too young to be fully vaccinated against pertussis remain at highest risk of severe disease and death. Data are needed to evaluate strategies offering direct protection of this vulnerable population, such as immunization of pregnant women and of newborns. The high rate of disease among preadolescents suggests waning of immunity from the diphtheria, tetanus, and acellular pertussis series; additional studies are warranted to evaluate the efficacy and duration of protection of the diphtheria, tetanus, and acellular pertussis series and the tetanus, diphtheria, and acellular pertussis series.


VAERS ID: 478216 (history)  
Form: Version 1.0  
Age: 91.0  
Sex: Male  
Location: Virginia  
Vaccinated:2012-11-19
Onset:2012-11-21
   Days after vaccination:2
Submitted: 2012-12-16
   Days after onset:25
Entered: 2012-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 0793510 / 1 LA / ID

Administered by: Unknown       Purchased by: Other
Symptoms: Chest X-ray, Cough, Dizziness, Headache, Increased bronchial secretion, Laboratory test, Pleural effusion, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Aenolol, prednisone Merck Sharpe, & D
Current Illness: No
Preexisting Conditions: High blood pressure
Allergies:
Diagnostic Lab Data: Chest x-rays, emergency room lab tests, extended hospital stage still going on.
CDC Split Type:

Write-up: Fluid in lungs, persistent rattling cough, excess mucous, headache, fever, dizziness, ....


VAERS ID: 478441 (history)  
Form: Version 1.0  
Age: 0.12  
Sex: Male  
Location: California  
Vaccinated:2012-11-29
Onset:2012-12-17
   Days after vaccination:18
Submitted: 2012-12-17
   Days after onset:0
Entered: 2012-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4292AA / 1 UN / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR C4357AA / 1 UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G10784 / 1 UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0036AE / 1 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Feeding disorder of infancy or early childhood, 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: 2012-12-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Probiotics
Current Illness: None
Preexisting Conditions: Gassy baby on hypoallergenic formula
Allergies:
Diagnostic Lab Data: Done at medical center
CDC Split Type:

Write-up: 12/16/12 baby fed less well. 12/17/12 found unresponsive. Did not respond to resuscitation efforts.


VAERS ID: 479777 (history)  
Form: Version 1.0  
Age: 63.0  
Sex: Male  
Location: Louisiana  
Vaccinated:2012-12-14
Onset:2012-12-16
   Days after vaccination:2
Submitted: 2012-12-30
   Days after onset:14
Entered: 2012-12-31
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH734AA / 1 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Dizziness, Eyelid function disorder, Vaccination complication, Viral infection
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-01-02
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ACIPHEX
Current Illness: None indicated on VAR
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Beginning 12/16/12, 2 days post flu vaccine, pt complained of dizziness which became progressively more severe. It''s more of the eyelids flipping upwards/jumping movement. Per wife, hospital ruled out stroke, aneurysm and are leaning toward viral infection or flu vaccine adverse event as cause. It has not been determined.


VAERS ID: 480310 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Female  
Location: New York  
Vaccinated:2012-12-19
Onset:2012-12-23
   Days after vaccination:4
Submitted: 2013-01-06
   Days after onset:14
Entered: 2013-01-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Public       Purchased by: Unknown
Symptoms: Bacterial test, Death, Malaise, Pericardial haemorrhage, Viral test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-12-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SPIRIVA; Gabapentin; Simvastatin; Diclofenac
Current Illness: None
Preexisting Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Viral and bacterial cultures of pericardial blood pending
CDC Split Type:

Write-up: According to son who was interrogated, decedent received flu vaccine 12/19 at hospital and was not feeling well after that; found dead at home 12/23, hemorrhagic pericarditis.


VAERS ID: 480899 (history)  
Form: Version 1.0  
Age: 89.0  
Sex: Male  
Location: Florida  
Vaccinated:2013-01-07
Onset:2013-01-07
   Days after vaccination:0
Submitted: 2013-01-10
   Days after onset:3
Entered: 2013-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U4542AA / 2 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Death, Diarrhoea, Viral infection, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-01-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Latanoprost eye drops, tamsulosin, possibly other, patient uses other pharmacies also
Current Illness: None reported at time of vaccination
Preexisting Conditions: High blood pressure
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Neighbor reported that the patient died 1-7-13. Inital cause has been diagnosed as vomiting and diarrhea probably caused by a virus. Due to its close approximation to vaccination I am reporting this incident.


VAERS ID: 480995 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Female  
Location: Nebraska  
Vaccinated:2012-10-03
Onset:2012-10-07
   Days after vaccination:4
Submitted: 2013-01-10
   Days after onset:95
Entered: 2013-01-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH730AB / UNK LA / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Death, Guillain-Barre syndrome, Pain in extremity
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Tendinopathies and ligament disorders (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-10-18
   Days after onset: 11
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: Diabetes; Coronary artery disease; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vaccine 10-3-12. To ER 10-12-12 with (L) arm pain. Seen 10-13-12 & transferred to cardiologist at hospital she declined there, was diagnosed with Guillain-Barre, transferred to where she expired.


VAERS ID: 481268 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Female  
Location: Florida  
Vaccinated:2013-01-10
Onset:2013-01-11
   Days after vaccination:1
Submitted: 2013-01-14
   Days after onset:3
Entered: 2013-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B370AA / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. H015034 / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F18876 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. H016902 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-01-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol
Current Illness: None known
Preexisting Conditions: Trisomy 18, clean bill of health from open heart surgery
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: None.


VAERS ID: 482344 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-01-23
Entered: 2013-01-23
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1301USA010664

Write-up: This spontaneous report as received via social media refers to a female patient of unknown age, who on an unspecified date was vaccinated with a dose of GARDASIL (dose and lot number were not reported). No other co-suspects were reported. No concomitant medications were reported. The other reported that the patient died after vaccination. The relatedness for the adverse event was unknown for GARDASIL. This is one of the several reports from the same source. Additional information is not expected.


VAERS ID: 482352 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-01-23
Entered: 2013-01-23
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1301USA010666

Write-up: This spontaneous report as received via social media who reported multiple patients (unknown age and gender) who on an unspecified date were vaccinated with a dose of GARDASIL (dose and lot number were not reported). No other co-suspects were reported. No concomitant medications were reported. The reporter stated that on an unspecified date, the patients died from the vaccine. No treatment information was reported. At the time of the report, the patients outcome for the adverse event was fatal. The relatedness for the adverse event was related for GARDASIL. This is one of the several reports from the same source. Additional information is not expected.


VAERS ID: 482371 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Male  
Location: Virginia  
Vaccinated:2012-10-24
Onset:0000-00-00
Submitted: 2013-01-24
Entered: 2013-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1206101W / 3 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Aphasia, Asthenia, Chest pain, Death, Gait disturbance, Guillain-Barre syndrome, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Chronic kidney diseas, hypertension, gout
Allergies:
Diagnostic Lab Data:
CDC Split Type: VA13002

Write-up: Hospitalized 12/12/12 through 12/22/12 at medical center. Complaints of 6 months'' increasing edema in hands and feet, current unsteady gait, decreased strength. Diagnosed with Guillain-Barre Syndrome. Readmit 1/3/13 with worsening weakness, dysphasia. 1/5/13, expired during transport by ambulance. Stopped at community hospital while en route. DOA at community hospital. Medical center reporting seen at another medical center prior to current medical center 1/3/13 admission for chest pain. Ruled out MI at that time.


VAERS ID: 483009 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: New Hampshire  
Vaccinated:2012-12-12
Onset:2012-12-31
   Days after vaccination:19
Submitted: 2013-01-30
   Days after onset:30
Entered: 2013-01-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B370BA / UNK LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH549AC / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F72495 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. H011458 / 1 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Blood bilirubin, Blood gases, Death, Respiratory disorder
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-12-31
   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: 10-23-2012 - Nystatin; mouth throat suspension
Current Illness: No
Preexisting Conditions: Twin; Mucocele oral; Neonatal feeding problems 10-18-12 resolved 10-27-2012; History of neonatal hyperbilirubinemia that was resolved on 10-27-2012
Allergies:
Diagnostic Lab Data: Umbilical Vbg; bilirubin
CDC Split Type: NH0906201212

Write-up: 12-17-2012 - Acute Respiratory Illness, ? SIDS.


VAERS ID: 483022 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2010-01-15
Onset:2010-01-18
   Days after vaccination:3
Submitted: 2013-01-30
   Days after onset:1108
Entered: 2013-01-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 6 AR / SYR
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / 1 AR / SYR

Administered by: Public       Purchased by: Public
Symptoms: Blood glucose increased, Blood test, Chills, Confusional state, Encephalitis viral, General physical health deterioration, Lumbar puncture abnormal, Mental status changes, Neck pain, Pyrexia, Urinary tract infection
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2011-05-17
   Days after onset: 483
Permanent Disability? Yes
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: Insulin, fluid pill, vitamin D, eye drops for Glaucoma.
Current Illness: None
Preexisting Conditions: Diabetes, Leaking heart valve
Allergies:
Diagnostic Lab Data: Blood work & lumbar puncture.
CDC Split Type:

Write-up: Extreme neck pain, increase blood sugar & confusion. Fever & chills began two days later. Took to doctor''s office on 01/25/2010 & was referred to ER where she was diagnosed with UTI & sent home with oral antibiotics. Health continued to deteriorate so had her taken by ambulance to ER where she wad admitted due to deminished mental capacity. Diagnosed with Viral Encaphlitis. A lumbar puncture done on 02/03/2010 to confirm diagnoses. IV anitibiotic was administered for 21 days. On 02/08/2010 was transferred to nursing home for completement of IV. Never regained health.


VAERS ID: 483055 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New Hampshire  
Vaccinated:2012-10-05
Onset:2012-11-05
   Days after vaccination:31
Submitted: 2013-01-31
   Days after onset:87
Entered: 2013-01-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0384AE / 1 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-11-05
   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: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data:
CDC Split Type: NH01320133

Write-up: MD visit at 1 week - healthy baby. 6 lbs 9 oz born at 39 weeks. ? SIDS death.


VAERS ID: 483215 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2013-01-16
Onset:2013-01-17
   Days after vaccination:1
Submitted: 2013-02-01
   Days after onset:15
Entered: 2013-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. AL2156 / 4 NS / IN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-01-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient deceased.


VAERS ID: 483614 (history)  
Form: Version 1.0  
Age: 0.36  
Sex: Male  
Location: South Carolina  
Vaccinated:2013-01-18
Onset:0000-00-00
Submitted: 2013-01-31
Entered: 2013-02-07
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B357BB / 2 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. H012570 / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 918175 / 2 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CB305A / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-01-21
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: No documentation of any problem. Have received word autopsy done - "child died of natural causes."


VAERS ID: 483818 (history)  
Form: Version 1.0  
Age: 56.0  
Sex: Male  
Location: Texas  
Vaccinated:2013-02-01
Onset:2013-02-02
   Days after vaccination:1
Submitted: 2013-02-04
   Days after onset:2
Entered: 2013-02-08
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH712AA / 1 AR / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-02-02
   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: VISTARIL; Temazepam; SEROQUEL; RISPERDAL
Current Illness: None
Preexisting Conditions: Hypertension; Schizophrenia
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Reported by family that he was found dead on 2/2/13.


VAERS ID: 483916 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Michigan  
Vaccinated:0000-00-00
Onset:2013-02-01
Submitted: 2013-02-06
   Days after onset:5
Entered: 2013-02-08
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Malaise, Meningitis bacterial
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-02-03
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201301601

Write-up: Initial report was received from a healthcare professional on 04 February 2013. A 19-year-old female patient had received an injection of MENINGOCOCCAL VACCINE (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later became ill and was hospitalized on 01 February 2013. The patient was diagnosed with bacterial meningitis. The patient died on 03 February 2013. No additional information was provided. Outcome was fatal. Documents held by sender: None.


VAERS ID: 485004 (history)  
Form: Version 1.0  
Age: 1.86  
Sex: Female  
Location: Utah  
Vaccinated:2013-01-21
Onset:2013-01-28
   Days after vaccination:7
Submitted: 2013-02-20
   Days after onset:23
Entered: 2013-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4547CA / 1 RL / IM
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0532AE / 2 LL / IM

Administered by: Private       Purchased by: Other
Symptoms: Death, Influenza A virus test positive, Laboratory test, Respiratory arrest, Resuscitation, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2013-01-30
   Days after onset: 2
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: PMD''s office reported that child had been recommended to take a multivitamin, unknown if child was taking.
Current Illness: None reported by PMD''s office
Preexisting Conditions: None reported by PMD''s office
Allergies:
Diagnostic Lab Data: Child had been seen at Emergency Room on 01/27/2013 and had positive rapid influenza A testing. No influenza testing through second Medical Center but did have series of testing to determine cardiac related event. Autopsy was declined by family.
CDC Split Type:

Write-up: Per hospital and family reports, child was talking to grandfather when she collapsed and stopped breathing. Grandfather performed CPR until EMS arrived and child was transported via AirMed to Medical Center. Child expired on 01/30/2013.


VAERS ID: 485188 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-02-21
Entered: 2013-02-21
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1302USA006176

Write-up: This spontaneous report as received from internet referred to three patients of unknown age. On an unknown date the patients were vaccinated with GARDASIL (Lot#, dose/frequency, route and duration were unspecified). Then on an unknown date the patients died (three deaths have been reported along with more reports of paralysis in girls who had gotten the poorly tested HPV vaccine). The date and cause of death were not reported. It was unknown whether autopsy was done. This is one of several reports that received from the same source. Additional information has been requested.


VAERS ID: 485434 (history)  
Form: Version 1.0  
Age: 0.01  
Sex: Male  
Location: New Hampshire  
Vaccinated:2013-01-02
Onset:2013-02-10
   Days after vaccination:39
Submitted: 2013-02-25
   Days after onset:15
Entered: 2013-02-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVC188CA / 1 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-02-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None noted
Allergies:
Diagnostic Lab Data: None noted
CDC Split Type: NH02112013

Write-up: Born at 39 weeks gestation. Newborn screenings WNL. May have been a twin.


VAERS ID: 485686 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Male  
Location: Colorado  
Vaccinated:2012-11-15
Onset:0000-00-00
Submitted: 2013-02-27
Entered: 2013-02-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / 1 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-12-13
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: WAES1302USA012087

Write-up: This spontaneous report as received from a consumer refers to an 82 year old male patient. The patient''s medical history and concurrent conditions were not provided. On 15-NOV-2012 the patient was vaccinated with a dose of ZOSTAVAX. Dose, route and lot number were not provided. No concomitant medications were reported. On an unknown date the patient experienced multi-organ failure and cardiac arrest. The outcome of multi-organ failure and cardiac arrest was reported as fatal. The patient died on 13-DEC-2012 at 1515 (military time) in the hospital. The cause of death was reported as cardiac arrest and multi-organ failure, according to the Death Certificate. No reporter causality was provided. Additional information has been requested.


VAERS ID: 485757 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: New York  
Vaccinated:2013-02-19
Onset:2013-02-19
   Days after vaccination:0
Submitted: 2013-02-25
   Days after onset:6
Entered: 2013-02-28
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB677CA / UNK UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H016238 / UNK UN / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U42927 / UNK UN / UN
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4431BA / UNK UN / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Cardiac arrest, Crying, Death, Endotracheal intubation, Respiratory arrest, Skin discolouration
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-02-20
   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: DILANTIN; Phenobarb
Current Illness: Medical record - cough - resp sym x 5 days (doc denies)
Preexisting Conditions: Microcephaly; seizure
Allergies:
Diagnostic Lab Data: See reverse
CDC Split Type:

Write-up: 2/19/13 23:24 Pt brought in by ambulance in cardiac arrest, "mother states pt has been having cough & URI symptoms since 5 days - seen by doctor 2/19/13 & given 4 vaccines. Pt sleeping & crying - suddenly pt turned white & was not breathing - 911 called & intubated. Doctor states he was not aware of any illness & child''s DILANTIN level was 1.0. No lab found in medical record child revived & transfer to another hospital where child died on 2/20/13.


VAERS ID: 485762 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-02-26
Entered: 2013-02-28
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-02-01
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: 2013066299

Write-up: This is a spontaneous report from a contactable physician through Pfizer Vaccine Representative. This physician reported for a 8 year old (unknown gender) patient who received a dose of PREVNAR 13 on unknown date. Relevant medical history and concomitant medication were unknown. It was reported that on an unknown date the patient had streptococcus pneumonia and meningitis. Therapeutic measures taken, if any, were unknown. The patient had not recovered from the reported events and passed away on an unknown date in Feb2013 due to streptococcus pneumonia and meningitis. At the time of reporting, it was unknown if autopsy was performed.


VAERS ID: 486413 (history)  
Form: Version 1.0  
Age: 49.0  
Sex: Female  
Location: Georgia  
Vaccinated:2012-09-14
Onset:2012-09-15
   Days after vaccination:1
Submitted: 2013-03-07
   Days after onset:173
Entered: 2013-03-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1204601 / UNK LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Abasia, Diarrhoea, Dysstasia, Hypersomnia, Hypokinesia, Intensive care, Lethargy, Malaise, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2012-10-01
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: couldnt move without assistance~ ()~~0.00~Patient|couldnt stand~ ()~~0.00~Patient|weakness~ ()~UN~12.75~Patient|~Influenza (Seas
Other Medications: Duonebs, Abilify, Azactam, Carvedilol, Diflucan, Diflucan, Levanquin, Solu-Cortef, Synthroid, Vancomycin. Allergies: Sulfa, Penicillin, Benadryl
Current Illness: After an hour of vaccine, patient was nausea, vomiting, diarrhea and couldn''t move or stand to go to bathroom.
Preexisting Conditions: Received vaccine at dialysis center. Dialysis of kidney, full-blown AIDS, but very active and lively before incident.
Allergies:
Diagnostic Lab Data: Yes. ER & ICU & CCU
CDC Split Type:

Write-up: Stated she wasnt feeling well. I thought it was from dialysis treatment. She went to sleep, slept longer than normal, tried to eat, vomiting, couldn''t move or stand without assistance. Refused to go to hospital, diarrhea on herself, sleeping, couldn''t move off couch to bed, could walk, kept saying she was sick wanted. Very lethargic, no fever, got help from two sons to help move to wash off diarrhea & vomit.


VAERS ID: 487277 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-03-05
Entered: 2013-03-20
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN

Administered by: Other       Purchased by: Other
Symptoms: Cardiac arrest, Death, Laboratory test normal, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (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: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013SE15191

Write-up: A report was received from a physician via a medical representative concerning a 3 year old female. Her medical history, concurrent diseases, and concomitant medications were not reported. On an unknown date, she received nasal FLUMIST. The medical doctor mentioned that two to three years ago a previously healthy 3 year old female died within three days of receiving FLUMIST in her office. The medical representative was uncertain whether symptoms began shortly after dose or three days later. At an unspecified time period after FLUMIST, the patient started vomiting and collapsed. She was taken to hospital three days after receiving FLUMIST and died. The physician stated that all the tests were negative, and the child was afebrile. The medical representative was uncertain whether an autopsy was performed. She also stated that the doctor thought the death was related to FLUMIST. The official cause of death was cardiac arrest. On an unspecified date, the patient died from the event of cardiac arrest, and at the time of reporting the outcome of the event of collapse and vomiting was unknown. According to the reporter the adverse event of cardiac arrest was considered to be serious with the serious criteria of death and the adverse event of vomiting was considered to be non-serious. According to the company physician the adverse event of collapse was considered to be serious with the serious criteria of important medical event. According to the reporter the adverse events were causally related to the suspect drug of FLUMIST.


VAERS ID: 487403 (history)  
Form: Version 1.0  
Age: 0.36  
Sex: Male  
Location: Florida  
Vaccinated:2013-03-07
Onset:2013-03-09
   Days after vaccination:2
Submitted: 2013-03-19
   Days after onset:9
Entered: 2013-03-21
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B357 / UNK UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR H1123 / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 918175 / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-03-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had been chronically ill with a history of T fistula with esophageal atresia which was repaired, traceomalacia, PDA (not specified) PFO (not specified), and cardiac issues.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201303977

Write-up: Initial report was received 11 March 2013 from a health care professional. A four-month-old male patient had received an injection of ACTHIB lot number UH609AA (corresponding sanofi pasteur SA lot number H1123-1), PEDIARIX (manufacturer GSK, lot number AC21B357 and PREVNAR (manufacturer Pfizer, lot number 918175) on 07 March 2013, and two days later on the evening of 09 March 2013, the patient passed away. He had previously received a first dose of RSV vaccine on an unspecified date. The patient had been chronically ill with a history of T fistula with esophageal atresia which was repaired, traceomalacia, PDA (patent ductus arteriosus), PFO (patent foramen ovale), and cardiac issues. He had no known allergies. The event outcome was fatal. Documents held by sender: None.


VAERS ID: 487601 (history)  
Form: Version 1.0  
Age: 0.36  
Sex: Male  
Location: Iowa  
Vaccinated:2013-03-20
Onset:2013-03-21
   Days after vaccination:1
Submitted: 2013-03-22
   Days after onset:1
Entered: 2013-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C4335AA / 2 LL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH774AB / 2 RL / UN
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR H1604 / 2 LL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F42899 / 2 RL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. H012979 / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-03-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Maternal smoker - 1.5 ppd
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Child was found unresponsive in crib on 3/21/13 am. Mom had fed at approx. 3 am and baby was fine. Found at 7 am face down in bassinet. 911 called. Pronounced dead at hospital.


VAERS ID: 487759 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2013-03-08
Onset:2013-03-12
   Days after vaccination:4
Submitted: 2013-03-25
   Days after onset:13
Entered: 2013-03-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR UH588AA / 1 UN / UN

Administered by: Private       Purchased by: Other
Symptoms: Abdominal distension, Choking sensation, Computerised tomogram abdomen abnormal, Death, Dyspnoea, Ear infection, Gastrectomy, Gastric perforation, Gastrointestinal gangrene, General physical health deterioration, Guillain-Barre syndrome, Haemodialysis, Mechanical ventilation, Plasmapheresis, Post procedural complication, Pyrexia, Renal failure, Respiratory failure, Surgery, Upper gastrointestinal haemorrhage
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal perforation (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Cardiomyopathy (broad), Demyelination (narrow), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-03-21
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Levofloxacin
Current Illness: No
Preexisting Conditions: Allergy to Sulfa drugs
Allergies:
Diagnostic Lab Data: As above
CDC Split Type:

Write-up: He started having high grade fever on 3/12, reaching up to 102.9. I asked him to go to his primary care physician who thought he had ear infection and prescribed Levofloxacin. He called me on 3/16/13 complaining of severe shortness of breath and choking sensation in the neck. He deteriorated over the next few days with worsening shortness of breath, persistent fever, renal and respiratory failure requiring hemodialysis and ventilator support. He also underwent a single course of plasmapharesis with presumed diagnosis of Guillain Barre Syndrome but did not respond. He had upper GI bleed and subsequent CT scan showed free air in the abdomen. He underwent emergency surgery that showed gastric gangrene and perforation. Total gastrectomy was performed. He had increasing abdominal distention post-surgically and passed away approximately 5 am on 3/21/2013.


VAERS ID: 489163 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Unknown  
Location: Virginia  
Vaccinated:0000-00-00
Onset:2013-01-25
Submitted: 2013-04-15
   Days after onset:79
Entered: 2013-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Foetal exposure during pregnancy, Toxicologic test
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-01-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1304USA006581

Write-up: Information has been received from a mother for GARDASIL, a Pregnancy Registry product, concerning her 8 week old baby. On an unknown date in December 2011 the mother was vaccinated with the first dose of GARDASIL (lot number 0626AA) (dose, route and injection site were not reported). On 28-FEB-2012, the mother was vaccinated with the second dose of GARDASIL (lot number, dose, route and injection site were not reported). On 23-MAR-2012 the mother found she was pregnant and on 26-NOV-2012 she delivered the infant. The baby was born on 26-NOV-2012, and died on 25-JAN-2013. Toxicology tests are being run to see the cause of death. The action taken and causality of death was not provided. The mother''s information was captured in MARRS # 1304USA006478 (Parent-Child Link). Additional information is not expected.


VAERS ID: 489391 (history)  
Form: Version 1.0  
Age: 10.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2012-12-01
Onset:2013-03-20
   Days after vaccination:109
Submitted: 2013-04-15
   Days after onset:26
Entered: 2013-04-17
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain upper, Cardiac arrest, Chest pain, Death, Dyspnoea, Influenza, Life support, Myocarditis, Resuscitation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-04-05
   Days after onset: 16
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: Not reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201304714

Write-up: Initial report was received on 08 April 2013 from an electronic lay press article. A 10-year-old female patient had received an injection of INFLUENZA VACCINE (trade name, manufacturer, lot number, route, site and exact date of administration not reported) in December 2012. The patient was diagnosed with strain B flu on 20 March 2013. Three days after the patient was diagnosed with the flu, she was rushed to the hospital after complaining of stomach and chest pains and difficulty breathing. She went into cardiac arrest the following morning, and doctors revived her after performing CPR for about two hours. She was placed on a life support system to restore oxygen to her blood. Doctors also put her on a machine to do the work of her heart while waiting for a transplant. The infection morphed into a serious case of myocarditis. The patient died from flu complications at 10:45 AM on 05 April 2013. Outcome was fatal. Documents held by sender: none.


VAERS ID: 489579 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Female  
Location: Wyoming  
Vaccinated:2012-11-21
Onset:2013-03-15
   Days after vaccination:114
Submitted: 2013-04-18
   Days after onset:34
Entered: 2013-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. H018093 / 1 RA / SC

Administered by: Private       Purchased by: Private
Symptoms: CSF test abnormal, Creutzfeldt-Jakob disease, Ear congestion, Electroencephalogram abnormal, Erythema, Neurological symptom, Nuclear magnetic resonance imaging abnormal, Sinus congestion, Terminal state
SMQs:, Anaphylactic reaction (broad), Dementia (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2013-04-25
   Days after onset: 41
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: Albuterol, Fluticasone nasal spray, glucosamine, B complex vitamin, Levothyroxine, Lipitor, Omega-3 FA, Singulair, Zyrtec
Current Illness: No
Preexisting Conditions: Hyperlipidemia
Allergies:
Diagnostic Lab Data: MRI, EEG, CSF evaluation all diagnostic of Creutzfeld Jacob Disease.
CDC Split Type:

Write-up: This is a concern given the timing of the onset of the second disease. There is no proof of any association but I feel that the condition is so rare that the timing of the Zostavax vaccination needs to be at least mentioned. The patient and her husband received Zostavax injections in Nov 2012. The patient developed a small localized erythematous reaction but her husband developed a full shingles reaction/rash to his right forehead which then cleared without event. In late January 2012 the patient started coming in with complaints about fullness in her ears, sinus congestion. She was treated with antibiotics and finally prednisone. While on prednisone she started to develop neurologic deficits in 3-15-13 that eventually progressed into major neurologic deficits and finally the diagnosis of Creutzfeld-Jacob Disease via MRI, EEG, and CSF evaluation. The patient is receiving comfort care at home as I write this and is expected to die within the next week. I am just concerned about the timing of the vaccination and then onset of symptoms and then diagnosis of CJD within 5 months.


VAERS ID: 489865 (history)  
Form: Version 1.0  
Age: 0.16  
Sex: Female  
Location: Tennessee  
Vaccinated:2013-04-22
Onset:2013-04-23
   Days after vaccination:1
Submitted: 2013-04-23
   Days after onset:0
Entered: 2013-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4360AA / 2 RL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHHVC188CA / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G57197 / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. H012974 / UNK MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Breath sounds abnormal, Crying, Eye movement disorder, Hypotonia, Lip disorder, Respiratory arrest, Respiratory tract congestion, Resuscitation, Skin discolouration, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-04-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zantac 15mg/ 1ml 1 ml BID
Current Illness:
Preexisting Conditions: Jaundice, GERD.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: At 9:02 am mother called and was worried about pt''s lip doing a funny thing, immediately spoke to mother concerning pt, and stated that pt''s lip had been doing something funny and had been crying and sounded a little congested and rattling, but had received shots yesterday and been put on Zantac for reflux, pt''s eyes had not been moving, but now were closed she thought she was tired from crying, noticed earlier that her forehead looked purple but better now and her buttocks looked a little purple but didn''t know why, stated her lip was getting better now, but her brother had tried saying her names but pt. did not focus her eyes on him just looked straight ahead, asked if pt was having distressed breathing and mom stated no, breathing fine, advised mom to bring pt. now to see Dr. and have pt looked at, ask pt. again if pt was having any distressed breathing, mom stated no, mother called back after getting off the phone with her at approximately 9:05am, mom called back 2 approximately 2 minutes after hanging up with her and told me that baby was not breathing and limp, advised to call 911 and told me she had, told her to start CPR, mom stated already had started CPR, wanted to know how many compressions, told mom 15 compressions with 2 breaths, advised papaw was doing breaths and she was doing compressions, advised to keep doing CPR till ambulance arrived, mom stated looked like the stomach was rising, keep doing CPR don''t stop, ask her to check for pulse, explained to where to check for pulse on infant, brachial pulse, but stated she was trying but couldn''t feel anything, advised keep doing CPR, don''t stop, the nurses here again called for an ambulance and told us they were 2 in route but didn''t know where they were located at, advised keep doing CPR, mom stated thought she heard some gargling, Dr took over phone call.


VAERS ID: 489874 (history)  
Form: Version 1.0  
Age: 29.0  
Sex: Female  
Location: California  
Vaccinated:2012-04-01
Onset:2013-04-02
   Days after vaccination:366
Submitted: 2013-04-23
   Days after onset:21
Entered: 2013-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / IM

Administered by: Public       Purchased by: Private
Symptoms: Exposure during pregnancy, Foetal death, Ultrasound scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-04-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: NO
Preexisting Conditions: PREGNANCY
Allergies:
Diagnostic Lab Data: ULTRASOUND, DELIVERY
CDC Split Type:

Write-up: FETAL DEATH.


VAERS ID: 490219 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: Virginia  
Vaccinated:2013-04-17
Onset:0000-00-00
Submitted: 2013-04-23
Entered: 2013-04-29
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C4378AA / UNK LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. H020604 / 2 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH768AA / UNK LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR H1605 / UNK LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F45132 / UNK RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. J000034 / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-04-21
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: None
CDC Split Type:

Write-up: No known reaction to vaccine. Patient passed away 4.21.13.


VAERS ID: 490225 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: Arizona  
Vaccinated:2013-03-26
Onset:2013-03-29
   Days after vaccination:3
Submitted: 2013-04-25
   Days after onset:27
Entered: 2013-04-29
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4357AA / 2 RL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. M014756 / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G73024 / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. H019492 / 2 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Death, 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: 2013-03-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Bronchiolitis-02/08/13
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient found unresponsive in crib at daycare. Resuscitative efforts unsuccessful.


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