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VAERS ID: 519235 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2011-12-02
Onset:2011-12-04
   Days after vaccination:2
Submitted: 2014-01-14
   Days after onset:772
Entered: 2014-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Autopsy, Confusional state, Congestive cardiomyopathy, Death, Dizziness, Dyspnoea, Jaundice, Pneumonia, Pyrexia, Vomiting
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-12-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1401USA004839

Write-up: Information has been received from a lawyer regarding a case in litigation concerning a male patient. On or about 02DEC2011, the patient received PNEUMOVAX23 for its intended purpose: the prevention of invasive pneumococcal disease. On or about 04DEC2011, the patient experienced fever, dizziness, weakness, vomiting, confusion, shortness of breath, and jaundice. On or about 04DEC2011 the patient was transported via ambulance to the hospital. On or about 04DEC2011, approximately 3 hours after his arrival, the patient died. On or about 06DEC2011, an autopsy revealed suggested pneumonia. The patient''s cause of death was dilated cardiomyopathy. As a direct and proximate result of PNEUMOVAX23 the patient died on 04DEC2011 (conflicting information received from the lawyer indicates that the patient died on 06DEC2011, therefore there are two different dates of death). Additional information has been requested.


VAERS ID: 519375 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Unknown  
Vaccinated:2011-12-14
Onset:2011-12-18
   Days after vaccination:4
Submitted: 2014-01-15
   Days after onset:759
Entered: 2014-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR - / UNK UN / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Private       Purchased by: Other
Symptoms: Acute respiratory failure, Coma, Condition aggravated, Death, Diabetic ketoacidosis, Dyspnoea, Endotracheal intubation, Mechanical ventilation, Pneumonia, Respiratory distress, Sepsis
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-11-02
   Days after onset: 684
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 60 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Type 1 diabetes mellitus
Preexisting Conditions: 12/14/2011, Diabetic ketoacidosis; 12/13/2011, Diabetes mellitus inadequate control, hospitalization
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1401USA004836

Write-up: Information was received regarding a case in litigation concerning a 26 year old female who suffered from Type 1, Juvenile Diabetes for the majority of her lifetime. On or about 13-DEC-2011, the patient was admitted to the hospital with a diagnosis of uncontrolled diabetes mellitus with ketoacidosis (DKA). The patient was treated with an insulin drip and met with a dietician while in the hospital. On 14-DEC-2011, while preparing for discharge, the patient was administered PNEUMOVAX23 and FLUZONE. The patient began experiencing shortness of breath on 18-DEC-2011 and was taken to hospital via ambulance. At the hospital the patient was diagnosed with pneumonia, acute respiratory failure and diabetic ketoacidosis (DKA). The patient was orally intubated and mechanically ventilated. Shortly after admission, the patient went into acute respiratory distress and became septic. The patient fell into a coma for approximately one month. The patient was hospitalized for a total of two months and was discharged on or about 09-FEB-2012. The patient never fully recovered from this hospitalization and spent the remainder of her life in and out of hospitals. The patient passed away on 02-NOV-2013 as a result of pneumonia. The patient suffered pneumonia, sepsis, respiratory distress/failure, coma and death which were a direct and proximate result of PNEUMOVAX23 and FLUZONE vaccinations. Upon internal review, coma, sepsis, and diabetic ketoacidosis were determined to be medically significant events. Additional information has been requested.


VAERS ID: 519605 (history)  
Form: Version 1.0  
Age: 71.0  
Sex: Male  
Location: Ohio  
Vaccinated:2013-10-11
Onset:2013-12-01
   Days after vaccination:51
Submitted: 2014-01-16
   Days after onset:46
Entered: 2014-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U4713AA / 1 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Acute disseminated encephalomyelitis
SMQs:, Noninfectious encephalitis (narrow), Demyelination (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Information not available. Patient has not filled prescriptions at pharmacy since 9/3/2013.
Current Illness: No
Preexisting Conditions: No indicated on Patient Questionnaire
Allergies:
Diagnostic Lab Data: ADEM
CDC Split Type:

Write-up: On 1/15/14 patient''s daughter informed me that patient was diagnosed with ADEM (acute disseminated encephalomyelitis) secondary to Fluzone HD. He was admitted on 12/1/13 and now is in a hospital.


VAERS ID: 520688 (history)  
Form: Version 1.0  
Age: 0.16  
Sex: Male  
Location: Unknown  
Vaccinated:2013-12-19
Onset:2013-12-24
   Days after vaccination:5
Submitted: 2014-01-27
   Days after onset:34
Entered: 2014-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS L24JG / UNK LL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. J004877 / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Congenital anomaly, Death, Intestinal malrotation, Intestinal obstruction
SMQs:, Congenital, familial and genetic disorders (narrow), Gastrointestinal obstruction (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2013-12-24
   Days after onset: 0
Permanent Disability? Yes
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1401USA010456

Write-up: This spontaneous report as received from a nurse practitioner via a company representative refers to a 9 week old male patient. No medical history was provided. On 17-DEC-2013 the patient was vaccinated with the first dose of ROTATEQ (lot number, expiration date were not reported) (suspension 2 ml, orally, indication: ''routine''). Seven days later, on 24-DEC-2013 the patient was hospitalized in medical clinic. The patient was diagnosed with a bowel obstruction and congenital malrotations on an unspecified date approximately in December 2013. The patient died on an unspecified date. The outcome of bowel obstruction and congenital malrotation was not reported. No cause of death reported. The relatedness between the events of bowel obstruction and congenital malrotation and ROTATEQ was not reported. The events of bowel obstruction and congenital malrotation were considered to be life threatening and disabling. Upon internal review the event of congenital malrotation was considered to be congenital anomaly. Additional information has been requested.


VAERS ID: 520888 (history)  
Form: Version 1.0  
Age: 66.0  
Sex: Female  
Location: Texas  
Vaccinated:2014-01-06
Onset:2014-01-22
   Days after vaccination:16
Submitted: 2014-01-27
   Days after onset:5
Entered: 2014-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 13452P / UNK LA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. J006921 / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Chest pain, Decreased appetite, Dysgeusia, Hypersomnia, Pain, Pain in extremity, Respiratory tract congestion
SMQs:, Taste and smell disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-01-23
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None at the time
Current Illness: Congestion the next day and hurting all over.
Preexisting Conditions: Diabetes, COPD
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Chest pain and hurting in both arms. Congestion and hurting all over body. Sleeping all the time. Loss of apetite and bad taste in mouth.


VAERS ID: 521295 (history)  
Form: Version 1.0  
Age: 0.23  
Sex: Female  
Location: Arizona  
Vaccinated:2014-01-27
Onset:0000-00-00
Submitted: 2014-01-28
Entered: 2014-01-30
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 7449K / 1 LG / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. J010385 / 1 LG / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G94060 / 1 LG / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. J008364 / 1 LG / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-01-27
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: URI
Preexisting Conditions: URI
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None stated.


VAERS ID: 521578 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-02-03
Entered: 2014-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death neonatal, Foetal exposure during pregnancy, Neonatal asphyxia, Sudden infant death syndrome, Varicella, Varicella post vaccine
SMQs:, Acute central respiratory depression (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow), Respiratory failure (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1401USA014558

Write-up: This spontaneous report was received from a consumer (mother) refers to a 7 weeks and 2 days old male patient. On an unknown date in November 1998 the patient''s mother was vaccinated with varicella virus vaccine live (manufacturer unknown) dose 1. The child was exposed to the suspect vaccine in utero when the mother was 5.5 months pregnant. On an unspecified date in 1998 the patient developed chicken pox in utero and was born with chicken pox on an unspecified date. On an unknown date in 1999 the patient passed away due to affixation/sudden infant death syndrome (SIDS) (death), when he was 7 weeks and 2 days old. The outcome of affixation/SIDS was reported as fatal. The outcome of drug exposure in utero, born with chicken pox and developed chicken pox in utero was unknown. The reporter considered developed chicken pox in utero, affixation/SIDS and born with chicken pox to be related to varicella virus vaccine live (manufacturer unknown). This case is linked to case # 1401USA014406, # 1401USA014557 and case # 1401USA014599 via parent-child link. Additional information has been requested.


VAERS ID: 521877 (history)  
Form: Version 1.0  
Age: 0.54  
Sex: Female  
Location: Indiana  
Vaccinated:2013-12-27
Onset:2014-01-05
   Days after vaccination:9
Submitted: 2014-02-05
   Days after onset:31
Entered: 2014-02-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS FF723 / 2 RL / UN
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4794BA / 1 LL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G77643 / 3 LL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. J008362 / 3 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-01-05
   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: POLY-VI-SOL with Iron; SYNAGIS
Current Illness: None
Preexisting Conditions: Preterm - 32 weeks
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: None.


VAERS ID: 522070 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-02-07
Entered: 2014-02-07
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: WAES1402USA002351

Write-up: This spontaneous report as received from a nurse via field representative refers to multiple unspecified patients of unknown age and gender. The nurse reported that multiple unspecified patients have come to her with concerned about GARDASIL due to reading unspecified Internet articles that claim multiple unspecified patients had died after receiving GARDASIL (lot#, dose and route not reported). The reporter stated the article was from "someone that claimed to be involved with the development of GARDASIL". The nurse did not have any patients that reported an adverse effect after receiving GARDASIL. The reporter stated "they got a call from the mother of a patient who just got GARDASIL who was crying and in hysterics on the phone because she had heard about all these side effects. This was happening on a daily basis". The reporter stated "I don''t have any details about the article". Additional information is not expected.


VAERS ID: 522134 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2013-10-09
Onset:2013-10-19
   Days after vaccination:10
Submitted: 2014-02-02
   Days after onset:106
Entered: 2014-02-07
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4780AA / 3 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Acute respiratory distress syndrome, Angina pectoris, Bronchitis, Candida infection, Chest discomfort, Chest pain, Endotracheal intubation, Haematuria, Haemorrhoid operation, Haemorrhoids, Pain in extremity, Pneumonitis, Scrotal pain, Sleep apnoea syndrome, Urinary retention, Viral infection
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (narrow), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (narrow), Other ischaemic heart disease (narrow), Hypersensitivity (broad), Tubulointerstitial diseases (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-02-01
   Days after onset: 105
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: NIZORAL; ISORDIL; NITROSTAT; RANEXA; DETROL; LIPITOR; TOPROL; PAXIL; ATIVAN
Current Illness: No
Preexisting Conditions: NKDA
Allergies:
Diagnostic Lab Data: Candida albican; Dubliniensis; ARDS after viral prodrome
CDC Split Type:

Write-up: 10/16/13 Urinary retention post-hemorrhoidectomy. 10/19/13 Hemorrhoid prolapse, leg pain, scrotal pain chest discomfort 11/12/13 Angina 11/18/13 Angina 11/22/13 angina 11/24/13 hematuria 11/26/13 sleep apnea 12/12/13 chest pain 12/23/13 acute bronchitis 1/11/14 pneumonitis 1/19/14 intubated.


VAERS ID: 522177 (history)  
Form: Version 1.0  
Age: 57.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2014-01-28
Onset:2014-01-31
   Days after vaccination:3
Submitted: 2014-02-07
   Days after onset:7
Entered: 2014-02-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1340IP / UNK AR / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-01-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Spiriva inhaler, Symbicort Inhaler, Furosemide 20mg qd, Ambien 10mg hs, Xanax 1mg bid, Lortab 10 mg tid, Predisone 10 mg, ASA 325mg qd, Albuterol nebulizer
Current Illness: Hx of recent hospitalization for pneumonia
Preexisting Conditions: COPD, Chronic home O2 use, Obstructive sleep disorder, HTN, Hx of skin Ca, Pulmonary Htn., CHF, Chronic back pain, Dyspnea
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death.


VAERS ID: 522595 (history)  
Form: Version 1.0  
Age: 59.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2013-09-01
Submitted: 2014-02-13
   Days after onset:165
Entered: 2014-02-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Hepatitis A, Neoplasm malignant
SMQs:, Liver infections (narrow), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A1060708A

Write-up: This case was reported by a consumer (spouse of subject) and described the occurrence of cancer in a 59-year-old male subject who was vaccinated with Hepatitis A vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date the subject received a dose of Hepatitis A vaccine (unknown details). At an unspecified time after vaccination with Hepatitis A vaccine, the subject experienced hepatitis A infection, cancer and possible vaccination failure. The subject died from cancer in September 2013. It was unknown whether an autopsy was performed. The reporter had previously reported another case with HAVRIX. See A0993321A for details on the other case. The cases have been noted as potentially legally significant.


VAERS ID: 522679 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Female  
Location: New Hampshire  
Vaccinated:2014-01-13
Onset:2014-01-24
   Days after vaccination:11
Submitted: 2014-02-14
   Days after onset:21
Entered: 2014-02-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4574AA / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G66539 / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. J002784 / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-01-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NH0214201403

Write-up: SUID/SIDS (Medical Examiner report not yet avail.).


VAERS ID: 523158 (history)  
Form: Version 1.0  
Age: 0.53  
Sex: Female  
Location: Connecticut  
Vaccinated:2014-02-12
Onset:0000-00-00
Submitted: 2014-02-20
Entered: 2014-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C4454BA / 3 RL / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4692CA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH967AA / 3 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G98915 / 3 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. J010970 / 3 MO / PO

Administered by: Private       Purchased by: Private
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: 2014-02-20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Hemangioma; Atopic dermatitis
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None - pt found unresponsive and deceased 2/20/14 approximately 5 AM.


VAERS ID: 523430 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-02-24
Entered: 2014-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Incorrect dose administered
SMQs:, Medication errors (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1402USA010298

Write-up: This spontaneous report as received from a health care worker via a field representative refers to her mother, a 75 year old female patient. On an unspecified date the patient was vaccinated with ZOSTAVAX (dose, frequency, route, lot # unknown) and then received a second dose of ZOSTAVAX "a year later" on an unspecified date. No untoward effects reported. The patient had since died. Healthcare worker stated that the cause of death of patient was unrelated to the ZOSTAVAX. Additional information has been requested.


VAERS ID: 523573 (history)  
Form: Version 1.0  
Age: 0.16  
Sex: Female  
Location: California  
Vaccinated:2014-02-12
Onset:2014-02-13
   Days after vaccination:1
Submitted: 2014-02-24
   Days after onset:11
Entered: 2014-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 7537C / UNK RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. J010385 / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G98820 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. J009725 / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-02-13
   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: Possible pneumonia
Preexisting Conditions: Trisomy 18, uncorrected ventriculoseptal defect, orogastric tube feedings, recurrent aspiration pneumonias
Allergies:
Diagnostic Lab Data: Unavailable.
CDC Split Type:

Write-up: Death.


VAERS ID: 523759 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Female  
Location: Unknown  
Vaccinated:2009-03-01
Onset:2012-05-01
   Days after vaccination:1157
Submitted: 2014-02-25
   Days after onset:665
Entered: 2014-02-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 1 UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Acute lymphocytic leukaemia, Blood immunoglobulin G abnormal, Death, Exposure to communicable disease, Immunodeficiency, Multi-organ failure, Polymerase chain reaction, Pyrexia, Rash generalised, Varicella post vaccine, Varicella virus test positive
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), 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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow), Sepsis (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-05-07
   Days after onset: 6
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: Dexamethasone
Current Illness: 04/2012, Chemotherapy; 03/2009, Acute lymphocytic leukaemia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Varicella-zoster virus (VZV) immunoglobulin G (IgG) (MAR-2011): Positive; 05/2012, Polymerase chain reaction, Varicella
CDC Split Type: WAES1402USA010964

Write-up: This literature marketed report as received from a physician refers to a 4 year old girl who had received her first dose of VARIVAX (Merck) in March 2009. She was diagnosed with acute lymphoblastic leukemia (ALL) in March 2011. At that time, she was varicella-zoster virus (VZV) immunoglobulin G (IgG)-positive. On 10-APR-2012, the girl was exposed to a mildly ill cousin who developed a varicella rash 2 days later (12-APR-2012). The episode was reported to the child''s oncologist after 13 days. The girl was prescribed 7 days of oral acyclovir (manufacturer unknown) and concurrently began her scheduled chemotherapy, which included a 5-day course of dexamethasone (manufacturer unknown) (prednisone equivalent dose of 23 mg/day). Twenty-two days after her varicella exposure (01-MAY-2012) the girl was taken to an emergency department for fever and abdominal pain. She was treated symptomatically; her caretakers were instructed to discontinue chemotherapy and to follow up with her oncologist. Two days later on 03-MAY-2012 the girl returned to the emergency department with a generalized rash. She was hospitalized and treated with intravenous acyclovir (manufacturer unknown) and antibiotics. However, she developed multi-organ failure and died on 07-MAY-2012. Varicella was confirmed by polymerase chain reaction testing, and no alternative diagnoses were found for her acute illness. This patient''s fatal varicella likely was the result of profound immunosuppression, resulting in part from the chemotherapy and corticosteroid treatment. Additional information has been requested.


VAERS ID: 523828 (history)  
Form: Version 1.0  
Age: 59.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2014-02-03
Onset:2014-02-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2014-02-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. J010332 / 1 RA / UN

Administered by: Public       Purchased by: Private
Symptoms: Atelectasis, Bronchitis, Computerised tomogram abnormal, Death, Mechanical ventilation, Pneumonia, Pneumonia aspiration, Rhinitis allergic
SMQs:, Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-02-22
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 12 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Allergic to ZITHROMAX and Sulfa drugs
Allergies:
Diagnostic Lab Data: Dx of pneumonia on 2-9-2014 at Hospital
CDC Split Type:

Write-up: 2-6-14 pt presents to Hosp. with resp s/s dx with bronchitis and allergic rhinitis tx with amoxicillin, ZYRTEC and Guaifenesin. On 2-9-14 back to Hosp dx per CT scan with early pneumonia aspiration or atelectasis pulse ox 88-92. Pt given tetracycline, FLAGYL and IMODIUM in addition to other meds given early pt d/c to home. On 2-11-14 pt presents to another Hosp. Dx with double pneumonia, admitted 2-18-14 placed on vent, 2-22-14 pt died.


VAERS ID: 524014 (history)  
Form: Version 1.0  
Age: 55.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-02-24
Entered: 2014-02-26
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blood glucose increased, Death, Diabetes mellitus inadequate control, Diabetic coma, Influenza
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: Diabetic
Allergies:
Diagnostic Lab Data: Flat-lined three times; blood glucose, Unknown, Unknown, Unknown
CDC Split Type: 2014SA022128

Write-up: Initial report was received on 20 February 2014 from an electronic lay press article. A 55 year-old male patient (date of birth not reported) with a history of diabetes had received an influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later developed the flu. The patient first became ill on a Thursday. "That afternoon, his blood sugar spiked, and they were unable to get it down. So they took him to the hospital and from there he flat - lined three times". By Friday night the patient was flown to another hospital where he died in a diabetic coma. Outcome was fatal. Documents held by sender: none.


VAERS ID: 525268 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Female  
Location: Alabama  
Vaccinated:2014-03-03
Onset:2014-03-04
   Days after vaccination:1
Submitted: 2014-03-07
   Days after onset:3
Entered: 2014-03-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 55CY5 / 2 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. J011112 / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G98915 / 2 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Death, Hypophagia, Lethargy
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-03-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None; SYNAGIS
Current Illness: Former premature infant
Preexisting Conditions: Premature; poor prenatal care; multiple scattered isolated hemangioma
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was a former 23 wk 6 day gestation premature infant who was discharged home from NICU on 2/27/14 into child protective services. She had her 2 mo immunizations in hospital and followed up with us on 3/3/14. She was given her 4 mo vaccines - which were the same as 2 mo shots. Became more lethargic on 3/3/14 and decreased PO intake. Died the following day.


VAERS ID: 525311 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Pennsylvania  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-03-10
Entered: 2014-03-10
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: WAES1403USA003155

Write-up: This spontaneous report as received from CDC (Centers for Disease Control) via company representative refers to 53 patients of unknown age and gender. On an unknown date these patients was vaccinated with GARDASIL (lot#, expiration date, dose, route not reported). These patients died after receipt of the vaccine. The causes of death were unknown. Additional information has been requested.


VAERS ID: 525431 (history)  
Form: Version 1.0  
Age: 38.0  
Sex: Female  
Location: Michigan  
Vaccinated:2011-05-01
Onset:2011-05-01
   Days after vaccination:0
Submitted: 2014-03-10
   Days after onset:1044
Entered: 2014-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

Administered by: Unknown       Purchased by: Private
Symptoms: Cardiac disorder, Cerebrovascular accident, Death
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-01-03
   Days after onset: 613
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No illnesses
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data: Na
CDC Split Type:

Write-up: I have to confirm the dates with her Nursing school, but approximately two weeks after receiving the shot my sister experienced stroke like symptoms, she went to the doctors and had to take off from school. Her heart was not checked, but had never been diagnosed with heart problems about a year later she died in her sleep from a heart problem that was misdiagnosed.


VAERS ID: 525494 (history)  
Form: Version 1.0  
Age: 0.21  
Sex: Female  
Location: Louisiana  
Vaccinated:2014-01-10
Onset:2014-01-11
   Days after vaccination:1
Submitted: 2014-03-07
   Days after onset:55
Entered: 2014-03-11
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS J9MS4 / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH879AB / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G95397 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. H020311 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-01-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Well child check up 2 month
CDC Split Type:

Write-up: Deceased 1/11/14 - mom found at 5AM no previous signs.


VAERS ID: 525546 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2013-12-19
Onset:2014-01-09
   Days after vaccination:21
Submitted: 2014-03-11
   Days after onset:60
Entered: 2014-03-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-01-09
   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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1403USA004123

Write-up: This spontaneous report as received from a physician refers to a male patient of unknown age. On 19-DEC-2013 the patient was vaccinated with ZOSTAVAX, subcutaneous. No details regarding the dosing regimen were provided. It was unknown if the patient received any co-suspected or concomitant medications. On 09-JAN-2014, the patient experienced patient deceased. No further details were provided. The action taken with ZOSTAVAX was unknown and a causality assessment was not provided. Additional information has been requested.


VAERS ID: 526290 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: Connecticut  
Vaccinated:2014-03-20
Onset:2014-03-21
   Days after vaccination:1
Submitted: 2014-03-21
   Days after onset:0
Entered: 2014-03-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4552AA / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H00004 / 2 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Death, Respiratory arrest, Status epilepticus
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-03-21
   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: TYLENOL
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Treated at Medical Center ER
CDC Split Type:

Write-up: Died of status epilepticus and respiratory arrest on 3-21-14.


VAERS ID: 526390 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Male  
Location: Florida  
Vaccinated:2014-03-14
Onset:2014-03-14
   Days after vaccination:0
Submitted: 2014-03-21
   Days after onset:7
Entered: 2014-03-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Cardiac arrest, Death, Endotracheal intubation, Respiratory distress
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 (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-03-14
   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: Per Ed records pt was taking aspirin, Coreg, amlodipine, lovastatin, Januvia, Ranexa, Pradaxa, and Protonix.
Current Illness: Unknown
Preexisting Conditions: Diabetes, a fib, bypass lower legs.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt arrived to ED in respiratory distress and was intubated, became asystolic and did not return. Pronounced at 19:05 March 14.


VAERS ID: 526544 (history)  
Form: Version 1.0  
Age: 0.35  
Sex: Female  
Location: D.C.  
Vaccinated:2013-12-27
Onset:2014-01-04
   Days after vaccination:8
Submitted: 2014-03-24
   Days after onset:78
Entered: 2014-03-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 2EB97 / 2 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH874AA / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G39292 / 2 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. J004875 / 2 - / IM

Administered by: Private       Purchased by: Public
Symptoms: Cardiac arrest, Death, Resuscitation, Unresponsive to stimuli, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), 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: 2014-01-04
   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: Poly-vi-sol
Current Illness: No
Preexisting Conditions: None except family history of hypercoaguability. Patient had been found to have elevated Factor VIII activity (without the other hypercoaguable states found in the family: Factor V Leiden and elevated lipoprotein A).
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was in usual state of health. Had bottle at about 2:30 AM and then put back to sleep in bed with father. Another family member checked on baby few hours later and found she was unresponsive with vomit in her mouth. Father attempted CPR; CPR en route to ED by EMS. Asystole noted on arrival in ED. Patient deceased.


VAERS ID: 526545 (history)  
Form: Version 1.0  
Age: 0.16  
Sex: Male  
Location: Oklahoma  
Vaccinated:2014-03-12
Onset:2014-03-13
   Days after vaccination:1
Submitted: 2014-03-17
   Days after onset:4
Entered: 2014-03-24
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS CA22T73 / 1 LL / UN
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. J011983 / 1 RL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H39262 / 1 LL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. J009772 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-03-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pt. found expired in bed with parents. Final autopsy pending.


VAERS ID: 526687 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Male  
Location: Unknown  
Vaccinated:2014-03-07
Onset:2014-03-19
   Days after vaccination:12
Submitted: 2014-03-25
   Days after onset:6
Entered: 2014-03-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J006857 / 1 UN / UN
SMALL: SMALLPOX (ACAM2000) / SANOFI PASTEUR WV04003A / 1 UN / -

Administered by: Military       Purchased by: Military
Symptoms: Cardiomegaly, Histology abnormal, Myocarditis, Sudden death, Toxicologic test
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-03-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown.
Current Illness: Unknown
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Cardiomegally with four chamber dilation of the heart. Histologic diagnosis of myocarditis. At the time of this report toxicology is still pending.
CDC Split Type:

Write-up: Sudden death. Cardiomegally with four chamber dilation. Histologic diagnosis of myocarditis. At the time of this report toxicology is still pending.


VAERS ID: 527072 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-03-31
Entered: 2014-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: WAES1403USA013069

Write-up: This spontaneous report as received from a consumer refers to a patient of unknown age. On an unknown date the patient received ZOSTAVAX (dose, route of administration, lot#, indication unspecified). On an unknown date the patient developed shingles after receiving ZOSTAVAX and passed away on an unspecified date. The outcome of shingles after receiving ZOSTAVAX was reported as fatal. The cause of death was reported as shingles. Autopsy results were not provided. This case is linked to 2 more reports from same reporter. Additional information has been requested.


VAERS ID: 527097 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Male  
Location: Nebraska  
Vaccinated:2014-03-19
Onset:2014-03-23
   Days after vaccination:4
Submitted: 2014-03-24
   Days after onset:1
Entered: 2014-03-31
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS NJ4N3 / 2 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH943AC / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H00137 / 2 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FB397A / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-03-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZANTAC
Current Illness: None
Preexisting Conditions: Esophageal reflux
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient died.


VAERS ID: 527273 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Male  
Location: Georgia  
Vaccinated:2013-11-25
Onset:2013-11-26
   Days after vaccination:1
Submitted: 2014-04-01
   Days after onset:125
Entered: 2014-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-01-19
   Days after onset: 54
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None that I know of.
Current Illness: Felt weak
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Emergency room. Guillain Barr? syndrome.


VAERS ID: 527362 (history)  
Form: Version 1.0  
Age: 10.0  
Sex: Male  
Location: Unknown  
Vaccinated:2013-10-29
Onset:2014-03-23
   Days after vaccination:145
Submitted: 2014-04-02
   Days after onset:10
Entered: 2014-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 55A29 / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cardiac disorder, Death, Influenza, Influenza B virus test positive, Oropharyngeal pain, Unresponsive to stimuli, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-03-25
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Automatic implantable cardioverter; Congenital heart defect; Heart surgery
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A1066974A

Write-up: This case was reported by a physician via a sales representative and described the occurrence of influenza B in a 10-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included automatic implantable cardioverter defibrillator pacer, congenital heart defect repaired by heart surgery. On 29 October 2013, the subject received a dose of FLUARIX (administration site and route unknown). On 23 March 2014, 5 months after vaccination with FLUARIX, the subject experienced sore throat. No test for flu was conducted and no antivirals were given. No swab testing for culture or sensitivity was done. At that time, he was stable from cardiac standpoint. On 25 March 2014, he was found unresponsive. A culture was took around pronouncement of the death which showed positive results for influenza B which was considered as a vaccination failure. The subject died on 25 March 2014 from cardiac complications and influenza B infection.


VAERS ID: 527990 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-04-10
Entered: 2014-04-10
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: WAES1404USA005186

Write-up: This spontaneous report as received from a physician via Company Representative refers to a 15 unspecified patients of unknown gender and unknown age. The reporting physician informed the representative that a friend of his posted an unspecified link on Facebook stating that 15 unspecified patients died after receiving GARDASIL (dose, lot/batch number, expiry date and indication was not reported). The physician would like to know where the information was coming from. The representative did not have any further information by the time of the report. The relatedness between the event and GARDASIL was not reported. Additional information has been requested.


VAERS ID: 528355 (history)  
Form: Version 1.0  
Age: 1.34  
Sex: Male  
Location: New Hampshire  
Vaccinated:2012-12-18
Onset:2012-12-20
   Days after vaccination:2
Submitted: 2014-03-24
   Days after onset:458
Entered: 2014-04-15
   Days after submission:22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM AC14B149CA / 1 LL / IM
HEPA: HEP A (HAVRIX) / SMITHKLINE BEECHAM AHAVB515AA / 1 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH259AB / 1 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Convulsion, Death
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-12-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Seizure resulting in death.


VAERS ID: 528766 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-04-18
Entered: 2014-04-18
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: WAES1404USA008954

Write-up: This spontaneous report was received from a registered nurse who read about the life story of a patient of unknown age on a website. On an unknown date the patient was vaccinated with GARDASIL, (dose, lot no. route not reported). On an unknown date the patient died from an unspecified cause. This is one of reports received from the same source. Additional information is not expected.


VAERS ID: 528914 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-04-17
Entered: 2014-04-21
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Hepatic enzyme increased
SMQs:, Liver related investigations, signs and symptoms (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: 14AV00007SP

Write-up: On 14APR2014, information was received from a consumer on behalf of his cousin. The reporter stated that his male cousin had received the Anthrax vaccine (date, dose, lot# not reported). On an unspecified date he experienced high liver enzyme levels. Subsequently, he died. Date of death, unknown. Cause of death, unknown. Follow up information has been requested.


VAERS ID: 529028 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Female  
Location: Florida  
Vaccinated:2013-01-23
Onset:2013-01-24
   Days after vaccination:1
Submitted: 2014-04-16
   Days after onset:446
Entered: 2014-04-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1203901 / UNK LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Abasia, Cystitis, Death, Dysstasia, Wheelchair user
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-01-02
   Days after onset: 343
Permanent Disability? Yes
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: Insulin; Colcory; UTORIC; Carvedilol; Bumetanide; Neutontin; Elopidogrel; Losartan; Tramadol
Current Illness: Diabetes; Congestive heart failure
Preexisting Conditions: Diabetes; Congestive heart failure
Allergies:
Diagnostic Lab Data: Was in hospital 7 times the next 12 mo.
CDC Split Type:

Write-up: Took Flu shot in January 2013 - the next day could not walk. Went to hospital was told had bladder infection - Live about 13 months. Could never walk again. Had flu shot in January 2013 - could not walk or stand the next day - was in a wheelchair until her death 1-2-14.


VAERS ID: 529682 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-04-24
Entered: 2014-04-29
   Days after submission:5
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, Influenza, Influenza virus test, Polymerase chain reaction
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: UNK
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: The patient had undergone RT PCR test for the diagnosis of influenza.
CDC Split Type: 2014SA050495

Write-up: Initial report received from literature on 11 April 2014. A 6 adult patients of age below 65 years, whose concomitant medications were not reported, had received 2013-14 seasonal Influenza Vaccine (batch number, route and anatomical site of administration were not reported) of unknown manufacturer on an unspecified date. The department of public health conducts surveillance on severe influenza like illness aged less than 65 years. This case includes the influenza with symptom onset on or after 29 September 2013 of 2013-14 influenza seasons. There were only 6 out of 28 patients whose vaccination status were known had received 2013-14 influenza seasonal vaccine greater than or equal to 2 weeks before symptoms onset. DPH sought the data from autopsy and medical records for fatal cases and reviewed available data for all severe cases for 2013-14 season vaccine. Data review includes patient''s demographics, clinical courses and treatment underlying medical conditions, influenza vaccination status and underlying medical conditions. There were 3 fatal influenza cases includes children aged less than 18 years and one fatal case includes a patient less than 5 years old. Of six patients with no known comorbid conditions predisposing them to complications from influenza, as defined by ACIP three were obese with body mass indices of 30-39. The data from 2013-14 influenza vaccination season indicates that the patients aged 41-64 years are at the higher risk of influenza. The antiviral treatment was underutilized by these patients and overreliance on rapid diagnostic test with poor sensitivity. The patient''s died on unspecified date. Documents held by sender: none.


VAERS ID: 530241 (history)  
Form: Version 1.0  
Age: 40.0  
Sex: Female  
Location: Michigan  
Vaccinated:2014-01-01
Onset:2014-01-01
   Days after vaccination:0
Submitted: 2014-03-11
   Days after onset:68
Entered: 2014-05-06
   Days after submission:56
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 LL / UN
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 RA / UN

Administered by: Other       Purchased by: Other
Symptoms: Agitation, Anaemia, Anaphylactic reaction, Angina pectoris, Angioedema, Arthralgia, Blood creatinine increased, Blood urea increased, Bradycardia, Cerebrovascular accident, Confusional state, Constipation, Convulsion, Cough, Death, Depression, Diarrhoea, Dizziness, Erythema multiforme, Gastric haemorrhage, Haemorrhage, Haemorrhage intracranial, Hallucination, Headache, Hepatic enzyme increased, Hyperglycaemia, Hypertension, Hypoglycaemia, Hypotension, International normalised ratio abnormal, Jaundice, Leukopenia, Myalgia, Nausea, Nephritis, Palpitations, Parkinsonism, Phlebitis, Pruritus, Purpura, Pyrexia, Rash, Renal failure acute, Renal tubular necrosis, Respiratory depression, Sedation, Skin discolouration, Skin exfoliation, Syncope, Tachycardia, Tachypnoea, Tardive dyskinesia, Thrombocytopenia, Transient ischaemic attack, Urticaria, Vision blurred, Vomiting, Wheezing
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Liver-related coagulation and bleeding disturbances (narrow), Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Asthma/bronchospasm (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dyskinesia (narrow), Parkinson-like events (narrow), Gastrointestinal haemorrhage (narrow), Oropharyngeal allergic conditions (narrow), Thrombophlebitis (broad), Acute central respiratory depression (narrow), Psychosis and psychotic disorders (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Glaucoma (broad), Hypertension (narrow), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (narrow), Other ischaemic heart disease (narrow), Vestibular disorders (broad), Renovascular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Tubulointerstitial diseases (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (narrow), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2014-01-01
   Days after onset: 0
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 14 days
   Extended hospital stay? Yes
Previous Vaccinations: Turned blue~Vaccine not specified (no brand name)~1~12.00~Patient|Turned purple~Vaccine not specified (no brand name)~2~8.00~Sib
Other Medications: Crotaline antivenin; No other meds
Current Illness: Illnesses
Preexisting Conditions: Pre-existing allergies
Allergies:
Diagnostic Lab Data: Relevant tests and labs
CDC Split Type:

Write-up: Agitation, Blurred Vision, Confusion, Depression, Dizziness, Hallucinations, Headache, Intracranial Bleed, Sedation, Seizures, Parkinsonism, Tardive Dyskinesia, TIA Stroke, Bleeding, Thrombocytopenia, Leukopenia, Anemia, Myalgia, Arthralgia, Phlebitis, Anaphylaxis, Fever, Angioedema, Skin Rash, Tachypnea, Resp Depression, Cough Wheeze, Rash, Erythema Multiforme, Urticaria Pruritus, Purpura, Sloughing, Constipation, Diarrhea, Nausea Vomiting, Gastric Bleeding, Palpitations, Hypertension, Hypotension, Syncope, Angina, Bradycardia, Tachycardia, Abnormal INR, Elevated Liver Enzymes, Jaundice, Elevated BUN SCr, Nephritis, Acute Tubular Necrosis, Acute Renal Failure, Hyperglycemia, Hypoglycemia and turned purple. Bupropion 300 mg BID, Aspirin 4 mg BID, Lisinopril 20 mg BID, Hydrochlorothiazide/propranolol 20 mg every day.


VAERS ID: 531898 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Female  
Location: Michigan  
Vaccinated:2014-04-28
Onset:2014-04-29
   Days after vaccination:1
Submitted: 2014-05-27
   Days after onset:28
Entered: 2014-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR CN532 / UNK LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Aphagia, Blood potassium decreased, Death, Discomfort, Hypertension, Pain
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Hypokalaemia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-05-03
   Days after onset: 4
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: Lisinopril, Thyroid. Please check medical records with Dr. My mother died 5 days after receiving this vaccine. Perhaps the CDC should revisit their recommendation that the vaccine should be given to all geriatric patients - please caution p
Current Illness: Frail, approximately 88 pounds, suffering from a TEF (Transesophageal Fistula as a result of a 5 cm tear of the esophagus that did not heal properly). The 5 cm tear occurred at the hospital during surgery
Preexisting Conditions: See above - my mother was frail at Dr. gave her this vaccine on her first patient visit to his office. He was aware my mother had a TEF.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: My mother began feeling achy, very uncomfortable, unable to eat. By Thursday she was hospitalized with uncontrollable high blood pressure and a potassium level of 2.9. This was precipitated by the DTAP vaccine given by Dr.


VAERS ID: 532074 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Kentucky  
Vaccinated:2014-03-21
Onset:2014-04-09
   Days after vaccination:19
Submitted: 2014-05-28
   Days after onset:49
Entered: 2014-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. J007943 / 1 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-04-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Vit K and Erythomycin Eye Treatment
Current Illness: None
Preexisting Conditions: Mother was HBsAg tested 8/30/2013 and negative
Allergies:
Diagnostic Lab Data:
CDC Split Type: KY201403

Write-up: NO information available to describe any adverse effects.


VAERS ID: 532797 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2007-10-02
Onset:2007-11-14
   Days after vaccination:43
Submitted: 2014-05-02
   Days after onset:2360
Entered: 2014-06-03
   Days after submission:32
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0181U / 1 LA / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Computerised tomogram head normal, Convulsion, Death, Electrocardiogram normal, Electroencephalogram abnormal, Full blood count normal, Liver function test normal, Nuclear magnetic resonance imaging brain abnormal, Pineal gland cyst
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-01-11
   Days after onset: 2250
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: ECG = normal sinus rhythm, normal ECG; Head MRI - Pineal cyst (6mm); Head CT - no evidence of acute intracranial abnormalities
CDC Split Type:

Write-up: 11/14/2007 - Seizure. Confirmed by EEG. Begun using DEPAKOTE. CBC and LFT''s - within nml limits.


VAERS ID: 533145 (history)  
Form: Version 1.0  
Age: 0.36  
Sex: Male  
Location: New Hampshire  
Vaccinated:2014-04-08
Onset:2014-04-21
   Days after vaccination:13
Submitted: 2014-06-06
   Days after onset:46
Entered: 2014-06-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 9EA47 / 2 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH948AB / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H06568 / 2 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41DB8403A / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-04-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Medical examiner report pending
CDC Split Type: NH060620149

Write-up: SUID/SIDS.


VAERS ID: 533336 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-06-10
Entered: 2014-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Ill-defined disorder
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: WAES1406USA003859

Write-up: Information has been reported in a study. The report includes VAERS reports following PNEUMOVAX 23 or Pneumococcal polysaccharide vaccine (PPSV23) brand unknown after 2002. The report includes reports information from 01-JAN-1990 to 31-JAN-2014. This spontaneous report as received from a other health professional refers to 4 patients. The median age of the patients was 69 years old; range being 23 to 98 years. Between 01-JAN-1990 and 31-DEC-2013 patients were vaccinated with PNEUMOVAX 23. On an unknown date the patients experienced death. The outcome of death was reported as fatal. The cause of death was reported as ''other non infectious''. The death of the patients was confirmed with medical records, autopsy reports and/or death certificates. The report has been split into cases according to cause of death. This case is linked to same reporter linked cases 1406USA003857 (respiratory disorder), 1406USA003863 (Unknown), 1406USA003858 (other infectious disorder), 1406USA003860 (gastrointestinal), 1406USA003861 (Neurological), 1406USA003862 (Undetermined) and 1406USA003351 (Cardiovascular). Additional information has been requested.


VAERS ID: 533337 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-06-10
Entered: 2014-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Cardiovascular disorder, Death
SMQs:, Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1406USA003351

Write-up: Information has been reported in a study. The report includes VAERS reports following PNEUMOVAX 23 or Pneumococcal polysaccharide vaccine (PPSV23) brand unknown after 2002. The report includes reports information from 01-JAN-1990 to 31-JAN-2014. This spontaneous report as received from an other health professional refers to 16 patients. The median age of the patients was 69 years old; range being 23 to 98 years. Between 01-JAN-1990 and 31-DEC-2013 patients were vaccinated with PNEUMOVAX 23. On an unknown date the patients experienced death. The outcome of death was reported as fatal. The cause of death was reported as Cardiovascular. The death of the patients was confirmed with medical records, autopsy reports and/or death certificates. The report has been split into cases according to cause of death. This case is linked to same reporter linked cases 1406USA003857 (respiratory disorder), 1406USA003858 (Other infectious disorder), 1406USA003859 (other non infectious disorder), 1406USA003860 (gastrointestinal), 1406USA003861 (Neurological), 1406USA003862 (Undetermined) and 1406USA003863 (Unknown). Additional information has been requested.


VAERS ID: 533339 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-06-10
Entered: 2014-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Nervous system disorder
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: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1406USA003861

Write-up: Information has been reported in a study. The report includes VAERS reports following PNEUMOVAX 23 or Pneumococcal polysaccharide vaccine (PPSV23) brand unknown after 2002. The report includes reports information from 01-JAN-1990 to 31-JAN-2014. This spontaneous report as received from a other health professional refers to 2 patients. The median age of the patients was 69 years old; range being 23 to 98 years. Between 01-JAN-1990 and 31-DEC-2013 patients were vaccinated with PNEUMOVAX 23. On an unknown date the patients experienced death. The outcome of death was reported as fatal. The cause of death was reported as neurological. The death of the patients was confirmed with medical records, autopsy reports and/or death certificates. The report has been split into cases according to cause of death. This case is linked to same reporter linked cases 1406USA003857 (respiratory disorder), 1406USA003863 (Unknown), 1406USA003859 (other non infectious disorder), # 1406USA003860 (gastrointestinal), 1406USA003858 (other infectious), # 1406USA003862 (Undetermined) and 1406USA003351 (Cardiovascular). Additional information has been requested.


VAERS ID: 533341 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-06-10
Entered: 2014-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Infection
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: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1406USA003858

Write-up: Information has been reported in a study. The report includes VAERS reports following PNEUMOVAX 23 or Pneumococcal polysaccharide vaccine (PPSV23) brand unknown after 2002. The report includes reports information from 01-JAN-1990 to 31-JAN-2014. This spontaneous report as received from a other health professional refers to 5 patients. The median age of the patients was 69 years old; range being 23 to 98 years. Between 01-JAN-1990 and 31-DEC-2013 patients were vaccinated with PNEUMOVAX 23. On an unknown date the patients experienced death. The outcome of death was reported as fatal. The cause of death was reported as other infectious. The death of the patients was confirmed with medical records, autopsy reports and/or death certificates. The report has been split into cases according to cause of death. This case is linked to same reporter linked cases 1406USA003857 (respiratory disorder), 1406USA003863 (Unknown), 1406USA003859 (other non infectious disorder), 1406USA003860 (gastrointestinal), 1406USA003861 (Neurological), 1406USA003862 (Undetermined) and 1406USA003351 (Cardiovascular). Additional information has been requested.


VAERS ID: 533480 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-06-11
Entered: 2014-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1406USA003862

Write-up: Information has been reported in a study. The report includes VAERS reports following PNEUMOVAX 23 or Pneumococcal polysaccharide vaccine (PPSV23) brand unknown after 2002. The report includes reports information from 01-JAN-1990 to 13-JAN-2014. This spontaneous report as received from an other health professional refers to 4 patients. The median age of the patients was 69 years old; range being 23 to 98 years. Between 01-JAN-1990 and 31-DEC-2013 patients were vaccinated with PNEUMOVAX 23. On an unknown date the patients experienced death. The outcome of death was reported as fatal. The cause of death was reported as ''undetermined''. The death of the patients was confirmed with medical records, autopsy reports and/or death certificates. The report has been split into cases according to cause of death. This case is linked to same reporter linked cases # 1406USA003857 (respiratory disorder), 1406USA003863 (Unknown), 1406USA003859 (other non infectious disorder), 1406USA003860 (gastrointestinal), 1406USA003861 (Neurological), 1406USA003862 (Undetermined) and 1406USA003351 (Cardiovascular). Additional information has been requested.


VAERS ID: 533481 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-06-11
Entered: 2014-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Gastrointestinal disorder
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: WAES1406USA003860

Write-up: Information has been reported in a study. The report concerns death reports in adult ages 19 years and Older following PNEUMOVAX 23. The report includes VAERS reports following PNEUMOVAX 23 or Pneumococcal polysaccharide vaccine (PPSV23) brand unknown after 2002. The report includes reports information from 01-JAN-1990 to 13-JAN-2014. This spontaneous report as received from an other health professional refers to 1 patient. The median age of the patients was 69 years old; range being 23 to 98 years. Between 01-JAN-1990 and 31-DEC-2013 patients were vaccinated with PNEUMOVAX 23. On an unknown date the patients experienced death. The cause of death was reported as gastrointestinal. The death of the patients was confirmed with medical records, autopsy reports and/or death certificates. The report concerns death reports in adult ages 19 and Older following PNEUMOVAX 23. The report has been split into cases according to cause of death. This case is linked to same reporter linked cases # 1406USA003857 (respiratory disorder), # 1406USA003863 (Unknown), # 1406USA003859 (other non infectious disorder), # 1406USA003858 (other infectious), # 1406USA003861 (Neurological), # 1406USA003862 (Undetermined) and # 1406USA003351 (Cardiovascular). Additional information has been requested.


VAERS ID: 533482 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-06-11
Entered: 2014-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: WAES1406USA003863

Write-up: Information has been reported in a study. This report concerns death events in adult ages 19 years and Older following PNEUMOVAX 23. The report includes US VAERS reports following PNEUMVOAX 23 or PPSV 23 brand unknown after 2002. The report includes reports information from 01-JAN-1990 to 31-JAN-2014. This spontaneous report as received from a registered nurse refers to 18 patients. The median age of the patients was 69 years old; range between 23 to 98 years. Between 01-JAN-1990 and 31-DEC-2013 patients were vaccinated with PNEUMOVAX 23. ON an unknown date the patients experienced death. The cause of death was reported as unknown. The death of the patients was confirmed with medical records, autopsy reports and/or death certificates. The report concerns death reports in adult ages 19 years and Older following PNEUMVOAX 23. The report has been split into cases according to cause of death. This case is linked to same reporter linked cases # 1406USA003857 (respiratory disorder), # 1406USA003858 (Other Infectious disorder), # 1406USA003859 (other non infectious disorder), # 1406USA003860 (gastrointestinal), # 1406USA003861 (Neurological), # 1406USA003862 (Undetermined) and # 1406USA003351 (Cardiovascular). Additional information has been requested.


VAERS ID: 533483 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-06-11
Entered: 2014-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1406USA003857

Write-up: Information has been reported in a study. The report includes VAERS reports following PNEUMOVAX 23 or Pneumococcal polysaccharide vaccine (PPSV23) brand unknown after 2002. The report includes reports information from 01-JAN-1990 to 13-JAN-2014. This spontaneous report as received from a other health professional refers to 11 patients. The median age of the patients was 69 years old; range being 23 to 98 years. Between 01-JAN-1990 and 31-DEC-2013 patients were vaccinated with PNEUMOVAX 23. On an unknown date the patients experienced death. The outcome of death was reported as fatal. The cause of death was reported as ''Respiratory''. The death of the patients was confirmed with medical records, autopsy reports and/or death certificates. The report has been split into cases according to cause of death. This case is linked to same reporter linked cases 1406USA003351 (Cardiovascular), 1406USA003858 (Other infectious disorder), 1406USA003859 (other non infectious disorder), 1406USA003860 (gastrointestinal), 1406USA003861 (Neurological), 1406USA003862 (Undetermined) and 1406USA003351 (Cardiovascular). Additional information has been requested.


VAERS ID: 533788 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2014-03-11
Onset:2014-03-12
   Days after vaccination:1
Submitted: 2014-06-13
   Days after onset:93
Entered: 2014-06-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. J013134 / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-03-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1406USA005455

Write-up: Information has been received from a third party claims administrator on behalf of a pharmacy concerning a male patient, who 11-MAR-2014 was vaccinated with ZOSTAVAX (lot # J013134, expiration date 17JAN2015). On 12-MAR-2014, the patient died (not further specified) a day after receiving the ZOSTAVAX vaccine. Additional information has been requested.


VAERS ID: 533907 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-06-13
Entered: 2014-06-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 4 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Bordetella test positive, Chemotherapy, Death, Lymphocyte percentage decreased, Lymphocyte percentage increased, Metastases to heart, Metastases to lung, Neoplasm progression, Pertussis, Pneumonia necrotising, Polymerase chain reaction, Pulmonary fibrosis, Pulmonary hypertension, Respiratory syncytial virus infection, Rhinitis, Vaccination failure, White blood cell count decreased, White blood cell count increased
SMQs:, Haematopoietic leukopenia (narrow), Lack of efficacy/effect (narrow), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Malignancy related conditions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Pulmonary hypertension (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Rhabdomyosarcoma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lymphocytes, 83%; Lymphocytes, 3%; White blood cells, 200/mm3; White blood cells, 31000/mm3
CDC Split Type: B1003170A

Write-up: This case was reported in a literature article and described the occurrence of pertussis in a 2-year-old subject of unspecified gender who was vaccinated with DTaP (manufacturer unspecified). Concurrent medical conditions included rhabdomyosarcoma for which chemotherapy had been started after he had completed the course of vaccinations. The authors report that no coughing contact was identified for the subject. No further information regarding the subject''s medical, family history or concurrent medication has been provided. On unspecified dates, the subject received 4 doses of DTaP vaccine (unknown route, injection site and batch number). In 2012, at an unspecified time after vaccination with DTaP vaccine, the subject experienced pertussis. No information has been provided regarding any symptoms displayed by the subject or any clinical examinations performed on him; but the authors report that the pertussis cases described in the article had to have at least one of the following symptoms along with a nasopharyngeal polymerase chain reaction positive test for Bordetella pertussis to be considered as confirmed pertussis cases: paroxysmal cough, whoop or post-tussive emesis. Therefore, this was considered as a vaccination failure. In 2012, the subject also experienced RSV infection (rhinitis). His level of white blood cells at presentation was 200/ mm3 (83% lymphocytes) and it rose to a maximum of 31000/mm3 (3% lymphocytes) during the course of the illness. The subject was treated with a prolonged extracorporeal membrane oxygenation course including necrotizing pneumonia and tumour progression. Neither leukophoresis nor exchange transfusion was performed. The subject died from death unspecified 78 days after the onset of pertussis. An autopsy was performed and showed evidence of pulmonary fibrosis and pulmonary hypertension. Lung metastasis and metastases to pericardium were noted. There was no evidence of ongoing infection.


VAERS ID: 534345 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-06-18
Entered: 2014-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Antibody test negative, B-lymphocyte count decreased, Blood immunoglobulin G decreased, CD4 lymphocytes decreased, CD8 lymphocytes decreased, Death, Immunoglobulin therapy, Pneumonia, Respiratory failure, T-lymphocyte count decreased
SMQs:, Anaphylactic reaction (broad), Haematopoietic leukopenia (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), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunodeficiency; Myopathy, at the age of 73 years; Prophylaxis
Preexisting Conditions: Pneumonia; Hospitlisation, 4 times per year for pneumonia; Onychomycosis; Oesophageal candidiasis; Candida infection; Tumour excision; Thymoma; Mediastinal mass, at the age of 65 years
Allergies:
Diagnostic Lab Data: Laboratory evaluation performed at 75 years of age revealed a low total absolute CD3+ cell count of 570 cells/mm3, an absolute CD3+ CD4+ cell count of 414 cells/mm3, and an absolute CD3+ CD8+ cell count of 141 cells/mm3. The response to mitogen and antigen stimulation was markedly diminished (phytohemagglutinin: 10,870 cpm; pokeweed mitogen: 8,311 cpm; concanavalin A: 20,962 cpm; Staphylococcus aureus Cowan strain: 2,644 cpm. Absolute CD19+ cells counts were low at 30 cells/mm3. Serum IgG levels were low at a level of 535 mg/dL. At the age of 73 year, elevated muscle enzyme levels (creatine phosphokinase, aldolase, and serum glutamic oxaloacetic transaminase) suggested a myopathy. Degeneration and regeneration of muscle fibers were noted accompanied by focal perimysial and endomysia lymphatic infiltrates. Electromyographic analysis suggested myopathic changes. Patient received the PNEUMOVAX 23, and both the prevaccine and 30-day postvaccine titers were absent.
CDC Split Type: WAES1405USA013794

Write-up: This literature marketed report as received from a public article, refers to a 75 year old male patient. The patient initially developed radiographic evidence of a mediastinal mass at the age of 65 years. Further evaluation and biopsy revealed the presence of a thymoma. Three years after the resection of the thymoma, the patient developed recurrent thrush, esophageal candidiasis, and onychomycosis. The patient was hospitalized for pneumonia 4 times per year before treatment. At the age of 73 years, with no prior history of muscle disease, he developed proximal muscle weakness that involved, most prominently, the muscles of his neck and shoulders. Elevated muscle enzyme levels (creatine phosphokinase, aldolase, and serum glutamic oxaloacetic transaminase) suggested a myopathy. A left deltoid muscle biopsy specimen revealed inflammatory myopathy without inclusive bodies. Degeneration and regeneration of muscle fibers were noted accompanied by focal perimysial and endomysia lymphatic infiltrates. Electromyographic analysis suggested myopathic changes. Laboratory evaluation performed at 75 years of age revealed a low total absolute CD3+ cell count of 570 cells/mm3, an absolute CD3+ CD4+ cell count of 414 cells/mm3, and an absolute CD3+ CD8+ cell count of 141 cells/mm3. The response to mitogen and antigen stimulation was markedly diminished (phytohemagglutinin: 10,870 cpm; pokeweed mitogen: 8,311 cpm; concanavalin A: 20,962 cpm; Staphylococcus aureus Cowan strain: 2,644 cpm. Absolute CD19+ cells counts were low at 30 cells/mm3. Serum IgG levels were low at a level of 535 mg/dL. He received the PNEUMOVAX 23 (for antigen stimulation), and both the prevaccine and 30-day postvaccine titers were absent. He was treated with intravenous immunoglobulin, 1 g/kg every 4 weeks, and oral fluconazole every other day. These therapeutic options stabilized his condition for several years. He eventually died of respiratory failure during a pneumonia infection. The association of thymoma with autoimmune and paraneoplastic disorders is well documented. Polymyositis is found in approximately 5% of thymoma cases; however, polymyositis has never been previously documented in a patient with confirmed GS. This case represents the first association of Good Syndrome (GS) (with thymoma and immunodeficiency) and polymyositis. Clarification was received stating that the indication should be changed to "prophylaxis" since the patient was hospitalized 4 times for pneumonia and the event of absent titers should be captured as it synonymously conveys vaccine failure even though not reported. Additional information has been requested.


VAERS ID: 534812 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2014-06-16
Onset:2014-06-17
   Days after vaccination:1
Submitted: 2014-06-19
   Days after onset:2
Entered: 2014-06-24
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. K004148 / 2 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Fatigue, Injection site pain, Myalgia, Somnolence
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-06-17
   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: None
Preexisting Conditions: Known extensive CAD and diffuse ASVD
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt was very sleepy very fatigued w/ any activity was not sweaty. Myalgia and weakness, fatigue, terrible (L) arm ache mid deltoid.


VAERS ID: 534975 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-06-24
Entered: 2014-06-26
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 4 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Chemotherapy, Death, Metastases to heart, Metastases to lung, Pertussis, Pulmonary fibrosis, Pulmonary hypertension, White blood cell count decreased, White blood cell count increased
SMQs:, Haematopoietic leukopenia (narrow), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Pulmonary hypertension (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Other chemotherapeutics
Current Illness: Unk
Preexisting Conditions: Rhabdomyosarcoma; Respiratory Syncytial Virus Infection; pulmonary hypertension; Patient had received 4 doses of DTaP vaccine before he received chemotherapy. The patient had a reported medical history of rhabdomyosarcoma and respiratory syncytial viral coinfection. The patient underwent prolonged ECMO course including necrotizing pneumonia and tumor progression. After fourth vaccination of TDAP, the patient underwent chemotherapy. As per the autopsy details, it was evident for pulmonary hypertension and fibrosis, metastasis to lung and pericardium, but no trace of ongoing infection found.
Allergies:
Diagnostic Lab Data: WBC count, Unknown, 200 cell/MM3; WBC count, Unknown, 31000 cell/mm3
CDC Split Type: 2014SA082403

Write-up: Initial report received from the literature article on 18 June 2014. A 2-year-old patient (gender not reported) had received fourth dose of TDAP vaccine (dose, lot number, route and site of vaccination not reported) on an unspecified date. The patient had received all previous three doses on unspecified dates. The patient had a reported medical history of rhabdomyosarcoma and respiratory syncytial viral coinfection. The patient underwent prolonged ECMO course including necrotizing pneumonia and tumor progression. After fourth vaccination of TDAP, the patient underwent chemotherapy. On an unspecified date, the patient developed pertussis. The patient died on an unspecified date. Time to death from illness onset was 78 days. The autopsy results were evident for pulmonary hypertension and fibrosis, metastasis to lung and pericardium, but no trace of ongoing infection found. Documents held by sender: none.


VAERS ID: 534988 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2014-06-23
Onset:2014-06-25
   Days after vaccination:2
Submitted: 2014-06-26
   Days after onset:1
Entered: 2014-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4853AA / UNK RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-06-25
   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: Fish oil; Coenzyme Q10
Current Illness: Was here for preventive exam
Preexisting Conditions: HTN; Allergies: LOPID, LIPITOR, Ibuprofen, Aspirin
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Unknown. Patient was at work. Taken to hospital and died. Details unknown.


VAERS ID: 535052 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Male  
Location: Indiana  
Vaccinated:2014-06-13
Onset:2014-06-14
   Days after vaccination:1
Submitted: 2014-06-27
   Days after onset:13
Entered: 2014-06-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 4M7GD / 2 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR J016188 / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H13994 / 2 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41DB417A / 2 MO / PO

Administered by: Public       Purchased by: Public
Symptoms: Adenovirus test positive, Blood culture negative, Cardiac arrest, Cardiac murmur, Cardio-respiratory arrest, Culture urine negative, Death, Electrocardiogram abnormal, Hypotonia, Intensive care, Musculoskeletal stiffness, Nervous system disorder, Nuclear magnetic resonance imaging abnormal, Pyrexia, Respiratory arrest, Resuscitation, Screaming, Staring
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Peripheral neuropathy (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), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Arthritis (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2014-06-20
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Q-var 40 mcg 2 puffs bid; Albuterol prn
Current Illness: Patient with URI symptoms, cough, RN that mom thought was resolving. Afebrile. Later found to have +adenovirus
Preexisting Conditions: 36 week preemie in newborn ICU for several weeks, readmitted to hospital 12/2013 with bronchiolitis and intubated at that time. Diagnosesd with VSD and PFO as newborn
Allergies:
Diagnostic Lab Data: Urine cx NGTD, blood cx NGTD, RVP with +adenovirus. Cardiac - h/o VSD/PFO, systolic murm on exam (baseline), repeat EKG with incomplete RBBB vs RVH, no conduction delay, Non accidental trauma work up negative, MRI 6/19/14 with progressive diffuse ischemia or white matter tracts as compared to priror consistent with global injury
CDC Split Type:

Write-up: Patient had fever of approx 101 on eve of date received vaccines, then had an episode described as eyes staring off and whole body going limp for 5 sec followed by all 4 extremity stiffening that lasted couple of seconds. He then returned to normal with total episode time ~10 sec. He then had another similar episode the following afternoon with return to normal. The eve following receiving vaccination mom heard loud scream from child''s room. She picked up child who was awake, alert. He then had another episode of eyes staring followed by going limp. This time he did not return to baseline and stopped breathing. EMS was called. Patient was in cardiac arrest. Required chest compressions upon arrival to ED. Patient coded for 35 min. To pediatric ICU, vent dependent with severe neurological impairment s/p prolonged cardiopulmonary arrest. Patient was terminally extubated.


VAERS ID: 535209 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Male  
Location: Unknown  
Vaccinated:2011-06-24
Onset:2011-07-04
   Days after vaccination:10
Submitted: 2014-06-29
   Days after onset:1091
Entered: 2014-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. 0620AA / UNK RA / SC

Administered by: Other       Purchased by: Other
Symptoms: Death, Endotracheal intubation, Injection site haemorrhage, Malaise
SMQs:, Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2011-07-04
   Days after onset: 0
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: COUMADIN; FLOMAX
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1406USA013096

Write-up: This spontaneous report as received from a pharmacist via a company representative refers to a 87 year old male patient. The pharmacist received this information from the patient''s daughter. On 04-JUL-2011 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose, frequency were unspecified). Concomitant therapies included COUMADIN and FLOMAX. On 04-JUL-2011, 12 hours of receiving ZOSTAVAX the patient passed away. The patient received the ZOSTAVAX and started to bleed heavily from the injection site. According to the patient''s daughter, on the day of the ZOSTAVAX injection and the patient stated that "he did not feel well and had lost a profuse amount of blood." He was taken by ambulance to an unspecified hospital and sought medical attention. The patient was intubated in the hospital. He passed away on 04-JUL-2011. No cause of death was provided. The outcome of the other events was unknown. The events were considered as disability and life threatening by the reporter. Additional information has been requested.


VAERS ID: 535858 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2013-10-01
Onset:0000-00-00
Submitted: 2014-07-04
Entered: 2014-07-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Herpes zoster, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1406USA013730

Write-up: This spontaneous report was received from a medical assistant via a field employee regarding an older male patient of unknown age. Medical Assistant said that the patient had "multiple unspecified comorbidities" regarding his health. No information about drug reactions and allergies was specified. On an unknown date in October 2013, The patient received ZOSTAVAX vial (dosing regimen unspecified). No concomitant medications were reported. Approximately on an unknown date in 2013, the patient developed a rash 3 days after the ZOSTAVAX was given. The rash was diagnosed as a severe case of shingles on an unspecified date. Medical Assistant stated that the patient died a few weeks later on an unspecified date. There was no product quality complaint with ZOSTAVAX. Cause of death and autopsy details were not provided. The outcome of the event severe case of shingles is unknown. The causality of the events was not specified by the reporter. Additional information is not expected.


VAERS ID: 535924 (history)  
Form: Version 1.0  
Age: 1.09  
Sex: Male  
Location: Washington  
Vaccinated:2014-01-08
Onset:2014-01-19
   Days after vaccination:11
Submitted: 2014-07-07
   Days after onset:168
Entered: 2014-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 55PZ4 / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH870AB / 2 LL / IM

Administered by: Public       Purchased by: Public
Symptoms: Autopsy, Cyanosis, Malaise, Nasopharyngitis, Sudden death, Toxicologic test normal, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-01-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Mild diarrhea in days prior, none day of vaccine
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt was vaccinated 01/08/2014. Died 01/19/2014. Was active police investigation but autopsy was negative. No signs of trauma on body, tox screen normal. Appears may have been Sudden unexplainable death of an infant. Infant was found blue and unresponsive in corner of playpen w 2 blankets over him. Detective said VAERS should be done, unable to know if vaccines played a role in death. Pt was ill with a cold at time of death.


VAERS ID: 536893 (history)  
Form: Version 1.0  
Age: 0.1  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-07-17
Entered: 2014-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death neonatal
SMQs:, Acute central respiratory depression (broad), Neonatal disorders (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1407USA005160

Write-up: Information has been received via social media (website) regarding a 5-week old female, who on an unspecified date received the RECOMBIVAX HB. The parent (not further specified if a mother or father) reported that "My 5-week old daughter died within hours of getting the Hepatitis B vaccine." No further information was reported.


VAERS ID: 537090 (history)  
Form: Version 1.0  
Age: 1.51  
Sex: Male  
Location: Tennessee  
Vaccinated:2014-07-11
Onset:2014-07-12
   Days after vaccination:1
Submitted: 2014-07-14
   Days after onset:2
Entered: 2014-07-21
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS T3PM5 / 4 RL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. J006955 / 1 RA / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J006693 / 1 LA / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-07-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Possible viral illness; low grade fever
Preexisting Conditions: 32 wk preemie
Allergies:
Diagnostic Lab Data: Autopsy was performed.
CDC Split Type:

Write-up: Child found dead the next morning by family member.


VAERS ID: 537166 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: New York  
Vaccinated:2014-07-14
Onset:2014-07-14
   Days after vaccination:0
Submitted: 2014-07-21
   Days after onset:7
Entered: 2014-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4671AA / 1 LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. J012588 / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H45392 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. K001453 / 1 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Death, Respiratory arrest, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (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), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-07-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt was found unresponsive and not breathing by mother approximately 6 hours after receiving vaccinations. Pt was transferred to hospital at 5:30pm via ambulance and was expired at 6:20pm. Unknown at this time cause of death.


VAERS ID: 538295 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2014-07-30
Onset:2014-07-30
   Days after vaccination:0
Submitted: 2014-07-31
   Days after onset:1
Entered: 2014-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H012973 / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-07-30
   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: Albuterol
Current Illness: Complaints of mild sore throat, but no objective signs of illness
Preexisting Conditions: Exercise induced asthma, dust allergy, intermittent asthma, ADHD
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Cardiorespiratory arrest and death.


VAERS ID: 538342 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-07-31
Entered: 2014-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Antibody test abnormal, Blood immunoglobulin A decreased, Blood immunoglobulin G decreased, Bronchiectasis, CD4 lymphocytes abnormal, Clostridium test negative, Cytogenetic analysis normal, Death, Haematocrit normal, Immunoglobulin therapy, Lymphocyte count normal, Monocyte count normal, Mycobacterium test positive, Natural killer cell count decreased, No therapeutic response, Platelet count decreased, Pneumonia, Selective IgA immunodeficiency, Selective IgG subclass deficiency, Sinusitis, Skin papilloma, Sputum culture positive, T-lymphocyte count decreased
SMQs:, Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Lack of efficacy/effect (narrow), Systemic lupus erythematosus (broad), Eosinophilic pneumonia (broad), Vasculitis (broad), Hypersensitivity (broad), 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: 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: Prophylaxis; Gene mutation; Antibody test abnormal; Hypogammaglobulinaemia; Lymphopenia; Sinusitis; Blood immunoglobulin A abnormal; Blood immunoglobulin G abnormal
Preexisting Conditions: Sinusitis, age 3; Otitis media, age 3; Historical drug, tetanus toxoid; Historical drug, globulin, immune, age 5 to age 10; Historical drug, Hib conj vaccine
Allergies:
Diagnostic Lab Data: Lymphocyte count (unknown date / age 3): normal; Monocyte count (unknown date / age 3): normal; Platelet level (unknown date / age 3): normal; Hematocrit level (unknown date / age 3): normal; IgG2 level (unknown date / age 3): deficiency; IgA level (unknown date / age 3): deficiency; Ribitol (PRP) titer (unknown date / age 3): 52 ng/mL; Ribitol (PRP) titer (unknown date / after booster): $g1200 ng/mL; Polyribosylribitol (PRP) titer (unknown date / age 5): 185 ng/ml decreased; Polyribosylribitol (PRP) titer (unknown date / age 14): increased significantly after the Hib vaccine; IgG level (unknown date / age 14): low; IgA level (unknown date / age 14): undetectable; B cells (unknown date / age 14): absent; CD4+ T-cell lymphopenia (unknown date / age 14): absent; He had absent tonsils, which had been barely visible on previous examinations. No mutations were found in the TACJ, PNP, ADA, BTK, or SH2DJA genes; Tetanus, 0.03 IU/ml; Tetanus, 0.14 IU/ml; Tetanus, 0.27 IU/ml
CDC Split Type: WAES1407USA013029

Write-up: Information has been received from the authors in a published letter to the editor, regarding a 14 year old male patient who did not respond to repeated vaccinations of PNEUMOVAX and PREVNAR. The patient presented at 3 years of age with recurrent otitis media and sinusitis. He had normal lymphocyte and monocyte counts, platelet numbers, and hematocrit levels. He had IgG2 and IgA deficiency and absent tetanus and low PRP (52 ng/mL) antibody titers. Tetanus and Haemophilus influenzae type b (Hib) vaccine boosters resulted in protective tetanus (0.4 IU/mL) and PRP ($g1200 ng/mL) titers. Two years later, his tetanus titer was undetectable, his polyribosylribitol phosphate (PRP) titer decreased to 1S5 ng/mL, and his IgG level was decreased at 444 mg/dL, prompting intravenous immunoglobulin (IVIG) initiation. At 10 years of age, IVIG was discontinued to reassess his antibody response. His tetanus titer increased from 0.14 to 0.27 IU/mL after a booster but waned within 1 year to 0.03 IU/mL. At 14 years of age, his PRP titer increased significantly after the Hib vaccine, but he did not respond to repeated vaccinations of PNEUMOVAX and PREVNAR; additionally, his IgG level was low, and his IgA level was undetectable. He had pneumonia and pansinusitis in the setting of absent B cells and CD4+ T-cell lymphopenia, and therefore IVIG was restarted. He had absent tonsils, which had been barely visible on previous examinations. No mutations were found in the TACJ, PNP, ADA, BTK, or SH2DJA genes. At 16 years of age, he had persistent warts on his hands and severe bronchiectasis. Sputum cultures were positive for Mycobacterium kansasii. Lymphocyte proliferation to mitogens and antigens was normal, but NK cell, monocyte, and platelet counts were low. Progressive respiratory decline led to his death at 22 years of age. Whole-exome sequencing on both patients identified a heterozygous mutation in GATA2 (c. C1061T) that was confirmed by means of Sanger sequencing. The mutation results in amino acid change from threonine to methionine at position 354 (T354M) in the second zinc finger domain9 and is predicted to be damaging to protein function by using both the PolyPhen (score 0.997) and SIFT (score 0) tools. The T354M mutation does not affect GATA2 expression or nuclear localization, but significantly impairs GATA2 binding to DNA and to the transcription factor PU.l, resulting in a dominant negative effect on transcriptional activation. The phenotypes associated with the T354M mutation autosomal dominant MDS/acute myeloid leukemia, MDS with pancytopenia, multilineage cytopenias, and opportunistic infections. One patient with this mutation had 1 episode of parainfluenza and Mycoplasma infection with normal immunoglobulin levels, another had pneumonias limited to childhood, and 3 others had mycobacterial and viral infections. Four subjects were healthy into adulthood. The patient presented with IgG2 and IgA deficiencies and an abnormal vaccine response, which has not been previously reported in patients with GATA2 mutations. No additional mutations were found through whole-exome sequencing that would account for the hypogammaglobulinemia seen in both patients. This report highlighted the importance of considering mutations in GATA2 in patients with hypogammaglobulinemia, particularly in the setting of abnormal lymphocyte subsets and monocyte counts. Additional information has been requested.


VAERS ID: 538501 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Male  
Location: New Mexico  
Vaccinated:2014-07-24
Onset:2014-07-24
   Days after vaccination:0
Submitted: 2014-08-01
   Days after onset:8
Entered: 2014-08-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. J011042 / UNK LA / IM

Administered by: Unknown       Purchased by: Other
Symptoms: Blood test, Cold sweat, Delirium, Diarrhoea, Endotracheal intubation, Influenza like illness, Intensive care, Pyrexia, X-ray
SMQs:, Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2014-08-12
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 14 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Ibuprofen, Omeprazole
Current Illness: Problems with oxygen and breathing
Preexisting Conditions: Pulmonary fibrosis
Allergies:
Diagnostic Lab Data: Admitted to ICU: x-rays, blood work, intubation, etc
CDC Split Type:

Write-up: Fever, delirious, diarrhea, flu-like symptoms, cold sweats; gave Tylenol, checked temperature, contacted a nurse.


VAERS ID: 538748 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Alabama  
Vaccinated:2014-08-01
Onset:2014-08-02
   Days after vaccination:1
Submitted: 2014-08-04
   Days after onset:2
Entered: 2014-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 7537C / 1 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UI047AA / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H45097 / 1 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FB401A / 1 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Hypotonia, Resuscitation, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-08-02
   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: Nystatin
Current Illness: Thrush
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Mom reports vomited several times on 8-2-14. States baby was getting diaper change and vomited. States baby went limp. CPR started and ambulance was sent.


VAERS ID: 539223 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Ohio  
Vaccinated:2014-07-28
Onset:2014-07-28
   Days after vaccination:0
Submitted: 2014-08-07
   Days after onset:10
Entered: 2014-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4798AA / 1 UN / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4837AB / 1 UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Cardiac failure, Lethargy, Myocarditis, Pyrexia, Troponin T increased, Vomiting
SMQs:, Cardiac failure (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2014-08-25
   Days after onset: 28
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 22 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None reported.
Preexisting Conditions: None elicited.
Allergies:
Diagnostic Lab Data: 8/3/2014 08:00 Troponin T: 10.090 (H)
CDC Split Type:

Write-up: Fever, lethargy. Later developed vomiting and went into heart failure. Preliminary diagnosis of Acute myocarditis.


VAERS ID: 539685 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2014-07-24
Onset:2014-07-31
   Days after vaccination:7
Submitted: 2014-08-13
   Days after onset:13
Entered: 2014-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C4565BA / 1 LA / IM
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR H14821 / 3 RA / IM

Administered by: Private       Purchased by: Other
Symptoms: Death, Influenza like illness
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-07-31
   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: None
Current Illness: No. Marathon runner. Vagal syncope 1 week earlier with full recovery, negative cardiac evaluation.
Preexisting Conditions: No known allergies
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient found deceased in his home. He had reported flu like symptoms to a family member via phone day before.


VAERS ID: 539960 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Wisconsin  
Vaccinated:2014-07-01
Onset:2014-07-02
   Days after vaccination:1
Submitted: 2014-08-15
   Days after onset:44
Entered: 2014-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C4587AA / UNK LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H39262 / UNK RL / IM

Administered by: Public       Purchased by: Other
Symptoms: Cyanosis, Death, Mechanical ventilation
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-07-04
   Days after onset: 2
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: Roseola
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was found blue in crib around 7:30 pm on the evening of July 2nd. 911 was call they got patient oxygen and was stabilized at hospital then was med flighted to another hospital where they put patient on a ventilator and he passed away July 4th around 845pm.


VAERS ID: 540269 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Arizona  
Vaccinated:0000-00-00
Onset:2014-07-31
Submitted: 2014-08-19
   Days after onset:19
Entered: 2014-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Death
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-07-31
   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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1408USA010190

Write-up: This spontaneous report as received from a physician via a company representative refers to a 12 year old female patient. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot#, dose, route not reported). Concomitant medications were not provided. The physician reported that she read a report, possibly online, about the patient who had a seizure on an unknown date after administration of GARDASIL and died on 31-JUL-2014. The cause of death was unspecified. The patient had sought unspecified medical attention. Outcome of seizure was unknown. Causality was not provided. Upon internal review, seizure was determined to be medically significant. Additional information is not expected because the reporter did not want to be contacted.


VAERS ID: 540483 (history)  
Form: Version 1.0  
Age: 0.9  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-08-19
Entered: 2014-08-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blindness, Brain death, Convulsion, Death, Gastrostomy, Posture abnormal, Ventriculo-peritoneal shunt
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: UNK
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2014SA110867

Write-up: Initial report received from a consumer, who is also the patient''s mother, on 14 August 2014. The following is verbatim from the report: "I lost my son at year and a half. But after 10 months. After he got the meningitis enoculation. He became brain dead blind dead outward posturing constant seizes. Gastrostomy tube and a shunt in his brain. Shot was what killed him. Panhandlers health." No further information was available at the time of the report. The patient outcome was fatal. Documents held by sender: None.


VAERS ID: 540489 (history)  
Form: Version 1.0  
Age: 55.0  
Sex: Male  
Location: California  
Vaccinated:2013-12-02
Onset:2013-12-02
   Days after vaccination:0
Submitted: 2014-08-20
   Days after onset:260
Entered: 2014-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS D43CT / UNK RA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Ageusia, Eye movement disorder, Facial asymmetry, Facial nerve disorder, Facial paresis, Headache, Nerve injury, Nuclear magnetic resonance imaging, VIIth nerve paralysis
SMQs:, Taste and smell disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hearing impairment (broad), Ocular motility disorders (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Bells Palsy~Influenza (Seasonal) (FluLaval)~UN~55.75~Patient
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Several doctor appointments including MRI and reports. No treatment known per four physicians. I have a file that has all information.
CDC Split Type:

Write-up: After vaccine, I had severe headaches for several weeks. By December 6, I had weird facial disfigurement. I went to hospital on December 8 thinking I had stroke. The emergency room diagnosed Bells Palsy with damage to the seven facial nerve. Follow-up appointments with my practitioner, neurologist, and hospital neurology department confirmed I had permanent nerve damage which lead to disfigurement, loss of facial movement on left side of face including, chin, cheek, taste, nose, eye, and forehead. I have regained maybe 30% but symmetry of my face is still not improved.


VAERS ID: 540590 (history)  
Form: Version 1.0  
Age: 0.16  
Sex: Female  
Location: Montana  
Vaccinated:2013-10-04
Onset:2013-10-05
   Days after vaccination:1
Submitted: 2014-08-20
   Days after onset:319
Entered: 2014-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 99R9E / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. J005668 / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G66538 / 1 UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. J003814 / 1 MO / PO

Administered by: Unknown       Purchased by: Other
Symptoms: Autopsy, Condition aggravated, Crying, Death, Diet refusal, Heart disease congenital, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Congenital, familial and genetic disorders (narrow), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-10-06
   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: Was taking Zantac
Current Illness: None known at the time
Preexisting Conditions: Nothing known at the time. After her death autopsy proved she did have a birth defect.
Allergies:
Diagnostic Lab Data: Autopsy confirmed she had an undetected congenital heart defect and the vaccines sped up her death.
CDC Split Type:

Write-up: Non stop crying, fever 102 degrees, refusal to eat.


VAERS ID: 540899 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-08-25
Entered: 2014-08-25
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: WAES1408USA009054

Write-up: Information was received from a physician via a company representative regarding unspecified patients (demographics or details of patients not provided). The physician stated that an unspecified pediatrician sent an email with an article from an unspecified pediatric or infectious disease journal that stated that there have been deaths associated with GARDASIL. No further information is expected.


VAERS ID: 541912 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2014-08-27
Submitted: 2014-09-01
   Days after onset:5
Entered: 2014-09-01
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: 2014-08-27
   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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1408USA016953

Write-up: This spontaneous report as received from a physician via company representative via on-line document (social media) (source unspecified) refers to an 11 or 12 year old female patient. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date the patient was vaccinated with GARDASIL (strength, dose, dose number, dose schedule, route, anatomical location, lot number and expiration date were unspecified). No concomitant therapies were reported. On 27-AUG-2014 the 11 or 12 year old female died after receiving GARDASIL. At the time of this report it was not known if an autopsy were performed. The outcome of the event was reported as fatal. The relatedness between the event and GARDASIL was not reported. Additional information has been requested.


VAERS ID: 541916 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2014-08-19
Submitted: 2014-09-01
   Days after onset:13
Entered: 2014-09-01
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: 2014-08-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1408USA013464

Write-up: This spontaneous report was received from a consumer who read an article on the internet refers to a 12 year old female patient. No medical history reported. On an unknown date, same day or day after they took her home the patient was vaccinated with GARDASIL (dose number and route of administration unknown) (lot number unknown). No concomitant therapies reported. On 19-AUG-2014 the patient went to bed and didn''t wake up (death). The patient died on 19-AUG-2014. The cause of death according to the consumer was reported as GARDASIL. The causality was unknown. Additional information has been requested.


VAERS ID: 543649 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2014-03-01
Submitted: 2014-09-14
   Days after onset:196
Entered: 2014-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1409USA002155

Write-up: This spontaneous report was received from a Nurse professional via a company representative regarding her mother (age unknown). Pertinent medical history and concurrent conditions were unspecified. On an unknown date the patient was vaccinated with PNEUMOVAX 23, injection due to a chronic respiratory issue (dose and route not reported). No other concomitant therapies reported. On an unknown date, the patient developed pneumococcal disease, a strain which PNEUMOVAX 23, was supposed to cover. On an unknown date in March 2014 (about 6 months ago) the patient died from an aneurysm which was after she developed the pneumococcal disease. The lab diagnostic tests were unspecified. It was unknown whether patient sought medical attention. The outcome of the event aneurysm was reported as fatal. The outcome of the event pneumococcal disease was unknown. The causality of the events was unspecified. No PQC involved. Additional information is not expected.


VAERS ID: 544217 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-09-18
Entered: 2014-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1409USA006093

Write-up: This spontaneous report as received from a physician (who heard from an unspecified media source) via a company representative refers to a 14 year old female patient. On an unknown date the patient was vaccinated with her first dose of GARDASIL (dose, route, lot number and expiration date not provided). Physician stated that the patient went home, felt a little sick, laid down and died on an unknown date. The outcome of felt a little sick was unknown. Relatedness between the events: felt a little sick and the patient died was not reported. Follow up information was received from a physician via company representative. Physician reported that media source stated that the patient was 12 years old (not 14 years as previously reported). Company representative stated that she found the article on a website and it may have been reported via other media channels. An official cause of death was not mentioned. Additional information has been requested.


VAERS ID: 544517 (history)  
Form: Version 1.0  
Age: 44.0  
Sex: Male  
Location: Iowa  
Vaccinated:2014-09-18
Onset:2014-09-19
   Days after vaccination:1
Submitted: 2014-09-19
   Days after onset:0
Entered: 2014-09-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UI189AA / 2 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-09-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data: Autopsy to be done
CDC Split Type:

Write-up: Pt received influenza vaccination previous day and passed away from believed to be heart attack the following morning. An autopsy is being performed.


VAERS ID: 544718 (history)  
Form: Version 1.0  
Age: 63.0  
Sex: Male  
Location: Unknown  
Vaccinated:2014-09-17
Onset:2014-09-18
   Days after vaccination:1
Submitted: 2014-09-23
   Days after onset:5
Entered: 2014-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED T56805 / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-09-18
   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:
Preexisting Conditions: Surgery (aortic aneurysm) excision
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014045210

Write-up: This medically confirmed report (initial receipt 19-Sep-2014) concerns a 63-year-old male patient. The patient recently underwent a surgery for aortic aneurysm excision (exact date unknown). It was unknown whether the patient received any other medications or immunizations. If the patient received anything else, it would have been outside the facility. On 17-Sep-2014, the patient received intramuscular AFLURIA injection (batch number T56805) at 0.5 ml annually. On 18-Sep-2014, approximately 12 hours after vaccination, the patient passed away. The cause of death was unknown. It was believed that no autopsy would be performed. The outcome was reported as ''death''. Reporter''s comments: The reporter assessed the causality as serious and unlikely due to AFLURIA.


VAERS ID: 544978 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Male  
Location: New York  
Vaccinated:2014-09-20
Onset:2014-09-22
   Days after vaccination:2
Submitted: 2014-09-23
   Days after onset:1
Entered: 2014-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U50188A / 6 UN / UN

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: 2014-09-22
   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: XANAX; ALIGN; PULMICORT; DIASTAT AcuDial; FLONASE; Folic Acid; ATROVENT; PREVACID Solutab; XOPENEX; Levetiracetam; Sulfasalazine liquid
Current Illness: None
Preexisting Conditions: Mental retardation; Cerebral palsy; seizure disorder; ulcerative colitis; global develop. delay; spastic quadriplegia
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient found unresponsive on 9/22/14 by parents in his bed. 911 called, ACLS protocol initiated, however pt expired and pronounced dead in ED.


VAERS ID: 545039 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Male  
Location: New Mexico  
Vaccinated:2014-09-19
Onset:2014-09-20
   Days after vaccination:1
Submitted: 2014-09-24
   Days after onset:4
Entered: 2014-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED T57105 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-09-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SEROQUEL; Sertraline
Current Illness: None
Preexisting Conditions: Depression
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: No adverse events after vaccine, but patient''s mother reported he passed away in sleep.


VAERS ID: 545049 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: New York  
Vaccinated:2014-08-26
Onset:2014-09-12
   Days after vaccination:17
Submitted: 2014-09-18
   Days after onset:6
Entered: 2014-09-24
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4724AA / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H65735 / 1 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FB434A / 1 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Crying, Death, Disseminated intravascular coagulation, Dyspnoea, Enema administration, Food intolerance, Haematochezia, Intussusception, Irritability, Lethargy, Shock, Ultrasound abdomen abnormal
SMQs:, Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Ischaemic colitis (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-09-15
   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: Hyoscyamine sulfate prescribed 9/12/14
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Abdominal US 9/14/14 confirmed intussusception
CDC Split Type:

Write-up: Fussiness and crying onset 9/12/14 early AM, blood in stool that AM. More lethargic 9/13/14, not tolerating feeds. Seen in Emergency Room 9/13/14 - 9/14/14 - diagnosed with right upper quadrant intussusception reduced with air enema. Symptoms of shock, disseminated intravascular coagulation, third spacing of fluid, difficulty ventilating and ultimate death on 9/15/14.


VAERS ID: 545052 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2014-09-17
Onset:0000-00-00
Submitted: 2014-09-23
Entered: 2014-09-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U4995AA / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (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: Unknown
Current Illness: UNK
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2014SA130724

Write-up: Initial report was received on 19 September 2014 from a health care professional. A male patient reported over the age of 65 years (date of birth not reported) had received on an unspecified date FLUZONE HIGH DOSE, (lot number, route and site of administration not reported) and within 24 hours of receiving the vaccine suffered cardiac death. Outcome was fatal. Documents held by sender: none.


VAERS ID: 545422 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Female  
Location: Oregon  
Vaccinated:2014-09-19
Onset:2014-09-25
   Days after vaccination:6
Submitted: 2014-09-26
   Days after onset:1
Entered: 2014-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / CONNAUGHT LABORATORIES K1183 / 1 LA / IM
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR UH844AA / 1 LA / SC

Administered by: Public       Purchased by: Other
Symptoms: Abdominal pain, Diarrhoea, Dyspnoea, Endotracheal intubation, Hypotension, Intensive care, Nausea, Platelet count decreased, Pulse abnormal, Respiration abnormal, Thrombocytopenia, Unresponsive to stimuli, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Haematopoietic thrombocytopenia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2014-09-26
   Days after onset: 1
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt c/o n/v/d, abd pain approximately 3-4 days after recieving the yellow fever and typhoid vacciniations. On 9/5/14 She saw her primary care doctor and was found to be hypotensive with SBP in the 70''s. Pt was given 3 liters NS and became short of breath. Sent to ER and found to be thromocytopenic with PLT count of 90. At 0530 on 9/26 pt was found to be unresponsive with agonal respirations and a thready pulse a code blue was called. Patient was intubated, given 1 dose of Epi and transfered to critical care.


VAERS ID: 545642 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Male  
Location: Ohio  
Vaccinated:2014-09-24
Onset:2014-09-26
   Days after vaccination:2
Submitted: 2014-09-29
   Days after onset:3
Entered: 2014-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. CJ2005 / 1 NS / IN

Administered by: Private       Purchased by: Private
Symptoms: Autopsy, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-09-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Autopsy report pending
CDC Split Type:

Write-up: Sudden unexplained death during nap; autopsy report pending.


VAERS ID: 546064 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-01
Entered: 2014-10-01
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: WAES1409USA014319

Write-up: This spontaneous report from an adverse event tweet as received via social media from a consumer refers to a healthy 12 year old female patient. On an unknown date, the patient was vaccinated with GARDASIL (route, lot # and expiration date were not provided). The reporting consumer published the following: healthy 12 year old girl died, on an unknown date, after unspecified HPV vaccine. It was unknown if the patient sought medical attention. It was unknown if autopsy was performed. The cause of death was not provided. The reporting consumer stated her daughter (nor son) would never get this vaccine. Clarification was received that the social media AE documented two different tweets, by two different twitter users, about the same 1 patient, regarding GARDASIL. Additional information is not expected, as there is no consent for followup.


VAERS ID: 546331 (history)  
Form: Version 1.0  
Age: 1.26  
Sex: Male  
Location: Tennessee  
Vaccinated:2014-08-27
Onset:2014-09-24
   Days after vaccination:28
Submitted: 2014-10-03
   Days after onset:9
Entered: 2014-10-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS T3PMS / 4 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. J006955 / 1 RA / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J009728 / 1 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Autopsy, Cardiac arrest, Death, Irritability, Respiratory arrest
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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-09-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Parents C/o "fussy"
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Autopsy pending results.
CDC Split Type:

Write-up: Was at daycare - had taken nap/aroused fussy - consoled/but then noted not breathing 911 - to ER/dx with cardiac arrest ELLD.


VAERS ID: 546527 (history)  
Form: Version 1.0  
Age: 85.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2014-09-19
Onset:2014-09-19
   Days after vaccination:0
Submitted: 2014-10-05
   Days after onset:16
Entered: 2014-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U5022BA / UNK RA / UN

Administered by: Unknown       Purchased by: Private
Symptoms: Abasia, Blood pressure increased, Blood test, Computerised tomogram, Dysstasia, Heart rate increased, Neurological examination
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-01-21
   Days after onset: 124
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Metoprolol; Namenda; Flomax; Aspirin; Finasteride; Super B12; Preservision
Current Illness: Dementia
Preexisting Conditions: Dementia
Allergies:
Diagnostic Lab Data: CT scan; blood work, evaluation by neurologist.
CDC Split Type:

Write-up: Could not stand or walk. Blood pressure and heart rate soared.


VAERS ID: 546781 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Male  
Location: California  
Vaccinated:2014-05-31
Onset:0000-00-00
Submitted: 2014-10-06
Entered: 2014-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / UN

Administered by: Unknown       Purchased by: Public
Symptoms: Death, Drug screen
SMQs:, Drug abuse and dependence (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: ~Vaccine not specified (no brand name)~~0.00~Patient
Other Medications: INVEGA SUSTENNA
Current Illness: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data: MDMA 3,4-metilendioximetanfetamina
CDC Split Type:

Write-up: Patient Died.


VAERS ID: 547820 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Arkansas  
Vaccinated:2014-10-10
Onset:2014-10-11
   Days after vaccination:1
Submitted: 2014-10-14
   Days after onset:3
Entered: 2014-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS E2297 / 1 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. K004540 / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H45100 / 1 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FB420A / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-10-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None noted
Preexisting Conditions: None noted
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: UNKNOWN.


VAERS ID: 548418 (history)  
Form: Version 1.0  
Age: 59.0  
Sex: Female  
Location: Colorado  
Vaccinated:2014-10-02
Onset:2014-10-02
   Days after vaccination:0
Submitted: 2014-10-16
   Days after onset:14
Entered: 2014-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI196AC / UNK LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Chest discomfort, Chills, Cough, Death, Endotracheal intubation, Eye pruritus, Headache, Hypotension, Laboratory test normal, Malaise, Multi-organ failure, Ocular hyperaemia, Pain, Pyrexia, Septic shock
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Glaucoma (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-10-15
   Days after onset: 13
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: No regular meds
Current Illness: None
Preexisting Conditions: Amoxicillin - rash; Osteoarthritis; Thrombocytosis
Allergies:
Diagnostic Lab Data: Labs done day of 10/2/14 physical basically normal
CDC Split Type:

Write-up: Pt received influenza vaccine 10/2/14. Called office 10/3 with c/o developing tight chest, red itchy eyes, then cough. Just wanted noted in chart 10/13 presented for office appt, c/o fever, chills, malaise, body ache and headache. Was hypotensive. Received TYLENOL, antiemetic, fluids, improved and sent home. Pt presented to hospital 10/13 in the evening critically ill, was intubated and on meds to maintain BP. She passed away 10/15/14 at 5P of multi-organ failure/septic shock.


VAERS ID: 549045 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-17
Entered: 2014-10-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LA / SYR
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Anal sphincter atony, Anxiety, Areflexia, Axillary mass, B-lymphocyte count, B-lymphocyte count decreased, Bacterial test negative, Biopsy lymph gland abnormal, Blood immunoglobulin A normal, Blood immunoglobulin M normal, Blood test normal, CD4 lymphocytes decreased, CD8 lymphocytes decreased, CSF cell count normal, CSF glucose normal, CSF protein normal, CSF white blood cell count increased, Chest X-ray normal, Computerised tomogram abnormal, Cytomegalovirus test negative, Death, Enterovirus test positive, Fatigue, Fungal test negative, Gram stain negative, HIV test negative, Herpes simplex serology negative, Hyporeflexia, Injection site discharge, Injection site reaction, Irritability, Laboratory test normal, Lymphadenitis, Lymphadenopathy, Lymphocyte percentage decreased, Mobility decreased, Mycobacterium tuberculosis complex test positive, Neutrophil percentage, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal, Poliomyelitis post vaccine, Poliovirus test positive, Polymerase chain reaction, Pyrexia, Respiratory distress, Scan with contrast abnormal, Skin lesion, Stool analysis, T-lymphocyte count decreased, Tenderness, Ultrasound abdomen abnormal, Unresponsive to stimuli, Vaccination complication, White blood cell count, Withdrawal of life support
SMQs:, Anaphylactic reaction (broad), Haematopoietic leukopenia (narrow), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Malignant lymphomas (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Severe combined immunodeficiency syndrome
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: CD3=6 cells/mm3, CD19=1, CD16/56=189; Imaging: Chest radiograph was normal, Brain and Spine MRI showed 8 mm lesion in right cerebral peduncle, prominent abnormal T2 weighted signal at cord T11 level on the left: additional abnormal signal and contrast enhancement of several nerve roots. Chest, abdomen and pelvis CT scan showed enlarged lymph nodes, left supraclavicular, and left axilla, retroperitoneal. Microbiology: Blood test showed no bacterial growth at 48 hours, later positive for AFB identified as mycobacterium bovis/BCG. Cerebrospinal fluid showed negative bacterial meningitis screen and gram stain, negative fungal smear and culture, negative PCR for HSV-1, HSV-2 and CMV. Stool analysis- enterovirus isolated, identified as immunodeficiency associated vaccine derived poliovirus type, Lymph node fine needle aspiration showed AFB stain positive. Complete blood count, Unknown, ALC-216 cell/mm3; CD4 lymphocytes, Unknown, 2; CD8 lymphocytes, Unknown, 0; HIV tests, Unknown, Negative; IgA, Unknown, Undetectable; IgM, Unknown, Undetectable; IgG, Unknown, 140 mg/dl; WBC, Unknown, 83 cell/mm3; Polymorphonuclear count, Unknown, 42%; Lymphocyte count, Unknown, 2%; protein, Unknown, 48 mg/dl; glucose, Unknown, 49 mg/dl
CDC Split Type: 2014SA141550

Write-up: Initial literature report received on 11 October 2014. A 7-month-old male patient, whose concomitant medications were not reported, had received a dose of BCG (in left deltoid, batch number and route of administration were not reported) and a dose of OPV (batch number, route and anatomical site of administration were not reported) of unknown manufacturer on an unspecified date. The patient has a medical history of SCIDS (severe combined immunodeficiency). It was reported that, after vaccination, the patient was brought to hospital emergency department in July 2013; he had a 6-week history of intermittent fever associated with draining skin lesion over the left deltoid at the site of BCG vaccination. The patient was diagnosed with acute lymphadenitis and prescribed trimethoprim and sulfamethoxazole and sent home. The patient was again brought to the emergency department with increased irritability and decreased movement of the left leg and was admitted to the hospital for the further evaluation. The patient appeared tired and anxious but was responsive to touch. The physical examination was negative for meningococcal signs, no evidence of respiratory distress was found. A firm, mobile, tender, 2x2 cm mass was palpated under the left axilla. The patient did not move his left leg spontaneously or in response to pain. Deep tendon reflexes were absent in the left leg and diminished in the right. Decreased anal sphincter tone was noted. The rest of the physical examination was found to be normal. The patient was diagnosed with VAPP (vaccine-associated paralytic poliomyelitis) after laboratory investigations. Laboratory investigations: Complete blood count- ALC-216 cells/mm3, lymphocytes subsets- CD3 6 cells/mm3, CD4 2, CD8 0, CD 19 1, CD16/56 189, HIV 1/2 was negative, Immunoglobulins- IgA and IgM undetectable, IgG 140 mg/dl. Cerebrospinal fluid test: White blood cell 83 cell/mm3, Polymorph nuclear neutrophils 50%, mononuclear cells 2%, protein 48 mg/dl, glucose 49 mg/dl. Imaging: Chest radiograph was normal, Brain and Spine MRI showed 8 mm lesion in right cerebral peduncle, prominent abnormal T2 weighted signal at cord T11 level on the left: additional abnormal signal and contrast enhancement of several nerve roots. Chest, abdomen and pelvis CT scan showed enlarged lymph nodes, left supraclavicular, and left axilla, retroperitoneal. Microbiology: Blood test showed no bacterial growth at 48 hours, later positive for AFB identified as mycobacterium bovis/BCG. Cerebrospinal fluid showed negative bacterial meningitis screen and gram stain, negative fungal smear and culture, negative PCR for HSV-1, HSV-2 and CMV. Stool analysis- enterovirus isolated, identified as immunodeficiency associated vaccine derived poliovirus type, Lymph node fine needle aspiration showed AFB stain positive. On an unspecified date, the child progressed to respiratory distress during further observation. It was reported that after consultation with multiple specialist physicians and with ethics committee review, the family chose to withdraw support and the child died shortly thereafter. Documents held by sender: None.


VAERS ID: 549295 (history)  
Form: Version 1.0  
Age: 46.0  
Sex: Male  
Location: Arizona  
Vaccinated:2014-10-21
Onset:2014-10-22
   Days after vaccination:1
Submitted: 2014-10-22
   Days after onset:0
Entered: 2014-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UI194AA / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-10-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Levetiracetam ER 500mg; Vimpat 150mg; Escitalopram 20mg
Current Illness: None reported
Preexisting Conditions: Seizure disorder- unspecified
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None were reported to the pharmacy. Clinical director wanted it reported for documentation purposes.


VAERS ID: 549512 (history)  
Form: Version 1.0  
Age: 90.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2014-10-17
Onset:2014-10-19
   Days after vaccination:2
Submitted: 2014-10-24
   Days after onset:5
Entered: 2014-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Blood test, Computerised tomogram, Death, Dizziness, Fall, Head injury, Hip fracture, Hip surgery, Malaise, Syncope, Ultrasound Doppler, X-ray
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Osteoporosis/osteopenia (broad), Osteonecrosis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-10-23
   Days after onset: 4
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: Synthroid, JCTZ, albuterol inh prn
Current Illness: Unknown
Preexisting Conditions: Cardiomegaly, COPD, hypothyroidism
Allergies:
Diagnostic Lab Data: CT scans, x-rays, carotid ultrasound, bloodwork
CDC Split Type:

Write-up: Patient told me that she had not felt well since she got the high dose flu shot last week. She was light headed and experienced syncope. As result of syncope she fell and hit the back of her head and fractured her left hip. Hip surgery ensued and was successfully performed. Upon release from hospital she was moved to a rehabilitation facility where she died the next morning. Patient attributed the syncope to the administration of the flu shot.


VAERS ID: 549727 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Female  
Location: Iowa  
Vaccinated:2014-10-06
Onset:2014-10-06
   Days after vaccination:0
Submitted: 2014-10-20
   Days after onset:14
Entered: 2014-10-24
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 9939E / 1 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. J014279 / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H86640 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. J011340 / 1 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Autopsy, 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: 2014-10-07
   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: Mild nasal congestion reported
Preexisting Conditions: Premature
Allergies:
Diagnostic Lab Data: Unknown at this time from ER.
CDC Split Type:

Write-up: Pt was found unresponsive at home by family taken to ER and pronounced dead. Autopsy report not available at this time.


VAERS ID: 549873 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Male  
Location: Unknown  
Vaccinated:2014-09-25
Onset:0000-00-00
Submitted: 2014-10-10
Entered: 2014-10-24
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U5042AA / UNK RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Lung disorder, Pulmonary fibrosis, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (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), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-10-02
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: Pulmonary fibrosis; Former smoker; Former drinker
Allergies:
Diagnostic Lab Data: (To date, I am aware of 5 of my patients that have died within 6 months of getting high dose flu vaccine since 2010.)
CDC Split Type:

Write-up: Patient had severe lung disease and I did consider him terminal but he had high dose flu vaccine and died soon after getting vaccine. Vaccine given 9/25/14 and patient died 10/2/2014. Presumed cause of death respiratory failure with underlying pulmonary fibrosis.


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