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VAERS ID: 549876 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Male  
Location: Unknown  
Vaccinated:2014-10-08
Onset:2014-10-10
   Days after vaccination:2
Submitted: 2014-10-10
   Days after onset:0
Entered: 2014-10-24
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U5042AA / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
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: 2014-10-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: To date, this is the 5th patient that I am aware of that has died within 6 months of getting high dose flu vaccine in my practice since 2010.
CDC Split Type:

Write-up: Patient had high dose flu vaccine and presented to ER non-responsive less than 2 days later. Date of vaccine 10-8-2014. Date of death 10-10-2014. Patient had underlying COPD and CHF but he was stable when I saw him 10-8-2014.


VAERS ID: 550386 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: Vermont  
Vaccinated:2014-09-22
Onset:2014-09-25
   Days after vaccination:3
Submitted: 2014-10-17
   Days after onset:22
Entered: 2014-10-28
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1412201 / 1 LA / UN

Administered by: Public       Purchased by: Private
Symptoms: Chest X-ray abnormal, Death, Fungal test positive, Gun shot wound, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Intensive care, Intentional self-injury, Pneumonia, Sputum abnormal, White blood cell count increased
SMQs:, Suicide/self-injury (narrow), Neuroleptic malignant syndrome (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (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: 2014-09-26
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Multiple see print out
Current Illness: None
Preexisting Conditions: SULFACET-R, Rash; ALEVE, unknown; Bee Sting, anaphylaxis
Allergies:
Diagnostic Lab Data: CXR showed multifocal pneumonia of (R) lung; Sputum light growth yeast; Rapid flu negative for flu A and B; CBC, WBC 14.2
CDC Split Type:

Write-up: Patient ended up hospitalized 3 days later with severe pneumonia he was hospitalized on 9/25/14 and placed in ICU. He signed out AMA on 9/26/14 and died of self inflicted gun shot.


VAERS ID: 550467 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: New Hampshire  
Vaccinated:2014-09-22
Onset:2014-09-27
   Days after vaccination:5
Submitted: 2014-10-28
   Days after onset:31
Entered: 2014-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4679AA / UNK UN / UN
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 9423K / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G65738 / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A1FB422A / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-09-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NH1028201414

Write-up: SUID/SIDS.


VAERS ID: 550758 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: New York  
Vaccinated:2013-09-22
Onset:2013-09-24
   Days after vaccination:2
Submitted: 2014-10-07
   Days after onset:378
Entered: 2014-10-28
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Intensive care, Laboratory test normal, Malaise
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-09-24
   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:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: My son was born a healthy 7lb baby boy with no underlying issues. On his 2nd day of life he quickly became ill and died within hours of being sent to the NICU. He was given Hep B vaccine the day before. Autopsy and WES test were all normal.


VAERS ID: 551921 (history)  
Form: Version 1.0  
Age: 0.13  
Sex: Male  
Location: Maryland  
Vaccinated:2014-10-27
Onset:2014-10-28
   Days after vaccination:1
Submitted: 2014-11-05
   Days after onset:8
Entered: 2014-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS S232P5 / 3 LL / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER SUI062AEA / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH SJ11484 / 1 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CB452A / 1 MO / PO

Administered by: Private       Purchased by: Other
Symptoms: Death, Epistaxis, Inappropriate schedule of drug administration, Incorrect dose administered, Mouth haemorrhage, Resuscitation
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-10-28
   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: US2014GSK016547

Write-up: This case was reported by a consumer and described the occurrence of death in a 6-week-old male patient who received PEDIARIX (batch number S232P5, expiry date 30th August 2016). Co-suspect products included PEDIARIX (batch number S232P5, expiry date 30th August 2016), PEDIARIX (batch number S232P5, expiry date 30th August 2016), PEDIARIX (batch number S232P5, expiry date 30th August 2016), ROTARIX (batch number A41CB452A, expiry date 31st January 2016) and Hib (batch number SUI062AEA, expiry date 10th October 2015). On 27th October 2014, the patient received the 1st dose of PEDIARIX (unknown) .5 ml, the 2nd dose of PEDIARIX (unknown) .5 ml, the 3rd dose of PEDIARIX (unknown) .5 ml, the 4th dose of PEDIARIX (unknown) .5 ml, the 1st dose of ROTARIX (oral) 1 ml and the 1st dose of Hib (unknown) .5 ml. On 27th October 2014, Not Applicable after receiving PEDIARIX, PEDIARIX, PEDIARIX and ROTARIX and an unknown time after receiving PEDIARIX, the patient experienced overdose, overdose and overdose. On 28th October 2014, the patient experienced death (serious criteria death and GSK medically significant), blood coming out from nose (serious criteria death) and blood coming out from mouth (serious criteria death). On 28th October 2014, the outcome of the death, blood coming out from nose and blood coming out from mouth were fatal. On an unknown date, the outcome of the overdose, overdose and overdose were unknown. The patient died on 28th October 2014. The reported cause of death was unknown cause of death. The reporter considered the death, blood coming out from nose and blood coming out from mouth to be almost certainly related to PEDIARIX, PEDIARIX, PEDIARIX, PEDIARIX and ROTARIX. Additional information received: The reporter was the patient''s maternal grandmother. She reported that her family had dual citizenship. Her daughter gave birth to the child in one country and was planning to return to another country on 30 October 2014. The doctor advised the mother to bring child for immunizations prior to the trip. The patient was growing very well, at 88% growth percentile for his weight and height with no medical concerns, he passed all the tests. The patient was administered all three PEDIARIX shots at the same time on 27 October 2014, in the afternoon, along with ROTARIX and the Sanofi Pasteur flu shot. The mother reported that the baby received 2 shots on his left leg and 2 shots on his right leg, but the doctor stated in his records that the baby got one shot on his left leg and the others in the right leg. The grandmother stated that her daughter returned home with the baby after the doctor visit and the baby slept. When he woke up, she fed him and then put him to bed around 12 midnight or 1am on 28 October 2014. When she woke up around 7 am he was already dead, with blood coming out of his nose and mouth. They called 911 and the baby''s mother tried to resuscitate him, then he was taken to hospital. At the hospital, the family was told he had been dead for a few hours and was formally pronounced death on 28 October 2014. The grandmother was willing to be contacted and the family will seek legal action because they felt the death was caused by the vaccines administered that day.


VAERS ID: 552234 (history)  
Form: Version 1.0  
Age: 5.0  
Sex: Male  
Location: Oregon  
Vaccinated:0000-00-00
Onset:2013-12-20
Submitted: 2014-10-20
   Days after onset:303
Entered: 2014-11-06
   Days after submission:17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN

Administered by: Other       Purchased by: Other
Symptoms: Brain injury, Chest X-ray abnormal, Cough, Croup infectious, Cyanosis, Death, Influenza, Obstructive airways disorder, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-12-29
   Days after onset: 9
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: Concomitant Drug(s) Not Reported
Current Illness: H1N1 influenza
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Soft-tissue X-ray of upper respiratory system, Upper respiratory system was collapsed
CDC Split Type: 2014SE79865

Write-up: A consumer report has been received concerning a 5 year old male patient. The patient''s concurrent disease included H1N1 virus infection. No concomitant medication was reported. The patient received FLUMIST (intranasal) on an unknown date. During an unspecified year in November he received the flu vaccine and came down with flu on 20-Dec. The patient experienced flu related complications. He was taken to the pediatrician when he developed a barking cough often characterizing croup. He was given doses of steroidal medication, prescribed by his pediatrician to combat the coughing, croup symptoms. His symptoms did not seem to be improving, so he was taken to the emergency room early Christmas morning. Doctors took a soft-tissue X-ray of his upper respiratory system and told it was collapsed a little. After spending the day with the patient, parents felt he needed to go back to the hospital. When his mother was changing his pants patient collapsed right in front of her and turned blue. Paramedics secured an airway. According to the patient''s mother, the patient suffered severe brain damage due to a lack of oxygen from a collapsed airway. The patient died from flu related complications, collapsed airway and brain damage on December 29. It was unknown if an autopsy was performed. The reporter considered the events of flu related complications, collapsed airway and brain damage to be serious based on death and hospitalization criteria.


VAERS ID: 553902 (history)  
Form: Version 1.0  
Age: 72.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2014-11-07
Submitted: 2014-11-17
   Days after onset:10
Entered: 2014-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal discomfort, Abdominal pain, Death, Dyspnoea, Leukaemia, Splenectomy, Splenomegaly
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2014-11-07
   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: WAES1411USA006508

Write-up: This spontaneous report was received from a pharmacist via company representative. The pharmacist reported on her 72 year old father. Information regarding patient''s medical history was not reported. On an unknown date the patient was vaccinated with PCV (manufacturer unknown) (lot#, expiration date, route of administration, anatomical location were not reported). Other suspect therapies administered the same day included influenza virus vaccine (manufacturer unknown). The pharmacist reported that her father died after receiving a combination of PCV (manufacturer unknown) and influenza virus vaccine (manufacturer unknown) at the same visit. On an unknown date the patient experienced pain and tightness similar to gallbladder symptoms. Then the patient was seen in the office of his unspecified physician again and determined to have an enlarged spleen. The patient was sent to an unspecified oncologist and was diagnosed as having leukemia on an unspecified date. The patient was hospitalized on an unknown date. The patient''s spleen was surgically removed, as it was continuing to enlarge. The patient never fully recovered from the surgery and experienced breathing problems and died before leaving the hospital on 07-NOV-2014. The cause of death was not reported. The outcome of pain and tightness similar to gallbladder symptoms, leukemia and enlarged spleen was not reported. The events of pain and tightness similar to gallbladder symptoms, leukemia, enlarged spleen which was surgically removed and breathing problems were determined to be life-threatening by the reporter. Upon internal review the events of leukemia and enlarged spleen which required surgical removal were determined to be medically significant. The relatedness between the events and the therapy with PCV (manufacturer unknown) was not reported. Additional information is not expected since the reporter did not want to be contacted in any way regarding this report.


VAERS ID: 554258 (history)  
Form: Version 1.0  
Age: 34.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2014-11-06
Onset:2014-11-07
   Days after vaccination:1
Submitted: 2014-11-18
   Days after onset:11
Entered: 2014-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED T57806 / UNK LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Autopsy, Death, Respiration abnormal, Resuscitation, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: To our knowledge alprazolam 2mg and hydrocodone/apap 7.5/325
Current Illness: No visible illnesses or complaints. No injection site reactions
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was found unresponsive at his home the next day by his mother. She called 911 and reported very light breathing. She and the paramedics tried to perform CPR but were unsuccessful and reported him dead at 2pm. Paramedics stated that it was similar to what they see in heart attack victims. No autopsy reports have been received as of 11-18-14.


VAERS ID: 554767 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Female  
Location: Florida  
Vaccinated:2014-07-08
Onset:2014-07-08
   Days after vaccination:0
Submitted: 2014-11-20
   Days after onset:135
Entered: 2014-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS ML507 / 3 RL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UI002AA / 2 LL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H08094 / 2 LL / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AHFB420A / 2 MO / PO

Administered by: Public       Purchased by: Public
Symptoms: Cerebral cyst, Childhood disintegrative disorder, Convulsion, Enzyme activity decreased, Irritability, Joint contracture, Muscle spasms, Nervous system disorder, Opisthotonus, Vision blurred
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Dystonia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None.
Current Illness: I felt she was a little more congested than normal. However Pediatrician said it is nothing to worry about.
Preexisting Conditions: None.
Allergies:
Diagnostic Lab Data: Activity of galactocerebrosidase is reduced.
CDC Split Type:

Write-up: No longer smiles or laughs. No longer can hold head up or try to sit up on her own. Clinching of the fist. Spasm/seizures. Extremely fussy. Hates being upright now. No longer can focus on things. Will not play with toys any more. Horrible arching of the back. Pushes her head back. Brain stopped growing at 4 months of age causing fontanelle to close. A few cysts on her brain.


VAERS ID: 554842 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2014-10-16
Onset:0000-00-00
Submitted: 2014-11-20
Entered: 2014-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Military       Purchased by: Other
Symptoms: Death, Intensive care, Mechanical ventilation, Motor dysfunction
SMQs:, Peripheral neuropathy (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-08
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pharyngitis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: My father began experiencing loss of motor function. Distal to proximal pattern. Was taken to the ER. Was transferred to ICU and became vent depend.


VAERS ID: 554987 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Male  
Location: Nevada  
Vaccinated:2014-10-17
Onset:2014-10-17
   Days after vaccination:0
Submitted: 2014-11-20
   Days after onset:34
Entered: 2014-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. CH2070 / 1 NS / IN

Administered by: Private       Purchased by: Other
Symptoms: Ataxia, Cardiac arrest, Diarrhoea, Dysarthria, Dysphagia, Enterovirus test positive, Eyelid ptosis, Gastrointestinal tube insertion, Influenza B virus test positive, Polymerase chain reaction, Respiratory failure, Rhinorrhoea, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Hypoglycaemia (broad), Hypokalaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-09
   Days after onset: 23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: PCR positive for influenza B; PCR positive for enterovirus
CDC Split Type:

Write-up: Per medical records. Per mother, child saw PCP and received FLUMIST on 10/17/14. By the time they arrived home the child developed watery diarrhea and vomiting. Next day child had droopy eyelids and rhinorrhea. Over the course of a few days this progressed to truncal ataxia, dysphagia, ptosis and slurred speech. The child progressed to respiratory failure and cardiac arrest. No treatment, aside from supportive fluids and tube feeding provided.


VAERS ID: 555192 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Male  
Location: Washington  
Vaccinated:2014-11-19
Onset:2014-11-21
   Days after vaccination:2
Submitted: 2014-11-21
   Days after onset:0
Entered: 2014-11-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI207AA / UNK LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Death, Dizziness, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-21
   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: Over the counter pain relievers, type is unknown.
Current Illness: No
Preexisting Conditions: None noted
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Unknown if attributed to vaccine. Patient had vaccination on 11/19/2014 symptoms of fever, dizziness, headache began next day. Patient demise time unclear may not be related however per process noting that vaccination had occurred in the previous 36 hours.


VAERS ID: 555555 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Male  
Location: Georgia  
Vaccinated:2014-10-02
Onset:0000-00-00
Submitted: 2014-11-12
Entered: 2014-11-25
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U5024BA / 2 RA / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Cardiac failure congestive, Death
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-10-05
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Wife states that her husband (patient) went into congestive heart failure and died a few days after receiving the flu vaccine.


VAERS ID: 556244 (history)  
Form: Version 1.0  
Age: 1.5  
Sex: Female  
Location: Nevada  
Vaccinated:2014-11-18
Onset:2014-11-18
   Days after vaccination:0
Submitted: 2014-12-01
   Days after onset:13
Entered: 2014-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 795AE / 3 LG / UN
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. K002746 / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J11488 / UNK UN / UN

Administered by: Private       Purchased by: Public
Symptoms: Autopsy, Death, Inappropriate schedule of drug administration
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-18
   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: No other medications
Current Illness: Unknown
Preexisting Conditions: PEDIARIX, at age of 2 months, which went uncomplicated; PEDIARIX, at age of 4 months, which went uncomplicated
Allergies:
Diagnostic Lab Data: 11/2014, Autopsy, not yet completed
CDC Split Type: US2014GSK027192

Write-up: This case was reported by a physician via call center representative and described the occurrence of death in sleep in a 18-month-old female patient who received PEDIARIX. Co-suspect products included PEDVAXHIB and PREVNAR. Previously administered products included PEDIARIX (at age of 2 months, which went uncomplicated) and PEDIARIX (at age of 4 months, which went uncomplicated). On 18th November 2014, the patient received the 3rd dose of PEDIARIX .5 ml, PEDVAXHIB and PREVNAR. On 18th November 2014, less than a day after receiving PEDIARIX, the patient experienced death in sleep (serious criteria death and GSK medically significant). On an unknown date, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the death in sleep was fatal and the outcome of the drug dose administration interval too long was unknown. The patient died on 18th November 2014. An autopsy was performed. It was unknown if the reporter considered the death in sleep to be related to PEDIARIX. Additional details were provided: It was unknown if the patient had concomitant medication or relevant medical history. All previous vaccinations went uncomplicated. It was unknown if the subject was hospitalized. The patient died at home. On 18 November 2014, the patient was vaccinated during the office hours, that evening she died and never woke up from a nap. The physician was waiting for an autopsy report which has not yet been completed. The physician reported that the parents requested a delayed dosing schedule: the 3rd dose be given at 18 months, rather than 6 months. The physician was available to contact.


VAERS ID: 556245 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2013-12-09
Onset:2014-03-10
   Days after vaccination:91
Submitted: 2014-11-28
   Days after onset:263
Entered: 2014-12-01
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cerebrovascular accident, Cerebrovascular disorder, 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: 2014-03-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Aspirin; atorvastatin; lisinopril and hydrochlorothiazide; metoprolol
Current Illness: Unknown
Preexisting Conditions: 2000, Hyperlipidaemia; 2000, Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2014027729

Write-up: This 73-year-old male subject was enrolled in a study. On 9th December 2013, the subject received the 2nd dose of Zoster VZV-gE-AS01B(intramuscular). On 8th October 2013, the subject received the 1st dose of Flu Seasonal QIV Dresden (intramuscular). The subject''s past medical history included hyperlipidemia and hypertension. Concomitant products included Aspirin, atorvastatin, lisinopril and hydrochlorothiazide and metoprolol. On 10th March 2014, 91 days after receiving Zoster VZV-gE-AS01B and 153 days after receiving Flu Seasonal QIV Dresden the subject developed severe - grade 3 cerebrovascular event. Serious criteria included death. The outcome of cerebrovascular event was fatal on 10th March 2014. The subject died on 10th March 2014. The reported cause of death was cerebrovascular disorder. An autopsy was not performed. The investigator considered that there was a reasonable possibility that the cerebrovascular event may have been caused by Zoster VZV-gE-AS01B and Flu Seasonal QIV Dresden. Investigator comments: Hospital medical records requested. Death certificate indicates immediate cause of death to be cerebrovascular accident occurring on 10/MAR/2014 with no specific time indicated (under 1 day) due to or as a consequence of hypertension. No autopsy was performed. Patient has history of hypertension and hyperlipidemia since 2000 and was receiving therapy for both conditions.


VAERS ID: 556239 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2013-11-21
Onset:2013-11-23
   Days after vaccination:2
Submitted: 2014-12-02
   Days after onset:374
Entered: 2014-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Private       Purchased by: Other
Symptoms: Death, Dyspnoea, Mobility decreased, Paralysis
SMQs:, Anaphylactic reaction (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-12-08
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Diabetic
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Paralysis, could not breathe, could not get out of bed, was given antibiotics at emergency room and sent home. Died 10 days later.


VAERS ID: 556292 (history)  
Form: Version 1.0  
Age: 10.0  
Sex: Male  
Location: New York  
Vaccinated:2014-10-15
Onset:2014-11-16
   Days after vaccination:32
Submitted: 2014-12-02
   Days after onset:16
Entered: 2014-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 3RE4F / 7+ LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Cardiac failure, Chest X-ray abnormal, Death, Extracorporeal membrane oxygenation, Feeling cold, Hyperhidrosis, Intensive care, Pneumonia, Viral test negative
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2014-11-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 30 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Amiodarone 5mg PO once a day Aspirin 81mg PO once a day Carvedilol 2.4mg PO twice a day Enalapril 4mg PO twice a day Polyethylene Glycol 17grams PO once a day Xopenex 0.63mg/3ml inhaled as needed for wheezing
Current Illness: Patient had had a viral illness 1 week prior with desat to 85% at school. On day of vaccine said he felt better.
Preexisting Conditions: Cardiomyopathy, atypical muscular dystrophy (not Becker or Duchenne)
Allergies:
Diagnostic Lab Data: Respiratory virus panel negative x2; CXR with L retrocardiac opacity on admission
CDC Split Type:

Write-up: Mother called mid morning that patient was cool and diaphoretic. Went to ED found to have worsening heart failure. Admitted to PICU 10/17/14, CXR with pneumonia, respiratory virus panel neg x 2, placed on ECMO 10/19/14. Patient died 11/16/14 of heart failure while on ECMO.


VAERS ID: 556731 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2014-11-07
Onset:2014-11-07
   Days after vaccination:0
Submitted: 2014-12-01
   Days after onset:24
Entered: 2014-12-03
   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: Death, Immediate post-injection reaction, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unk
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2014SA163456

Write-up: Initial unsolicited case received from a consumer on 24 November 2014, during routine media monitoring. Five patients, whose ages and genders were not reported, received Influenza vaccine (manufacturer and lot numbers not reported) on 07 November 2014. It was reported that the patients immediately developed a fever, and all died within one week of vaccination. No additional information pertaining to the patients was reported. Documents held by sender: None.


VAERS ID: 557160 (history)  
Form: Version 1.0  
Age: 7.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-12-05
Entered: 2014-12-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Death, Myocarditis infectious
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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHEH2014US024123

Write-up: Case number PHEH2014US024123, is an initial spontaneous report from a nurse received on 02 Dec 2014. This report refers to a 07 year old female patient. Medical history and concomitant medications were not reported. She was vaccinated with seasonal Influenza vaccine (manufacturer and batch number unknown) on an unknown date. On an unknown date, after vaccination, she experienced myocardial infection and died 4 days after vaccination. Outcome of the event myocardial infection was not reported. Cause of death and causality of the events was not reported. Seriousness assessment of myocardial infection was upgraded based on the NVS-IMS list. No additional information was available.


VAERS ID: 557251 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Female  
Location: Georgia  
Vaccinated:2014-11-07
Onset:2014-11-15
   Days after vaccination:8
Submitted: 2014-12-08
   Days after onset:23
Entered: 2014-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS XZ3SP / UNK UN / SYR

Administered by: Public       Purchased by: Other
Symptoms: Cardiac disorder, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: On Hospice Care and resident of long term care facility at time of vaccination
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Died from cardiac disease.


VAERS ID: 557253 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: Georgia  
Vaccinated:2014-11-07
Onset:2014-11-16
   Days after vaccination:9
Submitted: 2014-12-08
   Days after onset:22
Entered: 2014-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS XZ3SP / UNK UN / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: On Hospice care at long term care facilty
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Died from ??UTI/Sepsis.


VAERS ID: 557260 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-12-08
Entered: 2014-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1412USA003274

Write-up: This spontaneous report has been received from a consumer concerning 140 anonymous female patients of unknown age. On an unknown date patients were vaccinated with GARDASIL injection (dose/ dose in series/ route unknown). The reporter indicated that on an unspecified date, 140 anonymous women died after receiving GARDASIL. Cause of death was not reported. The reporter stated ''how many reported fatalities were needed for a product to be pulled from the market''. She further stated, ''with all of the side effects women experienced after receiving GARDASIL, Merck should not still be pushing the product and the product''s prescribing information needed to be updated''. The reporter indicated that she was seeking an attorney because ''Merck needs to update the GARDASIL prescribing information to include the 140 who have died because they received GARDASIL''. She enquired about the address for the Office of General Counsel. This is one of several reports received from the same reporter. Additional information has been requested.


VAERS ID: 557396 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Female  
Location: Vermont  
Vaccinated:2014-10-10
Onset:2014-10-11
   Days after vaccination:1
Submitted: 2014-12-09
   Days after onset:59
Entered: 2014-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX) / NOVARTIS VACCINES AND DIAGNOSTICS 014011A / UNK LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-10-22
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lantus; Metformin; Citalopram; Lisinopril; Immodium; Gabapentin; Acetaminophen
Current Illness: None evident at time of vaccination, other than pre-existing conditions.
Preexisting Conditions: Diabetes, COPD, arthritis, depression
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt. had diarrhea during nap. Increased Immodium, no other complaints following. Patient was found deceased 9:30 AM 10/22/2014. Was normal with no problems 5 PM previous evening.


VAERS ID: 557492 (history)  
Form: Version 1.0  
Age: 66.0  
Sex: Female  
Location: Unknown  
Vaccinated:2014-11-04
Onset:2014-11-13
   Days after vaccination:9
Submitted: 2014-12-05
   Days after onset:22
Entered: 2014-12-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1413301 / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Cardiac arrest, Death, Influenza, Malaise, Pulmonary oedema, Pyrexia, Resuscitation, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-13
   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: Type 2 diabetes mellitus, Values within normal limits and was being managed; Blood cholesterol increased, Values within normal limits and was being managed.
Preexisting Conditions: 11/13/2014, Resuscitation; Pyrexia
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHEH2014US024100

Write-up: Case number PHEH2014US024100 is a combined initial and follow up spontaneous report from a nurse received on 02 Dec 2014 and from quality assurance department (QA reference number: 340811) received on 03 Dec 2014. This report refers to a 66-year-old female patient. Her current conditions included type 2 diabetes and elevated cholesterol with values at normal limits and were being managed. She went for cardiac work up, 1-2 weeks prior to vaccination and everything was normal. She did not have any blockages, no complaints of chest pains, but had fever. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 04 Nov 2014. On the same date, since vaccination she was feeling ill and had flu. On an unknown date, she had fever. On 13 Nov 2014, she was burning up with fever, had taken off her night gown (Not typical behaviour), drank water, went to sofa, threw up en route and had cardiac arrest. Her husband performed CPR (cardiopulmonary resuscitation) and called the ambulance. In the emergency room, she was being resuscitated, but she died on the same day. No autopsy was performed. It was reported that something caused pulmonary edema. She had no congestive heart failure and not on any diuretics. The outcome of the events fever, feeling ill, flu and threw up was not reported. The outcome of the events pulmonary edema and cardiac arrest reported as death. The seriousness of the events fever, feeling ill, flu and threw up was not reported. The causality of the events was not reported.


VAERS ID: 558341 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Male  
Location: Nebraska  
Vaccinated:2014-10-02
Onset:2014-10-02
   Days after vaccination:0
Submitted: 2014-12-15
   Days after onset:74
Entered: 2014-12-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UI189AE / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Cardio-respiratory arrest, Chills, Computerised tomogram, Condition aggravated, Death, Gait disturbance, Pallor, Pyrexia, Rhinorrhoea, Tremor, X-ray
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), 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), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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, 13 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unk
Preexisting Conditions: Drug allergy; Sulfa allergy; The patient had drainage from the nose prior to vaccination.
Allergies:
Diagnostic Lab Data: CT scan and x-rays performed, results not provided.
CDC Split Type: 2014SA171839

Write-up: Initial unsolicited case received from a consumer, who is the patient''s wife, on 10 December 2014. An 82 year old male patient, with a history of allergies to Sulfa and REGLAN, received an intramuscular left deltoid injection of FLUZONE (lot number UI189AE) on 02 October 2014. The patient had nasal drainage at the time of vaccination. Three hours after receiving the vaccine, the patient''s right arm began shaking uncontrollably. His fingers were white, and he was weak and needed help to walk. He presented to the emergency department, where he was given fluids. The symptoms of shaking became worse, and progressed to "full body shaking". He underwent a CT scan and x-rays; results were not reported. He experienced chills and fever, and per the reporter had a possible lung infiltrate. He continued to have nasal drainage. He was treated with an antibiotic and admitted to the hospital, where he remained for 13 days. According to the reporter, the patient died from "respiratory cardiac conditions" on an unspecified date. Documents held by sender: None.


VAERS ID: 559752 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Illinois  
Vaccinated:2014-12-20
Onset:2014-12-23
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2014-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 5A5T5 / 1 UN / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UI114AA / 1 UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J11486 / 1 UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. J010985 / 1 MO / PO

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2014-12-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was found unresponsive by mother on 12/23/14 about 2:30 AM - paramedics took him to ER - transferred to another hosp. Pronounced dead.


VAERS ID: 559863 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-12-29
Entered: 2014-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1412USA012011

Write-up: This spontaneous report as received from a patient''s mother refers to a 12 year old healthy female patient and was identified during social media monitoring. Current conditions and medical history was not reported. On an unknown date, the patient was vaccinated with GARDASIL injection (strength, route, dose, frequency and indication not provided). No concomitant medication was reported. On an unknown date, the patient died. The outcome of the event was fatal. The causality assessment was provided as related (reported as GARDASIL suspected). Product quality complaint was not reported. Additional information has been requested.


VAERS ID: 560374 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Unknown  
Location: Iowa  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-12-31
Entered: 2015-01-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Febrile convulsion
SMQs:, Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (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: WAES1412USA013432

Write-up: This spontaneous report was received from a physician concerning a 3 year old patient (gender unknown), who on an unknown date was vaccinated with a varicella containing vaccine which could be possible VARIVAX (Merck) or PROQUAD (Merck) (vaccines, routes, doses, lot numbers and expiration dates were not provided). Other suspect therapies or concomitant medication were not provided. The physician reported, that she was told that a patient''s younger relative developed febrile seizure and on an unknown date died after getting the varicella containing vaccine. The physician stated that she was not sure the brand name of the vaccine (possibly VARIVAX (Merck) or PROQUAD (Merck)). The patient cause of death was febrile seizure. It was unknown if an autopsy was performed. Upon internal review, the event of febrile seizure was considered to be another important medical event. This is one of several reports received from the same source. Additional information is not expected because the physician did not have much information about the patient and refused to continue with the AE reporting.


VAERS ID: 560453 (history)  
Form: Version 1.0  
Age: 88.0  
Sex: Male  
Location: Rhode Island  
Vaccinated:2014-10-02
Onset:2014-11-27
   Days after vaccination:56
Submitted: 2015-01-05
   Days after onset:39
Entered: 2015-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U5016AA / UNK LA / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H86652 / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Balance disorder, Fall, Gait disturbance, Guillain-Barre syndrome, Lumbar puncture abnormal, Sensory loss, Urinary incontinence
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Accidents and injuries (narrow), Demyelination (narrow), Vestibular disorders (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-01-30
   Days after onset: 64
Permanent Disability? Yes
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: Heat Condition medications.
Current Illness: No
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Spinal Tap resulted in diagnosis of Guillain Barre disease
CDC Split Type:

Write-up: Unsteady on feet, loss of balance, loss of bladder control by weekend; loss of feeling in hands and arms by end of following week and constant falling.


VAERS ID: 560533 (history)  
Form: Version 1.0  
Age: 1.19  
Sex: Male  
Location: California  
Vaccinated:2014-12-22
Onset:2014-12-30
   Days after vaccination:8
Submitted: 2015-01-05
   Days after onset:6
Entered: 2015-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR U5036CA / 2 LA / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UI067AA / 4 LA / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J23867 / 4 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-12-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: Erb''s Palsy at birth; fully resolved.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt was found deceased in his crib on the morning of 12/30/2014. He did have a fever of 102 the night before.


VAERS ID: 560802 (history)  
Form: Version 1.0  
Age: 57.0  
Sex: Female  
Location: Georgia  
Vaccinated:2014-10-15
Onset:2014-10-19
   Days after vaccination:4
Submitted: 2015-01-08
   Days after onset:81
Entered: 2015-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UI198AA / UNK UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Atrial fibrillation, Cerebrovascular accident, Convulsion, Pneumonia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 41 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 10/15/14 - received dose. 10/24/14 - admitted hospital - pneumonia, seizures, stroke. 10/29/14 - discharged - diagnosed stroke, AFib, pneumonia. 12/23/14 - admitted - syncope, seizures, stroke. Presently hospital.


VAERS ID: 560982 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2014-05-12
Onset:2014-11-30
   Days after vaccination:202
Submitted: 2015-01-12
   Days after onset:43
Entered: 2015-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Oesophageal carcinoma
SMQs:, Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Human immunodeficiency virus.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015047726

Write-up: This medically confirmed spontaneous report (initial receipt-29-Dec-2014) concerns a patient of unknown demography. The patient had a concurrent condition of human immunodeficiency virus which was contributing to death but not resulting in the underlying cause of death. On 12-May-2014, the patient received influenza virus vaccine (manufacturer and batch number not reported). On 30-Nov-2014, the patient died due to metastatic esophageal carcinoma. The Medical Examiner or Coroner was contacted. The outcome was reported as fatal. Reporter comments: It was unknown if tobacco contributed to death. The manner of death was natural.


VAERS ID: 562128 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-01-23
Entered: 2015-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1501USA008947

Write-up: This spontaneous non-valid report as received via social media (Twitter) concerning "at least 9 girls per year". It was reported that "at least 9 girls per year are killed by the GARDASIL vaccine" (strength, dose, route of administration, lot# and expiry date unspecified) (dates of injections or adverse event not specified). Additional information is not expected as all available information has been provided and there is no patients and physician''s contact information and we could not do follow up with them.


VAERS ID: 562167 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Texas  
Vaccinated:2014-10-01
Onset:0000-00-00
Submitted: 2015-01-09
Entered: 2015-01-23
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Influenza, Influenza A virus test positive, Pulmonary congestion, Pulmonary haemorrhage, Staphylococcal infection, Staphylococcus test positive
SMQs:, Cardiac failure (broad), Haemorrhage terms (excl laboratory terms) (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2014-12-16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015SE03919

Write-up: A report from a physician concerns a 13 year old female patient. Relevant history, concurrent diseases and concomitant drugs were not reported. The patient received FLUMIST QUADRIVALENT (intranasal) in Oct-2014 at a local pharmacy. Apparently patient had received FLUMIST QUADRIVALENT at an outside pharmacy, so the doctor doesn''t have information on lot number. Patient passed away on 16-Dec-2014. Patient was positive for influenza A. The parents requested an autopsy, and the preliminary report states following Diagnosis: 1. Congestive hemorrhagic lungs. 2. Influenza A. 3. Staphylococcus aureaus (+) from the lungs. Physician said that once they receive the final autopsy report they will notify our office. The patient died from the congestive hemorrhagic lungs on 16-Dec-2014. The outcome of the staphylococcus aureus (+) from lungs and influenza A was unknown. The cause of death was congestive hemorrhagic lungs. An autopsy was performed. The reporter considered the congestive hemorrhagic lungs to be serious by the criterion of death and other events to be serious by the life threatening criterion.


VAERS ID: 562739 (history)  
Form: Version 1.0  
Age: 85.0  
Sex: Female  
Location: Florida  
Vaccinated:2014-11-19
Onset:0000-00-00
Submitted: 2015-01-27
Entered: 2015-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U5024BA / UNK RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Multiple myeloma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death.


VAERS ID: 562776 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Male  
Location: California  
Vaccinated:2014-12-22
Onset:2014-12-25
   Days after vaccination:3
Submitted: 2015-01-28
   Days after onset:34
Entered: 2015-01-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS E2297 / 1 RL / IM
HIBV: HIB (PROHIBIT) / SANOFI PASTEUR UI098AA / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J11488 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. K007911 / 1 MO / PO

Administered by: Public       Purchased by: Public
Symptoms: Autopsy, Blood sodium increased, Convulsion, Dehydration, Diet refusal, Ear infection, Fall, Irritability, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-01-02
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HE WAS GIVEN THE / Hep B /GSK (BRAND)/LOT NO. AHBVC20044/ ON THE DATE 11/01/2014 PNEUMOCCAL 13-VALENT 5ML 12/22/2014 08:19 AM ROUTE: IM RIGHT LEG. CHILDREN TUSSIN PAC TOLD ME IF HE GETS A COLD TO GIVE HIM 1.25 ML OF THE TUSSIN BECAUSE SH
Current Illness: SON HAD A COLD
Preexisting Conditions: NEW BORN TEST WAS NORMAL. HAD LITTLE JAUNDICE HE CAME HOME WITH PARENTS
Allergies:
Diagnostic Lab Data: STILL WAITING ON THE RESULTS CORONERS
CDC Split Type: 122812354

Write-up: ON CHRISTMAS MORNING MY SON HAD ROLLED OFF OF THE HE FUSSED BUT WAS OKAY LATER THAT DAY HE VOMITED TWO TIMES. LATER THAT MORNING OF 12/26/2014 HE URINATED AND HAD A FEVER OF 102.6 I GAVE HIM SOME TYLENOL AND THREE HOURS LATER HE STILL HAD A FEVER SO WE THE PARENTS TOOK HIM BACK TO THE DOCTORS OFFICE WHERE THE M.A WHO GAVE HIM IS VACCINES SHOT CHECKED HIS EARS AND GAVE HIM SOME TYLENOL HIS TEMP WAS 101.3. WE WAITED TO SEE A DOCTOR AND PAC CAME AND TOLD ME TO PUT HIM IN HIS BED BUT SINCE HE WAS NOT TAKING HIS BOTTLE AT THIS TIME SHE GAVE ME A CUP OF WATER AND A SYRINGE TO MAKE HIM URINATE FOR ALMOST TWO HOURS HE DID NOT URINATE BUT VOMITED SHE SAID HE HAD A EAR INFECTION THAT SHE PRESCRIBED HIM AMOXICILLIN AND TO SEE HIM BACK IN THREE WEEKS. LATER THAT AFTER NOON AFTER GIVING HIM HIS TWO DOSES OF THE TYLENOL AND AMOXICILLIN HE STARTED TO HAVE SEIZURES. WE/PARENTS RUSHED HIM TO THE HOSPITAL WERE THEY TOLD US HE WAS DEHYDRATED AND HIS SODIUM LEVELS WERE HIGH. SAYING THAT I COULD NOT HAVE CAME FROM HIS SHOT HE WAS GIVEN ON 12/22/2014 WE HAD TO HAVE GIVEN HIM SALT.


VAERS ID: 562913 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Female  
Location: California  
Vaccinated:2009-12-04
Onset:2009-12-29
   Days after vaccination:25
Submitted: 2014-05-28
   Days after onset:1610
Entered: 2015-01-28
   Days after submission:245
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3481AA / 2 RL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1251Y / 3 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D92436 / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0534Y / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Bacterial sepsis, Immunodeficiency, Otitis media acute
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2009-12-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: URI, Parent called about a URI on 15 Dec 2009 which lasted "about 1 week" and did not appear unusual. Nasal sinus congestion, Nasal congestion visit at 20 d of age; cold symptoms, 20 d visit had cold symptoms over past 3 days; cradle cap, at 2 month well care visit reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201309548

Write-up: Initial report received on 12 September 2013 from an investigator participating in a study under the reference number M5A11. A four-month-old female subject with no reported past medical history had received on 04 December 2009 the following vaccines: dose 2 of PENTACEL, Lot number C38481AA (route and site of administration not reported), dose 3 of Hep B, MSD lot number 1251Y (route and site of administration not reported), dose 2 of PNCV7, Pfizer lot number D92436 (route and site of administration not reported), and RV5, MSD lot number 0534Y (route and site of administration not reported) and 25 days later was found to have a bacterial sepsis due to acute otitis media. The subject has been napping at daycare and original workup was for SIDS. According to physician reviewing autopsy results states "rapidity of this overwhelmingly sepsis in an otherwise perfectly normal appearing child is quite unusual: speculated that it may have been secondary to an unknown immune deficiency which will probably never be known." The subject had received dose one of PENTACEL, lot number C3385AA on 13 October 2009. According to the investigator, discussion of potential consultation with immunology department and potential genetic testing but it was unknown whether either of these were pursued. If so, results were unavailable. No further information was available at the time of the report. The subject''s outcome was fatal. The event of bacterial sepsis due to acute otitis media was not related to the trial product. Follow-up information was received on 08 October 2013 from the investigator. The subject had a past medical history of a URI on 15 December 2009 which lasted a week, nasal congestion at 20 day visit and cradle cap at 2 month well visit. According to the report, at the 20 day visit the subject had cold symptoms over the prior 3 days, no fever, not much coughing and the subject was still feeding ok and having wet diapers and stools. "Dx: congestion of nasal sinus (primary encounter diagnosis) Note: may be secondary to Upper respiratory infection". The subject had received on 13 October 2009 an intramuscular left thigh injection of PENTACEL. On 04 December 2009, the subject had received an intramuscular right thigh injection of PENTACEL, and intramuscular left thigh injection of Hep B, an intramuscular left thigh injection of PCV7 and RV5 orally. Documents held by sender: medical records and autopsy report.


VAERS ID: 563453 (history)  
Form: Version 1.0  
Age: 1.06  
Sex: Male  
Location: Iowa  
Vaccinated:2014-11-10
Onset:2014-11-17
   Days after vaccination:7
Submitted: 2015-01-30
   Days after onset:74
Entered: 2015-01-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. K004856 / 1 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. J000202 / 1 RL / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. K002921 / 1 LL / SC

Administered by: Private       Purchased by: Unknown
Symptoms: Autopsy, Intestinal ischaemia, Intestinal malrotation, Volvulus
SMQs:, Congenital, familial and genetic disorders (narrow), Gastrointestinal obstruction (narrow), Ischaemic colitis (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-17
   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: Albuterol and PULMICORT Neb; SINGULAIR; AURALGAN drops
Current Illness: Cough; recurrent OM
Preexisting Conditions: Hypotonia; Pneumonia H/O; Recurrent OM; Delayed developmental milestone
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Midgut volvulus with bowel ischemia due to intestinal malrotation per autopsy report.


VAERS ID: 563459 (history)  
Form: Version 1.0  
Age: 0.45  
Sex: Male  
Location: California  
Vaccinated:2013-10-07
Onset:2013-10-09
   Days after vaccination:2
Submitted: 2015-02-02
   Days after onset:481
Entered: 2015-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS M3475 / 1 LL / IM
HEPA: HEP A (VAQTA) / MERCK & CO. INC. J003666 / 1 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH741AA / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G62434 / 1 RL / IM

Administered by: Unknown       Purchased by: Public
Symptoms: Diet refusal, Hypersomnia, Irritability
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-10-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No. He was very health.
Preexisting Conditions: No.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: He had no fever but was very grumpy. Wouldn''t eat. Sleeping a lot.


VAERS ID: 563535 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2014-11-18
Onset:2014-11-19
   Days after vaccination:1
Submitted: 2015-01-30
   Days after onset:72
Entered: 2015-02-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK RL / UN
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J11488 / UNK LL / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-19
   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: US2015GSK011141

Write-up: This case was reported by a nurse via other manufacturer and described the occurrence of unknown cause of death in a 15-month-old patient who received PEDIARIX. Co-suspect products included PREVNAR 13 (batch number J11488, expiry date November 2016) and HIB vaccine. On 18th November 2014, the patient received PEDIARIX, PREVNAR 13 and HIB VACCINE. On 19th November 2014, 1 days after receiving PEDIARIX, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The patient died on 19th November 2014. The reported cause of death was unknown cause of death. An autopsy was performed. It was unknown if the reporter considered the unknown cause of death to be related to PEDIARIX. Additional information was provided: No other medications and medical conditions. The patient was healthy without a lot of clinic visits. The patient passed away on 19 November 2014 at 9:50. An autopsy is currently being done. An investigation was performed on PREVNAR 13. The results showed no issues impacting the identity, strength, safety, purity or quality of the product.


VAERS ID: 563564 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-02-03
Entered: 2015-02-03
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: Epilepsy
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1502USA000289

Write-up: This spontaneous report was received from a pharmacist who was told about the event by patient''s friend. The report refers to a patient of unknown age and gender with a history of epilepsy. Current conditions and drug allergies were not specified by the reporter. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route of administration, lot# and expiration date were not specified). Concomitant medication was not specified by the reporter. On an unknown date, the patient experienced shingles of the brain which caused the patient''s death on an unknown date. It was not specified whether any treatment was given for the adverse event and whether the patient sought any medical attention. Laboratory test were not specified by the reporter. It was also reported that the deceased person had never had the chicken pox and the pharmacist asked if a patient who had never had the chicken pox can be vaccinated with ZOSTAVAX. The physician correlated the death to receipt of the ZOSTAVAX without having a prior case of the chickenpox. No product quality complain (PQC) was filed. Additional information is not expected, because the reporter did not wish to be contacted.


VAERS ID: 563794 (history)  
Form: Version 1.0  
Age: 32.0  
Sex: Male  
Location: Georgia  
Vaccinated:2012-12-31
Onset:2013-01-01
   Days after vaccination:1
Submitted: 2015-01-29
   Days after onset:758
Entered: 2015-02-03
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN

Administered by: Military       Purchased by: Military
Symptoms: Asthenia, Asthma, Cryptococcosis, Death, Dysphonia, Encephalopathy, Euthyroid sick syndrome, Headache, Hydrocephalus, Hyperkalaemia, Mechanical ventilation, Meningitis, Palpitations, Pleural effusion, Proteinuria, Pyrexia, Renal failure, Sepsis, Shock, Swelling, Toxoplasmosis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Hypersensitivity (narrow), Tumour lysis syndrome (narrow), Proteinuria (narrow), Tubulointerstitial diseases (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2013-01-30
   Days after onset: 29
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 54 days
   Extended hospital stay? Yes
Previous Vaccinations: Sepsis shock~Influenza (Seasonal) (no brand name)~UN~32.00~Patient
Other Medications: Lansoprazole; ondansetron; pyrimethamine; atovaquone; abacavir; azithromycin; heparin; clindamycin; zidovudine; clonidine; amlodipine; raltegravir; haloperidol; hydrocortisone; leucovorin calcium; omeprazole; morphine; vancomycin; FORTAZ; l
Current Illness: Nov. 20, 2011 was smother with plastic diagnose; toxoplasmosis; HIV pt.
Preexisting Conditions: Nov. 02, 2012 ER, admitted to ICU sepsis shock; pneumonic
Allergies:
Diagnostic Lab Data: Hydrocephalus; encephalopathy; sick euthyroid syndrome; renal failure; mild hyperkalemia; HFV; CNS toxoplasmosis; lung pleural effusion, cryptococcal; asthma; meningitis; proteinuria; shock
CDC Split Type:

Write-up: Headaches; fever; swelling; hoarseness; weakness; racing heart; sepsis shock.


VAERS ID: 563861 (history)  
Form: Version 1.0  
Age: 5.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-01-29
Entered: 2015-02-05
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cardiac arrest, Cough, Death, Influenza, Life support, Pyrexia, Resuscitation, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Unknown
Current Illness: UNK
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2015SA010906

Write-up: Initial unsolicited report was received via a lay press article on 27 January 2015. A five year-old female patient (date of birth not reported) had received on an unspecified date an influenza vaccine (manufacturer, lot number, route and site of administration not reported) and an unspecified amount of time later, experienced a cough and fever. The patient was seen in a clinic and prescribed steroids and a nebulizer. Hours later the patient collapsed and CPR was performed. The patient was found to have Influenza A. The patient was hospitalized and placed on life support. The patient suffered a cardiac arrest and died. Outcome was fatal. Documents held by sender: none.


VAERS ID: 564361 (history)  
Form: Version 1.0  
Age: 60.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2014-10-01
Onset:2014-10-03
   Days after vaccination:2
Submitted: 2015-01-27
   Days after onset:116
Entered: 2015-02-09
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK LA / UN

Administered by: Other       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: 2014-10-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Omeprazole; Lactulose; ZANAFLEX; SENEKOT; Fentanyl; LEXAPRO; Bisacodyl; NUTREN
Current Illness: None
Preexisting Conditions: Cerebral Palsy; Intellectual Disabilities; COPD; Dysphagia
Allergies:
Diagnostic Lab Data: Negative
CDC Split Type:

Write-up: Client received vaccine at 6pm on 10-1-14. Client was found unresponsive on 10-3-14 at 4:15 AM. Client was pronounced dead at 4:39 AM.


VAERS ID: 564470 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2014-10-24
Onset:2014-10-24
   Days after vaccination:0
Submitted: 2015-02-05
   Days after onset:104
Entered: 2015-02-10
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U5062AA / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Abasia, Blister, Bone pain, Death, Impaired driving ability, Mobility decreased, Musculoskeletal stiffness, Oxygen supplementation, Peripheral swelling, Pneumonia, Pruritus, Pyrexia, Rash pruritic
SMQs:, Cardiac failure (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Osteonecrosis (broad), Hypersensitivity (narrow), Arthritis (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-01-12
   Days after onset: 80
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prednisone
Current Illness: Latex allergy; Drug allergy
Preexisting Conditions: Nasal polyps
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2014SA152664

Write-up: Initial report received from a healthcare professional on 03 November 2014. A 78-year-old female patient had received first dose of FLUZONE HD (batch number U5062AA, Exp. date 25 May 2015), intramuscularly in left deltoid on 24 October 2014. The patient''s medical history includes AVELOX and latex allergy and concomitant medication was not reported. The patient had not received FLUZONE HD previously. On 24 October 2014 same day after vaccination, the patient had experienced itchy rash. After the rash patient experienced stiffness in the legs. Laboratory investigations and corrective treatment was not reported. It was reported that itchy rash was for 2 days but the outcome of the event was not reported. Follow-up information was received for this unsolicited case on 30 January 2015 from a consumer who is the patient''s daughter. Additional information was received the same day from the pharmacist who was the original reporter. According to the patient''s daughter, the patient was described as being in good shape at 78 years of age when she received the vaccine on 24 October 2014. The patient told her daughter that she had a fever and her bones were sore. The patient was on Prednisone at the time for nose polyps. On 25 October 2014, she had blisters on the back of her legs about the size of a dime and a nickel. The patient showed it to her doctor as she could not walk. She was hesitant to go back to the doctor. The patient experienced pneumonia like symptoms within the week and was put on oxygen. She could not drive because she could not move. She was treated with antibiotics two weeks later. She had swelling in her left leg. The patient was found dead in her chair on 12 January 2015. A pharmacist also reported the event on 30 January 2015 after the daughter had reported it to him. The patient had died on 12 January 2015. The patient had seen a healthcare provider for the first time after vaccination on 25 November 2014 and was treated with an antibiotic. Around this time the patient had developed pneumonia. The daughter reported that the patient had stopped taking the antibiotic because it made her itch. She returned to the healthcare practice on 8 December 2014 and was treated with another antibiotic and was placed on oxygen. The patient outcome is fatal. Documents held by sender: none.


VAERS ID: 564662 (history)  
Form: Version 1.0  
Age: 0.53  
Sex: Female  
Location: New Jersey  
Vaccinated:2015-02-06
Onset:2015-02-07
   Days after vaccination:1
Submitted: 2015-02-11
   Days after onset:4
Entered: 2015-02-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 9939E / 2 UN / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UI101AAA / 2 UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J23865 / 2 UN / IM

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: 2015-02-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: WELL CHILD
Preexisting Conditions: NO KNOWN ALLERGIES. WELL CHILD
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: PT RECEIVED PEDIARIX, HIB, AND PREVNAR ON 02/06/15. NO ADVERSE EVENT REPORTED DURING THAT DAY. NO SYMPTOMS. PT WAS FOUND UNRESPONSIVE AROUND 8AM ON 02/07/15. CAUSE OF DEATH HAS YET TO BE DETERMINED.


VAERS ID: 564720 (history)  
Form: Version 1.0  
Age: 71.0  
Sex: Male  
Location: Michigan  
Vaccinated:2015-02-10
Onset:2015-02-10
   Days after vaccination:0
Submitted: 2015-02-12
   Days after onset:2
Entered: 2015-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J75276 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-02-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient passed away 02/10/2015 due to Cardiac arrest.


VAERS ID: 564751 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: New York  
Vaccinated:2015-01-29
Onset:0000-00-00
Submitted: 2015-02-12
Entered: 2015-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. CL2126 / UNK NS / IN

Administered by: Private       Purchased by: Other
Symptoms: Abdominal pain, Culture urine negative, Death, Mental status changes, Pyrexia, Rash generalised, Ultrasound abdomen normal, Urinary tract infection, Viral infection, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-02-06
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Bilateral lower Abdominal pain
Preexisting Conditions: Aspergers
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Seen at PMD for adb pain (pt had menses at this time) on 1/30/15. Dx with UTI, started Bactrim and patient was stopped from meds after a few days due to neg urine cx and the patient also was feeling better. On Wed 2/4/15 the abd pain returned and the patient then developed a fever of 102.6 and an all over body rash (non-pruritic). Seen at PMD on that day and was dx with suspect viral illness. Abd ultrasound was also done at the PMD and negative. On Thurs 2/5 the patient came in to the hospital due to dramatic altered mental status and vomiting stomach contents. The mental status worsened throught out hospitalization. Patient passed away.


VAERS ID: 565640 (history)  
Form: Version 1.0  
Age: 1.1  
Sex: Female  
Location: Massachusetts  
Vaccinated:2015-02-13
Onset:2015-02-14
   Days after vaccination:1
Submitted: 2015-02-18
   Days after onset:4
Entered: 2015-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS F4327 / 1 LL / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U5064AB / 1 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Death, Peripheral coldness
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-02-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ranitidine; POLY-VI-SOL; Mupirocin Ointment
Current Illness: None
Preexisting Conditions: Cerebral palsy; Dystonia; Ischemic Encephalopathy; Central Vision Improvement; Microcephaly
Allergies:
Diagnostic Lab Data: Hospitalization for bronchiolitis - improved
CDC Split Type:

Write-up: Received first vaccines 2/13/15, no apparent problems that afternoon or evening, found dead in crib following AM - cold, likely died hours before. Complex PMH following anoxic/ischemic brain injury at birth. Hx seizures, weaned off anticonvulsants - 2m ago after EEG normal.


VAERS ID: 565783 (history)  
Form: Version 1.0  
Age: 99.0  
Sex: Female  
Location: Illinois  
Vaccinated:2015-02-17
Onset:2015-02-17
   Days after vaccination:0
Submitted: 2015-02-18
   Days after onset:1
Entered: 2015-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. K022886 / 1 RA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Cardiac arrest, Confusional state, Death, Nausea, Pulse absent, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-02-18
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Taking Synthroid 75mcg (0.075mg) tablet 1 tab(s) once a day; Taking Imdur 30 mg tablet, extended release 1 tab(s) once a day (in the morning); Taking amiodarone 100 mg tablet 1 TAB QOD; Taking Cozaar 50 mg tablet 1/2 tab(s) once a day; Taki
Current Illness: Hypertension, GERD, hypothyroidism
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 99 y/o female w/ IHD, OA came to office for Wellness exam. Doing well, no c/o''s. Was given a Pneumovax in right deltoid. Was told by son she was active w/ walker the rest of the day. Ate lunch and dinner well. Developed nausea, vomiting at 11PM. Became confused. Paramedics called. Caretaker found a pulse but paramedics did not. Pt taken to ED but was pulseless and asystolic on arrival. Pronounced dead around 12:25AM.


VAERS ID: 566311 (history)  
Form: Version 1.0  
Age: 1.14  
Sex: Female  
Location: Georgia  
Vaccinated:2015-02-19
Onset:2015-02-19
   Days after vaccination:0
Submitted: 2015-02-20
   Days after onset:1
Entered: 2015-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS E443F / 2 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. K008878 / 2 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. K002528 / 1 RA / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J16883 / 2 RL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. K011797 / 1 RL / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-02-19
   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: Levalbuterol 0.63 mg prn; ipratropium 0.2% bid via nebulizer; belcomethasone 40 mcg via spacer bid
Current Illness: None
Preexisting Conditions: G-tube dependent; history of pulmonary hypertension arthrogryposis; clinodactyly; polyhydramnios, single umbibical artery; macrocepaly, enlarged (L) kidney, Piere Robin Sequence, congenital hip dislocation; single umbilical artery; chronic resp. failure; anomaly of vertebrae, congenital anamaly of ribs and sterum; small but restrictive PDA; (L) aortic arch w/berrant (r) subclavian artery.
Allergies:
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: Patient had alarms last night (02/19/2015), mother tried to stimulate and called 911. EMT''s arrived and began transport to hospital, but patient arrested and was not able to be resuscitated in ED.


VAERS ID: 566447 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-02-23
Entered: 2015-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: 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: WAES1502USA008840

Write-up: Information has been received from a consumer referring to 109 patients of unknown age and gender. The patients'' concurrent condition and medical history not reported. The reporter had concerned about the patients were vaccinated with M-M-R II (lot#, dose and route not reported) and (3) live neurotoxin vaccines (manufacturer unknown) (strength, dose, lot# and route were not reported) were given in combination on unknown dates could create adverse effects. Concomitant therapy was not provided. On unknown dates, the patients died from the M-M-R II. It was not confirmed if autopsies were performed or not. The cause of death was unknown. Consumer could not confirm where he received this statistic. Additional information has been requested.


VAERS ID: 566449 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2009-10-06
Onset:0000-00-00
Submitted: 2015-02-23
Entered: 2015-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Dyskinesia, Encephalitis, Guillain-Barre syndrome, Hypertension, Malaise
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Hypertension (narrow), Demyelination (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015048932

Write-up: This spontaneous consumer report (initial receipt 11-Feb-2015) concerns a female patient. On the 06-Oct-2009, the patient received influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, the patient became very sick. The patient went into fetal position within 24 hours after vaccination and became hypersensitive, slided her legs out and moved her head in circles for weeks. Weeks later, the patient went to the medical centre and the doctor stated that she experienced Guillain Barre Syndrome and encephalitis. She was treated with antibiotics. The patient did not recover and passed away in Feb-2014. The exact cause of death was unknown. The outcome was reported as not recovered. Reporter''s comments: It was reported that the exact cause of death was unknown. The reporter did not specify how her mother passed away or if it was related to the flu vaccine.


VAERS ID: 566633 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: Texas  
Vaccinated:2015-02-17
Onset:0000-00-00
Submitted: 2015-02-23
Entered: 2015-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS F5J77 / UNK RL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UI147AA / UNK LL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J11485 / UNK LL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. K007247 / UNK MO / PO

Administered by: Private       Purchased by: Other
Symptoms: Death, Pathology test, 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: 2015-02-19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient passed away 2 days after a healthy well baby check up at the office, was found unresponsive, taken to ER where he was declared deceased. Results of pathology still pending.


VAERS ID: 566923 (history)  
Form: Version 1.0  
Age: 7.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-02-23
Entered: 2015-02-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Analgesic drug level increased, Autopsy, Brain oedema, Death, Decreased appetite, Hepatic steatosis, Influenza, Influenza A virus test positive, Renal tubular disorder, Reye's syndrome, Toxicity to various agents, Unresponsive to stimuli, Vomiting
SMQs:, Acute renal failure (broad), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug abuse and dependence (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Tubulointerstitial diseases (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), 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? 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: US2015GSK022605

Write-up: This case was reported in a literature article and described the occurrence of vomiting in a 7-year-old male patient who received Influenza vaccine. On an unknown date, the patient received Influenza vaccine (unknown). On an unknown date, 3 days after receiving Influenza vaccine, the patient experienced vomiting, appetite lost and influenza A virus infection. On an unknown date, the outcome of the vomiting, appetite lost and influenza A virus infection were unknown. The reported cause of death was Reye''s syndrome. An autopsy was performed. The autopsy determined cause of death was hepatic steatosis, kidney tubule disorder, cerebral edema, influenza A virus infection and salicylate intoxication. It was unknown if the reporter considered the vomiting, appetite lost and influenza A virus infection to be related to Influenza vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of vomiting in a 7-year-old male patient who had received unspecified influenza A vaccination (manufacturer unknown). No information on the patient''s medical or family history or concurrent condition was provided. On an unspecified date, the patient received unspecified influenza A vaccine (administration route and site unspecified; dosages unknown; batch numbers not provided). On an unspecified date, 3 days after receiving vaccination the patient developed profound vomiting and loss of appetite. The patient''s mother had given him PEPTO-BISMOL and Gatorade as treatment and sent the patient to bed. The patient was found unresponsive less than 12 hours later and pronounced dead 4 minutes after arrival at the hospital. Autopsy findings included diffuse mixed micro and macro vesicular steatosis of the liver, micro vesicular steatosis in the renal tubule cells, and cerebral edema. A postmortem nasopharyngeal swab screening was positive for influenza A. Toxicology was positive for salicylate. The outcomes of the events were unspecified. The authors did not comment on causality relationship between the vaccine and the event. The authors concluded that "Reye''s syndrome is a rare severe neurologic disorder consisting of a biphasic illness characterized by a viral infection followed by an acute onset of non-inflammatory encephalopathy and hepatic failure, with rapid progression to death if not properly treated. It most commonly affects children younger than 16 years of age who are treated with aspirin during certain viral infections, including varicella and influenza. The exact cause is unknown, but it is thought to result from mitochondrial impairment resulting from the actions of salicylate and its metabolites, hydroxyhippurate and gentisate. This impairment appears to be intensified during viral illnesses".


VAERS ID: 567040 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2014-12-02
Onset:2014-12-02
   Days after vaccination:0
Submitted: 2015-02-25
   Days after onset:85
Entered: 2015-02-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U5008BA / UNK UN / IM

Administered by: Public       Purchased by: Other
Symptoms: Antineutrophil cytoplasmic antibody positive, Asthenia, Biopsy kidney normal, Biopsy lung normal, Chest pain, Chills, Cough, Culture negative, Death, Dyspnoea, Influenza like illness, Intensive care, Nausea, Pneumonia, Renal failure acute, Respiratory failure, Vasculitis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vasculitis (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2015-02-23
   Days after onset: 83
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 30 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Psyllium 1.7g PO BID; chloecalciferol 50,000 IU PO monthly; amlodipine 2.5 mg daily; dicyclomine 10mg PO QID; clopidogrel 75mg PO daily; pravastatin 40 mg PO at bedtime; citalopram 20mg PO daily; metoprolol 50mg PO BID
Current Illness:
Preexisting Conditions: Hypertension, fibromyalgia, atrial fibrillation, CVA
Allergies:
Diagnostic Lab Data: Anti-myeloperoxidase Ab = 5.7 AI on 1/27 Anti-myeloperoxidase Ab = 5.2 AI on 2/6 Anti-proteinase 3 Ab = < 1.0 AI on 1/27 Anti-proteinase 3 Ab = < 1.0 AI on 2/6 Renal and lung biopsies both negative for vasculitis
CDC Split Type:

Write-up: Patient started out with flu-like symptoms starting on the night after the vaccine was administered. Per family, patient never fully returned to baseline state of health. Patient went on to develop chest pain and presented to hospital on 12/27 complaining of chest pain. ACS was ruled out and patient was discharged home the next day with a course of Ceftin for suspected pneumonia. Patient presented to the ED again on 1/22 with complaints of weakness, chills, nausea, dry cough, and increased shortness of breath. Patient was quickly transferred to the MICU with respiratory failure and acute renal failure. Patient was treated for pneumonia but did not respond to antibiotics and all cultures were negative. Patient was subsequently treated for suspected vasculitis based on ANCA studies with cyclophosphamide and methylprednisolone but subsequently expired on 2/23.


VAERS ID: 567070 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-09-02
Entered: 2015-02-25
   Days after submission:176
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Laboratory test, Microscopy, Neurological examination, Toxicologic test
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: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions: Dizziness; Visual impairment; Cold sweat; Nausea
Allergies:
Diagnostic Lab Data: Autopsy and microscopic, neuropathological, toxicological, and chemical evaluation, the immediate cause of death: Could not be ascertained.
CDC Split Type: 2014SE67987

Write-up: A spontaneous health professional report from a regulatory authority in an article, concerns a 19 year old female. The patient''s medical history included cold sweat, nausea, dizziness, and difficulty reading numbers on the day prior to death. Concomitant medications included quadrivalent human papilloma virus vaccine and meningococcal conjugate. Patient received Nasal FLUMIST QUADRIVALENT on an unknown date. The patient died 10 days after these vaccinations from unknown causes. Despite an extensive post-mortem examination including autopsy and microscopic, neuropathological, toxicological, and chemical evaluation, the immediate cause of death could not be ascertained. Autopsy revealed no obvious cause of death. The reporter assessed the death to be serious by the criterion of death.


VAERS ID: 567073 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-09-02
Entered: 2015-02-25
   Days after submission:176
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN

Administered by: Other       Purchased by: Other
Symptoms: Brain injury, Death
SMQs:, Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness: Atrial septal defect
Preexisting Conditions: Premature baby
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014SE68042

Write-up: A report from VAERS concerns a three year old male patient. The patient was born prematurely between gestational weeks 32 and 33 and suffered from atrial septal defect. The patient received nasal FLUMIST and 10 days later experienced hypoxic-ischemic brain injury. The patient died of the hypoxic-ischemic brain injury on an unknown date. It was unknown if autopsy was performed. The reporter assessed the event as serious due to death. Based on the information in this report, and awaiting the reporter''s assessment, the company physician considered the event to be at least possibly related to FLUMIST.


VAERS ID: 567086 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-09-02
Entered: 2015-02-25
   Days after submission:176
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN

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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014SE68022

Write-up: It is a spontaneous report to the VAERS program concerning a child patient with unknown gender and age. The patient''s medical history, concurrent diseases, and concomitant medications were not reported. On an unknown date, the patient received nasal FLUMIST. Two days after vaccination, the patient had a seizure, and the patient died. The cause of death was seizure. Interval after vaccination unknown. According to the reporter the seizure was considered to be serious with the serious criteria of death.


VAERS ID: 567087 (history)  
Form: Version 1.0  
Age: 7.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-09-02
Entered: 2015-02-25
   Days after submission:176
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Death, Mental status changes, Subacute sclerosing panencephalitis
SMQs:, Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (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, 16 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions: Subacute sclerosing panencephalitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014SE67999

Write-up: A spontaneous health professional report from a regulatory authority in an article. Vaccine Adverse Event Reporting System (VAERS), July 2013-April 2014, concerns a 7 year old female. The patient''s medical history included subacute sclerosing panencephalitis (SSPE). No concomitant diseases and concomitant medications were reported for consumer. Patient received Nasal FLUMIST QUADRIVALENT on an unknown date, and 64 days later she required hospitalization for 16 days for changes in mental status and progression of SSPE. The patient died from an unknown cause on an unspecified date. The report did not describe whether an autopsy was performed. The reporter assessed the death to be serious by the criterion of death.


VAERS ID: 567350 (history)  
Form: Version 1.0  
Age: 49.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-02-27
Entered: 2015-02-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: WAES1502USA011640

Write-up: This spontaneous report as received from a consumer, as part of a marketing research program refers to a 49 year old male patient. On an unknown date, the patient was vaccinated with a dose of pneumococcal vaccine (manufacturer unknown) (dose, route and lot # not reported). The consumer reported that on an unknown date, 2 months after vaccination, the patient died from pneumonia so he had no faith in pneumococcal vaccine (manufacturer unknown). The relationship between the event and pneumococcal vaccine, (manufacturer unknown) was not reported. Additional information is not expected. There is no contact information.


VAERS ID: 567978 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: Indiana  
Vaccinated:2014-09-26
Onset:0000-00-00
Submitted: 2015-02-26
Entered: 2015-03-04
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U5024CA / UNK LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Chest X-ray, Death, Full blood count, Pneumonia, White blood cell count
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-10-17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Unk
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Chest X-ray results not reported. WBC, Unknown, Unknown; CBC, Unknown, Unknown
CDC Split Type: 2015SA023263

Write-up: Initial unsolicited report was received from a certified medical assistant on 23 February 2015. This case is one of a cluster of "almost 10 patients" (eight of which were identified) received from the same reporter. The other patients are captured in cases 2014SA157362, 2015SA023267, 2015SA023893, 2015SA023902, 2015SA023910, 2015SA023917, 2015SA023924 and 2015SA023928. A 73 year-old elderly male patient had received on 26 September 2014 an intramuscular left arm injection of FLUZONE HIGH DOSE (lot number U5024CA with expiration date of 12 May 2015) and an unspecified amount of time later was diagnosed with pneumonia and died 21 days after vaccination on 17 October 2014. The patient had a chest x-ray, WBC and CBC results were not reported. Illness at the time of vaccination was none. Concomitant medications and pre-existing conditions were reported as "NA". No further information was provided. Outcome was fatal. According to the reporter, the report was reviewed and they had no additional information to report at the time. Documents held by sender: none.


VAERS ID: 567979 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Male  
Location: Indiana  
Vaccinated:2014-09-26
Onset:0000-00-00
Submitted: 2015-02-26
Entered: 2015-03-04
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U5024CA / UNK LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Chest X-ray abnormal, Death, Full blood count, Pneumonia
SMQs:, Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-12-17
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: None
Allergies:
Diagnostic Lab Data: Pneumonia noted per chest x-ray; CBC, Unknown, UNK
CDC Split Type: 2015SA023267

Write-up: Initial unsolicited report was received from a certified medical assistant on 23 February 2015. This case is one of a cluster of "almost 10 patients" received from the same reporter (with 8 patients identified). The other patients are captured in cases 2014SA157362, 2015SA023263, 2015SA023893, 2015SA023902, 2015SA023910, 2015SA023917, 2015SA023924 and 2015SA023928. An 83 year-old male patient had received on 26 September 2014 an intramuscular left arm injection of FLUZONE HIGH DOSE (lot number U5024CA with expiration date of 12 May 2015) and "shortly after vaccination" was diagnosed with pneumonia; the patient died on 17 December 2014, approximately 3 months after vaccination. The patient had a chest x-ray on which pneumonia was noted; CBC was obtained, but results were not reported. Illness at the time of vaccination was none. Concomitant medications and pre-existing conditions were reported as "NA". No further information was provided. Outcome was fatal. According to the reporter, the report was reviewed and they had no additional information to report at the time. Documents held by sender: none.


VAERS ID: 568282 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Ohio  
Vaccinated:2010-09-10
Onset:2011-01-15
   Days after vaccination:127
Submitted: 2015-03-05
   Days after onset:1510
Entered: 2015-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 LA / SYR

Administered by: Unknown       Purchased by: Public
Symptoms: Asthenia, Chills, Confusional state, Death, Dyspnoea, Fatigue, Laboratory test, Lymphadenopathy, Malaise, Muscular weakness, Pain in extremity, Rash, Skin infection, Urticaria, Wheezing
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-02-14
   Days after onset: 30
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~HPV (Gardasil)~~15.92~Patient
Other Medications: Nothing
Current Illness: NO
Preexisting Conditions: NO
Allergies:
Diagnostic Lab Data: All tests were complicated
CDC Split Type:

Write-up: Hives, swollen glands, chills, difficult breathing, feeling unwell, rash, skin infection, muscle weakness, tiredness, weakness confusion, leg pain and wheezing.


VAERS ID: 568470 (history)  
Form: Version 1.0  
Age: 85.0  
Sex: Female  
Location: Arizona  
Vaccinated:2014-11-07
Onset:2014-11-09
   Days after vaccination:2
Submitted: 2015-03-06
   Days after onset:117
Entered: 2015-03-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J49843 / 1 AR / IM

Administered by: Private       Purchased by: Public
Symptoms: Blood test, Blood test abnormal, Diarrhoea, Pneumonia, Sepsis, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-22
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 9 days
   Extended hospital stay? No
Previous Vaccinations: Blindness~Influenza (Seasonal) (no brand name)~1~73.00~Patient
Other Medications: Xarelto; levothyronine
Current Illness: None
Preexisting Conditions: Pulmonary Embolism July 2014
Allergies:
Diagnostic Lab Data: Bloodwork: Dx Sepsis secondary to pneumonia
CDC Split Type:

Write-up: Vomiting and diarrhea. Transferred by EMS to local hospital.


VAERS ID: 568771 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Massachusetts  
Vaccinated:2015-02-27
Onset:2015-02-28
   Days after vaccination:1
Submitted: 2015-03-09
   Days after onset:8
Entered: 2015-03-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4759AA/C4705AA / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J49844 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. K006805 / 1 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Death, Epistaxis, Eye swelling, Mouth haemorrhage, Resuscitation, Swollen tongue
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-02-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TYLENOL
Current Illness: None
Preexisting Conditions: None known
Allergies:
Diagnostic Lab Data: Unclear/unknown
CDC Split Type:

Write-up: Pt was discovered in parent''s bed in the morning on his side with swollen eye, nasal bleeding, swollen tongue, perioral petechiae. He was taken via paramedics to Hospital and was unable to be resuscitated.


VAERS ID: 568987 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Male  
Location: Indiana  
Vaccinated:2014-10-13
Onset:2014-12-27
   Days after vaccination:75
Submitted: 2015-03-05
   Days after onset:68
Entered: 2015-03-11
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI205AC / UNK LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Death, Influenza, Influenza virus test positive, Laboratory test abnormal, Pneumonia
SMQs:, Eosinophilic pneumonia (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: 2014-12-28
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: UNK
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Lab tests reported as - "ER + flu + pneumonia"
CDC Split Type: 2015SA023893

Write-up: Initial unsolicited report was received from a certified medical assistant on 23 February 2015. This case is one of a cluster of "almost 10 patients" received from the same reporter (with 8 patients identified). The other patients are captured in cases 2014SA157362, 2015SA023263, 2015SA023267, 2015SA023902, 2015SA023910, 2015SA023917, 2015SA023924, 2015SA023928. A 74 year-old patient, gender unknown had received on 13 October 2014 in the morning, an intramuscular left arm injection of FLUZONE QUADRIVALENT, lot number UI205AC with expiration date of June 2015 and at an unspecified time after vaccination was diagnosed with flu and pneumonia; the patient died on 28 December 2014, approximately 3 months after vaccination. Relevant diagnostic tests were reported as "ER + flu + pneumonia". Illness at the time of vaccination was none. Concomitant medications and pre-existing conditions were reported as "NA". No further information was provided. Outcome was fatal. According to the reporter, the report was reviewed and they had no additional information to report at the time. Documents held by sender: none.


VAERS ID: 569399 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-03-13
Entered: 2015-03-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Generalised tonic-clonic seizure, Immediate post-injection reaction
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (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? 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: WAES1503USA005208

Write-up: This spontaneous report as received from a consumer refers to her cousin, an approximately 3 years old male patient. On an unknown date, in early 1990''s the patient was vaccinated with M-M-R II, (therapy type HSA, dose and Lot# were not reported). On an unknown date, immediately after vaccination, the patient experienced general grand mal seizures that continued to worsen throughout a one year period. On an unknown date, when the patient was having up to 40 seizures a day, he was admitted to a hospital. On an unknown date, reported as one year after vaccination with M-M-R II the patient died. The cause of death was reported as seizure. Relatedness between grand mal seizure and M-M-R II was not reported. Upon internal review general grand mal seizures were considered to be medically significant. Additional information has been requested.


VAERS ID: 570312 (history)  
Form: Version 1.0  
Age: 0.35  
Sex: Female  
Location: Georgia  
Vaccinated:2015-03-13
Onset:2015-03-14
   Days after vaccination:1
Submitted: 2015-03-16
   Days after onset:2
Entered: 2015-03-18
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4640AB / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J75278 / 2 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CB470A / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-03-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: POLY-VI-SOL; MYLICON gtts
Current Illness: None
Preexisting Conditions: Premature 33 wks; VSD; Anemia; Bilateral retinopathy; Periorbital edema; Cystic periventricular leukomalacia
Allergies:
Diagnostic Lab Data: None yet
CDC Split Type:

Write-up: None stated.


VAERS ID: 570609 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2015-03-09
Onset:2015-03-10
   Days after vaccination:1
Submitted: 2015-03-16
   Days after onset:6
Entered: 2015-03-20
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J80527 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-03-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Aspirin; ZOLOFT; LIPITOR; SYNTHROID; Spironolactone; TRAVATAN Z; Carbidopa-Levodopa ER; Digoxin; JANUVIA; garlic; Dorzolamide HCl; LEVAQUIN; COREG; cinnamon; NUVIGIL
Current Illness: None
Preexisting Conditions: Parkinson''s; CAD; HTN; DM
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Received call from wife. Approx. 3AM pt. aspirated and 911 was called. Pt. expired in transport. Due to close proximity of vaccine administration we are reporting the event.


VAERS ID: 570801 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Unknown  
Vaccinated:2013-06-01
Onset:2014-10-10
   Days after vaccination:496
Submitted: 2015-03-22
   Days after onset:163
Entered: 2015-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK AR / SYR

Administered by: Unknown       Purchased by: Private
Symptoms: Death, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-10-11
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Syncope. Died at ER.


VAERS ID: 571016 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: West Virginia  
Vaccinated:2015-03-16
Onset:0000-00-00
Submitted: 2015-03-23
Entered: 2015-03-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4749AB / UNK RL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H64735 / UNK LL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. K004773 / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-03-19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Previously on methadone off x 3 weeks
Current Illness: None
Preexisting Conditions: In utero drug exposure
Allergies:
Diagnostic Lab Data:
CDC Split Type: WV1502

Write-up: None stated.


VAERS ID: 571944 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Male  
Location: New York  
Vaccinated:2015-03-27
Onset:2015-03-27
   Days after vaccination:0
Submitted: 2015-03-31
   Days after onset:4
Entered: 2015-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 5SR2L / 2 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Death, Dyskinesia, Fall, Headache, Resuscitation
SMQs:, Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-03-27
   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: None
Current Illness: Headache
Preexisting Conditions: Opiate addiction
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: After receiving vaccination, pt asked for ibuprofen for headache, then he went to church, then saw his attorney. When he came back, he sat down at a table, put his head down and reportedly had some spastic movements and fell over. They did CPR and used the AED without results. He coded at 3:25, was sent to the ED at 3:40 and passed at 4:10.


VAERS ID: 572818 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-04-04
Entered: 2015-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
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: Neoplasm malignant
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1503USA012613

Write-up: This spontaneous report was received from a former Merck field employee via company representative regarding a patient of unknown age and gender. The patient was diagnosed with unspecified cancer. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number, strength, dose, frequency and route of administration) (medication error). On an unknown date the patient died. The exact cause of the death was unknown. Causality assessment was not reported. Additional information has been requested.


VAERS ID: 573084 (history)  
Form: Version 1.0  
Age: 0.38  
Sex: Female  
Location: New York  
Vaccinated:2009-02-25
Onset:2009-02-27
   Days after vaccination:2
Submitted: 2015-04-08
   Days after onset:2230
Entered: 2015-04-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Death, Hypotonia, Respiratory arrest, Upper respiratory tract congestion, Vaccination complication
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-02-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Died 2 days after receiving routine 4 month vaccines. Reportedly, developed upper respiratory congestion, limpness, was taken to the ED, went into respiratory arrest and died. The mom states the death was linked to "pneumococcal vaccine in her lungs and blood".


VAERS ID: 573366 (history)  
Form: Version 1.0  
Age: 1.16  
Sex: Male  
Location: Michigan  
Vaccinated:2008-07-01
Onset:2008-07-02
   Days after vaccination:1
Submitted: 2015-04-09
   Days after onset:2472
Entered: 2015-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2950AA / 3 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF263AC / 3 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0215X / 1 RL / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1076U / 1 LL / SC

Administered by: Unknown       Purchased by: Other
Symptoms: Autopsy, Blood test, Decreased appetite, Diet refusal, Fatigue, Irritability, Pyrexia, Toxicologic test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-07-04
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: difficulty breathing~DTaP + HepB + IPV (no brand name)~2~0.42~Patient|difficulty breathing~DTaP + HepB + IPV (no brand name)~~0.
Other Medications: Albuterol
Current Illness: No
Preexisting Conditions: Tentative diagnosis of childhood asthma
Allergies:
Diagnostic Lab Data: Blood work from 07/01/2008; Autopsy protocol and toxicology
CDC Split Type:

Write-up: Irritability, fatigue, loss of appetite, fever, refusing to drink.


VAERS ID: 573401 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-04-10
Entered: 2015-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 4 UN / UN
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Acute respiratory distress syndrome, Aspiration bone marrow normal, Blood culture negative, Chest X-ray normal, Computerised tomogram normal, Death, Dyspnoea, Electroencephalogram normal, Enterobacter infection, Face oedema, Hypotension, Iatrogenic infection, Leukopenia, Lung consolidation, Mechanical ventilation, Multi-organ failure, Pancytopenia, Petechiae, Platelet count decreased, Pneumonia, Pyrexia, Respiratory tract infection, Septic shock, Stenotrophomonas sepsis, Stenotrophomonas test positive, Thrombocytopenia, Urinary tract infection pseudomonal, Varicella, Varicella virus test positive, White blood cell count decreased
SMQs:, Anaphylactic reaction (narrow), Agranulocytosis (narrow), Angioedema (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), 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), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Myelodysplastic syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 21 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Aspiration bone marrow, no evidence of leukaemia absent; Blood culture, Positive for Stenotrophomonas maltophilia absent; Blood culture, Negative absent; Body temperature, 101.1 degree F; Chest X-ray, Alveolar consolidation absent; Computerised tomogram, no intracranial lesions absent; Electroencephalogram, excluded subclinical seizures absent
CDC Split Type: US2015GSK047296

Write-up: This case was reported in a literature article and described the occurrence of varicella in a 15-year-old female subject who received DTP (A or W not known) vaccine. Previously administered products included DTP (A or W unknown) vaccine with an associated reaction of no adverse event (1st dose), DTP (A or W not known) vaccine with an associated reaction of no adverse event (2nd dose), DTP (A or W not known) vaccine with an associated reaction of no adverse event (3rd dose) and MMR vaccine with an associated reaction of no adverse event (2nd dose). Concomitant products included MMR vaccine. On an unknown date, an unknown time after receiving DTP (A or W not known) vaccine and Hib vaccine, the subject developed severe - grade 3 varicella. Serious criteria included death and hospitalization. Additional event(s) included fever, shortness of breath, face edema, petechial rash, hypotension, pneumonia with serious criteria of GSK medically significant, acute respiratory distress syndrome with serious criteria of GSK medically significant, pancytopenia with serious criteria of GSK medically significant, multi-organ failure with serious criteria of GSK medically significant, iatrogenic infection, enterobacter cloacae infection with serious criteria of GSK medically significant, respiratory tract infection with serious criteria of GSK medically significant, urinary tract infection pseudomonal with serious criteria of GSK medically significant, Stenotrophomonas sepsis with serious criteria of GSK medically significant, thrombocytopenia, leukopenia with serious criteria of GSK medically significant and lung consolidation. The subject was treated with acyclovir, antibiotics unknown, antifungals for systemic use, ciprofloxacin, meropenem, Sulfamethoxazole + Trimethoprim, Ticarcillin + Clavulanate and tigecycline. The outcome of varicella was fatal. The outcome(s) of the additional event(s) included fever (unknown), shortness of breath (unknown), face edema (unknown), petechial rash (unknown), hypotension (unknown), pneumonia (unknown), acute respiratory distress syndrome (unknown), pancytopenia (unknown), multi-organ failure (unknown), iatrogenic infection (unknown), enterobacter cloacae infection (unknown), respiratory tract infection (unknown), urinary tract infection pseudomonal (unknown), Stenotrophomonas sepsis (unknown), thrombocytopenia (unknown), leukopenia (unknown) and lung consolidation (unknown). The reported cause of death was varicella. It was unknown if the investigator considered the varicella, fever, shortness of breath, face edema, petechial rash, hypotension, pneumonia, acute respiratory distress syndrome, pancytopenia, multi-organ failure, iatrogenic infection, enterobacter cloacae infection, respiratory tract infection, urinary tract infection pseudomonal, Stenotrophomonas sepsis, thrombocytopenia, leukopenia and lung consolidation to be related to DTP (A or W not known) vaccine and Hib vaccine. Diagnostic results (unless otherwise stated, normal values were not provided): On 14th March 2009, Varicella virus test result was Positive absent. On an unknown date, Aspiration bone marrow result was no evidence of leukaemia absent. On an unknown date, Blood culture result was Negative absent. On an unknown date, Blood culture result was Positive for Stenotrophomonas maltophilia absent. On an unknown date, Body temperature result was 101.1 degree F. On an unknown date, Chest X-ray result was Alveolar consolidation absent. On an unknown date, Computerised tomogram result was no intracranial lesions absent. On an unknown date, Electroencephalogram result was excluded subclinical seizures absent. On an unknown date, Platelet count result was 30,000 /mcL. On an unknown date, White blood cell count result was 1,400 /mcL. Additional information received: This case was reported in a literature article and it described the occurrence of a varicella infection in a 15-year-old female patient who had been vaccinated with unspecified DTP vaccines, unspecified Hib vaccine and unspecified MMR vaccines (manufacturers unknown). The patient had been healthy prior to the event and had no known underlying medical conditions according to the authors. She lived in a community with low rates of varicella vaccination and the source individual was never identified. No further information on the patient''s medical or family history, concurrent medical conditions or concomitant medication was provided. On an unspecified dates, the patient received 4 doses of an unspecified DTP vaccine, 1 dose of an unspecified Hib vaccine and 2 doses of an unspecified MMR (administration routes and sites unspecified; dosages unknown, batch numbers not provided). Please note that the authors commented that she had not been vaccinated against varicella. On 12 March 2009, an unknown period after the vaccinations she was admitted to hospital with a 3-day history of a rash consistent with varicella and a 1-day history of fever and shortness of breath. Upon examination on admission, she was noted to be awake and alert, febrile (101.1 deg. F) dyspnoeic, had facial oedema, generalized petechial rash and hypotension; so she was diagnosed with septic shock. She was initially placed on non-invasive mechanical ventilation, but her respiratory function continued to deteriorate and she required invasive mechanical ventilation after 6 hours. In addition to this, she later developed pneumonia complicated by acute respiratory distress syndrome, pancytopenia, multi-organ dysfunction, iatrogenic colonization and infection (respiratory tract colonization with Enterobacter cloacae and urinary tract infection with Pseudomonas aeruginosa) and sepsis. Further deterioration of her respiratory function require progressively higher levels of oxygen and pressure during her last week in hospital. She died on day 21 of admission. Varicella was recorded as the underlying cause of death, and this was validated by an investigation performed by the state Department of Health. The authors did not mention if a post-mortem had been performed. Laboratory tests performed on admission revealed thrombocytopenia (platelet count: 30,000/mcL) and leucopoenia (white blood cell count: 1,400/mcL). Blood cultures taken on admission were negative, but direct fluorescent antibody test performed on a sample of vesicular fluid collected on 14 March 2009 was positive for varicella-zoster virus. Blood cultures taken on hospital days 19 and 20 were positive for Stenotrophomonas maltophilia. Further blood cultures collected while she was on antibiotics were negative. In addition to this the authors commented that she had been diagnosed with Enterobacter cloacae respiratory tract colonization and Pseudomonas aeruginosa urinary tract infection, but the details of those tests were not provided. She underwent multiple chest X-Rays that showed diffuse, tiny nodules in the lung parenchyma consistent with alveolar consolidation. Computed tomography scan did not identify any intracranial lesions and electroencephalography excluded any subclinical seizures. Bone marrow aspirate obtained during her hospitalisation showed no evidence of leukaemia according to the authors. Initial treatment consisted of intravenous acyclovir (started on day 4 of illness) and broad-spectrum antibiotics and antifungals, in addition to respiratory support. She was later commenced on ciprofloxacin, meropenem, trimethoprim-sulfamethoxazole, ticarcillin-clavulanate and tigecycline. The outcome of the event was death. The authors did not comment on any causal relationship between the vaccines the patient received and this event. The authors concluded that "Severe varicella can develop among unvaccinated healthy persons, and which patients might develop an especially severe course often is unpredictable. Persons without evidence of immunity to varicella should received 2 doses of varicella vaccine or a second dose if they have received only 1 dose, to prevent varicella and its severe complications."


VAERS ID: 573481 (history)  
Form: Version 1.0  
Age: 42.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2015-02-04
Onset:2015-03-05
   Days after vaccination:29
Submitted: 2015-04-10
   Days after onset:35
Entered: 2015-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. K005402 / 2 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J013732 / 1 LA / SC

Administered by: Public       Purchased by: Unknown
Symptoms: Autopsy, Death, Multi-organ failure, Polymerase chain reaction, Sepsis, Varicella post vaccine, Varicella virus test positive
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-03-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prednisone; amLODIPine 5 MG tablet; HYDROcodone-acetaminophen 5-325 MG per tablet; sulfamethoxazole-trimethoprim 800-160 MG per tablet; aspirin 81 MG tablet; omeprazole 20 MG capsule; predniSONE 20 MG tablet; Cholecalciferol 2000 UNITS CAPS
Current Illness: Patient listed for kidney transplant on Prednisone at baseline - doses varied prior to admission to the hospital. Also noted to be on mycophenolate. Also included IgA nephropathy, hypertension, hyperlipidemia, migraines, gout
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Varicella Zoster PCR (+) on 3/3/15
CDC Split Type:

Write-up: Admitted to hospital on 2/24/15 sepsis. Varicella verified on PCR with subsequent progressive multi-organ failure. Autopsy: Cause of death 3/5/15 ? disseminated varicella - final histology pending as of 4/6/15.


VAERS ID: 573976 (history)  
Form: Version 1.0  
Age: 0.16  
Sex: Male  
Location: North Carolina  
Vaccinated:2015-04-14
Onset:2015-04-15
   Days after vaccination:1
Submitted: 2015-04-15
   Days after onset:0
Entered: 2015-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS E443F / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. K008879 / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J49844 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. K006805 / UNK MO / PO

Administered by: Unknown       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: 2015-04-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: Umbilical hernia
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Found unresponsive.


VAERS ID: 575996 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-04-23
Entered: 2015-04-29
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic shock, Death, Pharyngeal oedema
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: UNK
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2015SA050399

Write-up: Initial unsolicited case received from a health care professional on 14 April 2015. A female patient (confidential), whose medical history and concomitant medications were not reported, had received a dose of Influenza Vaccine (batch number, route and site of administration were not reported) on unspecified date. On unspecified date, the patient experienced a severe reaction, swollen throat and anaphylactic shock and died while using the vaccine. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the events was fatal. Documents held by sender: None.


VAERS ID: 576026 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-04-29
Entered: 2015-04-29
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 creatinine increased, Blood pressure normal, Body temperature increased, Brain natriuretic peptide increased, Chest X-ray abnormal, Death, Dyspnoea, Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram T wave inversion, Electrocardiogram normal, Endotracheal intubation, General physical health deterioration, Heart rate normal, Hypoxia, Influenza, Influenza A virus test positive, Influenza like illness, Mechanical ventilation, Polyuria, Pulmonary congestion, Rales, Respiratory alkalosis, Respiratory distress, Resuscitation, Stress cardiomyopathy, Tachycardia, Troponin increased, Vaccination failure, Ventricular arrhythmia, Ventricular hypokinesia, X-ray abnormal
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (narrow), Eosinophilic pneumonia (broad), Other ischaemic heart disease (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Tubulointerstitial diseases (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (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, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: 5-Azacytidine
Current Illness: Hypertension; Hyperlipidaemia; Myelofibrosis; Acute myeloid leukaemia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 3 months after vaccination, nasopharyngeal swab was taken that was positive for influenza A antigen of the H3N2 strain. At admission, upon initial examination, she was noted to have important respiratory distress with laboured respiration, her temperature was 103.4 deg. F, her respiratory rate was 31 rpm and her oxygen saturation was 88% on air and 92% on a non-rebreather mask. According to the authors, her blood pressure and heart rate were within normal limits and her pulmonary auscultation was unremarkable. Her initial chest x-ray and electrocardiogram were unrevealing, but when repeated after 3 days the X-ray showed pulmonary vascular congestion and left basilar airspace disease; and the electrocardiogram showed new T-wave inversions in V3 to V6. Her cardiac troponin level was 1.949 ng/mL, creatinine was 1.3 mg/dL and brain natriuretic peptide was 2224 pg/mL. She underwent a bedside echocardiogram performed by a cardiologist that revealed a reduced left ventricular ejection fraction (30%) and severe hypokinesis of all mid to distal walls and apex.
CDC Split Type: US2015GSK057792

Write-up: This case was reported in a literature article and described the occurrence of death in a 84-year-old female patient who received Influenza vaccine. Concurrent medical conditions included hypertension, hyperlipidemia, myelofibrosis and acute myeloid leukemia. Concomitant products included 5-Azacytidine. On an unknown date, the patient received influenza vaccine (unknown). On an unknown date, 91 days after receiving influenza vaccine, the patient experienced death (serious criteria death and GSK medically significant), takotsubo cardiomyopathy, vaccination failure (serious criteria GSK medically significant), influenza (serious criteria hospitalization), respiratory distress (serious criteria hospitalization and GSK medically significant), labored respiration (serious criteria hospitalization), tachycardia, crackles lung, hypoxia (serious criteria GSK medically significant), respiratory alkalosis, ventricular arrhythmia (serious criteria GSK medically significant) and lung congestion (serious criteria GSK medically significant). The patient was treated with oseltamivir, operations and procedures (intubation), non-drug therapy (ventilation) and non-drug therapy (cardiopulmonary resuscitation). On an unknown date, the outcome of the death was fatal and the outcome of the takotsubo cardiomyopathy, vaccination failure, influenza, respiratory distress, labored respiration, tachycardia, crackles lung, hypoxia, respiratory alkalosis, ventricular arrhythmia and lung congestion were unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death, takotsubo cardiomyopathy, vaccination failure, influenza, respiratory distress, labored respiration, tachycardia, crackles lung, hypoxia, respiratory alkalosis, ventricular arrhythmia and lung congestion to be related to influenza vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of a vaccination failure in an 84-year-old female patient who had received unspecified seasonal influenza vaccine (manufacturer unknown). Concurrent conditions included hypertension, hyperlipidemia, myelofibrosis and associated acute myeloid leukemia. Concomitant medication included chemotherapy of which she had received the last cycle with 5-Azacytidine 3 weeks before the event. No further information on the patient''s concurrent medical conditions, medical and family history or concomitant medication was provided. On unspecified dates, the patient received a dose of unspecified seasonal influenza vaccine (dosage unknown; administration route unspecified; batch number not provided). On an unspecified date, approximately 3 months after the vaccination, the patient developed flu-like symptoms. She was seen at the oncology clinic 3 days later where a nasopharyngeal swab was taken that was positive for influenza A antigen of the H3N2 strain. Despite antiviral treatment, she required admission to hospital 2 days later due to respiratory distress and deterioration of the symptoms. Upon initial examination, she was noted to have important respiratory distress with laboured respiration; her temperature was 103.4 deg. F, her respiratory rate was 31 rpm and her oxygen saturation was 88% on air and 92% on an non-rebreather mask. According to the authors, her blood pressure and heart rate were within normal limits and her pulmonary auscultation was unremarkable. The patient seemed to improve with the continuation of the treatment on the following days; but 3 days after admission she required intubation and mechanical ventilation as she had become acutely short of breath, tachycardic with bibasilar crackles on auscultation, hypoxic and was noted to have respiratory alkalosis. After further examination she was first believed to have acute coronary syndrome but she was finally diagnosed with Takotsubo cardiomyopathy. However she developed a ventricular arrhythmia and she died on day 4 of hospitalisation despite aggressive medical treatment and cardiopulmonary resuscitation. This case was considered serious as it had a fatal outcome. Cause of death was unspecified, it was unknown if a post-mortem was performed. Her initial chest x-ray and electrocardiogram were unrevealing, but when repeated after 3 days the X-ray showed pulmonary vascular congestion and left basilar airspace disease; and the electrocardiogram showed new T-wave inversions in V3 to V6. Her cardiac troponin level was 1.949 ng/mL, creatinine was 1.3 mg/dL and brain natriuretic peptide was 2224 pg/mL. She underwent a bedside echocardiogram performed by a cardiologist that revealed a reduced left ventricular ejection fraction (30%) and severe hypokinesis of all mid to distal walls and apex. According to the authors, these results were suggestive of apical ballooning syndrome or Takotsubo cardiomyopathy. Initial treatment consisted of oral oseltamivir that was started at her oncology outpatient clinic. She later required intubation and mechanical ventilation, dieresis, unspecified medical management and unspecified cardiopulmonary resuscitation. The authors did not comment on any causal relationship between the events and the vaccination. The authors concluded that "Influenza A infection has rarely been linked to the development of Takotsubo cardiomyopathy. Excessive catecholamine release is believed to play a role in the pathogenesis and the treatment is largely empirical and supportive. Although Takotsubo cardiomyopathy -related mortality rates are low (1-3.2%), patients with associated severe infections such as influenza have a worse prognosis. Identifying influenza patients with higher mortality risks may allow for more favourable clinical outcomes in these patients".


VAERS ID: 576576 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-05-04
Entered: 2015-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Antibody test negative, Back pain, Blood culture, Capillary nail refill test abnormal, Death, Hepatitis, Intensive care, Lymphocyte count decreased, Lymphopenia, Multi-organ failure, Polymerase chain reaction positive, Poor peripheral circulation, Pyrexia, Rash, Rash vesicular, Vaccination failure, Varicella post vaccine, Varicella virus test positive
SMQs:, Hepatitis, non-infectious (narrow), Anaphylactic reaction (broad), Haematopoietic leukopenia (narrow), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Dehydration (broad), Sepsis (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Chemotherapy; T-cell type acute leukaemia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lymphocytes on admission (date unspecified): 200 count/mm2, showed lymphocytopenia. Polymerase chain reaction, virus was wild type VZV
CDC Split Type: WAES1505USA000487

Write-up: Information has been received from a published literature article. The patient in this case was a 15-year-old male patient with T-cell precursor acute lymphoblastic leukemia undergoing re-induction chemotherapy. His immunization records from school revealed that the boy had received one varicella vaccination (manufacturer unknown, lot #, dose and route were not reported) when he was 5 years old but none thereafter; he was up-to-date on other vaccines. We defined Day 1, as the day when the patient presented to the Emergency Department for fever and a sharp stabbing back pain. He had blood cultures drawn and received levofloxacin. On Day 2, he presented again with high fever and decreased peripheral perfusion, with prolonged capillary refilling time. Thus, he was admitted to the Pediatric Intensive Care Unit (PICU) and received intravenous antibiotics. Laboratory data on admission showed lymphocytopenia (200 count/mm2). After his general condition was stabilized, the re-induction chemotherapy regimen with vincristine, doxorubicin, asparaginase, and dexamethasone (manufacturer unknown) was resumed. On Day 3, he developed a non-vesiculated acne-like rash, believed to be related to the high dosage of dexamethasone (manufacturer unknown), based on its appearance. On Day 7, the rash started to vesiculate. Vesicular fluid was obtained and Varicella-Zoster Virus (VZV) deoxyribonucleic acid (DNA) was detected with polymerase chain reaction (PCR) analysis. Intravenous acyclovir was started. On Day 9, he developed hepatitis, which subsequently progressed to multi-organ failure and death. DNA analysis of the PCR product from the vesicle indicated that the virus was wild type VZV (5). VZV antibody titers were never obtained. The authors considered the event as vaccination failure and the patient died of disseminated varicella. This is one of 2 reports received from the same literature (other case # 1505USA000527). Additional information has been requested.


VAERS ID: 576747 (history)  
Form: Version 1.0  
Age: 0.11  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2015-04-21
Onset:2015-04-23
   Days after vaccination:2
Submitted: 2015-04-30
   Days after onset:7
Entered: 2015-05-05
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. K009953 / 2 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-04-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: No known adverse event.


VAERS ID: 576974 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2014-10-08
Onset:2014-10-09
   Days after vaccination:1
Submitted: 2015-05-01
   Days after onset:204
Entered: 2015-05-06
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1412301 / 1 AR / SYR

Administered by: Private       Purchased by: Unknown
Symptoms: Autoimmune disorder, Death, Eating disorder, Respiratory disorder
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2015-03-25
   Days after onset: 167
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: Mild rash-new detergent
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Medical records included
CDC Split Type:

Write-up: After flu shot developed autoimmune disease which kept her from eating and eventually her airway which led to her death 3-25-15.


VAERS ID: 577000 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Indiana  
Vaccinated:2005-03-09
Onset:2005-03-10
   Days after vaccination:1
Submitted: 2015-05-06
   Days after onset:3708
Entered: 2015-05-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HEPAB: HEP A + HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-03-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No.
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death.


VAERS ID: 577134 (history)  
Form: Version 1.0  
Age: 88.0  
Sex: Female  
Location: Maryland  
Vaccinated:2015-04-28
Onset:2015-04-28
   Days after vaccination:0
Submitted: 2015-05-05
   Days after onset:7
Entered: 2015-05-07
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L36485 / 1 UN / UN

Administered by: Private       Purchased by: Other
Symptoms: Cardiac arrest, Death, Resuscitation, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (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), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-04-29
   Days after onset: 1
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: Cardiac failure congestive, for at least 10-20 years; Hypertension, for at least 10-20 years; Hyperlipidaemia, for at least 10-20 years; Coronary artery disease, for at least 10-20 years; Cerebrovascular accident, for at least 10-20 years; Bedridden; Hip fracture; Weight decreased; White blood cell count increased
Allergies:
Diagnostic Lab Data: Blood work (date unspecified) Elevated white blood cell count
CDC Split Type: 2015149445

Write-up: This is a spontaneous report from a contactable physician. An 88-year-old female patient received PREVNAR 13 (Lot # L36485, Exp. date 01Oct2016, NDC code 00005197101), via an unspecified route of administration at 0.5 ml, single on 28Apr2015. Medical history included congestive heart failure, hypertension, hyperlipidemia, coronary artery disease and stroke. The patient had these medical conditions for at least 10-20 years. Patient was bedbound or wheelchair bound prior to receiving the vaccine. Blood work revealed elevated white blood cell count. Reporter said that she broke her hip, wasn''t able to stand on the scale, and had lost a lot of weight. The patient''s concomitant medications were not reported. On 28Apr2015, the patient experienced cardiac arrest. Therapeutic measures were taken as a result of cardiac arrest. The patient died on 29Apr2015. It was not reported if an autopsy was performed. The event was described as follows: about a half an hour after the vaccination, she had a cardiac arrest. Reporter did not witness the event. Patient had an arrest, and emergency was called. They resuscitated her and brought to the ER. She arrested again in the ER. Patient just saw reporter for a follow-up visit and reporter decided to give her the vaccine. The reporter called because she was wondering if it was an anaphylactic reaction to the PREVNAR or if there have been any similar reports, she stated she can''t prove or disprove that is what happened, but it is a possibility.


VAERS ID: 577375 (history)  
Form: Version 1.0  
Age: 0.82  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2015-04-15
Onset:2015-04-15
   Days after vaccination:0
Submitted: 2015-04-30
   Days after onset:15
Entered: 2015-05-08
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4743AA / 3 LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. K009953 / 3 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J75278 / 3 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-04-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: See attached
Current Illness: Cough
Preexisting Conditions: Krabbe''s Leukodystrophy -$g see attached
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: No known adverse event.


VAERS ID: 577427 (history)  
Form: Version 1.0  
Age: 0.26  
Sex: Female  
Location: Arkansas  
Vaccinated:2015-05-04
Onset:2015-05-05
   Days after vaccination:1
Submitted: 2015-05-08
   Days after onset:3
Entered: 2015-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS NM75A / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UI161AAB / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L13517 / 1 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CB466A / 1 MO / PO

Administered by: Public       Purchased by: Public
Symptoms: Autopsy, Bed sharing, Death, Irritability
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-05-05
   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:
Current Illness: None
Preexisting Conditions: Prenatal diagnosis of Dandy-Walker Variant noted on U/S 1/22/2015; U/S Doppler of head results after birth- Prominent cisterna magnum at the vermis, otherwise normal.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: The infant received Pediarix, ActHIB, PCV13 and Rotarix on 5/4/2015 at 3:35pm. No immediate issues post-vaccination in the clinic. The infant was found deceased the next morning, 5/5/2015. The coroner reported onset of rigor mortis upon arrival to pick infant up and approximate time of death 4-6 hours previously. The infant was sent to the Medical Examiner for autotopsy. The parents reported the infant had mild irritability/fussiness about 72 hours prior to death but no fever, diarrhea, oral intolerance, flaccidity or seizures. No history of seizures. The autopsy was essentially normal with no findings that would explain an acute death. The Medical Examiner did report that the child was co-sleeping between the two parents with heavy adult sized bedding.


VAERS ID: 577882 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Male  
Location: Texas  
Vaccinated:2014-09-22
Onset:2014-09-22
   Days after vaccination:0
Submitted: 2015-05-12
   Days after onset:232
Entered: 2015-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4539AA / 1 UN / UN
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 7SN99 / 2 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H65735 / 1 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. K007444 / 1 MO / PO

Administered by: Unknown       Purchased by: Private
Symptoms: Death, Diet refusal, Laboratory test, Mobility decreased, X-ray
SMQs:, Parkinson-like events (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2014-11-16
   Days after onset: 55
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 30 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: No medicine
Current Illness: After vaccination, my baby stop sleeping on side and most of the time he is on your back. He started giving up on feeding. He was on exclusively breast feeding. He started refusing feeding.
Preexisting Conditions: No other condition diagnosed before it. He had all the regular check up since his birth.
Allergies:
Diagnostic Lab Data: X-ray, and all other lab test (hospital has all the reports)
CDC Split Type:

Write-up: After day of vaccination, all of sudden he started giving up on feeding and stop turning on side. That never happen before vaccinations. His growth percentile was perfect at his 2 months pediatric visit (the day he got his 2 months vaccines).


VAERS ID: 577926 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-05-12
Entered: 2015-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Death, Epstein-Barr virus infection
SMQs:, 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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Bone marrow transplant; Lymphoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1505USA002898

Write-up: This spontaneous report was received from a pharmacist via company representative concerning a patient of unknown age and gender. The patient''s medical history included an unspecified lymphoma and bone marrow transplant (date was not provided). On an unknown date, the patient was vaccinated with ZOSTAVAX, subcutaneously (anatomical location, dose, strength and lot number were not provided). Co-suspect or concomitant therapies were not provided. On an unknown date, after receiving ZOSTAVAX, the patient died of possible complications of Epstein Barr Syndrome, it was unknown if an autopsy was performed. The patient sought medical attention through an office visit. No product quality complaint was involved. At the time of the report, the outcome of Epstein-Barr virus infection was fatal. the causal relationship between Epstein-Barr virus infection/death and vaccination with ZOSTAVAX was unknown. Additional information has been requested.


VAERS ID: 578421 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2015-05-11
Onset:2015-05-14
   Days after vaccination:3
Submitted: 2015-05-15
   Days after onset:1
Entered: 2015-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS G4R2R / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. K025004 / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L13522 / UNK LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. L004453 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-05-14
   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: Zantac
Current Illness:
Preexisting Conditions: Treated for reflux with Zantac
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Infant found dead at home.


VAERS ID: 578479 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Missouri  
Vaccinated:2015-01-10
Onset:2015-01-19
   Days after vaccination:9
Submitted: 2015-05-15
   Days after onset:115
Entered: 2015-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J75277 / UNK RA / IM

Administered by: Military       Purchased by: Military
Symptoms: Death, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2015-02-15
   Days after onset: 27
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Thyroid, Simvastatin 10 mg, Vytorin, albuterol sulfate
Current Illness: Emphysema
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type:

Write-up: Difficulty breathing taken to hospital SAO2 level 75 put on 15 liters O2 sent home on the 01/22/2015.


VAERS ID: 578511 (history)  
Form: Version 1.0  
Age: 59.0  
Sex: Male  
Location: Unknown  
Vaccinated:2014-10-29
Onset:2015-05-11
   Days after vaccination:194
Submitted: 2015-05-18
   Days after onset:7
Entered: 2015-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. K010645 / UNK LA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-05-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1505USA006373

Write-up: This spontaneous report was received from a pharmacist via a company representative refers to a 60 year old male patient. On an unknown date the patient was vaccinated with ZOSTAVAX (lot # and expiry unknown). The company representative read in the newspaper dated 14-MAY-2015, that was released on 13-MAY-2015, that a patient passed away on 11-MAY-2015, because of "complications due to a disseminated zoster virus". The representative stated that his wife overheard some unspecified individuals discussing the patient''s death and mentioned that the patient had received one dose of ZOSTAVAX. Another company representative reported that a pharmacist had reported to him that the same patient had died after receiving the ZOSTAVAX. Causality of event was not reported. Additional information has been requested.


VAERS ID: 579462 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-05-26
Entered: 2015-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Antibody test abnormal, Antinuclear antibody positive, Antiphospholipid antibodies positive, Antithrombin III, Areflexia, Autopsy, Beta-2 glycoprotein antibody positive, Blood homocysteine normal, Brain hypoxia, Brain oedema, CSF glucose decreased, CSF protein increased, CSF white blood cell count increased, Coagulation factor V level normal, Complement factor C3, Complement factor C4 decreased, Complement factor decreased, Computerised tomogram abdomen abnormal, Computerised tomogram head abnormal, Corneal reflex decreased, Death, Depressed level of consciousness, Double stranded DNA antibody positive, Endotracheal intubation, Facial pain, Headache, Hyporesponsive to stimuli, Infection, Mechanical ventilation, Meningitis, Mydriasis, Nuclear magnetic resonance imaging brain abnormal, Protein C, Protein S normal, Pupillary reflex impaired, Pyrexia, Splenic infarction, Streptococcus test positive, Vomiting
SMQs:, Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Corneal disorders (narrow), Vasculitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Hospitalisation; Systemic lupus erythematosus; Antiphospholipid syndrome
Preexisting Conditions: Ulcer; Intestinal perforation
Allergies:
Diagnostic Lab Data: (Date not provided): antibody test abnormal.
CDC Split Type: WAES1505USA012186

Write-up: Information has been received from the authors of the literature report. Learning Objective #1: To diagnose splenic infarction based on radiologic findings and the importance of vaccinations and early antibiotics in asplenic patients. Learning Objective #2: To suspect and perform hypercoagulable workup in patients presenting with evidence of end organ damage (splenic infarcts and abdominal pain) due to ischemia. Case: The authors present the case of a 26 year old female with past medical history significant for stercoral ulcer, complicated by bowel perforation who presented to the Emergency Department (ED) complaining of abdominal pain, vomiting, headache, subjective fever and facial pain. She was alert and oriented in the emergency department on arrival. She was given pain medications and fluids in the ED and basic labs were ordered. Four hours after her initial presentation, the patient was obtunded and minimally responsive to commands and intubated for airway protection. On repeat physical examination, her pupils were noted to be dilated and sluggish, with no corneal, cough or gag reflex. Stat computerized tomography (CT) scan of the head was negative for acute process and she was started on broad-spectrum antibiotics for suspected infection. Stat Magnetic Resonance Imaging (MRI) of the brain was suspicious for meningitis. Lumbar puncture was positive for Streptococcus pneumoniae, with protein 924 mg/dl, glucose <10 mg/dl, and white blood cells 3120 /UL with 86% polynuclear cells. Old records were reviewed. The patient''s spleen was small in size compared to prior abdominal CT. On an initial admission CT for bowel perforation, the spleen was 8.5 cm on coronal section with wedge-shaped pattern appearing to be a splenic infarct. Three months later, on admission with meningitis diagnosis and repeat abdominal CT noted the spleen 5.5 cm on coronal section. She had received PCV (manufacturer unknown) (lot # not provided) on her previous admission with low streptococcus pneumoniae antibody response to the vaccine except for a few subsets. Pathologic report findings from her previous bowel perforation (documented as stercoral ulcer) showed ischemic mucosal injury pattern with mesenteric fat necrosis and intravascular organizing thrombi. During the prior admission, hypercoagulable workup was initiated and noted a positive antinuclear antibody (ANA) with a titer of 1:5120 and positive antiphospholipid antibodies (Lupus anticoagulant IgM 22 M units, Beta 2 Glycoprotein IgA 47 A units, Anticardiolipin IgM 39M units). The rest of the hypercoagulable workup including protein C, protein S, antithrombin III, homocysteine, and Factor V Leiden mutation was negative. Further workup revealed positive anti double stranded (ds) DNA antibody; anti Ro/SSA antibody $g8 and Anti La/SSB antibody $g8. Her C3 was normal and C4 and CH50 were low. The patient underwent 2 weeks of meningitis treatment with ventilator support without any clinical or neurological improvement. Repeat CT head was consistent with cerebral edema and anoxic changes. Goals of care were addressed with family, treatment was withdrawn and unfortunately the patient passed away. Her autopsy findings were significant for a possibly infarcted spleen which weighed 35 g. Discussion: Systemic lupus erythematosus (SLE) is a chronic inflammatory disorder characterized by multiorgan involvement. Antiphospholipid (ApL) antibodies are positive in 33% of patients with SLE. Antiphospholipid antibody syndrome (APS) is an acquired thrombophilia, caused by autoantibodies to beta 2 glycoprotein, lupus anticoagulant or anticardiolipin. Splenic involvement is seen in 9-20% of patients with SLE. Auto splenectomy can occur in patients with SLE due to vasculitis or due to splenic artery thrombosis. Splenic artery thrombosis is more commonly seen in patients with positive ApL antibodies. Thrombocytosis along with presence of Howell Jolly bodies, target cells, ovalocytes and spherocytes on peripheral smear, and evidence of atrophic spleen on imaging studies are imperative tip-offs of autosplenectomy among these patients. Asplenic patients must be vaccinated against encapsulated organisms. Prompt initiation of antibiotics in asplenic patients with symptoms suggestive of infection; along with vaccination; have shown to reduce mortality. Mesenteric vasculitis and infarction are life threatening lower gastrointestinal manifestations of SLE. These patients may develop necrotic bowel segments, sepsis or perforation of their intestine. Patients with SLE can also develop thrombosis causing an acute presentation of the disease; more commonly seen among patients with coexisting APS. Autoimmune conditions, particularly SLE and APS are known causes of hypercoagulable state along with other hematologic conditions. Young patients with pathology findings suggestive of ischemia and vascular thrombosis must undergo a hypercoagulable workup, as early detection of these conditions and initiation of anticoagulants may decrease morbidity and mortality among these patients. Additional information has been requested.


VAERS ID: 579761 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-05-29
Entered: 2015-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 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: WAES1505USA013958

Write-up: This unconfirmed spontaneous report was received from a consumer and refers to two patients (children) (unspecified) of unknown age and gender. The consumer read in some publication or article, that on an unknown date, a couple of the children were vaccinated with Hepatitis B vaccine (manufacturer unknown) or a couple of other (unspecified) vaccines (route of administration, doses, lot number and expiry dates were not reported). On an unknown dates, after the vaccination, an unspecified number of the patients died. The cause of death was not reported. The relatedness between the vaccinations and death was not reported. Additional information has been requested.


VAERS ID: 580234 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Female  
Location: North Carolina  
Vaccinated:2015-05-28
Onset:2015-05-29
   Days after vaccination:1
Submitted: 2015-06-03
   Days after onset:5
Entered: 2015-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4743AA / 1 LL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS KZ9ZC / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J23862 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. K016260 / 1 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Brain injury, Cardiac arrest, Cardio-respiratory arrest, Computerised tomogram head abnormal, Crying, Death, Diarrhoea, Diet refusal, Dyspnoea, Endotracheal intubation, Hypophagia, Hypotonia, Intensive care, Resuscitation, Somnolence
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), 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), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-05-31
   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: Had had "cold symptoms" that were improved at time of vaccines
Preexisting Conditions: 31 week prematurity
Allergies:
Diagnostic Lab Data: No relevant labs as labs were secondary to "cardiac arrest"; head CT -$g c/w severe anoxic brain injury
CDC Split Type:

Write-up: This information is regarding the description of adverse events and treatment. Most of the information is basically being obtained from the pediatric intensivist information when the child was in the pediatric intensive care unit. At the time of vaccination, which was on May 28, 2015 Mom stated that her daughter had some cold symptoms that had actually gotten better. She was otherwise doing well. She did well the day of the vaccines and her visit for the well check with no issues nor significant exam findings. She apparently on May 29, 2015, the following day, decreased her oral intake and slept a lot during the day. At 1830 in the evening she had normal feed and went to sleep after 2 loose stools. At 2100 she refused to feed and was not crying and was limp. Once Mom put her in the car seat she was alert and looking around, crying, and kicking and at 2200 she went to sleep. On May 30, 2015 the mother woke her up at 8 o''clock in the morning and she began "gasping" and was limp after 1 ounce of formula feeding. The mother assessed or believed the child to be in cardiopulmonary arrest and started CPR. The EMS was called and intubated her and gave her epinephrine and continued CPR. She was taken to the local emergency room and then taken to the referral center with the pediatric intensive care unit.


VAERS ID: 580653 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2014-03-07
Onset:2014-03-07
   Days after vaccination:0
Submitted: 2015-06-05
   Days after onset:454
Entered: 2015-06-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Atrial septal defect, Cardiac murmur, Cardiomyopathy, Death, Foetal exposure during pregnancy, Hypotension, Labelled drug-drug interaction medication error, Metabolic acidosis, Respiratory distress, Sepsis, Shock, Tachycardia
SMQs:, Anaphylactic reaction (narrow), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Respiratory failure (narrow), Medication errors (narrow), 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: 2014-03-09
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZOFRAN; VALTREX; Epidural
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 2013, Heart rate, 156/min
CDC Split Type: US2015074999

Write-up: This retrospective pregnancy case was reported by a consumer via call center representative and described the occurrence of cardiomyopathy in a neonate female patient exposed to Hepatitis B vaccine at birth. The baby received the product. Co-suspect product exposures included ZOFRAN solution for injection/infusion and VALTREX unknown. The parent''s medical history included nausea and vomiting (The patient took ZOFRAN), cough and live birth (The patient had 2 previous pregnancies. Babies were born healthy). In 2013, the mother started ZOFRAN (intravenous) 4 mg at an unknown frequency. In January 2014, the mother started VALTREX (unknown) at an unknown dose and frequency. The patient experienced a drug exposure during pregnancy. The mother''s last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. In 2013, during her pregnancy, she had an ultrasound antenatal screen which showed a single fetus in a longitudinal lie, breech presentation. The amount of the amniotic fluid was normal. The placenta was anterior. Good fetal cardiac and extremity motion were seen. The fetus had a biparietal diameter of 5.7cm, a femur length of 4.2cm, both consistent with the gestational age of 23 weeks and 3 days. Head abdomen ratio was 1.16 and fetal heart rate was 156 beats per minute. The estimated weight based on this exam was 599+/-90g. Concomitant product exposures included medication unknown (Epidural). The neonate received Hepatitis B vaccine. At 41 weeks gestation, the patient was born via unknown delivery and weighed 2855 grams (6lbs 5oz) at birth. APGAR scores were 8 and 9, her length was 46cm and her head circumference was 33cm. Within 2 hours after the vaccination with Hepatitis B vaccine, the patient experienced cardiomyopathy (serious criteria death), shock (serious criteria death and GSK medically significant), sepsis (serious criteria GSK medically significant), respiratory distress (serious criteria GSK medically significant), tachycardia, heart murmur, metabolic acidosis and hypotension. On an unknown date, the patient experienced labeled drug-drug interaction medication error. The patient was treated with ATIVAN, phytonadione, aeptimyoclin, gentamicin, alprostadil, sodium chloride, hydrocodone bitartrate, Hydrocodine, ZOVIRAX, dopamine, epinephrine, Cefotaxima, milrinone, poractant alfa, vecuronium, sodium acetate and glucose + water (D5W). On 7th March 2014, the outcome of the drug exposure during pregnancy was unknown. On 9th March 2014, the outcome of the cardiomyopathy and shock were fatal. On an unknown date, the outcome of the sepsis, respiratory distress, tachycardia, heart murmur, metabolic acidosis, hypotension and labeled drug-drug interaction medication error were unknown. The patient died on 9th March 2014. The reported cause of death was cardiomyopathy and shock. It was unknown if the reporter considered the cardiomyopathy, shock, sepsis, respiratory distress, tachycardia, heart murmur, metabolic acidosis, hypotension, labeled drug-drug interaction medication error and drug exposure during pregnancy to be related to Hepatitis B and VALTREX. The reporter considered the cardiomyopathy, shock, labeled drug-drug interaction medication error and drug exposure during pregnancy to be related to ZOFRAN. It was unknown if the reporter considered the sepsis, respiratory distress, tachycardia, heart murmur, metabolic acidosis and hypotension to be related to ZOFRAN and VALTREX. Additional details were provided as follow from the legal department: The mother was taking ZOFRAN injection after going to the hospital at the beginning of the pregnancy for nausea and vomiting. The mother was sent home with one pill to take after leaving the hospital. She was given a prescription for the product that she did not fill. The baby was fine all through the pregnancy. The patient was given the product during the same time she was receiving an epidural. A healthy baby girl was born with no problems. The baby weighed six pounds and five ounces. The baby''s APGAR scored was noted as being 8/9 after birth in the medical records. The overall health of the baby after birth was good. The baby had ZOFRAN in her system and within two hours after giving birth, the baby started to have side effects (tachycardia, respiratory distress, cardiomyopathy and metabolic acidosis). The baby''s heart started to deteriorate and APGAR score began to fall. The baby suffered from tachycardia and then cardiomyopathy. During the time span from birth until March 9, 2014 the baby had metabolic acidosis before death. The doctor tried to counteract ZOFRAN with ATIVAN. After 2 days, the baby passed away from cardiomyopathy and irreversible shock. According to the death certificate the cause of death is listed as metabolic irreversible shock and did not put metabolic acidosis on the certificate. The mother also mentioned that the left ventricle was shortened and there was a hole in the heart. The mother noted all of the medications her daughter was given after birth and during the time she was in the hospital before her death. The mother believes that being given ZOFRAN by injection during the epidural was the cause of the heart problems her daughter experienced after birth leading to her death. The mother has been doing research to find out more information about the medications and possible drug interactions with the product. It is not known if she was given the generic or brand but believes that she received the brand name when she went to the hospital during the first trimester with her daughter. In her research, the mother noted that ZOFRAN and erythromycin has a drug interaction that can cause a serious reaction that can cause death. The hepatitis B vaccine can also cause a drug interaction with ZOFRAN. This is a legal significant cause according to the mother.


VAERS ID: 580758 (history)  
Form: Version 1.0  
Age: 88.0  
Sex: Female  
Location: Florida  
Vaccinated:2015-05-20
Onset:2015-05-20
   Days after vaccination:0
Submitted: 2015-06-07
   Days after onset:18
Entered: 2015-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 LA / UN

Administered by: Private       Purchased by: Other
Symptoms: Blood test, Body temperature increased, Chest X-ray, Chills, Computerised tomogram, Disorganised speech, Dysarthria, Dyspnoea, Echocardiogram, Irritability
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2015-06-09
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 21 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: My mother was on many medications and the list will have to be obtained from the pharmacy or her doctors I cannot answer the above question in 5 of 5, they will have to be gotten from the doctors and the hospital.
Current Illness: Heart Patient, Pacemaker, Kidney Patient, High Blood Pressure, Myeloma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: A number of test were administered: Blood Test, CT Scan, Chest X-Ray, TEE
CDC Split Type:

Write-up: Temperature of 103, Chills, scrambled speech, Irritable, Problems breathing.


VAERS ID: 580878 (history)  
Form: Version 1.0  
Age: 0.24  
Sex: Female  
Location: California  
Vaccinated:1990-05-19
Onset:1990-05-19
   Days after vaccination:0
Submitted: 2015-06-08
   Days after onset:9151
Entered: 2015-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / -
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / -
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / -

Administered by: Private       Purchased by: Other
Symptoms: Cold sweat, Crying, Death, Decreased appetite, Laboratory test, Lethargy, Pallor
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1990-05-21
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Patient was on nothing else...
Current Illness: Patient had been mildly ill about a month prior to her vaccinations. She was healthy for several weeks prior to vaccination.
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Too dang many to list you are welcome to get her records
CDC Split Type:

Write-up: My daughter got her vaccines and within hours was lethargic, no appetite, clammy to the touch, whimpering and pale.


VAERS ID: 581306 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-06-10
Entered: 2015-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

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: WAES1506USA004766

Write-up: This spontaneous report was received from a Licensed Practical Nurse who obtained the information from the web site where read an article which refers to two baby patients of unknown ages and genders. Concurrent conditions or pertinent medical history were not reported. On unknown date the patients were unsafe administer with a dose of hepatitis b vaccine (recombinant) (manufacturer unknown), rotavirus vaccine, live, oral, pentavalent (manufacturer unknown) orally, and BCG (manufacturer unknown) (lot #, expiration date, route of administration (for hepatitis B vaccine (recombinant) and BCG)) and doses were not reported for either vaccines). On unspecified dates, the two babies died (due to an unspecified reason) after receiving those vaccines. It was unknown if autopsy was performed. The nurse also mentioned that the consumer was now scared about having her child vaccinated in other country, therefore, the nurse would like to know any comparative information between the vaccines produced in different countries as lot#s and ingredients used or if those vaccines were in question. The relatedness of the suspected vaccines with death was not reported. This is one of several reports from the same source. Additional information has been requested.


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