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VAERS ID: 659587 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-10-17
Entered: 2016-10-17
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
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2016SA188839

Write-up: Initial unsolicited report received from a consumer via social media on 10 Oct 2016. This case is linked to 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851. (Same reporter source, same vaccine). This case involves a male patient (age not reported) who was vaccinated with a dose of Flu shot (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. The patient''s medical history and concomitant medications were not reported. On an unknown date, 30 hours following the vaccination, the patient died. The patient''s laboratory data and corrective treatment was not reported. It was unknown that Autopsy was performed. List of documents held by sender: none. Sender''s Comments: This is poorly documented case of death 30 hours following influenza vaccination. Time to onset is compatible but detail medical history, any co morbidity, past vaccination history leading to any severe reaction and allergic history is needed to further assess the case. Reported Cause(s) of Death: Death NOS.


VAERS ID: 660133 (history)  
Form: Version 1.0  
Age: 59.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2016-09-28
Onset:2016-09-28
   Days after vaccination:0
Submitted: 2016-10-18
   Days after onset:20
Entered: 2016-10-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UI669AA / 4 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-09-29
   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: Unknown
Current Illness: None
Preexisting Conditions: HTN, hyperlipidemia, chronic bronchial Asthma, anxiety disorder, depression, rt shoulder rotator cuff 2005, smoker
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type:

Write-up: Unknown. It was reported to us 2 days later that patient went to the hospital and died 9/29/2016.


VAERS ID: 660712 (history)  
Form: Version 1.0  
Age: 92.0  
Sex: Male  
Location: West Virginia  
Vaccinated:2016-10-11
Onset:2016-10-12
   Days after vaccination:1
Submitted: 2016-10-21
   Days after onset:9
Entered: 2016-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UI659AB / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Areflexia, Axonal neuropathy, CSF test normal, Death, Electromyogram abnormal, Guillain-Barre syndrome, Herpes simplex test negative, Immunoglobulin therapy, Intensive care, Muscular weakness, Nerve conduction studies abnormal, Peripheral sensorimotor neuropathy, Respiratory rate decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Respiratory failure (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-10-20
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Weakness
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Not aware of any
CDC Split Type:

Write-up: This is a 92 y.o., male a 92 year old male with past medical history of hypothyroidism, HTN, HLD, IBC, vitamin D deficiency, and anemia who presented with a complaint of progressive weakness in all four extremities x 2 days prior to presentation. Given concurrent absence of reflexes and progressive extremity weakness S/P recent immunization (flu shot), a 5 day course of IVIG was started and completed for a presumptive diagnosis of AIDP. As part of his evaluation, EMG/NC was remarkable for sensorimotor peripheral neuropathy with axonal an demyelinating features. No temporal dispersion or conduction block at this time, per report. A Lumbar puncture was obtained. CSF studies was not consistent with an infection so far, his HSV was also negative. The lumbar puncture was a difficult and traumatic tap with limited CSF fluid collected. We monitored his respiratory parameters with PVC/NIF Q2hrs. On 8/18/16, his respiratory status declined requiring HFNC 100% FIO2. Given that the family had requested he be intubated if needed on a temporary basis on admission despite a Postform stating otherwise, he was transferred to the ICU. However family eventually decided that the patient would not want to be intubated/trached or PEG placed. Supportive Care was consulted to facilitate the family discussion. Following a family meeting, "they agree with the option of weaning from HFNC while keeping pt comfortable with morphine." Early morning, on 10/20/16, the on call neurology resident was paged that the "patient does not have any spontaneous respirations." He was subsequently pronounced dead at 0250 on 10/20/2016.


VAERS ID: 660763 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-10-21
Entered: 2016-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (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: WAES1610USA011603

Write-up: Information has been received from a reporter via social media concerning eight patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unspecified dates, the patients received HPV vaccine (manufacturer unknown) (lot#, expire date, dose and route unknown). On unknown dates, the patients died. It was unknown if autopsy was done. The relationship between the events and vaccine was not confirmed. Upon internal review, death was determined to be medically significant. This is one of several reports received from the same reporter. Additional information is not expected because of lack of privately contactable information for the reporter. This is a new safety report and has been created due to safety report "US-009507513-1610JPN011009" having been created with the incorrect primary source country code. Unfortunately our system is not fully ICH-E2B (R2) compliant, so US-009507513-1610JPN011009 is being nullified and we have created this new safety report ID to reflect the correct country code. US-009507513-1610JPN011009 is now listed as an E2B Report Duplicate.


VAERS ID: 660964 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-10-19
Entered: 2016-10-21
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Exposure during pregnancy, Influenza, Influenza virus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab test was performed on unknown date; Influenza virus test, positive
CDC Split Type: US2016GSK152865

Write-up: This prospective pregnancy case was reported in a literature article and described the occurrence of vaccination failure in a female subject who received Flu seasonal TIV Dresden. On an unknown date, an unknown time after receiving Flu seasonal TIV Dresden, the subject developed vaccination failure. Serious criteria included hospitalization and GSK medically significant. Additional event(s) included unknown cause of death with serious criteria of death and GSK medically significant, influenza with serious criteria of hospitalization and vaccine exposure during pregnancy. The subject was treated with TAMIFLU. The outcome of vaccination failure was unknown. The outcome(s) of the additional event(s) included unknown cause of death (fatal), influenza (unknown) and vaccine exposure during pregnancy (unknown). The pregnancy was lost to follow up. The reported cause of death was unknown cause of death. The investigator considered that there was a reasonable possibility that the vaccination failure and influenza may have been caused by Flu seasonal TIV Dresden. It was unknown if the investigator considered the unknown cause of death to be related to Flu seasonal TIV Dresden. Relevant Tests: Lab test was performed on unknown date. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Influenza virus test result was positive unknown. Additional information was provided. This prospective pregnancy case was reported in a literature article and described the occurrence of suspected vaccination failure in a female aged between 15 and 44-year old who was vaccinated with unspecified influenza vaccine (manufacturer unknown). The patient was the part of study that described the epidemiology and clinical outcomes associated with hospitalizations for laboratory-confirmed influenza among pregnant women during recent influenza seasons and to assess the impact of early initiation of influenza antiviral treatment. The patient was a pregnant female. (In this study, 24 out of 63 pregnant women with severe influenza infection were aged between 15 and 24 year, 31 aged between 25 and 34 year and 8 were between 35 and 44 years. 63 pregnant women with severe influenza infection 21 had the underlying medical condition of asthma, 7 had metabolic disease, 5 had cardiovascular disease (excluding hypertension), 4 had immunocompromised condition, 2 had blood disorders/hemoglobinopathy, 2 had neurologic/neuromuscular disease and 1 had renal disease. The patient''s last menstrual period was on an unknown date. Estimated date of delivery was on an unknown date. No information on patient''s medical history, family history or concurrent condition or concomitant medication was provided. On an unspecified date between 2010 and 2014, the patient received unspecified influenza vaccine (administration route and site unspecified; dosage unknown; batch number not provided). On an unspecified date, an unknown period after vaccination, the patient was hospitalised within 2 days of an influenza virus-positive test result. Laboratory testing for influenza virus was performed at the discretion of the clinicians providing medical care, and confirmation included a positive result of reverse transcription polymerase chain reaction analysis, rapid antigen testing, direct or indirect fluorescent antibody staining, or viral culture. Out of 63 influenza positive patients, 57 were influenza A positive, 27 were H1N1 pdm09 positive, 7 were H3N2, 6 were influenza B virus positive. Influenza associated complication among 63 pregnant patients with severe influenza infection were: 35 had pneumonia, 6 had dehydration, 12 had asthma exacerbation, 26 had sepsis/shock, 25 had respiratory failure, 9 had acute respiratory distress syndrome, 7 had acute renal failure and 4 had pulmonary embolism. This case has been considered as suspected vaccination failure as time to onset was unknown. This case was considered serious due to hospitalisation. The patient was treated with TAMIFLU. The outcome of the pregnancy was lost to follow-up. On an unspecified date, the patient died. (In this study, 3 out of 4 fatal cases were treated more than 2 days after illness onset including one who was admitted within 2 days of illness onset, the date of illness onset was unknown for 1 patient. 3 of the deaths involved women less than 35 years of age with no underlying medical conditions). It was unknown if the autopsy was done. The cause of death was unknown. The authors did not comment on the relationship between influenza infection and unspecified influenza vaccine. The authors concluded that "Pregnant women are at risk of influenza complications during seasonal influenza. Influenza virus infection during pregnancy continues to be associated with maternal and infant morbidity, including ICU admission, preterm birth, fetal loss, and maternal death. All pregnant women should receive annual influenza vaccination to prevent influenza and associated complications for themselves and their infants. Early initiation of antiviral treatment may reduce hospital length of stay, particularly among women who have a more severe influenza presentation. When influenza is suspected among pregnant women, physicians should initiate antiviral treatment early, without waiting for laboratory test results."


VAERS ID: 661043 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-10-24
Entered: 2016-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1610USA011804

Write-up: This spontaneous report was received from a physician via company representative concerning 200 patients of unknown age and gender. The physician reported that an unspecified article provided information regarding patients who on dates were vaccinated with GARDASIL and died an unspecified time after vaccination. There was no product quality complaint reported. The reporter did not provide the causality assessment for the events. the cause of death was not specified. Upon internal review death was considered to be medically significant. Additional information has been requested.


VAERS ID: 661292 (history)  
Form: Version 1.0  
Age: 47.0  
Sex: Female  
Location: New York  
Vaccinated:2013-11-08
Onset:0000-00-00
Submitted: 2016-10-18
Entered: 2016-10-25
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1308801 / UNK LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Death, Tuberculin test, Urine analysis abnormal
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-11-10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATIVAN; simvastatin; risperidone; zolpidem; ziprasidone; imipramine
Current Illness: R/O UTI
Preexisting Conditions: NKDA; Allergic rhinitis hx; Schizophrenia
Allergies:
Diagnostic Lab Data: Pt had PPD planted on 11/8/13 and positive urine dipstick
CDC Split Type:

Write-up: Patient received an influenza vaccine on 11/8/2013. Pt had no reported signs or symptoms of an adverse reaction to the vaccine. Staff was informed on 11/10/13 that pt passed away in her sleep.


VAERS ID: 661663 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Female  
Location: Oklahoma  
Vaccinated:2015-12-03
Onset:2016-01-26
   Days after vaccination:54
Submitted: 2016-10-23
   Days after onset:270
Entered: 2016-10-25
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 5C2L4 / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Amnesia, Anxiety, Arthralgia, Asthenia, Catheter placement, Chest pain, Cystitis, Death, Decreased appetite, Dehydration, Diplopia, Dyspnoea, Guillain-Barre syndrome, Headache, Hypoaesthesia, Immobile, Insomnia, Intensive care, Kidney infection, Laboratory test, Nausea, Nightmare, Paraesthesia, Paralysis, Pneumonia, Sepsis, Stress, Urinary tract infection, Vision blurred
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Demyelination (narrow), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Ocular motility disorders (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (narrow), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2016-09-05
   Days after onset: 222
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Listed on patient record
Current Illness: Chronic cough; Dyspnea
Preexisting Conditions: No allergies; No birth defects
Allergies:
Diagnostic Lab Data: Numerous. Relevant tests began at hospital on 1/26/16. Diagnosis of Guillain-Barre Syndrome made at hospital after extensive testing on 1/30/16.
CDC Split Type:

Write-up: Blurred vision, double vision, severe headache, nausea, loss of energy, loss of strength, tingling in arms, hands, legs, feet, numbness in arms, hands, legs, feet, joint pain, anxiety, stress, shortness of breath, chest pain, paralysis, indwelling catheter, permanent immobility, memory loss, loss of appetite, dehydration, insomnia, nightmares, pneumonia, kidney infection, bladder infection, urinary tract infection, sepsis. Time Course: 1/26/16 (onset of Guillain-Barre)-9/5/2016 (date of death). Treatment: Hospital confinement, intensive care unit, and rehabilitation centers provided testing, medications, and physical therapy.


VAERS ID: 661549 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Male  
Location: Indiana  
Vaccinated:2016-10-19
Onset:2016-10-19
   Days after vaccination:0
Submitted: 2016-10-24
   Days after onset:5
Entered: 2016-10-26
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UI712AA / 1 RA / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-10-19
   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:
Current Illness: Unknown
Preexisting Conditions: NKA
Allergies:
Diagnostic Lab Data: Not known
CDC Split Type:

Write-up: Patient started not feeling well. Thought it was from flu shot. Had heart attack later in evening.


VAERS ID: 661651 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Female  
Location: Maine  
Vaccinated:2016-10-24
Onset:2016-10-25
   Days after vaccination:1
Submitted: 2016-10-26
   Days after onset:1
Entered: 2016-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI673AA / UNK LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-10-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: M.S.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt received flu shot approximately 1 pm 10/24/16 - seemed healthy. No adverse response reported. Pt found deceased in bed 10/25/16 am.


VAERS ID: 662535 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Virginia  
Vaccinated:2016-10-25
Onset:2016-10-26
   Days after vaccination:1
Submitted: 2016-10-30
   Days after onset:4
Entered: 2016-10-31
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 33E9E / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N44209 / 1 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A410B569A / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-10-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None except maternal subutex and smoking
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Apparent SIDS in ED 10/26/16 AM co-sleeper may have been in use.


VAERS ID: 663733 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Female  
Location: Oklahoma  
Vaccinated:2016-10-19
Onset:2016-11-01
   Days after vaccination:13
Submitted: 2016-11-03
   Days after onset:2
Entered: 2016-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS BB3T3 / 3 LL / IM
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI669AB / 2 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. M025192 / 2 LL / IM
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. M021729 / 1 RL / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N16561 / 3 LL / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Blood pressure measurement, Cardiac arrest, Cardio-respiratory arrest, Death, Endotracheal intubation, Heart rate, Respiratory rate, Resuscitation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-11-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: KEPPRA, Phenobarbital, zinc gluconate, clonazepam, ranitidine
Current Illness: Mother noted some non-pitting edema of legs and feet
Preexisting Conditions: microcephaly - lissencephaly with severe hypogenesis of the corpus callosum. Global developmental delay with static encephalopathy. Intractable seizures. Persistent bleeding and non-healing wounds. Developmental hip dysplasia.
Allergies:
Diagnostic Lab Data: HR, BP, RR all 0. iStat unable to run arterial blood gas.
CDC Split Type:

Write-up: Full arrest noted approximately 45 minutes after being put to bed at home. EMS notified and pt was transported to ED where she was intubated, given epi and sodium bicarb. She remained in total asystole during resuscitation efforts.


VAERS ID: 663843 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Female  
Location: Mississippi  
Vaccinated:2015-10-05
Onset:0000-00-00
Submitted: 2016-10-24
Entered: 2016-11-03
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. L015416 / 1 UN / UN

Administered by: Public       Purchased by: Other
Symptoms: Acute promyelocytic leukaemia, Ammonia normal, Aphonia, Ataxia, Cognitive disorder, Computerised tomogram normal, Confusional state, Decreased appetite, Electroencephalogram, HIV test negative, Hospitalisation, Laboratory test, Lumbar puncture normal, Mobility decreased, Nuclear magnetic resonance imaging, Personality change, Weight decreased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Haematological malignant tumours (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2016-03-12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 20 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PROTONIX
Current Illness: Weight-loss; Recent UTIs
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: (-), HIV; Unremarkable ammonia; MRI; CT; EEGs; Lumbar puncture, (-); various lab tests
CDC Split Type:

Write-up: Hospitalized 02-14-16. Confusion, ataxia, loss of appetite - wt loss, personality changes, motor and cognitive impairment, impaired executive function. She was admitted to hospital on 2-14-16 (x20 days). This illness attacked with a vengeance, "like a runaway train". Within a few days, mother could not move or make a sound. PML is an unrelenting, devastating disease.


VAERS ID: 664017 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-11-04
Entered: 2016-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 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: WAES1611USA000951

Write-up: This spontaneous report as received from a consumer via social media refers to a 15 year old female patient (reporter friend''s daughter). The patient''s medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patient was vaccinated with all three doses of either quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. vaccine (manufacturer unknown) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown), (dose, route, lot # and expiry date not reported). On an unknown date, the patient died after receiving all three doses of vaccine. The cause of death was unknown and it was not reported if an autopsy was performed. The reporter stated that, his/her friend did some research and she was convinced that the patient died because of this vaccine. The reporter also stated that his/her kids had received all other vaccines, but this vaccine had many risks. Causality was not provided by the reporter. No product quality complaint was involved. Upon internal review, death was determined to be medically significant. Additional information is not expected as contact details of the reporter are not available.


VAERS ID: 664059 (history)  
Form: Version 1.0  
Age: 51.0  
Sex: Male  
Location: Ohio  
Vaccinated:2016-10-12
Onset:0000-00-00
Submitted: 2016-11-04
Entered: 2016-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI669AC / UNK RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute respiratory distress syndrome, Critical illness, Dialysis, Dyspnoea, Endotracheal intubation, Mechanical ventilation, Pneumonia
SMQs:, Acute renal failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Interstitial lung disease (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Thrush
Preexisting Conditions: Depressive disorder, Osteoporosis, Arthritis, history of motor vehicle accident with traumatic brain injury, history of seizures, history of hip replacement
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: The patient was admitted to Hospital on 10/31/2016 with increase shortness of breath and O2 sat 64%. The patient is being treated for pneumonia. The patient then when into ARDS and required ventilation. The patient is still currently being treated at Hospital. He remains incubated and critically ill, he is now receiving dialysis. The patient''s loved ones insist that the patient started to take a turn for the worse after he received the flu shot.


VAERS ID: 664201 (history)  
Form: Version 1.0  
Age: 6.0  
Sex: Male  
Location: Washington  
Vaccinated:2016-09-30
Onset:2016-10-16
   Days after vaccination:16
Submitted: 2016-11-04
   Days after onset:19
Entered: 2016-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (KINRIX) / GLAXOSMITHKLINE BIOLOGICALS 43HB3 / 5 LL / IM
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI684AC / 4 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. M007964 / 2 RL / SC

Administered by: Private       Purchased by: Public
Symptoms: Anion gap normal, Blood alkaline phosphatase normal, Blood osmolarity decreased, Cough, Death, Diarrhoea, Dizziness, Fatigue, Headache, Nausea, Neutrophil count increased, Pain in extremity, Platelet count increased, Protein total increased, Pyrexia, Somnolence, Vomiting, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Vestibular disorders (broad), Noninfectious diarrhoea (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: 2016-10-30
   Days after onset: 14
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: Developmental concern, Esotropia of right eye, 4 pound weight gain in past 2.5 years
Allergies:
Diagnostic Lab Data: WBC 16.8, Platelets 530, neutrophils 13.2, anion gap 13, total protein 8.5, alkaline phos 166, calculated OSMO 273
CDC Split Type:

Write-up: Parents report intermittent illness since vaccination: fever(101) every other day x7 days, nausea, vomiting, diarrhea, headache, fatigue, somnolence, dizziness, cough, Left leg pain.


VAERS ID: 664389 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2013-02-01
Onset:2013-04-23
   Days after vaccination:81
Submitted: 2016-11-04
   Days after onset:1291
Entered: 2016-11-07
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Alanine aminotransferase increased, Condition aggravated, Death, Hepatitis B, Hepatitis B DNA decreased, Hepatitis B core antibody negative, Hepatitis B core antibody positive, Hepatitis B e antigen positive, Hepatitis B surface antibody positive, Viral titre increased
SMQs:, Liver related investigations, signs and symptoms (narrow), Liver infections (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Darunavir; ritonavir; raltegravir; etravirine; Mycophenolate; tacrolimus; prednisone; antithymocyte globulin
Current Illness: Haemodialysis; 1997, HIV infection; 1997, End stage renal disease
Preexisting Conditions: 10/2012, Transplant rejection; 1989, Acute hepatitis B; lamivudine + zidovudine, HIV infection; lopinavir and ritonavir, HIV infection; 2005, tenofovir; 11/2011, Renal transplant; 2012, Transplant rejection; anti-thymocyte globulin
Allergies:
Diagnostic Lab Data: Lab tests performed on unknown date. Between 1 May 2013 and 8 May 2013, HBsAg was negative (the preneutralisation value was 519 HBsAg. A reduction in HBsAg value did not occur during the confirmatory neutralisation step, though the sample may not have been adequately diluted per test kit instructions and anti-HBc, anti-HBs and HBeAg were positive). ALT was 170. Between 22 May 2013 and 27 May 2013, the patient was reported to be HBsAg with anti-HBs as positive and ALT as 80. The patient''s HBV genotype was A. The patient''s HBV whole genome sequences analysis indicated 99.9% genetic homology with the index patient of the same literature article. 03/2013, Alanine aminotransferase, 33 IU/L; 04/2013, Alanine aminotransferase, 155 IU/L; 06/2013, Alanine aminotransferase, 52 IU/L; 06/2013, Blood immunoglobulin M, negative; 05/2013, Hepatitis B DNA assay, 5.4 x 10E7 iu/ml; 07/2013, Hepatitis B DNA assay, 1.1 x 10E8 iu/ml; 05/2013, Hepatitis B core antibody, positive; 06/2013, Hepatitis B core antibody, positive; 06/2013, Hepatitis B e antibody, negative; 05/2013, Hepatitis B e antigen, Positive; 06/2013, Hepatitis B e antigen, positive; 05/2013, Hepatitis B surface antibody, positive; 06/2013, Hepatitis B surface antibody, positive; 04/2013 Hepatitis B surface antigen, Positive; 05/2013, Hepatitis B surface antigen, unknown; 06/2013, Hepatitis B surface antigen, positive; 05/2013, Viral titer, High
CDC Split Type: US2016GSK162968

Write-up: This case was reported in a literature article and described the occurrence of death NOS in a male patient who received Hepatitis B vaccine. The patient''s past medical history included acute hepatitis B, kidney transplant, transplant rejection and transplant rejection. Previously administered products included Lamivudine/zidovudine, lopinavir/ritonavir, tenofovir and antithymocyte globulin. Concurrent medical conditions included haemodialysis, HIV infection and end stage renal disease. Concomitant products included darunavir, ritonavir, raltegravir, etravirine, mycophenolate, tacrolimus, prednisone and antithymocyte globulin. In February 2013, the patient received the 1st dose of Hepatitis B vaccine. On 23rd April 2013, 61 days after receiving Hepatitis B vaccine, the patient experienced hepatitis B reactivation (serious criteria GSK medically significant). In December 2013, the patient experienced death NOS (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death NOS was fatal and the outcome of the hepatitis B reactivation was unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death NOS to be related to Hepatitis B vaccine. The reporter considered the hepatitis B reactivation to be related to Hepatitis B vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of hepatitis B virus (HBV) reactivation in a male aged 40-year or above who was vaccinated with unspecified HBV vaccine (manufacturer unknown). This case corresponds to source patient in this literature article. The patient was a part of the study that reviewed HBV serologic results of all facility haemodialysis patients and the HBsAg testing procedures at a commercial laboratory. The patient was under haemodialysis treatment. The patient was the source case in the literature article. No information on patient''s family or concomitant medication was provided. In 1989, the patient was diagnosed with acute HBV infection. Later, in 1997, the patient was diagnosed with human immunodeficiency virus (HIV) infection with secondary end-stage renal disease. Subsequently, long-term haemodialysis therapy was initiated in 1997. The patient had received antiretroviral therapy1 for HIV infection (Lamivudine/zidovudine, lopinavir/ritonavir, and beginning in 2005 HBV-suppressive including tenofovir (dosages unknown for all), which had been discontinued during preparation for kidney transplantation in November 2011. Between 2002 and 2011, the anti-HBc and anti-HBs was positive whereas HBsAg was negative. The antiretroviral therapy2 included darunavir (800 mg/d), ritonavir (100 mg/d), raltegravir (400 mg twice daily), and etravirine (200 mg twice daily). Immunosuppressive regimen included mycophenolate, tacrolimus, and prednisone; antithymocyte globulin in January 2012. During early 2012, the patient experienced acute transplant rejection and received antithymocyte globulin. In May 2012, after transplant failure, the patient returned to outpatient haemodialysis therapy and was documented as HBsAg negative. The anti-HBc and anti-HBs was positive and negative respectively. In August 2012, the anti-HBs were found positive. In October 2012, acute transplant rejection was again diagnosed and prednisone initiated at 30 mg/day; tapered dosing of 2.5-5 mg every other day during February 2013 was prescribed. The HBsAg was found negative when performed at laboratory A (the laboratory used by the facility for urgent testing). In January 2013, the patient was reported to be anti-HBs negative by routine testing initiated though standing orders at the facility. This result, interpreted as possible waning immunity, prompted HBsAg testing in February 2013. On 21February 2013, the patient''s first HBsAg test result A was initially reported as positive. The preneutralisation value was 354 HBsAg. A reduction in HBsAg value did not occur during the confirmatory neutralisation step, though the sample may not have been adequately diluted per test kit instructions. However, after a confirmatory neutralization step, the presence of HBsAg was not confirmed and the final result was reported as HBsAg negative. On an unspecified date in February 2013, after a subsequent negative HBsAg test result at Laboratory A with a different source patient sample, the patient received 1 dose of unspecified HBV vaccine (administration route and site unspecified; batch number not provided). On an unspecified date, in March 2013, peak alanine transaminase (ALT) level was 33 (Units: IU/L). During May 2012 to March 2013, the patient shared the same station 3 times weekly for 10 months with the index patient of the same literature article, who was dialysed immediately after the patient. Between 24 April 2013 and 30 April 2013, the patient was reported to be HBsAg positive at Laboratory B (the laboratory used by the facility for routine testing), and dialysing in isolation was started. The ALT level was 155 IU/L. Due to the HBsAg positive result, additional HBV serologic tests were conducted at Laboratory A and were available in early May 2013; HBsAg was not detected, despite a positive test result for hepatitis B e antigen (HBeAg) and high viral titre, a discrepancy not identified by facility staff despite their practice of reviewing all laboratory results upon receipt and again at weekly rounds. Between 1 May 2013 and 8 May 2013, HBsAg was negative (the preneutralisation value was 519 HBsAg. A reduction in HBsAg value did not occur during the confirmatory neutralisation step, though the sample may not have been adequately diluted per test kit instructions and anti-HBc, anti-HBs and HBeAg were positive). The HBV DNA was 5.4 x 10E7 IU/mL and ALT was 170. Between 22 May 2013 and 27 May 2013, the patient was reported to be HBsAg with anti-HBs as positive and ALT as 80. In June 2013, the lab tests revealed HBsAg, anti-HBc, anti-HBs and HBeAg as positive whereas anti-Hbe and IgM anti-HBc as negative. ALT was noted as 52. Samples obtained during July 2013 from the patient revealed HBV viral loads greater than 1.1 x 10E8 IU/mL. Subsequently, the patient was diagnosed with HBV reactivation. The patient resumed haemodialysis therapy in isolation. The patient''s HBV genotype was A. (In this study, laboratory A failed to strictly adhere to the HBsAg test manufacturer''s guidelines for adequate dilution of patient serum samples during the confirmatory neutralization step. Therefore, the patient''s sample might not have been adequately diluted in February and May 2013, resulting in potentially false-negative HBsAg results). The patient''s HBV whole genome sequences analysis indicated 99.9% genetic homology with the index patient of the same literature article. In December 2013, the patient died. HBV infection was not listed as a contributing cause. It was unknown if the autopsy was performed. The cause of death was unknown. This case has been considered serious due to death NOS. The authors did not comment on the relationship between HBV reactivation and unspecified HBV vaccine. The authors stated "The patient''s high viral titers and increased infectivity were likely related to severe immunosuppression and cessation of HBV-suppressive antiretroviral therapy". The authors concluded that "In conclusion, HBV transmission occurred after an HIV-positive hemodialysis patient with transplant-related immunosuppression experienced HBV reverse seroconversion and reactivation. Providers should be aware of this possibility, especially among severely immunosuppressed patients, and maintain stringent infection control". This is 1 of the 2 valid cases reported in the same literature article.


VAERS ID: 664407 (history)  
Form: Version 1.0  
Age: 43.0  
Sex: Female  
Location: Arkansas  
Vaccinated:2016-10-25
Onset:2016-10-26
   Days after vaccination:1
Submitted: 2016-10-28
   Days after onset:2
Entered: 2016-11-07
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 29PD2 / UNK LA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-10-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: None noted
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: AR176

Write-up: PT rec''d flu shot at an off site school clinic on 10-26-16, a friend of the pt stated pt had died; pt had been found deceased by her children that morning.


VAERS ID: 664784 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Texas  
Vaccinated:2016-10-24
Onset:2016-10-26
   Days after vaccination:2
Submitted: 2016-11-08
   Days after onset:13
Entered: 2016-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME) / SANOFI PASTEUR C5200AA / 1 RL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. M010212 / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M77275 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. L048854 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-10-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death.


VAERS ID: 664922 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Female  
Location: Oklahoma  
Vaccinated:2016-10-24
Onset:2016-11-04
   Days after vaccination:11
Submitted: 2016-11-07
   Days after onset:3
Entered: 2016-11-09
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UT5583NA / 1 RL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. I032182 / 1 LL / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. M006156 / 1 LL / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-11-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None noted
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient seen in ER on 11-4-16 and pronounced dead - possible SIDS. She was seen by us on 10-24-16 and given vaccinations - awaiting ME report.


VAERS ID: 665181 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Colorado  
Vaccinated:2016-09-27
Onset:2016-10-13
   Days after vaccination:16
Submitted: 2016-11-10
   Days after onset:28
Entered: 2016-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UI626AA / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arrhythmia, Aspiration pleural cavity, Autopsy, Chest X-ray, Computerised tomogram, Cytology, Death, Dyspnoea, Haematology test, Influenza like illness, Laboratory test, Pericardial effusion, Pericarditis, Pleural effusion, Pneumonia
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2016-10-28
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Was taking BP meds and statin.
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Thoracentsis with cytology. CAT scan, Chest X-Ray, chemistry, hematology. Autopsy found cause of death to be cardiac arrhythmia due to acute pericarditis and pericardial effusion.
CDC Split Type:

Write-up: Received flu vaccine requisite to his service as a volunteer at hospital ER. Previously healthy. Within 1 day of vaccination began complaining of flu-like symptoms. Developed pneumonia, pleural effusion, SOB. Was hospitalized, then released to home where he expired.


VAERS ID: 665318 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-11-10
Entered: 2016-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
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: 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: USPFIZERINC2016514968

Write-up: This is a spontaneous report from a contactable health care professional received via a Pfizer sales representative. A 73-year-old male patient received single dose of PREVNAR 13, via an unspecified route of administration on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced cardiac arrest 30 minutes after vaccination and died on an unspecified date. It was not reported if an autopsy was performed. Sender''s Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. In particular, the following relevant information is not available: medical history and concomitant medications. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Reported Cause(s) of Death: Cardiac arrest.


VAERS ID: 665371 (history)  
Form: Version 1.0  
Age: 85.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-11-11
Entered: 2016-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Bladder cancer, Death, General physical health deterioration, Haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FLUITRAN; PERDIPINE
Current Illness: Blood pressure abnormal
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1102USA00130

Write-up: Initial and follow-up information has been received from a healthcare professional and a pharmacist concerning an 85 year old female patient. Information about concurrent condition and medical history was not reported. On an unspecified date the patient was subcutaneously vaccinated with PNEUMOVAX NP injection (vaccination date, lot number, dose and indication not reported). On an unspecified date (from about 35 years ago), the patient had no health issue originally, she was continuously administrated with FLUITRAN and PERDIPINE as blood pressure medication. On an unspecified date (from about 15 days after vaccination), the patient suffered poor health suddenly. On an unspecified date (within one month after vaccination), the patient developed bleeding suddenly. The patient visited the hospital and found bladder cancer. On an unspecified date (within half a year), the patient died. The cause of death was bladder cancer. Information on autopsy was not reported. Reporter''s comment: The cancer primary doctor considered the vaccine was not the cause of death and considered the cause could not be identified. But the patient''s family did not agree and considered there was no other reason except the PNEUMOVAX NP. The reporting pharmacist considered that the bladder cancer was serious due to death. The reporting pharmacist did not assess the relationship of bladder cancer to PNEUMOVAX NP. Upon internal review, the event of bladder cancer was considered to be medically significant. Follow-up attempt was not made because the reporter did not wish to be contacted. Updated information received on 07-NOV-2016 from the pharmacist has been marked with double caret.


VAERS ID: 665843 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Female  
Location: New York  
Vaccinated:2016-09-27
Onset:2016-09-28
   Days after vaccination:1
Submitted: 2016-10-28
   Days after onset:30
Entered: 2016-11-14
   Days after submission:17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 13449211A / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-10-09
   Days after onset: 11
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: Many-contact facility (nursing home)
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was elderly in nursing home but developed a high fever after shot was administered. She had numerous preexisting conditions prior to shot, but I was told by staff she developed, for sure, a high fever and was sent to local hospital a few days after it was given.


VAERS ID: 665969 (history)  
Form: Version 1.0  
Age: 72.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2016-05-23
Onset:2016-06-01
   Days after vaccination:9
Submitted: 2016-11-14
   Days after onset:166
Entered: 2016-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M60993 / UNK LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Alanine aminotransferase normal, Anaplastic lymphoma kinase gene mutation, Anion gap normal, Aspartate aminotransferase normal, Atrioventricular block, Autopsy, Bacterial test negative, Base excess decreased, Basophil count increased, Blood albumin decreased, Blood bicarbonate decreased, Blood bilirubin normal, Blood calcium decreased, Blood chloride normal, Blood creatinine increased, Blood culture negative, Blood glucose normal, Blood lactic acid increased, Blood magnesium normal, Blood pH decreased, Blood phosphorus increased, Blood potassium increased, Blood sodium decreased, Blood thyroid stimulating hormone normal, Blood triglycerides increased, Blood urea increased, Blood urea nitrogen/creatinine ratio, Brain natriuretic peptide increased, Carbon dioxide decreased, Clostridium test, Culture stool positive, Culture urine, Death, EGFR status assay, Eosinophil count increased, Haematocrit decreased, Haemoglobin decreased, Influenza virus test negative, International normalised ratio normal, Laboratory test normal, Lymphocyte count normal, Lymphocyte percentage decreased, Monocyte count increased, Monocyte percentage increased, Neutrophil percentage increased, PCO2 decreased, Pneumonia, Protein total decreased, Prothrombin time normal, Red blood cell count decreased, Sputum culture positive, White blood cell count increased, White blood cells stool positive, White blood cells urine positive, pH urine normal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Cardiac failure (broad), Asthma/bronchospasm (broad), Dyslipidaemia (narrow), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (broad), Lactic acidosis (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Conduction defects (narrow), Retroperitoneal fibrosis (broad), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hyponatraemia/SIADH (narrow), Eosinophilic pneumonia (narrow), Lipodystrophy (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-06-17
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 23 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TYLENOL; NORVASC; CELEXA; VITAMIN D3; LASIX; GLUCOTROL; LOPRESSOR; CELLCEPT; DELTASONE; ZANTAC; PROGRAF; LEVEMIR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Hypertension; Kidney transplant; Lipidosis; Pain; Palpitation; Renal failure; Type II diabetes mellitus; Vitamin D deficiency
Allergies:
Diagnostic Lab Data: Test Date: 20160602; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result: 19; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: ALK gene mutation; Result Unstructured Data: Test Result: 81; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Anion gap; Result Unstructured Data: Test Result: 10; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Aspartate aminotransferase; Result Unstructured Data: Test Result: 20; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Nodal block; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Base excess; Result Unstructured Data: Test Result: -7; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Basophils; Result Unstructured Data: Test Result: 0.2; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Albumin; Result Unstructured Data: Test Result: 2.1; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Bicarbonate; Result Unstructured Data: Test Result: 18.9; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Bilirubin; Result Unstructured Data: Test Result: 1; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Calcium; Result Unstructured Data: Test Result: 1.04; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Calcium; Result Unstructured Data: Test Result: 7.8; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Chloride; Result Unstructured Data: Test Result: 103; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Creatinine; Result Unstructured Data: Test Result: 3.2; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160526; Test Name: Blood culture; Result Unstructured Data: Test Result: No growth detected; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Glucose; Result Unstructured Data: Test Result: 161; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Glucose; Result Unstructured Data: Test Result: 196; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Lactate; Result Unstructured Data: Test Result: 0.93; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Magnesium; Result Unstructured Data: Test Result: 2; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Phosphorus; Result Unstructured Data: Test Result: 4.7; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Potassium; Result Unstructured Data: Test Result: 3.8; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Sodium; Result Unstructured Data: Test Result: 134; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160528; Test Name: Thyroid stimulating hormone; Result Unstructured Data: Test Result: 1.09; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Triglycerides; Result Unstructured Data: Test Result: 163; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Blood urea nitrogen; Result Unstructured Data: Test Result: 44; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Blood urea nitrogen/creatinine ratio; Result Unstructured Data: Test Result: 14; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: BNP; Result Unstructured Data: Test Result: 454; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Carbon dioxide; Result Unstructured Data: Test Result: 21; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160527; Test Name: C.difficile colitis; Result Unstructured Data: Test Result: Not detected; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160527; Test Name: Stool culture; Result Unstructured Data: Test Result: Negative for shigella and campylobacter yersinia; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160527; Test Name: Stool culture; Result Unstructured Data: Test Result: Negative for salmonella; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160527; Test Name: Stool culture; Result Unstructured Data: Test Result: Leukocytes were positive for wbc and urine culture; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160527; Test Name: Stool culture; Result Unstructured Data: Test Result: Mixed flora, probable contamination; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: EGFR status assay; Result Unstructured Data: Test Result: 17; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Eosinophils; Result Unstructured Data: Test Result: 4.5; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Fraction of inspired oxygen; Result Unstructured Data: Test Result: 90; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Hematocrit; Result Unstructured Data: Test Result: 30.9; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Haemoglobin; Result Unstructured Data: Test Result: 10.2; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160526; Test Name: Influenza virus test; Result Unstructured Data: Test Result: Not detected; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: INR; Result Unstructured Data: Test Result: 1.1; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Lymphocytes; Result Unstructured Data: Test Result: 13.7; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Lymphocytes; Result Unstructured Data: Test Result: 1.2; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Monocytes; Result Unstructured Data: Test Result: 9.8; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Monocytes; Result Unstructured Data: Test Result: 0.9; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Neutrophils; Result Unstructured Data: Test Result: 70.2; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Oxygen saturation; Result Unstructured Data: Test Result: 90; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Partial pressure CO2; Result Unstructured Data: Test Result: 39.9; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Partial pressure CO2; Result Unstructured Data: Test Result: 20; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: pH; Result Unstructured Data: Test Result: 7.284; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: pH urine; Result Unstructured Data: Test Result: 5.0; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Protein; Result Unstructured Data: Test Result: 5.7; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Prothrombin time; Result Unstructured Data: Test Result: 12.4; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Red blood cell count; Result Unstructured Data: Test Result: 3.59; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160528; Test Name: Sputum culture; Result Unstructured Data: Test Result: Respiratory flora, light gram positive cocci; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160528; Test Name: Sputum culture; Result Unstructured Data: Test Result: Polymorphonuclear leukocytes; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: WBC count; Result Unstructured Data: Test Result: 20; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: White blood cell count; Result Unstructured Data: Test Result: 8.8; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low power field. Urine (02Jun2016): 612
CDC Split Type: USPFIZERINC2016522971

Write-up: This is a spontaneous report from a contactable nurse. A 73-year-old female patient received PREVNAR 13, (Lot unknown) 0.5 ml single, intramuscular in the left deltoid on 23May2016 for immunisation. Medical history included hypertension, type 2 diabetes mellitus, renal failure, depression, renal transplant, lipidosis, vitamin d deficiency, heart palpitation and pain. Concomitant medication included TYLENOL for pain from 29May2013, NORVASC from 04Jan2016, CELEXA for depression from 23May2016, VITAMIN D3 for Vitamin D deficiency from 03Aug2011, LASIX from 25Jan2016, GLUCOTROL for Diabetes type 2 from 29May2016, LOPRESSOR from 22Jan2014, CELLCEPT from 02Jul2013, DELTASONE from 03Mar2016, ZANTAC from 18Sep2013, PROGRAF from 02Jul2013, and LEVEMIR. The patient experienced bronchopneumonia on an unspecified date and died on 17Jun2016. The autopsy was done. The cause of death was Bronchopneumonia. The nurse mentioned that the day of vaccination it was reported that the patient was clear with her lungs. The patient underwent lab tests and procedures which included: On 26May2016, blood culture no growth detected, Influenza virus test not detected. On 27May2016, clostridium difficile colitis not detected, Culture stool: Mixed flora, probable contamination; Leukocytes were positive for wbc and urine culture; Negative for shigella and campylobacter Yersinia; Negative for salmonella. On 28May2016, blood thyroid stimulating hormone 1.09, Sputum culture: polymorphonuclear leukocytes; Respiratory flora, light gram positive cocci. SP4 was 1.45. On 02Jun2016, Alanine aminotransferase 19, anaplastic lymphoma kinase gene mutation 81, anion gap 10, aspartate aminotransferase 20, atrioventricular block , base excess -7, basophil count 0.2 , blood albumin 2.1, blood calcium 1.04 and 7.8, blood bilirubin 1, blood bicarbonate 18.9, blood chloride 103, blood creatinine 3.2, blood glucose 161 and 196, blood lactic acid 0.93, blood magnesium 2, blood phosphorus 4.7, blood potassium 3.8, blood sodium 134, blood triglycerides 163, blood urea 44, blood urea/creatinine ratio 14, brain natriuretic peptide 454, carbon dioxide 21, EGFR status assay 17, eosinophil count 4.5, fraction of inspired oxygen 90, haematocrit 30.9, haemoglobin 10.2, International normalised ratio 1.1, lymphocyte count 13.7 and 1.2, monocyte count 9.8 and 0.9, neutrophil count 70.2, oxygen saturation 90, PCO2 39.9 and 20, protein total 5.7, prothrombin time 12.4, red blood cell count 3.59, white blood cell count 20 and 8.8, pH body fluid 7.284, pH urine 5.0, Rate hz arterial 7, Prest/tinsp arterial 26, Peak arterial 10. Sender''s Comments: Based on the information provided in the case, a lack of efficacy with PREVENAR 13 in this patient cannot be excluded. Further information like causative agent and serotyping results is needed for a full medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Reported Cause(s) of Death: Bronchopneumonia.


VAERS ID: 670317 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Female  
Location: Unknown  
Vaccinated:2016-11-02
Onset:2016-11-03
   Days after vaccination:1
Submitted: 2016-11-14
   Days after onset:11
Entered: 2016-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. L017406 / UNK GM / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Dyspnoea, Fall, Fatigue, Injection site pain, Swelling
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamins (unspecified)
Current Illness: Heart rate irregular; Coagulation time shorted; Arthritis
Preexisting Conditions: 06/2016, Hospitalisation; 06/2016, Cerebrovascular accident; 06/2016, Immune system disorder; 06/2016, Pneumonia; 06/2016, Cardiac failure congestive
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1611USA005836

Write-up: Information has been received from a consumer referring to his spouse, a 76 year old female patient with heart rate irregular, coagulation time shortened and arthritis. In June 2016 the patient had a severe case of pneumonia that led to a prolonged hospital stay, heart failure, stroke and a compromised immune system, in which case, the physician recommended PNEUMOVAX 23 once she recovered. The patient had no drug reactions or allergies. Concomitant medication included heart regulator medication, blood thinner medication, vitamins and arthritis medication. On 02-NOV-2016 the patient was vaccinated with PNEUMOVAX 23 (lot #, expiration date and dose were unknown, intramuscular). On 03-NOV-2016, the patient experienced extreme fatigue, swollen, injection site pain, labored breathing and extreme dizziness which led to her falling. It was reported that therapy was not discontinued. The patient did not seek medical attention. No lab diagnostics studies were performed and no treatment was given for the events. At the time of reporting, the patient had not recovered from the events. Causality was not reported. Additional information has been requested.


VAERS ID: 666207 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Iowa  
Vaccinated:2016-11-08
Onset:2016-11-12
   Days after vaccination:4
Submitted: 2016-11-15
   Days after onset:3
Entered: 2016-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 39TA3 / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. L035878 / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M16259 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. L023870 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-11-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None reported by parent but noted lung congestion, parent denied fever.
Preexisting Conditions: None reported by parent
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Parent found unresponsive around 4 am, arrived at Hospital at 4:46 am, pronounced dead at 4:48 am.


VAERS ID: 666583 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Female  
Location: West Virginia  
Vaccinated:2016-10-13
Onset:2016-10-13
   Days after vaccination:0
Submitted: 2016-11-10
   Days after onset:28
Entered: 2016-11-15
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS A2Z34 / 1 RA / SYR

Administered by: Public       Purchased by: Unknown
Symptoms: Death, Malaise, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-10-16
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Torn meniscus Lt. knee; High blood pressure
Allergies:
Diagnostic Lab Data: Had pre-op testing done 10-13-16 11:00 AM right before getting flu shot. All pre-op records were looked at by our family Dr. all were great including EKG
CDC Split Type:

Write-up: 10:13 had pre-op work for upcoming knee surgery. Took flu shot after had to stop along road twice on way home to throw up stayed sick 14th 15th of Oct. Got her in bed about 11:30pm on the 15th. Went in to get her out of bed at 10:00 AM on the 16th, she had passed away several hours prior to. Patient had taken flu shot for years. She felt good morning of 13th.


VAERS ID: 666465 (history)  
Form: Version 1.0  
Age: 63.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2016-10-31
Onset:2016-11-03
   Days after vaccination:3
Submitted: 2016-11-16
   Days after onset:13
Entered: 2016-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR U1678AB / 2 UN / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Blood test, Death, Disseminated intravascular coagulation
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-11-04
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coagulation disorder; Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2016SA206725

Write-up: Initial unsolicited report received from a nurse on 09 Nov 2016. This case involves a 63-year-old female patient who was vaccinated with a dose of FLUZONE MULIT-DOSE VIAL QIV (batch number: U1678AB, expiry date: 30 Jun 2017, route, site and dose not reported) on 31 Oct 2016. Patient had previous history of coagulation disorder. Concomitant medications were not provided. On an unspecified date, post vaccination, the patient had DIC (Disseminated Intravascular Coagulation). On 03 Nov 2016, patient went to emergency room. Lab data includes full vitals, blood planel review and blood was drawn on 18 Oct 2016. Corrective treatment was not reported. On 04 Nov 2016, the patient passed away. List of documents held by sender: none.; Sender''s Comments: This is a poorly documented death case where patient passed away from DIC (Disseminated Intravascular Coagulation) after administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. It was to be noted that the patient had previous history of coagulation disorder of unknown etiology. The detailed autopsy report, detailed past medical history, concomitant medication and immune status at the time of vaccination would be helpful to assess this case further.; Reported Cause(s) of Death: Disseminated Intravascular Coagulation.


VAERS ID: 666730 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Male  
Location: Oklahoma  
Vaccinated:2016-09-30
Onset:2016-10-08
   Days after vaccination:8
Submitted: 2016-11-16
   Days after onset:39
Entered: 2016-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 9K7E4 / 2 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Abasia, Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2016-11-16
   Days after onset: 39
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 39 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NEXIUM; FLONASE; Levothyroxine; NEURONTIN; XYZAL; Indomethacin
Current Illness: Low back pain
Preexisting Conditions: IV Dye; Hypothyroidism; Gout; Arthritis; GERD; ED; Hypertriglyceridemia; Hiatal hernia; Allergic rhinitis
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 10-9-16 Pt unable to walk, ascending paralysis. Went to ER was admitted with Guillain-Barre.


VAERS ID: 667406 (history)  
Form: Version 1.0  
Age: 0.8  
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-11-21
Entered: 2016-11-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture negative, CSF cell count increased, CSF glucose decreased, CSF protein increased, CSF red blood cell count positive, Deafness, Death, Developmental delay, Haemolytic uraemic syndrome, Hernia, Hypophagia, Lethargy, Meningeal disorder, Meningitis pneumococcal, Pneumonia staphylococcal, Pyrexia, Renal injury, Respiratory failure, Respiratory tract congestion, Rhinorrhoea, Serology positive, Streptococcus test positive, Vomiting
SMQs:, Haemolytic disorders (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (narrow), Renovascular disorders (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), 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? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood culture; Result Unstructured Data: Test Result: Negative; Test Name: CSF cell count; Result Unstructured Data: Test Result: 93, Test Result Unit: /mm3; Test Name: CSF glucose; Result Unstructured Data: Test Result: less than 1, Test Result Unit: mg/dl; Test Name: CSF protein; Result Unstructured Data: Test Result: 1370, Test Result Unit: mg/dl; Test Name: CSF red blood cell count; Result Unstructured Data: Test Result: 171, Test Result Unit: /mm3; Test Name: Serology test; Result Unstructured Data: Test Result: 23 B
CDC Split Type: USPFIZERINC2016518578

Write-up: This is a literature spontaneous report. This is fifth of 7 reports and this case refers to Case 5: 9 month-old patient. Fourteen cases of pneumococcal meningitis and twelve cases of invasive pneumococcal disease (IPD) not including meningitis were identified. Between Jan2004 and Dec2012 there were 0 to 2 cases of pneumococcal meningitis each year. In contrast, the authors identified 7 cases of pneumococcal meningitis presenting in children aged 5 months to 6 years between Jul2013 and Dec2014. The duration of symptoms prior to presentation ranged from 2 to 5 days (mean 3.4 days). CSF analysis was remarkable for very modest pleocytosis observed in all but 1 child. Six children had a positive CSF Gram stain for Gram-positive diplococci with cultures positive for S pneumoniae. The 6-year-old child who was moribund on presentation had a positive blood culture and brain imaging, which showed meningeal enhancement and herniation. All 5 surviving children with meningitis experienced severe hearing loss and developmental impairment. In addition, 2 children developed seizures, 2 developed hemolytic uremic syndrome, 1 developed hydrocephalus requiring a shunt, 2 had transient cranial nerve palsy, 1 suffered persistent palsy of cranial nerve II, and 2 children died. Two patients completed immunization with pneumococcal 13-val conj vac (dipht CRM197 protein) and both were infected with nonvaccine serotype 23B. Two children were partially immunized with pneumococcal 13-val conj vac (dipht CRM197 protein) and both were infected with nonvaccine strains (22F, 15B). Three infections resulted from serotypes contained within pneumococcal 13-val conj vac (dipht CRM197 protein): A 5-month-old infant who received 2 doses of pneumococcal 13-val conj vac (dipht CRM197 protein) and a 6-year old with an unknown immunization history were both infected with serotype 19A, and an unimmunized toddler was infected with serotype 18C. Immunological studies performed on the 5-month-old showed normal immunoglobulins and total hemolytic complement. The patient had no known conditions such as asplenia or sickle cell anemia that would predispose to a pneumococcal infection. Discussion: The authors reported a cluster of cases of pneumococcal meningitis in young infants and children in the pneumococcal 13-val conj vac (dipht CRM197 protein) era associated with a very high degree of morbidity and mortality. All patients in this cluster experienced neurologic sequelae in contrast to rates of 40% to 63% reported in the recent literature. There were several possible explanations for the poor outcomes in these cases. The decreasing incidence of meningitis in general may lower practitioners'' suspicion for bacterial meningitis, which may lead to delayed diagnosis. The modest pleocytosis observed in 5 patients may reflect a less robust inflammatory reaction which in turn may be associated with fewer early symptoms, also leading to delayed diagnosis. The main limitation to this brief report was that it was not population-based, and the authors were thus not able to comment on incidence rates. Accordingly, the high degree of observed morbidity and mortality, in addition to the clustering of cases, may simply be a chance event. Nonetheless, it was alarming that 7 of 14 cases occurring during a 10-year period were observed during 17 months. A 9 month-old patient received immunization with three single doses of pneumococcal 13-val conj vac (dipht CRM197 protein) on unknown dates. On an unspecified date, the patient presented symptoms of fever, emesis, rhinorrhea, congestion with decreased oral intake and lethargy on day of admission, was hospitalized and diagnosed with pneumococcal meningitis. The duration of symptoms before diagnosis was 5 days. Laboratory data includes: blood culture negative; CSF Results: Nucleated Cells (/uL): 93; RBC (/uL): 171; Protein (mg/dl) 1370; Glucose (mg/dL): less than 1, Serotype: 23 B. Complications observed in hospital included: hemolytic uremic syndrome, kidney injury, respiratory failure. The patient died due to the events. Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht CRM197 protein) in the reporter''s country. This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht CRM197 protein) has submitted the same report to the regulatory authorities. Sender''s Comments: Serotype 23 B is not contained in pneumococcal 13-val conj vac (dipht CRM197 protein), therefore a lack of efficacy in this patient can be excluded. The Company considers the pneumococcal meningitis and its reported complications not related to pneumococcal 13-val conj vac (dipht CRM197 protein). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Linked Report(s): US-PFIZER INC-2016518540 different patient/event, same drug; Reported Cause(s) of Death: Kidney injury; Pneumococcal meningitis serotype 23 B; Respiratory failure; Hemolytic uremic syndrome.


VAERS ID: 667408 (history)  
Form: Version 1.0  
Age: 6.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-11-21
Entered: 2016-11-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, Brain herniation, CSF test, Cough, Death, Meningitis pneumococcal, Nuclear magnetic resonance imaging brain abnormal, Respiratory failure, Rhinorrhoea, Seizure, Streptococcus test positive
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Convulsions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Hypokalaemia (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood culture; Result Unstructured Data: Test Result: positive, meningeal enhancement and herniation; Test Name: CSF test; Test Name: Imaging procedure; Result Unstructured Data: Test Result: positive, meningeal enhancement and herniation; Test Name: Investigation; Result Unstructured Data: Test Result: 19A
CDC Split Type: USPFIZERINC2016518580

Write-up: This is a literature spontaneous report. This is the 7th of 7 reports. Fourteen cases of pneumococcal meningitis and twelve cases of invasive pneumococcal disease (IPD) not including meningitis were identified. Between Jan2004 and Dec2012 there were 0 to 2 cases of pneumococcal meningitis each year. In contrast, the authors identified 7 cases of pneumococcal meningitis presenting in children aged 5 months to 6 years between Jul2013 and Dec2014. The duration of symptoms prior to presentation ranged from 2 to 5 days (mean 3.4 days). CSF analysis was remarkable for very modest pleocytosis observed in all but 1 child. Six children had a positive CSF Gram stain for Gram-positive diplococci with cultures positive for S pneumoniae. The 6-year-old child who was moribund on presentation had a positive blood culture and brain imaging, which showed meningeal enhancement and herniation. All 5 surviving children with meningitis experienced severe hearing loss and developmental impairment. In addition, 2 children developed seizures, 2 developed hemolytic uremic syndrome, 1 developed hydrocephalus requiring a shunt, 2 had transient cranial nerve palsy, 1 suffered persistent palsy of cranial nerve II, and 2 children died. Two patients completed immunization with pneumococcal 13-val conj vac (dipht CRM197 protein) and both were infected with nonvaccine serotype 23B. Two children were partially immunized with pneumococcal 13-val conj vac (dipht CRM197 protein) and both were infected with nonvaccine strains (22F, 15B). Three infections resulted from serotypes contained within pneumococcal 13-val conj vac (dipht CRM197 protein): A 5-month-old infant who received 2 doses of pneumococcal 13-val conj vac (dipht CRM197 protein) and a 6-year old with an unknown immunization history were both infected with serotype 19A, and an unimmunized toddler was infected with serotype 18C. Immunological studies performed on the 5-month-old showed normal immunoglobulins and total hemolytic complement. The patient had no known conditions such as asplenia or sickle cell anemia that would predispose to a pneumococcal infection. Discussion: The authors reported a cluster of cases of pneumococcal meningitis in young infants and children in the pneumococcal 13-val conj vac (dipht CRM197 protein) era associated with a very high degree of morbidity and mortality. All patients in this cluster experienced neurologic sequelae in contrast to rates of 40% to 63% reported in the recent literature. There were several possible explanations for the poor outcomes in these cases. The decreasing incidence of meningitis in general may lower practitioners'' suspicion for bacterial meningitis, which may lead to delayed diagnosis. The modest pleocytosis observed in 5 patients may reflect a less robust inflammatory reaction which in turn may be associated with fewer early symptoms, also leading to delayed diagnosis. The main limitation to this brief report was that it was not population-based, and the authors were thus not able to comment on incidence rates. Accordingly, the high degree of observed morbidity and mortality, in addition to the clustering of cases, may simply be a chance event. Nonetheless, it was alarming that 7 of 14 cases occurring during a 10-year period were observed during 17 months. A 6-year-old patient received a single dose of pneumococcal 13-val conj vac (dipht CRM197 protein) (manufacturer unknown) on unknown date for immunization. On an unspecified date the patient presented symptoms of rhinorrhea, cough, seizure. The patient was hospitalized and diagnosed with pneumococcal meningitis. The duration of symptoms before diagnosis was 3 days. This child who was moribund on presentation had a positive blood culture and brain imaging, which showed meningeal enhancement and herniation. Serotype was 19A. CSF analysis was done. Complications observed in hospital included: respiratory failure, brain herniation. Outcome was fatal. Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht CRM197 protein) in the reporter''s country. This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht CRM197 protein) has submitted the same report to the regulatory authorities.; Sender''s Comments: Serotype 19A is contained in pneumococcal 13-val conj vac (dipht CRM197 protein), therefore a lack of efficacy in this patient cannot be excluded. The reported events of respiratory failure, brain herniation were reported as complication of the pneumococcal meningitis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Linked Report(s): US-PFIZER INC-2016518540 different patient/event, same drug; Reported Cause(s) of Death: Brain herniation; infection with serotype 19A; Respiratory failure.


VAERS ID: 667513 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: Kentucky  
Vaccinated:2016-11-08
Onset:2016-11-21
   Days after vaccination:13
Submitted: 2016-11-21
   Days after onset:0
Entered: 2016-11-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS M9L74 / 2 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. M025193 / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N16562 / 2 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. M019690 / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-11-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Fer-Iron
Current Illness: None
Preexisting Conditions: Reflux
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Received report from family friend that patient passed away on 11-21-16, unknown cause of death.


VAERS ID: 667860 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Male  
Location: Oregon  
Vaccinated:2016-11-01
Onset:2016-11-02
   Days after vaccination:1
Submitted: 2016-11-22
   Days after onset:20
Entered: 2016-11-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 579KX / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-11-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: CAD, HTN, DM, ESRD, Peripheral Vascular Disease, Systolic Heart Failure.
Preexisting Conditions: Ace Inhibitor
Allergies:
Diagnostic Lab Data:
CDC Split Type: OR201609

Write-up: Cardiac arrest on 11/02/2016.


VAERS ID: 668209 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2016-10-11
Onset:2016-10-20
   Days after vaccination:9
Submitted: 2016-11-10
   Days after onset:21
Entered: 2016-11-25
   Days after submission:15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UI634AB / UNK LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Asthenia, Blood potassium decreased, Blood sodium decreased, Dizziness, Guillain-Barre syndrome, Immunoglobulin therapy
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (narrow), Hyponatraemia/SIADH (narrow), Demyelination (narrow), Vestibular disorders (broad), Chronic kidney disease (broad), Hypokalaemia (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2016-11-10
   Days after onset: 21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Aspirin; acetaminophen; FEOSOL; PRILOSEC; pravastatin; calcium with Vitamin D; multivitamin with mineral; MIRALAX; prednisolone ophthalmic; alprazolam; ceftriaxone; ondansetron; pantoprazole; potassium chloride
Current Illness: Fall; urinary tract infection
Preexisting Conditions: Anxiety; GERD; Constipation; Breast cancer
Allergies:
Diagnostic Lab Data: Na critical 111
CDC Split Type:

Write-up: Weakness, dizziness, lightheadedness. Na level 127. K level 3.4. Sodium dropped to critical level 111. Treated with IVIG 20 gm, 200 mL IV daily for Guillain-Barre syndrome.


VAERS ID: 668794 (history)  
Form: Version 1.0  
Age: 88.0  
Sex: Male  
Location: New York  
Vaccinated:2016-11-11
Onset:2016-11-12
   Days after vaccination:1
Submitted: 2016-11-29
   Days after onset:17
Entered: 2016-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UI725AA / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Agitation, Mania, Seizure
SMQs:, Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-11-14
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vaccine at 330pm, during night-sleep was agitated next morning-mini seizure, manic next evening, following day full seizure in AM.


VAERS ID: 669289 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Female  
Location: Oregon  
Vaccinated:2016-10-28
Onset:2016-10-28
   Days after vaccination:0
Submitted: 2016-12-01
   Days after onset:34
Entered: 2016-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Cardiac arrest, Death, Dyspnoea, Immediate post-injection reaction, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-11-09
   Days after onset: 12
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:
Current Illness: None
Preexisting Conditions: COPD
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt developed immediate SOB and syncope. Was hospitalized from 10/28/16 to 11/1/16 for cardiac arrest following Pneumovax. She then was readmitted 11/9/16 and died.


VAERS ID: 669596 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Male  
Location: California  
Vaccinated:2016-10-25
Onset:2016-10-27
   Days after vaccination:2
Submitted: 2016-12-05
   Days after onset:39
Entered: 2016-12-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. M017983 / 3 LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Bradycardia, Brain death, Brain oedema, Cerebral haemorrhage, Cerebrovascular accident, Cerebrovascular disorder, Emotional disorder, Headache, Incontinence, Lethargy, Pyrexia, Repetitive speech, Seizure, Syncope, Tachycardia
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), 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), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2016-11-02
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Headaches, seizures, strokes, swelling of the brain, blood pooling in the brain, brain dead, repetitive speech, fainting, tachycardia, fever, lethargic, emotional, bradycardia, incontinent.


VAERS ID: 670177 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Female  
Location: Indiana  
Vaccinated:2016-08-24
Onset:2016-08-25
   Days after vaccination:1
Submitted: 2016-11-23
   Days after onset:90
Entered: 2016-12-07
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 95YX2 / 1 RL / UN
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. M010440 / 1 LL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M77275 / 1 RL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. L046320 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-08-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None known
Preexisting Conditions: None known
Allergies:
Diagnostic Lab Data: None known
CDC Split Type:

Write-up: Pt. received 2 mo immunizations PEDIARIX ROTATEQ PEDVAX PREVNAR 13 on 8/24/16. I have no information on autopsy or documented cause of death only that pt. was declared deceased on 8/25/16.


VAERS ID: 670576 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2016-11-15
Onset:0000-00-00
Submitted: 2016-12-01
Entered: 2016-12-08
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M56417 / UNK LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-11-16
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: Hypertension; Cardiomyopathy; Hypothyroid; Venous Insuff
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt found dead on AM of 11/16/16 at home in bed.


VAERS ID: 670814 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-12-09
Entered: 2016-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Vaccination complication
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131612USA003140

Write-up: This spontaneous report as received from an unspecified reporter, via social media, refers to a female patient of unknown age. The event was described in an online article. The patient''s medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an unidentified HPV vaccine (manufacturer unknown) 1 shot (name, lot number, route and site of administration were not provided). On an unknown date, the patient died. The author of the online article had the patient''s death as HPV shot related, however it was proved to be false. The reporter''s causality assessment between death and unidentified HPV vaccine (manufacturer unknown) was not reported. Upon internal review, the event of death was considered to be medically significant. Additional information is not expected as no contact details were provided.


VAERS ID: 671533 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2016-11-01
Submitted: 2016-12-12
   Days after onset:41
Entered: 2016-12-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Adverse event, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-11-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131612USA005706

Write-up: This spontaneous report was received on 09-DEC-2016 from the grandmother of an 11 year old female who experienced adverse events after receiving GARDASIL (see case # 1612USA005619). The reporter stated that in November 2016 (reported as three and a half weeks ago), a friend of her grandaughter''s died. It was unclear from the statement whether this girl received GARDASIL before her death. Cause of death was not reported. Upon internal review, died was considered medically significant. Additional information is not expected as the reporter did not provide contact information. Sender''s Comments: US-009507513-1612USA005619: Reported Cause(s) of Death: died.


VAERS ID: 672116 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-12-14
Entered: 2016-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Acute respiratory distress syndrome, Chest X-ray abnormal, Death, Dyspnoea, Human metapneumovirus test positive, Lung infiltration, Metapneumovirus infection, Pneumonia, Pneumothorax, Respiratory viral panel, Shift to the left, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Breast cancer, (in remission); Coronary artery bypass; Pericarditis, requiring a pericardial window; Mediastinitis; Hypertension; Diabetes mellitus
Allergies:
Diagnostic Lab Data: Lab tests were performed on an unspecified date. White cell count was elevated with a left shift in differential count (range and normal value not provided). There was confirmatory evidence on chest x-ray in the form of infiltrates. A rapid respiratory viral panel that confirmed MPV infection.
CDC Split Type: US2016GSK185291

Write-up: This case was reported in a literature article and described the occurrence of acute respiratory distress syndrome in a adult female patient who received Influenza vaccine Quadrivalent unspecified season. The patient''s past medical history included breast cancer (in remission), coronary artery bypass graft, pericarditis (requiring a pericardial window), mediastinitis, hypertension and diabetes mellitus. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, an unknown time after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced acute respiratory distress syndrome (serious criteria death, hospitalization and GSK medically significant), metapneumovirus infection (serious criteria hospitalization and GSK medically significant), pneumothorax (serious criteria death, hospitalization and GSK medically significant), pneumonia (serious criteria hospitalization and GSK medically significant), and shortness of breath (serious criteria hospitalization). On an unknown date, the outcome of the acute respiratory distress syndrome and pneumothorax were fatal and the outcome of the metapneumovirus infection, pneumonia and shortness of breath were unknown. The reported cause of death was acute respiratory distress syndrome and pneumothorax. The reporter considered the acute respiratory distress syndrome, metapneumovirus infection, pneumothorax, pneumonia and shortness of breath to be related to Influenza vaccine Quadrivalent unspecified season. Additional information was provided. This case was reported in a literature article and described the occurrence of human metapneumovirus (MPV) infection in an adult female patient who was vaccinated with unspecified influenza vaccine (manufacturer unknown). The patient was a nursing home resident with history of breast cancer (in remission), coronary artery bypass surgery, pericarditis requiring a pericardial window, mediastinitis, hypertension, and diabetes mellitus. The patient did not report any sick contacts. No information on patient''s family history or concomitant medication was provided. On an unspecified date, the patient received unspecified influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). On an unspecified date, an unknown period after vaccination, the patient presented with shortness of breath and clinical evidence of pneumonia. The patient''s white cell count was elevated with a left shift in differential count (range and normal value not provided). There was confirmatory evidence on chest X-ray in the form of infiltrates. [In this study, 3 out of the 4 patients received a CT scan of the chest confirming extensive bilateral infiltrates and evidence of pulmonary oedema suggesting acute respiratory distress syndrome (ARDS)]. It was reported that the patient had evidence of pneumonia with evidence of respiratory failure, and a rapid respiratory viral panel that confirmed MPV infection. The patient''s family refused intubation, and prolonged non-invasive ventilation causing pneumothorax and ARDS results in the patient''s demise. It was unknown if the autopsy was performed. This case has been considered serious due to death/hospitalisation. The authors did not comment on the relationship between MPV infection and unspecified influenza vaccine. The authors concluded that "The disease spectrum of MPV can vary widely, and the outcomes vary largely based on comorbidities. The infection can frequently lead to severe respiratory failure, progressing to ARDS and death, in the elderly or debilitated patients." This is 1 of the 2 valid cases in the same literature article.


VAERS ID: 673180 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-12-18
Entered: 2016-12-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131612USA007324

Write-up: This spontaneous report was received from a healthcare worker and refers to a patient of unknown demographics. No medical history, concurrent conditions, concomitant medications or past drugs of the patient were reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (lot #, expiry date and dosing details were not reported). Later, on an unspecified date, two weeks after administration of PNEUMOVAX23, the patient died in an unspecified location from an unspecified cause. Causality assessment was not provided. Upon internal review, the event, death was considered to be medically significant. Additional information has been requested. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 673301 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Georgia  
Vaccinated:2016-12-12
Onset:2016-12-14
   Days after vaccination:2
Submitted: 2016-12-19
   Days after onset:5
Entered: 2016-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 5X275 / 1 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. M014927 / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N05078 / 1 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CB573A / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-12-14
   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
Current Illness: cough and stuffy nose
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Baby has passed away. We are not sure if vaccines were the cause.


VAERS ID: 673303 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Georgia  
Vaccinated:2016-12-07
Onset:2016-12-09
   Days after vaccination:2
Submitted: 2016-12-19
   Days after onset:10
Entered: 2016-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 5X275 / 1 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. M014927 / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N05078 / 1 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CB573A / 1 MO / PO

Administered by: Private       Purchased by: Public
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: Ranitidine
Current Illness: congestion
Preexisting Conditions: At birth spent 5 days in NICU for respiratory problems.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Passed away. Not sure if vaccines were the cause?


VAERS ID: 673760 (history)  
Form: Version 1.0  
Age: 71.0  
Sex: Male  
Location: Utah  
Vaccinated:2015-10-29
Onset:2015-11-10
   Days after vaccination:12
Submitted: 2016-12-05
   Days after onset:391
Entered: 2016-12-20
   Days after submission:15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UI481AA / UNK RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-01-14
   Days after onset: 65
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None stated.


VAERS ID: 673761 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Mississippi  
Vaccinated:2016-12-08
Onset:2016-12-09
   Days after vaccination:1
Submitted: 2016-12-13
   Days after onset:4
Entered: 2016-12-20
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 33E9E / 3 LL / UN
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UT5583LA / 1 RL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UI717AA / 3 RL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N34937 / 3 LL / UN

Administered by: Unknown       Purchased by: Public
Symptoms: Condition aggravated, Genital labial adhesions, Irritability, Pallor, Rash, Respiratory arrest, Rhinorrhoea, Skin candida
SMQs:, Anaphylactic reaction (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-12-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NEXIUM; Albuterol
Current Illness: Runny nose; GER; h/o reactive airway
Preexisting Conditions: GER; h/o reactive airway
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pt received vaccines (6 month vaccines) on 12/8/16 at wellness appointment in clinic. Other than mild runny nose and labial adhesion and rash (candidal) under neck, exam was normal. MGM notes that pt did well that night but was a "little whiny". No respiratory distress. No fever. Woke up Friday (12/9) and was "pale". TYLENOL given, went to Health Department and noted to have "stopped breathing".


VAERS ID: 674054 (history)  
Form: Version 1.0  
Age: 1.25  
Sex: Male  
Location: Georgia  
Vaccinated:2016-11-29
Onset:2016-12-09
   Days after vaccination:10
Submitted: 2016-12-21
   Days after onset:12
Entered: 2016-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. M010426 / 1 LA / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. M025864 / 1 RA / SC

Administered by: Unknown       Purchased by: Private
Symptoms: Acute respiratory distress syndrome, Death, Endotracheal intubation, Enterovirus test positive, Extracorporeal membrane oxygenation, Human metapneumovirus test positive, Pyrexia, Respiratory distress, Upper respiratory tract infection
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2016-12-18
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Augmentin
Current Illness: Had hand, foot mouth and OM diagnosed 11/21 - on Augmentin. No symptoms on 11/29 other than candida diaper rash
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Human metapneumovirus, enterovirus positive
CDC Split Type:

Write-up: Had URI, fever, developed respiratory distress, intubated in ER, ARDS ECMO, coded x2 died 12/18/2016.


VAERS ID: 674690 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Washington  
Vaccinated:2016-12-21
Onset:2016-12-23
   Days after vaccination:2
Submitted: 2016-12-24
   Days after onset:1
Entered: 2016-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 33E9E / 1 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. M020100 / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N55175 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. M026316 / 1 MO / PO

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2016-12-23
   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: Nystatin oral solution
Current Illness: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Respiratory and cardiac arrest, extensive resuscitation attempted with short return of heart beat followed by cardiac arrest that did not respond to resuscitation and resulted in death.


VAERS ID: 674701 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Male  
Location: California  
Vaccinated:2016-12-21
Onset:2016-12-21
   Days after vaccination:0
Submitted: 2016-12-25
   Days after onset:4
Entered: 2016-12-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI658AB / UNK RA / SYR

Administered by: Unknown       Purchased by: Private
Symptoms: Atrial fibrillation, Death, Dyspnoea, Heart rate increased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-12-23
   Days after onset: 2
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: Aspirin, furosemide, potassium chloride CR, Lactobacillus PO, Magnesium oxide, atorvastatin, COMBIGAN, Duloxetine, Fluoxetine, ICAPS, isosorbide mononitrate, Latanoprost, metoprolol tartrate, nystatin.
Current Illness: Heart problems, Kidney problems, cold.
Preexisting Conditions: Acute On Chronic Systolic Congestive Heart Failure
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Difficulty in breathing, a fast heartbeat, and AFIB. Taken to the emergency room and patient died within 2 days.


VAERS ID: 675986 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Montana  
Vaccinated:2016-12-29
Onset:2016-12-30
   Days after vaccination:1
Submitted: 2016-12-30
   Days after onset:0
Entered: 2016-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS TB7KY / 3 RL / IM
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UT55835SA / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R12276 / 3 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-12-30
   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: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt deceased of suspected SIDS on the day following administration of routine 6 month vaccines as well as flu shot.


VAERS ID: 676210 (history)  
Form: Version 1.0  
Age: 0.0  
Sex: Male  
Location: Georgia  
Vaccinated:2016-12-02
Onset:2016-12-04
   Days after vaccination:2
Submitted: 2017-01-03
   Days after onset:30
Entered: 2017-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 37H34 / 1 RL / IM

Administered by: Public       Purchased by: Private
Symptoms: Circulatory collapse, Resuscitation, Shock
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-12-05
   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: D10W, erythromycin eye oint, vit K, Fluids with electrolytes
Current Illness: Possible CMV, Intermittent Tachy, Meconium Aspiration, Hypoglycemia, Low platelets, Low sodium
Preexisting Conditions: No Known Allergies
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vascular Collapse / Shock Treated with code blue procedures.


VAERS ID: 676211 (history)  
Form: Version 1.0  
Age: 0.0  
Sex: Male  
Location: Georgia  
Vaccinated:2016-11-29
Onset:2016-12-04
   Days after vaccination:5
Submitted: 2017-01-03
   Days after onset:30
Entered: 2017-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 37H34 / 1 LL / IM

Administered by: Public       Purchased by: Private
Symptoms: Circulatory collapse, Resuscitation, Shock
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-12-05
   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: D10W, Erythromycin Oint, Vit K, cefotaxime, mupirocin oint, aquaphor, gentamicin inj, glycerin supp, vancomycin, ampicillin
Current Illness: Possible Meconium Aspiration, respiratory distress
Preexisting Conditions: None Known
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vascular Collapse / Shock Treated with code blue procedures.


VAERS ID: 676389 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Male  
Location: North Carolina  
Vaccinated:2016-11-11
Onset:2016-11-12
   Days after vaccination:1
Submitted: 2017-01-03
   Days after onset:52
Entered: 2017-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. M026309 / 2 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-11-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Premature
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death.


VAERS ID: 676505 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2016-12-19
Onset:2016-12-24
   Days after vaccination:5
Submitted: 2017-01-04
   Days after onset:11
Entered: 2017-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
YF: YELLOW FEVER (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Acute kidney injury, Blood bilirubin increased, Blood creatinine increased, Blood pressure decreased, Blood smear test normal, Cardiac arrest, Chills, Chronic kidney disease, Clostridium test negative, Diarrhoea, Endotracheal intubation, Headache, Hypophagia, Hypotension, Influenza like illness, Jaundice, Life support, Malaise, Metabolic acidosis, Multiple organ dysfunction syndrome, Myalgia, Pain, Platelet count decreased, Pulmonary congestion, Pulseless electrical activity, Pyrexia, Renal tubular necrosis, Sinus tachycardia, Thrombocytopenia
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Anaphylactic reaction (broad), Acute pancreatitis (narrow), Angioedema (broad), Haematopoietic thrombocytopenia (narrow), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Renovascular disorders (broad), Chronic kidney disease (narrow), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (narrow), Tubulointerstitial diseases (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-12-30
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Trujeo, atorvastatin, doxazosin, montelukast, mirtazapine, dulaglutide
Current Illness: None; really unknown what time vaccination given at this time
Preexisting Conditions: Underlying history of Gilbert syndrome, history of previous nephrectomy, history of hypertension, diabetes, renal cancer with right nephrectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Time of onset: unknown; flu-like symptoms with myalgias, achiness and intermittent fever up to 102 F. Malaise, chills, and headache started on 12/24/2016; patient unable to eat or drink much, diarrhea started on 12/26/2016, Presented to the ED at 1217 PM hypotensive, Scr 3.07, T bili 2.7; patient admitted, seen by Infectious Disease physician, Internal Medicine, and critical care/pulmonary physicians; given IV fluid - responded to fluids initially; c. diff negative, fever, decrease BP and diarrhea persisted; thrombocytopenic, cefepime and steroids administered (x one dose each); thought to be possible vicerotropic yellow fever reaction - developed metabolic acidosis, acute kidney injury, likely acute tubular necrosis on CKD stage 3, patient intubated, PEA arrest on 12/28/2016, quick return of circulation with ACLS, pressors restarted, emergent HD; platelets now 23, on bicarbonate for acidosis; mild central pulmonary congestion, peripheral blood smear done, no hemolysis on smear, not suggestive of microangiopathic process, now jaundiced, intubated and on pressors; 12/29/2016 multiorgan failure persisted, developed sinus tachycardia,started on amiodarone for HR and rhythm control,albumin started to support BP.


VAERS ID: 676594 (history)  
Form: Version 1.0  
Age: 1.5  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-01-02
Entered: 2017-01-04
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 4 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Abdominal pain, Acute kidney injury, Alanine aminotransferase increased, Alpha 1 foetoprotein increased, Aspartate aminotransferase increased, Biopsy liver abnormal, Blood bilirubin increased, Chronic hepatitis B, Computerised tomogram liver abnormal, Death, Echocardiogram abnormal, Endotracheal intubation, General physical health deterioration, HIV test negative, Haemoglobin decreased, Hepatic cirrhosis, Hepatic failure, Hepatic lesion, Hepatic mass, Hepatitis B DNA assay positive, Hepatitis B e antigen positive, Hepatitis B surface antibody negative, Hepatitis C test negative, Hepatocellular carcinoma, Hepatomegaly, Hepatopulmonary syndrome, Hyperbilirubinaemia, Inappropriate schedule of drug administration, Laboratory test normal, Liver palpable, Mean cell volume decreased, Microcytic anaemia, Multiple organ dysfunction syndrome, Ocular icterus, Oedema peripheral, Palmar erythema, Respiratory failure, Scan with contrast abnormal, Splenomegaly, Ultrasound abdomen abnormal, Vaccination failure, Vertical infection transmission
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Liver infections (narrow), Anaphylactic reaction (broad), Acute pancreatitis (narrow), Angioedema (broad), Haematopoietic erythropenia (narrow), Lack of efficacy/effect (narrow), Haemorrhage laboratory terms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Tumour markers (narrow), Acute central respiratory depression (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Conjunctival disorders (narrow), Foetal disorders (broad), Liver malignant tumours (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Dehydration (broad), Hypokalaemia (broad), Sepsis (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: Hepatitis B Immune Globulin
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab tests were performed on unspecified date. Serum a-fetoprotein was markedly elevated at 100000 ng/mL. Abdominal ultrasound demonstrated a large, right-sided hepatic mass. Contrast-enhanced computed tomography (CT) scan was notable for a nodular liver, a large mixed density mass measuring 15 cm x 12 cm x 18 cm within the right hepatic lobe, multiple smaller hepatic lesions, splenomegaly, and diffuse pulmonary nodules concerning for metastatic disease. Open wedge liver biopsy, which revealed a well-differentiated hepatocellular carcinoma (HCC) with active micronodular cirrhosis that was HBsAg positive, a-Fetoprotein immunostaining was positive in the tumour cells. Her HBV genotype was type A with a P120T surface antigen mutation. Testing was negative for inherited cholestatic diseases. Alanine aminotransferase, 78 u/L; Aspartate aminotransferase, 419 u/L; Blood bilirubin, 16 mg/dL; Blood bilirubin, 5.5 mg/dL; Echocardiogram, consistent with hepato-pulmonary syndrome; HIV test, negative; Haemoglobin, 9.1 g/dL; Heart rate, 114 beats/min; Hepatitis B DNA assay, 100000 iu/ml; Hepatitis B e antigen, positive; Hepatitis B surface antibody, without any detectable; Hepatitis C virus test, negative; Mean cell volume, 76 fL; Respiratory rate, 48 breath(s)
CDC Split Type: US2016GSK193644

Write-up: This case was reported in a literature article and described the occurrence of vaccination failure in a 9-year-old female patient who received Hepatitis B vaccine. Co-suspect products included Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B Immune Globulin. On an unknown date, the patient received the 4th dose of Hepatitis B vaccine, the 3rd dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine, the 1st dose of Hepatitis B vaccine and Hepatitis B Immune Globulin at an unknown dose and frequency. On an unknown date, 7 years after receiving Hepatitis B vaccine and 8 years after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), chronic hepatitis B (serious criteria hospitalization and GSK medically significant), unknown cause of death (serious criteria death and GSK medically significant), hepatomegaly (serious criteria hospitalization), abdominal pain (serious criteria hospitalization), scleral icterus (serious criteria hospitalization), palmar erythema (serious criteria hospitalization), microcytic anemia (serious criteria hospitalization), hepatocellular carcinoma (serious criteria hospitalization and GSK medically significant), edema of lower extremities (serious criteria hospitalization), hepatic cirrhosis (serious criteria hospitalization and GSK medically significant), multi-organ failure (serious criteria hospitalization and GSK medically significant), respiratory failure (serious criteria hospitalization and GSK medically significant), hepatopulmonary syndrome (serious criteria hospitalization and GSK medically significant), acute renal failure (serious criteria hospitalization and GSK medically significant), inappropriate schedule of drug administration and vertical infection transmission. On an unknown date, the outcome of the vaccination failure, chronic hepatitis B, hepatomegaly, abdominal pain, scleral icterus, palmar erythema, microcytic anemia, hepatocellular carcinoma, edema of lower extremities, hepatic cirrhosis, multi-organ failure, respiratory failure, hepatopulmonary syndrome, acute renal failure, inappropriate schedule of drug administration and vertical infection transmission were unknown and the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the vaccination failure, chronic hepatitis B, unknown cause of death, hepatomegaly, abdominal pain, palmar erythema, microcytic anemia, hepatocellular carcinoma, edema of lower extremities, hepatic cirrhosis, multi-organ failure, respiratory failure, hepatopulmonary syndrome, acute renal failure, inappropriate schedule of drug administration and vertical infection transmission to be related to Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine. The reporter considered the scleral icterus to be related to Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of vaccination failure in a 9-year-old female patient who was vaccinated with unspecified hepatitis B virus (HBV) vaccine (manufacturer unknown). The patient was a previously healthy female. The patient''s mother''s prenatal records revealed that she was HBsAg positive during her pregnancy. She was unaware of her diagnosis and denied receiving any further testing or treatment. At the birth hospital, the patient was born full term via Caesarean section due to failure to progress. The patient was never breastfed. The patient did not have any other identified risk, either via blood-borne or sexual exposure, for hepatitis B virus infection by history. No information on patient''s concurrent condition or concomitant medication was provided. On unspecified dates, on day 1 of life, at the age of 3, 5 and 18-month, the patient received 4 doses of unspecified HBV vaccine (administration route and site unspecified; batch number not provided). The patient also received hepatitis B immune globulin (HBIG) on day 1 of life. There were no records of an evaluation for hepatitis B infection, including HBsAg and anti-HBs testing after the patient completed her vaccination series. On an unspecified date at the age of 9 years, an unknown period after the last dose of vaccination, the patient initially presented to an outside institution where she was noted to have marked hepatomegaly. Subsequently, the patient was admitted to the other hospital with 2 weeks and 2 days of pronounced scleral icterus. The patient''s examination was notable for an ill-appearing child with a pulse of 144 beats per minute and respiratory rate of 48 breaths per minute. She had a non-tender, but distended, abdomen with a firm liver edge palpable 5 cm below the right costal margin. She had non-pitting oedema in both lower extremities and palmar erythema. Laboratory studies revealed a microcytic anaemia (haemoglobin 9.1 g/dl, mean corpuscular volume 76 fL, elevated transaminases (aspartate aminotransferase 419 U/L, alanine aminotransferase 78 U/L, and hyper-bilirubinemia (total bilirubin 5.5 mg/dL). Serum a-fetoprotein was markedly elevated at 100000 ng/mL. Abdominal ultrasound demonstrated a large, right-sided hepatic mass. Contrast-enhanced computed tomography (CT) scan was notable for a nodular liver, a large mixed density mass measuring 15 cm x 12 cm x 18 cm within the right hepatic lobe, multiple smaller hepatic lesions, splenomegaly, and diffuse pulmonary nodules concerning for metastatic disease. The patient underwent open wedge livery biopsy, which revealed a well-differentiated hepatocellular carcinoma (HCC) with active micronodular cirrhosis that was HBsAg positive. A-Fetoprotein immunostaining was positive in the tumour cells. Investigation for an underlying ethology revealed positive serum HBsAg without any detectable hepatitis B surface antibody (anti-HBs). Hepatitis B virus (HBV) DNA was detected in the blood at 100000 IU/mL and she was hepatitis B envelope antigen (HBeAg) positive. Her HBV genotype was type A with a P120T surface antigen mutation. Testing was negative for HIV-1, hepatitis C virus, and inherited cholestatic diseases that could predispose her to HCC. Subsequently, the final diagnosis of hepatocellular carcinoma secondary to chronic hepatitis B infection was made. The patient rapidly deteriorated post-biopsy progressing to multisystem organ failure. She developed respiratory failure requiring endotracheal intubation and had echocardiogram findings consistent with hepato-pulmonary syndrome. She developed acute renal failure. Her liver disease decompensated with a total bilirubin increasing to a peak of 16 mg/dL with a predominant direct component, which precluded even palliative treatment of her malignancy. On hospital day 16, the patient died. The cause of death was unknown. It was not reported if the autopsy was performed. This case has been considered serious due to vaccination failure/hospitalisation/death. The authors stated, "Our patient developed chronic hepatitis B infection despite receiving adequate immunoprophylaxis. This scenario suggests that her virus, with its P120T surface antigen mutation, may have been a vaccine escape mutant." The authors concluded that "Increased awareness of vaccine escape mutant viruses should encourage strict adherence to current screening and treatment guidelines. However, clinicians should be cognizant that a few infants remain at risk of acquiring hepatitis B infection even if the provider has adhered closely to the guidelines."


VAERS ID: 677021 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-01-06
Entered: 2017-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TTOX: TETANUS TOXOID (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autonomic nervous system imbalance, Blood calcium increased, Blood creatine phosphokinase increased, Blood creatinine increased, Blood potassium normal, Blood pressure decreased, Blood sodium normal, Blood urea increased, Brain injury, Carbon dioxide decreased, Death, Electroencephalogram abnormal, Endotracheal intubation, General physical health deterioration, Hypermagnesaemia, Hypotension, Mobility decreased, Muscle spasms, Nuchal rigidity, Oxygen saturation normal, Pupil fixed, Salivary hypersecretion, Tetanus, Trismus, Urine output decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dystonia (narrow), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Atrial fibrillation
Preexisting Conditions: Medical History/Concurrent Conditions: Jaw stiffness; Comments: None
Allergies:
Diagnostic Lab Data: Test Name: Blood Pressure; Result Unstructured Data: 73/36; Comments: UNIT REPORTED AS:TORR; Test Name: oxygen saturation; Test Result: 95 %; Test Name: sodium; Result Unstructured Data: 140 millimole(s)/litre; Test Name: potassium; Result Unstructured Data: 4.1 millimole(s)/litre; Test Name: calcium; Test Result: 108 mg/dl; Test Name: carbon dioxide; Result Unstructured Data: 20 millimole(s)/litre; Test Name: Creatinine; Test Result: 2.0 mg/dl; Test Name: creatine phosphokinase; Result Unstructured Data: 1132 unit(s)/litre
CDC Split Type: USSA2017SA001045

Write-up: Initial unsolicited report received from the literature on 31-Dec-2016. The following is verbatim from the article: Abstract: Introduction: This is the 33rd Annual Report. As of 1 January 2015, 55 of the nation''s poison centers (PCs) uploaded case data automatically to database. The upload interval was 9.52 [7.40, 13.6] (median [25%, 75%]) minutes, creating a near real-time national exposure and information database and surveillance system. Methods: We analyzed the case data tabulating specific indices from the database. The methodology was similar to that of previous years. Where changes were introduced, the differences are identified. Poison center cases with medical outcomes of death were evaluated by a team of medical and clinical toxicologist reviewers using an ordinal scale of 1-6 to assess the Relative Contribution to Fatality (RCF) of the exposure. Results: In 2015, 2,792,130 closed encounters were logged by NPDS: 2,168,371 human exposures, 55,516 animal exposures, 560,467 information calls, 7657 human confirmed non-exposures, and 119 animal confirmed non-exposures. PCs also made 2,695,699 follow-up calls in 2015. Total encounters showed a 3.42% decline from 2014, while healthcare facility (HCF) human exposure cases increased by 5.09% from 2014. All information calls decreased by 15.5% but HCF information calls increased 2.67%, and while medication identification requests (Drug ID) decreased 31.7%, human exposures reported to PCs were essentially flat, increasing by 0.149%. Human exposures with less serious outcomes have decreased 2.95% per year since 2008 while those with more serious outcomes (moderate, major or death) have increased by 4.34% per year since 2000. The top 5 substance classes most frequently involved in all human exposures were analgesics (11.1%), household cleaning substances (7.54%), cosmetics/personal care products (7.41%), sedatives/hypnotics/antipsychotics (5.83%), and antidepressants (4.58%). Sedative/Hypnotics/Antipsychotics exposures as a class increased the most rapidly (2597 calls (11.4%)/year) over the last 14 years for cases showing more serious outcomes. The top 5 most common exposures in children age 5 years or less were cosmetics/ personal care products (13.6%), household cleaning substances (11.2%), analgesics (9.12%), foreign bodies/toys/miscellaneous (6.45%), and topical preparations (5.33%). Drug identification requests comprised 35.0% of all information calls. Database documented 1831 human exposures resulting in death with 1371 human fatalities judged related (RCF of 1-Undoubtedly responsible, 2-Probably responsible, or 3-Contributory). Conclusions: These data support the continued value of PC expertise and need for specialized medical toxicology information to manage more serious exposures, despite a decrease in calls involving less serious exposures. Unintentional and intentional exposures continue to be a significant cause of morbidity and mortality. The near real-time, always current status of database represents a national public health resource to collect and monitor exposure cases and information calls. The continuing mission of database is to provide a nationwide infrastructure for surveillance for all types of exposures (e.g., foreign body, viral, bacterial, venomous, chemical agent, or commercial product), the identification of events of public health significance, resilience, response and situational awareness tracking. Database is a model system for the real-time surveillance of national and global public health. This case involves 82-year-old female patient who was vaccinated with TETANUS TOXOID (batch number, expiration date, dose, route and site of administration were not reported) on an unspecified date. Patient had tripped and fell next to chicken coup; wound was sutured. Seven days later patient developed jaw stiffness and had ongoing medical history of atrial fibrillation which was treated with labetalol; later treated with amiodarone and digoxin. Concomitant medication was not reported. On an unspecified date, following vaccination patient developed trismus, hyper salivation, "lock jaw" and could not move neck, had diffuse muscle spasms for which was intubated and sedated with midazolam and fentanyl; magnesium infusion was continued (day 2), developed significant autonomic instability, patient was treated with cisatracurium, lorazepam, midazolam, and fentanyl but her spasms continued, developed hypomagnesaemia (reported as hypermagnesemia) and the infusion was stopped (On Day 3 ), decreased urine output, norepinephrine was increased following profound hypotension (50/30s) paralytic was stopped and the sedation was weaned (on Day 17), pupils were fixed and an EEG showed profound hypoxic injury (Day 21) and based on the prognosis, comfort measures were instituted and died on Day 22. On an unspecified date patient was hospitalized. Laboratory investigation included Blood Pressure: 73/36 Torr, Heart rates: 58 beats per minutes, Respiration rate 20 breaths per minute , oxygen saturation- 95%, sodium-140 mmol/L , potassium- 4.1 mmol/L, calcium-108 mg/dL, carbon dioxide- 20 mmol/L, blood urea nitrogen (BUN) test- 40, Creatinine -2.0 mg/dL, creatine phosphokinase (CPK)- 1132 U/L. On an unspecified date, patient received IVF and norepinephrine for hypotension, received furosemide for decreased urine output, benzodiazepines, magnesium and tetanus immunoglobulin and metronidazole as a corrective treatment. Outcome of event acute tetanus reported as fatal and for other events not reported. On an unspecified date patient was discharged from hospital. Cause of death: tetanus due to her leg lacerations. Manner of death: accidental. Autopsy was not performed. Documents held by sender: none. Sender''s Comments: The 82 years old female was reported to have had a fall during which she had wound which was sutured. Seven days later, she presented with jaw stiffness which warranted tetanus immunization. She gradually deteriorated, with symptoms compounding symptoms like lock jaw, muscle spasms, unable to move her neck, hypotension, autonomic instability. A diagnosis of acute tetanus was made. She had a history of atrial fibrillation which was before tetanus and was on treatment with several muscle relaxants, metronidazole, magnesium, lorazepam and then fentanyl was initiated. Norepinephrine was included in the therapy for hypotension. Few days later, she presented with magnesium toxicity and magnesium was discontinued. By day 21 her fixed pupils were fixed with EEG showing serious hypoxic injury. As there was a time lag between the fall, the wound, the development of the full symptoms of tetanus and the administration of the vaccine, it is unlikely that the vaccine (a toxoid) which could be the cause of death. Details regarding presence of tetanus spore from the wound may further aid in confirming the diagnosis and cause of death, which in this case is complications of tetanus. Reported Cause(s) of Death: tetanus.


VAERS ID: 677665 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-01-11
Entered: 2017-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131701USA003266

Write-up: This spontaneous report received from a consumer (patient''s mother) via social media regarding her son of unknown age. The patient''s medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with unspecified HPV Vaccine (manufacturer unknown), (dose, route, lot# not reported) for prophylaxis. On an unknown date, the patient died. She reported that her son died after vaccination. No PQC has been filed. Causality assessment was not provided. Upon internal review the event of death was determined to be medically significant. Additional information is expected.


VAERS ID: 677916 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-01-13
Entered: 2017-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131701USA004029

Write-up: This non-valid spontaneous report was received from a consumer via social media and refers to several female patients of unknown ages. On an unknown dates, the patients were vaccinated with a dose of either quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) injection (dose, route, site of vaccination, lot number and expiration date were not reported) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) injection (dose, route, site of vaccination, lot number and expiration date were not reported) for prophylaxis. The reporter did not specify the type of human papillomavirus (HPV) vaccine used. On an unknown date (reported as hours after this vaccine), the patients expired (reported as "friends lost their daughters. Upon internal review, the events of death was considered medically significant. This is one of the three cases provided by the same reporter. Additional information is not expected, as there was no contact information for the reporter provided. Sender''s Comments: US-009507513-1701USA005923: US-009507513-1701USA005922.


VAERS ID: 678221 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-01-16
Entered: 2017-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131701USA004850

Write-up: This spontaneous report was received from a consumer via social media, referring to an unspecified number of patients of unknown age and gender. Information about patients'' medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, the patients were vaccinated with a dose of an unidentified HPV vaccine (name and lot number not provided) for prophylaxis. The reporter stated that "did research and found out a leading scientist for the drug came out and said it''s killing kids". The reporter considered the event was related the unidentified Merck HPV vaccine. Upon internal review, the event "death" was considered to be medically significant. This is one of several reports received from same reporter. Additional information has been requested. Sender''s Comments: US-009507513-1701USA004856: US-009507513-1701USA005334: Interaction number.


VAERS ID: 678236 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Female  
Location: Ohio  
Vaccinated:2016-12-08
Onset:2016-12-14
   Days after vaccination:6
Submitted: 2017-01-16
   Days after onset:33
Entered: 2017-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (AFLURIA QUADRIVALENT) / SEQIRUS, INC. WTS005 / UNK RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Autoimmune disorder, Cold type haemolytic anaemia, Feeling abnormal, Nasopharyngitis, Skin discolouration
SMQs:, Haemolytic disorders (narrow), Dementia (broad), Hypotonic-hyporesponsive episode (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-12-26
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: none known of~ ()~~0.00~Patient
Other Medications: Multi Vitamin and aspirin daily. No prescriptions. Occasional Claritin.
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: She was diagnosed at facility with the rare Auto Immune disorder which can be triggered by a virus. She was on no medications and was healthy and independent.
CDC Split Type:

Write-up: Felt that she was getting a cold but had no fever, just didn''t feel right. By 12/21/2016 she was taken emergently to ER with blackened hands and feet, an AUTO IMMUNE REACTION called cold agglutinin. She was diagnosed at facility, and she was previously healthy and independent and something triggered this autoimmune response, perhaps the vaccine.


VAERS ID: 678378 (history)  
Form: Version 1.0  
Age: 39.0  
Sex: Male  
Location: Unknown  
Vaccinated:2016-07-29
Onset:2016-09-24
   Days after vaccination:57
Submitted: 2017-01-17
   Days after onset:115
Entered: 2017-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV634 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Alcohol abuse, Alcohol poisoning, Autopsy, Cardiomegaly, Cerebral disorder, Death, Drug abuser, Drug screen negative, Hepatitis, Hypertension, Hypertensive heart disease, Needle track marks, Paracentesis eye normal, Postmortem blood drug level increased, Renal disorder, Toxicity to various agents, Toxicologic test abnormal
SMQs:, Cardiac failure (broad), Hepatitis, non-infectious (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug abuse and dependence (narrow), Hypertension (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-09-24
   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:
Preexisting Conditions: Medical History/Concurrent Conditions: Impacted wisdom tooth; Tonsillectomy; Tonsillitis; Wisdom teeth removal; Comments: Tonsillitis; Tonsillectomy; Removal of wisdom teeth; Impacted wisdom tooth
Allergies:
Diagnostic Lab Data: Test Name: Post-mortem femoral blood test; Result Unstructured Data: Urine drug screen results at screening were negative. Autopsy - unknown date - Toxicologic analysis of post-mortem femoral blood revealed a toxic concentration of fentanyl. Methamphetamine, amphetamine, norfentanyl, and cotinine were also detected. Analysis of the vitreous fluid for electrolytes was unremarkable.
CDC Split Type: USEmergentBioSolutions17A

Write-up: Information was received on 04JAN2017, 09JAN2017, 10JAN2017 and 13JAN2017 from GlaxoSmithKline (GSK) in the form of a blinded CIOMS report. GSK physician indicated the study drug was unblinded and subject received ava (lot FAV634) only and did not receive raxibacumab. Death secondary to combined fentanyl and methamphetamine intoxication. This male subject was enrolled in a blinded GSK study. The subject received ava vs ava+raxibacumab+diphenhydramine from 29th July 2016 as a study participant. The subject''s past medical history included tonsillitis, tonsillectomy, removal of wisdom teeth and impacted wisdom tooth. On 24th September 2016, 57 days after the first dose of ava (lot FAV634) vs ava+raxibacumab+diphenhydramine, the subject developed grade 4 unknown cause of death. Serious criteria included death and medically significant. The outcome of unknown cause of death was fatal on 24th September 2016. The reported cause of death was unknown cause of death. The GSK investigator considered that there was no reasonable possibility that the unknown cause of death may have been caused by ava vs ava+raxibacumab+diphenhydramine. Additional information: GSK study site called subject on 27Sep2016 because he had not come to the site for his Day 29 appointment and was notified by the subject''s parent that he was found dead at home on 24Sep2016. Cause of death was unknown at this time. The subject had no medical history of angina pectoris, myocardial infarction, stroke, diabetes, hypertension and hyperlipidemia. Follow-up information received by GSK on 24th October 2016: The subject was a male in his late 30''s. Follow up information received by GSK on 01 November 2016: An autopsy was scheduled to be performed. Follow-up information received by GSK on 09 December 2016: On 24th September 2016, 57 days after the first dose of ava vs ava+raxibacumab+diphenhydramine, the subject developed grade 4 drug intoxication (combined fentanyl and methamphetamine intoxication). Serious criteria included death. The subject died on 24th September 2016. The investigator considered that there was no reasonable possibility that the drug intoxication may have been caused by ava vs ava+raxibacumab+diphenhydramine. GSK study site investigator text: autopsy showed evidence of chronic alcohol abuse and hypertensive cardiovascular disease, which significantly contributed to death. Autopsy revealed an enlarged (dilated) heart due to repeated alcoholic toxicity related to alcohol abuse. Long-standing high blood pressure, as evidenced by microvascular disease in the brain and kidney, also contributed to the enlargement of the heart. Autopsy report was reviewed by GSK on 09-Dec-2016 and the SAE information was updated. In addition to the autopsy finding, relevant diagnostic test results noted "there were findings of chronic intravenous drug abuse including needle tracks, inflammation and scarring of the liver, and injected foreign material within the lungs, liver and spleen. Toxicologic analysis of post-mortem femoral blood revealed a toxic concentration of fentanyl. Methamphetamine, amphetamine, norfentanyl, and cotinine were also detected. Analysis of the vitreous fluid for electrolytes was unremarkable". The report also noted that "enlarged hearts are pathologic, prone to electrical instability and sudden cardiac arrest, and less tolerant of the combined toxicity of fentanyl and methamphetamine". It should be noted that the subject did not report any history of hypertension to the study site. Additionally, the subject''s urine drug screen results at screening were negative.


VAERS ID: 679107 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: Wisconsin  
Vaccinated:2016-03-03
Onset:2016-03-04
   Days after vaccination:1
Submitted: 2017-01-23
   Days after onset:325
Entered: 2017-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 LL / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 2 RL / IM
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-03-07
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: NO
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: My son was put down for a nap about 12 or a bit after and he never woke up.


VAERS ID: 679160 (history)  
Form: Version 1.0  
Age: 0.0  
Sex: Female  
Location: New York  
Vaccinated:2012-07-31
Onset:2012-08-01
   Days after vaccination:1
Submitted: 2017-01-24
   Days after onset:1637
Entered: 2017-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVC188AA / UNK RL / IM

Administered by: Private       Purchased by: Other
Symptoms: Pallor, Respiratory arrest, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-08-02
   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: Pale, unresponsive and not breathing.


VAERS ID: 680133 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-01-30
Entered: 2017-01-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131701USA012873

Write-up: This spontaneous report was received from a social media via physician refers to atleast 32 female patients of unknown age. There was no information on concomitant medication, medical history and concurrent condition. On an unknown date, the patients were vaccinated with GARDASI) dose 0.5ml, intramuscular (lot # not reported). On an unknown date, the patients died. It was reported that it was unclear whether the death were related to the vaccine, and patients death after the shot did not mean the shots were necessary to blame. Upon internal review, the event of death was determined to be medically significant. This case has been linked with the MARRS case no. 1701USA010389. Additional information has been requested.


VAERS ID: 681597 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Female  
Location: Unknown  
Vaccinated:2015-12-03
Onset:0000-00-00
Submitted: 2017-02-06
Entered: 2017-02-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. L019835 / UNK UN / SC
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. L029484 / UNK UN / SC

Administered by: Other       Purchased by: Unknown
Symptoms: Acute hepatic failure, Acute kidney injury, Bronchopulmonary aspergillosis, Coagulopathy, Death, Emotional distress, Headache, Liver disorder, Liver transplant, Liver transplant rejection, Ocular icterus, Pain, Quality of life decreased, Rash, Respiratory failure, Seizure, Yellow skin
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cholestasis and jaundice of hepatic origin (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Convulsions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Conjunctival disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-02-05
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131702USA002372

Write-up: Information had been received on 06-FEB-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that female (age unknown) received ZOSTAVAX on 03-DEC-2015 for prevention of shingles. Within a matter of days, patient experienced yellowing skin and eyes. Patient was hospitalized and diagnosed with acute liver failure, acute hypoxic respiratory failure, coagulopathy and liver disease. It was reported that a known complication of shingles is that it can attack the liver. Patient also experienced rashes, seizures and headaches (dates not reported). Patient underwent a liver transplant but the new liver was rejected (date not reported). Patient experienced aspergillosis pneumonia and acute renal failure (dates not reported). On 05-FEB-2015, patient passed away (conflicting information as this date is prior to when patient was vaccinated). As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of ZOSTAVAX, patient sustained severe and fatal personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress and loss of enjoyment of life. Patient incurred medical expenses and other economic harm as a direct result of the use of ZOSTAVAX. Patient sustained serious personal injuries and related losses including, but not limited to, the following: required healthcare and services, incurred medical and related expenses and suffered mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life and other losses and damages up to and including death. Upon internal review, acute liver failure requiring liver transplant, acute hypoxic respiratory failure, seizures, aspergillosis pneumonia, acute renal failure, new liver was rejected and passed away were considered to be medically significant events. Additional information has been requested. Reported Cause(s) of Death: death.


VAERS ID: 682123 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Male  
Location: New York  
Vaccinated:2017-02-01
Onset:2017-02-02
   Days after vaccination:1
Submitted: 2017-02-10
   Days after onset:8
Entered: 2017-02-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (KINRIX) / GLAXOSMITHKLINE BIOLOGICALS 434B3 / 2 UN / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. M017347 / 2 UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. M036293 / 2 UN / UN

Administered by: Public       Purchased by: Other
Symptoms: Condition aggravated, Hypotension, Multiple organ dysfunction syndrome, Pyrexia, Seizure, Shock, Status epilepticus
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (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), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2017-02-20
   Days after onset: 18
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 17 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ONFI; TRILEPTAL
Current Illness: None
Preexisting Conditions: epilepsy; autism; microcephaly
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 4 year old boy with complicated medical condition-autism, seizure disorder, microcephaly - received 4 year old vaccines at regular check up. Was in good health at the visit. Following day, had a fever, then began having seizures -$g status epilepticus later admitted to hospital where he went into hypotensive shock and multi organ failure. Currently in critical condition.


VAERS ID: 682141 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Female  
Location: Georgia  
Vaccinated:2016-09-13
Onset:2016-09-13
   Days after vaccination:0
Submitted: 2017-01-31
   Days after onset:140
Entered: 2017-02-10
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1618901 / 1 RA / UN

Administered by: Private       Purchased by: Public
Symptoms: Abdominal discomfort, Cerebrovascular accident, Coma, Death
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-10-31
   Days after onset: 48
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 30 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Heart medication
Current Illness: No
Preexisting Conditions: Rheumatoid arthritis and A-fib (heart)
Allergies:
Diagnostic Lab Data: Normal physical, well developed and nourished
CDC Split Type:

Write-up: 9-13-16 Doctor appt. - within hours patient had some stomach discomfort that got worse over the week. She had the stroke on 9/20/16. The stroke in the patient''s brain was inoperable, in coma for a while, 6 weeks and 4 days later death.


VAERS ID: 682793 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: New York  
Vaccinated:2017-02-15
Onset:2017-02-16
   Days after vaccination:1
Submitted: 2017-02-16
   Days after onset:0
Entered: 2017-02-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS ZR474 / 1 RL / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS T797C / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R37129 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. M033338 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-02-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None, routine well visit
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Unattended death of infant reported via 911 dispatch by parents.


VAERS ID: 682795 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Kentucky  
Vaccinated:2017-01-31
Onset:2017-02-02
   Days after vaccination:2
Submitted: 2017-02-16
   Days after onset:14
Entered: 2017-02-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS M9174 / 1 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. M027884 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. M004890 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-02-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No meds
Current Illness: None
Preexisting Conditions: Prematurity
Allergies:
Diagnostic Lab Data: Autopsy is being done
CDC Split Type:

Write-up: ER called morning of 2-2-17. Child was found unresponsive. Pronounced deceased at the ER. Cause still being investigated, but vaccines were given on 1-31-17.


VAERS ID: 683406 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Tennessee  
Vaccinated:2016-12-07
Onset:2016-12-08
   Days after vaccination:1
Submitted: 2017-02-21
   Days after onset:75
Entered: 2017-02-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 4922C / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR U2845AA / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N16515 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. L009119 / 1 MO / PO

Administered by: Unknown       Purchased by: Other
Symptoms: Dyspnoea, Eye disorder, Feeling abnormal, Hyperhidrosis, Pyrexia, Rash
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-01-05
   Days after onset: 28
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: death~ ()~~0.17~Patient|breathing problems,h~ ()~~0.00~Patient|fever, sweating, rash~ ()~~0.00~Patient|severe pain and fussiness
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Severe fussiness, rashes, fever, sweating, eye problems, breathing problems.


VAERS ID: 684034 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Florida  
Vaccinated:2017-01-18
Onset:2017-01-21
   Days after vaccination:3
Submitted: 2017-02-24
   Days after onset:34
Entered: 2017-02-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5101AA / 1 LL / UN
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. M019671 / 2 RL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR U510AAA / 1 LL / UN
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR N1A451M / 1 LL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N05078 / 1 RL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. M005733 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-01-22
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: None stated.


VAERS ID: 684151 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: California  
Vaccinated:2016-11-14
Onset:2016-11-18
   Days after vaccination:4
Submitted: 2017-02-15
   Days after onset:89
Entered: 2017-02-28
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5041BA / 2 RL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UI553AAA / 2 LL / UN
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR N1A451M / 2 RL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N34937 / 2 LL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. M006111 / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-11-18
   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: POLY-VI-SOL
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None stated.


VAERS ID: 684399 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Tennessee  
Vaccinated:2017-02-28
Onset:2017-03-01
   Days after vaccination:1
Submitted: 2017-03-01
   Days after onset:0
Entered: 2017-03-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 352F9 / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. M036056 / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R37129 / 1 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS MD33Y / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ranitidine
Current Illness: None
Preexisting Conditions: Gastroesophageal reflux
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient died overnight the night following receiving vaccines.


VAERS ID: 684554 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Unknown  
Vaccinated:2016-04-18
Onset:0000-00-00
Submitted: 2017-03-02
Entered: 2017-03-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Meningococcal infection, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-11-27
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: US2017GSK029220

Write-up: This case was reported by a other health professional and described the occurrence of vaccination failure in a adult patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced vaccination failure (serious criteria GSK medically significant) and meningococcal infection (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the meningococcal infection was fatal. The reported cause of death was meningococcal infection. It was unknown if the reporter considered the vaccination failure and meningococcal infection to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient asked for a kit to test the clinical mening isolate if the strain was covered by the vaccine. The patient died on an unknown date. It was unknown if the autopsy was performed. This case was considered as suspected vaccination failure as the details regarding vaccination schedule, time to onset for the event and lab test confirmation was unknown.


VAERS ID: 686401 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Puerto Rico  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-03-20
Entered: 2017-03-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ENBREL
Current Illness: Kidney disorder; Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PR0095075131703USA005669

Write-up: This spontaneous report was received from a physician via a company representative and refers to a female patient of unknown age. The patient''s pertinent medical history included unspecified kidney problems. No information regarding the patient''s drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of unspecified pneumococcal vaccine (manufacturer unknown) (dose, route and site of administration, lot # and expiry date were not reported). Other suspect vaccines included influenza virus vaccine (unspecified) (date, dose, route and site of administration, lot # and expiry date were not reported). Concomitant therapies included ENBREL. On an unknown date, the patient was hospitalized for an unknown reason. The outcome of the event leading to hospitalization was not reported. On an unknown date, the patient died due to an unspecified cause. The relatedness between the events and pneumococcal vaccine (manufacturer unknown) and influenza virus vaccine (unspecified) was not reported. Upon internal review, the event of death was considered to be medically significant. Additional information has been requested.


VAERS ID: 686421 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Male  
Location: California  
Vaccinated:2017-03-17
Onset:2017-03-18
   Days after vaccination:1
Submitted: 2017-03-20
   Days after onset:2
Entered: 2017-03-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS TB7KY / 1 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR U1757AA / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N55175 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. M018958 / 1 - / IM

Administered by: Private       Purchased by: Public
Symptoms: Cyanosis, Death, Resuscitation, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), 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), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-03-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: recently completed Nystatin for thrush
Preexisting Conditions: Thrush
Allergies:
Diagnostic Lab Data: records sent to Coroner''s office for review
CDC Split Type:

Write-up: 6 weeks old found unresponsive by foster parents at 1230 PM. Cyanotic and CPR initiated- brought to ED via ambulance, patient transferred. Now deceased. Coroner''s office.


VAERS ID: 686558 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Unknown  
Location: Tennessee  
Vaccinated:2017-03-08
Onset:2017-03-09
   Days after vaccination:1
Submitted: 2017-03-21
   Days after onset:11
Entered: 2017-03-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C5055AB / 1 LL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 138T2T / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH Q04603 / 1 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS MD33Y / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-03-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Nystatin
Current Illness: Candida infection, treated with Nystatin
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2017037979

Write-up: This case was reported by a physician via sales rep and described the occurrence of sudden infant death syndrome in a 2-month-old patient who received ROTARIX. Co-suspect products included Nystatin unknown for thrush. Concurrent medical conditions included thrush (treated with Nystatin). On 8th March 2017, the patient received the 1st dose of ROTARIX (oral) and Nystatin at an unknown dose and frequency. On 9th March 2017, 1 days after receiving ROTARIX and Nystatin and 1 day after starting ROTARIX and Nystatin, the patient experienced sudden infant death syndrome (serious criteria death and GSK medically significant). On 9th March 2017, the outcome of the sudden infant death syndrome was fatal. The patient died on 9th March 2017. The reported cause of death was sudden infant death syndrome. The reporter considered the sudden infant death syndrome to be unrelated to ROTARIX and Nystatin. Additional details were provided as follows: On 8th March 2017, in morning, the patient received vaccination with ROTARIX at the physician visit. On the same day, the physician prescribed Nystatin for Thrush of the mouth. It was reported that the patient played all day and was fine. On 8th March 2017, in evening, the patient received a dose of Nystatin. On 9th March 2017, in morning, the patient was found dead. The physician mentioned it was not known if an autopsy was being done but potential Sudden infant death syndrome (SIDS) might be a cause. The sales representative had a little information. The contact details of the reporting physician were provided for the follow up.


VAERS ID: 686773 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Arkansas  
Vaccinated:2017-02-17
Onset:2017-02-18
   Days after vaccination:1
Submitted: 2017-03-22
   Days after onset:31
Entered: 2017-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 352F9 / 2 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. M036612 / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH Q04603 / 1 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS MD33Y / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-02-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Patient''s mother also reported co-bedding, which certainly increased risk of (if not ultimately caused) patient''s death.
CDC Split Type:

Write-up: Mother reported patient was abnormal looking and unresponsive. 911 called and CPR administered by EMTs. Patient arrived to ER, CPR still in progress, 4 doses epinephrine administered with no change. Patient declared dead at 6:28 AM (20 hours post vaccine administration).


VAERS ID: 688233 (history)  
Form: Version 1.0  
Age: 1.67  
Sex: Male  
Location: Colorado  
Vaccinated:2017-02-23
Onset:2017-02-24
   Days after vaccination:1
Submitted: 2017-03-27
   Days after onset:30
Entered: 2017-03-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UT5663JA / 3 LL / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 9TS3T / 2 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-02-24
   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: Clotrimazole cream 1% for diaper rash
Current Illness: none
Preexisting Conditions: hypospadias
Allergies:
Diagnostic Lab Data: autopsy completed with cause of death classified as undetermined
CDC Split Type:

Write-up: Death; patient was discovered unresponsive, prone in crib.


VAERS ID: 689125 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-04-03
Entered: 2017-04-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       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: 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: USSA2017SA047723

Write-up: Initial unsolicited report received from a nurse via other company (Pfizer) (manufacturer report number- 2017101323) on 20-MAR-2017. This case involves a male patient (unknown age) who was vaccinated with a dose of INFLUENZA VACCINE (FLU SHOT) (batch number, expiry date, route and site of administration were not reported) on an unspecified date. The patient''s medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced fever. On an unspecified date, patient died (reported as dropped dead). The cause of death was not reported. Patient''s lab data and corrective treatment were not reported. The events outcome was reported as fatal. It was unknown whether autopsy was performed or not. List of documents held by sender: none.; Sender''s Comments: Patient was vaccinated with flu shot had fever and died. Case is poorly documented, latency post vaccination is not provided, detailed medical history, past vaccination history and concomitant medication are unknown. Results of laboratory analysis and autopsy report are not provided. Additional information is required to fully assess role of the vaccine in reported event.; Reported Cause(s) of Death: Fever.


VAERS ID: 689235 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Male  
Location: Tennessee  
Vaccinated:2017-03-14
Onset:2017-03-15
   Days after vaccination:1
Submitted: 2017-04-04
   Days after onset:20
Entered: 2017-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 352F9 / 1 LL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UI736AA / 1 LL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N90908 / 1 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. M031650 / 1 UN / UN

Administered by: Unknown       Purchased by: Other
Symptoms: Death, Fatigue
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-03-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Death~DT+IPV+Hib+HepB (no brand name)~UN~0.17~Patient
Other Medications:
Current Illness: Had a cold week before
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: My son was extremely tired after getting shots I had to wake him to feed him the next morning he passed away.


VAERS ID: 690525 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Oregon  
Vaccinated:2015-07-09
Onset:2015-08-16
   Days after vaccination:38
Submitted: 2017-04-12
   Days after onset:605
Entered: 2017-04-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4877AC / 1 UN / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-08-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: He died unexpectedly and without cause according to coroner report.


VAERS ID: 690587 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-04-12
Entered: 2017-04-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Death, Hepatitis, Lymphoma
SMQs:, Hepatitis, non-infectious (narrow), Malignant lymphomas (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131704USA003355

Write-up: Information has been received from a physician referring to a patient of unknown age and gender. The patient''s concurrent condition, medical history and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route, lot number and expiration date unknown) for prophylaxis. On an unknown date, a few weeks later, the patient was diagnosed with an aggressive lymphoma and developed a severe hepatitis, It was reported that severe hepatitis led to his demise. The outcome of the event aggressive lymphoma was not reported. There were no specimens from the patient. Autopsy was not performed. The causal relationship between the events and ZOSTAVAX was not provided. Upon internal review, aggressive lymphoma and severe hepatitis were determined to be medically significant. Additional information has been requested. Reported Cause(s) of Death: a severe hepatitis.


VAERS ID: 690601 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-04-13
Entered: 2017-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Anaphylactic shock, Anaphylactoid reaction, Antinuclear antibody negative, Autopsy, Band neutrophil percentage increased, Blood culture negative, Blood lactate dehydrogenase normal, Blood lactic acid normal, Blood thyroid stimulating hormone normal, Body temperature increased, Cardiac arrest, Chest X-ray normal, Death, Echocardiogram abnormal, Endotracheal intubation, Eosinophil percentage increased, Flushing, Haemoglobin decreased, Hepatosplenomegaly, Hypotension, Intensive care, Leukostasis syndrome, Lymphocyte percentage decreased, Mast cell degranulation present, Mean cell volume normal, Multiple organ dysfunction syndrome, Neutrophil percentage increased, Platelet count decreased, Respiratory distress, Reticulocyte count normal, Rheumatoid factor negative, Right ventricular failure, Serum ferritin increased, Shock, Tachycardia, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (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 (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Malignancy related conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Dehydration (broad), Hypokalaemia (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: DALTEPARIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diarrhea; Eosinophilia; Hepatosplenomegaly; Intermittent headache; Vomiting; Weakness
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: 38.88 Celsius temperature; Test Name: white blood cell count; Result Unstructured Data: 13,500; Test Name: neutrophils; Test Result: 72 %; Test Name: lymphocytes; Test Result: 5 %; Test Name: eosinophils; Test Result: 11.7 %; Test Name: hemoglobin; Result Unstructured Data: 8.5 gram(s)/decilitre; Test Name: Mean corpuscular volume; Result Unstructured Data: 86.3; Test Name: platelet count; Result Unstructured Data: 110,000; Test Name: Ferritin; Result Unstructured Data: 391 nanogram(s)/millilitre; Test Name: hemoglobin; Result Unstructured Data: 5.9 gram(s)/decilitre; Test Name: white blood cell count; Result Unstructured Data: 42,000
CDC Split Type: USSA2017SA058814

Write-up: Initial unsolicited report received from the literature on 31 March 2017. This case involves a 25-year-old male patient who was vaccinated with a dose of INFLUENZA VACCINE and was also received a dose ACETAMINOPHEN WITH CODEINE, HYDROCORTISONE, a dose of DOBUTAMINE, a dose of NOREPINEPHRINE and a dose of EPINEPHRINE (batch number, expiration date, dose , site and route of administration was not reported) on an unknown date. Patient had medical history of intermittent headache and multiple ER visits for weakness, vomiting, diarrhea and a syncopal episodes was found to have massive hepatosplenomegaly and eosinophilia. Concomitant medications included Dalteparin subcutaneously for DVT prophylaxis. On an unknown date, following the vaccination, the patient developed temperature 102 degree Fahrenheit with stable hemodynamics. On an unknown date, evening of his second hospital day he acutely developed respiratory distress, hypotension and tachycardia 130/min with skin flushing. On an unknown date patient developed severely depressed left ventricle (echocardiogram showed). On an unknown date following the vaccination, within 5 hours of admission to the Medical Intensive Care Unit (MICU) patient developed refractory shock and asystole. On an unknown date following the vaccination, patient developed a rapidly progressive course of shock with multisystem organ failure, pulmonary leukostasis-associated right ventricular failure, severe anaphylactoid reaction, multiorgan failure and overwhelming anaphylactic shock. On an unknown date patient was hospitalized. Patient was intubated and transferred to the Medical Intensive Care Unit. It was reported that drop in hemoglobin was related to fluid resuscitation. On an unknown date patient died. It was also a case of Drug ineffective as hydrocortisone. Relevant laboratory test results included WBC (white blood cell count) 13,500 cells/?L with 72 percentage neutrophils, 5 percentage bands, 5 percentage lymphocytes, 11.7 percentage eosinophils, hemoglobin was 8.5 g/dL, Mean corpuscular volume (MCV) 86.3, platelet count: 110,000/?L. Venous lactate was 0.9 mmol/L. Ferritin was 391 ng/ml. Reticulocyte count, LDH (Lactate dehydrogenase), thyroid stimulating hormone (TSH), ANA (Anti Nuclear Antibodies) and RF (rheumatoid factor) were normal. Chest x-ray showed no abnormalities. Abdomen was benign with marked hepatosplenomegaly. Blood cultures were negative. On an unknown date Repeat CBC (complete blood count) showed hemoglobin 5.9g/dl, and white blood cell count 42,000/mcl with 30percentage degranulating mast cells. Patient received corrective treatment with adequate fluid resuscitation, hydrocortisone, broad-spectrum antibiotics, dobutamine, norepinephrine, epinephrine and vasopressin infusion. Outcome of temperature 102 Fahrenheit was not recovered and was fatal for other event. On an unspecified date autopsy was performed with following details: the bone marrow, spleen and liver were diffusely infiltrated by sheets of hypogranular, atypical, CD117+mast cells with large or double nuclei, open chromatin, and irregular nuclear membranes. These filled the pulmonary and coronary vessels and infiltrated cardiac and pulmonary parenchyma. Documents held by sender: none. Sender''s Comments: Reported symptoms and time to onset are consistent with the diagnosis of anaphylactic reaction. Time to onset is compatible with INFLUENZA VACCINE of unknown manufacturer, but additional information including but not limited to the patient''s immunization history (i.e., previous immunizations and any adverse events following immunization), allergic history, detail autopsy report and allergy testing to identify the culprit allergen are needed to further assess this case. In this case patient has history of mast cell leukemia with on and off symptoms, as mast cell leukemia can cause sudden release of histamine which could present with above reaction and also in autopsy it has been mentioned that there is infiltration of mast cells in bone marrow, liver and spleen. Based on available information the role of vaccine is unlikely. And also there is lack of efficacy for HYDROCORTISONE, DOBUTAMINE, NOREPINEPHRINE and EPINEPHRINE as patient experienced asystole and refractory shock even after administration of these drugs. Reported Cause(s) of Death: Severe anaphylactoid reaction; Autopsy-determined Cause(s) of Death: Severe anaphylactoid reaction.


VAERS ID: 690929 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Male  
Location: Kentucky  
Vaccinated:2017-03-31
Onset:2017-04-01
   Days after vaccination:1
Submitted: 2017-04-17
   Days after onset:16
Entered: 2017-04-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C5316AA / UNK RL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS M032649 / UNK LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R48402 / UNK LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. M011832 / UNK MO / PO

Administered by: Unknown       Purchased by: Public
Symptoms: Sudden death, Sudden infant death syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-04-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: Congenital umbilical hernia; Reflux diagnosed in nursery
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Sudden unexplained infant death.


VAERS ID: 691092 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Colorado  
Vaccinated:1994-06-20
Onset:1994-06-20
   Days after vaccination:0
Submitted: 2017-04-18
   Days after onset:8338
Entered: 2017-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPH: DTAP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Autopsy, Crying, Death, Immediate post-injection reaction, Initial insomnia, Musculoskeletal stiffness, Opisthotonus, Screaming, Sudden infant death syndrome
SMQs:, Neuroleptic malignant syndrome (broad), Dementia (broad), Dystonia (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Hypersensitivity (narrow), Arthritis (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 1994-06-21
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: prematurity 30 weeks, PROM 24 weeks
Allergies:
Diagnostic Lab Data: autopsy/SIDS
CDC Split Type:

Write-up: Screaming and crying starting immediately post-vac, including arched back and stiff limbs. Did not sleep until 0200 06/21/1994, found dead by mother 1000.


VAERS ID: 691264 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: Arizona  
Vaccinated:2016-12-05
Onset:2016-12-18
   Days after vaccination:13
Submitted: 2017-04-19
   Days after onset:121
Entered: 2017-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV459A / 1 - / IM
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR L1570 / 1 - / IM

Administered by: Military       Purchased by: Military
Symptoms: Death, Encephalitis autoimmune, Toxic epidermal necrolysis
SMQs:, Severe cutaneous adverse reactions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-02-23
   Days after onset: 67
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: none
Allergies:
Diagnostic Lab Data: died from Toxic Epidermal Necrolysis related to treatment of the anti-NMDA receptor encephalitis
CDC Split Type:

Write-up: Anti-NMDA receptor encephalitis after anthrax/typhoid vaccines.


VAERS ID: 691319 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: Washington  
Vaccinated:2015-12-08
Onset:2016-03-28
   Days after vaccination:111
Submitted: 2017-04-19
   Days after onset:387
Entered: 2017-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR U1431AB / 1 LA / SYR
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 294X9 / 1 RA / SYR
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER L014415 / 1 RA / SYR
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5020AA / 1 LA / SYR
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 9496S / 1 RA / SYR
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. L020002 / 2 LA / SYR

Administered by: Public       Purchased by: Unknown
Symptoms: Death, Generalised tonic-clonic seizure
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: 2017-04-08
   Days after onset: 376
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: First Grand Mal Tonic-Clonic Seizure (3/28/2016). Second Grand Mal Tonic-Clonic Seizure 1/20/2017. Third/Fourth Grand Mal Tonic-Clonic Seizure 3/10/2017. Fifth/Final Grand Mal Tonic-Clonic Seizure leading to death: 4/8/2017.


VAERS ID: 691409 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Male  
Location: Arizona  
Vaccinated:2016-09-23
Onset:2016-12-06
   Days after vaccination:74
Submitted: 2017-04-20
   Days after onset:134
Entered: 2017-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 2CK29 / 1 RA / IM

Administered by: Unknown       Purchased by: Other
Symptoms: Abnormal behaviour, Crying, Death, Irritability, Malaise, Speech disorder developmental, Staring
SMQs:, Dementia (broad), Psychosis and psychotic disorders (broad), 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: 2016-12-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: Patient didn''t feel well a few days after receiving the immunization, Dtap. He was very fussy and just not himself. He cried uncontrollably for approximately 1 hour before falling asleep. Patient''s speech regressed following the Dtap immunization. He also began staring at things.
CDC Split Type:

Write-up: Patient was put to bed by his parents the previous night. His Mother discovered him deceased in his bed the next morning.


VAERS ID: 691836 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Colorado  
Vaccinated:2011-07-08
Onset:2011-07-28
   Days after vaccination:20
Submitted: 2017-04-25
   Days after onset:2098
Entered: 2017-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0181AA / 1 AR / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS U3514AA / 2 AR / IM

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2011-07-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: autopsy determined unknown cause of death
CDC Split Type:

Write-up: Layed down to take a nap and never woke up.


VAERS ID: 691917 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Texas  
Vaccinated:2017-02-23
Onset:2017-02-24
   Days after vaccination:1
Submitted: 2017-04-25
   Days after onset:59
Entered: 2017-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS ZR474 / 1 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. M036612 / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R37129 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. M033338 / 1 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Anaphylactic reaction, Autopsy, Sudden infant death syndrome
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Neonatal disorders (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-02-24
   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: no
Preexisting Conditions: poor weight gain
Allergies:
Diagnostic Lab Data: current autopsy suspecting anaphylaxis to vaccines
CDC Split Type:

Write-up: SIDS.


VAERS ID: 692183 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-04-27
Entered: 2017-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131704USA009337

Write-up: This spontaneous report was received from a nurse via a company representative and refers to a patient of unknown demographics. No information regarding the patient''s medical history, concomitant medications, concurrent conditions and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, lot number and expiration date were not reported). Other suspect therapies included sterile diluent (dose, lot number an expiration date were not reported). On an unknown date, after receiving ZOSTAVAX the patient died. The cause of death was not reported. It was unknown, whether the autopsy had been performed. The relatedness between the event and ZOSTAVAX was not reported. Upon internal review, the event of death was considered to be medically significant. Additional information is not expected as there was no consent for further contact with the reporter.


VAERS ID: 692520 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Female  
Location: California  
Vaccinated:2015-12-03
Onset:2015-12-07
   Days after vaccination:4
Submitted: 2017-04-30
   Days after onset:509
Entered: 2017-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Public       Purchased by: Other
Symptoms: Asthenia, Dyspnoea, Headache, Hepatic failure, Pain, Rash, Seizure
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (narrow), Systemic lupus erythematosus (broad), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-02-05
   Days after onset: 60
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CELL CEPT, TACROLIMUS. IMMUNOSUPPRESSIVE DRUGS.
Current Illness: IMMUNOCOMPROMISE (POST LIVER TRANSPLANT) PATIENT.
Preexisting Conditions: IMMUNOSUPPRESSIVE THERAPY
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Liver failure, rashes, seizures, pain, headaches, weak. Shortness of breath.


VAERS ID: 692864 (history)  
Form: Version 1.0  
Age: 72.0  
Sex: Male  
Location: Unknown  
Vaccinated:2017-03-31
Onset:2017-03-31
   Days after vaccination:0
Submitted: 2017-04-07
   Days after onset:7
Entered: 2017-05-03
   Days after submission:26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. XM59T / UNK UN / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. L040053 / UNK RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Dyspnoea, Paraesthesia, Resuscitation, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-03-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MIRCERA
Current Illness:
Preexisting Conditions: Allergies - DEFINITY contrast; Acute kidney injury; Asthmatic bronchitis; COPD; Diastolic heart failure; HTN; Charcot-Marie-Tooth disease; Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Hemodialysis Patient receiving hemodialysis at approx 0934 pre BP 143/70, pulse 65. At approx 1204 BP 102/43, pulse 65. Patient was administered first dose of MIRCERA 100mcg IVP at 1158, Pneumococcal vaccine 23 IM 0.5ml at 1200, RECOMBIVAX 40mcg IM at 1201. At approx 1205 patient reported tingling in his ears and complained of shortness of breath, and then became unresponsive. CPR was initiated at 1205, 911 called, EMS arrived and transported patient at approx 1245 to hospital ER. Patient expired in ER.


VAERS ID: 693530 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Colorado  
Vaccinated:1992-02-20
Onset:1992-04-08
   Days after vaccination:48
Submitted: 2017-05-08
   Days after onset:9161
Entered: 2017-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 RA / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1992-04-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: death ruled as SIDS
CDC Split Type:

Write-up: Death CPR administered and taken to the hospital.


VAERS ID: 693621 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Male  
Location: Louisiana  
Vaccinated:2017-05-04
Onset:2017-05-04
   Days after vaccination:0
Submitted: 2017-05-09
   Days after onset:5
Entered: 2017-05-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R33240 / 1 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Cerebrovascular accident
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: 2017-05-05
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient had a stroke within 24 hours of leaving facility.


VAERS ID: 693670 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-05-09
Entered: 2017-05-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131705USA002407

Write-up: This spontaneous report was received from an unspecified source, concerning teenagers from unknown genders and ages, posted in an online article. The patients'' concurrent conditions, pertinent medical history and concomitant medications were not provided. On an unknown date, the patients were vaccinated with GARDASIL (dose number, anatomical location, lot # and expiration date were not known) for prophylaxis. Furthermore, it was reported that on unspecified dates, an unknown number of patients died due to unknown causes, after vaccination with GARDASIL, reported as "parents and women must know that deaths occurred". It was unknown if autopsies were done. No further information was cited. The relatedness between deaths and vaccination with GARDASIL was not provided. This is one of several reports received from the same source. Additional information is not expected as no contact details were given. Sender''s Comments: US-009507513-1705USA002408: US-009507513-1705USA002409: US-009507513-1705USA002410: US-009507513-1705USA002411: US-009507513-1705USA002412: US-009507513-1705USA002413: US-009507513-1705USA002414: US-009507513-1705USA002415: US-009507513-1705USA002416: US-009507513-1705USA002393: US-009507513-1705USA003214: ZA-009507513-1507ZAF012830: Reported Cause(s) of Death.


VAERS ID: 693757 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Massachusetts  
Vaccinated:2017-05-04
Onset:2017-05-06
   Days after vaccination:2
Submitted: 2017-05-10
   Days after onset:4
Entered: 2017-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C5276AB / 3 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH R56665 / 3 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-05-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: erythromycin ophthalmic ointment, polyvisol, acetaminophen
Current Illness: no
Preexisting Conditions: Former 26wk premie with cleft lip and palate, multiple hand and foot congenital abnormalities, persistent left superior vena cava, Atrial septal defect, sinus tachycardia
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient presented to ED on 5/6/2017 in cardio-respiratory arrest.


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