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VAERS ID: 581539 (history)  
Form: Version 1.0  
Age: 0.32  
Sex: Female  
Location: Washington  
Vaccinated:2015-06-05
Onset:2015-06-07
   Days after vaccination:2
Submitted: 2015-06-11
   Days after onset:4
Entered: 2015-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 5XK44 / 2 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UI277AAA / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L31684 / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. K017573 / 2 MO / PO

Administered by: Private       Purchased by: Other
Symptoms: Activated partial thromboplastin time prolonged, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood albumin decreased, Blood bilirubin normal, Brain death, Encephalopathy, Escherichia infection, Escherichia test positive, Haematocrit decreased, International normalised ratio increased, Nuclear magnetic resonance imaging brain abnormal, Platelet count increased, Prothrombin time prolonged, Pyrexia, Transaminases increased, Urinary tract infection, Vomiting, White blood cell count decreased
SMQs:, Liver related investigations, signs and symptoms (narrow), Liver-related coagulation and bleeding disturbances (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2015-06-10
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: WBC 5.25, Hct 31.2, Plt 545, Pro 19.1, INR 1.58, APTT 40.3, SGOT 4460, SGPT 2260, Albumin 2.6, Tbili 0.5. Urine culture grew E. coli. Brain MRI: multifocal areas of signal abnormality/restricted diffusion, many of which demonstrate irregular areas or rim enhancement, most prominent involving the bilateral thalami and cerebellar white matter. Primary differential considerations include acute necrotizing encephalopathy of childhood, acute disseminated encephalomyelitis and multifocal septic emboli.
CDC Split Type:

Write-up: Baby developed a fever and vomiting 6/7/15 PM, subsequently found to have transaminitis. She was admitted, developed encephalopathy and brain death by 6/8/15. She was also found to have an E. coli UTI.


VAERS ID: 582673 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Male  
Location: Missouri  
Vaccinated:2015-04-21
Onset:2015-04-24
   Days after vaccination:3
Submitted: 2015-06-22
   Days after onset:59
Entered: 2015-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L13063 / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: CSF test abnormal, Cryptococcus test positive, Meningitis cryptococcal
SMQs:, Guillain-Barre syndrome (broad), Opportunistic infections (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2015-06-04
   Days after onset: 41
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 27 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Amlodipine/HCTZ, Protocream
Current Illness:
Preexisting Conditions: Hypertension, Hypogonadism, Tobacco use
Allergies:
Diagnostic Lab Data: Positive cryptococcal antigen 1:1:320 in CSF
CDC Split Type:

Write-up: Positive cryptococcal menigitis s/p Prevnar 13.


VAERS ID: 582853 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Male  
Location: Arizona  
Vaccinated:2015-06-08
Onset:2015-06-10
   Days after vaccination:2
Submitted: 2015-06-23
   Days after onset:13
Entered: 2015-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR A14097 / 2 LA / UN

Administered by: Private       Purchased by: Private
Symptoms: Adenoidal hypertrophy, Computerised tomogram abnormal, Intensive care, Mechanical ventilation, Mononucleosis heterophile test positive, Pharyngeal oedema, Tonsillar hypertrophy
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2016-04-12
   Days after onset: 307
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 301 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Azithromycin; Steroid
Current Illness: Tonsillitis
Preexisting Conditions: Amoxicillin allergy
Allergies:
Diagnostic Lab Data: (+) Mono test at urgent care 6/10/15; (+) tonsil/adenoid/throat swelling on CT 6/13/15
CDC Split Type:

Write-up: Pt. was mildly ill with tonsillitis when vaccine given. 2 days later went to urgent care for worsening (throat swelling). 2 days later went to hospital ED for throat swelling and transported to another hospital. In PICU now x 3 days on ventilator. They think severe EBV infection, but unsure.


VAERS ID: 582897 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Ohio  
Vaccinated:2015-05-25
Onset:2015-06-02
   Days after vaccination:8
Submitted: 2015-06-23
   Days after onset:21
Entered: 2015-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 4257X / 1 RL / IM

Administered by: Public       Purchased by: Other
Symptoms: 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: 2015-06-02
   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: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Hand convulsions.


VAERS ID: 582912 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-06-23
Entered: 2015-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1506USA011395

Write-up: This spontaneous report as received from a consumer, as part of a marketing research program, and refers to his/her father of unknown age. The patient''s medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of pneumococcal vaccine (manufacturer unknown) (administration route, lot number and expiration date were not provided). No concomitant therapies were reported. The reporter stated that the patient died 3 months (also reported as 6 months) after being vaccinated from a stroke (cerebrovascular accident), for which the patient was hospitalized (dates not reported). The outcome of the cerebrovascular accident was reported as fatal. The cause of death was reported as cerebrovascular accident and it was unknown if an autopsy was performed. The relatedness between the cerebrovascular accident the Pneumococcal vaccine (manufacturer unknown) was not reported. Additional information is not expected, since the reporter did not want the company to contact the physician to discuss further.


VAERS ID: 583142 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Arizona  
Vaccinated:2015-06-19
Onset:2015-06-21
   Days after vaccination:2
Submitted: 2015-06-24
   Days after onset:3
Entered: 2015-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS Z2459 / 3 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L13524 / 3 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. K013868 / 3 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-06-21
   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: Vit D (breast feeding)
Current Illness: None
Preexisting Conditions: Atrial septal defect, peripheral pulmonary stenosis
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Found down at babysitters, attempted recusitation, DOA in ER.


VAERS ID: 583871 (history)  
Form: Version 1.0  
Age: 0.36  
Sex: Female  
Location: Colorado  
Vaccinated:2014-03-10
Onset:2014-03-16
   Days after vaccination:6
Submitted: 2015-06-29
   Days after onset:470
Entered: 2015-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR 90698 / 2 UN / SYR
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER 90670 / 2 UN / SYR
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 90680 / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-03-16
   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: No
Preexisting Conditions: Had IUGR (intrauterine growth restriction) and was delivered by c-section at 37 weeks. Had respiratory distress syndrome after being delivered and spent one week in NICU. Came home on oxygen for another two weeks. After that had no health problems and was on track developmentally.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient died. Diagnosis by coroner was SUIDS.


VAERS ID: 583976 (history)  
Form: Version 1.0  
Age: 0.37  
Sex: Female  
Location: West Virginia  
Vaccinated:2015-06-26
Onset:2015-06-28
   Days after vaccination:2
Submitted: 2015-06-30
   Days after onset:2
Entered: 2015-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 525T3 / 2 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. K025004 / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L33881 / 2 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CB466A / 2 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Gastrointestinal necrosis, Intensive care, Ischaemia, Laparotomy, Necrosis ischaemic, 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), Ischaemic colitis (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2015-07-05
   Days after onset: 7
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: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Found unresponsive in crib on 6/28/15. 20 min of CPR in ER before rhythm obtained in emergency room. Admitted to PICU. Necrosis of bowel due to ischemia. In Silo after laparotomy. Prognosis currently poor.


VAERS ID: 584129 (history)  
Form: Version 1.0  
Age: 10.0  
Sex: Female  
Location: New York  
Vaccinated:2015-06-28
Onset:2015-06-29
   Days after vaccination:1
Submitted: 2015-06-29
   Days after onset:0
Entered: 2015-07-01
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 9245B / UNK LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Cardio-respiratory arrest, Death, Seizure like phenomena
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), Convulsions (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-06-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient expired approximately 24 hours after receiving Tdap vaccine. Patient experienced seizure like activity and cardiopulmonary arrest while on sports field.


VAERS ID: 584344 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-06-30
Entered: 2015-07-02
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death neonatal, Foetal exposure during pregnancy
SMQs:, Acute central respiratory depression (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: UNK
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2015SA092506

Write-up: Initial unsolicited literature report received from a physician on 16 June 2015. This case is linked to 2015SA092507, 2015SA092508, 2015SA092509, 2015SA092510, 2015SA092511, 2015SA092512, 2015SA089479, 2015SA092722, 2015SA092723, 2015SA092724, 2015SA092725 (same vaccine). Abstracts: OBJECTIVE: To evaluate pregnancy outcomes of women who received Tdap vaccination at or after 32 weeks of gestation. Outcomes from consecutive pregnancies during which the mother received Tdap were also analyzed. METHODS: In a retrospective cohort study at a single institution, we compared pregnancy outcomes between those who accepted or declined Tdap at 32 weeks of gestation. Additionally, women who received Tdap vaccination in this and a prior pregnancy in the past 5 years were compared with multiparous women who only received Tdap in this pregnancy. RESULTS: Since 2013, 7,378 women who were offered the Tdap vaccine antenatally delivered at our institution: 7,152 accepted (97 percentage). There was no difference in stillbirths, major malformations, chorioamnionitis, 5-minute Apgar score, or cord blood pH. Neonatal complications including ventilation requirement, sepsis, intraventricular hemorrhage, and neonatal death were also similar. However, preterm birth rates at 36 weeks of gestation or less (6 percentage compared with 12 percentage, P less than 0.001), incidence of small for gestational age (10 percentage compared with 15 percentage, P equal to 03), and length of neonatal hospitalization (3.9 compared with 4.7 days, P less than 001) were all significantly increased in the unvaccinated cohort. No difference in neonatal outcomes was noted between women who were administered at least two Tdap vaccines in the past 5 years (n equal to 1,229) and those who received only a single dose (n equal to 4,159). CONCLUSION: No adverse pregnancy outcomes were identified in association with antepartum Tdap vaccination. This remained true in women receiving more than one Tdap vaccine in a 5-year timeframe. This may be the result of a type II error. A 7,378 number of female patients out of which (97 percentage) patients received Tdap vaccine and 226 (3 percentage) patients declined Tdap vaccine. A 7,152 number of female patients, whose medical history and concomitant medication were not reported had received a dose of Tdap (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. This is a case for 2 neonate patients (gender: unknown). The patients were exposed to Tdap vaccine in utero. The patients died on an unspecified date. Laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was fatal. Documents held by sender: none.


VAERS ID: 585031 (history)  
Form: Version 1.0  
Age: 59.0  
Sex: Male  
Location: Arizona  
Vaccinated:2014-10-15
Onset:2014-10-22
   Days after vaccination:7
Submitted: 2015-07-08
   Days after onset:259
Entered: 2015-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES UI189AA / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Central nervous system lesion, Hemiparesis, Hyperaesthesia, Injection site pain, Pain, Pain in extremity
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Extravasation events (injections, infusions and implants) (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2015-06-16
   Days after onset: 237
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 40 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Metoprolol,lisinopril,omeprazole,loratadine, aspirin,krill oil,lananoprost eye drops
Current Illness: no
Preexisting Conditions: high blood pressure, high cholesterol
Allergies:
Diagnostic Lab Data: left arm pain sensitive to touch, right side weakness, brain lesions, weakness
CDC Split Type:

Write-up: site of injection burning, severe sensitivity touch,aching


VAERS ID: 586133 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Florida  
Vaccinated:2015-03-26
Onset:2015-03-26
   Days after vaccination:0
Submitted: 2015-07-16
   Days after onset:112
Entered: 2015-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 4233K / 3 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J23862 / 3 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. K013410 / 3 MO / PO

Administered by: Private       Purchased by: Other
Symptoms: Cyanosis, Death, Peripheral coldness, Pulse absent, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-03-26
   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: Cold, Blue, not breathing, Lifeless, no pulse.


VAERS ID: 586425 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Male  
Location: Louisiana  
Vaccinated:2015-07-07
Onset:2015-07-09
   Days after vaccination:2
Submitted: 2015-07-20
   Days after onset:11
Entered: 2015-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS Y33F2 / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. L004738 / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L62074 / 1 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CB458A / 1 MO / PO

Administered by: Private       Purchased by: Private
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: 2015-07-10
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Slight fever on Thursday night. Friday put to sleep on stomach for 2 hours and mother found him deceased.


VAERS ID: 586965 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2015-07-09
Onset:2015-07-15
   Days after vaccination:6
Submitted: 2015-07-24
   Days after onset:9
Entered: 2015-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 300051971022 / UNK LA / IM
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. 300064963410 / UNK LA / SC

Administered by: Other       Purchased by: Other
Symptoms: Death, Local reaction, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-07-20
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1507USA010082

Write-up: This spontaneous report as received from a physician via company representative, refers to a 84 year old female patient. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, lot# and route of administered was not reported) and PREVNAR. On an unknown date the patient experienced "local reaction which was not specified" and swelling in her feet. The patient did not seek medical attention. On an unknown date the patient passed away. Relatedness between therapy and adverse event was not reported. Additional information is not expected, physician refused to contact to him.


VAERS ID: 586988 (history)  
Form: Version 1.0  
Age: 61.0  
Sex: Male  
Location: Texas  
Vaccinated:2015-01-05
Onset:2015-02-23
   Days after vaccination:49
Submitted: 2015-07-24
   Days after onset:150
Entered: 2015-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. K008881 / UNK UN / SC

Administered by: Military       Purchased by: Other
Symptoms: Acute respiratory failure, Biopsy skin abnormal, Death, Herpes zoster disseminated, Mental status changes, Pneumonia staphylococcal, Staphylococcal sepsis, Staphylococcus test positive
SMQs:, Anaphylactic reaction (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), Dementia (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Skin tumours of unspecified malignancy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2015-03-15
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 17 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Not documented, probably taking prednisone and mycophenolate mofetil
Current Illness:
Preexisting Conditions: Wegener''s granulomatosis with polyangitis, end stage renal disease, coronary artery disease, schizophrenia, chronic compensated ischemic cardiomyopathy
Allergies:
Diagnostic Lab Data: Abdominal punch biopsy with herpes virus cytopathic effect, compatible with herpes zoster, collected 2/25/15. MRSA detected in serum at admission 2/25/15.
CDC Split Type:

Write-up: Disseminated zoster infection, MRSA infection--sepsis and pneumonia, acute respiratory failure, altered mental status.


VAERS ID: 587213 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: Texas  
Vaccinated:2015-02-16
Onset:2015-03-03
   Days after vaccination:15
Submitted: 2015-07-18
   Days after onset:136
Entered: 2015-07-27
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4870AA / 1 RL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. K010535 / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J80526 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. K013661 / 1 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Death, Intussusception, Irritability, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal obstruction (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-03-03
   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: PRILOSEC
Current Illness: None
Preexisting Conditions: Milk allergy; GERD; 36 wk gest / maternal preeclampsia
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Intussusception; 15 days after receiving vaccinations. Presented to local ER with vomiting and irritability.


VAERS ID: 588137 (history)  
Form: Version 1.0  
Age: 0.59  
Sex: Female  
Location: California  
Vaccinated:2015-07-27
Onset:2015-07-27
   Days after vaccination:0
Submitted: 2015-07-31
   Days after onset:4
Entered: 2015-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4773AA / 1 RL / UN
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. K008986 / 3 LL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH I53937 / 2 LL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. K023157 / 1 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Death, Full blood count
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-07-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZANTAC
Current Illness: Apnea; Tracheomalacia; Prematurity; GER; Chronic lung disease
Preexisting Conditions: Apnea; Tracheomalacia; Prematurity; GER; Chronic lung disease
Allergies:
Diagnostic Lab Data: CBC
CDC Split Type:

Write-up: Patient has extreme prematurity 25 wks. Has Hx of Apnea, Tracheomalacia, GER, Breath-holding spell. Infant died on the same day vaccines were administered. Infant died in her sleep.


VAERS ID: 588222 (history)  
Form: Version 1.0  
Age: 5.0  
Sex: Male  
Location: Unknown  
Vaccinated:2004-07-09
Onset:2004-07-11
   Days after vaccination:2
Submitted: 2015-07-31
   Days after onset:4037
Entered: 2015-08-03
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Meningoencephalitis viral
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-07-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: UNK
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2015SA111946

Write-up: Initial unsolicited report received from a consumer (patient''s parent) on 25 July 2015. A male child patient (age not reported), whose medical history and concomitant medications were not reported, had received a dose of Meningococcal vaccine (batch number, route of administration and site of administration were not reported) on an unspecified date. On an unspecified date, two days later the patient died of viral meningoencephalitis. Laboratory investigations and corrective treatments were not reported. Documents held by sender: none.


VAERS ID: 589497 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-08-06
Entered: 2015-08-11
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Meningitis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious meningitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unk
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2015SA116634

Write-up: Initial unsolicited report received from a non-healthcare professional (patient''s relative) via social media on 01 August 2015. A 07-month-old female infant, whose medical history and concomitant medications were not reported, had received a dose of meningococcal vaccine (dose, dose in series, batch number, expiry date, route and site of administration were not reported) on an unknown date. Reporter stated that her neighbour back in the eighties was not fortunate enough as on an unknown date her daughter contacted meningitis after receiving the vaccination (time from first dose to onset not specified) and she died within few hours of having fever which her mother thought to be a simple fever. Laboratory investigations and corrective treatments were not reported. It was unknown if autopsy was performed. Documents held by sender: none.


VAERS ID: 590214 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-08-17
Entered: 2015-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (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: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1508USA005868

Write-up: This spontaneous report was received from a physician via company representative regarding 100 unspecified patients. The physician reported an adverse event involving an unspecified measles vaccine. The physician stated that he had read an unspecified article in a locally published newsletter (name of the newsletter not provided). The article stated that there were hundred deaths caused by Measles, Mumps, and Rubella Virus Vaccine, (manufacturer unknown) (dose, strength, dose number, Lot no, vaccination site not specified). Concurrent conditions, medical history and concomitant medications were not provided. No further information was provided. The cause of death was not reported. Product quality complaint (PQC) was not reported. Additional information has been requested.


VAERS ID: 590788 (history)  
Form: Version 1.0  
Age: 0.38  
Sex: Male  
Location: Texas  
Vaccinated:2015-07-07
Onset:2015-07-10
   Days after vaccination:3
Submitted: 2015-08-18
   Days after onset:39
Entered: 2015-08-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H65078 / 2 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Acoustic stimulation tests abnormal, Death, Expired product administered
SMQs:, Hearing impairment (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-07-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: None
Preexisting Conditions: 04/21/2015, Failure to thrive; 04/21/2015, ROTATEQ, 1st dose; 04/21/2015, PENTACEL, 1st dose; PREVNAR 13, 1st dose
Allergies:
Diagnostic Lab Data: Acoustic stimulation tests, bilateral abnormality
CDC Split Type: 2015227644

Write-up: This is a spontaneous report from a contactable licensed practitioner nurse. A 4-month-old male patient received on 07Jul2015 at 09:50 am the second dose of PREVNAR 13 (Lot/batch number: H65078, expiry date 30Jun2015, NDC number: 00005-1971-02) intramuscular on the right thigh at 0.5 ml single. Medical history included failure to thrive on 21Apr2015 and ongoing. Concomitant medications given on an unspecified date in 2015 included: second dose of ROTATEQ (manufactured by Merck, lot number K001832) oral and second dose of PENTACEL (manufactured by Sanofi, lot number C4679AA) administered intramuscular in left thigh. The patient previously received on unknown date, the first dose of PREVNAR 13 and on 21Apr2015 ROTATEQ and PENTACEL. The patient had no illness at the time of vaccination. The patient underwent on unknown date a hearing test and it showed a bilateral abnormality. The patient was administered with a 7 days expired PREVNAR 13. The patient did not receive any treatment after the vaccine was administered and no emergency room or doctor visit was requested. The patient passed away. The cause of death was not reported. Follow up (07Jul2015): New information reported from a contactable nurse includes: patient''s date of birth, date and time of vaccination, site of vaccination and dose, medical history, lab data, past vaccine history, causality assessment. Follow-up (12Aug2015): New information reported from a contactable nurse includes onset date of the medical history and siblings. Death added as event. Case upgraded to serious.


VAERS ID: 591741 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Unknown  
Vaccinated:2013-10-19
Onset:2014-05-04
   Days after vaccination:197
Submitted: 2015-05-21
   Days after onset:382
Entered: 2015-08-24
   Days after submission:95
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Completed suicide, Death, Gun shot wound
SMQs:, Suicide/self-injury (narrow), Accidents and injuries (narrow), Hostility/aggression (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-05-04
   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: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015SE51366

Write-up: A report has been received from a Study investigator concerning a 15 year old, female subject, Height: 5.1 inches; Weight: 140.0 Pounds, enrolled in study. FLUMIST QUADRIVALENT (intranasal) started on 19-Oct-2013. The patient experienced suicide/intentional self-harm with a firearm which started on 04-May-2014. The patient died from the event of suicide/intentional self-harm with a firearm on 04-May-2014. Assessment of the Serious criteria for the report was as follows: Death. The patient died on 04-May-2014. The cause(s) of death was/were suicide/intentional self-harm with a firearm and gunshot wound of head. The investigator considered that there was no causal relationship between suicide/intentional self-harm with a firearm and FLUMIST QUADRIVALENT.


VAERS ID: 591496 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-08-25
Entered: 2015-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1508USA009285

Write-up: This spontaneous report as received from a physician via company representative refers to a 12 year old patient of unknown gender. On an unknown date, the patient was vaccinated with GARDASIL (dose, lot# and route of administration was not reported). No concomitant medication was reported. The physician stated that unspecified person watched television show which reported that on an unknown date the patient died after receiving GARDASIL. Causality assessment was not provided. Additional information has been requested.


VAERS ID: 592715 (history)  
Form: Version 1.0  
Age: 1.75  
Sex: Female  
Location: Alabama  
Vaccinated:2015-08-31
Onset:2015-09-01
   Days after vaccination:1
Submitted: 2015-09-03
   Days after onset:2
Entered: 2015-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4679AA / 1 LL / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 9CJ5Y / 1 LL / IM
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. K022448 / 1 RL / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L60102 / 3 RL / UN

Administered by: Private       Purchased by: Public
Symptoms: Blood pH decreased, Cardiac arrest, Drug screen negative, Life support, Retching, Urine ketone body present, pH urine normal
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-09-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No illness
Preexisting Conditions: Umbilicus hernia since birth
Allergies:
Diagnostic Lab Data: Urine drug screen negative; Urinalysis-ph5, ketones 15, blood ph 6.7
CDC Split Type:

Write-up: Dr received phone call from ER at 9:46 am. Dr at ER states child presented to the ER via personal automobile. Mom states patient was gagging all night. Child was in cardiac arrest when she arrived in the ER at 8:16 am. Pediatric advanced life support protocol active for one hour using every cardiac drug per Dr.


VAERS ID: 595759 (history)  
Form: Version 1.0  
Age: 0.31  
Sex: Male  
Location: New Hampshire  
Vaccinated:2015-07-06
Onset:0000-00-00
Submitted: 2015-09-16
Entered: 2015-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS K7HF5 / 1 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L36484 / 2 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. K013861 / 2 UN / UN

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: 2015-07-24
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 (28 wks)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NH0916201502

Write-up: Sudden unexplained infant death (SUID).


VAERS ID: 597263 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-09-25
Entered: 2015-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1509USA01211

Write-up: Information has been received from news article via an unspecified reporter in a website referring to 140 patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with GARDASIL (strength, dose, dose#, route and lot# unknown). On unknown dates the patients died. It was unknown if autopsy was done. The cause was death was unknown. The reporter considered death to be associated with GARDASIL. This is one of several reports received from the same source. Additional information is not expected since there was no contact details provided.


VAERS ID: 597662 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Female  
Location: Florida  
Vaccinated:2015-08-20
Onset:2015-08-22
   Days after vaccination:2
Submitted: 2015-09-28
   Days after onset:37
Entered: 2015-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1000459 / 2 RA / SC
VARCEL: VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER 1015049 / 2 LA / SC

Administered by: Unknown       Purchased by: Public
Symptoms: Activities of daily living impaired, Bronchitis, Chest X-ray abnormal, Cough, Ecchymosis, Erythema, Full blood count normal, Haemoglobin decreased, Injection site pain, Mumps, Pyrexia, Respiratory arrest, Respiratory symptom, Resuscitation, Swelling face
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal infections (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-08-30
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Immodium, Flagyl, Calcium
Current Illness: None
Preexisting Conditions: History of short gut syndrome and SVC syndrome
Allergies:
Diagnostic Lab Data: CBC, = pediatricians office; chest xray- ER
CDC Split Type:

Write-up: Received 2 injections MMR and varicella. 1 injected in each arm. I questioned why in arm as patient''s extremities were very thin. Nurse said it was ok due to little needle and given SQ. 2 days later patient started with lowgrade fever and upper respiratory symptoms. Coughing. She missed school Mon & Tuesday. On Wed she went to her reg GI Dr. She had 103 fever and still coughing. Recommended back to ped. Returned to ped on Fri. Her reg Dr wasn''t in. They did a CBC which was ok but low Hgb which is her norm. O2 sat was ranging from 80 - 92. They were unsure if it worked. Dr recommended going to ER. Took her to ER. She had only 1 other complaint of rt arm hurt. They did chest xray and diagnosed bronchitis. Sent home on Zithromax, prednisone & breathing treatment. Sunday morning she woke up with left cheek swollen like mumps and a red ecchymotic area under her arm by chest. While getting her ready to go to hospital she took last breath. CPR started immediately and 911 called. Breaths did not seem to be going in. EMT took over CPR. Taken to hospital where they did get a heartbeat for less than a minute.


VAERS ID: 598101 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Texas  
Vaccinated:2015-01-28
Onset:2015-01-29
   Days after vaccination:1
Submitted: 2015-10-01
   Days after onset:244
Entered: 2015-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS G4R2R / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. K015464 / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J67644 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. K010755 / 1 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Autopsy, Peripheral coldness, Respiratory arrest, Resuscitation
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-01-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Polyvisol vitamin drops
Current Illness: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data: Autopsy was performed.
CDC Split Type:

Write-up: Awoke to find baby not breathing and skin cool to touch. Called 911. Administered CPR until EMS arrived. They took over and transported her to the hospital ER.


VAERS ID: 601733 (history)  
Form: Version 1.0  
Age: 0.76  
Sex: Female  
Location: Virginia  
Vaccinated:2015-10-08
Onset:2015-10-08
   Days after vaccination:0
Submitted: 2015-10-09
   Days after onset:1
Entered: 2015-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR U5304FA / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-10-08
   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: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data: Afebrile, no acute illness noted.
CDC Split Type:

Write-up: Pt at well-baby office visit 10/08/15. Received Fluzone quadrivalent, preservative-free, 0.25 mL IM dose appropriately. About ~6 hours later, found unresponsive at home. Parents called 911. EMS arrived at ~22:15 and began CPR. Brought to the ED where CPR and ACLS continued. Death pronounced at ~22:50. Unclear by hospital summary whether sudden infant death or vaccine-related. Autopsy being conducted to provide further details.


VAERS ID: 602879 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Male  
Location: South Dakota  
Vaccinated:2014-04-24
Onset:2015-09-23
   Days after vaccination:517
Submitted: 2015-10-16
   Days after onset:23
Entered: 2015-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4556AB / 1 LL / UN

Administered by: Public       Purchased by: Public
Symptoms: Death, Meningococcal sepsis, Myocarditis, Neisseria test positive
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-09-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Isolate tested as group Y
CDC Split Type: SD2015001

Write-up: Patient died with the cause of death being reported as Acute Myocarditis. Due to: Neisseria Meningitis Septicemia. Isolate tested as Group Y. Being reported as a breakthrough case.


VAERS ID: 603163 (history)  
Form: Version 1.0  
Age: 1.03  
Sex: Male  
Location: Georgia  
Vaccinated:2015-10-05
Onset:2015-10-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2015-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. L001626 / 4 LL / UN
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AD9Y4 / 1 LL / UN
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. K025005 / 3 LL / UN
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. L023111 / 1 RL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L36483 / 4 RL / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Interstitial lung disease, Laboratory test normal, Pyrexia, Sudden death, Toxicologic test normal, Viral myocarditis
SMQs:, Torsade de pointes/QT prolongation (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-10-08
   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:
Current Illness: Eczema; Allergic rhinitis
Preexisting Conditions: Eczema; Allergic rhinitis
Allergies:
Diagnostic Lab Data: Coroner''s report that toxicology and all other labs were negative. No bacterial infec and no allergic reaction.
CDC Split Type:

Write-up: Pt. received physical and shots on 10/5/15 and passed 10/8/15. Per family he had a fever x2d, no fever on 3rd day or 4th day and then died suddenly on 10/8/15. The coroner''s preliminary slides show viral myocarditis and interstitial pneumonia.


VAERS ID: 603438 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-10-15
Entered: 2015-10-20
   Days after submission:5
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: WAES1510USA004447

Write-up: Information has been received from a new article via an journalist in a website referring to 32 female patients of unknown age. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with doses of GARDASIL (dose, dose number, lot number, application and route were not reported). According to the research of Centers for Disease Control and Prevention, the researchers looked at problems reported to the Vaccine Adverse Events Reporting System in the 2.5 years since GARDASIL was licensed. Overall, 6.2 percent of the reported problems were considered serious. This included 32 deaths among women who received the vaccine. The exact adverse events were not reported. It was unknown if autopsy was done. The cause was death was unknown. It was reported that these types of reports could not determine whether adverse events were caused by the vaccine or just a coincidence. This is one of several reports received from the same source. Additional information is not expected since there was no contact details provided.


VAERS ID: 604092 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Georgia  
Vaccinated:2015-10-19
Onset:2015-10-19
   Days after vaccination:0
Submitted: 2015-10-22
   Days after onset:3
Entered: 2015-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cardiac arrest, Death, Resuscitation
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? Yes
Birth Defect? No
Died? Yes
   Date died: 2015-10-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis
Preexisting Conditions: Cardiac operation; Heart disease congenital
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1510USA009311

Write-up: This spontaneous report as received from a physician via a company representative refers to an approximately 2.5 year old male patient. The patient''s medical history included "hyperplastic left heart" and multiple unspecified heart surgeries. There was no information about the patient''s concurrent conditions or concomitant therapies provided. On 19-OCT-2015, at 12:30, the patient was vaccinated with a dose of M-M-R II, subcutaneously (lot # and expiration date were not reported), a dose of VARIVAX (Merck) (route of administration, lot # and expiration date were not reported) and a dose of an unspecified flu vaccine. On 19-OCT-2015, at 12:50, the patient was brought back to the provider''s office, apparently in cardiac arrest. The reporter stated they began performing cardiopulmonary resuscitation (CPR) on the patient and called for an ambulance. The ambulance took the patient to an emergency room. The reporter stated they received a call from the coroner''s office at 15:00, and was informed that the child died (on 19-OCT-2015). The event of cardiac arrest was reported as life threatening. The outcome of cardiac arrest was reported as fatal, however the cause of death was not provided. The relatedness between the adverse event and suspect therapies was not reported. Upon internal review, the event of cardiac arrest was considered to be medically significant. Additional information has been requested.


VAERS ID: 604306 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Female  
Location: Michigan  
Vaccinated:2015-10-10
Onset:2015-10-10
   Days after vaccination:0
Submitted: 2015-10-22
   Days after onset:12
Entered: 2015-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J80525 / UNK LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-10-11
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Diabetes pills. Osteoporosis. Blood pressure...lisinopril. Depression meds. I don''t know the names of most of these.
Current Illness: No. Diabetic.
Preexisting Conditions: No.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: I personally have no way to know if the Prevnar was the cause, so I thought you should know that this report is on behalf of my mother. I''m not sure what time on the tenth she actually got the vaccine, but at approximately 4:30pm the same day, she had a massive stroke and passed away. If possible, I would like to have someone contact me. Thank you.


VAERS ID: 604651 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2015-02-02
Onset:2015-02-02
   Days after vaccination:0
Submitted: 2015-10-23
   Days after onset:262
Entered: 2015-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. J75276 / UNK RA / UN

Administered by: Private       Purchased by: Private
Symptoms: Death, Malaise, Musculoskeletal pain, Pain in extremity, Respiratory arrest
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-04-10
   Days after onset: 66
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Low blood pressure; Heart condition
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: On 2-2-2015 pt. had arm pain. On 2-6-2015 pt. had extreme arm and shoulder pain, couldn''t breathe. Was transported by ambulance to hospital. Pt. was never well, and died on April 10,2015 at hospital.


VAERS ID: 604906 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2015-09-30
Onset:2015-10-20
   Days after vaccination:20
Submitted: 2015-10-26
   Days after onset:6
Entered: 2015-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 25L53 / UNK LA / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-10-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: COPD, STAGE 3 KIDNEY DISEASE, hx lung ca, anemia
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death - pt had co-morbities at the time, poss pneumonia, pneumothorax. Death occurred on a subsequent admission not the same as Prevnar 13 administration.


VAERS ID: 604925 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2015-10-02
Onset:2015-10-04
   Days after vaccination:2
Submitted: 2015-10-26
   Days after onset:22
Entered: 2015-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L99262 / 2 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-10-12
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Omeprazole 20mg capsule 1 po qd; Oxycodone 20mg 1q4h po prn; Oxybutynin ER 10mg 1po qd; Amlodipine 5mg 1 po qd; Lisinopril 10mg 1 po qd; Famotidine 20 mg 1poqhs; Alprazolam 0.5mg 1po tid; Sertraline 100mg 1po bid
Current Illness: None
Preexisting Conditions: Not Known Allergy
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type:

Write-up: As per patient spouse, He was admitted in hospital on 10/04/2015 due to pnuemonia and died on 10/12/2015. We don''t have hospital report.


VAERS ID: 605086 (history)  
Form: Version 1.0  
Age: 93.0  
Sex: Female  
Location: Maryland  
Vaccinated:2015-10-08
Onset:2015-10-10
   Days after vaccination:2
Submitted: 2015-10-22
   Days after onset:12
Entered: 2015-10-27
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX) / NOVARTIS VACCINES AND DIAGNOSTICS 173538 / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Cardiac failure congestive, Death, General physical health deterioration, Hospice care
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-10-15
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LASIX; MSIR; HALDOL; ZOFRAN; TYLENOL; Allopurinol; Amlodipine; COREG; Glipizide
Current Illness: Multiple chronic illnesses
Preexisting Conditions: Allergy: sulfa - see #7 for PMH
Allergies:
Diagnostic Lab Data: Family requested reporting of event.
CDC Split Type:

Write-up: Pt. was a home care hospice patient w/ a terminal diagnosis of CHF. Was in usual state of health on 10/08/2015. Son reports that patient began to rapidly decline over the next few days, ultimately dying on 10/15/15. RN reports no local reaction to vaccine. PMH significant for: DM II; cardiomyopathy; glaucoma; hypothyroidism; osteoporosis; renal insufficiency.


VAERS ID: 605430 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-10-27
Entered: 2015-10-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015358180

Write-up: This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age and ethnicity received a single dose of PREVNAR 13 on an unspecified date. Medical history and concomitant medications were not reported. The patient died from Guillain-Barre syndrome on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.


VAERS ID: 605991 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Male  
Location: South Dakota  
Vaccinated:2015-10-29
Onset:2015-10-30
   Days after vaccination:1
Submitted: 2015-10-30
   Days after onset:0
Entered: 2015-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UI450AA / UNK LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Cardiac arrest, Chest X-ray normal, Death, Fibrin D dimer increased, Myocardial necrosis marker increased
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage laboratory terms (broad), Myocardial infarction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-10-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Daily Aspirin, Daily calcium supplement, Daily fish oil supplement, Gaviscon daily for reflux, Lisinopril/ HCTZ 20-12.5, daily multivitamin, vitamin C daily
Current Illness: No
Preexisting Conditions: NKDA, history of heart murmur, cataract surgery in January 2015, hyperlipidemia, hypertension, squamous cell carcinoma of lip removed with no return of cancer.
Allergies:
Diagnostic Lab Data: Labs done in ER with elevated cardiac enzymes and elevated D-dimer. Chest xray was negative.
CDC Split Type:

Write-up: Cardiac Arrest at home while in bed sleeping next to wife. Brought in to ER in Cardiac Arrest. Coded for 20 minutes until time of death was called at 1:30am.


VAERS ID: 606526 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Male  
Location: Florida  
Vaccinated:2015-10-02
Onset:2015-10-11
   Days after vaccination:9
Submitted: 2015-10-25
   Days after onset:14
Entered: 2015-11-02
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Death, Dyspnoea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-10-15
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Parkinson''s; Heart disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: On or about 10/2/15 the pneumonia shot was administered. On 10/11/15 he began to have difficulty breathing and spiked a fever. He was transported to the hospital and treated with antibiotics and oxygen.


VAERS ID: 606644 (history)  
Form: Version 1.0  
Age: 0.47  
Sex: Female  
Location: California  
Vaccinated:2015-01-09
Onset:2015-01-15
   Days after vaccination:6
Submitted: 2015-11-02
   Days after onset:291
Entered: 2015-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS E2297 / 2 RL / UN
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. J015435 / 2 RL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J11488 / 2 LL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. K007911 / 2 MO / PO

Administered by: Public       Purchased by: Public
Symptoms: Death, Pneumonia viral
SMQs:, Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-01-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: NO
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient had no signs of anything. She had no fever, no cough, no raspyness. The night before/of her passing she was giggling and laughing and just a warm bright joy to be around. My husband put her to bed, and when we woke up we found that she had passed. The coroner was going to rule it was a SIDS death but then a few days pass we had been told it was Viral Pneumonia.


VAERS ID: 607441 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-11-04
Entered: 2015-11-04
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: WAES1511USA002460

Write-up: Information was received from a consumer on 30-OCT-2015 via Sanofi Pasteur (MSD) and refers to an unspecified number of children patients of unknown ages and genders. This report was found in the comments part of a petition about HPV vaccine. On an unspecified date, the patients were vaccinated with a dose of GARDASIL (lot number, expiration date, dose and route of administration were not reported). There was no concomitant medication reported. The reporter stated that "it''s hard to imagine that GARDASIL and other vaccines for the HPV virus were still on the market knowing the hundreds of our children that had died (dates were not specified) and those that had harmful adverse reactions and were living with new medical conditions after receiving the vaccine". The cause of death was not reported and it was unknown if autopsy was performed. This is one of several reports from the same reporter. Additional information is not expected as no reporter details were provided.


VAERS ID: 607797 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Male  
Location: Virginia  
Vaccinated:2015-10-01
Onset:2015-10-10
   Days after vaccination:9
Submitted: 2015-11-05
   Days after onset:26
Entered: 2015-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UI437AA / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Blood sodium increased, Hypernatraemia, Mental status changes
SMQs:, Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2015-11-09
   Days after onset: 30
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Flomax, Seroquel
Current Illness: None
Preexisting Conditions: Debility
Allergies:
Diagnostic Lab Data: Persistently elevated serum sodium, unresponsive to treatment.
CDC Split Type:

Write-up: Progressive hypernatremia to 180, with severe mental status changes.


VAERS ID: 608144 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Male  
Location: Washington  
Vaccinated:2015-10-27
Onset:2015-10-29
   Days after vaccination:2
Submitted: 2015-11-07
   Days after onset:9
Entered: 2015-11-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L99261 / 1 LA / IM

Administered by: Other       Purchased by: Public
Symptoms: Asthenia, Death, Dyspnoea, Feeling abnormal, Malaise, Prostate cancer, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Prostate malignant tumours (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-11-06
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Sulfa/trimeth, ASA, insulin (glargine and lispro, levetiracetam, amlodipine, atorvastatin, carvedilol, fluoxetine, furosemide, omeprazole, losartan, meclazine, Vitamin D3
Current Illness: Anemia of chronic disease, urinary tract infection
Preexisting Conditions: Anemia of chronic disease, urinary tract infection, CVA, Prostate Cancer, History of Colon Cancer, Dementia, CAD, Diabetes Type II
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Feeling poorly, fever, malaise. By Oct 31 dyspnea, weak admitted to hospital. Dx with CAP. Nov 6 died due to complications of CAP.


VAERS ID: 608222 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Male  
Location: Washington  
Vaccinated:2015-10-20
Onset:2015-10-20
   Days after vaccination:0
Submitted: 2015-11-09
   Days after onset:20
Entered: 2015-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI440AB / 2 LA / IM

Administered by: Unknown       Purchased by: Public
Symptoms: Asthma, Condition aggravated, Death, Decreased appetite, Disorientation, Dizziness, Flushing, Hallucination, Hyperhidrosis, Incontinence
SMQs:, Anaphylactic reaction (narrow), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-11-06
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Omeprazole; Potassium chloride; Simvistatin; Morphine; Albuterol sulfate; QVAR; Hydrochlorothiazide; Ipratropium Ativan; Metoprolol Tartrate
Current Illness: No
Preexisting Conditions: Asthma, COPD, Depression, high blood pressure
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Flushing, dizziness, sweating and disoriented. Then he had an asthma attack. Was put on steroids. They helped minimally. Within the next few days he lost appetite, started hallucinating, lost continence and 17 days after his vaccination, he died.


VAERS ID: 608707 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Florida  
Vaccinated:2015-10-06
Onset:2015-10-07
   Days after vaccination:1
Submitted: 2015-11-03
   Days after onset:27
Entered: 2015-11-10
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UI438AA / 2 UN / IM

Administered by: Other       Purchased by: Unknown
Symptoms: Cerebral haemorrhage, Computerised tomogram
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-10-21
   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: None
Preexisting Conditions: Hypertension; Prostate Ca
Allergies:
Diagnostic Lab Data: CT scan
CDC Split Type:

Write-up: Brain Hemorrhage.


VAERS ID: 609504 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2015-10-20
Onset:2015-10-20
   Days after vaccination:0
Submitted: 2015-11-08
   Days after onset:19
Entered: 2015-11-13
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 66521011802 / UNK UN / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-10-21
   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: Vomiting; Loss of appetite
Preexisting Conditions: He had sepsis in April of 2015
Allergies:
Diagnostic Lab Data: Autopsy denied at hospital by medical examiner
CDC Split Type:

Write-up: Patient received Flu shot on October 20 and became ill the same day. He was vomiting and shivering. He died the day after receiving Flu shot.


VAERS ID: 609819 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-11-12
Entered: 2015-11-16
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR - / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unk
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2015SA179107

Write-up: Initial unsolicited report received from a physician on 05 November 2015. This case was linked to 2015SA179115 and 2015SA179116 (same reporter). This case involves a patient (age and gender was not reported) who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, dose, dose in series and site of administration were not reported) intramuscularly on an unspecified date in 2015. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was not reported. Concomitant medications were not reported. On an unspecified date in 2015, following the vaccination, the patient died. Relevant diagnostic tests/laboratory data and corrective treatment was not reported. The outcome was fatal. List of documents held by sender: none.


VAERS ID: 609961 (history)  
Form: Version 1.0  
Age: 0.13  
Sex: Male  
Location: Alaska  
Vaccinated:2015-11-05
Onset:2015-11-06
   Days after vaccination:1
Submitted: 2015-11-16
   Days after onset:10
Entered: 2015-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS E3R4S / 1 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. K025002 / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L3381 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. K015816 / 1 MO / PO

Administered by: Other       Purchased by: Public
Symptoms: Pulse absent, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-11-06
   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: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: This 6-7 wk old child was given his 2 mo vaccines on 11-5-15. He was found without resp or pulse the morning of 11-6-15 in Mother''s home not sure if he was in a crib or mother''s bed.


VAERS ID: 610282 (history)  
Form: Version 1.0  
Age: 1.1  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-11-17
Entered: 2015-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. - / 1 UN / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 1 UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autoimmune haemolytic anaemia, Autopsy, Biopsy skin abnormal, Blood test abnormal, Coombs direct test positive, Coombs positive haemolytic anaemia, Cough, Death, Depressed level of consciousness, Diarrhoea, Disseminated intravascular coagulation, Eschar, General physical health deterioration, Hepatic failure, Herpes virus infection, Immune thrombocytopenic purpura, Immunoglobulin therapy, Immunohistochemistry, Jaundice, Leukocytosis, Lymphoblast count, Lymphocyte count decreased, Lymphopenia, Ophthalmic herpes zoster, Ophthalmological examination abnormal, Platelet count decreased, Polymerase chain reaction positive, Pyrexia, Rash, Rash papular, Renal failure, Rhinorrhoea, Rotavirus test negative, Rubivirus test positive, Rubulavirus test positive, Skin lesion, Transfusion, Varicella virus test positive, Varicella zoster virus infection, Viral test negative, White blood cell count increased
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), Haemolytic disorders (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Corneal disorders (broad), Ocular infections (narrow), Skin tumours of unspecified malignancy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Opportunistic infections (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Methylprednisolone sodium succinate
Current Illness: Gene mutation
Preexisting Conditions: Rotavirus vaccine (unspecified), drug tolerance
Allergies:
Diagnostic Lab Data: Immune thrombocytopenic purpura (date unknown): nadir 25,000 platelets/microliter. Varicella zoster virus (VZV) was detected in her cerebrospinal fluid (723 copies/mL), skin (137,156 copies/mL) and esophagus by PCR assays and immunohistochemistry. Stool samples submitted for viral electron microscopy were negative, including assessment for rotavirus. Lymphoblast count (date unknown): lymphopenic. White blood cell count (date unknown): leukocytosis. Biopsy skin, intranuclear inclusion bodies typical of Herpesvi; Blood test, autoimmune hemolytic anemia; Ophthalmological examination, corneal dendrites with features of VZV infection; Polymerase chain reaction, mumps and rubella
CDC Split Type: WAES1511USA007746

Write-up: Information has been received from the authors in a literature article concerning a patient with VARIVAX (Merck) (manufacturer unknown), M-M-R II and methylprednisolone (manufacturer unknown) therapy. At 13 months of age, a previous healthy girl with RAG2 deficiency presented acutely with fever, jaundice, cough, rhinorrhea, diarrhea and approximately 10 erythematous papules on her torso and extremities. Preliminary studies revealed direct Coombs positive anemia and leukocytosis with granulocytes predominating. Initial treatment measures included blood transfusions, intravenous immunoglobulin (MG) and high dose methylprednisolone (manufacturer unknown) (up to 80 mg/day), leading to transient resolution of hemolysis. In addition, she developed autoimmune thrombocytopenia (nadir 25,000 platelets/1/4.L). Three weeks after onset of illness, her rash evolved into discrete 3-mm eschars; however, very few, if any new skin lesions developed. Skin biopsy revealed intranuclear inclusion bodies typical of Herpesviridae and intravenous acyclovir was initiated. Despite antiviral therapy, which later included foscarnet, her clinical status deteriorated over subsequent weeks. Obtundation ensued, and the patient died due to complications of hepatic and renal failure, disseminated intravascular coagulation and recalcitrant autoimmune hemolytic anemia. Three weeks before onset of illness, the patient received her first VARIVAX (Merck) (manufacturer unknown) (dose and route unknown), MMR (manufacturer unknown) (dose and route unknown) and hepatitis A (manufacturer unknown). There was no obvious contraindication to the administration of live virus vaccination. She had previously received all vaccinations as per the Advisory Committee on Immunization Practices (ACIP) recommended schedule, including the rotavirus series, which were well tolerated. Prior to death, vaccine strain varicella zoster virus (VZV) was detected in her cerebrospinal fluid (723 copies/mL), skin (137,156 copies/mL) and esophagus by PCR assays and immunohistochemistry staining, respectively. Throat swabs, also obtained prior to death, detected mumps and rubella by PCR assays. Stool samples submitted for viral electron microscopy were negative, including assessment for rotavirus. Ophthalmic examination revealed corneal dendrites with typical features of VZV infection. Autopsy demonstrated VZV dissemination in the lungs and liver as well as profound lymphoid depletion of lymph nodes and thymic tissue. VZV, mumps and rubella isolated from the patient were confined as vaccine genotypes Oka, Jeryl-Lynn and RA 27/3, respectively. The reporter considered the events to be related to VARIVAX (Merck)(manufacturer unknown), MMR (manufacturer unknown), methylprednisolone (manufacturer unknown) and hepatitis A (manufacturer unknown). Upon internal review, renal failure, hepatic failure and disseminated intravascular coagulation were considered to be medically significant. Additional information has been requested.


VAERS ID: 610579 (history)  
Form: Version 1.0  
Age: 1.32  
Sex: Male  
Location: Utah  
Vaccinated:2015-11-12
Onset:2015-11-15
   Days after vaccination:3
Submitted: 2015-11-18
   Days after onset:3
Entered: 2015-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4924AA / 4 LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. L026599 / 3 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M20639 / 4 RL / IM

Administered by: Private       Purchased by: Private
Symptoms: Cardio-respiratory arrest, Respiratory symptom, Resuscitation
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: 2015-11-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Non-descended testicle
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Mom reports slight respiratory symptoms before bed on 11/14/15. Mom went to get him out of bed on 11/15/15 and he was in cardiopulmonary arrest. CPR was attempted with no improvement.


VAERS ID: 611113 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-11-22
Entered: 2015-11-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
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: WAES1511USA011162

Write-up: Information has been received from an unspecified reporter on a digital media via SPMSD on 18-NOV-2015, referring to a boy of unknown age. The patient''s pertinent medical history and concurrent condition were not reported. On an unknown date the patient was vaccinated with GARDASIL (lot#, expiration date, strength, dose and route were unknown). The patient''s concomitant medication was not reported. On an unknown date the patient died after vaccination. The cause of death was not reported. It was unknown if autopsy had done. The causality between the events and GARDASIL was not reported. Additional information has been requested.


VAERS ID: 611176 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-11-20
Entered: 2015-11-23
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Meningococcal infection
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Homosexual male
Preexisting Conditions: Unk
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2015SA184911

Write-up: Initial unsolicited report received from the literature on 12 November 2015. This case is linked to 2015SA184887, 2015SA188405, 2015SA188406, 2015SA188407, 2015SA188408 (same literature). Since 2012, three clusters of serogroup C meningococcal disease among men who have sex with men (MSM) have been reported. During 2012, 13 cases of meningococcal disease among MSM were reported by Department of Health and Mental Hygiene (1); over a 5-month period during 2012-2013, the Department of Public Health reported four cases among MSM; and during May-June 2015, the Department of Public Health reported seven cases of meningococcal disease among MSM. MSM have not previously been considered at increased risk for meningococcal disease. Determining outbreak thresholds for special populations of unknown size (such as MSM) can be difficult. The health department declared an outbreak based on an estimated increased risk for meningococcal infection in 2012 among MSM and human immunodeficency virus (HIV)-infected MSM compared with city residents who were not MSM or for whom MSM status was unknown. The Department of Public Health also declared an outbreak based on an increase in case counts and thresholds calculated using population estimates of MSM and HIV-infected MSM. Local public health response included increasing awareness among MSM, conducting contact tracing and providing chemoprophylaxis to close contacts, and offering vaccination to the population at risk. To better understand the epidemiology and burden of meningococcal disease in MSM populations and to inform recommendations, CDC analyzed data from a retrospective review of reported cases from January 2012 through June 2015. In May 2013 and again in August 2015, CDC requested that health departments review all cases of probable or confirmed meningococcal disease caused by any serogroup and reported among males during January 2012-June 2015 to the National Notifiable Disease Surveillance System, and, if possible, determine MSM status. The requests were made through a system, a secure communications network for public health officials, and follow-up with each health department occurred through individual e-mail correspondence. All health departments and the health departments responded to CDC''s request for information. Analysis of the data was restricted to cases occurring among MSM ages 18-64 years. During the case review period, 527 meningococcal disease cases among males aged 18-64 years were reported. Although MSM status is not routinely collected as part of national meningococcal case reporting and might be underreported, 74 cases were identified among MSM: 23 from one city, 14 from another, 11 from another, and 26 sporadic cases occurring in geographic areas where fewer than three cases of the same meningococcal serogroup were reported among MSM during a 3-month period. MSM status could not be verified for the other 453 meningococcal disease cases among men aged 18-64 years using available data, nor could CDC distinguish between health departments reporting zero cases in MSM and those that had no data on MSM status. Among the 74 reported cases among MSM aged 18-64 years, the median age was 31 years. Thirty-seven (52 percent) of 71 patients were one race, 29 (41 percent) were another race, two (3 percent) were another race, and three (4 percent) were other race. Neisseria meningitis serogroup C accounted for 62 (84 percent) cases; serogroup B, W, and Y accounted for five two, and three cases, respectively; and the serogroup for two patients were unknown. Overall, 24 (32 percent) cases were fatal, including six of the cases from one city (26 percent), five (36 percent) of another city cases, three (27 percent) of the other city cases, and 10 (38 percent) of the sporadic cases. Among 63 patients for who HIV status was reported, 37 (59 percent) were HIV-positive; among these, 11 (30 percent) died. Meningococcal vaccinations status was known for 41 patients; among these, six (15 percent) were vaccinated with a quadrivalent meningococcal vaccine. Five of the six vaccinated patients had serogroup C meningococcal disease, and two of the five died. Further analysis of meningococcal disease rates, risk factors, and pulsed-field gel electrophoresis data from all cases identified among MSM is ongoing. Information on MSM and HIV status of men reported with meningococcal disease is not currently noted on most meningococcal case report forms. However, representative and complete data on MSM and HIV status are needed to better understand the epidemiology of and potential risk factors for meningococcal disease among MSM and to inform prevention and control recommendations. Health departments are encouraged to attempt to determine MSM and HIV status during investigations of meningococcal disease cases caused by any serotype occurring among males aged 16 years. This case involves one of the six male patients (Age group between 18-64 years) who was vaccinated with a dose of Meningococcal vaccine (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unknown date. Medical history included Homosexuality (Men Who Have Sex With Men) and concomitant medication were not reported. The HIV status of the patient was not reported. On an unspecified date, following the vaccination, the patient developed serogroup C meningococcal disease. Laboratory test and corrective treatment were not reported. The outcome of the event was fatal. It was unknown if autopsy was performed. List of documents held by sender: none.


VAERS ID: 611452 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: California  
Vaccinated:2015-11-09
Onset:2015-11-12
   Days after vaccination:3
Submitted: 2015-11-23
   Days after onset:11
Entered: 2015-11-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. L017407 / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Blood test normal, Chest X-ray normal, Chest pain, Death, Electrocardiogram normal, Resuscitation, Syncope, Upper respiratory tract infection
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-11-16
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown, pt should be a coroners case
CDC Split Type:

Write-up: 11/12 Developed chest pain while playing basketball, seen at outside ER. By mom''s report CXR, ECG, blood nl. Was better slight URI sx 11/13 - 11/16 was at school sitting, laughing and talking to friends, collapsed and unable to be resuscitated. Pronounced dead at outside ER.


VAERS ID: 611701 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-11-23
Entered: 2015-11-25
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Meningococcal infection
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Homosexuality
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2015SA188405

Write-up: Initial unsolicited report received from the literature on 12 November 2015. This case is linked to 2015SA184887, 2015SA184911, 2015SA188406, 2015SA188407 and 2015SA188408 (same literature). Since 2012, three clusters of serogroup C meningococcal disease among men who have sex with men (MSM) have been reported. During 2012, 13 cases of meningococcal disease among MSM were reported by a Department of Health and Mental Hygiene (1); over a 5-month period during 2012-2013, another Department of Public Health reported four cases among MSM; and during May-June 2015, a third Department of Public Health reported seven cases of meningococcal disease among MSM in that area. MSM have not previously been considered at increased risk for meningococcal disease. Determining outbreak thresholds for special populations of unknown size (such as MSM) can be difficult. The first health department declared an outbreak based on an estimated increased risk for meningococcal infection in 2012 among MSM and human immunodeficiency virus (HIV)-infected MSM compared with city residents who were not MSM or for whom MSM status was unknown (1). Another Department of Public Health also declared an outbreak based on an increase in case counts and thresholds calculated using population estimates of MSM and HIV-infected MSM. Local public health response included increasing awareness among MSM, conducting contact tracing and providing chemoprophylaxis to close contacts, and offering vaccination to the population at risk (1-3). To better understand the epidemiology and burden of meningococcal disease in MSM populations and to inform recommendations, CDC analyzed data from a retrospective review of reported cases in January 2012 through June 2015. In May 2013 and again in August 2015, CDC requested that health departments review all cases of probable or confirmed meningococcal disease caused by any serogroup and reported among males during January 2012-June 2015 to the Surveillance System and, if possible, determine MSM status. The requests were made through a secure communications network for public health officials, and follow-up with each health department occurred through individual e-mail correspondence. All health departments and the health departments of specific cities responded to CDC''s request for information. Analysis of the data was restricted to cases occurring among MSM aged 18-64 years. During the case review period, 527 meningococcal disease cases among males aged 18-64 years were reported. Although MSM status is not routinely collected as part of national meningococcal case reporting and might be underreported, 74 cases were identified among MSM: 23 from one city, 14 from another, 11 from yet another, and 26 sporadic cases occurring in geographic areas where fewer than three cases of the same meningococcal serogroup were reported among MSM during a 3-month period. MSM status could not be verified for the other 453 meningococcal disease cases among men aged 18-64 years using available data, nor could CDC distinguish between health departments reporting zero cases in MSM and those that had no data on MSM status. Among the 74 reported cases among MSM aged 18-64 years, the median age was 31 years (range is equal to 20-59 years). Thirty-seven (52 percent) of 71 patients were one race, 29 (41 percent) were another race, two (3 percent) were yet another race, and three (4 percent) were other race. Neisseria meningitidis serogroup C accounted for 62 (84 percent) cases; serogroup B, W, and Y accounted for five, two, and three cases, respectively; and the serogroup for two patients was unknown. Overall, 24 (32 percent) cases were fatal, including six of the cases from one city (26 percent), five (36 percent) of another city cases, three (27 percent) of the other city cases, and 10 (38 percent) of the sporadic cases. Among 63 patients for who HIV status was reported, 37 (59 percent) were HIV-positive; among these, 11 (30 percent) died. Meningococcal vaccination status was known for 41 patients; among these, six (15 percent) were vaccinated with a quadrivalent meningococcal vaccine. Five of the six vaccinated patients had serogroup C meningococcal disease, and two of the five died. Further analysis of meningococcal disease rates, risk factors, and pulsed-field gel electrophoresis data from all cases identified among MSM is ongoing. Information on MSM and HIV status of men reported with meningococcal disease is not currently noted on most meningococcal case report forms. However, representative and complete data on MSM and HIV status are needed to better understand the epidemiology of and potential risk factors for meningococcal disease among MSM and to inform prevention and control recommendations. Health departments are encouraged to attempt to determine MSM and HIV status during investigations of meningococcal disease cases caused by any serotype occurring among males aged 16 years. This case involves one of the six male patients (age group between 18-64 years) who was vaccinated with a dose of Quadrivalent meningococcal vaccine (Manufacturer: unknown, batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. Medical history included Homosexuality (Men Who Have Sex With Men) and concomitant medication were not reported. The HIV status of the patient was not reported. On an unspecified date following the vaccination, the patient developed serogroup C meningococcal disease leading to death on an unspecified date. Laboratory investigation and corrective treatment were not reported. The outcome of the event was fatal. It was unknown if autopsy was performed. List of documents held by sender: none.


VAERS ID: 611827 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-11-26
Entered: 2015-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Adverse event, Death
SMQs:, Dementia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1511USA013397

Write-up: This spontaneous report was received from a physician via company representative regarding a female patient of unknown age. Patient''s concurrent condition, medical history and drug allergies were not reported. On an unknown date the patient was vaccinated with an injection of GARDASIL 9 (lot #, expiry date and dose number was not specified) intramuscularly and FLUMIST. The patient went back to the physician''s office the same day of vaccination for an unspecified reason. The next day, she did not participate in gym class at her school for an unspecified reason and died at an unknown time. Medical attention was not sought. The cause of death was unknown. There was no information as to if autopsy was performed or not. Causality assessment was not reported. Additional information has been requested.


VAERS ID: 612231 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-11-30
Entered: 2015-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1511USA014794

Write-up: This spontaneous report was received from a lead researcher in the development of the HPV vaccines via online article and refers to 44 female patients of unknown age. The patients medical history and concurrent condition were not reported. The reporter had announcement at the 4th Conference on Vaccination that GARDASIL should not be used. The reporter explained in her presentation that the cervical cancer risk was already extremely low, and that vaccinations were unlikely to have any effect upon the rate of cervical cancer. In fact, 70% of all H.P.V. infections resolve themselves without treatment in a year, and the number rises to well over 90% in two years. Reporter also mentioned the safety angle. All trials of the vaccines were done on children aged 15 and above, despite them currently being marketed for 9-year-olds. So far, 15,037 girls have reported adverse side effects from GARDASIL alone to the Vaccine Adverse Event Reporting System (V.A.E.R.S.), and this number only reflects parents who underwent the hurdles required for reporting adverse reactions. At the time of writing, 44 girls are officially known to have died from these vaccines. The reported side effects include Guillain Barre Syndrome (paralysis lasting for years, or permanently- sometimes eventually causing suffocation), Lupus, seizures, blood clots and brain inflammation. Parents are usually not made aware of these risks. The outcome of Guillain-Barre syndrome, noninfective encephalitis, thrombosis, seizure and systemic Lupus erythematosus was fatal. Causality was not provided. Additional information has been requested.


VAERS ID: 612719 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Puerto Rico  
Vaccinated:2013-08-19
Onset:2013-11-25
   Days after vaccination:98
Submitted: 2015-11-23
   Days after onset:728
Entered: 2015-12-02
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 5J5HT / 1 UN / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J006236 / 3 UN / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M12092 / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Brain neoplasm, Brain stem glioma, Computerised tomogram, Death, Dizziness, Malaise, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Non-haematological malignant tumours (narrow), Non-haematological tumours of unspecified malignancy (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-06-18
   Days after onset: 204
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Asthma
Allergies:
Diagnostic Lab Data: She receive MENACTRA vaccine in 2/25/2009 and FLUZONE in 10/03/2013
CDC Split Type:

Write-up: In 10/2013 she said I don''t fell well, I have something in my head. She have CT scan, but in 11/25/2013 she awoke with nausea, dizzy she get another CT scan. But on January 13, 2014 I bring her E.R. in Hospital and they Dx with Pontine Glioma Tumor Brain.


VAERS ID: 613330 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-12-07
Entered: 2015-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1512USA001558

Write-up: This spontaneous report was received from a non-healthcare professional via Twitter website as part of market research and refers to 32 patients at the age of 18 years old of unknown gender. No information regarding the patients'' medical history, concurrent conditions and concomitant therapies was provided. On an unknown date, the patients were vaccinated with a dose of GARDASIL (lot #, expiration date, exact doses and route of administration were not provided). On unknown dates, reported as 2 to 405 days after the last GARDASIL injection, the patients died. The cause of death was not reported. The reporter considered the event to be related to GARDASIL. Additional information has been requested.


VAERS ID: 613332 (history)  
Form: Version 1.0  
Age: 0.13  
Sex: Male  
Location: Kentucky  
Vaccinated:2015-11-03
Onset:2015-11-05
   Days after vaccination:2
Submitted: 2015-12-07
   Days after onset:32
Entered: 2015-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4814AAC4752BA / 1 LL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS I000877 / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH I99266 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. I008574 / 1 MO / PO

Administered by: Unknown       Purchased by: Other
Symptoms: Death, Victim of child abuse
SMQs:

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

Write-up: Infant died by alleged abuse by mother''s boyfriend.


VAERS ID: 613449 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-12-07
Entered: 2015-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: 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: TYLENOL; MOTRIN; SARA
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1512USA002586

Write-up: This spontaneous report was retrieved from a social network via Pfizer (assigned manufacturer control number: 2015420009) and was originally reported by the uncle of a male patient of unknown age. Information about the patient''s medical history and concurrent conditions was not provided. On an unknown date, the patient started therapy with TYLENOL and MOTRIN (for both therapies indication, dose, frequency, route of administration, lot number and expiration date were not provided). Subsequently, the patient was vaccinated with M-M-R II (dose, dose number, route of administration, lot number and expiration date were not provided). Other suspect therapies included SARA (indication, dose, frequency, route of administration, lot number and expiration date were not provided). Concomitant medication was not reported. According to the reporter, on an unknown date, SARA and M-M-R II "killed" his nephew. The reporter stated that he was life flighted to hospital and died. It was also reported that the patient was alive and flew to a county hospital and died. It was unknown if an autopsy was performed. The cause of death was also unknown. Additional information is not expected, since the reporter''s details were not provided.


VAERS ID: 613593 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-12-07
Entered: 2015-12-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Cardiac failure, Death
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2015US158435

Write-up: Case number PHHY2015US158435 is an initial spontaneous report received from a consumer (patient''s daughter) on 23 Nov 2015. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. The patient was vaccinated with influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unspecified date, she passed away from heart failure. The reporter stated that she did not think having the influenza vaccine over the years was related to the event. No further information was provided.


VAERS ID: 613837 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Female  
Location: New York  
Vaccinated:2015-12-03
Onset:2015-12-03
   Days after vaccination:0
Submitted: 2015-12-08
   Days after onset:5
Entered: 2015-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS 7DTZY / UNK UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Cerebrovascular accident, Computerised tomogram, Culture, Electroencephalogram, Hand-eye coordination impaired, Incontinence, Laboratory test, Lethargy, Mobility decreased, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain, Visual impairment
SMQs:, Anticholinergic 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), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2016-01-08
   Days after onset: 36
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 38 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: amLODIPine 5 MG tablet, acetaminophen 325 MG tablet, aspirin 81 MG tablet, cholecalciferol 1000 UNIT capsule, Cranberry 250 MG Caps, loperamide 2 MG capsule, psyllium 95 % packet, pyridoxine 100 MG tablet, sertraline 25 MG tablet, levothyro
Current Illness: Recovering from urinary tract infection
Preexisting Conditions: Dementia; allergy to sulfa drugs; COPD
Allergies:
Diagnostic Lab Data: MR, MR-A, CT Scan, EEG, cultures, many others
CDC Split Type:

Write-up: Patient reports "vertically misaligned" vision; unable to touch nose with finger with or without eyes open; other stroke-like symptoms; incontinence; extreme lethargy; very impaired mobility.


VAERS ID: 613846 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Female  
Location: Washington  
Vaccinated:2015-11-30
Onset:2015-11-30
   Days after vaccination:0
Submitted: 2015-12-08
   Days after onset:8
Entered: 2015-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4813AB / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L99259 / 2 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. L00897 / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-12-03
   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: Cholecalciferol
Current Illness: None
Preexisting Conditions: Achondroplasia syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 11/30/15 received vaccines. Drove out of town after vaccines and was unresponsive when arriving. Remained in ICU and pronounced dead on 12/3/15.


VAERS ID: 614067 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2015-10-14
Onset:2015-10-28
   Days after vaccination:14
Submitted: 2015-12-09
   Days after onset:42
Entered: 2015-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1515301 / UNK LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Activities of daily living impaired, Asthenia, Balance disorder, Dizziness, Dysarthria, Laboratory test normal
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-11-20
   Days after onset: 23
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: CALCIUM, ACYCLOVIR, METOPROLOL, MAG64
Current Illness: Multiple myeloma
Preexisting Conditions: Multiple myeloma
Allergies:
Diagnostic Lab Data: UNSURE
CDC Split Type:

Write-up: DIZZINESS, SLURRED SPEECH, WEAKNESS TO THE POINT OF NEEDING ASSISTANCE. UNBALANCED, HOSPITALIZATION, TESTS ALL NEGATIVE.


VAERS ID: 615110 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-12-14
Entered: 2015-12-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Encephalitis
SMQs:, Noninfectious encephalitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: UNK
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2015SA206305

Write-up: Initial unsolicited case received from non healthcare professional (consumer) on 04-Dec-2015. This case was linked to 2015SA206294 and 2015SA206306 (same reporter and same vaccine). This case involves a female patient (age was not reported) who was vaccinated with a dose of Meningococcal vaccine (manufacturer: unknown, dose, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, after vaccination patient had experienced encephalitis and then died. Lab tests and corrective treatments were not reported. The outcome of the event was fatal. Documents held by Sender: none.


VAERS ID: 615613 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-12-18
Entered: 2015-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1512USA007913

Write-up: This spontaneous report as received from a consumer refers to a 12 year old patient of unknown gender. The patient''s medical history, concurrent condition and concomitant medication were not reported. The reporter stated that he had seen a video on the website about a year ago, saying that a patient was vaccinated with a dose of GARDASIL (formulation, strength, dose, lot number and expiry date were not reported) (date of vaccination was not reported). On an unknown date, a week after vaccination (reported as a week after) the patient died. Product quality complaint (PQC) was not involved. The relatedness between the event and GARDASIL was not reported. Additional information has been requested.


VAERS ID: 615623 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-12-18
Entered: 2015-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1512USA009177

Write-up: This spontaneous report was received from a consumer. The reported an article. This report refers to a 149 patients of unknown age and gender. On unknown dates, the patients were vaccinated with GARDASIL (dose, route, lot # and expiration date were not provided). On unknown dates, the patients died. The cause of death was not provided. It was unknown whether the autopsies were performed or not. This is one of several reports received from the same reporter. Additional information is not expected as reporter details were not provided.


VAERS ID: 615626 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-12-18
Entered: 2015-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Adverse event, 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: WAES1511USA012376

Write-up: This non-valid social media spontaneous report as received from an unspecified reporter refers to unspecified number of children patients of unknown age and gender. The patients'' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with GARDASIL (dose, frequency, route, lot # and expiration date were not reported). It was reported that, parents who injected their children with GARDASIL were murdering and maiming them (onset date unknown). The outcome of adverse event was fatal. Upon internal review the event of murdering and maiming was considered to be disabling. This is one of several reports received from the same reporter. Additional information is not expected as no reporter''s contact details were provided.


VAERS ID: 615815 (history)  
Form: Version 1.0  
Age: 0.63  
Sex: Male  
Location: California  
Vaccinated:2015-12-02
Onset:2015-12-05
   Days after vaccination:3
Submitted: 2015-12-21
   Days after onset:16
Entered: 2015-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4887AA / 3 LL / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U5344AA / 1 UN / UN
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 732ZD / 3 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L63037 / 3 RL / IM

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Bacterial test, CSF culture negative, CSF test abnormal, Death, Fungal test, Viral test
SMQs:, Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-12-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None reported
Preexisting Conditions: None reported
Allergies:
Diagnostic Lab Data: Cloudy cerebrospinal fluid on autopsy, without growth on bacterial culture. Repeat bacterial studies, in addition to viral, fungal, and mycobacterial testing planned or in process.
CDC Split Type:

Write-up: Child died while sleeping. No reported evidence of illness prior to death.


VAERS ID: 616336 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Male  
Location: California  
Vaccinated:2015-12-14
Onset:2015-12-15
   Days after vaccination:1
Submitted: 2015-12-23
   Days after onset:8
Entered: 2015-12-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UI519AA / 2 LA / UN

Administered by: Other       Purchased by: Other
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: 2015-12-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Nitroglycerin; ramipril
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient suffered sudden death based on his wife''s statement. The event occurred 24 hours after the vaccine administration. There has been no medical examination to determine the cause of death or to establish relation to vaccine.


VAERS ID: 616361 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-12-21
Entered: 2015-12-24
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Pneumonia pneumococcal
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015453506

Write-up: This is a spontaneous report from a non-contactable consumer that reported for a patient (patient''s sister-in-law). A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, single dose. The patient medical history and the patient''s concomitant medications were not reported. The patient experienced pneumococcal pneumonia on an unspecified date and then died. It was not reported if an autopsy was performed. No follow up attempts possible. No further information expected.


VAERS ID: 616734 (history)  
Form: Version 1.0  
Age: 0.21  
Sex: Male  
Location: Oregon  
Vaccinated:2015-08-21
Onset:2015-08-27
   Days after vaccination:6
Submitted: 2015-12-29
   Days after onset:124
Entered: 2015-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS Y33F2 / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. L002867 / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L92844 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. K010323 / 1 MO / PO

Administered by: Unknown       Purchased by: Other
Symptoms: Death, Disease complication, Echocardiogram, Gene mutation, Ultrasound scan, X-ray
SMQs:, Congenital, familial and genetic disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-12-09
   Days after onset: 104
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 104 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Tylenol
Current Illness: None Noted
Preexisting Conditions: Primary Diagnosis ACTA2 Related Familial Thoracic Aortic Aneurysm and Pulmonary Hypertension.
Allergies:
Diagnostic Lab Data: Echo Cardiogram, Ultra sounds, XRAY
CDC Split Type:

Write-up: This patient Died at Hospital on 12/09/2015 of complications related to ACTA2.


VAERS ID: 616858 (history)  
Form: Version 1.0  
Age: 0.36  
Sex: Female  
Location: Arizona  
Vaccinated:2015-12-21
Onset:2015-12-29
   Days after vaccination:8
Submitted: 2015-12-30
   Days after onset:1
Entered: 2015-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4925AA / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M27767 / 2 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. L027726 / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-12-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: N/A
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: No s/s. Patient passed away at daycare.


VAERS ID: 616930 (history)  
Form: Version 1.0  
Age: 0.82  
Sex: Male  
Location: South Carolina  
Vaccinated:2015-12-16
Onset:2015-12-24
   Days after vaccination:8
Submitted: 2015-12-31
   Days after onset:7
Entered: 2015-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR U5344AA / 2 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Autopsy, Death, Pyrexia, Rhinorrhoea
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: 2015-12-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: White forelock syndrome/Piebaldism; No allergies; Had GERD as infant
Allergies:
Diagnostic Lab Data: Autopsy was performed.
CDC Split Type:

Write-up: According to parents, child developed some fever and runny nose 2 days after vaccine. Was doing OK - had a bottle at 3 AM on 12-24-2015 and was put back to bed and found dead in crib in morning. Autopsy by County coroner found no cause.


VAERS ID: 617885 (history)  
Form: Version 1.0  
Age: 0.9  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-01-06
Entered: 2016-01-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Bronchial wall thickening, Chest X-ray abnormal, Circulatory collapse, Cough, Death, Extracorporeal membrane oxygenation, Haemodynamic instability, Lung consolidation, Lymphopenia, Mechanical ventilation, Nasal congestion, Neutropenia, Pneumonia bacterial, Polymerase chain reaction positive, Pyrexia, Respiratory distress, Respiratory failure, Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Vasopressive therapy
SMQs:, Anaphylactic reaction (narrow), Agranulocytosis (broad), Haematopoietic leukopenia (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 (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), 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: Cytarabine (NGX); Palivizumab
Current Illness: Unknown
Preexisting Conditions: Antibiotics; Mechanical ventilation, Extracorporeal mechanical oxygenation support
Allergies:
Diagnostic Lab Data: Chest X-ray, Abnormal, Significant, Left lower lobe consolidation pneumonia suggestive of secondary bacterial infection; Polymerase chain reaction, Abnormal, Significant, Respiratory syncytial virus was detected
CDC Split Type: PHHY2015US170668

Write-up: Case number PHHY2015US170668, is an initial literature case report received on 24 Dec 2015. The author in the article discussed about acute respiratory infections (ARI) in children and adolescents with acute lymphoblastic leukemia. Patients (less than or equal to 18 years) who were newly diagnosed with acute lymphoblastic leukemia (ALL) and were enrolled on an ALL treatment protocol (total therapy XVI) between Oct 2007 and May 2011 were evaluated. The total therapy XVI therapy consisted of a 6-week remission induction, 8-week consolidation and 120-week continuation phase that included two 3-week periods of more intensive chemotherapy (reinduction I and reinduction II). This report refers to an 11-month-old female patient. Past medical history and concomitant medication was not reported. The patient started therapy with cytarabine (manufacturer: not reported) for acute lymphoblastic leukemia at an unknown dose and route from an unknown date. The patient received palivizumab (manufacturer: not reported) for immunoprophylaxis at an unknown dose and route on an unknown date. The patient was vaccinated with two doses of seasonal influenza vaccine (manufacturer and batch number: not reported) on unknown dates. It was reported that 10 days before developing illness, the patient had received palivizumab. Also it was reported that on an unknown date the patient received high dose of cytarabine for reinduction II chemotherapy. The patient was presented in the hospital with a 3-day history of progressively worsening cough, nasal congestion, fever, respiratory distress with profound neutropenia and lymphopenia for which the patient was hospitalized. Initial evaluation revealed the patient had bilateral peribronchial thickening and respiratory syncytial virus (RSV) was detected on a nasopharyngeal wash specimen by polymerase chain reaction (PCR). Treatment was started with aerosolized ribavirin in addition to oxygen support and broad spectrum antibiotic therapy. However, due to progressive respiratory deterioration and increasing fever, a chest x-ray was repeated on day 5 of hospitalization which demonstrated left lower lobe consolidation pneumonia suggestive of secondary bacterial infection. The patient''s treatment regimen included vancomycin, meropenem, azithromycin, voriconazole, palivizumab and aerosolized ribavirin. On day 28 of hospitalization, the patient experienced respiratory and hemodynamic failure which required mechanical ventilation and vasopressor followed by extracorporeal mechanical oxygenation support. The patient died 2 months after onset of the RSV infection. The outcome of events respiratory syncytial virus infection, respiratory failure, circulatory failure and pneumonia bacterial was fatal and outcome of events lymphopenia and neutropenia was not reported. Action taken with palivizumab and cytarabine was unknown. The author stated that despite the low incidence of viral ARI in children with ALL, the associated morbidity, mortality and delay in chemotherapy remain clinically significant. Viral lower respiratory tract infection was especially associated with high morbidity requiring intensive care-level support. The author concluded that in spite of current advances in ALL cure rates, molecular diagnostic techniques, antiviral therapies and active and passive immune prevention approaches, respiratory viral infections remain a significant burden in children with ALL.


VAERS ID: 618174 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-01-11
Entered: 2016-01-11
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: WAES1601USA003021

Write-up: This spontaneous non-valid report as received from an unknown source via Twitter refers to a patient of unknown age and gender. There was no information about the patient''s concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, route of administration, lot # and expiration date were not reported). On an unknown date, the patient experienced death (reported as "GARDASIL is killing"). The reporter considered death to be related to GARDASIL. Additional information is not expected as there were no contact details provided.


VAERS ID: 618329 (history)  
Form: Version 1.0  
Age: 72.0  
Sex: Female  
Location: Georgia  
Vaccinated:2015-12-01
Onset:2015-12-02
   Days after vaccination:1
Submitted: 2016-01-11
   Days after onset:40
Entered: 2016-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UI427AA / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal discomfort, Asthenia, Dizziness
SMQs:, Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-12-04
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamins, low-dose diuretic
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Upset stomach, weakness, dizziness. Patient drank fluids--broth and Gatorade. Symptoms continued for three days, with severe dizziness reported on third day.


VAERS ID: 618364 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-01-12
Entered: 2016-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Unevaluable event
SMQs:

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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1601USA002036

Write-up: This spontaneous report as received from a physician via an issue of a magazine refers to unspecified patients of unknown age and gender. No medical history or concurrent conditions were reported. On unknown dates the patients were vaccinated with GARDASIL (lot number and frequency unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. It was reported that, the GARDASIL had absolutely no effect on cervical cancer (vaccination failure) and it had very many adverse effects which destroys lives and also even kills (adverse event) (life threatening and death). It was also reported that cases of Guillain-Barre syndrome, paralysis of the lower limbs, vaccine induced multiple sclerosis (MS) and vaccine induced encephalitis could be found whatever the vaccine. The outcome of many adverse effects which destroys lives and also even kills was reported as fatal. The outcome of the other events were unknown. Additional information has been requested.


VAERS ID: 618411 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-01-12
Entered: 2016-01-12
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: WAES1601USA002066

Write-up: This spontaneous report as received via social media from an unspecified reporter, who obtained the information from the articles published on a web page, refers to many female patients of unknown age. The patients'' concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with unknown doses of GARDASIL (lot #, expiry date, route and site of administration were not reported). Concomitant medications were not reported. On unknown dates, many of patients died. The reason of death was not reported. The reporter considered the events to be related to GARDASIL (it was reported that "vaccine which has killed many women"). This is one of two reports received from the same reporter. Additional information has been requested.


VAERS ID: 618812 (history)  
Form: Version 1.0  
Age: 0.74  
Sex: Female  
Location: Ohio  
Vaccinated:2015-12-16
Onset:0000-00-00
Submitted: 2016-01-13
Entered: 2016-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR U5387DB / 1 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-12-18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No illness or disease
Preexisting Conditions: No preexisting conditions; Full term birth - uneventful
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received flu vaccine on 12-16-15 at a well child 9 month check. Patient had no preexisting conditions, no adverse reaction. Patient died on 12-18-15 from unknown causes pending autopsy/coroner report. No adverse reaction occurred prior to death.


VAERS ID: 619115 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-01-15
Entered: 2016-01-15
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? Yes
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: WAES1601USA003641

Write-up: Information has been received from an unspecified reporter via social media referring to thousands of unspecified female patients. On unknown dates the patients were vaccinated with GARDASIL (dose, lot # and route were unknown). On unknown dates. the patients were killed and disabled by therapy with GARDASIL. Outcome of disability was unknown. It was unknown if autopsies were performed. Additional information has been requested.


VAERS ID: 619116 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-01-15
Entered: 2016-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Bone cancer, Death, Incorrect route of drug administration
SMQs:, Medication errors (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1601USA004692

Write-up: Information has been received from a physician via company representative referring to a male patient of unknown age. The patient''s pertinent medical history and drug allergies were not reported. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot#, dose and strength unknown) subdermally. Later the patient died from bone cancer on an unknown date. It was unknown if autopsy was done. Causality was not provided. Additional information has been requested.


VAERS ID: 619400 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-01-17
Entered: 2016-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
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: WAES1601USA004246

Write-up: Information has been received from an unspecified reporter referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with HPV (manufacturer unknown)(lot#, strength, dosage, frequency and route unspecified). It was reported that the vaccine was causing death, permanent disability and damage to children around the world. It was ineffective and dangerous. The aluminum content far surpasses all safety levels (PQC). The outcome of the events was not reported. Additional information is not expected since there was no contact details provided.


VAERS ID: 619790 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: Louisiana  
Vaccinated:2015-02-13
Onset:2015-02-17
   Days after vaccination:4
Submitted: 2016-01-19
   Days after onset:336
Entered: 2016-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS KG34F / 2 LL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UI166AA / 2 RA / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J80526 / 2 RL / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FB508A / 2 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Diarrhoea, Irritability, Swelling, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-02-19
   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: Zantac, Hyland Teething tablets
Current Illness: None
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Swollen, fussy, vomiting, diarrhea.


VAERS ID: 619827 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-01-20
Entered: 2016-01-20
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: WAES1601USA006932

Write-up: This spontaneous report as received from a consumer who saw a segment of a broadcast refers to an unspecified number of female patients. The patient''s medical history was not reported. On an unknown dates, the patients were vaccinated with the doses of GARDASIL. On an unknown dates, the patients were losing their lives because of those. The reporter considered deaths to be related to GARDASIL. Additional information is not expected. This is one of several reports from the same reporter.


VAERS ID: 619835 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-01-20
Entered: 2016-01-20
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: WAES1601USA006178

Write-up: This spontaneous report was received from an unspecified reporter via an online article published and Vaccine Adverse Event Reporting System and refers to 236 patients of unknown age and gender. The patients'' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of quadrivalent HPV vaccine (manufacturer unknown) (route, dose, lot # and expiration date not reported). On unknown dates, the patients experienced death. It was unknown whether the autopsy was performed. The relatedness between death and quadrivalent HPV (manufacturer unknown) was not reported. This is one of several reports received from the same reporter. Additional information is not expected as no contact details were provided.


VAERS ID: 620017 (history)  
Form: Version 1.0  
Age: 0.15  
Sex: Female  
Location: Alabama  
Vaccinated:2016-01-04
Onset:2016-01-11
   Days after vaccination:7
Submitted: 2016-01-20
   Days after onset:9
Entered: 2016-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS E3R45 / 1 UN / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE183AA / 1 UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L87116 / 1 UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. L008034 / 1 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Autopsy, Oral discharge, Respiratory arrest, Rhinorrhoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

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

Write-up: Parents called on 1/15/16 and reported that on the morning of 1/11/16, the family found her in her crib, not breathing with congestion around nose and mouth. Taken by ambulance to hospital. Autopsy report pending per mom.


VAERS ID: 620336 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Florida  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-01-22
Entered: 2016-01-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Amyotrophic lateral sclerosis, 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: WAES1601USA007462

Write-up: This spontaneous report was received from a physician (a patient''s colleague) via company representative and refers to a male patient of unknown age. There was no information about patient''s pertinent medical history, concomitant medications, drug reactions or allergies reported. On an unspecified date in approximately 2014 (reported as "approximately 2 years ago"), the patient was vaccinated with ZOSTAVAX refrigerated vial (lot#, expiration date, dose, anatomical location and route of administration were not reported). Directly following the vaccination, in approximately 2014, the patient was diagnosed with the Lou Gehrig''s Disease (ALS). On an unknown date (reported as "recently"), the patient passed away. The cause of death was not provided. The outcome of the event of ALS was not reported. The reporting physician thought there might be a correlation between the event of ALS and vaccination with ZOSTAVAX. The relatedness between the patient''s death and ZOSTAVAX was not reported. Upon internal review the event of ALS was considered as medically significant. Additional information has been requested.


VAERS ID: 620475 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2009-09-22
Onset:2009-11-13
   Days after vaccination:52
Submitted: 2016-01-24
   Days after onset:2263
Entered: 2016-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3203AA / 7+ LA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Complications of transplanted lung, Condition aggravated, Death, Lung transplant, Total lung capacity decreased
SMQs:, Interstitial lung disease (broad), Eosinophilic pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-05-16
   Days after onset: 183
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: Interstitial Lung Disease; Parkinson''s Disease
Preexisting Conditions: Interstitial Lung Disease; Parkinson''s Disease
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: My father had interstitial lung disease for about 10 years at this point. He never received a flu shot before, & in the fall of 2009, there was widespread worry about swine flu. Because of his condition, he decided it was prudent to get a flu shot. Within 2 weeks of receiving the flu shot, his lung capacity went from 88% to 44% and he ended up in the hospital on oxygen. His condition continued to downgrade until 1-1-10 when he received a lung transplant (he was in such need at that time, he was placed on the list and called for a transplant in less than a week). I believe he would have died within a week or two of that time. He did eventually die on May 16, 2010 due to complications of the lung transplant.


VAERS ID: 621477 (history)  
Form: Version 1.0  
Age: 5.0  
Sex: Male  
Location: Wyoming  
Vaccinated:2015-08-13
Onset:2015-08-14
   Days after vaccination:1
Submitted: 2016-01-30
   Days after onset:169
Entered: 2016-02-01
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (KINRIX) / GLAXOSMITHKLINE BIOLOGICALS T325H / 1 UN / IM
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. L005296 / 1 UN / SC

Administered by: Private       Purchased by: Private
Symptoms: Death, Dyspnoea, Obstructive airways disorder, Oropharyngeal pain, Pharyngeal abscess, Pyrexia, Streptococcus test negative
SMQs:, Anaphylactic reaction (broad), Agranulocytosis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-08-18
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Developed fever next day then 3 days later developed sore throat - was seen in an Urgent Care - negative for strep. Two days later had difficulty breathing and expired in the ED of a large retropharyngeal abscess occluding airway - grew strep anginosus.


VAERS ID: 621565 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Georgia  
Vaccinated:0000-00-00
Onset:2012-01-01
Submitted: 2016-02-02
   Days after onset:1493
Entered: 2016-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Death, Myocardial infarction, Pain, Seizure, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Embolic and thrombotic events, arterial (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-01-12
   Days after onset: 1472
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 known and date of vaccination is UNKNOWN
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Possible Lyme disease, 3 and a half years of pain with seizures and tachycardia. Seizure led to heart attack and death on 1/12/16.


VAERS ID: 621574 (history)  
Form: Version 1.0  
Age: 1.21  
Sex: Male  
Location: Tennessee  
Vaccinated:2013-08-08
Onset:2013-08-10
   Days after vaccination:2
Submitted: 2016-01-21
   Days after onset:894
Entered: 2016-02-02
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4484AA / 3 RL / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J002318 / 1 LL / UN

Administered by: Private       Purchased by: Other
Symptoms: Blood culture negative, Chest X-ray normal, Death, Febrile convulsion, Full blood count normal, Pyrexia, Seizure, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-12-18
   Days after onset: 860
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Apparently none
Preexisting Conditions: None in record; delivered at 36 2/7 weeks gestation
Allergies:
Diagnostic Lab Data: CBC (WNL); Negative blood culture, and negative chest X-ray
CDC Split Type:

Write-up: Parents reported that pt. had a seizure after receiving PENTACEL and VARIVAX on 8/8/13 - his seizure occurred on 8/12/13 in conjunction with fever. Pt was evaluated at ED and released. Dx''d with febrile seizures. On 12/18/2015 pt was found unresponsive in his bed and was DOA after transport to Medical Center.


VAERS ID: 621689 (history)  
Form: Version 1.0  
Age: 0.29  
Sex: Male  
Location: Ohio  
Vaccinated:2016-01-02
Onset:0000-00-00
Submitted: 2016-02-03
Entered: 2016-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4814AA / 1 LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. L010595 / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L77778 / 1 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CB524A / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-01-02
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: We called to schedule next set of shots and were informed that patient has died.


VAERS ID: 621718 (history)  
Form: Version 1.0  
Age: 0.53  
Sex: Male  
Location: North Carolina  
Vaccinated:2013-11-06
Onset:2015-03-12
   Days after vaccination:491
Submitted: 2016-02-03
   Days after onset:328
Entered: 2016-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS J5LP9 / 3 LL / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4694EA / 1 LL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS NY79F / 3 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH850AB / 3 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G75064 / 3 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. J005237 / 3 MO / PO

Administered by: Private       Purchased by: Other
Symptoms: Autopsy, Blood chloride decreased, Blood sodium decreased, Blood urea increased, Death, Dehydration, Gastroenteritis, Hyponatraemia, Rotavirus infection, Rotavirus test positive
SMQs:, Acute renal failure (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Hyponatraemia/SIADH (narrow), Chronic kidney disease (broad), Noninfectious diarrhoea (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-03-13
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Rotavirus A detected by stool culture. Eye vitreous electrolytes detected low sodium of 116, low chloride and high urea nitrogen level supporting diagnosis of hyponatremic dehydration.
CDC Split Type:

Write-up: Child received three vaccines with Rotateq at age 2, 4, and 6 months, however, he contracted gastroenteritis on 3/12/15 and died from dehydration and Rota Virus A infection on 3/13/15 which was detected on autopsy.


VAERS ID: 621941 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Male  
Location: Maryland  
Vaccinated:2016-01-08
Onset:2016-01-15
   Days after vaccination:7
Submitted: 2016-02-04
   Days after onset:20
Entered: 2016-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 014458 / 1 UN / UN

Administered by: Private       Purchased by: Other
Symptoms: Biopsy bronchus normal, Bronchoalveolar lavage normal, Bronchoscopy normal, Chest X-ray normal, Computerised tomogram normal, Culture negative, Dyspnoea, Hypoxia, Intensive care, Microbiology test normal
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2016-04-15
   Days after onset: 90
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 80 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Allopurinol, prazosin, Zoloft, Flonase, Nyquil, Tylenol PRN, Aricept
Current Illness: Chronic dry cough
Preexisting Conditions: Chronic dry cough
Allergies:
Diagnostic Lab Data: Bronchoscopy with BAL and biopsy. Comprehensive microbiology tests and cultures. CT scan and chest x-rays.
CDC Split Type:

Write-up: Approximately 5-7 days after the vaccination he started having shortness of breath progressively getting worse. He was admitted to hospital on 1/27/2016 with hypoxia and was then transferred to ICU on 1/29/16 after bronchoscopy. He remains in ICU currently. All work up has been negative in regard to diagnosis.


VAERS ID: 622223 (history)  
Form: Version 1.0  
Age: 0.22  
Sex: Male  
Location: Kansas  
Vaccinated:1978-10-21
Onset:1978-10-21
   Days after vaccination:0
Submitted: 2016-02-09
   Days after onset:13625
Entered: 2016-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Private       Purchased by: Private
Symptoms: Death, Eye movement disorder, Meningitis bacterial
SMQs:, Ocular motility disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1978-10-23
   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: Baby vitamins
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Died of bacterial menigitis
CDC Split Type:

Write-up: Had to wait in waiting room because of my sons eyes rolling in back of head after shot.


VAERS ID: 622366 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-02-11
Entered: 2016-02-11
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: WAES1602USA005295

Write-up: This spontaneous report was received from a consumer referring to a 14 year old male patient. The patient''s concurrent conditions and medical history were not provided. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose, route, lot # and expiration date were not provided). Concomitant therapies were not reported. On an unspecified date the patient died. It was unknown if an autopsy was performed and which was the exact cause of death. On an unknown date the reporter wrote on the "Merck Corporate Twitter Account". The relatedness between death and GARDASIL was unknown. Additional information is not expected as the reporter did not provide contact details.


VAERS ID: 622986 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: California  
Vaccinated:2008-09-11
Onset:2013-03-20
   Days after vaccination:1651
Submitted: 2016-02-17
   Days after onset:1064
Entered: 2016-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0572X / 1 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Aphasia, Biopsy brain normal, Blood test, Brain neoplasm, Computerised tomogram, Death, Gait disturbance, Hypoaesthesia, Musculoskeletal disorder, Noninfective encephalitis, Nuclear magnetic resonance imaging, Scan brain, Speech disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypoglycaemia (broad), Non-haematological tumours of unspecified malignancy (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2016-01-16
   Days after onset: 1032
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 30 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: No reaction at the time
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: MRIs, Cat scans, biopsies
CDC Split Type:

Write-up: Started getting numbness in right hand and face. Was having trouble with finding words, didn''t go to the doctor until a few months later and they did brain scans and blood tests. Said there was inflammation in her brain after several tests and ruling out many different things. Inflammation progressively became worse in her brain, she had 2 brain biopsies in 2015 that came back inconclusive. Facility could not diagnose her. Inflammation still worsening by the end of 2015. Hardly able to walk anymore, can''t use her right hand at all anymore, can''t speak well at all either. By December 2015 was diagnosed with a brain tumor and died on 01/16/2016.


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