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VAERS ID: 491544 (history)  
Form: Version 1.0  
Age: 85.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-05-13
Entered: 2013-05-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Activities of daily living impaired, Anti-neuronal antibody negative, Antinuclear antibody negative, Areflexia, Ataxia, Athetosis, Blood thyroid stimulating hormone normal, CSF glucose normal, CSF protein increased, CSF white blood cell count negative, Cardiopulmonary failure, Cerebellar ataxia, Chronic inflammatory demyelinating polyradiculoneuropathy, Computerised tomogram abdomen normal, Computerised tomogram normal, Death, Decreased vibratory sense, Dizziness, Dyskinesia, Dysstasia, Electromyogram normal, Electrophoresis protein, Electrophoresis protein normal, Gait disturbance, Glycosylated haemoglobin normal, HIV test negative, Hepatic enzyme, Hypoaesthesia, Immunoglobulin therapy, Laboratory test abnormal, Loss of proprioception, Nerve conduction studies abnormal, Neurological symptom, Nuclear magnetic resonance imaging spinal normal, Paraesthesia, Peripheral sensory neuropathy, Radiculopathy, Romberg test positive, Somatosensory evoked potentials abnormal, Synovial cyst, Treponema test negative, Upper motor neurone lesion, Urine electrophoresis normal, Vitamin B12 normal
SMQs:, Cardiac failure (narrow), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dyskinesia (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Demyelination (narrow), Vestibular disorders (broad), Respiratory failure (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Congestive heart failure; Idiopathic pulmonary fibrosis
Allergies:
Diagnostic Lab Data: CSF analysis, Protein, 64.2 mg/dL, Elevated
CDC Split Type: 2013035891

Write-up: This literature report (initial receipt: 30-Apr-2013) concerns an 85-year-old male patient who had a medical history of congestive heart failure and idiopathic pulmonary fibrosis. He had no history of illicit drug use, excessive alcohol consumption, toxic exposures or family history of neurologic disorders. On an unspecified date, the patient received influenza vaccine (manufacturer and batch number not specified). On an unspecified date, 1 week after vaccination the patient developed tingling in his feet. 1 week later he developed a similar sensation in both hands. He reported difficulty unbuttoning his shirt and unsteadiness when walking. He had no prior similar symptoms, preceding illnesses, or recent changes in his health or medications. On examination, he had no cranial nerve deficits and full strength. He had preserved light touch, temperature, and pinprick sensation, but symmetrically diminished vibration sense and proprioception to the level of both wrists and ankles. Reflexes were absent bilaterally in his upper and lower extremities. On pronator drift testing, his arms drifted upward, and his fingers made small involuntary movements. On finger-nose testing the patient had difficulty reaching and maintaining contact with a target, which worsened with eyes closed. He had no Romberg sign, but had mild gait instability. The patient''s gait unsteadiness, upward drift of the arms with pseudoathetosis of the fingers (subtle movements suggestive of a proprioceptive deficit), and worsening of finger-nose testing with eyes closed suggest a sensory ataxia. Sensory ataxia, diminished vibration sense, decreased proprioception, and areflexia localized to the posterior columns, large fibers of peripheral nerves, or intervening dorsal root ganglia or nerve roots; the bilaterality, symmetry, and areflexia made a supratentorial etiology improbable. Before referral to the neurologist, the patient underwent laboratory evaluation for etiologies of peripheral neuropathy, revealing normal vitamin B12, thyroid stimulating hormone, hemoglobin A1C, serum and urine protein electrophoresis, and liver enzymes. Given the rapidly evolving nature of his symptoms and absent reflexes, he was admitted due to concern for possible Guillain-Barre syndrome (GBS). CSF analysis to assess for inflammation or infection revealed normal glucose (60 mg/dL), mildly elevated protein (64.2 mg/dL), and no red or white blood cells. Electromyography (EMG) and nerve conduction studies (NCS) were performed to distinguish between axonal and demyelinating etiologies of presumed polyneuropathy. NCS demonstrated reduced amplitudes of sensory nerve action potentials (SNAPs) in the sural (left 3.3 mV, right 0.60 mV), superficial peroneal (left 3.7 mV, right 3.3 mV), median (left 6.0 mV, right 6.1 mV), and ulnar nerves (left not recordable, right 5.2 mV); slightly reduced amplitudes of combined motor action potentials (CMAPs) of bilateral median (left 4.5 mV, right 2.5 mV), left ulnar (3.4 mV), and bilateral peroneal nerves (left 1.7 mV, right 1.9 mV); and normal nerve conduction velocities (NCV), distal latencies, and F waves. EMG was normal in bilateral tibialis anterior, left first dorsal interosseous, and left extensor digitorum brevis muscles. Due to the lack of weakness and bulbar symptoms and the NCS lacking features of demyelination with preserved F waves, GBS and subtypes of GBS including acute inflammatory demyelinating polyradiculoneuropathies (AIDP) and AIDP variants including Miller Fisher syndrome were ruled out. He underwent extensive but unrevealing evaluation for possible autoimmune, infectious, or paraneoplastic processes (serum antinuclear antibodies, SS-A [Ro], and SS-B [La]; rapid plasma reagin and HIV; anti-Hu, anti-GQ1B, and anti-GM1 autoantibodies; and computed tomography (CT) of the chest, abdomen, and pelvis). Although the etiology of his illness was unclear, intravenous immunoglobulin (IVIg) 0.4 g/kg/day was administered for 5 days. His symptoms remained stable and he was discharged for rehabilitation. He initially noted improvement in his gait and only minimal persistent numbness in his hands and feet. One month later, however, his gait acutely worsened over several days, such that he was too unsteady to walk or stand unassisted. He had a Romberg sign, swayed from side to side when standing, and had a magnetic gait. His sensory, motor, and reflex examinations were otherwise unchanged from his initial examination. The differential diagnosis of the patient''s progressive sensory symptoms includes chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and ganglionopathy. Ganglionopathy was diagnosed as it presents with sensory ataxia and deficits in proprioception and vibration sense with reduced SNAPs all seen in the patient. EMG/NCS were repeated and demonstrated relatively unchanged SNAPs and CMAPs compared to his prior NCS. Since worsening axonal neuropathy or ganglionopathy would have been expected to result in further decrement in his SNAPs, his clinical progression in the setting of stable electrodiagnostic studies suggested a more proximal lesion at the level of the nerve roots or posterior columns. In this patient, somatosensory evoked potentials (SSEPs) revealed no reproducible waveforms at any site. Given the presence of SNAPs on routine NCS, the absence of SSEPs suggests block of conduction more proximally (e.g., at the level of proximal nerve roots or posterior columns). Magnetic Resonance Imaging (MRI) of the spine with gadolinium was performed, demonstrating enhancement of numerous lumbosacral nerve roots and dorsal root ganglia with a normal-appearing spinal cord. Nerve biopsy was proposed, but deferred by the patient and his family. This constellation of clinical, electrodiagnostic, and imaging features is suggestive of chronic immune sensory polyradiculopathy (CISP). He was treated with another course of 5 days of IVIg followed by 1 g/kg over 2 days monthly for 4 months and prednisone 60 mg daily. His neurologic status did not improve with therapy, suggesting that he had developed irreversible damage to his proximal nerve segments. He died several months later from complications of his underlying cardiopulmonary disease.


VAERS ID: 491893 (history)  
Form: Version 1.0  
Age: 0.16  
Sex: Male  
Location: Arizona  
Vaccinated:2013-04-19
Onset:2013-04-19
   Days after vaccination:0
Submitted: 2013-05-08
   Days after onset:19
Entered: 2013-05-17
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B399BA / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F45589 / 1 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CB343A / 1 MO / PO

Administered by: Private       Purchased by: Unknown
Symptoms: Death, Foaming at mouth, Immediate post-injection reaction, Mouth haemorrhage, Pallor
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Convulsions (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-04-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Premature birth (21 days before the due date)
Allergies:
Diagnostic Lab Data:
CDC Split Type: AZ1307

Write-up: Immediately after the vaccines, the child looked pale and blood like foam came in the mouth. The child pooped too. The doctor came & stated after checking his mouth that he is normal and it is due to immunization.


VAERS ID: 492001 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Male  
Location: Unknown  
Vaccinated:2007-10-01
Onset:0000-00-00
Submitted: 2013-05-17
Entered: 2013-05-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS - / UNK UN / UN

Administered by: Military       Purchased by: Military
Symptoms: Abdominal infection, Coccidioidomycosis, Death, Immediate post-injection reaction, Immune system disorder, Infection, Laboratory test, Lung infection, Malaise, Osteomyelitis, Pain, Rib excision, Spinal laminectomy, Spinal operation
SMQs:, Eosinophilic pneumonia (broad), Osteonecrosis (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-04-22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: No history. In good health when he started working.
Allergies:
Diagnostic Lab Data: No test results provided. Per reporter, "too many to remember".
CDC Split Type: 13AV00009SP

Write-up: Spontaneous information received on 03MAY2013 and 08MAY2013 from a family member of a consumer. An adult male experienced Valley Fever (coccidioidomycosis), and subsequently died. Medical history - the subject was reportedly in good physical condition. No known medical history. History of events per adult subject''s father. Subject was immunized in October of 2007. Within a day of vaccination he experienced pain and illness, though the father could not remember the nature of immediate post-vaccination symptoms. He was eventually diagnosed with Valley Fever (coccidioidomycosis) contracted during his time at work. "He did not respond to treatment. The doctors said his immune system was not working. He had several surgeries. He was given many drugs that did not stop the infection." Reportedly, he was let go due to his illness. In 2011 he had 3 surgeries to remove 2 1/2 ribs and portions of his spinal bones, and further surgery to reinforce his spine. In 2013, he had "pockets" of infection in his bones; belly, and brain as well as his lungs. He refused treatment with a ventilator and subsequently died on 22APR2013. Per the subject''s father: "His work gave him the vaccines. The doctors treated his infection. The doctors said the vaccine did not cause his infection. They said the vaccines did not cause his immune system to stop working. The employer said we could not sue. The employer is not telling us everything."


VAERS ID: 492023 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Male  
Location: Unknown  
Vaccinated:2010-05-01
Onset:2011-05-01
   Days after vaccination:365
Submitted: 2013-05-20
   Days after onset:750
Entered: 2013-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Aphagia, Cardiac operation, Death, Faecal incontinence, Fatigue, Insomnia, Neoplasm malignant, Pain, Rash generalised
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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? 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: WAES1305USA009872

Write-up: This spontaneous report as received from a consumer refers to an approximately 77 years old male patient with cancer. Approximately in May 2010, reported as approximately 3 years ago, patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number and expiration date not reported). Reporter stated that patient wasn''t on anything and was pretty healthy. No concomitant medications were reported. On an unknown date the patient experienced cancer. Approximately in May 2011, reported as about two years ago, patient died. Reporter stated that she didn''t know if it was from cancer or vaccine and none of doctors could pinpoint the reason of death. On an unknown date the patient even had to have open heart surgery. Consumer reported also that at the end of his life (approximately in 2011) he experienced breaking out over his entire body, extremely painful, he couldn''t eat, couldn''t sleep and had temporary loss of bowel control. The patient complained also about pain through his entire body and severe fatigue. On an unknown date patient was hospitalized and then moved to hospice facility. He sought medical attention. The treatment given for the events were reported by the consumer as: the doctors said "maybe it''s this maybe it''s that". The outcome of open heart surgery, cancer, breaking out over his entire body, extremely painful, couldn''t eat, couldn''t sleep, temporary loss of bowel control, pain through his entire body and severe fatigue was not reported. The relatedness open heart surgery, cancer, breaking out over his entire body, extremely painful, couldn''t eat, couldn''t sleep, temporary loss of bowel control, pain through his entire body and severe fatigue between and ZOSTAVAX was not reported. Additional information is not expected.


VAERS ID: 492174 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Male  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-05-21
Entered: 2013-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-05-08
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: Chemotherapy; Precursor T-lymphoblastic lymphoma/leukaemia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1305USA010047

Write-up: This spontaneous report as received from a other health professional (medical student) refers to a currently 15 years old male patient with T cell precursor lymphoblastic leukemia (ALL) undergoing chemotherapy. On an unknown date the patient''s brothers were vaccinated with a dose of varicella virus vaccine live (manufacturer unknown) lot # dose not reported, it was not known if the patient had been vaccinated. On an unknown date, the patient experienced disseminated varicella (hospitalization) and died (on an unspecified date). The cause of death was unknown. At the time of the report the outcome for disseminated varicella, patient''s brothers were vaccinated with a dose varicella virus vaccine live were unknown. Additional information has been requested.


VAERS ID: 492192 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Female  
Location: Utah  
Vaccinated:2013-05-07
Onset:2013-05-08
   Days after vaccination:1
Submitted: 2013-05-21
   Days after onset:13
Entered: 2013-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C4335AA / 1 RL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. H010380 / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH792AD / 1 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR H1604 / 1 RL / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F45144 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. HD14899 / 1 MO / PO

Administered by: Unknown       Purchased by: Private
Symptoms: Autopsy, 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: 2013-05-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Infant was healthy on the date of vaccination. This was her first set of vaccines as mother/grandmother had elected to defer vaccination until the infant was a little older.
Preexisting Conditions: Presumed amniotic band sequence. Left arm had a constricted band with absent lower forearm and hand. Right leg with constrictor band below knee with no lower leg or foot. Infant had been discharged from the NICU on supplemental O2, but had been weaned off of O2 by the time of this appointment.
Allergies:
Diagnostic Lab Data: An autopsy has been conducted by the Medical Examiner and results are pending at this time.
CDC Split Type:

Write-up: Infant was found expired in her crib on the morning following vaccination. Mother reports that she had a tactile fever on the evening prior to her death.


VAERS ID: 492434 (history)  
Form: Version 1.0  
Age: 1.18  
Sex: Male  
Location: Unknown  
Vaccinated:2013-05-10
Onset:0000-00-00
Submitted: 2013-05-23
Entered: 2013-05-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DPP: DIPHTHERIA TOXOID + PERTUSSIS + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Dyspnoea, Rash
SMQs:, Anaphylactic reaction (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-05-20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Rash. Breathing problems.


VAERS ID: 492468 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-05-24
Entered: 2013-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1305USA013443

Write-up: This spontaneous report as received from a female consumer via company representative who refers to her niece. On an unknown date the patient was vaccinated with GARDASIL (route, dose, number of doses, lot# not reported). As was reported that on an unknown date the patient died from complications while using GARDASIL. No more information were provided. Additional information has been requested.


VAERS ID: 492545 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2013-03-11
Onset:2013-03-31
   Days after vaccination:20
Submitted: 2013-05-27
   Days after onset:57
Entered: 2013-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. 4019092 / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anaemia, Asthenia, Death, Palpable purpura, Sepsis, Urinary tract infection, Vasculitis
SMQs:, Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Guillain-Barre syndrome (broad), Vasculitis (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2013-05-09
   Days after onset: 39
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PRAVACHOL; KLOR-CON; Hydrochlorothiazide; SOMA; Atenolol; Amitriptyline hydrochloride
Current Illness: Perennial allergy; Hyperlipidaemia; Spinal osteoarthritis; Hypertension; Diabetes mellitus
Preexisting Conditions: C-reactive protein increased; Eosinophil count increased
Allergies:
Diagnostic Lab Data: Blood work (March 2013): Elevated C-reactive protein levels.
CDC Split Type: WAES1305USA014155

Write-up: This spontaneous report was received from a physician via a company representative concerning an 86 year old female patient with diabetes, hypertension, lumbar spondylosis, hyperlipidemia and chronic allergies. Patient''s medical history included elevated c-reactive protein and elevated eosinophil levels. On 11-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). Concomitant therapies included PRAVACHOL (20 milligrams), KLOR-CON 10 milligrams(mg), hydrochlorothiazide (dose unspecified), SOMA (350 mg), atenolol (50 mg) and amitriptyline hydrochloride (50 mg). On 31-MAR-2013, the patient experienced palpable purpura and vasculitis covering her body two weeks after receiving ZOSTAVAX. Her physician advised her to immediately go to the hospital. The patient was admitted to the hospital (name unspecified) on 31-MAR-2013 and was given medication to treat her condition (prednisone-dosage unspecified). The patient was discharged on 02-APR-2013. Approximately on an unknown date in April 2013, upon returning home the patient developed a urinary tract infection, and experienced profound weakness and anemia. The patient was readmitted to the unspecified hospital for these symptoms on 18-APR-2013. Upon discharge (exact date unspecified in 2013) the patient was sent to a rehabilitation center (unspecified) where she remained until two days before her death. The events were not resolved at the time of reporting. On 11-MAY-2013, the patient died due to sepsis. It was unknown if the autopsy was done. The physician noted that blood work that was taken from the patient directly preceding vaccination indicated that she had elevated C-reactive protein levels directly before she received the vaccine which may have been an indicator of the declining conditions of the patient. The relatedness for the events was unknown for ZOSTAVAX. The reporter considered the events to be life threatening. Additional information has been requested.


VAERS ID: 492765 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-05-29
Entered: 2013-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1305USA015672

Write-up: This spontaneous report as received from a consumer refers to the consumer''s neighbor of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMOVAX23 (strength, dose, via, indication, lot number and expiration date not reported). There was no concomitant medication reported. The reporter stated that the unspecified neighbor died on an unknown date from PNEUMOVAX23. This is one of several reports from the same source (MARRS case # 1305USA014871). Additional information has been requested.


VAERS ID: 493595 (history)  
Form: Version 1.0  
Age: 0.38  
Sex: Female  
Location: New Hampshire  
Vaccinated:2013-01-29
Onset:2013-03-11
   Days after vaccination:41
Submitted: 2013-06-06
   Days after onset:87
Entered: 2013-06-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B370BA / 1 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-03-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: NH0606137

Write-up: ? SIDS (death cert. not yet available).


VAERS ID: 493596 (history)  
Form: Version 1.0  
Age: 0.16  
Sex: Male  
Location: New Hampshire  
Vaccinated:2013-03-14
Onset:2013-03-26
   Days after vaccination:12
Submitted: 2013-06-06
   Days after onset:72
Entered: 2013-06-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21E3999AA / 1 UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH689AA / 1 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH F99044 / 1 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. H014898 / 1 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-03-26
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NH0606138

Write-up: ? SIDS (death cert. pending).


VAERS ID: 493598 (history)  
Form: Version 1.0  
Age: 0.42  
Sex: Female  
Location: New Hampshire  
Vaccinated:2013-02-13
Onset:2013-02-26
   Days after vaccination:13
Submitted: 2013-06-06
   Days after onset:99
Entered: 2013-06-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B370BA / 2 UN / UN
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4482BA / 1 UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH689AA / 2 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. H0011457 / 2 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-02-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: NH0606139

Write-up: ? SIDS (final death cert not avail.).


VAERS ID: 493599 (history)  
Form: Version 1.0  
Age: 0.01  
Sex: Male  
Location: New Hampshire  
Vaccinated:2013-01-29
Onset:2013-02-18
   Days after vaccination:20
Submitted: 2013-06-07
   Days after onset:108
Entered: 2013-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVC127AC / 1 RL / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-02-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NH06061310

Write-up: ? SIDS (death cert. not yet available).


VAERS ID: 493734 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-06-07
Entered: 2013-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunodeficiency; Discomfort
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1306USA001701

Write-up: This spontaneous report as received from a pharmacist (or pharmacy technician - it was not confirmed) via company representative refers to a female patient of unknown age and unknown medical history. The husband reporting on his wife to the pharmacist, on an unknown date the patient was vaccinated with ZOSTAVAX, (0.65 ml in one shot; subcutaneously) (lot number, exp. date not reported). On an unknown date reported as shortly after receiving ZOSTAVAX the patient had developed an infection in her heart and died from the infection in her heart shortly after having development of infection on an unknown date. It was reported that the patient may had been immunodeficient because her husband stated that she was not the healthiest prior to receiving ZOSTAVAX and that she might also have developed a rash after receiving ZOSTAVAX but neither the presence of immunodeficiency or the development a rash had been confirmed. The outcome of the heart infection was fatal. The cause of death was heart infection. The patient''s husband was adamant that ZOSTAVAX caused the infection in the patient''s heart. No legal issues was suspected at this time. Additional information has been requested.


VAERS ID: 493988 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2013-06-11
Onset:2013-06-12
   Days after vaccination:1
Submitted: 2013-06-12
   Days after onset:0
Entered: 2013-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C4335BA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH735AC / 1 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR H1604 / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G20393 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. H012117 / 1 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Cyanosis, Death, Hypotonia, Resuscitation
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-06-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Twin; Small for gestational age; 35 week; Prenatal drug use and cigarette smoking
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Infant found blue and limp in bassinet with twin (who was crying to be fed). 911 called. Ambulance crew could not resuscitate infant.


VAERS ID: 494024 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Male  
Location: Texas  
Vaccinated:2012-01-25
Onset:2012-01-25
   Days after vaccination:0
Submitted: 2013-06-12
   Days after onset:503
Entered: 2013-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1397AA / 1 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4032AA / 2 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Cerebral haemorrhage, Coma, Death, Haematemesis, Injection site bruising, Leukaemia, Oropharyngeal pain, Pyrexia, Unresponsive to stimuli
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Gastrointestinal haemorrhage (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-02-10
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None known
Current Illness: None known
Preexisting Conditions: None known
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: On 1/25/2012, as per mother patient developed a black bruise to the left upper arm where vaccines had been administered that covered most of the entire upper arm. On February 1, 2012, he developed a sore throat and fever that lasted a week. On February 7, 2012 at 11 am he reported to hospital. As per mother, patient was non-responsive and was throwing up blood-tinged saliva. He was flown out due to an internal hemorrhage. He was admitted to hospital at around 3 pm. After admission, he remained unresponsive. As per mother, the internal cerebral hemorrhage was too advanced and the patient was not a candidate for surgery so patient eventually became comatose. He passed away on 2/10/2012 at 2 am. Final diagnosis was cerebral hemorrhage and leukemia. As per parent, the client had no previous history of illnesses at the time of vaccination on 1/25/2012.


VAERS ID: 494498 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2013-05-01
Onset:0000-00-00
Submitted: 2013-06-18
Entered: 2013-06-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G54897 / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013180144

Write-up: This is an initial spontaneous report by a contactable physician. A female patient received PREVNAR 13 (Lot number: G54897, Expiration Date: 09Jan2014) unknown dose unknown, frequency ,unknown anatomical location of the administration for an unknown indication in May2013. Relevant medical history was unknown. Relevant concomitant medications were unknown. Vaccines given on the same day was unknown. Vaccines taken within the last four weeks were unknown. In 2013 she experienced pneumococcal pneumonia, pneumococcal sepsis and an unspecified condition to which she passed away. Relevant lab data was unknown. It was unknown if an autopsy was performed. At the time of report she had not recovered from an unspecified condition. At the time of report the clinical outcome for the other events were unknown.


VAERS ID: 494747 (history)  
Form: Version 1.0  
Age: 66.0  
Sex: Male  
Location: Michigan  
Vaccinated:2013-02-08
Onset:2013-02-08
   Days after vaccination:0
Submitted: 2013-06-16
   Days after onset:127
Entered: 2013-06-21
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. H020000 / 1 AR / UN

Administered by: Private       Purchased by: Private
Symptoms: Addison's disease, Arthralgia, Asthenia, Bacteraemia, Biopsy lymph gland, Candidiasis, Cardiac arrest, Chills, Cognitive disorder, Death, Decreased appetite, Diarrhoea, Differential white blood cell count, Dizziness, Dysstasia, Full blood count, Hunger, Lymphadenopathy, Metabolic function test, Nausea, Oedema peripheral, Oral pain, Pneumonia, Pruritus, Pyrexia, Rash generalised, Red blood cell sedimentation rate, Sepsis, Serum sickness, Urine analysis
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-06-05
   Days after onset: 116
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 20 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: SINGULAIR; MOBIC; Hydrocodone; Simvastatin
Current Illness: None
Preexisting Conditions: Arthritis; History of kidney stones
Allergies:
Diagnostic Lab Data: ESR; CBC with diff; CMP; Urinalysis; Lymph node biopsy
CDC Split Type:

Write-up: Symptoms = Serum sickness. Addison''s disease, bacteremia, sepsis, pneumonia in both lungs, swollen lymph nodes in chest, neck, underarms, daily chills & fever, rash all over, intense itching, nausea, dizziness, extreme weakness, hunger, swollen hands and feet, extreme joint pain in hands, feet, and knees, thrush, diarrhea. The last 2 weeks he would not eat (no appetite) and his mouth was very painful. There were times when he couldn''t think clearly. Most symptoms appeared soon after the vaccine and got worse with time. For the last week, he was too weak to stand for more than a few minutes. Treatment: Steroid shots, prednisone daily, BENADRYL, CLARITIN, anti-itch pills and cream, intravenous antibiotics (VANCOMYCIN, ROCEPHIN, ZITHROMAX, GENTAMYCIN), ZOSYN, ZANTAC, ZOFRAN, oxygen after 5-16-13, breathing treatments, COMBIVENT, SYMBICORT, MAGIC MOUTHWASH. My husband was in the ER 4 times, had 10 doctor visits, and was admitted to the hospital 3 times: 5-10-13 to 5-16-13; 5-21-13 to 5-31-13; 5-31-13 was taken by ambulance to hospital. He was discharged 6-4-13 and he died the next day. On 6-5-13, Dr at hospital inserted a breathing tube and a central line. My husband was to be flown to another hospital when he went into cardiac arrest on the plane and did not survive. Please tell me what happened. On February 8 before he got this vaccine, he was healthy and strong. I hope you will contact me.


VAERS ID: 494750 (history)  
Form: Version 1.0  
Age: 1.29  
Sex: Female  
Location: New York  
Vaccinated:2013-01-07
Onset:2013-01-07
   Days after vaccination:0
Submitted: 2013-06-20
   Days after onset:163
Entered: 2013-06-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B155BA / UNK LG / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB667CB / UNK RL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0258AE / UNK RL / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. H009535 / UNK LL / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Resuscitation, Sepsis
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2013-01-16
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013036599

Write-up: This medically confirmed spontaneous report (initial receipt 18-Jun-2013) concerns a female patient approximately 2 years old. Some time in January or February of 2013, the patient developed sepsis and subsequently passed away. The patient had received a flu shot (influenza vaccine, batch and manufacturer unspecified) prior to developing sepsis. The patient had been hospitalised (hospital information and duration unspecified) and CPR (cardiopulmonary resuscitation) had been conducted. The event outcome was fatal. Reporter''s comments: The reporter considered events serious due to hospitalisation, intervention to prevent serious criteria (CPR conducted), life threatening events (patient passed away) and death.


VAERS ID: 494783 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-06-21
Entered: 2013-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0901016A

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in an adult subject of unspecified gender who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). On an unspecified date, the subject received an unspecified dose of Influenza vaccine unspecified 2011-2012 season (administration site and route unknown, batch number not provided). At an unspecified time after vaccination with Influenza vaccine unspecified 2011-2012, the subject was hospitalised. The subject died from cause undetermined. It was unknown whether an autopsy was performed. Summary of the literature article: Annual influenza vaccine has been recommended for adults at high risk for influenza complications since 1960; universal vaccination has been recommended since 2010. Two recent reviews both reported that there is little evidence to support vaccine effectiveness against serious influenza complications for adults. Clinical trials have been too small to evaluate influenza complications, and most observational studies have not used laboratory-confirmed influenza as an outcome. The case-positive, control-negative study design is an efficient method to determine vaccine effectiveness that assures appropriate classification of cases and identifies controls with risk factors for both acute respiratory illness and propensity to seek medical care similar to those of influenza-positive patients. During the 2011-2012 influenza season, the authors enrolled hospitalized adults with acute respiratory illness and tested each for influenza using reverse transcription polymerase chain reaction. Influenza vaccination was verified in 35% (6/17) of adults with influenza-associated hospitalizations compared to 64% (97/152) of test-negative controls; adjusted vaccine effectiveness was 71.4% (95% confidence interval, 17.1% - 94.9%). Although the authors enrolled subjects with fairly broad eligibility criteria, discharge diagnoses were not associated with either influenza diagnosis or vaccination status. These data are among the first estimates of vaccine effectiveness for the 2011-2012 influenza season. More important, this study adds to the evidence indicating that inactivated influenza vaccine can prevent more than half of all influenza-associated hospitalizations in older adults. Influenza causes an average of 294 128 hospitalizations annually; most are in adults aged. 50 years. The authors''s conclusion stated that given current vaccination rates and a vaccine effectiveness of 60%, more than one-third of these hospitalizations could be prevented by increasing vaccination uptake in this population.


VAERS ID: 494837 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Female  
Location: Michigan  
Vaccinated:2013-05-15
Onset:2013-05-15
   Days after vaccination:0
Submitted: 2013-06-21
   Days after onset:37
Entered: 2013-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (KINRIX) / GLAXOSMITHKLINE BIOLOGICALS AC20B204AA / 5 LL / IM
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. H015624 / 2 LL / SC

Administered by: Public       Purchased by: Public
Symptoms: Death, Pulmonary aplasia
SMQs:, Congenital, familial and genetic disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-05-15
   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: Ventolin 90 mcg QID, glycopyrrolate 0.5mg QID, montelukast 4mg qHS, nitrofurantoin 25mg qHS, Flovent 11mcg BID
Current Illness: Multiple congenital abnormalities-see below
Preexisting Conditions: Chronic Respiratory Disease, Tracheal Anomoly, Sleep Apnea, Hydronephrosis, Polydactyly, esophogeal abnormalities, uretal obstruction
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Unknown-patient died at home on 5/15/13. Time of death not indicated on death certificate. Manner of death indicated as natural and pulmonary aplasia listed as cause of death.


VAERS ID: 495254 (history)  
Form: Version 1.0  
Age: 0.87  
Sex: Male  
Location: Kentucky  
Vaccinated:2013-06-19
Onset:2013-06-24
   Days after vaccination:5
Submitted: 2013-06-27
   Days after onset:3
Entered: 2013-06-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B421AA / 3 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH740AB / 3 LL / -
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 631939 / 3 LL / -

Administered by: Public       Purchased by: Public
Symptoms: Autopsy, Death, Fall, Respiratory tract congestion
SMQs:, Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Cororner will release copy of autopsy and coroners report will not be back for 2 months. Please submit a request on your letter head.
CDC Split Type:

Write-up: Pt died at Hospital 5 days after imm received no adverse reactions reported after immunizations given. Baby reported to have fallen off of couch on June 24th and put to bed with a bottle propped. No obvious signs of trauma or aspirations. No problems that day besides some congestion. Has a history of being seen in the ER for febrile seizures never reported at the health department. Child was going the next day for 9 month old check up. No history of of problems with any vaccine.


VAERS ID: 495494 (history)  
Form: Version 1.0  
Age: 1.13  
Sex: Male  
Location: Texas  
Vaccinated:2010-06-07
Onset:2010-06-11
   Days after vaccination:4
Submitted: 2013-06-30
   Days after onset:1115
Entered: 2013-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (MYCOBAX) / SANOFI PASTEUR - / 1 GM / SYR
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. - / 1 LG / SYR

Administered by: Unknown       Purchased by: Public
Symptoms: Haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-06-30
   Days after onset: 1115
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: Cephalhematoma
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vaccine recipient started to bleed on both hands and walked over a filled bathtub.


VAERS ID: 495685 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: New Hampshire  
Vaccinated:2013-04-29
Onset:2013-06-03
   Days after vaccination:35
Submitted: 2013-07-02
   Days after onset:29
Entered: 2013-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B412AA / 1 RL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH765AA / 1 LL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G03533 / 1 LL / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FB344A / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-06-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Hosp x18 d. after birth for withdrawal (mat. use of chronic pain meds)
Allergies:
Diagnostic Lab Data: Autopsy by medical examiner
CDC Split Type: NH07021312

Write-up: Possible SIDS (SUID).


VAERS ID: 496785 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-07-15
Entered: 2013-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart disease; Neurological disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0906457A

Write-up: This case was reported in a literature article and described the occurrence of acute myocardial infarction in a 53-year-old male subject who was vaccinated with DTPa (with small D and P, manufacturer unspecified). Concurrent medical conditions included multiple cardiac and neurological conditions. On an unspecified date, the subject received unspecified dose of DTPa (with small D and P) (administration site and route unknown, batch number not provided). 69 days after vaccination with DTPa (with small D and P), the subject experienced acute myocardial infarction and died. It was unknown whether an autopsy was performed. This is one of the 11 cases created from the same literature article. Summary of the literature article: Pre-licensure clinical trials for two licensed Tdap vaccines did not reveal any major safety concerns. However, routine use in large adolescent and adult populations could reveal rare and potentially serious adverse events (AEs). To characterize reported AEs following Tdap vaccination and identify potential safety concerns warranting further evaluation, we analyzed data from Vaccine Adverse Event Reporting System (VAERS) and assessed the frequency and proportions of AEs and reporting rates (reports per 100,000 vaccine doses distributed). A total of 2090 reports (7% were serious; 55% listed Tdap alone) involving Tdap vaccines were submitted to VAERS May 2005 - June 2007. The crude reporting rate was 10.2 per 100,000 vaccine doses distributed. The median age of vaccinees was 22 years, and the female to male ratio was about 2 to 1. The majority of reports distributed. The majority of reports described common local and systemic signs and symptoms, such as injection site reactions, fever, and headache. Rarely reported AEs included myopericarditis, demyelinating diseases of the central nervous system, Guillain-Barre Syndrome, syncope, encephalopathy/encephalitis, seizure, Bell''s Palsy, anaphylaxis, and thrombocytopenia. The author''s conclusion stated that because adolescents and adults were not routinely vaccinated against pertussis in the past, this surveillance summary provides important - and reassuring - information about the use of Tdap in these age groups. Although subject to the limitations of passive surveillance, the findings of this VAERS review support the pre-licensure clinical trial data with regard to the safety of the licensed Tdap vaccines. Continued monitoring of clinically significant AEs that are temporally associated with Tdap vaccination and further assessment of such events using controlled observational studies may provide additional information about the safety of these vaccines.


VAERS ID: 498463 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Female  
Location: New Hampshire  
Vaccinated:2013-07-18
Onset:2013-07-18
   Days after vaccination:0
Submitted: 2013-08-05
   Days after onset:18
Entered: 2013-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B412AA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR 48739AB / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH G36322 / 1 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FB353A / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-07-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Hx maternal drug use; poor weight gain
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: ?SIDS/SUIDS. Death cert. not yet avail. For autopsy report, contact Medical Examiner or HCP.


VAERS ID: 498956 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-08-09
Entered: 2013-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308USA003702

Write-up: Information has been received from a lawyer concerning a male (age unspecified) who on an unspecified date received a dose of PNEUMOVAX23 (route, dose, site and lot number not reported). Subsequently the patient died. The exact cause and date of death was not reported. It was unknown whether the patient underwent an autopsy. The reporter stated that it is believed that the PNEUMOVAX23 caused the patients death. Additional information has been requested.


VAERS ID: 499197 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Female  
Location: Florida  
Vaccinated:2013-05-29
Onset:2013-07-12
   Days after vaccination:44
Submitted: 2013-08-13
   Days after onset:32
Entered: 2013-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Cardiac disorder, Condition aggravated, Coronary artery disease, Diabetes mellitus, Hypertensive heart disease, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-07-12
   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: JANUVIA; COREG; naproxen; aspirin; clonidine; famotidine; EXFORGE; BYSTOLIC; NOVOLOG; LIPITOR
Current Illness: Hypertension; Drug hypersensitivity; Diabetes mellitus; Coronary artery disease; Hypertensive heart disease; Asthma
Preexisting Conditions: Sulfa, Drug hypersensitivity; penicillin (unspecified), Drug hypersensitivity; ZESTRIL, Drug hypersensitivity
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308USA003302

Write-up: This spontaneous report was received from a registered nurse and a healthcare worker concerning an approximately 65 year old female patient with asthma, hypertensive cardiac disease, coronary artery disease, diabetes, Penicillin allergy, Sulfa allergy and ZESTRIL allergy. On 18-DEC-2012, the patient first received JANUVIA. On an unknown date in January 2013, the patient started therapy with JANUVIA, 100 milligrams (1 tablet, orally, once daily). Other suspect therapy included 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date unspecified) administered subcutaneously on 29-MAY-2013. Concomitant therapies included COREG, naproxen (reported as NAPROXYN), aspirin, clonidine, famotidine, amlodipine besylate, EXFORGE, BYSTOLIC, NOVOLOG, LIPITOR and nasal aerosol (unspecified). On 12-JUL-2013, the patient was discovered to be deceased. The cause of death was determined to be sudden death related to diabetes, coronary artery disease, and hypertensive cardiovascular disease. It was unknown if autopsy was performed. The patient was hospitalized on 04-JUL-2013 due to symptoms of her heart disease. Her discharge date from the hospital was unable to be determined. The relatedness for the event was unknown for JANUVIA and ZOSTAVAX. Additional information has been requested.


VAERS ID: 499752 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: Mississippi  
Vaccinated:2013-03-29
Onset:0000-00-00
Submitted: 2013-04-08
Entered: 2013-08-16
   Days after submission:130
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B399BA / 2 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. H015041 / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F26481 / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. H011432 / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-03-30
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 known
Preexisting Conditions: None known
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None at time of vaccination. Pt died 3-30-13 per family report. No known connection to vaccine administration.


VAERS ID: 500201 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Male  
Location: Nevada  
Vaccinated:2013-08-20
Onset:0000-00-00
Submitted: 2013-08-21
Entered: 2013-08-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C4363AA / 1 LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. H011741 / 2 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH742AA / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G32010 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. J002785 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-08-20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Acetaminophen
Current Illness: None
Preexisting Conditions: Heart murmur
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: He received vaccines 8-20-13 at 11:30 AM in the office and was notified by Coroner''s office he had expired 8-21-13 by fax.


VAERS ID: 500225 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-08-23
Entered: 2013-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Loss of consciousness, Seizure like phenomena
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308USA010574

Write-up: This spontaneous report as received from a consumer''s mother refers to a patient of unknown age. The reporter''s daughter experienced seizure-like reaction, the patient convulsed for "2-3 seconds" and then "passed out" for a "few seconds" after receiving first dose of GARDASIL. (Captured in case 1308USA009926). The patient''s mother called the office after her child''s reaction and stated that she has done some research (source unknown) and found out that seizure-like reaction was common after GARDASIL administration and she also found from her research that someone has died from GARDASIL reaction and was concerned. In this unconfirmed AE report was reported on an unknown date this patient was vaccinated with GARDASIL (dosing information and route are unknown). On an unknown date this patient experienced GARDASIL reaction. The outcome of GARDASIL reaction was reported as fatal. No reporter causality provided. No consent to contact physician. Additional information is not expected.


VAERS ID: 500297 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Florida  
Vaccinated:2010-12-01
Onset:2010-12-18
   Days after vaccination:17
Submitted: 2012-11-14
   Days after onset:697
Entered: 2013-08-23
   Days after submission:281
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0732Z / UNK RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-12-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Deceased
CDC Split Type:

Write-up: My son was administered the Hep B vaccination at one day old and died at 18 days old almost to the minute of original vaccination date and time. I was told by VAERS if your gonna have a deadly reaction it will happen w/n 18 days.


VAERS ID: 500517 (history)  
Form: Version 1.0  
Age: 0.16  
Sex: Female  
Location: Oregon  
Vaccinated:2013-08-14
Onset:2013-08-15
   Days after vaccination:1
Submitted: 2013-08-26
   Days after onset:11
Entered: 2013-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 99R9E / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G62434 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. J003814 / 1 MO / PO

Administered by: Unknown       Purchased by: Public
Symptoms: Autopsy, Cardiac arrest, Death, Gastrointestinal necrosis, Irritability, Resuscitation, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-08-15
   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: Known preterm infant, 33 4/7 weeks estimated gestational age at birth
Allergies:
Diagnostic Lab Data: Full autopsy/medical examiner report pending
CDC Split Type:

Write-up: Excessive fussiness, vomiting, came to urgent care asystolic, time of death called after resuscitative efforts failed, small bowel necrosis determined at autopsy.


VAERS ID: 500986 (history)  
Form: Version 1.0  
Age: 0.64  
Sex: Male  
Location: Tennessee  
Vaccinated:2012-12-20
Onset:2012-12-21
   Days after vaccination:1
Submitted: 2013-08-26
   Days after onset:247
Entered: 2013-08-30
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C4136AA / 3 RL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH432AA / 3 RL / UN
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR 61083 / 3 LL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 918245 / 3 LL / UN

Administered by: Private       Purchased by: Public
Symptoms: Death, Feeling hot
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-12-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Felt hot but no temp. taken. Died in sleep.


VAERS ID: 501081 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2013-08-22
Onset:2013-08-25
   Days after vaccination:3
Submitted: 2013-08-30
   Days after onset:5
Entered: 2013-08-30
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? Yes
Birth Defect? No
Died? Yes
   Date died: 2013-08-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308USA014250

Write-up: This spontaneous report as received from a health care worker refers to a female patient of unknown age. On 22-AUG-2013 the patient was vaccinated with a dose of GARDASIL (dose, route, lot number not provided). On 25-AUG-2013 the patient was found dead in her dorm room. The cause of dead had not been specified. Additional information has been requested.


VAERS ID: 501076 (history)  
Form: Version 1.0  
Age: 0.59  
Sex: Male  
Location: Tennessee  
Vaccinated:2011-12-12
Onset:2011-12-29
   Days after vaccination:17
Submitted: 2013-09-02
   Days after onset:612
Entered: 2013-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4000AA / 3 RL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0571AA / 3 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH F08531 / 3 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-12-29
   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: Death.


VAERS ID: 501276 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: North Carolina  
Vaccinated:2013-08-28
Onset:2013-09-01
   Days after vaccination:4
Submitted: 2013-09-03
   Days after onset:2
Entered: 2013-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS HF2K2 / 1 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. J006417 / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G43220 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. J003952 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-09-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vit D
Current Illness: None
Preexisting Conditions: 33 week preemie
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Found in early morning app 0630 layed down at 2200.


VAERS ID: 501468 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Female  
Location: Florida  
Vaccinated:2013-08-09
Onset:2013-08-25
   Days after vaccination:16
Submitted: 2013-09-04
   Days after onset:10
Entered: 2013-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. J001693 / UNK LA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-08-28
   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: No acute illness.
Preexisting Conditions: Diabetes, HTN, Cardiac stents x 2
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Respiratory arrest.


VAERS ID: 501650 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: West Virginia  
Vaccinated:2013-09-05
Onset:2013-09-05
   Days after vaccination:0
Submitted: 2013-09-06
   Days after onset:1
Entered: 2013-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4668AA / UNK GM / IM

Administered by: Private       Purchased by: Other
Symptoms: Antibody test, Blood gases, Blood grouping, Blood lactic acid, Blood magnesium, Cardiac pacemaker insertion, Full blood count, Metabolic function test, Resuscitation, Sudden cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-09-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: CBC; CMP; MG; ABG; Blood type; Antibody screen; Lactate serum; Therma cooling denaplaced
CDC Split Type:

Write-up: Sudden cardiac death. Received CPR for 2 hours. Transvenous pacemaker placement.


VAERS ID: 501663 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Michigan  
Vaccinated:2013-08-09
Onset:2013-08-22
   Days after vaccination:13
Submitted: 2013-08-30
   Days after onset:8
Entered: 2013-09-06
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H020848 / 1 UN / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4584BA / 2 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-08-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No known allergies.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201309264

Write-up: Initial report was received 26 August 2013 from a health care professional. A 17-year-old female patient with no known allergies had received a second dose intramuscular injection of MENACTRA, lot number U4584BA and a first dose intramuscular injection of GARDASIL (manufacturer Merck, lot number H020848) (sites of administration not reported) on 09 August 2013, and 13 days later on 22 August 2013, the patient died. There was no contact with the physician after MENACTRA had been given. The patient had previously received a first dose injection of MENACTRA on 04 September 2008. The reporter had been contacted by the county medical examiner who informed the reporter about the death and requested the patient''s medical history. The reporter contacted the CDC (Centers for Disease Control and Prevention) who told them to call and report the event to VAERS. No additional information was provided at the time of the report. Documents held by sender: None.


VAERS ID: 502563 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Female  
Location: Maryland  
Vaccinated:2010-10-18
Onset:2010-11-26
   Days after vaccination:39
Submitted: 2013-09-05
   Days after onset:1013
Entered: 2013-09-16
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-12-04
   Days after onset: 373
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Past away. 12-4-2011.


VAERS ID: 502882 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Female  
Location: West Virginia  
Vaccinated:2013-08-07
Onset:2013-08-16
   Days after vaccination:9
Submitted: 2013-09-17
   Days after onset:32
Entered: 2013-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. J006082 / 1 UN / IM

Administered by: Unknown       Purchased by: Public
Symptoms: Asthenia, Blood culture, Chest X-ray, Chills, Computerised tomogram, Confusional state, Culture, Culture stool, Culture urine, Endotracheal intubation, Lumbar puncture, Nuclear magnetic resonance imaging, Pyrexia
SMQs:, Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-08-31
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 13 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Metoprolol; Levoxyl; Lasix; clonidine; aspirin; Crestor
Current Illness: None
Preexisting Conditions: Hypertension; Hyperlipidemia; Mitral valve regurg; Kidney stenosis
Allergies:
Diagnostic Lab Data: Lumbar puncture; MRIs of multiple organs; Lung xray, multiple; CT scans, multiple organs, multiple times; Drain fluid from pleural sac; Cultures of blood, urine, phlegm, feces, fluid from pleural sac
CDC Split Type:

Write-up: Fever, chills, weakness. 8/18/13- fever, weakness, confusion. Transport to hospital. given Tylenol in ER. Inpatient 8/19/13 through 8/20/13. At this time, treatment details for these 2 days are not available. Call from hospital 10am, moving to "special care". 10:20, daughter arrives, intubated and unstable. family request transport to better hospital. Air transport to another hospital at 1:30 PM on 8/20/13.


VAERS ID: 503021 (history)  
Form: Version 1.0  
Age: 1.08  
Sex: Female  
Location: New Mexico  
Vaccinated:2013-07-10
Onset:2013-07-30
   Days after vaccination:20
Submitted: 2013-09-18
   Days after onset:50
Entered: 2013-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB692AA / 1 UN / UN
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. J000564 / 4 UN / UN
MMR: MEASLES + MUMPS + RUBELLA (VIRIVAC) / MERCK & CO. INC. H009578 / 1 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G45476 / 4 UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. H017132 / UNK UN / UN

Administered by: Unknown       Purchased by: Public
Symptoms: Adenovirus infection, Alpha 1 foetoprotein normal, Amino acid level, Ammonia decreased, Anaemia, Anti-NMDA antibody negative, Antibody test, Antibody test negative, Antinuclear antibody negative, Aspergillus test, Asthenia, B-lymphocyte count, B-lymphocyte count decreased, Bacterial infection, Biopsy skin abnormal, Blood creatine phosphokinase decreased, Blood culture negative, Blood fibrinogen increased, Blood fibrinogen normal, Blood homocysteine normal, Blood immunoglobulin A normal, Blood immunoglobulin E, Blood immunoglobulin G normal, Blood immunoglobulin M increased, Blood lactate dehydrogenase increased, Blood lactic acid decreased, Blood lactic acid normal, Blood pyruvic acid, Blood pyruvic acid increased, Blood triglycerides increased, Blood urea, Bordetella test negative, Bronchial secretion retention, CD4 lymphocytes decreased, CD4/CD8 ratio, CD8 lymphocytes decreased, CSF culture negative, CSF oligoclonal band absent, CSF test abnormal, CSF test normal, Carnitine decreased, Cell marker, Cerebral atrophy, Ceruloplasmin, Chlamydia test negative, Clostridium test, Clostridium test negative, Complement factor, Corynebacterium test, Culture negative, Culture urine negative, Culture wound negative, Culture wound positive, Cytomegalovirus test, Cytomegalovirus test negative, Diarrhoea, Encephalopathy, Endotracheal intubation, Enterovirus test negative, Enzyme level test, Epstein-Barr virus test negative, Free fatty acids, Fungal test, Fungal test negative, General physical health deterioration, Gram stain positive, HIV test negative, Herpes simplex serology negative, Herpes virus infection, Human herpes virus 6 serology negative, Human rhinovirus test positive, Immunoglobulin therapy, Influenza B virus test, Influenza virus test negative, Intensive care, Jaundice, Klebsiella infection, Klebsiella test positive, Legionella test, Lipids, Lumbar puncture abnormal, Lymphocyte stimulation test, Measles antibody negative, Mumps antibody test, Muscular weakness, Mycoplasma test, Natural killer cell count, Nervous system disorder, Neurological decompensation, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal, Organic acid analysis, Parasite stool test negative, Polymerase chain reaction, Pseudomonas infection, Rash papular, Rhinovirus infection, Rubella antibody test, Scab, Serum ferritin increased, Stool analysis normal, T-lymphocyte count decreased, Thyroxine decreased, Transfusion, Tuberculin test negative, Urine analysis normal, Varicella virus test positive, Viral test negative, Vitamin B12, Warm type haemolytic anaemia, White matter lesion
SMQs:, Rhabdomyolysis/myopathy (broad), Cholestasis and jaundice of hepatic origin (narrow), Haemolytic disorders (narrow), Acute pancreatitis (broad), Angioedema (broad), Dyslipidaemia (narrow), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Dementia (broad), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypothyroidism (broad), Hyperthyroidism (broad), Lipodystrophy (broad), Normal pregnancy conditions and outcomes (broad), Skin tumours of unspecified malignancy (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2013-10-03
   Days after onset: 65
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 48 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Surface Marker T&B panel CD3 (T3): 18% (low) CD3 ABS: 58 (low) Surface marker CD4 (T4): 12% (low) Surface Marker T4 ABs: 40 (low) CD8 (T8): 5% (low) T8 ABS: 16 (low) CD4/CD8 ratio: 2.54 (nl) CD19 (B4): 68% (high) CD19 Abs: 225 (low) CD16/CD56 NK cells 15% (high nl) CD16/CD56 Absolute count 49 (low) IgA: 32 IgG 505 IgM 309 (high) IgE: 49.9 (nl 0-49) CH50: 25 (reference values have not been established for patients <16 yo) AH50: not done LDH: 2586 Ferritin: 1310 Fibrinogen: 337 Triglycerides: 150 Ammonia: 15 Lactate: 1.39 CK: <20 Stool reducing substances negative ANA profile negative Carnitine profile: total carnitine low (30) otherwise normal Pyruvic acid, B: 0.17 (high; nl 0.08-0.16) Pyruvic acid (mg/dL): 1.5 (high, nl 0.7-1.4) Homocysteine: 4.8 (nl 4.7-12.6) Alpha-fetoprotein: 2.1 Ceruloplasmin: 19.4 CSF and serum paraneoplastic lab: negative CSF and serum NMDA receptor antibody: negative Oligoclonal bands (CSF): negative 3 Methylglutaconic acid: normal Organic acid (urine): "slight 3-hydroxyisovaleric without 3-methylcrotonylglycine; rule out biotin deficiency or combined carboxylase deficiency" Total lipids: 680 Pending labs: Very long chain fatty acid Complete MTDNA analysis Lysosomal enzyme panel Plasmalogen Urine organic acid Plasma amino acids Acylcarnitine profile Vitamin B12 metabolites UPGC (testing for congenital porphyria) Lymphocyte stimulation CD31 recent thymic emigrants cytochip 5 cell (CGL) Pyridoxal 5-phosphate Folate/5MTHF (CSF) BH4/Neopterin profile (CSF) Amino acid (CSF) Toll-like receptor assay B-cell line immortalized with EBV Comprehensive SCID panel, 18 genes Vaccine antibodies: Rubeola virus IgM and IgG: negative S. Pneumoniae IgG Ab: All 23 serotype IgG levels low Diphtheria IgG: 0.020 (minimum level of protective antibody is 0.01-0.1; majority should demonstrate $g0.1) Tetanus IgG: 0.11 (minimum level of protective antibody 0.01-0.15; majority should demonstrate $g0.15) H. Influenzae B Ab IgG: 0.56 (reference .0.15; optimum antibody level is $g1.0 post vaccine) Microbiology: BAL studies: Pneumocystis stain: negative Gram stain: gram positive organism identified HSV and CMV negative Pertussis negative Mycoplasma negative Fungal culture negative Chlamydia trachomatis negative Mycoplasma negative Legionella negative Pending: M. Hominis and ureaplasma VZV studies: 9/4 CSF VZV PCR: positive; 723 copies/ml 9/12 CSF VZV PCR: pending VZV PCR (wound swab 9/12): positive, 137,156 copies/ml VZV PCR (2nd skin wound 9/12): in-process VZV PCR from BAL fluid: pending VZV PCR from serum:negative VZV IgM (serum): negative VZV IgG (serum): positive VZV IgM and IgG from CSF and serum: negative Other micro: Viral PCR: adenovirus, rhino/entero Urine culture (9/4): $g100,000 colonies Klebsiella Urine culture (9/11): no growth CSF studies: culture NGTD, EBV, CMV, HSV negative Blood cultures (9/4): NGTD Blood fungus culture (9/5): negative Stool wet mount: negative C diff: negative Stool O&P: negative Stool viral EM: negative Wound culture (9/6): rare normal skin flora isolated HHV6 PCR (serum): negative HHV-6 PCR (CSF): not done CMV (urine): negative Measles PCR (throat) negative Mumps PCR (thorat) in-process Rubella PCR (throat) in-process Parvo PCR (CSF): not done Aspergillus antigen: pending Enterovirus PCR (CSF): negative Enterovirus PCR (throat, rectum): negative HIV-1 DNA PCR: negative PPD skin test: negative
CDC Split Type:

Write-up: Patient presented to urgent care on 8/1/13 with 2 day history of diarrhea, possible fever, decreased energy, and jaundice. She also developed a disseminated flesh colored papular rash which would rapidly scab over. She was found to be profoundly anemic to 5.4 and was admitted to hospital. She required nearly daily transfusions due to new onset warm Ab hemolytic anemia which only improved slightly with a burst of high dose steroids as well as two treatments with IVIG. She also developed three other rashes during this hospital course. She had a massive diagnostic workup at Hospital, and had a skin biopsy of a lesion that appeared to be consistent with a herpes virus infection but was negative for HSV1 or HSV2. She was treated with IV acyclovir at meningitic dosing for 14 days. She also developed worsening encephalopathy with decreased ability to clear her own secretions. It was determined that she was deteriorating clinically and required further diagnostic workup at a tertiary care center. She was transferred to another hospital on 9/4/13. She was admitted to the PICU due to worsening neurologic status and has required prolonged intubation due to concern for neuromuscular weakness. LP on admission and subsequent skin lesion sample was positive for VZV DNA by PCR, and MRI brain and neck has shown diffuse cerebral atrophy and hyperintensity of basal ganglia, medulla, and cervical spine. She was treated with a burst of high dose steroids and 3 back-to-back doses of IVIG with improvement in her transfusion requirements. She was also treated with acyclovir and subsequently foscarnet with improvement in symptoms. Of note, she has had multiple infections during her hospital courses including rhinovirus, adenovirus, Pseudomonas, Ambiotrophia, and Klebsiella.


VAERS ID: 503830 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-09-24
Entered: 2013-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anti-neutrophil cytoplasmic antibody positive vasculitis, Antineutrophil cytoplasmic antibody positive, Death, Granulomatosis with polyangiitis, Renal failure chronic
SMQs:, Rhabdomyolysis/myopathy (broad), Interstitial lung disease (broad), Eosinophilic pneumonia (broad), Vasculitis (narrow), Chronic kidney disease (narrow), Hypersensitivity (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0923565A

Write-up: This case was reported in a literature article and described the occurrence of anti-neutrophil cytoplasmic antibody positive vasculitis in a 70-year-old male subject who was vaccinated with Influenza vaccine (unspecified) (unknown route, site of injection and batch number). On on unspecified date, the subject received unspecified dose of influenza vaccine (unspecified) (unknown route, site of injection and batch number). Three weeks after vaccination with Influenza vaccine (unspecified), the subject experienced anti-neutrophil cytoplasmic antibody positive vasculitis (perinuclear/myeloperoxidase), granulomatosis with polyangiitis which led to a end-stage renal disease. The kidney was the only organ involved. The subject was treated with cyclophosphamide and prednisone. At an unspecified date, the subject died. In the article, the cause of death of two fatal cases was reported (refractory vasculitis and bilateral pneumonia). However, no precision was available to link this case to one these two reported causes of death. This case is linked to 7 cases coming from the same publication.


VAERS ID: 504269 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Male  
Location: Florida  
Vaccinated:2013-01-28
Onset:0000-00-00
Submitted: 2013-09-26
Entered: 2013-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. H012570 / 1 RA / IM
MEN: MENINGOCOCCAL (MENOMUNE) / SANOFI PASTEUR UH324AC / 1 LA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. H014561 / 2 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Incorrect dose administered, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-02-21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Splenectomy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient given Pedvax HIB, PPV23 and MPSV4 on 28 Jan 2013 in facility per Dr prescription from PCM for splenectomy. Copy of vaccines given to patient before leaving clinic. On 06 Feb 2013 Patient was admitted to hospital and given as vaccines again due to pharmacist/doctors saying he had not recieved the vaccines. On 02/21/2013 patient passed away at the hospital from kidney failure.


VAERS ID: 504528 (history)  
Form: Version 1.0  
Age: 0.39  
Sex: Male  
Location: New Hampshire  
Vaccinated:2013-08-08
Onset:2013-09-08
   Days after vaccination:31
Submitted: 2013-09-26
   Days after onset:18
Entered: 2013-09-30
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B182BA / 2 UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH806AB / 2 UN / UN
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR J1028 / 2 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G20393 / 2 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. H016259 / 2 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-09-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NH0926201316

Write-up: S.U.I.D/S.I.D.S? Death cert. not yet available. For autopsy result, contact medical examiner or child''s HCP.


VAERS ID: 504693 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2013-09-13
Onset:2013-09-19
   Days after vaccination:6
Submitted: 2013-09-26
   Days after onset:7
Entered: 2013-09-30
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U4759AA / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Contusion, Death, Haematocrit normal, Haemoglobin normal, Haemoptysis, International normalised ratio decreased, Platelet count decreased, Pyrexia, White blood cell count normal
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-09-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COUMADIN; ASA; CELEBREX; PLAQUENIL; SINGULAIR; HTZ; ATIVAN
Current Illness:
Preexisting Conditions: The patient had a history of lupus, idiopathic thrombocytopenic purpura (ITP), anxiety and asplenia and allergies to DEMEROL, phenobarb and nitrofurantoin. The patient received regular FLUZONE in the past without problems.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201309690

Write-up: Initial report was received from a healthcare professional on 20 September 2013. A 67-year-old female had received an intramuscular injection in the left deltoid of FLUZONE HIGH-DOSE, lot number U4759AA, on 13 September 2013. On 19 September 2013, the patient went to the emergency room (ER) and was seen by her oncologist. She presented with coughing up blood, bruising and a fever. The patient died four hours after arrival to the ER. There was no bleeding or bruising at the injection site after vaccination and a 1 inch, 25 gauge needle was used. Lab data included platelets 88K, hemoglobin 12.9, hematocrit 38, INR 8 and WBC 6.5. Concomitant medication included COUMADIN, acetylsalicylic acid (ASA), CELEBREX, PLAQUENIL, SINGULAIR, hydrochlorothiazide (HTZ) and ATIVAN. The patient had a history of lupus, idiopathic thrombocytopenic purpura (ITP), anxiety and asplenia and allergies to DEMEROL, phenobarb and nitrofurantoin. The patient received regular FLUZONE in the past without problems. Outcome was fatal. Documents held by sender: None.


VAERS ID: 504792 (history)  
Form: Version 1.0  
Age: 94.0  
Sex: Female  
Location: Indiana  
Vaccinated:2013-09-29
Onset:2013-09-30
   Days after vaccination:1
Submitted: 2013-09-30
   Days after onset:0
Entered: 2013-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U4716AA / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-09-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Potassium Chloride; Clopidogrel
Current Illness:
Preexisting Conditions: Heart disease
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received FLUZONE high dose 9/29/13. Patient died 9/30/13, family believes the death is due to advanced age, not the vaccination.


VAERS ID: 504856 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2013-08-23
Onset:0000-00-00
Submitted: 2013-09-30
Entered: 2013-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR - / UNK UN / UN
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MK-9041A
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309USA012570

Write-up: This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and gender. On 23-AUG-2013 the patient was vaccinated with ZOSTAVAX, injection (dose, route and lot number unknown). Other suspect therapies included diphtheria toxoid, pertussis acellular vaccine (manufacturer unknown) and FLUZONE. On an unknown date in 2013 the patient experienced death, following unspecified surgery. The pharmacist stated that a physician (unspecified) called the pharmacy on 24-AUG-2013 and was inquiring about the 3(three) vaccinations that the patient had received. The physician stated that the patient had exhibited a fever. A request was made for the patient''s Primary Care Physician''s, name and contact information. A request was made for a copy of the patient''s Death Certificate and/or Autopsy Report. The pharmacist stated that there were several physician''s involved with the patient''s case. The pharmacist refused to give any information and stated that the patient''s information was being handled by Clinical Risk Management for Pharmacy. Relatedness between vaccination with ZOSTAVAX and death was not reported. Upon internal review surgery was considered medically significant. Additional information has been requested.


VAERS ID: 505344 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-02
Entered: 2013-10-02
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: WAES1310USA000561

Write-up: Information has been received from a consumer via a website concerning a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (lot#, dose, and route not provided). On an unknown date, the patient died in her shower. The patient was so healthy prior to the vaccination. The post mortem result stated cause of death unknown. This is one of several reports received from the same source. Additional information has been requested.


VAERS ID: 505350 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-02
Entered: 2013-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 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: WAES1310USA000491

Write-up: Information has been received from a consumer via a website concerning a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (lot#, dose, and route not provided). On an unknown date, the patient died 40 hours after her third shot of GARDASIL. The patient had been so healthy prior to the vaccination. The post mortem result stated cause of death unknown. This is one of several reports received from the same source. Additional information has been requested.


VAERS ID: 505358 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-07-15
Entered: 2013-10-02
   Days after submission:79
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arrhythmia, Death
SMQs:, Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: B0906456A

Write-up: This case was reported in a literature article and described the occurrence of cardiac arrhythmia in a 13-year-old male subject who was vaccinated with DTPa (with small D + P), (manufacturer unspecified). On an unspecified date, the subject received an unspecified dose of DTPa (with small D + P) (administration site and route unknown, batch number not provided). 14 days after vaccination with DTPa, the subject died from cardiac arrhythmia. An autopsy was performed and showed cardiac arrhythmia. This is one of the 11 cases created from the same literature article. Summary of the literature article: Pre-licensure clinical trials for two licensed Tdap vaccines did not reveal any major safety concerns. However, routine use in large adolescent and adult populations could reveal rare and potentially serious adverse events (AEs). To characterize reported AEs following Tdap vaccination and identify potential safety concerns warranting further evaluation, we analyzed data from the Vaccine Adverse Event Reporting System (VAERS) and assessed the frequency and proportions of AEs and reporting rates (reports per 100,000 vaccine doses distributed). A total of 2090 reports (7% were serious; 55% listed Tdap alone) involving Tdap vaccines were submitted to VAERS May 2005 - June 2007. The crude reporting rate was 10.2 per 100,000 vaccine doses distributed. The median age of vaccinees was 22 years, and the female to male ratio was about 2 to 1. The majority of reports described common local and systemic signs and symptoms, such as injection site reactions, fever, and headache. Rarely reported AEs included myopericarditis, demyelinating diseases of the central nervous system, Guillain-Barre Syndrome, syncope, encephalopathy/encephalitis, seizure, Bell''s palsy, anaphylaxis, and thrombocytopenia. The author''s conclusion stated that because adolescents and adults were not routinely vaccinated against pertussis in the past, this surveillance summary provides important - and reassuring - information about the use of Tdap in these age groups. Although subject to the limitations of passive surveillance, the findings of this VAERS review support the pre-licensure clinical trial data with regard to the safety of the licensed Tdap vaccines. Continued monitoring of clinically significant AEs that are temporally associated with Tdap vaccination and further assessment of such events using controlled observational studies may provide additional information about the safety of these vaccines.


VAERS ID: 505364 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-02
Entered: 2013-10-02
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: WAES1310USA000562

Write-up: Information has been received from a consumer via a website concerning a female patient of unknown age. On an unknown date, the patient was vaccinated with GARDASIL (lot#, dose, and route not provided). On unknown date, the patient died in her bath. The patient had been so healthy prior to the vaccination. The post mortem result stated a cause of death unknown. Additional information has been requested.


VAERS ID: 506338 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Ohio  
Vaccinated:2013-09-16
Onset:2013-09-16
   Days after vaccination:0
Submitted: 2013-10-08
   Days after onset:22
Entered: 2013-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C4452AA / UNK LL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVC253BA / UNK RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH807AA / UNK LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR J1281-1 / UNK LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G43220 / UNK RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. H016262 / UNK MO / PO

Administered by: Public       Purchased by: Other
Symptoms: Autopsy, Biopsy soft tissue, Death, Diarrhoea, Irritability, Pulse absent, Pyrexia, Respiratory arrest, Toxicologic test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-09-18
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Following her vaccines I gave her one dose of acetaminophen (Tylenol).
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: According the autopsy, she did not suffocate nor drown. Her heart appears to be good. At her doctor''s visits, Dr. checked to make sure her heart and lungs sounded good as well. He said they sounded great. Further results from the toxicology and tissue biopsy will be ready in about 4 more weeks.
CDC Split Type:

Write-up: She started to have a fever of 100.4 about 3:00 PM on 09/16/2013. I gave her Tylenol to lower the temperature. She continued to have a fever off and on for the night and following day. About 6:30 AM on 09/17/2013, she had diarrhea that leaked out of her diaper down her left leg onto her foot. On the morning of 09/18/2013, she was cranky and fussy. I was unable to calm her. She even refused her pacifier that she loved. About 11:00 AM, she was found on her back without a pulse and not breathing. She was pronounced dead at the hospital later that day.


VAERS ID: 507228 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Michigan  
Vaccinated:2013-10-04
Onset:2013-10-09
   Days after vaccination:5
Submitted: 2013-10-11
   Days after onset:2
Entered: 2013-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR U4779AA / 5 LL / IM

Administered by: Private       Purchased by: Private
Symptoms: Bradycardia, Cardiac arrest, Chromaturia, Cough, Nasopharyngitis
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-10-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Aldactone; LASIX; ASA; Ranitidine; Iron supplement; Albuterol; PULMICORT
Current Illness: None
Preexisting Conditions: Tricuspid atresia, s/p PA banding with PDA ligation (Nov 4, 2010), s/p hemi-Fontan (April 18, 2011), s/p hemi-Fontan takedown, with right modified Blalock-Taussig shunt (April 21, 2011), elevated mean MPA and LPA pressures, catheterization on (April 4, 2012); Bicuspid aortic valve with mod aortic stenosis (last ECHO 09/03/13); Ventricular septal defect; Atrial septal defect; Acute diastolic heart failure, pulmonary edema needing diuretics; Hypoplastic left heart; DVT with embolic injury to distal extremities (fingers bilaterally) - s/p LOVENOX; Probable bilateral femoral venous occlusion; CVA, left parieto-occipital infarct (December 2010); Right sided seizures - resolved, phenobarbital discontinued in July 2012 by pediatric neurologist - no seizure activity since; Necrotizing enterocolitis, ileal perforation, s/p small bowel resection and colostomy (December 10, 2010), s/p takedown and reanastomosis (March 23, 2011); Pneumoperitoneum (April 29, 2011); C. diff colitis causing prerenal failure, admitted August 1-11, 2011 - dehydration and diarrhea; GERD; Occlusion - left lower pulmonary vein by catheterization (April 4, 2012); Likely obstruction left upper pulmonary vein by catheterization (April 4, 2012); Chronic cyanosis - goal O2 sats $g60% on room air; Iron deficiency anemia; Febrile UTI - no VUR; RSV bronchiolitis (January 10, 2010); Acute bronchiolitis due to human metapneumovirus (admitted December 4-11, 2011); Symmetric IUGR; Neonatal narcotic withdrawal - s/p methadone; Refractive amblyopia bilateral; Hyperopia with astigmatism; Developmental delay - gross and fine motor, along with speech
Allergies:
Diagnostic Lab Data: 09:14 U/S probe cardiac full - no wall motion pronounced 09:16
CDC Split Type:

Write-up: 10/8/13 - cold/cough symptoms. Urine - orangish color. Albuterol neb. 10/9/13 - brachycardia -$g full arrest.


VAERS ID: 507230 (history)  
Form: Version 1.0  
Age: 0.21  
Sex: Male  
Location: California  
Vaccinated:2013-10-07
Onset:2013-10-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2013-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4483AA / 1 RL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. J005078 / UNK LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G94059 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. J001252 / 1 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Apnoea neonatal, Cardiac arrest, Convulsion, Epistaxis, Hypotonia, Intensive care, Laboratory test abnormal, Mouth haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2013-10-14
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Nystatin
Current Illness: Thrush; None other
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: + Seizure activity; No other informative labs
CDC Split Type:

Write-up: Sitting propped up on couch, father napping next to him. After a few minutes found slumped forward, lifeless, with blood around nose and mouth. Pt asystolic and apneic by paramedics. Transported to PICU. Pt with minimal cortical activity.


VAERS ID: 507356 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-12
Entered: 2013-10-16
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TTOX: TETANUS TOXOID (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: UNK
Current Illness: UNK
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2013SA097219

Write-up: Initial report was received on 30 September 2013 from another manufacturer who received the report from a consumer. An unidentified male patient with no reported past medical history had received tetanus adsorbed toxoid (manufacturer, lot number, route, site and date of administration not reported and an unspecified amount of time later died. According to the report, the patient''s sister reported that patient died after "12 doses of tetanus vaccine". No further information was available at the time of the report. The patient''s outcome was fatal. Addendum 09 October 2013: Upon internal review of this case, the vaccine was amended from tetanus adsorbed toxoid to tetanus toxoid. Documents held by sender: none.


VAERS ID: 507897 (history)  
Form: Version 1.0  
Age: 1.66  
Sex: Female  
Location: Colorado  
Vaccinated:2013-10-16
Onset:2013-10-17
   Days after vaccination:1
Submitted: 2013-10-18
   Days after onset:1
Entered: 2013-10-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 93HY5 / UNK LL / IM
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR U4779AA / UNK LL / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 5B23A / UNK RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G05787 / UNK RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-10-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Received call from coroner 10/17/13 that the patient had "died in the morning".


VAERS ID: 509086 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Female  
Location: Illinois  
Vaccinated:2013-09-24
Onset:0000-00-00
Submitted: 2013-10-22
Entered: 2013-10-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Back pain, Death, Decreased appetite, Dehydration, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-10-02
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: Bone marrow disorder, did not make enough red blood cells
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2013SA103597

Write-up: Initial report was received from a healthcare professional on 07 October 2013. An 86-year-old female patient had received an injection of FLUZONE HIGH-DOSE (lot number, route and site of administration not reported) on 24 September 2013 and an unspecified amount of time following vaccination experienced decreased appetite, stomach and back pain, was dehydrated and had increased white blood cells. The patient passed away on 02 October 2013, 8 days post-vaccination. The patient had a history of a "bone marrow issue in that did not make enough red blood cells". No additional information was provided. Outcome was fatal. Documents held by sender: None.


VAERS ID: 509639 (history)  
Form: Version 1.0  
Age: 0.12  
Sex: Female  
Location: Alabama  
Vaccinated:2013-09-27
Onset:2013-09-28
   Days after vaccination:1
Submitted: 2013-10-24
   Days after onset:26
Entered: 2013-10-25
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 99R9E / 1 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR J007097 / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH G57196 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. J003951 / 1 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Incorrect dose administered, Laboratory test normal, Phenylketonuria
SMQs:, Congenital, familial and genetic disorders (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-09-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: PKU WNL
CDC Split Type:

Write-up: None stated.


VAERS ID: 509650 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Female  
Location: Puerto Rico  
Vaccinated:2013-10-24
Onset:2013-10-25
   Days after vaccination:1
Submitted: 2013-10-25
   Days after onset:0
Entered: 2013-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1308501 / UNK RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-10-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNKNOWN
Current Illness: NONE
Preexisting Conditions: CARDIOVASCULAR DISEASE - NOT SPECIFIED
Allergies:
Diagnostic Lab Data: NONE AVAILABLE
CDC Split Type: PR0113

Write-up: PATIENT RECEIVED THE INFLUENZA VACCINE IN 10/24/2013 AT 7:20 PM DURING A MASS VACCINATION. THE FAMILY REFERS THE PATIENT WENT TO SLEEP AND DURING THE MORNING OF 10/25/2013 THE PATIENT''S DAUGHTER FOUND HER DEAD IN HER BED. THE FAMILY INDICATES THAT THEY KNEW THE PATIENT HEART CONDITION HISTORY AND BELIEVE HER DEATH WAS A RESULT OF NATURAL CASUES, STILL A VAERS REPORT WAS CREATED DUE TO THE SHORT TIME BETWEEN THE VACCINATION AND HER TIME OF DEATH.


VAERS ID: 509890 (history)  
Form: Version 1.0  
Age: 46.0  
Sex: Male  
Location: Illinois  
Vaccinated:2013-10-23
Onset:2013-10-23
   Days after vaccination:0
Submitted: 2013-10-28
   Days after onset:5
Entered: 2013-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 13394P / 7+ LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Chest pain, Malaise, Pharyngitis streptococcal
SMQs:, Agranulocytosis (broad), Oropharyngeal infections (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-10-27
   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: Amoxicillin 500mg; Nyquil Cold and Flu (per police report)
Current Illness: None known
Preexisting Conditions: None known
Allergies:
Diagnostic Lab Data: According to police report, strep throat.
CDC Split Type:

Write-up: According to police report, patient c/o "not feeling well since he got his flu shot". Patient went to hospital w/ c/o chest pain on 10/26/13 where he was dx with strep throat, prescribed medication and sent home.


VAERS ID: 509901 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Male  
Location: Unknown  
Vaccinated:2013-10-14
Onset:2013-10-21
   Days after vaccination:7
Submitted: 2013-10-28
   Days after onset:7
Entered: 2013-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. J007857 / UNK UN / SC

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2013-10-21
   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: No other medications
Current Illness: Chronic lymphocytic leukaemia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310USA011169

Write-up: This spontaneous report as received from a consumer refers to a his male friend of unknown age with CLL (Chronic lymphocytic leukaemia). On an unknown date, the patient was vaccinated with ZOSTAVAX (Lot, dose and route not provided). On an unknown date, the patient experienced died. On an unspecified date, the patient sought medical attention by doctor''s visit. The patient cause of death was not provided. The reporter considered this report as life threatening. Additional information has been requested.


VAERS ID: 510130 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Male  
Location: California  
Vaccinated:2013-08-19
Onset:2013-08-20
   Days after vaccination:1
Submitted: 2013-10-26
   Days after onset:67
Entered: 2013-10-29
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H020062 / 2 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Autopsy, Cardiac arrest, Death, Myocarditis, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-08-20
   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: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Autopsy.
CDC Split Type:

Write-up: Victim was found unresponsive/cardiac arrest in bed at home in the morning of 8/20/13. Autopsy showed cause of death was myocarditis.


VAERS ID: 510158 (history)  
Form: Version 1.0  
Age: 0.35  
Sex: Female  
Location: New Hampshire  
Vaccinated:2013-09-20
Onset:2013-10-07
   Days after vaccination:17
Submitted: 2013-10-29
   Days after onset:22
Entered: 2013-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4486AA / UNK UN / UN
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBBC263AA / 3 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH G47424 / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FB358A / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-10-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NH1029201318

Write-up: SUID / ? SIDS.


VAERS ID: 510192 (history)  
Form: Version 1.0  
Age: 45.0  
Sex: Male  
Location: Alabama  
Vaccinated:2013-09-04
Onset:2013-09-13
   Days after vaccination:9
Submitted: 2013-10-29
   Days after onset:46
Entered: 2013-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 55D72 / 1 UN / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Asthenia, Blood test normal, Computerised tomogram normal, Death, Dysstasia, Gait disturbance, Grip strength decreased, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Intensive care, Lumbar puncture abnormal, Nerve conduction studies abnormal, Paraesthesia, Pulseless electrical activity, Unresponsive to stimuli
SMQs:, Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Demyelination (narrow), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2013-09-27
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No medications
Current Illness: Left elbow pain
Preexisting Conditions: Chronic bronchitis, chronic left shoulder pain, obesity, obstructive sleep apnea
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient presents to outside ED for evaultion of new onset weakness with numbness/tingling in hands with progression to feet. He was having difficulty walking. CT and blood work was negative. Sent home with Dilaudid. On 9/16, he presents to his primary care docto. He is now unable to stand or hold objects in his hands. Denies fever, chills sweats or vision changes. He is admitted to hospital for neurologic work up. On 9/19, he is transferred to the MICU. Neurology consulted. based on findings from lumbar puncture and nerve conduction studies, diagnosis most consistent with GBS related to flu vaccine (FLUARIX QUADRIVALENT). Therapy with IVIG started on 9/19. On 9/27, patient became unresponsive with PEA arrest and expired.


VAERS ID: 510310 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-29
Entered: 2013-10-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 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: 2013307600

Write-up: This is a spontaneous report from a contactable consumer. A patient of unspecified age, ethnicity, and gender received PREVNAR, via an unspecified route of administration on an unspecified date at a single dose for an unspecified indication. The patient''s medical history and concomitant medications were not reported. On an unknown, the patient passed away from an unknown cause. Therapeutic measures taken in response to the event were unknown.The clinical outcome was fatal and it was unknown if an autopsy was performed.


VAERS ID: 510449 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Male  
Location: Utah  
Vaccinated:2013-10-15
Onset:2013-10-17
   Days after vaccination:2
Submitted: 2013-10-30
   Days after onset:13
Entered: 2013-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH888AB / UNK LA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Altered state of consciousness, Bacterial test negative, CSF white blood cell count positive, Drug screen, Encephalitis, Full blood count, Lumbar puncture, Malaise, Meningitis, Pyrexia, Urine analysis, White blood cell count normal
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug abuse and dependence (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2013-11-19
   Days after onset: 33
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: None known
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: LP, drug screen, urinalysis, CBC. CBC showed WBC 6.6. CSF showed WBC but no bacteria. Otherwise lab results not reported to me.
CDC Split Type:

Write-up: Malaise, fever at onset. Sought help in ER 10/20/2013. No dx given. 10/23/2013, altered consciousness, probable meningitis or encephalitis.


VAERS ID: 511031 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Indiana  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-11-01
Entered: 2013-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 2 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? 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: WAES1310USA015011

Write-up: This spontaneous report has been received from a pharmacist concerning to a patient of unknown age and gender. Current conditions, medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23, (dose, lot# and route not reported). On an unknown date (the following day)by accident the patient received a second dose of PNEUMOVAX23,(dose, lot# and route not reported). On an unknown date, the patient was hospitalized prior to patient''s demise. On an unknown date, the patient died. At the time of the report, the outcome was fatal and unknown for other events. Additional information has been requested.


VAERS ID: 511264 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-11-05
Entered: 2013-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Incorrect dose administered
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? 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: WAES1310USA015370

Write-up: This spontaneous report as received from a pharmacist refers to an unspecified patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (lot#, expiration date, dose, frequency, route and indication not reported). The following day, on an unspecified date, the same patient received a second dose of PNEUMOVAX23 (lot#, expiration date, dose and route not reported) by accident. The pharmacist stated that the patient was hospitalized, in an unspecified hospital, on unspecified dates, prior to the patient''s demise. The patient, on an unspecified date, died. Additional information has been requested.


VAERS ID: 511528 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-11-06
Entered: 2013-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Acute hepatic failure, Death
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1311USA000822

Write-up: This spontaneous report as received from a consumer via a twitter refers to his/her daughter of unknown age. On an unknown date the patient was vaccinated with GARDASIL, reported as "Merck HPV vaccine" (dose, frequency, route, lot# and expiration date unknown). On an unknown date the perfectly healthy patient died 2 weeks after vaccine acute liver failure. The reporter considered the vaccine murdered his/her daughter. Upon internal review, vaccine acute liver failure was considered to be medically significant. Additional information has been requested.


VAERS ID: 512092 (history)  
Form: Version 1.0  
Age: 66.0  
Sex: Male  
Location: Maine  
Vaccinated:2013-11-06
Onset:2013-11-06
   Days after vaccination:0
Submitted: 2013-11-08
   Days after onset:2
Entered: 2013-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS A4K92 / UNK LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Trazodone; Aspirin; Atorvastatin; Atenolol
Current Illness: No
Preexisting Conditions: HTN; Diabetes; Hyperlipidemia; Aortic Valve Disorder; Allergy to Lisinopril
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death.


VAERS ID: 512570 (history)  
Form: Version 1.0  
Age: 0.04  
Sex: Male  
Location: New Jersey  
Vaccinated:2013-11-04
Onset:2013-11-05
   Days after vaccination:1
Submitted: 2013-11-12
   Days after onset:7
Entered: 2013-11-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. J006511 / 1 LL / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-11-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: The vaccine was given on Nov 4, 2013. My son died that night in his sleep. He was 15 days old.


VAERS ID: 513224 (history)  
Form: Version 1.0  
Age: 1.13  
Sex: Male  
Location: Utah  
Vaccinated:2013-10-18
Onset:2013-10-18
   Days after vaccination:0
Submitted: 2013-11-14
   Days after onset:27
Entered: 2013-11-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR U4779AA / UNK RL / IM

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Culture, Cyanosis, Death, Resuscitation, Toxicologic test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-10-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: No lab tests
CDC Split Type: 2013SA108488

Write-up: Initial report was received on 23 October 2013 with additional information received on 03 November from a health care professional. A 13 month-old male patient who had no illness at the time of vaccination and no reported past medical history had received on 18 October 2013 at 1045 AM an intramuscular right thigh injection of FLUZONE QIV, lot number U4779AA and an unspecified amount of time later was found with no chest movement and blue. The patient was put to bed at 9 PM and at 1145 PM or 1245 AM the mother checked on the child who was found with no chest movement and the child was blue. Cardiopulmonary resuscitation (CPR) was performed with no response. An "autopsy done: gross examination unrevealing; no obvious cause of death identified; results of cultures, toxicology pending (will take up to ~6 weeks for results to come back)." No further information was available at the time of the report. The patient''s outcome was fatal. Documents held by sender: none.


VAERS ID: 513372 (history)  
Form: Version 1.0  
Age: 63.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:1999-11-20
Onset:1999-11-25
   Days after vaccination:5
Submitted: 2013-11-16
   Days after onset:5105
Entered: 2013-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 AR / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Blood test, Computerised tomogram, Diarrhoea, Influenza, Laboratory test abnormal, Lumbar puncture, Nausea, Nuclear magnetic resonance imaging
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-02-17
   Days after onset: 4102
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 60 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Type II pill
Current Illness: No
Preexisting Conditions: Type II diabetes
Allergies:
Diagnostic Lab Data: MRI, Catscan, blood work, spinal tap, test for poss. syndromes like Guillain Barre & others I can not remember
CDC Split Type:

Write-up: Flu symptoms- nausea, diarrhea.


VAERS ID: 513554 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2012-08-31
Onset:2012-12-20
   Days after vaccination:111
Submitted: 2013-11-15
   Days after onset:330
Entered: 2013-11-18
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. AJ2024 / 5 NS / IN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H010649 / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Cardiopulmonary bypass, Death, Dyspnoea, Influenza, Oropharyngeal pain, Pulmonary oedema, Pyrexia, Transfusion, Wheezing
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2013-01-08
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 15 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: UNK
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: 2013SA114788

Write-up: Initial report was received on 07 November 2013 from a nonhealth care provider from an unverified internet source. A 14 year-old female patient (date of birth not reported) had received on an unspecified date in August 2012 a Influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) and five months later on 08 January 2013 "died from complications of infection with Influenza Type A". The patient was evaluated at and urgent care with a bad sore throat, treated with Prednisone and was sent home. The sore throat evolved into a serious fever that included shortness of breath and wheezing. The patient''s lungs filled with fluid and was hospitalized. The patient had a heart and lung bypass with an "ACMO" machine and blood transfusions. Diagnostic and laboratory testing were not reported. The patient''s outcome was fatal. Documents held by sender: none.


VAERS ID: 513728 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-11-19
Entered: 2013-11-19
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: WAES1311USA007759

Write-up: This spontaneous report as received from a consumer (patients mother) via an unspecified person from an Immunization Coalition and company representative refers to a female patient of unknown age. No information regarding the patients medical history was provided. On an unknown date the patient was vaccinated with GARDASIL injection. Dose and route of administration were not provided. No concomitant medication was reported. In the email from the Immunization Coalition was stated that an unspecified mother claimed that her daughter died in 2008 as a result of GARDASIL. Additional information has been requested.


VAERS ID: 513769 (history)  
Form: Version 1.0  
Age: 7.0  
Sex: Female  
Location: Vermont  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-11-18
Entered: 2013-11-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Headache, Laboratory test, Pyrexia, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: Unknown
Current Illness: UNK
Preexisting Conditions: No pre-existing health conditions and was a very healthy child
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2013SA118114

Write-up: Initial report was received on 07 November 2013 from a non-health care provider from an unverified internet source. The reporter for this case is the same as case number 2013SA114788. A 7 year-old female patient (date of birth not reported) had received an Influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) at her annual checkup. The patient was reported to have no pre-existing health conditions and was a very healthy child. The patient developed a severe headache and fever one day after vaccination. Three days later, the patient stopped breathing and died without warning in her mother''s arm. Diagnostic and laboratory testing were not reported. No further details were available at the time of the report. The patient''s outcome was fatal. Documents held by sender: None.


VAERS ID: 514095 (history)  
Form: Version 1.0  
Age: 42.0  
Sex: Male  
Location: Texas  
Vaccinated:2013-11-12
Onset:2013-11-20
   Days after vaccination:8
Submitted: 2013-11-20
   Days after onset:0
Entered: 2013-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
JEV1: JAPANESE ENCEPHALITIS (IXIARO) / INTERCELL AG JEV11H91E / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-11-20
   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: No active medications
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Pending Forensic Examination
CDC Split Type:

Write-up: Sudden death, cardiac arrest of unknown cause at this time.


VAERS ID: 514396 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Male  
Location: North Dakota  
Vaccinated:2013-10-21
Onset:2013-10-21
   Days after vaccination:0
Submitted: 2013-11-20
   Days after onset:30
Entered: 2013-11-22
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH898AB / UNK RA / IM

Administered by: Public       Purchased by: Private
Symptoms: Asthenia, Death, Myocardial infarction, Pyrexia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-10-23
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Diabetes; Heart disease
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Client presented at PH office requesting Flu vaccine - came with spouse. Reviewed screening questions - no contraindications. Received phone call at home from spouse at 630. Client had shaking episode and weakness/fever. Went to hospital admitted - had heart attack next day and deceased. Spouse received flu vaccine at same time as client with no adverse events. Same vaccine from same multi-dose vial. Client denied any allergies or problems with any previous vaccines. No egg allergies. He was admitted to the hospital. No confirmation received from attending physician that flu vaccine caused heart attack.


VAERS ID: 514607 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Male  
Location: Louisiana  
Vaccinated:2013-11-15
Onset:2013-11-17
   Days after vaccination:2
Submitted: 2013-11-25
   Days after onset:8
Entered: 2013-11-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH906AB / 7+ RA / IM
TD: TD ADSORBED (NO BRAND NAME) / SANOFI PASTEUR U4502AA / 2 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-11-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown, Denied radiation, steroid, or chemo drugs per immunization questionnaire
Current Illness: Recent trauma, Pt reported falling off a ladder sustaining injuries in recent months
Preexisting Conditions: NKDA
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: My co-worker told me Sunday evening that patient died Sunday morning. I do not know details only that he passed away.


VAERS ID: 514612 (history)  
Form: Version 1.0  
Age: 50.0  
Sex: Female  
Location: Unknown  
Vaccinated:2013-10-01
Onset:0000-00-00
Submitted: 2013-11-25
Entered: 2013-11-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Brain death, Coagulopathy, Death, Dyspnoea, Feeling abnormal, Fluid retention, Gastrointestinal infection, Haemorrhage, Life support, Loss of consciousness, Platelet count decreased, Platelet transfusion, Renal failure, Septic shock, Swelling, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), 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 (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-11-02
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: Gabapentin; Herbal medication
Current Illness: Seizure
Preexisting Conditions: No relevant medical history
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A1050266A

Write-up: This case was reported by a consumer (patient''s mother) and described the occurrence of septic shock in a 48-year-old female patient who was vaccinated with Influenza vaccine (unspecified, manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included seizure. Concurrent medications included Gabapentin and Herbal medication. Co-suspect medication included LAMICTAL. In early 2012, the patient started Lamotrigine (oral) at 100 mg twice per day. In 2012, the patient initially experienced some numbness and tingling in her fingers (numbness in finger and tingling in finger) that made her fingers feel funny. She then was doing okay on Lamotrigine until she started having some light seizures over the last 6 months [2013]. As a result, the physician had just increased her dosase from 2 pills a day to 3 a day but the mother of the patient was not sure if she had actually started the increased dosage. In October 2013 the patient received a dose of Influenza vaccine unspecified (unknown). On the evening of 30 October 2013 the patient collapsed and lost consciousness. The patient never regained consciousness. She was taken to the hospital right away. The patient was hospitalised and it was discovered that the patient was hemorrhaging. She did not have any platelets in her blood (low platelet value) and when she was given platelets, her blood just was not clotting. She had a slight infection in her bowel, which cleared up within one day with antibiotics. The patient was also retaining fluid and was all swelled up and puffy. The patient was put on life support because she was not breathing properly. The patient''s kidneys failed on 01 November 2013 and on the 02 November 2013 her brain failed. She was therefore taken off life support on 02 November 2013 and died the same day. The death certificate listed septic shock as the cause of death. The patient''s mother reported that the doctors did not know what caused the septic shock but did not think it was medication-related. The patient had received the Influenza vaccine unspecified at work and within 2-3 weeks of the events leading to her death. According to the mother, the Influenza vaccine unspecified "may have triggered all of it." The patient had mentioned after receiving the vaccine that she "felt terrible/awfully bad afterwards" (onset less than 2-3 weeks after vaccination). At the time of reporting, the events were fatal. The patient died on 2 November 2013 from septic shock. It is unknown whether an autopsy was performed.


VAERS ID: 514629 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2012-03-01
Onset:2012-03-06
   Days after vaccination:5
Submitted: 2013-11-25
   Days after onset:629
Entered: 2013-11-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS 637BA / UNK LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Asthenia, Diplegia, Guillain-Barre syndrome, Immunoglobulin therapy, Mechanical ventilation, Respiratory disorder
SMQs:, Peripheral neuropathy (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (narrow), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Respiratory failure (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-03-14
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Aricept, Klonopin, Namenda, Mobic, and Tenormin.
Current Illness: Administered at discharge. Patient has been admitted to hospital with nausea, vomiting, diarrhea. Diagnosed with severe gastroenteritis and diverticulosis.
Preexisting Conditions: Hypertension, dementia, arthritis, hypothyroidism. Allergies: penicillin, erythromycin, codeine, hydrochlorothiazide.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient became very weak on 3/06/12 at home. Presented to ED with paralysis of lower extremities on 3/07. Neurology diagnosis: Guillain-Barre Syndrome. Treated with IVIG. Patient quickly developed respiratory issues and required ventilatory support.


VAERS ID: 514648 (history)  
Form: Version 1.0  
Age: 35.0  
Sex: Male  
Location: New York  
Vaccinated:2013-10-04
Onset:2013-11-03
   Days after vaccination:30
Submitted: 2013-11-25
   Days after onset:22
Entered: 2013-11-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AGRIFLU) / NOVARTIS VACCINES AND DIAGNOSTICS 1309001 / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Biopsy, Blindness
SMQs:, Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-11-05
   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: Novartis - lot 1309001 -exp 4/20/14 only one dose given. not sure about the manufacture or which type was given. His work place administered the shot.
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: There has been an autopsy and biopsy performed. Waiting on results.
CDC Split Type:

Write-up: Loss of vision. Admitted to Medical Center @ 7:00 AM.


VAERS ID: 514744 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Male  
Location: Florida  
Vaccinated:2013-09-17
Onset:2013-09-18
   Days after vaccination:1
Submitted: 2013-11-26
   Days after onset:69
Entered: 2013-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U4717AA / UNK LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-11-22
   Days after onset: 65
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Clopidogrel, furosemide, micalcin, tramadol, metoprolol, levothyroxine, lovastatin, terazosin
Current Illness:
Preexisting Conditions: Pulmonary Fibrosis
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever, Chills, Sweating.


VAERS ID: 514814 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-11-26
Entered: 2013-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: WAES1311USA011110

Write-up: This spontaneous report as from an other via social media who obtained the information from a campaign against the HPV vaccine and released a video, who reported that a 20 year old female patient prior to receiving GARDASIL was healthy, vibrant and fun-loving. It was reported that the patient''s physician gave her all the right reasons to receive GARDASOL. On an unknown date, was vaccinated with a dose of GARDASIL (dose and route not reported). Prior to receiving GARDASIL there was no mention of GARDASIL side effects. On an unspecified date, the patient began fainting and days later was found dead in bed. It was reported that it was no coincidence that the patient died after receiving GARDASIL. This is one of several reports received from the same source. No further information is available.


VAERS ID: 514858 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Female  
Location: Washington  
Vaccinated:2013-11-23
Onset:0000-00-00
Submitted: 2013-11-26
Entered: 2013-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U4787AA / UNK RA / IM
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. J006830 / UNK LA / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-11-25
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Meloxicam; Omeprazole; Ferrous sulfate
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient''s husband indicated she had reaction from vaccine and passed away. Do not have specific details.


VAERS ID: 514980 (history)  
Form: Version 1.0  
Age: 1.26  
Sex: Female  
Location: Ohio  
Vaccinated:2013-11-26
Onset:2013-11-26
   Days after vaccination:0
Submitted: 2013-11-27
   Days after onset:1
Entered: 2013-11-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B169BA / 4 LL / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH907AC / 2 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. J007097 / 4 LL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J001177 / 1 RL / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-11-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Autopsy pending
CDC Split Type:

Write-up: Cardiac arrest < 12 hours following administration. Prelim autopsy with unknown cause of death.


VAERS ID: 515346 (history)  
Form: Version 1.0  
Age: 0.9  
Sex: Male  
Location: Texas  
Vaccinated:2013-11-26
Onset:2013-11-28
   Days after vaccination:2
Submitted: 2013-12-02
   Days after onset:4
Entered: 2013-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH907ZA / 2 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-11-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No medications
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Pending
CDC Split Type:

Write-up: Infant was under the care of his Dad - information was obtained from Mom that was not present at the moment of the event. As per mom the infant was as usual in the morning and he went to take his nap from what he never woke up.


VAERS ID: 515434 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Male  
Location: Louisiana  
Vaccinated:2013-05-23
Onset:2013-07-04
   Days after vaccination:42
Submitted: 2013-12-03
   Days after onset:152
Entered: 2013-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H016238 / 1 LA / IM

Administered by: Private       Purchased by: Unknown
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: 2013-07-04
   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: ALBUTEROL
Current Illness: No illnesses at time of vaccination
Preexisting Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Sudden death. He was perfectly healthy. This vaccination is the only thing I can think of that would have caused this. Everything else in his life was normal, the same.


VAERS ID: 515469 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Female  
Location: New York  
Vaccinated:2013-09-10
Onset:2013-09-11
   Days after vaccination:1
Submitted: 2013-12-03
   Days after onset:83
Entered: 2013-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK AR / UN
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. J003806 / UNK LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Blood glucose fluctuation, Death, Headache, Oropharyngeal pain, Paraesthesia, Paralysis
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-11-09
   Days after onset: 59
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Her physician will have that info.
Current Illness: No
Preexisting Conditions: Diabetes, heart disease, high blood pressure, 2 aortic aneurysms.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Headache, sore throat, tingling of feet and hands, blood sugar unusually fluctuated. Patient had paralysis earlier in the day on day of death.


VAERS ID: 516246 (history)  
Form: Version 1.0  
Age: 89.0  
Sex: Female  
Location: Florida  
Vaccinated:2013-10-09
Onset:2013-11-13
   Days after vaccination:35
Submitted: 2013-12-04
   Days after onset:21
Entered: 2013-12-11
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / MEDEVA PHARMA, LTD. 1308701 / 1 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-11-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COREG; Torsemide; Warfarin
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None stated.


VAERS ID: 517250 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-12-20
Entered: 2013-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? 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: WAES1312USA008560

Write-up: This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (Lot #, expiry not reported). No concomitant medication was reported. On an unknown date the patient developed shingles and was hospitalized. Length of hospitalization was not reported. The patient eventually died. It was unknown what treatment the patient received for shingles. The outcome of shingles was reported as fatal. Additional information has been requested.


VAERS ID: 517530 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Unknown  
Location: Unknown  
Vaccinated:2013-11-14
Onset:2013-11-19
   Days after vaccination:5
Submitted: 2013-12-23
   Days after onset:34
Entered: 2013-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS X199H / UNK LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH872AA / UNK RL / IM

Administered by: Other       Purchased by: Other
Symptoms: Cardiac operation, Death neonatal, Hepatitis B surface antigen positive
SMQs:, Liver infections (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Neonatal disorders (narrow), Respiratory failure (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Heart disease congenital
Allergies:
Diagnostic Lab Data: Hepatitis B surface antigen positive, positive for hepatitis B surface antigens N/A
CDC Split Type: WAES1312USA009910

Write-up: This spontaneous report as received from a physician via company representative refers to a baby of less than 10 days old. The patient was born with many congenital heart anomalies. Drug reactions/allergies were unspecified by the reported. No demographics were provided for the baby. On an unknown date, the patient was vaccinated with Hepatitis B vaccine (manufacturer unknown) (lot#, route, dosage not reported) (routine immunization) shortly after birth. It is unknown whether the baby was given RECOMBIVAX HB or another company''s Hepatitis B product. It is also not known when or where the baby received this vaccine. No concomitant medications were reported. It was reported that the baby was born at one unspecified hospital, had heart surgery (fatal, medically significant and hospitalization at another unspecified hospital and then went to a third unspecified hospital, where the baby died (dates unspecified) (fatal and hospitalization. It is not known how long the baby stayed at any of the hospitals. After death, the parents of the baby wanted the organs of this baby to be donated. When tissues from this baby''s organs were tested, it was discovered that tissues from the baby''s liver were found to be positive for Hepatitis B surface antigens (fatal and hospitalization). The mother of this baby tested as not positive for surface antigens, so they determined that the surface antigens of the baby''s liver must have come from the vaccine itself. The liver was rejected as an organ for donation. The physician queried and would like to have phone conversation regarding how it was possible that tissue in an infant''s liver could be positive for Hepatitis B surface antigens when infants mother does not have Hepatitis B. Hepatitis B surface antigens were discovered in liver when testing to see if infant could be an organ donor. The company representative states that the infant had multiple health issues requiring surgery and it is assumed that infant had blood transfusions (fatal and hospitalization) but she was not positive (infants antibody were not positive). The outcomes of the reported events were reported as fatal. All the reported events were considered to be serious due to death and hospitalization except the event of heart surgery. The event baby had heart surgery was considered to be medically significant as per internal review in addition to hospitalization and being fatal. Additional information has been requested.


VAERS ID: 517719 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-12-24
Entered: 2013-12-26
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: 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: Unknown
Current Illness: UNK
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2013SA131895

Write-up: Initial report received from a healthcare professional (pharmacist) on 09 December 2013. This case is linked with cluster cases: 2013SA131929 and 2013SA131928 (Same vaccine, same reporter). A male patient, whose medical history and concomitant medications were not reported, had received a dose of Influenza QIV vaccine (manufacturer: not provided, lot number, dose number, route and anatomical site of administration were not reported) on an unspecified date. On an unspecified date after vaccination, the patient developed Guillain Barre Syndrome and the patient was died. Laboratory investigations and corrective treatments were not reported. No autopsy details were reported. Documents held by sender: none.


VAERS ID: 518204 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-01-02
Entered: 2014-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Concomitant vaccinations, medications and relevant medical history were unknown. It was unknown if adverse events occurred with previous immunizations, including influenza vaccinations.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A1055013A

Write-up: This case was reported by a healthcare professional via sales representative and described the occurrence of death (cause unknown) in a male subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date in 2013 the subject received a dose of FLULAVAL (unknown). In 2013, 2 months after vaccination with FLULAVAL, the subject experienced death (cause unknown). The subject died on an unspecified date in 2013, cause of death was not unknown. It was unknown whether an autopsy was performed.


VAERS ID: 518725 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Female  
Location: Ohio  
Vaccinated:2013-09-25
Onset:2013-09-26
   Days after vaccination:1
Submitted: 2014-01-08
   Days after onset:104
Entered: 2014-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U4759AA / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Asthenia, Barium swallow, Blood test, Computerised tomogram, Dysphonia, Dyspnoea, Echocardiogram, Electromyogram, Muscular weakness, X-ray
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2014-11-29
   Days after onset: 429
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SYNTHROID, LOSARTIN, TRAZADONE, CITALOPRAM, EYE DROPS, EYE ANTIBIOTIC
Current Illness: NONE
Preexisting Conditions: CODIENE ALLERGY, SELDANE ALLERGY; LEGALLY BLIND AT BIRTH
Allergies:
Diagnostic Lab Data: EMG, XRAYS, SWALLOW TEST, BLOOD TEST, PULMONARY DR, CAT SCAN, ECHO CARDIOGRAM
CDC Split Type:

Write-up: WOKE UP WITH HOARSENESS IN VOICE AND LABORED BREATHING WEAKNESS IN HANDS, ARMS, LEGS & FEET.


VAERS ID: 518872 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Michigan  
Vaccinated:2013-11-21
Onset:2014-01-04
   Days after vaccination:44
Submitted: 2014-01-10
   Days after onset:6
Entered: 2014-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. BJ2156 / 2 NS / IN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J007354 / 3 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-01-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ADDERALL XR; CELEXA
Current Illness: Anxiety; Attention deficit/hyperactivity disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1401USA002324

Write-up: This spontaneous report as received from nurse refers to a 14 year old female patient with attention deficit disorder and anxiety and with no drug reaction or allergies. On 14-JUL-2011 the patient was vaccinated with first dose of GARDASIL (dose, route of administration, lot number and expiration date were not provided), on 25-JUL-2012 patient received second dose of GARDASIL (dose, route of administration, lot number and expiration date were not provided) and on 21-NOV-2013 patient received third dose of recalled GARDASIL (lot number: J007354, expiration date 20-FEB-2016) (dose and route of administration were not provided). Secondary suspect therapy included FLUMIST which was given on 21-NOV-2013. Concomitant therapies included ADDERALL XR and CELEXA. It was reported that patient complained of headache on 04-JAN-2014 and she went to bed early that night. It was reported that "she never woke up". Patient died on 04-JAN-2014. Nurse has not been informed of the autopsy result so she could not determinate cause of death. Lab diagnostic studies were not performed. It was also reported that approximately 27 doses of the recalled lot of GARDASIL were also administered at reporter''s facility but she has not heard of any other adverse effects. The outcome of headache was unknown. The relatedness between death, headache and GARDASIL was unknown. Additional information has been requested.


VAERS ID: 518930 (history)  
Form: Version 1.0  
Age: 41.0  
Sex: Female  
Location: Missouri  
Vaccinated:2013-04-10
Onset:2013-04-30
   Days after vaccination:20
Submitted: 2014-01-10
   Days after onset:255
Entered: 2014-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. H018781 / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Acute respiratory distress syndrome, Death, Pneumonia, Rash generalised, Varicella
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2013-05-10
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Pt taking the following medications at time of vaccination. Prednisone, Cellcept, Topamax and Celebrex.
Current Illness: Unknown
Preexisting Conditions: Asthma, chronic autoimmune disease, migraines
Allergies:
Diagnostic Lab Data:
CDC Split Type: MO0101

Write-up: Generalized varicella rash. Pt admitted to hospital 05/05/2013. Treated with Acyclovir. Developed pneumonia and ARDs.


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