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VAERS ID: 623192 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: California  
Vaccinated:2016-02-11
Onset:2016-02-19
   Days after vaccination:8
Submitted: 2016-02-19
   Days after onset:0
Entered: 2016-02-22
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS JX792 / 1 LA / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. L030871 / 1 UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N35762 / 1 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-02-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Prematurity
Allergies:
Diagnostic Lab Data: Pending
CDC Split Type:

Write-up: Pt was preemie triplet in ICU at med ctr. Given vaccines 2/11/16. Discharge 2/15/16. Seen 2/16/16. Died of SIDS 2/19/16.


VAERS ID: 623311 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-02-22
Entered: 2016-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2016US023178

Write-up: literature case report received on 18 Feb 2016. The author in the article discussed about membranous nephropathy (MN) and severe acute kidney injury (AKI) following influenza vaccination. This report refers to a male patient of an unknown age. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date after receiving vaccination, the patient died from GB syndrome. It was unknown if an autopsy was performed. The author presented an interesting case of MN and severe AKI following the 2009 H1N1 vaccination (see case: PHHY2016US023093). Optimal therapy of influenza vaccine associated glomerular diseases including MN was unknown. The author concluded that based on the experience one can consider corticosteroid therapy in patients with MN and AIN following influenza vaccination. However, further studies are required to investigate the exact pathogenesis of influenza vaccine-induced MN.


VAERS ID: 623539 (history)  
Form: Version 1.0  
Age: 0.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2016-01-12
Onset:2016-01-13
   Days after vaccination:1
Submitted: 2016-02-23
   Days after onset:41
Entered: 2016-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS L019298 / 1 LL / IM

Administered by: Public       Purchased by: Other
Symptoms: Apnoea, Cyanosis, Respiratory arrest, Sudden infant death syndrome
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-02-01
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Born premature at 35 weeks
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data: Apnea/SIDS
CDC Split Type:

Write-up: I saw him turning blue and not breathing. I immediately picked him up and rubbed his back and patted his back to get him to breathe and immediately called the nurse. They came in 10 minutes later but they did not check him out and said he was fine.


VAERS ID: 623724 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Female  
Location: Colorado  
Vaccinated:2014-09-16
Onset:2014-09-28
   Days after vaccination:12
Submitted: 2016-02-25
   Days after onset:515
Entered: 2016-02-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UI192AA / 1 RA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Abasia, Coma, Computerised tomogram, Death, Electroencephalogram abnormal, Endotracheal intubation, Fall, Gaze palsy, Generalised tonic-clonic seizure, Intensive care, Malaise, Mechanical ventilation, Paralysis, Seizure, Unresponsive to stimuli
SMQs:, Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Dystonia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2014-10-11
   Days after onset: 13
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations: ~Influenza (Seasonal) (no brand name)~UN~5.00~Patient
Other Medications: Too many to list.
Current Illness: Pt. had multiple long-term, chronic illnesses. They were all stable at this time. Migraine headaches, pain to most of body, Osteoarthritis, RSD bilateral legs L$gR, COPD/Emphsyema, Vulvadynia, Muscle atrophy esp. to LLE, Difficulty voiding, Poor nutrition, GERD, Tachyarrhymias, Chronic constipation R/T narcotic use, MPD.
Preexisting Conditions: Allergies: Most ABX, Gabapentin, Vancomycin, Gentamycin, Medical condition: Debilitated, walked with assistance or used wheelchair, Mentally AA&O x 4, Able to do ADL mostly by self.
Allergies:
Diagnostic Lab Data: SEE CHART
CDC Split Type:

Write-up: 09/28/2014 c/o "BEING SICK". 10/02/2014 AT 7:00 am fell in BR. Unable to walk well even w/assistance. To ER by Ambulance. In ER, AA & O, moving all extremities. On the way to CT, she had a localized seizure involving BLE. Witnessed by myself and CT tech. Had CT< returned to ER. Had a longer T/C seizure beginning in BLE and then involving all parts of body. Head turned upward and to right. Eyes deviated upward and right but conjugate, Not responsive at this time. Lasted 1.45 minutes to 2 minutes. Given Ativan w/o change. No somulent again. Transferred to ICU. Later on during the same evening, she experienced a full T/C seizure lasting $g 30 minutes. Given paralytics to get her intubated and started on Diprovan drip along with other meds. Continued with paralytics and was ventilated. She had a 24/7 EEG monitor placed which continued to show seizure wave patterns. When they let her up from her meds, she was now paralysed and comatose. Remained ventilated. After a family conference with Internal Medicine and Pulmonologist, it was decided to extubate her and allow her to die. Which she did after 45-60 minutes. These were her wishes, in her Durable Medical POA.


VAERS ID: 624091 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Male  
Location: Michigan  
Vaccinated:2015-05-28
Onset:2015-06-07
   Days after vaccination:10
Submitted: 2016-02-26
   Days after onset:264
Entered: 2016-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS B54KE / 1 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Chills, Injection site cellulitis, Nausea, Purulent discharge
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-11-04
   Days after onset: 150
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Only non-prescription vitamins and supplements: Alpha lipoic acid, coenzyme Q10, multivitamin, Vitamin D, Vitamin C, aspirin (81 mg), saw palmetto, selenium, zinc acetate. Patient prescribed Zithromax 250 mg oral tablet: 250, PO, daily, 4
Current Illness: Onset of kidney disease
Preexisting Conditions: Allergies to penicillin and pollen, vaccine was given as treatment for a fall that had caused lacerations to the face
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Cellulitis of left upper arm in shich TDAP was given. Some pus was drained. Chills, nausea. Treatment: clindamycin and heparin injection and vancomycin IV overnight.


VAERS ID: 624251 (history)  
Form: Version 1.0  
Age: 0.02  
Sex: Female  
Location: Massachusetts  
Vaccinated:2014-04-18
Onset:2014-04-26
   Days after vaccination:8
Submitted: 2016-02-28
   Days after onset:673
Entered: 2016-02-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. H020605 / 1 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-04-26
   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: Nystatin
Current Illness: Jaundice, under 5lbs
Preexisting Conditions: Jaundice, prematurity, low birth weight, lost 13% of birth weight, had not reached full term due date
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death/SIDS.


VAERS ID: 624654 (history)  
Form: Version 1.0  
Age: 60.0  
Sex: Female  
Location: New Mexico  
Vaccinated:2014-07-08
Onset:2014-10-01
   Days after vaccination:85
Submitted: 2016-03-01
   Days after onset:517
Entered: 2016-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (TENIVAC) / SANOFI PASTEUR C4403BA / UNK LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Activities of daily living impaired, Dysarthria, Facial paresis, General physical health deterioration, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Started noticing muscle weakness in hands and had difficulty buttoning pants. Over the course of several months muscles in both arms and hands continued to weaken. By April 2015, I started having slurred speech and there is weakness in the facial muscles. My condition continues to deteriorate. Up until the tetanus vaccine I was perfectly healthy.


VAERS ID: 624689 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Male  
Location: Unknown  
Vaccinated:2016-02-02
Onset:2016-02-10
   Days after vaccination:8
Submitted: 2016-03-01
   Days after onset:20
Entered: 2016-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. L035687 / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Acute respiratory distress syndrome, Cough, Death, Dialysis, Dyspnoea, Laryngitis, Pneumonia, Renal failure, Respiratory failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Interstitial lung disease (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-02-17
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1602USA013002

Write-up: This spontaneous report has been received from the patient''s best friend''s wife, referring to a male patient of unknown age. The patient''s medical history and concurrent conditions were not provided. On 02-FEB-2016, the patient was vaccinated with PNEUMOVAX 23, (lot #, route, dose and expiration date were not provided). Concomitant therapies were not reported. On 10-FEB-2016, the patient became ill developing trouble breathing, coughing, and laryngitis. On an unknown date in February 2016, the patient was admitted to the hospital for acute respiratory distress syndrome (ARDS). The patient also developed respiratory failure and renal failure, and the patient was treated with dialysis. The patient also was being treated for pneumonia. The onset date of the events was reported as 10-FEB-2016. On 17-FEB-2016, the patient died, the cause of death was reported as pneumonia related issues. The outcome of laryngitis, and renal failure, was unknown. Upon internal review renal failure, acute respiratory distress syndrome and respiratory failure were considered to be medically significant events. Additional information has been requested.


VAERS ID: 624988 (history)  
Form: Version 1.0  
Age: 5.0  
Sex: Male  
Location: New York  
Vaccinated:2016-02-16
Onset:2016-02-22
   Days after vaccination:6
Submitted: 2016-03-02
   Days after onset:9
Entered: 2016-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR U5310DA / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-02-22
   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: Keppra, Robinul, Pediasure, vitamin B6
Current Illness: None.
Preexisting Conditions: Anoxic brain injury at birth, resulting in chronic encephalopathy, microcephaly, global developmental delay, seizure disorder, central vision impairment, and cerebral palsy. Also had history of bilateral metatarsus adductus, mild intermittent asthma, excessive salivation, and neuromuscular hip dislocation
Allergies:
Diagnostic Lab Data: Autopsy was performed by county medical examiner.
CDC Split Type:

Write-up: Pt was found deceased in bed by parent.


VAERS ID: 625003 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-02-27
Entered: 2016-03-03
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Adrenal atrophy, Air embolism, Anaphylactic shock, Autopsy, Body temperature increased, Cheyne-Stokes respiration, Chills, Cyanosis, Death, Ecchymosis, Emphysema, Eosinophil percentage, Epistaxis, Haemoglobin, Heart rate increased, Hypersensitivity, Hyperthermia, Injection site haemorrhage, Lymphocyte percentage increased, Mechanical ventilation, Mouth haemorrhage, Muscle contractions involuntary, Muscle spasms, Muscle twitching, Mydriasis, Neutrophil percentage decreased, Pericardial haemorrhage, Pulmonary congestion, Pulse abnormal, Puncture site haemorrhage, Pupillary light reflex tests abnormal, Rales, Red blood cell count normal, Respiratory arrest, Seizure, Shock, Staphylococcus test positive, Streptococcus test positive, Vaccination complication, Vaginal haemorrhage, Vein collapse, Vomiting, White blood cell count increased
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Agranulocytosis (broad), Angioedema (broad), Haematopoietic leukopenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Convulsions (narrow), Dyskinesia (broad), Dystonia (broad), 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), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (narrow), Retinal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (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: Acetylsalicylic acid; Drug reaction: Urticaria, For one day during the first year of life
Allergies:
Diagnostic Lab Data: Body temperature, 103 Fahrenheit, Significant; Body temperature, 109 Fahrenheit, Significant; Culture, Abnormal, Grew a streptococcus of the alpha group and Staphylococcus aureus; Eosinophil count, 3 %, Significant; Haemoglobin, 82.2 %, Significant; Haemoglobin, 80 %, Significant; Heart rate, 180/min, Significant; Heart rate, 240/min, Significant; Lymphocyte count, 61 %, Significant; Lymphocyte count, 74 %, Significant; Neutrophil count, 26 %, Significant; Neutrophil count, 36 %, Significant; Red blood cell count, 4.02 million red cells, Significant; Red blood cell count, 4.75 million red cells, Significant; White blood cell count, 7,400, Significant; White blood cell count, 44,000, Significant
CDC Split Type: PHHY2016US023690

Write-up: Case number PHHY2016US023690, is an initial literature case report received on 22 Feb 2016. The author discussed about the fatal allergic reaction due to influenza vaccine. This report refers to a 42-month-old female patient. Past drug history included acetylsalicylic acid and the patient experienced hives for one day during the first year of life which were thought to follow medication. There was no history of asthma and no family history indicative of allergy could be elicited. Prior to the injection of the vaccine the physician had attempted to obtain a history of allergy to eggs or chicken with negative results. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) subcutaneously at a dose of 0.5 ml on an unknown date. The patient complained of pains in the abdomen and chills followed by vomiting and convulsions four hours after the vaccination. On examination the patient had a rectal temperature of 109 F. The patient was hospitalized within two hours after the onset of symptoms. On admission to the hospital the patient showed pronounced cyanosis, pupils were widely dilated and unresponsive to light. The lungs showed moist rales over both pulmonary fields and the heart rate was 180 per minute. The abdomen was not distended. The extremities showed convulsive contractions during examination. During the seven hour stay in the hospital the patient became increasingly cyanotic despite oxygen and epinephrine hydrochloride therapy. It was noted that bleeding was pronounced at the sites of hypodermic puncture for the administration of medicaments and that large areas of ecchymosis developed around the injected sites. Slight bleeding was also noted from the vaginal and oral orifices. Convulsions occurred at one to two minute intervals. The convulsions ceased after about five hours and the temperature fell to 103 F. The heart rate increased in rapidity up to 240 per minute but remained regular. The respirations were noted to be Cheyne-Stokes in type. Two hours after entry to the hospital breathing ceased and artificial respiration was instituted. After the resumption of respiration constant bilateral twitching and spasms were noted. This was most decided in the lower extremities. Five hours after admission and seven hours after the onset of symptoms the patient showed great shock with pronounced collapse of the veins which rendered venipuncture difficult. Thirty minutes before death a surgical exposure of the right ankle vein was considered necessary for intravenous therapy. At that time an attempt was made to administer dextrose and saline solution with 10 per cent calcium gluconate. The patient was becoming more cyanotic and it was difficult to obtain the pulse beat. Artificial respiration was again instituted and after an intracardiac injection of epinephrine hydrochloride the patient was pronounced dead. Blood examination showed 80 per cent hemoglobin, 4.02 million red cells and 44,000 white cells with 36 per cent neutrophils, 61 per cent lymphocytes and 3 per cent eosinophils. The clinical picture of the patient was that of an allergic reaction which developed four hours after the injection and was characterized by convulsions, abdominal pain and vomiting with associated hemorrhagic phenomena., respiratory arrest, hyperthermia and death. The outcome of the event convulsions was recovered and outcome of other events was not reported. The cause of death was ascribed to anaphylactic shock secondary to the injection of influenza vaccine with air embolism as an immediate terminal contributory cause. A necropsy was performed about eleven hours after death which revealed the following: Heart: Air embolism was present in the right side of the heart and in the inferior vena cava; there were multiple epicardial hemorrhages. Thymus: Petechial subcapsular hemorrhages were present. Lungs: There were bilateral hypostatic congestion, emphysema of the right middle lobe and focal intra-alveolar hemorrhage. Adrenal: Decided bilateral atrophy was observed. Gastrointestinal Tract: Submucosal petechial hemorrhage of the esophagus was seen. Genitourinary Tract: There were submucosal petechial hemorrhages of the vagina. General: Multiple puncture wounds of the upper extremities and a recent phlebotomy wound of the right lower extremity were observed. Gross Observations: The body was that of the patient about 3 years of age and of normal height and weight. The left nostril showed abundant dried, blood tinged, foamy material. On the arms there were multiple hypodermic puncture marks in the region of the deltoid insertion on either side and small drops of fluid blood could be readily squeezed from the puncture wounds. The contiguous skin was ecchymotic. The left inguinal region showed recent venipuncture wounds with adjacent ecchymoses. The right longer extremity showed the presence of a recent transverse incision of the skin placed on the medial surface of the ankle and held together by interrupted sutures. The vagina showed the presence of two zones of submucosal hemorrhage just inside the fourchet. On incision of the fit it was noticed that the cut ends of the capillaries oozed fluid blood. When the thorax was opened both lungs lay free in the pleural sacs and did not appear hyperventilated. The right ventricle was greatly dilated and though its partly transparent wall multiple bubbles of air mixed with blood could be readily seen. With the circulation intact, several of the large venous pathways to the heart were exposed. The superior vena cava was natural. The left subclavian vain showed no evidence of air in its lumen. The inferior vena cava exposed along its entire length was seen to be distended and rounded and to contain a continuous column of frothy fluid blood along its entire length. The femoral vessels were exposed on both sides. Both femoral veins were collapsed. When the vessels were milked in a direction from the periphery to the trunk air bubbles were not recognized in either vessel; on milking the right iliac vein from the inguinal region in a cephalad direction, bubbles of air mixed with blood were seen. On exploration of the incised cutaneous wound of the right ankle at the site of phlebotomy, the underlying vein was readily identified and showed a ligature around its wall. Just proximal to the ligature a small nick corresponding to the site of puncture was readily identified. Anatomic Observations: Heart: The heart on removal weighed 909 Gm. The epicardial surfaces showed extensive Flame shaped hemorrhages both anteriorly and posteriorly. The right auricle and ventricle contained abundant fluid blood intimately mixed with numerous air bubbles of various sizes. The remainder of the examination of the heart revealed essentially normal structure. Lungs: The right lung weighed 120 Gm., the left 130 Gm. The posterior portions of both lobes of the left lung were dark red and on section cut with somewhat increased resistance to reveal a glistening, dark red, homogenous, nonconsolidated tissue, sections of which sank readily in water. The anterior portions of both lobes on this side were air containing and moderately congested and showed, in addition, scattered areas of circumscribed recent intra alveolar hemorrhage. The bronchi on this side showed intensely engorged mucosal surfaces having the appearance of red velvet. A culture taken from the main bronchus on this time grew a streptococcus of the alpha group and Staphylococcus aureus. The right lung had four lobes. The two lower lobes showed dark red circumscribed areas on their posterior portions, resembling those seen on the left side. In addition occasional lobules in the upper lobe appeared to be partly collapsed, being distinctly depressed below the adjacent pleural surfaces. One of the lobes also had a local area of emphysema on its anterior margin. The bronchi on this side resembled those of the left. The hilar nodes were natural. Thymus: The thymus was enlarged, weighed 30 Gm. and showed multiple subcapsular petechial hemorrhages. The cut surface was not noteworthy. Liver: The liver weighed 420 Gm. On section it revealed indistinctness of the lobular markings, the larger vessels oozing abundant blood. Spleen: The spleen weighed 55 Gm. and on section showed follicular hyperplasia. The pulp was firm and dark red. Adrenals: The adrenals were decidedly atrophic in appearance, the cortices being about 1 mm. in thickness. The medulla was similarly totally reduced on the side. Kidneys: The right kidney and left kidney each weighed 45 Gm. On section the cut surfaces were engorged. Uterus and Adnexa: The uterus and adnexa were natural for the age. Gastrointestinal Tract: The esophagus presented a few small submucosal hemorrhages in the distal half. The stomach contained about 2 ounces (59 cc.) of dark mucoid coagulum and showed normal mucosal surfaces. Lymphoid tissue: The Lymphoid tissues in the normal sites, more especially in the mesentery, were discretely enlarged and showed congested homogenous cut surfaces. Brain: The brain weighed 1,360 Gm and showed greatly engorged cerebral surfaces. On section the capillary systems in the gray and white matter were appreciably engorged. Microscopic examination showed sections of the lungs early acute interstitial inflammation in which mononuclear cells with fewer polymorphonuclear and only occasional eosinophils were seen. There was well defined intra alveolar and subpleural edema. In addition many of the air spaces showed recent intra-alveolar extravasation of red cells. Many colonies of bacteria were noted in the alveoli and bronchioles and were entirely devoid of any adjacent inflammatory cellular reaction. Occasional bronchioles showed the presence of their lumens of acidophilic albuminous exudate mixed with red cells. Sections of the heart muscle showed decided congestion of the vessels with scant areas of recent interstitial hemorrhage. There was well defined interstitial and subendocardial edema present. Sections of the spleen and lymph nodes displayed early follicular necrosis. The spleen on careful search failed to reveal any eosinophilic cells. The sections of the lymph node showed moderate eosinophilic cell infiltration. The adrenals manifested well defined cortical and medullary atrophy. The remainder of the organs revealed acute congestive change. The post mortem examination of the blood revealed 82.2 per cent hemoglobin, 4.75 million red cells and 7,400 white cells, with 26 per cent neutrophils, 74 per cent lymphocytes and a 0.87 color index. The author stated the fatal case of severe hemorrhagic allergic reaction occurred in the patient after influenza A and B vaccine was given subcutaneously in the prescribed dose. It was recommended that attempts should be made to further purify the various virus vaccines now becoming generally used so as to materially diminish the amount of reacting egg substances in the mediums of the marketed product. Since children appear more sensitive to egg protein than do adults greater precautions should be taken in this group of patients in the course of immunization with vaccines grown on egg mediums. The author concluded that simple precautions which have been outlined are observed should be little or no danger in continuing the vaccination of the civilian population with these agents which the accumulated evidence showed to have definite immunization value.


VAERS ID: 625196 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Male  
Location: Unknown  
Vaccinated:2000-12-26
Onset:2000-12-26
   Days after vaccination:0
Submitted: 2016-03-03
   Days after onset:5546
Entered: 2016-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 RA / SYR

Administered by: Other       Purchased by: Other
Symptoms: Apnoea, Bacterial test negative, Cardiac arrest, Computerised tomogram normal, Cough, Cyanosis, Cytogenetic analysis normal, Death, Dyskinesia, Ear tube insertion, Electroencephalogram normal, Epilepsy, Eye movement disorder, Febrile convulsion, Gaze palsy, Generalised tonic-clonic seizure, Grunting, Hypopnoea, Infection, Injection site erythema, Injection site swelling, Intensive care, Life support, Multi-organ failure, Muscle twitching, Neurological examination abnormal, Nuclear magnetic resonance imaging brain abnormal, Otitis media, Postictal state, Posturing, Pyrexia, Status epilepticus, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Convulsions (narrow), Dyskinesia (narrow), Dystonia (broad), Acute central respiratory depression (narrow), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hearing impairment (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-11-17
   Days after onset: 2517
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: Soto''s syndrome; Developmental delay; Autism spectrum disorder; Macrocephaly
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: On 9th April, 2002, the patient had a genetics evaluation, which found that the patient''s genetics were normal. An magnetic resonance imaging taken on 28 February 2001 was mostly normal, but the report noted the MRI showed evidence of frontal lobe atrophy of uncertain etiology. 12/27/2000, Body temperature, 102 degree C; 02/20/2001, Body temperature, 90 to 100 degree C; 12/28/2000, Computerised tomogram, normal; 12/28/2000, Electroencephalogram, normal; 02/21/2001, Electroencephalogram, normal; 11/17/2007, Neurological examination, no functioning; 02/26/2001, Nuclear magnetic resonance imaging, See text; 12/27/2000, White blood cell count, very high
CDC Split Type: US2016GSK029885

Write-up: This case was reported by a lawyer via other and described the occurrence of complex febrile convulsion in a 5-month-old male patient who received DTaP vaccine. Co-suspect products included pneumococcal vaccine and varicella vaccine. Concurrent medical conditions included Sotos syndrome, developmental delay, pervasive developmental disorder and macrocephaly. On 26th December 2000, the patient received the 2nd dose of DTaP vaccine. On 27th August 2001, the patient received pneumococcal vaccine and varicella vaccine. In December 2000, less than a day after receiving DTaP vaccine, the patient experienced complex febrile convulsion (serious criteria death, hospitalization and GSK medically significant), status epilepticus (serious criteria death and GSK medically significant), epilepsy (serious criteria death and GSK medically significant), injection site swelling, injection site erythema, apnea (serious criteria GSK medically significant), fever, cyanosis, twitching of limbs, Gaze Palsy (serious criteria GSK medically significant), shallow breathing, grunting and otitis media. On 6th February 2001, the patient experienced jerkiness and generalized tonic-clonic seizure (serious criteria GSK medically significant). On 16th November 2007, the patient experienced cardiac arrest (serious criteria death and GSK medically significant) and cough. On 17th November 2007, the patient experienced multi-organ failure (serious criteria death and GSK medically significant). The patient was treated with ATIVAN, ceftriaxone and phenobarbital. On 16th November 2007, the outcome of the complex febrile convulsion was fatal. On 17th November 2007, the outcome of the status epilepticus, epilepsy, cardiac arrest and multi-organ failure were fatal. On an unknown date, the outcome of the injection site swelling, injection site erythema, apnea, fever, cyanosis, twitching of limbs, Gaze Palsy, shallow breathing, grunting, otitis media, jerkiness, generalized tonic-clonic seizure and cough were unknown. The patient died on 17th November 2007. The reported cause of death was febrile seizure, status epilepticus, epilepsy, cardiac arrest and multi-organ failure. It was unknown if the reporter considered the complex febrile convulsion, status epilepticus, epilepsy, cardiac arrest, multi-organ failure, injection site swelling, injection site erythema, apnea, fever, cyanosis, twitching of limbs, Gaze Palsy, shallow breathing, grunting, otitis media, jerkiness, generalized tonic-clonic seizure and cough to be related to DTaP vaccine. Additional details were provided as follows: The patient was a healthy. On December 26, 2000, the patient received his second dose of the DTaP vaccine. The patient''s parents recalled that there was some swelling around the injection site (right upper extremity) and site was red. Early in the morning on 27 December 2000 (within 24 hours of vaccination), the patient''s parents found him seizing in his crib and took him to the emergency room. The seizure lasted about 15 minutes and was controlled with medication by the doctors. Five minutes later, the patient began seizing again with apnea and according to the timeline in the medical records, the second seizure was stopped when the patient was given an ATIVAN IV and oxygen. The medical records were unclear, but the second seizure lasted at least a few minutes, and it could have lasted as long as 15 minutes. It was noted that the first seizure was stopped at 4:30 A.M., the second seizure started five minutes later, and the second seizure was stopped at 4:50 A.M. The medical records document the patient''s condition on admission and his progression. On admission, the patient was cyanotic and actively seizing. The neurology consult on 27 December 2000, noted that the patient had returned to baseline. The patient had a very high white blood cell count, which suggested that the seizure was related to fever from infection rather than fever from immunization. The patient was administered ceftriaxone as a prophylactic, to be discontinued if bacterial cultures came back negative. His temperature was approximately 102 degrees. It was noted that the patient had no rash. The patient''s seizures involved bilateral arm twitching, with eyes rolled back with right side deviation. He was in the postictal phase for about 30 minutes, with shallow breathing, posturing, and grunting. The patient was admitted to the pediatric intensive care unit for monitoring. On 28 December 2000, the parents reported that the patient seemed to be completely himself. Although the bacterial cultures came back negative, ceftriaxone was continued to rule out sepsis. The patient''s condition was described as status post, prolonged seizure associated with fever. The note also stated that given the high WBC count, this was more likely secondary to infection that simply a febrile reaction to his immunizations. Later that day, it was found that the patient had otitis media, and he was to continue on ceftriaxone to treat it. The patient had no symptoms of an upper respiratory infection. A computerized tomography scan of the patient''s head and an electroencephalogram were normal. The patient was discharged on 29 December 2000, with instructions to continue using phenobarbital and to follow up with doctor in one month. On 29 January 2000, the patient saw doctor for a follow up visit. According to the doctor, the etiology of the seizure was uncertain, and he was concerned about a possible association with the patient''s DTaP vaccination. Doctor recommended not giving the next DTaP dose until a follow up EEG was completed. He noted that the patient''s height was under the 75th percentile, weight was above the 95th percentile, and head circumference was above the 95th percentile. The doctor also observed that the patient''s father head circumference was above the 95th percentile for adults. On 6th February 2001, the patient was admitted to the hospital again for seizures, the seizure lasted for approximately 20-25 minutes. When the seizure started, the patient''s eyes rolled up and to the right and he had jerking of the right arm, but these focal aspects generalized to tonic-clonic movements of all four extremities. The patient''s mother reported that he was afebrile when the seizure started, and the medical records noted that there was a question as to DTaP''s role in causing the first seizure. The diagnosis was status epilepticus. The patient''s overgrowth did not fit the Sotos syndrome pattern; he was big but proportionally so, and he was not abnormally tall at birth. His large head could be explained by ordinary genetics (his father''s head was big) or by his autism spectrum disorder. The patient had PDD, which resulted in developmental delay but it does not appear that this necessarily was related to his other conditions. At one time, the patient had advanced bone age, but the literature stated this is a non-specific finding and not limited to persons with Sotos syndrome. The patient was discharged on 7th February 2001. An undated, handwritten note in doctor''s record stated that, after the patient''s 6th February 2001 seizure, his epilepsy was almost definitively established. The patient again was admitted to the hospital for seizures on 20th February 2001. His temperature on admission was not noted, although he had a slight fever (99-100 degrees) the following day. An EEG performed on 21st February 2001 was normal. An magnetic resonance imaging taken on 26 February 2001 was mostly normal, but the report noted the MRI showed evidence of frontal lobe atrophy of uncertain etiology. The doctor was not certain if the atrophy was clinically significant. In March 2001, the patient did not receive his 6-month (third) DTaP vaccination. The patient was noted to be an alert, chubby, vigorous, handsome infant." His muscle bulk and tone were normal. The patient had seizures with some regularity over the next year. For example, on 13th April 2001, the patient had a febrile seizure. On 28th August 2001, the patient had a febrile seizure the day after he received pneumococcal and varicella vaccines. In November 2001, the patient was seen because he had a series of afebrile seizures. The patient''s treating neurologist, noted that the patient was a very attractive, non-dysmorphic child. In 2002, doctors observed that the patient displayed signs of other disorders. On 31st January 2002, a doctor noted that the patient had features of pervasive developmental disorder which was an autism spectrum disorder. On 13th March, it first was noted that the patient''s condition was consistent with Sotos syndrome. It appeared that the patient might have had Sotos syndrome, but the medical records were not entirely clear on this point. The patient had some physical signs of Sotos syndrome, such as a large head and body. The patient had been clear on this point. The patient had some physical signs of Sotos syndrome, such as a large head and body. The patient had been diagnosed with pervasive developmental disorder and developmental delay. On 9th April, doctors observed that he might have an advanced bone age. The patient, who 7 was 20 months old, had a bone age of 28 months. The patient''s bone age was two standard deviations above average. The patient had recurring otitis media. On 9th April, 2002, the patient had a genetics evaluation, which found that the patient''s genetics were normal, but the evaluation did not test for the NSD1 abnormalities associated with Sotos syndrome. On the other hand, the patient''s condition was not entirely consistent with Sotos syndrome. Although the patient had a large head, the patient''s father had a head size in the 95th percentile and although the patient''s head was big, it was not characteristically dysmorphic. Additionally, it appeared the patient was a large but proportionally sized baby, rather than just tall as seen in Sotos syndrome. On 21st October 2002, height: 57th percentile, weight: 93rd percentile and on 29th January 2000, height: under the 75th percentile, weight: above the 95th percentile, head circumference: above the 95th percentile. Despite the uncertainty of the findings, over the next few years the medical records consistently mentioned diagnoses of Sotos syndrome. However, two doctors appeared not to have accepted entirely the Sotos syndrome diagnosis. On 29th August 2002, doctor described the patient as having a history of possible Sotos syndrome. On 8th May 2003, doctor noted that the issue with Sotos syndrome was still not settled." The medical records shows that doctor never stated that she thought the patient had Sotos syndrome. In July 2003, the patient was taken to the Sotos syndrome support association annual meeting. An expert on Sotos syndrome, evaluated the patient, and he diagnosed the patient as having a Sotos-like disorder, possibly just macrocephaly. On 25th February 2002, the patient started receiving his DTaP vaccinations again, but the record did not indicate the reason. On 1st September 2002, the patient''s father wrote a letter to the patient''s pediatrician, in which he noted that the patient had experienced almost 40 seizure bouts between his 4 month checkup and his 18 month checkup. The previous six months, the patient had experienced only two febrile seizure bouts, both caused by ear infections. On 27th March 2003, the patient had surgery to have tubes placed in his ears due to recurring otitis media that was unresponsive to therapy. After December 2003, the patient had only occasional seizures. The patient had not had a seizure since December 2003. One seizure in January 2006. As per the medical records, the first mention of hypotonia was when the patient was six years old, but he claimed that actual assessment of hypotonia was fraught with error, and the lack of mention of hypotonia in the medical records before age six did not preclude the fact that he might not have had some hypotonia that was missed on exam. The patient continued to be developmentally delayed. On 16th November 2007, the patient went to the emergency room with a fever and a cough, while there, he had a seizure and went into status epilepticus, followed by bradycardiac arrest. On 17th November 2007, due to the absence of any neurologic functioning on repeated exams and overwhelming organ failure, it was decided to withdraw aggressive life support. The patient was pronounced dead six minutes later. The immediate cause of death was multisystem organ failure, which was a consequence of cardiac arrest, which was a consequence of the patient''s seizure disorder. Some medical records stated that the patient had a diagnosis of Sotos syndrome, while others stated that he did not. One of the patient''s treating neurologists, did not view the Sotos syndrome diagnosis as definitive and, most pertinently, an expert on Sotos syndrome, did not accept the patient''s diagnosis of Sotos syndrome, and instead suggested that it was a Sotos-like disorder, "possibly just macrocephaly. Although a DNA test became available for Sotos syndrome, the patient did not have it performed because insurance would not cover it. Prior genetic testing revealed no abnormalities. The petitioner was considered to be the entitled for compensation. This case was also reported in a literature article.


VAERS ID: 625345 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: Virginia  
Vaccinated:2014-08-28
Onset:2014-10-09
   Days after vaccination:42
Submitted: 2016-03-04
   Days after onset:512
Entered: 2016-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4724AA / 1 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H83180 / 1 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. J011336 / 1 UN / UN

Administered by: Unknown       Purchased by: Private
Symptoms: Autopsy, Death, Laboratory test, Respiratory arrest, Sudden infant death syndrome
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Neonatal disorders (narrow), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-10-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unsure of exact vaccinations at his 3 month visit but was given all that was suggested by Dr. Also was taking medicine for GERD prescribed by Dr.
Current Illness: No
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Autopsy and Labs
CDC Split Type:

Write-up: Patient stopped breathing when napping - no foul play, no obstruction or suffication. Autopsy diagnosed SIDS as cause of death.


VAERS ID: 625642 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-03-07
Entered: 2016-03-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USBEH2016059464

Write-up: This medically confirmed literature report (initial receipt 23-Feb-2016) concerns a male patient. On an unknown date, the patient received an influenza vaccine (brand, batch number and route unspecified) for indication not provided. On an unknown date following vaccination, the patient developed GB syndrome from which he died. The outcome was reported as fatal. Linked to case: 2016059460 (same reporter). Reporter''s Comments: Reporter comments: n/a. Sender''s Comments: Company''s evaluation and comment: Seriousness criterion/criteria: Fatal outcome. Listedness: Unlisted. Brand of Influenza vaccine not provided. Assessment according to the CSL Inactivated Influenza Virus Vaccine CCDS and the Afluria Product Information, GBS is unlisted due to the fatal outcome. Company Causality: Unassessable. Temporal relationship could not be established. GBS is a known class effect of Influenza vaccine in general and is mediated by immune attack on peripheral nerve myelin. Risk factors include upper respiratory, infections, (40% of cases) and or preceding diarrheal illness due to campylobacter infection (20%). The outcome is usually complete recovery over weeks to months however fatal outcome is due to autonomic disturbances resulting in cardiac arrest being the most common cause, in 20-30% of deaths. Due to missing information causality is unassessable.


VAERS ID: 625990 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-03-08
Entered: 2016-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1603USA002747

Write-up: This spontaneous report was received from a consumer referring to an unspecified number of children of unknown ages and genders. No concurrent or historical conditions were reported. The reporting consumer stated that GARDASIL was making lots of children sick and dying. The reporter stated that her granddaughter got really sick just after her doctor gave her the vaccine, she considered that this was not a good drug and that the vaccine was not safe (reported on MARRS case # 1603USA002754). The reporter considered the adverse events were related to GARDASIL. This is one of two reports received from the same source. Additional information is not expected, because no contact details were provided.


VAERS ID: 626063 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-03-08
Entered: 2016-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: WAES1508USA010157

Write-up: This spontaneous report was received from a consumer via a social media site concerning a female who on an unspecified date received GARDASIL. Concomitant medications and medical history were not provided. The reporter posted on the social media site. No further information was provided. Follow-up information was received on 04-MAR-2016 from a consumer via social media concerning a female who was reported to have received a dose of GARDASIL. It was reported: "The sudden death of a 12 year old girl... just hours after receiving the HPV GARDASIL vaccine has shocked the girl''s family and sent local medical asking questions as [...]". No other information was provided. Additional information is not expected.


VAERS ID: 626760 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Female  
Location: Unknown  
Vaccinated:2015-10-30
Onset:2016-02-26
   Days after vaccination:119
Submitted: 2016-03-11
   Days after onset:14
Entered: 2016-03-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M03211 / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-03-10
   Days after onset: 13
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:

Write-up: Was diagnosed influenza A, influenza B, and pneumonia. After having a good prognosis she died. She has both influenza and pneumonia vaccines in the fall.


VAERS ID: 626920 (history)  
Form: Version 1.0  
Age: 1.05  
Sex: Male  
Location: Indiana  
Vaccinated:2015-10-19
Onset:2015-10-23
   Days after vaccination:4
Submitted: 2016-03-14
   Days after onset:143
Entered: 2016-03-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U5319DA / 1 LL / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 9CJ5Y / 1 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. K002528 / 1 RL / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. K008824 / 1 RL / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-10-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No, child was well at the visit
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Autopsy report
CDC Split Type:

Write-up: Child found deceased.


VAERS ID: 627312 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-03-16
Entered: 2016-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Arrhythmia, Death, Electrocardiogram QT prolonged, Long QT syndrome, Product label issue
SMQs:, Torsade de pointes/QT prolongation (narrow), Conduction defects (narrow), Torsade de pointes, shock-associated conditions (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Medication errors (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: Electrocardiogram, long QT
CDC Split Type: WAES1603USA006278

Write-up: This spontaneous report was received from a pharmacist via a returned survey and refers to unspecified number of patients of unknown age and gender. There was no information about the patient''s concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with GARDASIL (dose, frequency, route of administration, lot # and expiration date were not reported). On unknown dates, the patients experienced arrhythmogenic events, arrhythmogenic deaths or long QT episodes. The reporter found out about those events from a Food and Drug Administration (FDA) document from 2010. Since the pharmacist had a patient with congenital Long QT syndrome and the patient''s family was unsure if GARDASIL was safe to give, the pharmacist wanted the same information for the most recent 6 years to make an educated assessment for the patient. The pharmacist complained that these serious events were not mentioned in the package insert, while that information was needed for the patient. The outcome of arrhythmogenic events and long QT episodes was unknown. The outcome of arrhythmogenic deaths was fatal. The reporter considered the events to be associated with GARDASIL. Additional information has been requested.


VAERS ID: 627859 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Female  
Location: Iowa  
Vaccinated:2015-10-19
Onset:2015-10-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2016-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UI475AA / UNK RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Ear pain, Malaise, Paralysis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2015-11-25
   Days after onset: 35
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:
Current Illness: None
Preexisting Conditions: See medical records
Allergies:
Diagnostic Lab Data: See medical records
CDC Split Type:

Write-up: 10/21/15 Malaise. Symptoms continued until hospitalized on 11/10/15 with high fever. 11/17/15 Went to doctor - still having low fever, malaise and ear pain. Hospitalized 11/18/15 weakness, paralysis.


VAERS ID: 628086 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Unknown  
Vaccinated:2016-03-08
Onset:2016-03-12
   Days after vaccination:4
Submitted: 2016-03-18
   Days after onset:5
Entered: 2016-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS J5TZ7 / 1 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UI413AA / 1 LA / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M16259 / 1 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41DB526A / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-03-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2016037101

Write-up: This case was reported by a physician via sales rep and described the occurrence of unknown cause of death in a 2-month-old patient who received PEDIARIX. Co-suspect products included ROTARIX and PREVNAR. On an unknown date, the patient received PEDIARIX at an unknown dose, ROTARIX at an unknown dose and PREVNAR. On 12th March 2016, an unknown time after receiving PEDIARIX and ROTARIX, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The patient died on 12th March 2016. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to PEDIARIX and ROTARIX. Additional details were received as follows: The reporter stated that, after receiving previous vaccinations with PEDIARIX, ROTARIX and PREVENAR 13, the patient died.


VAERS ID: 628753 (history)  
Form: Version 1.0  
Age: 85.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2016-03-15
Onset:2016-03-19
   Days after vaccination:4
Submitted: 2016-03-21
   Days after onset:2
Entered: 2016-03-23
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M51193 / 1 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Arthralgia, Contusion, Death, Joint dislocation
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-03-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic illnesses
Preexisting Conditions: Diastolic Dysfunction; A-Fib; OSA
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Increase joint pain. Bruise noted (R) subluxed shoulder. Death - 4 days later.


VAERS ID: 628774 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-03-23
Entered: 2016-03-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2016GSK039459

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a subject who received dTpa vaccine. Co-suspect products included human papillomavirus quadrivalent vaccine. On an unknown date, 11 days after receiving dTpa vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to dTpa vaccine. Additional information was provided: This case was reported in a literature article and it described the occurrence of death in a patient of unspecified gender between the ages of 9 and 26 years who had received an unspecified tetanus-diphtheria-acellular pertussis booster and an unspecified quadrivalent HPV vaccine (manufacturers unknown). The authors identified this case while performing a retrospective review of medical records looking for deaths within 30 days of vaccination. No further information on the patient''s concurrent medical conditions, medical and family history or concomitant medication was provided. On an unspecified date, the patient received an unspecified tetanus-diphtheria-acellular pertussis booster and an unspecified quadrivalent HPV vaccine. Dosages unknown; administration routes and sites unspecified; batch numbers were not provided. On an unspecified date between 1 January 2005 and 31 December 2011, 11 days after the vaccination, the patient died of unknown causes. This was a fatal case and a post-mortem was performed, but no cause of death was identified by the coroner. Treatment was unknown. According to the authors, the Vaccine Safety Datalink working group determined the relationship between the vaccines and this death to be indeterminate due to the lack of information that made impossible to confirm or discard a causal association. The authors concluded that "to our knowledge, this study currently represents the largest population-based epidemiologic investigation of the association between vaccination and death among individuals 9 to 26 years of age. Although there has been significant research conducted on deaths after vaccination in both infants and older adults, this study fills a void by investigating deaths among older children and young adults. We assessed deaths after vaccination on a population level as well as an individual level to provide a complete evaluation of vaccine safety with regard to death. This research should reassure the public with regard to the safety of quadrivalent vaccine, as well as other vaccines routinely administered to individuals 9 to 26 years of age".


VAERS ID: 629237 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2016-03-02
Onset:2016-03-02
   Days after vaccination:0
Submitted: 2016-03-25
   Days after onset:22
Entered: 2016-03-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. L013428 / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Cardio-respiratory arrest, Chronic kidney disease, Chronic obstructive pulmonary disease, Death, Hospice care, Intensive care, Lactic acidosis, Leukocytosis, Liver function test abnormal, Posture abnormal, Respiratory failure, Shock
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Lactic acidosis (narrow), 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), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Dystonia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-03-03
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: diltiazem (CARDIZEM CD) 360 MG ER capsule; Cholecalciferol (VITAMIN D3) 2000 UNITS CHEW; levofloxacin (LEVAQUIN) 250 MG tablet; ipratropium-albuterol (DUONEB) 0.5-2.5 (3) MG/3ML SOLN nebulizer solution; sevelamer (RENVELA) 800 MG tablet; wa
Current Illness:
Preexisting Conditions: Household Dust - sneezing/congestion, Lexapro - headache/migraine, Penicillins - itching, Sulfa Antiobiotics - itching, Questionable reaction to Revaclear dialyzer - became hypotensive/dizzing/slow to respond on two occasions.
Allergies:
Diagnostic Lab Data: Cause of Death: 1.S/P Cardiac arrest likely due to respiratory arrest. 2.Acute hypoxemic hypercapnic respiratory failure 3.Shock 4.Severe COPD 5.ESRD on HD 6.History of Afib on Chronic Coumadin therapy 7.Lactic acidosis 8.Leucocytosis 9.Abnormal LFT''s
CDC Split Type:

Write-up: Patient had her routine dialysis and was administered PPV23. Went home, felt weak. Husband found her slouched over. 911 called. Patient sent to ICU. Placed on comfort cares and passed away.


VAERS ID: 629385 (history)  
Form: Version 1.0  
Age: 90.0  
Sex: Female  
Location: New York  
Vaccinated:2015-10-28
Onset:2015-10-28
   Days after vaccination:0
Submitted: 2016-03-28
   Days after onset:152
Entered: 2016-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M03211 / UNK UN / UN

Administered by: Private       Purchased by: Other
Symptoms: Asthenia, Death, Decreased appetite, Nausea, Pneumonia, Tremor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-03-19
   Days after onset: 143
Permanent Disability? Yes
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: 81 mg. aspirin; levothyroxine; losartan
Current Illness: None
Preexisting Conditions: Penicillin, codeine, myacins, sulfa drugs
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Weakness, tremors, loss of appetite. My mother never really recovered after this. She was hospitalized a week or so after receiving the vaccine. She contracted a "community aquired pneumonia" in the hospital then had to go to a rehab center. his was the beginning of the end for her. She was weak with tremors and loss of appetite and nausea for weeks.


VAERS ID: 629846 (history)  
Form: Version 1.0  
Age: 0.11  
Sex: Female  
Location: Tennessee  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-03-29
Entered: 2016-03-30
   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: Bacterial infection, Bronchial wall thickening, Chemotherapy, Chest X-ray abnormal, Circulatory collapse, Cough, Death, Extracorporeal membrane oxygenation, Lymphopenia, Mechanical ventilation, Nasal congestion, Neutropenia, Pneumonia, Polymerase chain reaction positive, Pyrexia, Respiratory distress, Respiratory failure, Respiratory syncytial virus infection
SMQs:, Anaphylactic reaction (narrow), Agranulocytosis (broad), Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (narrow), Hypokalaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Medicinal Product Name as Reported by the Primary Source: Cytarabine
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute lymphocytic leukaemia (Acute lymphoblastic leukemia)
Allergies:
Diagnostic Lab Data: Test Name: Nasopharyngeal wash specimen; Result Unstructured Data: bilateral peribronchial; Test Name: Chest x-ray; Result Unstructured Data: Left lower lobe consolidation pneumonia
CDC Split Type: USBEH2016060509

Write-up: This medically confirmed literature report (initial receipt 15-Mar-2016) concerns an 11 months old female patient who had a medical history of acute lymphoblastic leukemia (ALL) and received a high dose of cytarabine for reinduction II chemotherapy. She presented with a 3 day history of progressively worsening cough and nasal congestion and new onset of fever and respiratory distress with profound neutropenia and lymphopenia for which she was hospitalised. She had received palivizumab immunoprophylaxis 10 days before the development of her illness and 2 doses of seasonal influenza vaccine. Initial evaluation revealed bilateral peribronchial thickening and RSV (respiratory syncytial virus) was detected on a nasopharyngeal wash specimen by PCR. Aerosolized ribavirin treatment was initiated in addition to oxygen support and broad spectrum antibiotic therapy. However, due to progressive respiratory deterioration and increasing fever, a chest x-ray repeated on day 5 of hospitalization demonstrated left lower lobe consolidation pneumonia suggestive of secondary bacterial infection. Her treatment regimen included vancomycin, meropenem, azithromycin, voriconazole, palivizumab, and aerosolized ribavirin. On hospital day 28, her condition progressed to respiratory and hemodynamic failure requiring mechanical ventilation and vasopressor followed by extracorporeal mechanical oxygenation support. She died 2 months after onset of the RSV infection. The outcome was fatal. Reporter''s Comments: n/a. Sender''s Comments: Company comments: Seriousness: Serious. Fatal Listedness: Unlisted. Vaccine brand unspecified. Assessment according to the agency for CSL Inactivated Influenza Virus Vaccine and the AFLURIA Product Information all events are unlisted except pyrexia, nasal congestion, and cough. Causality: Unassessable. The events pertaining to inappropriate age at vaccine administration is unassessable. For all other events, it is unrelated. The reports pertains to a pediatric patient undergoing chemotherapy who developed various respiratory symptoms. Further investigation revealed that causative agents were RSV and a bacterial pathogen. Patient has also received chemotherapy which can cause neutropenia and lymphopenia. In the clear presence of laboratory demonstration of offending causal agents, and a known recent history of leukemia and chemotherapeutic treatments, the reported systemic symptoms, respiratory events, and hematologic parameters are considered unrelated to influenza vaccine.


VAERS ID: 630145 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: Tennessee  
Vaccinated:2015-12-18
Onset:2015-12-21
   Days after vaccination:3
Submitted: 2016-04-02
   Days after onset:102
Entered: 2016-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS L49EE / 1 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. L030867 / 1 - / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L99276 / 1 - / IM

Administered by: Private       Purchased by: Public
Symptoms: Cardiac arrest, Hyporesponsive to stimuli, Resuscitation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-01-15
   Days after onset: 25
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 25 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Poly-Vi-Sol with Iron
Current Illness: no
Preexisting Conditions: 29 wk EGA premature holoprosencephaly absent corpus callosum hypoplastic cerebellum heterotopia ventriculosubgaleal shunt G-tube in place for feeding multiple developmental delays VSD
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient found by Mom poorly responsive. EMS called and arrived and able to resuscitate patient with multiple rounds of CPR and epinephrine. Patient brought to outlying ER then transferred to another Hospital with diagnosis of cardiac arrest.


VAERS ID: 630268 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: Arizona  
Vaccinated:2016-04-01
Onset:2016-04-03
   Days after vaccination:2
Submitted: 2016-04-04
   Days after onset:1
Entered: 2016-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS E3L32 / 1 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. L038501 / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M77341 / 1 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-04-04
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: None reported or evident on history or physical exam
Preexisting Conditions: no significant past medical history
Allergies:
Diagnostic Lab Data: autopsy pending
CDC Split Type:

Write-up: Cardiac arrest.


VAERS ID: 630511 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Louisiana  
Vaccinated:2015-05-20
Onset:0000-00-00
Submitted: 2016-04-04
Entered: 2016-04-06
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4806AA / 1 RL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS P292C / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 43522 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. K01022 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-05-29
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: Do not have coroner''s report
CDC Split Type:

Write-up: None stated.


VAERS ID: 630787 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Male  
Location: New York  
Vaccinated:2015-01-14
Onset:2015-01-14
   Days after vaccination:0
Submitted: 2016-04-09
   Days after onset:450
Entered: 2016-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI245AA / 7+ LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4812AA / 2 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-01-19
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Insulin, Levothyroxine, Albuterol
Current Illness: Within a couple of days, flu like symptoms developed. Death followed, early on January 19th. Coroner only mentioned pneumonia, which was not present prior to vaccination.
Preexisting Conditions: Diabetes, Asthma, more
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Flu like symptoms, followed by death on Jan 19. Coroner mentioned pneumonia.


VAERS ID: 630847 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Female  
Location: Unknown  
Vaccinated:2015-10-13
Onset:2015-11-06
   Days after vaccination:24
Submitted: 2016-04-08
   Days after onset:153
Entered: 2016-04-11
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH I87117 / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Bedridden, Chills, Death, Decreased appetite, Dizziness, Dysstasia, Fatigue, Hyperhidrosis, Lethargy, Listless, Malaise, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-11-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015378579

Write-up: This is a spontaneous report from a contactable consumer who reported for her mother. An 80-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on 27Oct2015 or 28Oct2015 and influenza vaccine, via an unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were not reported. The next day after vaccination (Oct2015), the patient was still very sick, dizziness/lightheadedness, loss of appetite, fatigue, listlessness, body aches, sweats, chills, fever, bedridden, lethargic, unable to stand. No treatment received. These symptoms started out the next day and increased plus multiplied within the time of her death. The patient died on 06Nov2015. It was not reported if an autopsy was performed. Follow-up (13Nov2015): New information reported from a contactable consumer includes: primary reporter''s information. Follow-up (08Jan2016): Follow-up attempts completed. No further information expected. Follow-up (04Apr2016): New information obtained from the same contactable consumer includes: additional events, additional suspect drug, date of administration of PREVNAR 13.


VAERS ID: 631561 (history)  
Form: Version 1.0  
Age: 0.35  
Sex: Female  
Location: Texas  
Vaccinated:2015-08-27
Onset:2015-08-27
   Days after vaccination:0
Submitted: 2016-04-14
   Days after onset:231
Entered: 2016-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4937AA / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. L008034 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-08-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No, she was never sick in the four months she was here. The doctor office, checked her temperature before the vaccine was administered, and examined her.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: She passed away.


VAERS ID: 632241 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: New Jersey  
Vaccinated:2016-04-13
Onset:2016-04-14
   Days after vaccination:1
Submitted: 2016-04-20
   Days after onset:6
Entered: 2016-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4915AA / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M60991 / 1 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41DB537A / 1 MO / PO

Administered by: Unknown       Purchased by: Public
Symptoms: Apnoea
SMQs:, Acute central respiratory depression (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-04-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Ex-premie at 27 weeks gestation
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Apnea.


VAERS ID: 632567 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Female  
Location: Alabama  
Vaccinated:2016-03-28
Onset:2016-04-11
   Days after vaccination:14
Submitted: 2016-04-13
   Days after onset:2
Entered: 2016-04-22
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 2PY24 / 2 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UI179AA / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M29042 / 2 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. L022447 / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-04-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Nystatin ointment
Current Illness:
Preexisting Conditions: Ankyloglossia
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient presented in full cardiac arrest, reportedly found down and not breathing. She was coded for $g 20 minutes without success - presented to hospital 4/11/2016.


VAERS ID: 632726 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-04-20
Entered: 2016-04-25
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / 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: Yes
Preexisting Conditions: Malaise
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2016216559

Write-up: This is a spontaneous report from a non-contactable physician communicated to a Pfizer sales representative. An elderly female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration at 0.5 ml, single on unknown date. Medical history included that the patient was very sick. Concomitant medications were not reported. Very very very old patient received PREVNAR 13 and the next day, she passed away on an unspecified date. It was not reported if an autopsy was performed. Physician causality assessment: 100% sure that the PREVNAR 13 had nothing to do with the patient''s passing. No follow-up attempts possible. No further information expected.


VAERS ID: 633027 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-04-26
Entered: 2016-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1604USA015430

Write-up: This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The physician mentioned that he recently reviewed a manuscript that reported a ZOSTAVAX-related death (dose, lot number, route, date of vaccination and date of the event were not provided). The report would be electronically published (journal unknown). The cause of death was not provided. It was unknown if autopsy was performed. The causality between the suspect drug and the event was not reported. Additional information has been requested.


VAERS ID: 634569 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: California  
Vaccinated:2015-09-02
Onset:0000-00-00
Submitted: 2016-05-06
Entered: 2016-05-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Fatigue, Influenza, Pain
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2015SA204766

Write-up: Based on the additional information received on 07 March 2016, this case initially considered as non-serious was upgraded to serious due to death of the patient. Initial unsolicited report received from a physician on 03 December 2015. This case involves a male patient (age unknown) who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, route, dose in series and site of administration were not reported) on 2 September 2015. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient experienced flu symptoms, exhaustion and body ache. Laboratory investigation and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none. Follow up information received from Physician on 07 March 2016. It was reported that, patient''s details could not be obtained as patient died (details not provided) on an unspecified date. Sender''s Comments: Initial case, reported events was flu symptoms, exhaustion and body ache with patient has since Deceased (from other reason)" date was not reported and in follow-up reported that patient has since Deceased (from other reason)" date was not reported. limited information was provided in document. Additional information on patient''s medical history and concomitant medications, health status at vaccination, final diagnosis and complementary investigations ruling out alternative etiology and autopsy report are needed for complete assessment. Based on available information, role of vaccine cannot be established. Reported Cause(s) of Death: death nos.


VAERS ID: 634742 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-05-06
Entered: 2016-05-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK 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: WAES1605USA003129

Write-up: This spontaneous report was received from a consumer referring to a young patient of unknown age and gender. The patient''s pertinent medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with GARDASIL (anatomical route of vaccination, lot number and expiration date were not provided). The patient''s concomitant medications were not reported. The reported stated, that after watching TV news, heard about a young child who collapsed and died after receiving GARDASIL. At the time of the report, the outcome was reported as fatal. Relatedness between the adverse event and vaccination with GARDASIL was not provided. This is one of several cases received from the same source. MARRS: 1605USA003026. Additional information has been requested.


VAERS ID: 634789 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2016-03-18
Onset:2016-03-24
   Days after vaccination:6
Submitted: 2016-05-09
   Days after onset:46
Entered: 2016-05-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C4709AA / UNK UN / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR L10011 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Autopsy, Death
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-03-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2016SA084263

Write-up: Initial unsolicited report received from a physician on 27 April 2016. This case involves a four-year-old female patient who was vaccinated with a dose of DAPTACEL (batch number C4709AA, expiration date: 24 February 2017, via intramuscular route, dose, dose in series and site of administration was not reported) and a dose of IPOL (batch number L1001-1, expiry date: 14 January 2017, via intramuscular route, dose, dose in series and site of administration was not reported), both on 18 March 2016. Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions was not reported. Concomitant medications were not provided. On an unspecified date following the vaccination, the patient developed abdominal pain and returned to the physician''s office on 23 March 2016 who requested that the child be taken immediately to the emergency room. It was reported that there was no information on what medical facility the patient was taken to or whether the patient was actually taken. On 24 March 2016, six days following vaccination, the patient died. Lab data and corrective treatment were not reported. Patient had not recovered from abdominal pain event at the time of death. It was reported that autopsy was pending. List of documents held by sender: none. Sender''s Comments: This is a poorly documented death case of a child who was vaccinated with diphtheria-15/tetanus/5 AC pertussis vaccine and IPV (VERO). Five days after vaccination, patient experienced abdominal pain and died the next day. Patient was taken for physician consultation on having abdominal pain, however was referred to emergency room and no further details were provided. No information regarding any previous history of abdominal pain, relevant medical and birth history, underlying cause of death and any diagnostic testing reports were provided. Autopsy result was not available. Due to the very limited available information, causality cannot be assessed for now. Reported Cause(s) of Death: abdominal pain; death nos.


VAERS ID: 636334 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2009-05-01
Submitted: 2016-05-20
   Days after onset:2576
Entered: 2016-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1605USA009589

Write-up: Information was received from a physician via an internet article regarding cases in litigation concerning female patients of unknown age, who received vaccinations with GARDASIL (lot numbers, dates of vaccination, dosages, and routes of administration not reported). It was reported that between May 2009 and September 2010, 16 deaths occurred after GARDASIL vaccination (causes of deaths not reported). It was unknown if autopsies were performed. Upon internal review, 16 deaths was determined to be medically significant. This is one of several reports from the same source. Additional information is not expected.


VAERS ID: 636483 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-05-23
Entered: 2016-05-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1605USA009476

Write-up: This spontaneous unconfirmed report was received from a healthcare worker via a company representative and refers to a patient of unknown age and gender. The reporter read about this information on the internet (unspecified website). No information regarding the patient''s pertinent medical history, concomitant medication and drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with a dose of unidentified Merck HPV vaccine (name, strength, dose, route of administration, anatomical location, lot # and expiration date were not provided). Reporter could not confirm whether the product was GARDASIL or GARDASIL 9. On an unknown date, 36 hours after receiving a dose of unidentified Merck HPV vaccine, the patient died of an unspecified cause. The relatedness between the patient''s death and unidentified Merck HPV vaccine was not reported. Upon internal review, the event of death was considered to be medically significant. Additional information is not expected as the reporter did not have any additional information and did not wish to be contacted regarding this report.


VAERS ID: 636685 (history)  
Form: Version 1.0  
Age: 0.0  
Sex: Female  
Location: Alabama  
Vaccinated:2010-08-16
Onset:2010-08-17
   Days after vaccination:1
Submitted: 2016-05-23
   Days after onset:2106
Entered: 2016-05-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK - / -

Administered by: Public       Purchased by: Other
Symptoms: Crying, Cyanosis, Depressed level of consciousness, Eye swelling, Glassy eyes, Jaundice, Respiratory arrest
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (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: 2010-08-22
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: vitamin K
Current Illness: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Stopped breathing, turned blue on extremities, stopped being alert, became jaundice, stopped crying, eyes always glassed over and swollen.


VAERS ID: 636811 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Michigan  
Vaccinated:2016-05-11
Onset:2016-05-12
   Days after vaccination:1
Submitted: 2016-05-13
   Days after onset:1
Entered: 2016-05-24
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C5070AB / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M77340 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. L037574 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-05-12
   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: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Infant was well on examination at visit when got her vaccines but was apparently found unresponsive that night.


VAERS ID: 637017 (history)  
Form: Version 1.0  
Age: 1.29  
Sex: Male  
Location: Idaho  
Vaccinated:2016-05-12
Onset:2016-05-22
   Days after vaccination:10
Submitted: 2016-05-25
   Days after onset:3
Entered: 2016-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS CY2SN / 4 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UI403AAA / 4 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-05-22
   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: None noted
Current Illness: None noted
Preexisting Conditions: Hypospadias
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was found unresponsive.


VAERS ID: 637176 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: New York  
Vaccinated:1985-10-10
Onset:2013-05-25
   Days after vaccination:10089
Submitted: 2016-05-26
   Days after onset:1097
Entered: 2016-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Private
Symptoms: Completed suicide, Death
SMQs:, Suicide/self-injury (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-05-25
   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: Child hood vaccines
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death by Suicide.


VAERS ID: 637297 (history)  
Form: Version 1.0  
Age: 94.0  
Sex: Female  
Location: Virginia  
Vaccinated:2016-05-09
Onset:2016-05-09
   Days after vaccination:0
Submitted: 2016-05-26
   Days after onset:17
Entered: 2016-05-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M51194 / UNK LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic reaction, Anaphylactic shock, Death, Endotracheal intubation, Intensive care, Lip swelling, Mechanical ventilation, Pneumonitis, Swelling, Swelling face
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Interstitial lung disease (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (narrow), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-05-19
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Baby aspirin; Simvastatin; CARTIA XT; Cilostazol; Lisinopril; Glimepiride; Oxybutynin; NITROGLYCERIN
Current Illness: Unknown
Preexisting Conditions: CELEBREX, hypersensitivity; 03/2012, PNEUMOVAX, Immunisation, No adverse event; Influenza virus vaccine, Immunisation, No adverse event; Type 2 diabetes mellitus; Hypertension; Blood cholesterol increased; Arteriosclerosis coronary artery; Glaucoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2016271852

Write-up: This is a spontaneous report from a contactable physician. A 94-year-old female patient received a single dose of PREVNAR 13, on 09May2016 at in the left deltoid. Medical history included type 2 diabetes mellitus, high blood pressure, high cholesterol, coronary atherosclerosis and glaucoma. Concomitant medication (all prescribed by cardiologist) included: baby aspirin at 81 mg daily, simvastatin at 20 mg daily, CARTIA XT 240, per 24 hours, cilostazol at 50 mg 2x/day, lisinopril at 10 mg daily, glimepiride at 2 mg 1x/day, oxybutynin 5 mg daily and nitroglycerin 0.4 mg, as needed sublingual. Past drug history included allergy to CELEBREX. On Mar2012 patient took PNEUMOVAX without any complications and with no problems and on unknown date patient had flu shots with no problems. On 09May2016 after giving the PREVNAR 13, the patient had a shock (anaphylactic shock) and she began to swell later in evening. She was admitted to the hospital on 09May2016 with anaphylactic shock. It was also reported that the patient had developed pneumonitis and her face and lips were swelling. The patient was intubated. She was in Intensive Care on the ventilator, and was in the emergency room for about 3 hours and the patient was given SOLU-MEDROL, BENADRYL and fresh frozen plasma. The patient subsequently died on 19May2016 due to anaphylactic reaction to PREVNAR 13. No autopsy was performed. The outcome of the other events was unknown.


VAERS ID: 637787 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Maryland  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-06-02
Entered: 2016-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Apnoea, Death, Pulse absent, Pyrexia, Respiratory tract congestion, Sudden infant death syndrome
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Neonatal disorders (narrow), Respiratory failure (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:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2016SA101526

Write-up: Initial unsolicited report received from the literature on 23 May 2016. Abstract: Background: Measles is resurging, with more than 700 confirmed cases since January 2014. During measles outbreaks, vaccination as early as at 6 months of age is sometimes recommended for infants who are at risk for exposure. Methods: We searched the Vaccine Adverse Event Reporting System for reports of measles, mumps, and rubella vaccine combined (MMR) or measles, mumps, rubella, and varicella vaccine combined (MMRV) vaccination in children less than 9 months of age. We performed a clinical assessment of each report and summarized the frequency, range, onset time, and severity of adverse events. Results: After excluding 346 reports because they were duplicates or because they contained insufficient information about the child''s age or vaccine(s), we retained 204 reports in the analysis, including 35 (17%) that were serious. Among the 169 non-serious reports, more than half (88; 52%) described a vaccination error without any adverse event per se. Other non-serious reports described fever, injection reactions, and gastrointestinal symptoms. Serious adverse events included developmental disorders, fever, and fussiness. There were 44 reports of fever, but only 4 cases began 5-12 days after immunization, the peak risk window. The vast majority of fever reports listed concomitant vaccines, such as diphtheria and tetanus toxoids, acellular or whole-cell pertussis vaccine. Conclusions: This review did not identify any major safety concerns. These findings may facilitate discussions about the risks and benefits of vaccinating infants who are potentially exposed to this life-threatening disease. This case involves a three-month-old male patient who was vaccinated with a dose of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED) (DTP) (manufacturer: unknown, batch number, expiration date, dose, route and site of administration were not reported) and a dose of MEASLES, MUMPS AND RUBELLA VACCINE (MMR) (manufacturer: other, batch number, expiration date, dose, route and site of administration was not reported) both on an unspecified date. The patient had no significant past medical history. Concomitant medications were not reported. On an unspecified date, same day (reported as within one day) following vaccination, the patient had experienced congestion and fever (temperature not specified). On the following morning, one day post vaccination, the patient was found pulseless, apneic. An autopsy was not performed, but the death certificate listed sudden infant death syndrome (SIDS) as the cause of death. Laboratory investigations and corrective treatment were not reported. The outcome of the events congestion and fever was not reported. List of documents held by sender: none. Sender''s Comments: In this case from medical literature, the 3-month-old patient died due to sudden infant death syndrome (SIDS) 2 days after having received vaccination with DTP and MMR. The reason for early administration of MMR was not stated. SIDS was considered as the cause of death in the death certificate though autopsy was not performed. The patient had developed fever and some unspecified congestion the next day after receiving the vaccines which could suggest the possibility of underlying infection. This case is insufficiently documented to draw a conclusion on a relationship with vaccine administration. Most frequent causes of sudden death in infants include infections, sudden infant death syndrome, inherent errors in metabolism, undiagnosed congenital anomalies. No information is provided on conditions at the time of death, sleeping position, patient''s history, previous vaccination history, autopsy or results of investigations; if performed in hospital. Moreover, the patient received two vaccines simultaneously making it difficult to assess the role of one vaccine in particular. Reported Cause(s) of Death: sudden infant death syndrome (SIDS).


VAERS ID: 637892 (history)  
Form: Version 1.0  
Age: 61.0  
Sex: Male  
Location: Texas  
Vaccinated:2016-04-22
Onset:2016-05-02
   Days after vaccination:10
Submitted: 2016-06-03
   Days after onset:32
Entered: 2016-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (ACAM2000) / SANOFI PASTEUR VV03011C / 5 LA / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiovascular examination, Death, Electrocardiogram T wave amplitude decreased, Myocardial infarction, Road traffic accident
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Accidents and injuries (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-05-05
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2016SA099702

Write-up: Initial solicited report received on 23 May 2016 from an investigator participating in a study. This case involves a 61-year-old male subject who had heart attack and car accident during the study participation. Medical history was not relevant on record and there were no concomitant medications on record. On 02 May 2016, 10 days after receiving a single dose of blinded therapy 2.5 mcl on 22 April 2016 (route and site of administration were not reported; batch number: VV-03-011-C and expiry date: 17 May 2016), the subject had heart attack and car accident. The event appeared after visit was not reported. Prior to study participation, the subject was a regularly attending plasma donor at the site since 28 July 2015. The subject was screened for participation in study protocol on 19 April 2016. There were no abnormalities found during the subject''s physical exam. The ECG showed normal sinus rhythm flat T waves in lead I, aVL and V2-V6 considered by the cardiologist as abnormal electrocardiogram (ECG) but insignificant. The set of labs as per standard to protocol and the physical examination during screening were reviewed on 21 April 2016 and considered acceptable by the primary investigator for enrollment. The subject was vaccinated after undergoing a second physical exam and basic cardiopulmonary assessment during the same visit. There were no abnormal findings during these exams on this day. The subject was seen at this site for day 3 post-vaccination site check on 25 April 2016 and underwent a basic cardiopulmonary assessment. This was the last contact this study site had with this subject. On 17 May 2016, after noticing that the subject had missing 3 visits, the site attempted to contact the subject; the subject''s roommate answered the phone, who in turn notified of the subject''s death. The roommate said that the subject had a heart attack while driving 02 May 2016. The subject was transported to an emergency room via ambulance and was admitted to an undisclosed inpatient wing of the hospital. It was currently unknown if the heart attack preceded the motor vehicle accident or if the motor vehicle accident preceded the heart attack. The subject was declared deceased on 05 May 2016. No other information was available at this moment. The principal investigator had considered that the heart attack and the motor vehicle accident are "unassessable" as the information was limited; reason for which he requested additional information from the treating hospital. The approval for the release of the subject''s medical records was pending until the subject''s death certificate had been issued from the coroner''s office. Basic cardiopulmonary assessment showed no abnormal findings at day 03 post-vaccination. Other lab data was recorded before vaccination and event onset. The corrective treatment were not reported. The outcome of the events heart attack and car accident was fatal and the subject died on 05 May 2016. According to the investigator, at the time of report the information was inconclusive to properly assess the case. Relationship to investigational product according to Company: not associated. The information whether the serious adverse event led to the termination of the subject from the study or not, was not reported. List of documents held by sender: none. Sender''s Comments: A 61-year-old male subject died 10 days after receiving a dose of ACAM2000 vaccine due to myocardial infarction and car accident. It was not clear which event preceded the other. Details of Autopsy and death certificate were not reported at the time of this report. Based on limited data available, the sponsor assesses this event as not related to study vaccine or procedure in agreement with the investigator. Reported Cause(s) of Death: myocardial infarction; road traffic accident.


VAERS ID: 638043 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-06-06
Entered: 2016-06-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1606USA001151

Write-up: This spontaneous report was received from a physician and refers to two patients of unknown demographics. The physician was told about the event by other patient. The patients'' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with GARDASIL or GARDASIL 9 (lot #, dose and route were not provided). On unknown dates, the patients died. The causes of death were not reported. The relatedness between the event and suspect vaccine was not reported. Upon internal review, the event of death was considered to be medically significant. Additional information has been requested.


VAERS ID: 638257 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-06-07
Entered: 2016-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1606USA001917

Write-up: This spontaneous report as received from a physician refers to two patients of unknown demographics. The patients'' pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patients were vaccinated with GARDASIL (strength, dose, frequency, therapy route, indication and lot number were not reported) (unspecified if the product was GARDASIL or GARDASIL 9). Concomitant medications were not reported. The physician reported that, an unspecified patient mentioned that two patients died after receiving the vaccine. The cause of the death was not reported. The outcome of event was fatal. Causality assessment was not provided. No product quality complaint was reported. Upon internal review, death was considered as medically significant. Additional information has been requested.


VAERS ID: 638374 (history)  
Form: Version 1.0  
Age: 0.37  
Sex: Male  
Location: New Mexico  
Vaccinated:2016-03-02
Onset:2016-03-03
   Days after vaccination:1
Submitted: 2016-06-08
   Days after onset:96
Entered: 2016-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS E443F / 2 RL / UN
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. L009649 / 2 LL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M77340 / 2 LL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. L023866 / 2 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Atrial septal defect, Autopsy, Cardiac failure congestive, Death, Influenza, Pyrexia, Unresponsive to stimuli
SMQs:, Cardiac failure (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Congenital, familial and genetic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-03-03
   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: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Autopsy by Medical Examiner cause of death congestive heart failure due to ASD (secundum) and Influenza A
CDC Split Type:

Write-up: Infant received PEDIARIX, PREVNAR, PEDVAX and ROTATEQ vaccines on 3/2/16. He had slight fever that evening. In AM afebrile, eating well. Mom put down for nap and 2 hrs later found him unresponsive.


VAERS ID: 638978 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Male  
Location: Oklahoma  
Vaccinated:2015-09-18
Onset:2015-09-21
   Days after vaccination:3
Submitted: 2016-06-13
   Days after onset:266
Entered: 2016-06-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI4228AB / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Feeling hot, Hyperhidrosis, Impaired work ability, Malaise, 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: 2015-09-21
   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: The only other medications we were aware of that patient was taking was high blood pressure medications. Patient was also on a CPAP machine nightly for his Sleep Apnea. Patient and his brother both have taken the flu shot every year their
Current Illness: No.
Preexisting Conditions: High blood pressure and sleep apnea.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient started feeling ill after his night shift started. He worked as an overnight stocker at the location where he received the vaccination. As the night went on, patient started feeling sick and after his lunch break around 2 am he got hot, feverish and was sweating profusely. He went and sat down in the meat cooler to try and cool down for a few minutes. After awhile he told his supervisor and a co-worker that he was leaving to go home sick. He asked his co-worker to get the chair for him he left in the cooler and left his jacket there overnight. It is not like patient to leave work early, much less ask someone to get a chair for him that he left behind. The next night he called in sick again from work which was Sunday, Sept. 20, 2015. He died later that evening according to paramedics whom did not find him until a good friend and next door neighbor found him laying on the floor in his home dead on Monday, Sept. 21 around 6:39 PM. The paramedics and sheriff said he had been gone for possibly 18-24 hours.


VAERS ID: 639404 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-06-14
Entered: 2016-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1606USA006441

Write-up: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. There was no information about the patient''s concomitant medications, allergies and pertinent medical history reported. On an unknown date, the patient was vaccinated with a dose of HPV vaccine (manufacturer unknown) (dose, strength, route of administration, lot# and expiry date were not reported) and a dose of FLUMIST (dose, strength, route of administration, lot# and expiry date were not reported). It was reported that the patient went back to the physician office the same day of vaccination for an unspecified reason. The next day (date unspecified), the patient died. Cause of death was not reported. The causality between the suspect vaccines and the patient''s death was not reported. Upon internal review the event was considered to be medically significant. This is one of several reports received from the same source. Additional information is not expected as there was no contact details provided.


VAERS ID: 639596 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-06-16
Entered: 2016-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Death, Herpes zoster disseminated, Herpes zoster infection neurological, Ophthalmic herpes zoster
SMQs:, Ocular infections (narrow), Sepsis (broad), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1606USA007102

Write-up: This spontaneous report was received from a pharmacist via company representative, and refers to an elderly male patient in his 70''s or older. Concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, lot and expiration date were not provided) by "injection" route). There were no concomitant medications and co-suspect therapies reported. On an unknown date, after the vaccination with ZOSTAVAX, the patient developed shingles in his eye, herpes zoster disseminated and herpes zoster infection neurological (reported as "spread to the optic nerve and brain). A year later, on an unspecified date, the patient died. It was unknown if an autopsy was performed. The outcome of ophthalmic herpes zoster, herpes zoster disseminated and herpes zoster infection neurological were unknown. The causality between the events and the use of ZOSTAVAX was not reported. Upon internal review, the events of ophthalmic herpes zoster, herpes zoster disseminated, herpes zoster infection neurological and death were considered medically significant. Additional information is not expected due to permission to contact the reporter was not granted.


VAERS ID: 639719 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: New York  
Vaccinated:2007-10-10
Onset:2009-12-01
   Days after vaccination:783
Submitted: 2016-06-16
   Days after onset:2388
Entered: 2016-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0515U / 1 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal discomfort, Alopecia, Amnesia, Anaemia, Antinuclear antibody, Autoimmune disorder, Fatigue, Full blood count, Headache, Mobility decreased, Muscular weakness, Oedema, Plasmapheresis, Scleroderma, Skin discolouration, Swelling face, Throat tightness, Thrombotic thrombocytopenic purpura, Vertigo, Visual impairment
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Haematopoietic erythropenia (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Parkinson-like events (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (narrow), Renovascular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 43 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: EXTREME FATIGUE, CONSTANT HEADACHES, AUTO IMMUNE DISEASES STARTING. STARTED BEING WORKED UP FOR LUPUS. CAME DOWN WITH A DANGEROUS CASE OF TTP AND NOW DEALING WITH A VERY SERIOUS CASE SCLERODERMA BECAUSE OF IT. NEVER HAD ANY OF THESE ISSUES BEFORE EVER.
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: ANA PANEL, CBC, ALL CAN BE PROVIDED.
CDC Split Type:

Write-up: HEADACHES, SEVERE FATIGUE, SKIN DISCOLORATION, MUSCLE WEAKNESS, SEVERE ANEMIA, FACE PUFFINESS, EDEMA, VERTIGO, HAIR LOSS, VISION CHANGES, MEMORY LOSS, SEVERE MOBILITY ISSUES, STOMACH DISCOMFORT, ESOPHAGUS TIGHTENING. GONE THROUGH IMMUNOSUPPRESSANTS, CELLCEPT, PLAQUENIL, RITUXAN TWICE, PLASMAPHERESIS EVER SINCE.


VAERS ID: 639883 (history)  
Form: Version 1.0  
Age: 0.24  
Sex: Female  
Location: South Carolina  
Vaccinated:2014-09-22
Onset:2014-10-05
   Days after vaccination:13
Submitted: 2016-06-17
   Days after onset:621
Entered: 2016-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS KN2FL / 1 LL / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS K002747 / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H65720 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. K004432 / 1 MO / PO

Administered by: Unknown       Purchased by: Public
Symptoms: Autopsy, Central nervous system infection, Malaise, Peripheral coldness, Pneumonia, Respiratory arrest, Spinal cord infection
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-10-05
   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 at all
Preexisting Conditions: None at all
Allergies:
Diagnostic Lab Data: Autopsy reports
CDC Split Type:

Write-up: We had no sign at all of anything being wrong with patient. Until the night of Oct 4th. When she just didn''t seem to feel well. We put her to bed around 130 a.m. and woke up just a few hours later to find her not breathing and cold in her bed. Upon completion of her autopsy it was found that she had pneumonia and infection of the brain and spine.


VAERS ID: 640247 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Female  
Location: Iowa  
Vaccinated:2016-06-21
Onset:2016-06-21
   Days after vaccination:0
Submitted: 2016-06-21
   Days after onset:0
Entered: 2016-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M79320 / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Fall, Head injury, Pulmonary embolism, Resuscitation
SMQs:, Embolic and thrombotic events, venous (narrow), Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-06-21
   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: Tramadol; simvastatin 20 daily; nifedipine 60 daily
Current Illness: No illness, patient said no know allergies or previous reactions to IMZ
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient dropped to the floor and hit her head shortly after being immunized with Prevnar. CPR administered on site. Patient later died at hospital. Dr./coroner believes it was not related to the shot but rather a pulmonary embolism.


VAERS ID: 640654 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: California  
Vaccinated:2016-06-21
Onset:2016-06-23
   Days after vaccination:2
Submitted: 2016-06-25
   Days after onset:2
Entered: 2016-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M79321 / 1 RL / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Death, Laboratory test
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-06-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Redness at injection site~DTaP + HepB + IPV (no brand name)~1~0.17~Patient
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Pending
CDC Split Type:

Write-up: Death.


VAERS ID: 640843 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Male  
Location: Indiana  
Vaccinated:2016-06-20
Onset:2016-06-22
   Days after vaccination:2
Submitted: 2016-06-28
   Days after onset:6
Entered: 2016-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. M006141 / UNK RA / UN

Administered by: Private       Purchased by: Private
Symptoms: Chills, Cough, Death, Malaise, Pneumonia, Pneumonia bacterial
SMQs:, Anaphylactic reaction (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-06-27
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Aspirin; ROCALTROL; PLAVIX; FOLBIC; KEPPRA; AMITIZA; PROCARDIA-XL; PRILOSEC OTC; CRESTOR
Current Illness: No
Preexisting Conditions: Chronic constipation; Chronic kidney disease, stage 5; Essential hypertension with goal blood pressure less than 140/90; Pure hypercholesterolemia; Hyperhomocysteinemia; Anemia due to other cause, not classified; Moderate aortic stenosis; Cerebral infarction due to unspecified occlusion or stenosis of unspecified carotid arteries; No known allergies
Allergies:
Diagnostic Lab Data: Community acquired bacterial pneumonia
CDC Split Type:

Write-up: Pt was seen in the office for a AWV on 6-20-16 and was fine. He was given a pneumonia vaccine that day. Wife called the office 6-24-16 stating he started getting sick on 6-22-16 with chills and a cough. Pt became sicker and went to ER on the 26th and died on the 27th. Patient is a 82 y.o. male who presents for a "Annual Wellness" exam. Current concerns included AWV. Pt still sees cardio once a year for HTN, HLD, aortic stenosis and hyperhomocystenemia. Sees neuro once a year for stroke. Chronic constipation - stable. Takes AMITIZA prn if needed.


VAERS ID: 641009 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Unknown  
Vaccinated:2013-06-19
Onset:2013-07-05
   Days after vaccination:16
Submitted: 2016-06-28
   Days after onset:1089
Entered: 2016-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Apnoea, Asphyxia, Autopsy, Bed sharing, Death, Dyspnoea, Eye discharge, Feeling cold, Foetal exposure during pregnancy, Frustration tolerance decreased, Gastrooesophageal reflux disease, Haemorrhage, Irritability, Oral candidiasis, Petechiae, Pharyngeal disorder, Purulent discharge, Respiration abnormal, Respiratory arrest, Resuscitation, Snoring, Streptococcus test positive, Unresponsive to stimuli, Visceral congestion
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-07-05
   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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2016GSK088828

Write-up: This retrospective pregnancy case was reported by a consumer via other and described the occurrence of asphyxiation in a male neonate exposed to Tdap in utero. The mother received the product. Co-suspect product exposures included FLUARIX, ENGERIX B pediatric, PEDIARIX, ROTARIX, ACTHIB and PREVENAR 13. On an unknown date, the mother received Tdap and seasonal influenza vaccine. On 19th April 2013, the mother received ENGERIX B pediatric. On 19th June 2013, the mother received PEDIARIX and ROTARIX. On an unknown date, the mother received ACTHIB at an unknown dose. On 19th June 2013, the mother received PREVENAR 13. The mother''s last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The neonate was exposed to Tdap during the second trimester of pregnancy. At [weeks gestation], the neonate was born via vaginal delivery. The neonate was diagnosed with apnea (serious criteria GSK medically significant), irritability and dyspnea exacerbated. On 5th July 2013, the neonate experienced asphyxiation (serious criteria death and GSK medically significant). On an unknown date, the neonate experienced apnea (serious criteria GSL medically significant), breathing arrested (serious criteria GSK medically significant), unresponsive to stimuli (serious criteria GSK medically significant), difficulty breathing, snoring, eye discharge, oral thrush and maternal exposure during pregnancy. The neonate was treated with ZANTAC and TYLENOL. On an unknown date, the outcome of the asphyxiation was fatal and the outcome of the apnea, breathing arrested, unresponsive to stimuli, apnea, difficulty breathing, snoring, irritability, eye discharge, oral thrush, dyspnea exacerbated and maternal exposure during pregnancy were unknown. The neonate died on 5th July 2013. The reported cause of death was asphyxia. An autopsy was performed. The autopsy determined cause of death was unresponsive to stimuli, petechia and visceral congestion. It was unknown if the reporter considered the unresponsive to stimuli to be related to Tdap and seasonal influenza vaccine. It was unknown if the reporter considered the asphyxiation, apnea, breathing arrested, difficulty breathing, snoring, irritability, eye discharge and oral thrush to be related to ENGERIX B pediatric. It was unknown if the reporter considered the asphyxiation, apnea, irritability and dyspnea exacerbated to be related to PEDIARIX and ROTARIX. Additional details were provided as follows: This case was retrieved from a media research. The patient''s mother received Tdap and flu vaccine during her 2nd trimester of the pregnancy. At 40 weeks of gestation, the patient''s mother went into labor in a medical center. She was tested positive for Group B streptococcus and was given 2 doses of the antibiotic penicillin. Rest of pregnancy and labs negative. Since discharge home, has been healthy without fever. Soon after, the patient was born unresponsive, weighing 9 pounds and 2 ounces and had to be resuscitated immediately. After he was resuscitated, the patient was deemed in good enough health and then was injected with the vitamin K shot and hepatitis B vaccine. The two combined shots contain approximately 350 mcg of aluminum and both are linked to breathing problems, among other things. By the time the patient was 3 weeks old, his mother noticed him having gasping episodes while sleeping in his bassinet. When he was awoke, he let out a snoring sound as he would catch his breath, then he would go back to bed. When the patient was 5 weeks old, his apnoea episodes started occurring more frequently, about once every hour. The patient''s mother had to blow into her son''s mouth and nose to get him breathing again. On 26th May 2013, the patient''s mother rushed her son to the emergency room at hospital, begging for help. She knew something was very wrong, but the doctor would not listen to her and wrote the patient''s breathing problems off as reflux and gave her a prescription for ZANTAC and told her to follow up with his paediatrician. She felt helpless and was frustrated as they would not hook up the patient to a breathing monitor. At this visit, the patient''s emergency documentation included that a 5 week old male, previously healthy, who presented with abnormal respirations as per his mom. The patient had been having one gasping episodes for the last 2 weeks which occurred once a night when he was sleeping and was not associated with any other symptoms. He was sleeping and his mom hears him gasp more than 1 time, which woke him up for a few seconds but then he easily goes back to bed. No perioral or acrocyanosis noted. Last night he would have gasping about once an hour. Also has been having some left eye purulent discharge and oral thrush. The patient was still being breastfed. He was breastfed for several weeks and then switched to formula. He had no congestion, no runny nose, and no swollen eyes, none of the things you would associate with a food allergy. Believing the doctors knew best, the patient''s mother gave her son the prescription ZANTAC. This did not help him. The patient''s apnoea spells continued while she waited for him to be seen by his paediatrician. The patient''s mother found out the paediatrician and was required to submit a referral to the hospital for them to test the patient at their sleep disorder clinic. On 7th June 2013, the paediatrician sent the referral for them to do apnoea testing on the patient. An appointment was made for him to be seen by a nurse practitioner at the sleep clinic the following Monday. By this time, the patient''s mother had to breathe in her son''s nose and mouth more than once when he stopped breathing. After getting home from that appointment, the patient received a phone call about an hour later and was told Monday''s appointment was cancelled. She was told the patient could not be seen by a nurse practitioner because he was too young and that only a doctor of medicine (MD) could see him, which did not make sense. The patient''s mother was told they would put him on a waiting list to be scheduled to be seen. She was so shocked and upset at this. None of the doctors were doing anything to help her son. Weeks went by and the patient was still not scheduled to be seen. Then on his two-months check-up approached. The patient''s mother took all three of her children in to receive the vaccines on time, but she did not know vaccines were linked to apnoea and breathing problems. At the patient''s two-month well-baby check-up, the doctor neglectfully recommended him to receive the routine vaccines. The doctor assured his mother that the vaccines were safe and signed off for the nurse to vaccinate the patient with 8 more vaccine doses, even though his breathing problems had not been addressed. The patient''s mother entrusted the doctor with her son''s life and signed the paper, giving consent to vaccine. On 19th June 2013, when the patient''s weighed almost 15 pounds, the nurse administered the PEDIARIX, ACTHIB, PREVENAR 13 and ROTARIX, via needle three injections and one oral dose, for a total of 8 vaccine doses. After the patient received those two-month vaccinations, he was cranky and was given TYLENOL, which was recommended by the doctor. The patient''s breathing issues worsened. Days passed and the apnoea spells continued. The patient''s mother felt helpless and did not know what to do while waiting for the patient to be scheduled for an appointment. She would prop up the patient on his Boppy pillow and on one occurrence, she witnessed the patient holding his face and not breathing for fifteen seconds. The patient''s mother was so scared because when he would sleep, he was gasping for air more often and his apnea episodes was worsened following the two-month vaccines, but none of the doctors would help him. On 4th July 2013, after an eventful firework celebration on Independency Day, the patient was laughing and playing on his Boppy pillow. He went to sleep at around 11:30 pm, in a natural, elevated position, cradled in his mother''s arm, on his back. He had a bassinet he often slept in but sleeping next to mom was more preferred this night. On 5th July 2013, around 5:08 am, five hours after they fell asleep, his mother woke up thinking it was odd that the patient did not wake up yet, because he would normally wake up sooner, to feed. The patient was still in the same position he fell asleep in. He was on his back and completely face up. His mother needed to get up and when she moved her arm out from under him, he rolled off her arm and onto his face. He did not try to move. The patient''s knew something was wrong. She picked him up and yelled his name. The patient was still warm, but his lips were cold. She yelled for his dad to call. It took the ambulance eight minutes to get to them and they only lived two blocks away. The ambulance showed up and emergency responders took the patient and tried to revive him. All attempts to resuscitate the patient were unsuccessful and he was pronounced dead at the hospital, at 5:51 am. He was only two and a half months old. When the patient died, the emergency responders noted that he had a significant amount of blood in the back of his throat and that no foul play was suspected. The patient''s parents were separated from each other and they felt like being held hostage and treated like criminals. Once the patient''s parents were allowed to leave the hospital, less than 2 hours later, hospital phoned his mother, to ask if she would give permission for them to donate the patient''s usable organs and tissue. The patient''s mother could not handle this and was so upset and told them not to touch her baby. The patient''s immediate cause of death on his autopsy report was labeled as probable asphyxiation, due to co-sleeping with an adult, leaving his mother feeling guilty she was responsible. It was ruled accidental. He had a significant amount of blood in the back of his throat and many of his organs were congested. His body was starved of oxygen. There were no signs of suffocation when he died, he was on his back and no object was obstructing his airways. The patient had no blood vessels that burst in his eyes, he had no petechiae in his eyes, no swelling of his face, no bruising on his face, no blood pooling in his face and his face was not discoloured, which are things a person would show signs of if they truly suffocated. Major findings during in the patient''s autopsy report were probably asphyxia, history of being found unresponsive, after co-sleeping with adult, thymus and lung petechiae and severe congestion of internal organs. Based on these findings, the patient''s immune system was overstimulated. These findings on his autopsy report are typical of someone who suffered a severe reaction, associated with an immune system or asthma related inflammatory response. Petechiae found in the thymus and lungs represents his capillaries were bleeding, where blood was able to leak into the skin. Vaccines can affect the thymus, but no vaccines were mentioned in his autopsy report. In viewing the vaccine package inserts to the vaccines given to the patient, one can read that sepsis, apnoea, breath holding, SIDS, allergic reaction, etc. are listed as associated risks to these vaccines. The patient''s mother was not informed by the paediatrician that all of the vaccines the patient received were associated with breathing problems and apnea as possible adverse reactions, which was stated on each of the vaccine package inserts to the vaccines given to the patient. Had the mother knew this information, she wouldn''t have allowed him to be vaccinated further. The patient''s death was plausibly an iatrogenic death, due to a medical intervention that involved vaccination. This should not be ignored and his mother, along with an endless number of other parents, wanted her child''s death certificate changed to acknowledge vaccines as the most plausible contributing factor in the death of their child.


VAERS ID: 641317 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: Florida  
Vaccinated:2015-08-28
Onset:2015-08-29
   Days after vaccination:1
Submitted: 2016-06-30
   Days after onset:306
Entered: 2016-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. 738472 / UNK - / ID

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2015-08-29
   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: ADHD
Preexisting Conditions: Allergies
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death


VAERS ID: 641781 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: Texas  
Vaccinated:2016-01-25
Onset:2016-02-18
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2016-07-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UI524AA / UNK LA / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M27555 / UNK LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Brain injury, Cardiac arrest, Chest X-ray abnormal, Coma, Death, Dyspnoea, Electrocardiogram normal, Malaise, Oxygen saturation decreased, Pleural effusion, Pneumonia bacterial, Pneumonia fungal, Resuscitation, Staphylococcal infection
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-03-08
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: See attached
Current Illness: None
Preexisting Conditions: Hypertensive under control w/med
Allergies:
Diagnostic Lab Data: See attached chest x-ray 2/3/16 was clear
CDC Split Type:

Write-up: Patient did not feel well at all within 1 hr of receiving the flu and PREVNAR 13 vaccines. On Feb 18 he started complaining of feeling like he had fluid on his lungs, went to emergency room. They did EKG was ok, chest x-ray showed small amount of fluid in left lung. Was given LASIX seemed to clear up. This was a Thurs doctor not in on Fri, was going to go to Dr on Tues, but early Tues 2/23/16 morning around 1:30 am was having trouble getting air into lungs went to hospital by ambulance around 6 AM. Heart stopped on way to hospital lungs so full of fluid his heart could not beat. Was resuscitated but due to already depleted oxygen level irreparable brain damage occurred, was in coma 2 weeks and passed. I know him being given the flu vaccine and the PREVNAR 13 vaccines at the same time killed my husband. This practice has to stop! He was transferred from one hospital to another. While in hospital we were advised of bacterial pneumonia, fungal pneumonia and B3 staph were present. Previously thought CHF or COPD but was never diagnosed with this. X-rays of 2/3/16 show all clear no signs of problems. Testosterone usage was not understood by doctor, at all. He used 1 mL every 10 days NOT 200 mg a week. Doctors in hospital said his usage had no relation to his condition. Once pneumonia found CHF and COPD dismissed.


VAERS ID: 642053 (history)  
Form: Version 1.0  
Age: 1.28  
Sex: Male  
Location: Texas  
Vaccinated:2016-02-17
Onset:0000-00-00
Submitted: 2016-07-06
Entered: 2016-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 2CK29 / 4 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. L038501 / 3 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M51192 / 4 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-02-18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Neonatal obstruction of nasolacrimal duct; Hernia repair
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Undetermined cause of death within 24 hours of vaccines.


VAERS ID: 643452 (history)  
Form: Version 1.0  
Age: 42.0  
Sex: Female  
Location: Georgia  
Vaccinated:2016-06-16
Onset:2016-06-30
   Days after vaccination:14
Submitted: 2016-07-15
   Days after onset:15
Entered: 2016-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (TENIVAC) / SANOFI PASTEUR U5411AA / UNK RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-06-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2016SA127425

Write-up: Initial unsolicited report received from other healthcare professional on 08 July 2016. This case involves a 42-year-old female patient who was vaccinated with a dose of TENIVAC (batch number: U5411AA, expiry date, site and route of administration not reported) on 16 June 2016. The patient''s pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as allergies: none known as per reporter; Medical History: none as per reporter. Concomitant medications were not reported. Any other vaccinations within 4 weeks of vaccinations was not reported. On 30 June 2016, 14 days following the vaccination, it was reported that the patient did not have any reactions at that time. Then stated they heard from another patient that, later that night of 30 June 2016, the patient had passed away. Relevant diagnostic tests/laboratory data was not reported. The patient''s corrective treatment was not reported. On 30 June 2016, the patient had died. List of documents held by sender: none. Sender''s Comments: This case concerns a death in a patient who was vaccinated with DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT and two other products. This case is not sufficiently documented. More information including and not limited to detailed Autopsy report and patient''s medical history, laboratory tests are needed to further assess this case. Based on the information provided; the role of vaccine cannot be assessed. Reported Cause(s) of Death: passed away.


VAERS ID: 644099 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-07-21
Entered: 2016-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2016SA131491

Write-up: Initial unsolicited report received from consumer via social media in on 09 Jul 2016. This case is linked to 2016SA128403, 2016SA131479 and 2016SA131486 (same vaccine, same reporter). This case involves a patient (age and gender were not reported) who was vaccinated with dose of MENINGOCOCCAL VACCINE (batch number, expiry date, route, dose and site of administration: not reported) on an unspecified date. The patient''s medical history and concomitant medications were not reported. On an unspecified date, two weeks after vaccination the patient died. It was unknown whether autopsy was performed and the cause of death was unknown. Documents held by sender: none. Sender''s Comments: This case corresponds to a poorly documented and non-medically confirmed social media report. Patient presumably received meningococcal vaccine for which the manufacturer was unknown. Clinical details- such as patient''s age, medical history, vaccination details, the name of the specific vaccine administered, clinical details surrounding the event, diagnostic work-up, cause of death and autopsy reports- are lacking to allow adequate medical assessment. Reported Cause(s) of Death: DEATH NOS.


VAERS ID: 644219 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-07-21
Entered: 2016-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2016SA131479

Write-up: Initial unsolicited report received from consumer via social media in on 09 Jul 2016. This case is linked to 2016SA128403, 2016SA131486, 2016SA131491 (same vaccine, same reporter). This case involves a patient (age and gender: not reported) who was vaccinated with dose of MENINGOCOCCAL VACCINE (batch number, expiry date, route, dose and site of administration: not reported) on an unspecified date. The patient''s medical history and concomitant medications were not reported. On an unspecified date, two weeks after getting the vaccination the patient died. It was unknown whether autopsy was performed and cause of death was unknown. Documents held by sender: none. Sender''s Comments: This case corresponds to a poorly documented and non-medically confirmed social media report. Patient presumably received meningococcal vaccine for which the manufacturer was unknown. Clinical details- such as patient''s age, medical history, vaccination details, the name of the specific vaccine administered, clinical details surrounding the event, diagnostic work-up, cause of death and autopsy reports- are lacking to allow adequate medical assessment. Reported Cause(s) of Death: death.


VAERS ID: 644220 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-07-21
Entered: 2016-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2016SA131486

Write-up: Initial unsolicited report received from consumer via social media on 09 Jul 2016. This case is linked to 2016SA128403, 2016SA131479, 2016SA131491 (same vaccine, same reporter). This case involves a patient (age and gender: not reported) who was vaccinated with dose of MENINGOCOCCAL VACCINE (batch number, expiry date, route, dose and site of administration: not reported) on an unspecified date. The patient''s medical history and concomitant medications were not reported. On an unspecified date, two weeks after getting the vaccination the patient died. It was unknown whether autopsy was performed. Documents held by sender: none.; Sender''s Comments: This case corresponds to a poorly documented and non-medically confirmed social media report. Patient presumably received meningococcal vaccine for which the manufacturer was unknown. Clinical details- such as patient''s age, medical history, vaccination details, the name of the specific vaccine administered, clinical details surrounding the event, diagnostic work-up, cause of death and autopsy reports- are lacking to allow adequate medical assessment. Reported Cause(s) of Death: death.


VAERS ID: 644705 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: California  
Vaccinated:2016-04-07
Onset:2016-04-07
   Days after vaccination:0
Submitted: 2016-07-25
   Days after onset:109
Entered: 2016-07-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 974JA / 2 UN / SYR
HIBV: HIB (ACTHIB) / SANOFI PASTEUR U1368AA / 1 UN / SYR
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M56416 / 1 UN / SYR
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FB549A / UNK MO / PO

Administered by: Unknown       Purchased by: Other
Symptoms: Diarrhoea, Foaming at mouth, Mouth haemorrhage, Muscle spasms, Pulmonary haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Convulsions (broad), Pseudomembranous colitis (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-04-08
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: nystagmus
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Child was cramping and diarrhea initially..then red foam from his mouth and lungs.


VAERS ID: 644887 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-07-26
Entered: 2016-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1607USA010382

Write-up: This spontaneous report was received from a Nurse Practitioner via a company representative who referred to a 67 year old male patient. Patient''s pertinent medical history, concomitant medication and drug reaction/allergies were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously, (strength, dose, lot # and expiration date were not provided). On an unknown date, after receiving the ZOSTAVAX, the patient was diagnosed with shingles then after a year from receiving the ZOSTAVAX the patient died. At the reporting time, the outcome of the event of shingles was unknown. The cause of the death was unknown. It was also unknown whether an autopsy was performed. The relatedness between the events and the ZOSTAVAX was not provided. Upon internal review, the patient''s death was considered to be medically significant. Additional information has been requested.


VAERS ID: 644888 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-07-26
Entered: 2016-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / 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: WAES1607USA010363

Write-up: This spontaneous report was received from an unspecified reporter via a company representative, concerning a patient of unknown age and gender. Patient''s pertinent medical history, concomitant medication and drug reactions/allergies were not reported. On approximately 2015, the patient was vaccinated with ZOSTAVAX (strength, dose, route, lot # and expiration date were not provided). On an unknown date, within a year of the injection, the patient died. The cause of death was unknown. It was unknown whether an autopsy was performed or not. There was no product quality (PQC) involved. The causality was not stated. Upon internal review, the event of death was considered as medically significant. Additional information has been requested.


VAERS ID: 645869 (history)  
Form: Version 1.0  
Age: 1.02  
Sex: Female  
Location: Michigan  
Vaccinated:2016-06-23
Onset:0000-00-00
Submitted: 2016-08-02
Entered: 2016-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS TS343 / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. M006709 / 3 RL / IM
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. M004892 / 1 RL / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M67951 / 4 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-07-01
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None known
Current Illness: Parents stated that the toddler had been running a low grade fever, sometimes up to 100.5 F since 6/19/2016. Parents stated that the fever goes up, and down, and sometimes there is no fever at all. Parents had been treating with TYLENOL as needed. 6/23/2016 at the 12 month well child visit medical records from the pediatrician recorded a temperature of 98.7 F.
Preexisting Conditions: none known
Allergies:
Diagnostic Lab Data: Toxicology screen; Autopsy
CDC Split Type:

Write-up: Toddler found died in her crib in the morning.


VAERS ID: 647968 (history)  
Form: Version 1.0  
Age: 44.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2016-02-16
Onset:2016-02-19
   Days after vaccination:3
Submitted: 2016-08-16
   Days after onset:178
Entered: 2016-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. L023387 / 2 RA / IM

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2016-10-04
   Days after onset: 227
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No known.
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type:

Write-up: Patient reported stroke like symptoms. Now sees a neurologist for further care. We were made aware on 07/31/2016.


VAERS ID: 648057 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2016-07-26
Onset:2016-07-30
   Days after vaccination:4
Submitted: 2016-08-16
   Days after onset:17
Entered: 2016-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. M002268 / 1 LA / UN
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. M004116 / 1 LA / UN

Administered by: Private       Purchased by: Private
Symptoms: Death, Headache, Intracranial aneurysm, Loss of consciousness, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-07-31
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: doxycycline
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vaccines given 7/26. 7/30 pt awoke with severe headache and vomiting. Went unconscious. Found to have had a cerebellar aneurysm. Pt died 7/31.


VAERS ID: 648058 (history)  
Form: Version 1.0  
Age: 1.25  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2016-07-29
Onset:2016-08-05
   Days after vaccination:7
Submitted: 2016-08-16
   Days after onset:11
Entered: 2016-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. L000459 / 1 RL / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-08-05
   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: FLOVENT HFA; Lansoprazole; Chlorothiazide; Furosemide; Methadone HCL; Oxygen; Multivitamin/Iron; Potassium chloride; Sodium chloride; Spironolactone; Nystatin; Clonidine; Albuterol Sulfate
Current Illness: None
Preexisting Conditions: Congenital heart disease; Hydrocephalus; Prematurity
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt received MMR 7/29. 8/5/16 presented to ER in asystole.


VAERS ID: 648696 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-08-21
Entered: 2016-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Adverse event, Cervix carcinoma, Death
SMQs:, Uterine and fallopian tube malignant tumours (narrow), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1608USA009148

Write-up: This spontaneous report as received from a health professional via a company representative refers to a patient of unknown age. No medical history or concurrent conditions were reported. On an unknown date in May of 2015, the reporter discussed in an unknown article that she is now pressing "red alert button on the devastating consequences and irrelevancy of the vaccine". The reporter stated in the article that the HPV vaccine is "more dangerous that the HPV Virus". The reporter also stated "there were many unknown severe adverse events that occurred and multiple unknown deaths as there are cervical cancer cases developing each year after vaccination with HPV vaccine". The HPV vaccine discussed in the article could not be verified as GARDASIL, GARDASIL 9 or product from another company. The outcome of cervix carcinoma and death was reported as fatal. The outcome of adverse event was unknown. The reporter considered the events to be related to the suspect therapies. Upon internal review, the events of cervix carcinoma and death were considered to be medically significant. Additional information has been requested.


VAERS ID: 648868 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-08-23
Entered: 2016-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Influenza
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-04-01
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: Alirocumab prefilled pen
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2016SA066470

Write-up: Initial information regarding this clinically sponsored solicited case was received on 28-Mar-2016 from patient''s wife via the Patient Support Program. This case concerns a male patient of unknown age who had multitude of health issues, COPD and he came down with influenza B an unknown duration after commencing treatment with influenza vaccine and PRALUENT. No information on any past drug, concomitant drug, medical history or concurrent condition was reported. On an unknown date, the patient commenced treatment with influenza vaccine (dose, form, route, frequency, lot/batch number and expiration date: unknown). On an unknown date, the patient received alirocumab injection at a dose of 75 mg every other week subcutaneously (lot/batch number and expiry date unspecified) for other and unspecified hyperlipidemia delivered via prefilled pen. Patient''s wife reported that the patient took the flu shot and came down with influenza B on an unknown date (latency: unspecified), because the patient had COPD (date and latency: unknown) so he was placed in the hospital. The patient was taking TAMIFLU as corrective treatment and was getting better. The reporter informed that the patient expired in April and that he had a multitude of health issues (onset and latency: unspecified). It was unknown whether an autopsy was done or not. It was reported that the patient had two injections up to that point. Action taken: Unknown for both the drugs. Outcome: fatal for multitude of health issues, Recovering for other events. Seriousness criteria: Hospitalization, patient died from multitude of health issues. Reporter causality: Unknown with respect to alirocumab and not reported with respect to influenza vaccine for multitude of health issues and unknown for both the drugs for other events. Company causality: Not associated with respect to both the drugs. Additional information was received on 23-May-2016 from patient''s wife: new event "multitude of health issues" added, action taken updated, form of alirocumab added and text updated accordingly. Reported Cause(s) of Death: multitude of health issues.


VAERS ID: 649444 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-08-26
Entered: 2016-08-26
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: WAES1606USA012148

Write-up: This spontaneous report was received from a physician via company representative, who saw an article by another physician. This report refers to 44 female patients of unknown age, whose concurrent conditions, medical history and concomitant medications were not known. On an unknown date, the patients were vaccinated with GARDASIL (details not known). As per the article the 44 patients died as a result of receiving GARDASIL and hence causality of death was considered to be related to the vaccine. The reporter considered the event serious (death). Upon internal review, death was considered to be medically significant. Additional information is not expected as the physician does not want to be contacted.


VAERS ID: 649671 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-08-29
Entered: 2016-08-29
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: WAES1608USA012926

Write-up: This spontaneous report was received from a physician via a company representative and refers to 44 female patients of unknown age. There was no information regarding the patients'' pertinent medical history, drug reactions, allergies or concomitant therapies provided. The physician found out about the event reported below from an online article. On unknown dates, the patients were vaccinated with doses of GARDASIL (lot #, expiration date, exact dose, site and route of administration were not reported). On unknown dates, the patients died as a result of receiving GARDASIL (also reported as they died from these vaccines). The relatedness between the event and GARDASIL was assessed as related. Upon internal review, the event of death was determined to be medically significant. This is one of two reports received from the same source. Additional information is not expected as there was no consent for follow-up.


VAERS ID: 649772 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Male  
Location: Hawaii  
Vaccinated:2016-08-26
Onset:2016-08-26
   Days after vaccination:0
Submitted: 2016-08-29
   Days after onset:3
Entered: 2016-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. L021609 / 1 LA / SC

Administered by: Other       Purchased by: Other
Symptoms: Cardiac arrest, Death, Myocardial infarction, Myocardial necrosis marker increased
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2016-08-27
   Days after onset: 1
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: Baclofen; Calcium/Vitamin D; Ibuprofen; Riluzole; Psyllium; Tolterodine
Current Illness:
Preexisting Conditions: ALS; Sleep apnea
Allergies:
Diagnostic Lab Data: Per son, cardiac enzymes elevated, indicating massive MI. No hospital records available for review.
CDC Split Type:

Write-up: Cardiac arrest, found unattended at home. Per hospital, had massive MI. Treated in ER/hospital. Passed away following morning.


VAERS ID: 650025 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-08-31
Entered: 2016-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1608USA013930

Write-up: This spontaneous report was received from a physician via a company representative and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients'' pertinent medical history, concomitant medication and drug reactions or allergies was reported. The physician reported that she reviewed an unspecified article that described the patients, who, on unknown dates, were vaccinated with doses of GARDASIL (strength, dose, route of administration, anatomical location, lot# and expiration date were not provided). On unknown dates, an unspecified amount of time after the doses were administered, the patients were diagnosed with Guillain-Barre Syndrome and there were 44 deaths associated with GARDASIL. The outcome of Guillain-Barre syndrome was reported as unknown. The reporter considered death to be related to GARDASIL. The relatedness between Guillain-Barre syndrome and GARDASIL was not reported. Upon internal review, the events of Guillain-Barre syndrome and death were considered to be medically significant. Additional information has been requested.


VAERS ID: 650027 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-08-31
Entered: 2016-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Diarrhoea, Pyrexia, Screaming, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Noninfectious diarrhoea (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2016SA157319

Write-up: Initial unsolicited report received from consumer (patient''s mother) via social media on 22 August 2016. This case is linked with case 2016SA157332 and 2016SA157340 (same social medica report). This case involves a two-month-old male patient who was vaccinated with a dose of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED) (DPT) (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. Patient''s ongoing illness, medical history and concomitant medications were not reported. On an unspecified date, post vaccination, patient developed high pitch screaming, a high fever, vomiting and diarrhea. The patient also developed additional symptoms. Patient''s mother contacted the pediatrician and decided to take her son to the emergency room. On an unknown date, patient died in the arms of mother on their way to the emergency room. It was not reported whether autopsy was performed or not. Laboratory investigations and corrective treatment were not reported. List of documents held by sender: none. Sender''s Comments: This is poorly documented social medical case where patient died after administration of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED) (Unknown manufacturer). No medical history, concomitant medications, lab/diagnostic or autopsy results accompany the case to help identify the cause of death. Investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.; Reported Cause(s) of Death: diarrhea; high fever; high pitch screaming; vomiting.


VAERS ID: 651556 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-09-09
Entered: 2016-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1609USA002304

Write-up: Information has been received from an unspecified person via a company employee referring to unknown number of patients of unknown age and gender. the patients'' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with GARDASIL (dose, lot #, expiration date and route not reported). the reporter stated that on unknown dates, the patients experienced pain and injury which caused by GARDASIL. Some patients also died due to the vaccine. the reporter stated that so many patient''s lives had been literally stolen from them due to GARDASIL. They could no longer play sports, dance, have fun and act like kids. the outcome of the events was unknown. the reporter considered the GARDASIL was related to the events. Upon internal review, the event of death was considered to be medically significant. This is one of several reports received from the same reporter. Additional information has been requested.


VAERS ID: 653657 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-09-15
Entered: 2016-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? 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: WAES1609USA006280

Write-up: Information has been received from a molecular biology student, who obtained the information from a Vaccine Adverse Event Reporting System (VAERS) report, concerning 235 patients of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with unspecified doses of GARDASIL (strength, dosage schedule, route, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant medications were not provided. On unknown dates, the patients died. The causes of death were unknown, and it was also unknown whether autopsies were performed. The reporter indicated that he read the deaths were related to GARDASIL and he was concerned about the number of deaths reported for GARDASIL products. Upon internal review, death was determined to be medically significant. Additional information has been requested.


VAERS ID: 654203 (history)  
Form: Version 1.0  
Age: 49.0  
Sex: Male  
Location: Arizona  
Vaccinated:2016-09-07
Onset:2016-09-08
   Days after vaccination:1
Submitted: 2016-09-19
   Days after onset:11
Entered: 2016-09-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS E09A9 / UNK RA / IM

Administered by: Public       Purchased by: Private
Symptoms: Fracture treatment, Wrist fracture
SMQs:, Accidents and injuries (narrow), Osteoporosis/osteopenia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-09-08
   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: CLOZARIL; REMERON; EFFEXOR
Current Illness: None - trauma
Preexisting Conditions: NKDA; hx knee replacement; fx clavicle; schizophrenia
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Seen 9/7/2016 - open fx (L) wrist. To OR for repair. Discharge same day.


VAERS ID: 654370 (history)  
Form: Version 1.0  
Age: 7.0  
Sex: Female  
Location: Unknown  
Vaccinated:2015-11-07
Onset:2016-02-14
   Days after vaccination:99
Submitted: 2016-09-20
   Days after onset:218
Entered: 2016-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN

Administered by: Other       Purchased by: Unknown
Symptoms: Abdominal pain upper, Cyanosis, Drug ineffective, H1N1 influenza, Malaise, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-02-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBAstraZeneca2016SE96940

Write-up: A spontaneous report has been received from a consumer concerning an 8 year old, female patient. No information regarding the relevant history, concomitant disease and concomitant drug was provided. Patient received nasal FLUMIST QUADRIVALENT (intranasal) on Nov-2015, 0.2 millilitres, unknown for prevent H1N1 and flu vaccination. It was reported that the patient received FLUMIST QUADRIVALENT vaccination in November-2015, but fell ill in February. Patient woke up on 14-February-2016 with a stomachache and had fingers and toes turned blue (preferred term: skin discolouration) and patient died suddenly from H1N1 (Preferred Term: H1N1 influenza), also known as swine flu both versions of FDA-approved FLUMIST QUADRIVALENT were supposed to prevent H1N1. CDC voted against using FLUMIST QUADRIVALENT this winter after studies found no protective benefit could be measured (Preferred Term: Drug ineffective) with three percent effectiveness CDC recommends traditional flu shot instead, which had an estimated effectiveness of 63 percent for children between the ages of two and 17. Patient''s parents are stunned by the CDC''s vote, saying they trusted their doctor''s recommendations. It was not known if this was the only dose she received. On 14-Feb-2016 the patient woke up with a stomach ache and died hours later (Preferred Term: Abdominal pain upper). Cause of death were H1N1, woke up with a stomach ache and died hours later/ stomachache and no protective benefit could be measured. It was unknown if autopsy was performed. The outcome of the event of fingers and toes turned blue was unknown. The company physician considered the events H1N1, no protective benefit could be measured and woke up with a stomach ache and died hours later/ stomachache to be serious due to fatal outcome. The reporter considered the event fingers and toes turned blue to be non-serious. The company physician suggested to not capture ill as an event. Corrected report 15-Sep-2016: Suspect product was corrected. Country of case and country of reporter was corrected. Narrative corrected. Summary of follow-up information received by AstraZeneca/MedImmune on 12-Sep-2016 from consumer: Event verbatim updated from woke up with a stomach ache and died hours later/ stomachache to stomachache. Seriousness criteria updated for event woke up with a stomach ache and died hours later/ stomachache to died from non serious. Indication added. Dosing regimen updated. Reporter details updated. Associated case ID added. Patient date of birth added. Narrative corrected. Sender''s Comments: Fatal events of H1N1 influenza and Abdominal pain upper are not listed in the company core data sheet for FLUMIST QUADRIVALENT. Drug ineffectiveness was also reported. No vaccine is 100% effective, so occasional vaccine failures may be expected. Drug ineffectiveness could contribute to H1N1 influenza. However there is insufficient information on patient''s relevant medical history, concurrent diseases, concomitant medication, diagnostic workup and autopsy results which makes causal relationship difficult to assess.; Reported Cause(s) of Death: H1N1; NO PROTECTIVE BENEFIT COULD BE MEASURED; WOKE UP WITH A STOMACH ACHE AND DIED HOURS LATER/ STOMACHACHE.


VAERS ID: 654870 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-09-22
Entered: 2016-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Death, Lung cancer metastatic
SMQs:, Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Neoplasm malignant
Preexisting Conditions: Exposure to toxic agent
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1609USA010094

Write-up: This spontaneous report as received from a consumer refers to her 73 year old husband with complications from cancers and who was exposed to the agent Orange chemicals in a war. On an unspecified date "in late 2013", the patient was vaccinated with a dose of ZOSTAVAX (dose and lot # not reported) subcutaneously. The consumer stated that the patient was feeling quite well at the time of vaccination. The consumer reported that on an unknown date, the patient experienced lung cancer that spread quickly. The consumer stated that they could not get him enough treatment fast enough and in September 2014, the patient died, "about nine months after receiving ZOSTAVAX". The cause of death was reported as lung cancer. It was unknown if an autopsy was performed. Upon internal review lung cancer was considered to be medically significant. Additional information has been requested.


VAERS ID: 655277 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: South Carolina  
Vaccinated:2016-08-31
Onset:2016-09-03
   Days after vaccination:3
Submitted: 2016-09-23
   Days after onset:20
Entered: 2016-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 7Y7FK / UNK LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. M006710 / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M98916 / 1 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FB566A / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-09-03
   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: Rhinorrhea
Preexisting Conditions: Had F.T.T. previously but resolved
Allergies:
Diagnostic Lab Data: Autopsy no cause determined/toxicology pending
CDC Split Type:

Write-up: 3 days after 2 month immunizations baby suddenly died.


VAERS ID: 655074 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Michigan  
Vaccinated:2016-09-11
Onset:2016-09-12
   Days after vaccination:1
Submitted: 2016-09-25
   Days after onset:13
Entered: 2016-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-09-12
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death


VAERS ID: 655573 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-09-26
Entered: 2016-09-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, 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: US2016GSK139073

Write-up: This case was reported by a consumer and described the occurrence of unknown cause of death in a 70-year-old female patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT at an unknown dose. On an unknown date, an unknown time after receiving FLULAVAL QUADRIVALENT, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The age at vaccination was not reported. The patient was the relative of the reporter. The patient received the vaccine and died on an unknown date due to an unknown cause. The autopsy details were not provided. Due to the patient''s death after taking the FLULAVAL vaccine, the reporter was afraid to get the vaccine.


VAERS ID: 655670 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Male  
Location: Colorado  
Vaccinated:2016-09-16
Onset:2016-09-16
   Days after vaccination:0
Submitted: 2016-09-27
   Days after onset:11
Entered: 2016-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-09-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death.


VAERS ID: 655683 (history)  
Form: Version 1.0  
Age: 34.0  
Sex: Male  
Location: Michigan  
Vaccinated:2016-08-27
Onset:2016-08-28
   Days after vaccination:1
Submitted: 2016-09-16
   Days after onset:19
Entered: 2016-09-27
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-09-08
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: He got flu shot on 8/27/16. According to family members he was admitted in hospital on 8/28/16 and passed away on 9/8/16.


VAERS ID: 655938 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-09-29
Entered: 2016-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1609USA013709

Write-up: Information has been received from an online article via a company representative. The article stated that a doctor said that the incidence of cervical cancer was very low and it was impossible for Merck''s Human papillomavirus (HPV) vaccine to lower the already low incidence of cervical cancer. It was reported that the promotion of this vaccine to prevent cervical cancer was entirely groundless, although it was promoted as this. The study confirmed that the indication of this vaccine had nothing to do with cervical cancer, however, the way of promotion still ignored this fact. In fact, there was no evidence to support that this vaccine could prevent any cancer. According to Merck''s labeling, this vaccine (the 1st generation) targeted four types of all the 40 types of HPV, which could be self-healing in short time. The article also concerned about the potential risks of this vaccine, as it indicated all the clinical trials were conducted among the females aged 15-year old or above, however, Food and Drug Administration (FDA) and Merck had extended the target users to girls of 9-year old and above, even boys. It was reported that so far there had been 15,037 cases of adverse drug reaction for this vaccine, and the statistics only included cases that met the very stringent validation criteria. There had been 44 girls that were confirmed to die of this vaccine. All kinds of adverse drug reactions included Guillain-Barre syndrome (paralysis), lupus erythematous, thrombus and encephalitis (Cerebral palsy) (captured in MARRS# 1609USA012858). This report refers to the 44 girls who were confirmed to die of this vaccine. Upon internal review, die of this vaccine was considered to be medically significant. Additional information has been requested.


VAERS ID: 655947 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-09-29
Entered: 2016-09-29
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: WAES1609USA013034

Write-up: Information was received from a chief researcher through an online article via a company representative referring to 44 female patients of unknown age. The patients'' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with GARDASIL (lot#, expiration date, dose and route were unknown). On unknown dates, the patients died of this vaccine. The cause of death was unknown. It was unknown if autopsy was performed. The reporter considered death to be related to GARDASIL. Upon internal review, death was determined to be a medically significant event. This is one of several reports received from the same reporter. Additional information is not expected.


VAERS ID: 657076 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Male  
Location: Ohio  
Vaccinated:2016-09-16
Onset:2016-09-23
   Days after vaccination:7
Submitted: 2016-09-29
   Days after onset:6
Entered: 2016-10-04
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS J3GT5 / 1 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. L020188 / 1 LL / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M77338 / 4 RL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. L049532 / 1 RL / SC

Administered by: Private       Purchased by: Public
Symptoms: Autopsy, Cardiac arrest, Death, Enterovirus test positive, Human rhinovirus test positive
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), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-09-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Esophageal reflux
Allergies:
Diagnostic Lab Data: Positive for enterovirus/rhinovirus
CDC Split Type:

Write-up: No adverse events at time of immunizations. 7 days late passed with unexplained cardiac arrest. Autopsy being completed.


VAERS ID: 657339 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Indiana  
Vaccinated:2016-09-30
Onset:0000-00-00
Submitted: 2016-10-05
Entered: 2016-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 5X275 / 1 RL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UI511AAA / 1 LL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N05078 / 1 LL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. M019707 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-10-01
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: Pt was taken to emergency room after full arrest at home. Dad reported that he woke up to family dog laying on child.


VAERS ID: 658368 (history)  
Form: Version 1.0  
Age: 58.0  
Sex: Male  
Location: Florida  
Vaccinated:2015-01-19
Onset:2015-02-01
   Days after vaccination:13
Submitted: 2016-10-10
   Days after onset:616
Entered: 2016-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Private       Purchased by: Other
Symptoms: Death, Dyspnoea, Fatigue, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia, Paralysis, Respiratory distress, Tracheostomy, Walking aid user
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Cardiomyopathy (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2016-06-02
   Days after onset: 486
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hip surgery - osteoarthritis
Preexisting Conditions: Diabetes
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: January 2015 - patient received vaccine during hip surgery. February 2015 - experienced tingling and numbness in hand/arms and impaired breathing continued and extreme fatigue. May - difficulty walking, used a walker. June 2015 - paralyzed, and was diagnosed with GBS. July 2015 - respiratory distress and had tracheostomy; treatment during period included immunosuppressants. Died on 6/2/16.


VAERS ID: 658520 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Male  
Location: North Carolina  
Vaccinated:2016-10-04
Onset:2016-10-06
   Days after vaccination:2
Submitted: 2016-10-11
   Days after onset:5
Entered: 2016-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 33E9E / 1 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. M020100 / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N24040 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. L046320 / 1 MO / PO

Administered by: Unknown       Purchased by: Public
Symptoms: Abdominal compartment syndrome, Abdominal distension, Abdominal operation, Bladder catheterisation, Blood lactic acid increased, Blood pH decreased, Central venous catheterisation, Colitis, Colostomy, Death, Depressed level of consciousness, Echocardiogram abnormal, Ejection fraction decreased, Endotracheal intubation, Gastrointestinal necrosis, General physical health deterioration, Hypoglycaemia, Hypotension, Infection, Intensive care, Intestinal ischaemia, Intestinal resection, Intussusception, Irritability, Malaise, Pallor, Pathology test, Synovial cyst, Transfusion, Vomiting, Wound closure, Wound evisceration
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (narrow), Cardiomyopathy (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Noninfectious diarrhoea (broad), Respiratory failure (broad), Hypoglycaemia (narrow), Dehydration (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2016-10-07
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: cleft lip and palate
Allergies:
Diagnostic Lab Data: see above. pH 6.5; Lactic acid $g20
CDC Split Type:

Write-up: Per mom, patient was fine when seen at well child visit and vaccinations on 10/4. He became irritable that night and more irritable the next day. Pt developed emesis x1 late on 10/05 and again on 10/06. Presented to outside emergency room where patient was distended, hypoglycemic, and severely ill appearing. Fluids and antibiotics given. In transport to us, required start of Dopamine. On arrival patient was hypotensive to 42/20 and epinephrine started. Pt was obtunded and grey appearing. Intubated emergently without need for sedation. Based on tense abdomen, patient was taken emergently to the operating room. After placement of central lines and a urinary catheter, the abdomen was opened. At this point labs returned with a pH of 6.5. He was felt to have abdominal compartment syndrome. The bowel was generally ischemic, but perfusion began to improve with the abdomen open and transfusion of blood and albumin. Exploration revealed an ileo-ileal intussusception. This was able to be reduced. Additionally, the patient had dilation of the descending and sigmoid colons with thickening consistent with colitis. A portion of the sigmoid colon was resected and sent for frozen section. Ganglion cells were identified and the pathologists noted colitis was more consistent with infectious etiology. An end colostomy was brought up and the abdomen was left open with a wound vac. On initial return to the ICU, the blood pressure was improved to 60-80 systolic. The patient was making good urine. Extremity perfusion was improved. About an hour and a half later, the patient began to deteriorate again. Lactic acid was rising to $g20. An echocardiogram revealed an ejection fraction of only 15%. I removed the abdominal dressing and the bowel below had clear necrosis. I re-explored him at the bedside. With evisceration of the bowel, the ejection fraction went up to 35%. On inspection, the ileum that had previously been intussuscepted was necrotic. This was approximately a foot and a half of bowel. This was resected. The remaining left colon and 1/2 of the transverse colon was now necrotic as well and was resected. The terminal ileum and right colon were viable, as was the small bowel proximal to the intussusception. The remaining bowel was placed in a silo bag. The patient continued to deteriorate. Six hours later, all visible bowel was necrotic. The patient was made comfort measures only and expired.


VAERS ID: 658608 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2016-03-22
Onset:0000-00-00
Submitted: 2016-10-10
Entered: 2016-10-12
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Endotracheal intubation, Headache, Insomnia, Laboratory test, Malaise, Mechanical ventilation, Nausea, Pneumonia, Pruritus, Sinus disorder, Unresponsive to stimuli, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-06-10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Diabetes; Heart attack
Allergies:
Diagnostic Lab Data: Test Date: 20160402; Test Name: Laboratory test; Result Unstructured Data: Test Result: unknown
CDC Split Type: USPFIZERINC2016466431

Write-up: This is a spontaneous report from a contactable consumer, the patient''s daughter. A 73-year-old female patient received PREVNAR 13, via an unspecified route of administration on 22Mar2016 at 0.5 ml single dose for immunization. Medical history included chronic obstructive pulmonary disease (COPD), diabetes, and heart attack. Concomitant medications were unknown; the patient was taking a lot of medications (medication list was not provided). The patient vaccination history was unknown. The reporter stated that she was reading her mother''s chart and that her mother had died. While reading the chart she noted that her mother received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) on 22Mar2016 from her doctor because she was at high risk. The patient experienced pneumonia, headache, nausea, itching, could not sleep for 2-3 days, and threw up. The clinical course was as follows: The patient sent a letter to her doctor dated 14Apr2016 which she refers to previously reporting headache, nausea, itching, could not sleep for 2-3 days, and threw up after receiving the vaccine. It was reported that the patient required a trip to the emergency room for the events of itching, headache, nausea, and difficulty sleeping. The patient had requested medication for nausea from her doctor and reported that headache was better. The patient underwent lab tests and procedures which included laboratory test with unknown results on 02Apr2016. Patient had a consult with internal medicine doctor on 07Apr2016. Patient complained of sinus issues and was placed on AMOXICLAV 875 mg for seven days from Apr2016 to completion on 14Apr2016. The patient saw the doctor because she was so sick from everything. The patient started to take ZITHROMAX on an unspecified date (described as the Tuesday prior to calling the ambulance, she was taking a Z Pak). The ambulance was called on 30Apr2016 because patient slipped out of bed and they could not get her back into bed. On the following Monday, she was unresponsive. She was admitted to the hospital on 30Apr2016, had to be intubated, lung was tapped a couple of times. The patient had COPD and could not get off of the ventilator. She was transferred to a different hospital three weeks after admittance and never left that hospital. Therapeutic measures were taken as a result of headache, nausea and threw up. The patient died on 10Jun2016 because she got pneumonia on an unknown date. An autopsy was not performed. Reported Cause(s) of Death: pneumonia.


VAERS ID: 658633 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Mississippi  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-10-12
Entered: 2016-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Influenza, Lung neoplasm malignant
SMQs:, Non-haematological malignant tumours (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2016SA184645

Write-up: Initial unsolicited report received from a consumer via other company (Pfizer) on 03-Oct-2016. Manufacturer Report Number: 2016444837. This case involves a female patient (age not reported) who was vaccinated with FLU SHOT (manufacturer: unknown) (batch number, expiry date reported as unknown, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient''s medical history and Concomitant medications were not reported (reported as none provided). On an unknown date, following the vaccination, the patient got a touch of the flu and lung cancer. The patient''s laboratory data (reported as none provided) and corrective treatment was not reported. The outcome of event: flu was not reported. It was reported that patient died 11-year ago and cause of death was lung cancer. List of documents held by sender: none. Sender''s Comments: This is poorly documented consumer case where influenza was reported after administration of influenza vaccine and patient died due to lung cancer. However detail autopsy report, date of death, onset of lung cancer and administration date would be helpful to assess this case further. According to provided information no conclusion can be drawn. Reported Cause(s) of Death: lung cancer.


VAERS ID: 659287 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-10-14
Entered: 2016-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Influenza, Influenza virus test positive, Intensive care, Laboratory test abnormal, Polymerase chain reaction positive, Vaccination failure, Viral test positive
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2016SA186633

Write-up: Initial unsolicited report received from the literature on 06-OCT-2016. Following is the verbatim from the article: Background. We describe the impact of early initiation of influenza antiviral treatment among pregnant women hospitalized with laboratory-confirmed influenza during the 2010-2014 influenza seasons. Methods. Severe influenza was defined as illness with less than or equal to 1 of the following: intensive care unit admission, need for mechanical ventilation, respiratory failure, pulmonary embolism, sepsis, or death. Within severity stratum, we used parametric survival analysis to compare length of stay by timing of antiviral treatment, adjusting for underlying conditions, influenza vaccination, and pregnancy trimester. Results. Among 865 pregnant women, the median age was 27 years (interquartile range [IQR], 23-31 years).Most (68%) were healthy, and 85%received antiviral treatment. Sixty-three women (7%) had severe influenza, and 4 died. Severity was associated with preterm delivery and fetal loss. Women with severe influenza were less likely to be vaccinated than those without severe influenza (14%vs 26%; P equal to .03). Among women treated with antivirals 2 days versus those treated more than 2 days from illness onset, the median length of stay was 2.2 days (interquartile range [IQR], 0.9-5.8 days; n equal to 8) versus 7.8 days (IQR, 3.0-20.6 days; n equal to 7), respectively, for severe influenza (P equal to .03) and 2.4 days (IQR, 2.3-2.5 days; n equal to 153) versus 3.1 days (IQR, 2.8-3.5 days; n equal to 62), respectively, for no severe influenza (P less than .01). Conclusions. Early initiation of influenza antiviral treatment to pregnant women hospitalized with influenza may reduce the length of stay, especially among those with severe influenza. Influenza during pregnancy is associated with maternal and infant morbidity, and annual influenza vaccination is warranted.+ Keywords. influenza; pregnancy; influenza antiviral treatment; length of stay; early antiviral treatment This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (manufacturer: unknown, batch number, expiry date, route and site of administration: not reported) on an unspecified date. Patient''s medical history and concomitant medications were not reported. On an unspecified date, post vaccination the patient had severe influenza and was hospitalized. On an unspecified date, post vaccination, the patient died (Patient was pregnant when she died). This was a case of vaccination failure. Patient''s laboratory data included: influenza virus test-positive result (Reported as patient was more likely to have presence of influenza A ((H1N1) pdm 09). Confirmation included a positive result of reverse transcription polymerase chain reaction analysis, rapid antigen testing, direct or indirect fluorescent antibody staining, or viral culture. Patient received corrective treatment with antiviral medication. It was unknown whether autopsy was performed. List of documents held by sender: none. Sender''s Comments: This case corresponds to a poorly documented literature report with a H1N1 influenza infection with a fatal outcome in a pregnant women. Patient was died due to severe influenza infection even though she was received influenza vaccine before for which the name of the manufacturer was unknown. This case is therefore a suspected vaccination failure. Clinical details- such as latency from vaccination, relevant medical history, previous vaccination history, clinical details surrounding the fatal event, the name of the specific vaccine administered, autopsy report and diagnostic work-up- are lacking to allow adequate medical assessment. Reported Cause(s) of Death: severe influenza/ influenza A (H1N1).


VAERS ID: 659512 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: Idaho  
Vaccinated:2016-10-13
Onset:2016-10-14
   Days after vaccination:1
Submitted: 2016-10-16
   Days after onset:2
Entered: 2016-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C5090AA / 2 LL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS EG9Y2 / 3 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N24040 / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. L047185 / 2 OT / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-10-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Neosure, Keppra, Topamax, omeprazole
Current Illness: No signs or symptoms of infection on 10-13-16.
Preexisting Conditions: Multiple congentital anomalies Delition chromosome #2 and trisomy 13, feeding problems with GJ tube, reflux, seizures, orthopedic problems
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Child was sleeping in mother''s arms sometime in the evening and noticed child was not breathing and immediately began CPR and called 911. Code called at hospital @1943pm. ONSET TIME ESTIMATED as I will not contact parents for this.


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