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VAERS ID: 694117 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Georgia  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-05-12
Entered: 2017-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Death, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: US0095075131705USA005362

Write-up: This spontaneous report was received from a physician via a company representative and refers to a male child patient. The patient''s concurrent conditions, medical history and concomitant therapies were not reported. Approximately in 1997 (reported as "about 20 years"), the patient was vaccinated with a dose of M-M-R II frequency reported as "one injection", parenteral route reported as "injection" (anatomical place of vaccination was not provided), for Measles, Mumps, and Rubella prophylaxis. Approximately in 1997 (reported as "two weeks after the vaccine was administered"), the patient experienced seizures and for an unspecified reason and the child passed away (death), subsequently on an unspecified date, the child passed away for an unspecified reason. At the time of reporting, the outcome of seizure was unknown. The reporter did not provide a causality assessment between M-M-R II, seizures and death. Upon internal review, seizures and the death were determined to be medically significant. Additional information is not expected, as the reporter did not provide consent to follow up.


VAERS ID: 694251 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Louisiana  
Vaccinated:0000-00-00
Onset:2016-07-05
Submitted: 2017-05-12
   Days after onset:311
Entered: 2017-05-15
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Death, Genital rash, Herpes zoster, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-07-09
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131705USA005955

Write-up: Information had been received on 10-MAY-2017 from a lawyer and the daughter of the deceased female regarding a case in litigation. It was alleged in litigation that a female patient (decedent) of unknown age was inoculated with ZOSTAVAX vaccine (Date, dose, route, site of administration, lot # and expiration date were not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The patient''s medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of Herpes Zoster. On or about 05-JUL-2016, the patient was treated in the emergency room, and later by urologist (as reported)(also reported as family nurse practitioner (FNP)) for an excruciating rash that spread to the female patient''s genitalia and inside her body. The female was diagnosed with severe shingles. On or about 06-JUL-2016, the female patient was treated at a family medicine facility, by a physician assistant (PA) for an ongoing and exceptionally severe outbreak of shingles. The patient was prescribed gabapentin to manage her symptoms. On or about 09-JUL-2016, the female died at her home due to unknown causes, which her estate believes was attributable to the unmanageable pain of her atypical shingles outbreak. At the time of death, the female was actively suffering from an active outbreak of Herpes Zoster on her body. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. The event of died at her home due to unknown causes was determined to be a medically significant event. Additional information has been requested.; Reported Cause(s) of Death: died at her home due to unknown causes.


VAERS ID: 694999 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-05-17
Entered: 2017-05-18
   Days after submission:1
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: 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: US0095075131705USA008403

Write-up: I belive this injection caused my daughter''s death; This spontaneous report was received from the patient''s father via social media, referring to a female patient of unknown age. The patient''s medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with unspecified human papillomavirus (HPV) vaccine (manufacturer unknown), dosage, route, lot# and expiration date were not provided. Concomitant therapies were not reported. The patient''s father stated that "he believed this injection caused his daughter death, the date of the patient''s death was not provided, It was unknown if an autopsy was done. The outcome of the event was fatal. Additional information has been requested.


VAERS ID: 695378 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Texas  
Vaccinated:2011-11-23
Onset:2011-11-23
   Days after vaccination:0
Submitted: 2017-05-19
   Days after onset:2003
Entered: 2017-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1317AA / 2 LA / UN

Administered by: Unknown       Purchased by: Other
Symptoms: Balance disorder, Burning sensation, Cerebral disorder, Death, Decompressive craniectomy, Disturbance in attention, Drowning, Feeding disorder, Feeling abnormal, Headache, Immediate post-injection reaction, Influenza, Laboratory test normal, Pain, Peripheral nerve operation, Polycystic ovaries, Postural orthostatic tachycardia syndrome, Weight increased
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Fertility disorders (narrow), Hypersensitivity (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-05-17
   Days after onset: 2001
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: allergic~Pertussis (no brand name)~~0.00~Patient
Other Medications:
Current Illness: no, was healthy, highly athletic, 4.0 student. Date of vaccination was sometime around 2009, but exact date unknown.
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: As soon as received GARDASIL vaccine, had burning thru entire body. Felt different after that. Balance issues, concentration issues. Said her brain felt different. Soon after that, had a virus that was thought to be flu. Treated with antibiotics. Had a headache that would not go away for 45 days. Went from being a 115 lb athlete, to a 155 lbs and could not eat. Hospitalized at two hospitals. Also hospitalized other times and other places afterwards. She never got better--had terrible pain. Had multiple tests and saw many doctors and all tests were normal. They could never find the cause of the headaches, but she did have 2 surgeries to improve the headaches-decompression surgery in 2015 and removal of nerves in forehead in 2016. She was diagnosed with POTS and with polycystic ovarian syndrome after vaccination. Had possible seizures-saw over 200 doctors. Died in the bathtub due to drowning.


VAERS ID: 695677 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-05-22
Entered: 2017-05-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Death
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: US0095075131705USA008454

Write-up: This spontaneous report as received from a healthcare worker also reported as a corporate executive via a company representative refers to a patient of unknown age and gender. There was no information about the patient''s concurrent conditions, medical history or concomitant medication. On an unknown date, the patient was vaccinated with ZOSTAVAX, for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The reporter stated that according to some pharmacist, the patient "died from getting ZOSTAVAX" on an unknown date. The cause of patient''s death was not reported. It was also unknown whether an autopsy has been performed. No further details were noted on the after-hours adverse event voicemail. Additional information has been requested.


VAERS ID: 695907 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-05-22
Entered: 2017-05-24
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Influenza virus test positive, Vaccination failure
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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab test performed on unspecified date during influenza season 2011-2012. In this study, among the 27 Influenza-Associated Paediatric Deaths without any high-risk medical conditions, influenza A virus was found in 18 patients and influenza B found in 9 patients. Influenza virus test, positive
CDC Split Type: US2017GSK074724

Write-up: This case was reported in a literature article and described the occurrence of vaccination failure in a child subject who received Flu seasonal TIV Dresden. On an unknown date, unknown after receiving Flu seasonal TIV Dresden, the subject developed vaccination failure. Serious criteria included death and GSK medically significant. Additional event(s) included influenza with serious criteria of death. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included influenza (fatal). The reported cause of death was influenza. The investigator considered that there was a reasonable possibility that the vaccination failure and influenza may have been caused by Flu seasonal TIV Dresden. Relevant Tests: Lab test performed on unspecified date during influenza season 2011-2012. In this study, among the 27 Influenza-Associated Paediatric Deaths without any high-risk medical conditions, influenza A virus was found in 18 patients and influenza B found in 9 patients. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Influenza virus test result was positive unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of suspected vaccination failure in a patient aged between 6-month and 17-years who was vaccinated with unspecified seasonal influenza vaccine (manufacturer unknown). The patient was a part of the study that used case cohort approach comparing influenza vaccination rates among influenza associated paediatric deaths from July 2010 through June 2014 with vaccination coverage estimated for cohorts of children to estimate the effectiveness of influenza vaccination against laboratory-confirmed influenza-associated death. The patient had no high-risk medical conditions. No information on patient''s family history or concomitant medication was provided. On an unspecified date during influenza season 2011-2012, the patient received unspecified seasonal influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age at vaccination was not provided. [In this study children were considered vaccinated (either fully or partially) if records indicated receipt of equal to or more than 1 doses of current season influenza vaccine equal to or more than 14 days before onset of illness. Partial vaccination was defined as receipt of 1 dose when health department personnel determined that 2 doses were indicated]. On an unspecified date during influenza season 2011-2012, equal to or more than 14 days after vaccination, the patient developed laboratory-confirmed influenza. Subsequently, the patient died. (In this study, among the 27 Influenza-Associated Paediatric Deaths without any high-risk medical conditions, influenza A virus was found in 18 patients and influenza B found in 9 patients). This case has been considered as suspected vaccination failure being the time to onset was unknown. This case has been considered serious due to death/suspected vaccination failure. Treatment of influenza was unknown. The authors did not comment on the relationship between influenza and unspecified seasonal influenza vaccine. The authors concluded, "Results of this study suggest that vaccination reduced the risk of influenza-associated death among children and adolescents and add to the evidence of benefits of influenza vaccination for children. Annual vaccination is an important strategy to prevent influenza and influenza-associated complications and deaths. These results support current recommendations for annual influenza vaccination for all children equal to or more than months of age".


VAERS ID: 696852 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-03-29
Entered: 2017-05-25
   Days after submission:57
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Drug hypersensitivity, Non-small cell lung cancer
SMQs:, Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-03-11
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: Aortic aneurysm; Atrial fibrillation; Neuropathy peripheral; Chronic obstructive pulmonary disease; Anxiety; Diphenhydramine, drug hypersensitivity; Diphenhydramine, drug hypersensitivity; Cefazolin, drug hypersensitivity; Cefazolin, adverse drug reaction
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2016072954

Write-up: This spontaneous case, initially received on 23-Aug-2016, was reported by a health professional and concerns a female patient. Past medical history included COPD (chronic obstructive pulmonary disease), peripheral neuropathy, atrial fibrillation, abdominal aortic aneurysm and anxiety. Drug history included drug reactions/allergies to cefazolin and diphenhydramine. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN) for indication not reported. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced drug reactions/allergies (outcome: not reported). On an unspecified date in July 2015, the patient began therapy with KEYTRUDA injection for advanced non-small cell lung cancer ''refractory to all prior treatment'' and died to progression of the disease. At the time of death on 11-Mar-2016, the patient was taking unspecified doses of the following medications: albuterol, alprazolam, DULCOLAX, SYMBICORT, DIPROLENE, vitamin B-12, COLACE, doxycycline, furosemide, gabapentin, MUCINEX, hydrocodone, DUONEB, lactobacillus, levothyroxine, magnesium chloride, metoprolol, morphine, multi-vitamin, prednisone, prochlorperazine and warfarin.


VAERS ID: 696747 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Virginia  
Vaccinated:2017-05-10
Onset:2017-05-11
   Days after vaccination:1
Submitted: 2017-05-15
   Days after onset:4
Entered: 2017-05-26
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C5320AA / 1 UN / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. M040423 / 2 UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R56665 / 1 UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. M033338 / 1 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Crying, Death, Musculoskeletal stiffness, Pallor, Pulse absent, Pyrexia, Resuscitation, Sinus bradycardia, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Disorders of sinus node function (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dystonia (broad), Parkinson-like events (broad), 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), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-05-11
   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:
Current Illness: None
Preexisting Conditions: Heart murmur noted, cardiology evaluation was pending
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever the evening after receiving vaccines. Parents gave TYLENOL. The infant was sleeping-then at 4:30 AM, the child cried out, then stiff and unresponsive; mother brought directly to ER. She was pale and pulseless upon arrival. Multiple rounds of CPR/epinephrine/atropine. Brief returns of sinus bradycardia. CPR discontinued at 07:19.


VAERS ID: 696835 (history)  
Form: Version 1.0  
Age: 89.0  
Sex: Female  
Location: New York  
Vaccinated:2017-03-16
Onset:2017-03-29
   Days after vaccination:13
Submitted: 2017-05-29
   Days after onset:61
Entered: 2017-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Other
Symptoms: CSF test normal, Herpes simplex test negative, Herpes zoster, Polymerase chain reaction, Rash, Varicella virus test negative, Viral test negative
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-05-18
   Days after onset: 50
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 29 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Essential hypertension, coronary atherosclerosis, aortic valve stenosis, vascular dementia, hyperlipidemia, diverticulosis with fistula of intestine s/p surgery, Alzheimer''s dementia
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Viral culture from skin lesion negative for HSV (04/26/17); HSV not detected in CSF; Varicella Zoster virus PCR <500 copies/mL ? ? ?
CDC Split Type:

Write-up: HZV rash to right sided post auricular large skin on face.


VAERS ID: 698130 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Female  
Location: Florida  
Vaccinated:2017-02-02
Onset:0000-00-00
Submitted: 2017-05-04
Entered: 2017-06-03
   Days after submission:30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS ZT5KJ4 / 2 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-02-25
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Probiotics; PEDIALYTE grown and gain; SYNAGIS is the shot
Current Illness:
Preexisting Conditions: Rett syndrome; Torticollis; scoliosis
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Stopped breathing, double ear infection from the first shot the month previous.


VAERS ID: 699198 (history)  
Form: Version 1.0  
Age: 88.0  
Sex: Male  
Location: South Carolina  
Vaccinated:2017-03-26
Onset:2017-03-27
   Days after vaccination:1
Submitted: 2017-06-06
   Days after onset:71
Entered: 2017-06-12
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. M043424 / 1 UN / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Chest X-ray, Computerised tomogram head, Confusional state, Disorientation, Swallow study
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-05-15
   Days after onset: 49
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: CT Brain; Chest X-ray; Swallow Test
CDC Split Type:

Write-up: On March 26, 2017 my husband was taken to the ER complaining of extreme fatigue and dizziness. At that time he was totally cognizant of his condition. He did not have dementia, he was appropriately forgetful (as I) for an 88 yr. old. After tested for lung x-rays and CT of his brain he was diagnosed with aspiration pneumonia or malignancy in one lung. He was admitted that evening and after being taken to his hospital room, a nurse administered PNEUMOVAX 23 to him. The next morning, I noticed he was confused and somewhat disoriented. After seeing the small card regarding the vaccine I was appalled and complained.


VAERS ID: 699790 (history)  
Form: Version 1.0  
Age: 0.67  
Sex: Female  
Location: New Mexico  
Vaccinated:2017-02-08
Onset:2017-02-09
   Days after vaccination:1
Submitted: 2017-06-16
   Days after onset:126
Entered: 2017-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C5290AA / 2 LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. L048849 / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N34937 / 3 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-02-09
   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: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Not available to provider
CDC Split Type:

Write-up: Unknown - Notified by subpoena for records from coroner of child''s death on day following vaccinate administration.


VAERS ID: 699844 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: California  
Vaccinated:2017-02-28
Onset:2017-05-05
   Days after vaccination:66
Submitted: 2017-06-15
   Days after onset:41
Entered: 2017-06-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5102AA / 3 UN / UN
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UT5594UA / 1 UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UI743A / 3 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH S15227 / 3 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. MO39068 / 3 UN / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Cyanosis, Death, Dyspnoea, Pneumonia, Serology test, X-ray
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-05-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Sickness
Allergies:
Diagnostic Lab Data: Test Name: Serology test; Test Name: X-ray
CDC Split Type: USPFIZER INC2017258111

Write-up: This is a spontaneous report from a contactable nurse received via a sales representative. A 8-month-old male patient of an unspecified race/ethnicity was fully vaccinated with PREVNAR 13 on unspecified date(s), at single dose(s), for immunisation. The reporter stated the patient was sick but did not provide further details. Concomitant medications were not reported. The patient died on an unspecified date in 2017 from pneumonia which developed on an unspecified date, after being fully vaccinated up to 8 months. Clinical course of event included the following information: the patient was sick and he had gone to the hospital. He first came to the doctor''s office who sent him to the hospital for an X-ray. He was sent home, then he went to see the doctor for follow-up and he was blue, he could not breathe. He went back to the hospital and died that night. It was not reported if an autopsy was performed. Sero-grouping test to confirm the strain was performed on an unknown date (pending result).; Sender''s Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. Further information like confirmative pathological/serotype results and vaccination schedule are needed for full medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: died from pneumonia and was fully vaccinated up to 8 months; died from pneumonia and was fully vaccinated up to 8 months.


VAERS ID: 700093 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Illinois  
Vaccinated:2017-06-13
Onset:2017-06-15
   Days after vaccination:2
Submitted: 2017-06-15
   Days after onset:0
Entered: 2017-06-19
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C5090AA / 1 LL / UN
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 754AB / 2 LL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R56665 / 1 RL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. M018957 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-06-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: SIDS. Patient died 6-15-17 in sleep.


VAERS ID: 700165 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-06-20
Entered: 2017-06-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunocompromised
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131706USA007618

Write-up: This spontaneous report was received from a pharmacist via an unspecified person in leadership of the company and field representative and refers to a patient of unknown age and gender. Information regarding the patient''s pertinent medical history, drug allergies/reactions and concomitant medications were unknown. The patient was immunocompromised. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU vial (lot and expiry date not reported) reconstituted with sterile diluent (Manufacturer unknown) injection (lot and expiry date unknown) for prophylaxis. Pharmacist mentioned that on an unknown date after vaccination, the patient died due to an unknown cause. Causality assessment was not provided. Upon internal review, death was considered to be medically significant. Additional information has been requested.; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 700432 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Florida  
Vaccinated:2017-06-13
Onset:2017-06-15
   Days after vaccination:2
Submitted: 2017-06-21
   Days after onset:6
Entered: 2017-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C5099AB / 3 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R56665 / 3 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. M040267 / UNK MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Chest X-ray, Death, Endotracheal intubation, Laboratory test, Pulse absent, Resuscitation
SMQs:, Angioedema (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-06-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Labs drawn and a chest AP xray obtained
CDC Split Type:

Write-up: Found by EMS on back in her crib. Pt was intubated and given 6 doses of epi in route to ER. Pt had no pulse on arrival. Pt received a larger ET tube and bicarb. Resucitation unsuccessful, pt expired.


VAERS ID: 700585 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: Missouri  
Vaccinated:2016-05-26
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C5054AB / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M67951 / 2 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FB529A / 2 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Death, Respiratory failure, Rib fracture, Skeletal survey abnormal
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Osteoporosis/osteopenia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-06-01
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: Heart Murmur
Allergies:
Diagnostic Lab Data: Bone Survey 6/2/16 multiple rib fractures
CDC Split Type:

Write-up: Respiratory failure leading to death.


VAERS ID: 700592 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Maryland  
Vaccinated:2016-12-01
Onset:2016-12-01
   Days after vaccination:0
Submitted: 2017-06-22
   Days after onset:202
Entered: 2017-06-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Other       Purchased by: Unknown
Symptoms: Contraindication to vaccination, Death
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-12-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cancer; Immunodeficiency
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131706USA006121

Write-up: This spontaneous report was received from a physician via a company representative, referring to a male patient, of an unknown age. The patient was diagnosed with "cancer" in an unspecified date. Concomitant medications were not mentioned. In approximately December 2016 (reported as "about six months ago"), while the patient was in the hospital, he was vaccinated with a shot of PNEUMOVAX23, subcutaneously as a standard protocol from the hospital (dose number, anatomical location, lot # and expiration date were not reported). Subsequently, the patient was discharged from the hospital. The next day, he passed away (death), approximately in December 2016. It was unknown if an autopsy was performed. The cause of death was unknown. The reporting physician stated that he felt that the patient should not have been vaccinated due to his "weakened immune system" and he was not pleased about the hospital''s conduct. He felt the hospital should have used individual judgment before vaccination. No causal relationship between therapy with PNEUMOVAX23 and death was provided. Upon internal review, death was considered medically significant. Additional information has been requested.; Reported Cause(s) of Death: it was not known what the cause of death was.


VAERS ID: 700841 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-06-23
Entered: 2017-06-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131706USA010785

Write-up: This spontaneous report was received from a social media via company representative regarding a 144 female patients of unknown age. There was no information about patient''s concomitant medications and pertinent medical history reported. On an unknown dates, the patients were vaccinated with GARDASIL, (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis. It was reported that on unspecified date, the patients died from unknown cause and it was also unknown if autopsy was performed. Additionally it stated that the pharmaceutical companies which made the GARDASIL, as well as the Agency which hold patents and earns profits from the GARDASIL said that they were all coincidence also that the mainstream media denied that these events were even happened. The relatedness between the event and therapy with GARDASIL was not reported. Upon internal review, death was determined to be medically significant event. This is one of several reports from the same source. Additional information is not expected as follow up information cannot be obtained. Sender''s Comments: US-009507513-1706USA010923: US-009507513-1706USA010924.


VAERS ID: 700974 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Louisiana  
Vaccinated:2016-11-18
Onset:2016-11-21
   Days after vaccination:3
Submitted: 2017-06-26
   Days after onset:216
Entered: 2017-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS P332D / UNK RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR 4XD9P / UNK LL / SYR

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

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

Write-up: Stopped breathing, passed away.


VAERS ID: 701173 (history)  
Form: Version 1.0  
Age: 1.58  
Sex: Male  
Location: New Jersey  
Vaccinated:2017-04-25
Onset:2017-04-26
   Days after vaccination:1
Submitted: 2017-06-29
   Days after onset:64
Entered: 2017-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5102BA / 4 LL / IM

Administered by: Private       Purchased by: Other
Symptoms: Autopsy, Death, Laboratory test normal, Lethargy, Pathology test, Pyrexia, Sudden death, Viral upper respiratory tract infection
SMQs:, Torsade de pointes/QT prolongation (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), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-05-12
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Death~DTaP (Daptacel)~4~1.67~Patient
Other Medications: None
Current Illness: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data: Autopsy and path reports are all negative and termed my son''s death "Sudden Unexplained Death"
CDC Split Type:

Write-up: My son received his 4th DTAP vaccine on 4/25/17 and within 24 hours developed cold like symptoms...this was very common after almost all vaccines...but never related it to vaccine injury until now...on 05/07/17 he developed a fever and was very lethargic...on 05/08/17 he seemed to be completely back to himself...on 05/12/17 I found him in his crib at 08:30 AM...he passed away that prior evening...


VAERS ID: 702494 (history)  
Form: Version 2.0  
Age: 0.67  
Sex: Female  
Location: Indiana  
Vaccinated:2017-03-07
Onset:2017-03-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2017-07-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. M036057 / 1 LA / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH Q04603 / 1 LL / IM

Administered by: Other       Purchased by: ?
Symptoms: Blood calcium decreased, Blood chloride decreased, Blood culture negative, Blood potassium increased, Blood sodium decreased, Carbon dioxide decreased, Central venous catheterisation, Computerised tomogram, Death, Decreased appetite, Dehydration, Ear pain, Haematocrit decreased, Haemoglobin decreased, Mechanical ventilation, Nuclear magnetic resonance imaging, Platelet count decreased, Ultrasound scan, White blood cell count increased, X-ray
SMQs:, Rhabdomyolysis/myopathy (broad), Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Hyponatraemia/SIADH (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-04-02
   Days after onset: 25
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None listed in History and Physical
Current Illness: None known
Preexisting Conditions: None known
Allergies: No Known allergies
Diagnostic Lab Data: This RN does not have access to all tests and results that was done on this patient. This RN has tried to contact both hospitals but has received no response
CDC Split Type:

Write-up: Patient was seen in immunization clinic to receive some vaccination. Patient is from a family and it is common for them to only receive certain vaccines and limit the amount of vaccines at one time below the recommended level. Patient received vaccines listed and this was only the second time she had received any vaccines. According to History and Physicals the patient was seen by the walk-in clinic for ear pain and not wanting to eat 3 days later but mom states that the problem started a couple hours after the vaccines were given. Patient was seen 2 days later by her family doctor which admitted her to the hospital with dehydration and possible strep, even though the patient was on antibiotics at this point.


VAERS ID: 703490 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Male  
Location: Illinois  
Vaccinated:2017-06-27
Onset:2017-07-01
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2017-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C5242AC / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R49357 / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. M041770 / 2 MO / PO

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, Bed sharing, Death, Laboratory test, Muscle rigidity, Resuscitation, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-07-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: See above. I do not have more information from medical examiner.
CDC Split Type:

Write-up: Baby was co-sleeping between parents and was found unresponsive and already rigid at around 6:30 am. Last known awake time was 3-3:30 am. Resuscitation attempted by unsuccessful. Full autopsy report is not completed at this time but the latest I heard from the mother of the baby is that there was no obvious cause on the exam of the baby and internal organs. There are tissue sample tests pending.


VAERS ID: 703833 (history)  
Form: Version 2.0  
Age: 3.0  
Sex: Male  
Location: New York  
Vaccinated:2017-01-16
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (KINRIX) / GLAXOSMITHKLINE BIOLOGICALS Y2N22 / 1 UN / UN
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. M038227 / 2 LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-02-01
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: CRANIOSYNOSTOSIS AT BIRTH
Preexisting Conditions:
Allergies: NONE
Diagnostic Lab Data: AUTOPSY
CDC Split Type:

Write-up: DEATH.


VAERS ID: 704246 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 2 UN / UN

Administered by: Unknown       Purchased by: ?
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: USPFIZERINC2017305597

Write-up: This is a spontaneous report from a contactable consumer who reported for his/her brother, via Pfizer-sponsored program. A male patient of an unspecified age received his second single dose of PREVNAR, on unspecified date for immunization. Medical history and concomitant medications were not reported. Previously, on an unknown date, the patient received the first dose of the vaccine. The patient died on an unspecified date, 4 months after getting the second pneumonia shot. It was unknown if autopsy was performed. It was reported that patient was up to date on all the pneumonia vaccines available at the time (2009). Reported Cause(s) of Death: patient died 4 months after getting a pneumonia shot.


VAERS ID: 704769 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Enterovirus infection, Enterovirus test positive, General physical health deterioration, Haemoglobin decreased, Human rhinovirus test positive, Intensive care, Neutrophil count decreased, Pneumococcal bacteraemia, Pneumococcal infection, Pneumonia, Pneumonia pneumococcal, Polymerase chain reaction positive, Respiratory tract infection, Reticulocyte count, Rhinovirus infection, Streptococcus test positive, Unresponsive to stimuli, Viral upper respiratory tract infection, White blood cell count normal
SMQs:, Agranulocytosis (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: penicillin (unspecified); pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197); PREVNAR 13
Current Illness: Prophylaxis; Sickle cell disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Lab result: 38.8 ?C; Test Name: Haemoglobin; Result Unstructured Data: Lab result: 6.3 g/dL; Test Name: Heart rate; Result Unstructured Data: Lab result: 0 /min; Test Name: Neutrophil count; Result Unstructured Data: Lab result: 2475 /mm3; Test Name: Reticulocyte count; Result Unstructured Data: Lab result: 196,400 /mm3; Test Name: White blood cell count; Result Unstructured Data: Lab result: 7500 /mm3
CDC Split Type: US0095075131707USA005977

Write-up: This literature report has been received from the author of a published literature article. Background: Patients with sickle cell disease (SCD) were at risk of fatal sepsis with encapsulated bacteria, such as Streptococcus pneumonia, because of the inherent autosplenectomy that occurred in SCD. This risk was thwarted with oral penicillin prophylaxis during the first 5 years of life, and with stringent vaccination against S. pneumoniae alongside routine childhood immunization. But compared with the general specific pediatric population, the rate of invasive pneumococcal disease (IPD) in patients with SCD still remained high, resulting in hospitalization and fatality. This study aimed to investigate IPD in a patient population with SCD that had received standard pneumococcal prophylaxis. Methods: Patients with SCD who developed IPD from 2004 up to 2013 were identified using microbiology records. Those records belonging to patients with SCD between the ages of 0 to 21 years were selected for inclusion in this retrospective study. Descriptive analysis of presence of risk factors for IPD, type of SCD, pneumococcal vaccination and prophylaxis status, clinical presentation, microbiological data, and the outcome of IPD was performed. Results: 8 patients with SCD developed IPD (7 bacteremia and 1 respiratory tract infection). Three of the 8 isolates underwent serotype analysis (15 C in 2 and 15 A in 1), none covered with the current vaccination program. One patient had fatal outcome (15 A). Conclusions: Breakthrough cases of IPD might involve non-vaccine isolates, and seemed to occur after 5 years of age when oral penicillin prophylaxis had been terminated. Non-vaccine serotypes could cause IPD in patients with SCD, especially in older patients who were no longer on oral penicillin prophylaxis and/or those patients with incomplete immunization status. Prompt institution of antibiotic and supportive therapy was essential for the survival of these patients. This case refers to a 5 year old male patient, with smoking exposure and was also on daycare. The patient had no sibling. Concomitant therapy included oral penicillin (complete), heptavalent pneumococcal conjugate vaccine (PCV7) (active) and PREVNAR 13 (active) for prophylaxis. On an unknown date, the patient received PNEUMOVAX 23 for prophylaxis. The patient presented from home with fever of 38.8 Celsius degrees (date unspecified). In 2013, the non-vaccine serotypes patient presented with IPD - respiratory tract infection/upper respiratory infection, resulting in hospitalization (date unknown). Focal infection/other culture: Rhinovirus/Enterovirus upper respiratory infection by polymerase chain reaction (PCR) (his nasal wash sample was positive for Rhinovirus/Enterovirus), pneumonia (concurrent radiological findings, which was likely from S. pneumoniae given his rapid deterioration and S. pneumoniae bacteremia. The concurrent viral infection might or might not have contributed to the severity of his presentation and was performed due to the clinical severity of his symptoms). Because of the deterioration in clinical status, the patient was transferred to the pediatric intensive care unit (PICU) but he succumbed to the severe infection (date of death unknown). The Clinical presentation data: heart rate was 0 /min (asystole). White blood cell count/ absolute neutrophil count (WBC/ANC): 7500/2475 /mm^3. Hemoglobin was 6.3 g/dL. Absolute reticulocyte count was 196,400 /mm^3. The other clinical findings at presentation: Unresponsive on arrival to emergency department. The microbiological and outcome data: Blood culture: S. pneumoniae positive; Time to culture positive: 27 hrs; S. pneumoniae Serotype analysis: 15 A; S. pneumoniae susceptibility: penicillin and ceftriaxone; PICU stay: Yes; outcome of the event: Died. The reporter considered the event to be related to PNEUMOVAX 23. Upon internal review, IPD - respiratory tract infection/upper respiratory infection was determined to be medically significant. This is one of several reports from the same literature. Sender''s Comments: US-009507513-1707USA005890. Reported Cause(s) of Death: invasive pneumococcal disease/respiratory tract infection/upper respiratory infection.


VAERS ID: 706604 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131708USA001102

Write-up: This information has been received from a consumer concerning unspecified patients of unknown age and gender. The patients'' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with GARDASIL 9 (dose, strength, frequency, route of administration, anatomical location, lot# and expiration date were not provided), for prophylaxis. The reporter stated that GARDASIL 9 was "killing people", but did not clarify whether she knew of any specific patients who died after receiving GARDASIL 9. Neither the cause of death nor whether an autopsy was performed was reported. Upon internal review, the event of death was considered to be medically significant. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 706869 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
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: US0095075131708USA000522

Write-up: This spontaneous report as received from a physician via field representative refers to a female patient of unknown age. The patient''s medical history, concurrent condition and concomitant medications were not reported. The physician reported that an unspecified patient stated that daughter of a friend, on an unknown date, vaccinated with either GARDASIL 9 or GARDASIL (dose, route, batch/Lot # unknown) for prophylaxis. Subsequently, on an unknown date the patient died. The cause of death was not reported. It was unknown if an autopsy was performed. Causality assessment was not provided. No PQC filed. The physician was not able to provide any further details. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 707642 (history)  
Form: Version 2.0  
Age: 0.5  
Sex: Male  
Location: Montana  
Vaccinated:2017-07-28
Onset:2017-07-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2017-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 52JC5 / UNK UN / UN

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, Culture tissue specimen, Hypersomnia, Lethargy, Respiratory arrest, Resuscitation, Sudden death, Toxicologic test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-07-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations: Parents report unusual lethargy for the 24 hours following the prior standard vaccines at 2 months and 4 months of age.
Other Medications: Patient was not taking any other medications of any kind at the time of the vaccination.
Current Illness: Mild eczema behind knees and elbows; hypospadias with chordee
Preexisting Conditions: None
Allergies: No known allergies
Diagnostic Lab Data: Autopsy performed. Awaiting toxicology and tissue cultures at this time.
CDC Split Type:

Write-up: Patient was unusually lethargic and slept from 9pm on July 28, 2017 to 9am on July 29, 2017. He remained lethargic throughout the day, and was last known alive at approximately 10pm on July 29, 2017. He went to sleep on his mother''s chest while she was reclining partially upright on a sofa. She also went to sleep and awoke approx. half hour later to find him not breathing. 911 call at 10:37pm with CPR in progress. Patient never revived and was pronounced dead at 11:15pm. SUIDI at this time; investigation ongoing.


VAERS ID: 708434 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
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: US0095075131708USA006054

Write-up: This spontaneous report was received from a physician via a company representative concerning a 12 year old female patient. Medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a dose GARDASIL 9 (dose, route, lot# and the expiration date were not reported) for prophylaxis. There was no concomitant medication provided. The primary reporter stated one parent of one unspecified patient presented physician with media article stating that " a twelve year old girl died a couple hours after receiving GARDASIL 9, a separate patient was said to have entered premature menopause according to a Pediatrician, and a former company doctor reported that this vaccine was dangerous (unevaluable event)." The cause of death was not provided by the reporter and it was unknown if the autopsy was performed at the reporting time. The outcome of premature menopause and unevaluable event was unknown. The reporter did not provide the causality between the events: premature menopause and unevaluable event and the suspect therapy. Upon internal review, death was determined to be medically significant.; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 708450 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Maine  
Vaccinated:2017-08-11
Onset:2017-08-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2017-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 178502 / UNK LA / IM

Administered by: Pharmacy       Purchased by: ?
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: NONE KNOWN TO PHARMACIST
Current Illness: NONE KNOWN
Preexisting Conditions: UNKNOWN
Allergies: NONE KNOWN
Diagnostic Lab Data: NONE KNOWN
CDC Split Type:

Write-up: PATIENT RECEIVED FLUAD SHOT AT APPROX. 4PM ON 8/11/2017. PATIENT LEFT PHARMACY APPROX 10 MINUTES AFTER RECEIVING SHOT. I WAS CONTACTED BY FAMILY MEMBER ON 8/12/2017 THAT PATIENT HAD PASSED AWAY SOMETIME DURING THE NIGHT. IT IS UNCLEAR IF THE SHOT CAUSED THE DEATH NOR IS THE FAMILY STATING THAT THEY BELIEVE IT DID. I WAS ADVISED TO FILL OUT THIS FORM AS A PRECAUTION. AGAIN- IT IS UNCLEAR IF SHOT WAS THE CAUSE.


VAERS ID: 709187 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-08-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Injection site vesicles, Lip and/or oral cavity cancer
SMQs:, Oropharyngeal neoplasms (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131708USA008382

Write-up: This spontaneous report was received from a Nurse concerning a female patient of unknown age. Information on the patient''s medical history, concurrent conditions and concomitant medications were not reported. It was unknown if the patient had any drug reactions or allergies. On an unknown date, the patient was vaccinated with ZOSTAVAX 19400 PFU (route: unspecified injection) (dose number, dose, unit, lot# and expiration date were not reported) for prophylaxis. Other suspect therapies included sterile diluent (MERCK STERILE DILUENT) (indication, route, dose, frequency, lot# and expiration date were not reported). On an unknown date, several days after vaccination, one vesicle appeared at the patient''s injection site and resolved on an unknown date. Later, the patient was diagnosed with oral cancer (death and medically significant). It was unknown if the patient received treatment. It was unknown if the patient sought medical attention. Approximately on an unspecified date in 2007 (10 years ago) the patient died. The cause of the death was oral cancer. It was unknown if autopsy was done. No product quality complaint was involved. Causality for the events was not reported. Upon internal review, the event oral cancer was determined to be medically significant.; Reported Cause(s) of Death: Oral cancer.


VAERS ID: 709438 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Illinois  
Vaccinated:2017-08-16
Onset:2017-08-23
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2017-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UI808AA / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-08-23
   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: Voltaren 1% gel; levothyroxine; metoprolol ER; prednisone
Current Illness: No known
Preexisting Conditions: No known
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death reported by physician 8/23/17.


VAERS ID: 710054 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: Indiana  
Vaccinated:2017-08-11
Onset:2017-08-22
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2017-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS PN595 / 2 LL / IM

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, Death neonatal, Gestational hypertension
SMQs:, Acute central respiratory depression (broad), Hypertension (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-08-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: NKDA
Diagnostic Lab Data: Autopsy currently in progress. Father reports Hep B vaccine caused the death of his daughter.
CDC Split Type:

Write-up: Patient unexpectedly passed away on 8/22/17. EDD: 7/3/17, Birth weight: 3.27kg. Mother''s Hx--Gravida: 4, Full Term Preg: 1, Preterm Preg: 1, Abortions: 1, Living Children: 2. Pregnancy complicated by HTN (non-medicated), CDX2, HSV, learning disability (FAS), tobacco use, asthma, anemia, PTSD, anxiety, depression, scoliosis, HA''s, GERD.


VAERS ID: 710135 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-08-28
Entered: 2017-08-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Meningitis, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Noninfectious meningitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2017GSK129338

Write-up: This case was reported by a consumer and described the occurrence of vaccination failure in a male patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced vaccination failure (serious criteria GSK medically significant) and meningitis (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the meningitis was fatal. The reported cause of death was meningitis. It was unknown if the reporter considered the vaccination failure and meningitis to be related to BEXSERO. Additional details were provided as follows: The reporter reported this case for his/her friend''s boyfriend. The age at vaccination was not reported. The patient had contracted meningitis from after receiving BEXSERO and died. This case was considered as suspected vaccination failure since the completion of vaccination schedule, time to onset of event and confirmatory laboratory test were unknown.


VAERS ID: 710759 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2017-08-30
Onset:2017-08-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2017-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C5338AA / 1 LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. N009802 / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH S31241 / 1 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AA755 / 1 OT / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-08-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pediatric Vitamins ADC (VITAMIN-MULTI ADC) 750-400-35 units-mg/mL Oral solution
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received vaccines in office 8/30/17. Patient was found unresponsive by parents at home 8/31/17 and was unable to resuscitate and resulted in death.


VAERS ID: 711038 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2017-08-21
Onset:2017-08-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2017-09-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. N001007 / UNK UN / UN

Administered by: Unknown       Purchased by: ?
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: 2017-08-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy to nuts; Angiotensin converting enzyme inhibitor foetopathy
Preexisting Conditions: Medical History/Concurrent Conditions: Neoplasm malignant
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131708USA011341

Write-up: Information has been received from a pharmacist referring to a female patient of unknown age with tolerances to ACE inhibitors and tree nut allergies. The pharmacist noted the patient did take other medications but did not provide a list. On 21-AUG-2017, the patient was vaccinated with PNEUMOVAX 23 (dose and frequency was not provided), lot # N001007 with expiration date 19-SEP-2018 for prophylaxis. On 22-AUG-2017, the patient died suddenly with possible toxic shock syndrome. Autopsy was unknown. The causal relationship between PNEUMOVAX 23 and the death was not provided. Upon internal review, death was determined to be medically significant. Reported Cause(s) of Death: possible toxic shock syndrome.


VAERS ID: 712091 (history)  
Form: Version 2.0  
Age: 0.67  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH S15227 / 3 UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Pneumonia streptococcal, Streptococcus test positive
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-05-05
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Serology test; Result Unstructured Data: Test Result: Serotype 35B
CDC Split Type: USPFIZERINC2017385966

Write-up: This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer (patient''s parent). A male patient of unspecified age and race/ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Relevant medical history and concomitant medications were not reported. The patient experienced Streptococcus pneumoniae serotype 35B. On an unspecified date the patient underwent lab tests and procedures which included serology test: serotype 35B. The patient died due to the event on 05May2017, he was almost 9 months old. It was unknown if an autopsy was performed. Reported Cause(s) of Death: Streptococcus pneumoniae serotype 35B.


VAERS ID: 712158 (history)  
Form: Version 2.0  
Age: 0.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2017-04-04
Onset:2017-04-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2017-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. M044031 / 1 RL / SYR

Administered by: Private       Purchased by: ?
Symptoms: Death, Decreased appetite, Diarrhoea, Irritability, Pain
SMQs:, Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-04-06
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: Started with diarrhea the day after her vaccination. Daughter was fussy and seemed to be in pain and not eating much. Patient died at hospital on 04/06/2017. Hospital 1: Medical Center ER, transferred to another city via helicopter. Hospital 2: Hospital.


VAERS ID: 712391 (history)  
Form: Version 2.0  
Age: 0.08  
Sex: Female  
Location: Mississippi  
Vaccinated:2017-06-30
Onset:2017-07-17
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2017-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 2YZ27 / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. N000237 / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R70447 / 1 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS 24ED2 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-07-19
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: She passed away.


VAERS ID: 712764 (history)  
Form: Version 2.0  
Age: 0.33  
Sex: Female  
Location: Iowa  
Vaccinated:2017-05-24
Onset:2017-05-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2017-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 3NM93 / 2 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. M047666 / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R70447 / 2 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. M035456 / 2 MO / PO

Administered by: Private       Purchased by: ?
Symptoms: Crying, Cyanosis, Death, Fatigue, Immediate post-injection reaction, Irritability, Resuscitation, Rhinorrhoea, Skin discolouration, Somnolence
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-05-25
   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: nothing more than a runny nose, no fevers
Preexisting Conditions: none
Allergies: none known
Diagnostic Lab Data:
CDC Split Type:

Write-up: Immediately during and after the shots, she was crying. Right after, she was very tired and drowsy. She fell asleep in the car on the way home. Napped for a very short time during the evening and was kind of fussy which was not normal for her. She was fed at around 9:30 PM that evening and fell asleep right after so she was laid down on her back in her crib. She was checked on at 11:30 and 12, still sleeping on her side. She was checked on at 6 the following morning and was face down. When she was flipped over she was all blue/discolored with fluids coming out of her nose. When EMS arrived, no resuscitation attempts were made.


VAERS ID: 713218 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Female  
Location: Georgia  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Death, Irritability, Respiratory arrest, Resuscitation
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-02-13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Gas drops
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: My baby quit breathing, was not able to be revived through CPR and passed away. Irritability in the weeks prior.


VAERS ID: 713612 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Unknown  
Vaccinated:2017-07-15
Onset:2017-09-18
   Days after vaccination:65
Submitted: 0000-00-00
Entered: 2017-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R49358 / UNK LA / IM

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2017-09-18
   Days after onset: 0
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: US0095075131709USA009379

Write-up: This initial spontaneous report was received from a physician via a company field representative referring to a male patient in his 60''s. Medical history, concurrent conditions and concomitant medications were unknown by the reporter. On unspecified Wednesday, the patient received PNEUMOVAX 23 (dose, route and lot # not provided). The patient developed Guillain-Barre syndrome five days later (also reported as "about two weeks ago" on 18-SEP-2017). The patient was hospitalized and passed away within the week after receiving unspecified treatment. The cause of death was Guillain-Barre syndrome. Causality assessment was not provided. The field representative found out that there may be legal action taken. Upon internal review, Guillain-Barre syndrome was considered medically significant. The physician felt Guillain-Barre syndrome was life-threatening. Additional information will not be requested as the reporter did not provide consent to be contacted. Reported Cause(s) of Death: Guillain-Barre syndrome.


VAERS ID: 713718 (history)  
Form: Version 2.0  
Age: 0.33  
Sex: Male  
Location: Kentucky  
Vaccinated:2017-09-19
Onset:2017-09-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2017-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 924Y3 / 2 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. N003537 / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 2 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS Y5EJ3 / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-09-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ZANTAC 15mg/mL syrup two times daily
Current Illness:
Preexisting Conditions: Failure to thrive; feeding problem; weight below third percentile
Allergies: Lactose intolerant
Diagnostic Lab Data: NA
CDC Split Type:

Write-up: Patient seen in our office on 9/19/2017 at 2:15 pm for a routine child health examination and weight check. Patient''s 4 month vaccines given, as listed above. On 9/20/2017, patient was found infant unresponsive by parents. EMS called and arrived to find parents performing CPR. Patient transferred via EMS to ED. CPR unsuccessful. Time of death called at 7:34am in the ED.


VAERS ID: 714035 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2017SA173163

Write-up: Initial unsolicited report received from the literature on 18-Sep-2017. This case is linked with: 2017SA173133. Verbatim of the article: This is the second phase 1 study of a respiratory syncytial virus (RSV) vaccine containing RSV fusion protein (sF) adjuvanted with glucopyranosyl lipid A (GLA) in a squalene-based 2% stable emulsion (GLA-SE). In this randomized, double blind study, 261 subjects aged _60 years received inactivated influenza vaccine (IIV), a vaccine containing 120 _g sF with escalating doses of GLA (1, 2.5, or 5 _g) in SE, or a vaccine containing 80 _g sF with 2.5 _g GLA in SE. Subjects receiving 120 _g sF with 2.5 or 5 _g GLA were also randomized to receive IIV or placebo. Immunity to RSV was assessed by detection of microneutralizing, anti-F immunoglobulin G, and palivizumab-competitive antibodies and F-specific gamma interferon enzyme linked immunosorbent spot assay T-cell responses. Higher adjuvant doses increased injection site discomfort, but at the highest dose, the reactogenicity was similar to that of IIV. Significant humoral and cellular immune responses were observed. The 120 _g sF plus 5.0 _g GLA formulation resulted in the highest responses in all subjects and in older subjects. These results confirm previous observations of vaccine tolerability, safety, and immunogenicity and were used to select the 120 _g sF plus 5.0g GLA formulation for phase 2 evaluation. Ethics statement. The study was carried out in accordance with the Declaration and good clinical practice guidelines. The study protocol and amendments and the subject informed consent document were approved by the Independent Review Board and the Review Board. All subjects provided written informed consent. Study design. In this phase 1b, double-blind, controlled, adjuvant-escalation (1.0, 2.5, and 5 _g of GLA) study conducted in adults _60 years of age, 264 subjects (healthy subjects or subjects with stable chronic illnesses) were to be enrolled at 5 centers in 2015. They were randomized by cohort, as described, using an Internet-based interactive response system. Subjects received 1 vaccine in cohorts 1 and 4. For cohorts 2 and 3, in which the subjects received an RSV vaccine and either IIV or placebo to assess the safety and immunogenicity of concurrently administered IIV and RSV vaccines, the vaccines were randomly assigned to be administered in the right or the left arm. The dose of 80 _g of sF plus 2.5 _g of GLA was included to bridge to phase 1a study data. In a preplanned interim analysis, some investigators were made unblind to the treatments after the subjects had completed 90 days of safety follow-up, but site staff and subjects remained blind to the treatments until the end of the study (day 361).Subjects. Subjects were required to be _60 years of age, to be not institutionalized or homebound, to weigh _40.9 kg, and to have met a gender-specific hemoglobin requirement. Major exclusions included an unstable medical condition or a recent change in therapy, receipt of influenza vaccine within the previous 60 days, receipt of products that could include exogenous antibodies, clinically significant abnormalities in screening tests, viral hepatitis, a history of or current autoimmune disorder other than hypothyroidism, immunosuppression, a body mass index of _40 kg/m2, or the taking of medications or the existence of conditions that could cause injection site bleeding. Study vaccines. sF in the postfusion conformation derived and modified from the sequence of an RSV A strain was expressed in a hamster ovary cell line. GLA-SE was provided by and licensed from Corporation pursuant to an existing agreement. RSV sF was from the same lot used in the phase 1a study; GLA-SE was remanufactured to use non-egg-derived phosphatidylcholine. FLUZONE was purchased commercially and provided to the study sites. To prepare vaccine on-site, lyophilized RSV sF was reconstituted with sterile water and combined with liquid diluent, GLA-SE, and SE in a mixing vial to reach the concentrations of sF, GLA, and SE specified for each cohort. For all vaccines, a single 0.5-ml dose was drawn into a covered syringe to maintain the blind and administered into the deltoid muscle with a needle of the gauge and length described in previously published guidelines. Study assessments. Specified solicited symptoms were recorded using a diary card between days 1 (dosing) and 7; AEs were recorded between day 1 and the day 29 visit; and serious AEs, new-onset chronic diseases, and AESIs, including events of potential autoimmune etiology, were recorded from days 1 to 361. Visits occurred on (approximately) days 1, 8, 29, 61, 91, 181, 271, and 361. Subjects were contacted by telephone at least monthly for safety follow-up. Toxicity grading was generally consistent with that on a standard table. This case involves 79-year-old male patient, who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date, dose, dose in series site and route of administration were not reported) on an unknown date. The patient''s medical history was not reported. Patient concomitantly received placebo as part of trial procedure. On an unknown date, 320 days following the vaccination patient had cardiac arrest. Other laboratory test and corrective treatment were not reported. On an unknown date, patient died. It was not reported whether autopsy was performed or not. As per the reporter relationship to study dosing was reported as not related. List of documents held by sender: none. Sender''s Comments: This case concerns a 79 year old male who died due to cardiac arrest on 320 days post vaccination with Inactivated Influenza vaccine (MFR unknown). Time to onset is too long to be compatible with the role of vaccine. More details regarding patient''s medical history (concurrent illness), previous vaccination history, time of death and autopsy report are needed for complete assessment of the case. Based on the available information no conclusion can be drawn. Reported Cause(s) of Death: cardiac arrest.


VAERS ID: 715873 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-09-29
Entered: 2017-10-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Malaise, Road traffic accident
SMQs:, Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201701684

Write-up: This serious initial spontaneous case, was received from other non-health professional via Merck on 25-Sep-2017, concerning a 23-year-old male patient. On an unspecified date, the patient was administered with influenza vaccine (dose, batch number, manufacturer, trade name, route of administration, anatomical location and expiry date: not reported). On an unspecified date, the patient became sick. The outcome of the event sick was not reported. It was reported that the patient had died due to auto accident on an unspecified date. It was unknown, whether autopsy was done.


VAERS ID: 716263 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2017-08-31
Onset:2017-09-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2017-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 2YZ27 / 1 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UI764AA / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R70447 / 1 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS Z23PT / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-09-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TYLENOL
Current Illness: None
Preexisting Conditions: None known
Allergies: NKA
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient passed away on 9/2/17. Cause was apparent SIDS but autopsy results are still pending.


VAERS ID: 716493 (history)  
Form: Version 2.0  
Age: 0.0  
Sex: Male  
Location: Alabama  
Vaccinated:2016-10-23
Onset:2016-10-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2017-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Private       Purchased by: ?
Symptoms: Blood sodium decreased, Developmental regression, Gastrointestinal disorder, Growth failure, Pulmonary function test decreased, Renal impairment, Seizure, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Neonatal disorders (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-12-04
   Days after onset: 42
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 28 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Could not keep sodium levels up, gastrointestinal problems, throwing up every feed, kidney function diminished, regression, slow growth, lung function diminished, uncontrollable seizures starting immediately after.


VAERS ID: 716526 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
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: US0095075131710USA001469

Write-up: This spontaneous report as received from social media via other and refers to a patient of unknown age and gender. The patient''s medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL (lot#, expiry date and dosing details were not reported) for prophylaxis. Later, on an unknown date, the patient died and the cause of death was unknown. It was unknown if an autopsy was performed. It was reported that, 63 reports on GARDASIL lot recalled, including one death (product quality issue). And the reports in vax from same lot given after recall. Causality assessment was not provided. Upon internal review, death was determined to be medically significant.; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 718413 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Completed suicide, Quality of life decreased
SMQs:, Suicide/self-injury (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: US0095075131710USA004070

Write-up: This spontaneous report was received from a physician via an online article, referring to a female patient of unknown age. The patient''s medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown date, the patient was vaccinated with GARDASIL (route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. The article reported that the girl''s life was destroyed after she was vaccinated with the GARDASIL, leading her to commit suicide. The reported did not mention the causality assessment between the events of suicide and quality of life decreased with GARDASIL. Upon internal review, suicide was determined to be medically significant. This is one of two cases from the same reporter. Sender''s Comments: US-009507513-1710USA005030.


VAERS ID: 719492 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Leukaemia
SMQs:, 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131710USA005030

Write-up: This spontaneous report was received from a physician via an online article, referring to a female patient of unknown age. The patient''s medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown date, the patient was vaccinated by her mother who was a nurse, with GARDASIL (route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. The article reported that the girl on an unspecified date developed leukemia and died. I was unknown if an autopsy was done to the patient. The reported did not mention the causality assessment between the events of leukemia and death with GARDASIL. Upon internal review, leukemia and death were determined to be medically significant.; Sender''s Comments: US-009507513-1710USA004070:


VAERS ID: 719758 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
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: US0095075131710USA005876

Write-up: This spontaneous report has been received from a newspaper article concerning a 10 year old patient of unknown gender. The patient''s medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On an unknown date the patient was vaccinated with a human papillomavirus vaccine (manufacturer unknown) (dose, dose number, route of administration, anatomical location, lot number and expiration date were not provided), for prophylaxis. It was reported that on an unknown date the human papillomavirus vaccine (manufacturer unknown) might have caused the death of the patient. It was unknown if an autopsy was done. The causal relationship between human papillomavirus vaccine (manufacturer unknown) and the event was considered as related. Upon internal review, death was determined to be medically significant.


VAERS ID: 720413 (history)  
Form: Version 2.0  
Age: 1.25  
Sex: Male  
Location: Connecticut  
Vaccinated:2017-10-02
Onset:2017-10-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2017-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C5308AA / 4 UN / UN
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR CT58975A / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH S35326 / 4 RL / IM

Administered by: Other       Purchased by: ?
Symptoms: Death, Endotracheal intubation, Resuscitation
SMQs:, Angioedema (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-10-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol; Hydrocortisone
Current Illness: 9/17/17 adm. to Hosp: viral URI/Disc. 9/18/17
Preexisting Conditions: Atopic dermatitis; Asthma
Allergies: Egg white; Peanuts; Wheat; Walnuts; Codfish; Cow''s milk; Shrimp
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was brought to ED at Hospital by family member and was DOA. Patient was intubated and CPR was performed for 25 minutes until patient was pronounced dead at 16:18 on 10/5/17.


VAERS ID: 721311 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: New Mexico  
Vaccinated:2017-08-09
Onset:2017-08-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2017-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 35ZF9 / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. M036056 / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N90908 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. M006111 / 1 MO / PO

Administered by: Private       Purchased by: ?
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: 2017-08-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: No adverse reactions noted at clinic visit 8/9/17. Patient found unresponsive; deceased on 8/11/17.


VAERS ID: 721793 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Female  
Location: New Jersey  
Vaccinated:2017-10-16
Onset:2017-10-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2017-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS J7KA7 / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R94917 / 1 RL / IM

Administered by: Private       Purchased by: ?
Symptoms: Apnoea, Base excess decreased, Blood bicarbonate decreased, Blood pH decreased, Bradycardia, Brain injury, Death, Electroencephalogram abnormal, Mechanical ventilation, PCO2 increased, Resuscitation, Seizure
SMQs:, Lactic acidosis (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-10-19
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: POLI-VI-SOL with Iron; Cyclogyl tropicamide Phenylephrine eye drops (caputo eye drops for eye examination)
Current Illness: Prematurity Ex 24 weeks gestation (Corrected gestational age 39.6 weeks); RDS (resolved 10/9- Off Oxygen 10/9); Hyponatremia (resolved 10/8); ROP stage 1 (last exam 10/16); Anemia of prematurity
Preexisting Conditions: ROP
Allergies: No
Diagnostic Lab Data: Blood gas at 1810 (10/16) after event PH 6.62/PCo2 46/HCO3 5.1/ Base deficit -31.5; EEG: abnormal Video EEG study to diffuse attenuation and undifferentiated activity signifying diffuse cerebral dysfunction.
CDC Split Type:

Write-up: Apnea and Bradycardia, seizure, Hypoxic brain injury, Death. Full Resuscitation. Ventilator support. Epinephrine, Dopamine, Insulin, hydrocortisone, Antibiotics. VERSED x1 dose, Phenobarbital Loading dose.


VAERS ID: 723801 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2016-03-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Balance disorder, Chills, Death, Injection site pain, Malaise, Musculoskeletal stiffness, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Vestibular disorders (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZERINC2017464467

Write-up: This is a spontaneous report from a contactable consumer via a Pfizer sales representative. An 84-year-old male patient of unknown race/ethnicity received in Mar2016 (during 6 month home visit) a single dose of PREVNAR 13 for immunization. Medical history included dementia. Concomitant medications were not reported. On an unspecified date in 2016, the patient reported initially pain at injection site then became sick within couple of days and fever and chills and stiff neck and pain in joints also reported balance problems. Patient was visited at the emergency room where they really couldn''t find anything wrong with him. Symptoms persisted, may be got little better over time. In Jul2016 patient died. No autopsy was performed. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 723815 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Kansas  
Vaccinated:2017-10-12
Onset:2017-10-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2017-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UI871AB / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Asthenia, Death, Dyspnoea, Dysstasia, Fatigue, Intervertebral disc disorder, Mobility decreased, Muscle spasms, Muscle tightness, Muscular weakness, Nuclear magnetic resonance imaging spinal abnormal, Pain in extremity, Paraesthesia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2017-10-20
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: low-dose Bayer, Allegra, Colon Health Supplement, Centrum Silver; Rx:
Current Illness:
Preexisting Conditions: Type II Diabetes, Heart Attack in 2000 (7 stents)
Allergies: none
Diagnostic Lab Data: 10/18/2017- with results on 10/20 in am- MRI- showed Congested Disc Disease in back
CDC Split Type:

Write-up: Friday- complained of leg cramps and the sensation of "not being able to move"; Saturday- tired, complained of pain in legs, "feet were tingly" and "calves were tight"; Monday- worked, but Dr could not see until Tuesday afternoon; Tuesday- collapsed in bathroom, crawled to wall and pulled self up, went home from work at noon; Wednesday- MRI no new symptoms; Thursday- complained of arms tingling; "legs were like noodles" and "couldn''t stand"; Friday- no strength in arms or legs, had trouble breathing, called ambulance at 1:09 pm; died at 2 pm.


VAERS ID: 723895 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Tennessee  
Vaccinated:2017-10-23
Onset:2017-10-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2017-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 2F977 / 1 RL / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS Z5297 / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH T08483 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. N015134 / 1 MO / PO

Administered by: Private       Purchased by: ?
Symptoms: Apnoea, Blood gases, Death, Resuscitation, Sudden infant death syndrome, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2017-10-25
   Days after onset: 0
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: blood gas
CDC Split Type:

Write-up: Found apneic and unresponsive. CPR was run x 2h but patient never revived. Cause of death was determined to be SIDS. No other SIDS risk factors were present. Baby was asleep on back in proper bed without blankets or pillows.


VAERS ID: 724443 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: South Carolina  
Vaccinated:2017-10-09
Onset:2017-10-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2017-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 179303 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Death, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-10-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: None reported by patient
Preexisting Conditions: None reported by patient
Allergies: None reported by patient
Diagnostic Lab Data: None reported by patient''s family
CDC Split Type:

Write-up: Patient received influenza vaccine on 10/9/2017. On 10/11/2017 patient suffered a myocardial infarction and passed away.


VAERS ID: 725534 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2017-10-23
Onset:2017-11-04
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2017-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS J7KA7 / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UI619AAA / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH S39564 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. M041814 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-11-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient presented to primary care office on Oct. 23, 2017 for 2 month well child check and received routine vaccines PEDIARIX, ACTHIB, Pneumococcal and ROTATEQ. Manager received a phone call for County Department of Health that the child passed away on Nov. 4, 2017.


VAERS ID: 725990 (history)  
Form: Version 2.0  
Age: 0.0  
Sex: Female  
Location: Arizona  
Vaccinated:2006-09-22
Onset:2006-09-26
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2017-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 289 / 1 RL / IM

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, Hepatomegaly, Splenomegaly, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Liver related investigations, signs and symptoms (narrow), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-09-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Autopsy
CDC Split Type:

Write-up: She died at 4 days old. Enlarged liver. Enlarged spleen. Labeled it sudden unexplained death.


VAERS ID: 726353 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: Maryland  
Vaccinated:2016-01-27
Onset:2016-01-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2017-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UI301AA / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M27555 / 1 RL / IM

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, Death, Decreased appetite, Dyspnoea, Irritability, Lethargy, Pallor
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-02-03
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NEXIUM
Current Illness: None
Preexisting Conditions:
Allergies: N/A
Diagnostic Lab Data: We found out that our daughter had MPS I, 4 months after she passed away. However, she should not have died from this condition at a mere 68 days old. Many doctors agreed that the vaccinations exacerbated the situation greatly. Until the vaccines she was total healthy and normal. Though photos and even complete autopsy couldn''t find a cause. It was myself who decided to have myself and my husband screened for genetic issues and even after it was discovered patient had the genetic issue, the doctors at the Hospital couldn''t believe the MPS I would have killed a baby that young. I have never found another case of a baby dying so young from MPS I.
CDC Split Type:

Write-up: Lethargy, substantial decreased eating - especially when trying to get her to eat, very pale in color. Eventually leading to breathing difficulties and death (one week from vaccinations). Starting the same afternoon of her vaccines, patient was very lethargic but fussy when awake. The next day and days to follow her eating substantially decreased and she was very pale in color. On February 2nd I noticed breathing changes, so I took her to the ER. She passed away at 68 days old on February 3rd. Now that I have done substantial research on adverse effects of vaccines, I know these vaccines had to do with her death.


VAERS ID: 726791 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: Tennessee  
Vaccinated:2017-04-24
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C5199AA / 1 LL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 39ZRL / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N97937 / 1 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41DB563A / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-04-25
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: Unknown
Allergies: No known medication allergies- unknown if had food allergies
Diagnostic Lab Data: Not known
CDC Split Type:

Write-up: Patient passed away on 4/25/2017. Did not talk to parents of child. Request for medical records came from Forensic Center on 4/25/2017 at 2:45 pm and that is when we found out the baby had died.


VAERS ID: 727653 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Louisiana  
Vaccinated:2015-06-26
Onset:2016-11-11
   Days after vaccination:504
Submitted: 0000-00-00
Entered: 2017-11-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Anxiety, Death, Emotional distress, Herpes zoster, Pain, Physical disability, Quality of life decreased, Rash, Skin lesion
SMQs:, Anaphylactic reaction (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131711USA008205

Write-up: Information has been received on 16-NOV-2017 from a lawyer and the executor of the estate of a deceased consumer (date of death and cause of death was not reported.) The patient was reported to be a male patient of unknown age. The patient''s prior concurrent conditions, medical history and concomitant medications are unknown. On or about On 26-JUN-2015, the patient received ZOSTAVAX(lot number and expiration unknown), subcutaneous for its intended purpose: the prevention of shingles. As a direct result of the vaccine, the patient suffered from a Shingles outbreak, in addition to chronic pain, rash and lesions to various parts of his body. The patient did not have a Shingles outbreak until 11-NOV-2016. As a direct result of the vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred medical expenses and other economic harm as a direct result of use of ZOSTAVAX. As a direct and proximate consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including, but not limited to, mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, medical and related expenses, and other losses and damages. Upon internal review, deceased was considered to be medically significant. Additional information has been requested. Reported Cause(s) of Death: deceased.


VAERS ID: 728254 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Virginia  
Vaccinated:2017-08-31
Onset:2017-09-05
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2017-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UI808AA / UNK LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Atypical pneumonia, C-reactive protein increased, CSF white blood cell count decreased, Computerised tomogram thorax abnormal, Death, Headache, Intensive care, Laboratory test, Pneumonia, Red blood cell sedimentation rate increased, X-ray normal
SMQs:, Interstitial lung disease (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-11-07
   Days after onset: 63
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 30 days
   Extended hospital stay? No
Previous Vaccinations: She had minor reactions to the flu vaccine in the past where she had flu-like symptoms for several days afterwards
Other Medications: Fish oil
Current Illness: NA
Preexisting Conditions: Ehlers-Danlos (assumed)
Allergies: Narcotics
Diagnostic Lab Data: Contact Winchester Medical Center. There were an extreme number of tests that were done.
CDC Split Type:

Write-up: Two days after the flu shot, my mother developed a headache that became so bad that she went to the hospital. It was determined that she *might* have meningitis. There was nothing ever definitive. SED rates and CRP were extremely high. Very low WBC in spinal tap. After weeks of being in and out of the hospital, she came home. She never regained her strength. Towards the end of October, she was taken by ambulance yet again for a headache. However, while she was in the ambulance it was noted that her O2 level was at 80%. They treated her in the hospital for the headache, but after I pointed it out to them, the doctor became concerned at her O2 levels as well. X-ray showed nothing substantial, but at my insistence, she had a CT scan of her lungs. Bilateral pneumonia with ground glass appearance. Diagnosed with atypical pneumonia. Started in the general admission ward. Then was moved to step down unit. And was eventually moved to the CCU and passed away on November 7, 2017, her 74th birthday. Immediate COD was ARDS.


VAERS ID: 728520 (history)  
Form: Version 2.0  
Age: 0.5  
Sex: Male  
Location: Florida  
Vaccinated:2017-11-20
Onset:2017-11-27
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2017-11-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4999AB / 3 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH S15240 / 3 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. N005619 / 3 MO / PO

Administered by: Private       Purchased by: ?
Symptoms: Death, Irritability, Teething
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-11-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE KNOWN
Preexisting Conditions: UMBILICAL HERNIA, SICKLE CELL TRAIT
Allergies: NONE KNOWN
Diagnostic Lab Data: NONE KNOWN
CDC Split Type:

Write-up: Received call from ER physician that infant had died. Mom reported child was a little fussy yesterday due to teething. She swaddled him and put him to bed. When she went in to check on him in the middle of the night he had expired.


VAERS ID: 728584 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: California  
Vaccinated:2017-10-17
Onset:2017-11-11
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2017-11-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI845AA / 1 AR / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R56671 / UNK AR / IM

Administered by: Private       Purchased by: ?
Symptoms: Adverse drug reaction, Chest X-ray abnormal, Death, Diarrhoea, Drug ineffective, Dyspnoea, Hospice care, Nausea, Pneumococcal bacteraemia, Pneumococcal sepsis, Pneumonia pneumococcal, Pyrexia, Streptococcus test positive, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-11-18
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CARBIDOPA LEVODOPA; FLOMAX; FINASTERIDE; TEMAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Enlarged prostate; Flu; Parkinson''s disease; Parkinsonian-like tremor; Sleep disorder
Allergies:
Diagnostic Lab Data: Test Date: 20171111; Test Name: Blood test; Result Unstructured Data: Test Result: Pneumonia bacteria in the blood stream. Septic.; Test Date: 20171111; Test Name: Chest X-ray; Result Unstructured Data: Test Result: Pneumonia
CDC Split Type: USPFIZER INC2017509222

Write-up: This is a spontaneous report from a contactable consumer (patient''s husband) and from the patient''s daughter. A 90-year-old male patient received PREVNAR 13 (NDC number 00005197105, lot R56671, exp.date 30Apr2018) and first dose of FLUZONE (lot UI845AA, exp.date 13Apr2019, NDC number 49281040188) both via intramuscular route in the arm for immunization on 17Oct2017 14:00 at 0,5ml single dose at the doctor''s office. Concomitant medications included Carbidopa Levodopa since 09Apr2015 at 25/100mg one tablet by mouth three times a day, FLOMAX since Feb2017 at 0.4mg one capsule by mouth once a day, finasteride since 26Apr2017 at 5mg one tablet by mouth daily and temazepam at 15mg two capsule every night at bedtime. Relevant medical history included Enlarged prostate since Jan2017, Flu since 2016, essential tremors of Parkinson''s disease, Parkinson''s started in Jan2017 and Sleep disorder. On 11Nov2017 the patient experienced fever and difficulty breathing. He was taken to the emergency room via an ambulance at 09:00 on 11Nov2017 because of these events. He was admitted into the hospital on 11Nov2017. Later that day of 11Nov2017, he was diagnosed with pneumonia. She mentioned as treatment of the pneumonia, he was given heavy antibiotics: Piperacillin, tazobactam, ZOSYN and vancomycin and he stated a list of side effects on these antibiotics nausea, vomiting and diarrhea. A Chest x-ray showed Pneumonia and blood test showed Pneumonia bacteria in the blood stream. She also mentioned that after the doctor told them that the staff could not do anything else for him, and the patient was near the end of his life, on 16Nov2017 he was transferred to Hospice and given Morphine. Again, this was given as part of his treatment for the end of life. The patient passed away on 18Nov2017 for pneumonia. No autopsy was done. Reported Cause(s) of Death: drug ineffective; Pneumonia.


VAERS ID: 728993 (history)  
Form: Version 2.0  
Age: 0.33  
Sex: Male  
Location: Utah  
Vaccinated:2017-10-12
Onset:2017-10-16
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2017-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR - / 2 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 2 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. M041815 / 2 MO / PO

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, Blood electrolytes decreased, Death, Dehydration, Diarrhoea, Enterococcus test positive, Explorative laparotomy, Gastrointestinal necrosis, Irritability, Nausea, Rotavirus test positive, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Hostility/aggression (broad), Ischaemic colitis (narrow), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad), Dehydration (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2017-10-17
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None known
Diagnostic Lab Data: Autopsy revealed diffuse intestinal necrosis (majority of small bowel and proximal portion of large bowel) without evidence of anatomic abnormality. There was no evidence of trauma; also no evidence of volvulus, intussusception, malrotation, or vascular abnormality. Postmortem bacterial cultures of CSF, blood, and lungs grew Enterococcus faecalis. Viral studies of the stool identified ROTATEQ vaccine strain. Postmortem vitreous electrolytes revealed evidence of dehydration. No definitive cause for the intestinal necrosis was determined. Cause of death was attributed to "Intestinal necrosis of undetermined etiology."
CDC Split Type:

Write-up: Decedent was in his usual state of health on a 4 month wellness check on 10/12/2017, at which time he received the ROTATEQ vaccination (among others). Decedent presented to pediatrician on 10/16/2017 for fussiness, irritability, and nausea. He continued to have nausea, vomiting, and diarrhea and his parents transported him to the hospital that evening. He arrived to the hospital in critical condition. He died shortly thereafter on 10/17/2017 at 0100 following an emergent bedside exploratory laparotomy that revealed diffuse intestinal necrosis without an identified cause.


VAERS ID: 730194 (history)  
Form: Version 2.0  
Age: 0.42  
Sex: Female  
Location: California  
Vaccinated:2017-12-06
Onset:2017-12-09
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2017-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 7MM3Z / 2 LL / -
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. N012920 / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH S43842 / 2 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS G32HJ / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-12-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: TYLENOL PRN
Current Illness: None
Preexisting Conditions: None
Allergies: NKA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Child found apneic, unresponsive, brought to hospital by EMS with CPR in progress, child expired.


VAERS ID: 731149 (history)  
Form: Version 2.0  
Age: 0.58  
Sex: Male  
Location: Kansas  
Vaccinated:2017-09-14
Onset:2017-09-20
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2017-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI826AC / UNK RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. N009963 / 2 MO / PO

Administered by: Private       Purchased by: ?
Symptoms: Adenovirus infection, Blood uric acid increased, Brain death, Dyspnoea, Hypotonia, Lethargy, Muscle spasms, Pyrexia, Resuscitation, Rhinovirus infection, Skin warm, Ultrasound kidney
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tumour lysis syndrome (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: 2017-09-29
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Bacolfen; Omeprazole; Total probiotic ?; NUTRI-WEST
Current Illness: On September 11th pts Neurologist called to say he was confident pt has Lesch Nyhan Syndrome after we did genetic testing, but he wanted to check pts Uric acid levels. We did, so on Sept. 12th and his uric acid levels were 9.2. On Sept. 14th when pt had his appointment with his Dr who gave him his vaccines, I told him pt was most likely going to be diagnosed with LNS, but his neurologist wanted to see where his uric acid levels were. Pt was given the rotavirus 1 and the influenza 1 On September 18th pt was officially diagnosed with LNS
Preexisting Conditions:
Allergies: none
Diagnostic Lab Data: I have all the records.
CDC Split Type:

Write-up: The morning of Sept. 20th pt was lethargic and burning up. I rushed him to the ER were he had a fever of 105.4. Once he was stable they transferred him by ambulance to Medical Center. There he was officially diagnosed with the rhinovirus and the adenovirus. I have discovered through his medical records, he possibly may have had RSV, which we were not made aware of. While in the hospital they did an ultrasound of his kidneys and checked his uric acid levels again, now they were at a 14.9. He was released on the 21st of September, and referred to a nephrologist. On the morning of the 27th, pt was in one of his spasms which were frequent with LNS, my husband was doing routine positioning taught by pt''s physical therapist to us, to help him out of his fits. At this point, pt gasped and went limp. My husband ran into my room and we called 911. It took them 48 minutes to get pt heartbeat back, and by this point pt was brain dead. He was officially declared brain death at 1313 on September 29th. Almost instantly after arriving to the hospital, they started to accuse my husband of shaking our son. We know his is not true and believe this was cause from the brain injury due to lack of oxygen and vaccine injury.


VAERS ID: 731865 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-12-22
Entered: 2017-12-27
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Herpes zoster, Multiple organ dysfunction syndrome
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (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: VALTREX
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2017195690

Write-up: This case was reported by a pharmacist via call center representative and described the occurrence of multi-organ failure in a elderly female patient who received FLULAVAL QUADRIVALENT. Co-suspect products included VALTREX unknown for shingles. On an unknown date, the patient received FLULAVAL QUADRIVALENT at an unknown dose. On 17th October 2017, the patient started VALTREX 1000 mg 3 times daily (3000 mg daily). On an unknown date, less than a year after receiving FLULAVAL QUADRIVALENT and VALTREX, the patient experienced multi-organ failure (serious criteria death and GSK medically significant) and shingles. The action taken with VALTREX was unknown. On an unknown date, the outcome of the multi-organ failure was fatal and the outcome of the shingles was unknown. The reported cause of death was multi-organ failure. It was unknown if the reporter considered the multi-organ failure and shingles to be related to FLULAVAL QUADRIVALENT. It was unknown if the reporter considered the multi-organ failure to be related to VALTREX. Additional details were reported as follows: The age at vaccination was not reported. The healthcare professional reported that a patient in a skilled nursing home facility was given FLULAVAL QUADRIVALENT and then developed shingles. The patient started VALTREX and went into multi-organ failure which resulted in her death. The pharmacist did not have information regarding timing of the FLULAVAL QUADRIVALENT dose given and development of shingles. The reporter had no information on batch number or expiration dates of the FLULAVAL QUADRIVALENT. The healthcare professional did not know patient''s date of death.


VAERS ID: 732139 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Georgia  
Vaccinated:2017-12-19
Onset:2017-12-27
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2017-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 14749221A / 1 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Death, Nausea, Sepsis, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-12-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: amiodarone; fludrocortisone; tizanidine; XARELTO
Current Illness: hip flexor strain; felt nauseated and threw up the night of the flu shot up until 12/22/17 and symptoms appeared to stop
Preexisting Conditions: atrial fibrillation; sinus node dysfunction
Allergies: NKDA
Diagnostic Lab Data: These would be at the hospital
CDC Split Type:

Write-up: Began with nausea vomiting on 12/19/17- 12/20/17. He died of Sepsis per hospital on 12/27/17.


VAERS ID: 732733 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: California  
Vaccinated:2017-09-20
Onset:2017-09-22
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2018-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR - / UNK LA / -

Administered by: Public       Purchased by: ?
Symptoms: Encephalopathy, Injection site pain, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2017-12-09
   Days after onset: 78
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Insulin- Diabetes 2
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pain in left shoulder where administered, Diagnosed with Encephalopathy. Started having seizures a week later.


VAERS ID: 732872 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-01-05
Entered: 2018-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Meningococcal infection, Neisseria test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SOLIRIS
Current Illness: Paroxysmal nocturnal haemoglobinuria
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab tests were performed on an unspecified date. The isolate initially was reported to be serogroup B, but subsequent testing at the Centers for Disease Control and Prevention (CDC) revealed that the strain actually was non-groupable. The isolate sequence type (ST-2578) was associated more commonly with asymptomatic carriage rather than invasive disease.
CDC Split Type: US2018GSK001145

Write-up: This case was reported in a literature article and described the occurrence of vaccination failure in a 16-year-old female subject who received Meningococcal ACWY vaccine. Co-suspect products included SOLIRIS for paroxysmal nocturnal hemoglobinuria. Concurrent medical conditions included paroxysmal nocturnal hemoglobinuria. On an unknown date, 183 days after receiving Meningococcal ACWY vaccine and Meningococcal B Recom vaccine + AIOH + OMV, the subject developed vaccination failure. Serious criteria included death and GSK medically significant. Additional event(s) included meningococcal infection with serious criteria of death and GSK medically significant. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included meningococcal infection (fatal). The reported cause of death was meningococcal infection. The investigator considered that there was a reasonable possibility that the vaccination failure and meningococcal infection may have been caused by Meningococcal ACWY and Meningococcal B Recom vaccine + AIOH + OMV. Relevant Tests: Lab tests were performed on an unspecified date. The isolate initially was reported to be serogroup B, but subsequent testing at the Centers for Disease Control and Prevention (CDC) revealed that the strain actually was non-groupable. The isolate sequence type (ST-2578) was associated more commonly with asymptomatic carriage rather than invasive disease. Additional information was provided. This case was reported in a literature article and described suspected vaccination failure in a 16-year-old female patient who was vaccinated with unspecified meningococcal ACWY (MenACWY) vaccine and unspecified meningococcal serogroup B (MenB-4C) vaccine (manufacturers unknown for both). This case corresponds to the meningococcal vaccines section of the article. The patient was a part of the study that provided data from the manufacturer who reported 16 cases of meningococcal disease (including 1 death) in 5207 person-years of eculizumab exposure between 2007 and 2014; the age range was 17 to 45 years, and all of them had received meningococcal vaccination. The patient had paroxysmal nocturnal hemoglobinuria. No information on patient''s family history or concomitant medications was provided. On an unspecified date, the patient received unspecified meningococcal ACWY (MenACWY) and unspecified meningococcal serogroup B (MenB-4C) vaccines (administration route and site unspecified; dosage unknown; batch number not provided for both). The patient had started SOLIRIS. Age of vaccinations was not provided. On an unspecified date, approximately 6 months after vaccinations and 1 month after eculizumab therapy, the patient developed meningococcal disease. The isolate initially was reported to be serogroup B, but subsequent testing at the Centers for Disease Control and Prevention (CDC) revealed that the strain actually was non-groupable. The isolate sequence type (ST-2578) was associated more commonly with asymptomatic carriage rather than invasive disease. On an unspecified date, the patient died despite apparently strong memory antibody response to the strain. Thus, a normally non-pathogenic strain led to fatal illness despite vaccination. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being full schedule was unknown. This case has been considered serious due to death/suspected vaccination failure. Treatment was unknown. The authors stated, "The CDC concluded that vaccination provides incomplete protection to eculizumab recipients". Additionally, the authors mentioned "FDA approved prescribing information includes a black-box warning for increased risk of meningococcal disease in recipients who take eculizumab".


VAERS ID: 732984 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: New York  
Vaccinated:2014-03-12
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-01-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. J008436 / UNK - / SC

Administered by: Pharmacy       Purchased by: ?
Symptoms: Death, Decreased immune responsiveness, Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
SMQs:, Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-02-24
Permanent Disability? No
Recovered? No
Office Visit? Yes
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: US0095075131801USA002348

Write-up: Information has been received on 04-JAN-2018 regarding a case in litigation from a lawyer and an estate administrator regarding a male patient of unknown age. The patient''s prior concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous on or about 05-MAR-2014, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 09-JUL-2015, the patient was treated at a medical center for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed VALTREX for management of his painful and persistent symptoms. On 24-FEB-2016, the patient succumbed to death with post-herpetic neuralgia listed a significant factor causing his death. Post-herpetic neuralgia is a chronic condition of intense pain and nerve damage secondary to herpes zoster infections. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment, with monetary damages. As a further proximate result, the patient has suffered and suffered significant medical expenses, and pain and suffering, and other damages, including his eventual death due to complications of his injuries. Additional information has been requested. Reported Cause(s) of Death: post-herpetic neuralgia.


VAERS ID: 733221 (history)  
Form: Version 2.0  
Age: 0.33  
Sex: Female  
Location: Kentucky  
Vaccinated:2018-01-04
Onset:2018-01-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 924Y3 / 2 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. N008080 / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH S15240 / 2 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. N003980 / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-01-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies: NONE
Diagnostic Lab Data: AUTOPSY 01/15/2018
CDC Split Type:

Write-up: INFANT DECEASED.


VAERS ID: 733241 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Meningococcal infection, Vaccination failure
SMQs:, Lack of efficacy/effect (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: ECULIZUMAB
Current Illness: Paroxysmal nocturnal hemoglobinuria
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2018SA004642

Write-up: Initial unsolicited report received from the literature on 04-Jan-2018. The following is verbatim from the article: The Advisory Committee on Immunization Practices (ACIP), a group of medical and public health experts, meets 3 times per year to develop recommendations for vaccine use. The group has 15 voting members, and each member''s term is 4 years. ACIP members and Centers for Disease Control and Prevention (CDC) staff discuss the epidemiology of vaccine-preventable diseases and vaccine research, effectiveness, safety data, and clinical trial results. Representatives from multiple agencies are present as liaisons to the ACIP. The ACIP met on June 21 to 22, 2017, to discuss catch-up vaccination for hepatitis A vaccine, influenza surveillance, influenza vaccine effectiveness, herpes zoster vaccine, the effect of varicella vaccination on the incidence of herpes zoster, meningococcal disease in patients taking eculizumab, and considerations for a potential third dose of MMR vaccine to combat ongoing mumps outbreaks. Updates on dengue virus epidemiology, Zika virus vaccines, anthrax vaccine, yellow fever vaccine, and the Vaccine Adverse Event Reporting System were given also. This case involves a 16-year-old female patient who was vaccinated with doses of MENACWY VACCINE and MENB-4C VACCINES (batch number, expiry date, dose, dose in series, route and site of administration were not reported for both the vaccines) on an unspecified date. The patient had medical history of paroxysmal nocturnal hemoglobinuria. Concomitant medication includes eculizumab for paroxysmal nocturnal hemoglobinuria which started on an unknown date approximately one month earlier. On an unspecified date, six months following the vaccinations, the patient experienced fatal meningococcal disease and vaccination failure. Laboratory investigation and corrective treatment were not reported. On an unknown date, the patient died despite apparently strong memory antibody response to the strain. It was unknown if autopsy was performed or not. List of the documents held by sender: none. Sender''s Comments: Vaccination failure may be expected with any vaccine, as no vaccine protects all vaccinated individuals. Concomitant medication in this report of fatal meningococcal disease included eculizumab for paroxysmal nocturnal hemoglobinuria. Eculizumab is a terminal complement inhibitor and therefore increases patient risk for meningococcal infections. Patients treated with eculizumab and without a history of prior vaccination are recommended to receive a meningococcal vaccine at least 2 weeks prior to receiving the first dose of eculizumab and be revaccinated according to current medical guidelines for vaccine use. In this case, vaccination with MenACWY and MenB meningococcal vaccines occurred prior to initiating treatment with eculizumab. Importantly, this case does not represent a confirmed vaccine failure to MenACWY because information on the specific serogroup involved was not available. The isolate initially was reported to be serogroup B, but subsequent testing revealed that the strain actually was nongroupable. Reported Cause(s) of Death: Fatal meningococcal disease.


VAERS ID: 733369 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
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: US0095075131801USA001975

Write-up: Information has been received from the authors of the published literature article. The authors used Social Media''s Public Streams Application Programming Interface (API) to collect live data. Between November of 2014 and January 2015, they systematically endeavored to select an optimal set of terms that would be parsimonious enough to be feasible yet broad enough to capture sufficient relevant information. Of the 2,000 comments, 1,887 (94.4%) were relevant to human papillomavirus (HPV). Thus, these 1,887 comments composed their final data-set. The vast majority of comments (n=1,668, 88.4%) originated from unique user accounts. Two hundred and four comments (10.8%) were from users who posted between two and five times, and 30 (1.6%) were from users who posted 10 or more times. Ninety-five (5.0%) comments were coded as having negative sentiment. These comments generally discouraged GARDASIL or GARDASIL 9 vaccination or expressed a particularly negative view toward it. Specific terms characteristic of these comments included "beware," "destroys lives," and "mystery illness." While sentiments were nearly always directly incorporated in to the comments themselves, negative sentiment could also often be inferred by the hashtags at the end of the comment. 78 (4.1%) comments explicitly claimed lack of safety. Examples of phrases included in comments describing lack of safety included "GARDASIL or GARDASIL 9 ruins live [sic]" and "girl dies shortly after receiving HPV vaccine." This case concerns to a healthy 12-year-old girl who died shortly after receiving HPV vaccine. The case was coded as lack of safety 77 (4.1%). The reporter considered death to be related to GARDASIL 9 and/or GARDASIL. Upon internal review death was considered to be a medically significant event. This is one of 2 reports derived from the same literature source, linked to case # 1801USA003508. Sender''s Comments: US-009507513-1801USA003508.


VAERS ID: 733389 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
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: US0095075131801USA003508

Write-up: Information has been received from the authors of the published literature article. The authors used a Public Streams Application Programming Interface (API) to collect live data. Between November of 2014 and January 2015, they systematically endeavored to select an optimal set of terms that would be parsimonious enough to be feasible yet broad enough to capture sufficient relevant information. Of the 2,000 responses, 1,887 (94.4%) were relevant to human papillomavirus (HPV). Thus, these 1,887 composed their final data-set. The vast majority (n=1,668, 88.4%) originated from unique user accounts. Two hundred and four tweets (10.8%) were from users who posted between two and five times, and 30 (1.6%) were from users who posted 10 or more times. Ninety-five (5.0%) were coded as having negative sentiment. These generally discouraged GARDASIL or GARDASIL 9 vaccination or expressed a particularly negative view toward it. Specific terms characteristic of these tweets included "beware," "destroys lives," and "mystery illness." While sentiments were nearly always directly incorporated in to the responses themselves, negative sentiment could also often be inferred by the hashtags at the end. 78 (4.1%) explicitly claimed lack of safety. Examples of phrases included in tweets describing lack of safety included "GARDASIL or GARDASIL 9 ruins live [sic]" and "girl dies shortly after receiving HPV vaccine." This case concerns to a girl who died shortly after receiving HPV vaccine. The case was coded as lack of safety 77 (4.1%). The reporter considered death to be related to GARDASIL 9 and/or GARDASIL. Upon internal review death was considered to be a medically significant event. This is one of 2 reports derived from the same literature source, linked to case # 1801USA001975. Sender''s Comments: US-009507513-1801USA001975:


VAERS ID: 733960 (history)  
Form: Version 2.0  
Age: 0.58  
Sex: Female  
Location: Texas  
Vaccinated:2017-11-17
Onset:2017-12-04
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2018-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 2F977 / 2 RL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 7BR2M / 1 UN / UN
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS Z5297 / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH S51635 / 2 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS GE2HJ / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-12-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Ear infection
Preexisting Conditions: None
Allergies: No known allergies
Diagnostic Lab Data: Toxicology labs are still being completed
CDC Split Type:

Write-up: Infant Death.


VAERS ID: 734042 (history)  
Form: Version 2.0  
Age: 0.5  
Sex: Female  
Location: Unknown  
Vaccinated:2017-12-20
Onset:2017-12-26
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2018-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 7275T / UNK LL / IM
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UT5949KA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UI807AAA / UNK RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH S15257 / UNK RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. N005077 / UNK MO / PO

Administered by: Unknown       Purchased by: ?
Symptoms: Autopsy, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-12-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cough (AT TIME OF VACCINATION.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2018SA009773

Write-up: Initial unsolicited report received from a nurse on 10-Jan-2018. This case involves a six-month-old patient (gender not reported), who was vaccinated with first dose of 0.25 ml FLUZONE QIV via intramuscular route (batch number: UT5949KA; expiry date, route and site of administration not reported) and PEDIARIX (manufacturer: GSK) (batch number, expiry date, dose, route and site of administration not reported) and ROTAVIRUS VACCINE (batch number, expiry date, dose, route and site of administration not reported) and PNEUMOCOCCAL CONJUGATE VACCINE (PCV12) (manufacturer: Pfizer) (batch number, expiry date, dose, route and site of administration not reported) on 20-Dec-2017. Patient had a mild cough at time of vaccination. No fever. Concomitant medications were not reported. On 26-Dec-2017 in morning, six days following the vaccination, patient was found dead. Patient was previously vaccinated with all vaccines other than FLUZONE QIV twice. Lab test and corrective treatment was not reported. Reporter stated an autopsy was being performed to determine cause of death and rule out SIDS (sudden infant death syndrome). Patient''s mother felt it was the flu shot (Fluzone QIV) that caused her child''s demise. Documents held by sender: none.; Sender''s Comments: Time to onset is compatible. The patient already had mild cough at the time of vaccination. No other medical history was reported. The patient also received Pediarix and Rotavirus vaccine on the same day as Fluzone QIV. Autopsy was being performed at the time of reporting to determine the cause of death and rule out SIDS. Considering that several different vaccines had been co-administered at the same time it is difficult to elicit role of each vaccine in reported event. Result of autopsy, patient medical history, past surgical history, and state of health at the time of vaccination would be helpful with identifying role of each vaccine in reported event.; Reported Cause(s) of Death: found dead the morning; Autopsy-determined Cause(s) of Death: found dead the morning


VAERS ID: 734494 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Male  
Location: Virginia  
Vaccinated:2018-01-12
Onset:2018-01-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-01-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C5420AA / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH T08484 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. N014983 / 1 MO / PO

Administered by: Private       Purchased by: ?
Symptoms: Apnoea, Cardio-respiratory arrest, Cyanosis, Death, Foaming at mouth, Musculoskeletal stiffness, Peripheral coldness, Pulse absent, Resuscitation, Unresponsive to stimuli, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (broad), Dystonia (broad), Parkinson-like events (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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-01-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Ranitidine; hydrocortisone topical cream
Current Illness: Well child check on 1/12/2018 only abn. finding was dry skin
Preexisting Conditions: Reflux; premature; admitted to hospital for Sepsis work-up 11/2/17
Allergies: None Known
Diagnostic Lab Data:
CDC Split Type:

Write-up: Child found unresponsive at 6:30 am on 1/13/2018, transported to ER via rescue squad, failed CPR, pronounced dead in ER. Mother last saw him alive at 1:30 am on 1/13/2018. Found unresponsive. This occurred several hours. Pt''s parents found patient (3moM unresponsive at approx 630 am. Last seen at 130am. Arrives in full arrest with CPR in progress. Pt is cyanotic, unresponsive. No lividity but stiffness noted. Cool to touch, emesis noted. Pink froth noted in OP. Emesis pink indicating recent tx w/ PO TYLENOL (confirmed by Mother). Pt saw PCP earlier in the day for routine vaccinations. No sx/sx of acute allergic/hypersensitivity rxn. The patient was found unresponsive. Down time before CPR (Unknown - likely hours given hx.). Paramedics findings: The patient was apneic and pulseless. Prehospital treatment: Compressions performed.


VAERS ID: 734518 (history)  
Form: Version 2.0  
Age: 0.33  
Sex: Male  
Location: Texas  
Vaccinated:2018-01-08
Onset:2018-01-16
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2018-01-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C5382AA / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH S15257 / 2 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-01-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE NOTED
Current Illness: NONE NOTED
Preexisting Conditions: NONE NOTED
Allergies: NKDA
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: PATIENT DECEASED ON 01/16/18 (POSSIBLE SIDS) UNDER INVESTIGATION.


VAERS ID: 734553 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-01-22
Entered: 2018-01-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Vaccination failure
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? No
Previous Vaccinations:
Other Medications: THERAFLU
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018GSK010706

Write-up: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Influenza vaccine Quadrivalent. Concomitant products included THERAFLU. On an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent. Additional details were reported as follows: The age at vaccination was not reported. It was reported that, 8 patients died from flu of which 7 patients had flu shot and all eight patient''s were on THERAFLU. This case was considered as suspected vaccination failure since time to onset and the lab test confirmation for the event was unknown. No further details provided about the product.


VAERS ID: 734557 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-01-22
Entered: 2018-01-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Vaccination failure
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? No
Previous Vaccinations:
Other Medications: THERAFLU
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018GSK010709

Write-up: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Influenza vaccine Quadrivalent. Concomitant products included THERAFLU. On an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent. Additional details were reported as follows: The age at vaccination was not reported. It was reported that, 8 patients died from flu of which 7 patients had flu shot and all eight patients were on THERAFLU. This case was considered as suspected vaccination failure since time to onset and the lab test confirmation for the event was unknown. No further details provided about the product. This case was one of the 7 cases, reported by the same reporter.


VAERS ID: 734560 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-01-22
Entered: 2018-01-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Vaccination failure
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? No
Previous Vaccinations:
Other Medications: THERAFLU
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018GSK010708

Write-up: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Influenza vaccine Quadrivalent. Concomitant products included THERAFLU. On an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent. Additional details were reported as follows: The age at vaccination was not reported. It was reported that 8 patients died from flu of which 7 patients had flu shot and all eight patients were on THERAFLU. This case was considered as suspected vaccination failure since time to onset and the lab test confirmation for the event was unknown. No further details provided about the product. This case was one of the 7 cases, reported by the same reporter.


VAERS ID: 734562 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-01-22
Entered: 2018-01-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Vaccination failure
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? No
Previous Vaccinations:
Other Medications: THERAFLU
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018008081

Write-up: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Influenza vaccine Quadrivalent. Concomitant products included THERAFLU. On an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent. Additional details were reported as follows: The age at vaccination was not reported. It was reported that, 8 patients died from flu of which 7 patients had flu shot and all eight patients were on THERAFLU. This case was considered as suspected vaccination failure since time to onset and the lab test confirmation for the event was unknown. No further details provided about the product.


VAERS ID: 734563 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-01-22
Entered: 2018-01-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Vaccination failure
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? No
Previous Vaccinations:
Other Medications: THERAFLU
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018GSK010707

Write-up: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Influenza vaccine Quadrivalent. Concomitant products included THERAFLU. On an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent. Additional details were reported as follows: The age at vaccination was not reported. It was reported that, 8 patients died from flu of which 7 patients had flu shot and all eight patients were on THERAFLU. This case was considered as suspected vaccination failure since time to onset and the lab test confirmation for the event was unknown. No further details provided about the product. This case was one of the 7 cases, reported by the same reporter.


VAERS ID: 734564 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-01-22
Entered: 2018-01-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Vaccination failure
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? No
Previous Vaccinations:
Other Medications: THERAFLU
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018GSK010704

Write-up: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Influenza vaccine quadrivalent. Concomitant products included THERAFLU. On an unknown date, the patient received Influenza vaccine quadrivalent. On an unknown date, unknown after receiving Influenza vaccine quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine quadrivalent. Additional details were reported as follows: The age at vaccination was not reported. It was reported that, 8 patients died from flu of which 7 patients had flu shot and all eight patients were on THERAFLU. This case was considered as suspected vaccination failure since time to onset and the lab test confirmation for the event was unknown. No further details provided about the product. This case was one of the 7 cases, reported by the same reporter.


VAERS ID: 734569 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-01-22
Entered: 2018-01-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Vaccination failure
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? No
Previous Vaccinations:
Other Medications: THERAFLU
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018GSK010705

Write-up: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Influenza vaccine Quadrivalent. Concomitant products included THERAFLU. On an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent. Additional details were reported as follows: The age at vaccination was not reported. It was reported that, 8 patients died from flu of which 7 patients had flu shot and all eight patients were on THERAFLU. This case was considered as suspected vaccination failure since time to onset and the lab test confirmation for the event was unknown. No further details provided about the product. This case was one of the 7 cases, reported by the same reporter.


VAERS ID: 734798 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-01-24
Entered: 2018-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Vaccination failure
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? No
Previous Vaccinations:
Other Medications: THERAFLU
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018GSK012203

Write-up: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Influenza vaccine Quadrivalent. Concomitant products included THERAFLU. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent. Additional details were reported as follows: The age at vaccination was not reported. The consumer posted on the internet about 8 flu deaths of which, 7 had the flu shot and all 8 took THERAFLU. The consumer asked what''s your take on who is to blame? It was unknown if an autopsy was performed or not. This case was considered as suspected vaccination failure since time to onset and the lab test confirmation for the event was unknown. This case is one of the 7 cases, reported by the same reporter for same event.


VAERS ID: 734964 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-01-24
Entered: 2018-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Vaccination failure
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? No
Previous Vaccinations:
Other Medications: THERAFLU
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018GSK012206

Write-up: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Influenza vaccine Quadrivalent. Concomitant products included THERAFLU. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent. Additional details were reported as follows: The age at vaccination was not reported. The consumer posted about 8 flu deaths of which, 7 had the flu shot and all 8 took THERAFLU. The consumer asked what''s your take on who is to blame? It was unknown if an autopsy was performed or not. This case was considered as suspected vaccination failure since time to onset and the lab test confirmation for the event was unknown. This case is one of the 7 cases, reported by the same reporter for same event.


VAERS ID: 734942 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-01-24
Entered: 2018-01-25
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Vaccination failure
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? No
Previous Vaccinations:
Other Medications: THERAFLU
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018GSK012205

Write-up: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Influenza vaccine Quadrivalent. Concomitant products included THERAFLU. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were reported as follows: The age at vaccination was not reported. The consumer posted on social media about 8 flu deaths of which, 7 had the flu shot and all 8 took THERAFLU. The consumer asked what''s your take on who is to blame? This case was considered as suspected vaccination failure since time to onset and the lab test confirmation for the event was unknown. This case is one of the 7 cases, reported by the same reporter for same event.


VAERS ID: 734951 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-01-24
Entered: 2018-01-25
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Vaccination failure
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? No
Previous Vaccinations:
Other Medications: THERAFLU
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018GSK012204

Write-up: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Flu seasonal QIV Dresden. Concomitant products included THERAFLU. On an unknown date, the patient received Influenza vaccine quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving influenza vaccine quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to influenza vaccine quadrivalent unspecified season. Additional details were reported as follows: The age at vaccination was not reported. The consumer posted on social media about 8 flu deaths of which, 7 had the flu shot and all 8 took THERAFLU. The consumer asked what''s your take on who is to blame? It was unknown if an autopsy was performed or not. This case was considered as suspected vaccination failure since time to onset and the lab test confirmation for the event was unknown. This case is one of the 7 cases, reported by the same reporter for same event.


VAERS ID: 735234 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: New York  
Vaccinated:2018-01-24
Onset:2018-01-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2018-01-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR U5958AA / N/A LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-01-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: VENTOLIN HFA 108; Albuterol Sulfate; Omeprazole
Current Illness: Asthma - 12/25/17; Abdominal Pain - 12/26/17
Preexisting Conditions: Asthma
Allergies: Tomatoes, Nuts
Diagnostic Lab Data:
CDC Split Type:

Write-up: 18 yo woman with a history of asthma was seen at ER for asthma exacerbation on 1/14/18 at 10 AM. She was treated with DUONEB and steroids with improvement of symptoms and was discharged on a course of prednisone. On 1/24/18 patient was seen for well visit with Dr. during which no complaints or abnormal exam findings were documented. A flu vaccine was administered at 3 pm. On 1/26/18 the patient was brought into hospital at 8:21 in cardiorespiratory arrest. After 60 minutes of resuscitation efforts, the patient was pronounced dead.


VAERS ID: 735308 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Oregon  
Vaccinated:2017-11-14
Onset:2017-11-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-01-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH S74425 / N/A AR / IM

Administered by: Private       Purchased by: ?
Symptoms: Cerebral haemorrhage, Cerebrovascular accident, Computerised tomogram head abnormal, Death, Loss of consciousness, Nuclear magnetic resonance imaging brain abnormal
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-11-17
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: B(1); RESTORIL; Fluticasone Nasal Spray; Finasteride
Current Illness:
Preexisting Conditions: Hyperlipidemia, Arthritis, Elevated PSA 1BPH, Renal Insufficiency
Allergies: NA
Diagnostic Lab Data: CAT scan 11/15/17 Massive cerebral hemorrhage (right side); Partial MRI 11/16/17 As above
CDC Split Type:

Write-up: Approximately 8 hours after the injection, patient suffered a massive right cerebral hemisphere stroke. He was unconscious when taken to emergency room. He did not regain full consciousness and died on 11/17/2017.


VAERS ID: 736883 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Illinois  
Vaccinated:2017-09-21
Onset:2017-11-13
   Days after vaccination:53
Submitted: 0000-00-00
Entered: 2018-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UT5937KA / N/A LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-11-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: patient did not indicate anything
Current Illness: patient did not indicate anything
Preexisting Conditions: patient did not indicate anything
Allergies: patient did not indicate anything
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received vaccine at an on-site flu clinic and experienced no symptoms at the time. Two months after the immunization, the patient passed away.


VAERS ID: 737217 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: California  
Vaccinated:2017-10-29
Onset:2017-11-13
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2018-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Dehydration, Diarrhoea, Dizziness, Dyspnoea, Influenza
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), Infective pneumonia (broad), Dehydration (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-11-22
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Hydralazine; Losartan; Chlorthalidone; Triamterene; Aripiprazole; Levothyroxine; Atorvastatin
Current Illness: No illnesses
Preexisting Conditions: Patient had a stroke 1 1/2 yrs prior to vaccination
Allergies: None
Diagnostic Lab Data: Lab sheet enclosed
CDC Split Type:

Write-up: After patient had flu shot Oct 29th 2017 within 2 weeks she became weak and short of breath and dizzy. Took her to Dr she said she probably had spot on her lung took her to Emergency-nothing on lungs said she was dehydrated. Sent her home. Next day she had diarrhea-I called Dr. she said it was flu. She would be fine in a couple of days.


VAERS ID: 737284 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-02-12
Entered: 2018-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Aphasia, Death, Hypokinesia, Social avoidant behaviour
SMQs:, Dementia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (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: US2018GSK022450

Write-up: This case was reported by a non-health professional via local affiliate and described the occurrence of speech loss in a 4-month-old patient who received DTaP vaccine. Co-suspect products included Rotavirus vaccine, Hepatitis B vaccine, Poliomyelitis vaccine (IPV) and Pneumococcal vaccine. On an unknown date, the patient received DTaP vaccine at an unknown dose, Rotavirus vaccine at an unknown dose, Hepatitis B vaccine at an unknown dose, IPV at an unknown dose and Pneumococcal Vaccine at an unknown dose. On an unknown date, less than a day after receiving DTaP vaccine, Rotavirus vaccine and Hepatitis B vaccine, the patient experienced speech loss (serious criteria death), movements reduced (serious criteria death) and withdrawn (serious criteria death). On an unknown date, the outcome of the speech loss, movements reduced and withdrawn were fatal. The reported cause of death was speech loss, movements reduced and withdrawn. The reporter considered the speech loss, movements reduced and withdrawn to be related to DTaP vaccine, Rotavirus vaccine and Hepatitis B vaccine. Additional details were reported as follows: This report was found in a debate article published in a newspaper (there was no information about the source of the information and no contact information to the author of the debate article). The Vaccination Court believed it was proven that the patient died of vaccines. The parents visited their pediatrician with their baby vaccinated with five different vaccines. According to the court documents, the patient''s physician described in his journal at the physician''s visit that, the patient was healthy, cooperative, well-fed and babbling. After the physician''s visit, in the afternoon, the parents noticed that the patient was no longer babbling, the patient was instead withdrawn, silent and moved less than before. Less than 24 hours later, the patient died. It was unknown if an autopsy was performed or not. The reporter considered the speech loss, movements reduced and withdrawn to be related to Poliomyelitis vaccine (IPV) and Pneumococcal vaccine as well.


VAERS ID: 737792 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2018-01-14
Onset:2018-01-24
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2018-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 3Z4KL / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Herpes zoster, Infection, Varicella virus test positive
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-02-13
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 19 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Furosemide, Benazepril, Meloxicam, Shingrix, Oxybutynin, Trazodone, Xeljanz, Janumet, Esomeprazole, Gabapentin, Dutasteride, Tamsulosin, Pravastatin, Ibuprofen
Current Illness:
Preexisting Conditions: Rheumatoid Arthritis, Hypertension, Diabetes
Allergies:
Diagnostic Lab Data: Tested positive for shingles
CDC Split Type:

Write-up: Infection. Tested positive for shingles.


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