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VAERS ID: 784459 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-11-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (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: USGLAXOSMITHKLINEUS2018GS

Write-up: This case was reported by a consumer via interactive digital media and described the occurrence of death in a 18-month-old male patient who received DTP (A or W not known) (DTP (A or W not known)) for prophylaxis. On an unknown date, the patient received DTP (A or W not known) at an unknown dose. On an unknown date, unknown after receiving DTP (A or W not known), the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death to be related to DTP (A or W not known). Additional information was reported as follows: This case was reported by a consumer via Interactive Digital Media. The age at vaccination was not reported. It was stated that the Dtap vaccine killed the patient, the patient was only 18 months old.; Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 784735 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Washington  
Vaccinated:2018-10-25
Onset:2018-10-28
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2018-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK MO / PO

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Haematemesis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-28
   Days after onset: 0
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131810USA014005

Write-up: This initial spontaneous report was received from a registered nurse via company representative, concerning a 2 month old male patient. The patient did not have pertinent medical history or drug reactions or allergies. The patient''s concomitant therapies included PEDIARIX, hib conj vaccine (unspecified), PREVNAR 13 and unspecified "2 month shots". On 25-OCT-2018, the patient was vaccinated with ROTATEQ, orally for "vaccination" (dose, strength and lot number were not reported). On 28-OCT-2018, the patient threw up blood (haematemesis), therefore, he was taken to an unspecified hospital and died on the same date. No laboratory test or studies were taken, moreover, it was unknown if an autopsy was performed. No product quality complaint (PQC) was reported. At the reporting time, the action taken was assessed as not applicable. The reporter did not provide a causality assessment for the event haematemesis. Upon internal review, the event haematemesis leading to death was determined to be medically significant. Reported Cause(s) of Death: The patient threw up blood.


VAERS ID: 784970 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Arizona  
Vaccinated:2018-10-27
Onset:2018-10-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UJ048AB / N/A RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Cancer/Chemo
Preexisting Conditions: Hypertension, hypothyrodism
Allergies: NKDA
Diagnostic Lab Data: Unknown
CDC Split Type:

Write-up: Patient''s daughter states she received the vaccine Saturday morning and in the afternoon she came down with flu symptoms and passed away that day from complications from the flu.


VAERS ID: 785075 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: California  
Vaccinated:2018-10-23
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 9A2KC / 1 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UI916AA / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH W11304 / 1 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS 92L9Y / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-27
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; None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Infant had vaccines on Tuesday 23rd and child was put to bed healthy on Fri 26th; parents checked on him at 1:30 AM Sat 27th and child was dead. Dx-Sudden Infant Death Syndrome.


VAERS ID: 785092 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: North Carolina  
Vaccinated:2018-09-11
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 4TG43 / 1 LG / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. R004964 / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH W11304 / 1 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS 9477J / 1 MO / PO

Administered by: Private       Purchased by: ?
Symptoms: Abnormal behaviour, Death, Eye injury, Scleral disorder
SMQs:, Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Corneal disorders (broad), Scleral disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-02
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: Torticollis
Preexisting Conditions: (She passed away 10/02/2018)
Allergies: N/A
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: I''ve noticed, she was not acting like her normal self when I took her to the doctor four days before she passed. I explained to the doctor about these mysterious spots that had shown up on the white part of the eye. The doctor diagnosed it as a eye injury, gave me antibiotics and sent us home. She died four days later. I feel the spots could have been her brain hemorrhaging.


VAERS ID: 785626 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / 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: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131811USA002457

Write-up: This spontaneous report was received from a consumer and refers to her 12-month-old daughter. The patient''s pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with M-M-R II (dose, frequency, site and route of administration, lot# and expiration date were not reported) for prophylaxis. Other suspect therapies included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On an unknown date, the patient passed away due to an unknown cause. It was not reported in an autopsy was performed. The relatedness between the event and M-M-R II or diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid was not reported.


VAERS ID: 785708 (history)  
Form: Version 2.0  
Age: 0.58  
Sex: Male  
Location: Arizona  
Vaccinated:2018-11-09
Onset:2018-11-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 427R5 / 2 LL / IM

Administered by: Private       Purchased by: ?
Symptoms: Cyanosis, Pulse absent, Respiratory arrest, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-11-12
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: NKA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Several hours after vaccine was administered, Mother found child unresponsive, not breathing and without pulse. Child taken to medical center via EMT. Other circumstances, Child was sleeping and mother stated found child blue with a teddy bear.


VAERS ID: 785949 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Immune-mediated adverse reaction
SMQs:, Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2018GS

Write-up: This case was reported by a physician via market research programs and described the occurrence of immune-mediated adverse reaction in a adult patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis. On an unknown date, the patient received Hz/su + AS01B at an unknown dose. On an unknown date, unknown after receiving Hz/su + AS01B, the patient experienced immune-mediated adverse reaction (serious criteria death and GSK medically significant). On an unknown date, the outcome of the immune-mediated adverse reaction was fatal. The reported cause of death was immune-mediated adverse reaction. The reporter considered the immune-mediated adverse reaction to be possibly related to Hz/su + AS01B. Additional details were provided as follows: This case was reported via interactive digital media. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The physician posted, a closed doctors forum that it was funny to see this post here after I had 2 cases of death following SHINGRIX vaccination. Both were devastating. It was lucky that your patient only got the rash. The physician was reported to Centers for Disease Control and Prevention (CDC). Cause of death did not seem infection related but more so of a exacerbated immunologic response to the vaccination. The physician written them up as case report. The physician would advise against giving this vaccination to any the patients who were receiving immunotherapy for either oncologic or rheumatologic conditions. The famous last words the heard from their documents were but they were not live virus. Reported Cause(s) of Death: Immune-mediated adverse reaction.


VAERS ID: 785950 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Immune-mediated adverse reaction
SMQs:, Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2018GS

Write-up: This case was reported by a physician via market research programs and described the occurrence of immune-mediated adverse reaction in a adult patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis. On an unknown date, the patient received Hz/su + AS01B at an unknown dose. On an unknown date, unknown after receiving Hz/su + AS01B, the patient experienced immune-mediated adverse reaction (serious criteria death and GSK medically significant). On an unknown date, the outcome of the immune-mediated adverse reaction was fatal. The reported cause of death was immune-mediated adverse reaction. The reporter considered the immune-mediated adverse reaction to be possibly related to Hz/su + AS01B. Additional details were provided as follows: This case was reported via interactive digital media. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The physician posted, a closed doctors forum that it was funny to see this post here after I had 2 cases of death following SHINGRIX vaccination. Both were devastating. It was lucky that your patient only got the rash. The physician was reported to Centers for Disease Control and Prevention (CDC). Cause of death did not seem infection related but more so of a exacerbated immunologic response to the vaccination. The physician written them up as case report. The physician would advise against giving this vaccination to any the patients who were receiving immunotherapy for either oncologic or rheumatologic conditions. The famous last words the heard from their documents were but they were not live virus. This case was 1 of the 10 cases, reported by same reporter. Reported Cause(s) of Death: Immune-mediated adverse reaction.


VAERS ID: 786304 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: North Dakota  
Vaccinated:2018-11-07
Onset:2018-11-10
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2018-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC4: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT) / SEQIRUS, INC. 252229 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-11-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASA, CARVEDILOL, FOLBEE, GLIPIZIDE ER
Current Illness: ANEMIA SECONDARY TO ABSORPTION ISSUES S/P GASTRIC BYPASS
Preexisting Conditions: TYPE 2 DIABETES; HYPERTENSION; HYPERLIPIDEMIA; KIDNEY STONES
Allergies: TRAMADOL
Diagnostic Lab Data:
CDC Split Type:

Write-up: DIED AT HOME, UNATTENDED? 11-10-2018.


VAERS ID: 787241 (history)  
Form: Version 2.0  
Age: 1.25  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2018-11-15
Onset:2018-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 57JT9 / 3 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UI906AA / 3 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH W28770 / 3 LL / IM

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, Drug screen, Resuscitation, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Drug abuse and dependence (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: 2018-11-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: FTT; plagiocephaly
Allergies: NKDA
Diagnostic Lab Data: Drug screen pending. Autopsy pending
CDC Split Type:

Write-up: Patient was found unresponsive in her bed on 11/16/2018 by mom and HH nurse. CPR performed. Patient did not respond. ? possible adverse reaction.


VAERS ID: 787148 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Unevaluable event
SMQs:

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131601USA002036

Write-up: This spontaneous report as received from a physician via an issue of magazine refers to unspecified patients of unknown age and gender. No medical history or concurrent conditions were reported. On unknown dates the patients were vaccinated with GARDASIL (lot number and frequency unknown) (dosing regimen and frequency unknown) for prophylaxis. No concomitant medications were reported. It was reported that, the GARDASIL had absolutely no effect on cervical cancer (Vaccination failure) and it had very many adverse effects which destroys lives and also even kills (adverse event) (life threatening and death). It was also reported that cases of Guillian-Barre syndrome, paralysis of the lower limbs, vaccine induced multiple sclerosis (MS) and vaccine induced encephalitis could be found whatever the vaccine. The outcome of many adverse effects which destroys lives and also even kills was reported as fatal. The outcome of the other events were unknown. Upon internal review, Guillian-Barre syndrome, paralysis of the lower limbs, vaccine induced multiple sclerosis (MS) and vaccine induced encephalitis were considered to be medically significant. Additional information has been requested. This case was previously considered valid, but per current process it was determined to be non-valid as no patient identifier. Therefore, it is being sent to distribution for the last time to notify all recipients. This is an amended report. The case will be sent to distribution (previously sent to non-valid).


VAERS ID: 787764 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-08-30
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2018GS

Write-up: This case was reported by a physician via other manufacturer and described the occurrence of arrhythmia in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced arrhythmia (serious criteria death and GSK medically significant). On an unknown date, the outcome of the arrhythmia was fatal. The reported cause of death was arrhythmia. It was unknown if the reporter considered the arrhythmia to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. On an unknown date, the patient experienced pulmonary arrhythmia and passed away. No additional information was provided. Reported Cause(s) of Death: arrhythmia.


VAERS ID: 787793 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2018-11-05
Onset:2018-11-05
   Days after vaccination:0
Submitted: 2018-11-23
   Days after onset:18
Entered: 2018-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 37RY4 / 2 RA / UN

Administered by: Other       Purchased by: Other
Symptoms: Bilevel positive airway pressure, Cardiac failure, Cardiogenic shock, Death, Dyspnoea, Endotracheal intubation, General physical health deterioration, Hypoxia, Intensive care, Malaise, Respiratory failure
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-11-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Chronic systolic heart failure from ischemic cardiomyopathy; NYHA Class III; EF <20%. Remote history of lung cancer.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 77M with a history of chronic systolic heart failure from ischemic cardiomyopathy, NYHA Class III, EF <20%. He was in clinic this AM for regular follow up. Has been doing well, at baseline for last few weeks. Did well at cardiology appt. Given hepatitis A vaccine while in clinic, no other new meds. Called back to cardiology appointment 3 hours after returning home to report he was not feeling well and was becoming progressively short of air. Patient was instructed to report to ED for evaluation. Patient presented to ED where he was noted to be hypoxic. Trialed briefly on bipap but then intubated given work of breathing and hypoxia. Patient was transferred to the ICU with a primary diagnosis of Acute Hypoxic Respiratory Failure. HF decompensation was suspected, with role of hepatitis A vaccine unclear. Patient continued to deteriorate and by 11pm that same evening developed cardiogenic shock. Patient''s wife made patient a DNR in event of cardiac arrest, and patient expired that evening at 11: 29 pm. Norepinephrine per titration protocol, vasopressin per titration protocol, epinephrine 1 mg once.


VAERS ID: 787810 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Kansas  
Vaccinated:2018-10-24
Onset:2018-10-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (AFLURIA QUADRIVALENT) / SEQIRUS, INC. - / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Atrophy, Autopsy, Cardiac disorder, Death, Left ventricular hypertrophy
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-25
   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; patient in Hospital setting on ward after colonoscopy. At home night meds 4 hours after injection. Gabapentin; warfarin; simvastatin; clonazapam, metformin
Current Illness: Constipation
Preexisting Conditions: Pulmonary embolism x 12 year ago
Allergies: IMITREX injectables
Diagnostic Lab Data: Autopsy performed 25 October 2018 states: Cardiac Atrophy and LVH Atrophy
CDC Split Type:

Write-up: Patient died in sleep 8 hours after injection.


VAERS ID: 788384 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-11-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
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? 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: USGLAXOSMITHKLINEUS2018GS

Write-up: This case was reported by a consumer via interactive digital media and described the occurrence of death in a male patient who received DTP (A or W not known) for prophylaxis. On an unknown date, the patient received DTP (A or W not known) at an unknown dose. On an unknown date, unknown after receiving DTP (A or W not known), the patient experienced death (serious criteria death and GSK medically significant) and seizure (serious criteria disability and GSK medically significant). On an unknown date, the outcome of the death was fatal and the outcome of the seizure was unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death and seizure to be related to DTP (A or W not known). Additional details were received as follows: The age at vaccination was not reported. The patient''s mother reported that, the patient received DPT shot. The patient presented with horrible seizures and he was profoundly handicapped at 2 years of age. The patient died at age of 25 years old (mentally at 16 month). The reporter also stated that the patient''s older sister who also received the vaccine was fine. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 789121 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Oregon  
Vaccinated:2018-10-22
Onset:2018-11-27
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2018-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI986AB / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-11-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol; alprazolam; aspirin; atenolol; atorvastatin; bisoprolol; cholecalciferol; ciclopirox; duloxetine; empagliflozin; fenofibrate micronized; fish oil; fluoxetine; glimepiride; HUMILIN R; hydrocodone-acetaminophen; lamotrigine; Lisino
Current Illness: no known acute illness
Preexisting Conditions: Hypertension; tobacco abuse; gouty nephropathy; chondromalacia patella; chronic pain (multiple sites); morbid obesity; hypercholesterolemia; chronic pancreatitis; alcohol dependence remission; insomnia; diabetic periopheral neuropathy; cardiomegaly 30% risk CAD; hypertriglyceridemia; anxiety disorder; coronary artery disease; dysphagia; sleep apnea; diabetes type 2 with complications
Allergies: Buproprion, escitalopram oxalate, mirtazapine
Diagnostic Lab Data: unknown
CDC Split Type:

Write-up: Patient deceased on 11/27/18. At time of this report, reason of death is unknown, per reporting guidelines from CDC this report is being submitted by administering facility as immunization was given approximately one month prior to death of patient. No known adverse event was reported by patient or other family member directly related to vaccine administration.


VAERS ID: 789407 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Amyotrophic lateral sclerosis, Autopsy, Central nervous system inflammation, Death, Gait disturbance, Grip strength decreased, Life support, Muscle atrophy, Muscular weakness, Paraesthesia, Paralysis, Quadriplegia, Spinal cord disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-03-01
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: US0095075131811USA012613

Write-up: This spontaneous report was received from a physician via an online article and refers to a 14-year-old female patient. The patient''s medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in 2008, the patient was vaccinated with a third dose of GARDASIL (route of administration, lot# and expiration date were not provided) for prophylaxis. On an unknown date in 2008 (also reported as nearly two years before 20-MAR-2009), reported as just months after her third and final booster GARDASIL shot, the patient developed degenerative muscle disease. She tripped on a hurdle than others in her class cleared easily. Moreover, the disease rapidly progressed; both her legs and then her arms became weak. She began to limp and had trouble gripping objects. The patient also felt pins and needles in her feet and her muscles athropied. The reporter stated that the disease progressed very rapidly, more quickly than typical for young ALS patients. Within a year, the patient was paralyzed (also reported as nearly completely paralyzed), a quadriplegic and was breathing only with the help of life support, but throughout the course of her illness her mind was as sharp as ever. Shortly afterwards, the patient died on an unknown date in March 2009, at the age of 15 years old. The cause of death was reported as amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig''s disease. The autopsy was performed on an unknown day. The autopsy results showed that the patient''s spinal cord was so inflammatory, very different that normally seen in ALS (as reported). The reporter considered amyotrophic lateral sclerosis to be related to GARDASIL. The physician reported that both the timing of the symptoms and autopsy results "suggest a link between" the vaccine and the fatal cases of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig''s disease. She also stated that with only two confirmed cases, they did not know for sure if it was coincidence or if they were connected to the vaccine. The pathology features all supported a temporal association between the illness and vaccination. The relatedness between the spinal cord inflammatory and GARDASIL was not provided. Upon internal review, the amyotrophic lateral sclerosis and spinal cord disorder were considered to be medically significant. Additionally, the event of amyotrophic lateral sclerosis was considered as caused disability. This is one of the several reports from the same reporter. Sender''s Comments: US-009507513-1812USA000379: US-009507513-1812USA000380: Reported Cause(s) of Death: amyotrophic lateral sclerosis; Autopsy-determined Cause(s) of Death: Spinal cord was so inflammatory. That is very different from what we normally see in ALS.


VAERS ID: 789408 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Amyotrophic lateral sclerosis, Autopsy, Death, Disease progression, Spinal cord disorder
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-08-01
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131812USA000379

Write-up: This spontaneous report was received from a physician via an online article and refers to a 20-year-old female patient. The patient''s medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a first dose of GARDASIL (route of administration, lot# and expiration date were not provided) for prophylaxis. On an unknown date, reported as within four months after her first GARDASIL shot, the patient developed symptoms of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig''s disease. The reporter stated that disease progressed very fast(the disease progressed more quickly than typical for young ALS patients). She died on an unknown date in August 2008 (reported as last August), reported as 28 months later (also reported as 13 months later), at the age of 22 years old. The cause of death was reported as amyotrophic lateral sclerosis (ALS). An autopsy was performed. The autopsy results showed that the patient''s spinal cord was so inflammatory(also reported as distinct immunological features), very different that normally seen in ALS (as reported). The reporter considered amyotrophic lateral sclerosis to be related to GARDASIL. The physician reported that both the timing of the symptoms and autopsy results "suggest a link between" the vaccine and the fatal cases of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig''s disease. She also stated that with only two confirmed cases, they did not know for sure if it was coincidence or if they were connected to the vaccine. The pathology features all supported a temporal association between the illness and vaccination. The relatedness between the spinal cord inflammatory and GARDASIL was not provided. Upon internal review, the amyotrophic lateral sclerosis and spinal cord inflammatory (disorder) were considered to be medically significant. This is one of the several reports from the same reporter. Sender''s Comments: US-009507513-1812USA000380: US-009507513-1811USA012613: Reported Cause(s) of Death: amyotrophic lateral sclerosis; Autopsy-determined Cause(s) of Death: spinal cord was so inflammatory. That is very different from what we normally see in ALS.


VAERS ID: 789482 (history)  
Form: Version 2.0  
Age: 0.42  
Sex: Male  
Location: Oregon  
Vaccinated:2018-10-12
Onset:2018-10-28
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2018-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK RL / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-29
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Had a cold sore
Preexisting Conditions: No
Allergies: NKA
Diagnostic Lab Data:
CDC Split Type:

Write-up: My 6 month old perfectly healty son went to sleep didnt wake up. He passed from SIDS and he recieved his shots 2 weeks prior.


VAERS ID: 789648 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-11-24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2018GS

Write-up: This case was reported by a consumer via other and described the occurrence of Guillain Barre syndrome in a 71-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. Previously administered products included SHINGRIX (received 1st dose on an unknown date). On an unknown date, the patient received the 2nd dose of SHINGRIX and Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving SHINGRIX and Influenza vaccine Quadrivalent unspecified season, the patient experienced Guillain Barre syndrome (serious criteria death, hospitalization and GSK medically significant), cardiac arrest (serious criteria death and GSK medically significant) and feeling unwell. On an unknown date, the outcome of the Guillain Barre syndrome and cardiac arrest were fatal and the outcome of the feeling unwell was unknown. The patient died on 24th November 2018. The reported cause of death was cardiac arrest and Guillain Barre syndrome. It was unknown if the reporter considered the Guillain Barre syndrome, cardiac arrest and feeling unwell to be related to SHINGRIX and Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that a good friend of a friend passed away past Saturday before the time of reporting and said that it was such a shock as she had not been ill. The patient had the new 2 dose shingles vaccine and then a flu shot and commented how she did not feel well after all of that. The husband of the patient took her to hospital on Friday and was diagnosed with Guillain Barre Syndrome. The patient went into cardiac arrest and then died. The patient had bridge at her home on Monday evening, went into hospital on Friday and died a week later on Saturday. Reported Cause(s) of Death: cardiac arrest; Guillain Barre Syndrome.


VAERS ID: 789733 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Maryland  
Vaccinated:2018-12-04
Onset:2018-12-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-12-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR UI952ABA / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH X34315 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. R015437 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-12-04
   Days after onset: 0
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: 33 week premature infant
Allergies: None
Diagnostic Lab Data: Brought to ER, unable to resuscitate, felt to be SIDS, autopsy pending
CDC Split Type:

Write-up: Baby put down for afternoon nap and found deceased by mother approximately 3pm.


VAERS ID: 790215 (history)  
Form: Version 2.0  
Age: 6.0  
Sex: Female  
Location: California  
Vaccinated:2018-11-27
Onset:2018-11-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-12-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS NB7R9 / 2 LL / IM

Administered by: Military       Purchased by: ?
Symptoms: Abdominal pain, Asthenia, Blood gases, Blood lactic acid, Chest pain, Cough, Death, Decreased appetite, Differential white blood cell count, Dyspnoea, Endotracheal intubation, Fatigue, Full blood count, Headache, Malaise, Metabolic function test, Peripheral swelling, Pulse absent, Pupil fixed, Pyrexia, Resuscitation, Unresponsive to stimuli, Vomiting
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-11-29
   Days after onset: 1
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: None known.
Allergies: No known food, latex, medication, or venom allergies.
Diagnostic Lab Data: unable to enter lab results due to VAERS reporting error. 29 November 2018 labs to include CBC, WBC differential, CMP, blood lactic acid level, and VBG drawn.
CDC Split Type:

Write-up: Completed based on review of ER note from 29 November 2018: Patient''s father reported on the morning of 28 November she started feeling weak and fatigued with some generalized malaise, anorexia, and subjective fevers. Per the father''s report no significant headache, cough, difficulty breathing, chest pain, abdominal pain, leg swelling. Her father stated that at one point he gave her a bath because she was feeling ill then placed her into bed and went to get her something to drink. While he was in the other room he heard her vomiting, rushed back into the room, and found her lying unresponsive and pulseless. He started CPR and called for his wife to call 911. Patient was transported by ambulance to the ER; while in the ambulance she received a dose of epinephrine and chest compressions were continued. On arrival to the ER she was noted to be in PEA. She was emergently intubated and resuscitation efforts to include multiple rounds of epinephrine, continuous chest compressions, multiple doses of bicarbonate, atropine, epinephrine drip, calcium gluconate, and glucose were administered. Following discussion with family after approximately one hour and 15 minutes of chest compressions and resuscitation in the ED, not including the prehospital chest compression time, since patient had no signs of life with fixed and dilated pupils the decision was made to discontinue resuscitative efforts. Time of death listed at 0120.


VAERS ID: 790241 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2018-12-06
Onset:2018-12-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-12-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 33T42 / 1 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Cardioversion, Pulse absent, Respiratory arrest, Resuscitation, Syncope, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2018-12-09
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Stated he only took vitamins no Rxs prescribed
Current Illness: None had flu shot on 11/6/18
Preexisting Conditions: None
Allergies: NKA
Diagnostic Lab Data: Contact hospital
CDC Split Type:

Write-up: Tdap given per MD order to pt. Came to HD, immunization given - stayed in dept app 15 minutes talking with staff and RN. Pleasant alert and oriented. App 5 min. later wife runs into HD and states her husband was not responding. This RN ran down to car - no respiratory effort occurring. No pulse noted. Compressions performed - 3 agonal like breaths occurred. Deputy sheriff on scene - defib 2 shocks then ambulance arrived on scene and took over pt''s care. Was transported to local hospital - heart rhythm came back as well as respiratory effort, but remained unresponsive. Transferred to another hospital. Had flu shot at clinic on 11/06/18. Pt received (.5mg) IV into (R) forearm (venous) during resuscitation (but doubt if this perfused to core) -$g app 7 min into resuscitation efforts. Not completely sure vaccine was cause of collapse - had walked up 2 flights of stairs and down after receiving vaccine -$g 85.5 yrs old.


VAERS ID: 790698 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Adverse event, Death, Vaccination complication
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2018GS

Write-up: This case was reported by a consumer via interactive digital media Facebook post and described the occurrence of adverse event in a female patient who received DTP (A or W not known) (DTP (A or W not known)) for prophylaxis. On an unknown date, the patient received DTP (A or W not known) at an unknown dose. On an unknown date, unknown after receiving DTP (A or W not known), the patient experienced adverse event (serious criteria death). On an unknown date, the outcome of the adverse event was fatal. The reported cause of death was adverse event. It was unknown if the reporter considered the adverse event to be related to DTP (A or W not known). Additional details were provided as follows: This case was received via social media post contents by the patient''s mother. The patient''s family had no issues in the past with the shot and thought by getting it could protect the daughter from getting it from him but unfortunately that''s the very thing that caused her granddaughter to have hospitalized. It was not fun but she was alive and happy with no brain damage. The age at vaccination was not reported. The reporter stated that the patient died from a reaction to the DPT vaccine. It was unknown if an autopsy was performed or not. This case was linked with case US2018GSK219962, reported by the same reporter.; Reported Cause(s) of Death: adverse event.


VAERS ID: 790904 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Mississippi  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Pharmacy       Purchased by: ?
Symptoms: Death, Herpes ophthalmic, Herpes zoster
SMQs:, Ocular infections (narrow), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-06-23
Permanent Disability? No
Recovered? No
Office Visit? Yes
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: US0095075131812USA003456

Write-up: Information has been received on 04-DEC-2018 regarding a case in litigation from a lawyer and the administrator of the estate concerning a deceased female patient of unknown age. There was no information provided regarding the patient''s prior concurrent conditions, medical history or concomitant medications. The patient''s healthcare providers, a pharmacist at a pharmacy, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2012, a pharmacist at a pharmacy, administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 16-NOV-2016 and 17-NOV-2016, the patient was treated by the patient''s healthcare provider at a hospital prompt care for shingles and an eye physician''s office for ocular shingles. On 23-JUN-2017, the patient passed away. The cause of death was not reported. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient''s injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of passed away is fatal and the causality of passed away is unknown. The outcome of the other events is unknown. The causality of the other events is related. Upon internal review, passed away and ocular shingles were considered to be medically significant. Additional information has been requested. Reported Cause(s) of Death: passed away.


VAERS ID: 790906 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Injury, Neoplasm progression
SMQs:, Malignancy related conditions (narrow), Accidents and injuries (narrow), Hostility/aggression (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: US0095075131812USA003673

Write-up: This spontaneous report was received from a non-healthcare professional via social media concerning a female patient of unknown age. The patient''s medical history, historical drugs, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, unit, route, lot # and expiration unknown) for prophylaxis. On an unknown date, the patient had tumor growth and serious injuries. On an unknown date, the patient died (cause of death was not reported). It was unknown if autopsy performed. The outcome of the events neoplasm progression and injury was unknown. The reporter did not provide the causality assessment for the events. The reporter considered the event injury to be medically significant. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 790907 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Epilepsy, 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: US0095075131812USA003708

Write-up: This spontaneous report as received from a non-healthcare professional via social media regarding a 14-year old female patient. 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, dose, strength were not reported) for prophylaxis. On an unknown date, the patient experienced seizure and epilepsy. On an unknown date, the patient died due to unknown cause (medically significant). It was unknown if autopsy was performed. Outcome of seizure and epilepsy was unknown. Causality for the events was not reported. Upon internal review, the events seizure and epilepsy were determined to be medically significant. This is one of the three reports from the same reporter. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 790908 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Nervous system injury
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: US0095075131812USA003848

Write-up: This spontaneous social media report was received from an unspecified reporter who posted an information on the internet referring to a male patient of unknown age. There was no information about the patient''s concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an unspecified human papillomavirus vaccine (manufacturer unknown) (dose, route of administration, lot# and expiration date were not reported). On an unknown date, the patient experienced serious permanent neurological injuries and passed away (reason unspecified). The outcome of the event of serious permanent neurological injuries was not reported. The relatedness between the events and an unspecified human papillomavirus vaccine (manufacturer unknown) was not reported. According to the reporter, the event of permanent neurological injuries was considered to be serious (medically significant).


VAERS ID: 791324 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Amenorrhoea, Balance disorder, Death, Fatigue, Mobility decreased
SMQs:, Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Fertility disorders (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131812USA003828

Write-up: This spontaneous report was received from an other reporter, who posted an information on independent site in social media and refers to a female (also reported as gender unknown) patient of unknown age. The patient''s medical history, concurrent conditions and concomitant drugs were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, lot#, expiry date, route and site of administration were not reported) for prophylaxis. Other suspect therapies included VIOXX tablets (dose, frequency, lot#, expiry date and indication were not reported). On an unknown dates, the patient experienced difficulty to get out of bed, fatigue (sometimes enormous fatigue), problems with balance and an unspecified other symptoms. She also, on an unknown date, lost her period. On an unknown date, the patient died (also reported as "killed"). Cause of death and information about autopsy were not reported. Action taken with suspected therapies was not reported. The outcome of non-fatal events was unknown. The relatedness between the event and suspected drugs was not reported.


VAERS ID: 791411 (history)  
Form: Version 2.0  
Age: 0.42  
Sex: Male  
Location: Unknown  
Vaccinated:2018-11-30
Onset:2018-12-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS H994T / 3 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. R013575 / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH W33490 / 2 OT / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS G7XE3 / 2 MO / PO

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, 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: 2018-12-01
   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: MYLICON drops Acetaminophen SB Saline Nasal drops
Current Illness: Upper respiratory infection, seborrhea, lacrimal duct stenosis
Preexisting Conditions: n/a
Allergies: Strawberry
Diagnostic Lab Data: autopsy ordered, but no results known
CDC Split Type:

Write-up: Infant was found unresponsive in his home on 12/1/2018. Taken to the hospital and after extensive resuscitation efforts, was pronounced dead.


VAERS ID: 792011 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Unknown  
Vaccinated:2018-10-19
Onset:2018-10-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 250802 / UNK LA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. R021048 / UNK RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-20
   Days after onset: 1
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131812USA005738

Write-up: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. The patient''s medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (strength, dose, frequency, route, lot # and expiry date were not reported). On an unknown date, shortly after receiving the PNEUMOVAX 23, the patient passed away (death). The cause of death was not reported. It was unknown if autopsy was performed. Causality assessment was not reported. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 792218 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / 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: US0095075131812USA005106

Write-up: This spontaneous report was received from a healthcare professional via social media refers to female patients of unknown age. The patients medical history, concurrent condition and concomitant medications were not reported. On an unknown date, the patients were vaccinated with GARDASIL for prophylaxis (strength, dose, frequency, route, lot# and expiry were not reported). On an unknown date, 7 out of the 8 women died in protocol GARDASIL (death), some experienced cough, erythema, swelling and pain. The cause of death was not reported and it was unknown if autopsy was performed. Outcome of pain, cough, erythema and swelling was unknown. Causality assessment of the events was not reported.


VAERS ID: 792503 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Angiogram retina, Angiogram retina abnormal, Anterior chamber inflammation, Blood test normal, Condition aggravated, Cytomegalovirus chorioretinitis, Death, Hepatic cirrhosis, Inflammatory marker test, Intraocular pressure test normal, Necrotising retinitis, Ophthalmological examination abnormal, Polymerase chain reaction positive, Varicella virus test positive, Varicella zoster virus infection, Vision blurred, Visual acuity reduced, Vitreous floaters, Vitritis
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (narrow), Ocular infections (narrow), Hypoglycaemia (broad), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: End stage liver disease; Type 2 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131812USA005657

Write-up: This spontaneous case was received from a health care professional on an unpublished manuscript and refers to a 62-year-old male patient. The patient''s concurrent conditions included end-stage liver disease and diabetes mellitus type 2 without retinopathy. Information on patient''s medical history and concomitant medications were not reported. It was also reported that the patient did not have other immune-related disorders or frequent infections. On an unknown date (also reported as 7 months ago), the patient was vaccinated with ZOSTAVAX for prophylaxis (dosing details, lot # and expiration date were not reported). On an unknown date, the patient presented with two day history of floaters and blurred vision in the left eye. The patient''s vision acuity was 20/60 (units not reported) and intraocular pressure was 16 mmHg. On an unknown date (7 months after vaccination), the patient underwent an unspecified examination which showed inflammation in anterior chamber and vitreous, multiple white retinal lesions and necrosis on presentation in the left eye. Late phase fluorescein angiogram showed late leakage and staining inferonasally corresponding to the area of CMV retinitis in the left eye and a normal appearing angiogram of the right eye. The patient was initially treated with oral valganciclovir and topical difluprednate for presumed cytomegalovirus (CMV) retinitis. On an unknown date, the patient also underwent unspecified blood tests for infectious and inflammatory etiologies which were negative apart from a borderline acute retinal necrosis (ARN). On an unknown date, subsequent polymerase chain reaction (PCR) test of his aqueous humor was positive for varicella zoster vaccine (VZV). The patient was treated with valacyclovir 1 gram 3 times per day which replaced valganciclovir. It was reported that after 10 weeks, his visual acuity improved to 20/50 (units not reported), vitritis resolved and retinal lesions became inactive. The treatment with valacyclovir was decreased to 1 gram daily and topical steroids were tapered. On an unknown date, the patient died from complications of his cirrhosis 6 months following his initial diagnosis of ARN (Hepatic cirrhosis). The patient had recovered from necrotizing retinitis was recovered. The outcome of varicella zoster virus infection was unknown. The causality assessment of the events was not provided. The reporters stated that the patient experienced milder disease and longer latency periods. The longer latency periods might be associated with wild-type virus in ARN due to VZV as well as systemic disease. The reporter stated that immunocompetence might play a role in ARN after VZV vaccination and the patient might have been relatively immune compromised due to end stage liver disease and diabetes. Upon internal review, necrotizing retinitis and hepatic cirrhosis were determined to be medically significant. This is one of the two reports received from the same source. Reported Cause(s) of Death: The patient died from complications of his cirrhosis.


VAERS ID: 792519 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE)) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USAstraZeneca2018SF63964

Write-up: A spontaneous report has been received from a consumer. The report concerns a male patient (age not provided) of Unknown ethnic origin. No medical history was reported. No concomitant products were reported. During 2009, the patient received the H1N1 FLUMIST (intranasal) once/single vaccine and died from reaction. It is not known whether an autopsy was performed. The cause of death was vaccination adverse reaction. The case was considered as serious due to fatal outcome. Sender''s Comments: The fatal event of vaccination complication is not listed in the company core data sheet for FLUMIST. Due to limited information on patient''s demographics, medical history, exposure to specific risk factors, concomitant drugs, dose and start date of the suspect drug, onset date and circumstances of the event, diagnostic and aetiologic workup and the absence of autopsy report it is not possible to make a conclusive assessment of the causal relationship between the event and suspect drug. Reported Cause(s) of Death: RECEIVED THE 2009 H1N1 FLUMIST VACCINE AND DIED FROM REACTION.


VAERS ID: 792692 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK - / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-03-24
Permanent Disability? No
Recovered? No
Office Visit? Yes
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: US0095075131812USA008105

Write-up: Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient''s medical history, concurrent conditions and concomitant medications were not provided. The patient''s healthcare providers recommended and/or prescribed ZOSTAVAX (lot# and route not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 22-JAN-2009, a healthcare provider administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 24-OCT-2016, the patient was treated by a healthcare provider for shingles. On 24-MAR-2017, the patient passed away. The cause of death was not provided. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX vaccine, and suffered physical, emotional and economic damages as a result of the patient''s injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The cause of death was not provided. Upon internal review passed away was considered to be medically significant. Additional information has been requested. Reported Cause(s) of Death: passed away.


VAERS ID: 792898 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / SYR

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: USGLAXOSMITHKLINEUS2018GS

Write-up: This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received Flu Seasonal QIV Dresden for prophylaxis. 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 unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: This case was reported by the patient''s daughter. The age at the vaccination was not reported. The reporter reported that nasty poison''s flu shot killed the patient last January. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 793888 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-12-01
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSEQIRUS201800196

Write-up: This is a serious study case, initially received from Physician on 26-Jan-2018, concerning an elderly, male patient in his 80''s, enrolled in market research study. The patient''s relevant medical history and social history was not reported. On an unspecified date, the patient was administered with Flu Vaccine Cell Subunit QIV NVD (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: injection (as reported), anatomical location, batch number and expiry date: not reported) for influenza vaccination. On an unspecified date, the patient diagnosed with Flu. The patient died due to flu over Xmas week, between 24-Dec-2017 and 31-Dec-2017. It was unknown, whether the autopsy performed. The reporter assessed the event (flu) as serious (death). Significant case amendment (26-Jan-2018): The ?as determined listedness'' of the event ''Flu'' was corrected from listed to unlisted in event assessment tab.; Reporter''s Comments: A male patient of unspecified age was diagnosed with flu (influenza) which resulted in fatal outcome, unspecified period after receipt of Flu Vaccine Cell Subunit QIV NVD.The causal role of study vaccine for influenza can not be assessed, as minimal information is available regarding vaccination date, onset latency, clinical presentation, detailed investigations (swab and blood culture, immunological tests), immune status of the patient prior to vaccination, concurrent conditions and relevant medical history. Similarly, since the strain and type of influenza is not known, vaccination failure cannot be considered.; Reported Cause(s) of Death: Flu.


VAERS ID: 794461 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Male  
Location: Washington  
Vaccinated:2018-11-19
Onset:2018-11-26
   Days after vaccination:7
Submitted: 2018-12-28
   Days after onset:32
Entered: 2019-01-03
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS H547E / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Cardiopulmonary failure, Death
SMQs:, Cardiac failure (narrow), Acute central respiratory depression (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: PVD; HLD; GERD; DM; HTN; morbidly obese
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Approx 1 week after administration cause of death reported to be cardio/pulmonary failure.


VAERS ID: 794483 (history)  
Form: Version 2.0  
Age: 1.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2017-01-30
Onset:2017-02-09
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2019-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. M039202 / 1 LG / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. M016234 / 1 LG / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R28322 / 3 LG / IM

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, Blood culture negative, CSF culture negative, Computerised tomogram head normal, Culture urine negative, Death, Dyspnoea, Electroencephalogram abnormal, Encephalopathy, Endotracheal intubation, Enterovirus test negative, Fall, Febrile convulsion, Herpes simplex test negative, Hypoxia, Intensive care, Lumbar puncture normal, Muscle twitching, Myoclonus, Nuclear magnetic resonance imaging brain normal, Pharyngitis streptococcal, Polymerase chain reaction, Seizure, Stridor, Tonic clonic movements, Urine analysis normal
SMQs:, Anaphylactic reaction (broad), Agranulocytosis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Dyskinesia (broad), Dystonia (broad), Oropharyngeal infections (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2018-01-04
   Days after onset: 329
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: Patient had an adenoidectomy on January 25, 2017 in which he had recovered well from.
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Lumbar Puncture- Negative results; CT head- Negative; EEG-"This is an abnormal EEG. 1) There is diffuse slowing of the background with diminished organization which is more prominent in the bitemporoparietal regions. 2) Push button event at 21:13 was not clearly epileptogenic. 3) There was prominent expression of intermixed beta range frequencies diffusely throughout the record, consistent with medication effect. These findings are suggestive of focal neuronal dysfunction of the bitemporoparietal regions with an underlying mild-moderate, non-specific encephalopathy. There clear epileptiform abnormalities."; MRI Brain w/anesthesia- Negative
CDC Split Type:

Write-up: From hospital report-"12 month-old previously healthy fully immunized male presents with seizures. Patient is a twin male born at 36w6d without any complications and did not require a NICU stay. Was developing normally and has not had any recent illness, fevers or trauma. He was in the care of his nanny that has been present for approximately 3-4 weeks he began having right arm twitching which turned into a generalized seizure and he fell down and nanny caught him. He continued to have a seizure for approximately 15 minutes while he was transported to the emergency department he did receive 1.3 mg of IM VERSED. In the emergency department he had a second seizure and received 1.7 mg of VERSED and he was intubated using 3mm ETT and rocuronium. Afterwards he was loaded with KEPPRA at 30mg/kg. Head CT was negative on the way to the ICU. UA negative. UCx and BCx were collected and pt given to ROCEPHIN. In the ICU, patient was continued on a VERSED drip. He appeared stable. He did have episodes of myoclonus. vEEG was obtained. I conducted a lumbar puncture. Prior to LP, patient had an episode of myoclonus followed by tonic clonic activity for which he received aditional VERSED. Discussed the results with neurology. His myoclonus is not seizure activity however tonic clonic activity was a seizure. He continued to have a foci of activity that was central and it was recommended he receive 20mg/kg of phenobarbital." Upon admission patient was initially transferred to the PICU. Pediatric Neurology was consulted who recommended an EEG and MRI Brain. The patient was placed on continuous vEEG and initially kept on a versed drip while intubated pending completion of MRI. MRI was completed without difficulty and resulted as normal; vEEG was completed while on VERSED drip and found to be abnormal. Findings were suggestive of focal neuronal dysfunction of the bitemporoparietal regions with an underlying mild-moderate, nonspecific encephalopathy, therefore per recommendations the patient was started on maintenance KEPPRA 20mg/kg BID. Patient was without recurrent encephalopathy or return of seizures therefore was extubated later that evening on 02/10. Patient was extubated following the MRI, unfortunately he had significant stridor, increased work of breathing, and hypoxemia following extubation which did not improve after Racemic Epi, DECADRON, or High Flow Nasal Cannula therefore the patient was reintubated. He remained stable and was continued on DECADRON, he was again extubated on 02/12 without any further difficulty or respiratory distress. Infectious disease work-up continued to be reassuring including blood, urine, and CSF cultures with no growth to date as well as negative HSV and Enterovirus CSF PCR''s. Patient was transferred to the floor where he remained stable with no further seizure activity. On day of discharge, he was afebrile and hemodynamically stable on RA and tolerating PO with adequate urine output. He had no seizures further seizures, antiepileptic therapy of KEPPRA 20mg/kg BID that was initiated. Patient subsequently had another occurrence of complex febrile seizures on August 20, 2017 related to strep throat. On January 4, 2018, patient passed away in his sleep. Autopsy report- cause of death related to seizure disorder.


VAERS ID: 794732 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Colorado  
Vaccinated:2018-12-10
Onset:2018-12-16
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2019-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C5557AA / 1 RL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS R004185 / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH W33490 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. R002702 / 1 MO / PO

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, Constipation, Death, Hypersomnia, Somnolence, Sudden infant death syndrome, Toxicologic test
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-12-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Waiting on Autopsy and toxicology reports.
CDC Split Type:

Write-up: Sleepiness-12/10/18-12/16/18 slept more than usual. No bowel movement-poop 12/10/18-12/16/18 Death, SIDS 7:32am on December 16th 2018.


VAERS ID: 795514 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2019-01-09
Onset:2019-01-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Death, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-01-10
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yes, but not known. Need to check with healthcare provider.
Current Illness: None known.
Preexisting Conditions: None known.
Allergies: Unknown.
Diagnostic Lab Data: None.
CDC Split Type:

Write-up: On Monday 1/7 my mother had her yearly physical and reported everything was fine and she was in good health. This was confirmed by the physician''s assistant. My mother reported getting the PNEUMOVAX 23 vaccine at pharmacy around 12:30 p.m. on 1/9/2019. That evening at 6:25 she sent a text message saying "my right arm is achy from my pneumonia shot and I''m getting chills. I''ll go home and take Tylenol." Then at 7:11 p.m. she reported "I am lying down at home." This was her last communication. The next morning she was found dead. THIS MUST BE INVESTIGATED IMMEDIATELY IN CASE THERE IS A BROADER ISSUE WITH THIS VACCINE LOT.


VAERS ID: 795791 (history)  
Form: Version 2.0  
Age: 0.75  
Sex: Male  
Location: South Carolina  
Vaccinated:2019-01-10
Onset:2019-01-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UT6259MA / 1 LL / IM

Administered by: Private       Purchased by: ?
Symptoms: Blood glucose, Body temperature decreased, Cardiac arrest, Cyanosis, Death, Endotracheal intubation, Resuscitation, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-01-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None known
Current Illness: Upper respiratory illness
Preexisting Conditions: None
Allergies: None known
Diagnostic Lab Data: Blood glucose noted in ED record
CDC Split Type:

Write-up: Per ER report, patient received his Flu vaccine at his 9 month well check. Parents took him home. He fed and then went down for a nap. One to two hours later mother reports finding the child cyanotic and unresponsive. EMS called and found him in asystole. EMS attempted resuscitation en route to ER by placing IO and attempted intubation. He was given epinephrine x 2. CPR continued in the ED. Warmed to 35.4, intubated with 3.5 cuffed ET and received multiple rounds of epinephrine. Chest compressions were recorded for 18 minutes. Time of death was called at 1814.


VAERS ID: 797631 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Oregon  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-04-11
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: US0095075131901USA006394

Write-up: Information has been received from a lawyer and an administrator for the estate of a deceased female patient of unknown age (DOB reported). No information was received regarding the patient''s past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 23-AUG-2012, the female patient was administered the ZOSTAVAX by a healthcare provider at a store pharmacy (Lot number, dosage and route of administration not provided). On or about 07-JUN-2016, the patient was treated by a healthcare provider at a clinic for the following injury resulting from her ZOSTAVAX use: Shingles. The administrator for the estate of a deceased female patient claims damages as a result of injury to themselves, and economic losses. The outcome of Shingles was unknown. It was also reported that the patient died on 11-APR-2018. The cause of death was not reported. It was unknown if an autopsy was performed. Upon internal review, the event of Death was determined to be a medically significant event. Additional information has been requested. Reported Cause(s) of Death: Death.


VAERS ID: 797713 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: New York  
Vaccinated:2018-12-08
Onset:2018-12-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UJ043AB / N/A RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Breath sounds abnormal, Death, Dysphagia, Resuscitation, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-12-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: risperidone; omeprazole; DEPAKOTE; calcium +D; ENSURE
Current Illness: Dysphagia; Bronchiectasis; Latent Tuberculosis; Pulmonary nodule; Mild dementia; Breast cancer; Bipolar disorder; Low weight
Preexisting Conditions: As above
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: The following is history obtained from family after the event: The patient left the office, went for breakfast, developed difficulty swallowing in the restaurant and was making sounds in her chest when breathing, was driven home by family, was not answering her family verbally, then EMS was called and they could not revive her, she was sent to the ER.


VAERS ID: 798191 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Tennessee  
Vaccinated:0000-00-00
Onset:2014-04-02
Submitted: 0000-00-00
Entered: 2019-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Acute left ventricular failure, Cardiac failure congestive, Chest pain, Death, Dyspnoea, Musculoskeletal chest pain, Pleuritic pain, Pneumonia
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-04-02
   Days after onset: 0
Permanent Disability? Yes
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: US0095075131901USA008522

Write-up: Information has been received from a lawyer and spouse (representative of estate of decedent) regarding a case in litigation concerning a female patient (Decedent) of unknown age. The patient''s medical history, concurrent conditions and concomitant medication use were not provided. In or around 27-JAN-2014, the patient (Decedent) was inoculated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the ZOSTAVAX vaccine, the patient (Decedent) suffered from focalized left chest wall tenderness, shortness of breath, pleuritic chest pain and chronic chest pain requiring hospitalizations. The patient (Decedent) was diagnosed with pneumonia and acute systolic congestive heart failure. As a direct and proximate result of these injuries, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the decedent suffered significant medical expenses, severe pain and suffering, other damages, and ultimately death on 02-APR-2014. The husband of decedent claimed wrongful death of Decedent. As a direct and proximate result of the ZOSTAVAX vaccine, the decedent suffered serious and dangerous side effects, including death, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including, but not limited to, the following: The patient required healthcare and services; the patient incurred medical and related expenses; and the patient suffered mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. The outcome of pneumonia and acute systolic congestive heart failure was considered to be unknown. The causality assessment was considered related. The cause of death was not reported. It was unknown if an autopsy was performed. Upon internal review, pneumonia, acute systolic congestive heart failure and death were determined to be medically significant events. Pneumonia and acute systolic congestive heart failure were considered to be disabling. Additional information has been requested.; Reported Cause(s) of Death: Death.


VAERS ID: 798255 (history)  
Form: Version 2.0  
Age: 0.33  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2019-01-22
Onset:2019-01-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (KINRIX) / GLAXOSMITHKLINE BIOLOGICALS 4ZH95 / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH W11304 W11304 / 2 - / -

Administered by: Private       Purchased by: ?
Symptoms: Cardiac arrest, Central venous catheterisation, Coma scale abnormal, Cyanosis, Death, Resuscitation, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-01-23
   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: no
Current Illness: no
Preexisting Conditions: no
Allergies: no
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient found unresponsive at home. Brought to the emergency room by EMS. Found to be in asystole, cyanotic and GCS = 3. Cardiopulmonary resuscitation initiated and central line placed, but patient remained unresponsive. Patent was pronounced dead at 02:41.


VAERS ID: 798970 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2019-01-24
Onset:2019-01-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2019-01-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 3C7ZG / 1 LA / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Private       Purchased by: ?
Symptoms: Death, Hepatitis A
SMQs:, Liver infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-01-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Hip replacement on 01/21/2019
Preexisting Conditions: Unknown
Allergies: EES, Ceclor
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vaccines provided on 01/24/2019 due to contact of acute hepatitis A. Patient died on 01/27/2019.


VAERS ID: 799571 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2019-01-25
Onset:2019-01-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-01-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 3R3AM / 1 AR / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-01-26
   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: tamsulosin; warfarin; cholecalciferol
Current Illness: none
Preexisting Conditions: BPH; age related cognitive decline; back pain; seronegative inflammatory arthritis
Allergies: sulfa drugs
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Patient had migratory pains the night after the vaccination. He died within 24 hours of unknown cause, unknown if related to vaccine.


VAERS ID: 799702 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Male  
Location: New York  
Vaccinated:2018-08-24
Onset:2018-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 4LP5Y / 2 RA / IM

Administered by: Military       Purchased by: ?
Symptoms: Death, Injection site erythema, Pain in extremity, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-08-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Digoxin, lovastatin, baby aspirin, calcium, sotolol.
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: I am sure the staff of the hospital where he received both doses (this was his second dose) do not see a connection between receiving this dose and his death, about 12 hours or less later. I am sure this has not been reported. I am not positive of the time of injection, nor the exact time of death, but it is roughly about 9-11 hours apart. I am not sure he got the right medicine. After the first dose, he complained seriously for a week of arm pain and injection site redness. This dose was easy! according to him. My brother spoke with him about 6 or 7pm that evening. No pain at all, but it had only been a few hours. He collapsed with sudden death at home that evening and was found dead the following day. It was clearly sudden (and unexpected); he had his gym bag packed and ready to go the next morning by the kitchen door. Even at 94, he still went to an exercise class three times a week and was very active. I had seen him exactly one week prior and he was totally fine. I will always be suspicious of this dose of SHINGRIX.


VAERS ID: 799758 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Autoimmune disorder, Death
SMQs:, Immune-mediated/autoimmune disorders (narrow)

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: US0095075131902USA000328

Write-up: This initial spontaneous report was received from an on-line article that was posted on social media and concerns an unspecified amount of patients who were vaccinated with GARDASIL. The article mentioned that the GARDASIL vaccine causes autoimmune problems that cause sudden debilitation and/or death. It was also noted that to date, it was believed that GARDASIL was responsible for the death of 121 young women (cause not specified) and for 57,520 reports of adverse events obtained by the Vaccine Adverse Events Reporting System (VAERS). All of the events were considered related to GARDASIL. Upon internal review, autoimmune problems and death of 121 young women were considered to be medically significant. Autoimmune problems were considered disabling. This is one of several reports received from the same reporter.; Sender''s Comments: US-009507513-0807USA02497:; Reported Cause(s) of Death: death; autoimmune disorder.


VAERS ID: 799837 (history)  
Form: Version 2.0  
Age: 2.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2017-09-25
Onset:2017-11-12
   Days after vaccination:48
Submitted: 0000-00-00
Entered: 2019-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR (L)UT5913LA / N/A UN / SYR

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, Death, Pyrexia, Respiratory arrest, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-11-12
   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: FEBRILE SEIZURE ON 2/8/2016 AFTER MMRV (MERCK L032759) AND HEP A (MERCK L015460) ON 01/29/2016 DTAP, HiB, IPV (SANOFI C4958AA)
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: AUTOPSY 11/13/17
CDC Split Type:

Write-up: Low-grade fever in the morning of 11/12/17, given 1 dose of Tylenol 9am, 1 dose of Ibuprofen 11am, acting normally all day without any issues; fell asleep on our family room carpet and within 10 minutes was found not breathing/unresponsive, TIME OF DEATH 8.05PM.


VAERS ID: 800255 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-02-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (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: US0095075131902USA001350

Write-up: This spontaneous report was received from a consumer and refers to a male patient who would be 5-year-old currently. The patient''s concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (strength, dose, frequency, route of administration, lot number and expiration date were not reported) for prophylaxis. On an unknown date, the patient died after receiving the hepatitis b vaccine (recombinant) (manufacturer unknown). The cause of death and information concerning autopsy were not reported. Causality assessment between the death and the hepatitis b vaccine (recombinant) (manufacturer unknown) was not provided. This is one of several reports from the same reporter.


VAERS ID: 800352 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Washington  
Vaccinated:2019-01-24
Onset:2019-01-30
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2019-02-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C553AA / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH W33490 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. R021069 / 1 MO / PO

Administered by: Private       Purchased by: ?
Symptoms: Abnormal behaviour, Autopsy, Brain death, Death, Decreased activity, Histology, Hypersomnia, Mechanical ventilation, Right ventricular hypertrophy, Toxicologic test, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (narrow), Guillain-Barre syndrome (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), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-01-31
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: 2/4/2019 (6th hospital day on ventilator, 5 days after brain death declared): Autopsy examination performed. Right ventricular hypertrophy was the only gross finding (pending histology, toxicology testing).
CDC Split Type:

Write-up: Over the next 4 days, showed a lack of smiling/laughing/playing, markedly increased sleep, began making bubbles. Slightly improving on 5th to 6th day, but still longer sleep patterns. On day 6, made "cooing" noise while being burped, then became unresponsive. Transported to the hospital and brain death pronounced the next day. Cause of death unknown.


VAERS ID: 800411 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-02-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK UN / UN
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: US0095075131902USA000011

Write-up: Information has been received from an unspecified reporter via an article about significant mortality decrease after vaccine shortage, referring to multiple unspecified patients of unknown age and gender. The patients'' medical history, concurrent conditions and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with RECOMBIVAX HB or GARDASIL 9, both for prophylaxis (strength, dose, frequency, route, lot #, expiration date and indication were not reported). It was reported that from 2003 to 2017, there was a yearly basis an average of 29 deaths after the use of the RECOMBIVAX HB. In 2018 there were only 6 of 2 which were linked to RECOMBIVAX HB. It was also reported that the recipient of the Merck vaccines, which contained aluminum, could lead to neurological and auto-immunological disorders. The outcome of the events was unknown. The causality assessment was not provided. Upon internal review, auto-immunological disorder was determined to be medically significant.


VAERS ID: 800981 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-02-11
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: US0095075131902USA002816

Write-up: This spontaneous report was received from a consumer via Pfizer refers to her daughter of unknown age. The patient concurrent condition, concomitant medication and medical history were unknown. On an unknown date, the patient was vaccinated with GARDASIL (strength, dose, frequency, route of administration, lot # and expiry date unspecified) for prophylaxis. On an unknown date, the patient died (death). The consumer also reported about 354 deaths due to GARDASIL. The consumer reported that her daughter''s information was on goggle. It was unable to clarify if reporter was referring to her daughter as one of the 354 deaths. The cause of death was not reported. It was unknown if autopsy was done. Causality assessment was also not reported.; Reported Cause(s) of Death: unknown.


VAERS ID: 801195 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Acute disseminated encephalomyelitis, Anti-VGCC antibody negative, Anti-muscle specific kinase antibody negative, Antibody test negative, Antinuclear antibody negative, Autopsy, CSF protein increased, CSF test normal, Death, Electromyogram abnormal, General physical health deterioration, Gliosis, Immunoglobulin therapy, Immunohistochemistry, Lymphocytic infiltration, Mechanical ventilation, Microscopy, Muscular weakness, Noninfective encephalitis, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal, Nystagmus, Pneumonia, Quadriplegia, Respiratory failure
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (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), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Demyelination (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Blindness; HIV infection (CD4 count 533/uL); Hypertension; Type II diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Antinuclear antibody; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Name: Cerebrospinal fluid protein; Result Unstructured Data: Test Result: elevated, Test Result Unit: unknown; Test Name: CSF test; Result Unstructured Data: Test Result: no evidence of infection, Test Result Unit: unknown; Test Name: Electromyogram; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: USGLAXOSMITHKLINEUS2019GS

Write-up: This case was reported in a literature article and described the occurrence of acute disseminated encephalomyelitis in a 65-year-old male patient who received Flu unspecified (Influenza vaccine) for prophylaxis. Concurrent medical conditions included hiv infection (CD4 count 533/uL), hypertension, type ii diabetes mellitus and blindness. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, less than a week after receiving Influenza vaccine, the patient experienced acute disseminated encephalomyelitis (serious criteria death and GSK medically significant), weakness in extremity (serious criteria hospitalization), respiratory failure (serious criteria hospitalization and GSK medically significant), quadriplegia (serious criteria hospitalization and GSK medically significant), nystagmus (serious criteria hospitalization) and multilobar pneumonia (serious criteria hospitalization and GSK medically significant). The patient was treated with immunoglobulins nos (Immunoglobulin) and steroids nos (Steroids). On an unknown date, the outcome of the acute disseminated encephalomyelitis was fatal and the outcome of the weakness in extremity, respiratory failure, quadriplegia, nystagmus and multilobar pneumonia were unknown. The reported cause of death was acute disseminated encephalomyelitis. An autopsy was performed. The autopsy determined cause of death was acute disseminated encephalomyelitis. It was unknown if the reporter considered the acute disseminated encephalomyelitis, weakness in extremity, respiratory failure, quadriplegia, nystagmus and multilobar pneumonia to be related to Influenza vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of acute disseminated encephalomyelitis in a 65-year-old male who was vaccinated with unspecified influenza vaccine (manufacturer unknown) for prophylaxis. The patient had a history of human immunodeficiency virus (HIV) infection (CD4 count 533/uL), hypertension, diabetes mellitus type II and blindness. No information on patient''s family history or concomitant medication was provided. On an unspecified date, the patient received unspecified influenza vaccine (administration site and route unspecified; dosages unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, 3 days after vaccination, the patient presented to hospital with acute weakness of all extremities. Subsequently, the patient was admitted. Initial laboratory workup showed elevated protein in cerebrospinal fluid and no evidence of infection. anti-nuclear,-VGCC,-MUSK and-GQ1b antibodies were negative. The patient was treated with intravenous immunoglobulin and steroids for possible Guillain-Barre Syndrome, however his condition deteriorated, and the patient developed respiratory failure requiring mechanical ventilation, complete quadriplegia, nystagmus, and multilobar pneumonia. Electromyography (EMG) demonstrated a severe diffuse demyelinating pattern. On day 16, brain magnetic resonance imaging (MRI) showed innumerable foci of T2 flair hyperintensity involving brain and spinal cord. On day 17 of hospitalisation, the patient died and permission for autopsy was granted. Neuropathologic examination showed multiple soft lesions with tan discoloration throughout the brain and spinal cord, predominantly involving periventricular white matter, bilateral basal ganglia, corpus callosum, cerebellar white matter, pons, medulla and upper cervical spinal cord. Microscopic examination showed discrete areas of demyelination surrounding vessels, with patchy macrophage aggregation, sparse CD8+ lymphocyte infiltration and mild reactive gliosis at the periphery. In a few of the lesions, the infiltrate was composed of neutrophils. Inflammation when present was perivascular or in the brain parenchyma and did not involve the vessel wall. No haemorrhage or viral inclusions were identified. Luxol fast blue stain demonstrated loss of myelin within the lesions. Neurofilament immunohistochemical stain highlighted relative preservation of axons, although spheroids and axonal disruption were also present. The findings were most consistent with the diagnosis of acute disseminated encephalomyelitis (ADEM) in a patient with HIV infection and recent influenza vaccination. This case has been considered serious due to death/hospitalisation. The authors stated, "ADEM presentation in patients with HIV may be atypical and should be considered with acute rapid worsening of weakness, especially in temporal relationship to vaccination". Lab Comments: Lab tests were performed on unspecified dates Anti-nuclear,-VGCC,-MUSK and-GQ1b antibodies were negative.Electromyography (EMG) demonstrated a severe diffuse demyelinating pattern. Neuropathologic examination showed multiple soft lesions with tan discoloration throughout the brain and spinal cord, predominantly involving periventricular white matter, bilateral basal ganglia, corpus callosum, cerebellar white matter, pons, medulla and upper cervical spinal cord. Microscopic examination showed discrete areas of demyelination surrounding vessels, with patchy macrophage aggregation, sparse CD8+ lymphocyte infiltration and mild reactive gliosis at the periphery. In a few of the lesions, the infiltrate was composed of neutrophils. Inflammation when present was perivascular or in the brain parenchyma and did not involve the vessel wall. No haemorrhage or viral inclusions were identified. Luxol fast blue stain demonstrated loss of myelin within the lesions. Neurofilament immunohistochemical stain highlighted relative preservation of axons, although spheroids and axonal disruption were also present. The findings were most consistent with the diagnosis of acute disseminated encephalomyelitis (ADEM) in a patient with HIV infection and recent influenza vaccination.; Reported Cause(s) of Death: Acute disseminated encephalomyelitis; Autopsy-determined Cause(s) of Death: Acute disseminated encephalomyelitis.


VAERS ID: 801369 (history)  
Form: Version 2.0  
Age: 0.33  
Sex: Male  
Location: North Carolina  
Vaccinated:2019-02-12
Onset:2019-02-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-02-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 9EI79 / 2 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. R013573 / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH W33490 / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. R021069 / 2 MO / PO

Administered by: Private       Purchased by: ?
Symptoms: Cyanosis, Death, Intensive care, Seizure like phenomena
SMQs:, Anaphylactic reaction (broad), Convulsions (narrow), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-02-13
   Days after onset: 1
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: mupirocin topical ointment; desonide topical cream
Current Illness: Nasal congestion
Preexisting Conditions:
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Child was in office on February 12th for his four month well visit where he received four vaccines, PEDIARIX, PREVNAR, Hib and Rotavirus. While in office he was alert and happy, smiling, and active. Per mother he was also alert and happy at home until he was put down for tummy time by the father around 5pm. Previously child was fed by dad and layed down on his stomach on the parent''s bed for tummy time, per dad. Father stepped out of the room to the living room and fell asleep. Next time child was checked on was once mom got home from work at 10:30pm and mom noticed he was blue but still breathing. Mother called 911 and once paramedics arrived he seemed to be having a seizure and was given medication. Child was rushed to hospital where he was put in NICU, and doctors stated there was nothing else that could be done. Child was disconnected the morning of Feb. 13th, 2019.


VAERS ID: 801449 (history)  
Form: Version 2.0  
Age: 1.33  
Sex: Male  
Location: North Carolina  
Vaccinated:2019-02-07
Onset:2019-02-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-02-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS GD47F / 2 LL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. R013302 / 1 RL / SC

Administered by: Private       Purchased by: ?
Symptoms: Influenza virus test negative, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin D
Current Illness: Anemia diagnosed on 2/7/19
Preexisting Conditions: None
Allergies: NKDA
Diagnostic Lab Data: Flu test at ER - negative results
CDC Split Type:

Write-up: 2/7/19 - well visit - VARIVAX and FLULAVAL given. 2/8/19 - phone call from parent - fever "high" no temp avail. gave MOTRIN. 2/9/19 - ER visit high fever Tmax 102.5 exam normal d/c to home. 2/12/19 - phone call from parent - concern for vomiting at 4:30pm. Advice given.


VAERS ID: 801700 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Biopsy skin abnormal, Biopsy stomach abnormal, Blood immunoglobulin A decreased, Blood immunoglobulin G decreased, Blood immunoglobulin M decreased, CD4 lymphocytes decreased, CD8 lymphocytes decreased, Candida test positive, Chest X-ray normal, Combined immunodeficiency, Cytogenetic analysis abnormal, Death, Dermatitis diaper, Diarrhoea, Escherichia bacteraemia, Escherichia urinary tract infection, Failure to thrive, Flow cytometry, Gastrostomy, Graft versus host disease, Human rhinovirus test positive, Hypoxia, Infection, Malaise, Malnutrition, Natural killer cell count increased, Oropharyngeal plaque, Polymerase chain reaction positive, Rales, Rash erythematous, Rash generalised, Respiratory distress, Respirovirus test positive, Rotavirus test positive, Staphylococcal bacteraemia, Stem cell transplant, T-lymphocyte count decreased
SMQs:, Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Haematopoietic leukopenia (narrow), Congenital, familial and genetic disorders (narrow), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Neonatal disorders (broad), Skin tumours of unspecified malignancy (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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:
Current Illness: Bronchiolitis (never resolved); Chronic diarrhoea; Combined immunodeficiency; Failure to thrive; Lymphopenia; Oral candidiasis (Developed at 2 weeks of age; failure to resolve despite 5 courses of antifungal therapy.); Respiratory disorder
Preexisting Conditions: Medical History/Concurrent Conditions: Antifungal treatment; Drug ineffective
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131902USA001902

Write-up: This literature marketed report was received from authors of a published article and refers to a 2-month-old infant female patient who presented at 4 months of age via inpatient consultation to allergy/immunology, with a chief complaint of lymphocytopenia (1.01 x 10^3 cells/microL), failure to thrive, thrush, persistent diarrhea, and recurrent respiratory illnesses. She was born uneventfully via normal spontaneous vaginal delivery to nonconsanguineous parents. At 2 weeks of age, she developed oral thrush, with failure to resolve despite 5 courses of antifungal therapy. Simultaneously, she also developed bronchiolitis that never resolved, with 6 primary care visits and 3 emergency department visits for respiratory symptoms before consultation. On an unknown date, when the patient was approximately 2 months old, she received immunizations that included ROTATEQ (dose, lot # and expiration date were not provided). Later, 4 weeks after immunizations around 3 months of age, she developed persistent watery diarrhea. The physical examination at 4 months showed an ill-appearing infant with adherent white plaques in the posterior oropharynx, diffuse expiratory crackles, and an erythematous, macerated diaper rash, without hepatosplenomegaly or lymphadenopathy. Flow cytometry demonstrated total CD3+ T-cell count 30 cells/microL, CD4+ T-cell count 30 cells/mL, CD8+ T-cell count less than 10 cells/microL, natural killer (NK) cell count 949 cells/microL, and B-cell count less than 10 cells/microL. Quantitative immunoglobulins demonstrated immunoglobulin (Ig) G 66 mg/dL, IgM less than 5 mg/dL, and IgA less than 5 mg/dL. Chest x-ray was notable for an absent thymic shadow and no focal consolidations. Infectious workup was positive for rhinovirus, parainfluenza, and rotavirus by polymerase chain reaction, and oral/esophageal candidiasis confirmed by fungal culture. A diagnosis of T-B-NK+ severe combined immunodeficiency (SCID) was made based on laboratory and imaging findings, the presence of multiple infections, and failure to thrive. Targeted genetic sequencing demonstrated compound heterozygous deletions of the DCLREC1 gene, including a gross deletion of exons 1 through 8 that has not been previously described. Testing for maternal T-cells indicated an absence of maternal DNA in peripheral blood CD3+ cells. At 5 months of age, the patient had a gastrostomy tube placed for severe malnutrition. She then underwent an unconditioned, CD34+ 24.7 x 10^6/kg selected megadose haploidentical paternal donor stem cell transplant (SCT) with CD3+ dose of 2.8 x 10^4/kg at 6 months of age. The CD34+ donor selection process was conducted using a Miltenyi Biotech Inc. CliniMACS CD34+ reagent system, which uses a CD34+ monoclonal antibody conjugated to an iron-dextran moiety. The target dose of CD34+ cells was greater than 20 x 10^6 CD34+ cells/kg, which is considered a ''''megadose'''' of CD34+ cells, and a target T-cell dose of 3 x 10^4 CD3+ cells/kg. Approximately 60 days post-SCT, she had worsening of her known viral infections, with no evidence of donor cell engraftment. Therefore, at 8 months of age, she underwent a second unconditioned CD34+ 48.9 x 10^6/kg selected megadose stem cell boost with CD3+ dose of 1.5 x 10^4/kg. At 9 months of age, she developed Escherichia coli bacteremia. By 10 months of age, she demonstrated engraftment of paternal T-cells. Unfortunately, she also developed worsening diarrhea and a diffuse rash. Skin and gastrointestinal biopsies confirmed pathology consistent with graft-versus-host disease (GVHD). She received etanercept 0.4 mg/kg subcutaneously for 8 doses within the first month of GVHD and was started on a regimen that she continued indefinitely, including beclomethasone 1 mg by mouth every 6 hours, tacrolimus 0.4 mg by mouth every 12 hours, prednisolone 6 mg by mouth daily, alpha-1 proteinase inhibitor 60 mg/kg intravenously weekly, and as needed topical hydrocortisone 1% cream, triamcinolone 0.1% cream, and clobetasol 0.05% ointment. At 14 months of age, she had a simultaneous E coli urinary tract infection (UTI) and Staphylococcus epidermidis bacteremia. At 18 months of age, she developed respiratory distress and hypoxia secondary to infection and worsening pulmonary GVHD and died.


VAERS ID: 801757 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: B-lymphocyte count, Biopsy skin abnormal, CD4 lymphocytes decreased, Condition aggravated, Death, Dermatitis, Dermatitis psoriasiform, Finger amputation, Hepatitis, Immunodeficiency, Immunoglobulin therapy, Immunohistochemistry, Immunology test, Immunology test abnormal, Natural killer cell count, Polymerase chain reaction positive, Progressive multifocal leukoencephalopathy, Pyoderma gangrenosum, Rubella, Rubivirus test positive, T-lymphocyte count decreased, Vaccination complication
SMQs:, Hepatitis, non-infectious (narrow), Haematopoietic leukopenia (narrow), Malignancy related conditions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Demyelination (narrow), Skin tumours of unspecified malignancy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Combined immunity deficiency; Granuloma skin
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131902USA004786

Write-up: This literature marketed report has been received from the authors of a published literature article, and refers to a 13-year-old patient of unknown gender. The patient''s concurrent condition included combined immunodeficiency CID (unknown genetics), reported as inherited immunodeficiency and cutaneous granuloma. The patient''s medical history and concomitant medications were not reported. On unknown dates at age of 5 and 9, the patient was vaccinated with M-M-R II (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient developed immunodeficiency-related vaccine-derived rubella virus (iVDRV). The patient had skin involvement that was described as initially psoriasiform or resembling pyoderma gangrenosum. The patient had chronic inflammation in skin, liver where rubella was detected by immunofluorescence or polymerase chain reaction (PCR). The Rubella capsid was detected and the iVDRV strain with multiple non-overlapping mutations was identified in the skin biopsy by sequencing viral genomes. The patient''s CD3 count was 453 cells/uL, CD4 count 189 cells/uL, CD19 count 312 cells/uL and natural killer (NK) cell count 105 cells/uL. The authors assessed CD3 and CD4 count as low, and NK count as normal. The cutaneous granulomas spread relentlessly and led to amputation of a finger in an effort to control the spread. The surgical control of the lesion was unsuccessful. The patient was treated with linezolid, clarithromycin, rifampin, isoniazid, ethambutal, voriconazole, posaconazole, interferon and intravenous immunoglobulin (IVIG) without improvement. Nitazoxanide was used for 5 months without clinical improvement although rubella became undetectable by immunohistochemistry. The patient may have stabilized with diminished rubella capsid detection, but this patient died on an unknown date from progressive multifocal leukoencephalopathy (PML). The authors considered the iVDRV to be related to M-M-R II. Upon internal review, the iVDRV was determined to be medically significant as the patient underwent surgical amputation of finger. This is one of seven reports derived from the same literature article (linked # 1902USA004783, 1902USA004784, 1902USA004785, 1902USA003143, 1902USA004787, 1902USA004788). Sender''s Comments: US-009507513-1902USA003143.


VAERS ID: 801759 (history)  
Form: Version 2.0  
Age: 1.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: B-lymphocyte count, Biopsy skin abnormal, Bone marrow disorder, CD4 lymphocytes decreased, Death, Dermatitis, Dermatitis psoriasiform, Hepatitis, Immunodeficiency, Immunoglobulin therapy, Immunology test, Immunology test abnormal, Inflammation, Laryngeal inflammation, Natural killer cell count, Nephritis, Polymerase chain reaction positive, Progressive multifocal leukoencephalopathy, Pyoderma gangrenosum, Rubella, Rubivirus test positive, Skin lesion, Stomatitis, T-lymphocyte count decreased, Vaccination complication
SMQs:, Acute renal failure (broad), Hepatitis, non-infectious (narrow), Severe cutaneous adverse reactions (broad), Haematopoietic cytopenias affecting more than one type of blood cell (broad), Haematopoietic leukopenia (narrow), Systemic lupus erythematosus (broad), Malignancy related conditions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Demyelination (narrow), Skin tumours of unspecified malignancy (broad), Hypersensitivity (narrow), Myelodysplastic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cartilage-hair hypoplasia; Granuloma skin
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131902USA004788

Write-up: This literature marketed report has been received from the authors of a published literature article, and refers to a 15-year-old patient of unknown gender. The patient''s concurrent condition included cartilage hair hypoplasia, reported as inherited immunodeficiency and cutaneous granuloma. The patient''s medical history and concomitant were not reported. On an unknown date at the age of 1 year, the patient was vaccinated with M-M-R II (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient developed immunodeficiency-related vaccine-derived rubella virus (iVDRV). The patient had skin involvement that was described as initially psoriasiform or resembling pyoderma gangrenosum. The patient had chronic inflammation in skin, liver, kidney, larynx, palate and bone marrow but rubella was detected by immunofluorescence or polymerase chain reaction (PCR) in skin, liver and kidney. The Rubella capsid protein was detected and the iVDRV strain with multiple non-overlapping mutations was identified in the skin biopsy by sequencing viral genomes. The patient''s CD3 count was 550 cells/uL, CD4 count was 450 cells/uL, CD19 count was 120 cells/uL and natural killer (NK) cell count was 120 cells/uL. The authors assessed CD3 and CD4 count as low, and NK count as normal. The patient was treated with azathioprine, azithromycin, mycophenolic acid and intravenous immunoglobulin (IVIG) with no improvement. The patient received also cyclosporine and steroids with partial response. Nitazoxanide was used largely as salvage therapy in this extremely ill patient but it had no obvious benefit. After 2 months of treatment with nitazoxanide, lesions in the skin, liver and kidney improved and improvement was sustained until the patient''s death. The patient died from progressive multifocal leukoencephalopathy (PML). The authors considered the iVDRV to be related to M-M-R II. Upon internal review, the iVDRV was determined to be medically significant as the patient was treated with immunoglobulin therapy. This is one of seven reports derived from the same literature article (linked # 1902USA004783, 1902USA004784, 1902USA004785, 1902USA004786, 1902USA004787, 1902USA003143). Sender''s Comments: US-009507513-1902USA003143.


VAERS ID: 801792 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: North Dakota  
Vaccinated:2016-12-31
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK - / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac failure congestive, Death, Herpes zoster
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-02-12
Permanent Disability? Yes
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: Routine health maintenance
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131902USA003777

Write-up: Information has been received regarding a case in litigation from a lawyer and the spouse of a deceased male patient of unknown age. No information was provided regarding the patient''s past medical history, concurrent conditions, or concomitant medication. In or around 31-DEC-2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). In approximately early 2017 [reported as "shortly after" receiving the ZOSTAVAX vaccine], the patient suffered congestive heart failure and shingles which required hospitalization. The patient''s ultimate cause of death was congestive heart failure. As a direct and proximate result of these injuries, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered significant medical expenses, severe pain and suffering, other damages, and ultimately death on 12-FEB-2017. As a direct and proximate result of the ZOSTAVAX, the patient suffered serious and dangerous side effects, including death, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of ZOSTAVAX, the patient suffered congestive heart failure and shingles, and untimely died a wrongful death on 12-FEB-2017. It is unknown if an autopsy was performed. Upon internal review, congestive heart failure was determined to be medically significant. Congestive heart failure and shingles were considered to be disabling. Additional information has been requested. Reported Cause(s) of Death: Congestive heart failure.


VAERS ID: 801951 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Autopsy, Death, Fall
SMQs:, Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2019GS

Write-up: This case was reported in a literature article and described the occurrence of fall in a 86-year-old female subject who received Hz/su + AS01B for prophylaxis. On an unknown date, 6 hrs after receiving Hz/su + AS01B, the subject developed fall. Serious criteria included death. The outcome of fall was fatal. The reported cause of death was fall. An autopsy was performed. The investigator considered that there was a reasonable possibility that the fall may have been caused by Hz/su + AS01B. Additional information was provided. This case was reported in a literature article and described the occurrence of fall in an 86-year-female who was vaccinated with SHINGRIX (GlaxoSmithKline) for prophylaxis. The patient was a part of a Centre for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) began safety monitoring of recombinant zoster vaccine (RZV; Shingrix), in the Vaccine Adverse Event Reporting System (VAERS) for the period between 20 October 2017 and 30 June 2018. No information on patient''s family or medical history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received SHINGRIX (administration route and site unspecified; dosages unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, between 6 hours and 6 weeks, the patient died due to a fall. Autopsy was performed on unspecified date (results not available). [In this study, according to autopsy reports, death certificates, or medical records, the median decedent age was 65 years (range = 61-86 years), and the interval from vaccination to death ranged from 6 hours to 6 weeks]. This case has been considered serious due to death. The authors commented, "CDC and FDA will continue to closely monitor the safety of RZV. Whereas the initial safety data for RZV are reassuring, the vaccine is still in the early uptake period. Understanding of the safety of RZV will advance as use increases and additional data become available from VAERS and from near real-time sequential monitoring in CDC''s Vaccine Safety Datalink."; Reported Cause(s) of Death: fall.


VAERS ID: 802356 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-02-20
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: US0095075131902USA005567

Write-up: This spontaneous report was received via voicemail from a field representative who learned of this adverse event from a nurse practitioner referring to a 17 year old patient of an unknown gender. The patient''s relevant medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9, for prophylaxis (strength, dose, frequency, route of administration, lot # and expiration date were not reported). On an unknown date (reported as "a couple of years ago"), the patient died from an unspecified cause It was unknown if an autopsy was performed or not. The causality assessment was not provided at the time of the report.; Reported Cause(s) of Death: on an unspecified date a couple years ago, the patient died from an unspecified cause.


VAERS ID: 802764 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Indiana  
Vaccinated:0000-00-00
Onset:2017-12-24
Submitted: 0000-00-00
Entered: 2019-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-12-24
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131902USA008584

Write-up: Information has been received regarding a case in litigation from a lawyer and the administrator for the estate of an approximately 85 year old male patient. No information was received regarding the patient''s past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2015, the patient was administered the ZOSTAVAX (lot number, dosage and route of administration not provided) by a pharmacist at a pharmacy. On an unknown date in 2015, the patient was treated by a healthcare provider at a hospital for the following injuries resulting from his ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient died on 24-DEC-2017. The cause of the patient''s death is unknown. It is unknown if an autopsy was performed. The patient claims damages as a result of: injury to themselves, wrongful death, survivorship action, and economic losses. Upon internal review, death was determined to be medically significant. Additional information has been requested.; Reported Cause(s) of Death: Death.


VAERS ID: 803047 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Georgia  
Vaccinated:0000-00-00
Onset:2017-03-01
Submitted: 0000-00-00
Entered: 2019-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-04-17
   Days after onset: 411
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: US0095075131902USA008647

Write-up: Information has been received on 15-FEB-2019 from a lawyer regarding a case in litigation concerning a 75 year old female patient. The patient''s medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2014 the patient was administered the ZOSTAVAX vaccine by healthcare provider (lot# and route unknown). In March 2017, the patient was treated by a physician for shingles as a result of vaccination with ZOSTAVAX. On 17-APR-2018 the patient died. The cause of death was not provided. It is unknown if an autopsy was performed. The patient claims damages as a result of: injury to themselves, injury to the person represented; wrongful death; survivorship action, loss of services; economic losses. Upon internal review death was considered medically significant. Additional information has been requested.; Reported Cause(s) of Death: died.


VAERS ID: 803062 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Oregon  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-12-11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Shingles
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131902USA008678

Write-up: Information has been received regarding a case in litigation from a lawyer and the spouse of a 71 year old deceased male patient. No information was received regarding the patient''s past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider at a hospital for the long-term prevention of shingles and zoster-related conditions. On or about 13-DEC-2016, the patient was administered the ZOSTAVAX (lot number, dosage and route of administration not provided) by a healthcare provider at a hospital. On or about 03-JAN-2017, the patient was treated by a physician at the hospital for the following injury resulting from his use of ZOSTAVAX: Shingles. The outcome of the shingles was unknown. The patient died on 11-DEC-2017. The cause of death was not reported. It is unknown if an autopsy was performed. There are claimed damages as a result of: injury to themselves, injury to the person represented, wrongful death, survivorship action, loss of consortium, loss of services, and economic losses. Upon internal review, death was determined to be medically significant. Additional information has been requested.; Reported Cause(s) of Death: Death.


VAERS ID: 803066 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Unknown  
Location: Texas  
Vaccinated:0000-00-00
Onset:2018-03-30
Submitted: 0000-00-00
Entered: 2019-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-03-30
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131902USA008685

Write-up: Information has been received regarding a case in litigation from a lawyer and an estate representative of an 82 year-old deceased patient of unknown gender. No information was received regarding the patient''s past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2015, at approximately 80 years of age, the patient was administered the ZOSTAVAX by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician at a family practice medical office for the following injury resulting from the ZOSTAVAX use: Shingles. The outcome of the shingles was unknown. It was also claimed that the patient died on 30-MAR-2018 at age 82 years old. Cause of death not provided. The patient claims damages as a result of: injury to themselves, wrongful death, survivorship action, and economic losses. Upon internal review, Death was determined to be a medically significant event. Additional information has been requested.; Reported Cause(s) of Death: Death.


VAERS ID: 803127 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Inappropriate schedule of product administration, Rabies
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-06-01
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: Medical History/Concurrent Conditions: Dog bite (bitten on the head area (category 3 exposure) by a sick dog)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEVN2019GS

Write-up: This case was reported in a literature article and described the occurrence of rabies in a 6-year-old male subject who received Rabies Vaccine for prophylaxis. Co-suspect products included equine rabies immune globulin vaccine for prophylaxis. Concurrent medical conditions included dog bite (bitten on the head area (category 3 exposure) by a sick dog). On an unknown date, less than a year after receiving Rabies Vaccine, the subject developed rabies. Serious criteria included death and GSK medically significant. Additional event(s) included inappropriate schedule of vaccine administered. The outcome of rabies was fatal in June 2014. The outcome(s) of the additional event(s) included inappropriate schedule of vaccine administered (unknown). The subject died in June 2014. The reported cause of death was rabies. The investigator considered that there was a reasonable possibility that the rabies may have been caused by Rabies Vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of rabies in a 6-year-old male who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for prophylaxis. This case corresponds to discussion section in this literature article. The patient was a part of the study to determine the epidemiologic characteristics of patients associated with delays in the initiation and completion of post-exposure prophylaxis (PEP). In this study, a retrospective review of all patients seen at the ten provinces between January 1, 2014-December 31, 2016 was performed. The patient had an unknown rabies vaccination history. On unspecified date in May 2014, the patient was bitten on the head area (comprised of bites to the head, face and neck area) by a sick dog. The exposure was defied as category 3 exposure (includes single or multiple transdermal bites or scratches, licks on broken skin). [In this study, "Sick" category refers to animals showing signs of weakness and inability to eat]. No information on patient''s family history or concomitant medication was provided. On unspecified date between May 2014 and June 2014, 2 days after the exposure, the patient received one dose of unspecified rabies vaccine (administration site and route unspecified; batch number not provided) instead of the World Health Organisation (WHO) recommended 1st dose of vaccination on the day of rabies exposure (Day 0). The patient additionally received Equine rabies immune globulin (eRIG). [In this study, based on WHO guidelines, patients receiving five doses of intramuscular vaccine and eight doses of intradermal vaccine were considered fully vaccinated. Patients receiving at least one dose were classified as vaccinated.]. The age of vaccination was either 6 or 7 years. On unspecified date between May 2014 and June 2014, an unknown period after vaccination, the patient developed unspecified symptoms of rabies and subsequently died about 6 days later in June 2014. The cause of death was rabies. It was unknown if autopsy was performed. This case has been considered serious due to death. Treatment was unknown. The authors did not comment on the relationship of rabies with unspecified rabies vaccine. The authors concluded, "Country has made tremendous progress towards reducing the burden of rabies. However, despite the wide availability of PEP, we found relatively low rates of vaccine completion. Our findings suggest provider training and patient education is needed to ensure appropriate treatment is completed. Moreover, our data suggest changes to information reported through the national surveillance system for monitoring good clinical practice for rabies prevention and control. This is 1 of the 3 valid cases reported in the same literature article.; Reported Cause(s) of Death: rabies.


VAERS ID: 803128 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2015-07-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 4 UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Inappropriate schedule of product administration, Rabies
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-08-01
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: Medical History/Concurrent Conditions: Dog bite (bitten on the head area (category 3 exposure) by a stray dog)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEVN2019GS

Write-up: This case was reported in a literature article and described the occurrence of rabies in a 72-year-old female subject who received Rabies Vaccine for prophylaxis. Co-suspect products included equine rabies immune globulin vaccine for prophylaxis. Concurrent medical conditions included dog bite (bitten on the head area (category 3 exposure) by a stray dog). Concomitant products included Rabies NVS (Rabies Vaccine), Rabies NVS (Rabies Vaccine) and Rabies NVS (Rabies Vaccine). On an unknown date, less than a year after receiving Rabies Vaccine, the subject developed rabies. Serious criteria included death and GSK medically significant. Additional event(s) included inappropriate schedule of vaccine administered. The outcome of rabies was fatal in August 2015. The outcome(s) of the additional event(s) included inappropriate schedule of vaccine administered (unknown). The subject died in August 2015. The reported cause of death was rabies. The investigator considered that there was a reasonable possibility that the rabies may have been caused by Rabies Vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of rabies in a 72-year-old female who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for prophylaxis. This case corresponds to discussion section in this literature article. The patient was a part of the study to determine the epidemiologic characteristics of patients associated with delays in the initiation and completion of post-exposure prophylaxis (PEP). In this study, a retrospective review of all patients seen between January 1, 2014-December 31, 2016 was performed. On unspecified date in July 2015, the patient was bitten on the head area (comprised of bites to the head, face and neck area) by a stray dog. The exposure was defied as category 3 exposure (includes single or multiple transdermal bites or scratches, licks on broken skin). No information on patient''s family history was provided. On unspecified dates in July 2015, on the day of exposure, the patient received all the 4 doses of unspecified rabies vaccines along with Equine rabies immune globulin (eRIG) (administration site and route unspecified; batch number not provided for all) instead of the World Health Organisation (WHO) recommended schedule respectively at day 0, 13 ,7, 14 and 28 of the exposure. [In this study, based on WHO guidelines, patients receiving five doses of intramuscular vaccine and eight doses of intradermal vaccine were considered fully vaccinated. Patients receiving at least one dose were classified as vaccinated.]. The age of vaccination was either 71 or 72 years. On unspecified date between July 2015 and August 2015, an unknown period after vaccination, the patient developed unspecified symptoms of rabies and subsequently died 2 days later in August 2015. The cause of death was rabies. It was unknown if autopsy was performed. This case has been considered serious due to death. Treatment was unknown. The authors did not comment on the relationship of rabies with unspecified rabies vaccine. The authors concluded, "Country has made tremendous progress towards reducing the burden of rabies. However, despite the wide availability of PEP, we found relatively low rates of vaccine completion. Our findings suggest provider training and patient education is needed to ensure appropriate treatment is completed. Moreover, our data suggest changes to information reported through the national surveillance system for monitoring good clinical practice for rabies prevention and control. This is 1 of the 3 valid cases reported in the same literature article.; Reported Cause(s) of Death: rabies.


VAERS ID: 803263 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: South Carolina  
Vaccinated:2018-09-19
Onset:2018-09-01
Submitted: 0000-00-00
Entered: 2019-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 4HY3T / N/A LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-09-21
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Fluticasone nasal spray, Propranolol, Valproic Acid, Clonazepam, Quetiapine, Hydrocerin, Benzonatate
Current Illness: Reactive airway disease, difficulty breathing, tooth ache, drowsy, aggressive behavior-impulsive control disorder
Preexisting Conditions: Hydrocephalus, cerebral palsy, seizures, anxiety, adolescent with aggressive behavior
Allergies: Iodine contrast & IV dye, Iodine
Diagnostic Lab Data: None
CDC Split Type:

Write-up: The decedent''s condition didn''t get better. 2 days after the vaccine, he was dead.


VAERS ID: 803503 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-02-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: USPFIZER INC2019087121

Write-up: This is a spontaneous report from a Pfizer-sponsored Program. A contactable consumer reported that a female patient (Consumer''s Mother) of unknown age received a single dose of PREVNAR 13 for immunization on an unknown date. Medical history and concomitant medications were not reported. The patient had this vaccine but died of pneumonia anyway on an unknown date. No follow-up attempts are possible, information about batch number cannot be obtained.; Reported Cause(s) of Death: Pneumonia.


VAERS ID: 803655 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Maryland  
Vaccinated:2019-01-07
Onset:2019-01-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2019-02-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Acute kidney injury, Alanine aminotransferase increased, Ammonia increased, Anxiety, Ascites, Aspartate aminotransferase increased, Atrial fibrillation, Bacteraemia, Blood albumin decreased, Blood bilirubin increased, Blood calcium decreased, Blood creatine phosphokinase increased, Blood creatinine increased, Blood culture positive, Blood iron decreased, Blood lactate dehydrogenase increased, Blood potassium increased, Blood urea increased, Blood urine present, Bundle branch block left, Carbon dioxide decreased, Cardiac failure congestive, Cardiomegaly, Cardiomyopathy, Cholelithiasis, Complement factor C3 decreased, Compression fracture, Computerised tomogram abnormal, Confusional state, Death, Dehydration, Delirium, Dysphagia, Dyspnoea, Eosinophil percentage decreased, Epstein-Barr virus antibody positive, Fall, Fatigue, Gait disturbance, Gastrointestinal oedema, Generalised oedema, Haematocrit decreased, Haematoma, Haemoglobin decreased, Hyponatraemia, Hypovolaemia, Immunodeficiency, International normalised ratio increased, Iron binding capacity total decreased, Lethargy, Leukocytosis, Lymphocyte count decreased, Lymphocyte percentage decreased, Malaise, Mean cell haemoglobin decreased, Memory impairment, Mental disorder, Metabolic encephalopathy, Neutrophil count increased, Neutrophil percentage increased, Normocytic anaemia, Nuclear magnetic resonance imaging abnormal, Pain, Platelet count decreased, Pleural effusion, Protein urine present, Prothrombin time prolonged, Pulmonary oedema, Red blood cell count decreased, Red blood cell sedimentation rate increased, Red cell distribution width increased, Restlessness, Sinus tachycardia, Transaminases increased, Transferrin saturation decreased, Ultrasound scan abnormal, Ventricular extrasystoles, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (broad), Acute pancreatitis (narrow), Angioedema (broad), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Myocardial infarction (broad), Anticholinergic syndrome (broad), Conduction defects (narrow), Supraventricular tachyarrhythmias (narrow), Ventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Akathisia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (narrow), Gallbladder related disorders (narrow), Gallstone related disorders (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hyponatraemia/SIADH (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (narrow), Depression (excl suicide and self injury) (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (narrow), Proteinuria (narrow), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (narrow), Hypokalaemia (broad), Sepsis (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-01-25
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 13 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Anastrozole, hydrochloroquine, prednisone, calcitriol, lipitor, gabapentin, L. thyroxin, effexor, eliquis
Current Illness: Had a cold in mid Dec
Preexisting Conditions: Schogrens syndrome, metastatic breast cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: The patient (my wife) died on Jan 25, 2019.


VAERS ID: 803721 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2018-08-01
Submitted: 0000-00-00
Entered: 2019-03-01
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: 2018-08-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131902USA010477

Write-up: Information has been received from a consumer referring to a 13 years old male patient. Information about concurrent condition, concomitant medication, drug reactions/allergies and pertinent medical history was not provided. On an unknown date, the patient was vaccinated with unspecified HPV vaccine for prophylaxis. The reporter did not clarify which HPV vaccine brand, valent or manufacturer had been administered but a Merck vaccine could not be ruled out (product origin unknown). The reporter reported that on an unknown date in August 2018 the patient died after receiving the HPV vaccine. It was unknown if an autopsy was performed or not. The causality between the event and the HPV vaccine was not reported.


VAERS ID: 804128 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic obstructive pulmonary disease; Coronary artery disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSEQIRUS201902090

Write-up: This is a literature case, initially received on 19-Feb-2019, concerning a 70-year-old, elderly male patient. The study describes the reports of anaphylaxis after vaccination reported to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. A descriptive analysis, including history of hypersensitivity (anaphylaxis, respiratory allergies, and drug allergies) and vaccines given were performed. The patient''s medical history included chronic obstructive pulmonary disease and coronary artery disease. The patient had no hypersensitivities. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, anatomical location, dose, route of administration, batch number, manufacturer, trade name and expiry date: not reported) for an unknown indication. On the same day, 258 minutes after the vaccination, the patient experienced anaphylactic reaction, difficulty in breathing and cardiopulmonary arrest. The documented cause of death was anaphylactic reaction (causality: related). It was unknown whether autopsy was performed or not. The author considered this case as serious (death). This case is cross-linked to the original case: 201902085 due to the same reporter.; Reporter''s Comments: A 70-year-old, male patient with medical history (chronic obstructive pulmonary disease and coronary artery disease) developed difficulty in breathing and cardiopulmonary arrest, 258 minutes after administration of INN Flu Vaccine. The reported cause of death was anaphylactic reaction. The case meets level 2 of Brighton Collaboration criteria of diagnostic certainty for anaphylactic reaction. Considering the plausible temporal relationship between vaccination and reported fatal events and lack of any alternative more plausible causes, the company assessed the events as possibly related to suspect vaccine. The company assessed the event anaphylactic reaction as serious (medically significant).; Reported Cause(s) of Death: Anaphylactic reaction.


VAERS ID: 804149 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Cardiac arrest, Death, Feeling abnormal, Syncope, Ventricular fibrillation, Wheezing
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension; Penicillin allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSEQIRUS201902091

Write-up: This is a literature case, initially received on 19-Feb-2019, concerning an 84-year-old, elderly, female patient. The study describes the reports of anaphylaxis after vaccination reported to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. A descriptive analysis, including history of hypersensitivity (anaphylaxis, respiratory allergies, and drug allergies) and vaccines given were performed. The patient''s current condition included hypertension and allergy to penicillin. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, anatomical location, dose, route of administration, batch number, manufacturer, trade name and expiry date: not reported) for an unknown indication. On the same day, 2 minutes after the vaccination, the patient felt funny and then collapsed. The patient had ventricular ?brillation (later speculated because of hypotension), which progressed to cardiac arrest. On examination, the patient also had wheezing. It was reported that, there was no documented evidence, but medical records indicated diagnosis of anaphylactic reaction. The author considered this case as serious (death). The author concluded that anaphylaxis of severe or life-threatening severity was very uncommon but could occur even among the persons without hypersensitivity. Most persons recovered fully with treatment, but serious complications, including possibility of death is a rare event. This case is cross-linked to the original case: 201902085 due to the same reporter.; Reporter''s Comments: An 84-year-old, female patient with current condition of hypertension known allergy to penicillin felt funny, collapsed and experienced ventricular ?brillation (later speculated because of hypotension), which progressed to cardiac arrest, within minutes after administration of INN Flu Vaccine. The case meets level 2 of Brighton Collaboration criteria of diagnostic certainty for anaphylactic reaction. The indicated cause of death was anaphylactic reaction. Considering the plausible temporal relationship between vaccination and reported fatal events (ventricular brillation, cardiac arrest and anaphylactic reaction) and lack of any underlying conditions or alternative more plausible causes, the company assessed the events as possibly related to suspect vaccine. The company assessed the events (cardiac arrest, anaphylactic reaction, Ventricular fibrillation) as serious (medically significant).; Reported Cause(s) of Death: Anaphylactic reaction.


VAERS ID: 804153 (history)  
Form: Version 2.0  
Age: 0.5  
Sex: Female  
Location: Minnesota  
Vaccinated:2019-02-27
Onset:2019-03-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2019-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS KZ41M / 3 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH W80810 / 3 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Cholecaciferol, Vitamin D3, (D-VI-SOL) 400 unit/mL drops
Current Illness:
Preexisting Conditions:
Allergies: No known allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient seen for routine well child exam 2-27-2019 with no abnormal findings. Vaccines given and no adverse reactions noted at time of injection.


VAERS ID: 804320 (history)  
Form: Version 2.0  
Age: 2.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cyanosis (The patient had periodic cyanosis.)
Preexisting Conditions: Medical History/Concurrent Conditions: Cavopulmonary anastomosis (The patient had hypoplastic left heart syndrome with subsequent cavopulmonary shunt procedure.); Hypoplastic left heart syndrome (The patient had hypoplastic left heart syndrome with subsequent cavopulmonary shunt procedure.); Premature birth (The patient was born premature at 33 weeks gestation.)
Allergies:
Diagnostic Lab Data: Test Name: Serum tryptase level; Result Unstructured Data: Increased.
CDC Split Type: USSEQIRUS201902085

Write-up: This is a literature case, initially received on 19-Feb-2019, concerning a 2-year-old, male child. The study describes the reports of anaphylaxis after vaccination reported to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. A descriptive analysis, including history of hypersensitivity (anaphylaxis, respiratory allergies, and drug allergies) and vaccines given were performed. The patient''s medical history included premature birth at 33 weeks of gestation, hypoplastic left heart syndrome with subsequent cavopulmonary shunt procedure. The current conditions of the patient included periodic cyanosis. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (anatomical location, dose, route of administration, batch number, manufacturer, trade name and expiry date: not reported) for an unknown indication. On the same day, the patient was also administered a combined non-company suspect vaccine, Measles vaccine;Mumps vaccine;Rubella vaccine;Varicella zoster vaccine (anatomical location, dose, route of administration, batch number, manufacturer, trade name and expiry date: not reported) for an unknown indication. On the same day, 20 minutes after the vaccination, the patient experienced a cardiopulmonary arrest and the patient died. Autopsy was performed, and the cause of death was reported as anaphylactic reaction (related). On post-mortem laboratory tests revealed an increased serum tryptase level. The outcome of the event cardiopulmonary arrest was not reported. The reporter assessed this case as serious (death).; Reporter''s Comments: A 2-year-old, male patient with medical history/concurrent condition (premature birth at 33 weeks of gestation, hypoplastic left heart syndrome with subsequent cavopulmonary shunt procedure and periodic cyanosis) experienced fatal cardiopulmonary arrest, 20 minutes after administration of INN Flu Vaccine. The autopsy reported the cause of death as anaphylactic reaction. The case meets level 2 of Brighton Collaboration criteria of diagnostic certainty for anaphylactic reaction. Considering the plausible temporal relationship between vaccination and reported fatal events (anaphylactic reaction and cardiopulmonary arrest) and lack of alternative more plausible causes, the company conservatively assessed the events as possibly related to suspect vaccine. However, co-administered combined measles, mumps, rubella and varicella vaccine was considered as non company suspect in this case. The company assessed the event ''anaphylactic reaction'' as serious (medically significant).; Reported Cause(s) of Death: Anaphylactic reaction.


VAERS ID: 804321 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Autopsy, Death, Respiratory failure, Tryptase increased
SMQs:, Anaphylactic reaction (narrow), 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 (narrow), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Hypokalaemia (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: Allergic reaction to antibiotics; Asthma; Drug allergy; Hereditary onycho-osteodysplasia; Penicillin allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Hepatitis C
Allergies:
Diagnostic Lab Data: Test Name: Serum tryptase; Result Unstructured Data: Increased.
CDC Split Type: USSEQIRUS201902086

Write-up: This is a literature case, initially received on 19-Feb-2019, concerning a 42-year-old, adult, female patient. The study describes the reports of anaphylaxis after vaccination reported to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. A descriptive analysis, including history of hypersensitivity (anaphylaxis, respiratory allergies, and drug allergies) and vaccines given were performed. The patient''s historical conditions included hepatitis C infection. The patient''s current conditions included: asthma, hereditary onychoosteodysplasia and was allergic to penicillin, quinolones and naproxen. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (anatomical location, dose, route of administration, batch number, manufacturer, trade name and expiry date: not reported) for an unknown indication. On the same day, the patient was administered non-company suspect drug ceftriaxone (route of administration: intramuscular, anatomical location, dose, batch number, manufacturer, trade name and expiry date: not reported) for an unknown indication. On the same day, 2 minutes after vaccination, the patient experienced respiratory failure and died. The autopsy was performed and the laboratory tests revealed an increased serum tryptase level. The documented cause of death was reported as anaphylactic reaction (causality: related). The reporter assessed the case as serious (death).; Reporter''s Comments: A 42-year-old, female patient with medical history/concurrent condition (asthma, hereditary onychoosteodysplasia and was allergic to penicillin, quinolones and naproxen) experienced fatal respiratory failure, 2 minutes after administration of INN Flu Vaccine. The reported cause of death was anaphylactic reaction. The case meets level 2 of Brighton Collaboration criteria of diagnostic certainty for anaphylactic reaction. Considering the plausible temporal relationship between vaccination and reported fatal events (anaphylactic reaction and respiratory failure) and lack of alternative more plausible causes, the company conservatively assessed the events as possibly related to suspect vaccine. However, multiple drug allergies especially and co-administered ceftriaxone (non company suspect) confound this case. The company assessed the events respiratory failure and anaphylactic reaction as serious (medically significant).; Reported Cause(s) of Death: Anaphylactic reaction.


VAERS ID: 804322 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Autopsy, Death, Respiratory tract oedema, Tryptase increased, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Depression
Allergies:
Diagnostic Lab Data: Test Name: serum tryptase level; Result Unstructured Data: Increased
CDC Split Type: USSEQIRUS201902087

Write-up: This is a literature case, initially received on 19-Feb-2019, concerning a 43-year-old, adult female patient. The study describes the reports of anaphylaxis after vaccination reported to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. A descriptive analysis, including history of hypersensitivity (anaphylaxis, respiratory allergies, and drug allergies) and vaccines given were performed. The patient''s historical condition included depression and current condition included: hypertension. Patient did not have hypersensitivities. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, anatomical location, dose, route of administration, batch number, manufacturer, trade name and expiry date: not reported) for an unknown indication. The following morning, after vaccination, patient was found dead. On autopsy, the body was noted to have patches of urticaria and airway swelling. The laboratory tests revealed an increased serum tryptase level. The documented cause of death was anaphylactic reaction (causality: related). The reporter assessed the case as serious (death). The author concluded that anaphylaxis of severe or life-threatening severity was very uncommon but could occur even among the persons without hypersensitivity. Most persons recovered fully with treatment, but serious complications, including possibility of death is a rare event. This case is cross-linked to the original case: 201902085 due to the same reporter.; Reporter''s Comments: A 43-year-old, female patient with medical history (depression and hypertension) was found dead, 1 day after administration of INN Flu Vaccine. The autopsy reported patches of urticaria, airway swelling and the cause of death as anaphylactic reaction. The case meets level 1 of Brighton Collaboration criteria of diagnostic certainty for anaphylactic reaction. Considering the plausible temporal relationship between vaccination and reported fatal event (anaphylactic reaction) and lack of any underlying conditions or alternative more plausible causes, the company assessed the events as possibly related to suspect vaccine. The company assessed the event anaphylactic reaction as serious (medically significant).; Reported Cause(s) of Death: Anaphylactic reaction.


VAERS ID: 804323 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Asthma, Autopsy, Cardio-respiratory arrest, Death, Wheezing
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Hypersensitivity (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: Allergy NOS; Asthma; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic headaches; Gout
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSEQIRUS201902088

Write-up: This is a literature case, initially received on 19-Feb-2019, concerning a 46-year-old, adult, male patient. The study describes the reports of anaphylaxis after vaccination reported to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. A descriptive analysis, including history of hypersensitivity (anaphylaxis, respiratory allergies, and drug allergies) and vaccines given were performed. The patient''s historical conditions included gout, chronic headaches and current conditions included hypertension, asthma and unspecified allergies (since unspecified dates). On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, anatomical location, dose, route of administration, batch number, manufacturer, trade name and expiry date: not reported) for an unknown indication. On an unspecified day, after the vaccination, the patient developed wheezing with subsequent cardiopulmonary arrest. Autopsy was performed, and the cause of death was acute reported as asthmatic bronchitis. The reporter assessed the case as serious (death). This case was linked to 201902085 due to same reporter.; Reporter''s Comments: A 46-year-old, male patient with current conditions (hypertension and asthma and unspecified allergies) developed wheezing with subsequent fatal cardiopulmonary arrest, on an unspecified day after administration of INN Flu Vaccine. The autopsy reported the cause of death as asthmatic bronchitis. The case lacks information important for the causality assessment, such as onset latency between the vaccination and reported events, concurrent medical condition and investigations to provide alternate aetiologies, and vaccination details, the company assessed the causality as unassessable. The case will be reassessed upon receipt of follow-up information.; Reported Cause(s) of Death: Acute asthmatic bronchitis.


VAERS ID: 804324 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSEQIRUS201902089

Write-up: This is a serious literature case, initially received on 19-Feb-2019, concerning a 65-year-old, elderly male patient. The study describes the reports of anaphylaxis after vaccination reported to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. A descriptive analysis, including history of hypersensitivity (anaphylaxis, respiratory allergies, and drug allergies) and vaccines given were performed. All serious reports and all nonserious reports with available medical records to determine if they met the Brighton Collaboration case definition for anaphylaxis or received a physician''s diagnosis were reviewed. The patient had no historical condition. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, anatomical location, dose, route of administration, batch number, manufacturer, trade name and expiry date: not reported) for an unknown indication. On the same day, 15 minutes after vaccination, the patient experienced airway swelling and cardiopulmonary arrest. Autopsy was performed, and the cause of death was reported as anaphylactic shock. The reporter assessed this case as serious (death).; Reporter''s Comments: A 65-year-old, male patient developed airway swelling and subsequent fatal cardiopulmonary arrest, 15 minutes after administration of INN Flu Vaccine. The autopsy reported the cause of death as anaphylactic shock. Considering the plausible temporal relationship between vaccination and reported fatal events and lack of any underlying conditions or alternative more plausible causes, the company assessed the events as possibly related to suspect vaccine. The company assessed the event ''anaphylactic shock'' as serious (medically significant).; Reported Cause(s) of Death: Anaphylactic shock.


VAERS ID: 804325 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Autopsy, Death, Sjogren's syndrome
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Lacrimal disorders (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSEQIRUS201902094

Write-up: This is a literature case, initially received on 19-Feb-2019, concerning a 75-year-old, elderly male patient. This is a review of safety profile of aIIV3 vaccine by analysing the reports of aIIV3 submitted from 01-Jul-2016 through 30-Jun-2018 to the vaccine adverse event reporting system (VAERS). On an unspecified date, the patient was administered FLUAD (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose, route of administration, anatomical location, batch number, trade name, manufacturer and expiry date: not reported] for an unknown indication. On an unspecified date, after vaccination, the patient died due to Sjogren''s syndrome. Autopsy was performed and the cause of death was reported as Sjogren''s syndrome. The reporter assessed this case as serious (death).; Reporter''s Comments: A 75-year-old, male patient developed fatal Sjogren''s syndrome, on an unspecified day after administration of FLUAD (TIV) Vaccine. The case lacks information important for the causality assessment, such as onset latency between the vaccination and reported event, vaccination details, concurrent medical conditions and investigations to provide alternate aetiologies, the causal role of suspect vaccine was assessed as unassessable. The case will be reassessed upon receipt of follow-up information.; Reported Cause(s) of Death: Sjogren''s syndrome.


VAERS ID: 804526 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: South Carolina  
Vaccinated:2008-06-18
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-03-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. 1822U / 1 RA / SC

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Facial paralysis, Herpes zoster meningoencephalitis, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hearing impairment (broad), Hypoglycaemia (broad), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-04-08
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Routine health maintenance
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131903USA000643

Write-up: Information has been received on 01-MAR-2019 regarding a case in litigation from a lawyer and the representative of the estate concerning a deceased male patient of unknown age. No information was received regarding the patient''s past medical history, concurrent conditions, or concomitant medication. On an unknown date, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose the prevention of shingles. On an unknown date, after receiving the ZOSTAVAX, the patient developed tremors, Bell''s palsy, and varicella encephalitis. On 08-APR-2017, the patient succumbed to his injuries and passed away. As a result, the patient suffered sustained severe and fatal personal injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, and loss of enjoyment of life. As a direct result of ZOSTAVAX, the patient incurred medical expenses, and other economic harm. As a direct and proximate result of ZOSTAVAX, the patient''s symptoms and diagnoses have resulted in physical limitations not present prior to ZOSTAVAX. As a result patient sustained severe and permanent personal injuries. Further, as a tragic consequence, 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 outcome of the events was considered fatal. It was unknown if autopsy was done. Upon internal review, Bell''s palsy, and varicella encephalitis were determined medically significant. Tremors, Bell''s palsy and varicella encephalitis were considered disabling. Additional information has been requested.; Reported Cause(s) of Death: Bell''s palsy; tremors; varicella encephalitis.


VAERS ID: 805374 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Texas  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-03-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Acute left ventricular failure, Acute respiratory failure, Cardiac failure congestive, Death, Dyspnoea, Intensive care, Myocardial infarction, Pneumonia
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-03-27
Permanent Disability? Yes
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: Routine health maintenance
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131903USA003709

Write-up: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding the patient''s medical history, concurrent conditions, or concomitant medications. On or around 02-MAY-2016, the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (date not further specified), the patient suffered acute respiratory failure, acute systolic congestive heart failure, shortness of breath, and pneumonia requiring admission into an intensive care unit. The patient was diagnosed with myocardial infarction, acute respiratory failure, acute systolic heart failure, and pneumonia. As a direct and proximate result of these injuries, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered significant medical expenses, severe pain and suffering, other damages, and ultimately death on 27-MAR-2017. As a direct and proximate result of ZOSTAVAX, the patient suffered serous and dangerous side effects, including death, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The cause of death was considered to be myocardial infarction, acute respiratory failure, acute systolic heart failure, and pneumonia. Causality assessment was related. Upon internal review, myocardial infarction, acute respiratory failure, acute systolic heart failure, and pneumonia were considered to be medically significant events. The lawyer considered myocardial infarction, acute respiratory failure, acute systolic heart failure, and pneumonia to be disabling. Additional information has been requested.; Reported Cause(s) of Death: acute respiratory failure; myocardial infarction; pneumonia; acute systolic heart failure.


VAERS ID: 806343 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-03-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131903USA007463

Write-up: This spontaneous report was received from a pharmacist via company representative concerning to a 21-year-old female patient. The patient''s concurrent conditions, medical history, drug reaction or allergies and concomitant medications were not reported. On an unspecified day in 2007 (reported as 12 years ago), the patient received a dose of GARDASIL (dose number, route of administration, lot# and expiration date were not reported). The pharmacist stated that he heard about a court case where the female patient died from arrhythmia after the administration of GARDASIL. It was unknown if an autopsy was performed. No additional information was provided. The causal relationship between de patient''s death and GARDASIL was unknown.; Reported Cause(s) of Death: developed a heart arrhythmia that caused death.


VAERS ID: 806371 (history)  
Form: Version 2.0  
Age: 0.92  
Sex: Female  
Location: Arkansas  
Vaccinated:2019-02-07
Onset:2019-02-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-03-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK LL / SYR
FLU4: INFLUENZA (SEASONAL) (AFLURIA QUADRIVALENT) / SEQIRUS, INC. - / UNK RL / SYR
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK RL / SYR
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK RL / SYR
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / UNK LL / SYR
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LL / SYR

Administered by: Private       Purchased by: ?
Symptoms: Blood test, Death, Eyelid function disorder, Febrile convulsion, Pyrexia, Urine analysis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-03-02
   Days after onset: 23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol for pain.
Current Illness: None
Preexisting Conditions: None.
Allergies: Latex
Diagnostic Lab Data: Blood and urine testing.
CDC Split Type:

Write-up: 4 hours after my daughter got her shots her fever wouldn''t go down. At 11pm that night she begain to have complex febrial seizures. She had 3 that night. After coming home she wasn''t the same. One of her eyes didn''t open as much as it should have and she was slower. Almost a month later she died in her sleep because of another febrial seizure.


VAERS ID: 806809 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: Tennessee  
Vaccinated:2019-01-08
Onset:2019-01-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2019-03-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS KZ4TM / 1 LL / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UI921AAA / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH W51943 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK MO / PO

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, Death, Decreased appetite, Infantile spitting up, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Neonatal disorders (narrow), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-01-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Gripe water and infant Tylenol was given right before vaccine.
Current Illness: None that we were aware of.
Preexisting Conditions:
Allergies: None that we were aware of.
Diagnostic Lab Data: An autopsy is being done at the moment but so far nothing has been found. I am doing the report to see if any of the vaccines had anything to do with her death.
CDC Split Type:

Write-up: She began spitting up more than normal and would not eat like she normally would. She ran no fever though. On the 10th of January she stopped breathing in her sleep. I am not sure that the vaccines were the cause of her death.


VAERS ID: 807604 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-03-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (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: US0095075131903USA011781

Write-up: Information has been received from a pharmacist and the patient''s husband referring to a female patient of unknown age. The patient''s medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as Pneumococcal vaccine) (dose, route, lot # and expiration date unknown) for prophylaxis. On an unknown date, the patient died after getting the vaccine. The cause of death was not reported. It was unknown if the autopsy was done. The causality between the event and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not reported. Reported Cause(s) of Death: Cause of Death: Unknown by reporter.


VAERS ID: 807785 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: New Hampshire  
Vaccinated:2019-03-13
Onset:2019-03-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / 1 - / -
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 - / -
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, Blood test, Chest X-ray normal, Choking, Condition aggravated, Death, Influenza virus test negative, Malaise, Pyrexia, Retching, Sepsis, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2019-03-18
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: TYLENOL
Current Illness: He was sick with a bad cough we were all going through an upper respiratory infection and I know he had it but the nurse practitioner wouldn''t listen to me. He had a seizure a month before that due to the gas medicine the Dr prescribed
Preexisting Conditions: He had acid reflux and at the time of his vaccines he was sick with a bad cough and a fever and he also had a seizure due to the gas medicine and the Dr said it was just a reaction I called 911 when he had the seizure and by the time they had gotten here he was a sleeping baby I was going every week to his Drs for weight checks because he was born at 6 lbs 10 ounces he left the hospital at 5 lbs 15 ounces so every week we were at the hospital for weight checks n trying to find formula that worked with him
Allergies: None
Diagnostic Lab Data: They haven''t done test related to the vaccines I need to call a lawyer because they did an autopsy and now I''ve to file so they''ll do the proper testing
CDC Split Type:

Write-up: My son was sick when he got his vaccines. He was only 2 months old. He had a fever when they gave it to him, they were only going to do one and somehow she thought it be a good idea to do three more. This was at his two month old well check up, but I was also bringing him there because he had a horrible cough and was sick. So after the vaccines he just got sicker and sicker throwing up fever Sunday 03/17/2019 I ended up at Hospital Emergency Room and they did nothing for him. They kept us there for 5 hrs and gave him ZOFRAN and another shot an antibiotic shot for Sepsis. They ran blood work, it wasn''t the flu. They did an X-ray it wasn''t pneumonia. The Dr ordered an IV but since the hospital didn''t have small enough needles didn''t do anything for him; didn''t send us to somewhere to treat my baby. He was dry heaving choking on his foam and saliva, it was awful my baby died the next morning when I got up they told me he would be fine this is so wrong.


VAERS ID: 808139 (history)  
Form: Version 2.0  
Age: 1.33  
Sex: Male  
Location: Ohio  
Vaccinated:2018-12-11
Onset:2019-01-03
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2019-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS T79X3 / 4 LL / IM
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS F4T2K / 1 RL / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS 4337E / 4 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH W33489 / 4 RL / IM

Administered by: Private       Purchased by: ?
Symptoms: 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: 2019-01-03
   Days after onset: 0
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: My Son went to the doctor for shots on December 11 2018. He got DTP/DTap /HIB/PCV/and Influenza (flu shot). This was his first time getting the flu shot. Research says it takes 2 weeks for the flu shot to start to take effect. Approx 3 weeks later we found our Son unresponsive on 1/3/2019.


VAERS ID: 808219 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Oklahoma  
Vaccinated:2018-09-24
Onset:2018-09-28
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2019-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C5461AA / 1 LL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS BJ54A / UNK LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH W11304 / 1 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS 44B4M / 1 MO / PO

Administered by: Private       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: 2018-09-28
   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:
Current Illness: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data: Seen at hospital, patient passed away
CDC Split Type:

Write-up: Spoke with mother 04/01/2019 called clinic stated patient had a cardiac arrest on 09/28/2018 and would like a Vaers completed.


VAERS ID: 808308 (history)  
Form: Version 1.0  
Age: 55.0  
Sex: Female  
Location: Virginia  
Vaccinated:2019-02-15
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-04-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 7L355 / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Injection site mass
SMQs:, Extravasation events (injections, infusions and implants) (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: No
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: No adverse event or signs happened at the time of administration but a month later patient''s boyfriend called and reported death of patient because of lump under the skin at site of injection.


VAERS ID: 808361 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-04-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Meningitis, Sudden death, Vaccination failure
SMQs:, Torsade de pointes/QT prolongation (broad), Lack of efficacy/effect (narrow), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious meningitis (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2019SA091448

Write-up: Initial information received on 29-Mar-2019 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional by phone. This case involves a 19 years old female patient who died suddenly from meningitis, while received vaccine MENINGOCOCCAL VACCINE. The patient''s past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL VACCINE produced by unknown manufacturer (lot number, expiry date, dose, dose in series, route and site of administration were not reported). On an unknown date, the patient developed a serious meningitis (meningitis) (reported as serogroup A), following the administration of MENINGOCOCCAL VACCINE. This event was leading to death. It was reported that the patient had been given the meningococcal vaccine but still contracted the deadly disease. It was also a case of suspected vaccination failure. No lab data was reported. Final diagnosis was (fatal) died suddenly from meningitis. It was not reported if the patient received a corrective treatment. The Patient died on an unknown date from meningitis. It was unknown if an autopsy was done. Documents held by the sender: None.; Sender''s Comments: This case corresponds to a poorly documented consumer report. Patient reportedly had received meningococcal vaccine for which the name and manufacturer were unknown. The patient died due to meningitis (reported as serogroup A) an unspecified amount of time after vaccination. Clinical details- such as latency from vaccination, medical history, clinical details surrounding the reported event, vaccination details, the name of the specific vaccine administered, and diagnostic work-up- are lacking to allow adequate medical assessment.; Reported Cause(s) of Death: Meningitis.


VAERS ID: 808527 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2019-03-07
Submitted: 0000-00-00
Entered: 2019-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-03-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2019GS

Write-up: This case was reported by a nurse via patient support programs and described the occurrence of death in a 61-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX.5 ml. On 7th March 2019, unknown after receiving SHINGRIX, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The patient died on 7th March 2019. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death to be related to SHINGRIX. Additional details were reported as follows: This case received from the healthcare provider via the vaccine patient assistance program. The age at vaccination was not reported. The patient passed away in hospice care, cause was unknown. The reporter declined consent for follow up.; Reported Cause(s) of Death: Death NOS.


VAERS ID: 809231 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: California  
Vaccinated:2015-01-27
Onset:2015-01-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4704AB-C4747AA / 1 LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. J013394 / UNK LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J23865 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. K007912 / 1 MO / PO

Administered by: Private       Purchased by: ?
Symptoms: Hypersomnia, Poor feeding infant
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-01-30
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Runny nose
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: After vaccines were given, sleeping more than normal, the next night was frustrated at the breast.


VAERS ID: 809522 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 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: US0095075131904USA005236

Write-up: This initial spontaneous report was received from a licensed practical nurse (LPN) via a Company representative and refers to a 21 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. The patient died in 2008 after receiving her third dose of GARDASIL (lot # not provided) (also reported that the patient died an unspecified time after receiving the third dose in 2008). Dates of the three doses were not provided. Cause of death was not specified. The LPN said that patients at the office were asking questions about the event/incident because there have been multiple online posts being made about the event (also reported as reports of the death are being circulated on the internet). The Company employee stated that the "lawsuit just got settled" so that is why people were asking about it again. The LPN asked the Company employee what the Company had to say about the incident. Causality was not specified. Upon internal review, death was considered to be medically significant. The LPN did not want to be contacted for follow-up.; Reported Cause(s) of Death: died.


VAERS ID: 809616 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-04-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic shock, Cardio-respiratory arrest, Death, Dyspnoea, Immediate post-injection reaction, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Drug hypersensitivity; Hypertension; Renal cell carcinoma
Preexisting Conditions: Medical History/Concurrent Conditions: Anaphylaxis
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131904USA004603

Write-up: Information has been received from the authors of the article and refers to a 50 year old male patient. The patient''s past medical history included past anaphylaxis, allergies to angiotensin-converting enzyme inhibitors (unspecified), hypertension, and renal cell carcinoma. The patient''s concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of pneumococcal polysaccharide vaccine (manufacturer unknown) for prophylaxis (dose number and route were unspecified). Immediately after vaccination, the patient experienced respiratory difficulty, seizure, and cardiorespiratory arrest. Subsequently, the patient died. The cause of death was reported as anaphylactic shock. It was unknown if an autopsy was performed. The authors considered anaphylactic shock to be related to pneumococcal polysaccharide vaccine (manufacturer unknown).


VAERS ID: 809662 (history)  
Form: Version 2.0  
Age: 1.0  
Sex: Male  
Location: Nebraska  
Vaccinated:2016-04-11
Onset:2016-04-21
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2019-04-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 1 LG / SYR
VARCEL: VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

Administered by: Private       Purchased by: ?
Symptoms: Brain death, Brain injury, Brain scan abnormal, Crying, Dark circles under eyes, Death, Diarrhoea, Hypophagia, Hypotonia, Pyrexia, Sepsis, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-04-24
   Days after onset: 3
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
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: I don''t have access to his exact record anymore. I know they did a scan of his brain which showed he was brain dead. He was declared deceased on 4/24/16
CDC Split Type:

Write-up: Woke up with a fever of 101, crying, diarrhea. Gave him a cool bath after changing him to get him clean/cool him down. He could not grab the water from the faucet, he missed it as if his hand wasn''t going where his brain told to. Tried to give him water, he wouldn''t drink any. He snuggled back to sleep, we transferred him to his crib. At 9am, he threw up in his sleep without even stirring, eyes had deep dark circles. We picked him up and he was limp. We took him to the ER where they said had severe brain damage. They treated him for sepsis.


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