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From the 4/30/2021 release of VAERS data:

Found 1,936 cases where Vaccine is FLU(H1N1) or FLU3 or FLU4 or FLUA3 or FLUA4 or FLUC3 or FLUC4 or FLUN(H1N1) or FLUN3 or FLUN4 or FLUR3 or FLUR4 or FLUX or FLUX(H1N1) or H5N1 and Patient Died



Case Details (Reverse Sorted by Onset Date)

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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: 788301 (history)  
Form: Version 1.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2018-11-06
Onset:2018-11-06
   Days after vaccination:0
Submitted: 2018-11-23
   Days after onset:17
Entered: 2018-11-27
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 1030A1A / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Dyspnoea, Heart rate increased, Hyperpyrexia, Oxygen saturation decreased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-11-07
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown to Ongoing, Bedridden
Preexisting Conditions: Unknown date, Decubitus ulcer, Sacral decubitus injury; Unknown date, Senile dementia, Patient bedridden
Allergies:
Diagnostic Lab Data: On 07-Nov-2018, the blood pressure was performed and the result was not reported. 07-NOV-2018, Heart rate, 130, elevated; 07-NOV-2018, Oxygen saturation, 70%, depressed
CDC Split Type: 201805593

Write-up: This is a spontaneous case, reported by physician to regulatory authority (regulatory reference number: IT-MINISAL02-510139) and initially retrieved (combinedly processed with follow-up received on 19-Nov-2018) on 16-Nov-2018, concerning a 89-year-old, elderly female patient. The patient''s historical condition included senile dementia and sacral decubitus injury (on an unspecified date) and the current condition included bedridden (reported as medical history) (since an unspecified date). On 06-Nov-2018, the patient was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, batch number: 1030A1A, anatomical location and expiry date: not reported). On the same day, after vaccination, the patient experienced hyperpyrexia (reported as appearance of fever). On 07-Nov-2018, the patient was taken to emergency room (ER) with equipment. The patient had gasping but not intubated through the will of her family. The patient''s general conditions got worsen. The patient''s oxygen (O2) saturation showed 70 percent (normal range not provided), heart rate showed 130 (normal range not provided) and blood pressure was performed for which result was not reported. On the same day (07-Nov-2018), the patient died. The cause of death was unknown and the autopsy was not performed. The outcome of the event hyperpyrexia was fatal, and for the events (oxygen saturation decreased and heart rate increased) was unknown. The outcome of the events reduced general condition and gasping was not reported. The reporter assessed the case as serious (death). Case Comment: An 89-year-old bedridden female patient with history of senile dementia, sacral decubitus injury experienced hyperpyrexia on the same day after receipt of FLUAD (TIV). Considering the plausible temporal relationship between vaccination to hyperpyrexia and plausible biological mechanism, the company assessed the causality for hyperpyrexia as related to suspect vaccine. On the next day the patient was taken to ER with dyspnea, decreased oxygen saturation, increased heart rate and worsened general condition. The events decreased oxygen saturation, increased heart rate and worsened general condition were considered as not related to suspect vaccine as they can be explained by concurrent dyspnoea and progressive age of the patient. The causality for the event dyspnoea (gasping) cannot be assessed in relation to suspect vaccine, as beside the progressive age of the patient, minimal details regarding diagnostic investigations, physical findings and medical history are provided, which can be alternate explanation for the event. The patient had a fatal outcome, however details regarding cause of death, autopsy are unavailable. Further assessment will be done upon receipt of new information.


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: 781658 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: New Mexico  
Vaccinated:2018-10-17
Onset:2018-10-25
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2018-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS ZA72G / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: severe anemia, was being worked up
Preexisting Conditions: none
Allergies: unknown
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Sudden death. Highly unlikely to be related, but I feel it needs to be reported. Agency investigating death, and were also advised.


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: 784764 (history)  
Form: Version 1.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2018-10-23
Onset:2018-10-24
   Days after vaccination:1
Submitted: 2018-11-06
   Days after onset:13
Entered: 2018-11-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 251225C1A / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Myocardial ischaemia
SMQs:, Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-24
   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:
Current Illness:
Preexisting Conditions: Unknown date, Myocardial infarcation acute
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201805125

Write-up: This spontaneous case, reported by other health professional (physician) to Regulatory Authority and initially retrieved on 02-Nov-2018 by Seqirus from Regulatory Authority (regulatory reference number: IT-MINISAL02-507702), concerns a 91-year-old, elderly, female patient. The patient''s historical condition included IMA (myocardial infarction acute). On 23-Oct-2018, the patient was administered FLUAD (TIV) [dose: 0.5 ml (1 DF), route of administration: intramuscular, batch number: 251225C1A, anatomical location and expiry date: not reported]. On an unspecified date in Oct-2018, the patient experienced ischemic heart disease. On 24-Oct-2018, one day after vaccination, the patient died. The suspected cause of death was reported as ischemic heart disease. It was unknown if autopsy was performed or not. The reporter assessed the case as serious (death). Case Comment: A 91-year-old female patient with previous history of acute myocardial infarction died, 1 day after receipt of FLUAD TIV vaccine. The cause of death was suspected as ischemic heart disease (IHD), an unspecified date after vaccination. The event IHD can be alternately explained by previous history of acute MI with possible existing myocardial ischaemia and the event death can be alternately explained by IHD, rather than the suspect vaccine. Also, there is no known biological plausibility between influenza vaccination and event IHD. Hence, the company assessed the causality of the events as not related. Progressive age of the patient is considered as risk/confounding factor.


VAERS ID: 813610 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: New York  
Vaccinated:2018-10-19
Onset:2018-10-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / UNK UN / UN
FLU4: INFLUENZA (SEASONAL) (AFLURIA QUADRIVALENT) / SEQIRUS, INC. - / UNK UN / UN
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, Death, Myocardial infarction, Myocarditis, Nausea
SMQs:, Acute pancreatitis (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-21
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: aspirin; lisinopril; LOPRESSOR; NORCO; MIRALAX; XANAX
Current Illness: CHF and Cardiomyopathy
Preexisting Conditions: None known
Allergies: COREG; ketorolac; ROBAXIN; SKELAXIN; tramadol
Diagnostic Lab Data: Autopsy done 10/22/2018. Marked changes to the heart muscle suggests of remote myocarditis
CDC Split Type:

Write-up: Became nauseous all day Saturday and Sunday morning, had heart attack Sunday in morning


VAERS ID: 856929 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Female  
Location: Arizona  
Vaccinated:2018-10-17
Onset:2018-10-20
   Days after vaccination:3
Submitted: 2020-01-16
   Days after onset:453
Entered: 2020-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC4: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT) / SEQIRUS, INC. 250783 / UNK - / -
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH X13847 / UNK - / -

Administered by: Unknown       Purchased by: Private
Symptoms: Asthenia, Death, Guillain-Barre syndrome, Laboratory test, Paralysis
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-12-22
   Days after onset: 63
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Hospital adm 11.09.18 - extensive labs,etc through date of death
CDC Split Type:

Write-up: Initial weakness, paralysis of extremities, Guilian Barre Syndrome with medical complications, hospital admission commencing 11.09.18 until death, 12.22.18.


VAERS ID: 792011 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Ohio  
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: 786869 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2018-10-19
Onset:2018-10-19
   Days after vaccination:0
Submitted: 2018-11-16
   Days after onset:28
Entered: 2018-11-18
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 1030C1A / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Wheelchair user; COPD
Preexisting Conditions: Flu jab, product used for unknown indication, previously the patient had flu jab for many years
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201805357

Write-up: This spontaneous case, initially received from a pharmacist on 12-Nov-2018, concerning an 81-year-old, elderly, female patient. The patient received flu jab for many years in past. The patient''s current condition included chronic obstructive pulmonary disease (COPD) (since an unspecified date). It was reported that, the patient brought by someone on a wheelchair for a flu jab. The patient had been trying to administer a flu jab but her surgery (unspecified) could not offer her until 31-Oct-2018 (as reported). On 19-Oct-2018, the patient was administered FLUAD (TIV) [batch number: 1030C1A, dose, route of administration, anatomical location and expiry date: not reported]. The patient was given all advice if she felt unwell and also patient information leaflet (PIL) was given. The patient waited in pharmacy to ensure no adverse effects. It was reported the following morning that, the patient died in her sleep in previous night. The cause of death and autopsy results were unknown. The reporter assessed the case as serious (death). Case Comment: A 81-year-old female patient with current condition of chronic obstructive pulmonary disease (COPD), was reported to have died in sleep the same night of vaccination with FLUAD (TIV). Considering the minimal information regarding medical history, signs/symptoms leading to death, cause of death and autopsy reports, the causal role of suspect vaccine cannot be assessed. Hence, the company assessed the causality as unassessable.


VAERS ID: 783606 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Male  
Location: Unknown  
Vaccinated:2018-10-15
Onset:2018-10-16
   Days after vaccination:1
Submitted: 2018-10-23
   Days after onset:7
Entered: 2018-11-02
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (AFLURIA QUADRIVALENT) / SEQIRUS, INC. YF39608 / 2 RA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-16
   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: None
Preexisting Conditions: Vitamin D deficiency; Constipation; Anemia; Neoplasm of right upper lobe of lung; Unintentional weight loss; Adenomatous polyp of colon; Gastro-esophageal reflux 1/19/16 EGD reflux esophagitis, gastric intestinal metaplasia. F/U January 2017; Seen in hospital anticoagulation clinic risk assessment completed 2/3/17; Atrial flutter goal INR 2.0 to 3.0; COPD - chronic obstructive pulmonary disease; Benign prostatic hypertrophy with outflow obstruction; Allergic rhinitis; Posttraumatic stress disorder; Insomnia related to PTSD; FH: Bowel cancer brother diagnosed colon cancer age 64, died age 65 Fpr colonoscopy 4/13/2004 1/19/16 colonoscopy. Multiple adenomas. Poor prep future care consult ordered for F/U April 2016. 4/19/16 colonoscopy. No polyps. F/U April 2021; HLD - hyperlipidemia; Chronic low back pain multilevel spinal canal stenosis; Coronary artery disease; History of coronary artery bypass grafting; Benign essential hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received immunization on 10/15/18 and passed away the next morning on 10/16/18. He had multiple other comorbidities, but death was sudden.


VAERS ID: 783320 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2018-10-11
Onset:2018-10-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2018-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / IM

Administered by: Other       Purchased by: ?
Symptoms: Death, Myocarditis
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-14
   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: KRPFIZERINC2018436209

Write-up: This is a spontaneous report from a contactable physician via Pfizer sales representative via Corporation, manufacturer control number 2018-10017, license party for PREVENAR 13. A 73-year-old patient was administered PREVENAR 13 intramuscular at single dose and influenza vaccine (3 valent) both on 11Oct2018 for immunization. Patient medical history and concomitant medications were not reported. On an unknown date in Oct2018, the patient experienced myocarditis, due to which died on Oct2018. It was unknown if an autopsy was performed. The patient went to a university hospital on 14Oct2018 and was confirmed as myocarditis. Since it was confirmed that the patient was administered 3-valent influenza vaccine and pneumococcal 13-val conjugate vaccine, the university hospital reported it to local government health center, who called the reporting physician, so the reporting physician got to know it. There was no special adverse events after the vaccines administrations. Follow-up (23Oct2018): This is a spontaneous report from a contactable physician via Corporation, manufacturer control number 2018-10017, license party for PREVENAR 13. The patient was administered PREVENAR 13 and influenza vaccine (3 valent) on 11Oct2018 together. About one week after the administration, local government health center informed the physician that the patient died due to myocarditis. The government health center told that the patient had been administered vaccines, so a related investigation might be conducted to the physician''s office. No follow-up attempts are possible; information about batch number cannot be obtained. Sender''s Comments: Fatal myocarditis occurred 3 days following the vaccination with both PREVENAR 13 and influenza vaccine (3 valent). There is no plausible mechanism to implicate PREVENAR 13 to the development of myocarditis. Given the patient''s old age, the underlying medical conditions most likely provided explanations for the onset of the event. More information especially medical history, concomitant medications and concurrent illnesses such as the predisposing factors including viral/bacterial infections are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Reported Cause(s) of Death: myocarditis.


VAERS ID: 781140 (history)  
Form: Version 1.0  
Age: 85.0  
Sex: Female  
Location: Ohio  
Vaccinated:2018-09-06
Onset:2018-10-13
   Days after vaccination:37
Submitted: 2018-10-23
   Days after onset:10
Entered: 2018-10-23
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 / IM

Administered by: Other       Purchased by: Unknown
Symptoms: Erythema, Peripheral swelling, Sepsis
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: 2018-10-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Redness, swelling of arm, sepsis.


VAERS ID: 780527 (history)  
Form: Version 1.0  
Age: 47.0  
Sex: Male  
Location: Florida  
Vaccinated:2018-10-11
Onset:2018-10-12
   Days after vaccination:1
Submitted: 2018-10-19
   Days after onset:7
Entered: 2018-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (AFLURIA QUADRIVALENT) / SEQIRUS, INC. YF38707 / 2 LA / SYR

Administered by: Other       Purchased by: Other
Symptoms: Acute respiratory distress syndrome, Alanine aminotransferase increased, Aspartate aminotransferase increased, Asthenia, Bilirubin conjugated increased, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin increased, Blood lactate dehydrogenase increased, Blood urine present, Bradycardia, Cardio-respiratory arrest, Chromaturia, Death, Diarrhoea, Fatigue, Haematuria, Haemoglobin decreased, Haptoglobin abnormal, Hyperbilirubinaemia, Hypotension, Life support, Malaise, Nausea, Packed red blood cell transfusion, Protein total decreased, Pyrexia, Resuscitation, Specific gravity urine normal, Urine ketone body absent, Urobilinogen urine increased, Vomiting, White blood cell count, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Anaphylactic reaction (broad), Acute pancreatitis (narrow), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Myelodysplastic syndrome (broad), Noninfectious diarrhoea (narrow), Tubulointerstitial diseases (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-14
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: No known allergies
Allergies:
Diagnostic Lab Data: 10/12/2018 04:25 Urine, UrColor, Red; Appear, Clear; USpGrav, 1.023; Urobil, 4; UrBlood, Large; UrBili, Neg; UKetone, Neg; 10/14/2018 23:00 PLASM, Protein, 6.0; Albumi, 3.5; TotBili, 15.1; DirBili, 49; ALT, 88; AST, 52; 10/14/2018 11:30 PLASM, Protein, 7.0; Albumi, 3.9; TotBili, 23.0; DirBili, 42; ALT, 84; AST, 66; 10/14/2018 06:30 SERUM, 6.5; 10/13/2018 23:35 PLASM, Protein, 6.8; Albumi, 3.8; TotBili, 19.5; DirBili, 32; ALT, 68; AST, 65; 10/12/2018 06:00 PLASM, Protein, 6.8; Albumi, 3.8; TotBili, 15.5; DirBili, 1.2; ALT, 29; AST, 46; AlkPhos, 81; 04/12/2018 00:40 PLASM, Protein, 7.1; Albumi, 4.0; TotBili, 0.6; DirBili, 0.2; ALT, 29; AST, 23; AlkPhos, 69
CDC Split Type:

Write-up: A 47 year old male with history of HTN, obesity, hyperlipidemia, obstructive sleep apnea, depression and anxiety, presents to ER on 10/12/18 with chief complaints of fatigue, weakness and hematuria x 1 day. Pt reported symptoms began after getting the flu shot the day prior. 1 episode of diarrhea in ED but none at home. Returned from 5 week trip, about 3 weeks prior to presentation. He received a flu vaccine immediately prior to the onset of his Sx and associates his Sx with this event. He reported that following said flu vaccination, he began to feel ill with fatigue and nausea/vomiting. No other medication changes. GI was consulted and felt that his unconjugated hyperbilirubinemia was not due to biliary causes. His hemolysis labs (haptoglobin and LDH) returned positive. Heme/onc was consulted. His Hbg downtrended 12-$g 7.7-$g 4.9, and he was noted to spike fever on 10/14 prior to his significantly reduced Hb at 12:30 am. He received 2UPRBC with f/u Hb to 6.9. WBC trended up from 15 (PMN 12)-$g 20.38 (PMN 17.39)-$g 22.5 (PMN 18.93)-$g 25.2 (PMN 55.67)-$g 29.02 (PMN 27.22). Bilirubin total (with indirect predominance throughout): 15.5-$g 19.5-$g 23. Patient initially stabilized with steroids, and determination was made to limit transfusion to keep Hbg greater than 6 to prevent worsening hemolysis. However, at approximately 23:00 10/14/18, patient had acute respiratory distress associated with bradycardia and hypotension, and then suffered cardiopulmonary arrest. He underwent multiple rounds of CPR and ACLS. Patient ultimately expired.


VAERS ID: 783967 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2018-10-10
Onset:2018-10-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2018-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cough, Death, Myocardial infarction, Nasal congestion, Pyrexia, Respiratory tract infection bacterial, Respiratory tract infection viral, Rhinorrhoea, Viral infection
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-21
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dementia (hospitalized in a psychiatric clinic, treatment followed for years but not specified); Hypertension (hospitalized in a psychiatric clinic, treatment followed for years but not specified)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRGLAXOSMITHKLINEGR2018GS

Write-up: This case was reported by a physician via sales rep and described the occurrence of respiratory tract infection viral in a 78-year-old male patient who received Flu Seasonal QIV Dresden (FLUARIX TETRA 2018-2019 season) for prophylaxis. Concurrent medical conditions included dementia (hospitalized in a psychiatric clinic, treatment followed for years but not specified) and hypertension (hospitalized in a psychiatric clinic, treatment followed for years but not specified). On 10th October 2018, the patient received the 1st dose of FLUARIX TETRA 2018-2019 season. On 12th October 2018, 2 days after receiving FLUARIX TETRA 2018-2019 season, the patient experienced respiratory tract infection viral (serious criteria death), runny nose, weakness, cough, nasal congestion and fever. In October 2018, the patient experienced heart attack (serious criteria death and GSK medically significant) and respiratory tract infection bacterial (serious criteria GSK medically significant). The patient was treated with DEPON, AVELOX, normal saline, Inhaler (Nos), medication unknown, Syrup (Nos) and Bronchodilator. On 21st October 2018, the outcome of the respiratory tract infection viral and heart attack were fatal. On an unknown date, the outcome of the respiratory tract infection bacterial was unknown and the outcome of the runny nose, weakness, cough, nasal congestion and fever were not recovered/not resolved. The patient died on 21st October 2018. The reported cause of death was respiratory infection and heart attack. An autopsy was performed. The reporter considered the respiratory tract infection viral and heart attack to be unrelated to FLUARIX TETRA 2018-2019 season. It was unknown if the reporter considered the respiratory tract infection bacterial to be related to FLUARIX TETRA 2018-2019 season. The reporter considered the runny nose, weakness, cough, nasal congestion and fever to be probably related to FLUARIX TETRA 2018-2019 season. Additional information was reported as follows: The patient was not vaccinated with FLUARIX TETRA before. On 12th October 2018, two days after vaccination with FLUARIX, the patient experienced viral infection like disease with symptoms runny nose, weakness, cough, nasal congestion and fever. On 15th October 2018, the patient experienced respiratory infection by ingestion. The patient was treated with DEPON for fever, syrup and inhaler for cough and normal saline for nasal congestion. The patient was also treated with AVELOX and unspecified Bronchodilator, but the patient still died on 21st October 2018. The autopsy report mentioned death cause heart attack and respiratory infection by ingestion. The physician correlated the occurrence of all the adverse events with FLUARIX except heart attack and respiratory infection. On the date of reporting, follow-up information was received from the Medical Department of the company and via another communication with the physician. The follow-up information clarified that the patient had experienced viral respiratory infection in the context to the viral infection like disease that was reported one day before the date of reporting. The respiratory tract infection caused by ingestion was of bacterial type. It was also stated that, regarding all the other adverse event, apart from respiratory infection and heart attack the reporter considered they are all related to FLUARIX TETRA and was not definite as reported before the date of reporting. Since, the patient''s vaccination took place in the context of vaccination of about 100 people within 2 days and therefore the reported considered the possibility of coincidence of vaccination with incubation period of the viral infection, due to the closed community of the clinic. This case was linked with case GR2018GSK196870, reported by the same reporter. Reported Cause(s) of Death: Respiratory infection by ingestion; Heart attack.


VAERS ID: 782046 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: South Carolina  
Vaccinated:2018-09-28
Onset:2018-10-11
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2018-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC4: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT) / SEQIRUS, INC. 252226 / 1 LA / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH W51762 / UNK RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-11
   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: KEPPRA; FAMOTIDINE; BENZONATATE; ONDANSETRON HCL; HYDROCHLOROTHIAZIDE; GABAPENTIN; METOPROLOL SUCC ER; HYDROCODONE-ACETAMINOPHEN; LOSARTAN POTASSIUM; WARFARIN SODIUM; PROAIR HFA; MCG/ACT INHALATION AEROSOL SOLUTION
Current Illness:
Preexisting Conditions: Epilepsy Marfan syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: My husband died after a seizure on October 11, 2018. His heart stopped. He was pronounced dead at Hospital. He had Marfan syndrome and a 4.9 abdominal aneurysm. He had never taken the flu shot since a time several years ago when he ended up getting the flu after taking it. He was due for surgery soon, so he agreed to take it.


VAERS ID: 784357 (history)  
Form: Version 2.0  
Age: 1.25  
Sex: Male  
Location: California  
Vaccinated:2018-10-09
Onset:2018-10-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5169AA / 4 LL / IM
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS Y279A / 1 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UI914AAA / 4 LL / IM

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, Death, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-12
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was found unconscious the morning of 10/12 in the crib. Declared dead shortly after. Autopsy pending.


VAERS ID: 783917 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2018-10-01
Onset:2018-10-09
   Days after vaccination:8
Submitted: 2018-10-29
   Days after onset:20
Entered: 2018-11-04
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 251216C1A / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Levothyroxine sodium; Lansoprazole; ACCRETE D3; Glyceryl trinitrate; LAXIDO; Clopidogrel; Alogliptin; Folic acid; Cassia senna; Metformin; Simvastatin
Current Illness: 2004 Diabetes mellitus;
Preexisting Conditions: 1997 to Unknown, Myocardial infarction; 1998 to Unknown, Coronary artery bypass graft; 2008 to Unknown, Thyroidectomy partial; 2009 to Unknown, Pulmonary fibrosis; 2015 to Unknown, Pneumonia; NOV-2017 to Unknown, Gastrointestinal bleed; APR-2017 to Unknown, Pneumonia; 29-Oct-2018 14:20, Admitted
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201804803

Write-up: This spontaneous case, reported by other health professional to Agency and initially retrieved on 23-Oct-2018 by Seqirus from Agency (regulatory reference number: GB-MHRA-EYC 00187376), concerns an 80-year-old, elderly, female, patient of height 162 cm. The patient''s medical history included myocardial infarction on an unspecified date in 1997, coronary artery bypass on an unspecified date in 1998, thyroidectomy partial on an unspecified date in 2008, pulmonary fibrosis on an unspecified date in 2009, pneumonia on an unspecified date in 2015 and on an unspecified date in Apr-2017, gastrointestinal bleed on an unspecified date in Nov-2017. The patient''s current condition included diabetes mellitus since an unspecified date in 2004. The concomitant medications included Levothyroxine Sodium (100 ug), Lansoprazole (30 mg), ACCRETE D3, Glyceryl Trinitrate, LAXIDO, Clopidogrel (75 mg), Alogliptin (25 mg), Folic Acid (5 mg), Cassia senna (7.5 mg), Metformin (2 g), Simvastatin (40 mg) for unknown indications. On 01-Oct-2018, the patient was administered FLUAD (TIV), dose: 0.5 ml, route of administration: intramuscular, batch number: 251216C1A, anatomical location and expiry date: not reported]. On 09-Oct-2018, 8 days after the administration of the vaccine, the patient died. The cause of death was unknown (reported as death unexplained). It was unknown if autopsy was performed or not. The reporter assessed the case as serious (death and hospitalization).


VAERS ID: 776286 (history)  
Form: Version 2.0  
Age: 1.0  
Sex: Male  
Location: Oklahoma  
Vaccinated:2018-10-01
Onset:2018-10-05
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2018-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR U1998AE / 1 RL / IM
HEPA: HEP A (VAQTA) / MERCK & CO. INC. R009953 / 1 RL / IM
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. R002938 / 1 LL / IM

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, Blood lead normal, Death, Full blood count normal, Pathology test, Pyrexia, Toxicologic test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zantac, Motrin, maybe Tylenol but unsure
Current Illness: 8/31/18 - diagnosed with left acute otitis media. Started Amoxil. (resolved) 9/19/18 - diagnosed with hand, foot, mouth (resolved)
Preexisting Conditions: Previously healthy
Allergies: None
Diagnostic Lab Data: All pending with medical examiner. Of note, CBC and lead screen were normal on 10/1/18 as part of his well check.
CDC Split Type:

Write-up: Received vaccines 10/1/18. Patient developed fever on of 10/3/18. Tmax 101. Mom gave Motrin before bed that night. Checked on him before she went to bed and his temp was 99. Next morning he was found dead in crib. No blankets, stuffed animals in crib. Autopsy found no signs of trauma. Tox screen, tissue samples still pending.


VAERS ID: 785896 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2018-10-02
Onset:2018-10-05
   Days after vaccination:3
Submitted: 2018-11-13
   Days after onset:39
Entered: 2018-11-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 251703B1A / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute hepatic failure, Alanine aminotransferase, Blood alkaline phosphatase increased, Blood bilirubin increased, Blood creatine increased, Death, Malaise
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Biliary system related investigations, signs and symptoms (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-17
   Days after onset: 12
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: Metformin; Memantine; CALCICHEW; Docusate
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 12-OCT-2018, Alanine aminotransferase, 833, elevated; 14-OCT-2018, Alanine aminotransferase, 1473, elevated; 12-OCT-2018, Blood alkaline phosphatase, 139, elevated; 14-OCT-2018, Blood alkaline phosphatase, 174, elevated; 12-OCT-2018, Blood bilirubin, 31, elevated; 14-OCT-2018, Blood bilirubin, 81, elevated; 12-OCT-2018, Blood creatine, 159, elevated; 14-OCT-2018, Blood creatine 252, elevated
CDC Split Type: 201805183

Write-up: This spontaneous case, reported by pharmacist to regulatory authority and initially retrieved on 05-Nov-2018 by Seqirus from regulatory authority (regulatory reference number: GB-MHRA-MIDB-66784cac-dea7-4c53-8752-1376963b4c04), concerns an 81-year-old, elderly female patient. The patient''s concomitant medications included metformin, memantine, CALCICHEW and Docusate for unknown indications. On 02-Oct-2018, the patient was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, batch number: 251703B1A (reported as 251703BIA), anatomical location and expiry date: not reported]. On 05-Oct-2018, 3 days after vaccination, the patient was unwell and was diagnosed with fulminant hepatic failure. On an unspecified date in Oct-2018, the patient was hospitalized. On 12-Oct-2018, the patient''s alanine aminotransferase was 833, alkaline phosphatase was 139, billrubin was 31 and creatine was 159 (units not reported) which showed elevated. On 14-Oct-2018, the patient''s alanine aminotransferase was 1473, alkaline phosphatase was 174, bilirubin was 81 and creatine was 252 (units not reported) which showed elevated. On 17-Oct-2018, the patient died. The patient''s cause of death was reported as fulminant hepatic failure and it was unknown whether autopsy was performed. The outcome of the events unwell was unknown, at the time of death. The reporter assessed the case as serious (death and hospitalization). Case Comment: An 81-year-old female patient experienced malaise and fulminant hepatic failure, 3 days after receipt of FLUAD (TIV) vaccine. The company assesses the causality for malaise as related due to plausible temporal relationship between vaccination and reported malaise. The company assesses the causality for acute hepatic failure as not related as there is no established evidence to suggest the causal role of suspect vaccine. However, acute hepatic failure might have contributed to the event malaise. At a later date, patient also experienced abnormal increase in liver enzymes such as alanine aminotransferase, alkaline phosphatase, bilirubin and raised serum creatinine which can be explained alternately by acute hepatic failure and hence company assesses the causality as not related.


VAERS ID: 898265 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: South Carolina  
Vaccinated:2018-10-01
Onset:2018-10-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-11-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (AFLURIA QUADRIVALENT) / SEQIRUS, INC. - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Death, Feeding tube user, Nausea, Seizure, Syncope, Unresponsive to stimuli, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-01-13
   Days after onset: 104
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 90 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Blood Pressure
Current Illness: Prostate Cancer
Preexisting Conditions: Prostate Cancer
Allergies:
Diagnostic Lab Data: She wasn''t sure if tests were related to vaccine
CDC Split Type:

Write-up: Patient experienced vomiting, nausea, body weakness, fainting, seizures, unresponsive, needed feeding tube, moved to long term care facility in January before he passed away on 01/13/2019 *Reporter was not sure of vaccine name and details so first flu was chosen


VAERS ID: 770068 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Texas  
Vaccinated:2018-09-04
Onset:2018-09-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UI994AA / 1 RA / IM
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 4LP5Y / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Death, Pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-09-07
   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: Fenofibrate, metoprolol, NORVASC, NOVOLOG, furosemide, omeprazole, gabapentin, atorvastatin, VASCEPA
Current Illness:
Preexisting Conditions: ''weak heart''
Allergies: penicillin, minocycline
Diagnostic Lab Data:
CDC Split Type:

Write-up: The patient received both vaccines on Tuesday afternoon. On Wednesday evening, she felt ''achy'' and ''had chills''. She passed away in her sleep on Thursday evening/Friday morning after 2:00am. The family said that she had a ''weak heart'' and that they don''t think her death was caused by the vaccines, but they also wanted us to report her death ''just in case'' because of the close proximity of her death to the vaccines.


VAERS ID: 751016 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2018-05-21
Onset:2018-05-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-05-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U19348B / 1 UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Choking sensation, Coronary artery disease, Death, Dysphagia, Pulmonary oedema, Resuscitation
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Other ischaemic heart disease (narrow), Hypersensitivity (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: Dysphagia; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUSA2018SA140623

Write-up: Initial information received on 23-May-2018 regarding an unsolicited valid serious case received from a nurse. This case involves a 76 years old female patient who experienced pulmonary oedema, coronary artery disease and dysphagia after vaccination with FLUZONE HIGH DOSE. The patient''s past medical treatment(s), vaccination(s) and family history were not provided. Patient had a history of stroke and dysphagia. On 21-May-2018, the patient received a dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine lot U19348B. The patient developed a serious pulmonary oedema following the administration of Influenza USP Trival A-B High Dose Subvirion Vaccine. This event was leading to death. The patient developed a serious coronary artery disease following the administration of Influenza USP Trival A-B High Dose Subvirion Vaccine. This event was leading to death. The patient developed a non-serious dysphagia following the administration of Influenza USP Trival A-B High Dose Subvirion Vaccine. Final diagnosis was dysphagia, (fatal) coronary artery disease and (fatal) pulmonary oedema. An unknown corrective treatment was received. The patient outcome is reported as Fatal on an unknown date for pulmonary oedema, as Fatal on an unknown date for stroke, as Fatal on an unknown date for coronary artery disease. Autopsy was not reported but death certificate was mentioned. The cause of death was reported as Pulmonary oedema and Coronary artery disease. Sender''s Comments: This case concerns a female patient who died a few hours after vaccination with FLUZONE HD. The time to onset is compatible with the role of vaccine. Patient suffered from choking sensation and was provided CPR by her daughter before this fatal outcome. Autopsy was performed and the cause of death was reported to be Pulmonary edema and coronary artery disease. Patient also had a history of stroke and dysphagia in the past. There is no information provided regarding patient''s medical condition at the time of vaccination and there are no lab tests provided that rule out alternate etiologies, particularly cardiovascular causes. Based upon the reported information and considering the past history of the patient, the role of the vaccine cannot be assessed. Reported Cause(s) of Death: pulmonary oedema; coronary artery disease.


VAERS ID: 778013 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2018-05-16
Onset:2018-05-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR - / UNK UN / IM

Administered by: Other       Purchased by: ?
Symptoms: Aggression, Agitation, Aphasia, Blindness, CSF test abnormal, Cerebrovascular accident, Cognitive disorder, Concomitant disease progression, Creutzfeldt-Jakob disease, Death, Dizziness, Electroencephalogram abnormal, Encephalopathy, Gait disturbance, Memory impairment, Nuclear magnetic resonance imaging brain abnormal, Reading disorder, Sedation, Visual impairment
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hostility/aggression (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? Yes
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: AUSA2018SA278801

Write-up: Initial information received on 08-Oct-2018 regarding an unsolicited valid serious case via TGA reconciliation under reference: (AU-TGA-0000437249). This case involves a 77 years old male patient who died due to concomitant disease progression, while he received vaccine FLUZONE HIGH DOSE. The patient''s past medical history and concomitant medication were not provided. On 16-May-2018, the patient received one dose unspecified injection of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via intramuscular route. On 17-May-2018, The patient developed a serious concomitant disease progression 1 day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event led to death of the patient. Case description: Patient was doing some reno work on a boat for 3 weeks and was feeling good and went back up on boat the next day but found he lost his ability to read as the words looked like they are jiggling/moving and mild dizzy. Also when he looked at his van, the car appears out of shape. No nausea or headaches, No weakness of face or limbs, patient never had eyes checked by optometrist before but he usually used a magnifying glass to read. On 28-May-2018, patient again represented to GP for assessment, and experienced visual loss, memory impairement / cerebrovasxular accident, thereafter, Referred to emergency department. Patient was hospitalised for stroke because he presented problems with 4 weeks of progressive functional that declined characterised. visual distortion progressed to almost complete visual loss, Cognitive impairment progressing to severe agitation, Receptive and expressive aphasia and Gait disturbance Principal Diagnosis Sporadic Creutzfeldt-Jakob Jacob Disease (CJD): Hedenhain variant. Patient was admitted under the neurology team, MRI of brain showed left occipital cortical ribboning, initial EEG showed with PLEDs in a similar location to MRI abnormality. Indicating a likely diagnosis of CJD. No family history, Negative antibodies on blood and CSF for autoimmune encephalitis, Progressive functional declined during inpatient stay, second Lipoprotein and MRI brain test was performed under general anaesthetic. MRI showed progressive bilateral widespread cortical ribboning, EEG was performed again and showed progressive generalised encephalopathy, there was a significant behavioural disturbance and aggression required security special and sedation, On 21-May-2018, Patient required visit to general physician 5 days post vaccination. (Other relevant tests included Physical examinations: Physical examinations: Temperature: 37 degree Celsius, Tymphanic BP (sitting): 140/79 Pulse: 50, Visual acuity - Right Eye 6/9, Left Eye - 6/24, MRI brain showing left occipital cortical ribboning. Initial EEG- with PLEDs in a similar location to MRI abnormality. LP and CSF- unremarkable biochemistry. 14-3-3 protein strongly positive. Tau protein positive. Indicating a likely diagnosis of CJD. CSF again positive for 14-3-3. MRI showing progressive bilateral widespread cortical ribboning. repeat EEG- progressive generalised encephalopathy. No focal neurological deficit. Referral to optometrist for urgent assessment Final diagnosis was (fatal) concomitant disease progression. As corrective measure, consulted with palliative care team for advice on sedation and decision was made for comfort cares. The outcome of the event was fatal and event end date was reported as 27-Jun-2018. No autopsy was performed (based on sentence reported as family decided against autopsy), the cause of death was not reported.; Sender''s Comments: This case involves a 77-year-old male patient who experienced concomitant disease progression leading to death the other day after receiving FLUZONE HIGH DOSE. Cause of death was not reported. Autopsy results are unavailable as family decided against autopsy. Post vaccination, Patient was also hospitalized for stroke, complete visual loss, cognitive impairment progressing to severe agitation, receptive and expressive aphasia, gait disturbance, sporadic Creutzfeldt-Jakob Jacob disease- Heidenhain variant (principal diagnosis). During inpatient stay, he experienced progressive functional decline. Lab tests results showed 14-3-3 protein strongly positive, tau protein positive, cerebrospinal fluid- came positive for 14-3-3. MRI showed progressive bilateral widespread cortical ribboning, and repetitive EEG showed progressive generalized encephalopathy. The loss of progressive body functionality due to multiple impairments played a role in this fatal outcome. In order to complete assessment of influenza vaccination in reported outcome, full past medical history and concomitant medications information is needed as well as results of autopsy report and laboratory evaluations.Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: Concomitant disease progression.


VAERS ID: 774885 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2018-05-08
Onset:2018-05-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2018-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER P07XA / UNK UN / UN
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. R002405 / UNK UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: cilazapril; amlodipine; simvastatin
Current Illness: Angina pectoris; Essential hypertension; Hyperlipidaemia; Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZ0095075131809NZL008995

Write-up: Information was obtained on a request by the Company from the Agency (CARM# 128778) via a case Line Listing concerning a 79 year old male patient. The patient''s concurrent conditions included an unspecified angina pectoris, essential (primary) hypertension, unspecified hyperlipidaemia and other medical conditions. The patient''s concomitant therapies included cilazapril, amlodipine and simvastatin. No information was provided regarding the patient''s medical history. On 08-MAY-2018, the patient was vaccinated with ZOSTAVAX 0.65 ml subcutaneously, lot number R002405 for prophylaxis (anatomical location expiration date were not reported) and INFLUENZA QUADRIVALENT route of administration reported as SY (Systemic) 0.5 ml lot number P07XA for prophylaxis (expiration date was not reported). On 10-MAY-2018, the patient experienced cardiac arrest and died on an unspecified date due to the event. It was unknown whether an autopsy was performed. Additionally, the agency considered cardiac arrest to be unrelated to vaccination with ZOSTAVAX. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between the zostavax vaccine and the reported event cardiac arrest cannot be established. More information regarding clinical course, and autopsy results are important for furhter assessment. Additionally the subject has as concurrent conditions angina pectoris, essential (primary) hypertension, unspecified hyperlipidaemia which are risk factors for the event. Company Comment- No changes to the product safety information are warranted at this time. Merck and Co., Inc., also known as MSD, continues to monitor the safety profile of the product.


VAERS ID: 770590 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2018-04-28
Onset:2018-05-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2018-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PER: PERTUSSIS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Autopsy, Brain death, Death, Influenza like illness, Interstitial lung disease, Loss of consciousness, Malaise, Nasopharyngitis, Respiratory arrest, Resuscitation, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-05-02
   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:
Current Illness:
Preexisting Conditions: Comments: Was perfectly fine and healthy before he received the vaccines
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUSA2018SA248885

Write-up: Initial information received on 04-Sep-2018 regarding an unsolicited valid serious social media case received from Consumer or non-Healthcare Professional. This case involves a 39 years old male patient who experienced acute respiratory distress syndrome, acute interstitial pneumonia a lung disease, seizure, cold, flu like symptoms and stop breathing, while he received INFLUENZA VACCINE and WHOOPING COUGH VACCINE. The Was perfectly fine and healthy before he received the vaccines. The patients concomitant medication and family history were not provided. On 28-April 2018, the patient received a dose of suspect INFLUENZA VACCINE from unknown manufacturer (lot number, route, site of administration, dose was not reported). On 28-April 2018, the patient received a dose of suspect whooping cough vaccine not produced by Sanofi (lot number, route, site of administration, dose was not reported). On an unknown date the patient developed cold and flu-like symptoms after getting injection on 28 Apr 2018 and decided to treat them with cold and flu tablets. In next 24 to 48 hours patients condition started deteriorated rapidly. On 1 May 2018, patient woke up and got ready for work, he was too sick and minutes later he had seizure and stopped breathing. The patients wife who is registered nurse performed CPR and ambulance was called, the paramedics rushed patient to hospital but never regained consciousness and was declared brain dead the next day. Lab data was not provided. An autopsy was done. The cause of death was reported as Interstitial lung disease and Acute respiratory distress syndrome. List of documents held by sender- none.; Sender''s Comments: A 39-year-old patient died 4 days after vaccination with FLU VACCINE (from unknown manufacturer) and WHOOPING COUGH VACCINE. The time to onset is compatible with the role of vaccines. The patient past medical history, concomitant medications were not reported. Autopsy report confirmed the cause of death as interstitial lung disease and acute respiratory distress syndrome. Additional information from past medical history, concomitant medication and laboratory infectious work-up to elicit other potential causes of acute interstitial pneumonia are needed to further evaluate role of influenza vaccine in reported events. Based upon the reported information, the role of the individual vaccine cannot be assessed.; Reported Cause(s) of Death: acute interstitial pneumonia; Autopsy-determined Cause(s) of Death: acute respiratory distress syndrome.


VAERS ID: 802985 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2018-05-01
Onset:2018-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 1 - / -
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 2 - / -
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / 1 - / -
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / 2 - / -
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blast cell crisis, Blast cell proliferation, Death, Extra dose administered, Product administered to patient of inappropriate age
SMQs:, Blood premalignant disorders (narrow), Myelodysplastic syndrome (broad), Medication errors (narrow), Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-01
   Days after onset: 153
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Leukemia
Preexisting Conditions: Medical History/Concurrent Conditions: Stem cell transplant
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEGLAXOSMITHKLINEDE2019GS

Write-up: blast crisis; inappropriate age at vaccine administration; extra dose administered; inappropriate age at vaccine administration; This case was reported by a physician via sales rep and described the occurrence of blast cell proliferation in a 75-year-old female patient who received DTPa-HBV-IPV+Hib (Infanrix hexa) for prophylaxis. Co-suspect products included DTPa-HBV-IPV+Hib (Infanrix hexa) for prophylaxis, Flu Seasonal QIV Dresden (Influsplit Tetra 2017/2018) for prophylaxis, Flu Seasonal QIV Dresden (Influsplit Tetra 2017/2018) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMOVAX 23) for prophylaxis. The patient''s past medical history included stem cell transplant. Concurrent medical conditions included leukemia. In May 2018, the patient received the 1st dose of Infanrix hexa. In June 2018, the patient received the 2nd dose of Infanrix hexa. In May 2018, the patient received the 1st dose of Influsplit Tetra 2017/2018. In June 2018, the patient received the 2nd dose of Influsplit Tetra 2017/2018. In May 2018, the patient received PNEUMOVAX 23. In May 2018, unknown after receiving Infanrix hexa and not applicable after receiving Infanrix hexa, Influsplit Tetra 2017/2018 and Influsplit Tetra 2017/2018, the patient experienced inappropriate age at vaccine administration. In June 2018, the patient experienced inappropriate age at vaccine administration and extra dose administered. On an unknown date, the patient experienced blast cell proliferation (serious criteria death). In October 2018, the outcome of the blast cell proliferation was fatal. On an unknown date, the outcome of the inappropriate age at vaccine administration, inappropriate age at vaccine administration and extra dose administered were unknown. The patient died in October 2018. The reported cause of death was blast cell proliferation. It was unknown if the reporter considered the blast cell proliferation to be related to Infanrix hexa, Infanrix hexa, Influsplit Tetra 2017/2018 and Influsplit Tetra 2017/2018. Additional details were provided as follows: This case was received from an anonymous physician. The physician wanted to stay anonymous as the case possibly was reported by another physician or a clinic. By duplication search the case was found locally. The age at vaccination was not reported. The patient with underlying leukemia was vaccinated two times with Infanrix Hexa and influenza vaccine (probably Influsplit Tetra). The batch numbers were not reported. In a longer timely distance to the vaccinations the patient experienced a blast crisis and died in October 2018. It was not reported, whether two doses of Infanrix hexa and the additional influenza vaccine were given accidentally or intentionally. Follow up would be requested.; Reported Cause(s) of Death: blast crisis


VAERS ID: 869880 (history)  
Form: Version 2.0  
Age: 1.0  
Sex: Female  
Location: Foreign  
Vaccinated:2018-05-04
Onset:2018-05-01
Submitted: 0000-00-00
Entered: 2020-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aggression, Areflexia, Autophobia, Brain oedema, Chills, Computerised tomogram head abnormal, Cytomegalovirus test negative, Death, Dengue virus test negative, Diarrhoea, Encephalitis, Endotracheal intubation, Epstein-Barr virus antibody negative, Faeces soft, Febrile convulsion, Flavivirus test negative, Lethargy, Mucous stools, Musculoskeletal stiffness, Polymerase chain reaction, Pyrexia, Respiratory failure, Seizure, Skin induration, Skin striae, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (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), Convulsions (narrow), Pseudomembranous colitis (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Hostility/aggression (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 15 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Dipirone; Ibuprofen
Current Illness: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 201805; Test Name: IgG; Result Unstructured Data: Test Result: not reactive, Test Result Unit: unknown; Test Date: 201805; Test Name: IgM; Result Unstructured Data: Test Result: Epstein Barr non reactive, Test Result Unit: unknown; Test Date: 20180508; Test Name: Body temperature; Result Unstructured Data: Test Result: 40, Test Result Unit: degree C; Test Date: 201805; Test Name: Body temperature; Result Unstructured Data: Test Result: increased, Test Result Unit: degree C; Test Date: 201805; Test Name: Computerized tomogram; Result Unstructured Data: Test Result: difuse cerebral edema, Test Result Unit: unknown; Test Date: 201805; Test Name: Cytomegalovirus test; Result Unstructured Data: Test Result: IGG not reactive 48.2, Test Result Unit: unknown; Test Date: 201805; Test Name: PCR; Result Unstructured Data: Test Result: not dectable, Test Result Unit: unknown
CDC Split Type: BRGLAXOSMITHKLINEBR2020AM

Write-up: Meningoencephalitis; stayed stretching; hard foot; Lethargy; WITHOUT REFLEXES; vomiting; stretching, writhing; hitting her / himself and with hard foot; febrile convulsion; Fever; chills; stayed hitting her/himself/stayed writhing; Diarrhea; softened stools; evacuation of stools with mucus; difuse cerebral edema; RESPIRATORY INSUFFICIENCY; Death; This case was reported by a other health professional via regulatory authority and described the occurrence of death in a 1-year-old female patient who received Men C NVS (Menjugate Liquid) (batch number 162001, expiry date unknown) for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis, TRIPLE VIRAL VACCINE (batch number 013N6095A, expiry date unknown) for prophylaxis, dipyrone (Dipirone) unknown for an unknown indication and ibuprofen unknown for fever. Concurrent medical conditions included breast feeding. On 13th April 2018, the patient received the 1st dose of Menjugate Liquid. On 4th May 2018, the patient received the 1st dose of Influenza vaccine Quadrivalent 2018-2019 season. On 13th April 2018, the patient received the 1st dose of TRIPLE VIRAL VACCINE. On 8th May 2018, the patient started Dipirone at an unknown dose and frequency and ibuprofen at an unknown dose and frequency. On 3rd May 2018, 20 days after receiving Menjugate Liquid, 364 days after receiving Influenza vaccine Quadrivalent 2018-2019 season, not applicable after starting Dipirone and ibuprofen and an unknown time after starting diazepam, the patient experienced diarrhea (serious criteria hospitalization) and soft stools (serious criteria hospitalization). On 8th May 2018, the patient experienced febrile convulsion (serious criteria hospitalization and GSK medically significant), fever (serious criteria hospitalization), chills (serious criteria hospitalization) and self hatred (serious criteria hospitalization). In May 2018, the patient experienced cerebral edema (serious criteria hospitalization and GSK medically significant) and mucus stools (serious criteria hospitalization). On 21st May 2018, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the patient experienced respiratory insufficiency (serious criteria hospitalization and GSK medically significant), meningoencephalitis (serious criteria hospitalization and GSK medically significant), vomiting (serious criteria hospitalization), stretch marks (serious criteria hospitalization), skin induration (serious criteria hospitalization), lethargy (serious criteria hospitalization), absent reflex (serious criteria hospitalization), stiffness (serious criteria hospitalization) and aggression (serious criteria hospitalization). The patient was treated with diazepam. The action taken with Dipirone was unknown. The action taken with ibuprofen was unknown. On an unknown date, the outcome of the death was fatal and the outcome of the respiratory insufficiency, meningoencephalitis, cerebral edema, febrile convulsion, diarrhea, fever, chills, self hatred, vomiting, mucus stools, stretch marks, skin induration, lethargy, absent reflex, soft stools, stiffness and aggression were unknown. It was unknown if the reporter considered the death, respiratory insufficiency, meningoencephalitis, cerebral edema, febrile convulsion, diarrhea, fever, chills, self hatred, vomiting, mucus stools, stretch marks, skin induration, lethargy, absent reflex, soft stools, stiffness and aggression to be related to Menjugate Liquid. It was unknown if the reporter considered the death, respiratory insufficiency, meningoencephalitis, cerebral edema, febrile convulsion, fever, chills, self hatred, vomiting, mucus stools, stretch marks, skin induration, lethargy, absent reflex, stiffness and aggression to be related to Influenza vaccine Quadrivalent 2018-2019 season, Dipirone and ibuprofen. Additional details were provided as follows: The patient was on breastfeeding. The patient medical history was born with a little more than 3,5 kg, born via vaginal labor, foot test performed and the little ear without alterations. The patient''s parent reported that the same was healthy and never needed hospitalization, attended all the appointments of puericulture, on the last appointment of April 2018 was weighting 10,400 kg and never had a seizure. The hygiene-sanitary conditions of the house were unsatisfactory, On 13th April 2018, the patient received Menjugate Liquid and Triple viral vaccine. On 4th May 2018, the patient received 1st dose of Influenza in the health center but without vaccinal comprovation. There were some divergencies of some start dates of symptoms between what was in the file and the mother reported during home visit. Research bias noted the patient''s mother emotional state prenatal care card lost, non-disponibility of child vaccination card. The patient was in complementary breastfeeding, parent reported that on days 3rd May 2018, and 4th May 2018, the patient presented diarrhea episodes with 5 daily evacuations with softened stools without blood and or mucus (Regular intestinal pattern of 1 evacuation / day) and had improvement of the clinical condition spontaneously without medical evaluation. On 3rd May 2018, the patient experienced diarrhea and softened stools. On 8th May 2018, the patient presented non-measured fever, parent administered by her own 10 drops of Ibuprofen. At night the patient presented chills, stayed hitting her/himself had 40 degree C fever and seizure. On 9th May the patient was hospitalized. The patient was taken to the emergency care unit and medicated with Dipirone, presented vomit and new episode of seizure crisis with evacuation of stools with mucus, being medicated with Diazepam according to the parent. The patient was intubated in the emergency care unit and transferred to HUT. On 25th May 2018, realized a possible AEPV. The patient evolved to death in 21st May 2018. On 19th June 2018, Cerebrospinal fluid was not collected because CT appointed diffuse cerebral edema. Less than 2 month after recevieng Menjugate and Influenza vaccine, less than 2 week after recevieng TRIPLE VIRAL vaccine and Ibuprofen, the patient followed without fever and stayed stretching, writhing, hitting her/himself and with hard foot. Chikungunya IGM serum non reactive, Epstein Barr IGM serum not reactive; Zika IGM serum not reactive. Quick IGM IGG dengue test not reactive; Zika IGG serum not reactive; Epstein Barr IGG not reactive; Chikungunya IGG serum not reactive, Cytomegalovirus IGM serum not reactive; Cytomegalovirus IGG not reactive (48,2); Zika PCR urine not detectable; Zika PCR Serum not detectable; Dengue PCR serum not dectable was performed a home visit to investigate the death. This case lacks a deepening in the investigation to be performed afterwards. Lab Comments: Zika IGM serum (not reactive), Zika PCR urine (not detectable)


VAERS ID: 767894 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2018-04-01
Onset:2018-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER A039C / 2 UN / SC
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 17C01A / 3 UN / SC
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS RT003 / 2 MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Blood immunoglobulin E normal, Cardio-respiratory arrest, Choking, Endotracheal intubation, Feeling cold, Obstruction, Pallor, Sudden death, Sudden infant death syndrome, Tryptase
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (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), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-04-01
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result: no elevation of non-specific IgE or triptease
CDC Split Type: JPPFIZER INC2018339063

Write-up: This is a spontaneous report from a contactable physician (who was in charge of legal autopsy) via regulatory authority. Regulatory authority number v18100354. A 4-month-old male patient received the 3rd dose of PREVENAR 13 (lot# 17C01A, exp date 29Feb2020), subcutaneous, in Apr2018, at single dose, for immunisation; 2nd dose of QUATTROVAC (lot# A039C), subcutaneous, in Apr2018, at 1 DF single, for immunisation; 3rd dose of INFLUENZA VACCINE, via an unspecified route of administration, in Apr2018, at 1 DF single, for immunisation; 2nd dose of ROTARIX (lot# RT003), oral, in Apr2018, at 1 DF single, for immunisation. The patient received aforementioned vaccines at the same time. Medical history and concomitant medications were not reported. Birth weight was 778 g. Previously the patient received 1st and 2nd dose of Prevenar 13, a dose of Quattrovac, 1st and 2nd dose of influenza vaccine, 1st dose of Rotarix all for immunisation. After vaccination in Apr2018, no change was noted. On the following day at 0:00 am, the patient went to sleep on the same bed with his mother, using mother''s arm as a pillow. Around 3:00 am, father went to sleep on the same bed. The patient slept in the middle. Respiratory condition was unknown. Around 7:30 am, father woke up and found out that the patient made a 90-degree turn and was sleeping in dorsal position. The patient became facial pallor, cold and still. Upon arrival of rescue crew, cardio-respiratory arrest was noted. The patient was rushed to a hospital. Cardiac massage, endotracheal intubation and adrenalin administration were performed, however, heart and lung did not recover. Death was confirmed about 1 hour after ambulance was called. Legal autopsy was performed 3 days after death. Only findings which suggested sudden death was found. No significant lesion or injury which might be significantly fatal was found. In blood test, elevation of non-specific IgE or triptease was not noted. No findings which suggested vaccination-induced allergy were found. Thus, the cause of death was nothing but sudden death unexplained. However, considering that the patient was sleeping in the middle of his parents, sudden infant death syndrome was considered as internal cause and naso-oral obstruction, or restricted chest movement as external cause. The possibility of choking death caused by naso-oral obstruction or pharynx obstruction due to hyperflexion of neck was considered since the patient was using mother''s arm as a pillow. The reporting physician classified the event as serious (death), considered that the causality was unassessable and commented as follows: In assessing the cause of death, there was no choice but to assess it as sudden death unexplained. Based on circumstances of finding and autopsy report, the possibilities of sudden infant death syndrome or choking death caused by naso-oral obstruction, restricted chest movement, or pharynx obstruction due to hyperflexion of neck were considered. Although no findings which suggested vaccination induced allergy were obtained by blood test, causal relation between vaccination and death was unknown. No follow-up attempts possible. No further information expected. Reported Cause(s) of Death: Sudden death unexplained; suspected sudden infant death syndrome; suspected asphyxia.


VAERS ID: 740872 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2018-02-15
Onset:2018-02-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-03-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UI830AB / UNK GM / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH S74423 / UNK GM / IM

Administered by: Other       Purchased by: ?
Symptoms: Electromyogram abnormal, Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-02-28
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: unknown
Preexisting Conditions: unknown
Allergies: unknown
Diagnostic Lab Data: LP showing albuminocytologic dissociation; OSH EMG consistent with AIDP/GBS
CDC Split Type:

Write-up: Pt. was given the flu vaccine on admission to the hospital as part of their admission assessment procedure on 2/15/2018. Guillain-Barre syndrome was diagnosed on 2/27/2018, treated with IV fluids, IVIG, steroids.


VAERS ID: 743123 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Female  
Location: California  
Vaccinated:2018-02-08
Onset:2018-02-11
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2018-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 5J594 / 7+ LA / IM
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. N026812 / 1 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M17013 / 1 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U5563AA / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Death, Influenza, Respiratory distress, Septic shock
SMQs:, Anaphylactic reaction (broad), Toxic-septic shock conditions (narrow), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-02-11
   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: vaginal itching
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received immunizations on 2/8/18. She presented to ED on 2/11/18 in respiratory distress/ septic shock and passed away the same day, presumably from Influenza B.


VAERS ID: 740050 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: New York  
Vaccinated:2018-02-01
Onset:2018-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-03-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UI883AB / N/A - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-02-01
   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: No info- he doesn''t come here- his wife only called so that we would report incident
Current Illness: Apparently there were, but his wife was not willing to discuss--- she stated that he has many problems and never elaborated
Preexisting Conditions: Apparently there were, but his wife didn''t elaborate--- His wife stated that she was under pressure from her family to report this. She doesn''t believe the flu shot had anything to do with it, but she wanted to report it since he died the same day he received it. She said that you can contact her if need be at his contact info.
Allergies: None that we know of
Diagnostic Lab Data: We have none available to us
CDC Split Type:

Write-up: Patient died at 5:15 the same day--- his wife performed cpr on patient until medical help arrived.


VAERS ID: 745051 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Unknown  
Vaccinated:2017-11-01
Onset:2018-01-31
   Days after vaccination:91
Submitted: 0000-00-00
Entered: 2018-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC4: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT) / SEQIRUS, INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Acute disseminated encephalomyelitis
SMQs:, Noninfectious encephalitis (narrow), Demyelination (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-02-14
   Days after onset: 14
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:

Write-up: Suspected acute disseminated encephalomyelitis. It is unknown if the vaccine was actually given- an order was placed, but record of administration unclear.


VAERS ID: 828199 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: West Virginia  
Vaccinated:2018-01-30
Onset:2018-01-30
   Days after vaccination:0
Submitted: 2019-04-24
   Days after onset:448
Entered: 2019-08-12
   Days after submission:110
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Feeling abnormal, Immediate post-injection reaction
SMQs:, Dementia (broad), Hypersensitivity (narrow)

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

Write-up: Happened at urgent care on 01/30/18. Patient received a flu vaccine that morning and stated he started feeling bad immediately. He went back to urgent care and was given a shot in the hip and sent home. He was found dead the next morning with no apparent cause.


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

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

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

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


VAERS ID: 736037 (history)  
Form: Version 1.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2018-01-12
Onset:2018-01-15
   Days after vaccination:3
Submitted: 2018-02-02
   Days after onset:18
Entered: 2018-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Chills, Death, Nausea, Pain
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-01-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2018GSK017070

Write-up: This case was reported by a consumer via call center representative and described the occurrence of death NOS in a 49-year-old female patient who received Influenza vaccine. On 12th January 2018, the patient received Influenza vaccine. On 15th January 2018, 3 days after receiving Influenza vaccine, the patient experienced death NOS (serious criteria death and GSK medically significant). In January 2018, the patient experienced pain, nausea and chills. On an unknown date, the outcome of the death NOS was fatal and the outcome of the pain, nausea and chills were not reported. The patient died on 15th January 2018. The reported cause of death was death NOS. It was unknown if the reporter considered the death NOS, pain, nausea and chills to be related to Influenza vaccine. Additional details were provided as follows: The GSK employee reported about a colleague. Less than a week after receiving Influenza vaccine, the patient experienced severe pain, nausea and chills over the entire weekend. The patient died due to unknown reason.


VAERS ID: 761392 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Maine  
Vaccinated:2017-12-11
Onset:2018-01-01
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2018-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI852AB / 2 UN / IM

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain, Abnormal loss of weight, Anaemia, Anorectal discomfort, Anti-aquaporin-4 antibody negative, Anti-ganglioside antibody negative, Anti-thyroid antibody negative, Anti-thyroid antibody positive, Anti-transglutaminase antibody negative, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Antiphospholipid antibodies negative, Anxiety, Asthenia, Back pain, Blood albumin normal, Blood creatine phosphokinase increased, Blood folate normal, Blood heavy metal normal, Blood magnesium normal, Blood thyroid stimulating hormone normal, Borrelia test negative, Burning sensation, C-reactive protein normal, CSF cell count normal, CSF glucose normal, CSF protein increased, Cardiac telemetry normal, Cognitive disorder, Complement factor C3, Complement factor C4, Complement factor normal, Completed suicide, Computerised tomogram abnormal, Constipation, Death, Decreased appetite, Dyspnoea, Dysuria, Ehrlichia test, Electroencephalogram normal, Electromyogram normal, Epstein-Barr virus test negative, Fall, Feeling abnormal, Feeling jittery, Gastrointestinal pain, Globulins increased, Glycosylated haemoglobin normal, Gram stain negative, Gun shot wound, HIV test negative, Head discomfort, Headache, Herpes simplex test negative, Hypoaesthesia, Infrequent bowel movements, Limb discomfort, Memory impairment, Metabolic function test normal, Micturition urgency, Muscle twitching, Muscular weakness, Nausea, Neck pain, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal, Oesophagogastroduodenoscopy, Pain in extremity, Panic attack, Paraesthesia, Polymerase chain reaction, Protein total increased, Renal cyst, Suicidal ideation, Treponema test negative, Varicella virus test positive, Vitamin B1, Vitamin B12 normal, Vitamin D, White blood cell count decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Peripheral neuropathy (broad), Suicide/self-injury (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Dyskinesia (broad), Dystonia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Depression (excl suicide and self injury) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-07-10
   Days after onset: 189
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Fish oil 1-2 times weekly, amlodipine 5mg daily, timolol 0.25% 1gtt each eye BID, PRILOSEC 20mg 2-3 times weekly, ibuprofen 800mg as needed, TYLENOL ES 500mg as needed
Current Illness:
Preexisting Conditions: Hypertension (stable), impaired fasting glucose, history of skin cancer, actinic keratosis, fatty infiltration of liver, chronic GERD, hypercholesterolemia, had Shingles 2017.
Allergies: muscle aches with statins, otherwise NKDA
Diagnostic Lab Data: *3/10/18 MRI brain, cervical, thoracic, and lumbar spine Brain: symmetric bilateral periventricular signal hyperintensity as well as seen in a pericallosal distribution suggestive of a demyelinating process. This might be confirmed with evaluation of CSF. Vascular structures as covered demonstrate a normal flow void. Spine: foraminal narrowing at C4, C5 but no cord signal abnormality or suggestion of cervical stenosis. Of note on T spine was predominantly erythropoietic red marrow suggestive of anemia and 1.3cm hyperintense cyst R kidney *3/17/18 MRI brain, cervical and thoracic spine: Brain: small focal and more patchy regions of T2 and T2 FLAIR signal hyperintensity within the supratentorial periventricular, centrum semiovale, and to lesser extent subcortical white matter appear entirely unchanged when compared to the 3/10/2018 exam. Although the possibility of a demyelinating process was raised on the report from the previous brain MRI and that such process cannot with certainty be excluded, I favor that these represent sequela of chronic microvascular ischemic change.*3/17/18 CT CAP: negative except fatty liver *3/19/18 EEG: negative *3/14/18 EMG: negative CBC: WBC count 3.2 on 3/18/18; (WBC count 3.6 on 3/17; 6.5 on 3/6). Otherwise normal CMP: 3/17/18: Total protein 8.5, alb 3.7, globulin 4.8 CRP: normal 1.0 CK normal (298) TSH: normal Vit B12: normal Vit B1: normal Vit D: low normal at 26.6 Folate normal Mg normal Hgb A1c normal at 5.6 heavy metals panel negative HIV negative lyme negative, anaplasma negative, ehrlichia negative EBV negative varicella zoster ab Ig positive (immune) treponemia pallidum Ab IgG + RPR negative Syphilis ab TP-PA indeterminate tissue transglutaminase negative complement C3,C4 normal thyroglobulin Ab negative thyroid peroxidase Ab 422.9 (<100) ANA negative Sjogrens Ab negative ACE negative Paraneoplastic auto antibody eval negative P-ANCA, C-ANCA negative Antiphospholipid Ab negative AntiMog Ab negative NMO/AQP4 FAC serum negative Ganglioside Ab panel negative CSF: 3/9/18: protein 101 (15-45); glucose 67, cell counts normal. MS panel elevated albumin but normal ratios. 3/19/18: protein 98, glucose 59, cell counts normal flow cytometry negative for lymphoma VZV PCR; Varicella zoster Ab IgG, IgM - negative HSV negative CSF gram stain negative. EGD 5/18/18, MRI brain and c-spine 5/17/18. EMG 4/27/18
CDC Split Type:

Write-up: Patient first evaluated by Clinic 3/2018. Reports in January 2018 reported some low back pain after working with a snow blower. A few weeks after this, noted some rectal and bladder burning and ''urgency'' - lasted 4-5 days and then resolved. Toward the end of Jan, flew to and back and had trouble getting out the airplane seat. In February 2018 went snowshoeing and fell, noted legs aching. Noted decreased power in the quads bilaterally and this progressed to a feeling ''like my legs are disconnected from me, like my quads are weak.'' Early March 2018, symptoms progressed and more noticeable. Felt like knees might give out when getting up and down. Went to the ED - had cardiac/syncope r/o on telemetry. Didn''t mention his lower extremity concerns during that visit. Symptoms continued. In April, patient reported legs "feeling buzzy", some numbness in upper extremities, particularly bilat pinky fingers, pins and needles from biceps to tips of fingers. Towards end of April, some abdominal pain reported, intermittently, decreased appetite. Some SOB, had panic attack, situational anxiety. Patient seen again in May, continued progression of paresthesias in upper extremities. Reports having "fogginess" worse in AM, feeling jittery, sometimes has the sense that "brain is on fire." Reported feeling anxious, ongoing. Frontal HA and neck pain reported. Situational anxiety ongoing. Passive suicidal thoughts with no plan or intent. End of May reported arms and legs feeling worse, losing strength despite exercise; unintended weight loss, GI cramps; twitching in arms, legs, hands, L$gR; headaches; mild cognitive foggy feeling; anxiety. Seen by office in early June, reported legs still feeling numb and "on fire", but overall better; HA and neck pain. Late June reported feeling jittery, anxious, with sense of doom. Again reported passive suicidality with no plan or intent; continued weight loss, bowel movements every 3-4 days with abdominal cramping, nausea. Discussed seeing a psychiatrist for ongoing anxiety. Seen multiple times between March and July with ongoing symptoms; saw several specialists for workup during this time. Most recently seen by our office 7/2/2018, plan to return to work discussed. Ongoing HAs, constipation, situational anxiety. Called office 7/9 feeling jittery and with mental fogginess and forgetfulness, SOB with exercise. Plan to see gastroenterology 7/10 for further testing. 7/10/18 self inflicted gunshot wound, patient deceased.


VAERS ID: 847333 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2018-01-01
Submitted: 0000-00-00
Entered: 2019-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Drug ineffective, Malaise, Pneumonia
SMQs:, Lack of efficacy/effect (narrow), 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: 2018-01-01
   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: FISA2019SA313247

Write-up: the patient received influenza vaccine, but it did not have effect on her, the vaccination did not work; Patient died due to Pneumonia; sick; Initial information received on 08-Nov-2019 regarding an unsolicited valid serious social media case received from a consumer/non healthcare professional (patient''s related) through a Company social media site. This case is linked to case 2019SA313244 via same reporter. This case involves a female patient of (age not reported) who was sick and died due to pneumonia (Pneumonia) while she received vaccine INFLUENZA VACCINE [INFLUENZA VACCINE]. No information regarding medical history past vaccinations, treatments or concomitant drug was reported. In 2017, the patient received a dose of suspect INFLUENZA VACCINE [INFLUENZA VACCINE] produced by unknown manufacturer, lot number and expiry date not reported via unknown route. in 2017, the patient was sick (malaise) (unknown latency) following administration of the vaccine. On Jan-2018, the patient died due to pneumonia (pneumonia) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death. It was a case of drug ineffective. Reportedly, the patient received [influenza] vaccination in 2017, but it did not have effect on her. She was sick and did not recover. She slept away [died] due to pneumonia in the beginning of Jan-2018. It was reported that the vaccination did not work. Other relevant tests included Details of lab data not reported. Final diagnosis was (fatal) Sickness and (fatal) patient died due to pneumonia. It was not reported if the patient received a corrective treatment. The outcome was reported as not recovered for sick and Fatal for patient died due to pneumonia (patient died in Jan-2018). It is unknown if an autopsy was done. The cause of death was reported as Pneumonia. There will be no information available on the batch number for this case.; Sender''s Comments: This case concerns a female patient (unreported age) who died due to pneumonia with symptom of malaise after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is unknown. Moreover, patient''s medical condition at the time of vaccination and lab tests were not reported. Based upon the reported information, the role of a vaccine cannot be assessed.; Reported Cause(s) of Death: died due to pneumonia


VAERS ID: 738345 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2017-11-15
Onset:2017-12-29
   Days after vaccination:44
Submitted: 2018-02-19
   Days after onset:52
Entered: 2018-02-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS AFLBA221AA / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-12-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TILIDIN; Vitamin D
Current Illness: 2014, Hepatic cancer; pain; Osteoporosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2018GSK025816

Write-up: This case was reported by a physician and described the occurrence of unknown cause of death in a 87-year-old female patient who received INFLUSPLIT TETRA (batch number AFLBA221AA, expiry date unknown). Concurrent medical conditions included liver carcinoma, pain and osteoporosis. Concomitant products included vitamin D and TILIDIN. On 15th November 2017, the patient received the 1st dose of INFLUSPLIT TETRA (intramuscular). On 29th December 2017, 44 days after receiving INFLUSPLIT TETRA, the patient experienced unknown cause of death (serious critieria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The patient died on 29th December 2017. The reported cause of death was unknown cause of death. An autopsy was not performed. The reporter considered the unknown cause of death to be unlikely related to INFLUSPLIT TETRA. Additional details were provided as follows: The patient received INFLUSPLIT TETRA on left deltoid. No treatment was performed. TILIDIN and vitamin D were applied permanently. This is one of the 9 cases, reported by the same reporter.


VAERS ID: 738352 (history)  
Form: Version 1.0  
Age: 94.0  
Sex: Male  
Location: Foreign  
Vaccinated:2017-11-15
Onset:2017-12-29
   Days after vaccination:44
Submitted: 2018-02-19
   Days after onset:52
Entered: 2018-02-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS AFLBA221AA / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-12-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LANITOP; TILIDIN
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2018GSK026160

Write-up: This case was reported by a physician and described the occurrence of stroke in a 95-year-old male patient who received INFLUSPLIT TETRA (batch number AFLBA221AA, expiry date unknown). Concomitant products included LANITOP and TILIDIN. On 15th November 2017, the patient received the 1st dose of INFLUSPLIT TETRA (intramuscular). On 29th December 2017, 44 days after receiving INFLUSPLIT TETRA, the patient experienced stroke (serious criteria death and GSK medically significant). On an unknown date, the outcome of the stroke was fatal. The patient died on 29th December 2017. The reported cause of death was stroke. An autopsy was not performed. The reporter considered the stroke to be unlikely related to INFLUSPLIT TETRA. Additional information was provided as follows: The patient was administered INFLUSPLIT TETRA on left upper arm. No treatment was performed. The patient''s concomitant medications LANITOP Digoxin and TILIDIN were applied permanently. This is 1 of the 10 linked cases, reported by the same reporter.


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

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

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

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


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

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

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

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


VAERS ID: 732645 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2017-12-07
Onset:2017-12-19
   Days after vaccination:12
Submitted: 2018-01-04
   Days after onset:16
Entered: 2018-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS AFLBA279AA / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-12-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Hypertension; Autoimmune thyroiditis; Psoriasis, treated with methotrexate
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IL2017GSK201506

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of death in a adult male patient who received FLUARIX TETRA (batch number AFLBA279AA, expiry date 31st August 2018). Concurrent medical conditions included hypertension, Hashimoto''s disease and psoriasis (treated with Methotrexate). On 7th December 2017, the patient received FLUARIX TETRA (intramuscular). On 19th December 2017, 12 days after receiving FLUARIX TETRA, 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 19th December 2017. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death to be related to FLUARIX TETA. Additional details were provided as follows: This report was received via the Epidemiological Department in the Agency. The age at vaccination was not reported. The patient was treated with Methotrexate for psoriasis (unknown if concomitant or historical drug). Cause of death was not reported. Since this was the second death report on FLUARIX TETRA vaccination with the same batch number, and in both cases the patients were vaccinated in the same clinic, the Agency requested information from the manufacturer on death cases and severe events reported globally on FLUARIX TETRA vaccine in general, and on this batch in particular; also, whether this batch was marketed in other countries. The Agency would update if additional information was received. No regulatory authority reference number was provided. This case was linked with the case IL2017GSK201505, reported by the same reporter. Upon internal review following correction was performed on 27th December 2017: This case is not linked with case IL2017GSK201505, case linking has been removed.


VAERS ID: 738261 (history)  
Form: Version 1.0  
Age: 100.0  
Sex: Female  
Location: Foreign  
Vaccinated:2017-11-15
Onset:2017-12-14
   Days after vaccination:29
Submitted: 2018-02-16
   Days after onset:64
Entered: 2018-02-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS AFLBA221AA / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-12-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tilidin
Current Illness: Renal failure, grade IV; Dementia; Pain
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2018GSK025854

Write-up: This case was reported by a physician and described the occurrence of stroke in a 100-year-old female patient who received INFLUSPLIT TETRA (batch number AFLBA221AA, expiry date unknown). Concurrent medical conditions included renal insufficiency (grade IV), dementia and pain. Concomitant products included Tilidin. On 15th November 2017, the patient received the 1st dose of INFLUSPLIT TETRA (intramuscular). On 14th December 2017, 29 days after receiving INFLUSPLIT TETRA, the patient experienced stroke (serious criteria death and GSK medically significant). On an unknown date, the outcome of the stroke was fatal. The patient died on 14th December 2017. The reported cause of death was stroke. An autopsy was not performed. The reporter considered the stroke to be unlikely related to INFLUSPLIT TETRA. Additional details were provided as follows: The patient received INFLUSPLIT TETRA on the left upper arm. No treatment was performed. Tilidin was applied permanently. This is one of the 9 linked cases reported by same reporter.


VAERS ID: 738344 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2017-11-15
Onset:2017-12-10
   Days after vaccination:25
Submitted: 2018-02-19
   Days after onset:71
Entered: 2018-02-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS AFLBA221AA / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-12-14
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BALDRIAN
Current Illness: Asthma; 2015, Breast cancer, from 2015, the source document it remained unclear whether the breast cancer was still persistent; Sleep disorder; Hypertension
Preexisting Conditions: KADCYLA; Neoplasm, until end of 2016 the patient received Kadcyla for tumor therapy
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2018GSK025845

Write-up: This case was reported by a physician and described the occurrence of acute cardiac insufficiency in a 83-year-old female patient who received INFLUSPLIT TETRA (batch number AFLBA221AA, expiry date unknown). Previously administered products include Kadcyla (until end of 2016 the patient received Kadcyla for tumor therapy). Concurrent medical conditions included asthma, breast cancer (from 2015, the source document it remained unclear whether the breast cancer was still persistent), sleep disorder and hypertension. Concomitant products included valeriana officinalis (Baldrian). On 15th November 2017, the patient received the 1st dose of INFLUSPLIT TETRA (intramuscular). On 10th December 2017, 25 days after receiving INFLUSPLIT, the patient experienced acute cardiac insufficiency (serious criteria death and GSK medically significant). On 14th December 2017, the outcome of the acute cardiac insufficiency was fatal. The patient died on 14th December 2017. The reported cause of death was acute cardiac insufficiency. An autopsy was not performed. The reporter considered the acute cardiac insufficiency to be unlikely related to INFLUSPLIT. Additional information was provided as follows: The patient was administered INFLUSPLIT on left upper arm. No treatment was performed. The patient''s concomitant products included Baldrian and Rami which were applied permanently. This is 1 of the 10 linked cases, reported by the same reporter.


VAERS ID: 738258 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2017-11-22
Onset:2017-12-02
   Days after vaccination:10
Submitted: 2018-02-16
   Days after onset:76
Entered: 2018-02-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS AFLBA221AA / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-12-04
   Days after onset: 2
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: Spironolactone; Bisoprolol; ASA
Current Illness: Diabetes mellitus; Hypertension
Preexisting Conditions: 2015, Cerebrovascular accident
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2018GSK025817

Write-up: This case was reported by a physician and described the occurrence of myocardial infarction in a 81-year-old male patient who received INFLUSPLIT TETRA (batch number AFLBA221AA, expiry date unknown). The patient''s past medical history included stroke. Concurrent medical conditions included diabetes (type IIB) and hypertension. Concomitant products included spironolactone, bisoprolol and ASA. On 22nd November 2017, the patient received the 1st dose of INFLUSPLIT TETRA (intramuscular). On 2nd December 2017, 10 days after receiving INFLUSPLIT TETRA, the patient experienced myocardial infarction (serious criteria death, hospitalization and GSK medically significant). On 4th December 2017, the outcome of the myocardial infarction was fatal. The patient died on 4th December 2017. The reported cause of death was myocardial infarction. An autopsy was not performed. It was unknown if the reporter considered the myocardial infarction to be related to INFLUSPLIT TETRA. Additional details were provided as follows: The patient was treated in intensive care unit. The patient received INFLUSPLIT TETRA on left deltoid. Spironolactone, Bisoprolol and ASA were applied permanently. This was one of the 9 cases, reported by the same reporter.


VAERS ID: 738256 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2017-11-06
Onset:2017-11-22
   Days after vaccination:16
Submitted: 2018-02-16
   Days after onset:86
Entered: 2018-02-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS AFLBA221AA / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-11-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ramipril; Amlodipine; Clopidogrel
Current Illness: Renal failure, grade III; Hypertension; Anaemia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2018GSK025850

Write-up: This case was reported by a physician and described the occurrence of stroke in a 81-year-old male patient who received INFLUSPLIT TETRA (batch number AFLBA221AA, expiry date unknown). Concurrent medical conditions included renal insufficiency (grade III), hypertension and anemia. Concomitant products included ramipril, amlodipine and clopidogrel. On 6th November 2017, the patient received the 1st dose of INFLUSPLIT TETRA (intramuscular). On 22nd November 2017, 16 days after receiving INFLUSPLIT TETRA, the patient experienced stroke (serious criteria death and GSK medically significant). On an unknown date, the outcome of the stroke was fatal. The patient died on 22nd November 2017. The reported cause of death was stroke. An autopsy was not performed. The reporter considered the stroke to be unlikely related to INFLUSPIT TETRA. Additional details were provided as follows: Ramipril, Amlodipine and Clopidogrel were applied permanently. The patient received INFLUSPLIT TETRA on the left upper arm. No treatment was performed. This is one of the 9 linked cases reported by same reporter.


VAERS ID: 731941 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2017-11-17
Onset:2017-11-20
   Days after vaccination:3
Submitted: 2017-12-24
   Days after onset:34
Entered: 2017-12-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 178102 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Death, Guillain-Barre syndrome, Monoparesis, Polyneuropathy, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (broad), Respiratory failure (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-12-10
   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:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201703592

Write-up: This serious initial spontaneous case, was received from a physician via health authority (RNF: IT-IT-MINISAL02-442255) on 14-Dec-2017, concerning a 77-year-old, elderly male patient. On 17-Nov-2017, the patient was administered with AGRIPPAL (dose: 0.5 ml, batch number: 178102, route of administration, anatomical location, expiry date: 31-Jul-2018). On 20-NOV-2017, after 4 days of vaccination, the patient had respiratory arrest, hyposthenia, polyneuropathy, Guillain Barre syndrome and limb paresis. On 10-Dec-2017, the patient died and it was unknown whether the autopsy was performed or not. The reporter assessed the events as serious due to death.


VAERS ID: 753093 (history)  
Form: Version 1.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2017-11-15
Onset:2017-11-19
   Days after vaccination:4
Submitted: 2018-06-06
   Days after onset:198
Entered: 2018-06-13
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS 177602 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute pulmonary oedema, Autopsy, Death
SMQs:, Cardiac failure (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-11-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Amlodipine; Esomeprazole; TRIATEC HCT
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201703218

Write-up: This is a serious spontaneous case, initially received from health authority (reported to health authority by a physician) (IT-MINISAL02-439043) on 24-Nov-2017 and concerns a 63-year-old, adult, female patient. Patient''s historical condition was not reported. The patient had no known allergies. Concomitant medications included: esomeprazole, TRIATEC HCT and amlodipine for an unknown indication. On 15-Nov-2017, at 16:45 hours, the patient received AGRIPPAL S1 (dose: 0.5 ml, route of administration: intramuscular, batch number: 177602, anatomical location and expiry date: not reported). On 19-Nov-2017 (in the morning), after 5 days of administration of vaccine, the patient was found dead on bed. It was reported that, autopsy was performed, and cause of death was reported as acute pulmonary oedema. The reporter assessed this case as serious (fatal) and the causality as not related to the suspect vaccine. Follow up report received via health authority on 22-Dec-2017: The patient''s age was added. The indication, route of administration, and vaccination date of the suspect vaccine was added. It was reported that, autopsy was performed, and cause of death was acute pulmonary oedema. The narrative was amended accordingly. Non-significant follow-up received via health authority (IT-MINISAL02-439043) on 08-Jan-2018: The patient had no known allergies. It was reported that the patient was not hospitalized. On 19-Nov-2017 (In the morning), the patient was found dead on bed. The narrative was amended accordingly. Follow-up received from health authority (reported to health authority by a physician) (IT-MINISAL02-439043) on 17-Jan-2018: "As reported causality" was changed from related to not related (in the event assessment tab). The narrative was amended accordingly. Follow-up received from health authority (reported to health authority by a physician) (IT-MINISAL02-439043) on 08-Jan-2018: No new information was available. Hence, no updates were made to the narrative. Non-significant case correction received with agency 24-Nov-2017: The case comment was amended. No changes were made in the narrative. Case Comment: The patient had concomitant medications that were suggestive of pre-existing cardiac condition/and associated diuretic. Medical history is deficient, but sudden death with autopsy suggestive of pulmonary edema suggest pre-existing cardiac condition. Time to onset is 5 days. Based on the available information, the company assesses the event death is not related to vaccine as it can be attributed to underlying medical condition. Further details regarding clinical status of the subject at the time of vaccination, any symptoms before the death, any known medical allergies or medical conditions and details on concomitant medications, are needed for complete assessment.


VAERS ID: 728208 (history)  
Form: Version 2.0  
Age: 5.0  
Sex: Male  
Location: Foreign  
Vaccinated:2017-11-15
Onset:2017-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2017-11-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUENZ TETRA) / MEDIMMUNE VACCINES, INC. JJ2612 / UNK NS / IN

Administered by: School       Purchased by: ?
Symptoms: Death, Lymphadenopathy, Oropharyngeal pain, Peripheral coldness, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-11-18
   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:
Preexisting Conditions: Medical History/Concurrent Conditions: Febrile convulsion (at the age of 18 months); Tonsillitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBAstraZeneca2017SF19265

Write-up: A spontaneous report has been received from a Pharmacist concerning 5 years 1 month old, male patient. The patient''s medical history included tonsillitis and was under ENT secondary medical care and febrile convulsion at the age of 18 months. Patient concurrent diseases and concomitant drugs are not provided. The patient received nasal FLUENZ TETRA (intranasal) (Batch number: JJ2612, expiry date: 15-Jan-2018) on 15-Nov-2017 and administered at a school. On Thursday and Friday (16th-17th) the patient complained of a sore throat but was still in school, the mother also said in relation to this that the child''s ''glands were up''. On Friday the mother gave the child ibuprofen and was ''ok'' and was then placed on bed. The mother checked in on the child at midnight and did not notice anything untoward. On Saturday (18-Nov-2017) morning at 9 AM, the mother went to the child and found he was cold and non-responsive and that he had passed away. The HCP stated that he believed the child might have been pronounced or assumed dead at the scene as no attempt of CPR was made. The date for a post mortem had not been set yet. The HCP said that given this new information he no longer thought it could have been anaphylaxis due to the length of time that had passed after administration and before the death. He also stated that he thought it more likely to be a patient specific event rather that a batch issue and he would not be quarantined any further vaccines to come in. The patient died on 18-Nov-2017 and the outcome of the event of sore throat was unknown. The cause of death was unknown. It was unknown if an autopsy was performed. The reporter assessed death as serious with fatal outcome. The company Physician assessed the event sore throat to be non-serious.; Sender''s Comments: This case concerns a male patient of 5 years, with reported fatal outcome with Q/LAIV (FLUENZ TETRA). Cause of death was further not specified. Due to limited information on concurrent conditions, cause of death, circumstances leading to death and autopsy details, it is not possible to make a conclusive assessment of the causal relationship of the fatal outcome with the suspect drug. Follow up information is being requested to make the case more complete and enable the assessment of the relationship.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH.


VAERS ID: 729268 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2017-11-16
Submitted: 2017-11-29
   Days after onset:13
Entered: 2017-12-03
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Angioedema, Death, Erythema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic 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: Pantoprazole; Losartan; Cardioaspirin; AZARGA; EUTIROX; EZETROL; DEURALL
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201703169

Write-up: This initial serious spontaneous case, was received on 23-Nov-2017, from a physician, via health authority (IT-MINISAL02-438383) concerning a female patient of unspecified age. The concomitant medications included pantoprazole, losartan, cardioaspirin, AZARGA, EUTIROX, EZETROL and DEURSIL. On an unspecified date, the patient was administered with AGRIPPAL S1 (dose: 1 dose (as reported), route of administration, anatomical location, batch number, expiry date: not reported). On 16-Nov-2017, the patient developed giant hives, erythema diffuse and angioedema. On an unspecified date, the patient deceased.


VAERS ID: 738220 (history)  
Form: Version 1.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2017-10-25
Onset:2017-11-14
   Days after vaccination:20
Submitted: 2018-02-16
   Days after onset:94
Entered: 2018-02-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS AFLBA221AA / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-11-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2018GSK025867

Write-up: This case was reported by a physician and described the occurrence of bronchitis in a 94-year-old female patient who received INFLUSPLIT TETRA (batch number AFLBA221AA, expiry date unknown). On 25th October 2017, the patient received the 1st dose of INFLUSPLIT TETRA (intramuscular). On 14th November 2017, 20 days after receiving INFLUSPLIT TETRA, the patient experienced stroke (serious criteria GSK medically significant). On an unknown date, the patient experienced bronchitis (serious criteria death). The patient was treated with azithromycin. On 14th November 2017, the outcome of the bronchitis was fatal. On an unknown date, the outcome of the stroke was not recovered/not resolved. The patient died on 14th November 2017. The reported cause of death was bronchitis. An autopsy was not performed. It was unknown if the reporter considered the bronchitis to be related to INFLUSPLIT TETRA. The reporter considered the stroke to be unlikely related to INFLUSPLIT TETRA. Additional details were provided as follows: The patient had no underlying disease or risk factors. The patient received INFLUSPLIT TETRA in the left upper arm. Less than a month after vaccination, the patient experienced bronchitis. Bronchitis was reported as cause of death. Treatment was not performed. The start date for bronchitis was reported. This is 1 of 9 cases, reported by the same reporter.


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

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

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

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


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

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

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

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


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

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

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

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


VAERS ID: 726306 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2017-11-06
Onset:2017-11-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2017-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. M047755 / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-11-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CN0095075131711CHN002992

Write-up: This spontaneous report was received from a physician regarding a 49 year old female patient. The patient''s medical history, concurrent condition and concomitant therapy were not reported. On 06-NOV-2017, the patient was vaccinated with PNEUMOVAX (strength, frequency, route of administration were not reported) lot# M047755, expiry date: 26-MAY-2018. In the morning on 06-NOV-2017, the patient was also inoculated with influenza virus vaccine (strength, frequency, route of administration, lot#, expiry date were not reported) for prophylaxis. On 06-NOV-2017, the patient died. It was unknown whether autopsy was performed.


VAERS ID: 738342 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2017-10-13
Onset:2017-11-03
   Days after vaccination:21
Submitted: 2018-02-19
   Days after onset:108
Entered: 2018-02-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS AFLBA221AA / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-11-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ramipril; ASS 100; Simva 40
Current Illness: Coronary artery disease; Lipids; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2018GSK025848

Write-up: This case was reported by a physician and described the occurrence of unknown cause of death in a 73-year-old male patient who received INFLUSPLIT TETRA (batch number AFLBA221AA, expiry date unknown). Concurrent medical conditions included coronary heart disease, lipids and hypertension. Concomitant products included ramipril, ASS 100 and Simva 40. On 13th October 2017, the patient received the 1st dose of INFLUSPLIT TETRA (intramuscular). On 3rd November 2017, 21 days after receiving INFLUSPLIT TETRA, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The patient died on 3rd November 2017. The reported cause of death was unknown cause of death. An autopsy was not performed. The reporter considered the unknown cause of death to be unlike related to INFLUSPLIT TETRA. Additional information was provided as follows: The concomitant products Ramipril, ASS 100 and Simva 40 were applied permanently. The patient was administered INFLUSPLIT TETRA on left upper arm. No treatment was performed. The discrepant information was reported, the reporter ticked both boxes unlikely and unknown for causality assessment (causality was updated as per the other linked cases). This is one of the 10 linked cases, reported by the same reporter.


VAERS ID: 728062 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2017-11-01
Onset:2017-11-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2017-11-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Malaise
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Blood pressure high; Diabetes; Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HK0095075131711HKG005901

Write-up: This spontaneous report was received from a physician via a company representative and refers to an around 80 year old patient of unknown gender. The patient''s concurrent conditions included diabetes and high blood pressure. There was no information about the patient''s medical history and concomitant medications provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiry date were not provided) and with unspecified flu vaccine (dose, route of administration, lot # and expiry date were not provided) at the same time. On an unknown date, the patient felt very tired and unwell and get into hospital after suspect vaccines injection. The physician asked if the adverse effect increased after both vaccine being given at the same time. The outcome of the events was unknown. The relatedness between the events and ZOSTAVAX was not reported.


VAERS ID: 730790 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2017-10-27
Onset:2017-10-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2017-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER N23N / UNK UN / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. N008420 / UNK UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-10-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Alzheimer''s disease; Immunisation; Vaccination
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NO0095075131712NOR003779

Write-up: Information has been downloaded from Agency (NO-NOMAADVRE-FHI-2017-00083). This spontaneous report as received from a physician refers to a 86-year-old female patient with Alzheimer''s disease. On 27-OCT-2017, the patient was vaccinated with PNEUMOVAX, 0.5 ml, subcutaneously, lot # N008420, (expiration date was unknown). On 27-OCT-2017, the patient was also vaccinated with INFLUVAC injection, intramuscularly, 0.5 ml, batch/lot # N23N. On 28-OCT-2017, the patient suddenly died. It was unknown if an autopsy was performed. Sender''s Comments: Reporter Comments: 02-NOV-2017, NIPH: Additional information will be requested. This is a preliminary report. Sender Comments: V?r ref.: 17/713.


VAERS ID: 753091 (history)  
Form: Version 1.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2017-10-20
Onset:2017-10-23
   Days after vaccination:3
Submitted: 2018-05-31
   Days after onset:220
Entered: 2018-06-13
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 35949421A / UNK UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arrhythmia, Blood count normal, Bronchitis, Death, Dyspnoea, General physical health deterioration, Red blood cell sedimentation rate
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-10-24
   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: Torasemide; Ramipril; Trimipramina; UBRETID; Pantoprazole; Tamsulosin; SEEBRI; Domperidone; Spironolactone; Levomepromazine
Current Illness:
Preexisting Conditions: Pulmonary embolism; Nicotine abuse; 31-May-2018 16:04, Meningitis; Oligophrenia (intellectual disability); COPD; Cardiac disorder; Cardiomyopathy; Schizophrenia; Renal insufficiency
Allergies:
Diagnostic Lab Data: 2On 23-Oct-2017: Pulmonary physical examination was performed, results were not reported. On same day, the subject''s count found to be normal; 3-OCT-2017, Red blood cell sedimentation rate inconclusive, 2mm/1h
CDC Split Type: 201703116

Write-up: This initial serious case, received on 14-Nov-2017, reported by other health professional via health authority (DE-PEI-PEI2017096532) and concerns a 59-year-old, adult, male patient (weight 82.0kg and 198 cm). The historical conditions included meningitis, schizophrenia, nicotine abuse and pulmonary embolism, COPD, cardiac disorder, cardiomyopathy, oligophrenia all from an unspecified date. The patient''s current condition included renal insufficiency (renal insufficiency grade III) (since unspecified date). The patient''s concomitant medications included: Torasemide, ramipril, Trimipramina, UBRETID, pantoprazole, Tamsulosin, SEEBRI, Domperidone, Spironolactone and Levomepromazine. On 20-Oct-2017, the patient was administered with AFLURIA (TIV) (route of administration: subcutaneous, batch number:35949421A, dose: (reported as 1 separate dose), anatomical location, expiry date: not reported). On 23-Oct-2017, 3-4 days (as reported) after vaccination, the patient experienced bronchitis, dyspnea and had afflicted general condition. On the same day, the patient''s blood count was normal, red blood cell sedimentation rate showed 2mm/1h and pulmonary physical examination was performed and results were not reported. On 24-Oct-2017, the patient experienced cardiac arrhythmia. The patient''s treatment measures included inhalation budesonide and inhalation short acting beta agonist (SABA). On the same day (24-Oct-2017) the patient died. The cause of death reported was cardiac arrhythmia. It was reported that, autopsy was not performed. The outcome of the events was reported as fatal. The reporter assessed the causality of the events as unassessable (unclassifiable). The health authority assessed this case as serious (death). Follow up received from a physician via health authority (DE-DCGMA-17175422) on 24-Nov-2017: Added patient''s demographics (weight and height), updated medical history (from current conditions to historical conditions COPD, cardiac disorder, cardiomyopathy, oligophrenia), changed event verbatim of the event reduced general condition to afflicted general condition, changed reported causality from not reported to unassessable. Updated narrative accordingly.


VAERS ID: 735472 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2017-10-16
Onset:2017-10-16
   Days after vaccination:0
Submitted: 2018-01-26
   Days after onset:102
Entered: 2018-01-28
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 179901 / UNK UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Incorrect route of drug administration
SMQs:, Drug abuse and dependence (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-10-17
   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: candesartan; nebivolol; nifedipine; XARELTO
Current Illness:
Preexisting Conditions: Metastatic melanoma; Dementia; Hypertonia; Apoplexy
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201800140

Write-up: This is a spontaneous case, initially received on 21-Jan-2018, was reported by a physician and concerns a 75-year-old, elderly, male patient. The patient''s historical conditions included metastasizing melanoma, dementia, hypertonia and apoplexy (on unspecified dates). The concomitant medications included candesartan, nebivolol, nifedipine, XARELTO for unknown indications. It was reported that, the patient had was administered FLUAD vaccine in the past and it was tolerated. On 16-Oct-2017, the patient was administered with FLUAD (TIV) (route of administration: subcutaneous, batch number: 179901, dose, anatomical location, expiry date) for an unknown indication (explicitly considered as inappropriate route of vaccination). It was reported that, the vaccine was stored according to the regulations. On 17-Oct-2017, after 2 days of vaccination, the patient passed away (died). The cause of death was not reported. It was unknown whether autopsy was performed. The reporter assessed this case as serious (fatal).


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

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

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

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


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

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

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

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


VAERS ID: 722211 (history)  
Form: Version 1.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2017-10-11
Onset:2017-10-11
   Days after vaccination:0
Submitted: 2017-10-20
   Days after onset:9
Entered: 2017-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic shock, Death, Dyspnoea, Hypersensitivity
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-10-14
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Influenza vaccine, received vaccine past years
Allergies:
Diagnostic Lab Data:
CDC Split Type: GR2017GSK159697

Write-up: This case was reported by a pharmacist via other and described the occurrence of allergic reaction in a 92-year-old female patient who received FLUARIX TETRA. Previously administered products included Flu vaccine (received vaccine past years). On 11th October 2017, the patient received FLUARIX TETRA. On 11th October 2017, less than an hour after receiving FLUARIX TETRA, the patient experienced allergic reaction (serious criteria death), allergic shock (serious criteria death and GSK medically significant) and dyspnea (serious criteria hospitalization). On an unknown date, the outcome of the allergic reaction and allergic shock were fatal and the outcome of the dyspnea was unknown. The patient died on 14th October 2017. The reported cause of death was allergic reaction and allergic shock. It was unknown if the reporter considered the allergic reaction, allergic shock and dyspnea to be related to FLUARIX TETRA. Additional details were reported as follows: The patient received FLUARIX TETRA and in an hour, the patient presented dyspnea, transferred to the hospital, where the symptom attributed to an allergic reaction from the vaccine. The patient was hospitalized, presented improvement but on the 3rd day the patient was died. All the above information came from the relatives of the patient via the pharmacist. No more information was available.


VAERS ID: 752841 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Florida  
Vaccinated:2017-10-03
Onset:2017-10-08
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2018-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR - / UNK RA / UN

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthropathy, Blood test normal, Chronic inflammatory demyelinating polyradiculoneuropathy, Death, Grip strength decreased, Muscular weakness, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Pain, Periarthritis, Resuscitation, Vaccination complication, Weight decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Arthritis (narrow), Tendinopathies and ligament disorders (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-01-22
   Days after onset: 106
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CENTRUM SILVER; Vitamin C; Fish Oil; Low-Dose Aspirin
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: Blood work-normal 10-23-17; Complete physical-normal 10-23-17; MRI 10-25-17 mild arthropathy
CDC Split Type:

Write-up: By October 8th patient felt extreme shoulder pain. On 10/23/17 appt. with Dr. - given 10-23-17 appt. with Dr.-given complete physical. Diagnosis: frozen shoulder. Five additional appointments - condition appointments-condition worsened. Twelve appointments with PT - no Therapist-no improvement. Pain spread throughout body, limb weakness, weight loss, could not hold eating utensils. Doctor and Physical Therapist Providers both recommended neurology group/no appt. until 02-03-18 apt until 2-03-18 died waiting. My husband was an active active, robust man until this vaccine shot. He weighed 175 pounds on October 1st, 2017, and at his last appointment on January 3rd, 2018, he registered 150 pounds. He could not hold a fork or juice glass. Both Dr. and Therapist said they could no longer help him and recommended the Neurologist Neurologists the first week in January. His appointment was set for February 3rd and he called every day to see if there was a cancellation; but he died 10 ten days before. He awakened at 1:00 to use the bathroom. When his legs gave out, I called 911 and did chest thrusts. The ambulance took him to the Hospital hospital where he died within one hour. Therapist said from his first appointment, on November 15th, that the cause was the flu shot. All symptoms point to Chronic Inflammatory Demyelinating Polyneuropathy. Here is a strong man who had never been hospitalized since a tonsillectomy at age 5 who dies from a vaccination designed to keep him healthy. What are the statistics of death from a flu shot? What compensation for wrongful death is covered by the FDA? Pharmacy certainly shuns responsibility for having an inexperienced girl administer the shot. I think there should be a precise warning given at the time of the shot, shot as opposed to the generic list of possible side effects. We wasted months treating a frozen should shoulder rather than see seeing a neurologist. I have saved all receipts and reports in my file. And you are welcome to verify husband''s patient''s physical condition from any of the 136 units in our condo who saw him walking daily, fishing, playing tennis, etc. You can also check with our neighbors who saw him boating, cycling, gardening, etc. etc.. One week before the vaccination he drove 1600 miles (with overnight stops along the way, of course). I will, and do, miss my loving husband of fifty three years-as years - as do our children and his twin sister. It is a difficult time for all of us.


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

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

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

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


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

Administered by: Private       Purchased by: ?
Symptoms: Adenovirus infection, Blood uric acid increased, Brain death, Dyspnoea, Hypotonia, Lethargy, Muscle spasms, Pyrexia, Resuscitation, Rhinovirus infection, Skin warm, Ultrasound kidney
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-09-29
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Bacolfen; Omeprazole; Total probiotic ?; NUTRI-WEST
Current Illness: On September 11th pts Neurologist called to say he was confident pt has Lesch Nyhan Syndrome after we did genetic testing, but he wanted to check pts Uric acid levels. We did, so on Sept. 12th and his uric acid levels were 9.2. On Sept. 14th when pt had his appointment with his Dr who gave him his vaccines, I told him pt was most likely going to be diagnosed with LNS, but his neurologist wanted to see where his uric acid levels were. Pt was given the rotavirus 1 and the influenza 1 On September 18th pt was officially diagnosed with LNS
Preexisting Conditions:
Allergies: none
Diagnostic Lab Data: I have all the records.
CDC Split Type:

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


VAERS ID: 753089 (history)  
Form: Version 1.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2017-08-31
Onset:2017-09-11
   Days after vaccination:11
Submitted: 2018-05-17
   Days after onset:248
Entered: 2018-06-13
   Days after submission:27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 098637403 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood immunoglobulin E normal, Cardiac failure, Death, Immunodeficiency, Leukaemia, Pneumonia, Pyrexia, Tryptase
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2017-09-15
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: 22-DEC-2016 to Unknown, Stem cell transplant, stem cell therapy; Unknown to Ongoing, Myelodysplastic syndrome, with excessive blasts
Allergies:
Diagnostic Lab Data: Biochemical investigation: Tryptase and IgE were in the lower laboratory reference range so that an allergic reaction to the vaccine can be excluded.
CDC Split Type: 201701620

Write-up: This serious spontaneous case, was received via Health Authority (DE-PEI-PEI2017080148) on 19-Sep-2017, concerning a 59-year-old, adult, male patient. The patient''s current condition included myelodysplastic syndrome with excessive blasts (since an unspecified date). The patient underwent stem cell transplant on 22-Dec-2016. On 31-Aug-2017, the patient was administered with AFLURIA TIV (dose: 0.5 ml (reported as 1 separate dose), route of administration: intramuscular, batch no: 098637403 (reported as 37403), anatomical location and expiry date: not reported). On 11-Sep-2017, the patient was administered with non-company suspect vaccine REPEVAX (route of administration: intramuscular, batch no: reported as KIA83, (reported as 1 separate dose), anatomical location, and expiry date: not reported). On 11-Sep-2017, after 12 days of vaccination with influenza vaccine, the patient got fever up-to 39 degrees Celsius and his condition worsened. On 12-Sep-2017, after 13 days of vaccination, the patient also developed fatal immunodeficiency/acute immunodeficiency with clinically known leukemia which lasted for 03 days (up to 15-Sep-2017). On 15-Sep-2017, after 18 days of vaccination, the patient also developed Pneumonia and decompensation cardiac. It was reported that, the patient required treatment without hospitalization. The patient died on 15-Sep-2017. On 19-Sep-2017, an autopsy was performed at 09:05 o''clock, on external inspection it showed, ears were formed regularly before and behind the ears there were no irregularities and the external auditory canals were free, no abnormalities or injuries on either wrist surface and both upper arms were without injury and conspicuousness. Internal inspection of cranial cavity showed, no severances of tissue connections or haemorrhages are discernible. The meninges were delicate and free of leaked blood. The so-called cap incision shows the regular anatomical structure of the cerebrum. In the cerebrum and mesencephalon, a distinct pressure cone, as well as flattened cerebral convolutions and blurred furrows was seen. The cardiac cavities as well as the vessels close to the heart were found to contain liquid as well as loosely clotted blood or corpse clots. The foramen ovale was closed. Circumference of the aortic valve was 75 mm, circumference of the mitral valve was 105 mm, circumference of the tricuspid valve was 130 mm, circumference of the pulmonary valve was 90 mm. Ventricular wall thickness dextrally was 3 mm, sinistrally was 18 mm. Heart weight was 410 g. In the anterior descending branch of the left coronary artery, individual fat deposits and low-degree calcifications were visible, which do not obstruct the lumina to a significant degree. Both lungs were large and heavy, the left lung weight 865 g, the right one 815 g. The pleura was delicate and reflective, but of a dark red-blue colour. The spleen was somewhat enlarged; it weight 270 g and had a smooth, reflective capsule. In the stomach, 20 mL of brownish liquid. No crystalline components or tablet residues were found. There were no inflammatory changes or haemorrhages present in the gastric mucosa. In the rectum, greenish pasty faeces. The mucous membrane of the intestine had some blackish discoloration of approximately pinhead size. The renal pelvises were seen with moderate growth of fat, free of inflammatory changes or haemorrhages. The aorta was of regular width in the thoracic section, it showed some fat deposits and only a few calcifications. Major autopsy findings showed massive congestion in the heart and the vessels near the heart, as well as the internal organs. Massively manifest haemorrhagic pulmonary oedema with over hydration and congestion of the pulmonary tissue. Development of a so-called upper inflow congestion with post-mortem lividity in the face as well as the carotid side of the neck, spread out to the chest like a collar. The necropsy provided evidence of cardiac decompensation of unclear genesis underlying the demise. Autopsy was ended at 10:05 o''clock. The autopsy revealed no injection sites, especially no vaccination sites. An acute shock reaction (acute anaphylactic shock of the immediate type) can be excluded due to the temporal relationships between vaccination and death, and the described symptoms. The onset of fever after vaccination that occurred as part of a vaccination reaction, was primarily due to the immune response to the vaccine and does not yet constitute an "allergic" reaction or adverse drug reaction. Nonetheless, to exclude a possible injury from immunisation or an unwanted allergic reaction to the vaccine, biochemical examination of the blood obtained during the autopsy for increased IgE and tryptase values was recommended. The biochemical laboratory markers tryptase and IgE were in the lower laboratory reference range, so that an allergic reaction to the vaccine can be excluded. Subject died because of acute immune deficiency in a condition of clinically known leukemia in a status post stem cell transplantation. For this reason, a bone marrow smear was prepared and a bone marrow chip retained, which can be further examined if necessary. Alternatively, viral inflammation of the pulmonary tissue (viral pneumonia) or another (viral) infection could also be considered as a cause of death, given the pronounced macro-morphologic pulmonary findings. However, these possibilities are unrelated to a vaccination three day before the death. Cause of death was reported as acute cardiac decompensation in case of suspected pulmonary inflammation. Besides cardiac decompensation, the forensic pathologists also speculated that the patient may have died of an acute immunodeficiency, viral pneumonia or viral infection. Manner of death was most likely natural death. The health authority considered this case as serious (death and life threatening). Follow up report received from Health Authority on 22-Sep-2017: The indication of the co-suspect REPEVAX was changed from myelodysplastic syndrome to prophylactic vaccination. Batch no for co-suspect REPEVAX was added. Description to be coded for the event was changed from decreased immune responsiveness to immunocompromised. The cause of death was updated from unknown causes of death to immunodeficiency. It was reported that, the patient required outpatient treatment without hospitalization. The narrative was amended accordingly. Non-significant follow-up received on 11-Oct-2017: No new information received. Non-significant case correction received on 18-Oct-2017: Suspect vaccine AFLURIA QUAD was changed to AFLURIA TIV in narrative. Significant case correction received on 18-Oct-2017: Batch no. of AFLURIA (TIV) was updated to 098637403 and narrative was amended accordingly. Follow up report received on 16-Oct-2017: Added new events as fever, decompensation cardiac, condition worsened, Pneumonia and Immunodeficiency. On 19-Sep-2017, an autopsy was performed and the results were updated. The narrative was amended accordingly. Significant case correction received with IRD 22-Sep-2017: The "Drug Not Administered" field was unchecked in product tab. Case Comment: This case concerns a 59 year old male patient with a history of myelodysplastic syndrome, had died due to fatal immunodeficiency, pneumonia, fever and acute cardiac decompensation, 16 days after receiving a dose of AFLURIA vaccine. Considering the underlying medical condition of myelodysplastic syndrome and available information, the causal role of company suspect vaccine is unlikely. Hence, the causality of events was assessed as not related.


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

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

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

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-08-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Voltaren 1% gel; levothyroxine; metoprolol ER; prednisone
Current Illness: No known
Preexisting Conditions: No known
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

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


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

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

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

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


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

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

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

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


VAERS ID: 777077 (history)  
Form: Version 2.0  
Age: 1.33  
Sex: Male  
Location: California  
Vaccinated:2017-02-14
Onset:2017-02-28
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2018-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5157AA / 4 LL / IM
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR U5359DA / 2 RL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 37H34 / 3 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. M034188 / 4 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N55175 / 4 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-02-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Passing.


VAERS ID: 688233 (history)  
Form: Version 1.0  
Age: 1.67  
Sex: Male  
Location: Colorado  
Vaccinated:2017-02-23
Onset:2017-02-24
   Days after vaccination:1
Submitted: 2017-03-27
   Days after onset:30
Entered: 2017-03-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UT5663JA / 3 LL / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 9TS3T / 2 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-02-24
   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: Clotrimazole cream 1% for diaper rash
Current Illness: none
Preexisting Conditions: hypospadias
Allergies:
Diagnostic Lab Data: autopsy completed with cause of death classified as undetermined
CDC Split Type:

Write-up: Death; patient was discovered unresponsive, prone in crib.


VAERS ID: 675986 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Montana  
Vaccinated:2016-12-29
Onset:2016-12-30
   Days after vaccination:1
Submitted: 2016-12-30
   Days after onset:0
Entered: 2016-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS TB7KY / 3 RL / IM
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UT55835SA / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R12276 / 3 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-12-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt deceased of suspected SIDS on the day following administration of routine 6 month vaccines as well as flu shot.


VAERS ID: 674701 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Male  
Location: California  
Vaccinated:2016-12-21
Onset:2016-12-21
   Days after vaccination:0
Submitted: 2016-12-25
   Days after onset:4
Entered: 2016-12-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI658AB / UNK RA / SYR

Administered by: Unknown       Purchased by: Private
Symptoms: Atrial fibrillation, Death, Dyspnoea, Heart rate increased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-12-23
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Aspirin, furosemide, potassium chloride CR, Lactobacillus PO, Magnesium oxide, atorvastatin, COMBIGAN, Duloxetine, Fluoxetine, ICAPS, isosorbide mononitrate, Latanoprost, metoprolol tartrate, nystatin.
Current Illness: Heart problems, Kidney problems, cold.
Preexisting Conditions: Acute On Chronic Systolic Congestive Heart Failure
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Difficulty in breathing, a fast heartbeat, and AFIB. Taken to the emergency room and patient died within 2 days.


VAERS ID: 678236 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Female  
Location: Ohio  
Vaccinated:2016-12-08
Onset:2016-12-14
   Days after vaccination:6
Submitted: 2017-01-16
   Days after onset:33
Entered: 2017-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (AFLURIA QUADRIVALENT) / SEQIRUS, INC. WTS005 / UNK RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Autoimmune disorder, Cold type haemolytic anaemia, Feeling abnormal, Nasopharyngitis, Skin discolouration
SMQs:, Haemolytic disorders (narrow), Dementia (broad), Hypotonic-hyporesponsive episode (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-12-26
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: none known of~ ()~~0.00~Patient
Other Medications: Multi Vitamin and aspirin daily. No prescriptions. Occasional Claritin.
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: She was diagnosed at facility with the rare Auto Immune disorder which can be triggered by a virus. She was on no medications and was healthy and independent.
CDC Split Type:

Write-up: Felt that she was getting a cold but had no fever, just didn''t feel right. By 12/21/2016 she was taken emergently to ER with blackened hands and feet, an AUTO IMMUNE REACTION called cold agglutinin. She was diagnosed at facility, and she was previously healthy and independent and something triggered this autoimmune response, perhaps the vaccine.


VAERS ID: 673761 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Mississippi  
Vaccinated:2016-12-08
Onset:2016-12-09
   Days after vaccination:1
Submitted: 2016-12-13
   Days after onset:4
Entered: 2016-12-20
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 33E9E / 3 LL / UN
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UT5583LA / 1 RL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UI717AA / 3 RL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N34937 / 3 LL / UN

Administered by: Unknown       Purchased by: Public
Symptoms: Condition aggravated, Genital labial adhesions, Irritability, Pallor, Rash, Respiratory arrest, Rhinorrhoea, Skin candida
SMQs:, Anaphylactic reaction (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-12-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NEXIUM; Albuterol
Current Illness: Runny nose; GER; h/o reactive airway
Preexisting Conditions: GER; h/o reactive airway
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pt received vaccines (6 month vaccines) on 12/8/16 at wellness appointment in clinic. Other than mild runny nose and labial adhesion and rash (candidal) under neck, exam was normal. MGM notes that pt did well that night but was a "little whiny". No respiratory distress. No fever. Woke up Friday (12/9) and was "pale". TYLENOL given, went to Health Department and noted to have "stopped breathing".


VAERS ID: 675075 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2016-11-25
Onset:2016-11-26
   Days after vaccination:1
Submitted: 2016-12-22
   Days after onset:26
Entered: 2016-12-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-12-01
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Multiple sclerosis; Paralysis; Respiratory disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2016IT176117

Write-up: Case number PHHY2016IT176117, is an initial spontaneous report from a physician (general practitioner) via company employee lay press (published on a local newspaper) through email received on 20 Dec 2016. This report refers to a 62 years old male patient. Past medical history was not reported. Current conditions included as multiple sclerosis that made his precarious condition and paralyzed for years with severe respiratory crisis. Concomitant medications were not reported. This 62 years old patient was vaccinated with FLUAD (batch number: not reported) on 25 Nov 2016. On 26 Nov 2016 the day after the vaccination the patient began to feel bad with high fever for two or three days. In the morning of the fourth day in Nov 2016 the patient did not respond to external stimuli and paramedical intervention was called. The patient''s condition did not improve also after the hospitalization (reason unspecified). The article reported also the suspect that the vaccine could have been defective. The family turned to a lawyer. On 01 Dec 2016 the patient died due to a fatal cardiac arrest at 11 AM. It was unknown whether autopsy was performed or not. The outcome of the events high fever and cardiac arrest was reported as fatal and for the events feeling abnormal and unresponsive to stimuli it was reported as condition unchanged for other events it was unknown. Seriousness of assessment of the events feeling abnormal and unresponsive to stimuli were upgraded to medically significant based on the information available in the source document. The general practitioner stated to rule out any relationship between the vaccine and the death of the patient (the patient was paralyzed for years with severe respiratory crisis). Causality for other events was not reported.


VAERS ID: 669694 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2016-11-18
Onset:2016-11-19
   Days after vaccination:1
Submitted: 2016-12-02
   Days after onset:13
Entered: 2016-12-04
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 167202 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Death
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-11-22
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Nodal arrhythmia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2016IT165868

Write-up: Case number PHHY2016IT165868, is an initial spontaneous report received from a healthcare professional via company (reference number 385768) on 30 Nov 2016. This report refers to a 76-years-old male patient. Past medical history was not reported. Current condition included nodal hypertensive tachycardia. Concomitant medications were not reported. The patient was vaccinated with FLUAD (batch number: 167202) at a dose of 0.5 ml intramuscularly on 18 Nov 2016. On 19 Nov 2016, due to acute epigastric pain the patient went to emergency room (ER). On 21 Nov 2016, the patient went to emergency room again due to condition worsening. On 22 Nov 2016, the patient died. The cause of death was unknown. It was unknown whether autopsy was done or not. The causality of the event was reported as suspected.


VAERS ID: 675489 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2016-11-16
Onset:2016-11-17
   Days after vaccination:1
Submitted: 2016-12-26
   Days after onset:39
Entered: 2016-12-28
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS AFLUA868AA / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Chest X-ray abnormal, Condition aggravated, Cough, Death, General physical health deterioration, Histiocytosis haematophagic, Hypogammaglobulinaemia, Immunoglobulin therapy, Intensive care, Lung infiltration, Multiple organ dysfunction syndrome, Palliative care, Pneumonia, Pyrexia, Serum ferritin increased
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), Malignancy related therapeutic and diagnostic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (narrow), Sepsis (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-11-25
   Days after onset: 8
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: ZYDELIG; Aciclovir; BACTRIM FORTE; DENTAN; SYMBICORT TURBUHALER; ALVDEDON; Omeprazole; KIOVIG
Current Illness: Unknown
Preexisting Conditions: Hypogammaglobulinaemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: SE2016190745

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of hemophagocytic lymphohistiocytosis in a 70-year-old male patient who received FLUARIX (batch number AFLUA868AA, expiry date unknown). Co-suspect products included ZYDELIG film-coated tablet for chronic lymphoid leukemia. The patient''s past medical history included hypogammaglobulinemia. Concomitant products included ACICLOVIR, BACTRIM FORTE, DENTAN, SYMBICORT TURBUHALER, ALVEDON, omeprazole and KIOVIG. On 16th November 2016, the patient received FLUARIX (intramuscular) .5 ml. On 12th January 2016, the patient started ZYDELIG (oral) 150 mg twice daily (300 mg daily). On 17th November 2016, 1 days after receiving FLUARIX, the patient experienced hemophagocytic lymphohistiocytosis (serious criteria death, hospitalization and GSK medically significant). On an unknown date, the outcome of the hemophagocytic lymphohistiocytosis was fatal. The patient died on 25th November 2016. The reported cause of death was hemophagocytic lymphohistiocytosis. The reporter considered the hemophagocytic lymphohistiocytosis to be possibly related to FLUARIX. The reporter considered the hemophagocytic lymphohistiocytosis to be possibly related to ZYDELIG. The batch number of FLUARIX was reported as AFLUA818AA. Based on a batch number review. The batch number was updated to AFLUA868AA. Initial received from a physician via regulatory authority on 23 December 2016: Report from a physician regarding a 70-year old man with advanced chronic lymphatic leukemia (CLL), previously transformed disease with 17p deletion. Treated initially with Ibrutinib, but due to progress exchanged to ZYDELIG 150 mg January 2016. Has been in stable remission and wellbeing. Receives FLUARIX 16-NOV-2016. That evening the man develops some cough and the day after, fever. Seeking emergency 18-Nov-2016 and is treated at hospital, at the medical clinic. Chest x-ray shows sparse infiltrates and pneumonia was suspected and investigating CMV, treated with CYMEVENE before the negative test results. Clinically, a rapid deterioration was seen. The man was moved to the intensive care unit and at the same time it was understood that this concerns hemophagocytic lymphohistiocytosis (HLH) with high values of Ferritin (about 57000) and soluble CD25. Multiple organ failure develops rapidly. Despite intensive care efforts and attempts to annul the progress with IVIg and steroids, the man further deteriorates and the treatment became palliative. The man deceases approximately one week after admission to hospital. Reporter suspects FLUARIX and ZYDELIG and says that "might affect modern treatment the risk of developing serious vaccine reactions? At least one event has been described with similar background". The reporter said that the man over the years has had a lot of respiratory problems, with suspected bronchiectasis and recurrent lower respiratory tract infections of varying severity. Because of this also gamma globulin treatment for hypogammaglobulinemia secondary to CLL. "The patient''s medical history covers several years and was very complicated from a haematological perspective," according to the reporter. Co-medications: acyclovir, BACTRIM FORTE, DENTAN, SYMBICORT TURBUHALER, KIOVIG and if necessary ALVEDON, omeprazole. Hemophagocytic lymphohistiocytosis.


VAERS ID: 731431 (history)  
Form: Version 1.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2016-11-17
Submitted: 2017-11-13
   Days after onset:361
Entered: 2017-12-21
   Days after submission:38
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201702960

Write-up: This initial spontaneous case, was received from other health professional via health authority (HA ID: IT-MINISAL02-436106) on 08-Nov-2017, concerning a 94-year-old elderly female patient. On an unspecified date, the patient was administered with FLUAD (dose, route of administration, anatomical location, batch number and expiry date: not reported). On 17-Nov-2016, the patient experienced malaise and her condition was worsened. On an unspecified date, the patient died. It was unknown, whether autopsy was done. The health authority assessed the events as serious (death) and considered the causality of the events as related. Case Comment: A 94-year-old female subject had died following vaccination. Details regarding date of vaccination, onset latency and clinical status of the subject at the time of vaccination are needed for further medical assessment. Thus, company assesses the causality as unassessable.


VAERS ID: 680575 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2016-10-25
Onset:2016-11-13
   Days after vaccination:19
Submitted: 2017-02-01
   Days after onset:80
Entered: 2017-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUENZ TETRA) / MEDIMMUNE VACCINES, INC. HF2241 / UNK NS / IN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-11-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CO-TRIMOXAZOLE; FUROSEMIDE; AMILORIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Palliative care
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBAstraZeneca2016SF38129

Write-up: A spontaneous report has been received from Pharmacist via RA concerning a 4 year old, female patient. Her medical history included palliative care. Concomitant medications included sulfamethoxazole, trimethoprim, furosemide and amiloride. On an unknown date, she received nasal FLUENZ TETRA (Intranasal), Lot number: HF2241. On 13-Nov-2016, the patient died. It was unsure whether there was any link to death however because the child who had multiple comorbidities died within a few weeks of this being administered. The cause of death was unexplained. It was unknown whether autopsy was performed or not. The reporter assessed the report to be serious due to death and important medical event. Sender''s Comments: The report concerns a 4-year-old female patient with fatal outcome with FLUENZ TETRA. The cause of death is not further specified. There is limited information on patients relevant medical history, concurrent diseases and autopsy report which makes the causal assessment difficult. Reported Cause(s) of Death: PATIENT DIED.


VAERS ID: 668794 (history)  
Form: Version 1.0  
Age: 88.0  
Sex: Male  
Location: New York  
Vaccinated:2016-11-11
Onset:2016-11-12
   Days after vaccination:1
Submitted: 2016-11-29
   Days after onset:17
Entered: 2016-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UI725AA / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Agitation, Mania, Seizure
SMQs:, Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-11-14
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vaccine at 330pm, during night-sleep was agitated next morning-mini seizure, manic next evening, following day full seizure in AM.


VAERS ID: 664922 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Female  
Location: Oklahoma  
Vaccinated:2016-10-24
Onset:2016-11-04
   Days after vaccination:11
Submitted: 2016-11-07
   Days after onset:3
Entered: 2016-11-09
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UT5583NA / 1 RL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. I032182 / 1 LL / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. M006156 / 1 LL / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-11-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None noted
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient seen in ER on 11-4-16 and pronounced dead - possible SIDS. She was seen by us on 10-24-16 and given vaccinations - awaiting ME report.


VAERS ID: 666465 (history)  
Form: Version 1.0  
Age: 63.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2016-10-31
Onset:2016-11-03
   Days after vaccination:3
Submitted: 2016-11-16
   Days after onset:13
Entered: 2016-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR U1678AB / 2 UN / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Blood test, Death, Disseminated intravascular coagulation
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-11-04
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coagulation disorder; Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2016SA206725

Write-up: Initial unsolicited report received from a nurse on 09 Nov 2016. This case involves a 63-year-old female patient who was vaccinated with a dose of FLUZONE MULIT-DOSE VIAL QIV (batch number: U1678AB, expiry date: 30 Jun 2017, route, site and dose not reported) on 31 Oct 2016. Patient had previous history of coagulation disorder. Concomitant medications were not provided. On an unspecified date, post vaccination, the patient had DIC (Disseminated Intravascular Coagulation). On 03 Nov 2016, patient went to emergency room. Lab data includes full vitals, blood planel review and blood was drawn on 18 Oct 2016. Corrective treatment was not reported. On 04 Nov 2016, the patient passed away. List of documents held by sender: none.; Sender''s Comments: This is a poorly documented death case where patient passed away from DIC (Disseminated Intravascular Coagulation) after administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. It was to be noted that the patient had previous history of coagulation disorder of unknown etiology. The detailed autopsy report, detailed past medical history, concomitant medication and immune status at the time of vaccination would be helpful to assess this case further.; Reported Cause(s) of Death: Disseminated Intravascular Coagulation.


VAERS ID: 667860 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Male  
Location: Oregon  
Vaccinated:2016-11-01
Onset:2016-11-02
   Days after vaccination:1
Submitted: 2016-11-22
   Days after onset:20
Entered: 2016-11-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 579KX / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-11-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: CAD, HTN, DM, ESRD, Peripheral Vascular Disease, Systolic Heart Failure.
Preexisting Conditions: Ace Inhibitor
Allergies:
Diagnostic Lab Data:
CDC Split Type: OR201609

Write-up: Cardiac arrest on 11/02/2016.


VAERS ID: 663733 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Female  
Location: Oklahoma  
Vaccinated:2016-10-19
Onset:2016-11-01
   Days after vaccination:13
Submitted: 2016-11-03
   Days after onset:2
Entered: 2016-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS BB3T3 / 3 LL / IM
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI669AB / 2 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. M025192 / 2 LL / IM
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. M021729 / 1 RL / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N16561 / 3 LL / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Blood pressure measurement, Cardiac arrest, Cardio-respiratory arrest, Death, Endotracheal intubation, Heart rate, Respiratory rate, Resuscitation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-11-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: KEPPRA, Phenobarbital, zinc gluconate, clonazepam, ranitidine
Current Illness: Mother noted some non-pitting edema of legs and feet
Preexisting Conditions: microcephaly - lissencephaly with severe hypogenesis of the corpus callosum. Global developmental delay with static encephalopathy. Intractable seizures. Persistent bleeding and non-healing wounds. Developmental hip dysplasia.
Allergies:
Diagnostic Lab Data: HR, BP, RR all 0. iStat unable to run arterial blood gas.
CDC Split Type:

Write-up: Full arrest noted approximately 45 minutes after being put to bed at home. EMS notified and pt was transported to ED where she was intubated, given epi and sodium bicarb. She remained in total asystole during resuscitation efforts.


VAERS ID: 739780 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Unknown  
Vaccinated:2016-11-07
Onset:2016-11-01
Submitted: 0000-00-00
Entered: 2018-03-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Contusion, Death, Decreased appetite, Depression, Fatigue, Headache, Hot flush, Injection site pain, Limb discomfort
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Depression (excl suicide and self injury) (narrow), Arthritis (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: Pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2017SA236193

Write-up: Based on information received on 15 Nov 2017, the following information has been amended: vaccine preferred name changed from "INFLUENZA QUADRIVALENT RECOMBINANT VACCINE" to "INFLUENZA VACCINE". Initial unsolicited case received from a consumer (patient wife) via other company Astellas Pharma under the MFR control number: 2016US015482 on 15 Nov 2017. This case involves 67-year-old male patient who was vaccinated with a dose of INFLUENZA VACCINE and a dose of PNEUMOCOCCAL VACCINE (Batch numbers, expiry date, dose, dose in series, route and site of administration were not reported for both the vaccines) on 07 Nov 2016. The patient also started treatment with 160 mg and 120 mg dose of XTANDI (Manufacturer: Astellas Pharma) (Batch numbers reported as 1539683PC and 1543982PC, expiry date not reported) daily once orally from an unknown dates for prostate cancer with metastasis and metastatic castrate resistant prostate cancer. (It was reported as patient had no changes after starting the drug and patient was enrolled in patient support program). Patient current condition was reported as pain. Other medical history was not reported. Concomitant medications were not reported. On an unknown date, after receiving the treatment with XTANDI, patient developed first episode of fatigue. On an unknown date in Jul 2016 and Oct 2016, after receiving the treatment with XTANDI, patient developed fatigue (second and third episode). On an unknown date in Nov 2016, following the vaccination and after the administration of XTANDI patient developed soreness in the arm and achiness at injection sites. On an unknown date, following the vaccination and after the administration of XTANDI, patient developed bruising, depression, hot flashes, loss of appetite, joint aches and headache. On an unknown date, following the vaccination and after the administration of XTANDI, patient died due to unknown cause. Patient relevant lab tests and corrective treatment were not reported. The outcome of the events fatigue, Hot flashes, soreness in the arm and achiness at injection sites were reported as not recovered and the outcome of all the other events were not reported. It was not known, whether autopsy was performed to the patient. The patient wife assessed the causal relationship between the suspect drug XTANDI and with the event soreness in arm as not related. List of documents held by sender: none. Sender''s Comments: The patient died post vaccination with influenza vaccine (Mfr Unk) and Pneumococcal vaccine. Time to onset was not reported. Patient had an ongoing medical condition of prostate cancer with metastasis and metastatic castrate resistant prostate cancer for which he was being treated with XTANDI. No autopsy results were available. Reported events may be related to preexisting medical condition which could have as well resulted in death. Based upon reported information the role of the vaccine cannot be established. Autopsy report confirming the cause of death is required to further assess the case. Reported Cause(s) of Death: Deceased.


VAERS ID: 664683 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2016-10-27
Onset:2016-10-31
   Days after vaccination:4
Submitted: 2016-11-08
   Days after onset:8
Entered: 2016-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-10-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes; Hypertension; Smoker
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZERINC2016511787

Write-up: This is a spontaneous report from a contactable physician through a Pfizer sales representative. An adult (about 40-42 year-old) male patient of an unspecified race and ethnicity received PREVENAR 13 at 0.5 ml single and influenza vaccine at 1 dosage form single, both intramuscular on 27Oct2016 for immunization. Medical history included ongoing diabetes and ongoing hypertension and the patient was a smoker; concomitant medications were not reported. The patient experienced myocardial infarction on 31Oct2016 due to which he died. Sender''s Comments: The Company considers the reported event of myocardial infarction most likely related to patient''s underlying clinical conditions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Reported Cause(s) of Death: Myocardial infarction.


VAERS ID: 664407 (history)  
Form: Version 1.0  
Age: 43.0  
Sex: Female  
Location: Arkansas  
Vaccinated:2016-10-25
Onset:2016-10-26
   Days after vaccination:1
Submitted: 2016-10-28
   Days after onset:2
Entered: 2016-11-07
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 29PD2 / UNK LA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-10-26
   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: Unknown
Current Illness: None noted
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: AR176

Write-up: PT rec''d flu shot at an off site school clinic on 10-26-16, a friend of the pt stated pt had died; pt had been found deceased by her children that morning.


VAERS ID: 661651 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Female  
Location: Maine  
Vaccinated:2016-10-24
Onset:2016-10-25
   Days after vaccination:1
Submitted: 2016-10-26
   Days after onset:1
Entered: 2016-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI673AA / UNK LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-10-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: M.S.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt received flu shot approximately 1 pm 10/24/16 - seemed healthy. No adverse response reported. Pt found deceased in bed 10/25/16 am.


VAERS ID: 668209 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2016-10-11
Onset:2016-10-20
   Days after vaccination:9
Submitted: 2016-11-10
   Days after onset:21
Entered: 2016-11-25
   Days after submission:15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UI634AB / UNK LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Asthenia, Blood potassium decreased, Blood sodium decreased, Dizziness, Guillain-Barre syndrome, Immunoglobulin therapy
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (narrow), Hyponatraemia/SIADH (narrow), Demyelination (narrow), Vestibular disorders (broad), Chronic kidney disease (broad), Hypokalaemia (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2016-11-10
   Days after onset: 21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Aspirin; acetaminophen; FEOSOL; PRILOSEC; pravastatin; calcium with Vitamin D; multivitamin with mineral; MIRALAX; prednisolone ophthalmic; alprazolam; ceftriaxone; ondansetron; pantoprazole; potassium chloride
Current Illness: Fall; urinary tract infection
Preexisting Conditions: Anxiety; GERD; Constipation; Breast cancer
Allergies:
Diagnostic Lab Data: Na critical 111
CDC Split Type:

Write-up: Weakness, dizziness, lightheadedness. Na level 127. K level 3.4. Sodium dropped to critical level 111. Treated with IVIG 20 gm, 200 mL IV daily for Guillain-Barre syndrome.


VAERS ID: 661549 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Male  
Location: Indiana  
Vaccinated:2016-10-19
Onset:2016-10-19
   Days after vaccination:0
Submitted: 2016-10-24
   Days after onset:5
Entered: 2016-10-26
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UI712AA / 1 RA / SYR

Administered by: Other       Purchased by: Private
Symptoms: Malaise, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-10-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: NKA
Allergies:
Diagnostic Lab Data: Not known
CDC Split Type:

Write-up: Patient started not feeling well. Thought it was from flu shot. Had heart attack later in evening.


VAERS ID: 778893 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Oregon  
Vaccinated:2016-06-01
Onset:2016-10-19
   Days after vaccination:140
Submitted: 0000-00-00
Entered: 2018-10-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / 1 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Bedridden, Confusional state, Death, Depressed level of consciousness, Gait disturbance, Loss of personal independence in daily activities, Mobility decreased, Pyrexia, Skin warm, Speech disorder
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-10-29
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Carbadopa levodopa And levathroxin
Current Illness: None
Preexisting Conditions: Parkinsons disease
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever. Confusion. Got up to go to the bathroom but did not need to go. Then said he went in his depends. Next morning he asked me what all that was about. I said I don''t know. It was not his normal state if being. I attributed it to the flu vaccine. Dad started getting weaker and weaker and having trouble walking. He could not get out of bed. He was finally confined to bed and needed 100% assistance. He had to start using the commode only. With help. Also depends undergarments all the time. Dad was bed bound and could do nothing. We had the tv on for him and music but he did not watch. Dad was having a harder and harder time of it. Everyday he got worse. I called Dr and he recommended hospice. Dad got weaker and could not talk anymore. He understood but could not speak. I could not understand why dad went downhill so fast could not move and could not speak. I called hospice knowing they help with the last 6 months of life if someone is dying. Hospice cake. Dad did not rouse when they pushed on his sternum. He was very hot. Hospice said he would be dead in 3 days. I was astounded. Why was my dad dying like this? I thought he would have 6 months at least. Dad could not talk but did waken somewhat when I had family say goodbye to him in the phone. I know it was the flu vaccine that made dad go downhill like that in one month and a half and die. The flu shot killed him. Dad wasn''t like that before. Dad could walk and talk. No more after the flu vaccine. The heavy metals in the flu vaccine like mercury could have given him heavy metal poisoning and also made his Parkinson''s worse. Dad was 90 years old. Your form keeps telling me he was 89 he was 90. Flue vaccine: influenza PF Quad ped/adol/Adult psat type t or vial dosage .5 milaliters right side. Dad died unexpectedly October 29th 2016, a month and 2 weeks after the flu shot, at the age of 90 years old.


VAERS ID: 664201 (history)  
Form: Version 1.0  
Age: 6.0  
Sex: Male  
Location: Washington  
Vaccinated:2016-09-30
Onset:2016-10-16
   Days after vaccination:16
Submitted: 2016-11-04
   Days after onset:19
Entered: 2016-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (KINRIX) / GLAXOSMITHKLINE BIOLOGICALS 43HB3 / 5 LL / IM
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI684AC / 4 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. M007964 / 2 RL / SC

Administered by: Private       Purchased by: Public
Symptoms: Anion gap normal, Blood alkaline phosphatase normal, Blood osmolarity decreased, Cough, Death, Diarrhoea, Dizziness, Fatigue, Headache, Nausea, Neutrophil count increased, Pain in extremity, Platelet count increased, Protein total increased, Pyrexia, Somnolence, Vomiting, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-10-30
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Developmental concern, Esotropia of right eye, 4 pound weight gain in past 2.5 years
Allergies:
Diagnostic Lab Data: WBC 16.8, Platelets 530, neutrophils 13.2, anion gap 13, total protein 8.5, alkaline phos 166, calculated OSMO 273
CDC Split Type:

Write-up: Parents report intermittent illness since vaccination: fever(101) every other day x7 days, nausea, vomiting, diarrhea, headache, fatigue, somnolence, dizziness, cough, Left leg pain.


VAERS ID: 665181 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Colorado  
Vaccinated:2016-09-27
Onset:2016-10-13
   Days after vaccination:16
Submitted: 2016-11-10
   Days after onset:28
Entered: 2016-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UI626AA / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arrhythmia, Aspiration pleural cavity, Autopsy, Chest X-ray, Computerised tomogram, Cytology, Death, Dyspnoea, Haematology test, Influenza like illness, Laboratory test, Pericardial effusion, Pericarditis, Pleural effusion, Pneumonia
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2016-10-28
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Was taking BP meds and statin.
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Thoracentsis with cytology. CAT scan, Chest X-Ray, chemistry, hematology. Autopsy found cause of death to be cardiac arrhythmia due to acute pericarditis and pericardial effusion.
CDC Split Type:

Write-up: Received flu vaccine requisite to his service as a volunteer at hospital ER. Previously healthy. Within 1 day of vaccination began complaining of flu-like symptoms. Developed pneumonia, pleural effusion, SOB. Was hospitalized, then released to home where he expired.


VAERS ID: 666583 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Female  
Location: Virginia  
Vaccinated:2016-10-13
Onset:2016-10-13
   Days after vaccination:0
Submitted: 2016-11-10
   Days after onset:28
Entered: 2016-11-15
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS A2Z34 / 1 RA / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-10-16
   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: Torn meniscus Lt. knee; High blood pressure
Allergies:
Diagnostic Lab Data: Had pre-op testing done 10-13-16 11:00 AM right before getting flu shot. All pre-op records were looked at by our family Dr. all were great including EKG
CDC Split Type:

Write-up: 10:13 had pre-op work for upcoming knee surgery. Took flu shot after had to stop along road twice on way home to throw up stayed sick 14th 15th of Oct. Got her in bed about 11:30pm on the 15th. Went in to get her out of bed at 10:00 AM on the 16th, she had passed away several hours prior to. Patient had taken flu shot for years. She felt good morning of 13th.


VAERS ID: 660712 (history)  
Form: Version 1.0  
Age: 92.0  
Sex: Male  
Location: West Virginia  
Vaccinated:2016-10-11
Onset:2016-10-12
   Days after vaccination:1
Submitted: 2016-10-21
   Days after onset:9
Entered: 2016-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UI659AB / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Areflexia, Axonal neuropathy, CSF test normal, Death, Electromyogram abnormal, Guillain-Barre syndrome, Herpes simplex test negative, Immunoglobulin therapy, Intensive care, Muscular weakness, Nerve conduction studies abnormal, Peripheral sensorimotor neuropathy, Respiratory rate decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Respiratory failure (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-10-20
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Weakness
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Not aware of any
CDC Split Type:

Write-up: This is a 92 y.o., male a 92 year old male with past medical history of hypothyroidism, HTN, HLD, IBC, vitamin D deficiency, and anemia who presented with a complaint of progressive weakness in all four extremities x 2 days prior to presentation. Given concurrent absence of reflexes and progressive extremity weakness S/P recent immunization (flu shot), a 5 day course of IVIG was started and completed for a presumptive diagnosis of AIDP. As part of his evaluation, EMG/NC was remarkable for sensorimotor peripheral neuropathy with axonal an demyelinating features. No temporal dispersion or conduction block at this time, per report. A Lumbar puncture was obtained. CSF studies was not consistent with an infection so far, his HSV was also negative. The lumbar puncture was a difficult and traumatic tap with limited CSF fluid collected. We monitored his respiratory parameters with PVC/NIF Q2hrs. On 8/18/16, his respiratory status declined requiring HFNC 100% FIO2. Given that the family had requested he be intubated if needed on a temporary basis on admission despite a Postform stating otherwise, he was transferred to the ICU. However family eventually decided that the patient would not want to be intubated/trached or PEG placed. Supportive Care was consulted to facilitate the family discussion. Following a family meeting, "they agree with the option of weaning from HFNC while keeping pt comfortable with morphine." Early morning, on 10/20/16, the on call neurology resident was paged that the "patient does not have any spontaneous respirations." He was subsequently pronounced dead at 0250 on 10/20/2016.


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