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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: 661292 (history)  
Form: Version 1.0  
Age: 47.0  
Sex: Female  
Location: New York  
Vaccinated:2013-11-08
Onset:0000-00-00
Submitted: 2016-10-18
Entered: 2016-10-25
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1308801 / UNK LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Death, Tuberculin test, Urine analysis abnormal
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-11-10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATIVAN; simvastatin; risperidone; zolpidem; ziprasidone; imipramine
Current Illness: R/O UTI
Preexisting Conditions: NKDA; Allergic rhinitis hx; Schizophrenia
Allergies:
Diagnostic Lab Data: Pt had PPD planted on 11/8/13 and positive urine dipstick
CDC Split Type:

Write-up: Patient received an influenza vaccine on 11/8/2013. Pt had no reported signs or symptoms of an adverse reaction to the vaccine. Staff was informed on 11/10/13 that pt passed away in her sleep.


VAERS ID: 664059 (history)  
Form: Version 1.0  
Age: 51.0  
Sex: Male  
Location: Ohio  
Vaccinated:2016-10-12
Onset:0000-00-00
Submitted: 2016-11-04
Entered: 2016-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI669AC / UNK RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute respiratory distress syndrome, Critical illness, Dialysis, Dyspnoea, Endotracheal intubation, Mechanical ventilation, Pneumonia
SMQs:, Acute renal failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Interstitial lung disease (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Thrush
Preexisting Conditions: Depressive disorder, Osteoporosis, Arthritis, history of motor vehicle accident with traumatic brain injury, history of seizures, history of hip replacement
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: The patient was admitted to Hospital on 10/31/2016 with increase shortness of breath and O2 sat 64%. The patient is being treated for pneumonia. The patient then when into ARDS and required ventilation. The patient is still currently being treated at Hospital. He remains incubated and critically ill, he is now receiving dialysis. The patient''s loved ones insist that the patient started to take a turn for the worse after he received the flu shot.


VAERS ID: 672116 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-12-14
Entered: 2016-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Acute respiratory distress syndrome, Chest X-ray abnormal, Death, Dyspnoea, Human metapneumovirus test positive, Lung infiltration, Metapneumovirus infection, Pneumonia, Pneumothorax, Respiratory viral panel, Shift to the left, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Breast cancer, (in remission); Coronary artery bypass; Pericarditis, requiring a pericardial window; Mediastinitis; Hypertension; Diabetes mellitus
Allergies:
Diagnostic Lab Data: Lab tests were performed on an unspecified date. White cell count was elevated with a left shift in differential count (range and normal value not provided). There was confirmatory evidence on chest x-ray in the form of infiltrates. A rapid respiratory viral panel that confirmed MPV infection.
CDC Split Type: US2016GSK185291

Write-up: This case was reported in a literature article and described the occurrence of acute respiratory distress syndrome in a adult female patient who received Influenza vaccine Quadrivalent unspecified season. The patient''s past medical history included breast cancer (in remission), coronary artery bypass graft, pericarditis (requiring a pericardial window), mediastinitis, hypertension and diabetes mellitus. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, an unknown time after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced acute respiratory distress syndrome (serious criteria death, hospitalization and GSK medically significant), metapneumovirus infection (serious criteria hospitalization and GSK medically significant), pneumothorax (serious criteria death, hospitalization and GSK medically significant), pneumonia (serious criteria hospitalization and GSK medically significant), and shortness of breath (serious criteria hospitalization). On an unknown date, the outcome of the acute respiratory distress syndrome and pneumothorax were fatal and the outcome of the metapneumovirus infection, pneumonia and shortness of breath were unknown. The reported cause of death was acute respiratory distress syndrome and pneumothorax. The reporter considered the acute respiratory distress syndrome, metapneumovirus infection, pneumothorax, pneumonia and shortness of breath to be related to Influenza vaccine Quadrivalent unspecified season. Additional information was provided. This case was reported in a literature article and described the occurrence of human metapneumovirus (MPV) infection in an adult female patient who was vaccinated with unspecified influenza vaccine (manufacturer unknown). The patient was a nursing home resident with history of breast cancer (in remission), coronary artery bypass surgery, pericarditis requiring a pericardial window, mediastinitis, hypertension, and diabetes mellitus. The patient did not report any sick contacts. No information on patient''s family history or concomitant medication was provided. On an unspecified date, the patient received unspecified influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). On an unspecified date, an unknown period after vaccination, the patient presented with shortness of breath and clinical evidence of pneumonia. The patient''s white cell count was elevated with a left shift in differential count (range and normal value not provided). There was confirmatory evidence on chest X-ray in the form of infiltrates. [In this study, 3 out of the 4 patients received a CT scan of the chest confirming extensive bilateral infiltrates and evidence of pulmonary oedema suggesting acute respiratory distress syndrome (ARDS)]. It was reported that the patient had evidence of pneumonia with evidence of respiratory failure, and a rapid respiratory viral panel that confirmed MPV infection. The patient''s family refused intubation, and prolonged non-invasive ventilation causing pneumothorax and ARDS results in the patient''s demise. It was unknown if the autopsy was performed. This case has been considered serious due to death/hospitalisation. The authors did not comment on the relationship between MPV infection and unspecified influenza vaccine. The authors concluded that "The disease spectrum of MPV can vary widely, and the outcomes vary largely based on comorbidities. The infection can frequently lead to severe respiratory failure, progressing to ARDS and death, in the elderly or debilitated patients." This is 1 of the 2 valid cases in the same literature article.


VAERS ID: 686401 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Puerto Rico  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-03-20
Entered: 2017-03-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ENBREL
Current Illness: Kidney disorder; Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PR0095075131703USA005669

Write-up: This spontaneous report was received from a physician via a company representative and refers to a female patient of unknown age. The patient''s pertinent medical history included unspecified kidney problems. No information regarding the patient''s drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of unspecified pneumococcal vaccine (manufacturer unknown) (dose, route and site of administration, lot # and expiry date were not reported). Other suspect vaccines included influenza virus vaccine (unspecified) (date, dose, route and site of administration, lot # and expiry date were not reported). Concomitant therapies included ENBREL. On an unknown date, the patient was hospitalized for an unknown reason. The outcome of the event leading to hospitalization was not reported. On an unknown date, the patient died due to an unspecified cause. The relatedness between the events and pneumococcal vaccine (manufacturer unknown) and influenza virus vaccine (unspecified) was not reported. Upon internal review, the event of death was considered to be medically significant. Additional information has been requested.


VAERS ID: 689125 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-04-03
Entered: 2017-04-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2017SA047723

Write-up: Initial unsolicited report received from a nurse via other company (Pfizer) (manufacturer report number- 2017101323) on 20-MAR-2017. This case involves a male patient (unknown age) who was vaccinated with a dose of INFLUENZA VACCINE (FLU SHOT) (batch number, expiry date, route and site of administration were not reported) on an unspecified date. The patient''s medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced fever. On an unspecified date, patient died (reported as dropped dead). The cause of death was not reported. Patient''s lab data and corrective treatment were not reported. The events outcome was reported as fatal. It was unknown whether autopsy was performed or not. List of documents held by sender: none.; Sender''s Comments: Patient was vaccinated with flu shot had fever and died. Case is poorly documented, latency post vaccination is not provided, detailed medical history, past vaccination history and concomitant medication are unknown. Results of laboratory analysis and autopsy report are not provided. Additional information is required to fully assess role of the vaccine in reported event.; Reported Cause(s) of Death: Fever.


VAERS ID: 690601 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-04-13
Entered: 2017-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Anaphylactic shock, Anaphylactoid reaction, Antinuclear antibody negative, Autopsy, Band neutrophil percentage increased, Blood culture negative, Blood lactate dehydrogenase normal, Blood lactic acid normal, Blood thyroid stimulating hormone normal, Body temperature increased, Cardiac arrest, Chest X-ray normal, Death, Echocardiogram abnormal, Endotracheal intubation, Eosinophil percentage increased, Flushing, Haemoglobin decreased, Hepatosplenomegaly, Hypotension, Intensive care, Leukostasis syndrome, Lymphocyte percentage decreased, Mast cell degranulation present, Mean cell volume normal, Multiple organ dysfunction syndrome, Neutrophil percentage increased, Platelet count decreased, Respiratory distress, Reticulocyte count normal, Rheumatoid factor negative, Right ventricular failure, Serum ferritin increased, Shock, Tachycardia, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Malignancy related conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Dehydration (broad), Hypokalaemia (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: DALTEPARIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diarrhea; Eosinophilia; Hepatosplenomegaly; Intermittent headache; Vomiting; Weakness
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: 38.88 Celsius temperature; Test Name: white blood cell count; Result Unstructured Data: 13,500; Test Name: neutrophils; Test Result: 72 %; Test Name: lymphocytes; Test Result: 5 %; Test Name: eosinophils; Test Result: 11.7 %; Test Name: hemoglobin; Result Unstructured Data: 8.5 gram(s)/decilitre; Test Name: Mean corpuscular volume; Result Unstructured Data: 86.3; Test Name: platelet count; Result Unstructured Data: 110,000; Test Name: Ferritin; Result Unstructured Data: 391 nanogram(s)/millilitre; Test Name: hemoglobin; Result Unstructured Data: 5.9 gram(s)/decilitre; Test Name: white blood cell count; Result Unstructured Data: 42,000
CDC Split Type: USSA2017SA058814

Write-up: Initial unsolicited report received from the literature on 31 March 2017. This case involves a 25-year-old male patient who was vaccinated with a dose of INFLUENZA VACCINE and was also received a dose ACETAMINOPHEN WITH CODEINE, HYDROCORTISONE, a dose of DOBUTAMINE, a dose of NOREPINEPHRINE and a dose of EPINEPHRINE (batch number, expiration date, dose , site and route of administration was not reported) on an unknown date. Patient had medical history of intermittent headache and multiple ER visits for weakness, vomiting, diarrhea and a syncopal episodes was found to have massive hepatosplenomegaly and eosinophilia. Concomitant medications included Dalteparin subcutaneously for DVT prophylaxis. On an unknown date, following the vaccination, the patient developed temperature 102 degree Fahrenheit with stable hemodynamics. On an unknown date, evening of his second hospital day he acutely developed respiratory distress, hypotension and tachycardia 130/min with skin flushing. On an unknown date patient developed severely depressed left ventricle (echocardiogram showed). On an unknown date following the vaccination, within 5 hours of admission to the Medical Intensive Care Unit (MICU) patient developed refractory shock and asystole. On an unknown date following the vaccination, patient developed a rapidly progressive course of shock with multisystem organ failure, pulmonary leukostasis-associated right ventricular failure, severe anaphylactoid reaction, multiorgan failure and overwhelming anaphylactic shock. On an unknown date patient was hospitalized. Patient was intubated and transferred to the Medical Intensive Care Unit. It was reported that drop in hemoglobin was related to fluid resuscitation. On an unknown date patient died. It was also a case of Drug ineffective as hydrocortisone. Relevant laboratory test results included WBC (white blood cell count) 13,500 cells/?L with 72 percentage neutrophils, 5 percentage bands, 5 percentage lymphocytes, 11.7 percentage eosinophils, hemoglobin was 8.5 g/dL, Mean corpuscular volume (MCV) 86.3, platelet count: 110,000/?L. Venous lactate was 0.9 mmol/L. Ferritin was 391 ng/ml. Reticulocyte count, LDH (Lactate dehydrogenase), thyroid stimulating hormone (TSH), ANA (Anti Nuclear Antibodies) and RF (rheumatoid factor) were normal. Chest x-ray showed no abnormalities. Abdomen was benign with marked hepatosplenomegaly. Blood cultures were negative. On an unknown date Repeat CBC (complete blood count) showed hemoglobin 5.9g/dl, and white blood cell count 42,000/mcl with 30percentage degranulating mast cells. Patient received corrective treatment with adequate fluid resuscitation, hydrocortisone, broad-spectrum antibiotics, dobutamine, norepinephrine, epinephrine and vasopressin infusion. Outcome of temperature 102 Fahrenheit was not recovered and was fatal for other event. On an unspecified date autopsy was performed with following details: the bone marrow, spleen and liver were diffusely infiltrated by sheets of hypogranular, atypical, CD117+mast cells with large or double nuclei, open chromatin, and irregular nuclear membranes. These filled the pulmonary and coronary vessels and infiltrated cardiac and pulmonary parenchyma. Documents held by sender: none. Sender''s Comments: Reported symptoms and time to onset are consistent with the diagnosis of anaphylactic reaction. Time to onset is compatible with INFLUENZA VACCINE of unknown manufacturer, but additional information including but not limited to the patient''s immunization history (i.e., previous immunizations and any adverse events following immunization), allergic history, detail autopsy report and allergy testing to identify the culprit allergen are needed to further assess this case. In this case patient has history of mast cell leukemia with on and off symptoms, as mast cell leukemia can cause sudden release of histamine which could present with above reaction and also in autopsy it has been mentioned that there is infiltration of mast cells in bone marrow, liver and spleen. Based on available information the role of vaccine is unlikely. And also there is lack of efficacy for HYDROCORTISONE, DOBUTAMINE, NOREPINEPHRINE and EPINEPHRINE as patient experienced asystole and refractory shock even after administration of these drugs. Reported Cause(s) of Death: Severe anaphylactoid reaction; Autopsy-determined Cause(s) of Death: Severe anaphylactoid reaction.


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

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Influenza virus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab test performed on unspecified date during influenza season 2011-2012. In this study, among the 27 Influenza-Associated Paediatric Deaths without any high-risk medical conditions, influenza A virus was found in 18 patients and influenza B found in 9 patients. Influenza virus test, positive
CDC Split Type: US2017GSK074724

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-03-11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Aortic aneurysm; Atrial fibrillation; Neuropathy peripheral; Chronic obstructive pulmonary disease; Anxiety; Diphenhydramine, drug hypersensitivity; Diphenhydramine, drug hypersensitivity; Cefazolin, drug hypersensitivity; Cefazolin, adverse drug reaction
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2016072954

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


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

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

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

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


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

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

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

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


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

Administered by: Other       Purchased by: Other
Symptoms: Death, Herpes zoster, Multiple organ dysfunction syndrome
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VALTREX
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2017195690

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


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

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: THERAFLU
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018GSK010706

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


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

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: THERAFLU
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018GSK010709

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


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

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: THERAFLU
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018GSK010708

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


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

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: THERAFLU
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018008081

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


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

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: THERAFLU
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018GSK010707

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


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

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: THERAFLU
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018GSK010704

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


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

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: THERAFLU
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018GSK010705

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


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

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: THERAFLU
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018GSK012203

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


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

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: THERAFLU
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018GSK012206

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


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

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: THERAFLU
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018GSK012205

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


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

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: THERAFLU
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018GSK012204

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


VAERS ID: 744725 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2018SA106974

Write-up: The following is verbatim from the article: BACKGROUND: Influenza-associated pediatric deaths became a notifiable condition in 2004. METHODS: We analyzed deaths in children aged less than 18 years with laboratory-confirmed influenza virus infection reported to the Centers for Disease Control and Prevention during the 2010-2011 to 2015-2016 influenza seasons. Data were collected with a standard case report form that included demographics, medical conditions, and clinical diagnoses. RESULTS: Overall, 675 deaths were reported. The median age was 6 years (interquartile range: 2-12). The average annual incidence was 0.15 per 100 000 children (95% confidence interval: 0.14-0.16) and was highest among children aged less than 6 months (incidence: 0.66; 95% confidence interval: 0.53-0.82), followed by children aged 6-23 months (incidence: 0.33; 95% confidence interval: 0.27-0.39). Only 31% (n = 149 of 477) of children aged 6 months had received any influenza vaccination. Overall, 65% (n = 410 of 628) of children died within 7 days after symptom onset. Half of the children (n = 327 of 654) had no preexisting medical conditions. Compared with children with preexisting medical conditions, children with none were younger (median: 5 vs 8 years old), less vaccinated (27% vs 36%), more likely to die before hospital admission (77% vs 48%), and had a shorter illness duration (4 vs 7 days; P less than .05 for all).CONCLUSIONS: Each year, influenza-associated pediatric deaths are reported. Young children have the highest death rates, especially infants aged less than 6 months. Increasing vaccination among children, pregnant women, and caregivers of infants may reduce influenza associated pediatric deaths. This case involves a two patients (age reported as less than seven months) who were partially vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date, dose, route and site of administration were not reported) on an unknown date. The patient''s medical history and concomitant medications were not reported. On an unspecified date, post vaccination, the patient died due to influenza. The patients were less than 7 months of age and therefore did not have time for full vaccination before death. The median time from symptom onset to death was 5 days (IQR: 2-11 days). Relevant lab investigations and corrective treatment were not reported. It was not reported if the autopsy was performed or not. List of documents held by sender: none. Sender''s Comments: This literature article describes two patients (less than 7 months of age, other details unknown) who died in association with Influenza infection. These patients were partially immunized with Influenza vaccine (unknown manufacturer). It is not a case of vaccination failure as complete immunization schedule was not followed. Time to onset, type and serotype of influenza infection are not reported. Based upon the reported information, the role of vaccine cannot be assessed. Reported Cause(s) of Death: Influenza.


VAERS ID: 753090 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-06-06
Entered: 2018-06-13
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal rigidity, Activated partial thromboplastin time shortened, Agitation, Anxiety, Aspiration pleural cavity, Asthenia, Bacterial infection, Blood bilirubin normal, Blood electrolytes normal, Blood lactate dehydrogenase increased, Blood uric acid increased, Blood uric acid normal, Breath sounds abnormal, C-reactive protein increased, Cardiac murmur, Chemotherapy, Chest X-ray abnormal, Coagulation test normal, Computerised tomogram abdomen abnormal, Computerised tomogram abdomen normal, Computerised tomogram pelvis, Computerised tomogram thorax abnormal, Cough, Crepitations, Croup infectious, Death, Decreased appetite, Dyspnoea, Echocardiogram normal, Empyema, Gastrointestinal examination normal, Haematocrit normal, Haemoglobin normal, Heart rate increased, Heart rate normal, Influenza, Intensive care, International normalised ratio normal, Lymphocyte percentage, Malaise, Mediastinal mass, Monocyte percentage increased, Neoplasm malignant, Neurological examination normal, Neutrophil percentage, Non-Hodgkin's lymphoma, Oropharyngeal pain, Orthopaedic examination normal, Orthopnoea, Oxygen saturation decreased, Oxygen therapy, Pallor, Pericardial effusion, Platelet count normal, Pleural effusion, Pleural fluid analysis, Pneumonia mycoplasmal, Precursor T-lymphoblastic lymphoma/leukaemia, Prothrombin time normal, Pyrexia, Red blood cell sedimentation rate increased, Respiratory rate increased, Rhinorrhoea, Streptococcus test negative, Superior vena cava stenosis, Tachycardia, Tachypnoea, Tracheal deviation, Tracheal stenosis, Transaminases, Use of accessory respiratory muscles, Vein disorder, White blood cell count increased
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Malignant lymphomas (narrow), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Haematological malignant tumours (narrow), Non-haematological malignant tumours (narrow), Infective pneumonia (narrow), Dehydration (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 14 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Albuterol
Current Illness: Croup infectious; Cough, 2 weeks; Cardiac murmur
Preexisting Conditions: Dexamethasone, croup infectious, 5-day course
Allergies:
Diagnostic Lab Data: On an unspecified date, rapid test was performed which showed negative results. On an unspecified date, Chest X ray was performed which revealed a right lower lobe pleural effusion. On an unspecified date, the patient''s head and neck examinations were performed which showed mild rhinorrhea. He had full range of motion at the neck with no evidence of cervical lymphadenopathy. On an unspecified date, cardiac examination was performed, which showed a harsh 2/6 systolic murmur at the left lower sternal border with no evidence of rubs or gallops, and normal central and peripheral pulses. On an unspecified date, pulmonary examination showed coarse breath sounds bilaterally with intermittent crackles and decreased breath sounds in the right lower lobe, without increased work of breathing or tachypnea. On an unspecified date, Physical examination was performed, which showed that the patient''s abdomen was soft, nontender with normal bowels sound. There was no hepatosplenomegaly, but slight generalized and no axillary lymphadenopathy was noted. Voluntary guarding was noted. On an unspecified date, the patient''s Genito-urinary examination was performed which was unremarkable and there was no noted inguinal lymphadenopathy. On an unspecified date, musculoskeletal examinations were performed which showed normal gait, full range of motion at all joints and no evidence of edema or swelling. On an unspecified date, neurological examination was performed, which revealed that, he had no focal neurological deficits and his cranial nerves were intact. On an unspecified date, (CT) scan of the chest, abdomen, and pelvis was performed, which showed a heterogeneous anterior mediastinal mass causing tracheal narrowing and deviation. A moderate size right pleural effusion and a small pericardial effusion were also noted, abdominal or pelvic abnormalities were noted. On an unspecified date, pleurocentesis was performed which showed T-cell lymphoblastic lymphoma. On an unspecified date, chest X-ray of anterior, posterior and lateral view was again performed which showed right lower lobe pleural effusion as well as right round paratracheal/anterior mediastinal mass with slight leftward shift of mediastinal structures. Blood lactate dehydrogenase, 1078 U/L, elevated; Blood pressure measurement, 95/62 mmHg, Inconclusive; Blood uric acid, 5.4 mg/dL, elevated; Body temperature, 37.20 degree C, Inconclusive; Body temperature, 101F, Inconclusive; C-reactive protein, 6.2 mg/dL, elevated; Haematocrit, 34%, Inconclusive; Haemoglobin, 12 g/dL, Inconclusive; Heart rate, 106 beats/minute, Inconclusive; Lymphocyte count, 22.7%, Inconclusive; Monocyte count, 9.5%, Inconclusive; Neutrophil count, 66%, Inconclusive; Oxygen saturation, 90%, depressed; Oxygen saturation, 98%; Oxygen saturation, 97%, Inconclusive, on room air; Red blood cell sedimentation rate, 108 mm/h, elevated; Respiratory rate, 32 beats/minute, Inconclusive; White blood cell count, 14600, Inconclusive
CDC Split Type: 201701692

Write-up: This initial Literature serious spontaneous case, was received from health professional (Physician) on 25-Sep-2017, concerning a 09-year-old male child patient. On an unspecified date, the patient was administered with influenza vaccine, (dose, route of administration, anatomical location, batch number, expiry date, manufacture and trade name was not provided). A 9-year-old otherwise healthy male presented to the emergency department (ED) with 3 weeks of decreased energy, decreased appetite, and a 2-week history of persistent cough. The patient was initially seen at an outside hospital ED 2 weeks before this most recent ED visit, predominantly for cough, and was discharged home with albuterol without a specific diagnosis. Two days after his initial ED visit, he went to see his primary care physician, was diagnosed with croup, and prescribed a 5-day course of dexamethasone. On an unspecified date, after the administration of vaccine, the patient started coughing again, predominantly at night. Three days prior, he was seen again by his primary care physician and was diagnosed with mycoplasma pneumonia. On the same day, a rapid strep was sent and it was negative. The patient was started on a 5-day course of azithromycin but had persistent and worsening cough. The morning of his visit to the ED, the patient was seen by his primary care physician and was given an albuterol treatment, which helped his cough. He was noted to be febrile to 101-degree F at his physician''s office. This was the first time during his course of illness that he had a fever. His cough was now also associated with rhinorrhea and mild sore throat. On an unspecified date, chest x-ray (CXR) was performed, which showed right lower lobe pleural effusion. On review of systems, he denied any chest pain, abdominal pain, nausea, vomiting, diarrhea, constipation, rashes, myalgia, arthralgia, weight loss, or night sweats. He had no recent travel or sick contacts, and there was no known human immunodeficiency virus or tuberculosis exposure. He was living with his mother who did not know his complete past medical history, but she stated that he was healthy, his immunizations were up to date, and he did not have any known allergies. His family history was unknown. He was taking albuterol as needed for cough and was on day 3 of 5 of azithromycin when he presented to ED for further evaluation. On an unspecified date in initial examination, he was well appearing and active but noted to be coughing frequently. His vital signs revealed a temperature of 37.20 degrees C, a heart rate of 106 beats per minute, a respiratory rate of 32 breaths per minute, a blood pressure of 95/62 mmHg, and an oxygen saturation of 97% on room air. His weight was 36.9 kg. His head and neck exam was notable only for mild rhinorrhea. He had full range of motion at the neck with no evidence of cervical lymphadenopathy. On an unspecified date, cardiac examination was performed, which showed a regular rate and rhythm, a harsh 2/6 systolic murmur at the left lower sternal border with no evidence of rubs or gallops, and normal central and peripheral pulses. It was reported that, the patient''s family was not aware that he had a heart murmur. On an unspecified date, on pulmonary examination, the patient had coarse breath sounds bilaterally with intermittent crackles and decreased breath sounds in the right lower lobe, without increased work of breathing or tachypnea. He had a persistent dry cough, worse when supine, with significant orthopnea. No axillary lymphadenopathy was noted. His abdomen was soft, non tender, and with normal bowels sounds. There was no hepatosplenomegaly, but slight generalized voluntary guarding was noted. On an unspecified date, genito-urinary examination was performed which was unremarkable, and there was no noted inguinal lymphadenopathy. On an unspecified date, musculoskeletal examination was performed, where the patient had a normal gait, full range of motion at all joints, and no evidence of edema or swelling. On an unspecified date, neurological examination was performed, where the patient had no focal neurological deficits and his cranial nerves were intact laboratory evaluation was significant for a white blood cell count of 14,600 (with 66% segmented neutrophils, 22.7% lymphocytes, and 9.5% monocytes). His hemoglobin was 12 g/dL, and his hematocrit was 34%. Platelets are within normal limits at 312,000 per micro liter. Inflammatory markers were elevated with a C-reactive protein of 6.2 mg/dL and an erythrocyte sedimentation rate of 108 mm/h. Coagulation studies were within normal limits: prothrombin time, 11.8 seconds, international normalized ratio, 1.8; and partial prothrombin time, 26 seconds. Lactic dehydrogenase was elevated at 1078 U/L, and uric acid was within upper limits of normal at 5.4 mg/dL. Electrolytes were within normal limits, as were his bilirubin and liver transaminase. His previously obtained CXR was solely an anterior/posterior view. On an unspecified date, CXR (X ray) with both anterior/posterior and lateral was performed again noted the right lower lobe pleural effusion as well as the right round paratracheal/anterior mediastinal mass with a slight leftward shift of mediastinal structures. On an unspecified date, computed tomography (CT) scan of the chest, abdomen, and pelvis was performed, which showed a heterogeneous anterior mediastinal mass causing significant tracheal narrowing and deviation. The left innominate and subclavian veins were not seen, likely owing to mass effect. A moderate size right pleural effusion and a small pericardial effusion were also noted. In addition, there was narrowing of the superior vena cava. No abdominal or pelvic abnormalities were noted. This constellation of findings was consistent with malignant neoplasm with lymphoma the most likely etiology. During his ED course, the patient had episodes of unrelenting cough, stating that he was unable to catch his breath. During these episodes, he would be tachycardic to the 150 seconds and his saturation would decrease to 90% on room air. He was extremely anxious and agitated. Oxygen was administered via a non-rebreather mask, subsequent to which the patient calmed down and had improved vital signs. Once calm, he was weaned back to room air and maintained oxygen saturations around 93% to 95%. He was given nebulized saline and racemic epinephrine treatments, which seemed to alleviate his symptoms. He was transitioned to 1 L of oxygen via nasal cannula, and his oxygen saturation rose to 98%. Oncology was consulted, and at that time, there was discussion about pursuing emergent radiation versus observing the patient after initiating high dose steroids. Given his inability to tolerate the supine position, he was admitted to the pediatric intensive care unit on high-dose steroids. Allopurinol and rasburicase were given before steroids to reduce the risks of tumor lysis syndrome and major electrolyte instability. At the time of admission to the pediatric intensive care unit, he was noted to be alert but ill appearing and pale, with mild tachypnea and tripod positioning. A pleurocentesis performed on hospital day number 1 was diagnostic for T-cell lymphoblastic lymphoma. He was started on chemotherapy according to protocol. Additional initial workup included an echocardiogram, which was within normal limits. He was discharged on hospital day number 14 on continued chemotherapy and initially did well. Unfortunately, he died from complications of his disease 7 months after his initial diagnosis. Autopsy performed was unknown Croup was initially on the primary care physician''s differential; however, croup is not a common diagnosis for children in this age group. Often, imaging is obtained in these instances if croup is diagnosed. With his recent onset of fever, a significant bacterial infection such as an empyema or viral influenza was unlikely, but a viral pneumonia was still a possibility, especially with evidence of pleural effusions on his most recent CXR. In assessing the complete blood count, tuberculosis is less likely with a normal lymphocyte percentage and pertussis is less likely with the lack of monocytosis.


VAERS ID: 763575 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-08-01
Entered: 2018-08-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Acute disseminated encephalomyelitis, Anti-VGCC antibody negative, Anti-ganglioside antibody negative, Anti-muscle specific kinase antibody negative, Antinuclear antibody negative, Autopsy, CD4 lymphocytes decreased, CSF protein increased, Central nervous system lesion, Death, Demyelination, Electromyogram abnormal, General physical health deterioration, Gliosis, Immunoglobulin therapy, Mechanical ventilation, Muscular weakness, Noninfective encephalitis, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal, Nystagmus, Pneumonia, Quadriplegia, Respiratory failure, White matter lesion
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Optic nerve disorders (broad), Demyelination (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 17 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: HIV infection, CD4 count: 533/uL; Hypertension; Type 2 diabetes mellitus; Blindness
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: On an unspecified date: Anti-nuclear, anti-VGCC (voltage-gated calcium channel), anti-MUSK and anti-GQ1b antibodies were found to be negative. On an unspecified date: On 16th day of hospitalization, magnetic resonance imaging (MRI) of brain showed innumerable foci of T2 flair hyperintensity involving brain and spinal cord. On an unspecified date: Electromyography (EMG) demonstrated a severe diffuse demyelinating pattern. CSF protein, elevated
CDC Split Type: 201803018

Write-up: This literature report, initially received on 23-Jul-2018, was reported by other health professional and concerns a 65-year-old, elderly, male patient. The patient''s current conditions included human immunodeficiency virus (HIV) infection (CD4 count 533/uL), hypertension, diabetes mellitus type II and blindness (since an unspecified date). On an unspecified date, the patient was administered Influenza Vaccine (dose, route of administration, batch number, anatomical location and expiry date, manufacturer and trade name: not reported). On an unspecified date, 03 days after vaccination, the patient was admitted to the hospital for acute weakness of all extremities. Initial laboratory workup was performed and showed elevated protein in cerebrospinal fluid and no evidence of infection was noted. Anti-nuclear, anti-VGCC (voltage-gated calcium channel), anti-MUSK and anti-GQ1b antibodies were found to be negative. The patient was treated with intravenous immunoglobulin and steroids for possible Guillan-Barre Syndrome, however his condition deteriorated, and he developed respiratory failure which required mechanical ventilation. The patient also experienced complete quadriplegia, nystagmus and multilobar pneumonia. Electromyography (EMG) showed a severe diffuse demyelinating pattern. On 16th day of hospitalization, magnetic resonance imaging (MRI) of brain showed innumerable foci of T2 flair hyperintensity involving brain and spinal cord. On 17th day of hospitalization, the patient died and permission for autopsy was granted. The autopsy was performed and neuropathologic examination showed multiple soft lesions with tan discoloration throughout the brain and spinal cord, predominantly involving periventricular white matter, bilateral basal ganglia, corpus callosum, cerebellar white matter, pons, medulla and upper cervical spinal cord. Microscopic examination showed discrete areas of demyelination surrounding vessels, with patchy macrophage aggregation, sparse CD8+ lymphocyte infiltration and mild reactive gliosis at the periphery. In a few of the lesions, the infiltrate was composed of neutrophils. Inflammation was perivascular or in the brain parenchyma and did not involve the vessel wall. No hemorrhage or viral inclusions were identified. Luxol fast blue stain demonstrated loss of myelin within the lesions. Neurofilament Immunohistochemical stain highlighted relative preservation of axons, although spheroids and axonal disruption were also present. The findings were more consistent with diagnosis of acute disseminated encephalomyelitis (ADEM). The outcome of the events respiratory failure, multilobar pneumonia and symptoms of ADEM (acute weakness of all extremities, complete quadriplegia, nystagmus, elevated protein in cerebrospinal fluid and severe diffuse demyelinating pattern) was not reported. The reporter assessed this case as serious (death and hospitalization).


VAERS ID: 768094 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / UN

Administered by: Unknown       Purchased by: ?
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131808USA009998

Write-up: This spontaneous report was received from a pharmacist via a company representative and refers to a elderly male patient of unknown age. Information regarding the patient''s pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. On an unknown date in 2017, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route, lot # and expiration date were not provided) for prophylaxis. At the same time, the patient received also a dose of influenza virus vaccine (unspecified) (reported as "Flu vaccine") (dose, route, lot # and expiration date were not provided) for an unknown indication. The pharmacist stated that, on an unknown date in 2017 (reported as "next day"), the elderly patient got sick and was hospitalized. The pharmacist reported that, shortly after that, the patient passed away on an unknown date in 2017. The cause of date was not reported. It was unknown if autopsy was done. The outcome of malaise was not reported. The causality between the events and PNEUMOVAX 23 was not reported. Reported Cause(s) of Death: Pharmacist reported the "elderly man passed away shortly after".


VAERS ID: 774701 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis
Preexisting Conditions: Medical History/Concurrent Conditions: Epstein-Barr virus infection
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131809USA010085

Write-up: This spontaneous report as received from a consumer and refers to her mother''s aunt, a 91-year-old female patient. The patient had a medical history of Epstein-Barr virus infection. The patient''s concurrent conditions, concomitant medications and drug reactions/ allergies were not reported. On an unspecified date, the patient was vaccinated with a dose of an unspecified pneumonia vaccine (manufacturer unknown) (captured as PNEUMOVAX23) and a dose of an influenza virus vaccine at the same time for prophylaxis (dose number, route, and lot # were not reported). On the same day at night, the patient passed away. The cause of death was not reported. It was unknown, if an autopsy was performed. The reporter''s causality assessment was not provided. This was one of two reports received from a same reporter.; Sender''s Comments: US-009507513-1809USA010075:; Reported Cause(s) of Death: Unknown cause of death.


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

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

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

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


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

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

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

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


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

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

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

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-12-01
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSEQIRUS201800196

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Autopsy, Death, Respiratory failure, Tryptase increased
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergic reaction to antibiotics; Asthma; Drug allergy; Hereditary onycho-osteodysplasia; Penicillin allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Hepatitis C
Allergies:
Diagnostic Lab Data: Test Name: Serum tryptase; Result Unstructured Data: Increased.
CDC Split Type: USSEQIRUS201902086

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


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

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

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

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy NOS; Asthma; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic headaches; Gout
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSEQIRUS201902088

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


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

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

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

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


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

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

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

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


VAERS ID: 811041 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Death, Respiratory failure, Tryptase increased
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CEFTRIAXONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Drug allergy; Hepatitis C; Hereditary onycho-osteodysplasia; Comments: hereditary onychoosteodysplasia
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2019SA111401

Write-up: Initial literature full article received on 08-Apr-2019 regarding an unsolicited valid serious case. This case was linked to 2019SA111409, 2019SA111422, 2019SA106595, 2019SA111434, 2019SA111441, 2019SA111446 (same literature). Literature abstract: Background: Anaphylaxis, a rare and potentially life-threatening hypersensitivity reaction, can occur after vaccination. Objective: We sought to describe reports of anaphylaxis after vaccination made to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. Methods: We identified domestic reports of anaphylaxis within VAERS using a combination of Medical Dictionary for Regulatory Activity queries and Preferred Terms. We performed a descriptive analysis, including history of hypersensitivity (anaphylaxis, respiratory allergies, and drug allergies) and vaccines given. We reviewed all serious reports and all nonserious reports with available medical records to determine if they met the Brighton Collaboration case definition for anaphylaxis or received a physician''s diagnosis. Results: During the analytic period, VAERS received 467,960 total reports; 828 met the Brighton Collaboration case definition or received a physician''s diagnosis of anaphylaxis: 654 (79%) were classified as serious, and 669 (81%) had medical records available. Of 478 reports in children aged less than 19 years, 65% were male; childhood vaccines were most commonly reported. Of 350 reports in persons aged 19 years or greater, 80% were female, and influenza vaccines were most frequently reported. Overall, 41% of reports described persons with no history of hypersensitivity. We identified 8 deaths, 4 among persons with no history of hypersensitivity. This case involves a 42 years old female patient who experienced Anaphylactic reaction, respiratory failure and increased serum tryptase level while she received vaccines INFLUENZA VACCINE (TRIVALENT). The patient''s past medical history included Asthma; Hereditary onycho-osteodysplasia; allergies to penicillin, quinolones, and naproxen; hepatitis C infection. The patient''s past medical treatment(s), vaccination(s) and family history were not provided. Concomitant therapy included ceftriaxone via intramuscular route. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (TRIVALENT) produced by unknown manufacturer lot number not reported via unknown route. On an unknown date, the patient developed a serious Anaphylactic reaction, respiratory failure and increased serum tryptase level, 2 minutes following the administration of INFLUENZA VACCINE, (TRIVALENT). These events were leading to death. Other lab test not reported. Final diagnosis was (fatal) Anaphylactic reaction, respiratory failure and increased serum tryptase level. It was not reported if the patient received a corrective treatment. It was not reported if an autopsy was performed. However, the cause of death was reported as Anaphylactic reaction.; Sender''s Comments: This case is from a literature article concerning a 02-year-old male patient who died due to anaphylactic reaction followed by cardiopulmonary arrest and increased tryptase 20 minutes after vaccination with INFLUENZA VACCINE (Inactivated influenza), MEASLES-MUMPS-RUBELLA VIRUS VACCINE and VARICELLA VACCINE. Past medical history included Hypoplastic left heart syndrome with subsequent cavopulmonary shunt procedure performed and periodic Cyanosis. Patient was born premature at 33 weeks gestation. Patient''s medical condition at time of vaccination and clinical course of the events are not reported. The cause of death was due to anaphylactic reaction and Postmortem lab tests revealed increased serum tryptase level. Rapid onset of symptoms after vaccination suggests vaccine played a role in this episode of anaphylaxis. Although, based upon the available information and nature of the event with multiple suspects, the role of individual vaccine cannot be assessed.; Reported Cause(s) of Death: Anaphylactic reaction.


VAERS ID: 811042 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Hypertension
Allergies:
Diagnostic Lab Data: Test Name: increased serum tryptase level; Result Unstructured Data: increased serum tryptase level
CDC Split Type: USSA2019SA111409

Write-up: Initial literature full article received on 08-Apr-2019 regarding an unsolicited valid serious case. This case was linked to 2019SA111401, 2019SA111422, 2019SA106595, 2019SA111434, 2019SA111441, 2019SA111446 (same literature). Background: Anaphylaxis, a rare and potentially life-threatening hypersensitivity reaction, can occur after vaccination. Objective: We sought to describe reports of anaphylaxis after vaccination made to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. Conclusion: Anaphylaxis after vaccination is rare and can occur among persons with no history of hypersensitivity. Most persons recover fully with treatment, but serious complications, including death, can occur. This case involves a 43 years old female patient who experienced anaphylactic reaction, while she received vaccines INFLUENZA VACCINE (QUADRIVALENT). The patient''s past medical history included hypertension; depression; patient had no hypersensitivities. The patient''s past medical treatment(s), vaccination(s) and family history were not provided. Concomitant therapy was not reported. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (QUADRIVALENT) produced by unknown manufacturer lot number not reported via unknown route in unknown site of administration. On an unknown date, within one day the patient developed a serious anaphylactic reaction with symptoms patches of urticaria, airway swelling increased (Respiratory tract oedema) and serum tryptase level increased following the administration of INFLUENZA VACCINE, (QUADRIVALENT). The event anaphylactic reaction was leading to death. Lab test included increased serum tryptase level. Final diagnosis was (fatal) anaphylactic reaction. It was not reported if the patient received a corrective treatment. Autopsy was performed and the cause of death was reported as anaphylactic reaction. Outcome for all the events was fatal. List of document held: none; Sender''s Comments: This case is from a literature article concerning a 43-year-old female patient who died due to Anaphylactic Reaction followed by patches of urticaria and airway swelling following Morning after vaccination with INFLUENZA VACCINE (QUADRIVALENT). Time to onset is compatible. Past medical history included hypertension; depression but no hypersensitivities. Autopsy results confirming the cause of death was due to Anaphylactic Reaction. Further information with patient''s medical condition at time of vaccination, clinical course of the events, laboratory results, concomitant therapy, family history including respiratory allergies, such as asthma and drug allergies are needed to reassess the role of vaccine.; Reported Cause(s) of Death: Anaphylactic reaction.


VAERS ID: 811043 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy NOS; Asthma; Chronic headaches; Gout; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2019SA111422

Write-up: Initial literature full article received on 08-Apr-2019 regarding an unsolicited valid serious case. This case was linked to 2019SA111401, 2019SA111409, 2019SA106595, 2019SA111434, 2019SA111441, 2019SA111446 (same literature). Background: Anaphylaxis, a rare and potentially life-threatening hypersensitivity reaction, can occur after vaccination. Objective: We sought to describe reports of anaphylaxis after vaccination made to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. Conclusion: Anaphylaxis after vaccination is rare and can occur among persons with no history of hypersensitivity. Most persons recover fully with treatment, but serious complications, including death, can occur. This case involves a 46 years old male patient who experienced acute asthmatic bronchitis, wheezing and subsequent cardiopulmonary arrest, while he received vaccine INFLUENZA VACCINE (TRIVALENT). The patient''s past medical history included, asthma; unspecified allergies; chronic headaches; gout and Hypertension. The patient''s past medical treatment(s), vaccination(s) and family history were not provided. Concomitant therapy was not reported. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (TRIVALENT) produced by unknown manufacturer lot number not reported via unknown route. On an unknown date, the patient developed a serious acute asthmatic bronchitis (asthma) with wheezing and had subsequent cardiopulmonary arrest (Cardio-respiratory arrest) (unknown latency) following the administration of INFLUENZA VACCINE, (TRIVALENT). The event acute asthmatic bronchitis was leading to death. Brighton level was 2. Lab test not reported. Final diagnosis was (fatal) Acute asthmatic bronchitis and subsequent cardiopulmonary arrest. It was not reported if the patient received a corrective treatment. It was not reported if an autopsy was performed or not, however documented cause of death was reported as acute asthmatic bronchitis. Outcome for all the events was fatal. List of document held: none; Sender''s Comments: This case is from a literature article concerning a 46-year-old male patient who died due to Acute asthmatic Bronchitis followed by wheezing with Subsequent cardiopulmonary arrest after vaccination with INFLUENZA VACCINE (TRIVALENT). Time to onset is unknown. Past medical history included Asthma; unspecified allergies; chronic headaches; gout; hypertension. Autopsy results confirming the cause of death was due to Acute asthmatic bronchitis. Further information with patient''s medical condition at time of vaccination and clinical course of the events, laboratory results, concomitant therapy, family history are needed for reassessment. Based upon the available information and considering the reported cause of death which is unrelated to vaccination, the role of individual vaccine is unlikely.; Reported Cause(s) of Death: Acute asthmatic bronchitis.


VAERS ID: 811044 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Medical History: None.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2019SA111434

Write-up: Initial information received from a literature article on 08-Apr-2019. This case is linked to cases 2019SA111409, 2019SA111401, 2019SA111422, 2019SA111446, 2019SA111441 and 2019SA106595 (same reporter). Literature abstract: Background: Anaphylaxis, a rare and potentially life-threatening hypersensitivity reaction, can occur after vaccination. Objective: We sought to describe reports of anaphylaxis after vaccination made to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. Methods: We identified domestic reports of anaphylaxis within VAERS using a combination of Medical Dictionary for Regulatory Activity queries and Preferred Terms. We performed a descriptive analysis, including history of hypersensitivity (anaphylaxis, respiratory allergies, and drug allergies) and vaccines given. We reviewed all serious reports and all nonserious reports with available medical records to determine if they met the Brighton Collaboration case definition for anaphylaxis or received a physician''s diagnosis. Results: During the analytic period, VAERS received 467,960 total reports; 828 met the Brighton Collaboration case definition or received a physician''s diagnosis of anaphylaxis: 654 (79%) were classified as serious, and 669 (81%) had medical records available. Of 478 reports in children aged less than 19 years, 65% were male; childhood vaccines were most commonly reported. Of 350 reports in persons aged 19 years or greater, 80% were female, and influenza vaccines were most frequently reported. Overall, 41% of reports described persons with no history of hypersensitivity. We identified 8 deaths, 4 among persons with no history of hypersensitivity. This case involves a 65 years old male patient who experienced anaphylactic reaction, while she received vaccine INFLUENZA VACCINE (TRIVALENT). Medical History: None. Concomitant medications were not reported. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (TRIVALENT) produced by unknown manufacturer (lot number, expiry date, dose, dose in series, route and site of administration were not reported). On an unknown date, the patient developed a serious anaphylactic reaction with symptoms like airway oedema and cardiopulmonary arrest, 15 minutes following the administration of INFLUENZA VACCINE (TRIVALENT). This event was leading to death. No lab data was reported. Final diagnosis was (fatal) anaphylactic reaction. It was not reported if the patient received a corrective treatment. The patient was died on an unknown date. It was unknown if an autopsy was done. However, the cause of death was reported as Anaphylactic reaction. Document held by the sender: none.; Sender''s Comments: This literature article describes a case of 65 years old male patient who was died due to anaphylactic reaction after vaccination with INFLUENZA TRIVALENT VACCINE. Time to onset is compatible with the role of vaccine. However, there was no information regarding lab tests ruling out alternate etiologies. The result of Autopsy should be provided to fully assess the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: Anaphylactic shock.


VAERS ID: 811045 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic obstructive pulmonary disease; Coronary artery disease; Comments: Relevant Medical History: No hypersensitivities
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2019SA111441

Write-up: Initial information regarding this serious valid case received from a literature article on 08-Apr-2019. This case is linked to cases 2019SA111409, 2019SA111401, 2019SA111422, 2019SA111434, 2019SA111446 and 2019SA106595 (same reporter). Literature abstract: Background: Anaphylaxis, a rare and potentially life-threatening hypersensitivity reaction, can occur after vaccination. Objective: We sought to describe reports of anaphylaxis after vaccination made to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. Conclusion: Anaphylaxis after vaccination is rare and can occur among persons with no history of hypersensitivity. Most persons recover fully with treatment, but serious complications, including death, can occur. This case involves a 70 years old male patient who experienced anaphylactic reaction, while he received vaccine INFLUENZA VACCINE (TRIVALENT). Patient had a medical history of chronic obstructive pulmonary disease and coronary artery disease but no hypersensitivities. Concomitant medications were not reported. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (TRIVALENT) produced by unknown manufacturer (lot number, expiry date, dose, dose in series, route and site of administration were not reported). On an unknown date, the patient developed a serious anaphylactic reaction with breathing difficult (Dyspnoea) and cardiopulmonary arrest (Cardio-respiratory arrest) 258 minutes following the administration of INFLUENZA VACCINE (TRIVALENT). This event was leading to death. No Lab data was reported. Final diagnosis was (fatal) anaphylactic reaction. It was not reported if the patient received a corrective treatment. The patient was died on an unknown date. (outcome fatal). It was unknown if an autopsy was done. The documented cause of death was reported as anaphylactic reaction. Document held by the sender: none.; Sender''s Comments: This case concerns a 70-year old male infant who died due to anaphylactic reaction with symptoms like difficulty in breathing and cardiopulmonary arrest, 258 minutes after vaccination with INFLUENZA TRIVALENT VACCINE. It was further reported that the most probable cause of death could be anaphylactic reaction. Notably, a history of chronic obstructive pulmonary disease and coronary artery disease, can increase the likelihood of a severe or even fatal episode of anaphylaxis, however no conclusion on the cause of death can be made at this point, as no autopsy results are available. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: Anaphylactic reaction.


VAERS ID: 811046 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Penicillin allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2019SA111446

Write-up: Initial information received from a literature article on 08-Apr-2019. This case is linked to cases 2019SA111409, 2019SA111401, 2019SA111422, 2019SA111434, 2019SA111441 and 2019SA106595 (same reporter). Literature abstract: Background: Anaphylaxis, a rare and potentially life-threatening hypersensitivity reaction, can occur after vaccination. Objective: We sought to describe reports of anaphylaxis after vaccination made to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. Methods: We identified domestic reports of anaphylaxis within VAERS using a combination of Medical Dictionary for Regulatory Activity queries and Preferred Terms. We performed a descriptive analysis, including history of hypersensitivity (anaphylaxis, respiratory allergies, and drug allergies) and vaccines given. We reviewed all serious reports and all nonserious reports with available medical records to determine if they met the Brighton Collaboration case definition for anaphylaxis or received a physician''s diagnosis. Results: During the analytic period, VAERS received 467,960 total reports; 828 met the Brighton Collaboration case definition or received a physician''s diagnosis of anaphylaxis: 654 (79%) were classified as serious, and 669 (81%) had medical records available. Of 478 reports in children aged less than 19 years, 65% were male; childhood vaccines were most commonly reported. Of 350 reports in persons aged 19 years or greater, 80% were female, and influenza vaccines were most frequently reported. Overall, 41% of reports described persons with no history of hypersensitivity. We identified 8 deaths, 4 among persons with no history of hypersensitivity. This case involves a 84 years old female patient who experienced anaphylactic reaction, while she received vaccine INFLUENZA VACCINE (TRIVALENT). The patient''s past medical history included Drug hypersensitivity and Hypertension. The patient''s past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (TRIVALENT) produced by unknown manufacturer (lot number, expiry date, dose, dose in series, route and site of administration were not reported). On an unknown date, the patient developed a serious anaphylactic reaction with symptoms like felt funny (feeling abnormal), ventricular fibrillation (later speculated because of hypotension), cardiac arrest, wheezing and collapsed (circulatory collapse) 2 min following the administration of INFLUENZA VACCINE (TRIVALENT). This event was leading to death. No Lab data was reported. Final diagnosis was (fatal) anaphylactic reaction. It was not reported if the patient received a corrective treatment. The patient was died on an unknown date. It was unknown if an autopsy was done. The cause of death was reported as Anaphylactic reaction. Document held by the sender: none.; Sender''s Comments: This case involves a 84-year-old female patient who was died due to anaphylactic reaction on an unknown date after vaccinated with INFLUENZA TRIVALENT VACCINE . The time to onset is compatible with the role of vaccine. Medical records indicate anaphylactic reaction. However, there was no information regarding lab tests ruling out alternate etiologies. The result of Autopsy should be provided to fully assess the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: anaphylactic reaction.


VAERS ID: 815315 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2019AM

Write-up: This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that what adults did not know about vaccines could kill them. Many adults were unaware that vaccines kill. The reporter''s friend''s dad died from a flu shot. The reporter''s friend''s baby died from her 4 month vaccines (unspecified).; Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 815530 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-05-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC4: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT) / SEQIRUS, INC. 252226 / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Alpha 1 foetoprotein normal, Death, Death neonatal, Foetal exposure during pregnancy, Prenatal screening test, Ultrasound antenatal screen normal
SMQs:, Acute central respiratory depression (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow), Normal pregnancy conditions and outcomes (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-05-09
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALINE; RHOPHYLAC; HUMULIN; METFORMIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Down''s syndrome (The father of baby-maternal uncle with down syndrome.); Comments: None
Allergies:
Diagnostic Lab Data: Test Date: 20181212; Test Name: MSAFP/serum markers; Result Unstructured Data: no major congenital malformations were noted. Test Date: 20181116; Test Name: Prenatal screening test; Result Unstructured Data: no major congenital malformations were noted on first trimester screening. Test Date: 20181212; Test Name: Prenatal screening test; Result Unstructured Data: no major congenital malformations were noted on second trimester screening. Test Date: 20190109; Test Name: Ultrasound scan; Result Unstructured Data: no major congenital malformations were noted.
CDC Split Type: USSEQIRUS201903453

Write-up: This is a spontaneous case, initially received from other health professional on 14-May-2019, concerning a female neonate patient. The patient''s family history included Down syndrome (father of baby-maternal uncle with Down syndrome). The patient''s mother was a 34-year-old who had 2 previous pregnancies reported with one previous spontaneous abortion and one previous full-term live birth. The patient''s maternal history included no congenital malformation and paternal history included Down syndrome. The current condition of patient''s mother included hyperthyroidism, anxiety, gestational and chronic hypertension, Rh-negative and diabetes mellitus. The concomitant medication of the patient''s mother included sertraline for hypertension, RHOPHYLAC (anti-D immunoglobulin) for Rh-negative, HUMULIN for diabetes mellitus and metformin for chronic hypertension. The patient''s mother did not use tobacco, alcohol or illicit drugs during pregnancy. The mother''s last menstrual period (LMP) date was 20-Aug-2018. On 06-Nov-2018, the patient''s mother had undergone ultrasound scan and no major congenital malformations were noted. On 09-Nov-2018, at the gestational age of 11 weeks, the patient''s mother received FLUCELVAX QIVc [route of administration: transplacental, batch number: 252226, dose, frequency, anatomical location and expiry date: not reported) for an unknown indication. The foetus was exposed to FLUCELVAX QIVc via transplacental route for an unknown indication. On 16-Nov-2018, the patient''s mother had undergone prenatal test (first trimester screening) and no major congenital malformations were noted. On 12-Dec-2018, the patient''s mother had had undergone prenatal test (second trimester screening) and no major congenital malformations were noted. On the same day, the patient''s mother underwent Maternal Serum Alpha-Fetoprotein Screening (MSAFP)/serum markers test and no major congenital malformations were noted. On 09-Jan-2019, the patient''s mother underwent prenatal test (anatomy ultrasound) and no major congenital malformations were noted. The patient''s mother gave a live birth to a female neonate at the gestational age of 37.1 weeks via vaginal method of delivery. The characteristics of the neonate included birth weight: 2806 grams, head circumference, length and appearance, pulse, grimace, activity, and respiration (APGAR) scores were not provided. No major congenital malformations (MCMs) were identified at birth. Six months after vaccination, the neonate died (reported as deceased). The mother''s estimated delivery date (EDD) was reported as 27-May-2019. The reporter assessed the case as serious (death). This case (201903453) is linked to 201903452 (mother case). Reporter''s Comments: A female neonate patient died (2 days post delivery), 6 months after maternal receipt of FLUCELVAX vaccine at 11 weeks of gestational age (considered as foetal exposure during pregnancy). The autopsy result is awaited. Considering the time frame of event, lack of detection of congenital anomalies in prenatal tests and post delivery, the event death assessed as not related to suspect vaccine. The maternal concurrent medical conditions hyperthyroidism, anxiety, gestational and chronic hypertension, Rh-negative and diabetes mellitus and concomitant medications are considered as risk factors. The case will be further assessed upon receipt of follow up information. The event foetal exposure during pregnancy assessed as not related considering the intended use of the vaccine. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 817681 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-06-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Areflexia, Autonomic nervous system imbalance, Biopsy, Bradycardia, CSF cell count, CSF lymphocyte count normal, CSF monocyte count increased, CSF protein increased, CSF red blood cell count, CSF white blood cell count negative, Computerised tomogram abnormal, Cytology normal, Death, Decreased vibratory sense, Dehydration, Demyelinating polyneuropathy, Electromyogram abnormal, Endotracheal intubation, Gait inability, Guillain-Barre syndrome, Hypotension, Immunoglobulin therapy, Mechanical ventilation, Muscular weakness, Nerve conduction studies abnormal, Nuclear magnetic resonance imaging brain abnormal, Paraesthesia, Plasmapheresis, Respiratory distress, Sepsis, Tachycardia, Walking aid user, Wheelchair user
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Angioedema (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Brain metastases; Melanoma limited to extremity (right thigh melanoma resection 3 years before); Metastatic melanoma (BRAF-V600 wildtype)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Brain computerized tomography; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Name: CSF cell count; Result Unstructured Data: Test Result: negative cytology, Test Result Unit: unknown; Test Name: Cerebrospinal fluid lymphocyte count; Test Result: 44 %; Test Name: CSF monocyte count; Test Result: 56 %; Test Name: Cerebrospinal fluid protein; Test Result: 37 mg/dl; Test Name: Cerebrospinal fluid protein; Test Result: 91 mg/dl; Test Name: CSF red blood cell count; Result Unstructured Data: Test Result: 21, Test Result Unit: unknown; Test Name: CSF red blood cell count; Result Unstructured Data: Test Result: 0, Test Result Unit: unknown; Test Name: CSF white blood cell count; Result Unstructured Data: Test Result: 7, Test Result Unit: unknown; Test Name: CSF white blood cell count; Result Unstructured Data: Test Result: 0, Test Result Unit: unknown; Test Name: Electromyogram; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Name: Nerve conduction studies; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Name: Nuclear magnetic resonance imaging brain; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Name: Physical examination; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: USGLAXOSMITHKLINEUS2019GS

Write-up: weakness of the lower and then upper; lost the ability to walk; Tendon reflex absent; respiratory distress; tachycardia; severely hypotension; possible sepsis; dehydration; Guillain-Barre syndrome/relapse of postvaccination GBS; dysautonomia; acute inflammatory demyelinating polyneuropathy; severely bradycardic; bilateral finger and toe paresthesia; This case was reported in a literature article and described the occurrence of guillain barre syndrome in a 66-year-old male patient who received Flu unspecified (Flu vaccine) for prophylaxis. Co-suspect products included nivolumab for metastatic melanoma. Concurrent medical conditions included melanoma limited to extremity (right thigh melanoma resection 3 years before), metastatic melanoma (BRAF-V600 wildtype) and brain metastases. On an unknown date, the patient received Flu vaccine at an unknown dose and nivolumab 240 mg at an unknown frequency. On an unknown date, 21 days after receiving Flu vaccine, the patient experienced guillain barre syndrome (serious criteria death, hospitalization and GSK medically significant), dysautonomia (serious criteria death and hospitalization), demyelinating polyneuropathy (serious criteria hospitalization and GSK medically significant), weakness of limbs (serious criteria hospitalization), unable to walk (serious criteria hospitalization), tendon reflex absent (serious criteria hospitalization), respiratory distress (serious criteria hospitalization and GSK medically significant), tachycardia (serious criteria hospitalization), hypotension (serious criteria hospitalization), bradycardia (serious criteria hospitalization and GSK medically significant), sepsis (serious criteria hospitalization and GSK medically significant), dehydration (serious criteria hospitalization) and paresthesia. The patient was treated with immunoglobulins nos (Immunoglobulin), prednisone, operations and procedures (Plasma Exchange) and mesalazine (Midodrine (Mesalazine)). The action taken with nivolumab was unknown (Dechallenge was unknown). On an unknown date, the outcome of the guillain barre syndrome and dysautonomia were fatal and the outcome of the demyelinating polyneuropathy, weakness of limbs, unable to walk, tendon reflex absent, respiratory distress, tachycardia, hypotension, bradycardia, sepsis, dehydration and paresthesia were unknown. The reported cause of death was guillain barre syndrome and dysautonomia. The reporter considered the guillain barre syndrome, dysautonomia, demyelinating polyneuropathy, weakness of limbs, unable to walk, tendon reflex absent, respiratory distress, tachycardia, hypotension, bradycardia, sepsis, dehydration and paresthesia to be related to Flu vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of Guillain-Barre Syndrome in a 66-year-old male who was vaccinated with unspecified flu vaccine (manufacturer unknown) for prophylaxis. He had a history of right thigh melanoma resection 3 years before. No information on patient''s family history or concomitant medication was provided. On an unspecified date, the patient received unspecified flu vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. The patient could be 65 or 66 years of age. The co-suspect product included Nivolumab. On an unspecified date, about 3 weeks after receiving a flu vaccination, the patient developed bilateral finger and toe paresthesia followed by weakness of the lower and then upper limbs. Examination 12 days after the onset of initial symptoms and a day after he lost the ability to walk revealed strength of 3/5 in upper-limb muscles, hip flexors, quadriceps, hamstrings, and 2/5 in the ankle dorsiflexors and plantar flexors, as assessed according to the Medical Research Council scale. Pinprick sensation was diminished up to the ankles and fingertips, vibration was lost at the toes, and deep tendon reflexes were absent at the knees and ankles. Cerebrospinal fluid (CSF) analysis showed white blood cell, 7 (56% monocytes, 44% lymphocytes); red blood cell, 21; protein, 37 mg/dL; and a negative cytology. A nerve conduction study 34 days after the flu vaccination demonstrated absent bilateral sural and right median sensory responses, prolonged distal and F wave latencies of the right median nerve, as well as very low amplitudes and very slow conduction velocities of all the motor responses. The results of nerve conduction study for the right median motor nerve were motor distal latency (MDL) was 8.2 milliseconds (ms) (normal value 4.1 ms), Distal amplitude was 1.0 millivolts (mV) (normal value 5.0), Proximal amplitude was 1.0 mV, conduction velocity in meter per second (CV (m/s)) was 44.5 (48.0), F Wave latency was found to be 40.5 mV (30.0). The results of nerve conduction study for the reft tibial motor nerve were MDL was found to be 5.8 ms (6.0), distal amplitude was 0.5 mV (5.0), Proximal amplitude was 0.07 mV, CV was 25.4 m/s (38.0). The results of nerve conduction study for the right tibial motor nerve were MDL was found 6.5 ms (6.0), distal amplitude was 0.15 mV (5.0), Proximal amplitude was 0.1 mV, CV was 23.5 m/s (38.0). The results of nerve conduction study for the right radial sensory nerve were distal amplitude was found to be 18.2 mV (15.0), CV was 57.5 m/s (50). The distal amplitude for the bilateral median sensory nerve was found to be 0 mV (15). The distal amplitude for the bilateral sural sensory nerve was found to be 0 mV (5). Needle electromyography (EMG) showed neurogenic recruitment in all the muscles tested in bilateral lower and right upper limbs and positive waves/fibrillation potentials in the cervical and lumbar paraspinal muscles. He was diagnosed with postvaccination GBS, and intravenous immunoglobulin (IVIg) 2 g/ kg was then administered over a period of 5 days. Brain MRI showed a 4 X 5-mm enhancing lesion with associated T2 hyperintensity and restricted diffusion in the right superior medial precentral gyrus, consistent with a brain metastasis. Computed tomography scan of the abdomen and pelvis showed multiple hepatic hypodense nodules, biopsy of which demonstrated metastatic melanoma, BRAF-V600 wildtype. His weakness initially improved after IVIg treatment to the point that he was able to ambulate 100 feet with an assistive device. However, his weakness worsened about 3 weeks later when he lost his ability to ambulate. At that time, the treating physicians considered the possibility of acute onset chronic inflammatory demyelinating neuropathy or paraneoplastic neuropathy. He then received IVIg 1 g/kg divided over a period of 2 days and was started on prednisone 60 mg/day and received nivolumab 240 mg, which was repeated after 13 days. His motor strength further declined dramatically about 12 days after the first dose of nivolumab, so that he was unable to sit in the wheelchair, resulting in his transfer to hospital. Physical examination revealed motor strength of 3/5 in upper extremities, 1/5 hip flexion and hip extension, and 0/5 in remaining lower extremity muscle groups. His deep tendon reflexes were trace in the upper extremities and absent at the knees and ankles, and there was diminished pinprick sensation in stocking/glove distribution and absent vibratory sensation at the toes. CSF analysis showed white blood cell, 0; red blood cell, 0; and protein, 91 mg/dL. A follow-up EMG study 91 days after the flu vaccination showed severely prolonged distal latencies, reduced amplitudes, very slow conduction velocities, and markedly prolonged F wave latencies. Temporal dispersion of the compound muscle action potential was present with distal stimulation of all the motor nerves, and there was conduction blocks in the right ulnar motor response with stimulation below and above the elbow. On day 91 after vaccination nerve conduction study was performed, The results of nerve conduction study for the right median motor nerve were MDL was 20.52 ms (4.1), distal amplitude was 1.0 mV (5.0), Proximal amplitude was 0.9 mV, CV was 26.5 m/s (48.0), F Wave Lat. was 66.0 mV (30.0). The results of nerve conduction study for the right ulnar motor nerve were MDL was 6.51 ms (3.8), distal amplitude was 1.0 mV (5.0), proximal amplitude was 0.6 mV (B.elbow) and 0.3 mV (A.elbow), CV was 27.2 m/s (48.0) and 21.6 m/s (48.0), F Wave Lat. (mV) was not reported (31.0). The results of nerve conduction study for the left tibial motor nerve were MDL was 18.28 ms (6.0), Distal amplitude was 0.3 mV (5.0), proximal amplitude was 0.1 mV, CV was found to be 16.1 m/s (38.0). The results of nerve conduction study for the right peroneal motor nerve were MDL was 22.5 ms (6.0), distal amplitude was 0.1 mV (3.0), proximal amplitude was 0.0 mV. The distal amplitude for the right radial sensory nerve, Bilateral median sensory nerve and Bilateral sural sensory nerve was respectively found to be 0 mV (15), 0 mV (15) and 0 mV (5). Needle EMG showed positive waves and fibrillation potentials and no motor unit activation in the right tibialis anterior and quadriceps, as well as severely reduced recruitment in right first dorsal interosseous, biceps, and deltoid. Antibodies to ANNA-1, Amphiphysin, ANNA-2, CRMP-5, PCA-1, PCA-2, PCA-Tr, GM1, and GD1b were negative. On day 2 of hospitalization, he developed respiratory distress, tachycardia, and hypotension. He was intubated and placed on mechanical ventilation, and then started on plasma exchange (PLEX). During the hospitalization, there were wide fluctuations in heart rate and blood pressure, which were partly attributed to dysautonomia secondary to acute inflammatory demyelinating polyneuropathy (AIDP) because they were persistent between the sessions of PLEX and present after other potential causes such as possible sepsis and dehydration were appropriately treated. He was started on midodrine on day 5 of hospitalization, but on day 9 became severely hypotensive and bradycardic, requiring pressure support, and subsequently expired as the family withdrew life-sustaining therapies. His GBS disability score during the course of his disease starting with administration of influenza vaccine was 2 (between day 20 and 30); 2-4 (between day 30 and 40), 3-4 (between day 40 and 60), 3-4 (between day 60 and 90), 5-6 (between day 90 and 100). Dysautonomia contributed to fatal outcome in the patient. It was unknown if autopsy was performed. The case is considered serious due to death and hospitalization. The author considered the event of Guillain-Barre Syndrome related to unspecified flu vaccine. The author stated ?The subacute course of the neuropathy in our patient and the timing of vaccination were consistent with a postinfluenza virus vaccination GBS''. The authors concluded, ?Our patient is the first report of severe GBS relapse after treatment with nivolumab, which was administered during a treatment-related fluctuation. We conclude that administration of checkpoint inhibitor. treatment during the acute stage of GBS may result in a severe, potentially fatal exacerbation and recommend exercising caution in starting administration of such treatments in patients who are in the acute stage or early in the recovery phase of GBS. Further studies for targeted therapies to treat life threatening AEs are warranted". Lab Comments: Lab tests were performed on unspecified dates A nerve conduction study 34 days after the flu vaccination demonstrated absent bilateral sural and right median sensory responses, prolonged distal and F wave latencies of the right median nerve, as well as very low amplitudes and very slow conduction velocities of all the motor response; needle electromyography (EMG) showed neurogenic recruitment in all the muscles tested in bilateral lower and right upper limbs and positive waves/fibrillation potentials in the cervical and lumbar paraspinal muscles. His motor strength further declined dramatically about 12 days after the first dose of nivolumab, so that he was unable to sit in the wheelchair, resulting in his transfer to our center. Physical examination revealed motor strength of 3/5 in upper extremities, 1/5 hip flexion and hip extension, and 0/5 in remaining lower extremity muscle groups. His deep tendon reflexes were trace in the upper extremities and absent at the knees and ankles, and there was diminished pinprick sensation in stocking/glove distribution and absent vibratory sensation at the toes. A follow-up EMG study 91 days after the flu vaccination showed severely prolonged distal latencies, reduced amplitudes, very slow conduction velocities, and markedly prolonged F wave latencies. Temporal dispersion of the compound muscle action potential was present with distal stimulation of all the motor nerves, and there was conduction blocks in the right ulnar motor response with stimulation below and above the elbow. Needle EMG showed positive waves and fibrillation potentials and no motor unit activation in the right tibialis anterior and quadriceps, as well as severely reduced recruitment in right first dorsal interosseous, biceps, and deltoid. Antibodies to ANNA-1, Amphiphysin, ANNA-2, CRMP-5, PCA-1, PCA-2, PCA-Tr, GM1, and GD1b were negative.; Reported Cause(s) of Death: Guillain Barre syndrome; dysautonomia


VAERS ID: 818717 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-06-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2019AM

Write-up: death; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Flu vaccine. Additional details were provided as follows: The age at vaccination was not reported. The reporter''s friend''s father died after flu shot. The reporter stated that either the vaccines are safe or they are not.; Reported Cause(s) of Death: Death NOS


VAERS ID: 820916 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, H1N1 influenza, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

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

Write-up: Suspected vaccination failure; swine flu; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Flu unspecified (Influenza vaccine) for prophylaxis. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and swine influenza (serious criteria death). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the swine influenza was fatal. The reported cause of death was swine influenza. It was unknown if the reporter considered the vaccination failure and swine influenza to be related to Influenza vaccine. Additional information was provided as follows: The age at vaccination was not reported. This case was reported by the patient''s brother. The patient received Flu shot and had swine flu. As per reporter, the patient died from this flu shot. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.; Reported Cause(s) of Death: Swine flu


VAERS ID: 826259 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chest X-ray normal, Death, Gene sequencing, H3N2 influenza, Influenza, Influenza A virus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2015; Test Name: Gene sequencing; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Date: 2015; Test Name: Influenza virus test positive; Result Unstructured Data: Test Result: influenza A/H3N2 virus infection, Test Result Unit: unknown; Test Date: 2015; Test Name: X-ray; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: USGLAXOSMITHKLINEUS2019GS

Write-up: Suspected vaccination failure; Influenza A/H3N2 virus infection; This case was reported in a literature article and described the occurrence of suspected vaccination failure in a 76-year-old male subject who received Flu vaccine for prophylaxis. Previously administered products included Influenza vaccine (at some point of time during the last 5 influenza seasons). On an unknown date, less than a year after receiving Flu vaccine, the subject developed vaccination failure. Serious criteria included death, hospitalization and GSK medically significant. Additional event(s) included influenza a virus infection with serious criteria of death and hospitalization. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included influenza a virus infection (fatal). The reported cause of death was influenza. The investigator considered that there was a reasonable possibility that the vaccination failure and influenza a virus infection may have been caused by Flu vaccine. Relevant Tests: The nasopharyngeal (NP) swab sample was collected on 18 February 2015. The sample was sent to the laboratory for influenza testing. The patient was diagnosed influenza A/H3N2 virus infection (confirmed by Film Array). Total deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) were extracted from samples and subjected to 16S rRNA gene sequencing for microbiota profiling and influenza virus gene segment sequencing, respectively. Linear discriminant analysis and effective size comparisons (LEfSe) was used to identify signature taxonomic groups and features that were most likely to significantly characterize the influenza-related compositional differences of the microbiota and defined bacterial community types using Dirichlet multinomial mixture (DMM) models. k-mer analysis was performed to identify underlying influenza virus sequence signatures for each sample and compared them to each other, visualized this measure of genetic distance by multidimensional scaling. No data was available on influenza virus sequencing for the sample. The patient was not diagnosed with pneumonia by chest X ray. The cluster identified for influenza A/H3N2 was corresponding to the 3C.2a genetic clade. Diagnostic results (unless otherwise stated, normal values were not provided): In 2015, Gene sequencing result was see text , Influenza virus test positive result was influenza A/H3N2 virus infection unknown and X-ray result was see text . Additional information was provided. This case was reported in a literature article and described the suspected vaccination failure in a 76 years old male who was vaccinated with unspecified influenza vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplementary table S1 reported in this literature article. The patient was part of cross-sectional study that aimed to characterize the microbiota of the nasopharynx by analyzing samples from individuals diagnosed with influenza A virus (IAV) H3N2 or influenza B virus (IBV) (Yamagata or Victoria) infections during the 2014-2015 influenza season and in healthy controls. The study investigated in more detail the relationship between host factors, such as age or vaccination status, and the respiratory microbiome in a specific influenza season that could help to better identify factors that contributed to influenza disease severity. The patient received influenza virus vaccine at some point of time during the last 5 influenza seasons. The patient was not immunocompromised. No information on patient''s family history or concomitant medication was provided. On an unspecified date during the 2014-2015 influenza season, the patient received unspecified influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). The age at vaccination was not provided but it could be 75 or 76 years old. On an unspecified date at 76 years of age, during the 2014-2015 influenza season, an unknown period (in same season) after vaccination, the patient was hospitalized and the nasopharyngeal (NP) swab sample was collected on 18 February 2015. The sample was sent to the laboratory for influenza testing. The patient was diagnosed influenza A/H3N2 virus infection (confirmed by Film Array). Total deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) were extracted from samples and subjected to 16S rRNA gene sequencing for microbiota profiling and influenza virus gene segment sequencing, respectively. Linear discriminant analysis and effective size comparisons (LEfSe) was used to identify signature taxonomic groups and features that were most likely to significantly characterize the influenza-related compositional differences of the microbiota and defined bacterial community types using Dirichlet multinomial mixture (DMM) models. k-mer analysis was performed to identify underlying influenza virus sequence signatures for each sample and compared them to each other, visualized this measure of genetic distance by multidimensional scaling. No data was available on influenza virus sequencing for the sample. The patient was not diagnosed with pneumonia by chest X ray. The cluster identified for influenza A/H3N2 was corresponding to the 3C.2a genetic clade. On an unspecified date, the patient died. It was unknown if an autopsy was performed. [In this study, the influenza virus-infected individuals had a slightly lower prevalence and abundance of Streptococcus, an enrichment of Dolosigranulum, and very low prevalence of Corynebacterium. 4 microbial community types (NP types) in the subjects tested. NP type A was significantly enriched in influenza infection, while NP type B dominated in the control group. While both community types C and D were slightly enriched in influenza patients, it was not at a significant level. In the influenza virus-infected subjects only, the less common influenza-associated NP type D was found predominantly in the young (less than 18 years old). NP type A was comprised primarily of Streptococcus and Dolosigranulum; NP type B, enriched was dominated by a combination of Streptococcus, Corynebacterium, and Comamonadaceae. NP type C was dominated by Moraxella, while NP type D had an overrepresentation of Staphylococcus. The different communities did not associate differently with either of the flu types (IAV versus IBV)]. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered as serious due to death/suspected vaccination failure / hospitalisation. Treatment was unknown. The outcome of event was death. The authors stated, "Influenza infection was shown to be significantly associated with microbial composition of the nasopharynx according to the virus type and the vaccination status of the patient. We identified four microbial community types across the combined cohort of influenza patients and healthy individuals with one community type most representative of the influenza virus-infected group. We also identified microbial taxa for which relative abundance was significantly higher in the unvaccinated elderly group; these taxa include species known to be associated with pneumonia. Our results suggest that there is a significant association between the composition of the microbiota in the nasopharynx and the influenza virus type causing the infection. We observe that vaccination status, especially in more senior individuals, also has an association with the microbial community profile. This indicates that vaccination against influenza, even when ineffective to prevent disease, could play a role in controlling secondary bacterial complications. The reasons for enhanced susceptibility to severe bacterial disease after influenza infection remain poorly defined. viral infection can disrupt this equilibrium and cause loss of some microbial populations and/or overgrowth of other pathogens, resulting in disease. Disruption of the URT microbiota has been found to be associated with community-acquired pneumonia. Even an unmatched influenza vaccine could prevent severe disease by modulating the respiratory bacterial communities. IAV and IBV virus infections were associated with a significantly different microbial community profile than that for uninfected individuals. Overall, these observations suggest that Corynebacterium could potentially protect the respiratory tract from pathogenic bacteria such as S. aureus and S. pneumoniae that are the most common cause of post-influenza pneumonia. We studied the composition of the nasopharynx microbiota at diagnosis, we cannot determine whether differences between healthy controls and influenza virus-infected individuals are due to the infection, the presence of a microbial community that predisposes to infection, or a combination of both. The effectiveness of the influenza vaccine varies in different seasons due to a number of factors, such as vaccine strain mismatch and host immune status, including history of previous influenza vaccination. We suggest that another potential factor is the host microbiome. It showed that in influenza virus-infected individuals the lack of vaccination in the current season is associated with the enrichment of different microbial taxa, such as Moraxella and Streptococcus, depending on the type of influenza virus (IAV versus IBV)". The authors concluded, "Our aims in this study were to determine whether the microbiota of the nasopharynx was different in individuals with influenza infection and to identify factors associated with the variations observed between infected subjects in different age groups. We found that during influenza infection, the nasopharyngeal microbiota of vaccinated individuals was strongly associated with higher levels of specific microbial taxa, with different microbial profiles relative to virus types and clades. These observations provide new insight into influenza infection and highlight a need for more studies to explore the mechanism of how influenza vaccines-live attenuated or killed-interact with the respiratory microbiota". This is 1 of the 127 valid cases reported in the same literature article. Lab Comments: The nasopharyngeal (NP) swab sample (sample ID A059) was collected on 18 February 2015. The sample was sent to the laboratory for influenza testing. The patient was diagnosed influenza A/H3N2 virus infection (confirmed by Film Array). Total deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) were extracted from samples and subjected to 16S rRNA gene sequencing for microbiota profiling and influenza virus gene segment sequencing, respectively. Linear discriminant analysis and effective size comparisons (LEfSe) was used to identify signature taxonomic groups and features that were most likely to significantly characterize the influenza-related compositional differences of the microbiota and defined bacterial community types using Dirichlet multinomial mixture (DMM) models. k-mer analysis was performed to identify underlying influenza virus sequence signatures for each sample and compared them to each other, visualized this measure of genetic distance by multidimensional scaling. No data was available on influenza virus sequencing for the sample. The patient was not diagnosed with pneumonia by chest X ray. The cluster identified for influenza A/H3N2 was corresponding to the 3C.2a genetic clade.; Reported Cause(s) of Death: Influenza A/H3N2 virus infection


VAERS ID: 826261 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chest X-ray normal, Death, Gene sequencing, H3N2 influenza, Influenza, Influenza A virus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2015; Test Name: Gene sequencing; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Date: 2015; Test Name: Influenza virus test positive; Result Unstructured Data: Test Result: influenza A/H3N2 virus infection, Test Result Unit: unknown; Test Date: 2015; Test Name: X-ray; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: USGLAXOSMITHKLINEUS2019GS

Write-up: Suspected vaccination failure; Influenza A/H3N2 virus infection; This case was reported in a literature article and described the occurrence of vaccination failure in a 84-year-old female subject who received Flu vaccine for prophylaxis. Previously administered products included Influenza vaccine (at some point of time during the last 5 influenza seasons). On an unknown date, less than a year after receiving Flu vaccine, the subject developed vaccination failure. Serious criteria included death, hospitalization and GSK medically significant. Additional event(s) included influenza a virus infection with serious criteria of death and hospitalization. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included influenza a virus infection (fatal). The reported cause of death was influenza. The investigator considered that there was a reasonable possibility that the vaccination failure and influenza a virus infection may have been caused by Flu vaccine. Relevant Tests: The nasopharyngeal (NP) swab sample was collected on 23 February 2015. The sample was sent to the laboratory for influenza testing. The patient was diagnosed influenza A/H3N2 virus infection (confirmed by Film Array). Total deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) were extracted from samples and subjected to 16S rRNA gene sequencing for microbiota profiling and influenza virus gene segment sequencing, respectively. Linear discriminant analysis and effective size comparisons (LEfSe) was used to identify signature taxonomic groups and features that were most likely to significantly characterize the influenza-related compositional differences of the microbiota and defined bacterial community types using Dirichlet multinomial mixture (DMM) models. k-mer analysis was performed to identify underlying influenza virus sequence signatures for each sample and compared them to each other, visualized this measure of genetic distance by multidimensional scaling. No data was available on influenza virus sequencing for the sample. The patient was not diagnosed with pneumonia by chest X ray. Diagnostic results (unless otherwise stated, normal values were not provided): In 2015, Gene sequencing result was see text unknown, Influenza virus test positive result was influenza A/H3N2 virus infection unknown and X-ray result was see text unknown. Additional information was provided. This case was reported in a literature article and described the suspected vaccination failure in a 84 years old female who was vaccinated with unspecified influenza vaccine (manufacturer unknown) for prophylaxis. This case corresponds to from supplementary table S1 reported in this literature article. The patient was part of cross-sectional study that aimed to characterize the microbiota of the nasopharynx by analyzing samples from individuals diagnosed with influenza A virus (IAV) H3N2 or influenza B virus (IBV) (Yamagata or Victoria) infections during the 2014-2015 influenza season and in healthy controls. The study investigated in more detail the relationship between host factors, such as age or vaccination status, and the respiratory microbiome in a specific influenza season that could help to better identify factors that contributed to influenza disease severity. The patient received influenza virus vaccine at some point of time during the last 5 influenza seasons. The patient was not immunocompromised. No information on patient''s medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date during the 2014-2015 influenza season, the patient received unspecified influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). The age at vaccination was not provided but it could be 83 or 84 years old. On an unspecified date at 84 years of age, during the 2014-2015 influenza season, an unknown period (in same season) after vaccination, the patient was hospitalized and the nasopharyngeal (NP) swab sample was collected on 23 February 2015. The sample was sent to the laboratory for influenza testing. The patient was diagnosed influenza A/H3N2 virus infection (confirmed by Film Array). Total deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) were extracted from samples and subjected to 16S rRNA gene sequencing for microbiota profiling and influenza virus gene segment sequencing, respectively. Linear discriminant analysis and effective size comparisons (LEfSe) was used to identify signature taxonomic groups and features that were most likely to significantly characterize the influenza-related compositional differences of the microbiota and defined bacterial community types using Dirichlet multinomial mixture (DMM) models. k-mer analysis was performed to identify underlying influenza virus sequence signatures for each sample and compared them to each other, visualized this measure of genetic distance by multidimensional scaling. No data was available on influenza virus sequencing for the sample. The patient was not diagnosed with pneumonia by chest X ray. On an unspecified date, the patient died. It was unknown if an autopsy was performed. [In this study, the influenza virus-infected individuals had a slightly lower prevalence and abundance of Streptococcus, an enrichment of Dolosigranulum, and very low prevalence of Corynebacterium. 4 microbial community types (NP types) in the subjects tested. NP type A was significantly enriched in influenza infection, while NP type B dominated in the control group. While both community types C and D were slightly enriched in influenza patients, it was not at a significant level. In the influenza virus-infected subjects only, the less common influenza-associated NP type D was found predominantly in the young (less than 18 years old). NP type A was comprised primarily of Streptococcus and Dolosigranulum; NP type B, enriched was dominated by a combination of Streptococcus, Corynebacterium, and Comamonadaceae. NP type C was dominated by Moraxella, while NP type D had an overrepresentation of Staphylococcus. The different communities did not associate differently with either of the flu types (IAV versus IBV)]. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered as serious due to death/suspected vaccination failure/hospitalisation. Treatment was unknown. The outcome of event was death. The authors stated, "Influenza infection was shown to be significantly associated with microbial composition of the nasopharynx according to the virus type and the vaccination status of the patient. We identified four microbial community types across the combined cohort of influenza patients and healthy individuals with one community type most representative of the influenza virus-infected group. We also identified microbial taxa for which relative abundance was significantly higher in the unvaccinated elderly group; these taxa include species known to be associated with pneumonia. Our results suggest that there is a significant association between the composition of the microbiota in the nasopharynx and the influenza virus type causing the infection. We observe that vaccination status, especially in more senior individuals, also has an association with the microbial community profile. This indicates that vaccination against influenza, even when ineffective to prevent disease, could play a role in controlling secondary bacterial complications. The reasons for enhanced susceptibility to severe bacterial disease after influenza infection remain poorly defined. viral infection can disrupt this equilibrium and cause loss of some microbial populations and/or overgrowth of other pathogens, resulting in disease. Disruption of the URT microbiota has been found to be associated with community-acquired pneumonia. Even an unmatched influenza vaccine could prevent severe disease by modulating the respiratory bacterial communities. IAV and IBV virus infections were associated with a significantly different microbial community profile than that for uninfected individuals. Overall, these observations suggest that Corynebacterium could potentially protect the respiratory tract from pathogenic bacteria such as S. aureus and S. pneumoniae that are the most common cause of post-influenza pneumonia. We studied the composition of the nasopharynx microbiota at diagnosis, we cannot determine whether differences between healthy controls and influenza virus-infected individuals are due to the infection, the presence of a microbial community that predisposes to infection, or a combination of both. The effectiveness of the influenza vaccine varies in different seasons due to a number of factors, such as vaccine strain mismatch and host immune status, including history of previous influenza vaccination. We suggest that another potential factor is the host microbiome. It showed that in influenza virus-infected individuals the lack of vaccination in the current season is associated with the enrichment of different microbial taxa, such as Moraxella and Streptococcus, depending on the type of influenza virus (IAV versus IBV)". The authors concluded, "Our aims in this study were to determine whether the microbiota of the nasopharynx was different in individuals with influenza infection and to identify factors associated with the variations observed between infected subjects in different age groups. We found that during influenza infection, the nasopharyngeal microbiota of vaccinated individuals was strongly associated with higher levels of specific microbial taxa, with different microbial profiles relative to virus types and clades. These observations provide new insight into influenza infection and highlight a need for more studies to explore the mechanism of how influenza vaccines-live attenuated or killed-interact with the respiratory microbiota". This is 1 of the 127 valid cases reported in the same literature article. Lab Comments: The nasopharyngeal (NP) swab sample (sample ID A073) was collected on 23 February 2015. The sample was sent to the laboratory for influenza testing. The patient was diagnosed influenza A/H3N2 virus infection (confirmed by Film Array). Total deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) were extracted from samples and subjected to 16S rRNA gene sequencing for microbiota profiling and influenza virus gene segment sequencing, respectively. Linear discriminant analysis and effective size comparisons (LEfSe) was used to identify signature taxonomic groups and features that were most likely to significantly characterize the influenza-related compositional differences of the microbiota and defined bacterial community types using Dirichlet multinomial mixture (DMM) models. k-mer analysis was performed to identify underlying influenza virus sequence signatures for each sample and compared them to each other, visualized this measure of genetic distance by multidimensional scaling. No data was available on influenza virus sequencing for the sample. The patient was not diagnosed with pneumonia by chest X ray.; Reported Cause(s) of Death: Influenza A/H3N2 virus infection


VAERS ID: 826262 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chest X-ray normal, Death, Gene sequencing, H3N2 influenza, Influenza, Influenza A virus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunocompromised
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2015; Test Name: Gene sequencing; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Date: 2015; Test Name: Influenza virus test positive; Result Unstructured Data: Test Result: influenza A/H3N2 virus infection, Test Result Unit: unknown; Test Date: 2015; Test Name: X-ray; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: USGLAXOSMITHKLINEUS2019GS

Write-up: Suspected vaccination failure; Influenza A/H3N2 virus infection; This case was reported in a literature article and described the occurrence of vaccination failure in a 86-year-old female subject who received Flu vaccine for prophylaxis. Previously administered products included Influenza vaccine (at some point of time during the last 5 influenza seasons). Concurrent medical conditions included immunocompromised. On an unknown date, less than a year after receiving Flu vaccine, the subject developed vaccination failure. Serious criteria included death, hospitalization and GSK medically significant. Additional event(s) included influenza a virus infection with serious criteria of death and hospitalization. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included influenza a virus infection (fatal). The reported cause of death was influenza. The investigator considered that there was a reasonable possibility that the vaccination failure and influenza a virus infection may have been caused by Flu vaccine. Relevant Tests: The nasopharyngeal (NP) swab sample was collected on 1 January 2015. The sample was sent to the laboratory for influenza testing. The patient was diagnosed influenza A/H3N2 virus infection (confirmed by Film Array). Total deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) were extracted from samples and subjected to 16S rRNA gene sequencing for microbiota profiling and influenza virus gene segment sequencing, respectively. Linear discriminant analysis and effective size comparisons (LEfSe) was used to identify signature taxonomic groups and features that were most likely to significantly characterize the influenza-related compositional differences of the microbiota and defined bacterial community types using Dirichlet multinomial mixture (DMM) models. k-mer analysis was performed to identify underlying influenza virus sequence signatures for each sample and compared them to each other, visualized this measure of genetic distance by multidimensional scaling. Influenza virus sequencing and 16S rRNA gene sequencing for the sample was done. The cluster identified for influenza A/H3N2 was corresponding to the 3C.2a genetic clade. The patient was not diagnosed with pneumonia by chest X ray. Diagnostic results (unless otherwise stated, normal values were not provided): In 2015, Gene sequencing result was see text unknown, Influenza virus test positive result was influenza A/H3N2 virus infection unknown and X-ray result was see text unknown. Additional information was provided. This case was reported in a literature article and described the suspected vaccination failure in a 86 years old female who was vaccinated with unspecified influenza vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplementary table S1 reported in this literature article. The patient was part of cross-sectional study that aimed to characterize the microbiota of the nasopharynx by analyzing samples from individuals diagnosed with influenza A virus (IAV) H3N2 or influenza B virus (IBV) (Yamagata or Victoria) infections during the 2014-2015 influenza season and in healthy controls. The study investigated in more detail the relationship between host factors, such as age or vaccination status, and the respiratory microbiome in a specific influenza season that could help to better identify factors that contributed to influenza disease severity. The patient received influenza virus vaccine at some point of time during the last 5 influenza seasons. The patient was immunocompromised. No information on patient''s medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date during the 2014-2015 influenza season, the patient received unspecified influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). The age at vaccination was not provided but it could be 85 or 86 years old. On an unspecified date at 86 years of age, during the 2014-2015 influenza season, an unknown period (in same season) after vaccination, the patient was hospitalized and the nasopharyngeal (NP) swab sample (sample ID A213) was collected on 1 January 2015. The sample was sent to the laboratory for influenza testing. The patient was diagnosed influenza A/H3N2 virus infection (confirmed by Film Array). Total deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) were extracted from samples and subjected to 16S rRNA gene sequencing for microbiota profiling and influenza virus gene segment sequencing, respectively. Linear discriminant analysis and effective size comparisons (LEfSe) was used to identify signature taxonomic groups and features that were most likely to significantly characterize the influenza-related compositional differences of the microbiota and defined bacterial community types using Dirichlet multinomial mixture (DMM) models. k-mer analysis was performed to identify underlying influenza virus sequence signatures for each sample and compared them to each other, visualized this measure of genetic distance by multidimensional scaling. Influenza virus sequencing and 16S rRNA gene sequencing for the sample was done. The cluster identified for influenza A/H3N2 was corresponding to the 3C.2a genetic clade. The patient was not diagnosed with pneumonia by chest X ray. On an unspecified date, the patient died. It was unknown if an autopsy was performed. [In this study, the influenza virus-infected individuals had a slightly lower prevalence and abundance of Streptococcus, an enrichment of Dolosigranulum, and very low prevalence of Corynebacterium. 4 microbial community types (NP types) in the subjects tested. NP type A was significantly enriched in influenza infection, while NP type B dominated in the control group. While both community types C and D were slightly enriched in influenza patients, it was not at a significant level. In the influenza virus-infected subjects only, the less common influenza-associated NP type D was found predominantly in the young (less than 18 years old). NP type A was comprised primarily of Streptococcus and Dolosigranulum; NP type B, enriched was dominated by a combination of Streptococcus, Corynebacterium, and Comamonadaceae. NP type C was dominated by Moraxella, while NP type D had an overrepresentation of Staphylococcus. The different communities did not associate differently with either of the flu types (IAV versus IBV)]. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered as serious due to death/suspected vaccination failure/hospitalisation. Treatment was unknown. The outcome of event was death. The authors stated, "Influenza infection was shown to be significantly associated with microbial composition of the nasopharynx according to the virus type and the vaccination status of the patient. We identified four microbial community types across the combined cohort of influenza patients and healthy individuals with one community type most representative of the influenza virus-infected group. We also identified microbial taxa for which relative abundance was significantly higher in the unvaccinated elderly group; these taxa include species known to be associated with pneumonia. Our results suggest that there is a significant association between the composition of the microbiota in the nasopharynx and the influenza virus type causing the infection. We observe that vaccination status, especially in more senior individuals, also has an association with the microbial community profile. This indicates that vaccination against influenza, even when ineffective to prevent disease, could play a role in controlling secondary bacterial complications. The reasons for enhanced susceptibility to severe bacterial disease after influenza infection remain poorly defined. viral infection can disrupt this equilibrium and cause loss of some microbial populations and/or overgrowth of other pathogens, resulting in disease. Disruption of the URT microbiota has been found to be associated with community-acquired pneumonia. Even an unmatched influenza vaccine could prevent severe disease by modulating the respiratory bacterial communities. IAV and IBV virus infections were associated with a significantly different microbial community profile than that for uninfected individuals. Overall, these observations suggest that Corynebacterium could potentially protect the respiratory tract from pathogenic bacteria such as S. aureus and S. pneumoniae that are the most common cause of post-influenza pneumonia. We studied the composition of the nasopharynx microbiota at diagnosis, we cannot determine whether differences between healthy controls and influenza virus-infected individuals are due to the infection, the presence of a microbial community that predisposes to infection, or a combination of both. The effectiveness of the influenza vaccine varies in different seasons due to a number of factors, such as vaccine strain mismatch and host immune status, including history of previous influenza vaccination. We suggest that another potential factor is the host microbiome. It showed that in influenza virus-infected individuals the lack of vaccination in the current season is associated with the enrichment of different microbial taxa, such as Moraxella and Streptococcus, depending on the type of influenza virus (IAV versus IBV)". The authors concluded, "Our aims in this study were to determine whether the microbiota of the nasopharynx was different in individuals with influenza infection and to identify factors associated with the variations observed between infected subjects in different age groups. We found that during influenza infection, the nasopharyngeal microbiota of vaccinated individuals was strongly associated with higher levels of specific microbial taxa, with different microbial profiles relative to virus types and clades. These observations provide new insight into influenza infection and highlight a need for more studies to explore the mechanism of how influenza vaccines-live attenuated or killed-interact with the respiratory microbiota". This is 1 of the 127 valid cases reported in the same literature article. Lab Comments: The nasopharyngeal (NP) swab sample was collected on 1 January 2015. The sample was sent to the laboratory for influenza testing. The patient was diagnosed influenza A/H3N2 virus infection (confirmed by Film Array). Total deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) were extracted from samples and subjected to 16S rRNA gene sequencing for microbiota profiling and influenza virus gene segment sequencing, respectively. Linear discriminant analysis and effective size comparisons (LEfSe) was used to identify signature taxonomic groups and features that were most likely to significantly characterize the influenza-related compositional differences of the microbiota and defined bacterial community types using Dirichlet multinomial mixture (DMM) models. k-mer analysis was performed to identify underlying influenza virus sequence signatures for each sample and compared them to each other, visualized this measure of genetic distance by multidimensional scaling. Influenza virus sequencing and 16S rRNA gene sequencing for the sample was done. The cluster identified for influenza A/H3N2 was corresponding to the 3C.2a genetic clade. The patient was not diagnosed with pneumonia by chest X ray.; Reported Cause(s) of Death: Influenza A/H3N2 virus infection


VAERS ID: 826263 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chest X-ray normal, Death, Gene sequencing, H3N2 influenza, Influenza, Influenza A virus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2015; Test Name: Gene sequencing; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Date: 2015; Test Name: Influenza virus test positive; Result Unstructured Data: Test Result: influenza A/H3N2 virus infection, Test Result Unit: unknown; Test Date: 2015; Test Name: X-ray; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: USGLAXOSMITHKLINEUS2019GS

Write-up: Suspected vaccination failure; Influenza B virus infection; This case was reported in a literature article and described the occurrence of suspected vaccination failure in a 79-year-old male subject who received Flu vaccine for prophylaxis. Previously administered products included Influenza vaccine (at some point of time during the last 5 influenza seasons). On an unknown date, less than a year after receiving Flu vaccine, the subject developed vaccination failure. Serious criteria included death, hospitalization and GSK medically significant. Additional event(s) included influenza b virus infection with serious criteria of death and hospitalization. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included influenza b virus infection (fatal). The reported cause of death was influenza b virus infection. The investigator considered that there was a reasonable possibility that the vaccination failure and influenza b virus infection may have been caused by Flu vaccine. Relevant Tests: The nasopharyngeal (NP) swab sample was collected on 15 April 2015. The sample was sent to the laboratory for influenza testing. The patient was diagnosed influenza B virus infection (confirmed by Film Array). Total deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) were extracted from samples and subjected to 16S rRNA gene sequencing for microbiota profiling and influenza virus gene segment sequencing, respectively. Linear discriminant analysis and effective size comparisons (LEfSe) was used to identify signature taxonomic groups and features that were most likely to significantly characterize the influenza-related compositional differences of the microbiota and defined bacterial community types using Dirichlet multinomial mixture (DMM) models. k-mer analysis was performed to identify underlying influenza virus sequence signatures for each sample and compared them to each other, visualized this measure of genetic distance by multidimensional scaling. 16S rRNA gene sequencing for the sample was done and no data was available for influenza virus sequencing. The patient was not diagnosed with pneumonia by chest X ray. Diagnostic results (unless otherwise stated, normal values were not provided): In 2015, Gene sequencing result was see text unknown, Influenza virus test positive result was influenza A/H3N2 virus infection unknown and X-ray result was see text unknown. Additional information was provided. This case was reported in a literature article and described the suspected vaccination failure in a 79 years old male who was vaccinated with unspecified influenza vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplementary table S1 reported in this literature article. The patient was part of cross-sectional study that aimed to characterize the microbiota of the nasopharynx by analyzing samples from individuals diagnosed with influenza A virus (IAV) H3N2 or influenza B virus (IBV) (Yamagata or Victoria) infections during the 2014-2015 influenza season in healthy controls. The study investigated in more detail the relationship between host factors, such as age or vaccination status, and the respiratory microbiome in a specific influenza season that could help to better identify factors that contributed to influenza disease severity. The patient received influenza virus vaccine at some point of time during the last 5 influenza seasons. The patient was not immunocompromised. No information on patient''s medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date during the 2014-2015 influenza season, the patient received unspecified influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). The age at vaccination was not provided but it could be 78 or 79 years old. On an unspecified date at 79 years of age, during the 2014-2015 influenza season, an unknown period (in same season) after vaccination, the patient was hospitalized and the nasopharyngeal (NP) swab sample was collected on 15 April 2015. The sample was sent to the laboratory for influenza testing. The patient was diagnosed influenza B virus infection (confirmed by Film Array). Total deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) were extracted from samples and subjected to 16S rRNA gene sequencing for microbiota profiling and influenza virus gene segment sequencing, respectively. Linear discriminant analysis and effective size comparisons (LEfSe) was used to identify signature taxonomic groups and features that were most likely to significantly characterize the influenza-related compositional differences of the microbiota and defined bacterial community types using Dirichlet multinomial mixture (DMM) models. k-mer analysis was performed to identify underlying influenza virus sequence signatures for each sample and compared them to each other, visualized this measure of genetic distance by multidimensional scaling. 16S rRNA gene sequencing for the sample was done and no data was available for influenza virus sequencing. The patient was not diagnosed with pneumonia by chest X ray. On an unspecified date, the patient died (emergency room). It was unknown if an autopsy was performed. [In this study, the influenza virus-infected individuals had a slightly lower prevalence and abundance of Streptococcus, an enrichment of Dolosigranulum, and very low prevalence of Corynebacterium. 4 microbial community types (NP types) in the subjects tested. NP type A was significantly enriched in influenza infection, while NP type B dominated in the control group. While both community types C and D were slightly enriched in influenza patients, it was not at a significant level. In the influenza virus-infected subjects only, the less common influenza-associated NP type D was found predominantly in the young (less than 18 years old). NP type A was comprised primarily of Streptococcus and Dolosigranulum; NP type B, enriched was dominated by a combination of Streptococcus, Corynebacterium, and Comamonadaceae. NP type C was dominated by Moraxella, while NP type D had an overrepresentation of Staphylococcus. The different communities did not associate differently with either of the flu types (IAV versus IBV)]. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered as serious due to death/suspected vaccination failure/hospitalisation. Treatment was unknown. The outcome of event was death. The authors stated, "Influenza infection was shown to be significantly associated with microbial composition of the nasopharynx according to the virus type and the vaccination status of the patient. We identified four microbial community types across the combined cohort of influenza patients and healthy individuals with one community type most representative of the influenza virus-infected group. We also identified microbial taxa for which relative abundance was significantly higher in the unvaccinated elderly group; these taxa include species known to be associated with pneumonia. Our results suggest that there is a significant association between the composition of the microbiota in the nasopharynx and the influenza virus type causing the infection. We observe that vaccination status, especially in more senior individuals, also has an association with the microbial community profile. This indicates that vaccination against influenza, even when ineffective to prevent disease, could play a role in controlling secondary bacterial complications. The reasons for enhanced susceptibility to severe bacterial disease after influenza infection remain poorly defined. viral infection can disrupt this equilibrium and cause loss of some microbial populations and/or overgrowth of other pathogens, resulting in disease. Disruption of the URT microbiota has been found to be associated with community-acquired pneumonia. Even an unmatched influenza vaccine could prevent severe disease by modulating the respiratory bacterial communities. IAV and IBV virus infections were associated with a significantly different microbial community profile than that for uninfected individuals. Overall, these observations suggest that Corynebacterium could potentially protect the respiratory tract from pathogenic bacteria such as S. aureus and S. pneumoniae that are the most common cause of post-influenza pneumonia. We studied the composition of the nasopharynx microbiota at diagnosis, we cannot determine whether differences between healthy controls and influenza virus-infected individuals are due to the infection, the presence of a microbial community that predisposes to infection, or a combination of both. The effectiveness of the influenza vaccine varies in different seasons due to a number of factors, such as vaccine strain mismatch and host immune status, including history of previous influenza vaccination. We suggest that another potential factor is the host microbiome. It showed that in influenza virus-infected individuals the lack of vaccination in the current season is associated with the enrichment of different microbial taxa, such as Moraxella and Streptococcus, depending on the type of influenza virus (IAV versus IBV)". The authors concluded, "Our aims in this study were to determine whether the microbiota of the nasopharynx was different in individuals with influenza infection and to identify factors associated with the variations observed between infected subjects in different age groups. We found that during influenza infection, the nasopharyngeal microbiota of vaccinated individuals was strongly associated with higher levels of specific microbial taxa, with different microbial profiles relative to virus types and clades. These observations provide new insight into influenza infection and highlight a need for more studies to explore the mechanism of how influenza vaccines-live attenuated or killed-interact with the respiratory microbiota". This is 1 of the 127 valid cases reported in the same literature article. Lab Comments: The nasopharyngeal (NP) swab sample was collected on 15 April 2015. The sample was sent to the laboratory for influenza testing. The patient was diagnosed influenza B virus infection (confirmed by Film Array). Total deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) were extracted from samples and subjected to 16S rRNA gene sequencing for microbiota profiling and influenza virus gene segment sequencing, respectively. Linear discriminant analysis and effective size comparisons (LEfSe) was used to identify signature taxonomic groups and features that were most likely to significantly characterize the influenza-related compositional differences of the microbiota and defined bacterial community types using Dirichlet multinomial mixture (DMM) models. k-mer analysis was performed to identify underlying influenza virus sequence signatures for each sample and compared them to each other, visualized this measure of genetic distance by multidimensional scaling. 16S rRNA gene sequencing for the sample was done and no data was available for influenza virus sequencing. The patient was not diagnosed with pneumonia by chest X ray.; Reported Cause(s) of Death: Influenza B


VAERS ID: 830007 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-08-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Antibody test negative, Areflexia, Autonomic nervous system imbalance, Biopsy liver abnormal, Blood pressure fluctuation, Bradycardia, Computerised tomogram abdomen abnormal, Computerised tomogram pelvis abnormal, Cytology normal, Death, Decreased vibratory sense, Dehydration, Demyelinating polyneuropathy, Disability assessment scale score decreased, Electromyogram abnormal, Endotracheal intubation, Gait inability, Guillain-Barre syndrome, Heart rate abnormal, Hepatic mass, Hypotension, Immunoglobulin therapy, Lymphocyte percentage increased, Mechanical ventilation, Metastatic malignant melanoma, Monocyte percentage increased, Muscular weakness, Nerve conduction studies abnormal, Nuclear magnetic resonance imaging brain abnormal, Paraesthesia, Plasmapheresis, Polyneuropathy in malignant disease, Protein total decreased, Protein total increased, Red blood cell count decreased, Red blood cell count increased, Respiratory distress, Sensory loss, Sepsis, Tachycardia, Walking aid user, White blood cell count decreased, Withdrawal of life support
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Peripheral neuropathy (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Malignancy related conditions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Dystonia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Hypertension (broad), Cardiomyopathy (broad), Demyelination (narrow), Skin malignant tumours (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Dehydration (narrow), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer surgery (three years ago)
Allergies:
Diagnostic Lab Data: Test Name: protein; Test Result: 91 {DF}; Test Name: rbc; Result Unstructured Data: 21; Test Name: rbc; Result Unstructured Data: 0; Test Name: white blood cell; Result Unstructured Data: 7; Test Name: white blood cell; Result Unstructured Data: 0; Test Name: lymphocytes; Test Result: 44 %; Test Name: monocytes; Test Result: 56 %; Test Name: protein; Test Result: 37 {DF}
CDC Split Type: USSA2019SA230137

Write-up: Guillain-Barre syndrome, acute inflammatory demyelinating polyneuropathy (AIDP); weakness of the lower and upper limbs; bilateral finger and toe paresthesia; dysautonomia; paraneoplastic neuropathy; respiratory distress; expired as the family withdrew life-sustaining therapies; dehydration; metastatic melanoma; tachycardia; hypotension; bradycardic; Sepsis; lost the ability to walk; Initial unsolicited valid serious case report received from a literature article on 16-Aug-2019. The following is verbatim from the article: Cancer immunotherapy with checkpoint inhibitors may result in neuromuscular immune-related adverse reactions, including Guillain-Barre syndrome (GBS)-like disease. On the other hand, checkpoint inhibitor therapy may result in exacerbation of underlying autoimmune diseases such as myasthenia gravis and multiple sclerosis. We present a patient who developed a severe and fatal relapse of postvaccination GBS after he was treated with nivolumab, a monoclonal antibody directed to programmed death-1 (PD-1), during a GBS treatment-related fluctuation. We recommend that caution be exercised in starting treatment with PD-1 inhibitors in the acute stage or early in the recovery period of GBS. Key Words: Guillain-Barre syndrome, checkpoint inhibitor, dysautonomia, nivolumab, PD-1. This case involves a 66 years old male patient who experienced weakness of the lower and upper limbs, bilateral finger and toe paresthesia, dehydration, metastatic melanoma, guillain-barre syndrome, respiratory distress, tachycardia, hypotension, acute inflammatory demyelinating polyneuropathy (aidp), guillain barre syndrome, bradycardic, sepsis, paraneoplastic neuropathy and dysautonomia, while he received vaccine INFLUENZA VACCINE. The patient''s past medical history included Cancer surgery with three years ago. The patient''s past medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient experienced a serious weakness of the lower and upper limbs (muscular weakness), bilateral finger and toe paresthesia (paraesthesia), dehydration, metastatic melanoma (metastatic malignant melanoma), Guillain-Barre Syndrome, acute inflammatory demyelinating polyneuropathy, respiratory distress on day 2 of hospitalization, tachycardia, hypotension, (aidp), guillain barre syndrome (demyelinating polyneuropathy), bradycardic (bradycardia), sepsis, paraneoplastic neuropathy, (polyneuropathy in malignant disease), lost the ability to walk and dysautonomia (autonomic nervous system imbalance) (Unknown latency) following the administration of INFLUENZA VACCINE. These events was leading to death. Patient was also hospitalized for these events. Relevant laboratory test results included: Lymphocyte count - On an unknown date: 44 % Monocyte count - On an unknown date: 56 % Protein total - On an unknown date: 37 mg/dL, on an unknown date: 91 mg/dL. Red blood cell count - On an unknown date: [21], on an unknown date: [0]. White blood cell count - On an unknown date: [7], on an unknown date: [0]. (Other relevant tests included Examination 12 days after the onset of initial symptoms and a day after he lost the ability to walk revealed strength of 3/5 in upper-limb muscles, hip flexors, quadriceps, hamstrings, and 2/5 in the ankle dorsiflexors and plantar flexors, as assessed according to the Medical Research Council scale.) Pinprick sensation was diminished up to the ankles and fingertips, vibration was lost at the toes, and deep tendon reflexes were absent at the knees and ankles and a negative cytology. A nerve conduction study 34 days after the flu vaccination demonstrated absent bilateral sural and right median sensory responses, prolonged distal and F wave latencies of the right median nerve, as well as very low amplitudes and very slow conduction velocities of all the motor responses, needle electromyography (EMG) showed neurogenic recruitment in all the muscles tested in bilateral lower and right upper limbs and positive waves/fibrillation potentials in the cervical and lumbar paraspinal muscles. Brain MRI showed a 4 3 5-mm enhancing lesion with associated T2 hyperintensity and restricted diffusion in the right superior medial precentral gyrus, consistent with a brain metastasis. Computed tomography scan of the abdomen and pelvis showed multiple hepatic hypodense nodules, biopsy of which demonstrated metastatic melanoma, BRAF-V600 wildtype. His weakness initially improved after IVIg treatment to the point that he was able to ambulate 100 feet with an assistive device. However, his weakness worsened about 3 weeks later when he lost his ability to ambulate. His motor strength further declined dramatically about 12 days after the first dose of nivolumab, so that he was unable to sit in the wheelchair, resulting in his transfer to our center. Physical examination revealed motor strength of 3/5 in upper extremities, 1/5 hip flexion and hip extension, and 0/5 in remaining lower extremity muscle groups. His deep tendon reflexes were trace in the upper extremities and absent at the knees and ankles and there was diminished pinprick sensation in stocking/glove distribution and absent vibratory sensation at the toes. A follow-up EMG study 91 days after the flu vaccination showed severely prolonged distal latencies, reduced amplitudes, very slow conduction velocities, and markedly prolonged F wave latencies. Temporal dispersion of the compound muscle action potential was present with distal stimulation of all the motor nerves, and there was conduction blocks in the right ulnar motor response with stimulation below and above the elbow. Needle EMG showed positive waves and fibrillation potentials and no motor unit activation in the right tibialis anterior and quadriceps, as well as severely reduced recruitment in right first dorsal interosseous, biceps, and deltoid. Antibodies to ANNA-1, Amphiphysin, ANNA-2, CRMP-5, PCA-1, PCA-2, PCA-Tr, GM1, and GD1b were negative. He was intubated and placed on mechanical ventilation, and then started on plasma exchange (PLEX). During the hospitalization, there were wide fluctuations in heart rate and blood pressure, which were partly attributed to dysautonomia secondary to acute inflammatory demyelinating polyneuropathy (AIDP) because they were persistent between the sessions of PLEX and present after other potential causes such as possible sepsis and dehydration were appropriately treated. He was started on midodrine on day 5 of hospitalization, but on day 9 became severely hypotensive and bradycardic, requiring pressure support, and subsequently expired as the family withdrew life-sustaining therapies. His GBS disability score4 during the course of his disease starting with administration of influenza vaccine The patient was treated with 2 g/kg IMMUNOGLOBULINS NOS (IMMUNOGLOBULIN I.V) over a period of 5 days for Guillain-Barre syndrome, 60 mg/kg PREDNISONE (PREDNISONE) for 2 daysand 240 mg NIVOLUMAB (NIVOLUMAB) which was repeated after 13 days. Final diagnosis was (fatal) dysautonomia, (fatal) paraneoplastic neuropathy, (fatal) sepsis, (fatal) bradycardic, (fatal) acute inflammatory demyelinating polyneuropathy (aidp), guillain barre syndrome, (fatal) Severe hypotension, (fatal) tachycardia, (fatal) respiratory distress, (fatal) guillain-barre syndrome, (fatal) metastatic melanoma, (fatal) dehydration, (fatal) bilateral finger and toe paresthesia and (fatal) weakness of the lower and upper limbs. The patient outcome was reported as fatal for all the event. The cause of death was reported conservatively captured as Muscular weakness, Paraesthesia, Demyelinating polyneuropathy, Polyneuropathy in malignant disease, Respiratory distress, Hypotension, Autonomic nervous system imbalance, Sepsis, Tachycardia, Dehydration, Metastatic malignant melanoma, Guillain-Barre syndrome and Metastatic malignant melanoma as it was unknown if an autopsy was done. List of document held by sender: none.; Sender''s Comments: This literature case concerns a 66 years old male patient died due to exacerbation of post influenza vaccination GBS after treatment with Nivolumab for metastatic melanoma. The time to onset is unknown. Moreover, patient''s medical condition and lab test at the time of vaccination were not reported. Based upon the reported information, the role of vaccine cannot be assessed.; Reported Cause(s) of Death: weakness of the lower and upper limbs; bilateral finger and toe paresthesia; acute inflammatory demyelinating polyneuropathy (AIDP), Guillain Barre syndrome; paraneoplastic neuropathy; respiratory distress; hypotension; dysautonomia; Sepsis; tachycar


VAERS ID: 837824 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Alabama  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS201917

Write-up: Guillain-Barre Syndrome; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a female patient who received Flu Seasonal TIV Dresden (Flu trivalent vaccine) for prophylaxis. On an unknown date, the patient received Flu trivalent vaccine at an unknown dose. On an unknown date, less than a year after receiving Flu trivalent vaccine, the patient experienced guillain barre syndrome (serious criteria death and GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was fatal. The reported cause of death was guillain barre syndrome. It was unknown if the reporter considered the guillain barre syndrome to be related to Flu trivalent vaccine Additional details were received as follows: The age at vaccination was not reported. The patient had a flu injection in 1978, and experienced Guillain-Barre Syndrome, and died on 23rd August 2018. The reporter consented to follow up. This case was linked with case US2019170062, reported by same reporter.; Reported Cause(s) of Death: Guillain Barre syndrome


VAERS ID: 847970 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USAstraZeneca2019SF60995

Write-up: DIED FROM FLUMIST; A spontaneous report has been received from a consumer concerning a 3 year old male patient. No medical history was reported. No concomitant products were reported. On an unknown date, the patient started receiving a treatment with Flumist (influenza vaccine (live, attenuated)), via nasal route. It was reported that nephew died from the Flumist (Preferred term: death). He was 3. They gave him the mist when he had slight cold like symptoms (cough and runny nose) He died within 36 hours of receiving the mist. It was not known whether an autopsy was performed. The cause of death was unknown. It was unknown if any action was taken with Flumist (influenza vaccine (live, attenuated)). The event was considered serious (death) by the reporter. The reporter considered the following event(s) related to treatment with Flumist (influenza vaccine (live, attenuated)): died from Flumist.; Sender''s Comments: The report concerns a 3 years old male patient, who died while on treatment with Q/LAIV (Flumist), the cause of death was not further specified. Due to limited information, relevant medical history, drug details, concurrent diseases, concomitant medication, circumstances leading to death, date and autopsy report it is not possible to make a conclusive assessment of the causal relationship of the event and suspect drug. ; Reported Cause(s) of Death: DIED FROM FLUMIST


VAERS ID: 850273 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Coma, Death, Feeling abnormal
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2019AM

Write-up: Went into a coma, and died 5 days later; Feeling really bad; This case was reported by a consumer via interactive digital media and described the occurrence of coma in a 54-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, 1 day after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced coma (serious criteria death and GSK medically significant) and feeling bad. On an unknown date, the outcome of the coma was fatal and the outcome of the feeling bad was unknown. It was unknown if the reporter considered the coma and feeling bad to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: This happened 2 years ago with the patient. Company started giving out free flu vaccines to the workers and their families. The patient was healthy. Right after getting the vaccine, she started feeling really bad, and the next evening when her husband came home, that night he had to call the squad. She went into a coma, and died 5 days later. This case has been linked to US2019AMR211990, reported by the same reporter.; Reported Cause(s) of Death: Coma


VAERS ID: 873618 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Ohio  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UJ306AA / UNK AR / -

Administered by: Private       Purchased by: ?
Symptoms: Cardiac failure congestive, Condition aggravated, Death, Dementia, Dysstasia, Fall, Feeling abnormal, Feeling hot, Gait disturbance, Intensive care, Malaise, Mobility decreased, Muscular weakness, Peripheral swelling, Walking aid user
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (narrow), Angioedema (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2020-04-27
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Metformin; Glimepride; Magnesium; Carvedilol; simvastin; low dose aspirin; Lorsartan; Furosemide; Omeprazole; Azopt; Timolol Maleate; Latanoprost; WARFARIN; LASIK; He had finished anti-biotic for pneumonia a few days before and was given me
Current Illness: PNEUMONIA, CHF,
Preexisting Conditions: Congestive heart FAILURE, DEMENTIA, DIABETICES, PROSTATE CANCER
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: My husband was in the hospital for pneumonia Dec. 01, 2019 and released to go home the 2nd, He was given anti-biotic to take for 10 days. We went to Dr.''s office on the 12th of Dec. and he was given a quad flu shot. He was okay until the 28th of Dec. He awoke on Sat. said he felt awful this went on and he was still sick the next day. He felt like he was burning up and running a temperature. I took it, was normal. He started having trouble walking when he got up. It looked like his legs had no muscle in them - I got him back in his chair and called the squad. They took him to the ER and he was unable to stand. They run test said they could find nothing wrong sent him home. I manage to get him in the house with a walker. He with my help and a walker went to go to bed, but couldn''t stand fell in the floor beside his bed. He could not move his legs to get to the bed. The squad was called and he was taken back to the hospital and admitted. They were more concerned about the small amount of dementia than his lack of not being able to stand or walk. He was given Serquel for dementia which made him hallucinate and get angry. He was let go to a nursing rehab for two nights. He could not stand or walk and fell both nights. He was returned to the ER and I would not let him return to the nursing home it was a nasty place. He was admitted to an assisted living memory care and still couldn''t walk or stand very well. He fell there and had to be taken back to the ER. Because of his not being able to walk very well swelling develop in his feet and legs badly and he had congestive heart failure. He was in ICU for 6 days. He was then taken to another rehab place where he had to sit in his room and the swelling collected again. I was not able to see the nursing home or him due to the virus restrictions. He was brought home after 18 days to end up in the ICU for days and still could not walk, I brought him home and he was unable to walk or move his legs. He passed away after about 7 days at home, I kept telling all the health people I thought it was the flu shot but all I got was smiles. I lost my husband of 58 years because of this.


VAERS ID: 882737 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Influenza, Pneumonia, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2020AM

Write-up: had flu shot and pneumonia shot...she died of the flu that turned into pneumonia; had flu shot and pneumonia shot...she died of the flu that turned into pneumonia; had flu shot and pneumonia shot...she died of the flu that turned into pneumonia; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA SHOT) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season and PNEUMONIA SHOT. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria death and GSK medically significant), pneumonia (serious criteria death and GSK medically significant) and influenza (serious criteria death). On an unknown date, the outcome of the vaccination failure, pneumonia and influenza were fatal. The reported cause of death was vaccination failure, pneumonia and influenza. It was unknown if the reporter considered the vaccination failure, pneumonia and influenza to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The case was reported by patient''s son or daughter. The age at vaccination was not reported. It was reported that the flu shots were risky and not very effective. The patient had flu shot and pneumonia shot. The patient was died of the flu that turned into pneumonia. It was reported that there was wrong strain that year. The case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation was not known; Reported Cause(s) of Death: Vaccination failure; Pneumonia; Influenza


VAERS ID: 887995 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Underdose
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2020AM

Write-up: died; Underdose; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant) and underdose. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the underdose was unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Flu vaccine. Additional case details were reported as follows: The reporter was patient''s grandchild. The age at vaccination was not reported. The patient received her first half flu shot, which led to underdose. On an unknown date patient was died. This was a medication error with harm. The follow up was not required.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 888716 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2020AM

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


VAERS ID: 889814 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA284897

Write-up: 2 family members died after getting vaccine; Initial information received on 08-Oct-2020 regarding an unsolicited valid serious social media case received from a consumer or non-healthcare professional via social media. This case is linked to cases 2020SA282978 and 2020SA282955 (same reporter). This case involves two patients who died after they received INFLUENZA VACCINE. The patient''s medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via an unknown route in an unknown administration site for prophylactic vaccination. On an unknown date, the reporter''s family members died (death) unknown latency following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. Other relevant tests were not reported. It was not reported if the patients received any corrective treatment before death. It was unknown if an autopsy was done and cause of death was not reported. There will be no information available on the batch number for this case.; Sender''s Comments: This poorly documented social media case concerns two patients of unknown age who died after vaccination with INFLUENZA VACCINE (produced by unknown manufacture). The time to onset was unknown. However, patient''s medical condition at the time of vaccination, autopsy result and lab tests ruling out alternate etiologies were not reported. Based on the limited information available, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: death


VAERS ID: 889815 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA285007

Write-up: deathly ill with the flu until it finally killed her; Initial information received on 07-Oct-2020 regarding an unsolicited valid serious social media case from a consumer/non-health care professional via public post on the Sanofi flu shot campaign. This case involves female patient (unknown age) who was deathly ill with the flu until it finally killed her (influenza), while she received INFLUENZA VACCINE. The patient''s past vaccinations included flu shots (INFLUENZA VACCINE) every year and every year she was deathly ill with the flu. Concomitant medication(s), medical treatment(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer lot number and expiration date were not reported) via an unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient was deathly ill with the flu and that it finally killed her (influenza) (serious) (Unknown latency) following the administration of INFLUENZA VACCINE. This event was leading to death. No laboratory data reported. It was not reported if the patient received a corrective treatment. The outcome of the event Influenza was fatal as the patient died due to it on an unknown date. It was not reported whether the autopsy was done or not and the cause of death was reported as Influenza. Information on the batch number to be requested.; Sender''s Comments: A case was reported which involves a female patient of unknown age who died due to influenza, after vaccination with INFLUENZA VACCINE (unknown manufacturer). Time to onset was unknown. The patient used to have flu shots every year and had got ill every time in the past. Additional information regarding patient''s relevant medical history, health condition at time of vaccination, concomitant medication and Laboratory tests, autopsy results is needed for complete assessment of the case. Thus, a role of the vaccine could not be assessed.; Reported Cause(s) of Death: deathly ill with the flu until it finally killed her


VAERS ID: 889944 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA285029

Write-up: passed away a week after the flu; Initial information was received on 09-Oct-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional. This case involves a female patient (age unspecified) who passed away a week after the flu (influenza), while she received vaccine INFLUENZA VACCINE. Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient passed away a week after the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. This event was leading to death. No laboratory data was provided. It was not reported if the patient received a corrective treatment. At the time of report, the outcome of event was fatal. It is unknown if an autopsy was done. The cause of death was captured as Influenza. Information on lot number was requested.; Sender''s Comments: This case reported involved a female patient (age unspecified) who passed away a week after influenza following vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination, concomitant medications, lab /radiological investigation excluding other etiologies and detail autopsy report would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.; Reported Cause(s) of Death: passed away a week after the flu


VAERS ID: 890176 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA288250

Write-up: paralysis; Initial information was received on 10-Oct-2020 regarding an unsolicited valid serious social media case received from a consumer/ non-healthcare professional via public post on the Sanofi flu shot campaign via social media. This case involves two patients of an unknown demographics who suffered with paralysis, when they received INFLUENZA VACCINE. The patients medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided. On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patients suffered with serious paralysis (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death. Case details: Reporter did not provided the product name, but since this was a public post on the Sanofi flu shot campaign, the Race for 200M it was assumed that the consumer was referring to the Sanofi flu vaccine. Reporter Commented that does company ever heard of French polio, one of the side effects of the flu shots, he/she know of two people that got it and suffered paralysis and death. Wake up sheep. Details of laboratory data were not reported. It was not reported if the patient received a corrective treatment (before death). It was unknown if an autopsy was done. The cause of death was captured as paralysis. Information on the batch number was requested.; Sender''s Comments: A case was reported from Social Media, which involves two patients of unknown demographics who suffered with paralysis and death following the administration of INFLUENZA VACCINE (unknown manufacturer). The time to onset was unknown. Additional information of past medical treatments, concomitant therapies, past vaccination and tolerance, allergic history, concurrent conditions, laboratory data and autopsy results are needed for complete assessment of the case. Based upon the reported information the role of the suspect product cannot be assessed. Missing data needed for further assessment of the case.; Reported Cause(s) of Death: paralysis


VAERS ID: 890691 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA285129

Write-up: Patient had never felt better and then suddenly died; Initial information was received on 12-Oct-2020 regarding an unsolicited valid serious case received from a consumer/ non-healthcare professional (patient''s spouse) via public post on the Sanofi flu shot campaign via Social Media. This case involves male patient (age not reported) who had never felt better and then suddenly died (malaise), while he received vaccine INFLUENZA VACCINE. The patient''s medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a serious adverse event as the patient had never felt better and then suddenly died (malaise) on an unknown latency following the administration of INFLUENZA VACCINE. This event was was leading to death. Case details: Product name was not provided, since this is a public post on the Sanofi flu shot campaign, the Race for 200M it was assuming that the consumer was referring to the Sanofi flu vaccine. The reporter commented on social media that ''my husband had never felt better then suddenly died'' Details of laboratory data were not reported. It was not reported if the patient received a corrective treatment. The outcome was reported as fatal as the patient suddenly died due to suspect vaccine on an unknown date It is unknown if an autopsy was done and the cause of death was captured as malaise. Information on the batch number was requested.; Sender''s Comments: A case was reported from Social Media, which involves male patient of unknown age who had felt unwell and then suddenly died following the administration of INFLUENZA VACCINE (unknown manufacturer). The time to onset was unknown. Additional information of past medical treatments, concomitant therapies, past vaccination and tolerance, allergic history, concurrent conditions, laboratory data and autopsy results is needed for complete assessment of the case. Based upon the reported information the role of the suspect product cannot be assessed. Missing data needed for further assessment of the case.; Reported Cause(s) of Death: Patient had never felt better and then suddenly died


VAERS ID: 890694 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA289512

Write-up: died from the flu shot; Initial information was received on 12-Oct-2020 regarding an unsolicited valid serious case from a non-health care professional via social media. This case is linked to case 2020SA289370 (same reporter). This case involves a female patient of unknown age who died (death), after receiving INFLUENZA VACCINE. The patient''s medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and other dosing details were not reported) for prophylactic vaccination. On an unknown date, the patient died (death), (unknown latency) following the administration of INFLUENZA VACCINE. Details of laboratory data were not reported. It was not reported if the patient received any corrective treatment before death. It was unknown if an autopsy was done and the cause of death was not reported. There will be no information available on the batch number for this case.; Sender''s Comments: This poorly documented social media case concerns a female patient of unknown age who died, after vaccination with INFLUENZA VACCINE (produced by unknown manufacture). The time to onset is unknown. Also, further information regarding patient''s concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations and autopsy result are needed to fully assess this case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: death nos


VAERS ID: 891188 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2020AM

Write-up: death; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a 25-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Influenza vaccine Quadrivalent unspecified season. Additional information was provided as follows: The age at vaccination was not reported. The patient died due to a domino effect started by taking the flu shot. It was unknown if the reporter consented to follow up.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 892131 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA294767

Write-up: the patient died from the flu shot; Initial information received on 19-Oct-2020 regarding an unsolicited valid serious case received from a consumer via social media. This case involves a male patient (unknown age) who died (death) after receiving INFLUENZA VACCINE. Medical history, medical treatments, vaccinations, family history and concomitant medications were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient died (death), (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. No laboratory data reported. It was not reported if the patient received a corrective treatment. Date of death was not reported. It was unknown at the time of reporting if an autopsy was done and the cause of death was not reported. Information on the batch number was requested.; Sender''s Comments: A case was reported from social media, which involved a male patient of an unknown age who died after vaccination with INFLUENZA VACCINE (unknown manufacturer). Time to onset was unknown. Additional information regarding patient''s relevant medical history, health condition at time of vaccination, concomitant medication and Laboratory tests, autopsy results for cause of death is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: Death NOS


VAERS ID: 892470 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA291986

Write-up: flu shot killed patient; Initial information received on 13-Oct-2020 regarding an unsolicited valid serious social media case received from a consumer or non-healthcare professional via social media. This case involves a male patient who died after he received INFLUENZA VACCINE. The patient''s medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via an unknown route in an unknown administration site for prophylactic vaccination. On an unknown date, the patient died (death) unknown latency following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. It was not reported if any laboratory tests were performed before he died. It was not reported if the patient received any corrective treatment before he died. The patient died on an unknown date. It was unknown if an autopsy was done and cause of death was not reported. Information on the batch number was requested.; Sender''s Comments: This poorly documented social media case concerns an elderly patient who died after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset was unknown. Also, patient''s medical condition at the time of vaccination, autopsy result and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: Death NOS


VAERS ID: 892503 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Maryland  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Immediate post-injection reaction
SMQs:, 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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA297972

Write-up: patient died right after receiving the vaccine; Initial information regarding an unsolicited valid serious case was received from a consumer/non-health care professional via agency (Reference number- 00324247) and transmitted to Sanofi on 20-Oct-2020. This case is linked to case 2020SA297516 and 2020SA298004 (same reporter). This case involves male patient (demographics unknown) who died right after receiving INFLUENZA VACCINE. Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient died right after receiving the INFLUENZA VACCINE. The event of death was also assessed as medically significant. The reporter asked about side effects, efficacy, and the difference between fluzone quadrivalent and fluzone high-dose quadrivalent. Also stated her friend (only described as 87 years old) was convinced that a flu vaccine killed her parents because they died right after receiving them. No laboratory data was provided. It was not reported if the patient received any corrective treatment before death. It was unknown if an autopsy was done and the cause of death was not reported. Information on lot number was requested for this case.; Sender''s Comments: This case concerns a male patient who died right after receiving the INFLUENZA VACCINE, produced by unknown manufacturer. The time to onset is compatible. Additional information regarding medical history, condition at the time of vaccination, concomitant medications, lab /radiological investigation excluding other etiologies and detailed autopsy report would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.; Reported Cause(s) of Death: Death NOS


VAERS ID: 893186 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Influenza, Pneumonia, Sepsis
SMQs:, Eosinophilic pneumonia (broad), 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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA302198

Write-up: flu; pneumonia; sepsis; Initial information received on 24-Oct-2020 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional via social media. This case is linked to cases 2020SA302174 (same reporter). This case involves a patient (unknown demographics) who experienced flu (influenza), pneumonia and sepsis, after receiving INFLUENZA VACCINE. The patient''s medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a serious flu (influenza) unknown latency following the administration of INFLUENZA VACCINE (reported as It was 90 days of misery). On an unknown date, the patient developed a serious pneumonia and sepsis unknown latency following the administration of INFLUENZA VACCINE (reported as It was 90 days of misery). Both the event was assessed as medically significant All the events were leading to death. Case details: Patient got the shot and the downhill trend. Laboratory details were not reported. It was not reported if the patient received a corrective treatment. It is unknown if an autopsy was done. The causes of death were reported as influenza, pneumonia and sepsis. Information on the batch number was requested.; Sender''s Comments: This poorly documented social media case concerns a patient (unknown demographics) who died due to influenza, pneumonia and sepsis after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset was unknown. However, patient''s medical condition at the time of vaccination, lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: flu; pneumonia; sepsis


VAERS ID: 893498 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Leg discomfort
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA300981

Write-up: A patient was dead the next day after receiving the flu shot; Initial information was received on 25-Oct-2020 regarding an unsolicited valid serious case from a consumer/non-healthcare professional via social media. This case involves a female patient (age unspecified) who was dead the next day after receiving the INFLUENZA VACCINE (death). Medical treatments, vaccinations, concomitant medications and family history were not provided. At the time of death, the patient had ongoing medical problems with her legs (leg discomfort). On an unknown date, the patient was in the hospital due to problems with her legs and received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient died the next day after receiving INFLUENZA VACCINE (death). This event was also assessed as medically significant. No laboratory data was provided. It was not reported if the patient received a corrective treatment before death. It was unknown if an autopsy was done. The cause of death was not specified. The information on batch number was requested for this case. Sender''s Comments: This poorly documented social media case involves a female patient who died (death NOS) the next day after receiving the INFLUENZA VACCINE, produced by unknown manufacturer. The time to onset is compatible. At the time of death, she had ongoing problems with her legs. Additional information regarding medical history, concomitant medications, lab investigation excluding other etiologies and detailed autopsy report would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.


VAERS ID: 894086 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA304713

Write-up: patient passed away; Initial information received on 28-Oct-2020 regarding an unsolicited valid serious social media case received from a consumer (non-healthcare professional). This case was linked to cases 2020SA304724 and 2020SA282884. This case involves a female patient of an unknown age who passed away (death), while she received INFLUENZA VACCINE (H1N1 vaccination). Medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination. On an unknown date, the patient passed away (death), three days following the administration of INFLUENZA VACCINE. This event was also assessed as medically significant. The medical examiner said from complications of the H1N1 vaccination, he/she would rather have the flu. Other relevant tests not reported. It was not reported if the patient received a corrective treatment before she died. It was unknown if an autopsy was done and cause of death was not reported. Information on the batch number was requested.; Sender''s Comments: This poorly documented social media case concerns a female patient of unknown age who died 3 days after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). Also, patient''s medical condition at the time of vaccination, autopsy result and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: patient passed away


VAERS ID: 894548 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA306225

Write-up: patient got the flu and died; Initial information received on 29-Oct-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional via social media. This case involves male patient of unknown age who got the flu and died (influenza), after receiving INFLUENZA VACCINE. Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date (reported as in September of 88), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination. On an unknown date (reported as in December 88), the patient got the flu and died (influenza) (serious event), approximately 3 months (exact latency unknown) following the administration of INFLUENZA VACCINE. No laboratory data reported. It was not reported if the patient was receiving any corrective treatment. It was unknown at the time of reporting if an autopsy was done and the cause of death was captured as influenza. Information on the batch number to be requested.; Sender''s Comments: This poorly documented social media case concerns a male patient of unknown age who had influenza and died after receiving INFLUENZA VACCINE. Time to onset is compatible. Also, patient''s medical condition at the time of vaccination, autopsy result and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: patient got flu and died


VAERS ID: 895425 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA283216

Write-up: reporter believe that flu vaccine killed reporter''s father; After internal review on 02-Nov-2020, the report upgraded from non-valid to valid: [suspect updated to INFLUENZA VACCINE]. Initial and live follow-up information regarding this unsolicited non-valid serious case from a consumer via social media on 07-Oct-2020. This case involved a male patient of unknown age who died (death), after he received INFLUENZA VACCINE. Medical history, medical treatment(s), vaccination(s), concomitant medication and family history of the patient were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination. On an unknown date, the patient died (death) (unknown latency) following the administration of INFLUENZA VACCINE. This event was also assessed as medically significant. It was reported that the INFLUENZA VACCINE killed reporter''s father. Relevant tests were not reported. It was not reported if the patient received a corrective treatment before he died. It was unknown if an autopsy was done and cause of death was not reported. Information on the batch number was requested. Follow up information received on 02-Nov-2020 regarding an unsolicited valid serious social media case received from a consumer. Case upgraded to valid case, suspect updated to INFLUENZA VACCINE, lot number requested and narrative updated accordingly.; Sender''s Comments: Sanofi company comment dated 02-Nov-2020: Follow up information received changes the previous assessment of this case as follows. This poorly documented social media case concerns a male patient of unknown age who died after vaccination with INFLUENZA VACCINE (unknown manufacturer). Also, patient''s medical condition at the time of vaccination, autopsy result and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: reporter believe that flu vaccine killed reporter''s father


VAERS ID: 896165 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA314745

Write-up: flu shot gave the flu and it killed; Initial information was received on 08-Nov-2020 regarding an unsolicited valid serious case from a non-health care professional via media. This case is linked to case 2020SA314784 (same reporter). This case involves a female patient of unknown age who was vaccinated with INFLUENZA VACCINE and it gave flu (influenza). The patient''s medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not reported. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination. On an unknown date, the patient developed serious flu (influenza), (unknown latency) following the administration of INFLUENZA VACCINE. This event was was leading to death. Details of laboratory data were not reported. It was not reported if the patient received any corrective treatment. It was unknown if an autopsy was done and as per reporter the cause of death was flu. Information on the batch number was requested.; Sender''s Comments: This poorly documented media case concerns a female patient of unknown age who died due to Influenza, after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. Further information regarding concurrent condition during vaccination, previous vaccination and tolerance, allergic history, autopsy result and laboratory investigations ruling out alternative etiologies are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: flu shot gave the flu and it killed


VAERS ID: 896193 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA314988

Write-up: died; Guillain Barre syndrome; Initial information was received on 08-Nov-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional (patient''s grandmother) via media. This case involves a male patient (age unspecified) who had Guillain-Barre syndrome and died (death) after he received INFLUENZA VACCINE. Medical history, medical treatment(s), past vaccination(s) concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a serious Guillain-Barre syndrome and died (death) (unknown latency for both the events), following the administration of INFLUENZA VACCINE. The event Guillain-Barre syndrome was assessed as medically significant. Details of laboratory data was not reported. It was not reported if the patient received a corrective treatment before death. At the time of report, the outcome of event Guillain-Barre syndrome was unknown. It is unknown if an autopsy was done. The cause of death was not reported. The information on batch number was requested for this case.; Sender''s Comments: This poorly document case received from media concerns a male patient who had Guillain barre syndrome and died after vaccination with INFLUENZA VACCINE, produced by unknown manufacturer. The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination, concomitant medications, lab/radiological investigation excluding other etiologies and detailed autopsy report would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.; Reported Cause(s) of Death: died


VAERS ID: 897646 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2020AM

Write-up: took the flu shot on a Tuesday and dead on Saturday; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, 4 days after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Influenza vaccine Quadrivalent unspecified season. Additional information was provided as follows: The age at vaccination was not reported. The reporter mentioned that, the patient had received a flu shot on tuesday and was dead on saturday. The reporter was warning people to not take any vaccines in order to be alive. The case is linked with the case- US2020AMR225462, reported by same reporter.; Sender''s Comments: US-GLAXOSMITHKLINE-US2020AMR225462:same reporter; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 898200 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-11-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA330938

Write-up: died; sick; Initial information was received on 18-Nov-2020 regarding an unsolicited valid serious case from social media via a consumer or non-health care professional (patient''s husband). This case involves a female patient (age unspecified) who was sick (Illness) and died (Death), after receiving INFLUENZA VACCINE. Medical history, medical treatment, vaccination, concomitant medication and family history were not provided. On an unknown date in 2016, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date in 2016, the patient was sick (Illness), 20 minutes following the administration of INFLUENZA VACCINE. On an unknown date in 2016, the patient died (death) 02 days following the administration of INFLUENZA VACCINE. This event was assessed as serious and medically significant. Details of laboratory data not reported. It was not reported if the patient received any corrective treatment before death. At the time of reporting outcome for illness was unknown. It is unknown if an autopsy was done. Cause of death was not clearly specified. Information on the batch number was requested.; Sender''s Comments: This social media case received involves a female patient (age unspecified) who had illness (latency: 20 minutes) and died (death) 02 days after vaccination with INFLUENZA VACCINE. The time to onset is compatible with role of vaccine. This was poorly document case in which cause of death was not clearly specified. However, information regarding concurrent condition during vaccination, previous vaccination and tolerance, laboratory investigations, autopsy result and other alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: died


VAERS ID: 898201 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-11-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA333277

Write-up: paralyzed and that led her to early death; Initial information was received on 19-Nov-2020 regarding an unsolicited valid serious social media case from a non-health professional via social media. This case was linked with the 2020SA333271 (same reporter). This case involves a female patient (of an unknown age) who was paralyzed and that led to her early death (paralysis), while the she received INFLUENZA VACCINE. Medical history, medical treatment(s), vaccination(s), concomitant medications, and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer, (lot number and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient was paralyzed and that led to early death (paralysis), (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death. Laboratory data was not reported. It was not reported if the patient received any corrective treatment or not. The outcome of the event was fatal. It was unknown if an autopsy was done. The cause of death was reported as paralysis. There will be no information available on the batch number for this case.; Sender''s Comments: This was a poorly documented social media case received from social media involves a female patient (age unspecified) who was died due to paralysis after vaccination with INFLUENZA VACCINE. The time to onset is unknown. Further information regarding concurrent condition during vaccination, previous vaccination and tolerance, laboratory investigations, autopsy result and other alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: paralyzed and that led to early death


VAERS ID: 898257 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-11-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA333188

Write-up: grandmother died from half flu shot; Initial information was received on 19-Nov-2020 regarding an unsolicited valid serious social media case from a consumer or non-healthcare professional. This case involves a female patient (age was not reported) who died (death), after she received INFLUENZA VACCINE. The patient''s medical history, past medical treatments, vaccinations, family history and concomitant medication were not reported. On an unknown date, the patient received a dose (reported as half dose) of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination. On an unknown date, the patient died (death), (unknown latency) following the administration of INFLUENZA VACCINE. Also, this event was assessed as medically significant. Details of laboratory data were no reported. It was not reported if the patient received any corrective treatment before death. At the time of reporting, it was unknown if an autopsy was done and the cause of death was not reported. Information on the batch number was requested.; Sender''s Comments: This poorly documented social media case concerns a patient of unknown age who died (death) after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. Also, the patient''s medical condition at the time of vaccination, concomitant therapy, allergic history, previous vaccination and tolerance, autopsy result and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: grandmother died from half flu shot


VAERS ID: 898388 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-11-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA334625

Write-up: Flu shot killed the patient; Initial information was received on 22-Nov-2020 regarding an unsolicited valid serious case received from a consumer. This case involves a male patient (unknown age) who died (death), while he received vaccine INFLUENZA VACCINE. The patient''s medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient died (death) (Unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. Case Detail: Product name was not provided. Since this was a public post on the Sanofi flu shot campaign it was assumed that the consumer was referring to the Sanofi flu vaccine Details of laboratory data were not reported. It was not reported if the patient received any corrective treatment. It was unknown if an autopsy was done and the cause of death was not reported. Information on the batch number was requested.; Sender''s Comments: This was a poorly documented case involves a male patient (unknown age) who died (death) after receiving INFLUENZA VACCINE (unknown manufacturer). Time to onset is unknown. Additional information regarding patient''s relevant medical history, health condition at time of vaccination and laboratory tests, autopsy results for cause of death is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: death NOS


VAERS ID: 898389 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-11-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA334807

Write-up: patient die from flu vaccine; Initial information was received on 20-Nov-2020 regarding an unsolicited valid serious case from the consumer or non-health care professional (patient''s friend) via social media. This case involves an unknown demographic patient who died (death), after vaccination with INFLUENZA VACCINE. The patient''s medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not reported. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination. On an unknown date, the patient died (death), (unknown latency) following the administration of INFLUENZA VACCINE. Also, this (death) event was assessed as medically significant. Details of laboratory data were not reported. It was not reported if the patient received any corrective treatment. At the time of reporting, it was unknown if an autopsy was done and the cause of death was not reported. Information on the batch number was requested.; Sender''s Comments: This poorly documented social media case concerns a patient of unknown age who died (death) after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. Also, the patient''s medical condition at the time of vaccination, concomitant therapy, allergic history, previous vaccination and tolerance, autopsy result and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed; Reported Cause(s) of Death: patient die from flu vaccine


VAERS ID: 899160 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Mechanical ventilation
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA341688

Write-up: died from the 2x flu vaccines and ventilator; Initial information was received on 25-Nov-2020 regarding an unsolicited valid serious case received from a consumer (patient''s relative) via social media. This case involves a male patient (unknown age) who was died from the 2x flu vaccines and ventilator (death), while he received INFLUENZA VACCINE. Medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient who was on ventilator was died (death) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. Details of laboratory data were not reported. It was not reported if the patient received any corrective treatment. It was unknown if an autopsy was done and the cause of death was not reported. Information on the batch number was requested.; Sender''s Comments: This was a poorly documented social media case received from social media involves a male patient (unknown age) who died (death) after receiving INFLUENZA VACCINE (unknown manufacturer). Time to onset is unknown. The patient was on ventilator. Additional information regarding patient''s relevant medical history, health condition at time of vaccination and laboratory tests, autopsy results for cause of death is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.


VAERS ID: 899700 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA344185

Write-up: died from flu shot; Initial information received on 28-Nov-2020 regarding an unsolicited valid serious case received from a consumer/ non- healthcare professional via social media. This case involves a female patient (unknown age) who died (death) after receiving INFLUENZA VACCINE. Medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient died (death), (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. It was also reported that just follow good hygiene, common sense and reporter haven''t had the flu for a long time. Details of laboratory data not reported. It was not reported if the patient received a corrective treatment. Date of death was not reported. It was unknown at the time of reporting if an autopsy was done and the cause of death was not reported. Information on the batch number was requested.; Sender''s Comments: A case was reported from social media, which involved a female patient of an unknown age who died after vaccination with INFLUENZA VACCINE (unknown manufacturer). Time to onset was unknown. Additional information regarding patient''s relevant medical history, health condition at time of vaccination, concomitant medication and Laboratory tests, autopsy results for cause of death is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: died from flu shot


VAERS ID: 900800 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA350192

Write-up: patient got Guillian-Barre / patient died from it/ passed away; wound up in a wheel chair suffered; Initial information received on 03-Dec-2020 regarding an unsolicited valid serious case from a non-health care professional (Patient''s Friend) via social media. This case involved female patient of unknown age who developed Guillian-Barre/ died from it /passed away (Guillain-Barre syndrome) and wound up in a wheel chair (wheelchair user) , after receiving INFLUENZA VACCINE. The patient''s past vaccinations included flu shot. Medical history, medical treatment(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient developed serious events of Guillian-Barre/ died from it/ passed away (Guillain-Barre syndrome) and wound up in a wheel chair (wheelchair user) unknown latency, following the vaccination. These events were assessed as medically significant and were leading to disability. It was reported that patient suffered for about 4 years. No laboratory data reported. It was not reported if the patient received a corrective treatment. The outcome was fatal for the event Guillain-Barre syndrome and died on an unknown date. It was unknown if an autopsy was done. The cause of death was reported as Guillain-Barre syndrome. Information on the batch number to be requested for this case; Sender''s Comments: This poorly documented social media involves a female patient of unknown age who presented Guillain-Barre syndrome, wounded up in a wheel chair and died after vaccination with an INFLUENZA VACCINE. Time to onset is unknown. The cause of death was unspecified. Moreover, additional information regarding their relevant medical history, health condition at time of vaccination and Laboratory tests, autopsy results is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: Guillain Barre syndrome


VAERS ID: 900801 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA350313

Write-up: patient died after getting the shot from what it was to prevent; Initial information received on 03-Dec-2020 regarding an unsolicited valid serious social media case received from a consumer or non-healthcare professional. This case involves a male patient (age not reported) who died after getting the INFLUENZA VACCINE from what it was to prevent (influenza). The patient''s medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer batch number and expiry date not reported via an unknown route in an unknown administration site for prophylactic vaccination. On an unknown date, the patient died (unknown latency) following the administration of INFLUENZA VACCINE from what it was to prevent (influenza). No laboratories details reported. It was not reported if the patient received any corrective treatment before he died. It was unknown if an autopsy was done. Information on the batch number was requested.; Sender''s Comments: This poorly documented social media case concerns a male patient who had influenza infection and died after vaccination with INFLUENZA VACCINE (unknown manufacturer). Also, patient''s medical condition at the time of vaccination, autopsy result and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: patient died after getting the shot from what it was to prevent


VAERS ID: 900887 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA350303

Write-up: patient laid down and never woke up (death NOS); Initial information received on 03-Dec-2020 regarding an unsolicited valid serious case received from a consumer or non-health care professional. This case is linked to case 2020SA350305 (same reporter). This case involves a 65-year-old female patient who laid down and never woke up (death), while she received INFLUENZA VACCINE. Medical history, medical treatment, vaccination, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient died (death) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. Case Detail: Product name was not provided. it was assumed that the consumer was referring to the Sanofi flu vaccine. Details of laboratory data were not reported. It was not reported if the patient received any corrective treatment. It was unknown if an autopsy was done and the cause of death was not reported. Information on the batch number was requested.; Sender''s Comments: This was a poorly documented case involves 65-year-old female patient who died (death) after receiving INFLUENZA VACCINE (unknown manufacturer). Time to onset is unknown. Additional information regarding patient''s relevant medical history, health condition at time of vaccination and laboratory tests, autopsy results for cause of death is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: patient laid down and never woke up (death NOS)


VAERS ID: 900888 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA350305

Write-up: patient laid down and never woke up (death NOS); Initial information received on 03-Dec-2020 regarding an unsolicited valid serious case received from a non-health care professional or consumer via social media. This case is linked to case 2020SA350303 (same reporter). This case involves a 73-year-old female patient who laid down and never woke up (death), while she received vaccine INFLUENZA VACCINE. The patient''s medical history, concomitant therapy, vaccination, past medical treatment(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced (by unknown manufacturer) [lot number and expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient died (death) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. Details of laboratory data were not reported. It was not reported if the patient received any corrective treatment. At the time of report, cause of death was not reported, it was unknown if autopsy was done. Information on the batch number was requested; Sender''s Comments: This was a poorly documented social media case involves 73-year-old female patient who died (death), after receiving INFLUENZA VACCINE. Time to onset is unknown. Additional information regarding patient''s relevant medical history, health condition at time of vaccination and laboratory tests, autopsy results for cause of death is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: patient laid down and never woke up (death NOS)


VAERS ID: 900928 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA350316

Write-up: Killed; Initial information was received on 03-Dec-2020 regarding an unsolicited valid serious social media case from a consumer/non-health care professional. This case involves a male patient (age unspecified) who was killed (death), while he received INFLUENZA VACCINE. Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient was killed (death) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. No laboratory data was provided. It was not reported if the patient received a corrective treatment before death. It is unknown if an autopsy was done. The cause of death was not specified. Information on batch number was requested for this case.; Sender''s Comments: This poorly documented case from social media involves a male patient who died (NOS) after receiving INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination, concomitant medications, lab /radiological investigation excluding other etiologies and detailed autopsy report would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.; Reported Cause(s) of Death: killed


VAERS ID: 901122 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA350707

Write-up: patient had flu and died from it; Initial information was received on 06-Dec-2020 regarding an unsolicited valid serious case received from a consumer or non health care professional via social media. This case involves a patient (unknown demographics) who experienced flu (influenza), after the patient received vaccine INFLUENZA VACCINE. The patient''s medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed serious flu (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE. This event was leading to death. Details of laboratory data were not reported. It was not reported if the patient received any corrective treatment. At the time of report, it was unknown if autopsy was done. Information on the batch number was requested.; Sender''s Comments: This was a poorly documented social media case received from social media involves patient (unknown demographics) who experienced influenza after receiving INFLUENZA VACCINE (unknown manufacturer). Time to onset is unknown. Additional information regarding patient''s relevant medical history, health condition at time of vaccination and laboratory tests, autopsy results for cause of death is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: patient had flu and died from it


VAERS ID: 901123 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA351521

Write-up: according to the autopsy report it contributed to killing my mother; Initial information was received on 04-Dec-2020 regarding an unsolicited valid serious social media case from a consumer via social media. This case involves female patient (unknown age) whom it was reported that according to the autopsy report INFLUENZA VACCINE contributed to killing her (death). Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) not reported via an unknown route at an unknown administration site prophylactic vaccination. On an unknown date, the patient died due to INFLUENZA VACCINE (death) (unknown latency). Additionally, this event was assessed as medically significant. It was not reported if the patient received any corrective treatment before death. An autopsy was done, however details were not reported. Information on the batch number was requested.; Sender''s Comments: This is a poorly documented social media case received from social media involves a female patient (unknown age) who died after receiving INFLUENZA VACCINE (unknown manufacturer). Time to onset is unknown. It was reported that according to the autopsy report it contributed to killing her. However there is no additional information regarding patient''s relevant medical history, health condition at time of vaccination and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: according to the autopsy report it contributed to killing my mother


VAERS ID: 901124 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Wheelchair user
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA351639

Write-up: patient is dead/Death NOS; after flu vaccination patient was on put on wheelchair; Initial information regarding an unsolicited valid serious case received from a consumer via social media on 04-Dec-2020. This case involves a male patient who recieved INFLUENZA VACCINE was put on wheelchair (Wheelchair user), then died (Death). The patient''s medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, (latency unknown) after flu vaccination patient was put on wheelchair (Wheelchair user), later he died (Death). Seriousness: event wheelchair user (disability). Laboratory details were not reported prior to death was not reported. It was not reported if the patient received a corrective treatment. It was unknown if an autopsy was performed and cause of death was not reported. There will be no information available on batch number for this case.; Sender''s Comments: Sanofi company comment dated 08-Dec-2020: This case concerns a male patient who was a wheelchair user and later died after vaccination with company suspect Influenza Vaccine. The time to onset was unknown. However, patient''s medical condition, concomitant medication ruling out alternate etiologies, laboratory tests were not reported. One vaccination preceded the events. Based upon the reported information, the role of an individual vaccine cannot be assessed.; Reported Cause(s) of Death: patient is dead/Death NOS


VAERS ID: 901125 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Neoplasm malignant
SMQs:, Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA351640

Write-up: flu shots ended up with cancer and gone from cancer; Initial information received on 03-Dec-2020 regarding an unsolicited valid serious social media case received from a consumer. This case involves two patients with unknown demographics who experienced cancer (neoplasm malignant), while he/she received INFLUENZA VACCINE. The patient''s medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were unknown. On an unknown date, patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, patients ended up with cancer (neoplasm malignant) (Unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death. Relevant laboratory data was not reported. It was not reported if the patient received a corrective treatment prior to death. It is unknown if an autopsy was done. The cause of death was reported as Neoplasm malignant. There will be no information available on the batch number for this case.; Sender''s Comments: This was a poorly documented social media case received from social media involves two patients with unknown demographics who had cancer (neoplasm malignant) and died after vaccination with an INFLUENZA VACCINE (unknown manufacturer). Time to onset is unknown. Also, patient''s medical condition at the time of vaccination, autopsy result and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: cancer


VAERS ID: 901346 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA352703

Write-up: patient died within 3 hours of the jab; Initial information received on 07-Dec-2020 regarding an unsolicited valid serious social media case received from a consumer or non-healthcare professional. This case involves a male patient (age not reported) who died within 3 hours after he received INFLUENZA VACCINE. The patient''s medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. In 1976, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination. In 1976, the patient died within 3 hours following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. The reporter also reported that vaccine manufacturers cannot be held liable for death or injury from a flu vaccine. Would you buy tires from someone knowing they do not stand behind their product? Why would you inject toxins, poison, aborted baby fetal tissue into your bloodstream to avoid getting a virus with a 99.7 percent survival rate? More people die of the side effects of the vaccine than the disease itself. The details of laboratory data were not reported. It was not reported if the patient received a corrective treatment before he died. It was unknown if an autopsy was done. The cause of death was not reported. Information on the batch number was requested.; Sender''s Comments: This poorly documented social media case concerns a male patient (age not reported) who died within 3 hours after vaccination with INFLUENZA VACCINE (unknown manufacturer). Also, patient''s medical condition at the time of vaccination, autopsy result and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: patient died within 3 hours of the jab


VAERS ID: 901521 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA354104

Write-up: Guillain-Barre syndrome; Initial information received on 07-Dec-2020 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional via social media. This case is linked to case 2020SA354103 (same reporter). This case involve female patient (age not reported) who experienced Guillain-Barre Syndrome, while she received vaccine INFLUENZA VACCINE. The patient''s medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer and lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a serious Guillain-Barre Syndrome (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death (Patient was buried on 06-Dec-2020). Laboratory details were not reported. It was not reported if the patient received a corrective treatment. It is unknown if an autopsy was done. The causes of death was reported as Guillain-Barre Syndrome. Information on the batch number was requested.; Sender''s Comments: This poorly documented social media case concerns a female patient (age not reported) who died due to Guillain-Barre Syndrome after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset was unknown. However, patient''s medical condition at the time of vaccination, lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: Guillain-Barre syndrome


VAERS ID: 901597 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA353950

Write-up: patient passed away, death NOS; Initial information received on 08-Dec-2020 regarding an unsolicited valid serious case received from a consumer via social media. This case is linked to case 2020SA353949. This case involves male patient of an unknown age who passed away (death), while he received vaccine INFLUENZA VACCINE. Medical history, medical treatment, concomitant medication, vaccination and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient passed away (death), one week following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. No laboratory data reported. It was not reported if the patient received a corrective treatment. At the time of reporting no autopsy was done and the cause of death was not reported. Information on the batch number was requested.; Sender''s Comments: This was a poorly documented social media case involves a male patient of an unknown age who died, one week after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is compatible with the role of the vaccine. Also, patient''s medical condition at the time of vaccination, autopsy result and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: patient passed away, death NOS


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