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From the 5/7/2021 release of VAERS data:

Found 86 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 and Appearance Date from '2020-09-01' to '2021-02-28'



Case Details

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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: 890008 (history)  
Form: Version 2.0  
Age: 1.08  
Sex: Male  
Location: Texas  
Vaccinated:2020-10-14
Onset:2020-10-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2020-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UT7081JA / 1 LL / IM

Administered by: Private       Purchased by: ?
Symptoms: Death, Influenza virus test negative, SARS-CoV-2 test negative
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-10-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: febrile seizure at 8mo after Pentacel, RotaTeq, Engerix-B, and Prevnar. Event self-resolved, never occurred again
Other Medications: Acetaminophen taken after vaccination
Current Illness: history of single febrile seizure 5/8/2020
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: COVID and flu negative
CDC Split Type:

Write-up: Child found deceased in bed.


VAERS ID: 890067 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Nevada  
Vaccinated:2020-09-08
Onset:2020-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) / SANOFI PASTEUR UJ460AB / 1 LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 4F99G / UNK - / -

Administered by: Pharmacy       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: 2020-10-12
   Days after onset: 34
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Diabetes, CVD, and hyperlipidemia
Allergies: NOne
Diagnostic Lab Data: Unknown
CDC Split Type:

Write-up: Wife called us on 10/15 to inform that patient did not do well after the vaccines. He was on ventilator for 5 days, then passed away.


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: 890303 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:2019-02-01
Submitted: 0000-00-00
Entered: 2020-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Computerised tomogram thorax abnormal, Cough, Death, Diarrhoea, Fatigue, H1N1 influenza, Hypotension, Influenza A virus test positive, Intensive care, Legionella infection, Legionella test positive, Pneumonia, Polymerase chain reaction positive, Pyrexia, Rhinorrhoea, Sepsis, Vaccination failure
SMQs:, Anaphylactic reaction (narrow), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-07-01
   Days after onset: 149
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: Angioimmunoblastic T-cell lymphoma; Chronic myelomonocytic leukemia (received a matched related donor (MRD) stem cell transplant (SCT) (in October 2018))
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 201902; Test Name: Body temperature; Result Unstructured Data: (Test Result:39,Unit:degree C); Test Date: 201902; Test Name: Body temperature; Result Unstructured Data: (Test Result:40,Unit:degree C); Test Date: 201902; Test Name: CT chest; Result Unstructured Data: (Test Result:showed left upper lobe pneumonia,Unit:unknown); Test Date: 201902; Test Name: urinary antigen test; Result Unstructured Data: (Test Result:Legionella pneumophila serotype 1 positive,Unit:unknown); Test Date: 2019; Test Name: Polymerase chain reaction; Result Unstructured Data: (Test Result:see text,Unit:unknown); Test Date: 201902; Test Name: Nasopharyngeal swab; Result Unstructured Data: (Test Result:Influenza A virus type: H1N1 positive,Unit:unknown); Test Date: 2019; Test Name: Nasopharyngeal swab; Result Unstructured Data: (Test Result:positive for influenza A/H1pdm09,Unit:unknown); Test Date: 2019; Test Name: Nasopharyngeal swab; Result Unstructured Data: (Test Result:positive for influenza A/H1pdm09,Unit:unknown); Comments: A repeat RP2 panel was still positive for influenza A virus. Neuraminidase sequence was WT (Wild-type) and Polymerase sequence was I38T.
CDC Split Type: USGLAXOSMITHKLINEUS2020GS

Write-up: Hypotension; Sepsis; Loose stool; suspected vaccination failure; influenza A/H1pdm09/influenza A H1 2009 (Influenza A virus type: H1N1); Chills; Rhinorrhea; recurrent high fevers; Dry cough; left upper lobe pneumonia; Tiredness; Death NOS; Legionella pneumophila; This case was reported in a literature article and described the occurrence of unknown cause of death in a 66-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis. Previously administered products included fludarabine, melphalan, alemtuzumab, total body irradiation, tacrolimus (prophylaxis) and rituximab (detectable circulating EBV DNA prior to transplant). Concurrent medical conditions included angioimmunoblastic t-cell lymphoma and chronic myelomonocytic leukemia (received a matched related donor (MRD) stem cell transplant (SCT) (in October 2018)). On an unknown date, the patient received Flu vaccine. In February 2019, less than a year after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), h1n1 influenza (serious criteria hospitalization), chills (serious criteria hospitalization), rhinorrhea (serious criteria hospitalization), fever (serious criteria hospitalization), dry cough (serious criteria hospitalization) and legionella pneumophila infection (serious criteria GSK medically significant). In July 2019, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the patient experienced lobar pneumonia (serious criteria GSK medically significant), hypotension (serious criteria hospitalization), sepsis (serious criteria hospitalization and GSK medically significant), loose stools (serious criteria hospitalization) and tiredness. The subject was treated with oseltamivir, antibiotics nos, baloxavir marboxil and azithromycin. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the vaccination failure, h1n1 influenza, chills, rhinorrhea, fever, legionella pneumophila infection, lobar pneumonia, hypotension, sepsis, loose stools and tiredness were unknown and the outcome of the dry cough was recovered/resolved. The subject died in July 2019. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death, vaccination failure, h1n1 influenza, lobar pneumonia, hypotension, sepsis, chills, rhinorrhea, fever, dry cough, loose stools, legionella pneumophila infection and tiredness to be related to Flu vaccine. Additional details were provided as follows: This case was reported in a literature article and described the suspected vaccination failure in a 66-years-old female patient, who was vaccinated with unspecified seasonal influenza vaccine (manufacturer unknown) for prophylaxis. This case corresponds to table 1 reported in this literature article. The patient was a part of the study which described the clinical and virological responses to oseltamivir and baloxavir treatment in five allogeneic SCT recipients, and molecular characteristics of the influenza virus population before and after treatment. [It was used baloxavir to treat five allogeneic SCT recipients that were still symptomatic and shedding influenza virus after completing one or more treatment courses of oseltamivir and characterized the viral isolates before and during treatment. Allogeneic SCT patients with influenza A virus infection who received oseltamivir with no resolution of symptoms and were persistently positive for influenza A virus by the FilmArray Respiratory Pathogen two panel were included in the study]. The patient had angioimmunoblastic T-cell lymphoma (AITL) in partial remission and chronic myelomonocytic leukemia (CMML) who received a matched related donor (MRD) stem cell transplant (SCT) (in October 2018). The patient received fludarabine, melphalan, alemtuzumab, and total body irradiation (TBI 400cGy) as conditioning and tacrolimus as post-transplant graft-versus-host disease (GVHD) prophylaxis. Because of detectable circulating EBV DNA prior to transplant, the patient received one dose of rituximab with her transplant conditioning. The patient received Rituximab in prior 6 months. Time duration from SCT was 0.30 years. The patient had not active GVHD. The patient (setting) was from inpatient. No information on patient''s family history was provided. On an unspecified date, the patient received annual unspecified seasonal influenza vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date in February 2019, an unknown period after the vaccination, the patient experienced chills, rhinorrhea, cough, and fever to 39 degree Celsius and was diagnosed with influenza A H1 2009 (Influenza A virus type: H1N1) using the RP2 panel. Nasopharyngeal swab in universal viral transport media (BD) was collected as part of routine clinical care. The patient did not receive immunosuppressive therapy at the time of influenza diagnosis. Oseltamivir therapy was initiated (for 5 days), but 5 days later the patient presented to the emergency department with recurrent high fevers to 40 degree Celsius, chills, rhinorrhea, dry cough, and loose stool. CT chest showed left upper lobe pneumonia, and a repeat RP2 panel was still positive for influenza A virus. The infection type was pneumonia. The patient was admitted to the intensive care unit for hypotension/sepsis and received broad-spectrum antibiotics and baloxavir 40 mg for influenza. The next day, a urinary antigen test for Legionella pneumophila serotype 1 was reported to be positive and antibiotic treatment with azithromycin 500 mg daily was started. The co-pathogen included Legionella. Her symptoms rapidly improved but the patient continued to complain of persistent cough and tiredness, and the RP2 panel was still positive for influenza A. A second dose of baloxavir 40 mg was administered 4 days after the initial dose, and the patient was discharged home two days later. When the patient returned to clinic for follow-up 1 and 3 weeks after discharge, her symptoms were much improved, the patient had no cough, but was positive for influenza A/H1pdm09 at both visits. The influenza outcome was persistent shedding. Neuraminidase sequence was WT (Wild-type) and Polymerase sequence was I38T. This case has been considered as suspected vaccination failure being the time to onset was unknown. On an unspecified date in July 2019, the patient died from progressive disease. It was unknown whether the patient''s autopsy was performed or not. [Nasopharyngeal swabs in universal viral transport media (BD) were collected as part of routine clinical care using standard procedures. Influenza was detected using the RP2 panel. Nucleic acid was isolated both using an automated platform (easyMAG) and using QIAamp kit in accordance with the manufacturers'' protocols. Nucleic acids extracted using the easyMAG platform were tested by real-time reverse transcriptase-PCR to confirm the presence of influenza virus. Nucleic acids extracted using QIAamp kits were sequenced with next-generation sequencing methods for whole-genome analysis. A total of five patients who were both symptomatic and persistently positive for influenza A on the RP2 panel after receiving oseltamivir were treated with baloxavir. Oseltamivir was administered at the standard dose of 75 mg twice/day orally. Baloxavir was administered orally as a single or two doses of 40 or 80 mg, based on weight, according to manufacturer''s instructions. All patients were profoundly immunocompromised because of allogeneic lymphodepleting SCT. In addition, two had received rituximab (monoclonal antibody directed to the lymphocyte surface protein CD20) within 6 months of influenza diagnosis, two had received prolonged immunosuppressive treatment for graft-versus-host disease (GVHD), and one was obese, a predisposing condition for severe influenza. All patients had coinfection with other pathogens, four of them had pneumonia and were hospitalized]. This case has been considered serious due to suspected vaccination failure, death and hospitalization. The author commented, "It has been repeatedly reported that the treatment of influenza in immunocompromised hosts is problematic, requiring prolonged treatment courses, causing an increased risk of the development of antiviral-resistant influenza variants. Moreover, because uncomplicated influenza in this patient population may present with few initial symptoms and no fever, the diagnosis is often delayed, and treatment with NAI is often initiated after the preferred 48-hour window from onset of symptoms. Baloxavir has been recently approved for the treatment of uncomplicated influenza. It has been shown that treatment with baloxavir is associated with a more rapid viral clearance. Here, we describe the treatment of five allogeneic SCT recipients with baloxavir who were still positive for influenza A after oseltamivir treatment. In 4 of these subjects, including those with demonstrated oseltamivir-resistant variants, treatment with baloxavir was followed by clinical improvement and viral clearance. Three patients did not have any detectable NAI resistance-associated changes in the influenza viruses sequenced at the time they received baloxavir, and we cannot exclude the possibility that more prolonged oseltamivir treatment may have also been effective for symptom resolution and viral clearance. We found that one of the treated subjects developed a PA variant after two doses of baloxavir. Although the patient improved and eventually cleared the infection, the potential for transmission of variant virus raises concern. Despite the small patient number and the lack of a control group, our data suggest that baloxavir may be a useful treatment option for infections with influenza virus with NAI-resistant variants, and/or in SCT patients who fail NAI treatment for other reasons. Combination therapy, including baloxavir and oseltamivir, has shown synergistic activity in vitro. This treatment option might be more effective and may decrease the emergence of resistant influenza variants in the immunocompromised host." The author concluded, "Our data suggest that baloxavir treatment can be effective in treating neuraminidase inhibitor-resistant influenza in profoundly immunocompromised patients. Randomized clinical trials are needed to define the role of baloxavir alone and combined with oseltamivir for the treatment of influenza in SCT recipients and other immunocompromised populations." This is 1 of the 3 valid cases reported in the same literature article.; Sender''s Comments: US-GLAXOSMITHKLINE-US2020GSK203425:Same reporter; Reported Cause(s) of Death: death NOS


VAERS ID: 890675 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:2018-12-01
Submitted: 0000-00-00
Entered: 2020-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Blood culture negative, Chest X-ray abnormal, Computerised tomogram thorax abnormal, Coronavirus infection, Coronavirus test positive, Cough, Death, Dyspnoea, Enterovirus infection, Fatigue, Gene sequencing, Influenza, Influenza A virus test positive, Intensive care, Pneumonia bacterial, Polymerase chain reaction positive, Productive cough, Pyrexia, Respiratory failure, Rhinovirus infection, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-01-01
   Days after onset: 396
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; Neoplasm malignant
Preexisting Conditions: Medical History/Concurrent Conditions: Acute myeloid leukemia (underwent a matched related donor (MRD) stem cell transplant (SCT) in November 2016); Graft versus host disease
Allergies:
Diagnostic Lab Data: Test Date: 201812; Test Name: Blood cultures; Result Unstructured Data: (Test Result:negative,Unit:unknown); Test Date: 201812; Test Name: Body temperature; Result Unstructured Data: (Test Result:39,Unit:degree C); Test Date: 201812; Test Name: Chest x-ray; Result Unstructured Data: (Test Result:see text,Unit:unknown); Test Date: 201812; Test Name: Chest computerized tomography; Result Unstructured Data: (Test Result:see text,Unit:unknown); Test Date: 201812; Test Name: next-generation sequencing; Result Unstructured Data: (Test Result:see text,Unit:unknown); Test Date: 201812; Test Name: RT-PCR; Result Unstructured Data: (Test Result:see text,Unit:unknown); Test Date: 201812; Test Name: Nasopharyngeal swab; Result Unstructured Data: (Test Result:positive for influenza A,Unit:unknown); Comments: Chest x-ray showed bilateral interstitial opacifications suggesting a possible superimposed bacterial pneumonia. RP2 (Respiratory Pathogen two panel) was positive for influenza A/H1pdm09 (Influenza A virus type: H1N1) and coronavirus 229E.Chest computerized tomography (CT) performed 3 weeks after admission showed variable change in multilobar pneumonia with improvement within the left upper lobe and progression in the left lower lobe. Weekly RP2 panels during this period were positive for influenza A and coronavirus 229E. A RP2 panel performed at discharge was positive for influenza A/H1pdm09, but it was unable to detect the virus in the same specimen by real-time RT-PCR or next-generation sequencing.At that time, the patient was asymptomatic and the RP2 panel was negative for influenza and still positive for coronavirus 229E. Neuraminidase sequence was H275Y and Polymerase sequence was WT (Wild-type).
CDC Split Type: USGLAXOSMITHKLINEUS2020GS

Write-up: suspected vaccination failure; influenza A/H1pdm09; coronavirus 229E; shortness of breath; Cough/productive cough; Fever; Death NOS; rhinovirus/enterovirus; rhinovirus/enterovirus; Fatigue; Bacterial pneumonia; Acute respiratory distress syndrome; hypoxic respiratory failure; This case was reported in a literature article and described the occurrence of unknown cause of death in a 61-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis. The subject''s past medical history included acute myeloid leukemia (underwent a matched related donor (MRD) stem cell transplant (SCT) in November 2016) and graft versus host disease. Previously administered products included fludarabine, melphalan, alemtuzumab, tacrolimus (prophylaxis), steroids and ruxolitinib. Concurrent medical conditions included neoplasm malignant and immunocompromised. On an unknown date, the patient received Flu vaccine. In December 2018, less than a year after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), influenza a virus infection (serious criteria hospitalization), coronavirus infection (serious criteria hospitalization), pneumonia bacterial (serious criteria GSK medically significant), acute respiratory distress syndrome (serious criteria GSK medically significant), hypoxic respiratory failure (serious criteria GSK medically significant), shortness of breath (serious criteria hospitalization), cough (serious criteria hospitalization), fever (serious criteria hospitalization), enterovirus infection (serious criteria GSK medically significant), rhinovirus infection and fatigue. In January 2020, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). The subject was treated with tacrolimus, oseltamivir, antibiotics nos, steroids nos (Steroids), prednisone, ruxolitinib, oxygen and baloxavir marboxil. In January 2020, the outcome of the unknown cause of death was fatal. On an unknown date, the outcome of the vaccination failure, influenza a virus infection, coronavirus infection, pneumonia bacterial, shortness of breath, cough, fever, enterovirus infection and rhinovirus infection were unknown and the outcome of the acute respiratory distress syndrome, hypoxic respiratory failure and fatigue were recovered/resolved. The subject died in January 2020. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death, vaccination failure, influenza a virus infection, coronavirus infection, pneumonia bacterial, acute respiratory distress syndrome, hypoxic respiratory failure, shortness of breath, cough, fever, enterovirus infection, rhinovirus infection and fatigue to be related to Flu vaccine. Additional details were provided as follows: This case was reported in a literature article and described the suspected vaccination failure in a 61-years-old female patient, who was vaccinated with unspecified influenza vaccine (manufacturer unknown) for prophylaxis. This case corresponds to table 1 reported in this literature article. The patient was a part of the study which described the clinical and virological responses to oseltamivir and baloxavir treatment in five allogeneic SCT recipients, and molecular characteristics of the influenza virus population before and after treatment. [It was used baloxavir to treat five allogeneic SCT recipients that were still symptomatic and shedding influenza virus after completing one or more treatment courses of oseltamivir and characterized the viral isolates before and during treatment. Allogeneic SCT patients with influenza A virus infection who received oseltamivir with no resolution of symptoms and were persistently positive for influenza A virus by the FilmArray Respiratory Pathogen two panel were included in the study]. The patient had a history of acute myeloid leukemia (AML). The patient underwent a matched related donor (MRD) stem cell transplant (SCT) in November 2016 conditioned with fludarabine, melphalan, and alemtuzumab and received tacrolimus as post-transplant graft-versus-host disease (GVHD) prophylaxis. Time duration from SCT was 2.12 years. The patient had active GVHD. The patient (setting) was from inpatient. The patient''s post-transplant course was complicated by cytogenetic disease relapse at 1 year. The patient received two donor lymphocyte infusions, which successfully controlled her malignancy but resulted in GVHD necessitating prolonged immunosuppression with systemic steroids, tacrolimus, and ruxolitinib. No information on patient''s family history was provided. On an unspecified date, the patient received unspecified influenza vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date in end of December 2018, an unknown period after the vaccination, the patient was admitted to an outside hospital complaining of shortness of breath, cough, and fever to 39 degree Celsius for 2 days prior to admission. Nasopharyngeal swab in universal viral transport media (BD) was collected as part of routine clinical care. The patient was found to be positive for influenza A. Chest x-ray showed bilateral interstitial opacifications suggesting a possible superimposed bacterial pneumonia. The infection type was pneumonia. The patient required high flow oxygen and was admitted to the intensive care unit. The patient was treated with oseltamivir, broad-spectrum antibiotics, and steroids for possible acute respiratory distress syndrome. Blood cultures were negative. After 4 days, the patient was transferred to the hospital, and on admission, RP2 was positive for influenza A/H1pdm09 (Influenza A virus type: H1N1) and coronavirus 229E. The patient received immunosuppressive therapy at the time of influenza diagnosis included prednisone 20 mg once a day (QD)/Ruxolitinib 5 mg twice a day (BID), Tacrolimus. The patient did not receive Rituximab in prior 6 months. The co-pathogen included rhinovirus/enterovirus. Treatment with oseltamivir for 5 days and broad-spectrum antibiotics for possible bacterial superinfection was continued for 10 days of total course. Despite this treatment, the patient continued to experience profound fatigue, productive cough, and hypoxic respiratory failure requiring oxygen supplementation (2-4L). Chest computerized tomography (CT) performed 3 weeks after admission showed variable change in multilobar pneumonia with improvement within the left upper lobe and progression in the left lower lobe. Weekly RP2 panels during this period were positive for influenza A and coronavirus 229E. Because of the concern for oseltamivir-resistant influenza, the patient received baloxavir (80 mg), once. The patient''s respiratory status, cough, and fatigue rapidly improved, and the patient was discharged home four days after baloxavir treatment. A RP2 panel performed at discharge was positive for influenza A/H1pdm09, but it was unable to detect the virus in the same specimen by real-time RT-PCR or next-generation sequencing. The patient missed follow-up appointments because of severe weather conditions and was readmitted for unrelated issues one month after discharge. At that time, the patient was asymptomatic and the RP2 panel was negative for influenza and still positive for coronavirus 229E. The influenza outcome was clearance. Neuraminidase sequence was H275Y and Polymerase sequence was WT (Wild-type). This case has been considered as suspected vaccination failure being the time to onset was unknown. On an unspecified date in January 2020, the patient succumbed to fatal complications of GVHD. It was unknown whether the patient''s autopsy was performed or not. [Nasopharyngeal swabs in universal viral transport media (BD) were collected as part of routine clinical care using standard procedures. Influenza was detected using the RP2 panel. Nucleic acid was isolated both using an automated platform (easyMAG) and using QIAamp kit in accordance with the manufacturers'' protocols. Nucleic acids extracted using the easyMAG platform were tested by real-time reverse transcriptase-PCR to confirm the presence of influenza virus. Nucleic acids extracted using QIAamp kits were sequenced with next-generation sequencing methods for whole-genome analysis. A total of five patients who were both symptomatic and persistently positive for influenza A on the RP2 panel after receiving oseltamivir were treated with baloxavir. Oseltamivir was administered at the standard dose of 75 mg twice/day orally. Baloxavir was administered orally as a single or two doses of 40 or 80 mg, based on weight, according to manufacturer''s instructions. All patients were profoundly immunocompromised because of allogeneic lymphodepleting SCT. In addition, two had received rituximab (monoclonal antibody directed to the lymphocyte surface protein CD20) within 6 months of influenza diagnosis, two had received prolonged immunosuppressive treatment for graft-versus-host disease (GVHD), and one was obese, a predisposing condition for severe influenza. All patients had coinfection with other pathogens, four of them had pneumonia and were hospitalized]. This case has been considered serious due to suspected vaccination failure, death and hospitalization. The author commented, "It has been repeatedly reported that the treatment of influenza in immunocompromised hosts is problematic, requiring prolonged treatment courses, causing an increased risk of the development of antiviral-resistant influenza variants. Moreover, because uncomplicated influenza in this patient population may present with few initial symptoms and no fever, the diagnosis is often delayed, and treatment with NAI is often initiated after the preferred 48-hour window from onset of symptoms. Baloxavir has been recently approved for the treatment of uncomplicated influenza. It has been shown that treatment with baloxavir is associated with a more rapid viral clearance. Here, we describe the treatment of five allogeneic SCT recipients with baloxavir who were still positive for influenza A after oseltamivir treatment. In 4 of these subjects, including those with demonstrated oseltamivir-resistant variants, treatment with baloxavir was followed by clinical improvement and viral clearance. Three patients did not have any detectable NAI resistance-associated changes in the influenza viruses sequenced at the time they received baloxavir, and we cannot exclude the possibility that more prolonged oseltamivir treatment may have also been effective for symptom resolution and viral clearance. We found that one of the treated subjects developed a PA variant after two doses of baloxavir. Although the patient improved and eventually cleared the infection, the potential for transmission of variant virus raises concern. Despite the small patient number and the lack of a control group, our data suggest that baloxavir may be a useful treatment option for infections with influenza virus with NAI-resistant variants, and/or in SCT patients who fail NAI treatment for other reasons. Combination therapy, including baloxavir and oseltamivir, has shown synergistic activity in vitro. This treatment option might be more effective and may decrease the emergence of resistant influenza variants in the immunocompromised host." The author concluded, "Our data suggest that baloxavir treatment can be effective in treating neuraminidase inhibitor-resistant influenza in profoundly immunocompromised patients. Randomized clinical trials are needed to define the role of baloxavir alone and combined with oseltamivir for the treatment of influenza in SCT recipients and other immunocompromised populations." This is 1 of the 3 valid cases reported in the same literature article.; Sender''s Comments: US-GLAXOSMITHKLINE-US2020GSK205640:Same reporter US-GLAXOSMITHKLINE-US2020GSK205641:Same reporter; Reported Cause(s) of Death: death NOS


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: 890866 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Florida  
Vaccinated:2020-09-28
Onset:2020-09-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2020-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) / SANOFI PASTEUR U5516AA / 2 AR / IM

Administered by: Senior Living       Purchased by: ?
Symptoms: Blood creatine phosphokinase increased, Death, Rhabdomyolysis
SMQs:, Rhabdomyolysis/myopathy (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (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: Unknown
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Received a call from beach saying that this patient died. Wife said that she believes it was as a result of a flu-clinic done on 9/28/20 where the patient received a flu-shot. She said that the patient was found dead in his room. Doctor said that he had elevated CPK levels. He died as a result of rhabdomyolysis. Patient''s wife said it was the flu-shot that killed him.


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


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