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

Found 1,944 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: 689530 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-04-04
Entered: 2017-04-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
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: No other medications
Current Illness: Left ventricular dysfunction; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AU2017GSK046876

Write-up: This case was reported in a literature article and described the occurrence of cardiac arrest in a 77-year-old male subject who received Flu seasonal TIV Dresden. Concurrent medical conditions included left ventricular dysfunction and hypertension. On an unknown date, 9 hrs after receiving Flu seasonal TIV Dresden, the subject developed cardiac arrest. Serious criteria included death and GSK medically significant. The outcome of cardiac arrest was fatal. The reported cause of death was cardiac arrest. The investigator considered the cardiac arrest to be possibly related to Flu seasonal TIV Dresden. Additional information was provided. This case was reported in a literature article and described the occurrence of sudden cardiac arrest in a 77-year-old male patient who was vaccinated with unspecified seasonal influenza vaccine (manufacturer unknown). The patient was a part of the report that summarized the national passive surveillance data for adverse events following immunisation (AEFI) reported to the Administration for 2014. The report focused on AEFI reported for vaccines administered during 2014 and trends in AEFI reporting over the 15-year period between 1 January 2000 and 31 December 2014. AEFI were notified to the Administration by state and territory health departments, health professionals, vaccine manufacturers and members of the public. All reports are assessed using internationally consistent criteria entered into the Adverse Drug Reactions System (ADRS) database. The patient had left ventricular dysfunction and a medical history of hypertension. No information on patient''s family history or concomitant medication was provided. On an unspecified date between 1 January 2014 and 31 December 2014, the patient received unspecified seasonal influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). On an unspecified date in 2014, 9 hours later after vaccination, the patient had sudden cardiac arrest. Subsequently, the patient died from sudden cardiac arrest. It was unknown if an autopsy was performed. This case has been considered serious due to death. Treatment was unknown. The authors stated "All deaths were investigated by the Administration and no clear causal relationship with vaccination was found. The death NOS was temporally associated with the receipt of vaccine". The authors concluded that "The total number of reported AEFI in 2014 decreased compared with 2013. The majority of AEFIs reported to the Administration were mild transient events. The data reported here are consistent with an overall high level of safety for vaccines included in the schedule". This is 1 of the 5 valid cases reported in the same literature article.


VAERS ID: 689533 (history)  
Form: Version 1.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-04-04
Entered: 2017-04-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DT: DT ADSORBED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Acute disseminated encephalomyelitis, Death
SMQs:, Noninfectious encephalitis (narrow), Demyelination (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: Wound infection
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AU2017GSK047446

Write-up: This case was reported in a literature article and described the occurrence of acute disseminated encephalomyelitis in a 58-year-old male subject who received Flu seasonal TIV Dresden. Concurrent medical conditions included wound infection. On an unknown date, 5 days after receiving Flu seasonal TIV Dresden and DT vaccine (UNK), the subject developed acute disseminated encephalomyelitis. Serious criteria included death and GSK medically significant. The outcome of acute disseminated encephalomyelitis was fatal. The reported cause of death was acute disseminated encephalomyelitis. The investigator considered the acute disseminated encephalomyelitis to be possibly related to Flu seasonal TIV Dresden and DT vaccine (UNK). Additional information was provided. This case was reported in a literature article and described the occurrence of acute disseminated myeloencephalitis in a 58-year-old male patient who was vaccinated with unspecified DT vaccine and unspecified seasonal influenza vaccine (manufacturer unknown for both). The patient was a part of the report that summarized the national passive surveillance data for adverse events following immunisation (AEFI) reported to the Administration for 2014. The report focused on AEFI reported for vaccines administered during 2014 and trends in AEFI reporting over the 15-year period between 1 January 2000 and 31 December 2014. AEFI were notified to the Administration by state and territory health departments, health professionals, vaccine manufacturers and members of the public. All reports are assessed using internationally consistent criteria entered into the Adverse Drug Reactions System (ADRS) database. The patient had an infected leg wound prior to vaccination. No information on patient''s family history or concomitant medication or concurrent condition was provided. On an unspecified date between 1 January 2014 and 31 December 2014, the patient received unspecified DT vaccine and unspecified seasonal influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided for both). On an unspecified date in 2014, 5 days after vaccination, the patient developed the symptoms of acute disseminated myeloencephalitis, which progressed over 6 weeks leading to death. It was unknown if an autopsy was performed. This case has been considered serious due to death. Treatment was unknown. The authors stated "All deaths were investigated by the Administration and no clear causal relationship with vaccination was found. The death NOS was temporally associated with the receipt of vaccine". The authors concluded that "The total number of reported AEFI in 2014 decreased compared with 2013. The majority of AEFIs reported to the Administration were mild transient events. The data reported here are consistent with an overall high level of safety for vaccines included in the schedule". This is 1 of the 5 valid cases reported in the same literature article.


VAERS ID: 692267 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-04-27
Entered: 2017-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
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: Left ventricular dysfunction
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUSA2017SA072916

Write-up: Initial unsolicited report received from Literature on 19-Apr-2017. This case is linked with 2017SA072920 and 2017SA072926 (same reporter). The following is the verbatim from the article: Abstract: This report summarises passive surveillance data for adverse events following immunization (AEFI) for 2014 reported to the Administration for 2014 and describes reporting trends over the 15-year period 01-Jan-2000 to 31-Dec-2014. There were 3,087 AEFI records for vaccines administered in 2014; an annual AEFI reporting rate of 13.2 per 100,000 population. There was a decline of 5% in the overall AEFI reporting rate in 2014 compared with 2013. This decline in reported adverse events in 2014 compared with the previous year was mainly attributable to fewer reports following the human papillomavirus (HPV) vaccine as it was the second year of the extension of the National HPV Vaccination Program to males. AEFI reporting rates for most vaccines were lower in 2014 compared with 2013. The most commonly reported reactions were injection site reaction (27%), pyrexia (18%), rash (16%), vomiting (9%), headache (7%), and syncope (5%). The majority of AEFI reports described non-serious events while 7% (n=211) were classified as serious. There were 5 deaths reported with no clear causal relationship with vaccination found. This case involves a 77-year-old male patient who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date dose in series, dose form, frequency not reported) on an unspecified date. The patient''s medical history included hypertension. Concurrent conditions included left ventricular dysfunction. Concomitant medications were not reported. On an unspecified date, nine hours following the vaccination, it was reported that the patient experienced sudden cardiac arrest and died later. Relevant laboratory investigations and corrective treatment were not reported. It was unknown if an autopsy was performed. All deaths were investigated by the Administration and no clear causal relationship with vaccination was found. List of documents held by the sender: None. Sender''s Comments: Patient died with sudden cardiac arrest 9 hours after vaccination. Time to onset is compatible, but patient had left ventricular dysfunction and hypertension which could be alternative explanation. However further information regarding patient''s medical condition, circumstances at the time of death, and detailed autopsy report would be needed for a complete assessment. Based on available information, contributory role of the vaccine cannot be assessed. Reported Cause(s) of Death: sudden cardiac arrest.


VAERS ID: 692268 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-04-27
Entered: 2017-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DT: DT ADSORBED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute disseminated encephalomyelitis, Death
SMQs:, Noninfectious encephalitis (narrow), Demyelination (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: Medical History/Concurrent Conditions: Wound infection
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUSA2017SA072920

Write-up: Initial unsolicited report received from the literature on 19 Apr 2017. This case is linked to 2017SA072916 and 2017SA072926 (same reporter). Abstract: This report summarises passive surveillance data for adverse events following immunization (AEFI) for 2014 reported to the Administration for 2014 and describes reporting trends over the 15-year period 1 January 2000 to 31 December 2014. There were 3,087 AEFI records for vaccines administered in 2014; an annual AEFI reporting rate of 13.2 per 100,000 population. There was a decline of 5% in the overall AEFI reporting rate in 2014 compared with 2013. This decline in reported adverse events in 2014 compared with the previous year was mainly attributable to fewer reports following the human papillomavirus (HPV) vaccine as it was the 2nd year of the extension of the National HPV Vaccination Program to males. AEFI reporting rates for most vaccines were lower in 2014 compared with 2013. The most commonly reported reactions were injection site reaction (27%), pyrexia (18%), rash (16%), vomiting (9%), headache (7%), and syncope (5%). The majority of AEFI reports described non-serious events while 7% (n=211) were classified as serious. There were 5 deaths reported with no clear causal relationship with vaccination found. This case involves a 58-year-old male patient who was vaccinated with a of INFLUENZA VACCINE and DIPHTHERIA AND TETANUS TOXOIDS (DIPHTHERIA AND TETANUS) (batch number, expiry date, dose, dose in series, route and site of administration was not reported) on an unknown date. The patient had an infected leg wound prior to vaccination. Concomitant medications were not reported. On an unspecified date, 5 days following the vaccination, the patient developed acute disseminated myeloencephalitis, which progressed over 6 weeks leading to death. Relevant laboratory test and corrective treatment was not reported. It was not reported, if the Autopsy was done or not as the Autopsy results were not reported. Documents held by sender: none. Sender''s Comments: Acute disseminated encephalomyelitisis reported in this case. Symptoms started 5 days after vaccination which is compatible with the role of the vaccine. Additional information regarding medical history, infectious history, any other co morbidities and other etiological work up are needed to further assess the case. In this case patient has history of infected leg wound prior vaccination which could have caused the ADEM. Based on available information the role of vaccine cannot be assessed. Reported Cause(s) of Death: Acute disseminated myeloencephalitis.


VAERS ID: 694318 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-05-11
Entered: 2017-05-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2012GSK000609

Write-up: This case was reported by a consumer via market research programs and described the occurrence of vaccination failure in a male patient who received Flu Seasonal TIV Dresden. On an unknown date, the patient received Flu seasonal TIV Dresden at an unknown dose. On an unknown date, unknown after receiving Flu seasonal TIV Dresden, the patient experienced vaccination failure (serious criteria death and GSK medically significant) and influenza (serious criteria death). On an unknown date, the outcome of the vaccination failure and influenza were fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to Flu seasonal TIV Dresden. Additional information was provided: This case is one of the multiple cases reported following the market research. The age at vaccination was not reported. This was the case of reporter''s grandfather. This case was considered as the suspected vaccination failure since the details of basic immunization, exact time to onset for the event and laboratory confirmation was not provided. The question and the reply for this case were: Why are you in favor of minimizing the number of vaccines? The consequences of a vaccine, like developing the pathology (the flu, my grandfather was vaccinated, contracted the flu and died of it, hepatitis B, my mother and my cousin contracted rheumatoid arthritis and multiple sclerosis following a recall .. my mother died of sudden death from polyarthritis at age 59). This case was linked with FR2012GSK000612 and FR2012GSK000614). MAH Comment: Suspected reasonable causal relationship based on the event vaccination failure is upgraded from ''Unknown'' to ''Yes'' as the event is listed for Flu seasonal TIV Dresden vaccine and downgraded for event influenza from ''Unknown'' to ''No'' as there is insufficient information provided for case assessment.


VAERS ID: 695558 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2016-12-09
Onset:0000-00-00
Submitted: 2017-05-18
Entered: 2017-05-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Bacterial disease carrier, Death, Foetal exposure during pregnancy, Trisomy 21
SMQs:, Congenital, familial and genetic disorders (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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: NO2017GSK073622

Write-up: This retrospective pregnancy case was reported by a physician via regulatory authority and described the occurrence of trisomy 21 in a female neonate exposed to Influenza vaccine unspecified in utero. The mother received the product. On 9th December 2016, the 35-year-old mother received Influenza vaccine unspecified. The mother''s last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The neonate was diagnosed with trisomy 21 (serious criteria death and congenital anomaly), streptococcal colonization (serious criteria death) and maternal vaccine exposure. On an unknown date, the outcome of the trisomy 21 and streptococcal colonization were fatal and the outcome of the maternal vaccine exposure was unknown. An autopsy was performed. The autopsy determined cause of death was trisomy 21 and streptococcal colonisation. It was unknown if the reporter considered the trisomy 21 and streptococcal colonization to be related to Influenza vaccine unspecified. See case NO2017033682 for details regarding the mother case. Initial information was received from physician via regulatory authority on 30-MAR-2017. Additional information will be requested. This is a preliminary report. Fetus - preliminary autopsy report - normal findings. Fetus - chromosomal analysis - trisomi 21. Fetus - streptococcal colonisation in placenta, vagina and throat. Final autopsy report will be requested.


VAERS ID: 700058 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-06-11
Entered: 2017-06-19
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Cyanosis, Death, Decreased appetite, Dyspnoea, Tachypnoea
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Infective pneumonia (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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201700835

Write-up: This initial spontaneous case, received on 05-Jun-2017, was reported by other non-health professional via health authority (RNF: IT-MINISAL02-283025) and concerns a male patient of an unspecified age. On an unspecified date, the patient received INN Flu Vaccine (dose, route of administration, anatomical location, trade name, manufacturer, batch number and expiration date: not reported). On an unspecified date, the patient had asthenia, cyanosis, dyspnea, tachypnea and inappetence. As a result, the patient was died on an unspecified date and it was unknown if an autopsy was performed or not. The Health Authority stated that the drug might have contributed for the events and assessed the causality between events and INN flu vaccine as related. This report was serious (death).


VAERS ID: 703236 (history)  
Form: Version 1.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-07-06
Entered: 2017-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS M81571 / UNK AR / UN

Administered by: Other       Purchased by: Other
Symptoms: Drug administered at inappropriate site, Nervous system disorder, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Drug abuse and dependence (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), Medication errors (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: GB2017103759

Write-up: This case was reported by a consumer via regulatory authority and described the occurrence of neurological disorder in a 64-year-old male patient who received Seasonal Influenza vaccine (batch number M8157-1 ?, expiry date unknown). In 2015, the patient received Seasonal Influenza vaccine (unknown). In 2015, less than a year after receiving Seasonal Influenza vaccine, the patient experienced neurological disorder (serious criteria death) and tingling of extremity. On an unknown date, the patient experienced pain in arm and vaccine administered at inappropriate site. On an unknown date, the outcome of the neurological disorder was fatal and the outcome of tingling of extremity, pain in arm and vaccine administered at inappropriate site were unknown. The reported cause of death was neurological disorder. It was unknown if the reporter considered the neurological disorder, tingling of extremity and pain in arm to be related to Seasonal Influenza vaccine. Additional details, The reported batch number doesn''t match with GSK batch number. The age at vaccination was not provided. Initial information was received on 05 July 2017. Initial unsolicited report received from a consumer (patient''s daughter) on 29-Jun-2017 and additional information received on 29-Jun-2017. This case involves a 64-year-old male patient who was vaccinated with an Influenza Vaccine (batch number: M8157-1, expiry date and route of administration was unknown), in the arm on an unspecified date in 2015. The patient''s medical history and concomitant medications were not reported. On an unspecified date in 2015, following the vaccination, the patient started feeling a lot of tingling and pain in his arm and eventually he developed some neurological problems which led to his death. This was a case of potential medication error due to vaccine administered at inappropriate site. The patient''s medical history and concomitant medications were not reported. On an unspecified date in 2015, following the vaccination, the patient started feeling a lot of tingling and pain in his arm and eventually he developed some neurological problems which led to his death. This was a case of potential medication error due to vaccine administered at inappropriate site. The patient''s laboratory data and corrective treatment were not reported. On an unknown date, the patient was died. It was unknown whether the autopsy performed or not. It was also reported that her mother then killed herself because it was too much for her to bear and she would also like to know how this vaccine is administered because the pharmacy that gave her father the vaccine did not inject it into the deltoid region. It was more in the middle section of the arm opposite to the elbow, where the crease is. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder''s compliance with the requirements set out in Directive and Module of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none. Sponsor comment: A 64 years old male who received influenza vaccine (from unknown manufacturer) and experienced feeling a lot of tingling and pain in his arm and eventually he developed some neurological problems which led to his death, however diagnosis was not confirmed. Exact time to onset is unknown. Details on patient''s medical history, concurrent condition, concomitant medication, time to onset, name of vaccine administered, confirm diagnosis, cause of death and autopsy report would be helpful to assess the cause. Based on the available information no conclusion can be drawn.


VAERS ID: 704825 (history)  
Form: Version 1.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-07-10
Entered: 2017-07-20
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER M81571 / UNK AR / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Nervous system disorder, Pain in extremity, Paraesthesia, Suicide of relative
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201700988

Write-up: This initial serious spontaneous case, was received from a consumer (patient''s daughter) via health authority on 05-Jul-2017, concerning a 64-year-old male patient. The patient''s medical history and concomitant medications were not reported. On an unspecified date in 2015, the patient was vaccinated with influenza virus vaccine polyvalent, batch number: M81571 (as reported M8157-1), anatomical location: arm, route of administration, expiry date: not reported). On an unspecified date in 2015, following the vaccination, the patient started feeling a lot of tingling and pain in his arm and eventually he developed some neurological problems which led to his death. The patient''s laboratory data and corrective treatment were not reported. It was also reported that her mother then killed herself because it was too much for her to bear and she would also like to know how this vaccine is administered because the pharmacy that gave her father the vaccine did not inject it into the deltoid region. It was more in the middle section of the arm opposite to the elbow, where the crease is. Outcome of the events tingling of extremity and pain in arm was not reported. Outcome of the event neurological disorder was fatal. Cause of death was reported as neurological disorder. It was unknown whether the autopsy performed or not. The health authority assessed this case as serious due to death. The heath authority provided the causal relationship between the event and suspect product as unassessable. Case Comment: This case concerns as 64-year-old male patient, who developed some neurological problem after receiving a dose of Seasonal Influenza Vaccine, which resulted in fatal outcome. Exact time to onset of the event, patient''s medical history, concurrent conditions, concomitant medications, final diagnosis and cause of death was not reported. Based on the available information the causal role of suspect vaccine cannot be assessed.


VAERS ID: 710745 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-08-30
Entered: 2017-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, H1N1 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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab tests were performed on an unspecified date. The patient''s respiratory specimen was obtained as part of routine influenza surveillance activities. The specimen was analysed for the presence of influenza virus, by real-time polymerase chain reaction (RT-PCR), at the local laboratory or the National Influenza Centres (NICs). The patient was found positive for A (H1N1) pmd09 virus.
CDC Split Type: SE2017GSK134022

Write-up: This case was reported in a literature article and described the occurrence of vaccination failure in a 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 H1N1 influenza with serious criteria of death. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included H1N1 influenza (fatal). The reported cause of death was H1N1 influenza. The investigator considered that there was a reasonable possibility that the vaccination failure and H1N1 influenza may have been caused by Flu seasonal TIV Dresden. Relevant Tests: Lab tests were performed on an unspecified date. The patient''s respiratory specimen was obtained as part of routine influenza surveillance activities. The specimen was analysed for the presence of influenza virus, by real-time polymerase chain reaction (RT-PCR), at the local laboratory or the National Influenza Centres (NICs). The patient was found positive for A (H1N1) pmd09 virus. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Influenza A virus test result was positive unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described suspected vaccination failure in a patient aged more than 1-year of unspecified gender who was vaccinated with unspecified influenza vaccine (manufacturer unknown). The patient was a part of study to test the feasibility of collecting influenza virus strain-based antigenic and genetic data; and to assess the collected data and explore the benefits of non-aggregate strain-based reporting. In this study, among vaccinated cases, 400 were males and 396 were females; of the influenza cases reported in this study, 492 of 521 were not immunocompromised and 29 had an underlying disease. No information on patient''s medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received unspecified influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, vaccination status was known for 798 of the 1,633 cases from all 11 countries. 130 had been vaccinated with the influenza vaccine for the 2013/14 influenza season]. Age of vaccination was not provided. On an unspecified date between week 40/2013 and week 39/2014, an unknown period after vaccination, the patient''s respiratory specimen was obtained as part of routine influenza surveillance activities. The specimen was analysed for the presence of influenza virus, by real-time polymerase chain reaction (RT-PCR), at the local laboratory or the National Influenza Centres (NICs). The patient was found positive for A (H1N1) pmd09 virus. Subsequently, the patient died. It was unknown if the autopsy was performed. 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 was unknown (In this study, exposure to antiviral drugs was reported as known for 725 of 1,633 influenza cases, and of these 576 had not been treated with antiviral drug). The authors did not comment on the relationship between influenza infection and unspecified influenza vaccine. The authors stated, "In this pilot study, 34/41 of fatal cases were related to A (H1N1) pdm09 infection, compared with 58% in eight countries reporting outcomes through hospital surveillance in 2013/14. In the hospital surveillance data, many of the influenza viruses are reported without subtype and therefore no exact comparison is possible. Overall, only 41 (3%) of the 1,633 viruses characterised were from fatal cases which does not show a bias of the data towards fatal case specimens being characterised. An earlier analysis of the 2013/14 season showed that fatal outcomes occurred mostly in adults more than 40 years of age; this pilot study showed the highest number of deaths in those equal to or more than 65 years of age. Based on our limited data on severe infection, hospitalised cases affected by A (H3N2) virus infection were mostly school aged children and the elderly, in line with the results of the meta-analysis for seasonal influenza".


VAERS ID: 711927 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-09-11
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
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: KR0095075131708KOR013788

Write-up: This literature report was received from a physician regarding 17 patients (elderly and adult). The objective was to assess adverse events following immunization (AEFI) and claims filed for compensation had been lacking. Reported AEFIs and compensation claims from 2011 to 2016 were reviewed. On an unknown date, the patients were vaccinated with pneumPRODIAX-23 for prophylaxis. Other suspect drugs included influenza virus vaccine. Total of 31 deaths have been filed between 2011 and 2016. Among them influenza vaccine and PRODIAX-23 were accounted for majority of deaths in adult and elderly (17 out of 18 cases). 10 out of 15 elderly subjects were reported to have an underlying disease. In all elderly death cases, causes of death other than vaccination, compounded by underlying disease and old age, were strongly suspected. Finally, rapid assessments for reported death cases had low association with immunization. The review included the reported AEFIs and related claims filed from 2011 to 2016, introduced the results of rapid responses to serious AEFIs during the same period, and compared the characteristics between compensated and dismissed cases. None of the 31 reported death cases during past six years showed causal association with a vaccine received under rapid response and evaluation. The authors considered the report of 17 deaths as related to PRODIAX-23 and influenza vaccine. Upon internal review, the event death was considered to be medically significant. Additional information has been requested.


VAERS ID: 715876 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
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: Unknown       Purchased by: Unknown
Symptoms: Acute respiratory distress syndrome, Death, Influenza, Malaise
SMQs:, Interstitial lung disease (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201701689

Write-up: This initial serious spontaneous case, was received on 26-Sep-2017, from other non-health professional, concerning a female patient of unspecified age. On an unspecified date, the patient was administered with Influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported. On an unspecified date, the patient was sick for a week, it was reported that the patient had contracted with influenza. On an unspecified date (reported as at the weekend), the patient died from acute respiratory distress syndrome. It was unknown, whether autopsy was performed.


VAERS ID: 719902 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-10-12
Entered: 2017-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS AFLBA235BA / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Product quality issue
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2017GSK155947

Write-up: This case was reported by a pharmacist via call center representative and described the occurrence of unknown cause of death in a 77-year-old male patient who received INFLUSPLIT TETRA (batch number AFLBA235BA, expiry date unknown). This case was associated with a product complaint. On an unknown date, the patient received INFLUSPLIT TETRA. On an unknown date, less than a year after receiving INFLUSPLIT TETRA, the patient experienced unknown cause of death (serious criteria death and GSK medically significant) and pharmaceutical product complaint. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the pharmaceutical product complaint 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 INFLUSPLIT TETRA. Additional details were provided as follows: The age at vaccination was not reported. The patient died after administration of INFLUSPLIT TETRA. The cause of death was not reported. The vaccinating physician complained the affected batch and refused to administer this batch again. This case was already sent to a regulatory authority. No more information was provided.


VAERS ID: 720537 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       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: CHOLECALCIFEROL; DIPYRIDAMOLE; THYROXINE; ALLOPURINOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZSA2017SA198734

Write-up: Initial unsolicited report received from a healthcare professional via the health authority (reference number: 111827) on 05-Oct-2017. This case was reported under annual report. This case involves a 81-year-old male patient, who was vaccinated with INFLUENZA TRIVALENT (batch number, expiry date, route, dose, dose in series and site of administration not reported) on an unknown date. Patient''s medical history was not reported. Patient''s concomitant medications included CHOLECALCIFEROL, DIPYRIDAMOLE, THYROXINE and ALLOPURINOL. On an unknown date, following the vaccination, the patient had cardiac arrest and expired on an unknown date. Lab test was not reported and corrective treatment was unknown. It was not reported whether autopsy was done or not. This case was under reports, which resulted in a fatal outcome regardless of causality. Documents held by sender: none. Sender''s Comments: This case concerns a 81 years old male patient who commenced therapy with influenza split triton thiomersal free vaccine on an unknown date. Patient died with cardiac arrest. Time to onset is unknown. Further information on the risks factors including any underlying disease, circumstances and patient''s medical condition at the time of death and detailed autopsy report would be needed for a complete assessment. This case is insufficiently documented to draw a conclusion on a relationship with vaccine administration. Reported Cause(s) of Death: Cardiac arrest.


VAERS ID: 723772 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-10-30
Entered: 2017-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: 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: On an unknown date, the smear test showed positive results for flu, but it was unspecified for which patient from the linked cases.
CDC Split Type: LU2017GSK164981

Write-up: This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a patient who received ALPHARIX TETRA. On an unknown date, the patient received ALPHARIX TETRA. On an unknown date, unknown after receiving ALPHARIX TETRA, the patient experienced vaccination failure (serious criteria GSK medially 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 ALPHARIX TETRA. Additional details were provided as follows: Five physician reported 22 cases flu. One of the physicians reported in a rest home for (very) old patients. The age at vaccination was not reported. In 2016, the patient received ALPHARIX TETRA. On an unknown date, at the beginning of the epidemic, the physician took 3 to 4 smears which were all positive for flu, but it was unspecified for which patient from the linked cases. The physician did not remember the strain and did not continue to take smears in other patients. This case was considered to be suspected vaccination failure, as the details regarding time to onset and exact laboratory test confirmation for influenza were unknown. The physician refused to be contacted for further follow-up. As no further information could be obtained, the case was closed. This is one out of 22 cases reported by the same reporter.


VAERS ID: 723962 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-10-30
Entered: 2017-10-30
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, 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: On an unknown date, the smear test showed positive results for flu, but it was unspecified for which patient from the linked cases.
CDC Split Type: LU2017GSK164985

Write-up: This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a patient who received ALPHARIX TETRA. On an unknown date, the patient received ALPHARIX TETRA. On an unknown date, unknown after receiving ALPHARIX TETRA, 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 ALPHARIX TETRA. Additional details were provided as follows: Five physician reported 22 cases flu. One of the physicians reported in a rest home for (very) old patients. The age at vaccination was not reported. In 2016, the patient received ALPHARIX TETRA. On an unknown date, at the beginning of the epidemic, the physician took 3 to 4 smears which were all positive for flu, but it was unspecified for which patient from the linked cases. The physician did not remember the strain and did not continue to take smears in other patients. This case was considered to be suspected vaccination failure, as the details regarding time to onset and exact laboratory test confirmation for influenza were unknown. The physician refused to be contacted for further follow-up. As no further information could be obtained, the case was closed. This is one out of 22 cases reported by the same reporter.


VAERS ID: 723970 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-10-30
Entered: 2017-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: 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: On an unknown date, the smear test showed positive results for flu, but it was unspecified for which patient from the linked cases.
CDC Split Type: LU2017GSK164983

Write-up: This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a patient who received ALPHARIX TETRA. On an unknown date, the patient received ALPHARIX TETRA. On an unknown date, unknown after receiving ALPHARIX TETRA, 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 ALPHARIX TETRA. Additional details were provided as follows: Five physician reported 22 cases flu. One of the physicians reported in a rest home for (very) old patients. The age at vaccination was not reported. In 2016, the patient received ALPHARIX TETRA. On an unknown date, at the beginning of the epidemic, the physician took 3 to 4 smears which were all positive for flu, but it was unspecified for which patient from the linked cases. The physician did not remember the strain and did not continue to take smears in other patients. This case was considered to be suspected vaccination failure, as the details regarding time to onset and exact laboratory test confirmation for influenza were unknown. The physician refused to be contacted for further follow-up. As no further information could be obtained, the case was closed. This is one out of 22 cases reported by the same reporter.


VAERS ID: 723979 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-10-30
Entered: 2017-10-30
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, 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: On an unknown date, the smear test showed positive results for flu, but it was unspecified for which patient from the linked cases.
CDC Split Type: LU2017GSK164995

Write-up: This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a patient who received ALPHARIX TETRA. On an unknown date, the patient received ALPHARIX TETRA. On an unknown date, unknown after receiving ALPHARIX TETRA, 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 ALPHARIX TETRA. Additional details were provided as follows: Five physicians reported 22 cases flu. One of the physicians reported in a rest home for (very) old patients. The age at vaccination was not reported. In 2016, the patient received ALPHARIX TETRA. On an unknown date, at the beginning of the epidemic, the physician took 3 to 4 smears which were all positive for flu, but it was unspecified for which patient from the linked cases. The physician did not remember the strain and did not continue to take smears in other patients. This case was considered to be suspected vaccination failure, as the details regarding time to onset and exact laboratory test confirmation for influenza were unknown. The physician refused to be contacted for further follow-up. As no further information could be obtained, the case was closed. This is one out of 22 cases reported by the same reporter.


VAERS ID: 723996 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-10-30
Entered: 2017-10-30
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, 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: On an unknown date, the smear test showed positive results for flu, but it was unspecified for which patient from the linked cases.
CDC Split Type: LU2017GSK164989

Write-up: This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a patient who received ALPHARIX TETRA. On an unknown date, the patient received ALPHARIX TETRA. On an unknown date, unknown after receiving ALPHARIX TETRA, 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 ALPHARIX TETRA. Additional details were provided as follows: Five physicians reported 22 cases flu. One of the physicians reported in a rest home for (very) old patients. The age at vaccination was not reported. In 2016, the patient received ALPHARIX TETRA. On an unknown date, at the beginning of the epidemic, the physician took 3 to 4 smears which were all positive for flu, but it was unspecified for which patient from the linked cases. The physician did not remember the strain and did not continue to take smears in other patients. This case was considered to be suspected vaccination failure, as the details regarding time to onset and exact laboratory test confirmation for influenza were unknown. The physician refused to be contacted for further follow-up. As no further information could be obtained, the case was closed. This is one out of 22 cases reported by the same reporter.


VAERS ID: 726667 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-11-14
Entered: 2017-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, 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: AU2017GSK174434

Write-up: This case was reported in a literature article and described the occurrence of motor vehicle accident in a elderly subject who received Flu seasonal TIV Dresden. On an unknown date, unknown after receiving Flu seasonal TIV Dresden, the subject developed motor vehicle accident. Serious criteria included death and GSK medically significant. The outcome of motor vehicle accident was fatal. The reported cause of death was motor vehicle accident. The investigator considered the motor vehicle accident to be unlikely related to Flu seasonal TIV Dresden. Additional information was provided. This case was reported in a literature article and described the occurrence of vehicle accident in an elder of unspecified gender who was vaccinated with unspecified influenza vaccine (manufacturer unknown). The patient was reported to immunisation surveillance systems. No information on patient''s medical or family history or concomitant medication or concurrent condition 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. It was reported that the vaccination was uneventful. On an unspecified date between July 2007 and June 2016, an unknown period after the vaccination, the patient had vehicle accident. Subsequently, the patient died. It was unknown if an autopsy was performed. This case has been considered serious due to death. Treatment was unknown. The authors commented "Two deaths were reported, unlikely to have been vaccine-related. As a result of high annual influenza vaccination coverage in this population, coupled with age-related baseline mortality rates, deaths coincident with vaccination are likely to be more frequent in older people; robust investigation and causality assessment are therefore critical". This is 1 of the 2 valid case reported in the same literature article.


VAERS ID: 726770 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-11-14
Entered: 2017-11-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Acute disseminated encephalomyelitis, Death
SMQs:, Noninfectious encephalitis (narrow), Demyelination (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: AU2017GSK174379

Write-up: This case was reported in a literature article and described the occurrence of acute disseminated encephalomyelitis in a elderly subject who received Flu seasonal TIV Dresden. On an unknown date, unknown after receiving Flu seasonal TIV Dresden, the subject developed acute disseminated encephalomyelitis. Serious criteria included death and GSK medically significant. The outcome of acute disseminated encephalomyelitis was fatal. The reported cause of death was acute disseminated encephalomyelitis. The investigator considered the acute disseminated encephalomyelitis to be unlikely related to Flu seasonal TIV Dresden. Additional information was provided. This case was reported in a literature article and described the occurrence of acute disseminated encephalomyelitis in an elder of unspecified gender who was vaccinated with unspecified influenza vaccine (manufacturer unknown). The patient was reported to Immunization surveillance systems. No information on patient''s medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, 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 between July 2007 and June 2016, an unknown period after the vaccination, the patient had post-vaccination diagnosis of acute disseminated encephalomyelitis. Subsequently, the patient died. It was unknown if an autopsy was performed. This case has been considered serious due to death. Treatment was unknown. The authors commented "Two deaths were reported, unlikely to have been vaccine-related. As a result of high annual influenza vaccination coverage in this population, coupled with age-related baseline mortality rates, deaths coincident with vaccination are likely to be more frequent in older people; robust investigation and causality assessment are therefore critical". This is 1 of the 2 valid cases reported in the same literature article.


VAERS ID: 727133 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       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: CASA2017SA224959

Write-up: Initial unsolicited social media report received from a consumer on 31-Oct-2017. This case involves a four elderly adults patients (gender not reported), who were vaccinated with INFLUENZA VACCINE (batch number, expiry date, dose, dose in series and site of administration were not reported) on an unknown date. Patient''s medical history and concomitant medication was not reported. On an unspecified date, following the vaccination patients died. It was reported that 4 seniors die with the flu at our local retirement home shortly after getting their free flu shot last year. Laboratory investigation and corrective treatment was not reported. It was not reported whether autopsy was performed or not. List of the documents held by sender: none. Sender''s Comments: This is a poorly documented death case with Information 4 elderly adults die with the flu at local retirement home after getting their free flu shot. Time to onset is not reported. The cause of death is unknown. No information is provided on conditions at the time of death, patient''s medical history, previous vaccination history, time to onset, autopsy and results of investigations, etc. This case is insufficiently documented to draw a conclusion on a relationship with vaccine administration. Reported Cause(s) of Death: flu like syndrome.


VAERS ID: 727134 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: ?
Symptoms: Death, Malaise, 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: CASA2017SA224962

Write-up: Initial unsolicited social media report received from a consumer on 02 Nov 2017. This case involves a male patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. Patient''s medical history and concomitant medication was not reported. On an unknown date, after having a flu shot, patient became severely ill and patient died at the age of 87 following severe reactions. Laboratory investigation and corrective treatment were not reported. The outcome of the event severely ill, severe reactions was not reported. It was not reported whether autopsy was performed or not. List of the documents held by sender: none. Sender''s Comments: In this case, patient was severely ill and died following severe reactions after vaccination with Influenza vaccine (MFR UNK). This is a poorly documented case. Further information on time to onset, vaccine manufacturer, medical history, immune status at the time of vaccination, previous vaccination and tolerance and confirmed diagnosis for the patient''s events and cause of his death are needed to fully assess this case. Based upon available information the role of the vaccine cannot be assessed. Reported Cause(s) of Death: who had a flu shot died at age 87 following severe reactions.


VAERS ID: 728550 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-11-28
Entered: 2017-11-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Myocardial infarction, Pneumonia, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Myocardial infarction (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: 2013, Influenza vaccine, prophylaxis, Pneumona, received in 2013 and ended up in hospital due to pneumonia, had heart attack, heart disorder and weakened every organ (case number: AU2017GSK180223)
Allergies:
Diagnostic Lab Data:
CDC Split Type: AU2017GSK180226

Write-up: This case was reported by a consumer via interactive digital media and described the occurrence of pneumonia in a adult female patient who received Influenza vaccine. Previously administered products included Influenza vaccine with an associated reaction of pneumonia (received in 2013 and ended up in hospital due to pneumonia, had heart attack, heart disorder and weakened every organ (case number: AU2017GSK180223)). On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine, the patient experienced pneumonia, (serious criteria death and GSK medically significant), renal failure (serious criteria GSK medically significant) and heart attack (serious criteria GSK medically significant). On an unknown date, the outcome of the pneumonia was fatal and the outcome of the renal failure and heart attack were not reported. The reported cause of death was pneumonia. It was unknown if the reporter considered the pneumonia, renal failure and heart attack to be related to Influenza vaccine. Additional details were provided as follows: The report was received from a consumer via GlaxoSmithKline social media. The patient had her shots every year. In 2014, the patient had flu shot and she experienced pneumonia, kidney failure and heart attack. Ten weeks later the patient died. The patient was not going to have 2014 flu shot after the reaction of 2013. Follow up would be conducted. The case was linked with the case AU2017GSK180223, reported by the same reporter for the same patient.


VAERS ID: 728854 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Dyspnoea, Malaise
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CASA2017SA238347

Write-up: Initial unsolicited social media report received from a consumer (family member of patient) on 25-Nov-2017. This case is linked with: 2017SA238350_2017-CAN-008697 (Same reporter). This case involves a male patient (age not reported), who was vaccinated with INFLUENZA VACCINE (batch number, expiry date, dose and site of administration were not reported) on an unknown date. Patient''s medical history and concomitant medication was not reported. On an unspecified date, few hours following the vaccination patient did not felt well and as per the physician it was a common thing. On an unknown date, few days following the vaccination, patient started to experience breathing issues and ambulance was called and patient died in hospital two days later (hospitalization date not reported). Other details regarding hospitalization were not provided. Laboratory investigation and corrective treatment was not reported. Outcome of the events "feeling unwell" and "difficulty breathing" was not reported. It was not reported whether autopsy was performed or not. List of the documents held by sender: none. Sender''s Comments: No information regarding patients age, medical history or condition at the time of vaccination was provided. Patient''s death could be a result of underlying etiology unrelated to vaccination. Feeling unwell and breathing issues could be due to an undiagnosed underlying medical condition that would be revealed while performing autopsy. Additional details regarding patient''s medical history, product name or lot number and autopsy results will be required to further assess the case. Based upon reported information the causality of the events could not be assessed with respect to the vaccine. Reported Cause(s) of Death: died in hospital.


VAERS ID: 729780 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       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: CASA2017SA242730

Write-up: Initial unsolicited social media report received from a consumer (patient''s family) on 30-Nov-2017. This case involves a female patient (age not reported), who was vaccinated with INFLUENZA VACCINE (FLU SHOT) (batch number, expiry date, dose and site of administration were not reported) on an unknown date. Medical history and concomitant medication was not reported. On an unspecified date, same day following the vaccination, patient got sick. On an unknown date, two weeks after the vaccination patient was hospitalized. On an unknown date, after the vaccination patient died (reported as never came home). Laboratory investigation and corrective treatment was not reported. Outcome of the event sick was not reported. It was not reported whether autopsy was done or not. List of the documents held by sender: none.; Sender''s Comments: Patient reported to be sick the same day of her flu shot. Hospitalized 2 weeks later for an unknown reason. The time to onset was compatible. Very poorly documented case retrieved on Internet (No information regarding product name, vaccination dates, patients age, medical history and medical condition at the time of vaccination, event details, diagnosis, autopsy results confirming the cause of death. Based upon reported information the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: never came home.


VAERS ID: 731222 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       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: CASA2017SA238350

Write-up: Based on information received on 12-Dec-2017, the report previously considered as non-valid became valid: [Adverse event was reported]. Initial unsolicited social media report received from non-healthcare professional on 25-Nov-2017. This case is non-valid as reason for death was not specified. This case is linked with 2017SA238347 same reporter. This case involves male patient (age not reported) who was vaccinated with dose of INFLUENZA VACCINE (SHOT) (batch number, expiry date, route and site of administration were not reported) on an unspecified date. The patient''s medical history and concomitant medication were not reported. On an unspecified date, 48 hours following the vaccination patient was found dead in his apartment. Laboratory investigation and corrective treatment were not reported. It was not reported whether autopsy was performed. Follow up report received from non-healthcare professional on 12-Dec-2017. This case involves patient (Age reported as late 70s). Patient received Flu Shot in the morning. On an unspecified date, (Reported as same year) post vaccination patient had complained of not feeling well. He told another neighbor next day not feeling well and going to bed. Don''t know how long he was dead before they found him almost dead a week later. Outcome of not feeling well was not reported. List of documents held by sender: none. Sender''s Comments: No information regarding patients'' medical history or condition at the time of vaccination was provided. Elderly Patient whose death could be a result of underlying etiology unrelated to vaccination. Additional details regarding patient''s medical history, product name or lot number and autopsy results are required to further assess the case. Based upon reported information, a role of the vaccine cannot be established. Reported Cause(s) of Death: found death.


VAERS ID: 732124 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-12-28
Entered: 2017-12-29
   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: Cerebrovascular accident, Death
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: DE2017GSK200698

Write-up: This case was reported by a physician via call center representative and described the occurrence of stroke in an unspecified number of adult patients who received INFLUSPLIT TETRA. On an unknown date, the patient received INFLUSPLIT TETRA at an unknown dose. On an unknown date, 28 days after receiving INFLUSPLIT TETRA, the patient experienced stroke (serious criteria death and GSK medically significant). On an unknown date, the outcome of the stroke was fatal. The reported cause of death was stroke. It was unknown if the reporter considered the stroke to be related to INFLUSPLIT TETRA. Additional information was provided as follows: The age at vaccination was not reported. At the beginning of October 2017, the physician started vaccinating patients with INFLUSPLIT TETRA. At review of documentations, the physician noticed that approximately 10 to 15 patients (older than sixty years) experienced stroke approximately four weeks after vaccination and died. The autopsy details were not provided. Batch number was requested.


VAERS ID: 732304 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-12-29
Entered: 2018-01-02
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS AFLBA279AA / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Computerised tomogram, 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: No other medications
Current Illness: Peripheral vascular disorder; Hypertension; Chronic obstructive pulmonary disease; Myocardial ischaemia; Diabetes mellitus; Hepatitis C
Preexisting Conditions: Influenza vaccine, Prophylaxis; Cardiac arrest, several cardiac arrests and resuscitation was required
Allergies:
Diagnostic Lab Data: 2017, Computerised tomogram, not available unknown
CDC Split Type: IL2017GSK201505

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of unknown cause of death in a 60-year-old male patient who received FLUARIX TETRA (batch number AFLBA279AA, expiry date 31st August 2018). The patient''s past medical history included cardiac arrest (several cardiac arrests and resuscitation was required). Previously administered products included Flu vaccine. Concurrent medical conditions included peripheral vascular disease, hypertension, chronic obstructive pulmonary disease, ischemic heart disease, diabetes and hepatitis C. On an unknown date, the patient received FLUARIX TETRA (intramuscular). On an unknown date, 3 days after receiving FLUARIX TETRA, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The patient died in 2017. The reported cause of death was unknown cause of death. An autopsy was not performed. It was unknown if the reporter considered the unknown cause of death to be related to FLUARIX TETRA. Additional details were reported as follows: The age at vaccination was not reported, but could be 59 or 60 year old. This report was received from epidemiological department in the Ministry of Health. In 2017, the patient received FLUARIX TETRA. The patient''s last visit at his family physician was on 7th November 2017, for receiving referrals for tests and prescriptions for medications for hepatitis C treatment. After clarification with the police, they were called to the deceased''s house by the neighbors after he had not been seen for two days. The deceased was transferred to the forensic medicine, no autopsy was performed and no tests were performed. Tomography scan was performed (the ministry of health did not had the results). Date and cause of death were not known. The Ministry of Health would update if additional information was received. No Regulatory authority reference number was provided.


VAERS ID: 734789 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
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: US2018GSK012189

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: 734799 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
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: US2018GSK012202

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: 734811 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
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: US2018GSK012207

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: 734999 (history)  
Form: Version 1.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
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: 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2018GSK012024

Write-up: This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a 90-year-old male patient who received INFLUSPLIT TETRA. On an unknown date, the patient received INFLUSPLIT TETRA at an unknown dose. On an unknown date, less than a year after receiving INFLUSPLIT TETRA, the patient experienced vaccination failure (serious criteria GSK medically significant), pneumonia (serious criteria death and GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the pneumonia was fatal and the outcome of the influenza was not reported. The reported cause of death was pneumonia. It was unknown if the reporter considered the vaccination failure, pneumonia and influenza to be related to INFLUSPLIT TETRA. Additional details were provided as follows: The age at vaccination was not reported. The patient died from pneumonia on an unspecified date. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for influenza were not provided. This case has been linked with case DE2018GSK012025 and DE2018GSK012026 reported by same reporter. Follow up had been requested.


VAERS ID: 735129 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-01-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hospitalization; Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: KR0095075131801KOR007904

Write-up: This literature marketed report as received from the authors of the published article, entitled as stated below, refers to elderly inpatients who were the subject of study on the effects of pneumococcal and influenza vaccination. The medical records of 1076 inpatients over 65 years old between October 2015 and March 2016 were reviewed. There were 676 males and 400 females. The following baseline conditions were reported within the population of 1076 patients: Hypertension (421 patients), Diabetes mellitus (290), Cancer (307), Operation (611), Admission (754), Tuberculosis (230), Smoking (357), Alcohol (268), Anticoagulant procedure (228), Anticoagulants (274); Fall down (912), Bed sore (161), Epilepsy (4), Renal disease (34), Cardiac disease (153), Allergy (86), Dysphagia (51), Gait disturbance (352), Circulatory symptoms (34), Respiratory symptoms (679). On unspecified dates, the patients were vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). On unspecified dates, some of them also received pneumococcal conj vaccine (unspecified) and/or influenza virus vaccine (unspecified). It was reported that 790 patients out of 1076 were vaccinated either with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown), or pneumococcal conj vaccine (unspecified); 758 patients out of 1076 were vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown); 47 patients out of 1076 were vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) and pneumococcal conj vaccine (unspecified); 831 patients out of 1076 were vaccinated with influenza virus vaccine (unspecified). On unspecified dates, 484 patients out of 1076 presented with pneumonia and 218 patients out of 1076 died. It was reported that there was no significant effect on pneumonia and mortality by pneumococcal vaccination (including pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) and/or pneumococcal conj vaccine (unspecified)) in elderly inpatients. In elderly inpatients, the pneumococcal vaccination rate was high, but its effectiveness was uncertain. However, influenza vaccination had a positive effect in reducing pneumonia-associated morbidity.


VAERS ID: 735469 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2016-05-20
Onset:0000-00-00
Submitted: 2018-01-26
Entered: 2018-01-28
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Back pain, Base excess decreased, Blood bicarbonate increased, Blood cholesterol normal, Blood creatine normal, Blood glucose normal, Blood thyroid stimulating hormone increased, Blood triglycerides normal, Blood urea increased, Brain hypoxia, C-reactive protein normal, Cardiomyopathy, Chest X-ray abnormal, Chronic obstructive pulmonary disease, Crepitations, Death, Decreased appetite, Depression, Dyspnoea, Echocardiogram abnormal, Emphysema, FEV1/FVC ratio, Forced expiratory volume decreased, Forced vital capacity decreased, Haematocrit decreased, Haemoglobin decreased, High density lipoprotein normal, Hypotonia, Insomnia, International normalised ratio decreased, Low density lipoprotein normal, Malaise, PCO2 normal, PO2 decreased, Pericardial effusion, Prostatic specific antigen normal, Pruritus, Pyrexia, Thyroxine decreased, Transient ischaemic attack, White blood cell count increased, pH body fluid normal
SMQs:, Acute renal failure (broad), Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Haematopoietic erythropenia (broad), Peripheral neuropathy (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (narrow), Eosinophilic pneumonia (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Depression (excl suicide and self injury) (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (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: amiodarone; mirtazapine; MODURETIC; DUOMO; omeprazole; BAMIFIX; prednisone; DUOFLAN; FLUIR; SPIRIVA; DUOVENT; complex B; FLUIMUCIL; PRELONE; DEPO-MEDROL
Current Illness: 14-SEP-2016, COPD; 14-SEP-2016, Emphysema pulmonary; 14-SEP-2016, Depressive disorder; Drug allergy; Adenocarcinoma of prostate
Preexisting Conditions: Cough; Productive cough; Shortness of breath; Feeling unwell; Smoker, smoked for 40 years-30 cigarettes/day, stopped 6 years ago; DECADURABOLIN; 06-SEP-2015, Chest pain; Cardioversion; 16-SEP-2015, HIXIZINE, pruritus cutaneous; Edema legs
Allergies:
Diagnostic Lab Data: 24-MAY-2016, Blood bicarbonate, 29.5, inconclusive; 17-JAN-2017, Blood cholesterol, 157, inconclusive; 24-MAY-2016, Blood creatine, 0.76, inconclusive; 17-JAN-2017, Blood creatine, 1.22, inconclusive; 17-JAN-2017, Blood glucose, 85, inconclusive; 17-JAN-2017, Blood thyroid stimulating hormone, 107,872, elevated; 17-JAN-2017, Blood triglycerides, 88, inconclusive; 24-MAY-2016, Blood urea, 29, inconclusive; 17-JAN-2017, Blood urea, 30, inconclusive; 24-MAY-2016, C-reactive protein, 6, inconclusive; 17-JAN-2017, FEV1/FVC ratio, 100%, inconclusive; 17-JAN-2017, Forced expiratory volume, 30%, inconclusive; 17-JAN-2017, Forced vital capacity, 31%, inconclusive; 24-MAY-2016, Haematocrit, 38, inconclusive; 17-JAN-2017, Haematocrit, 40, inconclusive; 24-MAY-2016, Haemoglobin, 12.7, inconclusive; 17-JAN-2017, Haemoglobin, 12.3, inconclusive; 17-JAN-2017, High density lipoprotein, 61, inconclusive; 24-MAY-2016, International normalised ratio, 0.28, inconclusive; 17-JAN-2017, Low density lipoprotein, 78, inconclusive; 24-MAY-2016, Oxygen saturation, 95.8%, inconclusive; 24-MAY-2016, PCO2, 43, inconclusive; 24-MAY-2016, PO2, 76.6, inconclusive; 17-JAN-2017, Prostatic specific antigen, 1.430, inconclusive; 17-JAN-2017, Thyroxine, 0.3, inconclusive; 24-MAY-2016, White blood cell count, 11280, inconclusive; 17-JAN-2017, White blood cell count, 8490, inconclusive; 24-MAY-2016, pH body fluid, 7.45, inconclusive. On 23-May-2016, XR HDWC: thorax small atelactasic opacity in the URL causing discrete retention of the parentique side IPSI sequelar aspect discrete broncopathies on ACN bases. Examinations showed: 54.80 KG, BP: 120/80, NSR, 2T, reduction of MV, sparse crepitations. On 08-Aug-2016, examinations showed, 55.25 KG 120/80, NSR, 2T, hypophonese, reduction of MV, rare to sparse crepitations, flat abdomen, flaccid, without organomegaly. On 27-Jan-2017, ECHO showed cardiomyopathy with discrete LV contraction dysfunction, EF-teycholz-54%, LVO-discrete, RV contraction dysfunction F degree discrete-discrete VO, biatrial overload discrete diastolic dynamics, changed relaxation pattern, discrete aortic and mitral reflux, aortic root dilation, pulmonary hypertension - estimated PASP (Pulmonary arterial systolic pressure) between 42 and 47 mmHg, minimal pericardic stroke.
CDC Split Type: 201702712

Write-up: This is a spontaneous case, initially received on 27-Oct-2017, from a physician, concerns a 67-year-old, elderly male patient. The patient''s historical conditions included cough, shortness of breath and chest pain (06-Sep-2015), smoked for 40 years-30 cigarettes/day (reported that, stopped 6 years ago), no alcohol, UG (as reported) for 20 years and double stabbing pain. The patient''s historical drugs included, prednisone, DUOFLAM, FLUIMUCIL, PRELONE, DEPO-MEDROL, DECA-DURABOLIN. The patient''s current conditions included, allergy to simple amoxicillin, lung problems for more than 10 years, productive chronic cough, progressive shortness of breath to exertion, COPD (chronic obstructive pulmonary disease), pulmonary emphysema, anxious disorder-depression (since 14-Sep-2015). The patient''s concomitant medications included amiodarone, mirtazapine, MODURETIC, DUOMO, omeprazole, BAMIFIX, FLUIR, SPIRIVA, DUOVENT (for shortness of breath), complex B. On 06-Sep2015, X-ray HMC (head motion component) performed, hyperinsufflation and discreet oligaemia was not confirmed. The same day, hospitalized for cough and shortness of breath. On the same day, in night, he felt unwell with chest pain with irritation to LUL. HR (heart rate) was 185 bpm (beats per minute). He underwent cardioversion and was discharged on an unspecified date and the discharge medications included CLAVULIN 500, amiodarone 200 and NEBS (nebulization) 4 times continuously. Examinations showed, weight: 54.45 KG, BP (blood pressure): 130/80, SAT (saturation)-91%, HR (heart rate)-92 bpm (beats per minute). ("RCR") NSR (Normal sinus rhythm), 2T reduction of MV rare, sparse crepitations, digged, flaccid abdomen without edema. On 08-Sep-2015, it was reported that he suffered from the lungs for more than 10 years with productive chronic cough, progressive shortness of breath to exertion but never saw a specialist. The patient was hospitalized once last year due to double stabbing pain, sneezing and showed serious OVD with reduced FVC (forced vital capacity) with response FEV1 (Forced expiratory volume) -29%. On 14-Sep-2015 diagnosis of COPD, pulmonary emphysema, anxious disorder - depressive was done. The lab tests performed included, HMT (hematocrit) 40, HB (hemoglobin) 14.3, LEUKO (leukocytes) 9,100, ESR (erythrocyte sedimentation rate)-4, GLUC (glucose) -90.8, total cholesterol - 191, creatinine-1.05, HDL (high density lipoproteins)-60, urea- 37, PSA (Prostate-specific antigen- 6.22, TSH (thyroid stimulating hormone)-3.55, AES- 1000, LEUKO- 250 CELS, stools (negative). On 15-Sep-2015, 24H Holter (HS) monitoring was done, which showed sinus rhythm, isolated VES and paired-discrete SVES isolated. On 16-Sep-2016, had marked skin night pruritus and was treated with HIXIZINE. On 18-Sep-2015, thorax CT FSAVI showed extensive emphysema focuses centrilobular and paraseptal predominating in the upper lobes: estimated around 50 to 60% compromised area Atelectatic stresses in the lower lobes and ML areas of architectural distortion with irregular node in the URL, fibrosis bronchi of LRL with no secretion inside pulmonary artery trunk with increased dimensions. On 25-Sep-2015 ECHO KAIO showed IAO without repercussion and discreet expansion of the aortic root. On 29-Oct-2015, he was better and breathing more easily, the prescribed medicines were continued. There was significant desaturation (94 to 74). It was reported that, he was nervous with flood-stayed in a shelter, hence added mirtazapine 20. URO, if prostate adenocarcinoma is discarded DECADURABOLIN series would be given. On 17-Nov-2015, the lab tests performed included, HMT-36.6, HB-12.1, LEUKO-7.300, PSA-3.89 GLUC-110 and CREAT (creatinine)-0.93, urea-30.5, EAS-3,000 CELS, 250 LEUKO-12,000, red blood cells, Urocult (negative). On 27-Nov-2015, US of urinary system -WNL (within normal limit), US (ultrasound) of transrectal prostate volume increased prostate with irregular contours and heterogeneous texture. The prescribed drugs were continued. On 20-May-2016, the patient was administered with influenza vaccine, (dose, route, anatomical location, batch number, expiry date, manufacturer and trade name: not reported). On an unspecified date, the subject was administered with ULTIBRO (dose: 110+50 mcg, aspire 1 capsule, route: respiratory, batch number, expiry number) for an unknown indication. On an unspecified date in May-2016, the patient felt very sick, which worsened with high fever and dyspnea. On 23-May-2016, the patient was taken to the emergency medical services and treated with DIPYRONE 500, paracetamol, levoflox 500-7 Days. Examinations showed, 54.80 KG, BP (blood pressure): 120/80, NSR, 2T, reduction of MV, sparse crepitations. The XR (X-ray) HDWC: thorax small atelectasis opacity in the URL causing discrete retention of the parentique side IPSI sequelar aspect discrete bronchopathies on ACN bases. The events shortness of breath improved. He resumed eating and had complaints of insomnia. The patient continued with the drug, along with DUOMO AP-1 when going to bed. On 24-May-2016, HMT-38, HB-12.7, LEUKO-11280, PH-7.45, PCO2 (partial pressure of carbon dioxide)-43, PO2 (partial pressure of oxygen)-76.6, HCO3 (bicarbonate)-29.5, BE (bioequivalence)-5.60, SAT (saturation)-95.8%, urea-29, CREAT-0.76, INR (international normalized ratio)-.28, CRP (C-reactive protein)-6. On 25-May-2016, he was hospitalized, and transient ischemic attack was suspected, and the physician talked about brain hypoxia. The patient was discharged on 27-May-2016. On 30-May-2016, he was well until recently and weighed 60 KF (as reported). On 08-Aug-2016, the patient was well (eats and sleeps) in the period, did his personal activities himself (bathes and gets dressed by himself). The drug MODURETIC was discontinued and DUOMO was replaced by HP 2 MG plus 5MG. The examinations showed 55.25 KG 120/80, NSR, 2T, hypophonese, reduction of MV, rare to sparse crepitations, flat abdomen, flaccid, without organomegaly. On 16-Jan-2017, the patient had anorexia and requested vitamin and was prescribed COBA VITAL (4mg, take 1 tablet, before breakfast, lunch and dinner, for 120 days). On 17-Jan-2017, HMT-40 HB-12.3, Leuko-8490, CREAT-1.22, UREA-30, PSA-1.430, T4-0.3, TSH (thyroid stimulating hormone)-107.872, GLUC-85, total cholesterol-157, HDL (high density lipoproteins)-61, LDL (low density lipoproteins)-78, TRIG (triglycerides)-88. On 19-Jan-2017, FVC (forced vital capacity)-31%, FEV1 (Forced expiratory volume)-30%, TIFF (FEV1/FVC ratio)-100%. The treatment medications included, PURAN T4 50 mcg, take 1 tablet, fasting, for 20 days after 88 mcg same day, DIVELOL 6.25 MG, take 1 tablet, twice a day (in the morning and at night), until the reassessment furosemide 40 mg 60 tablets, take 1/2 tablet, and ALDACTONE 25 mg 60 tablets, 1 tablet in the morning, for continuous use. On 26-Jan-2017, the patient was hospitalized due to serious exacerbation, but was not sure due to irregular drug and treated for low back pain. On 27-Jan-2017, in the hospital pruritus was found in the back, suspected Zoster and was given HIXIZINE 25 mg, 1 tablet, when going to bed continuous use, predominantly nocturnal, he does not have vesicles or remainders. The patient fed very little and collected gaso that time. ECHO (echocardiography) showed cardiomyopathy and discrete LV (left ventricle) contraction dysfunction, EF-teycholz-54%, SVE-discrete, RV (right ventricle) contraction dysfunction F degree discrete-discrete SV, biatrial overload discrete diastolic dynamics, changed relaxation pattern, discrete aortic and mitral reflux, aortic root dilation, pulmonary hypertension - estimated PASP between 42 and 47 mmHg, minimal pericardial effusion. The outcome of the events was not reported, except for dyspnea which was improved. On 04-Jul-2017, it was reported that, the patient died after using ULTIBRO 0.11/0.05 MG. It was unknown, whether autopsy was done. The reporter considered this report as serious (fatal and hospitalization). The causality of the events was not reported. Follow up received on 19-Jan-2018: Additional event malaise was added. The event cold was no longer reported, and symptoms mapped to cold (pyrexia and dyspnoea) were made as separate diagnosis. The narrative was amended accordingly.


VAERS ID: 741443 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-03-20
Entered: 2018-03-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / 1 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2018GSK045832

Write-up: This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a 10-year-old male patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received the 1st dose of Influenza vaccine Quadrivalent .5 ml. On an unknown date, less than a year 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 information was provided as follows: The age at vaccination was not reported. The physician was not sure if the flu vaccination was performed with INFLUSPLIT TETRA but it was a quadrivalent flu vaccine (not specified). The patient died from Influenza infection (strain not specified). This case was considered suspected vaccination failure as the exact time to onset of the event was unknown. No further information was provided.


VAERS ID: 743138 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anticoagulant therapy, Contusion, Death, Drug interaction, Haemoptysis, International normalised ratio decreased, Platelet count decreased, Pyrexia
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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: HYDROXYCHLOROQUINE; HYDROCHLOROTHIAZIDE; MONTELUKAST; LORAZEPAM; CELECOXIB; ASA; warfarin
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: international normalized ratio; Result Unstructured Data: 8
CDC Split Type: ITSA2018SA095111

Write-up: Initial unsolicited report received from literature on 26 Mar 2018. This case is linked with 2018SA095112, 2018SA095116 and 2018SA095117 (same literature). The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Results: 116 AEFI reports submitted to VAERS and 83 from another database were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves 67 years old female patient who was vaccinated with dose of INACTIVATED SPLIT VIRUS INFLUENZA VACCINE (batch number, expiry date, route and site of administration were not reported). The patient also received dose of warfarin (batch number, expiry date and route were not reported) on an unspecified date. The patient''s medical history was not reported. Patient concomitant medication includes hydroxychloroquine, hydrochlorothiazide, montelukast, lorazepam, celecoxib, ACETYLSALICYLIC ACID (ASA). On an unspecified date, six days post vaccination patient had contusion, hemoptysis, international normalized ratio decreased (8 revealed in lab test), platelet count decreased, pyrexia and she died. Other laboratory investigation showed coughing up blood. Corrective treatment was not reported. It was unknown whether autopsy was performed or not. The reporter assessed the causal relationship with INACTIVATED SPLIT VIRUS INFLUENZA VACCINE and WARFARIN for the events as indeterminate and drug interaction probability scale reported as possible (3). List of documents held by sender: none. Sender''s Comments: A 67year-old female experienced contusion, hemoptysis, INR decreased, Platelet count decreased, pyrexia and died 6 days post vaccination with Inactivated, split-virus influenza vaccine. Neither medical history was reported nor patient medical condition at the time of vaccination. Lab tests revealed blood in cough which is indicative of a possible preexisting underlying infectious etiology. The patient was also receiving warfarin at the time of vaccination which is indicative of a preexisting medical condition. Additional information regarding patient''s medical history, condition at the time of vaccination, vaccine name or lot number and tests performed to identify alternate causes must be provided. Based upon reported information the role of the vaccine cannot be assessed. Reported Cause(s) of Death: contusion; hemoptysis; INR decreased; platelet count decreased; pyrexia.


VAERS ID: 743268 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anticoagulant therapy, Cerebral infarction, Computerised tomogram abnormal, Death, Drug interaction, Haemorrhage intracranial, International normalised ratio fluctuation, International normalised ratio increased, Rectal haemorrhage, Unresponsive to stimuli
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (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: Warfarin
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSA2018SA095112

Write-up: Initial unsolicited report received from literature on 26 Mar 2018. This case is linked with 2018SA095111, 2018SA095116, 2018SA095117 (same literature). The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and agency, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, over dosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from agency were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves 64 years old male patient who was vaccinated with a dose of Influenza vaccine and dose of Warfarin (batch number, expiry date, route and site of administration were not reported for both suspect product) on an unspecified date. Patient''s medical history and concomitant medication was not reported. On an unspecified date, thirty days post vaccination and administration of Warfarin, patient had cerebral infarction, computerized tomogram abnormal, hemorrhage intracranial, INR fluctuation, rectal hemorrhage, unresponsive to stimuli and patient died. It was also a case of possible drug interaction. Corrective treatment were not reported. It was unknown whether autopsy was performed or not. The reporter assessed the adverse events following immunization and drug interaction probability scale as indeterminate (possible). The Horn Drug Interaction Probability Scale indicated a possible interaction between warfarin and the influenza vaccination. List of documents held by sender: none. Sender''s Comments: This literature article reports about a 64 year old adult male who died experiencing intracranial hemorrhage, rectal hemorrhage and elevated INR (International Normalized Ratio) 30 days after having received Influenza vaccine. The time to onset is compatible. However, there is no autopsy report confirming the cause of death. Patient''s past medical history includes fluctuations in INR and ongoing treatment with warfarin. INR elevation is an expected event with Warfarin therapy, with or without drug interaction with Influenza vaccine, and it is a possible cause of intracranial and rectal hemorrhages. Moreover, considering the age and past medical history of the patient, it is not possible to comment on the fatal outcome without ascertaining the cause of death first. Reported Cause(s) of Death: Cerebral infarction; Elevated INR; Intracranial hemorrhage; Rectal hemorrhage; Unresponsive to stimuli.


VAERS ID: 743269 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Albumin CSF increased, Arrhythmia, CD4/CD8 ratio, CSF immunoglobulin increased, CSF oligoclonal band, CSF protein increased, Cardiac failure, Cardiopulmonary failure, Chromaturia, Death, Guillain-Barre syndrome, Hypoaesthesia, Hypotonia, Mobility decreased, Muscular weakness, Nephropathy, Pain in extremity, Paralysis, Pneumonia, Renal impairment, Rhabdomyolysis, Sepsis, Supraventricular tachycardia
SMQs:, Rhabdomyolysis/myopathy (narrow), Acute renal failure (narrow), Cardiac failure (narrow), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Demyelination (narrow), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), 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? No
Previous Vaccinations:
Other Medications: TAMSULOSIN; HYDROCHLOROTHIAZIDE; CLONIDINE; GEMFIBROZIL; ACETYLSALICYLIC ACID; TORSEMIDE; QUINAPRIL; VALSARTAN; PREGABALIN; INSULIN; PARICALCITOL; CALCIUM; simvastatin
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetic nephropathy; End stage renal disease (DUE TO GBS); Guillain Barre syndrome; Stroke; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: CD4/CD8 ratio; Result Unstructured Data: NORMAL; Test Name: CSF oligoclonal band; Result Unstructured Data: UNK; Comments: ISOELECTRIC FOCUSING; Test Name: Protein total; Test Result: 133 mg/dl; Test Name: IgG; Test Result: 11.20 mg/dl; Test Name: albumin; Test Result: 77.7 mg/dl
CDC Split Type: ITSA2018SA095116

Write-up: Initial unsolicited report received from literature on 26 Mar 2018. This case is linked with 2018SA095111, 2018SA095112 and 2018SA095117 (same literature). The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and Database, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, overdosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from Database were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves 63-year-old male patient who was vaccinated with dose of INFLUENZA VACCINE TRIVALENT (dose in series not reported) and also received a dose of SIMVASTATIN (batch number, expiry date, route and site of administration were not reported for both suspect product) on an unspecified date. Patient had a medical history of type 2 diabetes mellitus, diabetic nephropathy, end stage renal disease due to Guillain-Barre syndrome and stroke on an unknown date. Concomitant medication included TAMSULOSIN, HYDROCHLOROTHIAZIDE, CLONIDINE, GEMFIBROZIL, CALCIUM, FISH OIL, ACETYLSALICYLIC ACID, TORSEMIDE, QUINAPRIL, VALSARTAN, PREGABALIN, INSULIN and PARICALCITROL on an unknown date. On an unspecified date, 22 days post vaccination and administration of SIMVASTATIN, patient had Cardiac or Cardiopulmonary failure, arrhythmia, supraventricular tachycardia, Guillain-Barre syndrome, muscular weakness, paralysis, hypotonia, hypoesthesia, pain in extremity, mobility decreased, rhabdomyolysis, nephropathy, chromaturia, renal impairment, pneumonia, sepsis and death and patient died. Laboratory data included patient was performed CD4/CD8 ratio which result was normal, CSF oligoclonal band for isoelectric focusing (result: unknown), total protein of 133 mg/dl, immunoglobulin G of 11.20 mg/dl and albumin test of 77.7 mg/dl. Corrective treatment were not reported. It was unknown whether autopsy was performed or not. The reporter assessed the adverse events following immunization and drug interaction probability scale as inconsistent (not applicable). It was reported that pharmacodynamic drug interactions included with "Acetylsalicylic Acid; Gemfibrozil; Torsemide; Quinapril; Valsartan; Pregabalin; Insulin; Paricalcitol" and pharmacokinetic drug interactions included with Gemfibrozil. List of documents held by sender: none. Sender''s Comments: This literature article reports about a 63 year old adult male who died experiencing Cardiopulmonary failure, Pneumonia, Rhabdomyolysis, GBS and Sepsis 22 days after having received INFLUENZA VACCINE. The time to onset is compatible. However, there is no autopsy report confirming the cause of death. Patient''s past medical history includes diabetes, kidney disease and stroke and ongoing treatment with swimvastatin. There is a possibility that the events are related to SIMVASTATIN therapy. Moreover, considering the age and past medical history of the patient, it is not possible to comment on the fatal outcome without ascertaining the cause of death first. Reported Cause(s) of Death: arrhythmia; Cardiopulmonary failure; chromaturia; Guillain Barre Syndrome; hypoesthesia; hypotonia; mobility decreased; muscular weakness; nephropathy; pain in extremity; paralysis; Pneumonia; renal impairment; Rhabdomyolysis; Sepsis; supraventricula


VAERS ID: 743270 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anticoagulant therapy, Coagulopathy, Death, Drug interaction, International normalised ratio increased
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Haemorrhage laboratory terms (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: Warfarin
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: DVT (DEEP VEIN THROMBOSIS); Non-Hodgkin''s lymphoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSA2018SA095117

Write-up: Initial unsolicited report received from literature on 26 Mar 2018. This case is linked with 2018SA095111, 2018SA095112 and 2018SA095116 (same literature). The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Results: 116 AEFI reports submitted to VAERS and 83 from agency were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves 75 years old female patient who was vaccinated with dose of INFLUENZA H1N1 MONOVALENT (Batch number, expiry date, dose, route and site of administration were not reported). Patient also received dose of warfarin (batch number, expiry date, route of administration were not reported) on an unspecified date. Patient had predisposition condition of non-Hodgkin''s lymphoma and chronic DVT (deep vein thrombosis). Concomitant medication was not reported. On an unspecified date, three days post vaccination patient had coagulopathy, drug interaction international normalized ratio increased and she died. Laboratory investigation and corrective treatment were not reported. It was unknown whether autopsy was performed or not. The reporter assessed the causal relationship with INFLUENZA H1N1 MONOVALENT and Warfarin for the events as indeterminate and drug interaction probability reported as possible (3). List of documents held by sender: none. Sender''s Comments: This literature article reports about a 75 year old elderly female who died experiencing coagulopathy 3 days after having received INFLUENZA VACCINE. The time to onset is compatible. However, there is no autopsy report confirming the cause of death. Patient''s past medical history includes Non-Hodgkin''s Lymphoma (NHL) and deep venous thrombosis (DVT) and ongoing treatment with warfarin. Coagulopathy is an expected event with Warfarin therapy, with or without drug interaction with Influenza vaccine. Moreover, considering the age and past medical history of the patient, it is not possible to comment on the fatal outcome without ascertaining the cause of death first. Reported Cause(s) of Death: Coagulopathy; death; Death NOS; INR increased.


VAERS ID: 750609 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-05-25
Entered: 2018-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Acute haemorrhagic leukoencephalitis, Computerised tomogram abnormal, Computerised tomogram head abnormal, Computerised tomogram spine, Death, H1N1 influenza, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Noninfectious encephalitis (narrow), Demyelination (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab tests were performed on an unspecified date. The patient underwent urgent admission computed tomography (CT) followed by magnetic resonance imaging (MRI) of brain and spine. Contrast enhanced CT (CECT) and high resolution MRI imaging was performed on both 1.5T and 3.0T MR scanners with contrast. MR spectroscopy was also obtained. The patient was diagnosed with H1N1 positive influenza-associated acute encephalopathy. The patient had follow up MRI to assess the disease course and the treatment response. The patient CT and MRI of brain and spine demonstrated necrotizing haemorrhagic encephalopathy on Susceptibility Weighted Imaging (SWI) in basal ganglia and brain stem with tissue necrosis which led to death. The imaging findings reflected the severity of disease from mild to severe.
CDC Split Type: AU2018GSK092682

Write-up: This case was reported in a literature article and described the occurrence of suspected vaccination failure in a 7-year-old 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, hospitalization and GSK medically significant. Additional event(s) included influenza with serious criteria of death and hospitalization and acute necrotizing hemorrhagic leukoencephalitis with serious criteria of death, hospitalization and GSK medically significant. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included influenza (fatal) and acute necrotizing hemorrhagic leukoencephalitis (fatal). The reported cause of death was acute necrotizing hemorrhagic leukoencephalitis. The investigator considered that there was a reasonable possibility that the vaccination failure, influenza and acute necrotizing hemorrhagic leukoencephalitis may have been caused by Flu seasonal TIV Dresden. Relevant Tests: Lab tests were performed on an unspecified date. The patient underwent urgent admission computed tomography (CT) followed by magnetic resonance imaging (MRI) of brain and spine. Contrast enhanced CT (CECT) and high resolution MRI imaging was performed on both 1.5T and 3.0T MR scanners with contrast. MR spectroscopy was also obtained. The patient was diagnosed with H1N1 positive influenza-associated acute encephalopathy. The patient had follow up MRI to assess the disease course and the treatment response. The patient CT and MRI of brain and spine demonstrated necrotizing haemorrhagic encephalopathy on Susceptibility Weighted Imaging (SWI) in basal ganglia and brain stem with tissue necrosis which led to death. The imaging findings reflected the severity of disease from mild to severe. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Computerised tomogram result was see text unknown. On an unknown date, Influenza virus test result was positive for H1N1 infection unknown. On an unknown date, Nuclear magnetic resonance imaging result was see text unknown. Additional information was provided. This case was reported in a literature and described the suspected vaccination failure; H1N1 positive influenza associated acute encephalopathy in 7-year-old patient of unspecified gender who was vaccinated with unspecified influenza vaccine (manufacturer unknown). The patient was part of the study that was reviewed 4 cases (7, 8, 12 and 16 years old) of influenza-associated acute encephalopathy (2 confirmed H1N1 and 2 influenza A associated influenza-associated acute encephalopathy). No information on patient''s medical history or family history or concomitant medication or concurrent condition 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, an unknown period after vaccination, the patient was found positive for H1N1 infection. The patient underwent urgent admission computed tomography (CT) followed by magnetic resonance imaging (MRI) of brain and spine. Contrast enhanced CT (CECT) and high resolution MRI imaging was performed on both 1.5T and 3.0 T MR scanners with contrast. MR spectroscopy was also obtained. The patient was diagnosed with H1N1 positive influenza-associated acute encephalopathy. The patient had follow-up MRI to assess the disease course and the treatment response. The patient CT and MRI of brain and spine demonstrated necrotizing haemorrhagic encephalopathy on Susceptibility Weighted Imaging (SWI) in basal ganglia and brain stem with tissue necrosis which led to death. It was unknown if an autopsy was performed. It was reported that the imaging findings reflected the severity of disease from mild to severe. This case has been considered serious due to death/hospitalisation/Suspected vaccination failure. Treatment was unknown. The author considered the event of H1N1 positive influenza associated acute encephalopathy as post-immunisation on unspecified influenza vaccine. The author concluded "The influenza-associated acute encephalopathy is most prevalent in paediatric population and is comparable in frequency with herpes encephalitis. Influenza A-associated encephalopathy is usually milder with reversible imaging findings and grey matter involvement is rare. H1N1-positive IAE is severe haemorrhagic form causing basal ganglia and brain stem necrosis. This imaging signature is peculiar and helpful in differentiating herpes and other viral encephalopathies."


VAERS ID: 753133 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
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: Unknown       Purchased by: Unknown
Symptoms: Death, Pneumonia
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown to Ongoing, Osteoporosis, very big deficiency of Vitamin D and calcium; Unknown to Ongoing, Vitamin D deficiency; Unknown to Ongoing, Calcium deficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201800944

Write-up: This serious spontaneous case, initially received from other non-health professional on 08-Mar-2018, concerning an elderly female patient of unspecified age. The patient''s current conditions included: osteoporosis, deficiency of Vitamin D and calcium. On an unspecified date in 2016, the patient was administered influenza vaccine, (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date in Oct-2015, the patient was also administered with non-company suspect drug ACLASTA (route of administration: intravenous, once a year, dose, anatomical location, batch number, expiry date: not reported). On an unspecified date in 2017, after administration of the flu vaccine, the patient experienced pneumonia. On an unknown date, the patient passed away. As per the reporter, the cause of her death was pneumonia which was occurred due to flu vaccine. It was unknown whether autopsy was performed. The reporter considered this case as serious (fatal) and assessed the causality as related to the suspect vaccine. Case Comment: An elderly female with vitamin D and calcium (reported as big deficiency), died due to pneumonia after receiving INN flu vaccine (after an unknown period). The patient was taking ACLASTA for Vitamin D deficiency, with unspecified renal condition prevented further use of ACLASTA. Vitamin D deficiency and progressive age are known to increase predisposition to infection. Hence, considering the minimal information provided regarding onset latency, lab investigations confirming the causative organism for pneumonia and concomitant medical conditions, the company assesses the events as not related to suspect vaccine.


VAERS ID: 753529 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Influenza, Lymphoma
SMQs:, Malignant lymphomas (narrow), Haematological malignant tumours (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: Immunocompromised
Preexisting Conditions: Medical History/Concurrent Conditions: Chemotherapy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FISA2018SA147150

Write-up: progressive lymphoma; progressive lymphoma; influenza A (H1N1); Initial unsolicited report received from literature in Finland on 30-May-2018. Abstract: Background: Influenza A(H1N1) causes serious complications in immunocompromised patients. The efficacy of seasonal vaccination in these patients has been questioned. AIM: To describe two outbreaks of influenza A(H1N1) in immunocompromised patients. METHODS: Two outbreaks of influenza A(H1N1) occurred in our institution: on the kidney transplant ward in 2014 including patients early after kidney or simultaneous pancreas-kidney transplantation, and on the oncology ward in 2016 including patients receiving chemotherapy for malignant tumours. Factors leading to these outbreaks and the clinical efficacy of seasonal influenza vaccination were analysed. FINDINGS: Altogether 86 patients were exposed to influenza A(H1N1) during the outbreaks, among whom the seasonal influenza vaccination status was unknown in 10. Only three out of 38 vaccinated patients were infected with influenza A(H1N1), compared with 20 out of 38 unvaccinated patients (P = 0.02). The death of one out of 38 vaccinated patients was associated with influenza, compared with seven out of 38 unvaccinated patients (P = 0.06). Shared factors behind the two outbreaks included outdated facilities not designed for the treatment of immunosuppressed patients. Vaccination coverage among patients was low, between 40% and 70% despite vaccination being offered to all patients free of charge. Vaccination coverage of healthcare workers on the transplant ward was low (46%), but, despite high coverage on the oncology ward (92%), the outbreak occurred. CONCLUSION: Seasonal influenza vaccination was clinically effective with both a reduced risk of influenza infection and a trend towards reduced mortality in these immunocompromised patients. Several possible causes were identified behind these two outbreaks, requiring continuous awareness in healthcare professionals to prevent further outbreaks. This case involves a patient (age and gender not reported) who was vaccinated with a dose of Influenza vaccine (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient''s medical history revealed that, the patient was immunocompromised. It was reported that, the patient is in chemotherapy. Concomitant medications were not reported. On an unspecified date, following the vaccination, the patient developed influenza A (H1N1) and had progressive lymphoma. On an unspecified date, the patient died due to progressive lymphoma. Lab data and corrective treatment were not reported. The outcome of events was not reported. It was unknown if autopsy was done. List of documents held by sender: none.; Sender''s Comments: This case concerns a patient with history of immunocompromised status and chemotherapy who developed Influenza A (H1N1) infection and lymphoma an unspecified time after vaccination with INFLUENZA vaccine. The latency is not known. Patient''s immunocompromised state and chemotherapy also hinder adequate antibody response development with vaccination. In addition, further information and lab data will be needed to rule out alternate causes of lymphoma. Based upon the reported information, role of the vaccination cannot be assessed and the case cannot be judged to be a vaccination failure.; Reported Cause(s) of Death: progressive lymphoma


VAERS ID: 753821 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Death, Drug interaction, Haemoptysis, International normalised ratio decreased, Labelled drug-drug interaction medication error, Platelet count decreased, Product administration error, Pyrexia
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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: Influenza vaccine; ASA; Celecoxib; Warfarin; HYDROCHLOROTHIAZIDE; Lorazepam; Montelukast sodium; HYDROXYCHLOROQUINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: INR; Result Unstructured Data: Test Result: 8, Test Result Unit: unknown; Test Name: Platelet count; Result Unstructured Data: Test Result: Abnormal, Test Result Unit: unknown
CDC Split Type: ITGLAXOSMITHKLINEIT201810

Write-up: INR decreased; Platelet count decreased; Contusion; Drug interaction; Hemoptysis; Pyrexia; Labelled drug-drug interaction medication error; Drug administration error; This case was reported by a other health professional via regulatory authority and described the occurrence of inr decreased in a 67-year-old female patient who received Flu Seasonal TIV Dresden (Influenza vaccine) for prophylaxis. Co-suspect products included acetylsalicylic acid (Asa) tablet for drug use for unknown indication, celecoxib unknown for drug use for unknown indication, lorazepam unknown for drug use for unknown indication, montelukast sodium unknown for drug use for unknown indication, warfarin sodium (Warfarin) tablet for drug use for unknown indication, hydrochlorothiazide unknown for drug use for unknown indication and hydroxychloroquine unknown for drug use for unknown indication. On an unknown date, the patient received Influenza vaccine (unknown), Asa (unknown) at an unknown dose and frequency, celecoxib (unknown) at an unknown dose and frequency, lorazepam (unknown) at an unknown dose and frequency, montelukast sodium (unknown) at an unknown dose and frequency, Warfarin (unknown) at an unknown dose and frequency, hydrochlorothiazide (unknown) at an unknown dose and frequency and hydroxychloroquine (unknown) at an unknown dose and frequency. On an unknown date, unknown after receiving Influenza vaccine, Asa, celecoxib, lorazepam and montelukast sodium and an unknown time after starting Warfarin, the patient experienced inr decreased (serious criteria death and other: serious as per reporter), platelet count decreased (serious criteria death and other: serious as per reporter), contusion (serious criteria death and other: serious as per reporter), drug interaction (serious criteria death and other: serious as per reporter), hemoptysis (serious criteria death and other: serious as per reporter), fever (serious criteria death and other: serious as per reporter), labeled drug-drug interaction medication error (serious criteria death and other: serious as per reporter) and drug administration error (serious criteria death and other: serious as per reporter). On an unknown date, the outcome of the inr decreased, platelet count decreased, contusion, drug interaction, hemoptysis, fever, labeled drug-drug interaction medication error and drug administration error were fatal. The reported cause of death was inr decreased, hemoptysis, platelet count decreased, pyrexia, drug administration error, contusion, drug interaction and labelled drug-drug interaction medication error. The reporter considered the inr decreased, platelet count decreased, contusion, drug interaction, hemoptysis, fever, labeled drug-drug interaction medication error and drug administration error to be possibly related to Influenza vaccine, Asa and Warfarin. It was unknown if the reporter considered the inr decreased, platelet count decreased, contusion, drug interaction, hemoptysis, fever, labeled drug-drug interaction medication error and drug administration error to be related to celecoxib, lorazepam and montelukast sodium. Initial information was reported by a other health professional via regulatory authority on 11th June 2018: death nos, inr decreased, platelet count decreased, contusion, drug interaction, hemoptysis, pyrexia, labelled drug-drug interaction medication error and drug administration error. Sender''s comment: Limited information about event details of death, exact cause of death, complete medical history, concomitant medications, relevant investigations and autopsy findings, if any, precludes a meaningful causality assessment for event death. Without details regarding therapy dates of the suspect drugs (hydrochlorthiazide, celecoxib,lorazepam and montelukast sodium) and their indication, clinical course of the reported events, event start date, time to onset of events, supporting investigations (with base line value) precludes the meaningful causality assessment of all reported events. Hence, causality assessed as not assessable with suspect drugs. Note: Death nos was reported as event, however it was removed as cause of death were reported. Lab Comments: On unknown date the patient underwent below lab test and result was found as: International normalised ratio: 8 Platelet count: Abnormal; Reported Cause(s) of Death: International normalised ratio decreased; Haemoptysis; Platelet count decreased; Pyrexia; Drug administration error; Contusion; Drug interaction; Labelled drug-drug interaction medication error


VAERS ID: 756776 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Body temperature increased, Death, Influenza like illness
SMQs:, Neuroleptic malignant 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: Medical History/Concurrent Conditions: Exposure to communicable disease (Patient was among resident cases of influenza-like-illness during respiratory outbreak in care homes)
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result: equal to or more than 37.8, Test Result Unit: degree C
CDC Split Type: GBGLAXOSMITHKLINEGB2018GS

Write-up: This case was reported in a literature article and described the occurrence of influenza like illness in a subject who received Influenza vaccine unspecified 2013-2014 season for prophylaxis. Concurrent medical conditions included exposure to communicable disease (Patient was among resident cases of influenza-like-illness during respiratory outbreak in care homes). On an unknown date, less than a year after receiving Influenza vaccine unspecified 2013-2014 season, the subject developed influenza like illness. Serious criteria included death. The outcome of influenza like illness was fatal. The reported cause of death was influenza like illness. It was unknown if the investigator considered the influenza like illness to be related to Influenza vaccine unspecified 2013-2014 season. Relevant Tests: Lab test performed on unspecified date: Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Body temperature result was equal to or more than 37.8 degree C. Additional information was provided. This case was reported in a literature and described the occurrence of influenza-like-illness (ILI) in a patient of unspecified age and gender who was vaccinated with unspecified influenza vaccine 2013-2014 season (manufacturer unknown) for prophylaxis. This case corresponds to table 1 and 2 reported in this literature article. The patient was part of the study that described the characteristics of respiratory outbreaks in care homes during a four-year period (2012-13, 2013-14, 2014-15, and 2015-16), and aimed to identify factors that predict which respiratory outbreaks were more likely to be positively identified as influenza. The influenza season runs from week 40 (early October) to week 20 (mid-May). Outbreaks were notified between weeks 40 and 18 (30-week duration). The patient was among the resident cases of ILI during respiratory outbreaks in care homes. No information on patient''s family history or concomitant medication was provided. On an unspecified during 2013-2014 influenza season, the patient received unspecified influenza vaccine 2013-2014 season (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date between early October 2013 and mid-May 2014 of influenza season, an unknown period after vaccination, the patient had developed ILI during a respiratory outbreak. [In this study, a respiratory outbreak was defined as 2 or more cases of ILI arising with the same 48 h period, or 3 or more cases arising within the same 72 h period which meet the same clinical case definition and where an epidemiological link can be established. ILI was defined as oral temperature of equal to or more than 37.8 deg.C plus new onset or acute worsening of one or more respiratory symptoms: cough (with or without sputum), hoarseness, nasal discharge or congestion, shortness of breath, sore throat, wheezing, sneezing, chest pain, or in older people an acute deterioration in physical or mental ability without other known cause. Respiratory specimens were collected for virological testing. Ninety-two of the 95 outbreaks were tested for influenza, with 70/92 testing positive. Influenza A (H3) was the most frequent flu type reported (89%), with only small proportions of the other flu types identified; 4% Flu B; 3% Flu A (untyped); and 1% Flu A (H1N1)]. On an unspecified date, the patient died associated with ILI during the respiratory outbreak. [In this study, an outbreak-associated death was defined as that occurring due to confirmed influenza, or respiratory symptoms that a clinician felt might be attributed to influenza]. It was unknown if an autopsy was performed. The case has been considered as serious due to death. Treatment was unknown. The authors did not comment on the relationship between the event of ILI and unspecified influenza vaccine 2013-2014 season. The authors concluded, "this study has added to the body of evidence showing the clinical significance of respiratory outbreaks in care homes during the influenza season. This reinforces the importance of seasonal influenza vaccination for care home residents and staff and good outbreak management in order to reduce the associated morbidity and mortality. Early recognition of potential outbreaks, efficient laboratory testing and reporting of results, implementation of infection control advice, including antiviral treatment and prophylaxis if appropriate, reduce transmission of infection in a care home. Accurate data reporting and recording enable a clear picture of the severity of an outbreak to be identified and assessed". Lab Comments: Lab test performed on unspecified date; Reported Cause(s) of Death: Influenza like illness.


VAERS ID: 760606 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-07-23
Entered: 2018-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute respiratory distress syndrome, Arthralgia, Asthenia, Community acquired infection, Condition aggravated, Cough, Influenza, Influenza A virus test positive, Intensive care, Myalgia, Polymerase chain reaction, Pyrexia, Renal failure, Respiratory tract infection, Rhinorrhoea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Arthritis (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Non-tobacco user; Kidney failure
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body temperature, Greater than 38, elevated; Influenza virus test, Influenza virus A, Positive; On an unspecified date: Nasopharyngeal aspirate or bronchoalveolar lavage was tested and was found to be positive for influenza virus A infection. Laboratory diagnoses were performed using multiplex ANYPLEX II RV16 and RB5 PCR assay (Seegene) or the Film array 1 respiratory panel (Blomerieux).
CDC Split Type: 201802953

Write-up: This literature report, initially received on 12-Jul-2018, was reported by other health professional and concerns an 82-year-old, elderly male patient. This study was conducted on a continuous series of 249 confirmed influenza infections, for which poorly neutralized in vitro strains, was considered as reason for vaccination failure and more severe diseases. A continuous series of patients who were hospitalized from 24-Dec-2017 (week 52) through 01-Apr-2015 (week 14) with symptoms of respiratory infection (fever, cough, dyspnoea), with or without headache, myalgia, or arthralgia were included in the study. The diagnostic procedures for viral respiratory tract infections included at least one respiratory sample (nasopharyngeal aspirate or bronchoalveolar lavago) which was positive for influenza virus. Laboratory diagnoses was performed using multiplex ANYPLEX (TM) II RV16 and RBS PCR assays (Seegene) or the Film array 1 respiratory panel (Blomerieux) for emergency cases. Young children (less than 5 years) and elderly patients (greater than 65 years) were known to be at high risk of complications and were included in this study. Nosocomial infections were defined as those which had symptom onset after 48 hours of hospitalization or admission in a nursing home. Young children were at lower risk of comorbidities (OR = 0.16, 95precent Cl - 0.08 0.35), admission in ICU (OR = 0.14, 95percent Cl = 0.04 0.51) and severe disease (OR = 0.29, 95percent Cl = 0.14 0.61) in comparison to patients aged 5-65 years. In contrast, elderly patients were at higher risk of comorbidities (OR = 2.00, 95pecent Cl = 1.05 3.79) but at lower risk of atypical infections (OR = 0.23, 95percent Cl = 0.09 0.61) and they were more frequently vaccinated (OR = 3.30, 95percent Cl = 1.18 9.24) in comparison to patients aged 5-65 years. Also, elderly patients were at higher risk of infection with A(H3N2) (OR = 2.39, 95percent Cl = 1.16 4.94) and at lower risk of infection with A(H1N1) pdm09 (OR = 0.33, 95percent Cl = 0.14 0.82) in comparison to patients aged 5-65 years. The 2014-2015 influenza season started with a high risk of vaccination failure because of the predominant circulation of variant strains. This risk was further increased by the low vaccination coverage (53percent) of patients at risk of severe influenza disease. Vaccination failure was confirmed by the low estimated vaccine effectiveness (VE), especially for elderly patients greater than 65 years (VE = 5 percent, 95 percent Cl = -8-16 percent). This study identified that elderly patients (OR = 3.30, 95 percent Cl = 1.18 9.24), comorbidities (OR = 14.75, 95 percent Cl = 1.83 118.75) and female patients (OR = 0.38, 95 percent Cl = 0.16 0.92) were associated with influenza vaccination. The patient had no history of alcohol and tobacco use. The patient''s current condition included Kidney failure (since an unspecified date). On an unspecified date, the patient was administered influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On 04-Feb-2015 (reported as week 6), the patient was hospitalized due to the fever, cough, myalgia, arthralgia, asthenia and rhinorrhea which were considered as symptoms of respiratory infection. During hospitalization, nasopharyngeal aspirate or bronchoalveolar lavage was tested and was found to be positive for influenza virus A infection which was diagnosed as community acquired infection. Laboratory diagnoses was performed using multiplex ANYPLEX (TM) II RV16 and RB5 PCR assays (Seegene) or the Film assay 1 respiratory panel (Biomerieux). Subsequently, the patient was diagnosed with influenza A. On an unspecified date, the patient was admitted to the intensive care unit (ICU) with initial complication severe acute respiratory distress syndrome (ARDS) and subsequent complication kidney failure. The patient was hospitalized for 08 days in ward and was under observation for kidney failure. No antiviral medications were received. On an unspecified date, the patient died. It was unknown, whether autopsy performed. At the time of this report, the outcome of the events was not reported. The reporter assessed the events (influenza, vaccination failure, ARDS and kidney failure) as serious (hospitalization). As per the reporter, the events- Influenza A virus infection and vaccination failure were related to the suspect vaccine. This case was cross-linked to case 201802947 (same reporter).


VAERS ID: 760607 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-07-23
Entered: 2018-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arthralgia, Asthenia, Community acquired infection, Cough, Death, H3N2 influenza, Influenza, Influenza A virus test positive, Myalgia, Polymerase chain reaction, Pyrexia, Respiratory tract infection, Rhinorrhoea, Sepsis, Vaccination failure
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body temperature, greater than 38 Fever, elevated; On an unspecified date: Nasopharyngeal aspirate or bronchoalveolar lavage was tested and was found to be positive for Influenza virus A [H3N2] infection. Laboratory diagnoses were performed using multiplex Anyplex II RV16 and RB5 PCR assays (Seegene) or the Film array 1 respiratory panel (Biomerieux).
CDC Split Type: 201802970

Write-up: This literature report, initially received on 12-Jul-2018, was reported by other health professional and concerns an 81-year-old, elderly, male patient. This study was conducted on a continuous series of 249 confirmed influenza infections, for which poorly neutralized in vitro strains, was considered as reason for vaccination failure and more severe diseases. A continuous series of patients'' who were hospitalized from 24-Dec-2014 (week 52) through 01-Apr-2015 (week 14) with symptoms of respiratory infection (fever, cough, dyspnoea), with or without headache, myalgia, or arthralgia were included in the study. The diagnostic procedures for viral respiratory tract infections included at least one respiratory sample (nasopharyngeal aspirate or bronchoalveolar lavage) which was positive for influenza virus. Laboratory diagnoses were performed using multiplex Anyplex (TM) II RV16 and RB5 PCR assays (Seegene) or the Film array 1 respiratory panel (Biomerieux) for emergency cases. Young children (less than 5 years) and elderly patients (greater than 65 years) were known to be at high risk of complications and were included in this study. Nosocomial infections were defined as those which had symptom onset after 48 hours of hospitalization or admission in a nursing home. Young children were at lower risk of comorbidities (OR = 0.16, 95 percent Cl = 0.08 plus or minus 0.35), admission in ICU (OR = 0.14, 95 percent Cl = 0.04 plus or minus 0.51) and severe disease (OR = 0.29, 95 percent Cl = 0.14 plus or minus 0.61) in comparison to patients aged 5 plus or minus 65 years. In contrast, elderly patients were at higher risk of comorbidities (OR = 2.00, 95 percent Cl = 1.05 plus or minus 3.79) but at lower risk of atypical infections (OR = 0.23, 95 percent Cl = 0.09 plus or minus 0.61) and they were more frequently vaccinated (OR = 3.30, 95 percent Cl = 1.18 plus or minus 9.24) in comparison to patients aged 5 plus or minus 65 years. Also, elderly patients were at higher risk of infection with A (H3N2) (OR = 2.39, 95 percent Cl = 1.16 plus or minus 4.94) and at lower risk of infection with A (H1N1) pdm09 (OR = 0.33, 95 percent Cl = 0.14 plus or minus 0.82) in comparison to patients aged 5 plus or minus 65 years. The 2014-2015 influenza season started with a high risk of vaccination failure because of the predominant circulation of variant strains. This risk was further increased by the low vaccination coverage (53 percent) of patients at risk of severe influenza disease. Vaccination failure was confirmed by the low estimated vaccine effectiveness (VE), especially for elderly patients greater than 65 years (VE = 5 percent, 95 percent Cl = 8-16 percent). This study identified that elderly patients (OR = 3.30, 95 percent Cl = 1.18 plus or minus 9.24), comorbidities (OR = 14.75, 95 percent Cl = 1.83 plus or minus 118.75) and female patients (OR = 0.38, 95 percent Cl = 0.16 plus or minus 0.92) were associated with influenza vaccination. The patient''s current condition included diabetes. On an unspecified date, the patient was administered influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On 05-Mar-2015 (reported as week 10), the patient was hospitalized due to the fever (body temperature greater than 38 or less than 35), cough, myalgia, arthralgia, asthenia and rhinorrhea which were considered as symptoms of respiratory infection. During hospitalization, nasopharyngeal aspirate or bronchoalveolar lavage was tested and was found to be positive for Influenza virus A infection which was diagnosed as community acquired infection. Laboratory diagnoses were performed using multiplex Anyplex (TM) II RV16 and RB5 PCR assays (Seegene) or the Film array 1 respiratory panel (Biomerieux). Subsequently, the patient was diagnosed with influenza A, H3N2 infection [sequence reported as 3C.2a] [considered as vaccination failure]. The patient''s initial complication was sepsis. The event was considered as severe and no antiviral medications were taken. The patient was hospitalized for 06 days. On an unspecified date, the patient died. It was unknown if autopsy was performed. The outcome of the events was not reported. The reporter assessed the events influenza infection and sepsis as serious (hospitalization, and death). As per the reporter, the events- Influenza A virus infection and vaccination failure were related to the suspect vaccine. This case was linked to 201802947 due to same reporter. Case Comment: an 81-year-old, male patient, with diabetes mellitus was hospitalized with symptoms of respiratory infection (fever, cough, myalgia, arthralgia, asthenia, and rhinorrhea) and diagnosed with influenza infection (considered as vaccination failure), an unknown period after receipt of INN flu vaccine. The causality for the events influenza virus infection and vaccination failure was considered as unassessable, due to minimal information regarding onset latency between vaccination to events. Subsequently the patient had complication of sepsis and died, an unspecified period after receipt of suspect vaccine. The event sepsis was considered as not related to suspect vaccine, considering the infectious aetiology of the event. The event death can be explained by sepsis in a diabetic elderly person, rather than suspect vaccine. Hence, the event death was considered as not related to suspect vaccine. The case will be reassessed upon receipt of new information. The company assessed the case as serious (hospitalization, medically significant).


VAERS ID: 766702 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
TTOX: TETANUS TOXOID (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Other       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: BRGLAXOSMITHKLINEBR2018GS

Write-up: This case was reported by a consumer via market research programs and described the occurrence of unknown cause of death in an unspecified number of patients who received Flu Seasonal QIV Dresden for prophylaxis. Co-suspect products included Yellow Fever Vaccine for prophylaxis and Tetanus Vaccine for prophylaxis. On an unknown date, the patient received Flu Seasonal QIV Dresden at an unknown dose, Yellow Fever Vaccine at an unknown dose and Tetanus Vaccine at an unknown dose and frequency. On an unknown date, unknown after receiving Flu Seasonal QIV Dresden, 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 Seasonal QIV Dresden. Additional details were provided as follows: The age at vaccination was not reported. The consumer informed that a few people (not specified) died after taking vaccine. The batch numbers were nor provided. No information regarding patients was provided. No further detail was provided. Reported Cause(s) of Death: Death NOS.


VAERS ID: 766704 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       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: BRGLAXOSMITHKLINEBR2018GS

Write-up: This case was reported by a consumer via market research programs and described the occurrence of unknown cause of death in a patient who received Flu Seasonal QIV Dresden (Flu Seasonal QIV Dresden) for prophylaxis. On an unknown date, the patient received Flu Seasonal QIV Dresden at an unknown dose. On an unknown date, unknown after receiving Flu Seasonal QIV Dresden, 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 Flu Seasonal QIV Dresden. Additional details were reported as follows: The patient''s demographic details were not reported. The age at vaccination was not reported. The batch number and expired date were not reported. The reporter informed that, some people died after taking Flu vaccine. No further information was provided.; Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 766834 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Other       Purchased by: ?
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRGLAXOSMITHKLINEBR2018GS

Write-up: This case was reported by a consumer via market research programs and described the occurrence of vaccination failure in a male patient who received Flu Seasonal QIV Dresden for prophylaxis. Co-suspect products included Yellow Fever Vaccine for prophylaxis. On an unknown date, the patient received Flu Seasonal QIV Dresden at an unknown dose and Yellow Fever Vaccine at an unknown dose. On an unknown date, unknown after receiving Flu Seasonal QIV Dresden, the patient experienced vaccination failure (serious criteria death and GSK medically significant) and influenza (serious criteria death). On an unknown date, the outcome of the vaccination failure and influenza were fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to Flu Seasonal QIV Dresden. Additional information was reported as follows: The age at vaccination was not reported. The reporter stated that he lost his brother due to the disease, even after the vaccination and stated that the vaccine was ineffective. The real reason for death was not clear. No further details were provided. This case was considered for suspected vaccination failure as the time to onset for the reaction was unknown. Reported Cause(s) of Death: Influenza.


VAERS ID: 768377 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR - / UNK - / -

Administered by: Other       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: BRGLAXOSMITHKLINEBR2018GS

Write-up: This case was reported by a consumer via market research programs and described the occurrence of death in an unspecified number of patients who received Flu vaccine unspecified for prophylaxis. Co-suspect products included YELLOW FEVER VACCINE for prophylaxis. On an unknown date, the patient received Flu vaccine unspecified at an unknown dose and YELLOW FEVER VACCINE at an unknown dose. On an unknown date, unknown after receiving Flu vaccine unspecified, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The reported cause of death was death. It was unknown if the reporter considered the death to be related to Flu vaccine unspecified. Additional details were provided as follows: The age at vaccination was not reported. It was reported that, the unspecified number of patients died after receiving Flu vaccine and YELLOW FEVER VACCINE. It was not clear which vaccine the reporter refers. The batch and expiry date of Flu vaccine and YELLOW FEVER VACCINE were not reported. It was unknown if the reporter considered the death to be related to YELLOW FEVER VACCINE as well. No further information was provided. Reported Cause(s) of Death: Death.


VAERS ID: 771461 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure acute, Death, Intensive care, Myocardial infarction
SMQs:, Cardiac failure (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiomyopathy
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEGLAXOSMITHKLINEDE2018GS

Write-up: This case was reported by a physician and described the occurrence of myocardial infarction in a 80-year-old male patient who received Influenza vaccine for prophylaxis. Concurrent medical conditions included cardiomyopathy. On an unknown date, the patient received Influenza vaccine .5 ml. On an unknown date, 3 days after receiving Influenza vaccine, the patient experienced myocardial infarction (serious criteria death and GSK medically significant) and acute cardiac insufficiency (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required). On an unknown date, the outcome of the myocardial infarction was fatal and the outcome of the acute cardiac insufficiency was unknown. The reported cause of death was myocardial infarction. It was unknown if the reporter considered the myocardial infarction and acute cardiac insufficiency to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. On an unspecified date, the patient received a dose of an unknown Influenza vaccine (manufacturer and season unspecified). Approximately two days post vaccination the patient experienced acute heart insufficiency which required intensive care treatment. The patient was hospitalised for intensive care treatment. Approximately 3 to 4 days post vaccination, the patient died from myocardial infarction. It was unknown whether or not an autopsy was performed. Reported Cause(s) of Death: Myocardial infarction.


VAERS ID: 774818 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
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

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Chest pain, Death, Dyspnoea, Influenza, Myocarditis
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? 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: ITSA2018SA268054

Write-up: Initial information received on 22-Sep-2018 regarding an unsolicited valid serious case issued from a literature article. This case is linked to cases 2018SA268028, 2018SA268046, 2018SA268054, 2018SA268066, 2018SA268077, 2018SA268091, 2018SA268096, 2018SA268116, 2018SA268136, 2018SA268144, 2018SA268154, 2018SA268180, 2018SA268794, 2018SA268803, 2018SA268809, 2018SA268813, 2018SA268832, 2018SA268839, 2018SA268849, 2018SA268859, 2018SA268864, 2018SA268872, 2018SA268876, 2018SA268889, 2018SA268901, 2018SA268907, 2018SA268912, 2018SA268929, 2018SA268936, 2018SA268946, 2018SA268957, 2018SA268965, 2018SA268974, 2018SA268988, 2018SA268995, 2018SA269004, 2018SA269014 same literature article. The following is the abstract from the article- Aim- To characterize cases of myocarditis (MC) and pericarditis (PC) recorded in the Vaccine Adverse Event Reporting System (VAERS). Methods- Cases were extracted from VAERS (2011-2015) and assessed for causality using standardized WHO algorithm. Disproportionality analysis was performed through reporting odds ratio (ROR) with 95 percent CI. MEDLINE was also searched. Results- In VAERS, 199 cases of MC or PC were collected, among which 149 reported smallpox vaccine. The remaining were 15 cases in YOUNGER GROUP (YG, b18 years old) and 35 in OLDER GROUP (OG, N18 years old). Main reported vaccines were against Human Papilloma Virus (n- 6) in YG and influenza (n-16) in OG. Causality always resulted undeterminate for YG, whereas either undetermined (30 cases) and correlated (3 cases) for OG. Statistically significant ROR was found in YG for meningococcal vaccine (ROR- 3.55, 95 percent CI- 1.23-10.24) and in OG for thyphoid vaccine (11.13, 7.73-16.03), Japanese encephalitis vaccine (8.54, 2.7-27.01), anthrax (25.5, 18.8-34.5), and, as expected, smallpox (71.88, 49.25-104.89). In database, 91 articles were found- positive/possible causality was frequently reported. Conclusions- MC and PC after immunization appear extremely rare, only in very few cases can a role of vaccine be actually identified. Signals for vaccines against typhus, Japanese encephalitis, anthrax and meningococcus warrant monitoring. This case involves a 10 years old female patient who experienced myocarditis, while she received vaccine INFLUENZA VACCINE. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number, expiry date and dose not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious myocarditis 3 months following the administration of INFLUENZA VACCINE. This event was leading to death. On an unknown date, the patient developed a serious chest pain 3 months following the administration of INFLUENZA VACCINE. This event was leading to death. On an unknown date, the patient developed a serious dyspnoea 3 months following the administration of INFLUENZA VACCINE. This event was leading to death. On an unknown date, the patient developed a serious influenza 3 months following the administration of INFLUENZA VACCINE. This event was leading to death. On an unknown date, the patient developed a serious abdominal pain 3 months following the administration of INFLUENZA VACCINE. This event was leading to death. Lab data was not reported. Final diagnosis was (fatal) myocarditis. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Fatal on an unknown date for myocarditis, as Fatal on an unknown date for chest pain, as Fatal on an unknown date for dyspnoea, as Fatal on an unknown date for influenza and as Fatal on an unknown date for abdominal pain. It is unknown if an autopsy was done. The cause of death was reported as Myocarditis, Chest pain, Dyspnoea, Influenza, Abdominal pain. The Causality assessment (AEFI) was Undetermined. List of documents held by sender- none.; Sender''s Comments: This literature article describes a 10 years old child who was reported to have developed Myocarditis, Chest pain, Dyspnoea, Influenza, Abdominal pain 3 months after vaccination with INFLUENZA VACCINE produced by unknown manufacturer resulting in death. The date of vaccinations, the date of events, the date of death was not reported. No information regarding medical history and tolerance to previous vaccinations was reported. Also there is no information regarding virus strain, lab tests confirming the diagnosis and patient''s immunological response to assess a potential vaccination failure. Autopsy confirmation is also not provided. Based upon reported information, the role of vaccine cannot be assessed.; Reported Cause(s) of Death: Chest pain; Myocarditis; dyspnoea; influenza; abdominal pain.


VAERS ID: 775088 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Death, Diarrhoea, Fatigue, Influenza like illness, Myocarditis, Nausea
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSA2018SA268794

Write-up: Initial information received on 22-Sep-2018 regarding an unsolicited valid serious case received from a literature. Abstract- To characterize cases of myocarditis (MC) and pericarditis (PC) recorded in the Vaccine Adverse Event Reporting System (VAERS). Methods: Cases were extracted fromVAERS (2011-2015) and assessed for causality using standardized WHO algorithm. Disproportionality analysis was performed through reporting odds ratio (ROR) with 95%CI. Database was also searched. results: In VAERS, 199 cases of MC or PC were collected, among which 149 reported smallpox vaccine. The remaining were: 15 cases in ''YOUNGER GROUP'' (YG; b18 years old) and 35 in ''OLDER GROUP'' (OG; N18 years old). Main reported vaccines were against Human Papilloma Virus (n = 6) in YG and influenza (n = 16) in OG. Causality always resulted "undeterminate" for YG, whereas either "undetermined" (30 cases) and "correlated" (3 cases) for OG. Statistically significant ROR was found in YG for meningococcal vaccine (ROR = 3.55; 95%CI = 1.23-10.24) and in OG for thyphoid vaccine (11.13; 7.73-16.03), Japanese encephalitis vaccine (8.54; 2.7-27.01), anthrax (25.5; 18.8-34.5), and, as expected, smallpox (71.88; 49.25-104.89). In database, 91 articles were found: positive/possible causality was frequently reported. Conclusions: MC and PC after immunization appear extremely rare; only in very few cases can a role of vaccine be actually identified. Signals for vaccines against typhus, Japanese encephalitis, anthrax and meningococcus warrant monitoring. This case is linked to cases 2018SA268028, 2018SA268912, 2018SA268046, 2018SA268054, 2018SA268066, 2018SA268077, 2018SA268091, 2018SA268096, 2018SA268116, 2018SA268136, 2018SA268144, 2018SA268154, 2018SA268180, 2018SA268803, 2018SA268809, 2018SA268813, 2018SA268832, 2018SA268839, 2018SA268849, 2018SA268859, 2018SA268864, 2018SA268872, 2018SA268876, 2018SA268889, 2018SA268901, 2018SA268907, 2018SA268929, 2018SA268936, 2018SA268946, 2018SA268957, 2018SA268965, 2018SA268974, 2018SA268988, 2018SA268995, 2018SA269004, 2018SA269014 (same literature article). This case involves a 61 years old male patient who experienced myocarditis/biopsy-proven myocarditis, diarrhoea, fatigue, influenza like illness and nausea, while he received vaccine INFLUENZA VACCINE. The patient''s medical history included Asthma. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported. On an unknown date ¸the patient developed a serious myocarditis/biopsy-proven myocarditis, diarrhoea, fatigue, influenza like illness and nausea, four- months following the administration of INFLUENZA VACCINE. This event was leading to death. Autopsy revealed myocarditis. No specific lab data reported. Final diagnosis was (fatal) nausea, (fatal) influenza like illness, (fatal) fatigue, (fatal) diarrhoea and (fatal) myocarditis/biopsy-proven myocarditis. The patient didn''t receive any corrective treatment. The patient outcome is reported as fatal on an unknown date for all the events. An autopsy was done. The results of autopsy showed Myocarditis. The Causality assessment (AEFI) was Undetermined. List of documents held by sender: none.; Sender''s Comments: This literature article describes a 61 years old male patient who experienced myocarditis/biopsy-proven myocarditis, diarrhea, fatigue, influenza like illness and nausea, four- months after vaccination with INFLUENZA VACCINE produced by unknown manufacturer resulting in death. The date of vaccinations, the date of events, the date of death was not reported. No information regarding medical history and tolerance to previous vaccinations was reported. Also there is no information regarding virus strain, lab tests confirming the diagnosis and patient''s immunological response to assess a potential vaccination failure However, Autopsy confirmation provided myocarditis as the factor. Based upon reported information, the role of vaccine cannot be assessed.; Autopsy-determined Cause(s) of Death: myocarditis.


VAERS ID: 775104 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Asthenia, Chills, Death, Dyspnoea, Ejection fraction decreased, Epstein-Barr virus test positive, Headache, Jaundice, Myalgia, Myocarditis, Weight increased, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (narrow), Cholestasis and jaundice of hepatic origin (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MESALAZINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ulcerative colitis (in treatment with mesalazine.)
Allergies:
Diagnostic Lab Data: Test Name: ejection fraction test; Result Unstructured Data: decreased; Test Name: epstein-barr virus; Result Unstructured Data: positive; Test Name: wbc increased; Result Unstructured Data: increased
CDC Split Type: ITSA2018SA268929

Write-up: Initial information received on 22-Sep-2018 regarding an unsolicited valid serious case issued from a literature article. Abstract- To characterize cases of myocarditis (MC) and pericarditis (PC) recorded in the Vaccine Adverse Event Reporting System (VAERS). Methods: Cases were extracted fromVAERS (2011-2015) and assessed for causality using standardized WHO algorithm. Disproportionality analysis was performed through reporting odds ratio (ROR) with 95%CI. Database was also searched. Results: In VAERS, 199 cases of MC or PC were collected, among which 149 reported smallpox vaccine. The remaining were: 15 cases in ''YOUNGER GROUP'' (YG; b18 years old) and 35 in ''OLDER GROUP'' (OG; N18 years old). Main reported vaccines were against Human Papilloma Virus (n = 6) in YG and influenza (n = 16) in OG. Causality always resulted "undeterminate" for YG, whereas either "undetermined" (30 cases) and "correlated" (3 cases) for OG. Statistically significant ROR was found in YG for meningococcal vaccine (ROR = 3.55; 95%CI = 1.23-10.24) and in OG for thyphoid vaccine (11.13; 7.73-16.03), Japanese encephalitis vaccine (8.54; 2.7-27.01), anthrax (25.5; 18.8-34.5), and, as expected, smallpox (71.88; 49.25-104.89). In database, 91 articles were found: positive/possible causality was frequently reported. Conclusions: MC and PC after immunization appear extremely rare; only in very few cases can a role of vaccine be actually identified. Signals for vaccines against typhus, Japanese encephalitis, anthrax and meningococcal warrant monitoring. This case involves a 61 years old male patient who experienced giant-cell myocarditis/ biopsy-proven myocarditis along with symptoms of Abdominal distension, asthenia, chills, dyspnoea, headache, jaundice, myalgia, weight increased, while he received vaccine INFLUENZA VACCINE. The patient''s past medical history included Colitis ulcerative with in treatment with mesalazine on an unknown date. The patient''s past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MESALAZINE (MESALAZINE) for Colitis ulcerative. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported (expiry date, dose, dose in series, route and site of administration were not reported). On an unknown date, the patient developed a serious giant-cell myocarditis/ biopsy-proven myocarditis (myocarditis) 7 days following the administration of INFLUENZA VACCINE. This event was leading to death. On an unknown date, the patient developed a serious abdominal distension 7 days following the administration of INFLUENZA VACCINE. This event was leading to death. On an unknown date, the patient developed a serious chills 7 days following the administration of INFLUENZA VACCINE. This event was leading to death. On an unknown date, the patient developed a serious dyspnoea 7 days following the administration of INFLUENZA VACCINE. This event was leading to death. On an unknown date, the patient developed a serious asthenia 7 days following the administration of INFLUENZA VACCINE. This event was leading to death. On an unknown date, the patient developed a serious headache 7 days following the administration of INFLUENZA VACCINE. This event was leading to death. On an unknown date, the patient developed a serious jaundice 7 days following the administration of INFLUENZA VACCINE. This event was leading to death. On an unknown date, the patient developed a serious weight increased 7 days following the administration of INFLUENZA VACCINE. This event was leading to death. On an unknown date, the patient developed a serious myalgia following 7 days the administration of INFLUENZA VACCINE. This event was leading to death. On an unspecified date, patient was performed ECE test (result: not reported). Relevant laboratory test results included: Ejection fraction decreased - On an unknown date: (result: decreased) Epstein-Barr virus antibody positive - On an unknown date: (result: positive) White blood cell counts increased - On an unknown date: (result: increased) Final diagnosis was giant-cell myocarditis/ biopsy-proven myocarditis with symptoms. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Fatal on an unknown date for giant-cell myocarditis/ biopsy-proven myocarditis, for abdominal distension, for chills, for dyspnoea, for asthenia, for headache, for jaundice, for weight increased, for myalgia. It is unknown if an autopsy was done. The cause of death was not reported. The Causality assessment (AEFI) was Undetermined. Documents held by the sender: none.; Sender''s Comments: This literature article describes a 61 years old adult male patient who was reported to have developed Giant-cell Myocarditis, abdominal distension, chills, dyspnea, asthenia, headache, jaundice, weight increased and myalgia 7 days after vaccination with INFLUENZA VACCINE produced by unknown manufacturer resulting in death. The date of vaccinations, the date of events, the date of death was not reported. Patient had a medical history of ulcerative colitis. Lab tests confirming the diagnosis & Autopsy confirmation is also not provided. Based upon reported information, the role of vaccine cannot be assessed.


VAERS ID: 776835 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       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: Acute respiratory failure; Chronic obstructive pulmonary disease; Diabetes
Preexisting Conditions: Medical History/Concurrent Conditions: Unwell (been unwell for a week prior to influenza vaccination)
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUGLAXOSMITHKLINEAU2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 76-year-old male subject who received influenza vaccine for prophylaxis. The subject''s past medical history included unwell (been unwell for a week prior to influenza vaccination). Concurrent medical conditions included chronic obstructive pulmonary disease, diabetes and acute respiratory failure. On an unknown date, less than a year after receiving influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The subject died in 2015. The reported cause of death was unknown cause of death. The investigator considered the unknown cause of death to be possibly related to influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death not otherwise specified (NOS) in a 76-year-old male who was vaccinated with unspecified influenzae vaccine (manufacturer unknown) for prophylaxis. The patient was part of report that summarised passive surveillance data for adverse events following immunisation (AEFI) for 2015 reported by 28 February 2016 to the Therapeutic Goods Administration (TGA) by state and territory health departments, health professionals, vaccine companies and the public, and compared them to long-term trends. [In this study, records contained in the Adverse Drug Reactions System (ADRS) database were eligible for inclusion in the analysis if a vaccine was recorded as ‘suspected'' of involvement in the reported adverse event and either (a) the vaccination occurred between 1 January 2000 and 31 December 2015, or (b) for records where the vaccination date was not recorded, the date of onset of symptoms or signs occurred between 1 January 2000 and 31 December 2015]. The patient had history of chronic obstructive pulmonary disease (COPD), diabetes and acute respiratory failure. The patient had been unwell for a week prior to influenza vaccination. No information on patient''s family history or concomitant medications was provided. On an unspecified date in 2015, the patient had 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 2015, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. The case was reported to TGA. The case was assessed using internationally consistent criteria and was entered into the ADRS database. The case has been considered serious due to death. [In this study, an AEFI was defined as ‘serious'' if it met one or more of the following criteria: (1) results in death; (2) is life-threatening; (3) requires inpatient hospitalisation or prolongation of existing hospitalisation (4) results in persistent or significant disability/incapacity; (5) is a congenital anomaly/ birth defect or; (6) is a medically important event or reaction]. The authors commented, "Two deaths were reported as temporally associated with receipt of vaccines in 2015. A clear causal relationship with vaccination was unable to be determined due to confounding factors". The authors concluded "The reported AEFIs decreased in 2015 compared with 2014. The majority of AEFIs reported to the TGA were mild, transient events. The data reported here are consistent with an overall high level of safety for vaccines included in the NIP schedule." This is 1 of the 2 valid cases reported in the same literature article.; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 776938 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Death, Pneumonia, Squamous cell carcinoma of lung
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Blood cholesterol increased; Chronic obstructive pulmonary disease; Diabetes; Lung cancer
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUGLAXOSMITHKLINEAU2018GS

Write-up: This case was reported in a literature article and described the occurrence of pneumonia in a 73-year-old male subject who received Flu seasonal TIV Dresden for prophylaxis. Concurrent medical conditions included chronic obstructive pulmonary disease, diabetes, blood cholesterol increased and lung cancer. On an unknown date, less than a year after receiving Flu seasonal TIV Dresden, the subject developed pneumonia. Serious criteria included death and GSK medically significant. The outcome of pneumonia was fatal. The reported cause of death was pneumonia, chronic obstructive pulmonary disease and squamous cell carcinoma of lung. The investigator considered the pneumonia to be possibly related to Flu seasonal TIV Dresden. Additional information was provided. This case was reported in a literature article and described the occurrence of pneumonia in a 73-year-old male who was vaccinated with unspecified influenzae vaccine (manufacturer unknown) for prophylaxis. The patient was part of report that summarised passive surveillance data for adverse events following immunisation (AEFI) for 2015 reported by 28 February 2016 to the regulatory authority by state and territory health departments, health professionals, vaccine companies and the public, and compared them to long-term trends. [In this study, records contained in the Adverse Drug Reactions System (ADRS) database were eligible for inclusion in the analysis if a vaccine was recorded as ‘suspected'' of involvement in the reported adverse event and either (a) the vaccination occurred between 1 January 2000 and 31 December 2015, or (b) for records where the vaccination date was not recorded, the date of onset of symptoms or signs occurred between 1 January 2000 and 31 December 2015]. The patient had history of severe chronic obstructive pulmonary disease (COPD), diabetes, high cholesterol and lung cancer. No information on patient''s family history or concomitant medications was provided. On an unspecified date in 2015, the patient had 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 2015, more than 2 weeks after vaccination, the patient was hospitalised with pneumonia. Subsequently on an unspecified date, the patient had died. The causes of death were pneumonia, severe COPD and squamous cell carcinoma of the lung. It was unknown if an autopsy was performed. The case was reported to regulatory authority. The case was assessed using internationally consistent criteria and was entered into the ADRS database. The case has been considered serious due to death/hospitalisation. [In this study, an AEFI was defined as ‘serious'' if it met one or more of the following criteria: (1) results in death; (2) is life-threatening; (3) requires inpatient hospitalisation or prolongation of existing hospitalisation (4) results in persistent or significant disability/incapacity; (5) is a congenital anomaly/ birth defect or; (6) is a medically important event or reaction]. The authors commented, "Two deaths were reported as temporally associated with receipt of vaccines in 2015. A clear causal relationship with vaccination was unable to be determined due to confounding factors". Reported Cause(s) of Death: pneumonia; severe chronic obstructive pulmonary disease; squamous cell carcinoma of the lung.


VAERS ID: 777163 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAGLAXOSMITHKLINECA2018GS

Write-up: This case was reported by a consumer via call center representative and described the occurrence of pneumonia in a male patient who received seasonal Influenza vaccine unspecified for prophylaxis. On an unknown date, the patient received seasonal Influenza vaccine unspecified at an unknown dose. On an unknown date, unknown after receiving seasonal Influenza vaccine unspecified, the patient experienced pneumonia (serious criteria death and GSK medically significant). On an unknown date, the outcome of the pneumonia was fatal. The reported cause of death was pneumonia. It was unknown if the reporter considered the pneumonia to be related to seasonal Influenza vaccine unspecified. Additional information received as follows: This case was reported by the patient''s granddaughter. The age at vaccination was not reported. The consumer said that vaccines made people sick. The patient (the reporter''s grandfather) died of pneumonia few years before the reporting day, not too long after receiving the flu shot. No consent for follow up was given. This was 1 of the 4 cases reported by the same reporter. Reported Cause(s) of Death: pneumonia.


VAERS ID: 778699 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Death, Pneumonia, Squamous cell carcinoma of lung
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Diabetes; High cholesterol; Lung cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUSA2018SA283347

Write-up: Initial unsolicited report received from the literature on 08-Oct-2018. Verbatim of the article: Abstract: This report summarises passive surveillance data for adverse events following immunization (AEFI) for 2015 reported to the Therapeutic Goods Administration and compares them to long-term trends. There were 2,924 AEFI records for vaccines administered in 2015; an annual AEFI reporting rate of 12.3 per 100,000 populations. There was a decline of 7% in the overall AEFI reporting rate in 2015 compared with 2014. This decline in reported adverse events in 2015 compared to the previous year was mainly attributable to fewer reports following the HPV vaccine and replacement of monovalent vaccines (Hib, MenCCV and varicella) with combination vaccines such as Hib-MenC, and MMRV. AEFI reporting rates for most individual vaccines were lower in 2015 compared with 2014. The most commonly reported reactions were injection site reaction (26%), pyrexia (17%), rash (16%), vomiting (8%) and headache (7%). The majority of AEFI reports (85%) were described as non-serious events. There were two deaths reported, but no clear causal relationship with vaccination was found. This case involves a 73-year-old male patient who was vaccinated with influenza vaccine (batch number, expiry date, dose and route of administration were not reported) on an unspecified date in 2015. Patient''s medical history included chronic obstructive pulmonary disease, Diabetes mellitus, Blood cholesterol increased and Lung neoplasm malignant. Concomitant medication was not reported. On an unknown date, post vaccination the patient developed a serious pneumonia (unknown latency), squamous cell carcinoma of the lung (lung neoplasm malignant) and severe chronic obstructive pulmonary disease (chronic obstructive pulmonary disease) (unknown latency). The patient was hospitalized. The patient died on an unspecified date due to the events. It was unknown whether autopsy was performed. Patient''s lab data and corrective treatment was not reported. It was reported that a clear causal relationship with vaccination was unable to be determined due to confounding factors. List of the documents held by sender: none.; Sender''s Comments: This case concerns an elderly patient who presented with pneumonia, squamous cell carcinoma of the lung and severe chronic obstructive pulmonary disease. Patient''s medical history included chronic obstructive pulmonary disease, Diabetes mellitus, Blood cholesterol increased and malignant Lung neoplasm . The events are possibly related to disease progression with no relation to vaccination. Based upon the reported information, the role of the vaccine is unlikely.; Reported Cause(s) of Death: pneumonia; severe COPD; squamous cell carcinoma of the lung.


VAERS ID: 778981 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-10-16
Entered: 2018-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart disease, unspecified
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201804441

Write-up: This spontaneous case, initially received from other non-health professional on 12-Oct-2018, concerns a 65-year-old, elderly male patient. The patient''s current condition included heart disease (reported as otherwise was well). On an unspecified date, the patient was administered FLUAD (TIV) [dose, route of administration, anatomical location, batch number and expiry date: not reported]. On the following day of vaccine administration, the patient fell ill and was admitted to the hospital. Later that day, the patient passed away. It was unknown whether autopsy was performed. The cause of death was not reported. The reporter assessed the case as serious (death and hospitalization). Case Comment: A 65-year-old male patient with concurrent heart disease, passed away one day after receipt of FLUAD. Aside close temporal relationship, minimal information is available regarding the severity of concurrent heart disease, cause of death, medication history. Hence, company assessed the causality as unassessable. Further assessment will be done upon receipt of new information.


VAERS ID: 784401 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-11-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV QUEBEC) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       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: CAGLAXOSMITHKLINECA2018GS

Write-up: This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in an unspecified number of patients who received Seasonal Influenza vaccine unspecified for prophylaxis. On an unknown date, the patients received Seasonal Influenza vaccine unspecified. On an unknown date, unknown after receiving Seasonal Influenza vaccine unspecified, the patients 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 possibly related to Seasonal Influenza vaccine unspecified. Additional details were provided as follows: The case was reported via SHINGRIX page. The age at vaccination was not applicable. The reported stated that he /she knew too many people, seniors, who died after getting the flu shot. No lot number and expiry date were provided. No consent to healthcare professional (HCP) information for follow up. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 785546 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / UN

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Bone loss, Breast pain, Bronchitis, Confusional state, Death, Diarrhoea, Dysphagia, Dyspnoea, Ear pain, Face injury, Fall, Fungal infection, Gastrointestinal inflammation, Haemarthrosis, Mucous stools, Nausea, Non-cardiac chest pain, Oesophageal discomfort, Oesophagitis, Osteonecrosis of jaw, Renal cyst, Upper limb fracture, Urinary hesitation
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), 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), Accidents and injuries (narrow), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Cardiomyopathy (broad), Lipodystrophy (broad), Osteoporosis/osteopenia (narrow), Osteonecrosis (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Hypoglycaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-01-22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CALCIUM; VITAMIN D3; LISINOPRIL; HCT BETA; PANTOPRAZOLE
Current Illness: Aortic valve incompetence; Arrhythmia absoluta; Atrial fibrillation; Essential hypertension; Hypertension arterial; Mitral valve incompetence; Osteoporosis; Senility; Tricuspid incompetence
Preexisting Conditions: Medical History/Concurrent Conditions: Arm fracture; Fall; Flu vaccination
Allergies:
Diagnostic Lab Data:
CDC Split Type: DESANOFIAVENTIS2013SA0376

Write-up: Initial report received on 10-Apr-2013: This case was extracted from the website of the Health Authority (authority number DE-BFARM-13103437), initially reported by a consumer via the regulatory authority (DE-CADRBFARM-2013004808) to the agency. The case involves an 83-year-old female patient who suffered from osteoporosis. In 2004, she fell and broke both arms (hospitalisation for more than three weeks) after a flu vaccination. Concomitant medication was not provided. At an unspecified date, a therapy with ibuprofen (trade name not provided) for unknown indication was started. Additionally, the patient was treated with the following drugs: clodronic acid once weekly for osteoporosis since 01-Jul-2000, alendronate sodium, influenza virus vaccine polyvalent, tetanus toxoid and alendronic acid. On 01-Jan-2005, the patient experienced diarrhoea, confusion, bronchitis, esophagitis, fungal infection, swallowing disorders, dyspnoea, osteonecrosis of jaw, non-cardiac chest pain, ear pain, renal cyst and mucus in stool. Control examinations for bone density were not performed according to the reporter. Action taken concerning the suspect drugs and corrective treatment were not provided. On 22-Jan-2006, the patient died. The causal relationship between the events and suspected drugs were not provided. Additional information received on 22-JUL-2013 by letter. The hospital physician stated that they could not provide the patient''s hospital file, on legal and ethical grounds. Further information will therefore not be available. Additional information regarding this unsolicited case downloaded from regulatory authority database without narrative (level 2A), was received on 05-Nov-2018 from a Physician via Health Authority under reference DE-EMA-DD-20181030-zaviour_n-110139. On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported via unknown route. On 30 Nov 2004, patient received MUTIGRIP (batch number, expiry date were not reported). In 2004, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via oral route. On 28-Nov-2005 she also received a dose of the same vaccine with an unknown batch number via unknown route. On 30-Nov-2004 she also received a dose of the same vaccine with an unknown batch number via oral route. On an unknown patient received Ibuprofen, FOSAMAX Via Oral Route, FOSAVANCE and ALENDRONATE SODIUM via oral route, however stopped on 22 Jan 2006. On an unknown date, patient received TETANOL PUR. On 01-Jul-2000, the patient started taking BONEFOS 1 DF QW oral (with an unknown batch number) for Osteoporosis. As concomitant medication, patient received Calcium Brause, Vitamin D3, Lisinopril, Hct Beta, and Pantoprazole. Patient''s ongoing medical history included: Hypertension arterial, Osteoporosis, Mitral valve incompetence, Atrial fibrillation, Arrhythmia absoluta, Senility, Tricuspid incompetence, Aortic valve incompetence, Essential hypertension. As previous vaccination, patient received TETANUS VACCINE on 07-Feb-1997. It was also a case of actual medication error due to wrong route of administration (Both vaccines were given via oral route). On 05-DEC-2005, 5 years 5 months 4 days post vaccination, patient developed events Bacterial pneumonia, Injury in face, Common Cerebri, Swelling at right knee, Chest ache, Vomiting once, Wound at forehead and eyebrow, Heamatoma at right knee, Colitis. On 15-DEC-2005, 5 years 5 months 14 days post vaccination, patient developed events Dyspnoea. On 01-JAN-2005, 4 years 6 months post vaccination, patient developed events Respiratory distress, Breast pain, Fall, Oesophageal discomfort, Bone loss in jaw, mucus in stool, Renal cyst, Ear pain, esophagitis, Fungal infection NOS, chest pain (non-cardiac), swallowing disorder, dyspnea, Osteonecrosis of jaw, Bronchitis, Confusional state, Diarrhoea, this events assessed as death. Acute respiratory insufficiency this event assessed as medical significant. On an unknown date, patient developed non-serious Gastroenteritis non-infectious NOS, Joint hematoma, Nausea, Urinary hesitancy. Autopsy was not performed. Causes of death was reported as Confusion, Face injury, Commotio cerebri, Dyspnea, Joint hematoma, Renal cyst, Oesophageal discomfort, Swelling of R knee, Chest pain, Breast pain, Mucous stool, Esophagitis, Bone loss in jaw, Chest pain (non-cardiac), Bacterial pneumonia, unspecified, Fungal infection NOS, Vomiting, Swallowing disorder, Ear pain, Diarrhea, Osteonecrosis of jaw, Respiratory distress, Bronchitis, fall, Wound. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder''s compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Sender''s Comments: Medical comment: Based on review of available reported data does not allow for a proper causality assessment. Causality cannot be completely assessed due to limited information. MAC for ibuprofen: The review of available reported data does not allow for a proper causality assessment of the role of ibuprofen for reported events due to limited information. Sender''s Comments: Follow-up information received on 05-Nov-2018 changes the previous company assessment as follows: This case concerns a 83 years old female patient who died after presented with Bronchitis, Osteonecrosis of jaw, Non-cardiac chest pain, Oesophagitis, Renal cyst, Mucous stools, Face injury, Concussion, Haemarthrosis, Oesophageal discomfort, Respiratory distress, Pneumonia bacterial, Haemarthrosis, Acute respiratory failure, Urinary hesitation and other symptoms. Post intake of Tetanus Toxoid, Influenza Vaccine, MUTAGRIP along with other non-company suspects. Concomitant therapies included Ibuprofen, Vitamin D3, Lisinopril, Hct Beta, Pantoprazole. Time to onset is too long to be compatible. Autopsy was not performed although cause of death suggestive of death due to Confusion, Face injury, Commotio cerebri, Dyspnea, Joint hematoma, Renal cyst, Oesophageal discomfort, Swelling of R knee, Chest pain, Breast pain, Mucous stool, Esophagitis, Bone loss in jaw, Chest pain (non-cardiac), Bacterial pneumonia, unspecified, Fungal infection NOS, Vomiting, Swallowing disorder, Ear pain, Diarrhea, Osteonecrosis of jaw, Respiratory distress, Bronchitis, fall, Wound. Patient had multiple ongoing medical conditions which give suspicion of progression of the events. For a precise causality assessment, detailed descriptions of the events along with autopsy and lab results are needed. Based on available information the role of individual suspects cannot be assessed. Reported Cause(s) of Death: Bacterial pneumonia, unspecified; Fungal infection NOS; Vomiting; Swallowing disorder; Ear pain; Diarrhea; Osteonecrosis of jaw; Respiratory distress; Bronchitis; Fall; Wound; Breast pain; Face injury; Brain disorder NOS; Joint hematoma; Oesophageal.


VAERS ID: 788880 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death, Product administered to patient of inappropriate age, Wrong product administered
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-07-24
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: BRSA2018SA323355

Write-up: Initial information received on 22-Nov-2018 regarding an unsolicited valid serious case received from received from Physician via from partner company on 22-Nov-2018 and transmitted to Sanofi on 22-Nov-2018 and additional information was received on 23-Nov-2018. This case involves a 9 days old male patient who died after receiving Influenza Vaccine instead of Hepatitis B Vaccine. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect Influenza Vaccine produced by unknown manufacturer lot number, expiry date not reported via unknown route in unknown administration site instead of suspect Hepatitis B Vaccine not produced by Sanofi Pasteur lot number not reported. On an unknown date, the patient received the influenza vaccine instead the hepatitis B vaccine (medication error situation). It was an actual medication error due to wrong product administered, inappropriate age at vaccine administration and died 9 days after the application (death). Lab data was not provided. Final diagnosis was (fatal) patient received the influenza vaccine instead the hepatitis B vaccine (medication error situation) and died 9 days after the application. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Fatal on 24-Jul-2016. It is unknown if an autopsy was done. The cause of death was reported as Death NOS and Wrong product administered. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none. Sender''s Comments: This case concerns a neonate patient who received the Influenza Vaccine produced by unknown manufacturer instead the hepatitis B vaccine (medication error situation) and died 9 days after the application. Patient''s past history, medical condition at time of vaccination and clinical course of the events which preceded to death are not reported. Death could have been caused due to any of the alternate etiologies unrelated to vaccination. Autopsy results confirming the cause of death along with any lab tests performed if any should be provided. Based upon reported information the role of the vaccine cannot be assessed. Reported Cause(s) of Death: Death NOS; wrong vaccine administered.


VAERS ID: 794791 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2018-11-17
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. R012427 / 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: HK0095075131812HKG012739

Write-up: This spontaneous report was received from a physician via company representative regarding a currently 85 years-old male patient. The patient''s relevant medical history, concurrent conditions and concomitant medications were not reported. On 17-NOV-2018, the patient went to hospital for anti-itch shot and on the same day he was vaccinated with PNEUMOVAX 23 (strength, dose, frequency were not reported, lot # R012427 and expiration date: 07-DEC-2019 for prophylaxis) and influenza virus vaccine inactivated (unspecified). On an unknown date in 2018, the patient died (medically significant), and the patient''s daughter informed the doctor about his death on 24-DEC-2018. The cause of death was not reported. It was unknown if autopsy was performed. The patient''s daughter also stated that it was the doctors fault to inject the three shots on the same day for her father. After the evaluation, the physician thought the patient''s death did not relate to PNEUMOVAX 23 because the patient did not come back for assessment after 3 days, and he did not know what was happened in that month period. This is one of the three reports received from the same reporter. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between PNEUMOVAX 23 and the reported event of death cannot be established. Causality assessment is impacted by concurrent vaccination and limited information regarding concurrent conditions, medical history, concomitant medications and cause of death. Company Comment- No changes to the PNEUMOVAX 23 product safety information are warranted at this time. Merck and Co., Inc., continues to monitor the safety profile of the product.; Sender''s Comments: HK-009507513-1812HKG012745: HK-009507513-1812HKG012741:; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 795792 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       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: ESSA2019SA008724

Write-up: Initial information received on 08-Jan-2019 regarding an unsolicited valid serious case received from a consumer/non-health care professional via press release. This case involves 3 patients (age was not reported) of unknown demographics had died because of the flu, according to the Health Department web page Country three of the deceased patients were vaccinated with INFLUENZA VACCINE. The patient''s past medical history, medical treatment(s), vaccination(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, expiry date, dose, dose in series, route and site of administration was not reported). On an unknown date, following the vaccination the patients had died because of flu. This event was leading to death. According to the information indicated in the press release (based on the information included in the Health Department web page of the Country, four people of unknown demographics had died because of the flu since the vaccination campaign had started in the Country. According to the Health Department web page of the Country three of the deceased patients were vaccinated. (Other relevant tests included no lab data.) Final diagnosis was (fatal) three people of unknown demographics had died because of the flu. It was not reported if the patient received a corrective treatment. It was unknown if an autopsy was done. The cause of death was reported as flu. List of documents held by sender: none. Sender''s Comments: Three people of unknown age and gender passed away due to influenza infection were reported by Health Department. Date of vaccination, past medical history, concomitant medication, date of death are not reported. Additional details from vaccination history, past medical history, concomitant medication, as well as clinical and laboratory investigation. Surrounding reported events are needed to fully assess causality for this case. Based on available information the role of vaccine cannot be assessed. Reported Cause(s) of Death: Flu like symptoms.


VAERS ID: 796520 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death, H1N1 influenza, Influenza, Influenza A virus test positive, Polymerase chain reaction 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:
Current Illness: Hemodialysis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Influenza A virus test positive; Result Unstructured Data: Test Result: Influenza A(H1N1) subtype, Test Result Unit: unknown; Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: BEGLAXOSMITHKLINEBE2019GS

Write-up: This case was reported in a literature article and described the occurrence of suspected vaccination failure in a subject who received quadrivalent seasonal influenza vaccine for prophylaxis. Concurrent medical conditions included hemodialysis. On an unknown date, unknown after receiving quadrivalent seasonal influenza vaccine, the subject developed vaccination failure. Serious criteria included death and GSK medically significant. Additional event(s) included H1N1 influenza with serious criteria of death. It was unknown if an autopsy was performed. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included H1N1 influenza (fatal). The reported cause of death was H1N1 influenza. The investigator considered that there was a reasonable possibility that the vaccination failure and H1N1 influenza may have been caused by quadrivalent seasonal influenza vaccine. Relevant Tests: Lab tests were performed between December 2017 and April 2018, the patient was found positive for type A influenza virus (H1N1 subtype) through PCR Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Influenza A virus test positive result was Influenza A (H1N1) subtype unknown. On an unknown date, Polymerase chain reaction 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 patient of unspecified age and gender who was vaccinated with unspecified quadrivalent seasonal influenza vaccine (manufacturer unknown) for prophylaxis. The patient was a part of retrospective analysis that assessed the group of hemodialysis (HD) patients from December 2017 to April 2018 who were infected by the influenza virus type A or B and their vaccination status. The study also determined whether C-reactive protein (CRP) analysis and influenza virus detection by polymerase chain reaction (PCR) assay help to distinguish bacterial or viral infection and improve patient care. No information on patient''s family history or concomitant medication was provided. On an unspecified date, the patient received unspecified quadrivalent seasonal influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). On an unspecified date between December 2017 and April 2018, an unknown period after vaccination, the patient developed symptoms suggestive of flu and/or unexplained CRP. The patient was found positive for type A influenza virus (H1N1 subtype) through PCR. [In this study, in the ‘PCR positive'' group (n = 29), 20 patients were empirically treated with antibiotics. When the PCR returned positive, immediately stopped the antibiotics in a large majority of patients (n = 13/20), except for bacterial superinfection (n = 7/20)]. Subsequently, on an unspecified date, the patient died. The cause of death was Influenza A (H1N1) infection. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered serious due to death/suspected vaccination failure. The author did not comment on the relationship between the event of influenza A (H1N1) infection and unspecified quadrivalent seasonal influenza vaccine. The author concluded, "In our study, influenza virus vaccination rate in our HD centre was higher than those published in the literature but it does not reach the goal of the WHO. Half of infected HD patients were vaccinated which confirms the data and the relative lack of effectiveness of the vaccine in this population. For this 2017-2018 epidemic, vaccinated HD patients were more infected by influenza virus type B than type A in our centre. This might suggest that influenza virus type B was more virulent or not well covered by the quadrivalent vaccine. Interestingly, high CRP level was frequently seen and not helpful to discriminate bacterial or viral infection. However, we suggest that PCR analysis on nasopharyngeal swabs is a promising tool to reduce the rate of futile antibiotic treatment". Lab Comments: Lab tests were performed between December 2017 and April 2018, the patient was found positive for type A influenza virus (H1N1 subtype) through PCR. Reported Cause(s) of Death: Influenza A (H1N1) infection.


VAERS ID: 796527 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       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: Diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had no comorbidity and never smoked. The patient''s age at the time of enrollment was 78.0 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015 Influenza seasoning year, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 15 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the Southeast region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796528 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Other       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: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had no comorbidity and never smoked. The patient''s age at the time of enrollment was 92.0 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 46 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796529 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       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: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had no comorbidity and never smoked. The patient''s age at the time of enrollment was 81.0 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2016, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 50 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796530 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       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: Medical History/Concurrent Conditions: Smoker (Still smokes or ever smoked but stopped less than 1 month)
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included smoker (Still smokes or ever smoked but stopped less than 1 month). On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplement data 2 in this literature article. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling Thai adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had no comorbidity. The patient was still smoker or had a smoking status but stopped smoking less than 1 month. The patient''s age at the time of enrollment was 82.2 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2016, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 43 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries." This is 1 of 777 valid cases reported in the same literature article.; Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796531 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       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: Cerebrovascular disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included cerebrovascular disorder. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had had comorbidity of Cerebrovascular disease and never smoked. The patient''s age at the time of enrollment was 73.2 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 23 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796532 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       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: Cancer; Diabetes; Smoker (Still smokes or ever smoked but stopped less than 1 month)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included cancer, diabetes and smoker (Still smokes or ever smoked but stopped less than 1 month). On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of Cancer and Diabetes. The patient was still smoker or had a smoking status but stopped smoking less than 1 month. The patient''s age at the time of enrollment was 66.4 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 3 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796533 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       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: Cerebrovascular disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included cerebrovascular disorder. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The had comorbidity of Cerebrovascular disease and never smoked. The patient''s age at the time of enrollment was 69.6 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 41 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796534 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       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: Pulmonary tuberculosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included pulmonary tuberculosis. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of pulmonary tuberculosis and never smoked. The patient''s age at the time of enrollment was 77.1 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 5 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796535 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       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: Cerebrovascular disorder; Smoker (Still smokes or ever smoked but stop less than 1 month)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included cerebrovascular disorder and smoker (Still smokes or ever smoked but stop less than 1 month). On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of cerebrovascular disease and the patient was still smoker or had a smoking status but stopped smoking less than 1 month. The patient''s age at the time of enrollment was 74.6 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 42 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796536 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       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: Cerebrovascular disorder; Chronic kidney disease; Diabetes; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker (Ever smoked but stopped equal to or more than 1 month)
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included diabetes, smoker (Ever smoked but stopped equal to or more than 1 month), hypertension, cerebrovascular disorder and Chronic kidney disease. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of diabetes, hypertension, cerebrovascular disease and chronic kidney disease and the patient had a smoking status but stopped smoking equal to or more than 1 month. The patient''s age at the time of enrollment was 82.1-year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2016, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 33 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796537 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       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: Diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included diabetes. Additional information was provided. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of diabetes and never smoked. The patient''s age at the time of enrollment was 72.8-year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2016, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 43 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796539 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       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: Diabetes
Preexisting Conditions: Medical History/Concurrent Conditions: Pulmonary tuberculosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included diabetes and pulmonary tuberculosis. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of pulmonary tuberculosis and diabetes and never smoked. The patient''s age at the time of enrollment was 67.8-year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2016, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 26 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796562 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       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: Smoker (Still smokes or ever smoked but stopped less than 1 month)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included smoker (Still smokes or ever smoked but stopped less than 1 month). On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had no comorbidity. The patient was still smoker or had a smoking status but stopped smoking less than 1 month. The patient''s age at the time of enrollment was 68.9 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 42 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796563 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       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: Smoker (Still smokes or ever smoked but stopped less than 1 month)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included smoker (Still smokes or ever smoked but stopped less than 1 month). On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had no comorbidity. The patient was still smoker or had a smoking status but stopped smoking less than 1 month. The patient''s age at the time of enrollment was 72.0 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 26 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796564 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       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: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had no comorbidity and never smoked. The patient''s age at the time of enrollment was 82.2 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 31 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796565 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       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: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had no comorbidity and never smoked. The patient''s age at the time of enrollment was 76.3 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 10 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796566 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       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: Smoker (Still smokes or ever smoked but stopped less than 1 month)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included smoker (Still smokes or ever smoked but stopped less than 1 month). On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had no comorbidity. The patient was still smoker or had a smoking status but stopped smoking less than 1 month. The patient''s age at the time of enrollment was 75.0 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 7 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796567 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       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: Medical History/Concurrent Conditions: Smoker (Ever smoked but stopped smoking equal to or more than 1 month)
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included smoker (Ever smoked but stopped smoking equal to or more than 1 month). On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had no comorbidity. The patient had a smoking status but stopped smoking equal to or more than 1 month. The patient''s age at the time of enrollment was 70.1 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 4 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796568 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       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: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had no comorbidity and never smoked. The patient''s age at the time of enrollment was 73.1 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 4 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796569 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       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: Medical History/Concurrent Conditions: Smoker (Still smokes or ever smoked but stopped less than 1 month)
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included smoker (Still smokes or ever smoked but stopped less than 1 month). On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had no comorbidity. The patient was still smoker or had a smoking status but stopped smoking less than 1 month. The patient''s age at the time of enrollment was 75.3 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 38 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796570 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       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: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had no comorbidity and never smoked. The patient''s age at the time of enrollment was 68.1 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 46 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796571 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       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: Medical History/Concurrent Conditions: Smoker (Ever smoked but stopped smoking equal to or more than 1 month)
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included smoker (Ever smoked but stopped smoking equal to or more than 1 month). On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had no comorbidity. The patient had a smoking status but stopped smoking equal to or more than 1 month. The patient''s age at the time of enrollment was 67.3 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 28 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796572 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       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: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had no comorbidity and never smoked. The patient''s age at the time of enrollment was 79.5 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 32 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in this country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796573 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       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: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had no comorbidity and and never smoked. The patient''s age at the time of enrollment was 74.5 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 2 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796574 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       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: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had no comorbidity and and never smoked. The patient''s age at the time of enrollment was 89.9 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2016, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 34 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796575 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       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: Cancer
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker (The patient had a smoking status but stopped smoking equal to or more than 1 month)
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included cancer and smoker (The patient had a smoking status but stopped smoking equal to or more than 1 month). On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of cancer. The patient had a smoking status but stopped smoking equal to or more than 1 month. The patient''s age at the time of enrollment was 83.6-year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 49 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults in Thailand, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796576 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       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: Hypertension; Smoker (The patient had a smoking status but stopped smoking less than 1 month)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included hypertension and smoker (Still smokes or ever smoked but stop less than 1 month). On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplement data 2 in this literature article. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of hypertension. The patient still smokes or ever smoked but stop less than 1 month. The patient''s age at the time of enrollment was 76.4 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 40 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies in specific country and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796577 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       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: Chronic kidney disease; Diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included diabetes and chronic kidney disease. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of Diabetes and Chronic kidney disease and never smoked. The patient''s age at the time of enrollment was 67.4 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 38 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796578 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       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: Cerebrovascular disorder
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker (Ever smoked but stopped equal to or more than 1 month)
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included cerebrovascular disorder and smoker (Ever smoked but stopped equal to or more than 1 month). On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplement data 2 in this literature article. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of Cerebrovascular disease. The patient had a smoking status but stopped smoking equal to or more than 1 month. The patient''s age at the time of enrollment was 81.8 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 6 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796579 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       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: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine. Concurrent medical conditions included hypertension. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had had comorbidity of Hypertension and never smoked. The patient''s age at the time of enrollment was 80.6 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 33 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796580 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       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: Diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included diabetes. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of Diabetes and never smoked. The patient''s age at the time of enrollment was 71.6 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 28 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796581 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       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: Diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included diabetes. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplement data 2 in this literature article. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had had comorbidity of Diabetes and never smoked. The patient''s age at the time of enrollment was 69.3 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 27 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796582 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       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: Coronary artery disease; Heart disorder (Abnormal heart rythms); Thalassemia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly female subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included thalassemia, coronary artery disease and abnormal heart rythms. On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a female patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplement data 2 in this literature article. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling Thai adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had had comorbidity of Thalassemia, Coronary artery disease and Abnormal heart rythms. The patient never smoked. The patient''s age at the time of enrollment was 67.8 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 25 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries in the region." This is 1 of 777 valid cases reported in the same literature article.; Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 796583 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       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: Chronic bronchitis
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker (Ever smoked but stopped equal to or more than 1 month)
Allergies:
Diagnostic Lab Data:
CDC Split Type: THGLAXOSMITHKLINETH2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent medical conditions included chronic bronchitis and smoker (Ever smoked but stopped equal to or more than 1 month). On an unknown date, less than a year after receiving trivalent inactivated influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to trivalent inactivated influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death NOS in a male patient aged equal or more than 65 years who was vaccinated with unspecified trivalent inactivated influenza vaccine (IIV3) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to supplement data 2 in this literature article. The patient was a part of 2-year prospective cohort study to measure the effectiveness of trivalent inactivated influenza vaccine (IIV3) to prevent laboratory-confirmed influenza among community dwelling adults aged equal or more than 65 years during 2015-16 and 2016-17 influenza seasons. The study conducted from May 2015 to May 2017. The influenza season was defined as June of each year through May of the following year (e.g. the 2015-16 season spanned June 2015-May 2016). The patient had comorbidity of chronic bronchitis and the patient had a smoking status but stopped smoking equal to or more than 1 month. The patient''s age at the time of enrollment was 69.1 year. No information on patient''s family history or concomitant medication was provided. On an unspecified date in 2015, the patient received unspecified trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, at week 37 of follow-up, the patient was found dead. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. The author stated that, "Our study provides evidence of influenza VE in a middle-income tropical country representative of a region that has been largely under-represented to date in global influenza VE studies. We show that seasonal influenza vaccines can provide moderate protection among community-dwelling older adults, provided there is a good match between the circulating viruses and vaccine strains and document variation in influenza VE across two study seasons. We also demonstrate the feasibility of using self-swabbing and a prospective cohort design to assess VE among older adults. Future studies in other tropical countries can use a similar study design over multiple seasons to ensure at least one season with a good match, to assess the impact of influenza vaccination over time. In addition to contributing to the global evidence base for influenza vaccination among older adults, data from this study will directly inform influenza vaccination policies and other countries in the region." This is 1 of 777 valid cases reported in the same literature article. Reported Cause(s) of Death: Unknown cause of death.


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