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

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

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

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


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

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

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

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


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

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

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

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


VAERS ID: 902085 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA354698

Write-up: pneumonia; Initial information received on 09-Dec-2020 regarding an unsolicited valid serious case received from a consumer. This case involves female patient of an unknown age who experienced pneumonia, while she received vaccine INFLUENZA VACCINE. Medical history, medical treatment, concomitant medication, vaccination and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a serious pneumonia (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death. It was also reported that patient developed pneumonia and never recovered from it, she passed away. Details of laboratory data not reported. It was not reported if the patient received a corrective treatment. Date of death was not reported. It was unknown at the time of reporting if an autopsy was done and the cause of death was not reported. Information on the batch number was requested.; Sender''s Comments: This was a poorly documented case involves a female patient of an unknown age who died due to pneumonia, after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. However, patient''s medical condition at the time of vaccination, concomitant therapy, previous vaccination and tolerance, allergic history, autopsy result and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: Pneumonia


VAERS ID: 902087 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Meningitis viral
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: USSA2020SA355323

Write-up: viral meningitis; Initial information was received on 08-Dec-2020 regarding an unsolicited valid serious case from a non-healthcare professional. This case involved a 48-year-old female patient who had viral meningitis (meningitis viral), after she received INFLUENZA VACCINE (MONOVALENT) (H1N1: Hemagglutinin Type 1 and Neuraminidase Type 1) and died. The patient''s medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not reported. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (MONOVALENT) produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination. On an unknown date, the patient developed serious viral meningitis (meningitis viral), 2 days following the administration of INFLUENZA VACCINE (MONOVALENT). This event was assessed as medically significant and was leading to death. Details of laboratory data were not reported. It was not reported if the patient received any corrective treatment. On an unknown date, 2 days after vaccination, the patient had died due to viral meningitis. It was unknown if an autopsy was done and the cause of death was reported as viral meningitis. Information on the batch number was requested.; Sender''s Comments: This poorly documented case concerns a 48-year-old patient who had meningitis viral, after vaccination with INFLUENZA VACCINE (MONOVALENT) (produced by unknown manufacturer) and died 2 days after meningitis. The time to onset is unknown. Also, patient''s medical condition at the time of vaccination, autopsy result, previous vaccination and tolerance, lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: Viral meningitis


VAERS ID: 902545 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / UNK - / -

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

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

Write-up: died; This case was reported by a consumer via interactive digital media and described the occurrence of death in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, 4 days after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were received as follows: The age at vaccination was not reported. The patient had died from Flu vaccine after 4 days of receiving vaccine.; Sender''s Comments: US-GLAXOSMITHKLINE-US2020AMR240811:same reporter; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 924934 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2021SA003714

Write-up: green bret syndrome and he died from it; Initial information was received on 05-Jan-2021 regarding an unsolicited valid serious social media case from a consumer. This case is linked to case 2021SA003660 (same reporter). This case involves male patient (of an unknown age) who had green bret syndrome and he died from it (Guillain-Barre Syndrome) after receiving NFLUENZA VACCINE. Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed serious green bret syndrome and he died from it (Guillain-Barre Syndrome) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death. Details of laboratory data were not reported. It was not reported if the patient received any corrective treatment. On an unknown date, the outcome was reported as fatal for the event Guillain-Barre syndrome. It is unknown if an autopsy was done. The cause of death was reported as Guillain-Barre syndrome. Information on the lot number was requested.; Sender''s Comments: This was a poorly documented social media case involves male patient (of an unknown age) who had Guillain-Barre Syndrome and died from it, after receiving INFLUENZA VACCINE. Time to onset is unknown. Additional information regarding patient''s relevant medical history, health condition at the time of vaccination, laboratory tests ruling out other alternate etiologies and autopsy results is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: green bret syndrome


VAERS ID: 981303 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2021SA025266

Write-up: pneumonia; Initial information was received on 21-Jan-2021 regarding an unsolicited valid serious case from a consumer/non-health care professional. This case involves an 87 years old male patient who had a fatal pneumonia, while he received INFLUENZA VACCINE. It is unknown if the patient had any medical history, concomitant disease or risk factor. Medical treatment(s), past vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination On an unknown date, the patient developed a serious pneumonia (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death. The patient was full of hair, most of his teeth and healthy to his last year with no flu shot ever until the last year. It is unknown if the patient experienced any additional symptoms/events There were no laboratory data/results available. It was not reported if the patient received a corrective treatment before death. At the time of report, the outcome of event was fatal It is unknown if an autopsy was done. The cause of death was Pneumonia. Information on batch number was requested for this case; Sender''s Comments: This poorly documented case, involves an 87 years old male patient who had a fatal pneumonia following the administration of INFLUENZA VACCINE (unknown manufacturer). The time to onset was unknown. Additional information regarding patient''s medical history, condition at the time of vaccination, concomitant medications, lab /radiological investigation excluding other etiologies and detailed autopsy report would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed; Reported Cause(s) of Death: pneumonia


VAERS ID: 1022215 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Lung disorder, 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: USSA2021SA044762

Write-up: died of pulmonary complications resulting from pneumonia; died of pulmonary complications resulting from pneumonia; Initial information was received on 18-Dec-2020 regarding an unsolicited valid serious social media case from a consumer/other non-professional (patient wife). This case involves male patient (of an unknown age) who died due to pulmonary complications resulting from pneumonia (pneumonia) and (lung disorder), after vaccination with INFLUENZA VACCINE. Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patient received a dose suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at an unknown administration site. On an unknown date, the patient had serious pulmonary complications resulting from pneumonia (pneumonia) and (lung disorder) (within a week) following the administration of INFLUENZA VACCINE. These events were leading to death. The event pneumonia was assessed as medically significant. It was unknown if the patient experienced any additional symptoms/events. The reporter stated that, do not trust anything medical without knowing all ingredients and side effects. Details of laboratory data were not reported. It was not reported if the patient received any corrective treatment. It was unknown if an autopsy was done. The cause of death was reported as Pneumonia and Lung disorder. Information on the lot number was requested.; Sender''s Comments: This was a poorly documented social media case involving a male patient (of an unknown age) who had pneumonia and lung disorder and died from it, after receiving INFLUENZA VACCINE from unknown maufacturer. Time to onset is unknown. Additional information regarding patient''s relevant medical history, health condition at the time of vaccination, laboratory tests ruling out other alternate etiologies and autopsy results is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: died of pulmonary complications resulting from pneumonia; died of pulmonary complications resulting from pneumonia


VAERS ID: 1030860 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2021SA051232

Write-up: two patient died after vaccination with INFLUENZA; Initial information received on 10-Feb-2021 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional. This case involves two patients (unspecified age and gender) who died after receiving INFLUENZA VACCINE (death). The medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, two patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, two patients died after vaccination with INFLUENZA (death) unknown latency following the administration of INFLUENZA VACCINE.. The event was also assessed as medically significant. It was unknown if the patients experienced any additional symptoms/events. It was unknown if there were lab data/results available. It was not reported if the patients received a corrective treatment before death. An autopsy was not done and the actual cause of death was not reported at the time of reporting. The reporter could not provide any other information about the case. Information on the batch number was requested.; Sender''s Comments: This case concerns two patients (unspecified age and gender), who died after vaccination with INFLUENZA VACCINE (death) (produced by unknown manufacturer). The time to onset was unknown. However, patients medical condition at the time of vaccination, autopsy result and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: lost 2 friends who took it


VAERS ID: 1040925 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2021SA056035

Write-up: Patient died from a flu shot; Initial information was received on 12-Feb-2021 regarding an unsolicited valid serious case from a consumer or non-health care professional via social media. This case involves a male patient (age unspecified) who died (death), after he received INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease or risk factor. Past medical treatment, vaccination, family history and concomitant medication were not reported. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination. On an unknown date, the patient died (death), (unknown latency) following the administration of INFLUENZA VACCINE. This event was also assessed as medically significant. It was unknown if the patient experienced any additional symptoms/events before death. It was unknown if there were laboratory data/results available. It was not reported if the patient received any corrective treatment before death. It was unknown if an autopsy was done. The cause of death was not clearly specified (patient was died from flu shot). At the time of reporting it was reported that, product name was not provided and it was reported via public post on the Sanofi flu shot campaign hence reporter assumed that the consumer was referring to the Sanofi flu vaccine. There will be no information available on the batch number for this case.; Sender''s Comments: This was a poorly documented social media case received from involved a male patient (age unspecified) who died (death) after administration of INFLUENZA VACCINE. The time to onset is unknown. Further information regarding medical history, concomitant disease or risk factor, concurrent condition during vaccination, previous vaccination and tolerance, laboratory tests ruling out other alternate etiologies and autopsy results is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: patient died from a flu shot


VAERS ID: 1045647 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2021SA058227

Write-up: patient died from a flu shot; Initial information was received on 12-Feb-2021 regarding an unsolicited valid serious case from a consumer or non-health care professional via social media. This case is linked to case 2021SA056035. (same reporter) This case involves a male patient (reporter''s father in-law) (age unspecified) who died (death), after he received INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease or risk factor. Past medical treatment, vaccination, family history and concomitant medication were not reported. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination. On an unknown date, the patient died from a flu shot (death) (unknown latency) following the administration of INFLUENZA VACCINE. This event was also assessed as medically significant. It was unknown if the patient experienced any additional symptoms/events before death. It was unknown if there were laboratory data/results available. It was not reported if the patient received any corrective treatment before death. It was unknown if an autopsy was done. The cause of death was reported as, the patient died from a flu shot. At the time of reporting it was reported that, product name was not provided and it was reported via public post on the Sanofi flu shot campaign hence reporter assumed that the consumer was referring to the Sanofi flu vaccine. There will be no information available on the batch number for this case.; Sender''s Comments: This was a poorly documented social media case received from involved a male patient (age unspecified) who died (death) after administration of INFLUENZA VACCINE. The time to onset is unknown. Further information regarding medical history, concomitant disease or risk factor, concurrent condition during vaccination, previous vaccination and tolerance, laboratory tests ruling out other alternate etiologies and autopsy results is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: patient died from a flu shot


VAERS ID: 1056673 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2021SA056822

Write-up: Flu shots do kill; Initial information received on 11-Feb-2021 regarding an unsolicited valid serious case received from a consumer/non-hcp via media. This case involves Adult female patient (reporter''s mother in-law) (age unspecified) who died (death), after she received INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease or risk factor. Past medical treatment, vaccination, family history and concomitant medication were not reported. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient died from flu shot (death) (unknown latency) following the administration of INFLUENZA VACCINE. It was unknown if the patient experienced any additional symptoms/events before death. It was unknown if there were laboratory data/results available. It was not reported if the patient received any corrective treatment before death. It was unknown if an autopsy was done. There will be no information available on the batch number for this case.; Sender''s Comments: This was a poorly documented media case which involves an adult female patient who died, after she received vaccines INFLUENZA VACCINE. The time to onset was unknown. Further information regarding medical history, concomitant disease or risk factor, concurrent condition during vaccination, previous vaccination and tolerance, laboratory tests ruling out other alternate etiologies and autopsy results is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: Flu shots do kill


VAERS ID: 1122744 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUR4: INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT) / PROTEIN SCIENCES CORPORATION - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory failure, Aspiration, Asthenia, Atrial fibrillation, Bronchial secretion retention, Condition aggravated, Coronary artery disease, Death, Gastrointestinal haemorrhage, Hypertension, Immunoglobulin therapy, Mechanical ventilation, Muscular weakness, Myasthenic syndrome, Pneumonia, Respiratory failure, Shock haemorrhagic
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Supraventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Malignancy related conditions (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Ischaemic colitis (broad), Hypertension (narrow), Eosinophilic pneumonia (broad), Other ischaemic heart disease (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Coronary artery disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2021SA091252

Write-up: weakness/progressive generalized muscle weakness/neuromuscular weakness of unknown etiology; respiratory failure/acute hypoxic respiratory failure; recurrent aspiration; recurrent mucus plugging; pneumonia; gastrointestinal bleeding; hemorrhagic shock; hypertension; Atrial fibrillation; possibly GBS; Eaton-Lambert syndrome; myasthenia gravis; Initial information received on 13-Mar-2021 regarding an unsolicited valid serious case from a other health professional. This case is linked to cases 2021SA091271, 2021SA091226, 2021SA091286, 2021SA091303, 2021SA091334, 2021SA091349, 2021SA091366, 2021SA091398, 2021SA091448, 2021SA091468, 2021SA091489, 2021SA091516, 2021SA091556, 2021SA091604, 2021SA091690, 2021SA091745, 2021SA091782, 2021SA091798, 2021SA091833, 2021SA091855 and 2021SA091879. (Same Literature article) Abstract: On October 7, 2016, the Food and Drug Administration approved recombinant hemagglutinin quadrivalent influenza vaccine (RIV4) (Spodoptera frugiperda cell line; Flublok Quadrivalent) for active immunization for the prevention of influenza disease in individuals 18 years of age and older. Clinical trials did not reveal any major differences in adverse events or serious adverse events following Flublok Quadrivalent versus standard dose quadrivalent inactivated influenza vaccine. To improve our understanding of the safety profile of this vaccine, we reviewed and summarized adverse event reports after Flublok Quadrivalent administration to the vaccine adverse event reporting system (VAERS). Through June 30, 2020, VAERS received 849 reports after RIV4 vaccination. The vast majority (810; 95%) were nonserious. Among serious events, there were 10 cases of Guillain-Barre syndrome, including 5 people who required mechanical ventilation and 2 people who died. Many allergic reactions were reported as non-serious, but required interventions to treat a life-threatening event, example: epinephrine, nebulizers, albuterol, glucocorticoids, and supplemental oxygen. Two people experienced a positive rechallenge (which are allergic reactions after repeated vaccination with RIV4), including a person who despite premedication with antihistamines developed respiratory difficulties, required epinephrine, and was transported to the emergency department. The occurrence of anaphylaxis and other allergic reactions in some individuals may reflect an underlying predisposition to atopy that may manifest itself after an exposure to any drug or vaccine and does not necessarily suggest that Flublok Quadrivalent is particularly allergenic. Post marketing safety surveillance will continue to be vital for understanding the benefits and risks of quadrivalent recombinant influenza vaccine. This case involves a 84 year old male patient who experienced weakness/progressive generalized muscle weakness/neuromuscular weakness of unknown etiology (muscular weakness), respiratory failure/acute hypoxic respiratory failure (acute respiratory failure), recurrent aspiration (aspiration), recurrent mucus plugging (bronchial secretion retention), pneumonia, gastrointestinal bleeding (gastrointestinal haemorrhage), hypertension, atrial fibrillation, possibly GBS (Guillain-Barre syndrome) and Eaton-Lambert syndrome (myasthenic syndrome) or myasthenia gravis, after he received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV]. Past medical treatment, vaccination family history and concomitant medications were not reported. At the time of the event, the patient had ongoing coronary artery disease. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [lot number, expiry date and other dosing details were not reported] via an unknown route at unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a serious weakness (muscular weakness) and respiratory failure (acute respiratory failure), 10 days following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. The patient was hospitalized for this event. The hospital management included mechanical ventilation, intravenous immunoglobulin, and glucocorticoids as a corrective treatment to the patient. It was reported that, patient''s hospital course was complicated by pneumonia, hemorrhagic shock (shock haemorrhagic) due to gastrointestinal bleeding (gastrointestinal haemorrhage), hypertension, and atrial fibrillation. The medical records state that he had neuromuscular weakness of unknown etiology, possibly GBS (Guillain-Barre syndrome), Eaton-Lambert syndrome (myasthenic syndrome) or myasthenia gravis. (unknown latency) The inpatient death summary listed, acute hypoxic respiratory failure with recurrent mucus plugging (bronchial secretion retention) and recurrent aspiration (aspiration) in the setting of progressive generalized muscle weakness. (unknow latency) The pneumonia, shock haemorrhagic, gastrointestinal haemorrhage, atrial fibrillation, Guillain-Barre syndrome, myasthenic syndrome, myasthenia gravis, aspiration, bronchial secretion retention and aspiration were assessed as medically significant. Details of laboratory data not reported. It was not reported if the patient received any additional corrective treatment before death. At the time of reporting, event outcome for pneumonia, gastrointestinal haemorrhage, shock haemorrhagic, hypertension, atrial fibrillation, Guillain-Barre syndrome and myasthenic syndrome or myasthenia gravis was not reported at the time of reporting. The muscular weakness, acute respiratory failure, aspiration and bronchial secretion retention were the events which were listed in death summery hence outcome of these events was considered as Fatal. At the time of reporting, date of death was not reported. It was unknown if an autopsy was done also the cause of death was clearly reported. There will be no information available on the batch number for this case.; Sender''s Comments: This case involved a 84 year old male patient who presented with muscular weakness, acute respiratory failure, aspiration, bronchial secretion retention, pneumonia, gastrointestinal haemorrhage, hypertension, atrial fibrillation, Guillain-Barre syndrome and myasthenic syndrome or myasthenia gravis after the administration of FLUBLOK QIV. Although time of onset is compatible for muscular weakness and acute respiratory failure, concurrently present Lambert Eaton Syndrome and gastrointestinal hemorrhage may indicate complications of existing comorbidities offering potential alternative etiology. At the time of reporting patient had ongoing coronary artery disease. Muscular weakness, acute respiratory failure, aspiration and bronchial secretion retention were the events which listed in death summery. Moreover, information regarding previous vaccination/medical treatment and tolerance, concomitant medications, other additional underlying risk factors if any and their etiological factors, autopsy result and laboratory investigations results, would be needed for further assessment of the case. Based on reported information role of suspect vaccine cannot be assessed.; Reported Cause(s) of Death: weakness/progressive generalized muscle weakness/neuromuscular weakness of unknown etiology; respiratory failure/acute hypoxic respiratory failure; recurrent aspiration; recurrent mucus plugging


VAERS ID: 1135597 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, H1N1 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: USSA2021SA097591

Write-up: died from the Swine flu; Initial information was received on 09-Oct-2020 regarding an unsolicited valid serious case from a consumer or other non-professional via media. This case involves a female patient (age unspecified) who died from the Swine flu (H1N1 influenza), after she received INFLUENZA VACCINE (MONOVALENT) (Swine flu vaccine). Medical history, past medical treatment, vaccination, family history and concomitant medication were not reported. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (MONOVALENT) produced by unknown manufacturer (lot number, expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient died from the serious Swine flu (H1N1 influenza), (unknown latency) following the administration of INFLUENZA VACCINE (MONOVALENT). Details of laboratory data not reported. It was not reported if the patient received any corrective treatment before death. It was unknown if an autopsy was done. The cause of death was reported as H1N1 influenza. Information on the batch number was requested.; Sender''s Comments: This poorly documented media case involves female patient (age unspecified) who died from the H1N1 influenza, after vaccination with INFLUENZA VACCINE (MONOVALENT) (Swine flu vaccine) (unknown manufacturer). Time to onset was unknown. Further information regarding concurrent condition during vaccination, previous vaccination/treatment and tolerance, autopsy result, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed."; Reported Cause(s) of Death: Swine flu


VAERS ID: 1137227 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2021SA098235

Write-up: A 40 year old patient took the flu shot and died; Initial information was received on 10-Oct-2020 regarding an unsolicited valid serious case from a consumer/non-healthcare professional via Media. This case involves a 40 years old male patient who died (death), after he received INFLUENZA VACCINE. The patient''s medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (batch number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination. On an unknown date, the patient died (death) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death. The details of laboratory data were not reported. It was not reported if the patient received a corrective treatment before death. It was unknown if an autopsy was done. The cause of death was not reported. At the time of reporting, the outcome was fatal. Information on the batch number was requested.; Sender''s Comments: This poorly documented media case concerns a 40-year-old male patient who died after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. Additional information regarding patient''s medical history, condition at the time of vaccination, concomitant medications, lab /radiological investigation excluding other etiologies and detail autopsy report would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: A 40 year old patient took the flu shot and died


VAERS ID: 1284618 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Connecticut  
Vaccinated:2019-11-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Bronchitis, COVID-19, Death, General physical health deterioration, Illness, Pneumonia
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (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: Low blood pressure
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2021AM

Write-up: Died of Covid; Got pneumonia as well; Got bronchitis; Flu shot / her / health declined after that; got sick for over a year now; This case was reported by a consumer via other manufacturer and described the occurrence of covid-19 in a elderly female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis. Concurrent medical conditions included low blood pressure. In November 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, less than 2 years after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced covid-19 (serious criteria death), pneumonia (serious criteria GSK medically significant), bronchitis, general physical health deterioration and sickness. On an unknown date, the outcome of the covid-19 was fatal and the outcome of the pneumonia, bronchitis, general physical health deterioration and sickness were unknown. The reported cause of death was covid-19. It was unknown if the reporter considered the covid-19, pneumonia, bronchitis, general physical health deterioration and sickness to be related to Influenza vaccine Quadrivalent 2019-2020 season. Additional details were provided as follows: The case was reported by patient''s daughter. The age at vaccination was not reported. In 2019, the patient received Flu vaccine and got bronchitis, and pneumonia as well and ever since she got sick for over a year. The patient''s health declined after that. The patient was elderly, so the reporter was very careful in following up on protocol. The reporter stated that the patient died of Covid. The reporter consented to follow up. This is 1 of 3 cases reported by the same reporter.; Sender''s Comments: US-GLAXOSMITHKLINE-US2021AMR095136:Same reporter US-GLAXOSMITHKLINE-US2021AMR095203:Same reporter. Flu shot reporter''s case.; Reported Cause(s) of Death: COVID-19


VAERS ID: 38079 (history)  
Form: Version 1.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 1991-12-17
Entered: 1991-12-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chills
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: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: requested
CDC Split Type: CO4045

Write-up: Devel chills early evening p/flu shot; expired sometime that evening;


VAERS ID: 71497 (history)  
Form: Version 1.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 1995-02-15
Entered: 1995-02-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / MEDEVA PHARMA, LTD. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Cerebrovascular accident
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: none
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: none
CDC Split Type: EML95038A

Write-up: pt recvd vax; 2 mo afterwards, had a fatal stroke; previously pt had uneventfull flu vax;


VAERS ID: 72359 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 1995-03-22
Entered: 1995-03-27
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES - / UNK - / -

Administered by: Other       Purchased by: Other
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO5845

Write-up: sudden death following vax (1994); No other details from Danish Committee on ADR, ADR case rpt no 941140;


VAERS ID: 80178 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:1995-10-16
Onset:0000-00-00
Submitted: 1995-12-14
Entered: 1995-12-20
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 2 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Coronary artery disease, Malaise, Myocardial ischaemia, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Other ischaemic heart disease (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: ~ ()~~~In patient
Other Medications: nitrazepam; Bumetanide/KCL;
Current Illness:
Preexisting Conditions: myocardial ischaemia; insomnia;edema;malignant lymphoma;carcinoma,squamous cell;
Allergies:
Diagnostic Lab Data: autopsy on oct95, signs of coronary thrombosis & evidence of myocardial ischemia;
CDC Split Type: WAES95115073

Write-up: pt recvd vax;pt became very ill 1 day p/ vax;vomited dark brown fluid;found dead 23oct95;post mortem showed signs of coronary thrombosis 2-3 days prior to death;evidence of myocardial ischemia;probable COD was coronary artery disease;


VAERS ID: 150146 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2000-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / MEDEVA PHARMA, LTD. 753042 / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Adrenal haemorrhage, Chills, Epistaxis, Meningitis, Pulmonary oedema, Sepsis
SMQs:, Cardiac failure (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Noninfectious meningitis (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: NONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: post-mortem lab work revealed that the pt had meningitis
CDC Split Type: MPU2000001230

Write-up: After receiving his flu vax, pt developed a nosebleed. The pt had never had a nose bleed before and was reported to be fit and healthy prior to vax. He developed rigors and was hospitalized. His condition deteriorated and he was admitted to intensive care. The pt died 3 days after receiving the vax. A post-mortem revealed the cause of death to be septicemia, bilateral adrenal hemorrhage, and pulmonary edema.


VAERS ID: 206349 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2002-10-05
Onset:0000-00-00
Submitted: 2003-07-16
Entered: 2003-07-18
   Days after submission:2
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: Unknown
Symptoms: Pneumonia, Sepsis
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-05-06
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: There was a suggestion that septicaemia was brought about by a urinary tract infection (no details provided).
Allergies:
Diagnostic Lab Data:
CDC Split Type: E200301403

Write-up: A 76 year old female patient received pneumococcal and influenza immunizations on 10/5/02. She is reported to have had pneumonia from which she did not recover. She is also reported to have had Septicaemia. Severity of the conditions is stated as unknown. However, the outcome was fatal (date of death 5/6/03). Post mortem was performed. Sudden death was discounted. Probable cause of death was Septicaemia and Pneumonia. Reaction text states "No definite cause of death was evident at autopsy, but the histology findings suggested that the patient died of pneumonia brought about by septicaemia. It was suggested that the septicaemia was brought about by a urinary tract infection (no details are provided). No further information is expected. Case is closed.


VAERS ID: 206467 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2002-10-05
Onset:0000-00-00
Submitted: 2003-07-15
Entered: 2003-07-22
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pneumonia, Sepsis, Urinary tract infection
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-05-06
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: UNK
Allergies:
Diagnostic Lab Data: Autopsy: no definite cause of death; Post-mortem study: sudden death discounted; Diagnostic pathological examination: suggest patient died of pneumonia brought about by septicemia.
CDC Split Type: WAES0307USA01189

Write-up: Information has been received from a health authority concerning a 76 year old female patient who on 10/5/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Concomitant vaccination included a dose of influenza virus vaccine. Subsequently, the patient developed pneumonia from which she did not recover. The patient also developed septicemia. The severity of the conditions was unknown, however, the outcome was fatal (date of death: 5/6/03). A post mortem study was performed. Sudden death was discounted. Probable cause of death was Septicemia and Pneumonia. (Outcome of Septicemia Fatal, associated direct or indirect). No definite cause of death was evident at autopsy, but the histiology findings suggested that the patient died of pneumonia brought about by septicemia. It was suggested that the septicemia was brought about by a urinary tract infection. The case is closed. Additional information is not expected.


VAERS ID: 247751 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2005-09-29
Onset:0000-00-00
Submitted: 2005-11-18
Entered: 2005-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS DFLUA014A / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: B0399618A

Write-up: This male subject was enrolled in the prophylactic double blind study 104438 (FluarixUS-004). On 29 September 2005, he received the dose of influenza vaccine (Fluarix) or placebo (IM U deltoid). The subject received a dose of Fluarix (lot nbr DFLUA014A). On an unknown date, after the 1st dose of blinded vaccine, the subject died, cause of death is unknown. Investigator causality was unknown at the time of report.


VAERS ID: 249914 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2005-11-03
Onset:0000-00-00
Submitted: 2005-12-29
Entered: 2005-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Cardiac disorder, Coma, Inflammation, Malaise, Pericarditis, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Bendrofluazide, Ramipril, Diclofenac, Orlistat
Current Illness: Gastric Ulcer;Hypertension;Obesity;Proteinuria
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: B0404878A

Write-up: This case was reported by a regulatory authority and described the occurrence of pulmonary edema in a 67 year old male subject who was vaccinated with influenza virus vaccine (influenza vaccine, manufacturer unspecified) for prophylaxis. Concurrent medical conditions included gastric ulcer, hypertension, obesity and proteinuria. Concurrent medications included bendrofluazide, ramipril and diclofenac. On Nov 3 2005 the subject received unspecified dose of influenza vaccine (unknown). At an unspecified time after vaccination he complained of feeling unwell and confined himself to bed. He was found on his bed and was unresponsive - dead. An autopsy was performed ans showed cloudy fluid around the heart, acute inflammation around the surface of the heart, acute pericarditis and pulmonary edema. An inquest is being arranged.


VAERS ID: 255574 (history)  
Form: Version 1.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-05-15
Entered: 2006-05-17
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Fatigue, Headache, Myalgia, Ocular hyperaemia, Pneumonia, Pyrexia, Respiratory disorder, Vaccine positive rechallenge
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Glaucoma (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (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: The pt had a previous history of having a febrile reaction to influenza vaccine. No further information was provided.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200601078

Write-up: Initial report from 01Nov05 received on 09May06. A 72 yr old male pt with previous history of a febrile reaction to influenza vaccination developed red eyes, respiratory symptoms, fever, headache, fatigue and myalgia 12 hrs after receiving the influenza vaccine. The products trade name, manf, lot number, route, site and date of administration was not reported. Per reporter, the pt did not seek medical attention. He remained febrile for eight days and was diagnosed with pneumonia. The pt died 54 days post vaccination due to complications despite medical care. There was insufficient evidence to determine a causal association. Same reporter in case 200601079.


VAERS ID: 255575 (history)  
Form: Version 1.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-05-15
Entered: 2006-05-17
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Dyspnoea, Eye irritation, Pharyngolaryngeal pain, Rhinitis
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Corneal 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: 200601079

Write-up: Initial report from 01Nov05 received on 09May06. A 66 yr old male pt developed eye irritation, sore throat, rhinitis and difficulty breathing within one day after receiving the influenza vaccine. The product''s trade name, manf, lot number, route, site and date of administration not reported. Per reporter, the pt died suddenly eight days later. There was insufficient evidence to determine a causal association.


VAERS ID: 264670 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2005-10-14
Onset:0000-00-00
Submitted: 2006-10-13
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / -
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pyrexia, Sepsis, Shock
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Arteriosclerosis, coronary disease, surgery, cardiac valve disease, type I diabetes mellitus, apoplexy.
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0610USA07430

Write-up: Information has been received from a physician concerning an elderly polypathic male with arteriosclerosis, coronary heart disease (including surgery Nos), valvular heart disease, Type I diabetes mellitus and apoplexy who in 2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant suspect therapy included a dose of influenza virus vaccine (unspecified). Three days post-vaccination, the patient experienced a mild fever. The symptoms worsened and he was hospitalized. Eight days later the patient died because of "septic chock". Other business partner numbers included. No further information is available.


VAERS ID: 265421 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-10-26
Entered: 2006-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Anaemia haemolytic autoimmune, Cardiovascular disorder
SMQs:, Haemolytic disorders (narrow), Systemic lupus erythematosus (broad), Cardiomyopathy (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1997-04-21
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: A0624951A

Write-up: This case was reported by a consumer and described the occurrence of autoimmune hemolytic anemia in a female subject of unspecified age who was vaccinated with influenza virus vaccine (Influenza vaccine unspecified, manufacturer unspecified) for prophylaxis. A physician or other health care professional has not verified this report. In 1990 the subject received unspecified dose of Influenza vaccine unspecified (unknown). At an unspecified time after vaccination with Influenza vaccine unspecified the subject experienced autoimmune hemolytic anemia and aortic valve problem. The subject died on 21 April 1997, cause of death was not reported. It was unknown whether an autopsy was performed.


VAERS ID: 266749 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2006-11-07
Onset:0000-00-00
Submitted: 2006-11-14
Entered: 2006-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA196AC / UNK LA / -

Administered by: Other       Purchased by: Other
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-11-08
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lansoprazole, Anoreine,, (Carrageenan + Zinc oxide + Bismuth subjallate), Macrogol 3350, Proctolog
Current Illness: Constipation, dental care, hemorrhoids, hypertension arterial, shoulder pain.
Preexisting Conditions: Fatigue
Allergies:
Diagnostic Lab Data:
CDC Split Type: B0445909A

Write-up: This case was reported by a pharmacist and a physician an described the occurrence of death in a 83 year old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The subjects past medical history included a scan for unk indication in June 2006 and fatigue during the summer 2006. Concurrent medical conditions included constipation, hemorrhoids, slight hypertension arterial and shoulder pain. Concurrent chronic treatment included Lanzor, Anoreine suppository, Tansipeg, Protolog topic, Depoject. On 10/30/2006, a treatment with Zithromax, Pyralvex, and Diantalvic was prescribed for three days for dental care (NOS). On 11/7/06 the subject received unspecified dose of Fluarix (batch reference AFLUA196AC). The physician reported that the day vaccination, the subject was in good health condition, except shoulder pain. On 11/8/06 in the morning, less than one day after vaccination, the subject''s son found his mother dead in her bed, peaceful. An autopsy was not performed. The physician and pharmacist causality assessment was unk.


VAERS ID: 268885 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-14
Entered: 2006-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: 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: B0449781A

Write-up: This case was reported in a literature article and described the occurrence of sudden death in a 75 year old subject of unspecified gender who was vaccainted with influenza virus vaccine, manufacturer unspecified, for prophylaxis. On an unspecified date the subject received unspecified dose of Influenza vaccine as well as an unspecified prescriptions medication. Two days after vaccination with Influenza vaccine, the subject started feeling unwell. Eight days later, the subject died. The author considered the events were related to vaccination with Influenza vaccine and the co administered unspecified medication. the subject died, cause of death is not specified.


VAERS ID: 344474 (history)  
Form: Version 1.0  
Age: 94.0  
Sex: Male  
Location: Foreign  
Vaccinated:2008-11-14
Onset:0000-00-00
Submitted: 2009-04-17
Entered: 2009-04-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Herpes zoster, No reaction on previous exposure to drug
SMQs:, Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Gabapentin; Fentanyl
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: D0061289A

Write-up: This case was reported by a foreign regulatory authority (# DE-PEI-PEI2009002438) and described the occurrence of herpes zoster in a 94-year-old male subject who was vaccinated with INFLUSPLIT SSW 2008/2009, GlaxoSmithKline. Concurrent medications included Gabapentin and Fentanyl. Previous annual vaccinations with seasonal INFLUSPLIT SSW, GlaxoSmithKline, given on unknown dates, have been well tolerated. On 14 November 2008 the subject received a dose of INFLUSPLIT SSW 2008/2009 (0.5 ml, unknown). At an unspecified time post vaccination with INFLUSPLIT SSW 2008/2009, on an unknown date, the subject experienced herpes zoster. The subject was hospitalised for an unknown period of time. The reporter considered that the event was life threatening. The outcome of the event was fatal. On an unknown date the subject died from herpes zoster. It was unknown whether an autopsy was performed. No further information will be available.


VAERS ID: 349790 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2005-11-07
Onset:0000-00-00
Submitted: 2009-06-23
Entered: 2009-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Confusional state, Death, Hallucination, Lethargy
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-12-02
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: MA20091497

Write-up: We received the following information from a health care professional via the Regulatory Agency on 09 JUN 2009: A female patient was vaccinated with either INFLUVAC (batch no. H21) or an influenza vaccine made by Chiron as a single dose on 07 NOV 2005. Within a few days, she was lethargic and remained in bed till at least the 14 NOV 2005. At the same point she became confused and had hallucinations and was admitted to the Accident and Emergency department at hospital. On 02 DEC 2005, the patient died. Regulatory Agency no.: ADR 20432832. Other no.: GB-SOLVAY-00309002515.


VAERS ID: 352835 (history)  
Form: Version 1.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2000-10-17
Onset:0000-00-00
Submitted: 2009-07-31
Entered: 2009-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS 18505B9 / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-11-01
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: No relevant medical history
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0585454A

Write-up: This case was reported by a detective constable and described the occurrence of the unexplained death of a 70-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline), BCG (non-gsk), Tuberculosis vaccine, Tetanus vaccine, (non-gsk) (AGRIPPAL) and (non-gsk) PNEUMOVAX. According to notes in the subject''s diary, on 17 October 2000 the subject received unspecified dose of FLUARIX (1 injection, batch number 18505B9), expiry date 31 May 2001). On unspecified dates the subject received an unspecified dose of Tuberculosis vaccine (1 injection), 3 unspecified doses of Tetanus vaccine within a single year (1 injection), an unspecified dose of AGRIPPAL (1 injection) and an unspecified dose of PNEUMOVAX (1 injection). According to the subject''s diary the subject''s partner at the time administered all the vaccinations. There were no records of these vaccinations in the subject''s records from his doctor. In November 2008, at an unspecified time after vaccination with AGRIPPAL, PNEUMOVAX, the Tetanus vaccines and Tuberculosis vaccine, and within years of vaccination with FLUARIX, the subject experienced unexplained death. The subject died from ''natural causes''. It was unknown whether an autopsy was performed. Verbatim text received: A detective constable reported on 23/07/2009 that the police were investigating a case of a deceased 70 year old male patient who had died from ''natural causes'' in November 2008. According to the notes in the patient''s diary, he had received some vaccinations which were administered by his partner at the time (dates unknown) but there were no records of the vaccinations given in the patient''s records from his doctor. These vaccines included tuberculosis vaccine, three tetanus injections in one year, PNEUMOVAX, AGRIPPAL and a flu vaccine (administered on 17/10/2000) with the batch details 18505B9. This batch has been confirmed by GSK Order Services Department to be a FLUARIX vaccine, with expiry 31/05/2001. He had tried to contact the deceased''s general practitioner (GP), however the GP was unavailable. No further information was available at the time of reporting. The enquirer had indicated that the cause of death was unrelated to the flu vaccination.


VAERS ID: 355834 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-08-28
Entered: 2009-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute disseminated encephalomyelitis, Death, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (narrow), Cardiomyopathy (broad), 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: Cardiac therapy: Unknown
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20092273

Write-up: We received the following additional information from the full text article on 18 AUG 2009: The objective of this article was to describe the voluntary reports of adverse events associated with vaccination received by a foreign country in 2004-2006. The total number of reports related to influenza vaccines was slow: 25, 9 and 31, respectively. Most of these reports involved adult patients. Conclusion: it is difficult to assess the causal relationship between vaccine administration and the reported symptoms. The data on possible adverse events related to vaccines found in the database provide no cause to question the safety of vaccines. In 2004 25 adverse effects were reported, thereof 12 considered serious. In some of these cases the minimal criteria were included in the article and therefore further separate cases were created: Miscarriage (see case MA2009-2270), death (n=4) (see cases MA2009-2272-2275), hepatitis (n=1), angina pectoris (n=1), shock (n=1), leukoclastic vasculitis (n=1), acute disseminated encephalomyelitis (ADEM; n=1) (this case). In 2005 nine reports were received, including six serious cases: hepatitis (n=1), serum sickness (n=1), cerebral infarction in combination with rhabdomyolysis (n=1), TIA (n=1), vasculitis in combination with fever (n=1), erythema multiforme (n=1). In 2006 31 reports were received, including 11 serious reports: chest pain and liver function disorder (n=1), GBS with tetraparesis and respiratory insufficiency (n=1), vasculitis (n=1), facial paresis (n=1), septic shock (n=1), cerebrovascular accident (n=1), erythema multiforme (n=1), severe dizziness (n=1), sudden death (n=4). In 2007: one case of sudden death. The outcome, except in the fatal cases, was not reported. Addendum: The co-author inform us on 19 AUG 2009 that all serious events had been reported to the MAHs, and that he cannot provide any further information after so many years. No change in assessment.


VAERS ID: 355835 (history)  
Form: Version 1.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-08-28
Entered: 2009-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Cardiac therapy: Unknown
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20092275

Write-up: We received the following additional information from the full text article on 18 AUG 2009: The objective of this article was to describe the voluntary reports of adverse events associated with vaccination received by a foreign country in 2004-2006. The total number of reports related to influenza vaccines was slow: 25, 9 and 31, respectively. Most of these reports involved adult patients. Conclusion: it is difficult to assess the causal relationship between vaccine administration and the reported symptoms. The data on possible adverse events related to vaccines found in the database provide no cause to question the safety of vaccines. In 2004 25 adverse effects were reported, thereof 12 considered serious. In some of these cases the minimal criteria were included in the article and therefore further separate cases were created: Miscarriage (see case MA2009-2270), death (n=4) (this case, 60-year-old male, see also cases MA2009-2272-2274), hepatitis (n=1), angina pectoris (n=1), shock (n=1), leukoclastic vasculitis (n=1), acute disseminated encephalomyelitis (ADEM; n=1) (see case MA2009-2271). In 2005 nine reports were received, including six serious cases: hepatitis (n=1), serum sickness (n=1), cerebral infarction in combination with rhabdomyolysis (n=1), TIA (n=1), vasculitis in combination with fever (n=1), erythema multiforme (n=1). In 2006 31 reports were received, including 11 serious reports: chest pain and liver function disorder (n=1), GBS with tetraparesis and respiratory insufficiency (n=1), vasculitis (n=1), facial paresis (n=1), septic shock (n=1), cerebrovascular accident (n=1), erythema multiforme (n=1), severe dizziness (n=1), sudden death (n=4). In 2007: one case of sudden death. The outcome, except in the fatal cases, was not reported. Addendum: The co-author inform us on 19 AUG 2009 that all serious events had been reported to the MAHs, and that he cannot provide any further information after so many years. No change in assessment.


VAERS ID: 355836 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-08-28
Entered: 2009-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: MA20092274

Write-up: We received the following additional information from the full text article on 18 AUG 2009: The objective of this article was to describe the voluntary reports of adverse events associated with vaccination received by a foreign country in 2004-2006. The total number of reports related to influenza vaccines was slow: 25, 9 and 31, respectively. Most of these reports involved adult patients. Conclusion: it is difficult to assess the causal relationship between vaccine administration and the reported symptoms. The data on possible adverse events related to vaccines found in the database provide no cause to question the safety of vaccines. In 2004 25 adverse effects were reported, thereof 12 considered serious. In some of these cases the minimal criteria were included in the article and therefore further separate cases were created: Miscarriage (see case MA2009-2270), death (n=4) (this case, elderly male, see also cases MA2009-2272-2273 and -2275), hepatitis (n=1), angina pectoris (n=1), shock (n=1), leukoclastic vasculitis (n=1), acute disseminated encephalomyelitis (ADEM; n=1) (see case MA2009-2271). In 2005 nine reports were received, including six serious cases: hepatitis (n=1), serum sickness (n=1), cerebral infarction in combination with rhabdomyolysis (n=1), TIA (n=1), vasculitis in combination with fever (n=1), erythema multiforme (n=1). In 2006 31 reports were received, including 11 serious reports: chest pain and liver function disorder (n=1), GBS with tetraparesis and respiratory insufficiency (n=1), vasculitis (n=1), facial paresis (n=1), septic shock (n=1), cerebrovascular accident (n=1), erythema multiforme (n=1), severe dizziness (n=1), sudden death (n=4). In 2007: one case of sudden death. The outcome, except in the fatal cases, was not reported. Addendum: The co-author inform us on 19 AUG 2009 that all serious events had been reported to the MAHs, and that he cannot provide any further information after so many years. No change in assessment.


VAERS ID: 355837 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-08-28
Entered: 2009-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Cardiac therapy: Unknown
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20092272

Write-up: We received the following additional information from the full text article on 18 AUG 2009: The objective of the article was to describe the voluntary reports of adverse events associated with vaccination received by the foreign country in 2004-2006. The total number of reports related to influenza vaccines at agency was low: 25, 9 and 31, respectively. Most of these reports involved adult patients. Conclusion by agency: it is difficult to assess the causal relationship between vaccine administration and the reported symptoms. The data on possible adverse events related to vaccines found in the agency database provide no cause to question the safety of vaccines. In 2004-25 adverse effects were reported, thereof 12 considered serious. In some of the cases the minimal criteria were included in the article and therefore further separate cases were created: Miscarriage (see case MA2009-2270), death (n=4) (this case, elderly female, see also cases MA2009-2273-2275), hepatitis (n=1), angina pectoris (n=1), shock (n=1), leukoclastic vasculitis (n=1), acute disseminated encephalomyelitis (ADEM; n=1). In 2005 nine reports were received, including six serious cases: hepatitis (n=1), serum sickness (n=1), cerebral infarction in combination with rhabdomyolysis (n=1), TIA (n=1), vasculitis in combination with fever (n=1), erythema multiforme (n=1). In 2006 31 reports were received, including 11 serious reports: chest pain and liver function disorder (n=1), GBS with tetraparesis and respiratory insufficiency (n=1), vasculitis (n=1), facial paresis (n=1), septic shock (n=1), cerebrovascular accident (n=1), erythema multiforme (n=1), severe dizziness (n=1). In 2007; one case of sudden death. The outcome, except in the fatal cases, was not reported. Addendum: The co-author informed us on 19 AUG 2009 that all serious events had been reported to the MAHs, and that he cannot provide any further information after so many years. No change in assessment.


VAERS ID: 355839 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-08-28
Entered: 2009-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Angina pectoris, Cerebral infarction, Cerebrovascular accident, Chest pain, Dizziness, Erythema multiforme, Facial paresis, Guillain-Barre syndrome, Hepatitis, Leukocytoclastic vasculitis, Liver function test abnormal, Pyrexia, Respiratory failure, Rhabdomyolysis, Septic shock, Serum sickness, Shock, Transient ischaemic attack
SMQs:, Rhabdomyolysis/myopathy (narrow), Liver related investigations, signs and symptoms (narrow), Hepatitis, non-infectious (narrow), Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (narrow), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Demyelination (narrow), Other ischaemic heart disease (narrow), Vestibular disorders (broad), Vasculitis (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20091893

Write-up: We received the following additional information from the full text article on 24 JUN 2009: The objective of this article was to describe the voluntary reports of adverse events associated with vaccination received by a foreign country in 2004-2006. The total number of reports related to influenza vaccines was slow: 25, 9 and 31, respectively. Most of these reports involved adult patients. Conclusion: it is difficult to assess the causal relationship between vaccine administration and the reported symptoms. The data on possible adverse events related to vaccines found in the database provide no cause to question the safety of vaccines. Addendum: We received the following additional information from the full text article on 16 AUG 2009. In 2004 25 adverse effects were reported, thereof 12 considered serious. In some of these cases the minimal criteria were included in the article and therefore further separate cases were created: miscarriage (see case MA2009-2270), death (n=4) (see cases MA2009-2272-2275), hepatitis (n=1), angina pectoris (n=1), shock (n=1), leukoclastic vasculitis (n=1), acute disseminated encephalomyelitis (ADEM; n=1) (see case MA2009-2271). In 2005 nine reports were received, including six serious cases: hepatitis (n=1), serum sickness (n=1), cerebral infarction in combination with rhabdomyolysis (n=1), TIA (n=1), vasculitis in combination with fever (n=1), erythema multiforme (n=1). In 2006 31 reports were received, including 11 serious reports: chest pain and liver function disorder (n=1), GBS with tetraparesis and respiratory insufficiency (n=1), vasculitis (n=1), facial paresis (n=1), septic shock (n=1), cerebrovascular accident (n=1), erythema multiforme (n=1), severe dizziness (n=1), sudden death (n=4). In 2007: one case of sudden death. The outcome, except in the fatal cases, was not reported. Addendum: The co-author inform us on 19 AUG 2009 that all serious events had been reported to the MAHs, and that he cannot provide any further information after so many years. No change in assessment.


VAERS ID: 357653 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-09-18
Entered: 2009-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK RA / IJ

Administered by: Other       Purchased by: Other
Symptoms: Antineutrophil cytoplasmic antibody positive, Biopsy kidney abnormal, Death, Dialysis, Glomerulonephritis, Pneumonia, Vasculitis, Wegener's granulomatosis
SMQs:, Acute renal failure (narrow), Interstitial lung disease (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Eosinophilic pneumonia (broad), Vasculitis (narrow), Chronic kidney disease (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Biopsy kidney, Abnormal
CDC Split Type: B0592682A

Write-up: This case was reported in a literature article and described the occurrence of Wegener''s granulomatosis in a 70-year-old male subject who was vaccinated with INFLUENZA vaccine (manufacturer unspecified). The subject was referred to the hospital with a suspected rapidly progressive glomerulonephritis. The renal biopsy showed diffuse extracapillary pauci-immune glomerulonephritis and circulating C-ANCA (antineutrophil cytoplasmic antibodies) directed against antisense proteinase 3 (PR3) could be detected. Wegener''s granulomatosis with severe renal involvement was diagnosed and treatment with immune suppressant drugs as IV pulse of glucocorticoids and oral cyclophosphamide instituted. The diagnosis of ANCA associated vasculitis was confirmed by clinical, serological and histopathological methods. Three weeks earlier the subject has received an influenza vaccination by his general practitioner. Despite therapy, the subject became dialysis dependent and acquired severe bilateral pneumonia which finally took a fatal course. The subject died, cause of death is not specified. It was unknown whether an autopsy was performed.


VAERS ID: 358621 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-09-29
Entered: 2009-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Antineutrophil cytoplasmic antibody positive, Biopsy kidney abnormal, Death, Dialysis, Glomerulonephritis, Pneumonia, Wegener's granulomatosis
SMQs:, Acute renal failure (narrow), Interstitial lung disease (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Eosinophilic pneumonia (broad), Vasculitis (narrow), Chronic kidney disease (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20092519

Write-up: We received the following literature report on 17 SEP 2009: Whether autoimmune or rheumatic disease may be precipitated after vaccination is controversially discussed among experts. Here the authors describe four cases of new onset or relapsing antineutrophil cytoplasmic antibodies associated vasculitis occurring in timely association with Influenza vaccination. In the literature different subtypes of vasculitis have been repeatedly reported after influenza vaccination. Several trials in patients with preexisting auto-immune disease failed to indicate an increased risk for disease recurrence after influenza vaccination but these investigations might be underpowered to detect this very rare but relevant side effect. Although this report does not prove a causal association between vaccination and vasculitis, It seems possible that in rare cases vaccination might induce vasculitic disease. This case refers to one of four patients (see also ref. cases MA2009-2517, -2518 and 2520). A 70-year-old male patient was referred to the hospital with suspected rapidly progressive glomerulonephritis. Renal biopsy showed diffuse extracapillary pauci-immune glomerulonephritis, and circulating CANCA directed against PR3 could be detected. Wegener''s granulomatosis with severe renal involvement was diagnosed and treatment with IV pulse glucocorticoids and cyclophosphamide p.o instituted. Three weeks earlier this patient has received an influenza vaccination by his general practitioner. Despite therapy the patient became dialysis dependent and acquired severe bilateral pneumonia which finally took a fatal course. Addendum: We received follow-up information from one of the authors on 21 SEP 2009: Batch numbers are not available as patients were not vaccinated from the authors. Cases occurred about five to ten years ago. The author only sees a temporal relationship to the vasculitic disease, not a causal one. No new events. No change in assessment.


VAERS ID: 366656 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-11-10
Entered: 2009-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A0815500A

Write-up: This case was reported by a consumer and described the occurrence of death in an elderly male subject who was vaccinated with influenza vaccine trivalent (seasonal Influenza vaccine unspecified, manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of seasonal Influenza vaccine unspecified (unknown). At an unspecified time after vaccination with seasonal Influenza vaccine unspecified, the subject experienced death. It was reported that the elderly man died after receiving the flu shot a few years ago. The subject died from death nos. It was unknown whether an autopsy was performed.


VAERS ID: 368421 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-11-16
Entered: 2009-11-18
   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: Antineutrophil cytoplasmic antibody positive, Biopsy kidney abnormal, Death, Dialysis, Glomerulonephritis, Pneumonia, Wegener's granulomatosis
SMQs:, Acute renal failure (narrow), Interstitial lung disease (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Eosinophilic pneumonia (broad), Vasculitis (narrow), Chronic kidney disease (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2009021366

Write-up: Report received via the medical literature on 11-NOV-2009. Four case reports are included in the paper, this report refers to case 3. The other cases in the paper are reported as CSL cases 2009021367, 2009021368 and 2009021369. A 70 year-old male patient (initials and date of birth unknown) received influenza vaccine (unknown brand) on an unknown date. Patient''s medical history and concomitant medications unknown. Three weeks after the administration of the suspect drug the patient developed rapidly progressive glomerulonephritis. Renal biopsy showed diffuse extracapillary pauci-immune glomerulonephritis, and circulating CANCA directed against PR3 could be detected. Wegener granulomatosis with severe renal involvement was diagnosed and treatment with IV pulse glucocorticoids and CYC po instituted. The patient became dialysis dependent and acquired severe bilateral pneumonia. The patient finally died on an unknown date of pneumonia. The case was reported as serious because of the fatal outcome. The company considered events to be possible in relation to the suspect drug. Information derived from this AE report does not change the current safety profile of the product. Cause of death is unknown.


VAERS ID: 369535 (history)  
Form: Version 1.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-11-09
Onset:0000-00-00
Submitted: 2009-11-23
Entered: 2009-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER E0542 / UNK LA / IJ

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Arthralgia, Chest discomfort, Chills, Death, Influenza like illness, Mouth ulceration, Pain, Pruritus, Swollen tongue
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Systemic lupus erythematosus (broad), Dementia (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Arthritis (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? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Simvastatin
Current Illness: Insulin-dependent diabetes mellitus
Preexisting Conditions: Took antihistamine, paracetamol, ibuprofen. IDDM
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0604342A

Write-up: This case was reported by the regulatory authority (# GB-MHRA-FLU 00027480) and described the occurrence of death (nos) in a 49-year-old female patient who was vaccinated with influenza virus vaccine (manufacturer unspecified). Concurrent medical conditions included insulin-dependent diabetes mellitus. Previous and/or concurrent vaccination included influenza virus vaccine (manufacturer unspecified; unknown) given on an unspecified date. Concurrent medications included Simvastatin. On 09 November 2009 the patient received a dose of Influenza virus vaccine (1 injection, unknown). At an unspecified time after vaccination with Influenza virus vaccine, the patient experienced flu like symptoms, joint pain, chest tightness, pain, itching, swelling of tongue, mouth ulcer and rigors. The regulatory authority reported that the events were disabling. The reaction severity was bad enough to affect every day activities. The patient was treated with Antihistamines, Paracetamol and Ibuprofen. At an unspecified time after vaccination with Influenza virus vaccine, the patient died from unknown cause of death. It was unknown whether an autopsy was performed. Verbatim Text : Reaction Severity: Bad enough to affect every day activities, Caused death.


VAERS ID: 370600 (history)  
Form: Version 1.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-11-30
Entered: 2009-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (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: Unknown
Preexisting Conditions: The subject had gone to see her physician 2 weeks prior to vaccination with the Pandemic vaccine H1N1 unspecified and seasonal Influenza vaccine unspecified and was "completely healthy".
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A0825039A

Write-up: This case was reported by a consumer and described the occurrence of hemorrhage in a 43-year-old female subject who was vaccinated with PANDEMIC VACCINE H1N1 (unspecified, manufacturer unspecified), influenza vaccine trivalent (seasonal Influenza vaccine unspecified). A physician or other health care professional has not verified this report. Relevant medical history included that the subject had gone to see her physician 2 weeks prior to vaccination with the PANDEMIC VACCINE H1N1 unspecified and seasonal Influenza vaccine unspecified and was "completely healthy". In 2009 the subject received unspecified dose of PANDEMIC VACCINE H1N1 unspecified (unknown), and unspecified dose of seasonal Influenza vaccine unspecified (unknown). On an unspecified date in 2009, less than one week after vaccination with PANDEMIC VACCINE H1N1 unspecified and seasonal Influenza vaccine unspecified, the subject experienced hemorrhage. The subject died from hemorrhage. It was unknown whether an autopsy was performed.


VAERS ID: 371554 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-10-07
Onset:0000-00-00
Submitted: 2009-12-03
Entered: 2009-12-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Drooling, Increased upper airway secretion, Nasopharyngitis, Pneumonia aspiration
SMQs:, Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DOMPERIDONE; DIGOXIN; LANSOPRAZOLE; OXYBUTYNIN; EASPRIN; DILTIAZEM; BENDROFLUAZIDE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2009021595

Write-up: Report received from a physician on 1-Dec-2009. An 87 year-old female patient (date of birth 14-Jul-1922) received ENZIRA intramuscularly on 7-Oct-2009. Concomitant medications included domperidone 10mg three times daily, digoxin 75 micrograms once daily, lansoprazole 30mg once daily, oxybutynin 5mg twice daily, aspirin 75mg once daily, diltiazem 60mg three times daily and bendrofluazide 2.5mg once daily, all taken orally for the CVE (cardiovascular event). An unknown time after administration of ENZIRA, the patient developed mild catarrh and phlegm/mucous/saliva running down side of mouth. Treatment details are unknown, but the reporter indicated that the symptoms were mild and the patient recovered from this event. However, on the 23-Oct-2009, 16 days after the administration of the suspect drug ENZIRA, the patient died. The cause of death was reported as aspiration pneumonia. The reporter stated that he was reporting the event on behalf of the family and that he personally did not consider that the event was an adverse reaction to the ENZIRA. The reporter did not consider the event serious. The case was reported as serious because the patient outcome was fatal. The company considered events to be unlikely in relation to the suspect drug. Information derived from this AE report does not change the current safety profile of the product. Cause of death is unknown. Follow-up: Case 2009021595 is a duplicate of case 2009021548. Case 2009021595 has been nullified in our database as case 2009021548 contains all information regarding the patient and event.


VAERS ID: 372544 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-12-10
Entered: 2009-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / IJ

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Arthralgia, Blood product transfusion, Cerebral haemorrhage, Condition aggravated, Death, Diarrhoea haemorrhagic, Glomerulonephritis, Lung neoplasm, Purpura, Skin ulcer, Vasculitis cerebral
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Vasculitis (narrow), Chronic kidney disease (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological tumours of unspecified malignancy (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Deoxyspergualin; CORTICOSTEROIDS
Current Illness: Wegeners Granulomatosis
Preexisting Conditions: Glomerulonephritis due to Wegeners Granulomatosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20095562

Write-up: We received the following information from the above mentioned literature article on 3 DEC 2009. A male patient, born in 1984, was diagnosed at the age of 12 years with PR3-ANCA-associated glomerulonephritis due to Wegener''s Granulomatosis. He was treated with cyclophosphamide, methylprednisone and azathioprine. In 2004, the patient developed a biopsy-proven renal relapse. Deoxyspergualin, an antiproliferative drug with effects on lymphocyte and macrophage function and neutrophil production, was started in combination with high dose steroids. Because haematuria and proteinuria persisted, the kidney was re-biopsied and showed persistently active glomerulonephritis with new necrotizing and crescentic lesions. The fourth and fifth cycle went uncomplicated. In the sixth cycle, our patient received an influenza vaccination (manufacturer and batch no. unknown). Shortly after this vaccination, a severe relapse occurred with purpura, arthralgias, new nodular lung lesions and active glomerulonephritis. Deoxyspergualin was stopped, and mycophenolate mofetil (2 g/day) in combination with high-dose corticosteroids and plasma exchange was given. Despite this therapy, he developed severe ulceration of the legs, abdominal pain with bloody diarrhoea and intracerebral haemorrhage due to cerebral vasculitis resulting in death. The patient experienced a fatal relapse occurring shortly after influenza vaccination. Vaccination was done while our patient had active glomerulonephritis suggesting that (further) activation of the vasculitic process after influenza vaccination was caused by so-called bystander activation [4] in which vaccination resulted in activation of antigen presenting cells expressing the autoantigen proteinase 3.


VAERS ID: 375855 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-01-05
Entered: 2010-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / IJ

Administered by: Other       Purchased by: Other
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2009GB59590

Write-up: Initial consumer report received on 24 Dec 2009: On an unreported date the patient was vaccinated by Flu vaccine (batch unknown). The patient felt unwell after being vaccinated. He went home to sleep and in the morning his wife couldn''t wake him up. The patient had passed away (dates unspecified). No further information was received.


VAERS ID: 376711 (history)  
Form: Version 1.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-01-13
Entered: 2010-01-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) / NOVARTIS VACCINES AND DIAGNOSTICS - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthma, Death, Influenza
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2010-01-10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Lung disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2010IL01204

Write-up: Initial report received from a newspaper on 11 Jan 2010: This patient, with a history of pulmonary disease, was vaccinated for the first time with Influenza virus vaccine H1N1 INN on an unspecified date (reported as 8 days ago). The patient had a severe asthma attack on an unspecified date and was taken to the emergency room. The patient was diagnosed with H1N1 virus infection. He received a respiratory (unspecified) treatment along with PERAMIVIR (unknown). The patient''s condition deteriorated and he passed away on 10 Jan 2010. The causality assessment by the foreign health regulatory authority was stated as there was no relation between the vaccine and the death.


VAERS ID: 380608 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-02-17
Entered: 2010-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
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: Bleomycin; Granulocyte col. stim. fact; Cytotoxic agent
Current Illness: Seminoma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A0843851A

Write-up: This case was reported by a physician and described the occurrence of death nos in an adult male subject, around 69 or 70 years of age, who was vaccinated with PANDEMIC VACCINE H1N1 (unspecified, manufacturer unspecified), influenza vaccine trivalent (seasonal Influenza vaccine unspecified). Concurrent medical conditions included seminoma. Concurrent medications included Bleomycin, Granulocyte colony stimulating factor (GCSF) and Cytotoxic agent "PVB" (Unknown cancer therapy drug). On an unspecified date, at the same time, the subject received unspecified dose of PANDEMIC VACCINE H1N1 unspecified (unknown), unspecified dose of seasonal Influenza vaccine unspecified (unknown). At an unspecified time after vaccination with PANDEMIC VACCINE H1N1 unspecified and seasonal Influenza vaccine unspecified, the subject experienced death nos. The internist felt it was not related to vaccination with PANDEMIC VACCINE H1N1 unspecified and seasonal influenza vaccine unspecified but due to the bleomycin. She felt there was not enough of a dose of bleomycin to cause death, however, was unsure of the true cause. The subject died from death nos. It was unknown whether an autopsy was performed.


VAERS ID: 386367 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-04-29
Entered: 2010-04-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Convulsion, Death
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2010022712

Write-up: Report received via media on 23-APR-2010. A female patient received flu vaccination (brand unspecified) on an unknown date. The patient''s medical history and concomitant medications were unknown. On an unknown date, 1 week after vaccination with the suspect drug, the patient had convulsions. The patient died in hospital after having huge convulsions. The report states it was not confirmed that the vaccination caused it. The reporter also states the whole thing seems too coincidental. The event outcome was fatal. The reporter considered events possible to the suspect drug. The case was reported as serious due to fatality. The company considered events possible to the suspect drug. Information derived from this AE report does not change the current safety profile of the product. Cause of death is unknown.


VAERS ID: 386483 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-04-30
Entered: 2010-05-03
   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: Death, Multi-organ failure, Pneumonia
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: underlying chronic diseases
Allergies:
Diagnostic Lab Data:
CDC Split Type: E201002615

Write-up: Case of fatal outcome retrieved from the literature on 20-Apr-2010. Reporting of adverse events following immunisation (AEFI) has been mandatory by law since 1988. The goal of the study was a detailed analysis of reported AEFI received by an office of public health between 1991 and 2001. Overall, 1013 AEFI were reported during the study period. This case is linked with 13 other cases issued from the literature (same article, different vaccines, different reactions): E2010-02609, E2010-02610, E2010-02611, E2010-02612, E2010-02613, E2010-02614, E2010-02616, E2010-02842, E2010-02843, E2010-02844, E2010-02845, E2010-02846 and E2010-02847. A 75-year-old male patient with underlying chronic diseases died 5 hours to 6 days after receiving an injection with influenza vaccine (batch number, manufacturer unknown) on an unspecified date. The death was assessed to be unrelated to immunisation because of other plausible causes of death: pneumonia with consecutive multiorgan failure. Two similar reactions occurred after influenza vaccination (cases E2010-02614 and E2010-02616). No further information is expected.


VAERS ID: 386484 (history)  
Form: Version 1.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-04-30
Entered: 2010-05-03
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IJ

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: unspecified several underlying chronic diseases
Allergies:
Diagnostic Lab Data:
CDC Split Type: E201002616

Write-up: Case of fatal outcome retrieved from a literature article on 20-Apr-2010. In one particular foreign country, reporting of adverse events following immunisation (AEFI) has been mandatory by law since 1988. The goal of the study was a detailed analysis of reporting AEFI received by a foreign Federal Office of Public Health between 1991 and 2001. Overall, 1013 AEFI were reported during the study period. This case is linked with 13 other cases issued from the literature (same article, different vaccines, different reactions): E2010-02609, E2010-02610, E2010-02611, E2010-02612, E2010-02613, E2010-02614, E2010-02615, E2010-02842, E2010-02843, E2010-02844, E2010-02845, E2010-02846 and E2010-02847. A 72-year-old female patient with unspecified several underlying chronic diseases was found dead 5 hours after receiving an injection of influenza vaccine (batch number, manufacturer unknown) on an unspecified date. The death was assessed to be unrelated to immunisation because of other plausible causes for death: several underlying chronic diseases. Two similar reactions occurred after influenza vaccination (cases E2010-02614 and E2010-02615). No further information expected.


VAERS ID: 386626 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-05-03
Entered: 2010-05-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IJ

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (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: Underlying chronic disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: E201002614

Write-up: Case of fatal outcome retrieved from the literature on 20-Apr-2010. Reporting of adverse events following immunisation (AEFI) has been mandatory by law since 1988. The goal of the study was a detailed analysis of reported AEFI received by Office of Public Health between 1991 an 2001. Overall, 1013 AEFI were reported during the study period. This case is linked with 13 other cases issued from the literature (same article, different vaccines, different reactions): E2010-02609, E2010-02610, E2010-02611, E2010-02612, E2010-02613, E2010-02615, E2010-02616, E2010-02842, E2010-02843, E2010-02844, E2010-02845, E2010-02846 and E2010-02847. An elderly patient aged over 70 and of unspecified sex with underlying chronic diseases experienced a fatal myocardial infarction after receiving an injection of influenza vaccine (batch number, manufacturer unknown) on an unspecified date. The time to onset was between 5 hours and 6 days. The death was assessed to be possibly related to immunisation. Two similar reactions occurred after influenza vaccination (cases E2010-02615 and E2010-02616). No further information expected.


VAERS ID: 389998 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-05-12
Onset:0000-00-00
Submitted: 2010-06-02
Entered: 2010-06-04
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Cardio-respiratory arrest, Convulsion, Death, Neurological examination normal, Pyrexia, Resuscitation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: Febrile seizure~Influenza (Seasonal) (no brand name)~0~18.00~Patient
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: simple febrile seizure at 18 months of age
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2010AR35307

Write-up: Initial information received from ministry of health on 31 May 2010: This child had medical history of simple febrile seizure at 18 months of age after being vaccinated with the corresponding vaccines of childhood immunizations calendar and together with seasonal influenza vaccine. Results of neurological study were normal. The patient was vaccinated with influenza monovalent vaccine (manufacturer and batch number unknown) on 12 May 2010 (at the age of 2.5 year). On the same day after vaccination, the patient experienced febrile episode (registry of temperature was not informed) which was treated with antipyretic. In night, the patient experienced convulsive episode which lasted two hours approximately. This child experienced cardio-respiratory arrest which lasted 15 minutes (exact date not specified). The patient was transferred to other town in order to receive a better assistance. During the transfer, the child experienced cardio-respiratory arrest which lasted for 15 minutes. When arriving to that town, the child was already with encephalic death. Notwithstanding, the child was taken to other city where encephalic death and child death were confirmed. The reported commented that this case was assessed as related to the vaccine in spite of the fact that the vaccine was not directly the cause of death.


VAERS ID: 391953 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-07-01
Entered: 2010-07-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (CSL)) / CSL LIMITED - / UNK UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Staphylococcal sepsis
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-09
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Amlodipine; AVASTIN; CALTRATE; FERRUM H
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2010024954

Write-up: Report received from a foreign Regulator on 21-JUN-2010 (case: 269157). A patient received a single dose of PANVAX H1N1 (batch #: unknown) on 28-OCT-2010. Further clarification on correct vaccination date has been requested. Concomitant medication that the patient was receiving included amlodipine, AVASTIN, CALTRATE and FERRUM H. Medical history was not provided at the time of reporting. On an unknown date the patient developed Staphylococcus aureus septicemia with H1N1 vaccination. The patient died on 09-NOV-2009. The reporter considered the event possibly related to PANVAX. It was reported that the vial was possibly contaminated. The reporter stated that the death outcome ''maybe drug''. The case was reported as serious because of the patient''s death. The company considered the event conditionally related to the suspect drug PANVAX H1N1 pending follow-up information on clarification of injection date. Information derived from this AE report does not change the current safety profile of the product. Cause of death is unknown. Death date: 09-Nov-2009.


VAERS ID: 400621 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-09-27
Entered: 2010-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Acute disseminated encephalomyelitis, CSF test abnormal, Death, Nuclear magnetic resonance imaging abnormal, Quadriplegia, Respiratory depression
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Respiratory failure (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Cerebrospinal fluid abnormal, ADEM; Nuclear magnetic resonance ima, ADEM
CDC Split Type: B0674505A

Write-up: This case was reported in a literature article and described the occurrence of acute disseminated encephalomyelitis in a 75-year-old female subject who was vaccinated with influenza vaccine trivalent (seasonal Influenza vaccine unspecified, manufacturer unspecified). On an unspecified date the subject received unspecified dose of seasonal Influenza vaccine unspecified (unknown). Within 3 to 5 weeks after vaccination with seasonal Influenza vaccine unspecified, the subject experienced quadriplegia and respiratory depression. Relevant test results included cerebrospinal fluid and magnetic resonance imaging which revealed acute disseminated encephalomyelitis. The subject was treated with methylprednisolone and plasma exchange therapy. The subject subsequently expired. Although a rare occurrence, the clear indication that certain vaccines could trigger serious autoimmune diseases should be recognized.


VAERS ID: 401942 (history)  
Form: Version 1.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-10-05
Entered: 2010-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: D0069009A

Write-up: This case was reported by a physician via another manufacturer and described the occurrence of death - at present cause unknown - in a 95-year-old female subject who was vaccinated with INFLUSPLIT SSW 2010/2011 (GlaxoSmithKline). On an unknown date in 2010 the subject received a dose of INFLUSPLIT SSW 2010/2011 (0.5 ml, unknown). Approximately one day post vaccination with INFLUSPLIT SSW 2010/2011, on an unknown date in 2010, the subject died from an unknown cause (death - at present cause unknown). It was unknown whether an autopsy was performed. The reporting physician considered that death - at present cause unknown - was unrelated to vaccination with INFLUSPLIT SSW 2010/2011. The case was received from foreign country. Follow-up information has been requested.


VAERS ID: 407697 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2010-10-27
Onset:0000-00-00
Submitted: 2010-11-08
Entered: 2010-11-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA637AA / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Infection, Product quality issue
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-10-30
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A0890390A

Write-up: This case was reported by a nurse via a sales representative and described the occurrence of death nos in an adult male subject who was vaccinated with FLUVIRAL (GlaxoSmithKline). On 27 October 2010 the subject received unspecified dose of FLUVIRAL (unknown). On 30 October 2010, three days after vaccination with FLUVIRAL, the subject experienced death nos. This was also considered a pharmaceutical product complaint. The subject died on 30 October 2010 from death nos. It was unknown whether an autopsy was performed. Additional information received from the sales representative on 3 November 2010 indicated that infection (onset date not specified) was suspected as a possible cause of death, and that an autopsy was going to be performed.


VAERS ID: 415677 (history)  
Form: Version 1.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-09-21
Onset:0000-00-00
Submitted: 2011-01-28
Entered: 2011-01-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Asthenia, Death, Feeling hot, Hepatic mass, Myocardial infarction, Ultrasound scan abnormal
SMQs:, Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-01-06
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: Type 2 diabetes mellitus; Cardiovascular disorder; Hypertension
Allergies:
Diagnostic Lab Data: Ultrasound scan, Abnormal, Revealed hepatic mass
CDC Split Type: PHHO2011PH00676

Write-up: Initial report received on 07 Jan 2011: This patient was enrolled in a study. The patients medical history included diabetes mellitus, hypertensive cardiovascular disease. The patient received the vaccination on 21 Sep 2010 at 17:24 hrs. On 06 Jan 2011 at 09:50 hrs the patient was died at home. No consultation was done. Autopsy was not performed. The investigator did not suspect a relationship between the event and the study vaccine. Following an internal review performed on 11 Jan 2011 the patient had medical history of diabetes mellitus type 2. Follow-up received on 19 Jan 2011: The cause of death was myocardial infarction. On an unspecified date, the patient developed body weakness and enlargement of the abdomen. An ultrasound scan revealed a hepatic mass. The patient died at home whilst sitting and complaining that she was ''hot''. Death certificate revealed myocardial infarction. The investigator did not suspect a relationship between the myocardial infarction and the study vaccine. In the absence of an investigator''s causality assessment, Novartis has processed the event ''hepatic mass" as suspected for reporting purposes. The case will be reassessed on receipt of follow-up information.


VAERS ID: 416369 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-10-20
Onset:0000-00-00
Submitted: 2011-02-07
Entered: 2011-02-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / CSL LIMITED 098617501 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Completed suicide, Drowning
SMQs:, Suicide/self-injury (narrow), Accidents and injuries (narrow), Hostility/aggression (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FERRUS SULPHATE; Dosage was 200 mg BID; LACTULOSE; Dosage was 20 ml, 10-20ml; LORAZEPAM; Dosage was 1 mg TID; CLANZAPINE; Dosage was 5 mg QD; SODIUM PICOSULFATE; Dosage was 5 ml BID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011027523

Write-up: This medically confirmed spontaneous report received from a Coroner''s Officer (initial receipt 31-JAN-2011) concerns a 65 year old patient. The patient was taking the following concomitant medications: Farasulfate, lactulose syrup, lorazepam, olanzapine and sodium picosulphate. On 20-Oct-2010, the patient received ENZIRA with batch number 0986 17501. On an unknown date following vaccination, the patient committed suicide by drowning. The patient added in his suicide note he believed "the injection was not the flu jab". The patient had previously received the ''flu jab'' (influenza vaccine, brands unknown) in 2003, 2004, 2006, 2007 and 2008 with no reported adverse events. The event outcome was fatal. Cause of death is unknown. No autopsy findings.


VAERS ID: 420695 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-04-08
Entered: 2011-04-11
   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: 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: Healthy patient
Allergies:
Diagnostic Lab Data: No data
CDC Split Type: 201102033

Write-up: Initial report received from a healthcare professional in a foreign country on 30 March 2011 through the affiliates under the local reference number BR2011-157. A male patient (age and age group not specified), who was healthy, had received an Influenza vaccine (manufacturer, batch number, dose number, route, site and side of administration unknown) on an unspecified date. On an unspecified date, the patient presented complications and died. The reporter stated that he had knowledge of a consumer, whose grandfather, who was healthy, presented complications and died, after receiving the vaccine." No additional information was provided. List of documents held by sender: none.


VAERS ID: 421462 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-04-20
Entered: 2011-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / UN

Administered by: Other       Purchased by: Other
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: No other medications
Current Illness: Unknown
Preexisting Conditions: Myocardial infarction, 3 months before receipt of the vaccine; Coronary artery disease, Double vessel coronary disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011AU32737

Write-up: Case number PHHY2011AU32737 is an initial literature report received on 15 Apr 2011: Authors described passive surveillance data for adverse events followed by immunisation in 2009. This report refers to a middle aged male patient. He had medical history of inferior myocardial infarction 3 months before vaccination and was diagnosed with double vessel coronary disease. He was vaccinated with pandemic influenza virus vaccine (manufacturer and batch number unknown). He was well when seen approximately 8 hours post-vaccination and no other reactions were observed or reported. He died one day after vaccination which was recorded as temporally associated with receipt of vaccine. The authors concluded that, it was unlikely that the vaccine had any role in this patient''s death.


VAERS ID: 423435 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-05-19
Entered: 2011-05-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / CSL LIMITED 098618802 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Brain injury, Congenital anomaly, Drug exposure during pregnancy, Stillbirth
SMQs:, Congenital, familial and genetic disorders (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (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: 2011028537

Write-up: This health authority report (initial receipt 10-MAY-2011) concerns a neonate. On an unknown date the patient was exposed to 0.5ml of ENZIRA (batch number: 09861818802) via transplacental route. On an unknown date the patient experienced stillbirth at term. There was evidence of an old brain injury, not the cause of death, but suggestion that the reporter needed to exclude chance of vaccine as a cause. The event outcome was fatal. The cause of death was stillbirth. At the time of death, the patient had not recovered from the event ''old brain injury''. The reporter considered events to be serious due to death and congenital abnormality. Batch record review of lot number 098618802 received on 18-MAY-2011 noted that all deviations related to the manufacture of this lot were assessed as having no impact on product quality. All QC testing was satisfactory with no out of specification results reported. There are no outstanding issues related to this lot that would potentially affect product quality. In conclusion, there has been no assignable cause drawn from this investigation that would indicate any association with the adverse event reported.


VAERS ID: 425073 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-05-17
Onset:0000-00-00
Submitted: 2011-06-09
Entered: 2011-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthma, Bronchopneumonia, Cardiac arrest, Cardiopulmonary failure, Chest X-ray abnormal, Condition aggravated, Cough, Cyanosis, Death, Dyspnoea, Eosinophil count normal, General physical health deterioration, Haematocrit decreased, Haemoglobin decreased, Lung infiltration, Monocyte count normal, Nasopharyngitis, Neutrophil count, Platelet count increased, Pneumonia, Pyrexia, Respiratory disorder, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Asthma/bronchospasm (narrow), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-05-27
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: Asthma, Progression of concomitant disease bronchial asthma severe; Pneumonia
Preexisting Conditions: Febrile convulsion; Simple febrile seizure secondary to pneumonia and urinary tract infection; Urinary tract infection; Simple febrile seizure secondary to pneumonia and urinary tract infection
Allergies:
Diagnostic Lab Data: 05/26/2011, Chest X-ray, abnormal, bronchopneumonia, lung infiltrates, both lungs; 05/26/2011, Eosinophil count, 4; 05/26/2011, Haematocrit, 96; 05/26/2011, Haemoglobin, 29; 05/26/2011, Monocyte count, 5; 05/26/2011, Platelet count, 576; 05/26/2011, White blood cell count, 25.5, Leukocytes: 37
CDC Split Type: PHHO2011PH09115

Write-up: Case number PHHO2011PH09115, is an initial report received on 27 May 2011, from clinical study. This 2-year-old female subject was enrolled in a study. The subject''s medical history included pneumonia, simple febrile seizure secondary to pneumonia and urinary tract infection and on 13 Jan 2011 the subject was diagnosed with asthma. The subject started the study vaccination on 17 May 2011 at 19:49. On 22 May 2011 (4 days after commencing the study vaccine), the subject experienced cough and colds without fever. No medications were given. On 25 May 2011, the subject experienced a persistent cough and colds with severe fever and difficulty in breathing. The subject was treated with 3 doses of salbutamol nebuliser in the ER and the subject experienced slight relief. The subject was advised for admission but her parents refused. The subject experienced an acute episode of tight air entry and cyanosis. With further explanation from the physician, the subject''s mother opted for hospital admission on 26 May 2011. The same day (in the night), the subject experienced another episode of tight air entry with cyanosis and the physician suggest for intubation but the subject''s relatives refused for it. However, the subject''s mother and grandmother refused and secured a waiver. The same day, the subject underwent a chest x-ray which showed lung infiltrates in both lungs. The diagnosis was bronchopneumonia. The subject received treatment with cefuroxime, hydrocortisone, nebulisation with salbutamol. COMBIVENT, paracetamol and an aminophylline drip was started. The subject''s laboratory tests were as follows: hemoglobin 9, hematocrit 20, WBC (white blood cell), 25.5, ''segmented'' 53, lymphocytes 37, monocytes 5, eosinophil 4 and their platelet count was 576. On 27 May 2011 around 5 AM, the subject experienced another episode of cyanosis and tight air entry. The subject''s condition deteriorated and eventually went into cardiac arrest at 06:05 AM. The subject died. An autopsy was not performed. The subject''s final diagnosis was cardiorespiratory failure secondary to pneumonia with bronchial asthma severe in acute exacerbation. The investigator stated that ''the subject was suffering from recurrent pneumonia. The first episode was on 13 Jan 2011 and was completely treated. The second episode was on 06 Mar 2011 and was also completely treated. The last episode was on 25 May 2011 and she died on 27 May 2011''. The investigator indicated that a possible contributory factor to the event was progression of concomitant disease bronchial asthma severe. The seriousness criterion for bronchopneumonia was death. The investigator reported that the events were suspected to treatment with the study vaccine and the rationale was the occurrence of signs and symptoms within 1 week from the time of vaccination. Follow up received on 03 Jun 2011: Asthma med history and diagnosis date, no autopsy, recurrent pneumonia info., labs. Follow up received on 08 Jun 2011, prior to circulation of previous follow up: Medical history updated, rationale for causality, treatments updated, hospitalisation details, causality for bronchopneumonia and seriousness.


VAERS ID: 425110 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-06-09
Entered: 2011-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / ID

Administered by: Other       Purchased by: Other
Symptoms: Bronchopulmonary aspergillosis, Death, Obliterative bronchiolitis
SMQs:, Interstitial lung disease (narrow), Eosinophilic pneumonia (broad), Infective pneumonia (narrow), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Lung transplant
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0724903A

Write-up: This case was reported in a literature article and described the occurrence of pulmonary aspergillus in an adult subject of unspecified gender who was vaccinated with FLUVIRAL (GlaxoSmithKline). Concurrent medical conditions included lung transplant. In 2008, the subject received an unspecified dose of FLUVIRAL (intradermal, administration site unknown, batch number not provided). 141 days after vaccination with FLUVIRAL, the subject died from aspergillus lung infection and bronchiolitis obliterans syndrome. It was unknown whether an autopsy was performed. The subjects of this study had receive FLUVIRAL or MUTAGRIP. It was not specified which vaccines was administered in this subject. Summary of the literature article: In this study, the authors compared the immunogenicity of influenza vaccine administered intradermally to the standard intramuscular vaccination in lung transplant recipients. The patients were randomized to receive the trivalent inactivated seasonal 2008-9 influenza vaccine containing either 6 ug (intradermal) or 15 ug (intramuscular) of hemagglutinin per viral strain. Immunogenicity was assessed by measurement of geometric mean titer of antibodies using the hemagglutination-inhibition (HI) assay. Vaccine response was defined as a 4-fold or higher increase of antibody titers to at least one vaccine antigen. Eighty-five patients received either the intradermal (n = 41) or intramuscular (n = 44) vaccine. Vaccine response was seen in 6 of 41 patients (14.6%) in the intradermal vs 8 of 43 (18.6%) in the intramuscular group (p = 0.77). Seroprotection (HI greater than or equal to 1:32) was 39% for H1N1, 83% for H3N2 and 29% for B strain in the intradermal group vs 28% for H1N1, 98% for H3N2 and 58% for B strain in the intramuscular group (p =0.36 for H1N1, p = 0.02 for H3N2, p less than 0.01 for B). Mild adverse events were seen in 44% of patients in the intradermal group and 34% in the intramuscular group (p = 0.38). The authors'' conclusion stated that the immunogenicity of the 2008-9 influenza vaccine given intradermally or intramuscularly was overall poor in lung transplant recipients. Novel strategies for influenza vaccination in this population are needed.


VAERS ID: 425582 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-06-10
Entered: 2011-06-16
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Acute respiratory failure, Bronchiolitis, Death, Leukopenia, Malaise, Mechanical ventilation, Neutropenia, Pyrexia, Stridor, Viral test negative
SMQs:, Anaphylactic reaction (broad), Agranulocytosis (broad), Angioedema (broad), Haematopoietic leukopenia (narrow), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: viral test, negative
CDC Split Type: PHHY2011AR50175

Write-up: Case number PHHY2011AR50175 is a combined initial and follow-up spontaneous report received from the health authority respectively on 07 Jun 2011 and 09 Jun 2011. This report refers to a 2 year old boy. He was vaccinated with AGRIPPAL (batch number: unknown) on an unspecified date. One day after vaccination, the child presented with fever, malaise, and stridor and was taken to the emergency room. Viral tests were performed and the results were negative. He was diagnosed with bronchiolitis. After 24 hours, the child was hospitalized with acute respiratory failure, fever, leucopenia and severe neutropenia. Mechanical ventilation was difficult and the child died within 24 hours. The events were reported as not-related to the INFLUENZA vaccine.


VAERS ID: 429116 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-08-02
Entered: 2011-08-08
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Activated partial thromboplastin time, Antineutrophil cytoplasmic antibody positive, Autopsy, Biopsy artery abnormal, Biopsy skin abnormal, Blood fibrinogen increased, Condition aggravated, Cryptococcosis, Cytomegalovirus infection, Death, Fatigue, General physical health deterioration, Haemoglobin decreased, Headache, Mean cell volume, Microscopic polyangiitis, Platelet count, Pneumocystis jiroveci pneumonia, Pulmonary vascular disorder, Pyrexia, Red blood cell count, Renal impairment, Temporal arteritis, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Pulmonary hypertension (broad), Optic nerve disorders (broad), Vasculitis (narrow), Skin tumours of unspecified malignancy (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Renal failure chronic
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Activated partial thromboplastin time, 86.4%; Antineutrophil cytoplasmic antibody, Positive; Biopsy skin, Abnormal, Revealed microscopic polyangiitis with pulmonary involvement and the presence of myeloperoxidase specific anti-neutrophil cytoplasmic antibodies; Blood fibrinogen, 692.7 mg/dL; Haemoglobin, 8.6 g/dl; Mean cell volume, 91.5%; Platelet count, 30.8x10^4; Red blood cell count, 295x10^4/ul; White blood cell count, 6600/ul
CDC Split Type: PHHY2011JP68029

Write-up: Case number PHHY2011JP68029 is an initial spontaneous literature report received on 27 Jul 2011. The authors presented a case of microscopic polyangiitis and giant cell arteritis after influenza vaccination. This report refers to a 67 year old female patient. Her medical history included chronic kidney disease. She was vaccinated with influenza vaccine (strain, manufacturer and batch number: unknown. So, conservatively coded as influenza virus vaccine-unknown INN) on unspecified date. She experienced fever and headache after vaccination. She also presented with worsening of renal function. Temporal artery and skin biopsy were performed and she was diagnosed with giant cell arteritis and microscopic polyangiitis with pulmonary involvement and presence of myeloperoxidase-specific anti-neutrophil cytoplasmic antibodies (MPO-ANCA) were diagnosed. She was treated with prednisolone and symptoms improved. However, 2 months later she presented with general physical weariness. She was diagnosed with pneumocystis pneumonia, cytomegalovirus infection and cryptococcosis. Despite intensive treatment, she died and an autopsy was performed. The authors commented that influenza vaccination can cause different types of vasculitis, microscopic polyangiitis and giant cell arteritis.


VAERS ID: 434190 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-09-09
Entered: 2011-09-13
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Condition aggravated, 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: Inferior myocardial infarct; Double vessel coronary disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011029706

Write-up: This literature report (initial receipt 30-Aug-2011) concerns a middle aged male patient. The patient had suffered an inferior myocardial infarct 3 months before receipt of the vaccine and was diagnosed with double vessel coronary disease. In 2009, the patient was vaccinated with pH1N1 vaccine. The patient was well when seen approximately 8 hours post vaccination and no other reactions were observed or reported. One day post vaccination, the patient died. The event outcome was fatal. This one report of death was recorded as temporally associated with receipt of pH1N1 vaccine. It is regarded as unlikely that the vaccine had any role in this patient''s death. Cause of death is unknown.


VAERS ID: 437885 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-11-01
Onset:0000-00-00
Submitted: 2011-10-11
Entered: 2011-10-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute disseminated encephalomyelitis, Anaesthesia, Brain stem syndrome, C-reactive protein increased, CSF lymphocyte count abnormal, CSF monocyte count negative, CSF neutrophil count increased, CSF protein increased, CSF test normal, CSF white blood cell count increased, Central nervous system lesion, Cytology normal, Death, Dysarthria, Encephalopathy, Endotracheal intubation, Extensor plantar response, Fatigue, General physical health deterioration, Headache, Hemiparesis, Hemiplegia, Hiccups, Incontinence, Laboratory test normal, Lymphocyte percentage decreased, Malaise, Monocyte percentage, Muscle spasticity, Nausea, Nervous system disorder, Neurological examination abnormal, Neutrophil percentage increased, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal cord abnormal, Plasmapheresis, Pleocytosis, Pneumonia, Quadriplegia, Reflexes abnormal, Respiratory failure, Rheumatoid factor negative, Spinal cord disorder, VIth nerve paralysis, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Haematopoietic leukopenia (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Demyelination (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Ocular motility disorders (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Malignant lymphomas (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Past medical history included non-insulin dependent diabetes mellitus type 2, dyslipidemia, hypertension, hypothyroidism and a seronegative arthropathy. She had no other recent illness, history of tuberculosis, or travel history in the preceding 24 months. She had never previously received influenza vaccination.
Allergies:
Diagnostic Lab Data: MRI of the brain and spine: a long segment of T2 hyperintensity extending from the caudal medulla down the entire length of the cervical cord terminating at T6. Spinal cord expansion was present throughout this segment, maximal at C5/C6. Skip lesions were also present through the rest of the spinal cord down into the conus medullaris. Patchy enhancement was present on postgadolinium sequences throughout. The remainder of the brain MRI was within normal limits for her age (non-specific white matter changes). Cerebrospinal fluid (CSF): lymphocytic pleocytosis (white blood cell count of 208/uL), comprised 56% neutrophils, 29% lymphocytes and 15% monocytes, and elevated protein of 911 mg/L. CSF cytology was negative for malignant cells. Comprehensive parainfectious workup and rheumatologic panel were negative apart from an elevated CRP of 37.4 mg/L.
CDC Split Type: 201109459

Write-up: Initial report received on 27 September 2011 via a search of the scientific literature in a foreign country. ABSTRACT: Introduction: Approximately 5% of cases of acute disseminated encephalomyelitis (ADEM) are preceded by vaccination within 1 month prior to symptom onset. This occurs rarely following influenza immunization. Methods: Case presentation and literature review. Results: A 75-year-old woman developed acute disseminated encephalomyelitis within 3 weeks of receiving the seasonal influenza vaccine. The patient subsequently passed away, despite treatment with methylprednisolone and plasma exchange therapy. Conclusions: The literature on post-influenza vaccination encephalomyelitis is limited. The majority of published cases had favourable outcomes following treatment with intravenous methylprednisolone. Given the limited number of cases, no incidence estimates have been published. CASE PRESENTATION: A 75-year-old woman presented in November 2008 with a 20 day history of headache, malaise, fatigue, intractable hiccups, nausea and vomiting. Symptoms began evolving 2 days following receipt of the inactivated seasonal influenza vaccine. The patient developed left hemiparesis 20 days post-immunization (PI) and by 29 days PI had progressed to hemiplegia and hemianesthesia of the left side. She then became encephalopathic and developed brainstem involvement with a left abducens palsy, dysarthria, right hemiparesis, and incontinence. Her neurological exam demonstrated bilateral spastic tone, brisk reflexes and extensor plantar responses. Her past medical history included non-insulin dependent diabetes mellitus type 2, dyslipidemia, hypertension, hypothyroidism and a seronegative arthropathy. She had no other recent illness, history of tuberculosis, or travel history in the preceding 24 months. She had never previously received influenza vaccination. Magnetic resonance imaging (MRI) of the brain and spine demonstrated a long segment of T2 hyperintensity extending from the caudal medulla down the entire length of the cervical cord terminating at T6. Spinal cord expansion was present throughout this segment, maximal at C5/C6. Skip lesions were also present through the rest of the spinal cord down into the conus medullaris. Patchy enhancement was present on postgadolinium sequences throughout. The remainder of the brain MRI was within normal limits for her age (non-specific white matter changes). Her cerebrospinal fluid (CSF) demonstrated lymphocytic pleocytosis (white blood cell count of 208/uL), comprised 56% neutrophils, 29% lymphocytes and 15% monocytes, and elevated protein of 911 mg/L. A comprehensive parainfectious workup and rheumatologic panel were negative apart from an elevated CRP of 37.4 mg/L. CSF cytology was negative for malignant cells. Her clinical and radiologic findings fulfilled published criteria for ADEM. Despite treatment with broad-spectrum antibiotics, acyclovir, methylprednisolone and plasma exchange (7 treatments in 14 days), the patient continued to deteriorate to quadriplegia and required intubation secondary to hypercapneic respiratory failure. She developed pneumonia and passed away 70 days PI. This literature report also contained a table of reported cases of post-influenza vaccination encephalomyelitis/ADEM published since 1982. The cases contained a possible sanofi pasteur influenza vaccine are reported in the following cases: E2005-00990, 2010-00355, 2011-09595, 2011-09626, and 2011-09627.


VAERS ID: 440323 (history)  
Form: Version 1.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-10-24
Entered: 2011-10-26
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK LA / SYR

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Blood culture positive, Body temperature increased, C-reactive protein increased, Chest X-ray abnormal, Clostridial infection, Clostridium test positive, Crepitations, Culture tissue specimen positive, Death, Dysarthria, Gas gangrene, Gastrointestinal disorder, Heart rate increased, Malaise, Microbiology test abnormal, Musculoskeletal pain, Nausea, Oedema, Procalcitonin increased, Pyrexia, Respiratory distress, Septic shock, Skin discolouration, Soft tissue infection, Soft tissue necrosis, Speech disorder, Subcutaneous emphysema
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Toxic-septic shock conditions (narrow), Dementia (broad), Pseudomembranous colitis (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (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? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: lithium; pantoprazole
Current Illness: depression; oesophageal stenosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood pressure, 100/70 mmHg, significant; Body temperature increased, 38.2 degrees C, high; chest x-ray, significant, showed extensive subcutaneous emphysema; c-reactive protein, 305 mg/ml, significant; heart rate, 120 beats/min, high; procalcitonin, 52.7 ng/ml, significant
CDC Split Type: PHHY2011NL91897

Write-up: Case number PHHY2011NL91897 is an initial literature report received on 18 Oct 2011. Authors presented a case of fatal Clostridium septicum gas gangrene in an individual who received the H1N1 influenza vaccine. This report refers to a 71-year-old female patient. Her medical history revealed a depressive disorder and oesophageal stenosis as a result of corrosive ingestion. Her medication comprised only lithium and pantoprazole. She was vaccinated with H1N1 influenza vaccine (manufacturer and batch number: unknown) into her left forearm on an unspecified date. She started feeling unwell one day after receiving the vaccine, complaining of abdominal pain and nausea (without vomiting). Three days after vaccination, she presented to the emergency department of the hospital. During presentation at the hospital. She developed fever, rapidly progressive pain in the left shoulder and blurred speech. At presentation in the emergency room, she was severely ill with a blood pressure of 100/70 mmHg, a pulse rate of 120 beats/min and a temperature of 38.2 C. The patient was in severe respiratory distress. Although the physical examination of her left shoulder region by her general practitioner, two hours before presentation was unremarkable, in the ER she was found to have oedematous, discoloured skin and crepitus, extending from the left shoulder. Laboratory analysis revealed a procalcitonin of 52.7 ng/ml and a C-reactive protein of 305 mg/l. Chest X-ray showed extensive subcutaneous emphysema. The presence of septic shock manifestations and rapidly progressive skin changes raised the suspicion of necrotising soft-tissue infection. Antibiotic therapy was immediately initiated with flucloxacillin, clindamycin and ciprofloxacin. The diagnosis was confirmed during an acute surgical exploration, indicating extensive soft tissue necrosis spreading from the left arm to the back and the contralateral side. Complete debridement was judged impossible. Because of progressive septic shock and lack of treatment options, therapy was discontinued. She died several hours after presentation. Microbiological examination of blood and tissue cultures identified Clostridium septicum as the sole aetiological microorganism. Authors stated that life-threatening skin and soft-tissue infections (SSTIs) are infrequent and difficult to diagnosis. Among gas-forming SSTIs, the pathogens most frequently responsible are Clostridium species. The patients history was unremarkable, apart from the depressive disorder. Particularly, there was no evidence of colorectal cancer or a compromised immune system. Although the initial abdominal pain and nausea in this patient might suggest an intestinal focus, it was more likely that they result from release of clostridial toxins, which had been related to gastrointestinal symptoms. In this patient, fatal gas gangrene of the left shoulder developed three days after intramuscular injection of the H1N1 influenza vaccine in the left forearm, suggesting a causative association. This report emphasized the fulminant evolution of gas gangrene and added influenza vaccination to the list of conditions associated with the risk of gas gangrene development. At the same time, this was the first report on fatal C. septum gas gangrene in an individual who received the H1N1 influenza vaccine.


VAERS ID: 442224 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-11-10
Entered: 2011-11-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Acute respiratory distress syndrome, Death, Influenza, Influenza A virus test positive, Influenza like illness, Live birth
SMQs:, Interstitial lung disease (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Normal pregnancy conditions and outcomes (narrow), 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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Polymerase chain reaction, Positive, H1N1 influenza virus infection
CDC Split Type: PHHY2011TR098288

Write-up: Case number PHHY2011TR098288 is an initial literature report received on 04 Nov 2011. The authors discussed about maternal deaths associated with H1N1 influenza virus infection. This report refers to an adult female patient. She was vaccinated with H1N1 pandemic vaccine (manufacturer and batch number: unknown) on unspecified date. It was unknown that whether the patient was pregnant at the time of vaccination. She delivered a full term live infant on unspecified date. The patient experienced influenza like symptoms within one week after vaccination (after delivery). She was diagnosed with confirmed H1N1 influenza virus infection using reverse transcriptase-polymerase chain reaction. The patient later developed acute respiratory distress syndrome/illness and died on unspecified date. The medical record/death certificate listed H1N1 influenza as an underlying cause of death. The authors commented that H1N1 vaccines become effective only after 21 days after vaccination. This 3-week interval between vaccination and an effective immune response to H1N1 influenza may explain the death of the patient who is only vaccinated 1 week prior to onset of the symptoms.


VAERS ID: 443557 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-11-22
Entered: 2011-11-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Bladder cancer, Death
SMQs:, Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: acute coronary syndrome
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011TH100690

Write-up: Case number PHHY2011TH100690 is an initial literature case received on 15 Nov 2011. Authors stated that INFLUENZA vaccination reduces cardiovascular events in patients with acute coronary syndrome. They did a prospective randomized open with blinded endpoint (PROBE) study in patients who had been admitted due to acute coronary syndrome (ACS) within 8 weeks during Nov 2007 to Oct 2008. Total of 439 patients (age: 65 +/- 9 years) were recruited into this study, of which 221 patients were randomized to vaccine group and 218 patients were randomized to the control group. The median time of follow-up was 360 (range 3-365) days. All patients received standard ACS care, including coronary revascularization, as determined by the primary cardiologist. This case refers to a patient of unknown age and gender who was randomized to vaccine. group. The patient''s medical history included acute coronary syndrome (ACS). The patient was vaccinated with single-dose intramuscular injection of split, inactivated INFLUENZA (manufacturer and batch number: unknown) at a dose of 0.5 mL on an unknown date. On an unknown date the patient died of bladder carcinoma. Authors concluded that this study demonstrated a significant reduction in major adverse cardiovascular event (MACE) in ACS patients receiving the INFLUENZA vaccine compared with controls. It was also stated that addition of INFLUENZA vaccination to standard treatment for an acute coronary syndrome reduced major cardiovascular events.


VAERS ID: 445105 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-12-08
Entered: 2011-12-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Death, General physical health deterioration, Hyperpyrexia, Malaise
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011IT106515

Write-up: Case number PHHY2011IT06515 is an initial spontaneous report received from a health care professional on 02 Dec 2011. This report refers to 53-year-old male patient. He was vaccinated with INFLUENZA (manufacturer and batch number: unknown) on an unspecified date. After vaccination, he developed sudden malaise and hyperpyrexia from an unknown date. He was hospitalized in the infective ward of a local hospital. His condition worsened and he died after a few days. Cause of death was not reported. The causality was not reported.


VAERS ID: 445893 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-12-19
Entered: 2011-12-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (CSL)) / CSL LIMITED - / UNK UN / UN
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011030534

Write-up: This literature report (initial receipt 10-Dec-2011) concerns patients who were vaccinated with H1N1 or seasonal influenza vaccines (WAVES 2011030535) from 01-Jul-2009 through 31-Jan-2010 and reported to VAERS (Vaccine Adverse Event Reporting System). There were 42 deaths reported following H1N1 vaccine. Of these, 18 (43%) were male, median age was 49.5 (range 1 - 94) and the median onset interval from vaccination to adverse event was 3 days (range 0 - 55). There were 7 death reports where the patient also received season influenza and H1N1 vaccination on the same day. The reported cause of death category after inactivated vaccine record review were cardiac (20), infectious (8), multiple systems (5), neurologic (4), motor vehicle accident (1), pregnancy complication (1), respiratory (1) and unknown (2). Underlying medical conditions and risk factors for cardiovascular disease were present among 94% (45/48) of the patients who died following live attenuated and inactivated H1N1 vaccination. In some cases the cause of death was clearly unrelated to vaccination (e.g. meningococcal sepsis, ruptured aortic aneurysm). No deaths from anaphylaxis were reported. There were 99 verified reports of GBS (Guillain-Barre syndrome) reports, 86 following inactivated and 12 following live, H1N1 vaccinations (1 unknown type). Of the 99 verified GBS reports, 93 had symptom onset within 42 days following vaccination; the distribution by onset interval (day of vaccination to onset of symptoms) was: 26, week 1 (22 on day 0-4); 27, week 2; 12, week 3; and 28, weeks 4 - 6. Twenty-four of the verified GBS cases had received seasonal influenza vaccine on the same day or within 30 days of the H1N1 vaccine. Reporting rate of verified GBS reports within the 42 day window were .42 and 1.75 per million H1N1 vaccinations for age <25 years and age $g or = 25 years, respectively. Of the 86 GBS reports following inactivated H1N1 vaccinations, 48 (56%) were male, median age was 55 years (range 1 - 83). Of these 86 reports, median onset interval from H1N1 vaccination to GBS was 13.5 days (range 0 - 71). Thirteen (15%) of the 86 cases had same day seasonal influenza and H1N1 vaccination. The author also verified 117 reports of anaphylaxis, 101 following inactivated and 15 following live, attenuated H1N1 vaccinations (1 unknown type). Sixty-nine (60%), 34 (29%) and 13 (11%) occurred <1, 1 - 4 and 5 - 24 hours following vaccination, respectively (1 unknown). The reporting rate for verified anaphylaxis was 1.4 per million H1N1 vaccinations (1.6 per million inactivated and 0.9 per million live, attenuated vaccines). Of the 101 anaphylaxis reports following inactivated H1N1 vaccinations, 31 (30%) were male, median age was 30 years (range 1 - 82). Of these 101 reports, median onset interval from H1N1 vaccination to anaphylaxis was 0 day (range 0, 0). Fifteen (15%) of the 101 cases had same day seasonal influenza and H1N1 vaccination. The event outcome was not reported.


VAERS ID: 448745 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-02-01
Entered: 2012-02-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Disease complication, Fallot's tetralogy, Hypoxia
SMQs:, Asthma/bronchospasm (broad), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Eosinophilic pneumonia (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: No medical history reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201201097

Write-up: Case retrieved from the literature on 23 January 2012. Unique worldwide case ID: MX-SP-2012-01002. In a foreign country, the database corresponding to the event temporarily associated with vaccination (ETAV) associated with influenza (A [H1N1] and seasonal) immunization reported between December 2009 and June 2010 was analyzed. Patients who displayed at least one ETAV after the administration of H1N1 vaccine and/or seasonal influenza vaccine were included. Cases were considered to be probable vaccine-related if they met the temporality criterion, i.e., appearance of the event within 52 days after vaccination, including immediate hypersensitivity reactions. In terms of association and biological plausibility, a causal ETAV is the one that appears after the administration of the vaccine and requires demonstration through clinical, epidemiological and laboratory findings. It would imply that the vaccine caused the event directly and undoubtedly. When causality cannot be demonstrated, the event is defined as a coincidental ETAV, which refers to medical incidents that would have taken place in the same manner, with or without the application of the vaccine. During the study period, a total of 27,048,330 vaccine doses against H1N1 and 18,442,171 doses against seasonal influenza were applied across the country. A total of 597 ETAV corresponding to the application of the anti-H1N1 and/or anti-seasonal influenza vaccine were reported. A total of 57 events considered serious were reported during the period analyzed. 48 cases could be linked with sanofi pasteur product (manufacturer unknown). All of these cases were linked with the case 2012-01002, considered as the case of reference. A 01-year-old female patient, with no reported medical history and concomitant therapy, had received a combination of vaccine against H1N1 (manufacturer unknown, batch number, number in series, route and site of administration not reported) and of vaccine against seasonal influenza (manufacturer unknown, batch number, number in series, route and site of administration not reported) on an unspecified date. It was not notified if vaccines contain adjuvent. On an unspecified date, the patient developed hypoxic crisis (reported as final diagnosis). The initial diagnosis was Tetralogy of Fallot. The hypoxic crisis was secondary to Tetralogy of Fallot. Complications were considered the cause of death. It was not specified if the patient was hospitalized. No corrective treatment was reported. This interval was reported as 3h. the patient died on an unspecified date. According to the author, the event was considered as "CNR" (coincidental not related). According with the author, this case was assessed as serious due to medically important condition. Documents held by sender: none.


VAERS ID: 448748 (history)  
Form: Version 1.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-02-01
Entered: 2012-02-02
   Days after submission:1
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: No medical history reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201201141

Write-up: Case retrieved from the literature on 23 January 2012. Unique worldwide case ID: MX-SP-2012-01002. The database corresponding to the events temporarily associated with vaccination (ETAV) associated with influenza (A [H1N1] and seasonal) immunization reported between December 2009 and June 2010 was analyzed. Patients who displayed at least one ETAV after the administration of H1N1 vaccine and/or seasonal influenza vaccine were included. Cases were considered to be probable vaccine-related if they met the temporality criterion, i.e., appearance of the event within the 52 days after vaccination, including immediate hypersensitivity reactions. In terms of association and biological plausibility, a causal ETAV is the one that appears after the administration of the vaccine and requires demonstration through clinical, epidemiological and laboratory findings. It would imply that the vaccine caused the event directly and undoubtedly. When causality cannot be demonstrated, the event is defined as a coincidental ETAV, which refers to medical incidents that would have taken place in the same manner, with or without the application of the vaccine. During the study period, a total of 27,048,330 vaccine doses against H1N1 and 18,442,171 doses against seasonal influenza were applied across the country. A total of 597 ETAV corresponding to the application of the antiinfluenza A (H1N1) and/or anti-seasonal influenza vaccine were reported. A total of 57 events considered serious were reported during the period analyzed. 48 cases could be linked with sanofi pasteur product (manufacturer unknown). All of these cases were linked with the case 2012-01002, considered as the case of reference. A 92-year-old female patient, with no medical history nor concomitant therapy reported, had received on an unspecified date her dose of vaccine against seasonal influenza (manufacturer unknown, batch number, number in series, route and site of administration not reported). The vaccine was without adjuvant. On an unspecified date, the patient developed pneumonia (reported as initial and final diagnosis). It was not specified if the patient was hospitalized. No corrective treatment was reported. The patient died on an unspecified date. This interval was reported as "8" (no unit reported). According to the author, the event was considered as "CNR" (coincidental not related). Documents held by sender: none.


VAERS ID: 448767 (history)  
Form: Version 1.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-02-01
Entered: 2012-02-02
   Days after submission:1
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, Septic shock
SMQs:, Toxic-septic shock conditions (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No medical history reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201201139

Write-up: Case retrieved from the literature on 23 January 2012. Unique worldwide case ID: MX-SP-2012-01002. In a foreign country, the database corresponding to the event temporarily associated with vaccination (ETAV) associated with influenza (A [H1N1] and seasonal) immunization reported between December 2009 and June 2010 was analyzed. Patients who displayed at least one ETAV after the administration of H1N1 vaccine and/or seasonal influenza vaccine were included. Cases were considered to be probable vaccine-related if they met the temporality criterion, i.e., appearance of the event within 52 days after vaccination, including immediate hypersensitivity reactions. In terms of association and biological plausibility, a causal ETAV is the one that appears after the administration of the vaccine and requires demonstration through clinical, epidemiological and laboratory findings. It would imply that the vaccine caused the event directly and undoubtedly. When causality cannot be demonstrated, the event is defined as a coincidental ETAV, which refers to medical incidents that would have taken place in the same manner, with or without the application of the vaccine. During the study period, a total of 27,048,330 vaccine doses against H1N1 and 18,442,171 doses against seasonal influenza were applied across the country. A total of 597 ETAV corresponding to the application of the anti-H1N1 and/or anti-seasonal influenza vaccine were reported. A total of 57 events considered serious were reported during the period analyzed. 48 cases could be linked with sanofi pasteur product (manufacturer unknown). All of these cases were linked with the case 2012-01002, considered as the case of reference. A 46-year-old female patient, with no medical history nor concomitant therapy reported, had received on an unspecified date her dose of vaccine against seasonal influenza (manufacturer unknown, batch number, number in series, route and site of administration not reported). It was not specified if the vaccine contains adjuvant. On an unspecified date, the patient developed pneumonia (reported as final diagnosis). The initial diagnosis was septic shock. It was not specified if the patient was hospitalized. No corrective treatment was reported. The patient died on an unspecified date. This interval was reported as "0" (no unit reported). According to the author, the event was considered as "CNR" (coincidental not related). Documents held by sender: none.


VAERS ID: 448768 (history)  
Form: Version 1.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-02-01
Entered: 2012-02-02
   Days after submission:1
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, Pneumonitis
SMQs:, Interstitial lung disease (narrow), Eosinophilic pneumonia (narrow), Hypersensitivity (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: No medical history reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201201140

Write-up: Case retrieved from the literature on 23 January 2012. Unique worldwide case ID: MX-SP-2012-01002. The database corresponding to the events temporarily associated with vaccination (ETAV) associated with influenza (A [H1N1] and seasonal) immunization reported between December 2009 and June 2010 was analyzed. Patients who displayed at least one ETAV after the administration of H1N1 vaccine and/or seasonal influenza vaccine were included. Cases were considered to be probable vaccine-related if they met the temporality criterion, i.e., appearance of the event within the 52 days after vaccination, including immediate hypersensitivity reactions. In terms of association and biological plausibility, a causal ETAV is the one that appears after the administration of the vaccine and requires demonstration through clinical, epidemiological and laboratory findings. It would imply that the vaccine caused the event directly and undoubtedly. When causality cannot be demonstrated, the event is defined as a coincidental ETAV, which refers to medical incidents that would have taken place in the same manner, with or without the application of the vaccine. During the study period, a total of 27,048,330 vaccine doses against H1N1 and 18,442,171 doses against seasonal influenza were applied across the country. A total of 597 ETAV corresponding to the application of the anti-influenza A (H1N1) and/or anti-seasonal influenza vaccine were reported. A total of 57 events considered serious were reported during the period analyzed. 48 cases could be linked with sanofi pasteur product (manufacturer unknown). All of these cases were linked with the case 2012-01002, considered as the case of reference. A 54-year-old male patient, with no medical history nor concomitant therapy reported, had received on an unspecified date his dose of vaccine against seasonal influenza (manufacturer unknown, batch number, number in series, route and site of administration not reported). The vaccine was without adjuvant. On an unspecified date, the patient developed pneumonia (reported as final diagnosis). The initial diagnosis was pneumonitis. It was not specified if the patient was hospitalized. No corrective treatment was reported. The patient died on an unspecified date. This interval was reported as "1" (no unit reported). According to the author, the event was considered as "CNR" (coincidental not related). Documents held by sender: none.


VAERS ID: 448901 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-02-01
Entered: 2012-02-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Apparently healthy
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201201039

Write-up: Case retrieved from the literature on 23 January 2012. Unique worldwide case ID: MX-SP-2012-01002. In a foreign country, the database corresponds to the events temporarily associated with vaccination (ETAV) associated with H1N1 and seasonal immunization reported between December 2009 and June 2010 was analyzed. Patients who displayed at least one ETAV after the administration of H1N1 and/or seasonal influenza vaccine were included. Cases were considered to be probable vaccine-related if they met the temporality criterion, i.e., appearance of the event within the 52 days after vaccination, including immediate hypersensitivity reactions. In terms of association and biological plausibility, a causal ETAV is the one that appears after the administration of the vaccine and requires demonstration through clinical, epidemiological and laboratory findings. It would imply that the vaccine caused the event directly and undoubtedly. When causality cannot be demonstrated, the event is defined as a coincidental ETAV, which refers to medical incidents that would have taken place in the same manner, with or without the application of the vaccine. During the study period, a total of 27,048,330 vaccine doses against H1N1 and 18,442,171 doses against seasonal influenza were applied across the country. A total of 597 ETAV corresponding to the application of the H1N1 and/or anti-seasonal influenza vaccine were reported. A total of 57 events considered serious were reported during the period analyzed. 48 cases could be linked with sanofi pasteur product (manufacturer unknown). All of these cases were linked with the case 2012-01002, considered as the case of reference. A 02-year-old male patient, apparently healthy, had received on an unspecified date his dose of vaccine against H1N1 (manufacturer unknown, batch number, number in series, route and site of administration not reported). The vaccine was without adjuvant. No concomitant therapy was reported. On an unspecified date, the patient developed GBS (Guillain Barre syndrome) (reported as initial and final diagnosis). it was not specified if the patient was hospitalized. No corrective treatment was reported. The patient died on an unspecified date, due to acute flaccid paralysis complications. This interval was reported as "4" (no unit reported). According to the author, the event was considered as "CNR" (coincidental not related). Fourteen confirmed cases of GBS according to Brighton Criteria were reported. All were ruled as unrelated coincidental events, given that vaccination against H1N1 as an antecedent occurred in seven cases (50%); immunization against seasonal influenza occurred in four cases (28.5%), and the joint administration of both vaccines occurred in three cases (21.4%). Documents held by sender: none.


VAERS ID: 448994 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-02-01
Entered: 2012-02-02
   Days after submission:1
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, Neurological infection, Status epilepticus
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No medical history reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201201146

Write-up: Case retrieved from the literature on 23 January 2012. Unique worldwide case ID: MX-SP-2012-01002. In a foreign country, the database corresponding to the event temporarily associated with vaccination (ETAV) associated with influenza (A [H1N1] and seasonal) immunization reported between December 2009 and June 2010 was analyzed. Patients who displayed at least one ETAV after the administration of H1N1 vaccine and/or seasonal influenza vaccine were included. Cases were considered to be probable vaccine-related if they met the temporality criterion, i.e., appearance of the event within the 52 days after vaccination, including immediate hypersensitivity reactions. In terms of association and biological plausibility, a causal ETAV is the one that appears after the administration of the vaccine demonstration through clinical, epidemiological and laboratory findings. It would imply that the vaccine caused the event directly and undoubtedly. When causality cannot be demonstrated, the event is defined as a coincidental ETAV, which refers to medical incidents that would have taken place in the same manner, with or without the application of the vaccine. During the study period, a total of 27,048,330 vaccine doses against H1N1 and 18,442,171 doses against seasonal influenza were applied across the country. A total of 597 ETAV corresponding to the application of the antiinfluenza H1N1 and/or anti-seasonal influenza vaccine were reported. A total of 57 events considered serious were reported during the period analyzed. 48 cases could be linked with sanofi pasteur product (manufacturer unknown). All of these cases were linked with the case 2012-01002, considered as the case of reference. A 26-year-old female patient, with no medical history nor concomitant therapy reported, had received on an unspecified date her dose of vaccine against seasonal influenza (manufacturer unknown, batch number, number in series, route and site of administration not reported). It was not specified if the vaccine contains adjuvant. On an unspecified date, the patient developed neuroinfection (reported as final diagnosis). The initial diagnosis was SE (status epilepticus). It was not specified if the patient was hospitalized. No corrective treatment was reported. The patient died on an unspecified date. This interval was reported as "7" (no unit reported). According to the author, the event was considered as "CNR" (coincidental not related). Documents held by sender: none.


VAERS ID: 448749 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-02-01
Entered: 2012-02-03
   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: Death, Hypersensitivity, Immediate post-injection reaction, Pneumonia
SMQs:, Angioedema (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), 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: No medical history reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201201142

Write-up: Case retrieved from the literature on 23 January 2012. Unique worldwide case ID: MX-SP-2012-01002. In a foreign country, the database corresponding to the event temporarily associated with vaccination (ETAV) associated with influenza (A [H1N1] and seasonal) immunization reported between December 2009 and June 2010 was analyzed. Patients who displayed at least one ETAV after the administration of H1N1 vaccine and/or seasonal influenza vaccine were included. Cases were considered to be probable vaccine-related if they met the temporality criterion, i.e., appearance of the event within 52 days after vaccination, including immediate hypersensitivity reactions. In terms of association and biological plausibility, a causal ETAV is the one that appears after the administration of the vaccine and requires demonstration through clinical, epidemiological and laboratory findings. It would imply that the vaccine caused the event directly and undoubtedly. When causality cannot be demonstrated, the event is defined as a coincidental ETAV, which refers to medical incidents that would have taken place in the same manner, with or without the application of the vaccine. During the study period, a total of 27,048,330 vaccine doses against H1N1 and 18,442,171 doses against seasonal influenza were applied across the country. A total of 597 ETAV corresponding to the application of the anti-H1N1 and/or anti-seasonal influenza vaccine were reported. A total of 57 events considered serious were reported during the period analyzed. 48 cases could be linked with sanofi pasteur product (manufacturer unknown). All of these cases were linked with the case 2012-01002, considered as the case of reference. A 78-year-old female patient, with no medical history nor concomitant therapy reported, had received on an unspecified date her dose of vaccine against seasonal influenza (manufacturer unknown, batch number, number in series, route and site of administration not reported). The vaccine was without adjuvant. On an unspecified date, the patient developed pneumonia (reported as initial and final diagnosis). It was not specified if the patient was hospitalized. No corrective treatment was reported. The patient died on an unspecified date. This interval was reported as "7" (no unit reported). According to the author, the event was considered as "CNR" (coincidental not related). Documents held by sender: none.


VAERS ID: 448751 (history)  
Form: Version 1.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-02-01
Entered: 2012-02-03
   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: 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: No medical history reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201201143

Write-up: Case retrieved from the literature on 23 January 2012. Unique worldwide case ID: MX-SP-2012-01002. In a foreign country, the database corresponding to the events temporarily associated with vaccination (ETAV) associated with H1N1 and seasonal immunization reported between December 2009 and June 2010 was analyzed. Patients who displayed at least one ETAV after the administration of H1N1 vaccine and/or seasonal influenza vaccine were included. Cases were considered to be probable vaccine-related if they met the temporality criterion, i.e., appearance of the event within the 52 days after vaccination, including immediate hypersensitivity reactions. In terms of association and biological plausibility, a causal ETAV is the one that appears after the administration of the vaccine and requires demonstration through clinical, epidemiological and laboratory findings. It would imply that the vaccine caused the event directly and undoubtedly. When causality cannot be demonstrated, the event is defined as a coincidental ETAV, which refers to medical incidents that would have taken place in the same manner, with or without the application of the vaccine. During the study period, a total of 27,048,330 vaccine doses against H1N1 and 18,442,171 doses against seasonal influenza were applied across the country. A total of 597 ETAV corresponding to the application of the anti-H1N1 and/or anti-seasonal influenza vaccine were reported. A total of 57 events considered serious were reported during the period analyzed. 48 cases could be linked with sanofi pasteur product (manufacturer unknown). All of these cases were linked with the case 2012-01002, considered as the case of reference. A 60-year-old female patient, with no medical history nor concomitant therapy reported, had received on an unspecified date her dose of vaccine against seasonal influenza (manufacturer unknown, batch number, number in series, route and site of administration not reported). The vaccine was without adjuvant. On an unspecified date, the patient developed pneumonia (reported as initial diagnosis). The final diagnosis was not notified. It was not specified if the patient was hospitalized. No corrective treatment was reported. The patient died on an unspecified date. This interval was reported as "13" (no unit reported). According to the author, the event was considered as "CNR" (coincidental not related). Documents held by sender: none.


VAERS ID: 448912 (history)  
Form: Version 1.0  
Age: 8.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-02-01
Entered: 2012-02-06
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute myeloid leukaemia, Bicytopenia, Death, Intraventricular haemorrhage
SMQs:, Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Myelodysplastic syndrome (broad), Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No medical history reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201201042

Write-up: Case retrieved from the literature on 23 January 2012 dealing with 48 serious cases. The unique worldwide case ID is MX-SP-2012-01002. In a foreign country, the database corresponding to the events temporarily associated with vaccination (ETAV) associated with H1N1 and seasonal immunization reported between December 2009 and June 2010 was analyzed. Patients who displayed at least one ETAV after the administration of H1N1 vaccine and/or seasonal influenza vaccine were included. Cases were considered to be probable vaccine-related if they met the temporality criterion, i.e., appearance of the event within the 52 days after vaccination, including immediate hypersensitivity reactions. In terms of association and biological plausibility, a causal ETAV is the one that appears after the administration of the vaccine and requires demonstration through clinical, epidemiological and laboratory findings. It would imply that the vaccine caused the event directly and undoubtedly. When causality cannot be demonstrated, the event is defined as a coincidental ETAV, which refers to medical incidents that would have taken place in the same manner, with or without the application of the vaccine. During the study period, a total of 27,048,330 vaccine doses against H1N1 and 18,442,171 doses against seasonal influenza were applied across the country. A total of 597 ETAV corresponding to the application of the anti-H1N1 and/or anti-seasonal influenza vaccine were reported. A total of 57 events considered serious were reported during the period analyzed. 48 cases could be linked with sanofi pasteur product (manufacturer unknown). All of these cases were linked with the case 2012-01002, considered as the case of reference. An 08-year-old male patient, with no medical history nor concomitant therapy reported, had received on an unspecified date his dose of vaccine against H1N1 (manufacturer unknown, batch number, number in series, route and site of administration not reported). The vaccine was without adjuvant. On an unspecified date, the patient developed AML (Acute myeloblastic leukemia, type M2) (reported as final diagnosis), complicated by intraventricular hemorrhage. The initial diagnosis was bicytopenia. It was not specified if the patient was hospitalized. No corrective treatment was reported. The patient died on an unspecified date. Complications of the disease was considered the cause of death. This interval was reported as "1" (no unit reported). According to the author, the event was considered as "CNR" (coincidental not related). Documents held by sender: none.


VAERS ID: 449323 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-02-14
Entered: 2012-02-15
   Days after submission:1
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
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: No reported concomitant therapy; The patient had a medical history of Myasthenia Gravis
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201201396

Write-up: Case received from a Healthcare Professional on 30 January 2012 under the reference number MX-2012-001. A patient (initials, gender and date of birth unknown), with a medical history of myasthenia gravis and no reported concomitant therapy, had received a dose of influenza vaccine (manufacturer, batch number, route and site of administration unknown) on an unknown date. The patient died on an unspecified date. Corrective version created to add a source/reporter screen with health care professional as the source and physician as the qualification of the reporter in order that the box "health professional" is ticked on the CIOMS form.


VAERS ID: 449620 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-02-14
Entered: 2012-02-15
   Days after submission:1
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, Breast pain, Cough, Death, Decreased appetite, Dehydration, Hypotension, Hypothermia, Injection site pain, Pain, Pneumonia, Septic shock, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Toxic-septic shock conditions (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Lipodystrophy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (narrow), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-05-02
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: Unknown medical history and concomitant therapy
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201201655

Write-up: Case received from a Healthcare Professional via the local affiliate on 07 February 2012 under the reference number BR-BT2012-0352. A female patient (age not reported), with an unknown medical history and concomitant therapy, had received a dose of influenza vaccine (manufacturer, batch number, route and site of administration unknown) on an unspecified date. One day post-vaccination, the patient experienced lack of appetite, pain the body and pain at the injection site. On 29 April 2011, the patient had dehydration, hypotension, hypothermia, vomiting and weakness. She was taken to hospital and was treated with intravenous hydration and IM PLASIL. She was discharged from hospital on the same day. On 30 April 2011, the symptoms persisted and she developed cough and pain in breast. She was admitted to hospital on 30 April 2011. The patient died on 02 May 2011. The death diagnosis was septic shock and community-acquired pneumonia.


VAERS ID: 449803 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-02-10
Entered: 2012-02-17
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2012KR011042

Write-up: Case number PHHY2012KR011042, is an initial literature report received on 06 Feb 2012: The authors discussed about serious adverse events following receipt of trivalent inactivated influenza vaccine, between 2003 and 2010. This report refers to unknown age and gender patient. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on unspecified date (between 2003 and 2010). After vaccination, the patient experienced Guillain-Barre syndrome and died on unspecified date. The authors reported that the event was potentially associated (definite/probable/possible) to the influenza vaccination.


VAERS ID: 449804 (history)  
Form: Version 1.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-02-13
Entered: 2012-02-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: CD4 lymphocytes, CD8 lymphocytes, Cough, Cytomegalovirus test positive, Death, Dyspnoea, Epstein-Barr virus test positive, H1N1 influenza, Influenza virus test positive, Karnofsky scale, Lower respiratory tract infection, Mechanical ventilation, Polymerase chain reaction, Pyrexia, Rales, Respiratory failure, Rhinorrhoea, T-lymphocyte count, Upper respiratory tract infection, Vaccine virus shedding, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Hypokalaemia (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, 90 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prednisone
Current Illness: Acute myeloid leukaemia; Diabetes mellitus; Nephropathy; Lung disorder; Stem cell transplant; Graft versus host disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: CD4 lymphocytes, 121 micro liter, Baseline; CD8 lymphocytes, 691 micro liter, baseline; Karnofsky scale, 70, Significant; Viral test positive, H1N1 positive, Significant, Positive for H1N1. Co pathogens included CMV and EBV.
CDC Split Type: PHHY2012CH011571

Write-up: Case number PHHY2012CH011571 is an initial literature case received on 08 Feb 2012. Authors described the clinical features and outcome of H1N1 after allogenic hematopoietic stem cell transplant (allo-HSCT) patients who were vaccinated with seasonal/pandemic influenza vaccine. This case refers to a 40-year-old male patient with the history of acute myeloid leukemia, and was in complete remission. His medical history also included of diabetes, renal and pulmonary disease. He underwent allo-HSCT from a HLA identical sibling donor. He received a partial T-cell depleted transplant by myeloblative conditioning regimen. He was pretreated heavily before allo-HSCT as post-transplant maintenance therapy. He had GvHD and was receiving immunosuppressive drugs and prednisone equivalent 30mg/day. His Karnofsky score was at 70. His baseline CD3/CD4/CD8 cells were at 861/121/691 micro liters respectively. He had been vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on an unspecified date. He experienced fever, cough, rhinorrhea, and dyspnea on unspecified date. Abnormal physical findings included wheezes/rales on pulmonary auscultation. He also had upper and lower respiratory tract infections. Samples for H1N1 virus testing were taken that included nasopharyngeal swabs and broncho-alveolar lavage. The H1N1 virus was detected in samples using a real-time reverse transcription-PCR assay in accordance with the protocol from US Centers for Disease Control and Prevention. The patient was diagnosed with H1N1 infection. Co-pathogens included Cytomegalovirus and Epstein-Barr virus. These H1N1 virus isolates were analyzed to determine the presence of H275Y NA and the result was positive. He had symptomatic viral shedding for the period of 21 days. He was treated with oseltamivir at a dose of 75 mg twice daily. The patient developed an oseltamivir resistant strain, 7 days after oseltamivir initiation. He was then treated with intravenous ZANAMIVIR for twenty days. He was hospitalized for 90 days and was under mechanical ventilation for 70 days. He subsequently died of respiratory failure within 94 days of symptoms onset. Authors stated that close contact with children less than or equal to 12 years or adolescents in the previous 7 days was the most frequently suspected mode of transmission. In conclusion, although most allo-HSCT recipients had mild symptoms from H1N1 infection as does the general population, high immunosuppression and emergence of oseltamivir-resistant strains were responsible for a substantial number of deaths in the allo-HSCT setting. Complications included higher rates of LRTI, prolonged viral shedding and respiratory failure. This study strongly supports the need for vaccination and monitoring of family households, especially children.


VAERS ID: 459549 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-07-17
Entered: 2012-07-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Dementia, Influenza, Laziness, Nasopharyngitis, Pain
SMQs:, Dementia (narrow), Noninfectious encephalopathy/delirium (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: The patient''s ongoing illness, medical history, risk factors and concomitant vaccines or medications were unknown.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201206866

Write-up: Initial spontaneous serious adverse event report was received from a consumer on 10 July 2012 via social media, under the Local reference number BR-BT2012-0412. The reporter for this case also reported another adverse event, which is captured in case number 2012-06867. A female (patient age and birth date not reported, also reported as grandmother) received an injection of INFLUENZA VACCINE, manufacturer unknown, lot number unknown, (route, site, side and dose in series not reported) on an unspecified date (reported as unknown). On an unspecified date, the patient presented with symptoms of cold, flu, pain, lazy. After six years, the patient died with dementia problems. The patient''s ongoing illness, medical history, risk factors and concomitant vaccines or medications were unknown. The patient''s height and weight were unknown. Laboratory and diagnostic tests were reported as unknown. Treatments were reported as unknown. No additional information was provided. The patient''s outcome was reported as fatal. Documents held by sender: None.


VAERS ID: 459561 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-07-17
Entered: 2012-07-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Fatigue, Influenza, Nasopharyngitis, Pain, Renal disorder
SMQs:, 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: The patient''s ongoing illness, medical history, risk factors and concomitant vaccines or medications were unknown.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201206867

Write-up: Initial spontaneous serious adverse event report was received from a consumer on 10 July 2012 via social media, under the Local reference number BR-BT2012-0413. The reporter for this case also reported another adverse event, which is captured in case number 2012-06866. A male (patient age and birth not reported, also reported as grandmother) received an injection of INFLUENZA VACCINE, manufacturer unknown, lot number unknown, (route, site, side and dose in series not reported) on an unspecified date (reported as unknown). On an unspecified date, the patient presented with symptoms of cold, flu, pain, lazy. After six years, although reported in very good health condition, the patient developed kidney problems and died. The patient''s ongoing illness, medical history, risk factors and concomitant vaccines or medications were unknown. The patient''s height and weight were unknown. Laboratory and diagnostic tests were reported as unknown. Treatments were reported as unknown. No additional information was provided. The patient''s outcome was reported as fatal. Documents held by sender: None.


VAERS ID: 460365 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-07-26
Entered: 2012-07-27
   Days after submission:1
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, 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: The patient''s past medical history was unknown.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201207093

Write-up: Initial report was received on 23 July 2012 via the local affiliate under local reference number BR-BT2012-0422 which was describe in a lay media journal. An unidentified patient (gender and date of birth not reported) had received an Influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) and unspecified amount of time later developed an influenza virus A/H1N1 and died. According to the reporter, the event was serious due to death and other medically important event "suspect vaccine failure". No further information was available at the time of the report. The patient''s outcome was fatal. Documents held by sender: none.


VAERS ID: 461449 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-08-07
Entered: 2012-08-09
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / CSL LIMITED - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Vaccination failure
SMQs:, Lack of efficacy/effect (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: 2012032979

Write-up: This spontaneous consumer report (initial receipt: 02-AUG-2012) concerns a 65-year-old female patient. On an unknown date the patient received FLUVAX (batch number was not provided). It was reported that the patient died due to vaccination failure.


VAERS ID: 462459 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-08-10
Entered: 2012-08-20
   Days after submission:10
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, 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: Unknown
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201207585

Write-up: Initial report was received on 10 August 2012 from a health care professional via the local affiliate (local reference number BR-BT2012-0429) which involved a cluster of four unidentified patients. Four unidentified patients had received an Influenza vaccine (lot number unknown; manufacturer, route, site and date of administration not reported) and unspecified amount of time later, the patients presented with Influenza A/H1N1 and died. According to the reporter, they had four registered cases of death from influenza A/H1N1 in vaccinated patients. Concurrent illnesses, personal and family medical histories and corrective treatments were unknown. In addition to seriousness criteria of death, this case was also considered to as Other Medical Important - specify: suspected vaccine failure. Relationship was reported as unknown. No additional information was provided at the time of the report. Documents held by sender: None.


VAERS ID: 462460 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-08-17
Entered: 2012-08-20
   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: 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: 2012-07-18
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: The patient had no comorbidities.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201207591

Write-up: Initial report was received from a lay media journal report via the local affiliate under local reference number BR-BT2012-0428. A 68 year-old female who did not have any comorbidities had received an Influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) and unspecified amount of time later presented with Influenza A/H1N1 and died on 18 July 2012. According to the reporter, the event was considered serious - other medically important event: suspected vaccine failure. No laboratory or diagnostic tests were reported. No further information was available at the time of the report. The patient''s outcome was fatal. Documents held by sender: None.


VAERS ID: 462461 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2011-10-01
Onset:0000-00-00
Submitted: 2012-08-17
Entered: 2012-08-20
   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: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unspecified major chronic conditions.
Allergies:
Diagnostic Lab Data: A number of cases were selected for swabbing from each outbreak according to different criteria: a random sample of influenza like illness (ILI), hospitalised patients or all ILI cases. Nasopharyngeal swabs were tested for detection of influenza virus by real time reverse transcription polymerase chain reaction (RT-PCR) and cell culture using a Madin-Darby canine kidney (MDCK) cell line. Isolates were sent to the National Reference Centre, National Center for Microbiology, for influenza genotyping.
CDC Split Type: E201205224

Write-up: Case of vaccination failure retrieved from a literature search performed on 07-AUG-2012. Case medically confirmed. In the 2011/2012 season, three influenza outbreaks were studied in nursing homes with high vaccination coverage. Attack rates ranged from 2.9% to 67%. Influenza A/18/2011 (H3N2) virus strain was isolated from the three outbreaks. According to the article, all three nursing homes had carried out an influenza vaccination campaign in OCT-2011 (trade name, batch number, route and site of administration not reported), reaching coverage from 82% to 97%. Problems concerning the vaccine lot, its conservation or administration were ruled out. A number of cases were selected for swabbing from each outbreak according to different criteria: a random sample of influenza like illness (ILI), hospitalised patients or all ILI cases. Nasopharyngeal swabs were tested for detection of influenza virus by real time reverse transcription polymerase chain reaction (RT-PCR) and cell culture using a Madin-Darby canine kidney (MDCK) cell line. Isolates were sent to the National Reference Centre, National Center for Microbiology, for influenza genotyping. The influenza outbreaks occurred between week 4 and week 8 of 2012, coinciding with the epidemic wave in the region. Influenza virus A (H3N2) was identified in all the three outbreaks, and the genotyped strains were characterised as A/18/2011 (H3N2), coinciding with the strain most frequently found in the non-institutionalised population during this season. The attack rates were much higher in nursing homes (range 2.9% to 67%) than those in the general population aged 65 and over (0.9%). The attack rates in vaccinated persons ranged between 2.6% and 66%. The attack rates did not differ significantly between vaccinated and non-vaccinated persons in any of the nursing homes. During the outbreak investigation 57 ILI patients were detected with vaccine failure, 13 of whom had laboratory-confirmed influenza. In vaccinated persons, the time between vaccination and onset of ILI symptoms ranged between 92 and 142 days. Overall, 5% of the ILI cases (3/63) in the three nursing homes required hospitalisation, and death occurred in 3% of those affected (2/63), all of them in vaccinated persons with previous major chronic conditions. The results may indicate insufficient vaccine effectiveness to contain the spread of the influenza virus in nursing homes during this season. A recent study has reported moderate vaccine effectiveness in the 2011/12 season and suggests a limited match between vaccine and circulating influenza viruses. Some limitations should be acknowledged in the study of these outbreaks. Information on ILI cases and vaccination status among nursing homes'' workers and frequent visitors was not systemically collected. The design and the size of the study were not adequate to obtain estimates of the vaccine effectiveness. However, the high attack rate in vaccinated persons and the number of vaccine failure suggest reduced vaccine protection in these nursing home. In conclusion, influenza vaccination should be complemented with other hygiene measures in institutionalised settings.


VAERS ID: 469972 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-10-15
Entered: 2012-10-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Death, Infection
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: PHHY2012KR090553

Write-up: Case number PHHY2012KR090553 is an initial literature report received on 10 Oct 2012. The author discussed a study which presented the retrospective review of data from the foreign Centers for Disease Control and Prevention adverse events following immunization surveillance system and vaccine compensation programs and assessed cases of sudden death in the first 2 years of life following immunization that were reported between 1994 and 2011 using standardized assessment by the Brighton collaboration. This report refers to a child whose age was not reported. The patient''s medical history and concomitant medications were not reported. The patient was vaccinated with pandemic influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date, the patient experienced infectious disease and died. The literature stated that the event could be meningitis, encephalitis, bacterial sepsis, myocarditis, gastroenteritis or pneumonia. The author stated that although most of the cases identified in the study might be coincidental, continuing surveillance and thorough investigation were needed for more definitive assessment of the safety of immunization and its potential association to the infant mortality. The author concluded the article that the study data did not support the epidemiologic studies necessary to determine whether a causal association existed between immunization and adverse events following immunization (AEFI) and it did not provide important information in the causative role of vaccination and sudden death in the vaccinees in the first two years of life.


VAERS ID: 470046 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-10-15
Entered: 2012-10-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Death, Injury
SMQs:, Accidents and injuries (narrow), Hostility/aggression (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2012KR090547

Write-up: Case number PHHY2012KR090547 is an initial literature report received on 10 Oct 2012. The author discussed a study which presented the retrospective review of data from the foreign centers for disease control and prevention adverse events following immunization surveillance system and vaccine compensation programs and assessed cases of sudden death in the first 2 years of life following immunization that were reported between 1994 and 2011 using standardized assessment by the Brighton collaboration. This report refers to a child whose age was not reported. The patient''s medical history and concomitant medications were not reported. The patient was vaccinated with H1N1 (manufacturer and batch number: not reported) on an unknown date. On an unknown date, the patient experienced accidental injury and died. The literature stated that the event could be asphyxia, subdural hematoma or an unspecified traumatic injury. The author stated that although most of the cases identified in the study might be coincidental, continuing surveillance and thorough investigation were needed for more definitive assessment of the safety of immunization and its potential association to the infant mortality. The author concluded the article that the study data did not support the epidemiologic studies necessary to determine whether a causal association existed between immunization and adverse events following immunization (AEFI) and it did not provide important information on the causative role of vaccination and sudden death in the vaccinees in the first two years of life.


VAERS ID: 471214 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-10-23
Entered: 2012-10-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, 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: The patient''s ongoing illness, medical history, risk factors and concomitant vaccines or medications were reported as unknown. History of adverse event to previous administration of vaccine or drug was reported as unknown. (According to the news, the patient was part of priority groups for vaccination, because of presented risk factors such as lung disease, obesity, diabetes or heart disease for example. It was not specified the risk factor of each patient).
Allergies:
Diagnostic Lab Data: Unknown.
CDC Split Type: 201209627

Write-up: Initial report was received from a consumer collected through lay media via the local affiliate on 15 October 2012, providing information of two vaccinated patients who died with suspect of influenza A/H1N1. The reporter for this case is also the same reporter (same vaccine, manufacturer unknown, and same adverse events) for case number 2012-09628. An unknown patient (gender, age, birth date not reported) received an injection of influenza vaccine, manufacturer unknown, (lot number unknown and route, site, side and dose in series not reported) on an unspecified unknown date. On an unknown date, the patient died with suspect of influenza A/H1N1. There was no information available about the patient, nor the details of vaccination, but according to the news, the patient was part of priority groups for vaccination, because of presented risk factors such as lung disease, obesity, diabetes or heart disease for example. It was not specified the risk factor for the patient. The patient''s ongoing illness, medical history, risk factors and concomitant vaccines or medications were reported as unknown. History of adverse event to previous administration of vaccine or drug was reported as unknown. Laboratory or diagnostic testing and corrective treatments were reported as unknown. It was unknown if the patient was hospitalized. No additional information was available at the time of the report. The patient''s outcome was reported as fatal. Documents held by sender: None.


VAERS ID: 471216 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-10-23
Entered: 2012-10-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, 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: The patient''s ongoing illness, medical history, risk factors and concomitant vaccines or medications were reported as unknown. History of adverse event to previous administration of vaccine or drug was reported as unknown. (According to the news, the patient was part of priority groups for vaccination, because of presented risk factors such as lung disease, obesity, diabetes or heart disease for example. It was not specified the risk factor of each patient).
Allergies:
Diagnostic Lab Data: Unknown.
CDC Split Type: 201209628

Write-up: Initial report was received from a consumer collected through lay media via the local affiliate on 15 October 2012, providing information of two vaccinated patients who dies with suspect of influenza A/H1N1. The reporter for this case is also the same reporter (same vaccine, manufacturer unknown, and same adverse events) for case number 2012-09627. An unknown patient (gender, age, birth date not reported) received an injection of influenza vaccine, manufacturer unknown, (lot number unknown and route, site, side and dose in series not reported) on an unspecified unknown date. On an unknown date, the patient died with suspect of influenza A/H1N1. There was no information available about the patient, nor the details of vaccination, but according to the news, the patient was part of priority groups for vaccination, because of presented risk factors such as lung disease, obesity, diabetes or heart disease for example. It was not specified the risk factor for the patient. The patient''s ongoing illness, medical history, risk factors and concomitant vaccines or medications were reported as unknown. History of adverse event to previous administration of vaccine or drug was reported as unknown. Laboratory or diagnostic testing and corrective treatments were reported as unknown. It was unknown if the patient was hospitalized. No additional information was available at the time of the report. The patient''s outcome was reported as fatal. Documents held by sender: None.


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